Elitech ChloroChek Chloridometer 3400, User Manual

Page 1: ...CHLOROCHEK M O D E L 3 4 0 0 User s Manual CHLORIDOMETER ...

Page 2: ...CHLOROCHEK Chloridometer Sweat Chloride Analyzer Model 3400 USER S MANUAL 57 2006 03B Last update 10 14 2020 ...

Page 3: ...2 2017 ELITechGroup Inc All rights reserved Printed in the United States of America The information in this document is subject to change without notice ...

Page 4: ...7 4 3 Calibration and Meter Check 29 4 4 Cleaning the ChloroChek 30 4 5 Changing the Power Fuses or Voltage Setting 31 Section 5 Digital Data Management 5 1 Digital Data Output 32 5 2 Lab Options Menu Structure 34 5 3 Log Format Options 35 5 4 CSV Format 36 5 5 XML Format 38 5 6 Legacy CSV Format 41 5 7 Error Messages 42 5 8 Checksums 43 5 9 Using a Barcode Scanner for ID Input 44 Appendix A Speci...

Page 5: ...formation Interferences Any salts containing chloride or other halides halogens such as fluoride bromide or iodide will interfere and cause an elevated reading CLSI acknowledges this in the C34 A3 guideline In addition to chloride other halides such as bromide and iodide are also detected using a chloridometer Therefore if a sweat sample contains other halides in addition to chloride they will be ...

Page 6: ...e by pushing the top of the ampule back while holding onto the base It is recommended to use a plastic sleeve when breaking ampules ELITech Group provides two protective sleeves with each new box of sweat controls SS 150 The reagent set contains acetic acid and nitric acid If discharged in the plumbing system rinse with plenty of water The symbols defined below may appear on the packaging material...

Page 7: ...d Touch Screen Display Measurement Electrode Titration Beaker and Holder Handle for lowering the electrode carriage into the titration beaker Pipette guides are on the side of the handle Instrument Front Silver Electrodes Black housing cathode Red housing anode ...

Page 8: ...rument Rear Panel Power Entry Module Power Switch I on O off Product Model Serial Number Label Fuse holder for two phase fuse protection of power supply COM 1 Serial data input port Not active in this model COM 2 Serial data output port RS232 port USB data output port ...

Page 9: ...omplete Accessories and consumables included in the shipment Reference Number Item Description Quantity Model 3400 ChloroChek Chloridometer 1 RP 481 Silver Electrode red housing anode 1 RP 482 Silver Electrode black housing cathode 1 RP 483 Measurement Electrode 1 RP 484 Titration Beaker 2 RP 485 Magnetic Stir Bar 2 RP 486 Magnetic Stir Bar Retriever 1 RP 487 Silver Cleaning cloth 1 RP 535 Data Ca...

Page 10: ...ertification CE compliance requires that the device together with the buffer solution gelatin solution and standard solution and accessories be used in the manner described in this manual Any deviation from the specification or independent modification of the device the buffer solution gelatin solution and standard solution or accessories without the express consent of the manufacturer may result ...

Page 11: ... Buffer Solution plus 20 drops of Gelatin Solution is maximum of 14 days when kept in a sealed opaque vessel and stored at 25 46 4 F 2 C to 8 C 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 It is recommende...

Page 12: ...11 SECTION 3 OPERATING THE CHLOROCHEK 3 1 Menu Structure ...

Page 13: ...o displays brief information about the system Display adjust contrast of the screen Screen saver select the amount of time until the screen saver activates from 1 minute to 60 minutes In order to avoid damage to the screen it is recommend that the screen saver be used The Settings menu contains the ID Management options Users may select from automatic numeric alphanumeric or none for ID type for a...

Page 14: ...cathode black housing electrodes in the appropriate colored receptacle The short side of the electrode goes into the receptacle leaving the long end exposed 3 Install Measurement Electrode The Measurement Electrode must be aligned to match the 3 pin connections without binding Push the Measurement Electrode straight into the receptacle when the pins have been correctly aligned The Measurement elec...

Page 15: ...ottle of SS 248GS and 37 flasks for SS 248BS The 1 bottle of SS 248GS contains enough Gelatin Solution to prepare all 37 flasks of SS 248BS Each flask of SS 248BS contains 10 mL of Buffer Solution 1 Add 20 drops of Gelatin Solution SS 248GS to one flask of Buffer Solution SS 248BS 2 Put the cap back on the flask and carefully swirl or invert it to mix it thoroughly This forms the Working Solution ...

Page 16: ...Solution is prepared and used A new Working Solution should be prepared and used each day 1 With the instrument on press MEASURE on the display 2 Place the filled titration beaker in the beaker receptacle 3 Lower the handle to bring the electrode set down into the Working Solution and the Ready button will appear ...

Page 17: ...CEL ends the conditioning cycle and returns user to the Main screen If this is done the Working Solution must be replaced 5 In the following display the user will be asked to wait until the system has reached its Working Point A runtime display under the message visualizes this process Proceed immediately to the next step ...

Page 18: ...correctly sized pipette tip onto a 10 µL fixed volume piston pipette ELITech Group has an appropriate pipette AC 178 and pipette tips SS 253 available 8 Place the pipette tip well into the 100 NaCl H2O mmol L Standard Solution holding the tip in the solution during the entire filling phase Avoid drawing air into the pipette during the filling phase Allow the piston to smoothly and slowly retract u...

Page 19: ...iscard the tip 10 When the ChloroChek recognizes the added standard solution the display will read CONDITIONING 11 When the conditioning is complete the ChloroChek is ready to use NOTE In cases where conditioning is not successful user must clean the electrodes and prepare a new Working Solution see Section 3 3 NOTE On rare occasions the ChloroChek may skip the conditioning step and move directly ...

Page 20: ... of each laboratory and any regulatory requirements Results should be within the defined ranges If values fall outside of the defined ranges then clean the measurement electrodes see Section 4 2 or check the accuracy of the pipette see Section 4 1 Quality control materials should be used in accordance with local state and or federal guidelines NOTE Over time and use the anode red housing silver el...

Page 21: ...ase Avoid drawing air into the pipette during the filling phase Allow the piston to smoothly and slowly retract until it has returned to its initial position Wait for about one second and then remove the pipette from the solution If there are drops on the outside of the pipette tip carefully remove them with a lint free tissue do not draw out any solution from the pipette tip through capillary for...

Page 22: ... result of the sample Keep in mind that this result is below the specified linearity range of the ChloroChek and should be recorded as 10 mmol L NOTE If larger samples are used 10 µL take into account that the concentration is reported on the basis of the titration for a 10 µL sample Adjust the reading according to the volume of pure sweat in the sample using a procedure validated by the laborator...

Page 23: ...JECT screen appears follow steps 1 and 2 for sample preparation and injecting sample 4 The ChloroChek recognizes the added sample and the display will start counting up from 0 until it reaches the final value The final value remains on the RESULT screen until another sample is pipetted into the Working Solution begin end batch is selected single sample is selected or until user presses STANDBY on ...

Page 24: ... pipette another sample into the Working Solution following Steps 1 3 above The ChloroChek will automatically recognize each sample when injected and the value for the last sample injection will be displayed on the screen The user may also select begin end batch or single sample dependent upon ID management settings and follow prompts to continue testing a batch or single sample See Appendix D for...

Page 25: ...on A freshly prepared Working Solution should be a transparent red color As a Working Solution is used it will appear cloudy If a freshly prepared Working Solution appears cloudy it should be discarded The titration beaker should then be carefully cleaned and a new Working Solution prepared 2 Raise the handle to lift the electrode set out of the Working Solution 3 Remove the stir bar from the Work...

Page 26: ...odes with deionized water Remove the electrodes from the electrode carriage for easy rinsing and drying 6 Dry the titration beaker stir bar and electrodes with lint free tissue To prevent oxidation store cleaned and well dried electrodes in their individual plastic containers 7 The ChloroChek is now ready for use again with a freshly prepared Working Solution ...

Page 27: ...surement of the standard solution or controls No plausible measurement values Contaminated electrodes Mechanically defective electrodes Clean electrodes with silver cleaning cloth and rinse with distilled water Replace electrodes and working solution Measurement electrode Conditioning not successful Unable to begin the measurement series Contaminated electrode Mechanically defective electrode Clea...

Page 28: ...r cleaning cloth and microfiber cloth is provided as RP 487 1 Place the small pink or green microfiber cloth and the large blue or orange silver polishing cloth near each other on a lab bench or other hard surface 2 Remove the electrodes from the ChloroChek 3 Observe the angle of the measurement electrode tip demonstrated below When the correct angle has been achieved aggressively pull the tips of...

Page 29: ...e into the ChloroChek 10 Prepare a fresh working solution 11 Lower probes into the working solution 12 Press Measure then Ready 13 Add 10uL of 100mmol L NaCl standard If conditioning successful appears continue to check instrument prior to use as described in Section 3 4 14 At the end of the session press Standby then Exit 15 Remove the electrodes measurement electrode silver anode and silver cath...

Page 30: ...g occurs ChloroChek not able to condition even after electrodes have been cleaned and or replaced Correct quality control values while using Sweat Control Solutions SS 150 are not achieved after verification that the pipette is delivering the correct volume Calibration is checked during a maintenance check or meter check by the manufacturer or service agency and if necessary recalibration is perfo...

Page 31: ...e down the instrument surfaces CAUTION Do not contact the instrument with excessive moisture This can seep into the interior and cause damage to the instrument Use a damp cloth only 2 Rinse surfaces thoroughly with a cloth dampened with tap water 3 Dry surfaces with a dry cloth or allow to air dry Other commonly used detergents such as Mikrozid AF Liquid Bacillol plus 3 Korsolex plus 4 or similar ...

Page 32: ...fuses for the power setting to be used 1 To replace the fuses use a small screwdriver to remove the fuse holder on the rear of the unit 2 Remove and replace the two fuses The unit has two phase protection Use the following fuses 200 240 VAC power supply 0 5 A slow LAG 100 120 VAC power supply 1 A slow LAG NOTE When inserting the fuse holder return it to its original position with the correct volta...

Page 33: ...A software driver is required to use the USB port Connect the ChloroChek to the PC using the USB cable and switch it on The operating system of the PC detects the interface automatically installs the required software driver and notifies the user that installation was successful The USB port can now be used as an additional COM interface A serial port program such as PuTTY or HyperTerminal must be...

Page 34: ...ollowing 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 0x0d CR to separate lines Baud Rate Transfer speed is 9600 Bits s Data Format 8 data bits no parity 1 stop bit ...

Page 35: ...34 SECTION 5 DIGITAL DATA MANAGEMENT 5 2 Lab Options Menu Structure ...

Page 36: ...APIs Human readable Checksum acts as backup Not very compact Legacy CSV CSV format from previous generations of devices Compatible with legacy devices and interfaces Syntax not always clear May cause data to be misinterpreted Works best with AC 191 Printer For reasons of security it is strongly advised not to use this format with a networked computer End of Line Markers Name Description ASC11 CR C...

Page 37: ... When the instrument is started a line is published with version information to prevent future compatibility problems This line contains the short name of the device type followed by the version numbers of the mainboard and the components connected to it A typical intro line looks like the following CM20 Main V1 80 COM V1 7 D V1 10 NOTE Software driver must be open when powering on the machine or ...

Page 38: ...nymous with the term batch sample Sample ID appears if entered manually or set to automatic Void if Sample ID type is none date Date and time in combined ISO 8601 format e g 2015 12 31T13 45 value Measurement result without decimal places regardless of language setting dimension Unit of the measurement value published in quotation marks mmol l regardless of language setting device no Serial Number...

Page 39: ...from a single measurement Batch Contains several results from a batch measurement Ticket A ticket consists of an XML tag which corresponds to one published ticket If it relates to a single measurement it contains an additional XML tag called MEASUREMENT which contains the measurement and the associated metadata If it relates to a batch measurement one ticket may contain several measurements A tick...

Page 40: ...nguage setting Value will not be present if it is a mismeasurement Unit Unit of measurement in mmol l regardless of language setting Will not be present if it is a mismeasurement Failure Error identifier see Error messages section DeviceNo Serial Number of ChloroChek alphanumeric CheckSum Checksum of previous values in this line see Checksum section Message Human readable message in selected langu...

Page 41: ...asurements are then implemented within that batch Ticket class BATCH serialno 3400140127 versions CHLOROCHEK Main V1 80 COM V1 6 Measurement BatchId BATCH01 sampleId SampleId 01 sampleId DateTime 2016 12 22T12 55 30 DateTime Value 21 Value Unit mmol l Unit DeviceCode 3400140127 DeviceCode CheckSum 1fe1219fa897b340c91407c191af319d CheckSum Measurement Ending the batch also closes the ticket Ticket ...

Page 42: ... ID appears if entered manually or set to automatic A minus sign is displayed if Batch ID type is none or Single Sample is selected during measurement The term charge is synonymous with the term batch sample Sample ID appears if entered manually or set to automatic Void if Sample ID type is none date Date of the measurement in English notation mm dd yyyy mm Month two digits 01 12 dd Day two digits...

Page 43: ...ice failure Notification Meaning ABORT User cancels by pressing the exit key LIFT User cancels by lifting the sensor MFAIL Measurement could not be completed successfully CFAIL Conditioning could not be completed successfully MABORT Measurement was canceled IFAIL Unexpected injection of sample EXHAUST Working solution has been used up ...

Page 44: ...ent SampleId 01 SampleId DateTime 2016 12 22T12 55 30 DateTime Value 21 Value Unit mmol l Unit DeviceNo 3400140127 DeviceNo CheckSum a173e3f754290e77f1b5ac689d3d2486 CheckSum Measurement Or 01 2016 12 22T12 55 30 21 mmol l 3400140127 a173e3f754290e77f1b5ac689d3d2486 And the above contents are strung together to form 012016 12 22T12 55 30mmol l3400140127 The MD5 checksum for this string is A1 73 e3...

Page 45: ...he COM1 RS232 port and attach power cable Plug unit into power source and ensure a green light appears on the top of the barcode reader 3 Enter the measurement screen and condition the working solution Once the Ready screen appears follow the instructions in section 3 7 for sample measurement with ID management or refer to flow charts using ID management in Appendix D 4 Screens are dependent upon ...

Page 46: ...door use no direct sunlight Operating temperature ambient 50 F to 95 F 10 C to 35 C Storage temperature 40 F to 158 F 40 C to 70 C Room humidity 5 80 non condensing Altitude up to 2000 m 6562 feet Electrical Voltage 100 120 VAC 200 240 VAC Frequency 50 60 Hz Power 20 VA Electrical connection Detachable power supply cord Fuses 2 HBC breaking capacity 1500 A 1 0 A for 100 120 VAC 0 5 A for 200 240 V...

Page 47: ...p by mail telephone fax or e mail at the address and numbers listed below ELITechGroup Inc 370 West 1700 South Logan Utah 84321 8212 USA Telephone 1 435 752 6011 1 800 453 2725 United States Canada Fax 1 435 752 4127 US Email Service_EBS elitechgroup com Service Sales_EBS elitechgroup com Sales Web Page www elitechgroup com European Authorized Representative MT Promedt Consulting GmbH Altenhofstra...

Page 48: ...k box of 960 tips SS 253 10 µL Fixed Volume Pipette AC 178 ChloroChek Supplies Item Reference Number Ampule Organizer for Sweat Controls AC 071 Squirt Bottle for Water 500 mL AC 180 Serial Printer AC 177 Chlorochek Barcode Reader AC 192 ChloroChek Replacement Parts Item Reference Number Silver Electrode red housing anode RP 481 Silver Electrode black housing cathode RP 482 Measurement Electrode RP...

Page 49: ...APPENDIX D FLOW CHARTS FOR SAMPLE MEASUREMENT USING ID MANAGEMENT Screen Cascade for Batch ID Type None ...

Page 50: ...49 APPENDIX D FLOW CHARTS CONTINUED Screen Cascade for Batch ID Type Auto ...

Page 51: ...50 APPENDIX D FLOW CHARTS CONTINUED Screen Cascade for Batch ID Type Auto Continued ...

Page 52: ...51 APPENDIX D FLOW CHARTS CONTINUED Screen Cascade for Batch ID Type Numeric ...

Page 53: ...52 APPENDIX D FLOW CHARTS CONTINUED Screen Cascade for Batch ID Type Numeric Continued ...

Page 54: ...53 APPENDIX D FLOW CHARTS CONTINUED Screen Cascade for Batch ID Type Alpha Numeric ...

Page 55: ...54 APPENDIX D FLOW CHARTS CONTINUED Screen Cascade for Batch ID Type Alpha Numeric Continued ...

Page 56: ...y of CF in a sibling or a positive newborn screening result and an increased sweat chloride concentration by pilocarpine iontophoresis on two or more occasions or identification of two CF causing mutations or demonstration of abnormal nasal epithelial ion transport METHOD 1 Based on CLSI recommendations C34 A3 2009 Coulometric titration PRINCIPLE ChloroChek operates according to the principle of c...

Page 57: ...ative of CF Range Infants 0 6 months Cl 29 mmol L Cl 30 59 mmol L Cl 60 mmol L Beyond Infancy 6 months 18years Cl 39 mmol L Cl 40 59 mmol L Cl 60 mmol L Adults 18 years Cl 39 mmol L Cl 40 59 mmol L Cl 60 mmol L Exact ranges for adults are not fully defined Refer to CLSI C34 A3 for more information ...

Page 58: ... Materials Authorization RMA number hazard free certification and decontamination instructions for equipment that is being returned for warranty repair or credit 2 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 repairs 3 Clean the equipment before returning it to ELITech Group NOTE Shipping costs are paid ...

Page 59: ...weat Control Level 3 240 98 1 0 1 0 100 mmol L NaCl Standard 240 100 1 0 1 0 Repeatability Determined with one ChloroChek unit and one operator Sample n Mean Standard Deviation CV 10 mmol L NaCl Standard 40 10 1 0 5 4 7 Sweat Control Level 1 40 22 5 0 8 3 5 Sweat Control Level 2 40 49 3 0 8 1 7 Sweat Control Level 3 40 98 6 0 8 0 9 100 mmol L NaCl Standard 40 100 1 0 9 0 9 Correlation Two comparat...

Page 60: ...l L The parameters of the linear regression for the 90 samples were as follows Regression Parameters Lower 95 CI Upper 95 CI Intercept 0 979 1 879 0 082 Slope 1 060 1 043 1 089 Correlation coefficient r 0 99 Predicate Device Total ChloroChek 8 0 0 8 0 3 1 4 0 0 78 78 Total 8 3 79 90 Where Indicative of CF Intermediate Equivocal Normal The result on the predicate device was 38 mmoL L and was 41 mmo...

Page 61: ...e Measurement of Quantitative Procedure a Statistical Approach Approved Guideline CLSI NCCLS document EP6 A 2003 23 16 3 Evaluation of Precision Performance of Quantitative Measurement Methods Approved Guideline Second Edition CLSI NCCLS document EP5 A2 2004 24 25 4 Method Comparison and Bias estimation Using Patient Samples Approved Guideline Second Edition CLSI NCCLS document EP9 A2 2002 22 19 ...

Page 62: ...ELITechGroup Inc 370 West 1700 South Logan Utah 84321 8212 USA 800 453 2725 1 435 752 6011 WWW ELITECHGROUP COM ...