Instruction Manual SUPER GL2
Contents
1. 04 Operation Part 2 Display supplies In the display are shown following data Supplies SUPER GL ok Cups XXXX Buffer XXXX ml Samples XXXXXX Maintenance XX XX XX Maintenance samples XXXXXXX samples until next maintenance Adjust bubble detector Diode Empf Diff Schw XXX XXX By touching the key Repeat an automatically incident for new adjusting the sensitivity starts After this incident the display shows Diode Empf Diff Schw XXX XX XXX XXX and a additional button Save If there is a big difference between the data of the both upper lines we recommend repeating this incident With the button Save the actual values will be saved to adjust the bubble detector in the best Way 5 3 3 3 Read key card Enables you to read the inserted key card Supplies of system solution and or sample cups are electronically stored on the key card The key card thus guarantees the operation of the entire system device and consumption materials to insure the analysis quality A key card is included with every package of haemolysing system solution or pre filled sample cups By reading the key card the supply of haemolysing system solution or pre filled sample cups within the device is increased When the supply is exhausted the device reports Please read key card To read the key card insert it into the reading device on the front panel 5 3 3 4 Service For trained service personnel only Description is in the servi2. 6 3 1 Browse menus and set numerical values by touching the respective areas Please note that dark shaped areas describe the status OFF or INACTIVE but light shaped areas describe the status ON or ACTIVE While operating SUPER GL 2 you have to note that there are some menu points functions which you need for day to day operation and there are also some you only need in service cases The functions of day to day operation you could use without any special identification and they are changeable The service function only should used by special trained personnel because of it is protected by a keyword ATTENTION If there are not authorized contacts in protected areas the manufacturer assumes no liability for wrong measurement results The following page shows the menu structure of SUPER GL 2 If you ve got more questions please ask the manufacturer or your distribution partner 28 01 2010 Page 21 of 45 Rev 03 O eration Part 1 STAND BY START MENUE program E Adjust Controls Methods f Functions Select Print Program E Plasma ref glucose on off In E Actions E Read KeyCard Service Barcode on off User ID calibration stable Autocalibration Calibration start Calibration Memory of show results delete Fig 4 3 Main program branches 15 03 2010 Page 22 of 45 STAT Names of Controls Limits of glucose Limits of lactate measurement Memory of co
3. Place the device on a horizontal smooth and dry surface Please choose a location where the device is protected from direct sunlight and extreme variations in temperature since these can impair measuring results Requirements on the set up location no direct humidity influence no direct sunlight no strong electromagnetic fields or ionizing radiation no rapid changes in temperature because of windows doors air conditioning etc level water proof support clearance over the entire footprint Connecting the device to the power supply Please make sure that the voltage noted on the power adapter is the same as the voltage of your power grid The device is connected to the power supply via the included power supply adapter Connect the power supply cable to the power supply adapter Plug one end of the power supply adapter into the power connector at the right side of the device see fig 4 1 and the other end into the socket Connecting the printer Please make sure that the voltage noted on the power adapter is the same as the voltage of your power grid The printer is supplied with power via the second connection of the line cord The jack of the printer cable is inserted into the printer interface on the right hand panel of the device s casing s fig 4 1 and connected to the corresponding interface on the back panel of the printer Connecting EDP s fig 4 1 Plug the EDP cable into the EDP port at the right
4. START on the TOUCH SCREEN To measure a STAT sample e Press STAT on the TOUCH SCREEN in Stand by mode or while measuring a sample series To start a control sample series proceed as follows e Only the occupied control positions are measured no samples e Press the following areas on the TOUCH SCREEN in Stand by mode MENU gt CONTROLS gt MEASURING Prior to each of these measuring regimes a calibration is carried out unless a different calibration option was chosen Other calibration options are enabled and explained by service personnel upon customer request 4 6 2 Chain operation The determination of quick and control samples is carried out as described in 4 6 1 To start a sample series proceed as follows see 5 3 2 1 e Switch on chain operation Methods Adjust Count e Place sample cups on the sample plate Chain operation is characterized by stopping the series at the first unoccupied position You then have three ways to continue measuring samples e Sample button Measuring of the series is continued at the position flashing in the Sample area e New plate button Measuring of the series is continued at position 1 on the plate The counting of the sequential numbers numbers within the series is continued with the next higher sequential number e New series button Measuring of the series is continued at position 1 on the plate Counting of the sequential numbers is restarted with number 1 02
5. a STAT sample very quick The results of measurement will be showed at the Touch screen and will printed out or they could be sent to EDP There is also the possibility to measure the samples with a barcode for a better management by EDP For further information on measuring principle and sample taking please refer to the appropriate chapters 02 11 2009 Page 9 of 45 Rev 02 Introduction 1 3 Indication Contraindication Indication The SUPER GL 2 analyser is used for measuring of glucose and or lactate in human sample material Suitable sample material e capillary or venous or arterial blood serum plasma cerebro spinal fluid for more materials ask the manufacturer The sample may contain the following anticoagulants glycolysis blockers heparin citrate fluoride EDTA The SUPER GL2 analyser must only be used and operated by trained personnel Contraindication Using unsuitable sample material can result in faulty measuring results If in doubt call the manufacturer Operating the device for home testing is expressly forbidden 1 4 Manufacturer s liability Legal liability and warranty claims are expressly excluded in the following cases gross negligence or wilful damage of the device parts thereof or consumption material unauthorized opening of the device by untrained personnel without proper service training force majeure e g stroke of lightning water damage fire nonobservance of user manu
6. chemical laboratories The compliance with the valid norms and statutes is documented through the visibly attached CE Label The CE Label signifies compliance with all pertaining laws and regulations and consequently safety and confidence By employing an altogether newly developed technology for the determination of glucose and lactate it is possible to fulfil all requirements of quality assurance e g RiliBak Guidelines of the Federal General Medical Council for Quality Assurance in Medical Laboratories in medical laboratories while maintaining easy handling and minimum operating effort All users are thus able to achieve analysis results that meet the quality demands 02 11 2009 Page 7 of 45 Rev 03 Introduction 1 2 2 Declaration of compliance EU Declaration ot Contormity The device fulfils the requirements of the following EU norms and guidelines We do not guarantee the fulfilment of these norms and guidlines after unauthorized name Analyzer SUPER GL 2 Dr M ller Ger tebau GmbH Burgker Str T 33 D O 708 Fre eital modificotion of the device following standards and guidlines DIN EN 61326 DIN EN 61010 1 DIN EN 61010 2 081 DIN EN 61010 2 10 Electrical equipment for measurement control and laboratory use EMC requirements Part 1 general requirements Safety requirements for electrical equipment for measurement control and laboratory use Part 1 General requirements Sa
7. 0 Page 31 of 45 Rev 04 Operation Part 2 5 3 3 Functions 5 3 3 1 Adjust Time Setting of the time in form HH MM Set date A changing of the date normally isn t possible Dialog language Currently are following dialog languages possible German English Czech and Russian More languages are possible after request In this menu you also can choose the printing form of date and time EDP interface parameters Enables configuration of the EDP interface This should only be done with competent consultation 5 3 3 2 Actions Rinsing of the system By the help of a pump solution will be pumped through the system from the suction hose in a defined time This can be system solution or another solution i e for disinfection In this case the sensor will be destroyed Emptying By the help of the pump the system will be emptied In this case the suction hose should be outside the bottle with system solution Changing allotment device see maintenance Moves the plunger in a position for changing Display sensor Shows the currently programmed data of the sensor In the display are shown following data Sensor Super GL ok Samples XXXX Days XX Method example 3 5 14 3 12 The digits means in the sequence method number optional reinforcing glucose maximum reinforcing glucose optional reinforcing lactate maximum reinforcing lactate Expiry Month Year Life time Month Activation Date 15 03 2010 Page 32 of 45 Rev
8. 11 2009 Page 25 of 45 Rev 02 Operation Part 1 To measure a quick sample press STAT on the TOUCH SCREEN in Stand by mode or while measuring a sample series To start a control sample series i e only the occupied control positions are measured no samples successively press the following areas on the TOUCH SCREEN in Stand by mode MENU gt CONTROLS gt MEASURING Chain operation is only recommended with an auto calibration type For more information see chapter 4 6 3 Explanation to measuring value memory By choosing this menu item the measured rotor series will be shown By choosing the menu item values the single values of the dark shaped rotor batch will be shown Printing out and sending values to EDP are also possible in this mode either the dark shaped batch or the dark shaped value Explanation to control value memory By choosing this menu item the measured controls will be shown By pressing the button Ko1 Ko2 Ko3 you will see the values for control 1 2 or 3 or you will print them out It will be printed the values from the dark shaped are up to the actual control value every time 4 6 3 Calibration To guarantee correct measuring results the SUPER GL 2 needs a valid calibration So the device calibrates for each option of measurement automatically To customer request our service will activate also other calibration options In this case following areas are available By pressing menu item Calibrati
9. 30 mmol l 4 5 270 mg dl Amount of sample material 10 20 ul sample diluted with 500 1000 ul heamolysate system solution Precision 20 samples Glucose 216 mg dl lt 1 5 Lactate 90 mo dl lt 2 0 Storage period of sensor 12 month Storage temperature of sensor 2 C up to 8 C Life time of sensor 1 month guarantee 2 months poss Interfaces Printer V 24 EDP V 24 eee G 3 MERE 57225 C s dL Approx 12 W x j C 22 NN NN LLL a O C MN Approx 9 kg MEE G C 5 3 Manufacturer Dr M ller Geratebau GmbH Burgker Str 133 01705 Freital Fig 7 1 List of Technical data 15 03 2010 Page 45 of 45 Rev 04
10. Error messages Troubleshooting 6 4 1 Warnings Before printing the measured results the device checks whether set warning limits have been exceeded The sample warning limits chapter 5 are relevant for the determination of patients samples control limits chapter 5 are relevant for the determination of control samples The following warning are displayed and printed Explanation Values above measuring range limit Values below measuring range limit Previous control measurement outside the control limits and below or above the sample warning Below or above the sample warning or control limits 6 4 2 Errors while measuring Measuring value defective only Measuring signal is loaded with an interference version glucose signal which is more than 70 of the measuring signal The interference signal is compensated but measuring value is less precise than a non disturbed signal versions plausible repeat measuring Zero line instable appears incidentally gt repeat incident changing reagent gt choose Washing system obstructed gt rinsing by hand Sensor defective gt change sensor electronic error gt call service Calibration value to low choosing wrong cup Sensor defective gt change sensor electronic error gt call service Calibration drift to high Appears incidentally gt calibrate new Rapid change of temperature gt calibrate new System obstructed gt rinsing by hand Sensor defective g
11. Instruction Manual SUPER GL 2 Valid for Version 10 9 Effective from March 2010 Manufacturer Copyright Dr M ller Geratebau GmbH Burgker Str 133 D 01705 Freital Distributor Service Hotline Monday Friday from 7 a m until 6 p m If you have any questions concerning our products or would like to place an order please contact 49 0 351 649 12 93 49 0 351 64 50 42 Or contact us via Fax 49 0 351 649 15 04 Email support glukose de or info glukose de You will find the current version of this manual on our website www glukose de 15 03 2010 Page 1 of 45 Rev 04 Table of contents A Table of contents Page Rev A Table of contents c L PEE 03 Bo lt lt lt Table of figures 2a 4 _ 05 CMM Table of symbols sss o RENE 02 1 _ Preface 6 02 Ef Introduction L D erri 02 1 2 o The SUPERGW2 ss 6 02 1 2 1 Basics eee rRNA 03 12 2 Declaration of compliance L 8 _ 02 i E Device and accessories 9 02 1 2 4 Overview of functionality 9 02 1 3 Indication Contraindication 10 02 1 4 Manufacturer s liability aa 10 02 is NR Warranty LLL 10 02 2 ler zoo Sea AS SS SS sS S sss Jl 02 Zl Introduction 0 00000 00000 0 0 0 0 0 0 0 11 02 2 2 _ Responsibility Training the operator 11 o 02 2 39 corner General safety instructions 11 J 02 2 4 Product specific safe
12. able of figures Overall view SUPERGI2 J Fig 1 1 6 02 Declaration of compliance Fig 1 2 8 02 View device Fig 1 3 9 02 Accessories usura eur rur rur per rer ap pcr ed Fig 1 4 9 02 Flow schema L Fig S 1 a 14 02 Diagram of measuring principle only glucose Fig 3 2 14 02 Diagram of measuring principle glucose lactate Fig 3 3 15 ee 02 Overall view SUPERGI2 Fig 3 4 16 02 Accessories 00 0 0 0 0000 00 0 0 0 0 0 0 0 0 0 0 Fig 3 4 16 02 Connections SUPERGI2 Fig 4 1 20 03 Touch Screen 0 0 0 Fig 4 2 21 03 Main program branches L Fig 4 3 P P NE 03 Sample preparation using open end capillary Fig 4 4 24 02 View washing container 1 Fig 6 1 37 04 View sample canula u u ur do l aa Fig 6 2 37 04 Sensor holder dosed Fig 6 3 38 04 Sensor holder open aaa Fig 604 38 04 View supply and waste container Fig 6 5 39 03 Table of errors during measuring sisi i Fig 6 6 40 03 List of technical data Fig 7 1 34 02 15 03 2010 Page 4 of 45 Rev 05 Table of symbols C Table of symbols Symbols on device Symbol Follow instruction manual In vitro Diagnostica CE Compliance serial number Symbols on consumptions materials Contents of package LOT Batch number F Symbols in instruction manual Symbol Ba
13. al and package inserts 1 5 Warranty For their products Dr Muller Geratebau GmbH gives a two year warranty according to EU Directive 1999 44 EG starting with the day of purchase Consumption material because of shorter shelf life and parts subject to wear they should be replaced on a yearly basis are expressly excluded from this warranty For further information on spare parts and consumption material please refer to the appropriate chapter 02 11 2009 Page 10 of 45 Rev 02 Safety 2 Safety 2 1 Introduction The following chapters concern the safety of the person operating the device Read these chapters carefully PRIOR to starting up the device because they contain general safety warnings warnings concerning the personal safety of the person operating the device and warnings for the protection of the device Displaying the following safety warnings does not release the person operating the device from adhering to the safety measures of the facility 2 2 Responsibility Training of the operator The SUPER GL2 analyser must only be used and operated by trained personnel An employee of the manufacturer or of an authorized distributor will introduce the operation of the device Every user is responsible for adhering to safety health and legal regulations and operating the device only according to its intended use Interpreting the results and diagnosing on that basis must be left to a medical practitioner Op
14. c MO ME OB 5 uuu x ee eee x Zx zx zy 2 ee 2 2 Z 2 2 2 2 2 2 22 cn 04 5 3 2 3 Print 9 9 9 9 9 9 99 99 99 5slhhy LLL Cn E 04 5 3 2 4 Programming 31 04 5 3 2 5 Plasma reference glucose sss L 31 _ 04 cono ee Functions eee 32 04 Doo e il o cur uttter tetur aaa aulas ha ha a aar t o 32 04 5 3 3 2 Actions 9 9 9 9 9 9 9 9 999995 uu Cy MEN 04 5 3 3 3 Read key card LL LL CC ee 04 5 3 3 4 Service 5 9 9 9 9 9 9 LLL So NEN 03 5 3 3 5 Barcode on off 34 _ 03 59 9 9365 USF dB s eee mea e d 34 1 03 oho AG rer Measuring value memory 34 _ 03 5 3 4 Available cards i i unra z uuu Ci NE 04 6 Maintenance and troubleshooting 36 0 02 s ME Introduction nuna aun 365 e 02 6 2 uc Maintenance 9 unra au 30 02 6 3 Servicing U uuu u uu a aa ci ate 02 6 3 1 Cleaning and disinfection aa 36 0 02 6 3 2 Exchange of piston cylinder system cy ox 03 6 39 39 ee Exchange of canula and washing chamber SP PER 03 6 3 4 Exchange of sensor SO xa 04 6 9 5 Exchange of supply and waste container SO ec 03 6 3 6 Switching off the device 40 02 6 4 Error Messages Troubleshooting as 4l 02 6 4 1 Warnings MN ERE a 41 _ 02 6 4 2 Errors while measuring e 41 03 6 4 3 Mechanical errors S a a 42 _ oot 02 6 4 4 Measuring errors 43 02 7 Technical data 45 03 15 03 2010 Page 3 of 45 Rev 05 Table of figures B T
15. case of malfunctions stop operating the device immediately Prior to continuing to operate the device read the notes concerning cleaning error messages and troubleshooting After consulting the manufacturer or authorized distributor you may ship the device for repairs to the manufacturer or authorized distributor Use only original accessories and spare parts to avoid damage to device and people Repairs must only be conducted by the manufacturer or by companies authorized by the manufacturer The use of reagents and consumption materials that are not expressly recommended by the manufacturer can cause severe measuring errors and malfunctions and is therefore not permissible If the user opens the device without authorization the user shall not be entitled to any rights concerning the liability for the device and damages caused thereby Maintenance intervals The SUPER GL 2 needs maintenance once a year by trained personnel The touch screen will print out a message after expiration of the maintenance rate Without regular maintenance false measuring results can occur that are not the responsibility of the manufacturer For further information please refer to the chapter Maintenance Troubleshooting 02 11 2009 Page 12 of 45 Rev 02 Description of the analyser 3 Description of analyser 3 1 Introduction This chapter describes the analyser s measuring principle layout and accessories and the consumption material This c
16. ce manual 15 03 2010 Page 33 of 45 Rev 03 Operation Part 2 5 3 3 5 Barcode on off This function determines separately for control quick and normal samples whether the bar codes on the cups are read or not To switch touch the button Button dark Button light bar code is not read bar code is read Note The bar code reader is always active since it also serves to recognize occupied positions on the sample plate If you want to use the bar code scanner to identify samples please note the following e max bar code length 12 characters e attach the bar code label to the marking on the sample cup e the bar codes must be facing to the outside of the sample plate e the device s operation is limited productivity wise if sample cups without bar code labels are used while the bar code scanner is active Note It is possible to improve the readability of particular bar codes by special configuration In this case please contact the manufacturer or service 5 3 3 6 User ID Enter a number for the operator using the device 5 3 4 Measuring value memory The measuring value memory is a ring buffer The most recent measuring values approx 500 values for one method by only using glucose 250 values each by using both methods simultaneous are stored As soon as the buffer is full the oldest values are deleted The measuring value memory can be deleted manually The stored values can be e displayed e Sent repeatedl
17. change the containers only in stand by mode and when the washing container and the sample canula are installed The changing of these bottles should be done in a short time because of washing the system there will be a little bit solution left from time to time Furthermore the supply container that was last emptied should be used as a waste container because the repeated use of containers could affect the function of the level sensor fig 6 5 view of supply and waste container Removal of Supply and Waste Container 1 Open the device cover 2 Remove the canula 3 Remove the containers supply left waste right Insertion of Supply and Waste Container 1 If necessary open the device cover 2 Insert the containers supply left waste right 3 Open the containers and insert the canula 4 Close the device cover 15 03 2010 Page 39 of 45 Rev 03 Maintenance and troubleshooting 6 3 6 Switching of the device To switch off the device for a longer period of time or for transport proceed as follows 1 Rinse the device 2 Empty the system by removing the hose from the supply bottle and push the bottom Emptying 3 Switch off the device and disconnect Please store all consumables as written at the packages Disposing of the device For the disposal of devices manufactured after April 2006 customers in Germany should contact the manufacturer 15 03 2010 Page 40 of 45 Rev 03 Maintenance and troubleshooting 6 4
18. erating the device for home testing is expressly forbidden 2 3 General safety instructions Prior to operating the device read the entire instruction manual especially the instructions for sample taking If you have any questions please contact the manufacturer or authorized distributor Every person working with the device must be acquainted with the relevant safety rules prior to operating the device and these rules should be kept at hand all the time Please pay attention to all general safety rules for laboratories such as wearing protective gloves and the applicable disinfection and hygiene regulations 02 11 2009 Page 11 of 45 Rev 02 Safety 2 4 2 5 To avoid risk of electric shock do not place the device or power supply in water or other liquids If the cable or the power supply adapter is damaged in any way you must not continue using the power supply Never touch the plug of the power supply adapter with wet hands The power supply adapter must only be used indoors and must be protected from humidity Product specific safety instructions The device may only be used for the intended use with special attention to the defined usage restrictions and constraints that have to be strictly adhered to if need be contact the manufacturer Operate the device only on smooth horizontal surfaces Avoid variations in temperature drafts direct sun light and vibrations These can result in faulty measuring values In
19. fety requirements for electrical equipment for measurement control and laboratory use Part 2 081 Particular requirements for automatic and semi automatic laboratory equipment and other purposes Safety requirements for electrical equipment for measurement control and laboratory use Part 2 101 Particular requirements for in vitro diagnostics IVD medical equipment In vitro diagnostics The CE mark was fixed to the device Valid from SUPER GI2 SN 1011 Freital 01 06 2009 n G AL Company Manager Ralf G nther Fig 1 2 Declaration of compliance 02 11 2009 Page 8 of 45 s amp Pa W ISO 13485 m o 2002 03 2002 08 2004 07 2003 09 1998 10 Lt Company Manager Martin Sch fer Rev 02 Introduction 1 2 3 Device and accessories Deliverables Designation uantit SUPER GL 2 Sample rotor Power connection cable Power supply adapter for device and printer Printer DPU 414 Printer cable Instruction manual PB Optional EDP cable 1 Other sample rotors 1 printer DPU 414 power supply unit V EDP coble printer coble Fig 1 3 View device Fig 1 4 Accessories 1 2 4 Overview of functionality The SUPER GL 2 analyser is an automatic analyser for the determination of glucose and or lactate in prediluted samples at a ratio of 1 50 i e in hemolysed blood samples The device measures series up to 30 patient samples and has the possibility to measure
20. g the device to guarantee correct and faultless operation The device must only be used for the described indication and must only be used and operated by trained personnel Every user is responsible for adhering to safety health and legal regulations and operating the device only according to its intended use Interpreting the results and diagnosing on that basis must be left to a medical practitioner Operating the device for home testing is expressly forbidden In daily operation regular checks of the results should be made if needed an additional control measurement should be carried out Do not switch off the device or disconnect it from the power supply while it is running If this happens malfunctions can occur the next time the device is switched on If you suspect a malfunction or faulty measuring results please inform the person responsible for the device immediately If necessary this person will contact the manufacturer or distributer to solve the problem 02 11 2009 Page 18 of 45 Rev 02 Operation Part 1 4 3 Installing the device Before start up check the supplied device and accessories for completeness referring to the list under 3 4 If anything is missing please contact your supplier immediately Furthermore please check all parts for intactness Proper and safe operation is only guaranteed when using original parts and accessories NEVER use damaged parts or parts from other manufacturers
21. hapter will provide you with forward information For detailed instructions and descriptions of the device please refer to chapter Operation 3 2 Intended use The SUPER GL 2 analyser is an automatic analyzer for the determination of glucose and or lactate in prediluted samples at a ratio of 1 50 i e in haemolysed blood samples Suitable sample material e capillary or venous or arterial blood serum plasma cerebro spinal fluid for more materials ask the manufacturer The sample may contain the following anticoagulants glycolysis blockers heparin citrate fluoride EDTA When using non stabilized sample material time between taking the sample and stabilizing it with glucose system solution should not exceed 15 minutes The sample material is taken out of closed sample cups that are placed on a sample rotor The containers for the washing and waste solution are located inside the device Both containers must be replaced at the same time since they are adjusted to each other The device has the following features Determination of glucose and or lactate using the enzymatic amperometric measuring principle Automatic STAT sample measurement or sample series measurement up to 30 samples automatic detecting the barcode also for STAT sample automatic calibration before every series or STAT sample serial printer interface programmable EDP interface 02 11 2009 Page 13 of 45 Rev 02 Description of the anal
22. hing container and attach it to the provided connector Loosen the screw of the sample canula and pull the canula out of the washing container Place the sample canula in a glass Fill the syringe with distilled water or system solution and press the water from the hose toward the sample canula The liquid should come out of the canula If it does not clean the canula with a cleaning wire and or exchange the sensor e The syringe can be moved evenly but with resistance and the liquid flows back and forth inside the hose In this case the error of the device is inside the housing and the device needs to be serviced With these simple measures most problems in the flow system can be solved The problems can result in the following Scattering measuring values Could also be a result of incorrect sample preparation Check by measuring a standard cup several times A defect sensor could also be the cause Calibration is not stable drift too high Could be caused by extreme temperature variations e g direct sun Calibration not possible value too low A defective insensitive sensor could also be the cause Frequent occurrence of the error margin maximum 02 11 2009 Page 44 of 45 Rev 02 Technical data 7 Technical data Measuring time per sample Single sample 45 sec Series only glucose approx 20 sec Series glucose lactate approx 20 sec O Measuring range Glucose 0 8 50 mmol l 11 910 mg dl Lactate 0 5
23. ician Please contact our service hotline free of charge 6 2 Maintenance The SUPER GL 2 needs maintenance once a year by trained personnel The touch screen will print out a message after expiration of the maintenance rate Please contact the manufacturer or distributor immediately to make an appointment for service 6 3 Servicing The following operations can and should be carried out by the operator These actions are part of diligent care and serve to enhance the device s life span They are NOT maintenance or service work these may only be carried out by authorized service personnel 6 3 1 Cleaning and disinfection Please adhere to the regulations valid in your laboratory with regard to cleaning and disinfecting the device For disinfection wipe the entire accessible surface of the device with a cloth containing disinfectant Use a disinfectant for surface disinfection Also note the instructions of the manufacturer of the disinfectant 02 11 2009 Page 36 of 45 Rev 02 Maintenance and troubleshooting 6 3 2 Exchange of piston cylinder system For changing the piston cylinder system proceed as follows the in the order specified Choose at the touch screen menu gt functions gt actions gt change dosage The plunger moves into a position for changing Turn off the device Open the device s back panel Screw off the piston cylinder system from the valve block Remove piston cylinder system by folding ou
24. nd if necessary s Ww circulation enhancing measures such as lotions and massaging the spot to yield a sufficient sample amount On the following page taking capillary blood using open end capillaries is described and shown Proceed likewise with an end to end capillary 02 11 2009 Page 23 of 45 Rev 02 Operation Part 1 Taking capillary blood from the earlobe or the finger pad and filling the capillary over both markings Make sure it is properly filled sufficient amount of blood no air bubbles no drops of blood at the end of the capillary etc Carefully wipe off the outer surface of the capillary Break the capillary at the predetermined breaking point predetermined breaking point is located in the middle between two markings Insert the completely filled capillary into the pre filled sample cup Shake sample cup until the blood has completely left the capillary Fig 4 4 Sample preparation using open end capillary 02 11 2009 Page 24 of 45 Rev 02 Operation Part 1 4 6 Measuring 4 6 1 Rotor operation The SUPER GL 2 allows for measurements in two modes of operation e Determination of quick and control samples e Determination of a sample series To start a sample series proceed as follows e Place sample cups on the sample plate You do not have to start in position 1 and you may leave positions empty since the device possesses automatic sample cup recognition e In Stand by mode press
25. ntroduction This part of the instruction manual describes special functions and settings relevant to the user Furthermore it gives additional information about quality control and some problems that can be solved by the user 5 2 Menu functions As described in chapter 4 there are two types of device functions functions which are needed for day to day operation and functions which are only should be used by trained stuff For working with following functions you need besides special knowledge also exact knowledge about the menu structure of the SUPER GL2 The overview of the menu structure you find in fig 4 3 5 3 Programming 5 3 1 Basics The programming of controls calibration versions and printer settings are described in chapter 4 Following functions influence measuring results and their displaying and should only be activated by trained stuff maybe by calling the service 5 3 2 Method 5 3 2 1 Adjust The following settings can be made here Measuring cycle e Here you can select in which position of the series control measurements or recalibration take place e Acycle consists of a maximum of 8 segments e The Back button deletes the last segment The sample type is added by touching the button e In chain operation mode the cycle is executed until for the first time a sample is selected Afterwards only samples are processed 15 03 2010 Page 29 of 45 Rev 03 Operation Part 2 Sample repetition Thi
26. ntrols show Cycle Sample repeat Count Reset parameters Reset EDP Reset no of parameters Glucose Lactate Glucose Lactate print parameter list Unit glucose Unit lactate Value correction glucose Value correction lactate Warning limit glucose Warning limit lactate Adjust time Adjust date Language EDP ie automatical calibration Washing Emptying Change syringe Show dates of sensors Show supplies Adjust bubble detector description in service manual depending on configuration Rev 03 Operation Part 1 4 5 Preparing the measuring process 4 5 1 Basics The SUPER GI2 uses prefilled reagents For each analysis a prefilled reaction cup is needed For measuring with SUPER GL2 you also have to use a biosensor calibration cups and control material The sample cups you have to put into the signed positions at the sample rotor and after that you can start to measure a series 4 5 2 Sample preparation Please observe the instructions on the package insert of the reagent cups concerning sample preparation The following notes complement the above notes and they are only valid if capillary blood is used as sample material When drawing a capillary blood sample do not compress the tissue Compressing the tissue leads to a dilution of the blood sample with intracellular fluid and NC can thus lead to faulty results For taking a capillary z V blood sample use suitable lancets a
27. on Auto calibration activated upon customer request Activates auto calibration mode If the button is highlighted after touching auto calibration is active In Stand by the period of time until the next calibration is displayed Calibration takes place cyclically in the selected intervals In addition the Cal off button is displayed Touching this button deactivates auto calibration 02 11 2009 Page 26 of 45 Rev 02 Operation Part 1 Calibration stable activated upon customer request This works just like auto calibration except that the next cyclic calibration is executed only when measuring is requested Start calibration Executes a calibration If Auto calibration is activated in the menu Functions Adjust a new area auto calibration will be shown If you choose ON the new started device starts after the warming time the calibration automatically and remains in the statues auto calibration ADVICE After switching on the device will calibrate every time before sample measurement for the first two hours 4 6 4 Controls The SUPER GL2 has three control positions to meet the requirements of quality control To guarantee an effective quality control all three positions can be programmed Following input options are programmable for each parameter e Name of the control lower warning limit for glucose upper warning limit for glucose lower warning limit for lactate upper warning limit for lactate For all
28. proper functioning of the device Always keep in mind that the hose pump works as a suction pump and that it produces a low pressure in the system Leaking liquid is always a sign of permeability e g worn seals of the washing container loose hoses Or an incorrectly inserted sample canula Check for unobstructed flow and leakage Switch off the device and switch it back on after 2 seconds Thereby making sure that the pump is working Make sure that the pump is turning Uncover the waste bottle and watch whether liquid drops in regular intervals If it does there is no problem in the flow system If no liquid is dropping out the system is either leaky or obstructed In this case proceed as follows 02 11 2009 Page 43 of 45 Rev 02 Maintenance and troubleshooting Remove the hose from the suction side of the hose pump and put a matching injection syringe onto the hose With the syringe suck liquid out of the supply bottle Watch the liquid in the hose between sample canula and sensor There are three possible reactions e The syringe can easily be moved there are many air bubbles or only air in the hose That means the system is leaking The easiest way to find the leak is to look where the air bubbles occur Check all connections and if necessary exchange the hoses and the washing container e he syringe can hardly be moved and the liquid in the hose barely moves That means the system is obstructed Loosen the hose from the was
29. s ERROR Fe RAM 1 name of error There can be more similar messages of errors which are printed out to the same schema 02 11 2009 Seite 42 von 45 Rev 02 Maintenance and troubleshooting 6 4 4 Measuring Errors Glucose and lactate are determined using the enzymatic amperometric measuring principle The measuring signal is produced as a current change at an electrode due to a chemical reaction with the immobilized enzyme In the SUPER GL2 a special measuring process is used that operates with a minimum amount of sample material The hose between canula and sensor is critical for the proper functioning of this process Therefore this hose must only be replaced by an original spare part You can visually check proper operation by watching the air bubbles between sample and washing Version glucose The air bubble that is drawn before a sample has to pass the sensor completely before sample will be measured The air bubble that is drawn after measuring the sample has to stop and stay for a while in front of the sensor Version glucose lactate The air bubble that is drawn before a sample has to stop in front of the sensor until the sample taking arm has returned to the upward position The air bubble that is drawn after a sample has to stop in front of the sensor for a while As with all flow systems unobstructed flow through and imperviousness of the canal between the sample canula and the hose pump is very important for the
30. s function interacts with the sample warning limits To select an item touch the button Highlighted buttons are active Counting e Here you can choose between a sequential number and a sample number of the day e Chain operation is intended for users needing devices with sample chains see also 4 6 2 e To switch chain operation on off select the menu item Chain operation Two buttons On Off are displayed Touch the appropriate button The active button is highlighted Reset parameters This function resets the programmed parameters and the device returns into the delivery status This function should be used for plant hires to erase the customer specific settings In detail it happens as follows Sample number get number 1 Time gets EU Standard Year gets 4 digits Language changed to German Measuring unit gets mg dl Sample repetition gets status OFF Sample number of the day gets status OFF Calibration modus gets status inactive device calibrates before each series and before each STAT Time of calibration stability gets 20 min Time of auto calibration gets 30 min Upper and lower warning limits of controls will be set to range limits Sample warning limits will be set to range limits Correction factor for methods gets standard values Chain operation gets status OFF Cycle gets standard value Measuring value memory and control value memory were erased Reset sample number This function sets
31. side of the device and connect the other end with your EDP Please pay attention to the notes in the manual for interfaces and also to the notes from your EDP partner The jack of the printer cable is inserted into the printer interface on the right hand panel of the device s casing s fig 4 1 and connected to the corresponding interface on the back panel of the printer 02 11 2009 Page 19 of 45 Rev 02 Operation Part 1 The following image shows the interfaces on the right hand panel of the casing of the SUPER GL2 EDP Prinier Power 2 Fig 4 1 Connections SUPER GL2 4 4 Initial operation When the device was installed as described above proceed as follows Exchange the sensor chapter 6 3 4 Exchange the supply and waste containers chapter 6 3 5 This procedure completes the installation of the device Warning To avoid loss of data the device must not be switched off unless in Stand by mode or if required by a corresponding error message After switching on the device it will enter Stand by mode after the necessary warm up period 28 01 2010 Page 20 of 45 Rev 03 Operation Part 1 The SUPER GL 2 is operated with the help of the Touch Screen only cl fig farther down Fig 4 2 Touch Screen When operating the touch screen please note press only lightly do not use pointed or sharp objects do not use any solvents for cleaning excepting the solution for cleaning and disinfection chapter
32. ssories In addition further optional accessories can be ordered Both the manufacturer and the authorized distributors will gladly supply you with information about connecting interfaces 02 11 2009 Page 16 of 45 Rev 02 Description of the analyser 3 6 Consumption material To operate the analyser following consumption material is needed Prefilled sample cups without capillaries or with end to end capillaries or with open end capillaries for taking the sample calibration solution bottles with haemolysed system solution sensor glucose or sensor glucose lactate control material For detailed instructions on the use of these consumption materials please refer to the chapter Operation of this manual 02 11 2009 Page 17 of 45 Rev 02 Operation Part 1 4 Operation Part 1 4 1 Introduction In this part of the instruction manual all information is included that is useful for the day to day operation of the device In part 2 all additional information is included that is important for understanding the functions complementary functions and certain sources of possible problems The qualified personnel for the device must be familiar with both parts and must also have the medical knowledge to be able to interpret the acquired values correctly Conclusions for a therapy may only be drawn by a medical practitioner 4 2 Safety instructions As mentioned before certain safety warnings must be heeded when operatin
33. t change sensor Electronic error gt call service Error sample System obstructed gt rinsing by hand Connection hose sample canula sensor heavy discoloured Sample canula maladjusted defective Sample cup empty Remaining quantity in the sample cup is not enough for a measurement fig 6 6 Table of errors during the measuring 08 02 2010 Page 41 of 45 Rev 03 Wartung und Fehlerbehebung 6 4 3 Mechanical errors If there are the following errors displayed the operator can t do anything without the help of the service personal The displaying is only for the service to describe more exactly the errors Type of errors Communication error ERROR name of the component no Ackn no quittance of command Handler doesn t send a quittance of command ERROR name of the component Timeout Error of device light barrier ERROR name of the component light barrier doesn t open Handler doesn t reach end position ERROR name of the component 3 tries ERROR name of the component 3 tries reference run Problem of communication between controlling computers ERROR name of the component device not available Wrong parameter in the memory ERROR name of the component Parameter Flash Hardware and Software don t fit together ERROR name of the component Hardware version Plunger doesn t reach the dependent end position ERROR plunger type of error in clear text Error lifter ERROR lifter can t prick Intern memory error
34. the actual sample number number of the sequence or daily number to number 1 02 11 2009 Page 30 of 45 Rev 02 Operation Part 2 5 3 2 2 Select This menue item is only available in version glucose lactate Here you can select the parameter which you want to measure i e glucose or lactate as single parameter or both simultaneous from one sample 5 3 2 2 Print Prints out the parameter list 5 3 2 4 Programming Measuring unit You can choose between mmol l and mg dl Warning limits Enter a lower and an upper warning limit For samples found outside these limits an automatic repetition of the measurement can be programmed Correction of measuring value This function offers a separated for glucose and lactate if necessary correction function with the equation y mx n to adapt this device to a giant laboratory equipment if it S necessary 5 3 2 4 Plasmareference glucose Using this function you are able to manipulate the glucose values Using Plasmaref Glucose off the glucose values which came from blood samples will be calculated as blood sample values Using Plasmaref Glucose on the instrument will determinate the haematocrit values if the sample is a blood sample Both values will be used to calculate the blood value into a plasma value In this case will be printed out Glucose Haemolysate Samples plasmaref when the instrument starts a series or when it measures controls or STAT samples 15 03 201
35. three control positions the values stored can be displayed 4 6 5 Method In device alternatives Glucose Lactate following settings are possible e Glucose e lactate e Glucose and Lactate 15 03 2010 Page 27 of 45 Rev 03 Operation Part 1 4 6 6 Printer settings The intended printer DPU 414 has several interface options Follow these steps for setting programming the printer for use with SUPER GL2 1 Keep the on Line button pressed whole switching on the printer You will receive a print out of the current settings 2 Press On Line again to reprogram the printer 3 Press On Line for ON and Feed for OFF 4 Press Feed at the end of the programming to confirm The following settings are required for SUPER GL2 Position SW1 SW2 SW3 1 OFF ON ON 2 ON ON ON 3 ON OFF ON 4 OFF ON ON 5 ON ON ON 6 OFF ON OFF 7 ON ON ON 8 ON OFF OFF 4 7 Switching off the device You may switch off the device if there are no functions working NEVER switch off the device during calibration or washing otherwise the device may have malfunctions If the device is switched off for a longer time i e during the vacation you have to rinse and to empty the device to avoid drying the hoses Please store also the consumables i e sensors and calibration solution as written at the package For more questions please don t hesitate to contact us 02 11 2009 Page 28 of 45 Rev 02 Operation Part 2 5 Operation Part 2 5 1 I
36. tside and pulling off To install the piston cylinder system follow the instructions in reverse order Secure back panel 6 3 3 Exchange of canula and washing container fig 6 1 View washing container fig 6 2 View sample canula Removal 1 2 3 NO U1 Turn off the device Remove the hose of the supply bottle Place this hose in a little container or some cellulose at the table maybe there is some liquid left inside of the hose Remove the hose 1 Loosen the screw 2 Remove needle Remove washing container from the holding down fitting by pushing it backwards and lifting upwards 15 03 2010 Page 37 of 45 Rev 04 Maintenance and troubleshooting Installation 1 Insert washing container into the holding down fitting 2 Insert sample canula 3 Connect hose to the washing container 4 Insert the hose of the supply into the supply container 6 3 4 Exchange of sensor Removal of Sensor Open the sensor holder by pulling the lever fig 6 3 Sensor holder closed Remove the sensor fig 6 4 Sensor holder open 15 03 2010 Page 38 of 45 Rev 04 Maintenance and troubleshooting Installation of Sensor Open the packaging and take out the sensor Open the sensor holder by pulling the lever 3 fig 7 8 Insert sensor Close the sensor holder T WN 6 3 5 Exchange of supply and waste container To avoid interference with the operation of the device it is recommended to ex
37. ty instructions 12 O 02 235 Maintenance interval 12 02 CNET Description of analyzer f 13 02 3 l Introduction L 13 02 53 2 us Intended use 13 02 CC NE Measuring principle U sss 14 02 3 4 _ Lavotit arid WIOM onion uuu uuu uu ur 2203232 526 26i 16 _ 02 5 5 ME Accessories eee L6 x 02 36 eet Consumption material L 17 02 4 _ Operation Parti J ss 18 02 4 1 _ Introduction L 18 J 02 4 2 1 Safety instructions L iE o 2 02 4 3 1 Installing the device 19 02 44 Initial operation 0 ur o K aaa a aaa 20 02 4 5 1 Preparing the measuring process ie NN 02 4 5 1 Basics eee o gt CAE 02 4 5 2 Sample preparation i L runa 02 4 6 Measuring 25 s 02 4 6 1 Rotor operation uu 25 lokal 02 4 6 2 Chain operation L o gt us 03 4 6 3 Calibration 26 ss 02 4 6 4 CODEFOIS IPA atre ae e e a a I GSSs 03 4 6 5 Method 9 9 9 9 9 9 9 9 9 sl 2 7 02 4 6 6 Printer settings I su ade ur e u a a 286 02 4 7 Switching off the device sss ZO col 02 15 03 2010 Page 2 of 45 Rev 05 Table of contents Page Rev MES Operation Part2 ss Ir e 01 aa a aaa aaa Do E 02 ol E Introduction 9 n 29 ___ 02 o D Menufunctions uuu sura ua a 29 voce 02 DES qs Programming PEN 02 5 3 1 Basics U LLL LLL 29 _ 02 eNEAN ORN aae MR RR ERE Po 03 ROSE M 29 uuu 2 03 oi
38. wm ee mS ll e Bold italics Very important notes Explanation of terms Authorized people are people who have gained expert knowledge by completing training courses offered by the manufacturer or authorized companies 02 11 2009 Page 5 of 45 Rev 02 Introduction 1 Preface 1 1 Introduction Congratulations on purchasing the SUPER GL 2 analyser We hope you will find working with your analyser satisfying and successful In the following chapter The SUPER GL 2 you will find a first overview of your analyser what parameters you can measure what further devices and accessories belong to your analyser and an overview of the device s functionality Furthermore you will receive information on safety on liability and warranty and on indications or contraindications of your analyser For further and more detailed information please read the corresponding chapters 1 2 The SUPER GL 2 The SUPER GL2 analyser is a device for biochemical analysis in in vitro diagnostics The device is an analyser for determination of glucose and or lactate Fig 1 1 Overall view SUPER GL 2 02 11 2009 Page 6 of 45 Rev 02 Introduction 1 2 1 Basics The SUPER GL2 was designed using the latest technology along with decades of experience in the area of production of clinical chemical analysers It fulfils all legal specifications with regard to design and production that are required of all devices used in clinical
39. y to the EDP e printed repeatedly e erased 15 03 2010 Page 34 of 45 Rev 03 Operation Part 2 The Button detect coefficient of variation COV calculate the mean value and the CV of the last measured series To see the measuring value memory there are two display levels In the level displayed first all rows start with a T A T stands for a plate i e every row can contain a maximum of 60 samples Use the arrow to select a plate If you press the Print button the results of the plate marked in black are printed Sending data to the EDP works correspondingly If you press the Value button the results of the plate marked in black are displayed Now the values marked in black can be printed or sent 5 3 4 Available cards Key card Key cards are supplied with packages of haemolysing system solution and pre filled sample cups They are used to read the supplies Other cards More cards i e for changing the language etc you get from the manufacturer or your distributor 15 03 2010 Page 35 of 45 Rev 03 Maintenance and troubleshooting 6 Maintenance and troubleshooting 6 1 Introduction This chapter gives information on maintenance of the SUPER GL2 and about problems that may occur and how you might be able to solve them yourself If you are unsure about certain aspects DO NOT try anything you might think appropriate without qualified technical help DO NOT open the device without an authorized service techn
40. yser 3 3 Measuring principle The determination of glucose with the SUPER GL 2 is based on an electro chemical measuring principle with a biosensor With the help of an analyser pump system solution calibration solution control material or patient s material is conveyed through a sensor The electrodes inside the sensor are separated from the liquid by sealing layers containing immobilized enzymes The following figures show the flow schema and the reactions taking place inside the sensor Sensor sample or system solution Fig 3 1 Flow schema gluconic acid H O ff Pt electrode 2e Fig 3 2 Diagram of measuring principle only glucose 02 11 2009 Page 14 of 45 Rev 02 Description of the analyser LOD gluconic gluconic acid ped pyruvat HO H O H O das d mE Fig 3 3 Diagram of measuring principle glucose lactate 02 11 2009 Page 15 of 45 Rev 02 Description of the analyser 3 4 Layout and view V printer DPU 414 power supply unit EDP coble printer coble Fig 3 4 Overall view SUPER GL 2 Fig 3 5 Accessories Deliverables Description uantit SUPER GL 2 1 Sample rotor Power connection cable Power supply adapter for device and printer Printer DPU 414 Printer cable Instruction manual B Optional EDP cable 1 Other sample rotors 1 3 5 Accessories As described and shown above the SUPER GI2 comes with standard acce
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