User Guide - Wolf Laboratories
Contents
1. www gonotec com El Gesellschaft f r Me und Regeltechnik mbH User Guide CHLORIDMETER CM 20 August 2012 Version 1 07 Contents 1 Contents 1 1 Table of Contents Regole 2 1 1 Table ft Gontenls iie eh t ee e ebd etas Hanse 2 1 2 1lustrations e eer aeta ated n d aat daa lichen be qub abhieettl ap hi cal iosibekes bd tende 5 1 3 Tables t te elt dada i e ete re bei iu Erich 5 2 Notes Safety Notices and Warnings 6 3 INTPOQUCHON unse 7 3 1 Application Fields of the Chloride Meter 0444444444400n0nnnnnnnnnnnnnennnnnnennnnnnnnnennnnenn 7 3 1 1 Application Restrictions of the Chloride Meter 444400snsnnennnnnennnennnnennnnnnnenennnnnnn 7 3 2 Chloride Meter Measurement Method s244444444400nennnnnnnnennnnnnnennnnnnnennennnnennnnern nenn 7 3 3 SpecifiGatlons s t rii aa aa aae a aa ubestedis ahnen aies 8 3 4 Unpacking the Chloride Meter en en aan 9 3 9 Packaging Contents irure to ie annahm os ca 9 4 Design of the Chloride Meter 10 4 1 Overview of Display and Connectors sssssssesseeeene ener nennen nennen 10 4 2 Power oupply i siii ter t HER EH des I LEER RELIER NE ERE Le PN GERM Der E 11 4 3 Dimensi ns and Weight nena eoo E aot UR et iot det 11 5 Setup and Initial Operation 12 5 1 Safety and2. 4 Place the filled measurement vessel into the trough provided for it in the chloride meter 5 Move the measurement sensor unit downward into the working solution 6 Now touch the READY field Note If you do not wish to perform a measurement you can end further measurement by touching the CANCEL field this will take you back to the Welcome screen 7 In the following display you will be asked to wait until the system has reached its working point A runtime display under NICO ects ales ols the message visualizes this process Then the system must be conditioned CANCEL Fig 7 measurement working point 8 2 Conditioning Conditioning must always be done when the chloride meter is turned on a measurement procedure or a measurement series has been canceled or if the working solution has been changed 8 After the working point is reached you will be asked to pipette 20 ul 0 02 ml of the standard solution 100 mmol l 60 9 0100 into the working solution CRNCEL Fig 8 measurement standard solution 18 Measuring a Sample Solution The chloride meter recognizes the addition of the standard After the conditioning is completed a measurement should be Measuring a Sample Solution To do so place an OPC ampoule One Point Cut ampoule of the 100 mmol l standard solution onto a flat surface and hold it steady with one hand With the other hand break off the head of the ampoule carefully and wit
3. After the measurement is finished the message THE MEASUREMENT WAS SUCCESSFUL will display and the result value is indicated on the display in mmol l If you would like to take another sample pipette another 20 ul sample into the measuring vessel If you would like to end the measurement series touch the END field on the touch screen display Fig 11 successful measurement Note If the chloride meter does not automatically begin upon addition of the sample it is probably because the chloride concentration is W less than 10 mmol l Increase the concentration using the standard solution by adding 20 ul of the standard solution 60 9 0100 Subtract 100 mmol l of the standard from the final result Measuring a Sample Solution Measuring a Sample Solution 8 4 Executing a Sample Measurement with Printer single probe If your device is equipped with a printer Option D you can use it to log the measurement results The result of every sample will be printed if you turn on the option USE PRINTER in the screen at the beginning of each measurement run Every sample shall get a unique identifier Sample ID This can be done manually or automatically Use printer Fig 12 measurement printer modus single probe 1 Before each sample series one should check the calibration of the chloride meter by running a test measurement with a 100 mmol standard solution 2 After successful measurement please press the SINGLE SAMPLE
4. Alphanumeric device description e g CM20 lt deviceno gt Unique device identifier alphanumerisch 24 Digital Data Output Interface Option COM Maintenance of the Chloride Meter 10 Maintenance of the Chloride Meter 10 1 Replacing the Measurement Electrode or Silver Anode Y Pull out the power plug of the equipment 77 Risk of electric shock For purposes of replacement the measurement electrode can be manually pulled out downward and can be inserted upward Insertion of the plug is easy since the connection pins are designed such that it is impossible to install the contacts the wrong way round Note The measurement electrode can be easily replaced with one hand without the use of additional tolls However do not insert or remove the electrode at an angle During removal the entire measuring equipment could be pulled down with it Push the measurement electrode up until it is completely engaged seated firmly Titration electrodes are inserted into the colored receptacles of the measurement equipment according to their color marking red black 10 2 Comparison Control Measurements A comparison control measurement must be carried out and documented according to applicable laboratory guidelines using a 3 level control solution e g SS 150 Wescor Inc If a control measurement deviates from the prescribed target range the manufacturer or the service agency must be notified 10 3 Safety Checks Saf
5. a constant amount of silver ions is released at the anode The silver ion concentration is Arbeitsl sung maintained by the measurement electrodes indicator electrodes which are dipped into the solution By adding a chloride sample Magnet r hrfisch the free silver ions form a non soluble silver Fig 1 Schematic Drawing Coulometric Titration Introduction 7 Introduction chloride precipitate together with the free chloride ions of the sample Ag Cl AgCI The indicator current drops and by controlling the generator current silver ions are released until all chloride ions are precipitated as silver chloride This restores the original silver ion concentration end point The period of flow of the generator current is measured during the titration process and is proportional to the chloride ion concentration Depending on the type of sample no more than 50 measurements should be carried out using one batch of working solution 3 3 Specifications Measurement 0 999 mmol l display Measuring range 10 999 mmol l Resolution 1 mmol l over the entire measurement range Sample volume 20 ul nominal Reproducibility 2 digit 20 ul sample amount at 100 mmol l Linearity 1 mmol l or 1 between 10 299 mmol l 8 Introduction Introduction 3 4 Unpacking the Chloride Meter After receipt of the shipment the chloride meter should be immediately unpa
6. 14 measurement sample injection enne eem nennen 21 Fig 15 measurement sample reading sssssssssseeseeee eene eene nennen 21 Fig 16 meas rement printer use en aan ee ert o nn ua Ene 22 Fig 17 measurement probe numbering ssssssseeeeeenm eene menn enn 22 Fig 18 measurement sample injection enne nne 22 Fig 19 measurement sample reading sss eene eene mener nnns 22 Fig 20 Incorrect feed direction of paper roll ssssssssssseseeeem eene 27 Fig 21 Correct feed direction of paper roll sssssssssseeeeeme eee 27 Fig 22 Replacing the ribbon iiie n eene RUBENS 27 Eig 23 POWer SWIICh ian dic ern ve idein eise 28 1 3 Tables Table 1 Cause and remedy of malfunctions sssessssseeene ener 29 Contents 5 2 Notes Safety Notices and Warnings The symbols and abbreviations defined below may appear on the packaging material on the serial number plate or in the operating instructions IV J In vitro diagnostic device This product meets the requirements of EEC Directive 98 79 relating to in vitro diagnostic devices Attention refer to documentation Please follow the safety notices in the equipment operating instructions Use by The date that follows indicates the expiration data as year month K P m m O The name of the product batch follows AJ TI
7. E Article number or order number The following pages provide a step by step introduction to using maintaining and servicing the measurement equipment Passages requiring special attention are marked as follows measurement results for example by This symbol warns of the danger of corrupting improper use of measuring vessels This symbol warns of the danger of damaging W the unit or the measurement system for example as a result of improper servicing Ee Note or tip Subject to errors and technical changes The information contained in this document may be changed without prior notice 2009 Gonotec Gesellschaft f r MeB und Regeltechnik mbH All rights reserved Reproduction of this document in any form is permissible only with the prior written consent of Gonotec Gesellschaft fur MeR und Regeltechnik mbH The trademarks used in this document GONOTEC and FKGO are trademarks of Gonotec Gesellschaft f r Me und Regeltechnik mbH Other trademarks and trade names used in this document may be trademarks or names of the corresponding companies or their products Gonotec Gesellschaft f r Me und Regeltechnik mbH does not assert any claim to trademarks or trade names other than its own Chloride Meter Model Chloridmeter CM 20 2009 August 2012 Version 1 07 Introduction 3 Introduction 3 1 Application Fields of the Chloride Meter The Gonotec Chloridmeter CM 20 Chloride Meter is a non invasive in vitro diagno
8. buffer solution 37x10 ml bottles and stabilizer 1x30 ml bottle 60 9 0100 Standard solution 100 mmol I NaCl packaged in 10 ampoules each Accessories and Replacement Parts Item no Item 60 3 0010 Silver electrode anode 60 3 0020 Silver electrode cathode 60 3 0030 Measurement electrode 60 9 0001 Titration beaker special beaker 60 9 0002 Magnetic stir bar 60 9 0003 Magnetic stir bar retriever 60 9 0004 Silver cleaning cloth with oxidation protection for electrode cleaning 30 9 1010 Printer paper for OSMOMAT 030 D 010 auto CM20 30 9 1020 Endless ink ribbon cassette for OSMOMAT 030 D 010 auto CM20 20 9 0165 Data cable for RS232 connection CM20 on request Barcode hand scanner with power supply and cable 32 Appendix Packaging unit qty 1 1 Packaging unit qty 1 Fos Oo EX E BY ai Appendix Classification of the IVD The chloride meter made by us is a non invasive in vitro diagnostic product according to EEC Directive 93 42 Medical Devices Law The chloride meter is not named in Annex Il list A or B of the Directive 98 79 EEC for in vitro diagnostics Compliance is declared per Annex III Number 6 of Annex Il is disregarded since the unit s intended use does not include personal use EC Conformity Statement Chloride Meter Gonotec GmbH GSG Hof Reuchlinstr 10 11 D 10553 Berlin We hereby declare that the chloride meter complies with Directive 98 79 EEC Compliance is declared per Annex I
9. password protected The password is set during commissioning the device by a laboratory supervisor The password can be changed as often as desired Note A lost password can only be reset by the manufacturer or its authorized service provider 10 6 2 Function Checking Only accessible by the manufacturer or by a service partner 10 6 3 Re Initialization When you return the unit to its factory settings the entire system is re started and re initialized 10 7 Printer Maintenance Ensure that no foreign objects enter the unit during unit maintenance work The mechanics and the measurement system could be damaged when restarted 10 7 1 Printer Paper Change Press the paper feed button to eject any remaining paper from the printer Do not pull on the paper since this could damage the printing device 1 Carefully push against the printer shaft The printer unit automatically pushes out of the housing Remove the empty roll core from the carriage 26 Maintenance of the Chloride Meter Maintenance of the Chloride Meter 2 Insert a new paper roll Ensure the correct feed direction of the paper roll Fig 6 Fig 20 Incorrect feed direction of paper roll 3 Cut off the end of the paper so that it is even and guide it into the paper slot from above Hold the paper feed button pressed Q until about 2 cms extend from the housing 4 Push the printer unit back into the housing a slight latching wil
10. principle START turn on device Start Message show all available options Working Point reached working point injection detected Conditioning conditioning finished injection detected Measurement measurem finished Preserve Solution Measurement Only available if printer Option D is installed ENTER Fig 4 Menu Structure 14 Menu Structure of the Chloride Meter Menu Structure of the Chloride Meter 6 1 Display and Keypad Overview gonolec IMFO MEASURE SETTINGS Please touch the buttons above Fig 5 Touch screen 6 2 Menu Functions Operating the CM 20 chloride meter is very easy using the touch screen display After you have turned on the equipment you can initially select between the menu items Information Measurement or Settings by touching the corresponding symbol In the Information menu item you will find brief information about your system To continue touch the CONTINUE field At the end you quit the menu item and will return to the start In the Settings menu item you can perform basic settings to leave this item press BACK Setting options include language display screen saver factory settings and internal settings Language You can select the language in which the device operates You can select between German and English Display You can adjust the contrast of the device Make sure that the device is set
11. the entire measurement range Printer function PTFE magnetic stir bar Error message cylindrical Communications Indoor use no direct sunlight Option COM 10 C to 35 C 50 F to 95 F 40 C to 70 C 40 F to 158 F 5 80 non condensing up to 2000 m 100 120 VAC 200 240 VAC 50 60 Hz 20 VA Detachable power supply cord 0 5 A for 200 240 VAC 1 0 A for 100 120 VAC integral lithium cell 10 years typical 2 IP21 205 x 220 x 360 mm 8 x 8 7 x 14 2 inches 5 7 kgs 12 54 Ibs Manufacturer Gonotec GmbH GSG Hof Reuchlinstr 10 11 10553 Berlin GERMANY Graphical dot matrix printer date time and sample information on each measurement 216 characters per row Normal paper 43mm wide various print modes single print batch printing Printed in plain text 2 x RS232 one RS232 reserved for barcode reader 1x USB Tel 49 0 30 7809588 0 Fax 49 0 30 7809588 88 E mail contact gonotec com Web www gonotec com
12. Devices and equipment which should be connected to the RS232 and or USB W interfaces must comply with the relevant safety standards Wary of the potential damage to man and machine Digital Data Output Interface Option COM 23 Digital Data Output Interface Option COM The following data format will be used for output Formatting ASCII a comma character ASCII 0x2C is used to separate the data columns and the carriage return character ASCII OxOd lt CR gt to separate lines Baud Rate transfer speed is 9600 Bits s Data Format 8 data bits no parity 1 stop bit Before any data output at the beginning of a charge or a single sample measurement the following header will be printed charge sample date time value device device no lt CR gt Then the following output will be printed after every successful measurement lt charge gt lt sample gt lt date gt lt time gt lt value gt lt device gt lt deviceno gt lt CR gt Output Content lt charge gt Charge ID or a minus sign if no charge is running alphanumeric lt sample gt Sample ID alphanumeric lt date gt Date of the measurement in English notation mm dd yyyy mm Month two digits 01 12 dd Day two digits 1 31 yyyy Year four digits 0000 9999 time Time of measurement in English notation HH MM HH Hour 00 23 MM Minute 00 59 lt value gt Measurement result without decimal places in mmol l device
13. Function Checklrgr oue d e eee nf 26 10 6 3 Re lnitialiZationi ie ere ete HER ee 26 10 7 Printer Mainternarice uinea eden medecin ea ances ee the en an deni 26 10 4 1 Printer Paper Change erede bete rl o eee ee 26 10 2 Ribbon Changer ea ete aa rt ela ide eut 27 10 8 Replacing a Defective Power Fuse ssssssssseeeeneeneeenen emen 28 10 8 1 Forfeiture of Measurement System Warranty sssssssessee eee 28 11 Error Messages and Troubleshooting 29 11 1 Classification of Malfunctions by Component Group sssee eee 29 12 Buffer Stabilizer and Standard Solutions 30 12 1 Provisions of Certification kill Lie 30 12 2 GOMpOSitiOn ni es e Wc Mert tU e pet aote ne ee eb tet Qe goes 30 12 3 Safety and Handling Information ssssssssses eene 30 12 327 Standard Sol tlon ert ette a allein 30 12 3 2 Buffer and Stabilizing Solution sssesseeeeenee ene ener 31 12 4 Storage and Shelf Life reet ann 31 12 4 1 Standard Sol tionisa teda pne ede entem eerte 31 12 4 2 Acid Buffer and Stabilizer Solution Working Solution ee 31 Contents 3 Contents hilo 0 lt 1 b dis I 32 Consumables vinee Re RR a BUE RR I RR RM 32 Accessories and Replacement Parts sssssssssssssssesse eee 32 Classification of the IVD ececcceccececeeeeeeeeeeeeeeeeeeeeceaaaecee
14. HER LEGAL THEORY AND NOTWITHSTANDING PRIOR NOTIFICATION OF THE POSSIBILITY OF SUCH A LOSS Respective Jurisdiction This warranty statement guarantees the customer certain legal claims The customer may have other legal claims that go beyond those outlined here Such claims vary by state in the US by province in Canada and by nation elsewhere in the world Elements of this warranty statement that conflict with local laws can be regarded as amended to comply with the applicable laws For this reason certain warranty exclusions and restrictions outlined here may be of no relevance to the customer In some states of the US in some Canadian provinces and in some countries outside North America for example the following national laws apply a Exclusion of the fact that the warranty exclusions and restrictions named here restrict the legal rights of a customer for example Great Britain b Restriction of the possibilities for manufacturers to enforce such warranty exclusions and restrictions c Granting of additional warranty claims for the customer fixing of the validity period for implied warranty services that the manufacturer may not exclude or nonadmission of restrictions relating to the validity period for implied warranty services THE FOLLOWING APPLIES TO CONSUMER TRANSACTIONS IN AUSTRALIA AND NEW ZEALAND THE CONDITIONS OF THIS WARRANTY STATEMENT NEITHER EXCLUDE LEGAL RIGHTS APPLICABLE TO THE SALE OF GONOTEC PRODUCT
15. Handling Information 0 ee cece eeeeceeeeeeeneeeeeeaeeeeeeaeeeeeeeaeeeeeecaeeeeeeneeeeeeneeeeseaes 12 5 2 Kriown Risks during Use nase ea anna een 13 6 Menu Structure of the Chloride Meter 14 6 1 Display and Keypad Overview sssssssseee enne ene enen nenne enne enne 15 6 2 Men Functions aua E dee HOA e HR e dto em bie dee Re ers 15 f Calbrationze iic os ale 17 2 Contents Contents 8 Measuring a Sample Solution 18 9717 Pr paration zs strenue nonet 18 8 2 GONGITIONING E etie mei nee 18 8 3 Executing a Sample Measurement without Printer seee enn 20 8 4 Executing a Sample Measurement with Printer single probe seeeeeee 21 8 5 Executing a Sample Measurement with Printer Charge 22 9 Digital Data Output Interface Option COM 23 10 Maintenance of the Chloride Meter 25 10 1 Replacing the Measurement Electrode or Silver Anode sssssse en 25 10 2 Comparison Control Measurements sssssssssessseeeeeeene eene nennen 25 10 3 Safety Ghecks ar oni EEE EET RAEE E AA A EET AE 25 10 4 Meter Checks rtu mni ER 25 10 5 Internal Quality Checks 2 Linee co Lione teinte pede ei EO De ede cu dc b eene dudes 26 10 6 Settings han RE HD Eee Ati il eee eee 26 10 6 1 Settingithe Date and Tire nie ehe 26 10 6 2
16. S TO SUCH CUSTOMERS NOR REPRESENT A RESTRICTION OR AMENDMENT OF SUCH RIGHTS BUT INSTEAD REPRESENT A SUPPLEMENT TO THESE RIGHTS EXCEPT TO THE EXTENT PERMISSIBLE UNDER THE LAW Appendix Returning Parts for Warranty Repair or Credit All products returned for repair or credit must be prepared as follows 1 Call or write to request a free return order for equipment that is being returned for warranty repair or credit You may also request a return order for equipment that is being returned for non warranty repair but you will be liable for the cost of the return order Clean and disinfect the equipment before returning it to us We will charge a processing fee for cleaning and disinfecting contaminated equipment Equipment that is greatly contaminated will be returned at the customer s expense Secure the corresponding transport fasteners Enclose written information explaining the reason for returning the equipment If the equipment is being returned for credit you must include all accessories power cord software media manuals etc Return the equipment in its original packaging If you no longer have the original packaging you may purchase replacement packaging from Gonotec Do you have a high sample volume and or cannot afford downtime During the warranty time we will provide you with a temporary unit at no cost Transport costs are only incurred outside the warranty period Before Calling Gonotec Note When
17. a control solution Please consider the advices in the chapter CONDITIONING respectively the correct way to inject a sample 4 The chloride meter automatically detects the injection and will Fas ie measurement start the measurement While the measurement is running the sample injection message CONDITIONING IS RUNNING will be shown on the display You can track the measurement process by reading the increasing measure value If you like to abort the measurement l please press the CANCEL button 7 mmo 5 After the successful measurement the message MEASUREMENT SUCCESSFUL and the measurement result value in mmol l will be displayed Additionally the result will be Use printer BEGIN CHARGE STANDBY SINGLE SAMPLE inted Fig 19 measurement printed on paper sample reading If you like to measure another sample please just inject 20 ul of the next sample into the measurement vessel To end a running charge press END CHARGE Afterwards the device is in single sample mode again until you begin another charge If you like to end the whole measurement series press the STANDBY button on the touch screen to enter the standby mode and then press CANCEL 22 Measuring a Sample Solution Digital Data Output Interface Option COM 9 Digital Data Output Interface Option COM If the device is equipped with a digital data output interface Option COM you will find three digital output connectors at the rear site of the device The
18. ance statement and transfer responsibility to the originator of said actions 12 2 Composition Standard solution FKGO 100 60 9 0100 contains 100 mmol l of sodium chloride in distilled water For precise concentration information see the analysis certificate for each batch The acid buffer consists of a diluted acetic acid nitric acid solution 12 3 Safety and Handling Information 12 3 1 Standard Solution The standard solution is not dangerous according to EC Directive 67 548 EEC Poison class F no poison class Switzerland p German water hazard class WGK 1 slightly hazardous to water Storage class German association of chemical industries VCI 10 13 miscellaneous liquids and solids According to GLP institute requirements regulations on the federal national Disposal P and local level Note The standard solution consists of chemicals Accordingly all precautionary measures and regulations must be adhered to and applied do not swallow do not taste always wear gloves etc Container clear glass OPC ampoules Nominal volume 1 ml The ampoules have a breaking ring with a breaking ring color blue dot The ampoule can be opened manually by breaking it off at this point Follow all safety precautions for the handling of glass splintering breakage etc 30 Buffer Stabilizer and Standard Solutions Buffer Stabilizer and Standard Solutions 12 3 2 Buffer and S
19. button on the screen If the automatic sample numbering was activated you will be asked to inject the sample In manual sample numbering you will be asked to enter the Sample ID and then to inject the sample Alternatively you can inject the sample directly without pressing any button The measurement then starts automatically and you will be asked for Fig 13 measurement the Sample ID after the measurement has finished PERO al 3 Now inject 20ul of the sample sweat urine serum or rather a standard or a control solution Please consider the advices in the chapter CONDITIONING respectively the correct way to inject a sample CRNCEL Fig 14 measurement sample injection 4 The chloride meter automatically detects the injection and will start the measurement While the measurement is running the message CONDITIONING IS RUNNING will be shown on the display You can track the measurement process by reading the increasing measure value If you like to abort the measurement please press the CANCEL button 5 After the successful measurement the message MEASUREMENT SUCCESSFUL and the measurement result value in mmol l will be displayed Additionally the result will be its r a 7 mmol l printed on paper 6 Ifyou like to measure another sample please just inject 20 ul of ter the next sample into the measurement vessel If you like to end the measurement press the STANDBY button on the touch Fig 15 measurement samp
20. calling Gonotec have your unit s serial number ready The serial number helps our service technicians to more quickly record the unit and determine a procedure If possible switch on the unit before calling Gonotec s technical service Use a telephone that is close to the unit You may be asked to provide detailed information while running operations or apply other troubleshooting methods that can only be performed on the unit itself Ensure that you have the equipment documentation handy Warning Before undertaking any work on the equipment read the safety notices in the appropriate chapters of this manual Tel 49 030 7809588 0 toll free Germany only 0800 7846027 Appendix 35 Appendix Specifications BB Overview Standard model Sample volume Start up Time Test Time Reproducibility Measurement display Measuring range Resolution Integrated stirrer Environment Operating temperature ambient Storage temperature Room humidity Altitude Electrical Voltage Frequency Power Mains connection Fuses 2 HBC breaking capacity 1500 A Memory backup Overvoltage category Pollution degree Protection Rating Dimensions WDH Weight Net 36 Appendix Options 20 ul Printer Option D immediately from standby and power on Approx 20 seconds 2 digits 20 ul at 100 mmol l Number of digits 0 999 mmol l 10 999 mmol l Paper 1 mmol l over
21. ces print media or accessories not supported or supplied by Gonotec or D f Use of the equipment in a manner not covered by the product specifications For Gonotec chloride meters the use of accessories in particular measurement electrodes and titration electrodes made by manufacturers other than Gonotec does not void the customer s warranty claims or any 2 customer support contracts between Gonotec and the customer If however such use results in malfunctions or damages to the chloride meter and the measurement and stirring equipment due to the use of titration beakers measurement and titration electrodes by others Gonotec shall assess the normal fees for the time and material required to repair the chloride meter in order to fix such malfunctions or damages If Gonotec is notified within the warranty period of a defect in a software product in media measurement electrodes or titration electrodes and if the Gonotec warranty applies to the defect Gonotec shall replace the defective product If Gonotec is notified within the warranty period of a defect in a hardware product and if the Gonotec warranty applies to the defect Gonotec shall repair or replace the defective product at its discretion If Gonotec is unable to repair or replace a defective 3 product to which the Gonotec warranty applies Gonotec shall refund the purchase price of the product within a reasonable period following notification of the respecti
22. cked and checked for obvious signs of damage sustained during shipping If any damage is found notify the manufacturer or your distributor Gonotec GmbH Tel 49 0 30 7809588 0 GSG Hof Reuchlinstr10 11 Fax 49 0 30 7809588 88 10553 Berlin E mail contact gonotec com GERMANY Web www gonotec com Toll free service number for Germany 0800 7846027 The packaging for this equipment was specially designed to ensure safe and hygienic transport The packaging is re usable Please save the packaging in case the unit needs to be shipped back to Gonotec for repairs or servicing This will save you the time and money needed to find equally suitable packaging 3 5 Packaging Contents Check to make sure the contents of your shipment are complete We cannot accept responsibility for any missing items reported at a later date Accessories and consumables included in the shipment quantity Item number Item epa 1 60 00 Chloridmeter CM20 1 60 3 0010 Anode silver electrode 1 60 3 0020 Cathode silver electrode 1 60 3 0030 Measurement electrode 1 60 9 0001 Titration beaker special beaker 1 60 9 0002 Magnetic stir bar 1 60 9 0003 Magnetic stir bar retriever 1 60 9 0004 Silver cleaning cloth with oxidation protection 1 60 9 0010 Acid buffer solution 37x10 ml and stabilizer 1x30 ml 1 60 9 0100 Standard solution 100 mmol l packaged in 10 ampoules each 1 20 9 0100 Power cable 1 Quick Start Guide 1 User Guide A comple
23. e that it is reinserted into its same original 7 position 10 8 1 Forfeiture of Measurement System Warranty Use of non supported measurement or titration electrodes that will destroy the measurement system even if done during the warranty period shall result in forfeiture of the warranty claim of repair or replacement of the measurement system 28 Maintenance of the Chloride Meter Error Messages and Troubleshooting 11 Error Messages and Troubleshooting The following explains the error messages reported by the unit along with their possible causes 11 1 Classification of Malfunctions by Component Group The following presents an overview of the individual component groups identifying the function of each component its potential malfunctions the effects of the malfunctions on the measurement system the possible causes of the malfunctions and the procedure for correcting each malfunction Conditioning cannot help minimize damage in this case It is thus of no consequence whether these malfunctions occur during conditioning or during a sample measurement Some errors can be remedied directly by the user or an in house medical equipment technician other errors require return of the unit to the manufacturer Component Groups function Titration electrode Anode Cathode Measurement electrode Pipette Table 1 fluctuating measurement values during measurement of the standard conditioning not succes
24. eeeee ca ceaeaaeaeeeeeeeseseccasaeeeeeeeseseccuseeeeeeesensnnaeees 33 EC Conformity Statement Chloride Meter sss emnes 33 Provisions of Certification eene eren en nnne nennen ihnen nennen senes 33 Limited Warranty 2 1 2 reto eo eroe ioo ae 34 Returning Parts for Warranty Repair or Credit 35 Before Calling Gonotec cnn ee ped in nee eR 35 Specilicati hsa u ne 36 4 Contents Contents 1 2 Illustrations Fig 1 Schematic Drawing Coulometric Titration sssssseeeen mmm 7 Fig 2 Frontal view of the chloride meter ssssssssseeee eem eene enn 10 Fig 3 Rear view of the chloride meter ennemis 11 Fig 4 Menu Structure seereis oi n enntre e e iine pie reni e deed et al hee e E de end evt 14 Fig 5 Touch Screen u a dan tm era ed ne a A ee 15 Fig 6 measurement Start iii engin eder bb aa oig eq NEATE 18 Fig 7 measurement working ponteareas e eene nennen nnne ener nennen enn 18 Fig 8 measurement standard solution eene enne 18 Fig 9 measurement conditionirig 1o Ea ite E edad ub bee e d lee 19 Fig 10 sample measurement a eL D SHEER e gU Ha D eti ie pet edere bagues 20 Fig 11 Successful measurement ere ar epa niea etate pad eed tedio riti h ities 20 Fig 12 measurement printer modus single probe esesse eem 21 Fig 13 measurement probe numbering eseina e ERE EEA A E EER enn 21 Fig
25. equipment is to be decommissioned make sure it is sufficiently disinfected This will W make sure that the equipment has been decommissioned in accordance with local accident prevention guidelines For cleaning and decontamination of the device and its surface commercially in clinical chemical laboratories commonly used detergents such as Mikrozid AF Liquid Bacillol plus 3 Korsolex plus 4 or similar are recommended These are also recommended by the Robert Koch Institute for IVD laboratory devices 12 Setup and Initial Operation Setup and Initial Operation The unit does not emit harmful substances either during operation or when switched off Symbols on the unit and its serial number plate meet the requirements of the following standards DIN EN 61010 1 DIN EN 61010 2 101 DIN EN 61326 DIN EN 62304 DIN EN 62366 DIN EN 591 DIN EN 375 and DIN EN 980 harmonized standard for medical devices according to 3 No 17 of the German Medical Device Law MPG Regarding the checking of meters please refer to the applicable laboratory guidelines in this regard 5 2 Known Risks during Use An acid buffer and a stabilizer solution are used during measurement Make sure you read the attached safety data sheets concerning appropriate safety measures and handling of these solutions Setup and Initial Operation 13 Menu Structure of the Chloride Meter 6 Menu Structure of the Chloride Meter Brief illustration of handling
26. ety checks should be conducted in accordance with relevant accident prevention guidelines For annual maintenance safety checks meter checks contact your dealer or Gonotec 10 4Meter Checks Once per year a meter check and calibration must be carried out by the manufacture or service agency Nonetheless the user should perform the following checks Control measurements must be carried out in accordance with applicable laboratory guidelines Measurement readings and any evaluation results must be logged If the system is to be used for immediate diagnostics for patients RiliBAK requires the following In such cases a single control sample measurement must be done at least once per week if patient samples are examined through this process during the respective calendar week We recommend that the 3 level control solution SS 150 of Wescor Inc be used Maintenance of the Chloride Meter 25 Maintenance of the Chloride Meter s Guidelines of the German Medical Association for Quality Assurance of Medical Laboratory Investigations Volume7 Feb 15 2008 Par 2 1 5 10 5 Internal Quality Checks A programmable microcontroller monitors the unit s functions The failure of individual functional groups in the unit results in a malfunction that either outputs an error message or shuts down the unit 10 6 Settings 10 6 1 Setting the Date and Time Within the menu Settings select Lab to change the date and time The settings are
27. h only slight pressure across the printed point on the neck of the ampoule Note Do not try to break off the OPC ampoules across an arbitrary point of S the neck or with force You could be injured by the shattering of the entire ampoule Now place a correctly sized pipette tip onto your 20 ul fixed volume microliter piston pipette or your multivolume pipette set to 20 ul Press the piston of the pipette into the pipette up to the first pressure point and hold the piston there Lead the pipette tip into the standard solution and leave the pipette tip in the solution during the filling phase Allow the piston of the pipette to slowly and smoothly retract until the piston is relocated in its initial position Make sure that you do not take in any air Wait for a second and then remove the pipette from the solution There are now exactly 20 ul of solution in the pipette tip If you see drops on the outside of the pipette tip carefully remove them with a lint free paper tissue do not draw off any solution from the pipette tip through capillary forces of the paper tissue or repeat the process with a new pipette tip Place the pipette with the filled pipette tip into the working solution located in the chloride meter Use one of the two guides at the measuring sensor unit as a guide Dip the tip into the working solution and press the piston up to the second pressure point in order to completely eject the solution Pull the pipette out of the working so
28. l be felt Fig 21 Correct feed direction of paper roll 10 7 2 Ribbon Change The ink ribbon cassette must be replaced when the printout no longer has sufficient contrast 1 Tear off any paper strip from the slot before replacing the ribbon 2 Presson the right side of the ribbon cassette using light finger pressure The cassette is released from the printer A 3 Take out a new ribbon and rotate the rotating knob clockwise with your index finger to tighten the ribbon Fig 22 Replacing the ribbon 4 Insert the ribbon in the printer The paper must be between the ribbon and the ribbon cassette Tighten the ribbon by twisting the knob again 5 Press and hold the paper feed button until approx 2 cms of the printer paper are protruding from the housing and then close the door Maintenance of the Chloride Meter 27 Maintenance of the Chloride Meter 10 8 Replacing a Defective Power Fuse v Before replacing a defective power fuse unplug the unit from the power supply Risk of f electric shock To replace the fuses use a small screwdriver to remove the fuse holder on the rear of the unit The two fuses can now be replaced The unit has two phase protection Use so called HBC fuses with a breaking capacity of 1500 A Others are not allowed 200 240 VAC power supply 0 5 A slow LAG 100 120 VAC power supply 1A slow LAG Fig 23 Power switch v When inserting the fuse holder it is imperativ
29. le reading screen to enter the standby mode and then press CANCEL Measuring a Sample Solution 21 Measuring a Sample Solution 8 5 Executing a Sample Measurement with Printer Charge If your device is equipped with a printer Option D you can use it to log the measurement results and organize them in charges Every charge shall have a unique charge number Charge ID and every sample in this charge shall have a unique Sample ID within this charge Both can be done manually or automatically n did Fig 16 measurement printer the chloride meter by running a test measurement with a 100 modus charge 1 Before each sample series one should check the calibration of mmol standard solution 2 After successful measurement press the BEGIN CHARGE button on the screen If the automatic charge numbering was activated as well as the automatic sample numbering you will be asked to inject the sample In manual charge and or sample numbering you first will be asked to enter the Charge ID and the Sample ID and then to inject the sample If you have already started with a charge before you also can inject the next Fig 17_ measurement probe numbering sample of this charge directly without pressing any button If manual numbering is selected in the settings you will be asked for the Sample ID after the measurement has been finished 3 Now inject 20ul of the sample sweat urine serum or rather a standard or
30. ll of the Directive The CE mark on the unit acknowledges this Date 01 07 2009 Signature of managing director ssssesess Provisions of Certification CE compliance requires that the unit is installed and operated in the manner described in this manual Any deviation from the specifications or independent modifications of the unit without the express consent of Gonotec GmbH may result in a violation of CE requirements Such actions invalidate the compliance statement and transfer responsibility to the originator of said actions Appendix 33 Appendix Limited Warranty Gonotec product Software Measurement electrode Chloride meter A 1 34 Duration of B Limited Warranty 90 days 180 days 1 year Extension of the Limited Warranty C Gonotec guarantees the end user that Gonotec products 1 shall be free from manufacturing and material defects for the above periods of validity from the purchase date The end user must provide proof of the purchase date For software products Gonotec s limited warranty applies only to the non execution of programming instructions Gonotec does not guarantee that the operation of a product will proceed without errors or interruptions Gonotec s limited warranty applies only to defects that arise during normal operation of the product It does not apply under the following conditions d Inadequate servicing or improper modification e Use of software interfa
31. lution with the piston pressed Make sure that you do not pipette the solution at the electrodes or at the wall of the beaker Pipette the solution directly into the working solution close to the center solution automatically whereupon the message PROCEEDING WITH CONDITIONING will display Conditioning in progress taken using the 100 mmol 60 9 0100 standard to check the calibration Fig 9 measurement conditioning Measuring a Sample Solution 19 Measuring a Sample Solution 8 3 Executing a Sample Measurement without Printer Chloride meter CM20 without option D or deactivated printer this can be done by using the check box use printer in Fig 10 14 15 16 17 18 20 Before each sample series the calibration of the chloride meter should be checked using the 100 mmol standard solution After conditioning is finished add 20 pl of your sample solution sweat urine serum or standard solution control solution Follow the instructions from the CONDITIONING chapter with regard to the information on the correct way to add sample Fig 10 sample measurement The chloride meter automatically recognizes that sample has been added and automatically begins the measurement The message PROCEEDING WITH CHLORIDE MEASUREMENT will display You can track the measurement visually through the incremental display value If you would like to cancel the measurement touch the CANCEL field
32. ride Meter 11 Setup and Initial Operation 5 Setup and Initial Operation Place the chloride meter onto a flat and solid surface such as a laboratory table Avoid direct sunlight onto the LCD touch screen so that instructions and measurement results can be easily read Use the power cord provided to connect the chloride meter from the power input socket at the rear of the unit to an earthed wall power outlet It is also important to ensure that the voltage indicated on the serial number plate W matches that of your electricity network Incorrect voltage will cause the fuse in the power supply unit to blow Turn on the chloride meter at the power switch at the rear After a short self test the Welcome screen appears on the touch screen display This screen is made up of three touch sensitive fields INFORMATION MEASUREMENT and SETTINGS 5 1 Safety and Handling Information The chloride meter is an electric laboratory measurement device It should therefore be handled according to the safety provisions and precautions for electric measurement control and laboratory equipment Warning an apparatus with CLASS construction shall be connected to a mains socket outlet with a protective earthing connection Where the mains plug or an appliance coupler is used as the disconnect device the disconnect device shall remain readily operable To disconnect the equipment from the mains remove the mains plug from the mains outlet If the
33. sful conditioning fails fluctuating measurement values no plausible measurement values unable to begin the measurement series unable to begin the measurement series no plausible measurement values Cause and remedy of malfunctions Possible Cause contaminated electrodes mech defective electrode contaminated electrodes mech defective electrode incorrect or used solution pipette defective or incorrect use of the pipette clean the electrodes with the silver cleaning cloth and then rinse with distilled water replace the electrodes clean the measurement electrode with the silver cleaning cloth and then rinse with distilled water replace the measurement electrode use new original solution examine pipette and examine the handling of the pipette Fehler Verweisquelle konnte nicht gefunden werden 29 Buffer Stabilizer and Standard Solutions 12 Buffer Stabilizer and Standard Solutions 12 1 Provisions of Certification CE compliance requires that the device together with the buffer stabilizer and standard solutions and accessories be used in the manner described in this manual Any deviation from the specifications or independent modifications of the device the buffer stabilizer and standard solutions or accessories without the express consent of the manufacturer may result in a violation of CE requirements Such actions invalidate the compli
34. stic device It is used to determine the chloride concentration in sweat urine serum and other body fluids Its purpose is to provide information to help identify diagnose monitor and treat physiological conditions states of health and illnesses The equipment may only be operated by specialists or those persons whose training or skills have provided them with the necessary practical experience see MPBetreibV German Medical Devices Operator Ordinance 3 1 1 Application Restrictions of the Chloride Meter Please ensure that no other halogens such as fluoride bromide or iodide are present in the samples Also no oxidizers may be added to the samples Plausibility checks of the results must be performed by the doctor by means of the pertinent literature 3 2 Chloride Meter Measurement Method The Gonotec CM 20 chloride meter operates according to the principle of coulometric titration Two silver electrodes the generator electrodes anode and cathode are dipped into a measuring vessel filled with working solution The working solution consists of an acid buffer and a colloid stabilizer that keeps the silver chloride which arises later on in suspension Since the buffer does not contain any silver Anode ions the silver ion concentration and thus Kathode the indicator current see below is brought Messelektrode to a specific end point By means of a constant current generator current between the two silver electrodes
35. tabilizing Solution The buffer and stabilizing solution are hazardous materials according to EC Directive 67 548 EEC Information on safety and handling can be found in the attached safety data sheets 60 9 0010 Acid buffer solution Container Screwed cover plastic bottles Nominal volume 10 ml 60 9 0010 Stabilizer solution Container Screwed cover dropper bottle Nominal volume 30 ml IN Please read the safety data sheets 12 4 Storage and Shelf Life When stored unopened in their original containers at 5 C to 45 C the consumables have a shelf life up to the expiration date indicated on the packaging Do not continue to use the consumables after the expiration date 12 4 1 Standard Solution Once the ampoule has been opened the standard solution shelf life is up to hour at 22 C 12 4 2 Acid Buffer and Stabilizer Solution Working Solution The shelf life of fresh working solution acid buffer with stabilizer solution is a maximum of 14 days when kept in a sealed opaque vessel Working solution which contains silver chloride that is to be used for measuring purposes should be used as soon as possible since it can react photochemically with light reduction of the precipitated silver chloride into elementary silver We recommend that a new working solution is prepared for each measurement series Buffer Stabilizer and Standard Solutions 31 Appendix Appendix Consumables Item no Item 60 9 0010 Acid
36. te listing of accessories and consumables is located in the appendix Introduction 9 Design of the Chloride Meter 4 Design of the Chloride Meter 4 1 Overview of Display and Connectors Measurement equipment consists of e Measurement electrode e Silver electrodes cathode anode Titration beaker holder with integrated stirrer Chloridmeter Fig 2 Frontal view of the chloride meter 10 Design of the Chloride Meter Housing front plate with integrated display LCD touch screen Handle for manually lowering the measurement equipment into the titration beaker with integrated pipetting aid Optional integrated dot matrix printer Design of the Chloride Meter C 2 a a a Option RS232 interface COM1 RS232 interface COM2 USB interface Power switch 1 on O off Characteristics for device fuse to be used Fuse holder for two phase fuse Serial number plate with protection of information on serial number power supply CE power voltage frequency and power consumption C 0 294 C 2X m uu Fig 3 Rear view of the chloride meter 4 2 Power Supply Autoselective power supply 100 120 VAC 200 240 VAC 50 60 Hz Power consumption 20 VA 4 3 Dimensions and Weight Dimensions width x depth x height 205x220x360 mm Weight approx 5 7 kgs Design of the Chlo
37. up such that no direct sunlight is directed at the screen Screen saver You can select the amount of time until the screen saver activates from 30 seconds to 10 minutes or you can disable it completely Menu Structure of the Chloride Meter 15 Menu Structure of the Chloride Meter In order to avoid damage to the screen we urgently recommend that the screen saver N is used Printer If the device is equipped with a printer Option D you can trigger a paper feed when you have mounted a new paper roll And you can select if Charge ID or Sample ID will be generated automatically or must be entered manually alphanumeric or numeric With automatic numbering the device restarts counting at midnight every day with Charge ID 1 respectively Sample ID 1 Within each Charge the automatic Sample ID starts with 1 too Protocol Port Ifthe device is equipped with the Option COM you can choose a data port for data transmission to PC Factory settings Here you can return the equipment to the factory settings Note The device will switch to English mode Lab Here you can enter or change the date and time Password protection is possible At initial operation a password can be freely selected by the supervisor Note A lost password can only be reset by the manufacturer or its authorized service provider Service Only accessible by the manufacturer or by a service partner When you quit Settings you will return to the start Now
38. upper serial data port COM1 RS232 can be used to connect a bar code reader A compatible and ready configured bar code reader can be purchased via Gonotec GmbH respectively via an authorized dealer The use of other bar code readers which are not supplied by Gonotec GmbH is not recommended because of possible incompatibility issues The chloride meter CM20 also can log the measured results through the serial data connector in the middle of the interface connector COM2 RS232 Bitte w hlen Sie The relevant data port may be selected under the menu SETTINGS option PROTOCOL PORT In the following display selection between COM2 and COM3 USB is possible The operation ofthe USB port requires a software driver In the following there are two options available to install the driver as mentioned below Automatic installation connection of the chloride meter CM20 to a PC via the USB cable and following switch on The PC s operating system recognizes the interface automatically installs the required software driver and then signalizes the successful installation Now the USB port may be used as additional COM interface Manuel installation The PC does not recognize the chloride meter automatically and or the operating system is not supplied with the required software driver In that case please refer to enclosed CD which contains the installation guide and software driver for the relevant Windows operating system required
39. ve defect Gonotec is not obligated to repair or replace a product or refund its purchase price until the customer returns the defective product to Gonotec Replacement products may be new or almost new as long as their functionality is at least that of the replaced product The Gonotec limited warranty is applicable in all countries in which Gonotec sells the applicable product The following countries and regions are exceptions All countries outside the EU In these countries the warranty is only valid in the country in which the product was purchased Contracts for additional warranty services such as on site service may be available from an authorized Gonotec sales partner Appendix _ Limitation of the Warranty TO THE EXTENT PERMISSIBLE UNDER THE APPLICABLE LOCAL LAWS NEITHER GONOTEC NOR ITS SUPPLIERS SHALL ASSUME ANY ADDITIONAL WARRANTY SERVICES OR ACCEPT ANY OTHER CONDITIONS EXPRESS OR IMPLIED WITH REGARD TO THE GONOTEC PRODUCTS Limitations of Liability To the extent permissible under the applicable local laws the legal remedies named here shall be the sole and exclusive legal remedies available to the customer TO THE EXTENT PERMISSIBLE UNDER THE APPLICABLE LOCAL LAWS AND WITH THE EXCEPTION OF THE OBLIGATIONS EXPRESSLY NAMED HERE NEITHER GONOTEC NOR ITS SUPPLIERS SHALL BE LIABLE FOR DIRECT OR INDIRECT SPECIFIC INCIDENTAL OR CONSEQUENTIAL LOSSES WHETHER BASED ON A CONTRACT A TORTIOUS ACT OR ANOT
40. you can begin with your measurements Touch the MEASUREMENT button to start the procedure The system starts the measurement sequence and leads you through it using simple instructions until a successful measurement has been carried out Please refer to Chapter 8 Measurement of a Sample Solution for information on the precise sequence 16 Menu Structure of the Chloride Meter 7 Calibration 7 Calibration The chloride meter is delivered in calibrated condition from the factory Calibration by the user is not required Calibration is checked and if necessary recalibration is performed during an Ee annual maintenance check or meter check by the manufacturer or service agency Calibration 17 Measuring a Sample Solution 8 Measuring a Sample Solution After turning on the device you can start using the chloride meter immediately 8 1 Preparation 1 Add 20 drops of Gelatin solution stabilizer 60 9 0010 to a 10 ml flask of acid buffer solution 60 9 0010 seal the buffer flask shut and carefully turn it over a few times Pull down the probe afterwards 2 Make sure that the chloride meter is turned on and touch the MEASUREMENT field on the touch screen display with your finger 3 On the display you will be asked to add the working solution Fig 6 measurement start that you have just prepared buffer and stabilizer and the magnetic stir bar 60 9 0002 to the beaker 60 9 0001 of the CM20 chloride meter
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