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combi - Frank`s Hospital Workshop

1. EA specimen re Figure 21 Construction of the pCO measuring chain combilse Instruction Manual Version 4 01 Page 93 Maintenance combi E Line 6 2 4 1 Regeneration of the pCO Sensor Polishing serves to regenerate the glass surface ofthe pCO sensor unit in cases of low slope values 1 Exchange of the Membrane shell is essential after polishing NOTE Do not install used membrane shells again The following maintenance accessories and expendable materials are required Leather covered cork 5011042 Abrasive and cleaner 5011041 Demineralised water silicon carbide Electrode cleaner 50 6 10 84 alcoholic compounds Cleaning tissue Adhesive tape Gloves un je pCO filling solution 50 12035 pCO membraneshell 50 12030 Regeneration procedure wear gloves for your own safety 1 Remove the Sensors from the Sensor Array as described in chap ter 6 2 1 Removal of Sensors 2 Unscrew the black cap of the Sensor Illustr a XN Illustration a 3 Pull the pCO Sensor upwards out of the casing Illustr b Illustration b Page 94 combitine Instruction Manual Version 4 01 Maintenance combi E Line 4 Pull the used casing off the inside part while turning slightly Illustr c Attention filling solution can be spilled o
2. A manual start of the rinsing cycle can become necessary if sample leftovers are remaining in the measuring capillary after the automatic rinsing at the end of a measurement The rinsing cycle will be performed automatically with WASH Solution While rinsing a backlight is on behind the measuring capillary and the valve compartment for a visual control The STAND BY or WARM UP PHASE dialogue appears when a rinsing cycle is performed This function cannot be performed during WARM UP PHASE The Hb Sensor must be activated separately see chapter 3 5 1 5 Activation of Hb Sensor A manual start of a 2 point calibration cycle It can be necessary after Sensor maintenance installation of a new Sensor after any maintenance procedures e Press the 2 key to perform a full Calibration the following dialogue appears combitine Instruction Manual Version 4 01 Page47 Measurement and Special Functions combi E Lin Cancellation Calibration Error CALIBRATION SOLUTION BGA 3 The lowest line always indicates the Solution which is currently in use All active Sensors are calibrated in the following sequence a pCO Sensor with BGA 1 3 b pCO Sensor with BGA 2 4 c pH and ISE Sensors with CAL3 d pH and ISE Sensors with CAL4 CAL4 M e GLU and LAC Sensors with CAL4 M e pO Sensor with AIR Sensors that are marked with an error like e g SLOPE will also be cali brated Error marks ca
3. Solve problem Exchange pH Sensor unit see chapter 6 2 Yes see chapter 6 2 Run Calibration cycle see chapt 3 5 1 2 Install Bags into Bag Adapter s 3 2 Yes lt Clean pH Glass Membrane with Electrode Cleaner gt le Of blood inside the pH Sensor asing or at the pH Glass Make sure that all Sensors are fixed at their positions and that Sensor Catch is closed Check or replace Roller Pump Tubes Are any clots Yes Membrane No Remove blood clots see chapter 6 2 Are all O rings present at the Sensor Casings Clean pH Glass Membrane with Electrode Cleaner install new O rings 1 0 x 0 8 Check the liquid Valves and the connecting Tubes between Valves and Bags for blockage Remove blockage Service stuff only combikfine Instruction Manual Version 4 01 Page 75 ErrorMessages combi E Line 4 6 ISE Slope Error Problem solving guide for pH and electrolyte Sensors SLOPE Print out Run REAGENT TEST a a Pane Gl Seah SENSOR PARAMETER EC1 and EC2 to check transportation of ensitivity OF all Sensors Ou gt for control purpose gt 3 500V Cal Solutions CAL3 4 of range at the same time chapter 3 5 1 6 see chapt 3 5 2 9 Sensor Cables connected to th
4. combikfine Instruction Manual Version 4 01 Page 127 Appendix combi E Lin Capillaries Capillaries for instruments without Hb sensor 250 pc 5063008 hep capillaries 8 cm 100ul up to 4 parameter 250 pc 5063010 hep capillaries 10 cm 125ul up to 6 parameter 250 pc 5063012 hep capillaries 12 cm 150ul up to 8 parameter Capillaries for instruments with Hb sensor 250 pc 5063012 hep capillaries 12 cm 150ul up to 4 parameter 250 pc 5063014 hep capillaries 14 cm 150ul up to 7 parameter 250 pc 5063015 hep capillaries 16 cm 200ul up to 11 parameter 250 pc 5063030 metal stirrers for capillaries 1 pe 5063035 magnet for metal stirrers 500 pc 5063040 end caps for capillaries various accessories 2 rl 50 6 50 00 printerpaper 1 set 4064000 maintenance set complete 5 pc 3 7 200 aspiration pipe for control solution 1 pe 5066055 ampoule holder for aspiration pipe 2 pc syringe 2 ml 1 set Fuses 2 x 2 5 A 1 pc mains cable 1 pc instruction manual pc piece bot bottle pcl parcel rl roll 7 7 Interface Description Serial Interface RS 232 The transfer of data in the combilixe program is performed with following parameter 9600 Baud 8 data bit 1 start bit 1 stop bit no parity bit no handshake Data will be sent automatically after a sample or QC measurement only at the time of printing in ASCII code Page 128 combitine Instruction Manual Version 4 01 Appe
5. This function cannot be performed during WARM UP PHASE Depending on the sample throughput it is necessary to perform a clean ing of the analysis system with Protein Remover as recommended refer to chapter 6 1 Maintenance Schedule To obtain high reproducibility of measure results and high stability of sensors it is essential to use ESCHWEILER Protein Remover CLEAN1 order no 5 6 10 80 at latest after performance of 100 tests or at least once a week Protein and Lipid sediments cause false voltages on Sensors and therefore false results Protein and Lipid sediments cause shortened life time of membranes Carry out this program if the results of the Quality Control are out of range Carry out this program if the results of the Quality Control are out of range For protein removal e fill a Syringe with about 1ml of Protein Remover order no 50 6 10 80 Be careful Protein Remover is aggressive wear suitable gloves Sodium Hypochloride e Press the 8 key to display the test dialogue e Proceed as displayed on dialogue e Insert the Syringe into the Sample Port e Inject Protein Remover slowly into the Sample Port e Remove the Syringe from the Sample Port as requested The Protein Remover remains in the analysis system for about 60 sec onds After that time the analyser performs two wash cycles and a cali bration cycle automatically Termination When there is no action within 30 sec the STAND B
6. age Gas Purpose This program indicates the generated O Sensor voltage after air has been added The voltage usually lies between 500 and 100m V At a disconnected O Sensor cable the voltage must be 1700 mV 50 mV This value is preadjusted by the manufacturer It can in some instruments be at 1660m V This variation is due to individual dynamic characteristics of the O amplifier and O sensors If not call for the Technical Service There is a danger of O value deviation combikine Instruction Manual Version 4 01 Page 57 Measurement and Special Functions combi E Lin Carry out test 3 5 2 6 Test Air Pressure Purpose CAUTION and Temperature e Press the 5 key to display TEST pO GAS dialogue TEST PO2 GAS QUIT E O2 162 V mV 14 17 CAL 25MIN Refer to chapter 4 4 if the value is out of range e Press the QUIT key to return to the STAND BY dialogue With this program the following parameters are indicated Thermostat temperature controlled at 37 0 C 0 2 Air pressure BP barometric pressure in mmHg or kPa Thermostat temperature The temperature of the thermostat is measured with a temperature Sen sor which is located inside the metal block of the thermostat The indi cated temperature should be 37 0 C 0 2 C A Thermal protection switch is also located at the rearside of the thermostat to avoid over heating Temperature deviations of more than 1 C caus
7. 3 5 3 4 Settings Purpose Carry out function The standard values of Hb FIO2 and RQ are preset to the following val ues Pre settings Range Hb 15 0g dl 0 0 30 0g dl FIO2 20 9 15 0 100 0 RQ 0 85 0 70 1 00 PRINTOUT 1 1 to 4 printouts factor e Press 4 key to display the Settings dialogue SETTINGS PRINTOUTS 1 HB 15 0 FIO2 20 9 RQ 0 85 GAS mmHg META mmol l 14 17 CAL 25 MIN Note Settings that need no change can be skipped or confirmed by pressing the ENTER key Acolon appears behind HB Enter the desired Hb value by numerical keys and press ENTER key to confirm If an Hb Sensor is installed the Hb value will be used only if the Hb Sensor is inactivated or SLOPE is indicated Acolon appears behind FIO2 e Enter the desired FIO value by numerical keys and press ENTER key to confirm Acolon appears behind RQ Enter the desired RQ value by numerical keys and press ENTER key to confirm Acolon appears behind PRINTOUTS Enter the desired number of print outs by numerical keys and press ENTER key to confirm Every print out will be copied x times A colon appears behind UNIT GAS e Select the desired unit for pO pCO P50 AADO and barometric pressure by corresponding key between mmHg or KPa The new standard values are now stored and taken into account in all following sample measurements combilse Instruction Manual Version 4 01 Page
8. 61 5mV CFx Cro at37 0 C Nernst factor The inner buffer solution Cl has a constant Cl concentration Therefore the voltage ECI is proportional to the chloride ion concentration of the added specimen Clx which is to be determined The conductive system of the measuring Sensor makes the connection to the outside of the CI PVC membrane with the electrically conductive filling solution The conductive system of the Reference Sensor makes the connection to the inside of the PVC membrane with the electrically conductive electrolyte solution of the Reference Sensor and the added specimen With this connection the potential difference won through a specimen Clx at the PVC membrane is conducted to a measuring am plifier and displayed CI Sensor 50 3 40 00 inner electrolyte Cl filling solution 50 3 40 35 conducting system 50 3 4010 Cl PVC membrane shell 50 3 40 30 Amplifier Eor Reference Sensor 40 5 10 00 conducting system 50 5 1010 3 ref filling solution 50 5 10 35 ref membrane shell 50 5 10 30 diaphragma membrane measuring capillary with specimen Cl x Figure 26 Set up of the Cl measuring chain Page 108 combikine Instruction Manual Version 4 01 Maintenance combi E Line 6 2 10 Principle of Li measurement The principle of the Li measurement is based on the fact that at a PVC membrane which is permeable for Lit ions an electrical potential differ
9. A suitable disinfectant is available by BODE Chemie Hamburg Bacillol is recommended for areas at risk of infection where rapid contact times and drying times are necessary BODE Chemie GmbH amp Co Melachtonstr 27 22525 Hamburg Germany Phone 49 0 40 54 00 60 Internet www bode chemie de Another suitable disinfectant is available by S amp M Sch lke amp Mayr TERRALIN Liquid Sch lke amp Mayr GmbH Robert Koch Str 2 22851 Norderstedt Germany Phone 49 0 40 521 00 0 Internet www schuelke mayr com See the website for your nearest representation Ask for an EC Material Safety Data Sheet according to EC 91 155 If a person swallowed any chemical solution may be while servicing wash out mouth with water If provided person is unconscious than call a physician If inhaled remove to fresh air If breathing becomes difficult than call a physician In case of contact immediately wash skin with soap and copious amount of water In case of contact with eyes flush with copious amounts of water for at least 15 minutes Assure adequate flushing by separating the eyelids with fingers than call a physician Repairs to the analyser may only be carried out by trained personnel and replacement parts have to comply with the analyser specifica tions Incase of analyser problems contact your representative In this Manual a bullet gt draws your attention to an instruc
10. In case oftechnical questions problems concerning the Combiline it is recommended to send this data sheet to your Technical Service NOTE Excerpt from a Sensor parameter print out ESCHWEILER COMBILINE II SENSOR PARAMETER DATE 06 49 10 04 10 O2 SENSOR TIME SLOPE EC1 EC2 0629 140 1660 401 MEAS mV 380 BGAL BGAH 0 0 153 2 mmHg mmHg CO2 SENSOR TIME SLOPE EC1 EC2 0629 74 1654 1772 MEAS mV 1815 BGA L BGA H 62 5 34 5 mmHg mmHg HB SENSOR HBR HBT 0 818 1 599 MEAS mV 100 1372 SOFTWARE 2500 COUNTER 3628 Time Date of the printout Sensor name EC1 EC2 sensor voltages in mV Time Slope EC1 EC2 EC1 O2 Zero point voltage fixed BGA L O2 Zero point BGA H partial pressure of O2 in air next Sensor parameter EC1 EC2 sensor voltages in mV Time Slope EC1 EC2 BGA L low value BGA1 3 pCO2 BGA H high value BGA2 4 pCO2 B Activation Parameters efection and Transmission voltages of i last Hb measurement nstalled software version actual value Sample Counter EC1 calibration voltage 1 zero point occurs at Calibration with BGA 1 3 for the pCO Sensor Calibration with CAL 3 for ISE and pH Sensors EC2 Calibration voltage 2 occurs at Calibration with BGA 2 4 for pCO Sensors Calibration with CAL4 or CAL 4 M for ISE and pH Sensors Calibration with AIR for the pO Sensor Page 54 combikine Instru
11. Power Connection 5 m S 2 iS Oo Figure 11 Power connector Fuse compartment The Power connector is located at the rear side of the Combiline and contains the Power Switch ON I OFF 0 fuse compartment for replacement refer to chapter 6 4 acold device plug combilse Instruction Manual Version 4 01 Page 19 Introduction combi E Lin Power Requirement CAUTION CAUTION Model Type Identification Fan Note that the mains voltage must meet following requirements The necessary operating voltage is indicated on the Type Plate Voltage Frequency Main fuses 115 230V 50 60 Hz 2 x 250 V T2 5A time lag Please observe Type Plate on the rear side The Combiline has to meet the local requirements If not don t use it and call for the Technical Service The Main Cable used has to meet the local regulations e g VDE CSA C22 2 no 21 and no 49 The cable has to be designed with NYLHY The recommended length is 0 5 m and the minimum cross section is 3 x 0 75 mm CE ESCHWEILER combi Line Type CL1234568 12 Hb No CL1001 AC 115V 230V 50 60Hz 70W I T 2 5A 250V ESCHWEILER GmbH amp Co KG Holzkoppelweg 35 D 24118 Kiel www eschweiler kiel de Made in Germany Figure 12 Type Plate The Combiline Type Plate indicates CE Certification Type Combiline xx SNo Combiline S
12. NOTE Keep a sample device with sufficient volume of sample mate rial free of air bubbles ready See chap 1 2 3 Specimen Collection for detailed information Measurements can only be carried out if the STAND BY dialogue is evi dent STAND BY PROGRAMM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE MEASURE K ACTIVE NA ACTIVE CA ACTIVE CL ACTIVE QC LI ACTIVE GLU ACTIVE LAC ACTIVE HB ACTIVE RESPIRATION GAS 10 45 CAL 90 MIN To carry out PROGRAM Submenu functions refer to chapter 3 5 To set the Combiline in ECONOMY mode refer to chapter 3 6 If an error occurs refer to chapter 4 Error Messages Page 36 combi amp se Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 1 Using Syringe or Capillary Syringe Capillary CAUTION If a Calibration Solution needs to be replaced or the Waste Bottle is full refer to chapter 3 7 Replacements To run a measurement proceed as follows e Press the MEASURE key The following dialogue appears PREPARATION PLEASE WAIT FOR SAMPLE INPUT REQUEST 12 15 CAL 45 MIN Wait for approx five seconds The following dialogue appears auto matically PREPARATION SYRINGE INJECT SAMPLE SLOWLY AND WAIT TO REMOVE SAMPLE DEVICE CAPILLARY INSERT INTO SAMPLE PORT AND PRESS lt ENTER gt KEY RESPIRATION FOLLOWS 12 15 CAL 45 MIN Inser
13. combikine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 7 2 1 CAL3 CAL4 M 3 7 3 Waste Solution hae a Biohazard Unscrew the cap The cap might be used later to close the full Waste Bottle after its replacement The Wash bottle is closed by an alu minium film Cut the aluminium film crosswise with a scalpel and push it into the bottle Lift the Wash Bottle Adapter equipped with a long plastic tube Insert the tube into the Wash Solution Bottle and put the Adapter over the Bottle see figure 14 Press the corresponding QUIT key to confirm the replacement When the CAL3 or CAL4 Bottle is empty the analyser permits no further measurements or calibrations and the following message will be dis played CAL3 SOLUTION QUIT PLEASE CHECK Check if the bottle is really empty otherwise the transportation way could be disturbed If necessary check the transportation of liquids as described in chapter 3 5 2 9 Fora replacement proceed as follows Pull out the empty Bottle and take a new one e Cut the aluminium film crosswise with a scalpel and push it into the bottle Lift the CAL3 Bottle Adapter equipped with a long plastic tube Insert the tube into the Wash Solution Bottle and put the Adapter over the Bottle e Press the corresponding QUIT key to confirm the replacement After measurement the specimens are collected in the Waste Bottle togethe
14. ence occurs when this membrane separates two solutions with different Li values The resulting potential difference voltage ELi is propor tional to the difference of the Li ion concentrations for the two solu tions ULi 61 5mV Li x Lito at 37 0 C Nernst factor The inner buffer solution Lit has a constant Li concentration Therefore the voltage ELi is proportional to the lithium ion concentration of the added specimen Li x which is to be determined The conductive system of the measuring Sensor makes the connection to the outside of the Li PVC membrane with the electrically conductive filling solution The conductive system of the Reference Sensor makes the connection to the inside of the PVC membrane with the electrically conductive electrolyte solution of the Reference Sensor and the added specimen By this connection the potential difference won through a specimen Li x at the PVC membrane is conducted to a measuring am plifier and displayed Lit Sensor 50 3 4000 inner electrolyte Lito filling solution 50 3 50 35 conducting system 50 3 50 10 Li PVC membrane shell 50 3 50 30 0 6 mmol l Amplifier Reference Sensor 40 5 10 00 conducting system 50 5 10 10 ref filling solution 50 5 10 35 ref membrane shell 50 5 10 30 diaphragma membrane measuring capillary with specimen Li x Figure 27 Set up of the Li measuring chain combilse Instruction Manual V
15. stepper motors or any other mechanical movements Wear gloves in all cases if there is a risk of infection Avoid any direct contact with samples that are potentially infectious or which may generate other risks to the human body Aids Hepatitis etc In case of direct body contact go and wash the contaminated area immediately Use a suitable skin disinfection solution Ask your doctor for aid If sample material blood or reagent is spilled onto the analyser wipe it off immediately and refer to the chapter 2 Maintenance and Hy giene Do not open a waste bottle as long as the analyser is in process Page 6 combitine Instruction Manual Version 4 01 Safety Issues combi E Line Reagents and Controls CAUTION Restrictions for Samples Rea gents and Conirols CAUTION Accuracy and Precision of the Measured Results CAUTION Fire and Explosion Hazards CAUTION Operator Qualification 12 Maintenance and Hygiene CAUTION Observe the suggestions in the package inserts for an exact use of the reagents and quality controls Note that reagents and quality con trol material can be biological material Don t use Reagents Controls and other Liquids after expiration date Avoid any liquid penetration into the analyser For consumables no guarantee can be provided for any resistance against organic solvents For this reason do not use any organic sol vents unless such solvents are expressly indicated
16. 1 0 x 0 8 the Sensor casings Glas part of Sensor unit damaged or broken V Check the liquid Valves No and the connecting Tubes between Valves and Bags for blockage N Run Calibration cycle exchange Sensor unit lt Remove blockage 2 see chapt 3 5 1 2 9 Service stuff only Page 74 combitine Instruction Manual Version 4 01 Error Messages combi E Line 4 5 pH Slope Error pH SLOPE Sensitivity of pH Sensor out of range only other ISE Sensors OK Problem solving guide for pH Sensor SLOPE Print out SENSOR PARAMETER for control purpose see chapt 3 5 1 6 EC1 and EC2 of pH Sensor gt 3 500V Yes Is pH Sensor Cable connected to the Sensor No Activate REAGENT TEST to check transportation of Calibration Solutions see chapt 3 5 2 9 Are all Calibration Solutions transported free of air bubbles Connect Cable Are the Calibration solutions installed correctly and filled with liquid No Check Ref Sensor filling level air bubbles membran defect Remove and open pH Sensor to check it visually or scratches in the pH Glass Membrane Check with magnifying Glass pH Glass Membrane covered with deposits No
17. ACTIVE PH ACTIVE K ACTIVE MEASURE NA ACTIVE CA ACTIVE CL ACTIVE LI ACTIVE QC GLU ACTIVE LAC ACTIVE HB ACTIVE RESPIRATION GAS 10 45 CAL 40 MIN Go as described above for the next sample The results of the sample measurements are stored on an integrated SD Card the results of 32000 measurements can be stored there To display the results proceed as follows e Press the PROGRAM key one time to get access to the OPERATION menue Press the 8 key to access the data memory The results of the last measurement will be displayed then 1130150310 QUIT PO2 90 0 PCO2 39 0 PH 7 410 PRINT K 4 5 NA 144 CA 1 23 CL 100 LI 0 45 NEXT GLU 3 20 LAC 2 55 HB 14 2 H 41 0 PREVIOUS actual number of totally CA7 4 1 22 547 548 stored results 547 of 548 After selection of DISPLAY MEASURED VALUES first the measured values appear on the screen For display of the calculated AB Param eters press the ENTER key Press ENTER key again to return the previous display of measure results e Press the corresponding PRINT key for a print out e Press the corresponding QUIT key to return to the STAND BY dia logue be done automatically after approx 30 sec e Press the ENTER key to display the calculated AB parameters Remarks A question mark is shown if the max measuring time was exceeded For more details refer to chapter 4 Error Messages Lithium va
18. Before servicing for the above mentioned reasons it is advis able to have a look at the measures discussed in chapter 4 Errormessages Page 84 combitine Instruction Manual Version 4 01 Maintenance combi E Line Regeneration of Sensors Sensor filling levels 6 2 1 Removal of Sensors CAUTION A regeneration of Sensors is only possible for pO pCO and pH Sen sors See chapter 6 2 3 1 and 6 2 5 1 All the other ISE Sensors can be refreshed by changing the membrane shell and the conducting system both with the corresponding filling solu tion see chapter 6 2 6 1 Membrane shells for Nat Kt Ca Cl Lit Sensors must be filled until 2 3 mm below the upper edge The Ref Sensor must be filled completely The pO and pCO Sensors must be filled until the red mark The Sensors are located behind the white front cover below display There in the solid state thermostat they form the measuring unit lined up in a row This set up permits fast convenient removal of the Sen sors Open the REAGENTTEST menu before removal of a Sensor out of the array This avoids any liquid penetration into the thermostate during maintenance measures To remove the Sensors Run REAGENT TEST in the SERVICE TEST menu and keep the dia logue still displayed during this procedure Press 1 key for Suction see chapter 3 5 2 9 Open the front cover Release the Sensor Catch by pulling on the right side R
19. Do not use any other rinsing or cleaning solutions as recommended by the manufacturer or representative Waste liquid has to be disposed in compliance with the legislation In order to ensure a flawless operation of the analyser measure control samples and watch the function of the analyser closely Faulty measurement results may result in an incorrect diagnosis or range danger for patient Do not place any flammable or hazardous explosive material in the proximity of the device Electrical sparks could cause fire or explo sions The analyser should only be operated by trained personnel Im proper operation of the analyser might cause inaccurate measuring results No organic acid based cleaning substances should be applied In stead use cleaner designed for cleaning and disinfecting laboratory analysers Only use a dampened cloth to clean the analyser Never spray or pour cleaning solution directly onto the analyser that may negatively impact the analyser s functions significantly Keep the analyser clean and do not spill liquids onto it In case liquids were spilled onto the analyser immediately absorb liq uid with a suitable cloth Contact your distributor if your control measurements do not produce the expected results combikine Instruction Manual Version 4 01 Page7 Safety Issues combi E Lin Recommended Disinfectant Solutions 13 First Aid Measures 14 Repairs CAUTION Useful hint NOTE
20. In determining the pO the principle of polarography is employed A typi cal current and voltage characteristic is used The oxygen molecules dissolved in a specimen gas or solution diffuse through the teflon membrane and are electrochemically reduced at the platinum cathode which lies at a constant polarization voltage of 800 mV Through the electrons delivered by cathode and taken up by anode ref erence system a current flow occurs in the electrolyte The current current due to the concentration gradient is taken up in the Combiline with a special measuring amplifier and displayed The height of the current due to the concentration gradient is propor tional to the quantity of the oxygen molecules diffusing through the teflonmembrane Construction of the pO measuring chain 700 mv U Pol pO2 closure cap Reference System f platinum cathode glass shaft m electrolyte Ka Q teflon membrane 25um i P specimen SZ a Figure 22 Construction of the pO measuring chain Page 98 combiline Instruction Manual Version 4 01 combi E Line 6 2 5 1 Regeneration of the NOTE pO Sensor Deposits on the glass surface of the pO sensor uni
21. tion Example e Press enter key to confirm Page 8 combikine Instruction Manual Version 4 01 Introduction combi E Line 1 Introduction 1 1 Intended Use IVD 1 2 System Description Functions Operation Generals The ESCHWEILER Combiline is a microprocessor controlled auto matic analysis system for quantitative measurement and calculation of pH electrolyte haemoglobin blood gas and metabolite parameter of a single sample of human whole blood or serum The Combiline is intended for use by trained operators in hospital labs and or specialist doctor s offices for in vitro diagnostics The samples are inserted directly into the Sample Port from capillary tubes syringes vacutainers or other sample intake systems The material to be measured is automatically sucked into the analysis system from capillaries and is injected from syringes into which can be seen from outside window The sample quantity needed to fill the analyser system completely is controlled by a Light Barrier The sample volume is approx 50 150ul de pending on the model type The analysis system consists of individually replaceable Sensor mod ules The thermostating at 37 0 C 0 2 is done by a solid state thermo stat and is not software controlled refer to chapter 3 5 2 6 The calibration of the Sensors is fully automatic or can be carried out manually Sample and calibration waste is collected in a dispo
22. 0 50 330 30 Ca membrane shell with membrane 50 3 30 35 Ca fillsolution bot 20 ml Cl Sensor 50 3 40 00 Cl Sensor complete 503 40 10 CF conducting system 50 3 40 20 Cl Sensor casing 50 11025 gasket for Sensor casing 1 8x 1 0 50 3 40 30 Cl membrane shell with membrane 50 3 40 35 Cl fillsolution bot 20 ml Li Sensor 50 3 50 00 Li Sensor complete 50 350 10 Li conducting system 50 35020 Lit Sensor casing 50 11025 gasket for Sensor casing 1 8x 1 0 5035030 Li membrane shell with membrane 50 3 50 35 Li fillsolution bot 20 ml Reference Sensor 4051000 reference sensor complete 5051010 reference conducting system 5032015 gasket for conducting system 3 2 x 1 8 505 10 20 reference Sensor casing 50 11025 gasket for Sensor casing 1 8x 1 0 4051050 reservoirforreference Sensorcasing 5051030 ref membrane shell with membrane 5051035 reference fillsolution bot 20 ml Sensor units various 40 5 2000 Sample Light Barrier Sensor LB 50 11025 gasket for Sensor casing O ring 1 8x 1 0 40 71030 device for specimen input 50 7 20 90 Temperature Sensor for temp regulation NTC Data sheets about liquid content can be requested from manufacturer combiline Instruction Manual Version 4 01 Appendix combi E Line 7 3 Specifications for Safety The ESCHWEILER Combiline meets the following directives 2004 108 EG Electromagnetic Compatibility 2006 95 EG Low voltage directive Applie
23. 2 4 Storage of Standard Data How to understand Standard Data Standard Data are parameter which are entered in the Menu STANDARD DATA e g Calibration data Date and Time etc The Standard Data of the Combiline are stored in an internal memory buffered by a Lithium Battery This means that the Standard Data en tered by the user are saved in the memory during brief power interrup tions or if it is switched off manually Combiline was switched off for less than 8 minutes When the Combiline is switched on again a calibration is carried out automatically using the Standard Data which have been entered previ ously Combiline was switched off for less than 24 hours In this case all manually entered data are still saved in the memory Af ter switching on the analyser starts the Warm Up Phase After that a calibration follows automatically using the Standard Data which have been entered previously Combiline switched off for more than 24 hours After power on the analyser requires the parameter for BGA 1 3 and BGA 2 4 by showing the Calibration Data dialogue as long as the pa rameter are entered The parameter for Hb haemoglobin are still saved in the memory All previously entered Standard Data are returned to the values pro grammed by the factory except Date and Time The Combiline is cali brated automatically after a one hour Warm Up Phase Standard Data can be changed manually during the Warm Up Phase Factory settings
24. 6 months 6 9 months s chapter pO x 6 2 5 1 pCO x 6 2 5 1 K x 6 2 6 1 Na without membrane 6 2 1 2 Ca 6 2 6 1 Cl 6 2 6 1 Li 6 2 6 1 GLU 1000 tests or 30 days LAC 400 tests or 15 days Ref x 6 2 11 pH poss regeneration 6 2 3 1 6 2 12 Table 4 Table Change of Membranes Renewal of filling solution and check of conducting system 4 weeks 8 weeks s chapter pO 8 12 6 2 5 1 pCO 8 12 6 2 5 1 K x 6 2 6 1 Na X 6 2 6 1 Ca X 6 2 6 1 Cl X 6 2 6 1 Li x 6 2 6 1 GLU Biosensor not necessary LAC Biosensor not necessary Ref X 6 2 11 pH closed system 6 2 3 1 Table 5 Renewal of filling solution check of conducting system only together with a new membrane shell The replacement of the conducting systems for K Na Ca CF and Li Sensors should be done when required i e if the brown Ag AgCl coat is worn out or damaged You can see it if the colour of the conducting system has changed from brown to silver grey partly or whole To avoid a colour change the conducting systems of the ISE Sensors always should be filled with enough filling solution combikfine Instruction Manual Version 4 01 Page 83 Maintenance combi E Lin 6 2 Maintenance of Sen sors Generals When is it time to service or re place a Sensor NOTE Previous experience has shown that it is advisable to service the pO and pCO Sensors at intervals of approx 8 12 weeks The maintenance interval depends much
25. PRESS lt ENTER gt KEY ASPIRATION FOLLOW 10 45 CAL 45 MIN Insert the Syringe or Douglas Pounch into the Sample Port Page 44 combiline Instruction Manual Version 4 01 combi E Line 3 4 1 Urine NOTE Press the Gas out of the syringe or Douglas Pounch The sample will be transported automatically into the Sensor s capillaries Follow the instructions given in the dialogue A print out of the results of pO and pCO takes place automatically after completion of the measurement by printer The STAND BY dialogue ap pears than This function is available in combi amp se ISE only It is used for measuring K Na and CI in urine samples Urine measurements are made with syringes Preparation of urine samples Urine samples have to be diluted as follows Pipette 0 9ml of urine dilution solution order no 1 4 710 into a suitable vessel e g Eppendorf reaction vessel To obtain a high as possible precision an automatic pipette should be used Then pipette 0 1ml urine into the vessel Close the reaction vessel and mix the content well Fill the diluted sample into a 1ml or 2ml disposable syringe Do not dilute urine samples by direct filling of urine and urine diluting solution into a syringe Otherwise dilution mistakes may be caused The storage time of Urine samples should not exceed 24 hours The samples should be kepi at a cool place during the whole time of storage refriger
26. case of deviations call for Technical Service e Press the QUIT key to return to the STAND BY dialogue This program serves for checking the sample detection Sensor LB at the end point of the measuring capillary In case of any Light Barrier malfunction this function should be used first Possible indications Sample or Calibration Solution is not detected Press the 7 key to display the test dialogue TEST LB QUIT LB 2125 mV TEST RINSING AFTER QUIT OR 30 SEC 14 17 CAL 25MIN At first the Light Barrier voltage for AIR is indicated e Press the corresponding TEST key WASH Solution will be sucked in automatically The Light Barrier voltage for watery solution is indicated then Voltages of Correctly adjusted Light Barriers should lie within the follow ing ranges LB voltage for air 1 600 2 500V LB voltage for WASH 0 200 0 500V Call for Technical Service if the indications do not appear like described Sample light barrier or its capillary need to be adjusted or exchanged For adjustment or capillary replacement please note service manual combilse Instruction Manual Version 4 01 Page59 Measurement and Special Functions combi Eu Lin 3 5 2 8 Protein Removal Purpose CAUTION Carry out removal 3 5 2 9 Reagent Test Test of Liquid Transport Purpose Termination e Press the QUIT key to return to the STAND BY dialogue This will be done automatically after 30 sec
27. follow the display dialogue Insert syringe into the Sample Port and inject sample material slowly into the Port until you hear a beep sound Remove the sy ringe from the sample port afterthe second beep sound Before introducing a syringe into the Sample Port make sure that the syringe is filled completely and without air bubbles The Sensor Array is the central unit of the analysis system and is thermostated at 37 0 C 0 2 The Combiline can be equipped with dif ferent Sensors depending on the customer s needs If the analyser is equipped with a Haemoglobin Sensor it is installed on the left side of the array Release the Sensor Catch lever only for Sensor maintenance otherwise the analysis system is open Make sure that the analyser system is closed co mbiline Instruction Manual Version 4 01 Page 13 Introduction combi E Lin sample light barrier Support Area NOTE sensor catch closed pos Figure 7 Sensor Array A Sensor Catch is located beside the Ref Sensor whitch locks up the liquid system of the Sensor group If any liquid is flowing through the analysis system a back light is on to display the liquid flow and possi ble sediments can be seen For more information about the Sensors re fer to chapter 6 2 Maintenance of Sensors The light barrier LB2 at the end of the Sensor group controls the flow of the Calibration and Washing solution and also the filling level of an intr
28. glass capillary membrane with conductive electrolyte solution of the Reference Sensor and the added specimen With the connection thus made the potential difference won through a specimen Na x at the Na glass membrane is conducted to a measuring amplifier and displayed Na Sensor 50 3 20 00 inner electrolyte Na o filling solution 50 3 20 35 conducting system 50 3 2010 Nat Glass membrane 140 mmol l Amplifier E Nat Reference Sensor 40 5 10 00 conducting system 50 5 10 10 ref filling solution 50 5 10 35 ref membrane shell 50 5 10 30 diaphragma membrane measuring capillary with specimen Natx Figure 24 Set up of the Na measuring chain Page 106 combiline Instruction Manual Version 4 01 Maintenance combi E Line 6 2 8 Principle of Ca measurement The principle of the Ca measurement is based on the fact that at a PVC membrane which is permeable for Ca ions an electrical potential difference occurs when this membrane separates two solutions with dif ferent Ca values The resulting potential difference voltage EK is proportional to the difference of the Ca ion concentrations for the two solutions UCa 30 75mV Ca Ca at 37 0 C Nernst factor The inner buffer solution Ca has a constant Ca concentration There fore the voltage ECa is proportional to the calcium ion concentration of the added specimen Ca x which is to be determin
29. high 12x150 ml Special Solutions 50 6 10 80 Protein remover 1x 100 ml 5061084 Electrode cleaner 50 ml 5061088 Activating solution for pH sensor 20 ml Quality Controls Control Solutions for BGA 50 620 10 Level acidosis 30 ampoules 50 6 20 20 Level II normal 30 ampoules 50 6 20 30 Level III alkalosis 30 ampoules Control Solutions for BGA plus E 50 6 20 40 Level acidosis 30 ampoules 50 6 20 50 Level Il normal 30 ampoules 50 6 20 60 Level Ill alkalosis 30 ampoules Control Solutions for BGA ISE and metabolites 506 2045 Blood Gas control EGL Level acidosis 30 ampoules 50 6 20 55 Blood Gas control EGL Level II normal 30 ampoules 50 6 2065 Blood Gas control EGL Level III alkalosis 30 ampoules Data sheets about liquid content can be requested from manufacturer combikfine Instruction Manual Version 4 01 Page 119 Appendix combi E Line Article no description packing unit Sampling Systems Capillaries 50 6 30 08 hep capillaries 8 cm lg 250 pcs 50630 10 hep capillaries 10 cm lg 250 pcs 5063012 hep capillaries 12 cm 150ul 250 pcs Capillaries for instruments with Hb sensor 50630 14 hep capillaries 14 cm 175ul 250 pcs 50630 16 hep capillaries 16 cm 2001 250pcs 50 6 30 30 metal stirrers for capillaries 250 pcs 50 6 30 35 magnet for stirrer 50 6 30 40 end caps for capillaries 500 pcs Aspiration Pipes 3 7 200 pipe for control solution activating solution etc 10 pcs 50 6 30 55 amp
30. operation and if the Bottles or Bags have been installed properly If no Calibration Bags or empty Bags are present this is indicated in the dialogue The Combiline cannot prepare for measurementthen As long as the WARM UP PHASE appears the Combiline is NOT READY for Measurement An opening of the Sample Port will be ignored by the Software e Close the Cover of the Support Area Before transport of the Combiline all liquid bottles must be removed from the analyser and their tubes must be evacuated by the use of the program REAGENTTEST in Service Test menu see chapter 3 5 2 9 The waste bottle must also be emptied see chapter 3 7 3 To transport the Combiline proceed as follows e Wear protective gloves for your safety e Move the Combiline to the edge of the table so that you can safely grip under the bottom part at the longer sides of the Combiline e To transport carefully lift the Combiline with one person at each end Be careful there are screws beneath the analyser If the Combiline has to be put out of service the Calibration Solution containers Wash Solution Bottle and the Waste Bottle must be re moved In addition the tube system must be emptied by the use of the program REAGENTTEST see chapter 3 5 2 9 and the Roller Pump Tubes have to be removed from the Roller Body to avoid unnecessary mechanical stress Proceed as follows analyser is powered on e Press the corresponding OPERATION key two times to dis
31. person should do this kind of work If a fuse is burned you have to find out the reason If the fuse needs to be replaced or controlled proceed as follows Switch OFF the Combiline e Disconnect the power cord between Combiline and mains e Carefully pull out the fuse compartment by a screwdriver as shown in figure 31 compartment Figure 31 Fuse compartment e Check the fuses If the fuse is burned replace it by a fuse of the same type 230V 2 5 A time lag Don t repair a fuse The accessory kit supplies different type of fuses The fuse types 1A and 2A are for internal use by the Technical Service only Insert the fuse compartment in its housing e Reconnect Combiline to power supply and check proper operation Contact authorised customer service in case that the exchange of fuse has been unsuccessful Note that the operating voltage is set by the manufacturer and cannot be changed by the user The Combiline needs to be cooled by a built in fan at the rear The Fan is located at the rearside Make sure that the air outlet is not covered Filter exchange is not required combilse Instruction Manual Version 4 01 Page 115 Maintenance combi E Lin 6 6 Replacement of Roller Pump Tubes Installation Roller Pump Tubes are equipped with two Stoppers strengthened parts near both ends For the transport of exact amounts of liquids the Tubes must be tentioned over the Roller Pumps Th
32. sedimentations on the Sensor or the Sensor is slowly worn out the Sensor becomes inert Concentration or partial pressure is out of range Sensor Membrane is worn out or defective Remedy Proceed in the following order e Make sure that samples don t contain air bubbles e Runa Protein removal cycle s chapter 3 5 2 8 If the mark is still present check the correspond ing Sensor of it s indolence e Check the Sensor indolence as described in the corresponding chapters 3 5 2 1 to 3 5 2 4 The pCO Sensor can be checked with TEST BGA 3 and BGA 4 The pH and Ref Sensor can be checked with TEST CAL3 and CAL4 M The indicated voltages should be stabilised within 30 to 60 seconds After that tolerance of 5 to 10 mV is normal If the Sensor is not stabilised e replace the Membrane of the corresponding Sensor Page 72 combitine Instruction Manual Version 4 01 Error Messages combi E Line 4 3 pCO Slope Error Problem solving guide for pCO gt Sensor SLOPE Print out SENSOR PARAM for control purpose chapter 3 5 1 6 Check PCO SLOPE Sensitivity of pCO Sensor out of range chapter 3 5 1 3 __ CALIBRATION DATA Run REAGENT TEST gt to check transportation of Cal solutions BGA 1 2 3 4 chapt 3 5 2 9 Are BGA1 3 and BGA2 4 transported free of air bubbles If Sensor Cable connected to the Sensor Yes No C
33. the WARM UP PHASE While calibration process high and low level Calibration Solutions cause a different voltage on the Sensor Membrane The high and low level voltages are stored in the internal memory constitute a two point calibration curve to compute the results The reason for longer calibra tion cycles are justified in the change of the membrane voltage caused by deposits on the Sensor Membrane The programmed calibration cy cles are a compromise between cost and precision of results In STAND BY mode there is a preprogrammed automatic calibration cy cle of 90 minutes see feet line CAL xx MIN An automatic calibration cycle can be interrupted by introducing a sample In ECONOMY mode there is a preprogrammed cycle of 240 minutes A calibration cycle cannot be interrupted The duration of a calibration process depends mainly on the condition of the Sensors and their membranes The average length of time needed for a calibration is approximately 4 5 minutes After 60 minutes when the WARM UP PHASE is over a calibration cy cle will be performed automatically The following dialogue appears CALIBRATION SOLUTION BGA3 SOLUTION BGA4 SOLUTION CAL3 SOLUTION CAL 4 SOLUTION CAL4 M GAS 15 24 combikine Instruction Manual Version 4 01 Page27 Introduction combi E Line During this process every Calibration Solution and GAS AIR will be aspi rated for a Sensor calibration A backlight is on for a
34. without membrane shell regarding its 1 filling level If necessary fill it up Check also its conducting NOTE system regarding its coat colour lt should be brown 1 Remove the ISE Sensor out of the Array as described in chapter 6 2 1 Removal of Sensors 2 Unscrew the conducting system together with the membrane shell out of the casing 3 Pull the membrane shell out of the conducting system and dispose it The conducting system of the ISE Sensors must not be cleaned because the brown coloured coat will be damaged If the colour has changed to white or silver the conducting sys CAUTION tem must be replaced Na ISE 1 conducting system 2 membrane shell 3 sensor casing Figure 24 ISE Sensors exploded view Page 104 combitine Instruction Manual Version 4 01 Maintenance combi E Line Filling level of the membrane shells NOTE gt o gt o N Fill up the new membrane shell to 75 with the corresponding filling solution Avoid air bubbles inside the solution otherwise a Slope error message could occur Use your fingers to tip on the shell to remove air bubbles Lead the conducting system new into the membrane shell so that it fits closely with it Clean the Sensor casing inside with a lint free cloth and with some drops of electrode cleaner Attention Don t drop electrode cleaner directly into the casing the casing could be torn partl
35. 051035 50 3 10 30 5031035 50 320 35 50 3 30 30 50 3 30 35 50 3 50 30 50 3 50 35 50 3 40 30 50 3 40 35 50 11042 50 11041 50 1 1050 50 6 10 84 50 6 10 80 4061011 406 10 40 4061050 4061045 40 6 10 56 Quality controls 50 11025 pO membrane shell with membrane pO fillsolution pCO2 shell with Membrane pCO fillsolution Ref membrane shell with membrane Ref fillsolution depending on ordered type configuration K membrane shell with membrane K fillsolution Na fillsolution Ca membrane shell with membrane Ca fillsolution Lit membrane shell with membrane Li fillsolution Cl membrane shell with membrane Cl fillsolution various accessories for Sensors cork with leather cleaning paste silicon carbide pO polishing kit electrode cleaner tape for closing of ventilation holes at membrane shells exchange tool for sample light barrier capillary Proteinremover for Combiline BGA E and BGA WASH 2 M Rinsing solution for BGA plus E BGA3 Calibration solution BGA plus E low BGA4 Calibration solution BGA plus E high CAL3 Calibration solution for BGA plus E low CAL 4 M Calibration solution for BGA plus E high Blood Gas Control plus EGL Evaluation Kit C 510 for BGA electrolytes and metabolites o ring for Sensor casing all 1 8 x 1 0 pc piece bot bottle Amp Ampoule 20 ml 20 ml 50 ml 20 ml 20 ml 20 ml 20 ml 20 ml 50 ml 100 ml
36. 1 analysers otherwise disturbances could appear orresults NOTE could be wrong Refer to chapter 3 7 1 forthe replacement of Calibration Solution Bags Don t replace a Calibration Solution Bag while the COMBILINE is pow ered OFF If a Calibration Solution Bag is empty this is shown on Display Figure 9 Support Area COMBILINE BGA In COMBILINE BGA the Calibration Solution Bag BGA1 serves for determining the low Sensor signal lower calibration point of the pCO and pH The Calibration Solution Bag BGA2 serves for determining the high Sensor signal upper calibration point of the pCO and pH In COMBILINE BGA E and all metabolite versions the Calibration Solution Bag BGAS serves for determining the low Sensor signal lower calibration point of the pCO The Calibration Solution Bag BGA4 serves for determining the high Sensor signal upper calibration point of the pCO In COMBILINE ISE BGA E and all metabolite versions the Calibration Solution Bottle CAL3 serves for determining the low Sensor signal lower calibration point of the ISE and pH sensors In COMBILINE ISE and BGA E the Calibration Solution Bottle CAL4 serves for determining the high Sensor signal upper calibration point of the ISE and pH sensors The calibration parameter are stored in the internal memory combilse Instruction Manual Version 4 01 Page 15 Introduction combi E Line WASH2 M BGA3 BGA4 CAL4 M Waste CAL3 SIE eye BG
37. 2 Service stuff only Page 76 combitine Instruction Manual Version 4 01 Explanation ofTestparameter combi E Line 5 Explanation of Testparameter 5 1 Entered Values Following test parameters are pre defined in menu STANDARD DATA SETTINGS for result reports Hb Haemoglobin concentration in whole blood A standard haemoglobin concentration of 15g dl is prescribed If the Hb concentration of a patient deviates from this value the individual Hb concentration of the patient can be entered by keyboard after initiation of the measurement This step is not necessary for analysers with the Hb measurement option The standard haemoglobin concentration which is valid for every meas urement can be set between 0 0 and 30 0 g dl in the menu STANDARD DATA SETTINGS If the Hb Sensor is installed the pre defined Hb parameter is only used if the Hb Sensor is inactivated or SLOPE is indicated FIO Oxygen content of the inhaled air in vol A standard FIO value of 20 9 oxygen content of the atmosphere is prescribed by the analyser The standard value can be set in the menu STANDARD DATA SETTINGS and is then valid for all following measure ments To measure samples taken from patients under artificial respiration the individually used oxygen content of the respiration air FIO can be en tered during the measurement The input range includes an O content of 15 100 RQ Respiration quotient Th
38. 5011015 gasket for Sensor unit 8 0 x 1 0 50 1 20 20 pCO2 Sensor casing 50 11021 screw cap for Sensor casing 50 11025 gasket for Sensor casing 1 8x 1 0 50 1 20 30 pCO membrane shells pack 5 pcs 50 12035 pCO fillsolution bot 20 ml pH Sensor 50 1 30 00 pH Sensor complete 50 1 30 10 pH Sensor unit 50 1 30 20 pH Sensor casing 5011021 screw cap for Sensor casing 5011025 gasket for Sensor casing 1 8 x 1 0 Hb Sensor 50 2 1000 Hb Sensor type II complete Lactate Sensor 50 4 10 00 Lactate Biosensor complete 1 pc Glucose Sensor 50 4 20 00 Glucose Biosensor complete 1 pc Data sheets about liquid content can be requested from manufacturer combikfine Instruction Manual Version 4 01 Page 121 Appendix combi E Lin Article no description packing unit K Sensor 5031000 K Sensorcomplete 5031010 K conducting system 5031020 K Sensor casing 50 11025 gasket for Sensor casing 1 8x 1 0 5031030 K membrane shell with membrane 5031035 K fillsolution organic tenside buffer substances bot 20 ml Na Sensor 50 3 20 00 Na Sensor complete btl bottle 50320 10 Na conducting system 5032015 gasket for conducting system 3 2 x 1 8 50 3 20 20 Nat Sensor casing 50 11025 gasket for Sensor casing 1 8x 1 0 5032035 Na fillsolution bot 20 ml Ca Sensor 50 3 30 00 Ca Sensor complete 50 3 30 10 Ca conducting system 50 3 30 20 Ca Sensor casing 50 11025 gasket for Sensor casing 1 8x 1
39. 65 Measurement and Special Functions combi E Lin 3 5 3 5 Sensor Selection Purpose Carry out selection With this menu individual Sensors can be activated or inactivated ac cording to the user s need or in case of a Sensor malfunction After re placement of a defective Sensor the new one can be activated in this dialogue ON The Sensor is active It takes part in the measurements and calibrations ON activated in STAND BY dialogue OFF The Sensor is inactive It does not take part in the measure ments and is not calibrated either OFF inactivated in STAND BY dialogue Press 6 key to display the dialogue SENSOR SELECTION PO2 ON PCO2 ON PH ON K ON NA ON CA ON LI ON CL OFF ON GLU ON LAC ON HB OFF OFF 14 17 CAL 25MIN A colon appears behind PO2 To inactivate a Sensor press the corresponding OFF key To activate a Sensor press the corresponding ON key The colon appears behind the next Sensor now go o as described In case of a Sensor activation a calibration of all Sensors is performed automatically The STAND BY dialogue appears after the last confirmation Page 66 combikine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 5 3 6 AB Parameter Selection Purpose Carry out selection The AB parameter acid base calculated from measured and entered values are printed out only if the measurement is finished With the p
40. A4 Sa Oue 0 m ll Figure 9 and 9a Support Area Combiline BGA E Combiline meta CAL3 CAL4 M CAL4 K 1 80 mmol 5 50 mmol l 5 50mmol Nat 110 mmol l 155 mmol 150 mmol Cat 0 50 mmol l 1 50 mmol l 1 50 mmol l Cl 90 mmol l 130 mmol l 130 mmol l Li 0 35 mmol l 2 0 mmol l 2 0 mmiol l pH 6 91 7 38 7 38 GLU 5 00 mmol l LAC 5 00 mmol l Table 1 Concentrations of CAL3 and CAL4 M and CAL4 The concentrations given in table 1 for CAL3 CAL4 M and 1 CAL4 are continually stored in the internal memory of the NOTE Combiline Therefore solutions with different concentrations cannot be used The Bag s label indicates the name of the Calibration Solution and the ordernumber content of 130 ml chargenumber storage condition at 18 25 C expiration date standard values CE mark Consumption of Calibration Solutions The Combiline needs for every calibration process 0 8 ml Calibration Solution from each bag bottle Page 16 combitine Instruction Manual Version 4 01 Introduction combi E Lin Wash Solution WASH1 WASH2 One bottle of WASH1 contains 330 ml of WASH1 Solution One bottle of WASH2 contains 250ml of WASH2 Solution in combiline BGA E and 330ml of WASH2 in combiline ISE It is absolutely necessary for cleaning the Sample Port the analysis system and at last all tubes Wash Solution WASH2 M One bottle of WASH 2 M contains 250ml of WASH2 M Solution WASH M is use
41. Cover e Press QUIT key to return to the STAND BY menu e Wait until the temperature is stabilized to 37 0 C 0 2 see Service Test menu select Air Temp 6 key e Runa CALIBRATION cycle OPERATION menu 2 key The STAND BY dialogue will appear after calibration Page 86 combiline Instruction Manual Version 4 01 Maintenance combi E Lin Biosensors Glucose Lactate Run REAGENT TEST in the SERVICE TEST menu and keep the dia logue still displayed during this procedure Glucose Sensor REF 5042000 LOT CVUTXXW p Take the corresponding Biosensor out of its package Immediately put the Biosensor flushing into its right position The up IVD CE A E a a per position is for the Glucose sensor the lower position for the Lac D 24118 Kiel Holzkoppelweg 35 Tel 49 0 431 54 6580 tate sensor see fig 22 Make sure that the contact surface is placed inwards the liquid contact place is on the left side Attention while inserting of the Biosensor don t misplace the 1 internal O ring NOTE Fasten the plastic screw carefully to fix the sensor in its position For conditioning of the Biosensors touch Meta to fill the capillary with rinsing solution WASH 2 M Touch Exit to leave the dialogue and close the blue cover The Biosensors take about 120 min for conditioning and activation After that a calibration cycle will be carried out automatically The sensors
42. ESCHWEILER combi E Lie Blood Gas Electrolyte Metabolite Analyser For In Vitro Diagnostic Use Instruction Manual C Development Manufacturing Sales Technical Service Made in Germany E Eschweiler GmbH amp Co KG Instruction Manual ManualVersion Manual History Software Copyrights Manufacturer The latest Manual version is 4 01 Order No 40 8 90 11 Print IM 401 combiline 2_2010 PDF Copyright 2010 by Eschweiler GmbH amp Co KG Holzkoppelweg 35 24118 Kiel No part of this Manual may be reproduced in any form without the written permission of Eschweiler GmbH amp Co KG Manual ANALYSER Software Revision Version Version Date 4 01 2500 April 2010 The software for the combitine Analyser is the User and Instrument Con trol Software for the combiline The combitine Software is the intellectual property of Eschweiler GmbH amp Co KG hereafter Eschweiler Intellectual property rights shall remain with Eschweiler You are entitled to use the combi amp se Software and the printed accompa nying material at your place of work only Any violations of property rights or copyright or trademark or conditions of use may be subject to legal action Eschweiler GmbH amp Co KG Holzkoppelweg 35 24118 Kiel Germany Phone 49 431 54 6580 FAX 49 431 5494 23 Internet http www eschweiler kiel de E Mail info eschweiler kiel de Instruction Manual Consumable solutions and sp
43. Figure 13 Software Overview SERVICE TEST 1 BGA1 3 2 BGA2 4 3 CAL3 A CAL4 5 GAS 6 AIR TEMP 7 LIGHT BARRIER 8 PROTEIN 9 REAGENT TEST press 3x OPERATION key to select Menu STANDARD DATA 1 CALIBRATION DATA 2 DATE TIME 3 CORRELATION 4 SETTINGS 5 SENSOR SELECTION 6 AB PARAMETER combikfine Instruction Manual Version 4 01 Page 25 Introduction combi E Line 1 3 Power Up Procedure This chapter explains what the Combiline is doing after switching on what dialogues appear and what functions will be performed until the STAND BY dialogue appears Power up the Combiline only after the installation procedure as described in chapter 2 3 CAUTION Switching ON e Set the Power Switch on the rear in position I Only ifthe Combiline was switched off for more than 24 hours 1 a dialogue appears first to enter the BGA 1 3 BGA 2 4 values NOTE See chapter 1 2 4 The following dialogue appears for about 3 seconds NOT READY RESTART PLEASE WAIT RESET As long as this dialogue appears you can press the corresponding soft key RESTART The analyser will warm up All entered parameters and all settings made are present in the memory RESET The analyser will warm up All parameters and all settings are reset to t
44. GA 3 to open the access to the corresponding metal canula see figure 15 installation Remove the empty bag and release the Slide Bar BGA 3 A light bar rier signal will be sent than to the controller Take a new Calibration Solution Bag which is to be replaced Press and hold the Slide Bar A for BGA 3 Press the Septum B of the new bag against a small resistant over the metal canula Release the Slide Bar BGA 3 The Septum is now fixed by the Slide Bar The Calibration Solution will be sucked in automatically The dialogue CALIBRATION DATA appears automatically to control or change the calibration parameter only for BGA 3 BGA 4 Proceed as described in chapter 3 5 3 1 For the replacement of CAL3 CAL4 M just unscrew the empty bottle from the connecting cap and remove the empty bottle from the support area Then install a new bottle put the feeding tube into the new bottle and screw the cap on again Then place the new bottle in the support area When the Wash Solution Bottle is empty the analyser permits no further measurements or calibrations and the following message will be dis played WASH SOLUTION QUIT PLEASE CHECK Check if the bottle is really empty otherwise the transportation way could be disturbed If necessary check the transportation of liquids as described in chapter 3 5 2 9 For a replacement proceed as follows e Pull out the empty Wash Solution Bottle and take a new one Page 68
45. Hb Sensors can be equipped differently according to the user s need Sensorarray Thermostated at 37 0 C 0 1 backlighted for visual liquid control e g sediments flow etc inside the measuring capillary Two light barriers for liquid control Warming up time 1 hour Sensor parameter range unit resolution pO 0 800 mmHg SI units selectable 0 1 pco 5 200 mmHg Sl units selectable 0 1 pH 6 000 8 000 pH 0 001 total haemoglobin tHb 3 30 g dl 0 1 barometric pressure 500 900 mmHg SI units selectable 1 0 Na 20 250 mmol l 1 0 K 0 20 mmol l 0 1 Ca 0 5 00 mmol l 0 01 Lit 0 40 5 00 mmol l 0 01 Cl 20 250 mmol l 1 0 GLU 0 30 mmol l 0 550 mg l 0 1 LAC 0 20 mmol l 0 180 mg l 0 1 Patient parameter to enter patient temperature 13 43 C 0 1 haemoglobin tHb 0 30 g dl if not measured 0 1 fraction of inspired O FIO2 15 100 only relevant for AaDO2 respiratory quotient RQ 0 7 1 0 only relevant for AaDO2 Calculated parameter actual bicarbonate HCO3 A 10 50 mmol l 0 1 standard bicarbonate HCO3 S 10 50 mmol l 0 1 base excess BE 25 25 mmol l 0 1 standard base excess SBE 25 25 mmol l 1 0 total CO TCO2 10 50 mmol l 0 1 buffer base BB 0 100 mmol l 0 1 O saturation of Hb O2sat 20 100 0 1 O content or concentr O2CT 0 40 0 1 pO at 50 O2 sat P50 10 50 mmol l 0 01 alveolar to arterial oxygen tension grade AaDO2 0 800 mmHg 0 1 haematocrit Hct 0 100 onl
46. I ACTIVE QC GLU ACTIVE LAC ACTIVE HB ACTIVE RESP GAS 10 45 CAL 90 MIN If you press the corresponding PROGRAM key one time the OPERATION menu appears as shown below OPERATION 1 RINSE 2 CALIBRATION 3 CALIBRATION BGA 4 CALIBRATION ISE 5 CALIBRATION HB 6 SENSOR PARAMETER 7 ECONOMY MODE Qc 8 DISPLAY MEASURED VALUES PROGRAM not available during MEASURE WARM UP RESP GAS 10 45 CAL 90 MIN The menu functions listed in the dialogue can be selected by pressing the corresponding key on keypad Example Press 1 key to carry out the RINSE function or press 6 key to access the SENSOR PARAMETER listing The dialogue will automatically return to STAND BY if no selection has been made within 60 secs or the corresp QUIT key has been pressed Page 46 combiline Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 5 1 OPERATION Menu 3 5 1 1 Rinse Purpose Carry out Rinsing 3 5 1 2 Calibration Purpose Carry out Calibration To access the OPERATION Menu proceed as described in chapter 3 5 The purpose and the use of the functions are described in the chapters 3 5 1 1 up to 3 5 1 7 as follows The function DISPLAY MEASURED VALUES is described in the chapter 3 1 1 e Press the 1 key to access the RINSE function the following dialogue appears while rinsing RINSE PLEASE WAIT 14 17 CAL 25 MIN
47. Page 30 combitine Instruction Manual Version 4 01 Installation combi E Line e Connect the Power Cord supplied between the Combiline and mains connection Power ON First setting into operation e Set the Power Switch at the rear in position I The following dialogue NOT READY appears for about 3 seconds NOT READY RESTART PLEASE WAIT RESET G e Press the corresponding RESET key within 3 seconds In case of passing this dialogue switch the analyser OFF and ON again The RESET function calls up the following dialogue for the input of the Calibration Bag s BGA 1 3 and C2 calibration parameters Input of Calibration Parameters Take the Calibration Bags supplied out of their packages CALIBRATION PARAMETER co2 BGA3 4 BGA3 69 0 BGA4 31 0 example for Combiline BGA E Parameter for BGA 3 BGA1 a colon appears behind BGA3 Not for Type Combiline ISE e Enter the pCO parameter printed on the Calibration Bag BGA3 or BGA red stripe by numerical keys e g 69 0 mmHg e Press ENTER key to confirm Parameter for BGA4 BGA2 acolon appears behind BGA4 Not for Type Combiline ISE e Enter the pCO parameter printed on the Calibration Bag BGA4 or BGA2 blue stripe by numerical keys e g 31 0 mmHg combilixe Instruction Manual Version 4 01 Page 31 Installation combi E Line e Press ENTER key to confirm The entered calibration parameters ar
48. SE INPUTS If you don t select anything out of this dialogue the displayed patient data disappear after 20 sec and the measurement will start for all possi ble values Following selections can be made ONLY BGA for the measurement of pO and pCO values ONLY ISE for the measurement of electrolyte values INPUTS to enter patient specific data Proceed as shown below QUIT to terminate Proceed as shown below Type combi amp in e BGA by pressing of ONLY ISE the pH value 1 will be measured only In case of no selection all values will NOTE be measured pO pCO and pH Page 38 combiline Instruction Manual Version 4 01 Measurement and Special Functions combi E Line Termination of aMeasurement Input of Patient Data NOTE QUIT If you are intended to terminate the measurement press the cor responding QUIT key The sample will be washed out The STAND BY dialogue will then appear During the first 20 sec after the MEASUREMENT dialogue is shown it is possible to enter patient specific data like A patient ID number The offered ID number consists of the current date and time and can be overwritten Thecurrent patient temperature Temp The haemoglobin concentration HB The FIO value FIO Oxygen content of the inhaled air The respiration quotient RQ Proceed as follows Press the corresponding INPUT key Parameters that need no change can be confir
49. SE CHECK It is recommended to replace the full Waste Bottle with an empty Wash Solution Bottle Refer to chapter 3 7 3 for the replacement of the Waste Bottle The cap must be cleaned and decontaminated regularly in accord ance to the maintenance schedule Note that the content of the Waste Bottle is potential infectious biological material Wear suitable GLOVES if you intended to CAUTION replace the Waste Boitle to protect yourself Disposal of Waste Solution Biological material has to be disposed off in accordance with the national guidelines for the disposal of biological material combitine Instruction Manual Version 4 01 Page 17 combi E Lin Solution summary designation amount order no COMBl amp ne BGA WASH 1 330ml 4061000 BGA 1 130ml 4061020 BGA 2 130ml 406 1030 COMBl amp xe ISE WASH 2 330ml 4061015 3 4 110 CAL3 330ml 4061060 3 4 100 CAL 4 330ml 4061065 3 4 500 COMBl amp ne BGA E WASH 2 250ml 4061010 BGA 3 130ml 4061040 BGA 4 130ml 4061050 CAL3 150ml 4061045 CAL 4 150ml 4061055 combilinereta WASH 2 M 250ml 4061011 BGA 3 130ml 4061040 BGA 4 130ml 406 1050 CAL3 150ml 4061045 CAL 4 M 150ml 406 1056 Page 18 combitine Instruction Manual Version 4 01 Introduction combi E Line Rear side SD Card Mains plug RS232 plug Mains Fuses Operation LED for SD Card Mains Switch SD Card Fan Figure 10 Rear View
50. Y dialogue appears automatically With the help of this program the liquid pumps roller pumps and the valves can be activated manually In this way air bubbles which are trapped in the transport tubes can be removed and the function of pumps and valves can be tested Page 60 combiline Instruction Manual Version 4 01 Measurement and Special Functions combi E Line Carry out test This program should be used if you are intended to remove a Sensor out of the Sensor Array e g for maintenance purposes Hold this pro gram activated as long as the liquid system is open Use this program also for any other maintenance work at the liquid system e g for the replacement of Roller Pumps tubes e Press the 9 key to display the test dialogue REAGENT TEST QUIT 1 SUCTION 2 WASH 3 BGA3 4 BGA4 5 CAL3 6 CAL 4 7 GAS VALVE in combiline S 8 META 10 45 CAL 90 MIN Press the corresponding numerical key to start the function desired Every function will be performed as long as the numerical key is pressed Press QUIT key to return to the STAND BY dialogue Wash Solution will be sucked in automatically Function description Abbreviation in parentheses indicates the functional part of the liquid system that must be activated and therefor can be therefore controlled by the operator or Technical Service by pressing the corresponding key SUCTION liquid will be sucked out of the
51. ade of pH sensitive glass when this membrane separates two solutions with differing pH values The potential difference which thus occurs voltage EpH is pro portional to the pH difference of the two solutions UpH 61 5mV pHx pHo at 37 0 C Nernst factor The inside buffer solution pHo has a constant pH value Therefore the voltage EpH is proportional to the pH value of the added specimen pHx which is to be determined The conducting system of the measuring Sensor makes the connec tion to the outside of the glass capillary membrane with the electrically conductive buffer solution The conducting system of the Reference Sensor makes the connection to the inside of the glass capillary mem brane with the electrolyte solution of the Reference Sensor which also conducts electricity and the specimen which is put in With the connec tion thus made the potential difference won by specimen pHx at the pH glass membrane is conducted to a measuring amplifier and displayed Amplifier Eph Reference Sensor 40 5 10 00 conducting system 50 5 10 10 pH Sensor 50 1 30 00 ref filling solution 50 5 10 35 conducting system ref membrane shell 50 5 10 30 inner buffer pHo diaphragma membrane measuring capillary with specimen pH x pH glass membrane Figure 20 Construction of pH Measuring chain combilse Instruction Manual Version 4 01 Page 89 Maintenance combi E Line 6 2 3 1 Regene
52. al safety DANGER Please read the Instruction Manual in its entirety prior to operating the Combiline In order to ensure a high level of performance all warnings and references to technical safety in this Instruction Manual have to be followed The cautions and safety regulations in this Instruction Manual meet in ternational classifications Warns of a risk of injury or of a risk to life for example by electrical shock Warns of a risk of injury or of the analyser being severely damaged Warns of a risk of biological material like blood or other human or animal specimen Risk of infection Potential infectious area material Introduces rules to be observed The following safety issues have to be observed at all times Check that the operating voltage is set correctly before you connect the device to the main power supply To connect the analyser to the main power supply use only sockets which are grounded to avoid the risk of an electrical shock Use only grounded extension power cords The used power cord has to correspond to the country specific regulations Never intentionally disconnect the grounding contacts There is the risk of electrical shock if the protective conductor is inter rupted within or outside the analyser and or the grounded contacts have been disconnected from the line Never remove protective guards or secured components since you could expose electrically live parts in this way Elec
53. aner and a lint free cellulose cloth Attention Don t drop electrode cleaner directly into the casing the casing could be torn partly caused by evaporation coldness 14 Put the inside part into the casing from the top and twist slightly to the right or left until it clicks into the torsion protector Illustr i Illustration i 15 Screw the cap onto the Sensor and tighten it slightly Illustr a 16 Install the regenerated Sensor into the thermostat See chapter 6 2 2 Installation of Sensors 17 Runacalibration cycle program CALIBRATION or CALIBRATION BGA As the Sensors in the COMBILINE operate at a working temperature of 37 0 C a warming up period of about 30 minutes is recommended after regeneration Page 102 combitine Instruction Manual Version 4 01 Maintenance combi E Line 6 2 6 Principle of K meas urement The principle of the Kt measurement is based on the fact that at a PVC membrane which is permeable for K ions an electrical potential differ ence occurs when this membrane separates two solutions with different K values The resulting potential difference voltage EK is proportional to the difference of the K ion concentrations for the two solutions UK 61 5mV K x K o at 37 0 C Nernst factor The inner buffer solution Kt has a constant K concentration Therefore the voltage EK is proportional to the potassium ion concentration of the added specimen K x whic
54. ange 10 to 50 mmol l BE Baseexcess BE is defined as the bicarbonate amount above or below the nor mal content 0 mmol l of buffer base and depends on the Hb concentra tions entered and the measured pH and pCO values Range 25 to 25 mmol l SBE Standard base excess SBE is defined as the bicarbonate amount above or below the normal content 0 mmol l of buffer base Calculation is made from the measured pH and pCO values and an Hb concentration of 6 g 0 1 I Range 25 to 25 mmol l TCO Total carbon dioxide TCO indicates the sum of the bicarbonate concentration and the physi cally dissolved carbon dioxides in the plasma Range 10 to 50 mmol l BB Bufferbases BB shows the sum of all buffer anion concentrations in the blood hae moglobin bicarbonate protein phosphate Range 0 to 100 mmol l O SAT Oxygen saturation of the haemoglobin The oxygen saturation shows the percentage of possible bonding points of the haemoglobin which are occupied by oxygen O SAT is independ ent of the Hb concentration Range 20 to 100 O CT Oxygen concentration O CT is the sum of physically dissolved and chemically bonded oxygen and is mainly determined by pO and Hb Range 0 to 40 p50 Semi saturation pressure The semi saturation pressure p50 shows the oxygen partial pressure at which the haemoglobin is 50 loaded with oxygen Range 10 to 50 nmmHg AaDO Alveolararterial oxygen pressure difference Th
55. arameter 77 5 1 EnteredValues uunnnurennnnnnnnnnnennnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnen 77 5 2 Measured Parameters uunnursnnnnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnn 78 5 3 Calculated Parameter uuuusnusnnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 79 Maintenance sssssssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 81 6 1 Maintenance Schedule uusuusnnnennnennnnnnnnnnnnnnnnnnnnnnnnnnn 81 6 2 Maintenance 0fSensorS unusnunnnnennnunnnnnnnnnnnnnnnnnnnnnnnnnnn 83 6 2 1 Removal of Sensors ensinei 84 6 2 2 Installation of Sensors e een 85 6 2 3 Principle ofpH measurement sees 87 6 2 3 1 Regeneration ofthe pH Sensor 89 6 2 4 PrincipleofpCO2 measuremert ue 92 6 2 4 1 Regeneration ofthepCO2 Sensor 93 6 2 5 Principle ofpO2 measuremert u 97 6 2 5 1 Regeneration of the pO2 Sensor 98 6 2 6 Principle of K measurement uueeeeneennen 102 6 2 6 1 Exchange of the ISE Sensor Membrane Shell103 6 2 7 Principle ofthe Na measurement 105 6 2 8 Principle of Ca measurement un 106 6 2 9 Principle of Cl measurement 107 6 2 10 Principle of Lit measurement en 108 6 2 11 Reference Sensor nuusnessennnnnnnnnnnnnnnnnnnnnn 109 6 2 13 Metabolite sensors 4umsssnnsennnnnennnnn nennen 112 Page 2 combikine Instruction Ma
56. are parts from other manufactur ers used in ESCHWEILER Analysers We point out specifically that fault free operation of our analysers can be guaranteed only when originalESCHWEILER solutions andspareparts are used The name ESCHWEILER with its decades of experience in the field of blood gas analysis also stands for the quality of the spare parts and consumable solutions ESCHWEILER sensors and solutions form a functional unit whose components are optimally adapted to each other Measuring accuracy and long life of the sensors are the goal of this system Through intensive development work the chemical compositions of our solutions have been adjusted optimally to the ESCHWEILER sensors and guarantee besides precise measurements the greatest possible protec tion of the sensitive sensor surfaces For example special wetting solutions are used which have a decisive influence on the unconstrained contact between sensor and solution in the measuring capillary At the same time suitable preservatives prevent the growth of micro organisms in the consumable solutions andkeep them from being introduced into the measuring capillaries of the ESCHWEILER analysers The characteristics and concentrations of both the wetting and the preservative substances are selected according to the special require ments of our sensors Fault free operation of our analysers with measuring accuracy and long sensor life are the main goals of our quality
57. arrier Slide Bar ea put in B Bag s Septum lt 2 Da Metal Tube m Bag installed 7 um i Metal Tube am gt Slide Bar released Figure 15 Installation of Calibration Solution Bags Just behind the installation of the Calibration Solution Bags z BGA 1 3 and BGA 2 4 the dialogue for the input or control of 1 the Calibration Parameters appears again Check again if the NOTE parameters shown on dialogue meet the parameters printed on Bag s labels False parameters can cause false results If necessary see step G for the input of Calibration Parameters If a problem should arise during transport of the Calibration Solution this will be indicated on display e g SOLUTION BGA 3 QUIT PLEASE CHECK To solve the problem refer to chapter 3 7 1 for more information I Activation of the Hb Sensor If installed If the analyser is equipped with an Hb Sensor proceed as described in chapter 3 5 1 5 Calibration of Hb Sensor combilse Instruction Manual Version 4 01 Page 33 Installation combi E Lin Ventilation of the Tube System End of Installation 2 4 Transport of the Combiline 2 5 Storage of the Combiline Le The air is automatically removed from the transport tubes of the WASH and Calibration Solutions when the analyser is set in
58. ation e Page 100 combitine Instruction Manual Version 4 01 combi E Line 7 Polish the glass tip of the pO sensor unit with circling movements on the polishing surface illustr f Continue polishing procedure for approx 10 seconds Illustration f 8 Wipe off the shaft the glass tip and the silver ring with a bit of electrode cleaner and a lint free cleaning tissue Illustr d 9 Put 1 2 drops of Electrode Cleaner into anew membrane covered casing and immediately spin it out again The Electrode Cleaner helps to prevent the formation of air bubbles when the filling solution is filled in 10 Fill the thus prepared casing to the red filling mark with pO filling solution approx 7 drops Fill the casing evenly and free of bubbles Please note not to overfill the filling mark Illustr g Illustration g combikine Instruction Manual Version 4 01 Page 101 combi E Lin 11 Push the filled casing onto the Sensor with slight twisting move ments Illustr h Don t close the ventilation hole with your fingers N Illustration h 12 Wipe off the outside of the Sensor and casing with a bit of Elec trode Cleaner and a lint free cleaning tissue Then close the ventila tion hole with a piece of yellow tape which is delivered together with the pre membraned casings 13 Then clean the inside of the Sensor casing as well with a bit of Electrode Cle
59. ator 4 C Due to decomposition products measuring of older samples can cause damages of the ISE sensors e Press the corresponding URINE key and the following dialogue appears PLEASE WAIT FOR SAMPLE INPUT REQUEST PREPARATION URINE MEASUREMENT USE DILUTION SYRINGE INJECT SAMPLE AND WAIT TO REMOVE SAMPLE DEVICE CAPILLARY INSERT INTO SAMPLE PORT AND PRESS lt ENTER gt KEY ASPIRATION FOLLOW 10 45 CAL 45 MIN Insert sample device into the Sample Port Follow the instructions given in the dialogue A print out of the results of K Na and CI takes place automatically after completion of the measurement by printer The STAND BY dialogue appears than combilse Instruction Manual Version 4 01 Page45 Measurementand Special Functions combi E Li 3 5 Operation Menus The software offers different useful functions which can be selected by the operator The menus can be selected by the corresponding PROGRAM key and functions can be selected by the numerical keys The functions are sorted into three submenus OPERATION SERVICE TEST and STANDARD DATA Some functions can only be carried out when the Combiline is already warmed up In the Software overview those functions are marked with a star see figure 13 and further descriptions STAND BY PROGRAM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE K ACTIVE MEASURE NA ACTIVE CA ACTIVE CL ACTIVE L
60. bration BGA Purpose Carry out 3 5 1 4 Calibration ISE Purpose Carry out This function cannot be performed during WARM UP PHASE Not accessible for type Combiline ISE A manual start of calibration for pO and pCO Sensors only It can be necessary after pO pCO Sensor maintenance installation of a new pO or pCO Sensor e Press the 3 key to perform the Calibration for pO and pCO Sensors only A dialogue appears indicating CALIBRATION for SOLUTION BGA 1 3 SOLUTION BGA 2 4 and GAS When the calibration process is finished the STAND BY dialogue ap pears The time for the next automatic calibration is set to 90 MIN For further information refer to chapter 3 5 1 2 This function cannot be performed during WARM UP PHASE Not accessible for type Combiline BGA A manual start of calibration for ISE Sensors only It can be necessary after an ISE Sensor maintenance after installation of any new ISE or pH Sensor after exchange of membrane shells of the concerned sensor e Press the 4 key to perform the Calibration for ISE Sensors A dialogue appears indicating CALIBRATION for SOLUTION CAL3 SOLUTION CAL4 or CAL4 M When the calibration process is finished the STAND BY dialogue ap pears The time for the next automatic calibration is set to 90 MIN For further information refer to chapter 3 5 1 2 combilse Instruction Manual Version 4 01 Page49 Measurement and Special Functions combi E Lin
61. ction Manual Version 4 01 Measurement and Special Functions combi E Line 3 5 1 7 Economy Mode Activation of Economy Mode Inactivation of Economy Mode MEAS Sensor voltage of the last measurement BGAL Concentration of low level calibration material referring to the values of pCO of BGA 1 3 BGAH Concentration of high level calibration material referring to the values of pCO of BGA 2 4 The Economy Mode serves for saving reagents in times of low operat ing rate of the Combiline In the Economy Mode calibrations are carried out in an interval of four hours only While the Combiline is operated in the Economy Mode measurements cannot be carried out directly e Press the corresponding ECONOMY PROGRAM key to activate the Economy Mode in STAND BY dialogue The following dialogue ap pears ECONOMY MODE QUIT 14 17 CAL 240 MIN e Pressing the corresponding QUIT key the Combiline returns to STAND BY mode In Economy Mode calibration cycles are prolonged from 90 to 240 min utes If you are leaving the Economy Mode the Combiline carries out a calibration cycle if the last cycle has been finished more than 90 minutes ago is at once ready for measurements if the last calibration cycle has been finished within 90 minutes combilse Instruction Manual Version 4 01 Page55 Measurement and Special Functions combi E Lin 3 5 2 SERVICE TEST Menu 3 5 2 1 Test pCO Sensor vol
62. d e g oximeter Page 50 combi amp se Instruction Manual Version 4 01 combi E Line Carry out Hb Activation NOTE HB SENSOR HBR HBT 0 970 0 517 MESS mV 1182 320 printout of Hb sensor parameter HB R Reflexion factor HB T Transmission factor MESS Hb sensor voltages for Reflexion and Transmission measurement of the last sample measurement in millivolt The use of Hb calibration is not required anymore only the input of two parameters forrefexion and Transmission HB R and HB T is necessary After setting the Combiline into operation sensor related parameters have to be entered by keyboard After that the Hb sensor is active for measurement These parameters HB R and HB T are printed ona white flag at the Hb sensor cable The sample volume required for a fully equipped Combiline BGA E HB is min 210 240ul The sample volume required for a combiline BGA HB is approx 160u1l So it is of particular relevance to use capillaries with adequate volume Prerequisite for accurate and reproducible measurement of tHb is a sufficient heparinization of the whole blood sample with 60 80 IU ml Coagulation onset of the blood sample leads to false in this case too low tHb measurement Please note that this measure method is suitable for measurement of whole blood only Quality controls are not usable The measure range of the Hb sensor is 3 30g dl Hb wi
63. d for BGA 1 3 chapter 3 5 2 1 Difference Supply of BGA 2 4 calibration solution Page 56 combikine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 5 2 3 Test pH ISE Sensor Voltage CAL3 Purpose Carry out test The program gives information about the behaviour of the pH and ISE Sensors The function is not available in Combiline BGA This program indicates the generated Sensor voltages after calibration solution CAL3 has been added The voltages lie within a range of 3 5 V The indicated voltages should be stabilized within approx 60 seconds If not check the transportation of the corresponding Calibration Solution s chapter 3 5 2 9 and the condition of the corresponding Sensors s chapter 3 5 1 6 Voltages over 3 5 V points to air bubbles inside of the Ref Sensor or to a defective membrane of the corresponding Sensor Voltage fluctuations within 5 to 10 mV are normal and not relevant e Press the 3 key to display TEST CAL3 dialogue TEST CAL3 QUIT E PH 136 mV EK 142 mV ENA 960 mV ECA 537 mV E Ll 1012 mV 14 17 CAL 25 MIN Refer to chapter 4 5 and 4 6 ifthe values are out of range Press the QUIT key to return to the STAND BY dialogue 3 5 2 4 Test pH ISE Sensor Volt ISE CAL4 M Proceed as described for CAL3 chapter 3 5 2 3 Difference Supply of CAL4 or CAL4 M calibration solution 3 5 2 5 Test O Sensor Volt
64. d harmonised standards EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use General requirements EN61010 2 08 A1 Safety requirements for electrical equipment for measurement control and laboratory use Particular requirements for laboratory equipment for analysis EN61010 2 101 Safety requirements for electrical equipment for measurement control and laboratory use Particular requirements for in vitro diagnostic IVD medical equipment Emission EN 55011 A2 Industrial scientific and medical radio frequency equipment Emission Class B EN 61000 3 2 Harmonic current emissions EN 61000 3 3 Voltage fluctuation and flicker Immunity EN 61326 1 Electrical equipment for measurement control and laboratory use EMC requirements Industrial requirement EN61000 4 2 Electrostatic discharge immunity test EN 61000 4 3 A1 Radiated radio frequency electromagnetic field immunity test EN 61000 4 4 Electrical fast transient burst immunity test EN61000 4 5 Surge immunity tests EN 61000 4 6 Immunity to conducted disturbances induced by radio frequency fields EN61000 4 11 Voltage dips short interruptions and voltage variations immunity test combitine Instruction Manual Version 4 01 Page 123 combi E Lin 7 4 Declaration of Con formity automatic analysing systems Eschweiler GmbH amp Co KG Holzkoppelweg 35 D 24118 Kiel phone 49 0 431 546580 e mai
65. d in combiline meta only t is absolutely necessary for cleaning the Sample Port the analysis system and at last all tubes Use only original ESCHWEILER Wash Solutions for Combiline analysers otherwise disturbances could appear or CAUTION results could be wrong The Wash Solution Bottle has to be replaced when the message WASH SOLUTION PLEASE CHECK is indicated on Display The empty Wash Solutions Bottle must be used for the Waste Bottle replacement For replacement of Wash Bottle refer to chapter 3 7 2 The WASH2 M SO LUTION Bottle is controlled by a level Sensor The bottle s label indicates the name of the solution and the ordernumber amount charge number storage condition at 18 25 C expiration date CE mark Consumption of Wash Solution WASH1 and WASH2 The Combiline needs for every washing cycle 2 0ml WASH1 or WASH2 Solution Consumption of Wash Solution WASH2 M The Combiline needs for every washing cycle 3 0ml WASH2 M Solution A washing cycle will be performed automatically after every measure ment If there is no measurement requested after 10 min of the last measure ment or calibration process the analysis system will be filled with 0 7ml Wash Solution until the next measurement is requested or a calibration process is started automatically by the software Waste Bottle The Waste Bottle adapter cap is equipped with a level Sensor A full Waste Bottle is indicated on Display WASTE BOTTLE PLEA
66. diments Protein sediments can cause potential changes at the Sen sors regular maintenance measures are therefore necessary combitine Instruction Manual Version 4 01 Page 21 Introduction combi E Lin 1 2 3 Specimen Collection NOTE Use of heparin Procuring a sample Proper extraction and handling of blood samples before the analysis for blood gas analytical determinations are extremely important in order to assure that the measured values received correspond to the actual real blood conditions It is recommended to contact professional workgroups in other hospitals to exchange knowledge and experience with them regularly to be up to date Use only heparinised sample collecting devices syringes or capillaries If the Combiline is equipped with Na Sensor don tuse Na heparin Li Sensor don tuse Li heparin In these cases use ammonia heparin with a concentration of 80 ie ml vol Otherwise corresponding measuring values could be wrong Arterial blood Samples for pH and blood gas analysis are preferably taken from an artery Usually the extraction is accomplished through puncture of the arteria femoralis brachialis or radialis Through catheterizing and sur gical operations however access to other arteries is also possible Use of venous blood samples has found its way into clinical laboratories to some extent but it must be kept in mind that although the material procurement is sim
67. e 3 5 1 5 Activation of Hb Sensor Function Carry out Hb factor input NOTE Hb Sensor activation can be carried out in STAND BY mode only Activation In order to maintain the measuring accuracy for determination of Hband to activate the Hb sensor an input of two factors HB R and HB T has to be carried out in STAND BY mode In case the COMBILINE was switched off for less than 24 hours the Hb factors are retained in the memory and the sensor remains ACTIVE In case the COMBILINE was switched off for more than 24 hours The Hb factors have to be entered as described below the Hb sensor is marked with OFF The mentioned Hb factors are printed on a white flag at the Hb sensor cable see attached photo To activate the Hb sensor e Press the 5 key in OPERATION MENU to perform the Hb calibration process the following dialogue appears HB SENSOR HB R 0 000 HBT Enter the HB R value given on the white ensign at the Hb sensor by keypad e g 0 920 and press the Enter key to confirm The following dialogue appears HB SENSOR HBR 0 920 HBT 0 000 Enter the HB T value given on the white ensign at the Hb sensor by keypad e g 0 592 and press the Enter key to confirm The input range for HB R and HB T is 0 300 to 2 000 For quality control of the Hb Sensor whole blood specimens whose Hb concentration have already been determined with the help of suitable measuring methods may be use
68. e If external damage to the shipping box is evident ask the carrier s agent to be present when the Combiline is unpacked e Check the Combiline and the accessories for external damage such as dents or scratches on the analyser housing If damage is found contact your representative immediately If the shipping box is not damaged check the cushioning material for signs of severe stress as an indication of rough handling in transport Retain the packing material for possible future use See chapter 7 6 for a detailed list combitine Instruction Manual Version 4 01 Page29 Installation combi E Lin 2 2 Operating Condi tions Ambienttemperature 12 Cto 32 C roomtemperature Relative humidity 30 90 no condensation NOTE 2 3 Installation Process A Install the Combiline only in a suitable laboratory establishment Keep the Combiline away from very strong electromagnetic influences Beware the Combiline of mechanical vibrations Place the Combiline in a sufficient distance from the wall so that con nected cables cannot be pinched and the fan can work properly Avoid big temperature fluctuations to protect condensation of water Avoid direct sunlight Avoid direct stream of an air conditioner Install the Combiline so that the access to the mains switch and the mains connection is always possible Proceed the installation process in the following order A I Placement of Combiline e Place the Combi
69. e AaDO parameter is defined as the difference of the oxygen content between the alveolar air and the arterial blood measured pO Range 0 to 800 mmHg Page 80 combitine Instruction Manual Version 4 01 combi E Line HCT Haematocrit Haematocrit is defined as the percentage of red blood cells to the total blood volume Range 0 to 100 Only in connection with an Hb measurement H Hydrogen ion concentration Calculated from the measured pH Range 10 1000 nmol l SHUNT Fraction of venous blood which is not oxygenated while paassing through alveoli in the lung A GAP Concentration difference between measured cations Na and K and the anions Cl and HCO A AGAP Na K Cl HCO A combilse Instruction Manual Version 4 01 Page 81 Maintenance combi E Lin 6 Maintenance NOTE Carry out all maintenance actions in accordance with the safety issues as described in chapter Safety Issues 6 1 Maintenance Sched ule In order to keep up the reliability of the Combiline over a long period of time it is necessary to carry out regular maintenance checks Check maintenance daily weekly quarterly halfyearly s chapter Quality control measurement Check moisture filter bottle Replace Pinch Valve Tubes Check filling level of Liquid Bottles Bags gt Empty Waste Bottle Check Printer Paper replacement Check supply of Printer Paper Check pCO pH calibr
70. e Roller Pump 2 is for test ing of Lactate and Glucose and is available in combiline meta versions only The tubes should be replaced according to the maintenance schedule Figure 32 Roller Pumps For the replacement or installation of the Tubes for the Roller Pump pro ceed as follows e Change to the REAGENT TEST dialogue see chapter 3 5 2 9 e Press the corresponding SUCTION key for about 2 sec to empty the Tubes e Remove the Tubes to be replaced at the Roller Pumps and remove the parts from Liquid System Adapters 1 2 4 5 6 and 7 Roller Pump tube for Reagents RP1 e Put the new Tube to the connectors 2 3 4 and 5 and connect it with the tube at position 3 as shown in figure 32 e Pull the Tube through the lower Tension Block and position both Stop pers into the Stopper section at the back see figure 32 e Carefully pull the Tube over the upper Roller Pump Roller Pump tube for WASH RP1 Page 116 combikine Instruction Manual Version 4 01 Maintenance combi E Line 6 7 Replacement of Sample Port Adapter Put the new Tube to the connector 1 and fit the other into the WASH valve and connect the end with the sample port insert as shown in figure 32 Pull the Tube through the right Tension Block and position both Stop pers into the Stopper section at the front see figure 32 Carefully pull the Tube over the lower Roller Pump Press the 7 key GAS for some seconds to align the tubes Pres
71. e Roller Pump to avoid unnecessary me chanical stress Protect the Combiline with a dust cover during storage or if available use the shipment box combilse Instruction Manual Version 4 01 Page35 Measurement and Special Functions combi E Li 3 Measurement and Special Functions At this point the operator should be familiar with the key func tions introduced in chapter 1 and the Combiline is installed CAUTION properly as described in chapter 2 It is absolutely necessary that only skilled persons should carry out measurements CAUTION Sample introduction Samples could be introduced into the Combiline in several ways by syringe see chapter 3 1 by capillary see chapter 3 2 by Eschweiler aspiration pipe see chapter 3 3 by other containers for blood gas diagnostic Sample volumes required approximately forsyringe approx 500ul in the syringe for capillary combitine BGA 70 85 combikine ISE 50 80ul combitine BGA E 80 140ul combikine BGA 120ul combiline BGA E 100 150 Sample volumes required for analysers with Hb sensor approx forsyringe approx 500ul in the syringe for capillary combilise BGA HB BGA E HB 120 200ul for capillary Combiline BGA HB BGA E HB 200ul The required sample volumes are depending on the number of installed sensors Use heparinized blood only Eschweiler capillaries contain Ammonium Heparin 80 ie ml vol 1
72. e Sensors including Ref Sensor Are the Calibration Bags installed correctly and filled with liquid Are all Calibration Solutions transported free of air bubbles Yes No Be sure that the bags are installed properly Connect Cable Make sure that all Sensor fixed at their positions Remove and open are h h gt Ref Sensor to check zn Sensor Catch is it visually refill Reference Check or replace Roller Membrane Shell Pump Tubes Filling level of Ref Membrane Shell OK Leakage in the Ref Membrane Are any clots of blood some where in the measuring capillary Yes Remove blood clots Install new Ref Reference Membrane ull membrane shell damaged or dirty Are all O rings present at the Sensor Casings he ves install new O rings 0 x 0 8 Let air bubble rise up by tipping against the gt Membrane Shell Reinstall Ref Sensor Air bubble at the bottom of the Ref Sensor Yes see chapter 6 2 No V Check the liquid Valves and the connecting Tubes between Valves and Bags for blockage T N exchange reference i conducting system gt Run Calibration cycle lt Remove blockage of the concerned see chapter 3 5 1 2 Sensor chapt 6
73. e available for the user which make it possible to localize functional disturbances quickly The operability of the Combiline and the Sensors is monitored automatically and continuously Irregularities for example in the function of the Sensors or the supply with working materials are indicated at once 1 2 1 System Overview and Terms The Combiline Dialogue Area consists of LCD Display and Keypad Built in Printer Support Area consists of Wash and Waste Solution Bottle Combiline BGA Waste Bottle BGA1 BGA2 WASH1 Combiline ISE Waste Bottle CAL3 CAL4 M WASH2 Combiline BGA E Waste Bottle WASH2 BGA3 BGA4 CAL3 CAL4 Combiline meta Waste Bottle WASH2 M BGA3 BGA4 CAL3 CAL4 M Combin ti a Analysis Area consists of Sample Port Sensor Array thermostated at 37 0 C Figure 1 Combiline front view Dialogue Area Headline 1 2 3 Display of Menus Display ai Q G 6 Information Zune ons G 8 8 Parameter Feetline Q ESCHWEILER Figure 2 Dialogue Area Page 10 combitine Instruction Manual Version 4 01 Introduction combi E Line LCD Display Keypad Built in Printer Software dialogues are shown by the 16 line 30 characters each LCD Display which is back lighted The contrast is adjusted by the manufac turer and can be readjusted by the Technical Service only The software dialogue appears in four sections on the display The headline upp
74. e false values of the pO pCO and pH Sensors Control the temperature every day because a temperature deviation is not controlled and indicated on display A temperature adjustment should only be done by the Techni cal Service Air pressure The Combiline is equipped with an air pressure Sensor which measures the current atmospheric air pressure for the calibration of the pO Sensor Range 500 900 mmHg SI units selection see chapter 3 5 3 4 The indicated air pressure should be compared with a reference barom eter If there is a deviation of more than 5 mmHg call Technical Serv ice A failure of the measured air pressure leads to a Slope error of the pO Sensor The pO Sensor is calibrated by air The current air pressure is assigned to the measured O value The value is usually approximately 150 mmHg on ocean level 20 9 Vol O depending on air pressure The normal air pressure on ocean level is approx 760 mmHg Page 58 combikine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line Carry out test 3 5 2 7 Test Light Barriers Purpose Carry out test Ranges Reference Voltage The reference voltage of the analog digital converter is 2 048 V The de viation must not exceed 0 020 V Otherwise measure results might be wrong Press the 6 key to display TEST AIR TEMP dialogue TEST QUIT EREF 2048 mV TEMP 37 0 C BP 744 mmHg In
75. e respiration quotient gives the relationship between CO produced and O consumed A standard value of 0 85 is set in the equipment This value can be changed during a measurement between 0 70 and 1 00 if the RQ has been for example determined with a respirometer The standard RQ can be changed in the menu STANDARD DATA SET TINGS TEMP Patienttemperature If no other entry is made the measured values for pO pCO and pH are output for a patient temperature of 37 0 C If the temperature of a patient deviates from this value after the sample is taken the current temperature can be entered during the measurement by keyboard The measuring results are then automatically converted into the temperature entered Influence of the manual entered temperature value The measured pO pCO and pH values will be corrected in depend ence of the entered temperature Temperature is increasing pO pCO values increase pH value decrease decreasing pO pCO values decrease pH value increase combitine Instruction Manual Version 4 01 Page77 Explanation ofTestparameter combi E Lin 5 2 Measured Parameters BP barometric pressure Air pressure BP The current air pressure is measured continuously by an integrated air pressure Sensor The values for pO and pCO depend on the current air pressure This has to be taken into account when the electrodes are calibrated For the measurements the measured air pressure at the
76. e stored in the internal memory now and the following dialogue appears WARM UP PHASE PROGRAM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE K ACTIVE NA ACTIVE CA ACTIVE CL ACTIVE LI ACTIVE GLU ACTIVE LAC ACTIVE HB is OFF HB OFF START It must be activated CALIBRATION manually 10 45 AUTO 54 MIN H Installation of Calibration Solution Bags Type Combiline BGA E installation of Calibr Solution BGA3 BGA4 CAL3 CAL4 Type Combiline meta installation of Calibr Solution BGA3 1 BGA4 CAL3 CAL4 M NOTE Type COMBILINE BGA installation of Calibr Solution BGA1 BGA2 only Type Combiline ISE installation of Calibr Solution CAL3 CAL4 only Press the Slide Bar BGA 1 3 on the Bag Adapter A to open the access to the corresponding metal canula s figure 15 Press the Septum B of the Bag BGA 1 3 against a small resistant over the metal canula Release the Slide Bar BGA 1 3 C The Septum is now fixed by the Slide Bar A light barrier announces the placement to the soft ware so that the Calibration Solution will be sucked in automati cally Proceed as described above for the installation of the remaining Calibration Bag BGA 2 4 Page 32 combitine Instruction Manual Version 4 01 Installation combi E Line Septum of the Calibration A Solution Bag Light B
77. ed The conductive system of the measuring Sensor makes the connection to the outside of the Ca PVC membrane with the electrically conduc tive filling solution The conductive system of the Reference Sensor makes the connection to the inside of the PVC membrane by electri cally conductive electrolyte solution of the Reference Sensor and the added specimen With this connection the potential difference won through a specimen Ca x at the PVC membrane is conducted to a measuring amplifier and displayed 1 25 mmol l Amplifier Reference Sensor 40 5 10 00 conducting system 50 5 10 10 Cat Sensor 50 3 30 00 inner electrolyte Ca o filling solution 50 3 30 35 ref filling solution 50 5 10 35 ref membrane shell 50 5 10 30 conducting system 50 3 3010 diaphragma membrane measuring capillary with specimen Ca x Ca PVC membrane shell 50 3 30 30 Figure 25 Set up of the Ca measurement chain combikine Instruction Manual Version 4 01 Page 107 Maintenance combi E Lin 6 2 9 Principle of Cl meas urement The principle of the Cl measurement is based on the fact that at a PVC membrane which is permeable for Cl ions an electrical potential differ ence occurs when this membrane separates two solutions with different Cl values The resulting potential difference voltage ECI is propor tional to the difference of the Cl ion concentrations for the two solu tions UCI
78. emove the connected Cable from the Sensor Remove the Sensor forwards 1 from the Sensor Array and lift it up 2 see figure 17 aa le Figure 17 Sensor removal steps combilse Instruction Manual Version 4 01 Page85 Maintenance combi E Li 6 2 2 Installation of NOTE Sensors Sensor cable ID Hb sensor with input module XE afln N gt ee Sensor Catch Figure 18 Sensor Array Proceed as follows e Run REAGENT TEST s chapter 6 2 1 menu during installation e Set the Sensor into the Sensor Array with the grip to the front 1 Pay attention to the Sensor position and don t damage the O Ring Sensor D clip aluminium plate Figure 19 Sensor installation steps The Sensor must perceptibly click into place at the rear 2 3 Install further Sensors into their positions as described During installation make absolutely sure that all Sensors are clicked into the Sensor Array and their specimen channels form one continuous capillary e Close Sensor Catch by pushing it in closed position e Connect the appropriate Cables with the Sensors and pay attention to the identifications e Check the liquid flow using Wash function 2 key or BGA 3 3 key If the liquids transport function is ok the liquids will be transported into the Waste Bottle If not a transportation malfunction is evident Check Sensor installation and go as described e Close the
79. er section indicates the analyser status and actions e g STAND BY WARM UP PHASE CALIBRATION DATA etc In the middle section between headline and feetline the software indi cates Software menus measured results system parameter etc The feetline lower section indicates the system time on the left side e g 14 27 and the timer countdown for the next automatic system calibration e g CAL 25 min on the right side The right section indicates functions to be carried out by pressing the corresponding right hand Soft Key like e g OPERATION START CALI BRATION QUIT etc 000 numerical keys 9097 090 00H decimal point key clear data key ENTER key Figure 3 Keypad With the numerical keys all number entries can be made in dialogues except during measurement Forexample sample identification number FIO and RQ values values for configuration of the analyser such as calibration parameter or time and date Decimal point key With this key commas and decimal points required for numerical en tries can be entered Clear data key With the correction key C numbers entered in an activated menu can be deleted This makes a new entry possible without opening the dia logue again The built in printer and its thermal paper 56 mm wide are located on upper side of the Combiline A red stripe on the left side of a print out indicates that the paper supply is only sufficient for a few more print outs For
80. erialNumber Volt Operating voltage VA Max power consumption Hz Power frequency Manufacturer Address Internet Address Model variations Combiline BGA BGA Blood gas Combiline ISE ISE Electrolytes Combiline BGA E BGA ISE Combiline BGA HB equipped additionally with Hb Sensor Combiline BGA E HB equipped additionally with Hb Sensor Combiline meta equipped additionally with metabolites Combiline meta HB equipped with metabolites and Hb Sensor The system is protected against overheating by two cooling fans They are running continuously At the rear side of the Combiline one fan is equipped with a dust filter which has to be replaced regularly see chapter 6 5 Page 20 combi amp se Instruction Manual Version 4 01 Introduction combi E Line RS232 Interface Labels 1 2 2 Functional Descrip tion The Serial interface RS232 can be used for the data transfer to the host computer Refer to chapter 7 7 for the interface description A yellow label is located at the Mains Connector to indicate high volt age A white blue label indicates T V SUD i e the analyser is tested about safety The Liquid System is a closed system in which calibrations will be per formed automatically in programmed cycles Calibration Solutions Air and Wash Solution are transported through the Sensor unit by a Pump and several Control Valves The transportation of a sample and other solutions is guaranteed by a
81. ersion 4 01 Maintenance combi E Lin 11 Push the filled casing onto the Sensor with slight twisting move ments Illustr h Don t close the ventilation hole with your fin MR if Illustration h 12 Wipe off the outside of the Sensor and casing with a bit of Elec trode Cleaner and a lint free cleaning tissue Then close the ventila tion hole with a piece of yellow tape which is delivered together with the pre membraned casings 13 Then clean the inside of the Sensor casing as well with a bit of Electrode Cleaner and a lint free cellulose cloth Attention Don t drop electrode cleaner directly into the casing the casing could be torn partly caused by evaporation coldness 14 Put the inside part into the casing from the top and twist slightly to the right or left until it clicks into the torsion protector Illustr i Illustration i 15 Screw the cap onto the Sensor and tighten it slightly Illustr a 16 Installthe regenerated Sensor into the thermostat See chapter 6 2 2 Installation of Sensors 17 Runacalibration cycle START CALIBRATION or CALIBRATION BGA As the Sensors in the Combiline operate at a working temperature of 37 0 C a warming up period of about 30 minutes is recommended after regeneration combi amp se Instruction Manual Version 4 01 Page 97 Maintenance combi E Lin 6 2 5 Principle of pO measurement according to Clark
82. ersion 4 01 Page 109 Maintenance combi E Lin 6 2 11 Reference Sensor Filling solution We recommend replacing the filling solution of the Reference Sen sor every three months t has to be changed at the latest when the electrode voltages UK1 and Uk2 in particular that of the pH Sensor see Sensor Parameter exceed 3Volt or 3V Conducting system The reference conducting system basically requires no maintenance however it must not stand dry over a longer period of time several hours The reference conducting system absolutely must always be cov ered with sufficient filling solution even including inside the refer ence Sensor casing Otherwise the function of the Reference Sensor will be impaired This generally leads to slope errors of the pH and ISE Sensors or to distortion of the measured values The level of the filling solution should be checked every four weeks and filled up as needed Reference casing with membrane The reference membrane casing has an average life span of approx six to nine months depending on the number of specimen measurements which are carried out It has to be replaced at the latest when the elec trode voltages UK1 and UK2 of the ISE and pH Sensors see Sensor Parameters exceed 3Volt or 3V or when slope errors are indicated for these Sensors fixing Screw cap Reference conducting system 505 10 10 Reservoire for reference Sensor casing 40 5 10 50 Reference membrane s
83. ethod has been largely replaced through the capillary technique Page 22 combikine Instruction Manual Version 4 01 Introduction combi E Line Storage of the samples Arterialized capillary blood Procuring of arterialized capillary blood from the periphery is relatively simple Capillary blood which is extracted after hyperaemia through puncture of the skin corresponds in its composition with arterial blood since it comes mainly from arteriols The skin is preferably punctured in the ear lobe in infants in the heel The blood must flow freely and in suf ficient quantity The point of extraction should not be pinched because this leads to the addition of blood from the venol and of tissue fluid dis torting the results Local hyperaemia can be achieved mechanically thermically or chemi cally Chemical hyperaemia using Finalgon salve or Rubriment oil has been proved very effective After application it should be allowed to re act for 5 10 minutes then rubbed off with dry tissue paper then wiped off with 70 80 alcohol After the puncture using a one way stiletto dis card the first drop and catch the blood which then flows out spontane ously in heparinized capillaries free of air bubbles Capillaries Extraction is done according to the method recommended by Siggard Andersen The horizontally held capillary is introduced into the middle of the drop of blood to avoid contamination with air The capillaries are c
84. for mixing of the specimen end caps to close the capillary magnet to pull the stirrer out of the capillary combilse Instruction Manual Version 4 01 Page41 Measurement and Special Functions combi E Lie 3 3 Quality Control Test CAUTION CAUTION The Quality Control mode is used for the measuring of quality control solutions In principle all blood gas or blood gas electrolyte control so lutions can be used according to the instructions of their manufacturers Pay attention to country specific guidelines for quality control regula tions The use of control materials makes it possible to evaluate the Combiline regarding the correctness and accuracy of the measuring results For input of Quality Control material from ampoules the use of a special ESCHWEILER Aspiration Pipe order no 50 6 30 50 is necessary see figure 15 Aspiration Pipes are included in the accessories of the Combiline Aspiration Pipe order no 3 7 200 Ampoule Holder order no 50 6 30 55 Ampoule with control material Figure 15 Aspiration Pipe To introduce the control material proceed as follows Keep ampoule holder and aspiration pipe ready Before measuring shake the ampoule for 10 seconds to mix the con tents Restore the control to the bottom ofthe ampoule by gentle tap ping Protect fingers with tissue paper or gloves to avoid injury Snap the ampoule open Observe the suggestions in the package inserts for a
85. h is to be determined The conductive system of the measuring Sensor makes the connection to the outside of the K PVC membrane with the electrically conductive filling solution The conductive system of the Reference Sensor makes the connection to the inside of the PVC membrane with the electrically conductive electrolyte solution of the Reference Sensor and the added specimen With this connection the potential difference won through a specimen K x at the PVC membrane is conducted to a measuring am plifier and displayed 4 5 Amplifier mmol l EK Reference Sensor 40 5 10 00 conducting system 50 5 10 10 Kt Sensor 50 3 10 00 inner electrolyte K o filling solution 50 3 10 35 ref filling solution 50 5 10 35 ref membrane shell 50 5 10 30 conducting system 50 3 1010 diaphragma membrane measuring capillary with specimen K x K PVC membrane shell 50 3 10 30 Figure 23 Set up of Kt measuring chain combilse Instruction Manual Version 4 01 Page 103 Maintenance combi E Line 6 2 6 1 Exchange of the ISE Sensor Mem brane Shell To exchange a membrane shell or conducting system of one of the ISE Sensors K Ca CF Li proceed as follows ing level weekly If necessary fill it up Check also the con 7 To assure a perfect function of the ISE Sensors check the fill ducting system regarding its coat colour It should be brown Check the Na Sensor
86. he inside part vertically onto the prepared leather cork and clean and polish with light pressure and for about 20 circular movements on the leather Illustr e Illustration e 8 Wipe off the shaft and the glass membrane with a bit of Electrode Cleaner order no 50 6 10 84 and a lint free cellulose cloth Illustr C combitine Instruction Manual Version 4 01 Page91 Maintenance combi E Line 9 Clean the inside part of the casing with a bit of Electrode Cleaner and a lint free cellulose cloth Attention Don t drop electrode cleaner directly into the casing the casing could be torn partly caused by evaporation coldness 10 Put the inside part into the casing from the top and screw the cap onto the Sensor and tighten it slightly Illustr f Illustration f 11 Return the cleaned Sensor into the Sensor Array as described in chapter 6 2 2 Installation of Sensors 12 Carry out a calibration cycle Run START CALIBRATION or CALIBRATION ISE only As the Sensors in the Combiline operate at a working temperature of 37 0 C a warming up period of about 30 minutes is recom mended after regeneration see function Air Temp Page 92 combitine Instruction Manual Version 4 01 Maintenance combi E Line 6 2 4 Principle of pCO measurement according to Severinghaus Determination of the pCO is based on the principle of an indirect pH measurement Here the pH val
87. he manufacturer settings The analyser demands the input of the parameter for the Calibration Solutions BGA 1 3 and BGA 2 4 The WARM UP PHASE dialogue appears as shown below WARM UP PHASE PROGRAM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE K ACTIVE NA ACTIVE CA ACTIVE CL ACTIVE LI ACTIVE GLU ACTIVE LAC ACTIVE HB OFF START CALIBRATION 10 45 AUTO 54 MIN Page 26 combiline Instruction Manual Version 4 01 Introduction combi E Line Calibration cycle The dialogue indicates which Sensors are installed and if they are set to ACTIVE or not Refer to chapter 3 5 3 6 Sensor Selection for an activa tion inactivation of Sensors The feet line indicates the real time and an automatic Calibration will be done in e g AUTO 54 MIN after warming up count down timer By pressing the corresponding OPERATION key again and again you can select one of the following submenus OPERATION SERVICE TEST STANDARD DATA to carry out different functions see software overview figure 13 Func tions which are marked with a star cannot be carried out during warming up By pressing the corresponding START CALIBRATION soft key you can shorten the WARM UP PHASE Use this function only after powering up again when the analyser is already warmed up A calibration cycle will be performed at once After that the STAND BY dialogue appears The Combiline will not allow a measurement during
88. hell with membrane 50 5 10 30 Reference Sensor casing 50 5 10 20 Figure 28 Reference Sensor complete Reference Sensor complete 40 5 10 00 Page 110 combiline Instruction Manual Version 4 01 Maintenance combi E Lin For Replacement of the Reference Membrane casing proceed in the following order 1 Toreplace the Reference Membrane casing remove the Refer ence Sensor as described in chapter 6 2 1 Removal of Sensors 2 Unscrew the cap and pull it upward off 3 Take the now loose inner part completely out by lifting it up out of the Sensor casing 4 Unscrew the reference conducting system It mast not dry out over a longer time 5 Spin out the filling solution use a paper towel to catch the solu tion 6 Pull the used membrane casing off the attachment 7 Push a new Reference Membrane casing over the O ring of the attachment 8 Fill the casing and membrane shell through the upper opening of the attachment almost completely with reference filling solution 50 5 10 35 If there are any air bubbles directly above the mem brane cause them to rise by tapping on the outside of the mem branecasing Air bubbles at this location cause slope error indica tions for the pH and ISE Sensors 9 Screw the conducting system into the upper opening of the at tachment Attention Filling solution can be spilled out 10 Clean the Sensor casing inside with a lint free cl
89. icated with SLOPE error as well Activate REAGENT TEST to check transportation of Cal Solutions BGA 1 2 3 4 chapt 3 5 2 9 PO SLOPE Print out Sensitivity of pO gt SENSOR PARAMET for control purpose nsor f ran Sensor out of range chapter 3 5 1 6 Yes Are all Calibration Solutions transported free of air bubbles Calibration Bags installed correctly and filled with liquid Sensor Cable connected to the Sensor Yes No No Make sure that the Yes Connect Cable gt bags are properly lt installed s 3 2 No indicated air pressure gt Air pressure sensor must be checked by T Service Remove and open Sensor to check it visually Make sure that all Sensors are fixed at their positions No and that Sensor Catch is Filling level of Membrane Shell OK Install new closed Is Sensor unit dry Membrane Shell Check or replace roller from outside N pump Tubes Runa washing cycle Are any Membrane Mes Run Protein Yes_ Ciots of blood some or Sensor casing dirty or entspr Teile 7 Removal where in the measuring damaged from neve Check liquid capillary outside i system Membrane older Are all than three month install new O rings O rings present at
90. ing the ENTER key combilse Instruction Manual Version 4 01 Page63 Measurement and Special Functions combi E Lin 3 5 3 3 Correlation Purpose Carry out function Acolon appears behind DAY Enter the day by the numerical keys and press ENTER key to con firm The colon now appears behind MONTH The input has to be made as described above The new Date and Time is stored in the memory The Time is indicated on the display Date and Time are printed out to gether with measured values Sensor parameters and status print out Setting of Correlation factors This dialogue can be used if you are in tended to bring the COMBILINE into line with another analyser You have to compute the correlation factors by yourself e Press 3 key to display the Correlation factor dialogue CORRELATION PO2 1 000 PCO2 1 000 PH 0 000 K 1 000 NA 1 000 CA 1 000 CL 1 000 LI 1 000 HB 1 000 14 17 CAL 25 MIN Parameter range pH 0 050 all other 0 800 to 1 200 20 Enter the factor behind the colon and press ENTER key to confirm Note for pH factor If a correlation factor is entered press the ENTER key to confirm PLUS and MINUS will appear The entered value will be added or subtracted from the result Press corresponding key for setting of PLUS or MINUS addition or subtraction Page 64 combikine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line
91. key 11 Conducting system 103 Consumption of Calibration Solutions 16 Consumption of Wash Solution 16 D Decimal point 11 Display contrast 12 Douglas Pouch 44 duration of a calibration process 27 E end caps 41 F Fan 19 G Guarantee 125 H Hb 79 HB R 49 HB T 49 Hb Sensor 49 50 51 HCO3 A 80 HCO3 S 80 HCT Haematocrit 80 l Input of Patient Data 39 p50 Semi saturation pressure 80 Patient temperature 39 77 pCO2 78 pH 78 pO2 78 Power frequency 20 Power Requirement 20 Protein deposits 59 Protein Remover 59 Q QC level 43 R RANGE 47 range error 83 realtime 27 Relative humidity 30 Repairs 8 replacement 8 RESET 26 RESTART 26 S Sample count 52 Sample introduction 36 SBE Standard base excess 80 SD Card 19 sensitivity of the Sensor 83 Sensor Array 12 Sensor Catch 85 SENSOR PARAMETER 52 Page 130 combitine Instruction Manual Version 4 01 Appendix combi E Line Septum 15 Slide Bar 15 SLOPE 47 52 70 83 slope error 73 74 75 76 Software Overview 25 stability 83 T TCO2 80 Type Plate 20 V vacutainers 9 Ventilation of the Tube System 34 W WARM UP PHASE 26 Wash Solution Bottle 17 Waste Bottle 17 combikfine Instruction Manual Version 4 01 Page 131 Appendix combi E Lin Notices Page 132 combitine Instruction Manual Version 4 01
92. l info eschweiler kiel de fax 49 0 431 549423 homepage www eschweiler kiel de Declaration of EC Conformity as defined by EC In Vitro Diagnostica IVD directive 98 79 EG Eschweiler GmbH amp Co KG Holzkoppelweg 35 D 24118 Kiel Germany declares that the product Description blood gas electrolyte and metabolite analysers Model ESCHWEILER combi Line to which this declaration relates is in accordance with the provisions of the following directives 2004 108 EG Electromagnetic Compatibility 2006 95 EG Low Voltage Directive Applied harmonised standards EN 61010 1 Safety requirements for electrical equipment for measurement control and laboratory use General requirements EN 61010 2 08 A1 Safety requirements for electrical equipment for measurement control and laboratory use Particular requirements for laboratory equipment for analysis EN 61010 2 101 Safety requirements for electrical equipment for measurement control and laboratory use Particular requirements for in vitro diagnostic IVD medical equipment Emission EN 55011 A2 Industrial scientific and medical radio frequency equipment Emission Class B EN 61000 3 2 Harmonic current emissions EN 61000 3 3 Voltage fluctuation and flicker Immunity EN 61326 1 Electrical equipment for measurement control and laboratory use EMC requirements Industrial requirement EN 61000 4 2 Electrostatic discharge immunity test EN 61000 4 3 A1 Radiated radi
93. l l 9 008 mg dl Slope ranges GLU 30 300 LAC 30 300 Measurement Successive measurement of Hb BGA ISE and Metabolites Sensors are not allowed to be kept dry for more of 1 hour af ter activation Otherwise Sensors may get damaged irrevers ibly Figure 30 Biosensor backside and front side view Page 112 combikine Instruction Manual Version 4 01 combi E Line Installation Measurement CAUTION Figure 30aBiosensor module White plastic screw is unlocked Glucose sensor is out of working position After unpacking immediately install the sensors into the Metabolite sen sor unit upper slot Glucose sensor lower slot Lactate sensor Before installation activate the REAGENT TEST program in menue SERVICE key 9 Then press key 7 Gas to to empty the measuring cell To install the sensor strips loosen the corresponding screw at the Metabolite sensor unit and remove the old sensor strip by pulling it out to the right side Then carefully insert the new sensor strip Attention Do not displace the O ring 5 0x1 0 inside the Metabolite sen sor unit Fasten the screw again Then stop the REAGENT TEST with the QUIT key Metabolite sensors will automatically be filled with WASH2 M solution for conditioning then The Metabolite Sensors need approx 120 minutes for conditioning and activation of the enzyme membranes After conditioning and calibration the sensors are ready for use Successi
94. line on a suitable laboratory table Positioning and Control of Tubes Open the Orange Cover See figure 4 The two Roller Pump tubes are in a parking position to avoid me chanical stress e Proceed as described in chapter 6 8 and figure 32 for a proper installation of the Roller Pump tubes e Check if all visual tubes are free and do not pinch or snap The Sensors are already installed by the manufacturer and they are ready for operation See figure 4 and 7 Installation and control of the Waste Solution Bottle There is an unlabelled empty Bottle supplied for the collection of waste liquids pre installed by the manufacturer see figure 14 Check if the cap is placed properly Installation of the Wash Solution Bottle Replace the empty Wash Solution bottle with a new one supplied with the Combiline Unscrew the cap the bottles for Combiline BGS E are supplied without screw cap The cap will be used later to close the full Waste Bottle after its replacement The Wash Solution bottle is closed by an aluminium film coat Cut the aluminium film crosswise with a scalpel and push the cut film into the bottle Lift the Wash Bottle Adapter equipped with a long plastic tube Insert the tube into the Wash Solution Bottle and put the Adapter flushing over the Bottle see figure 14 Power Connection e Verify whether the Combiline meets the local power require ments as described in chapter 1 2 1 under Power requirement
95. ll be measured if the sample light barrier detects a whole blood sample Otherwise the programmed standard Hb value is displayed e g 15g dl and used for the calculation of the acid base parameters In case of too less sample volume a Transmission voltage of 4 000V is detected The displayed Hb value will be 0 0g dl then This can be observed on a sensor parameter printout which can be made after a sample measurement See sensor parameter printout combilse Instruction Manual Version 4 01 Page51 combi E Lin Hb factors HB R and HB T fi Hb sensor type II Hb sensor type II installed in combiline Page 52 combitine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 5 1 6 Sensor Parameter Purpose Carry out Sensor parameters This function cannot be performed during WARM UP PHASE The Sensor parameters give information about the current status con dition of the Sensors They are expressed in percent Check the Sensor parameters as described in the Maintenance sched ule or in case of any malfunction Additionally the software revision number and the actual sample count is printed Press the 6 key to display the Sensor parameters the following dis play appears SENSOR PARAMETER QUIT 02 140 co2 70 PH 99 PRINT K 91 NA 96 CA 89 CL 91 LI 82 GLU 127 LAC 97 15 47 CAL 25MIN SLOPE in sensitivity of the Sensor It is comp
96. losed after being filled and the blood thoroughly mixed with heparin The two ends of the capillaries are closed with plastic caps and the capillaries are then rolled between the palms of the hands This assures an excellent mixture of blood and heparin See chapter 3 2 In storing the samples it must be kept in mind that metabolism contin ues to take place after extraction For the metabolism of the cells espe cially the leukocytes sour metabolites e g milk acids are formed which alter the acid base parameter The degree of this acid formation depends on the number of leukocytes and especially on the tempera ture With a normal number of 5000 10 000 leukocytes mm blood analysis should take place within 15 20 minutes Through cooling at 0 4 C the period can be extended up to 2 hours Furthermore the pCO will fall be cause of the temperature reduction so that the gas exchange is facili tated by the lower partial pressure slope to the atmosphere If in the case of longer storage below the measuring temperature the plasma is separated and the measurement is then carried out at a higher temperature the results are a higher pH value and lower gas val ues than in whole blood The logical consequence is that the erythro cytes must be resuspended before warming up to measuring tempera ture that is before the sample is put into the analyser combitine Instruction Manual Version 4 01 Page 23 Introduction combi E Line 1
97. lue is value is out of range lt 0 4 or gt 2 5 Page 40 combitine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line ESCHWEILER COMBILINE II NAME 1226250310 DATE 12 26 25 03 10 BP 760 mmHg TEMP 37 0 HB 14 2 g 0 1l HCT 42 6 FIO2 20 9 RQ 0 85 PO2 90 0 mmHg PCO2 39 0 mmHg PH 7 410 H 38 9 nmol l K 4 5 mmol l NA 144 mmol l CA 1 23 mmol l CA7 4 1 24 mmol l CL 100 mmol l LI 1 4 mmol l GLU 3 20 mmol l LAC 2 55 mmol l HCO3A 23 9 mmol l HCO3S 24 2 mmol l BE 0 8 mmol l SBE 0 1 mmol l TCO2 24 9 mmol l BB 48 3 mmol l O2SAT 96 9 O2CT 19 8 P50 26 55 mmHg AADO2 16 0 mmH A GAP 24 6 mmol SHUNT 44 ACID BASE STATUS NORMAL RANGE Patient ID number Date and Time List of measured and calculated results Figure 14 Print out of Results example for combi amp ne BGA E 3 2 Accessories for cap illaries For combifine the following capillary size is required capillaries 8cm 100ul for analysers up to 3 test parameters capillaries 10 cm 125ul for analyser sup to 6 test parameters capillaries 12 cm 150ul for analysers up to 11 test parameters capillaries 14 cm 175ul for analysers with Hb up to 9 parameters capillaries 16 cm 200uI for all analysers with Hb up to 11 parameters The capillaries are coated with ammonium heparin 80 i e ml For a storage of filled capillaries following additionals are available magnet stirrer
98. measuring capillary as long as the button is pressed SP VE1 VE2 BL VG WASH Wash Solution will be transported through the meas capillary as long as the button is pressed RP BL VG VE1 BGA 3 Calibr Solution BGA 3 will be transported through the meas capillary as long as the button is pressed RP BL VG ABS VE1 BGA 4 Calibr Solution BGA 4 will be transported through the meas capillary as long as the button is pressed RP1 BL VG ABS VE1 CAL3 Calibr Solution CAL 3 will be transported through the meas capillary as long as the button is pressed RP BL VG ABS VE1 CAL 4 Calibr Solution CAL 4 M will be transported through the meas capillary as long as the button is pressed RP1 BL VG ABS VE1 GAS AIR will be transported through the meas capillary as long VALVE as the button is pressed RP VG BL ABS VE1 combilixe Instruction Manual Version 4 01 Page 61 Measurement and Special Functions combi E Lux 3 5 3 STANDARD DATA Menu 3 5 3 1 Calibration Data Purpose CAUTION META WASH2 M is transported through the metabolite sensors RP1 RP2 BL VG ABS VE1 META Abbreviation description RP Roller Pump SP Suction pump BL back light VG valve array ABS ABS valve VE1 VE1 valve VE2 VE2 valve In case of liquid transport trouble check liquid system about blockage or leaks sensor positioning and installation Sample Port if it s open Se
99. med or skipped by pressing the ENTER key Acolon appears behind the patient number e Enter the number desired by numerical keys max 8 figures e Change or confirm the number by pressing the ENTER key Acolon appears behind TEMP Enter the current patient temperature and press ENTER key to con firm Acolon appears behind HB Enter the current Hb concentration and press ENTER key to confirm value is ignored when an active Hb Sensor is present A colon appears behind FIO e Enter the current FIO value and press ENTER key to confirm Acolon appears behind RQ Enter the current RQ value and press ENTER key to confirm not available for Type Combiline ISE The INPUT dialogue disappears The measurement process starts now After approximately 45 sec the measured results are indicated and printed out automatically see the following dialogue MEASUREMENT QUIT PO2 90 0 HCO3 23 9 PCO2 39 0 HCO3S 24 2 PH 7 410 BE 0 3 K 4 5 SBE 0 1 NA 144 TCO2 24 9 CA 1 23 PB 48 3 CL 100 O2SAT 96 9 LI 0 45 O2CT 19 8 GLU 3 20 P50 26 55 LAC 2 55 AADO2 16 0 A GAP 24 6 H 41 0 SHUNT 4 4 CA7 4 1 22 During indication of results the sample will be washed out of the Sensor capillary and the STAND BY dialogue appears combilse Instruction Manual Version 4 01 Page 39 Measurement and Special Functions combi E Li 3 1 1 Display and Print Re sults STAND BY PROGRAM PO2 ACTIVE PCO2
100. n electronically controlled Roller Pump and with help of light barriers By pressing the MEASURE soft key the system prepares for the intro duction of a sample by the use of a Syringe or Capillary Further instruc tions about the procedure will be shown on display A Capillary is coupled to the Liquid System metal canula automati cally by the Sample Port Guide The suck in of the sample will take place automatically after pressing the ENTER key A Syringe is coupled in the same way but the sample must be injected into the Port manually The measuring process is normally completed after 45 60 seconds the results are shown automatically and are printed out The sample material or in the case of a calibration the Calibration Solu tion will be sucked out by a Vacuum Pump and is guided into the Waste Bottle with the help of Control Valves After a measurement an automatic washing cycle takes place in order to clean Tubes Sample Port and Sensor capillaries The Vacuum Pump produces only a low pressure no liquid is trans ported through for the fast disposal of sample material Wash or Cali bration Solution Moisture that possibly reaches the Vacuum Pump is intercepted by the Moisture Absorber this must be controlled regularly and emptied manu ally if necessary by the service stuff While transporting liquids the Sensor Array is background illuminated in order to be able to recognize disturbances in the flow as well as se
101. n exact use ofthe quality controls Note that quality control material can be biological material Put the Aspiration Pipe with Ampoule Holder over the ampoule as shown in the figure 15 and immediately introduce the control into the analyser according to the following instruction Blood Gas control material should be sampled immediately after opening to avoid evaporation Page 42 combitine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line Test procedure Proceed in principle as described in chapter 3 1 Using a Capillary for a QC measurement STAND BY PROGRAM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE K ACTIVE MEASURE NA ACTIVE CA ACTIVE CL ACTIVE Ll ACTIVE QC GLU ACTIVE LAC ACTIVE HB ACTIVE RESPIRATION GAS 12 15 CAL 45 MIN Pressthe corresponding QC key and the following dialogue appears PLEASE WAIT FOR SAMPLE INPUT REQUEST QC LEVEL 1 INSERT ADAPTER IN THE SAMPLE PORT LEVEL 2 AND SELECT LEVEL LEVEL 3 LEVEL 4 12 15 CAL 45 MIN Insert the Aspiration Pipe like a capillary into the Sample Port until the first resistant to adapt the metal canula Selection ofa QC level LEVEL 1 acidosis LEVEL 2 normal LEVEL 3 alkalosis LEVEL 4 highpO Press the corresponding LEVEL key to select the QC Level The QC material is aspirated automatically out of the ampoule now Follow the inst
102. n only made disappear after a successful calibra tion cycle Sensors that are inactivated OFF will not be calibrated The average length of time needed for a full calibration cycle is approx 4 5 minutes Type Combiline BGA or ISE it takes only about 3 minutes During the calibration the voltage values of the Sensors or the current of the pO Sensor which are generated by the Calibration Solutions are stored in the internal memory The values of the Calibration Solutions which are also stored in the in ternal memory are assigned to the measured electrode signals Thus when an unknown sample is measured conclusions can be drawn on the basis of the electrode signals about the partial pressure values and ion concentrations present in the sample The STAND BY dialogue appears when the calibration process is per formed The countdown timer shows the time for the next automatic cali bration process A manual started calibration process cannot be cancelled If an error occurs during a calibration status messages are shown in the dialogue Error messages which can appear after calibrations are SLOPE sensitivity of a Sensor The messages appear with designation of the corresponding Sensor For further information on calibration error their avoidance and correc tion see chapter 4 Error messages Page 48 combiline Instruction Manual Version 4 01 Measurement and Special Functions combi E Line 3 5 1 3 Cali
103. nce values refer to K D rner Klinische Chemie und Haema tology Enke Verlag Stuttgart 3 Auflage 1999 Parameter Unit Measure Range Reference Range pO mmHg 0 800 65 100 kPa 0 107 8 66 13 33 pCO mmHg 5 200 35 48 male 32 45 female kPa 0 66 26 6 4 66 6 4 male 4 26 6 0 female pH 6 0 8 0 7 36 7 44 K mmol l 0 0 20 0 3 5 5 1 Na mmol l 20 250 135 145 Cat mmol l 0 0 5 0 1 12 1 32 Cl mmol l 20 250 97 100 Lit mmol l 0 40 5 0 GLU mmol l 0 0 30 mg dl 0 0 545 LAC L mmol l 0 0 20 mg dl 4 5 180 tHb g dl 3 30 13 3 17 7 male 11 7 15 7 female Baro pressure mmHg 500 900 kPa 66 7 120 Table 2 Reference values for adults The above listed reference values refer to adults for new born babies and children values can be different Detailed information is given in the above mentioned literature and chapter 7 8 combitine Instruction Manual Version 4 01 Page79 Explanation ofTestparameter combi E Lin 5 3 Calculated Param eter HCO A Actual plasma bicarbonate concentration Parameter for the non respiratory component of the acid base balance which however is influenced by the lung function Range 10 to 50 mmol l HCO SStandard bicarbonate concentration Parameter for the non respiratory component of the acid base balance Bicarbonate concentration in plasma at a pCO of 40 mmHg a tempera ture of 37 C and complete oxygen saturation of the haemoglobin R
104. ndix combi E Line 7 8 Reference Literature K D rner Klinische Chemie und Haematology Enke Verlag Stuttgart 3 Auflage 1999 Oswald M ller Plathe S ure Basen Haushalt und Blutgase Georg Thieme Verlag Stuttgart New York 1998 H W Davenport S uren Basen Regulation Thieme Stuttgart New York 1979 E Hoffmann Funktionelle Biochemie des Menschen Bd 1 Akademie Verlag Berlin 1985 H Greiling A M Gressner Lehrbuch der Klinischen Chemie und Pathobiochemie Schattauer Verlag ISBN 3 7945 1304 5 A P Adams C E W Hahn Priciples and Practice of Blood Gas Analysis Franklin Scientific London 1982 P Asterup W Severinghaus The History of Blood Gases Acids and Bases Munksgaard Kopenhagen 1986 P Kildberg Quantitative Acid Base Physioloy A Odense University Press Odense 1981 E Pruden O Siggaard Andersen N W Tietz Blood Gases and pH Testbook of Clinical Chemistry S 1191 1221 Saunders Philadelphia 1986 combi amp se Instruction Manual Version 4 01 Page 129 Appendix combi E Lux 8 Index A K AaDO2 Alveolararterial oxygen pressure K 78 difference 80 L Airpressure 78 Ambient temperature 30 Li 78 ampoule holder 42 Lithium battery 6 Aspiration Pipe 42 M automatic Calibration 27 B magnet stirrer 41 N BB Bufferbases 80 BE Base excess 80 Na 78 beeper 12 numericalkeys 11 Cc O CA 78 O2CT Oxygen concentration 80 Cancellation of a Measurement 39 P CE Certification 20 Cl 78 Clear data
105. nformation ifthe Wash Solution Bottle is empty refer to chapter 3 7 2 for de tailed information if the Waste Solution Boitle is full refer to chapter 3 7 3 for detailed information Page 28 combitine Instruction Manual Version 4 01 Installation combi E Line 2 Installation Proce dure CAUTION CAUTION NOTE 2 1 Unpacking Claims Unpacking Mechanical Inspection Provided Materials Prior to the installation of the Combiline read the instructions in chapter Safety Issues first for your own safety The safety and functionality of the Combiline is guaranteed only if the Combiline is installed according to the operating instructions The Combiline is intended for continuous operation and should be kept in operation all the time to insure high meas uring accuracy If physical damage is evident or the Combiline does not meet specifica tions when received notify the carrier and your nearest representative Your representative will arrange for repair or replacement of the Combiline If the Combiline is to be shipped to a representative or service office attach a paper showing the owner s address Combiline model type Combiline serial number and repairrequired The original shipping material should be used Your representative will provide information and recommendations on materials to be used if the original packing material is not available or not reusabl
106. nsor Catch could be opened Positioning of Calibr Solution Bags To access the STANDARD DATA Menu proceed as described in chapter 3 5 The purpose and the use of the functions are described in the chap ters 3 5 3 1 up to 3 5 3 7 as follows STANDARD DATA PROGRAM 1 CALIBRATION DATA 2 DATE TIME 3 CORRELATION 4 SETTINGS MEASURE 5 SENSOR SELECTION 6 AB PARAMETER Qc RESPIRATION GAS 10 45 CAL 90 MIN The Standard Data of the Combiline are stored in an internal memory buffered by a Lithium Battery This means that the Standard Data en tered by the user are saved in the memory during brief power interrup tions or if the analyser is switched off manually s chapter 1 2 4 The values for pCO of the Calibration Solution BGA 3 and 4 and the pCO and pH of the calibration solution BGA1 and 2 can be different from Lot no to Lot no therefore the parameter are not stored perma nently The dialogue for the Calibration data appears automatically if the Calibration Solution Bag has been just replaced or the analyser has been switched off for more than 24 hours After every exchange of the Calibration Solution Bags an in put or checkup of the calibration values becomes necessary Use values printed on Bag s label Page 62 combikine Instruction Manual Version 4 01 Measurement and Special Functions combi E Line Enter Calibration Data NOTE 3 5 3 2 Date and Time P
107. nual Version 4 01 Contents combi E Line 6 3 Moisture Absorber nnuunnnnennnnnnnnnnnennnnnnnnnnnennnnnnnnnnnennnn 113 6 4 Fuse Replacement ecccccseeeeeeeeeeeseseeeeeeseeseeeneeeneees 114 6 5 Replacement of Fan Filter nnneennennnnnnnennnnnnnnnnnennnn 114 6 6 Replacement of Roller Pump Tubes ccccsseeseeeeees 115 6 7 Replacement ofSample Port Adapter ss eceee 116 6 8 Disposal of the Combiline uuusuusnn0onnennnnnnnnnnnnn 116 APPENDIX uses 119 7 1 ListofConsumables uuuuussnnnennennnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 119 7 2 List Of Spare Parts uunusnnesnnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 121 7 3 Specifications for Safety unnnennnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 123 7 4 Declaration of Conformity uurssnsnnnnnnnnnnnnnnnnnnnnnnnnnnnn 124 7 5 Technical Specifications uuuneusnnnennnnnnnnnnnnnnnnnnnnnnnn 125 7 6 Materials Provided with the Combiline 127 7 7 Interface Description uessrnnesnnnnnennnnnnnnnnnennnnnnnnnnnnnnn 129 7 8 Reference Literature uuununssnnsnnnnnnennnnnnnnnnnnnnnnnnnnnnnnnnnn 129 Li Le sss scenes EAN NENNEN nnmnnn 130 combilse Instruction Manual Version 4 01 Page3 Contents combi E Lin Page 4 combitine Instruction Manual Version 4 01 Safety Issues combi E Line Safety Issues 11 Hazards and Pre cautions DANGER CAUTION NOTE Electric
108. o duced sample LB1 is out of function Example Cat Sensor with exploded parts measurement capillary Csi od Figure 8 Calcium Sensor example The Combiline carries out Sensor calibrations automatically in a prepro grammed cycle of 90 min but in ECONOMY mode in a cycle of 240 minutes To determine the relationship between the Sensor signals and the partial pressure and ISE values of samples the Combiline uses high and low level Calibration Solutions For determination of Blood Gas results calibration solutions BGA1 and BGA2 are used in the COMBILINE BGA For this BGA3 and BGA4 are used in the COMBILINE BGA E and versions with metabolites For determination of the electrolyte concentrations the calibration solutions CAL3 and CAL4 are used in COMBILINE BGA E and COMBILINE ISE BGA blood gas analysis ISE lons selective electrode meta metabolites Calibrator Solution Bags and Wash Solution are consumables see chap ter 7 1 List of Consumables Page 14 combiline Instruction Manual Version 4 01 Introduction combi E Lin Calibration Solution Bags The bags are connected to the analysis system by the bag s Septum to the corresponding Adaptor Don t misplace Bags The Adaptor with a Slide Bar is named after the corresponding Calibra tion Solution Bag and is software controlled by a light barrier Use only ESCHWEILER Calibration Solutions for COMBILINE
109. o frequency electromagnetic field immunity test EN 61000 4 4 Electrical fast transient burst immunity test EN 61000 4 5 Surge immunity tests EN 61000 4 6 Immunity to conducted disturbances induced by radio frequency fields EN 61000 4 11 Voltage dips short interruptions and voltage variations immunity test ESCHWEILER GmbH amp Co KG Kiel 01 04 2010 EC declaration combilineV2 IVD engl 01012010 ESCHWEILER Telefon 0431 546580 Deutsche Bank AG Kiel Commerzbank Kiel Postbank GmbH amp Co KG Telefax 0431 549423 Kto Nr 0324 426 Kto Nr 7224488 Hamburg 24676 204 Holzkoppelweg 35 info eschweiler kiel de BLZ 210 700 20 BLZ 210 400 10 BLZ 200 100 20 D 24118 Kiel www eschweiler kiel de SWIFT DEUTDEHH 210 SWIFT COBADEFFXXX SWIFT PBNKDEFF IBAN DE46 2107 0020 0032 4426 00 IBAN DE66 2104 0010 0722 4488 00 IBAN DE56 2001 0020 0024 6762 04 Gerichtsstand Place of Jurisdiction Kiel USt ID Nr DE 188048227 Handelsregister Kiel HRA 3736 KI Kompl Eschweiler Verwaltungs GmbH Kiel HRB 4610 KI Gesch ftsf hrer Horst H Kock Page 124 combitine Instruction Manual Version 4 01 Appendix combi E Line 7 5 Technical Specifica tions Analyser type fully automated analyser for in vitro diagnostic of blood gas electrolyte Haemoglobin and Metabolites Note different according to the Combiline Types Processor Z80 microcontroller Sensors pO pCO K Ca Lit Nat Cl pH GLU LAC Ref
110. on the number of the test throughput Maintenance of the pH electrolyte and Reference Sensors is limited mainly to checking the level of their filling solutions and refilling the so lutions if necessary The best way to check the condition of the Sensors and their mem branes is regular observance of the slope parameter in the menu SEN SOR PARAMETER of the OPERATION menu Another way of checking the Sensors function and measuring accu racy is the use of Quality Control Solutions Basically there are two ways of carrying out maintenance of the Sensors 1 Eschweiler customer service offers regenerated pO and pCO Sen sors for exchange 2 The user can use ready made Membrane Casings and carry out cleaning of the pO and pCO Sensors himself This method of Sen sor maintenance is the more economical alternative Servicing replacement of a Sensor becomes necessary when after sev eral weeks of operation changes in the sensitivity of the Sensor or in the stability of measured results are noticed Signs of this may be Indication of a slope error Slow sinking of the slope toward the lower limit of the permissible slope range Slow rising of the slope of the pO Sensor towards the upper limit of the permissible slope range Indication of arange error Long measuring and calibration times Nonreproducible measured results Results of the Quality Control measurements outside the permissi ble tolerances
111. onnect Cable Remove and open Sensor to check it visually gt see chapter Filling level of Membrane Shell OK Sensor unit dry from outside Install new Membrane Shell Make sure that the bags are properly installed s chap 3 2 Membrane or Sensor casing dirty or damaged from outside Yes Run a washing cycle Protein Remo val Check liquid system of leakages Membrane older than three month Are Calibration Bags No installed correctly Yes Make sure that all Sensors are fixed at their positions and that Sensor Catch is closed Check or replace Roller pump Tubes Are any clots of blood somewhere in the meas capillary Yes install new O rings Are all O rings present at the Sensor casings V Check the liquid Valves and the connecting Tubes between Valves and Bags for blockage 1 0 x 0 8 Glas part of Sensor unit No J damaged or broken V exchange Run Calibration cycle lt Sensor unit chapt 3 5 1 2 Remove blockage Service stuff only combikfine Instruction Manual Version 4 01 Page 73 ErrorMessages combi E Line 4 4 pO Slope Error Problem solving guide for pO2 Sensor SLOPE Are other Sensors ind
112. oth and with some drops of electrode cleaner Attention Don t drop electrode cleaner directly into the casing the casing could be torn partly caused by evaporation coldness 11 Set the complete internal core back into the casing by turning it slightly to get into its proper position Reassemble the closing cap 12 Install the Reference Sensor in its position as described in chap ter 6 2 2 Installation of Sensors 13 Carry outa calibration cycle after reinstallation Make sure that the temperature is already warmed up 30 minutes After warming up entirely air bubbles could be present inside 1 of the refilled membrane shell and could cause a Slope error NOTE message for pH and ISE Sensors Ifthat happened go back to step 4 to remove air bubbles combilse Instruction Manual Version 4 01 Page 111 combi E Lin 6 2 13 Metabolite Sensors Storage In refrigerator at 2 8 C in closed original package Lifetime GLU 1000 samples or approx 30 days LAC 400 samples or approx 15 days lactate typ L Rinsing solution WASH M order no 50 6 10 15 Calibration solution CAL4 M order no 40 6 10 56 GLU 5 0 mmol l LAC 5 0 mmol l Na 155 Measurement Successive measurement of Hb BGA ISE and Metabolites Precision GLU 0 0 20 0 mmol l 5 20 0 30 0 mmol l 10 LAC 0 0 10 0 mmol l 5 10 0 20 0 mmol l 10 15 Units GLU 1 mmol l 18 02 mg dl LAC 1 mmo
113. oule holder for aspiration pipe 1 pc Printer Paper 50 6 50 00 printer paper pack 2 rolls For sensor maintenance 5011041 cleaning paste silicon carbide 1 box 5011045 cork with leather 1 pc 50 11050 pO polishing kit 1 pc Data sheets about liquid content can be requested from manufacturer Page 120 combiline Instruction Manual Version 4 01 Appendix combi E Line 7 2 List of Spare Parts Article no description packing unit Accessories for Maintenance 60 6 40 00 service set complete for combiline BGA ISE BGA E 1 set 60 6 40 10 set tubings for roller pump cl BGA ISE BGA E 2 pcs 60 6 40 01 service set complete for combiline meta 1 set 60 6 40 11 set tubings for roller pump cl BGA ISE BGA E 3 pcs 4064015 tubing for magnetic valve VE1 1 pe 40 6 40 20 tubing for magnetic valve VE2 1 pe 40 6 40 25 tubing for magnetic valve ABS 1 pe 3 8 106 sample port insert 1 pe 40 6 40 40 filter for fan 1 pc 40 6 40 45 moisture filter 1 pc Sensors pO Sensor 50 1 10 00 pO Sensor complete 50 11010 pO Sensor unit with membrane shell 5011015 gasket for Sensor unit 8 0 x 1 0 50 1 10 20 pO Sensor casing with screw cap 5011021 screw cap for Sensor casing 5011025 gasket for Sensor casing 1 8 x 1 0 50 1 10 30 pO membrane shells pack 5 pcs 5011035 pO fill solution bot 20 ml pCO Sensor 50 12000 pCO Sensor complete 50 1 20 10 pCO Sensor unit with membrane shell
114. paper replacement refer to chapter 3 7 4 for technical details refer to chapter 7 5 combilse Instruction Manual Version 4 01 Page 11 Introduction combi E Line Beeper A sound is heard by a beeper after switching the power ON after specimen is detected by a light barrier to remove a syringe or capillary from Sample Port Analysis Area The white cover can be taken down to access the analytic parts Regulator for Display Contrast g play Sensor Array Valve Array Window for the visual control of liquid flow Roller Pump 1 Roller Pump 2 for Metabolites Figure 4 Analysis Area Sample Port The Sample Port is designed for the use of syringes capillary tubes vacutainers or other sample intake systems It is equipped with a tube for washing or cleaning purposes Page 12 combitine Instruction Manual Version 4 01 Introduction combi E Line Sample introduction by a capil lary To start a measurement of a capillary sample press MEASURE key and follow the display dialogue Insert capillary into the Sample Port until a resistant is given The capil lary is automatically guided to the analysis system metal canula After pressing the ENTER key the sample is aspirated automatically from the capillary Sample introduction by a syringe NOTE Sensor Array Figure 5 Sample Port and sample introduction To start ameasurement of a syringe sample press MEASURE key and
115. parameters entered Check Temperature and Air pressure Protein Removal after 100 tests or Cleaning of the COMBILINE s Housing Cleaning of Sample Port Waste Bottle cap e Disinfect Sample Port Waste Bottle cap Check Sensor status parameter Replace Roller Pump Tubes 7 Replace Sample Port Set including tube General check byTechnical Service Exchange of inner tubings incl in service set Check and adjustment of air pressure Check and adjustment of thermostate temp Check and adjustment of operating voltages 3 6 2 3 6 3 3 5 3 1 3 5 2 6 3 3 6 3 3 5 2 8 12 12 12 3 5 1 6 6 6 6 7 Table 3Maintenance schedule Test functions especially fortheTechnical Service Test BGA 1 3 pCO Sensor see chapt 3 5 2 1 Test BGA 2 4 pCO Sensor see chapt 3 5 2 2 Test CAL 3 pH ISE Sensor see chapt 3 5 2 3 Test CAL 4 M pH ISE Sensor see chapt 3 5 2 4 Test GAS pO see chapter 3 5 2 5 Test Light Barrier see chapter 3 5 2 7 Test Liquid Transport see chapter 3 5 2 9 Maintenance schedule for Sensors lier The time intervals listed in the following tables are calculated to an average throughput of tests In times of a larger test throughput the maintenance measures should be done ear Page 82 combiline Instruction Manual Version 4 01 Maintenance combi E Line Membrane change 4 weeks 8 12 weeks 3
116. play the SERVICE TEST menu e Press 9 key to display the REAGENT TEST dialogue For further operation take the CSP Adapter Calibration Solution Port a part of the Combiline accessories and a bottle filled with distilled water e Remove the Calibration Solution Bag BGA 1 3 and connect the CSP Adapter instead Put the tube into the distilled water bottle e Press the 3 key for BGA 3 to suck distilled water for about 5 sec e Remove the tube out of the distilled water Page 34 combitine Instruction Manual Version 4 01 Installation combi E Line Press the 3 key again for about 5 sec to suck the water out of the system Proceed as described for the other Calibration Solution Bag BGA 2 4 Take the feeding tube of Calibration solution CAL3 and put it into the container with destilled water Press the 5 key to suck destilled water for about 5 sec Remove the tube out of the distilled water Press the 5 key again for about 5 sec to suck the water out of the system Proceed as described for the other Calibration Solution CAL4 M Clean the cap of the Waste Bottle with a lint free cloth and a suitable disinfection solution as recommended in chapter 2 Maintenance and Hygiene Clean disinfect also the Sample Port Flap especially on its contami nated places Danger of infection Replace the Wash Solution bottle by an empty one Dispose the Waste Solution in compliance with the legislations Remove the tubes from th
117. pler in comparison to arterial puncture venous blood can only be used when parameter of the metabolic components alone are to be determined Syringes The samples are taken in airtight glass or plastic syringes Glass sy ringes are used more frequently because the easy action plunger reacts passively to the arterial pulsation of the flowing blood The syringe plunger must however be coated with paraffin oil on the sides to seal it and then the clearance volume must be filled with heparin free of air bubbles Other anticoagulants such as Citrat Oxalate EDTA cannot be used because they shift the electrolyte values and pH value and thus considerably distort the acid base parameter When plas tic syringes are used the clearance volume must also be filled with heparin The gas permeability of most synthetic syringes however rep resents a source of error for O and CO so that the analysis should take place immediately after extraction The time of the analysis can be extended up to 2 hours for cooled samples Venous blood When puncturing a vein the following points must be observed If a tour niquet is used extraction must follow quickly because a haemostasis causes a rise in the capillary pCO and a reduction of the pH During extraction the tourniquet must not be loosened the fist should not be closed and no pumping should take place Since the venous blood per mits only a limited statement about the acid base household this m
118. r Calibration solution BGA 3 and BGA 4 130 ml bag for pCO CAL3 and CAL4 M 130ml bottle for electrolytes and metabolites loaded from EEPROM Software Languages available English German Ask your representative for more information LCD display illuminated 15 lines 30 characters each Keypad 0 9 ENTER key C clear point 4 corresponding keys appealing to Software functions 56 mm thermal printer for paper rolls up to a diameter of 60mm RS 232 real time clock for date and time requirement 70W voltage 115 230V 50 60Hz fuses 250V 2 5 Atime lag Adapter with fuse compartment and noise filter and cold plug Rel humidity 30 90 no condensation temperature 12 to 32 C height 402 mm width 325 mm depth 432 mm 13 kg The scope of the guarantee is determined by the laws in the country where the Combiline is purchased If you have any questions about guarantee please contact your authorised representatives Your cash register receipt is a valid guarantee coupon Page 126 combikine Instruction Manual Version 4 01 Appendix combi E Line 7 6 Materials Provided with the combiline Sensors pc bot pc bot pc bot a ee i b b pc bot bot pc bot pc bot pc bot ee ee ee pc box pc bot pc pc bot ou 3 a bot bag bag bot bot Ph MO hw PD PP 1 pcl Gaskets 10 pc Reagents 50 1 1030 5011035 50 1 20 30 50 120 35 50 5 10 30 5
119. r with Calibration and Wash Solutions The filling level of the Waste Bottle is controlled by a Level Sensor When the maximum per missible filling level is reached the analyser permits no further meas urements or calibrations When the Waste Solution Bottle needs to be replaced that will be indi cated on display WASTE BOTTLE QUIT PLEASE CHECK Forareplacement proceed as follows Wear gloves for your own safety e Pull out the Waste Solution Bottle Be careful there is a risk of infec tion Pull bottle together with cap out of the position angle both slightly up Hold cap and pull the bottle downwards out of the cap combilse Instruction Manual Version 4 01 Page69 Measurement and Special Functions combi E Lin e Clean the cap with a lint free cloth and a suitable disinfection solu tion as recommended in chapter 2 Maintenance and Hygiene e Dispose the Waste Solution in compliance with the legislations e Replace the full Waste Bottle with an empty Wash Solution Bottle e Press the corresponding QUIT key to confirm the replacement 3 7 4 Printer Paper The printer s thermal paper order no 50 5 50 00 is located on the upper side of the Combiline under a covered paper box A red stripe on the print out indicates that the paper supply is only sufficient for a few more print outs Paper specifications Roll diameter up to 60mm Roll width 57mm Paper thickness 0 04mm To replace a roll of
120. rage of the Combiline unsuuunnnsnnnnnnnnnnnunnnnnnnnnnnnn 34 3 Measurement and Special Functions 36 3 1 Using Syringe or Capillary uunssunnnnsnnnnnnnnnnnnnnnnnnnnnnnnn 37 3 1 1 Display and Print Results nen 40 3 2 Accessories for capillaries uenuunnennnnennnnnnnnnnnnnnnnnnnn 41 3 3 Quality ControlTest uuusenssnnsnnennnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 42 34 RespirationG S usss0 4ur0u0 00 Heinen tiere 44 3 4 1 Urine Measurement ccccccceceeeeeseeeeeeeeeeeeeeeeeeeees 45 3 5 Operation Menus uuuusesunsenannnnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnn 46 3 5 1 OPERATION Menu ccceeeeeeeeeteeeeeeeeteeeeees 47 3 5 1 1 RINSE xia oe sates cxsawaana a case E eauanpereid 47 3 5 1 2 Galibration anne 47 3 5 1 3 Calibration with BGA Solution 49 3 5 1 4 Calibration with ISE Solution 49 3 5 1 5 Activation of Hb Sensor u nen 50 3 5 1 6 Sensor Parameter cccceeeseeeceeseeeeeteees 53 3 5 1 7 ECONOMY ModE 2 40 55 3 5 2 SERVICE TEST Menu nennen 56 3 5 2 1 Test pCO2 Sensor voltage BGA3 56 3 5 2 2 Test pCO2 Sensor voltage BGA 4 56 3 5 2 3 Test pH ISE Sensor Voltage CALS 57 3 5 2 4 Test pH ISE Sensor Volt ISE CAL4 M 57 3 5 2 5 Test O2 Sensor Voltage Gas 57 combilse Instruction Manual Ve
121. ration of the pH Sensor The pH Sensor can be regenerated for several times The polish of the glass membrane should only be done when it is necessary The following maintenance accessories and expendable materials are required Leather coveredcork 50 11042 Abrasiveandcleaner 50 11041 silicon carbide Electrode cleaner 50 6 10 84 alcoholic compounds Adhesive tape Aqua Dist Gloves Regeneration procedure 1 Remove the pH Sensor from the thermostat as described in chap ter 6 2 1 Removal of Sensors 2 e Unscrew the black cap of the Sensor Illustr a Illustration a 3 Pull the pH Sensor upwards out of the casing Illustr b Illustration b 4 Wipe off the glass membrane with a bit of Electrode Cleaner and a lint free cellulose cloth Illustr c Don t remove the O ring at the membrane Do not remove the O ring at the glass membrane while clean ing the membrane CAUTION Page 90 combitine Instruction Manual Version 4 01 Maintenance combi E Lin Illustration c Carry out step 6 to 8 only at extreme pollution or if the slope 1 values are still down below 95 NOTE 6 Put some Cleaning Paste Silicon Carbide order no 50 1 10 41 on the leather covered cork and mix with a few drops of distilled water lllustr d Illustration d 7 Setthe glass tip of t
122. re mostly made of aluminium and precious metal e Electronic parts must be disposed off in accordance with the guide lines for the disposal of electronic parts Page 118 combitine Instruction Manual Version 4 01 combi E Line 7 APPENDIX 7 1 List of Consumables Article no description packing unit Calibration and Rinsing solutions for COMBILINE BGA 40 6 10 00 3 4 100 WASH 1 Rinsing solution for BGA 6x330 ml 406 1020 BGA 1 Calibration solution BGA low 12x130 ml 406 1030 BGA 2 Calibration solution BGA high 12x130 ml for COMBILINE BGA E 4061010 WASH 2 Rinsing solution for BGA plus E 8x250 ml 406 10 40 BGA3 Calibration solution BGA plus E low 12x130 ml 406 1050 BGA4 Calibration solution BGA plus E high 12x130 ml 406 1045 CAL 3 Calibration solution for ISE low 12x150 ml 4061055 CAL 4 Calibration solution for ISE high 12x150 ml for COMBILINE ISE 40 6 10 15 3 4 110 WASH 2 Rinsing solution for BGA plus E and ISE 6x330 ml 40 6 10 60 3 4 400 CAL3 Calibration solution for ISE low 6x330 ml 40 6 10 65 3 4 500 CAL4 Calibration solution for ISE high 6x330 ml for Combiline meta 4061011 WASH 2 M Rinsing solution for BGA plus E 8x250 ml 406 10 40 BGA 3 Calibration solution BGA plus E low 12x130 ml 406 10 50 BGA 4 Calibration solution BGA plus E high 12x130 ml 406 10 45 CAL 3 Calibration solution for BGA plus E low 12x150 ml 406 1056 CAL 4 M Calibration solution for BGA plus E
123. requirements Only if ESCHWEILER original parts and solutions are used we can meet these requirements Please support us in doing this Instruction Manual Contents combi E Lin Contents 1 Salely ISSU S 4z ssnsasrssssseensnnssannnnsuneerneee 5 11 Hazards and Precautions uurserssnnnnnennnnnnnnnnnnnnnnnnnnnnnennnn 5 12 Maintenance and Hygiene unnenssnnnnnennnnnnnnnnnnnnnnnnnnnnnennnn T 13 First AidMeasures unesesnnnnnnnnennnnnnnnnnnennnnnnnnnnnennennnnnnnnnne 8 l4 Repais cns A 8 1 Introduction nee 9 1 1 Intended Use nunsennnnunnnennnnnnnnnnnennnnnnnnnnnennnnnnnnnnnnennnnnnnn 9 1 2 System Description u 9 1 2 1 System Overview and Terms nen 10 1 2 2 Functional Description uus442244444Hen nennen 21 1 2 3 Specimen Collection 20044 nennen 22 1 2 4 Storage of Standard Data een 24 1 2 5 Software Overview nesssnnneennnnnennnnennnnnnnennnen 25 1 3 Power Up Procedure uuuuussnssenunnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnenn 26 2 Installation Procedure uursseennnnnnnnnnnnnnnnn 29 2 1 Unpacking uunneesnnnnenennnnnnnnnnnnnnnnnnnnnnennnnnnnnnnnennnnnnnnnnnennnn 29 2 2 Operating Conditions nssussenennnnnnnnnnnnnnnnnnnnnnnnnnnnannn 30 2 3 Installation Process unnnnenennnnnnnnnunnnnnnnnnnnnnnnnnnnnnnnnnnnnn 30 2 4 Transport of the Combiline uurrssunnnnnnnnnnnnnnnennnnnnn 34 2 5 Sto
124. rogram AB PARAMETER the expression of unneeded acid base parameter can be inhibited Parameter that had already been ex cluded from expression can be switched on again ON Parameter are expressed OFF Parameter are not expressed Press the 7 key to display the AB parameter dialogue AB PARAMETER HCO3A OFF HCO3S ON BE ON SBE ON TCO2 ON BB ON O2SAT ON O2CT ON P50 ON ON AADO2 ON AGAP ON SHUNT ON OFF SB STATUS ON Acolon appears behind HCO3A To inactivate a calculation press the corresponding OFF key To activate a calculation press the corresponding ON key The colon appears behind the next parameter The selection is made for all parameter as described above The STAND BY dialogue appears after the last confirmation combikine Instruction Manual Version 4 01 Page67 Measurement and Special Functions combi E Li 3 7 Replacements 3 7 1 Calibration Solution Replacement 3 7 2 Wash Solution If an empty Calibration Solution Bag needs to be replaced that will be indicated on display e g BGA 3 QUIT PLEASE CHECK A similar message appears if any other bag is empty Check if the bag is really empty otherwise the transportation way could be disturbed e g the Sample Port is open If necessary check the transportation of liquids as described in chapter 3 5 2 9 Proceed as follows for the replacement of BGA 3 as example Press and hold the Slide Bar A for B
125. rsion 4 01 Page 1 Contents combi E Lin 3 5 2 6 Test Air Pressure and Temperature 58 3 5 2 7 Test Light Barriers ccceeeesseeceeeeeeeeeeees 59 3 5 2 8 Protein Removal nassen 60 3 5 2 9 Reagent Test Test of Liquid Transport 61 3 5 3 STANDARD DATA Menu oce 62 3 5 3 1 Calibration Data cceceecceeeesesteeeeeeeeeeeaes 62 3 5 3 2 Date and IIM Essin sni aonair eiaa 63 3 5 3 3 Gorrelaii n unse 64 3 5 3 4 SEIINGS netter genen 65 3 5 3 5 Sensor Selection 224444244404n nn 66 3 5 3 6 AB Parameter Selection 67 3 7 Replacement unnnurennnnnnnnnnennnnnnnnnnnennnnnnnnnnnenennnnnnnnnnen 68 3 7 1 Calibration Solution cccceccceeseeeeeeseeesneeeees 68 3 7 2 Wash Solution ussssssssssssnennsssennnnnenneneennnnnn 68 3 7 2 1 CALI CAL 4 0 eect saioaren 69 3 7 3 Waste Solution cccccccceeeeeeeeeeeeeeeeeseeeeseneees 69 3 7 4 Printer Paper u en 70 Error Messages sssceeeseeeeeeeseeeeeeeeees 71 4 1 Error Eleminations unsssnnnsennnnnnnnnnnennnnnnnnnnnennnnnnnnnnnnen 71 4 2 Errorindications secossa 71 4 3 pCO2 SlopeError uuuunssnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 73 4 4 PO2 SlopeError 44 400000GHHaannnannassnnnnnannnirnnnnenenn 74 45 pH SlopeError u ur nie 75 4 6 ISE Slope Error uunssnnsnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnnn 76 Explanation of Testp
126. ruction as displayed in the dialogue A print out of the results takes place automatically after completion of the measurement by integrated thermal printer combilse Instruction Manual Version 4 01 Page43 Measurement and Special Functions combi E Lin 3 4 Respiration Gas e Make sure that the QC results correspond to the expected range otherwise start a calibration cycle and repeat the QC test In case of failure Print out Sensor Parameters and check them s chapter 3 5 1 6 Run Protein Removal cycle s chapter 3 5 2 8 Call for Technical Service if the problem is still evident When the measurement option RESPIRATION GAS is selected the parameter pO and pCO of the introduced gas sample will be measured Respiration gas samples can be introduced directly like a capillary into the Sample Port from a Glass Syringe or from a Douglas Pouch Proceed in principle as described in chapter 3 1 Using a Capillary fora respiration gas measurement STAND BY PROGRAM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE K ACTIVE MEASURE NA ACTIVE CA ACTIVE CL ACTIVE LI ACTIVE QC GLU ACTIVE LAC ACTIVE HB ACTIVE RESP GAS 10 45 CAL 40 MIN Press the corresponding RESPIRATION GAS key and the following dialogue appears PLEASE WAIT FOR SAMPLE INPUT REQUEST PREPARATION RESPIRATION GAS INJECT SLOWLY FROM THE SAMPLE DEVICE INSERT ADAPTER IN THE SAMPLE PORT AND
127. s QUIT key to return to the STAND BY dialogue Roller Pump tube for Metabolites Roller Pump RP2 e Put the new Tube to the connectors 6 and 7 e Pull the Tube through the Tension Block and position both Stoppers into the Stopper section see figure 32 e Carefully pull the Tube over the upper Roller Pump The Sample Port Adapter to fix up Syringes or Capillaries must be re placed according to the maintenance schedule A replacement set is available by manufacturer Order no 1 8 106 Proceed as described as follows Open the dialogue REAGENT TEST in SERVICE TEST menu Remove the white front cover Pull the WASH tube out of the red sample port insert Screw the red sample port insert counterclockwise out of its white holder Take a new sample port insert and turn it clockwise into the holder The hole for connection of the WASH tube must point to left top Put the WASH tube into the corresponding hole of the sample port insert Press the 2 key WASH for some seconds to let WASH solution flow through the system Press QUIT key to return to the STAND BY dialogue combitine Instruction Manual Version 4 01 Page 117 Appendix combi E Line 6 8 Disposal of the Combiline In case of disposing the combi amp se ask your representative if he takes the analyser back In other cases following features should be observed e Make sure that the Combiline has been decontaminated before dis posal Mechanical parts a
128. sable Waste Bottle with a filling level control Empty Wash Solution Bottles are used as Waste Bottles The Combiline is operated with the help of a menu controlled dialogue by Soft keys and a 16 line LCD display By this Keypad inputs such as changes in the standards Hb FIO and RQ the calibration parameter or the date and time can be made Inthe SERVICE menu REAGENTTEST the individual functions are carried out as long as the corresponding key is pressed If a Calibration Solution Bag or Bottle is empty this is shown in the dis play After a new bag or bottle has been replaced and the QUIT key has been pressed the analysis system is ventilated automatically The Combiline is then ready for use again If the Waste Bottle is full this is also indicated After the Waste Bottle has been replaced the Combiline is ready to measure again At all times the Combiline remains switched ON and is continuously calibrated in a programmed cycle In times of reduced sample activity for example at night the Combiline can be operated in an Economy mode with extended calibration cycle times combilse Instruction Manual Version 4 01 Page9 Introduction combi E Line All Sensors can be switched ON or OFF individually by the user as needed The system remains ready for operation It is also possible to select the computed values which are to be expressed individually Maintenance Several easily operated test and function programs ar
129. sor like ISE BGA and Metabolite Sensors after a calibration cycle Cause Sensor s slope is out of range because Sensor Membrane is defect Sensor unit is defect air bubbles in Calibration Solution cover more or less the concerned Sensor combi amp se Instruction Manual Version 4 01 Page71 ErrorMessages combi E Lux especially for pH and ISE Sensors possible disturbance of the Ref Sensor Call Tech Service Remedy Proceed in the following order e call up the REAGENT TEST menu s chapter 3 5 2 9 and check visually all Solutions about air bubbles If air bubbles present in a solution press the corresponding button to rinse them out If air bubbles are still evident call Technical Service to solve it Run a manual Calibration cycle s chap 3 5 1 2 If SLOPE is indicated furthermore go to the next step Replace the Sensor Membrane of the indicated Sensor s chapter 5 2 The problem should be solved now If not call Technical Service In the following chapters 4 3 4 4 4 5 and 4 6 special diagrams are shown to solve indicated SLOPE errors Proceed as necessary Message is indicated with a result on display as long as the measure procedure is going on It is indicated on the printout in case the pernissible time for measurement has been exceede by the sensor In that case it will remain on the display as well Cause Air bubbles in sample are still located at a Sensor Owing to
130. standard configuration Unit Partial pressure mmHg Metabolites mmol l HB Standard 15g dl FIO2 20 9 RQ 0 85 Printouts 1 Correlation 1 000 pH 0 000 Electrodes ACTIVE all Hb activation Hb sensor not active Calibration Data pCO2 pH must be set by the operator only for Model types with pCO and pH Sensor Page 24 combitine Instruction Manual Version 4 01 Introduction combi 1 2 5 Software Overview POWER UP COMBILINE Y Rev 2 500 WARM UP PHASE press 1x OF 1 HOUR t AUTO CALIBRATION OPERATION key to select Menu OF SENSORS OPERATION 1 RINSE 2 CALIBRATION ECONOMY STAND BY 3 CALIBRATION BGA PROGRAM DIALOGUE 4 CALIBRATION ISE 4 5 ACTIVATION HB 6 SENSOR PARAMETER 7 ECONOMY MODE 8 DISPLAY MEASURED as MEASURING DIALOGUES press 2 x Sample introduction by OPERATION key selection of to select Menu PRINT MEASURE SYRINGE or CAPILLARY specify BGA and meta values only ISE and meta values only QC specify LEVEL 1 LEVEL 2 LEWEIL LEVEL 4 ASPIRATION GAS Attention Sofware functions marked with are not accessible during Warming Up Software functions marked with are not available in BGA types Software functions marked with are not available in ISE types
131. t can cause high slope values and pO slope error indications Polishing serves to remove deposits from the glass surface of the pO sensor unit Exchange of the Membrane shell is essential after polishing Do not install used membrane shells again The following maintenance accessories and expendable materials are required pO polishing kit 50 1 10 50 Demineralised water Electrode cleaner 50 6 10 84 alcoholic compounds Cleaning tissue Adhesive tape Gloves pO filling solution 5011035 pO membrane shell 50 11030 Regeneration procedure wear gloves for your own safety 1 Remove the Sensors from the Sensor Array as described in chap ter 6 2 1 Removal of Sensors 2 Unscrew the black cap of the Sensor Illustr a Illustration a 3 Pull the pO or pCO Sensor upwards out of the casing Illustr b A AN Illustration b combitine Instruction Manual Version 4 01 Page99 combi E Lin 4 Pull the used casing off the inside part while turning slightly Illustr c Attention filling solution can be spilled out N SS Mf 7 Illustration c 5 e Wipe off the shaft the glass tip and the silver ring with a bit of Electrode Cleaner and a lint free cleaning tissue Illustr d Illustration d 6 Place some drops of demineralised water on the surface of the pO polishing kit Illustr e Illustr
132. t the syringe into the sample port of the Combiline as shown in figure 5 Inject sample slowly from syringe into sample port Stop injec tion after the first acoustic signal e Remove the Syringe after the second acoustic signal Insert the capillary into the sample port of the Combiline as shown in figure 5 Press ENTER key The sample is aspirated automatically Remove the Capillary after the second acoustic signal The flow of the sample can be controlled as long as the Sensor Array is back lighted The process is controlled by a Light Barrier and a beep is heard when the filling is done A second beep indicates that the syringe has to be removed When there is no detection of specimen by the Light Barrier an auto matic wash cycle starts and the STAND BY dialogue appears The following dialogue appears when the filling process is finished combikfine Instruction Manual Version 4 01 Page 37 Measurementand Special Functions combi E Lin PREPARATION PLEASE REMOVE SAMPLE DEVICE 12 18 CAL 41 MIN e Remove the Sample device from the Sample Port CAUTION ments could be wrong Remaining of the syringe or capillary in the Sample Port will affect washing of the measuring capillary Following measure The following dialogue appears automatically MEASUREMENT 1130150310 TEMP 37 0 HB 15 0 FIO2 20 9 RQ 0 85 11 30 CAL 41 MIN QUIT ONLY BGA ONLY I
133. tage BGA 1 3 Purpose Carry out test 3 5 2 2 Test pCO Sensor voltage BGA 4 To access the SERVICE TEST Menu proceed as described in chapter 3 5 The purpose and the use of the functions are described in the chapters 3 5 2 1 up to 3 5 2 9 as follows SERVICE 1 BGA3 2 BGA4 3 CAL3 4 CAL4 5 GAS 6 AIR TEMP 7 LIGHT BARRIERS 8 PROTEIN 9 REAGENT TEST TEST OPERATION START CALIBRAT 10 45 CAL 90 MIN This function indicates the generated pCO Sensor voltage and pH voltage in Combiline BGA after calibration solution BGA 1 3 has been added The voltages lie within a range of 3 5 V The programs give information about the behaviour of the pCO Sensor and pH sensor in Combiline BGA The indicated voltage should be stabilized within approx 60 seconds Differences of only small mV should be seen as normal see chapter 3 5 2 3 Otherwise e check the transportation of the BGA 1 3 Calibration Solution s chap ter 3 5 2 9 and the condition of the pCO Sensor s chapter 3 5 1 6 Reasons Calibration Solution is not transported free of air bubbles Sensor membrane is dirty or defective pCO or pH Sensor is worn out inert e Press the 1 key to display TEST BGA 1 3 dialogue TEST BGA 3 ECO2 1679 QUIT mV Refer to chapter 4 3 ifthe value is out of range e Press the QUIT key to return to the STAND BY dialogue Proceed as describe
134. then are ready for testing marked green Attention Biosensors after its activation may not be kept 1 dried over a longer time 1 hour They would be damaged NOTE combikine Instruction Manual Version 4 01 Page 87 combi E Lin Replacement of O Rings To replace the O Rings of the Biosensor module proceed as follows Pay attention to the figures in chapter 6 2 13 and figure 22 Run REAGENT TEST in the SERVICE TEST menu and keep the dia logue still displayed during this procedure Press 1 key for Suction see chapter 3 5 2 9 Loosen the plastic fixing screws 2 and remove Biosensors Unscrew the module retaining screws 1 with dishes Put all dismantled parts onto a lint free tissue Pull the exposed O Rings out of their position with a suitable tool Replace O Rings No 50 2 10 25 in their positions with a suitable soft tool pos 3 Assemble Biosensor module Install Biosensors as described before 1 module retaining screws dishes 2 sensor fixing screws 3 o rings 4 glucose biosensor 5 laktate biosensor 6 sample capillary 7 electrical signal pins biosensor liquid contact place contact side inside Figure 22 Biosensor measuring module Page 88 combitine Instruction Manual Version 4 01 Maintenance combi E Lin 6 2 3 Principle of pH meas urement The principle of the pH measurement is based on the fact that an elec trical potential difference occurs at a membrane m
135. thermal paper proceed as shown in below figures open paper box and take out remaining paper e put new paper roll into the paper box and pull out some paper then close paper box Page 70 combitine Instruction Manual Version 4 01 Error Messages combi E Line 4 Error Messages 4 1 Error Eleminations 4 2 Error Indications NOTE Error Messages When an error message is indicated on dialogue 1 the cause must be basically solved 2 The error messages can be eliminated by carrying out a calibration cycle This applies only if the cause of the error has first been eliminated The analyser s functions are controlled permanently by the internal proc essor Any malfunctions are reported to the user by display STAND BY PROGRAM PCO2 SLOPE MEASURE QC RESPIRATION GAS 14 17 CAL 25MIN The meanings of the abbreviations used are described on the following pages Sensors for which an error message is shown supply no measuring results during a sample measurement In case of failure of the pO Sensor the parameters O SAT O CT p50 and AADO are not calculated In case of failure of the pCO or pH Sensor the acid base pa rameters HCO A HCO S BE SBE TCO and PB and the SB status are not calculated If an error message is indicated for all Sensors the Combiline permits no further sample measurements Error Message SLOPE appears instead of ACTIVE for a Sen
136. time of the calibration is taken into consideration pO Partial pressure of the oxygen in mmHg or kPa Measuring range 0 800 mmHg or 0 107 kPa pco Partial pressure of carbon dioxide in mmHg or kPa Parameter for res piratory component of the acid base balance Measuring range 5 200 mmHg or 0 66 26 6 kPa In the menu STANDARD DATA an expression of the values for 1 pO pCO and BP in mmHg or kPa can be selected NOTE pH Measuring unit for the current hydrogen ion concentration Measuring range 6 0 8 0 Electrolytes K Potassium ion concentration Measuring range 0 0 20 mmol l Nat Sodium ion concentration Measuring range 20 250 mmol l CA Calcium ion concentration Measuring range 0 0 5 0 mmol l Ca7 4 calculated Calcium ion concentration computed for a pH value of 7 4 Li Lithium ion concentration Measuring range 0 40 5 0 mmol l CI Chloride ion concentration Measuring range 20 250 mmol l Page 78 combitine Instruction Manual Version 4 01 Explanation ofTestparameter combi E Line Metabolites GLU concentration of glucose in mmol l or mg dl C concentration of lactate in mmol l or mg dl Haemoglobin Hb totalhaemoglobin The tHb is the sum of all Hb derivatives and is expressed in g dl Meas uring range 3 30 g dl Parameter overview The following table shows the units and ranges off all parameters measured in a fully equipped Combiline The refere
137. trical connection contacts plugs sockets etc can be electri cally live combilse Instruction Manual Version 4 01 Page5 Safety Issues combi E Lin Mechanical Safety Analyser is operating CAUTION Biological Material Risk of Infection Biohazard Even after an analyser has been switched off components e g ca pacitors can be under voltage as the result of an electrical charge All current carrying parts are sources of danger for an electrical shock Surfaces floors work tables have not to be moist when you are working with any electrical device Carry out only the maintenance work and or the replacement of parts described in these Instruction Manual Unauthorized work on the analyser can lead to the guarantee obliga tion becoming null and void with necessary expensive service work to correct it All work which requires the analyser to be opened have to be car ried out by an authorised technician who is familiar with the risks related thereto Use only replacement fuses of the stated type and with the stated nominal current Never use fuses which have been repaired There is a Lithium battery on MAIN BOARD that have to be re placed by the authorised technical service every 5 years In case of a battery fault all memorised parameter might be lost Never open or unscrew analyser s casing parts while it is switched ON There is a risk of injury due to moving parts as fans pumps
138. ue is measured of a bicarbonate solution pHx which is separated from the specimen to be determined by a CO permeable Teflon membrane Through the membrane CO diffuses out of the specimen into the bicarbonate solution until a balance is reached between the two solutions The resulting pH change in the bicarbonate solution is directly proportional to the CO diffused through the mem brane HCO H 6 1 log 3 S x PCO Henderson Hasselbach equation HCO3 bicarbonate concentration in mmol l pCO carbon dioxide partial pressure in mmHg S 0 03 mmol l x mmHg The pH change is measured as voltage difference by pH glass mem brane which separates the bicarbonate solution and a reference solution with set pH value The reference system makes the electrical connec tion to the outside of the glass membrane with the conductive Bicarbo nate Solution The conducting wire in the inside of the electrode forms the electrical connection to the inside of the glass membrane with the conductive Reference Solution The thus created voltage difference is transmitted to a measuring amplifier and displayed Construction of the pCO measuring chain pCO2 closure cap Z MH Reference System conducting system reference solution pH 0 4 bicarbonate solution _ pH glass membrane teflon membrane 25um
139. urpose Carry out function Press the 1 key to display the dialogue CALIBRATION DATA co2 BGA 3 71 8 BGA 4 31 0 Values for BGA 3 a colon appears behind BGA 3 Not for Type Combiline ISE e Enter the pCO value e g 71 5 printed on the Calibration Bag BGA 3 red by numerical keys and press ENTER key to confirm Values for BGA 4 a colon appears now behind BGA 4 Not for Type Combiline ISE e Enter the pCO value e g 31 0 printed on the calibration bag BGA 4 blue by numerical keys and press ENTER key to confirm The entered calibration values are stored in internal memory The Combiline now performs automatically a calibration cycle except in WARM UP PHASE The STAND BY dialogue appears for further actions Type COMBILINE BGA additional request for the input of the pH values See Calibr Bags BGA 1 BGA 2 With this function Time and Date which are blended in at the bottom line of the display are set Date and Time are generated by a battery operated real time clock and continue running when the Combiline is out of operation A change can be necessary if there is a change in summer and wintertime after a service action e g a battery exchange e Press 2 key to display the Date and Time dialogue DATE TIME DAY 27 MONTH 02 YEAR 10 HOUR 14 MINUTE 22 14 20 CAL 16 MIN Note Values that need no correction can be skipped or confirmed by press
140. ut D Mf 7 Illustration c 5 e Wipe off the shaft the glass tip and the silver ring with a bit of Electrode Cleaner and a lint free cellulose cloth Illustr d Attention Do not wipe off the brown coloured silver silver chloride layer at pCO Sensor CAUTION Illustration d 6 Put some Silicon Carbide on the leather covered cork and mix with a few drops of distilled water Illustr e Illustration e combitine Instruction Manual Version 4 01 Page95 Maintenance combi E Line 7 Set the glass tip of the inside part vertically onto the prepared leather cork and clean and polish with light pressure and about 20 circular movements on the leather Illustr f Illustration f 8 Wipe off the shaft the glass tip and the silver ring with a bit of electrode cleaner and a lint free cleaning tissue Illustr d 9 Put 1 2 drops of Electrode Cleaner into anew membrane covered casing and immediately spin it out again The Electrode Cleaner helps to prevent the formation of air bubbles when the filling solution is filled in 10 Fill the thus prepared casing to the red filling mark with pO filling solution or with pCO filling solution approx 7 drops Fill the casing evenly and free of bubbles Please note not to overfill the filling mark Illustr g Illustration g Page 96 combitine Instruction Manual V
141. uted from the difference between EC1 and EC2 calibration voltage 1 2 The slope of an electrode is a measure for its sensitivity This results from the difference of the voltage values reached during a 2 point cali bration The slope of the different Sensors must lie within the following ranges pO 75 230 pCO 50 110 pH 86 110 K 75 110 Nat 66 110 Ca 66 110 Cr 66 110 Li 66 110 GLU 30 300 LAC 30 300 If the slope of an electrode lies outside the given range an appropriate message will be displayed If some or all Sensor parameters are out of the allowed range check the transportation of all Calibration Solutions as described in chapter 3 5 2 9 air bubbles through leaks or stenoses If only some of the Sensor parameters are out of the allowed range combilse Instruction Manual Version 4 01 Page53 Measurementand Special Functions combi E Lin check if air bubbles are located inside of the ISE or REF Sensors pre supposed the transportation of Calibration Solutions is ok refer to chapter 3 5 2 9 6 2 Print out More detailed Sensor parameter will be printed out by pressing the corre change the membrane of the indicated Sensors sponding PRINT key during indication of the Sensor parameters On the print out slope values and high level calibration voltages of the last six calibrations are shown This data give information about stability of the Sensors
142. ve measurement of Hb BGA ISE and Metabolites 1 Feeding of sample by operator 2 Hb measurement 3 BGA ISE measurement 4 Specimen transport to Metabolite sensors with following measure ment of GLU and LAC 5 Rinsing of the measuring cells with WASH2 M Sensors are not allowed to be kept dry after activation in the ana lyser Sensors may get damaged irreversible otherwise combilse Instruction Manual Version 4 01 Page113 Maintenance combi E Lin 6 3 Moisture Absorber Purpose Siphon off of the Moisture Ab sorber Biohazard The purpose of the Moisture Absorber is to protect the Vacuum Pump from the suck in of moisture This Absorber collects the moisture and must be removed by opening of the screw at the bottom The moisture absorber is located behind the front panel inside the combitine housing Accessible for Service staff only In case that the Absorber is filled with moisture it must be emptied by authorized service personnel as described as follows e Open the front panel e Wear gloves for your own safety biological material e Hold absorbing cloth under the Absorber and open the plastic screw The collected moisture drops out e After emptying carefully turn the plastic screw in e Press the Absorber back in its feeder clip Page 114 combiline Instruction Manual Version 4 01 Maintenance combi E Line 6 4 Fuse Replacement 6 5 Fan Only a trained
143. while to allowa visual control of remaining liquid or sediments inside the transportation way of the Sensor s capillary Keep the white front cover closed otherwise the temperature will be influenced and the calibration values of Sensors could be different Re sults can be wrong When the calibration cycle is finished the STAND BY dialogue appears STAND BY PROGRAM PO2 ACTIVE PCO2 ACTIVE PH ACTIVE MEASURE K ACTIVE NA ACTIVE CA ACTIVE CL ACTIVE Qc LI ACTIVE GLU ACTIVE LAC ACTIVE HB OFF RESPIRATION GAS 10 45 CAL 90 MIN This STAND BY dialogue should be seen as a MAIN MENU The current system time appears and the countdown time for the next auto calibra tion cycle All further operations you can carry out from here like start different measurements by opening the Sample Port see chap ter 3 for detailed information open submenus by pressing the corresponding PROGRAM key to carry out different functions see chapter 3 5 for detailed information set the Combiline in ECONOMY mode see chapter 3 6 for detailed information display and print results see chapter 3 1 1 for detailed information The STAND BY dialogue will be changed automatically ifan error is evident refer to chapter 4 for detailed information fora calibration cycle refer to chapter 3 5 for detailed information if a Calibration Solution Bag is empty refer to chapter 3 7 1 for de tailed i
144. y caused by evaporation coldness Screw the Sensor carefully back into the casing Install Sensor into its position as described in chapter 6 2 2 Installation of Sensors Carry out a calibration cycle after installation Make sure that the analyser is already warmed up After warming up entirely air bubbles could be present inside of the refilled membrane shell and could cause a Slope error message If that happened go back to step 4 to remove air bubbles combilse Instruction Manual Version 4 01 Page 105 Maintenance combi E Lin 6 2 7 Principle of the Na measurement The principle of the Na measurement is based on the fact that at a membrane made of Na sensitive glass an electrical potential difference occurs when this membrane separates two solutions with different Na values The resulting potential difference voltage ENat is proportional to the difference of the Na ion concentrations of the two solutions ENat 0 61 5mV Na x Na o at37 0 C Nernst factor The inner buffer solution Nato has a constant Na concentration There fore the voltage ENa is proportional to the Na value of the added speci men Na x which is to be determined The conducting system of the measuring Sensor makes the connection to the outside of the glass capillary membrane with the electrically con ductive buffer solution The conducting system of the Reference Sensor makes the connection to the inside of the
145. y in combination with tHb 0 1 hydrogen ion concentration H 10 1000 nmol l Anion Gap AGAP 0 99 mmol l 0 1 Shunt SHUNT 0 50 0 1 acid base status relevant diagnosis recorded on printer combikfine Instruction Manual Version 4 01 Page 125 Appendix combi E Lin Guarantee Valve array Sample Port Pumps Liquid control by System liquid Software Dialogue Printer Interface System time Technical data of Power Environment conditions Dimensions Weight approx electrical control of liquids backlighted for visual control of e g sediments flow etc Adapter for different capillaries and syringes cleaned with Wash Solution automatically 1 roller pump 2 roller pumps in metabolite versions 1 suction pump Suction pump roller pump suction valve ventilation valve vacuum vessel moisture absorber combitine BSA Wash 330 ml bottle Waste bottle 330 ml equipped with a level Sensor Calibration solution BGA 1 and BGA 2 130 ml bag for pCO and pH combitine SF Wash 330 ml bottle Waste bottle 330 ml equipped with a level Sensor CAL3 and CAL4 330 ml bottle for electrolytes combitine B A F Wash 250 ml bottle Waste bottle 250 ml equipped with a level Sensor Calibration solution BGA 3 and BGA 4 130 ml bag for pCO CAL3 and CAL4 130ml bottle for electrolytes combiline ea Wash 250 ml bottle Waste bottle 250 ml equipped with a level Senso

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