Instruction Manual - Dr. Müller Gerätebau
Contents
1. Cycle gets standard value Measuring value memory and control value memory were erased Reset sample number This function sets the actual sample number number of the sequence or daily number to number 1 15 04 2010 Page 30 of 45 Rev 04 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 3 Print Prints out the parameter list 5 3 2 4Programming 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 5 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 o2. excepting the solution for cleaning and disinfection chapter 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 speedy 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 speedy If youve got more questions please ask the manufacturer or your distribution partner 15 04 2010 Page 21 of 45 Rev 04 O eration Part 1 STAND BY START MENUE STAT Controls program Names of Controls Limits of glucose Limits of lactate measurement Memory of controls show Methods Adjust Cycle Sample repeat Count Reset parameters Reset no of parameters Select Glucose Lactate Glucose Lactate Print print parameter list Program Unit glucose Unit lactate Value correction glucose Value correction lactate Warni
3. 45 Rev 04 Table of figures B Table of figures Overall view SUPER GL speedy Declaration of compliance View device Accessories Flow schema Diagram of measuring principle only glucose Diagram of measuring principle glucose lactate Overall view SUPER GL speedy Accessories Connections SUPER GL speedy Touch Screen Main program branches 15 04 2010 Sample preparation using open end capillary Page 4 of 45 Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig Fig T QJ N Q N N SAO Yt a a s ee 5 AuURWNHE BRWNHE Page Rev AANA 6 02 Ps 8 02 IREA 9 02 bee 25 De 02 CERN 14 02 eee 14 202 SERN 15 02 er 16 02 ee tess LO 02 20 03 ee 21 03 Roatan 22 03 eae 24 02 eee 37 04 aes 37 04 re 38 04 ee 38 04 ro 39 03 AA 40__ 03 r 34 _ 02 Rev 04 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 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 15 04 2010 Page 5 of 4
4. Stand by mode press 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 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 res
5. 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 15 04 2010 Page 19 of 45 Rev 04 Operation Part 1 The following image shows the interfaces on the right hand panel of the casing of the SUPER GL speedy 1 EDP Printer Power 2 3 1 power Jack 2 connection for printer 3 connection for EDP Fig 4 1 Connections SUPER GL speedy 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 15 04 2010 Page 20 of 45 Rev 04 Operation Part 1 The SUPER GL speedy 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
6. hesitate to contact us 15 04 2010 Page 28 of 45 Rev 04 Operation Part 2 5 Operation Part 2 5 1 Introduction 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 GL SPEEDY 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 A cycle 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 Af
7. 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 gt 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 15 04 2010 Page 41 of 45 Rev 04 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 nam
8. suitable lancets and if necessary X circulation enhancing measures such as lotions and es 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 15 04 2010 Page 23 of 45 Rev 04 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 15 04 2010 Page 24 of 45 Rev 04 Operation Part 1 4 6 Measuring 4 6 1 Rotor operation The SUPER GL speedy 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
9. 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 service manual 15 04 2010 Page 33 of 45 Rev 04 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
10. 3 ua General safety instructions ss 11 02 24 Product specific safety instructions 12 O 02 2 5 o oe a Maintenance interval OC 12 02 r C uQ Description of analyzer f 13 02 352 1 _ Introduction U 13 02 53 2 ee Intended use ia 13 1 02 3 3 Measuring principle U L 14 02 3 4 Layout and view 16 02 STe EROE Accessories eee 16 02 3 6 _ coca Consumption material oo 17 02 4 _ Operation Part ur L 18 2 02 41 _ Introduction 18 2 02 4 2 Safety instructions saa aaa IE e AS 02 43 Installing the device L 19 Z oO 02 44 Initial operation 0 uur sro a1A a aaa 20 ss 02 4 5 Preparing the measuring process au 2 5 nz 02 4 5 1 BasicSsu eee PLC TE 02 4 5 2 Sample preparation _ i L DC EA 02 4 6 _ Measuring U uuu a 25 a 02 4 6 1 __ Rotor operation_______ a aaa 29 s 02 4 6 2 Chain operation L 25 03 4 6 3 Calibration 26 ss 02 46 4 COIHNTOL c EENE E a 03 4 6 5 Method OOOO 27 so 2 1 02 4 6 6 Printer settings sss I ra l a ua a 286 02 47 Switching off the device n sa aaa 2O u 02 15 04 2010 Page 2 of 45 Rev 04 Table of contents Page Rev s ma masa Operation Part2 ss Ir e 01 aa a aaa aaa 2 an 02 ol Q Introduction L 29 ___ 02 5 2 2 221 Menu functions UU uuu sura ua a 29 oe 02 oho nee Programming iS araoa 02 5 3 1 BasicS uu UU U uuu uuu uu a 29 _ 02 eNEAN ORN aae EE EAA Sed ee eee ee ee ee ee ee eee eae 7S ae 03 oh cc Ad
11. 5 Rev 04 Introduction 1 Preface 1 1 Introduction Congratulations on purchasing the SUPER GL speedy analyser We hope you will find working with your analyser satisfying and successful In the following chapter The SUPER GL speedy 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 speedy The SUPER GL speedy analyser is a device for biochemical analysis in in vitro diagnostics The device is an analyser for determination of glucose and or lactate F lt DS i V x em coe et asli u_u Ss a a a Fig 1 1 Overall view SUPER GL speedy 15 04 2010 Page 6 of 45 Rev 04 Introduction 1 2 1 Basics The SUPER GL speedy 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 chemical laboratories The compliance with the valid norms and statutes is documented through the visibly attached CE Label The CE Label signifies
12. Instruction Manual SUPER GL so ec y Valid for Version 10 9 Effective from April 2010 Manufacturer Copyright Dr Muller 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 04 2010 Page 1 of 45 Rev 04 Table of contents A Table of contents Page Rev A Table of contents c nnunrnreoruauunnnrr a 7 AEEA 03 Bo lt lt lt Table of figures ur L 4 _ 05 Oe Table of symbols 0 re aaa a aaa gt eonun 02 l _ Prefa c E fC C nnnr r vsuJK T 6 fc 2 eee 02 1 1 OOOO Introduction nec tna tn ta ng get 2 ee 02 i _ The SUPER GL speedy Oo aeaa 02 1 2 1 Basics eee 03 L222 Declaration of compliance L oe 02 ES Device and accessories lt o lt lt oO oZ O O 2 22222 9 OoOO 02 1 24 _ Overview of functionality 9 Z 02 1 3 2 Indication Contraindication 1O 02 14 Manufacturer s liability a aa 10 02 5 ree Warranty 0 0 u sur Mua ua aa 1D 02 ae S JI y 2 ee D DD nee ee ee eer eee 22 2 sa Jl o oO O 02 21 Introduction o O Jl o o 02 2 2 Responsibility Training the operator sss 11 02 2 9
13. JUSU uu usu fasg fase tn sc tn sc tp ac nec tna tnactnac tna tac natn sa fase asalaaafasa ahs 29 uuu 2 03 Ae OARE 5 uuu x ee eee x Zx zx zy 2 ee 2 2 Z 2 2 2 2 2 2 22 Ci eee 04 5 3 2 3 O N kL Cy eee 04 5 3 2 4 Programming ur ur Lu aa a 31 04 5 3 2 5 Plasma reference glucose sss L 31 _ 04 oho ho ee Functions eee 32 04 oe et a L e il o u ee oe oe bua ua 32 04 5 3 3 2 Actions Cy ee 04 5 3 3 3 Read key card sisi usursa LU a aa cc ee 04 5 3 3 4 Service U uuur uuu uuur auaunusr a D L 03 5 3 3 5 Barcode on off 34 _ 03 5 35 5 6 USF ID U u ec ee ee er ed 3 4 03 oho AG lt a Measuring value memory 34 _ 03 5 3 4 Available cards U unra z uuu Ci ae 04 6 Maintenance and troubleshooting 36 0 02 O l eaa Introduction cio uu 22 02 6 2 Maintenance r lt L 36 _ 02 6 3_ Servicing U uuu u uu a aa ci PI 02 6 3 1 Cleaning and disinfection aa 36 0 02 6 3 2 Exchange of piston cylinder system _____ CTA 03 Soc ee Exchange of canula and washing chamber E TARENTE 03 6 3 4 Exchange of sensor SO li 04 6 3 5 Exchange of supply and waste container ____ 39 ee 03 6 3 6 Switching off the device 40 02 6 4 __C Error Messages Troubleshooting as 4i 02 6 4 1 Warnings U ee ee ce ee usus ua uu Qu g 41 _ 02 6 4 2 Errors while measuring aa 41 _ 03 6 4 3 Mechanical errors S a a 42 _ 02 6 4 4 Measuring errors 43 02 7 Technical data 45 03 15 04 2010 Page 3 of
14. arantee 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 15 04 2010 Page 18 of 45 Rev 04 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 Place the device
15. 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 repeatedly to the EDP e printed repeatedly e erased 15 04 2010 Page 34 of 45 Rev 04 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 04 2010 Page 35 of 45 Rev 04 Maintenance and troubleshooting 6 Maintenance and troubleshooting 6 1 Introduction This chapter gives information on maintenance of the SUPER GL speedy and about problems that may occur and how you might be able to solve them yourself If you a
16. 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 15 04 2010 Page 7 of 45 Rev 04 Introduction 1 2 2 Declaration of compliance EU Declaration of 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 Dr Miller Gerdtebau GmbH Burgker Str 133 D 01705 Frettal modification of the device SUPER G s o c y 7 SUPER GL sacechy following standards and guidlines DIN EN 61326 DIN EN 61010 1 DIN EN 61010 2 081 DIN EN 61010 2 101 98 79 EG 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 Satety requirements for electrical equipment for measurement control and laboratory use Part 2 081 Particular requireme
17. e 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 errors ERROR Fe RAM 1 name of error There can be more similar messages of errors which are printed out to the Same schema 15 04 2010 Page 42 of 45 Rev 04 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 GL speedy 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
18. er warning limit for lactate upper warning limit for lactate For all 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 04 2010 Page 27 of 45 Rev 04 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 GL SPEEDY 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 GL SPEEDY 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
19. f necessary exchange the hoses and the washing container e The syringe can hardly be moved and the liquid in the hose barely moves That means the system is obstructed Loosen the hose from the washing 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 15 04 2010 Page 44 of 45 Rev 04 Technical data 7 Technical data Measur
20. he disposal of devices manufactured after April 2006 customers in Germany should contact the manufacturer 15 04 2010 Page 40 of 45 Rev 04 Maintenance and troubleshooting 6 4 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
21. ing 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 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 mg 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 Re ee 7 77 57225 C x Approx 12 W x j C O a O C aes Approx 9 kg L 5 2 5 3 G C 5 3 Manufacturer Dr M ller Geratebau GmbH Burgker Str 133 01705 Freital Fig 7 1 List of Technical data 15 04 2010 Page 45 of 45 Rev 04
22. l 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 15 04 2010 Page 11 of 45 Rev 04 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 case of malfunctions stop operating the device immediately Prior to con
23. lable By pressing menu item Calibration 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 15 04 2010 Page 26 of 45 Rev 04 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 GL speedy 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 low
24. nd 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 15 04 2010 Page 9 of 45 Rev 04 Introduction 1 3 Indication Contraindication Indication The SUPER GL speedy 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 GL speedy 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 manual and package inserts 1 5 Warranty For their products Dr Muller Gerateba
25. ng limit glucose Warning limit lactate Plasma ref glucose on off Functions Adjust Adjust time Adjust date Language EDP ie automatical calibration Actions Washing Emptying Change syringe Show dates of sensors Show supplies Adjust bubble detector Read KeyCard Service description in service manual Barcode on off User ID Calibration calibration stable Autocalibration Calibration start Memory of E show depending on configuration results delete Fig 4 3 Main program branches 15 04 2010 Page 22 of 45 Rev 04 Operation Part 1 4 5 Preparing the measuring process 4 5 1 Basics The SUPER GL speedy uses prefilled reagents For each analysis a prefilled reaction cup is needed For measuring with SUPER GL speedy 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 w dilution of the blood sample with intracellular fluid and NC can thus lead to faulty results For taking a capillary E 2 blood sample use
26. nts 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 G speedy SN 0071 and SUPER GL speedy SN 0010 Freital 04 03 2008 Kall YKL Company Manager Ralf G nther Fig 1 2 Declaration of compliance 15 04 2010 Page 8 of 45 a l amp W ISO 13485 m o 2002 03 2002 08 2004 07 2003 09 1998 10 Company Manager Martin Sch fer Rev 04 Introduction 1 2 3 Device and accessories Deliverables Designation uantit SUPER GL speedy 1 Sample rotor 1 Power connection cable 1 Power supply adapter for device and printer 1 Printer DPU 414 1 Printer cable 1 Instruction manual 1 Optional EDP cable 1 Other sample rotors 1 oe i printer DPU 414 power supply unit EDP cable printer cable Fig 1 3 View device Fig 1 4 Accessories 1 2 4 Overview of functionality The SUPER GL speedy 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 a STAT sample very quick The results of measurement will be showed at the Touch screen a
27. on further optional accessories can be ordered Both the manufacturer and the authorized distributors will gladly supply you with information about connecting interfaces 15 04 2010 Page 16 of 45 Rev 04 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 15 04 2010 Page 17 of 45 Rev 04 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 operating the device to gu
28. 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 side of the device
29. ptional reinforcing lactate maximum reinforcing lactate Expiry Month Year Life time Month Activation Date 15 04 2010 Page 32 of 45 Rev 04 Operation Part 2 Display supplies In the display are shown following data Supplies SUPER GL ok Cups XXXX Buffer XXXxX 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
30. re 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 technician Please contact our service hotline free of charge 6 2 Maintenance The SUPER GL speedy 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 15 04 2010 Page 36 of 45 Rev 04 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 po
31. rt sensor Close the sensor holder T Q N 6 3 5 Exchange of supply and waste container To avoid interference with the operation of the device it is recommended to exchange 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 04 2010 Page 39 of 45 Rev 04 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 t
32. sition 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 outside 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 04 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 04 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 Inse
33. tarted with number 1 15 04 2010 Page 25 of 45 Rev 04 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 Kol 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 avai
34. terwards only samples are processed 15 04 2010 Page 29 of 45 Rev 04 Operation Part 2 Sample repetition This 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
35. th the SUPER GL speedy 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 15 04 2010 Page 14 of 45 Rev 04 Description of the analyser LOD gluconic gluconic acid penna pyruvat H O H O H O dah 1 Fig 3 3 Diagram of measuring principle glucose lactate 15 04 2010 Page 15 of 45 Rev 04 Description of the analyser 3 4 Layout and view V 1 ad meets printer DPU 414 power supply unit EDP cable printer cable Fig 3 4 Overall view SUPER GL speedy Fig 3 5 Accessories Deliverables Description uantit SUPER GL speedy 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 GL speedy comes with standard accessories In additi
36. tinuing 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 speedy 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 15 04 2010 Page 12 of 45 Rev 04 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 chapter will provide you with forward information For detailed instruc
37. tions and descriptions of the device please refer to chapter Operation 3 2 Intended use The SUPER GL speedy 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 15 04 2010 Page 13 of 45 Rev 04 Description of the analyser 3 3 Measuring principle The determination of glucose wi
38. 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 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 15 04 2010 Page 43 of 45 Rev 04 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 i
39. u 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 15 04 2010 Page 10 of 45 Rev 04 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 GL speedy 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 Operating the device for home testing is expressly forbidden 2 3 Genera
40. ut Glucose Haemolysate Samples plasmaref when the instrument starts a series or when it measures controls or STAT samples 15 04 2010 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 o
Download Pdf Manuals
Related Search