CONTENTS A. Preface 5

Transcription

1 V2 Reference Manual

2 CONTENTS A. Preface 5 Intended Use 7 Intended Audience 7 Chapters and Contents 7 Conventions 9 Ordering Information 9 Technical Assistance 9 1. Description 10 Introduction 11 Installing the Biolyte Features 18 Analytes 18 Main Components 19 Tubing 20 Flow Controller 20 Pump 21 Waste Valve and Reference Valve 22 Waste Valve 22 Reference Valve 22 Sampler 23 Electrode Carrier 24 Measuring Electrodes 25 Reference Electrode 25 Air Detector 25 Input/Output Devices 26 Keypad 26 Liquid Crystal Display (LCD) 28 Alarm 28 Printer 28 Acceptable Samples 29 Sample Handling Requirement 29 Serum 30 Plasma 30 Whole Blood 31 Urine 31 Cerebrospinal Fluid 31 Acceptable Anticoagulants 32 Interfering Substances 32 Drugs Showing No Lithium Interference 33 Reference Intervals 34 Display Range for Analytes Set Up 35 Introduction 36 Set Up Options in Menu 37 Selecting Electrodes 37 Selecting Units of Measurement 38 Setting Resolution Values 39 Setting Two-point Calibration Interval 40 Setting Date and Time 41 Setting Results/Printer 43 Setting Reference Values 44 Setting Panic Values 45 Setting Offsets Values 46 Setting Operation Options 47 3.Operation 49 Introduction 50 Software Description 50 Main Screen 50 Start/Standby Function Key 51 Samp. Type Function Key 52 Calibrate Function Key 53 Analyze Function Key 55

3 Status Function Key 59 Flowpath Function Key 60 Menu Function Key 61 Set Up Options 61 Operation Options 61 Data Options 61 Data Recall 62 Data Transfer 63 Data Clear 63 Software Version 65 Diagnostic 65 Maintenance 65 QC function Key 65 Biolyte 2000 Operation 66 Shortcut Procedures 67 Power On 67 Selecting Electrodes 67 Set Sample Type 67 Selecting Analysis Modes 67 Calibration 68 Manual Calibration 68 Auto-Calibration 68 Analysis : Serum/Plasma 68 Analysis : Whole Blood 69 Analysis : Urine 69 Analysis : CSF Maintenance 70 Introduction 71 Maintenance Function 71 Condition 72 Condition Na 72 Condition f_path 75 Clean Flow Path 78 Reagent Information 81 Prime 82 Probe Adjustment 83 Calibrate Pump Frequency 84 Daily Maintenance 85 Checking the Reagent Pack Level 85 Cleaning the Sample Inlet Port 85 Conditioning Na Electrode 85 Conditioning the Flow Path with Serum 85 Checking Slope & Flow Time 86 Checking the Electrode Slope 86 Checking the Flow Time 86 Periodic Maintenance 86 Flow Path Maintenance Cycle 86 Replacing the W-line 87 Replacing the R-line 88 Replacing the S-line 89 Replacing the A-line/B-line 90 Replacing the Probe 91 Replacing the Electrodes 92 Non-routine Maintenance 93 Cleaning the Sample Inlet Port 93 Cleaning the Probe 93 Standby Mode 93 Replacing the Reagent Pack 94 Installation of Thermal Paper 97 Shutdown Quality Control (QC) 99 Introduction 100 Analyze Control 101 QC Setup 105 Print Westgard Rules Violation 108 Statistics 110 Browse QC Data 111 Print QC Data 112 Print L-J Chart 113 Browse Statistics 115

4 Print Statistics 116 Clear QC Data Troubleshooting 118 Introduction 120 Troubleshooting Theory 120 Troubleshooting Procedure 121 Solving Flow Problems 121 Indicator of Flow Related Problem 122 Flow Times 122 Air and Fluid Readings 123 Confirming a Flow Problem 124 Possible Sources of Flow Problem 125 Flow Path Check 126 W-line Check 126 S-line/Electrode Carrier Check 127 Probe Check 128 A-line & B-line Check 129 R-line Check 129 Septum Check 130 Diagnostic 132 Device Exercise 132 Valve Exercise 133 Pump Exercise 134 Probe Exercise 135 Device Test 136 Speaker Test 136 Printer Test 137 LCD Test 138 Keypad Test 138 Sampler Sensor Test 139 Serial Port Test 140 Air Detector Test 141 Error Log 142 View Error Log 142 Print Error Log 143 Clear Error Log 144 System Test 144 Probe Position 145 Pump Movement 146 Valves Set 146 Sensor mv Data 147 Error Code 148 Introduction to Error Codes 148 Display Error Code 148 Problem Solving Procedures 148 Interpreting Error Codes 150 Error Code Reference Theory 198 Introduction 199 Origin of the Potential Measurement 200 Calculation of Na, K, Cl, and Li Concentration 204 Electrode Calibration 206 Two-Point Calibration 206 Two-Point Calibration Sequence 206 One-point Calibration 207 Direct vs. Indirect Methodologies 208 Plasma Volume Displacement Error 208 Bicarbonate 208 Protein Binding 208 Combined Effects 209 Halogen Effects on Chloride Determination Appendix 211 Appendix I : Warranty of Products 212 Appendix II : Specifications of Biolyte Appendix III : Performance of Biolyte Appendix IV : Warning Messages 220 Appendix V : Labels on the Biolyte Appendix VI : Description of IEC Letter Symbols 221 Appendix VII : Location of Serial Ports 222 Appendix VIII : Error Codes 222

5 Appendix IX : Spare Parts List of Biolyte Appendix X : Consumable List of Biolyte

6 A. Preface A. Preface 5 Intended Use 7 Intended Audience 7 Chapters and Contents 7 Conventions 9 Ordering Information 9 Technical Assistance 9 5

7 6 V2 Reference Manual

8 Intended Use The Biolyte 2000 is intended for in vitro diagnostic use by healthcare professionals in the quantitative determination of sodium, potassium, chloride, or lithium (option) in whole blood, serum, and plasma; sodium, potassium, and chloride in whole blood, serum, plasma, urine and CSF. All the data reported from the Biolyte 2000 are for clinical reference. If abnormal clinical data occur, further studies and evaluation of these data are suggested to ensure clinical safety. Intended Audience The Biolyte 2000 V2 Reference Manual is written for healthcare professionals who operate the Biolyte Users do not need prior experience with BioCare products, but should have been trained on the instrument by BioCare s designated personnel. This manual describes the Biolyte 2000 and explains how to test samples with them. Chapters and Contents The Biolyte 2000 V2 Reference Manual includes the following chapters : Chapter 1, Description, gives instructions on installation, lists the Biolyte 2000 s operating features, describes its operating components, and specimen handling requirements. Chapter 2, Set Up, describes the instrument s Set Up options and explains how to modify them. Chapter 3, Operation, explains how to enter sample data, analyze samples, and calibrate the instrument. Chapter 4, Maintenance, explains how to perform the instrument maintenance procedures. Chapter 5, Quality Control, explains how to monitor the performance of the instrument 7

9 with quality control standards. Chapter 6, Troubleshooting, describes error codes and explains how to repair the Biolyte Chapter 7, Theory, describes the principles of electrode theory and the process of electrode calibration. This chapter also includes the equations that the instrument uses to calculate the Biolyte 2000 s concentration for each electrode. Chapter 8, Appendix, lists all of Biolyte 2000 s system specifications, warning messages, labels on the Biolyte 2000, description of IEC letter symbols, consumable information, error codes, reference list and parts list. 8 V2 Reference Manual

10 Conventions This manual uses the following conventions: Bulleted lists contain itemized or summarized information. Numbered lists contain procedure steps Notes are written in Italics and provide important or helpful operating information. WARNINGS are written in italicized capital letters and provide information that is important for user or instrument protection. Initial Capital Letters begin the name of software screens & menu options. Square marked letters are used for the names of keys on the Biolyte 2000 s keypad. Bold typed captions in the left-hand margin of some pages restate important information that appears in the text or contain additional information that complements the text. Throughout the software operating procedures, quick reference steps in the left-hand margin graphically explain how to access the software screens that are explained in the text. Ordering Information Users can order more copies of the Biolyte 2000 V2 Reference Manual (Part. No.: ), from BioCare Corporation Marketing Department at or to sales@biocare.com.tw. When encountering any question arising from different language versions, the English version will be the principal reference. Technical Assistance For technical assistance with users Biolyte 2000, call BioCare Corporation s Customer Service Center at

11 1. Description Introduction 11 Installing the Biolyte Features 18 Analytes 18 Main Components 19 Tubing 20 Flow Controller 20 Pump 21 Waste Valve and Reference Valve 22 Waste Valve 22 Reference Valve 22 Sampler 23 Electrode Carrier 24 Measuring Electrodes 25 Reference Electrode 25 Air Detector 25 Input/Output Devices 26 Keypad 26 Liquid Crystal Display (LCD) 28 Alarm 28 Printer 28 Acceptable Samples 29 Sample Handling Requirement 29 Serum 30 Plasma 30 Whole Blood 31 Urine 31 Cerebrospinal Fluid 31 Acceptable Anticoagulants 32 Interfering Substances 32 Drugs Showing No Lithium Interference 33 Reference Intervals 34 Display Range for Analytes V2 Reference Manual

12 Introduction This chapter lists the Biolyte 2000 s testing parameters, specimen requirements, describes its main operating components, and provides an overview of major software functions. The Biolyte 2000 appears in Figure 1-1. Note: Reference to lithium is only applicable to analyzers with this electrode. Figure 1-1. Biolyte

13 Installing the Biolyte 2000 Those unfamiliar with the Biolyte 2000 should read chapter 1 before proceeding. Users must complete the following steps to install the Biolyte Some procedures may not apply to all instruments. Unpacking the Biolyte 2000 and accessory boxes. Confirming voltage range. Assembling and installing electrodes. Installing the septum. Installing the probe. Installing the tubing. Installing the reagent pack. Powering on the instrument. Preparing the printer. Conditioning electrodes and flow path. Performing instrument calibration. The Biolyte 2000 weighs approximately 24 lbs. (11 kg) (without reagent pack). BioCare recommends that at least 1 person help to remove the instrument from its shipping carton and place it on the counter. Complete the following steps to install and assemble the instrument : Unpacking the Biolyte 2000 and Accessory Boxes 1. Inspect the boxes for any shipping damage. Contact BioCare if necessary. 2. Put the box facing up. Open the top lid of the carton box. Take out the accessory box. 3. Open the accessory box and check its contents with the enclosed packing list before proceeding with the installation. Contact BioCare if users are missing users parts. 4. Remove the top foam end cap. Gently remove the Biolyte 2000 from the carton box and place it on the counter. 5. Remove the reference manual and the power cord from the carton box. 12 V2 Reference Manual

14 Confirming Voltage Range 6. The power input module permits the Biolyte 2000 to run at 0.6A/ VAC. 7. Confirm that the voltage of users laboratory is in the range of Biolyte 2000 s specification. Turn the instrument around in order to view the backside. The powerinput module is located where the power cord connects to the Biolyte Figure 1-2. Power Input Module and Fuse Socket. 8. Confirm the availability of appropriate fuse for the required voltage. See Table 1-1 below for the fuse that is required for the Biolyte Change the fuse according to the instructions in Chapter 4, Maintenance. Table 1-1. Fuse for Various Line Voltages. V A Fuse Requirement A SB (T2.0A/250V) 13

15 Assembling and Installing Electrodes 9. Remove the electrodes and electrode carrier from the packing material. 10. Place the electrode carrier on the table with the locking lever pointing towards the installer. Press the locking lever down to its Open position (see Figure 1-3). Figure 1-3. Open Position. 11. Insert each electrode into the electrode carrier as follows: a. Insert the electrode with the pins facing up and to the left side of the electrode. Note that the gasket placement of each electrode (except for the spacer) will be towards the top. b. Align the lip of the electrode to the guide rails at the side of the electrode train. Slide in the electrodes from the bottom towards the top of the electrode train. c. Install the electrode in the following order: Spacer, Reference Electrode, Chloride Electrode or Lithium Electrode, Sodium Electrode, Potassium Electrode, and Air Detector (see Figure 1-4). The electrodes are keyed so users cannot install them upside down. Note: Make sure there is a sealing gasket between each of the electrodes in the carrier. 14 V2 Reference Manual

16 Note: Make sure there is a sealing gasket between each of the electrodes in the carrier. Figure 1-4. Electrode Carrier with Installed Electrodes. 12. Engage the locking lever at the bottom of the carrier to secure all the electrodes in the carrier. The lever should be in its Closed position. 13. Align the connector pins on the electrode and the electrode carrier with the receptacles on the instrument. 14. Gently push the electrode carrier into place on the Biolyte 2000, pressing from the bottom and the top simultaneously. Note: Align the guiding ground rod on the electrode train to the hole on the analyzer. Make sure that you push in the guiding ground rod in first. Installing the Probe 15. Open the analyzer door. 16. Unscrew the locking screw from the top of the sampler arm. 17. Insert the long end of the probe through the sampler arm and into the septum. 18. Slip the locking screw over the short end of the probe. Finger tightens the locking screw onto the sampler arm. Figure 1-5. Probe. 15

17 Installing the Septum 19. Remove a septum from the reagent pack. 20. Lift the sampler to the manual position and install the septum into the bayonet lock located on the under surface of the sampler. Turn the septum clockwise 1/4 turn to lock it in place. Figure 1-6. Install the Septum. Installing the Tubing Figure 1-7 shows the location of the tubing. 21. Connect 1 end of the S-line (Sample Tubing) to the down side of the electrode carrier and thread the other end to the probe. 22. Detain the yellow collar at the left pump bracket, then loosen the pump by lifting the locker, Connect the W-line to the top of the electrode carrier. Thread the W-line into place inside of the waste valve. Attach the fitting on the reagent harness. 23. Connect the R-line (Reference Tubing) to the left-hand side of the electrode carrier. Thread the R-line into place inside of the reference valve. Attach the fitting on the reagent harness. 24. Connect the A-line (STD-A Tubing) and B-line (STD-B Tubing) to the septum. Attach the fitting on the reagent harness. Figure 1-7. Install tubing. 16 V2 Reference Manual

18 Installing the Reagent pack 25. Unscrew the bottle caps of all reagents and the waste bottle. 26. Place a reagent pack half-way onto the fluid deck. 27.Insert the tubing harness straws into the appropriate bottles. 28.Push the reagent pack all the way in. 29.Check all tubing connections. Incorrect installation may result in backward flow and contamination of reagent packs. 30. Plug the RMS into the RMS port (See Figure 1-8 for the location of the RMS port). Powering on the Instrument 31. Insert the female end of the power cord into the Power Input Module plug receptacle. Please position the equipment properly, to prevent that it is difficult to operate the disconnecting service. Plug the other end of the cord into a wall socket. 32. Switch the power button ON. It is located on top of the Power Input Module. The instrument is now powered on. 33. The instrument screen should now display the system initialization procedure. Preparing the Printer 34. Install the printer paper according to the instructions in Chapter 4, Maintenance. Conditioning Electrodes and Flow Path 35. Perform the conditioning procedure for the sodium electrode, as described in Chapter 4, Maintenance. 36. Perform the conditioning procedure for the flow path, as described in Chapter 4, Maintenance. Performing Instrument Calibration 37. From the Menu Screen, press 6 to access the Maintenance Screen. Select the Prime option. Select the Full Prime option, then press Enter key to initiate a full prime of all fluids. 38. Press Calibrate key to initiate a manual calibration. Repeat procedure at least one more time. Refer to Chapter 6, Troubleshooting, in the event of error codes. The users may now proceed to Chapter 2, Set-up Options, followed by the analysis of specimens as described in Chapter 3, Operation. 17

19 Features The Biolyte 2000 is a state-of-the-art electrolyte analyzer that test serum, plasma, CSF, whole blood, and urine. The Biolyte 2000 uses a microcomputer-based operating system to measure analytes, calculate results, and rapidly perform state analyses. The Biolyte 2000 s quantitated analytes are listed according to sample type and analysis mode in Table 1-2. The Biolyte 2000 is highly flexible laboratory instrument and includes many operating features that can be modified to accommodate users changing work environment. Users can adapt the Biolyte 2000 to fit users laboratory testing needs and define its operating parameters for the technicians who will use it. Analytes Table 1-2. Biolyte 2000 s Available Analytes by Analysis Mode and Sample Type. Analysis Mode Analytes Sample Type Serum/Plasma Urine CSF Whole Blood Manual Sodium Potassium Chloride Lithium* SEMI-AUTO Sodium Potassium Chloride Lithium* * Remarks that this part is optional. 18 V2 Reference Manual

20 Main Components The Biolyte 2000 s Main Components (Figure 1-8) include tubing and flow controller to aspirate fluids, an electrode carrier to analyze samples and several communication devices to receive and display information. The Biolyte 2000 also includes a replaceable reagent pack that contains all of the reagents to calibrate the instrument and analyze samples. Figure 1-8. Main Components. Note: Instruments may vary according to the options ordered. 19

21 Tubing A series of plastic tubing transports fluids throughout the Biolyte These tubing include all tubing that extends from the reagent pack to the analytical components on the front of the Biolyte Note: The flow path is the route that fluids travel in, throughout the Biolyte Single tubing called the W-line carries fluids out of the analytical components and back into the reagent pack. Any fluids that exit the Biolyte 2000 are considered waste and are drained into a waste bottle inside the reagent pack. Note: Suction in the W-line draws all fluids through the flow path. Flow Controller The flow controller works to direct fluids through the flow path. The flow controller includes a pump, a waste valve, a reference valve, and a sampler, all of which are controlled by the Biolyte 2000 s microcomputer. The microcomputer turns the pump on and off, opens and closes the waste valve and reference valve, and directs the sampler so that the proper fluids are aspirated in the appropriate timing sequence. The Biolyte 2000 needs accurately timed fluid flow to operate properly, and the microcomputer coordinates the flow controller so the appropriate fluids are delivered to the correct components when they are needed. 20 V2 Reference Manual

22 Pump The pump (Figure 1-9) is mounted to the front of the Biolyte 2000 and consists of a roller cage that is connected to a stepping motor. Figure 1-9. Pump. When the microcomputer turns the stepping motor on, the roller cage rotates to aspirate fluids through the W-line, which stretch across the pump s roller cage. As the pump rotates, it creates a vacuum inside of these tubing; it pushes reference solution through the R-line into the reference electrode, promotes the transport of specimens and standards along the flow path, and pulls waste fluids through the W-line out of the flow path. Waste fluids empty into a waste bottle inside the reagent pack. The pump operates at 2 speed which the microcomputer controls so that fluids aspirate at the proper times. 21

23 Waste Valve and Reference Valve The waste valve and reference valve help control the flow of fluids during the instrument s operating cycles. All instruments include a waste valve and a reference valve. Waste Valve The waste valve is located on the front of the instrument and on the top of the reference valve. Reference Valve The reference valve is located on the front of the instrument and below the waste valve. Figure Location of Waste Valve and Reference Valve. 22 V2 Reference Manual

24 Sampler The sampler, which is located on the front of the Biolyte 2000, controls which fluids are aspirated into the electrode carrier for analysis. The 2 main components of the sampler are the septum (Figure 1-5) and the probe (Figure 1-6). The septum is a plastic cylinder that is partitioned into four compartments. Each compartment holds air or a reagent from the reagent pack. Rubber washers called septa separate the compartments and prevent fluids from leaking and mixing inside of the septum. The probe is a blunt-ended metal tubing that aspirates fluids into the Biolyte The probe moves to different positions inside of the septum to aspirate reagents and extends out of the septum to aspirate sample or air. The sampler accepts fluids in 2 different positions. In the Manual Mode (Figure 3-27B), the sampler aspirates a specimen from a hand-held container. In the Semi-Auto Mode (Figure 3-27A), the sampler automatically aspirates specimen from the sample cup. The sampler is designed to aspirate reagents from inside the septum during specimen analyses, calibration and maintenance procedures. 23

25 Electrode Carrier The electrode carrier (Figure 1-11) houses the analytical components that measure analyte concentrations in a sample. It includes the measuring electrodes, a reference electrode, a spacer, and an air detector. Each measuring electrode quantitates a specific analyte. Figure Electrode Carrier. Sealing gaskets, which prevent any fluid leakage, connects the electrodes and the air detector. 24 V2 Reference Manual

26 Measuring Electrodes During an analysis or calibration, fluid fills the electrode carrier and each electrode generates an electrical potential (or current) in proportion to the amount of its specific analyte in the fluid. Then the microprocessor calculates the concentration of each analyte in the fluid, based on the output of each electrode. Reference Electrode The reference electrode supplies a continuous electrical potential in contrast to a measuring electrode. The reference electrode's potential varies with each particular sample. Because electrical potential can only be measured in comparison to a known voltage, the Biolyte 2000 uses constant voltage supplied by the reference electrode, to measure the potential produced by each measuring electrode. Air Detector The air detector is located below the potassium electrode and has 2 functions: it verifies the presence of air or fluid in the electrode train. The microcomputer monitors the air detector so that it knows when to stop the pump from aspirating a fluid once it fills the electrode train. When the air detector takes a reading during an analysis, it knows whether it is detecting air or fluid. The air detector is an optical sensor that can detect air and fluids. 25

27 Input/Output Devices Use the following input and output devices to communicate with the Biolyte 2000 : Keypad Liquid Crystal Display (LCD) Alarms Printer Keypad The keypad (Figure 1-12) is located on the left, front side of the Biolyte 2000 and contains both numeric and function keys. Figure Keypad. 26 V2 Reference Manual

28 The function keys are described in Table 1-3. Table 1-3. The Function Keys. Key Analyze Calibrate Function Initiates a specimen analysis or restart an interrupted analysis. Initiates a 2-point calibration. Delete characters on an input screen. Enter Esc Flowpath Menu QC Samp. Type Status Start/Standby A select highlighted number of data, initiates sequences, and selects options. The Enter key transfers data from the screen to the microcomputer. Aborts procedures and calls up the previous screen. Accesses the Main Screen. Interrupts an analysis. Begins and ends a flow path maintenance sequence. Displays the Main Screen from the sensor Status Screen. Accesses QC functions. Displays the Sample Type Set Screen. Displays the Full Sensor Status Screen and the Biolyte 2000Status Screen. Makes the screen of Biolyte into Standby Mode. Press again to return to Main Screen. 27

29 Liquid Crystal Display (LCD) The Biolyte 2000 uses 40 characters * 4 lines LCD screen. The Biolyte 2000 s main screen is shown in Figure /05/04 <<Biolyte>> 11:20: * Sample Type : Serum/Plasma * Status : Not ready Figure Main Screen. The main screen contains the following information: the currents date and time, sample type, and status. Alarm The Biolyte 2000 produces an alarm in response to input errors or problems that occur during automatic operation. The Biolyte 2000 beeps to inform users of the following conditions: An attempt to enter too many characters. Entry of an illegal value. A system, calibration, or analysis error has occurred. The Biolyte 2000 sounds an alarm to inform users of the following conditions : The flow path maintenance has timed out. A parameter has exceeded a panic limit. An operator warning is present. Most alarms repeat until users shut them off by pressing any key on the keypad or by accessing another procedure. Printer The thermal printer provides hard copies of test results, calibration information, maintenance information, and error messages. 28 V2 Reference Manual

30 Acceptable Samples The following chart lists acceptable sample types for the different parameters measured: PARAMETER Sodium Potassium Chloride Lithium SPECIMEN MATRIX Serum, plasma, whole blood, or urine Serum, plasma, whole blood, or urine Serum, plasma, whole blood, urine or CSF Serum, plasma, whole blood Sample Handling Requirement Because the specimens are biohazardous and infectious, users must wear gloves during all analysis process. Proper sample handling is critical to ensure that values obtained accurately reflect the in vivo state. Ensure that all samples have been obtained and stored following consistent, clinically accepted protocols. The following is a discussion of general guidelines in reference to sample collection handling requirements for the Biolyte The NCCLS Approved Guideline on Procedures for the Handling and Processing of Blood Specimens indicates that serum or plasma should be physically separated from contact with cells as soon as possible to a maximum time limit of 2 hours from the time of collection. It is also recommended that a contact time of less than 2 hours be established for serum or plasma sample intended for potassium analysis. 29

31 Serum Collect blood for serum samples in plain vacuum tubing or serum separator tubing. Allow the sample to clot for approximately one half-hour. Following clot retraction, centrifuge at 1000 RCF for 10 to 15 minutes, uncap the tubing, and use a syringe or bulb pipette to obtain a serum sample. Take the sample from the area close to the cells if possible, if the sample cannot be analyzed immediately, then separated serum should remain at 22 o C (room temperature) for no longer than 8 hours. If assays will not be completed within 8 hours, the serum sample should be stored refrigerated at 2 to 8 o C. If assays will not be completed within 48 hours or if the serum sample is to be stored beyond 48 hours, the samples are to be stored frozen at -20 o C. Plasma Collect whole blood for plasma samples with minimal stasis, without exercise of the arm, in vacuum tubing containing either sodium or lithium heparin. Whole blood specimens are not to be chilled unless there are documented recommendations for doing so. Obtain plasma by centrifuging heparinized whole blood within 1-hour of collection. Following centrifugation at 1000 RCF for 10 to 15 minutes, remove the cap and use a syringe or bulb pipette to obtain a plasma sample. Take the sample from the area close to the cells. Plasma samples more than 1-hour old should be centrifuged immediately prior to analysis to remove any fibrin clots. If assays will not be completed within 8 hours, the plasma sample should be stored refrigerated at 2 to 8 o C. If assays will not be completed within 48 hours or if the plasma sample is to be stored beyond 48 hours, the samples are to be stored frozen at -20 o C. 30 V2 Reference Manual

32 Whole Blood Blood samples should be collected with minimal stasis, without exercise of the arm. Collect blood for analysis on the Biolyte 2000 in vacuum tubing containing either sodium or lithium heparin. Whole blood specimens are not to be chilled unless there are documented recommendations for doing so. It is particularly important to ensure that samples are well mixed before introduction into the Biolyte Urine Careful attention to urine sample handling is critical to ensure that accurate results are obtained. Urine specimens should be collected in a clean, sterile container with a non-spill, anti-evaporation lid. BioCare Corporation does not make any recommendations as to the duration of collection. To ensure the accuracy of the urine measurement, it is essential that urine be analyzed within 2 hours of collection or refrigerated at temperatures between 2 and 8 o C for extended periods to prevent the growth and metabolism of microorganisms. Urine allowed to sit unperceived at room temperature for extended periods of time will begin to decompose. Acidification to a ph less than 3 may be used to preserve urine samples for extended storage times. For urine electrolytes, boric acid may be used. The amount of acid preservative to be used is dependent upon the collection period and urine output. Cerebrospinal Fluid Lumbar puncture to collect cerebrospinal fluid (CSF) for analysis must be performed by a physician. Spinal fluid should be collected into plain sterile tubing labeled with the time of collection and with numbers indicating the sequence in which the tubing were obtained if multiple tubing are used. A serum or plasma sample or both should be obtained at the time of spinal fluid collection to aid in diagnosis. CSF samples should be analyzed as soon as possible after the time of collection and should not be stored. References : NCCLS. Procedures for the Handling and Processing of Blood. Document H18-A Vol. 10 No. 12. Jacobs., Kasten, DeMott, and Wolfson, ed Laboratory Test Handbook. Lexi-Comp Inc. Tietz, N.W., ed Textbook of Clinical Chemistry. W.B. Saunders Co. 31

33 Acceptable Anticoagulants Sodium and lithium heparin is the recommended anticoagulants for plasma specimens. EDTA, citrate, oxalate, or sodium fluoride is not recommended for use as anticoagulants. Depending on the amount of heparin used in the collection container and whether it is filled to capacity with blood, heparin concentrations may vary significantly. Sodium heparin may elevate sodium results, and lithium heparin will elevate lithium results. Liquid heparin when present in excess may cause errors by dilution. Our experience suggests that lyophilized sodium or lithium heparin giving a final concentration in blood of not more than 30 I.U./mL is acceptable in the critical care laboratory. Biolyte 2000 users should take careful note of these considerations when establishing reference intervals and interpreting results. Interfering Substances The following substances at the concentrations indicated have been shown to produce an approximate 2% increase in the chloride concentration: β-hydroxybutyrate (25 mmol/l) acetoacetate (25 mmol/l) formate (10 mmol/l) lactate (25 mmol/l) salicylate (50 mg/dl) citrate (10 mmol/l) 32 V2 Reference Manual

34 Drugs Showing No Lithium Interference Adding them to sera containing 1.5 mmol/l lithium tested the following medications. The drug concentrations selected were based on NCCLS publication EP7--P 1986 Vol. 6, No. 13 (Proposed Guideline for Interference Testing in Clinical Chemistry). Expected lithium levels were recovered in each case. DRUG DOSAGE( G/ML) DRUG DOSAGE( G/ML) Phenobarbital 20 Mallaril 10 Primidon 20 Prolixin 1500 Carbamazepine 10 Allopurinol 60 Ethosuximide 70 Compazine 3 Phenytoin 20 Lorazepam 1 The possibility exists that of the numerous prescriptions and nonprescription medications commonly administered some combination of drugs or their metabolites or both may be encountered which will affect the lithium sensor. 33

35 Reference Intervals Each laboratory should establish and maintain its own reference intervals based on its patient population. Table 1-4. Reference Intervals Serum Urine (24hr.) Whole Blood CSF Sodium Potassium Chloride Lithium mmol/l mmol/l mmol/l mmol/l mmol/day mmol/day mmol/day mmol/l mmol/l mmol/l mmol/l (Therapeutic range ) 1 Tietz. Norbert W., Ed Textbook of Clinical Chemistry. W.B. Saunders Co. 2 Statland. Bernaid Clinical Decision Levels for Lab Tests. Medical Economics Books. Display Range for Analytes The following display ranges are used by the Biolyte 2000 to check for result range errors (low or high), if the concentration of an analyte falls outside the range for a specimen sample type; the specimen cannot be tested for that analyte. Table 1-5. Display Range by Sample Type. Analytes Serum, Plasma, Whole Blood CSF Urine Sodium mmol/l mmol/l Potassium mmol/l mmol/l Chloride mmol/l mmol/l mmol/l Lithium mmol/l Note : 1. The Serum/Plasma display ranges also apply to serum or plasma specimens that are analyzed as microsamples. 2. References to chloride or lithium or both are not applicable to instruments without these electrodes. 34 V2 Reference Manual

36 2. Set Up Introduction 36 Set Up Options in Menu 37 Selecting Electrodes 37 Selecting Units of Measurement 38 Setting Resolution Values 39 Setting Two-point Calibration Interval 40 Setting Date and Time 41 Setting Results/Printer 43 Setting Reference Values 44 Setting Panic Values 45 Setting Offsets Values 46 Setting Operation Options 47 35

37 Introduction The Biolyte 2000 s Set Up options let users define the instrument s operating parameters to accommodate users laboratory s testing needs. To access the Set Up Screen (Figure 2-1), from the Menu Screen (Figure 3-16), input 1 and press Enter key. Note: References to chloride or lithium or both are only applicable to instruments with these electrodes. << SETUP >> Input No.? 1 10:06:12 1. Test select 2. Units setting 3. Resolution set 4. 2-Pt cal setup 5. Date/Time set 6. Results settings Figure 2-1. Set Up Screen. To select a Set Up option, input the number of the option and press Enter key. 36 V2 Reference Manual

38 Set Up Options in Menu Selecting Electrodes Use this function to turn ON or OFF each electrode. Figure 2-2 shows the Test Select Screen. 1. The flowchart on the left side of this page is the step-by-step procedure for Selecting Electrodes. Procedure << TEST SELECT >> 11:20:51 1. Na+ : ON 2. K+ : ON 3. Cl- : ON 4. Li+ : OFF >>Press Enter key to change. (ON,OFF) Figure 2-2. Test Select Screen. 2.Use keys to move the cursor, and press Enter key to turn ON or OFF the test electrode. 3.After setting the test electrode, press Esc key twice to return to the Menu Screen. MENU Screen 1 SETUP Screen 1 TEST SELECT Screen 37

39 Selecting Units of Measurement The Units Setting Option lets users select the units of measurement for the analysis report of each test. Figure 2-3 shows the Units Setting Screen, which lists all of the system tests and the units of measurement that, users can select for each one. 1. The flowchart on the left side of this page is the step-by-step procedure for Selecting Units of Measurement. Procedure << UNITS SETTING >> 08:30:32 1. Na+ : mmol/l 2. K+ : mmol/l 3. Cl- : mmol/l 4. Li+ : mmol/l >>Press Enter key to change. (mmol/l,meq/l) Figure 2-3. Units Setting Screen. 2. Use keys to move the cursor, and press Enter key to change the units of measurement. 3. After setting the units of measurement, press Esc key twice to return to the Menu Screen. MENU Screen 1 SETUP Screen 2 UNITS SETTING Screen Note: Only Na + and K + can be set to mmol/l or meq/l. 38 V2 Reference Manual

40 Setting Resolution Values The Resolution Set Option lets users specify the number of decimal places that the Biolyte 2000 reports for sodium, potassium, chloride, and lithium results. Figure 2-4 shows the Resolution Set Screen with the alternate resolution values. 1.The flowchart on the left side of this page is the step-by-step procedure for Setting Resolution Values. << RESOLUTION SET >> 08:30:32 1. Na+ : K+ : Cl- : Li+ : 1.23 >>Press Enter key to change. (123,12.3) Figure 2-4. Resolution Set Screen. 2.Use keys to move the cursor, and press Enter key to change the number of decimal places. 3.After setting the resolution values, press Esc key twice to return to the Menu Screen. Procedure MENU Screen 1 SETUP Screen 3 RESOLUTION SET Screen Resolution : Table 2-1. Resolution Options for Analytes Analyte 1 mmol/l 0.1 mmol/l 0.01 mmol/l Na + K + Cl - Li + x x x x x x x 39

41 Setting Two-point Calibration Interval The 2-Pt Calibration Setup Option lets users specify the two-point calibration interval for Biolyte Figure 2-5 shows the 2-Pt Calibration Setup Screen. 1. The flowchart on the left side of this page is the step-by-step procedure for Setting two-point Calibration Interval. Procedure << 2-PT CALIBRATION SETUP >> 11:20:51 * Calibration interval : 2 hour >>Range : 1-12 hour Figure Pt Calibration Setup Screen. 2.Input the number 1~12, and press Enter key to set the two-point calibration interval. 3.After setting the two-point calibration interval, press Esc key twice to return to the Menu Screen. MENU Screen 1 SETUP Screen 4 2-Pt CALIBRATION SETUP Screen 4.If the input number is larger than 4, Biolyte 2000 will alarm, and return to the previous value. 40 V2 Reference Manual

42 Setting Date and Time The Biolyte 2000 displays the date and time on each screen and on every printout. Users must enter the date and time when the instrument is first powered up; users can change it at any time. The internal clock has a battery that will maintain the correct date and time during long power outages. Figure 2-6 shows the Date/Time Set Screen. Complete the following steps to change the date and time : Note: The Biolyte 2000 displays time in military units (i.e. 1:00PM. = 13:00). 1.The flowchart on the left side of this page is the stepby-step procedure for Setting Date and Time. << DATE/TIME SET >> 11:08:08 ************************************ * 1999/03/30 15:46:20 * ************************************ Figure 2-6. Date/Time Set Screen. On the Date/Time Set screen, a blinking cursor appears next to the first date field. Procedure MENU Screen 1 SETUP Screen 5 DATE/TIME SET Screen 2.At the cursor, input a digit. Once input, cursor automatically jumps to the next digit. Note: For the year, once the last 2 digits are input, the first 2 digits automatically change accordingly (e.g. Input 00, system automatically displays 2000). 41

43 3. Use keys to move the position of cursor to the desired place, and use numerical key to input date or time. Then, at the end of the input, press Esc key twice to return to the Menu Screen. 4. When the input date or time is invalid, system will display a warning message Invalid! on line 1 of LCD (see Figure 2-7). << DATE/TIME SET >> Invalid! 11:08:08 ************************************ * 1999/02/30 15:46:20 * ************************************ Figure 2-7. Date/Time Set Invalid Screen. 5.Users must reset if Invalid appears. 42 V2 Reference Manual

44 Setting Results/Printer The Results Set Option lets users define the reference values, panic values, and offsets values. Figure 2-8 shows the Results Set Screen. 1. The flowchart on the left side of this page is the step-by-step procedure for accessing the Results Set Screen. << RESULTS SET >> Input No.? 1 11:20:51 1. Reference set 4.Printer:OFF 2. Panic set 3. Offsets Figure 2-8. Results Set Screen. 2.Input 1~4 and press Enter key to select function or press Esc key twice to return to the Menu Screen. 3.The default value of printer is OFF. Please input 4 and press Enter key to turn printer on. 4. Printer OFF function is designed for end-user who is able to analyze samples if the printer is defective. This is a temporary action; please replace related parts as necessary. Procedure MENU Screen 1 SETUP Screen 6 RESULTS SET Screen 43

45 Setting Reference Values The Reference Set Option lets users define the reference values of Biolyte Figure 2-9 shows the Reference Set Screen. 1. The flowchart on the left side of this page is the step-by-step procedure for Setting Reference Values. << REFERENCE SET >> 11:20:51 <Blood> Low High Low High 1. Na+ : K+ : Cl : Li+ : Figure 2-9. Reference Set Screen. 2. Press Samp.Type key to change sample types. Note: <Blood> means serum/plasma or whole blood. 3. Use keys to move the cursor. 4. Input the number (0.00~999), and press Enter key to set the reference values. 5. After setting the reference values, press Esc key 3 times to return to the Menu Screen. Procedure MENU Screen 1 SETUP Screen 6 RESULTS SET Screen 1 REFERENCE SET Screen 6. If the input number is larger than 1000, Biolyte 2000 will alarm, and return to the previous value. 7. If the analysis data is out of the range of the reference values, Biolyte 2000 will automatically mark <Ref or >Ref. 8. The resolution of the reference values depends on Resolution Set. 44 V2 Reference Manual

46 Setting Panic Values The Panic Set Option lets users define the panic values of Biolyte Figure 2-10 shows the Panic Set Screen. 1.The flowchart on the left side of this page is the step-by-step procedure for Setting Panic Values. << PANIC SET >> 11:20:51 <Blood> Low High Low High 1. Na+ : K+ : K+ : Li+ : Figure Panic Set Screen. Note: 1. <Blood> means serum/plasma or whole blood. 2. Only the panic values of serum/plasma and whole blood can be set. 2. Use keys to move the cursor. 3. Input the number (0.00~999), and press Enter key to set the panic values. 4.After setting the panic values, press Esc key 3 times to return to the Menu Screen. 5.If the input number is larger than 1000, Biolyte 2000 will alarm, and return to the previous value. Procedure MENU Screen 1 SETUP Screen 6 RESULTS SET Screen 2 REFERENCE SET Screen 6.If the analysis data is out of the range of panic values, Biolyte 2000 will automatically mark <Pan or >Pan. 7.The Resolution of the panic values depends on Resolution Set. 45

47 Setting Offsets Values The Offsets option lets users enter slope and intercept values for each analytical parameter so that users can correlate results from the Biolyte 2000 with other instruments in users lab. Figure 2-11 shows the Offsets Screen. 1.The flowchart on the left side of this page is the step-by-step procedure for Setting Offsets. Procedure << OFFSETS >> 11:20:51 <Serum> Slope Int. Slope Int. * Na+ : * K+ : * Cl- : * Li : Figure Offsets Screen. 2.Press Samp. Type key to change sample types. Note: <Serum> indicates for both serum and plasma samples and <WB> indicates for whole blood samples. 3.Use keys to move the cursor. 4.Input the number of slope or intercept. Main Menu Screen 1 SETUP Screen 6 RESULTS SET Screen 3 OFFSETS Screen 5.Press Enter key to change the sign (+/-) of intercept. 6.After setting the slope and intercept, press Esc key 3 times to return to the Menu Screen. 7.Table 2-2 shows the range of slope & intercept. Table 2-2. Range of Slope and Intercept. Cl - Na + K + Li + Slope 0.8~ ~ ~ ~1.3 Intercept ±8.0 ±10.0 ±0.5 ± V2 Reference Manual

48 Setting Operation Options The Operation Options allow users to set the analysis result and alarm option. Figure 2-12 shows the Operation Screen. 1. The flowchart on the left side of this page is the step-by-step procedure for Setting Operation Options. << OPERATION >> 11:20:51 1.Patient copy : OFF 2.ID required :OFF 3.Calib. print : ON 4.MV print :OFF 5.Mess. print : ON 6.Alarm :ON Figure Operation Screen. 2.Use keys to move the cursor, and press Enter key to switch the operation options ON or OFF. Procedure MENU Screen 2 OPERATION Screen 3.After setting the operation options, press Esc key to return to the Menu Screen. 4.Table 2-3 shows the description of the operation options. 5.Table 2-4 shows the description of the message. 47

49 Table 2-2. Description of the Operation Options. Option Default Set Description Patient copy ID required Calib. print MV Print Mess. Print Alarm OFF OFF ON OFF ON ON Biolyte 2000 will print two analysis results if it were set ON. Users must input ID before analysis procedure if it were set ON. Biolyte 2000 will print the calibration result after calibration if it were set ON. Biolyte 2000 will print results of analysis & calibration including voltage of signals if it were set ON. 1. Biolyte 2000 will print results including worry message if occurred if it were set ON. 2. Table 2-3 shows the worrying messages. System will alarm when error occurred if it were set ON. Table 2-3. Description of the Message. Message < Ref > Ref < Pan > Pan Drift NC Description Means assay concentration is less than reference low limit. Means assay concentration is greater than reference high limit. Means assay concentration is less than panic low limit. Means assay concentration is greater than panic high limit. Means E_0 drift is greater than E_0 drift limit. Means the electrode isn t calibrated. 48 V2 Reference Manual

50 3.Operation Introduction 50 Software Description 50 Main Screen 50 Start/Standby Function Key 51 Samp. Type Function Key 52 Calibrate Function Key 53 Analyze Function Key 55 Status Function Key 59 Flowpath Function Key 60 Menu Function Key 61 Set Up Options 61 Operation Options 61 Data Options 61 Data Recall 62 Data Transfer 63 Data Clear 63 Software Version 65 Diagnostic 65 Maintenance 65 QC function Key 65 Biolyte 2000 Operation 66 Shortcut Procedures 67 Power On 67 Selecting Electrodes 67 Set Sample Type 67 Selecting Analysis Modes 67 Calibration 68 Manual Calibration 68 Auto-Calibration 68 Analysis : Serum/Plasma 68 Analysis : Whole Blood 69 Analysis : Urine 69 Analysis : CSF 69 49

51 Introduction This chapter includes two parts: software description (software screen) and analysis operation procedures. Most display screens and operation procedures are described in this chapter. Software Description Main Screen Push the Power Switch to ON position to turn the Biolyte 2000 on. Power Switch is located at the backside of the Biolyte 2000 (see Figure 1-2). After system initiated, the screen will change to the Main Screen. System Initial... 11:20:45 >> Setting the flow rate... 10:06:12 << CONDITION Na >> 10:06:12 >>Pull the sampler out, then press ENTER key to start. >>Press ESC key to quit. << CONDITION FLOW PATH >> 10:06:12 >>Pull the sampler out, then press ENTER key to start. >>Press ESC key to quit. << CALIBRATION >> 10:06:12 Remaining 48 sec. Rinse STD-A * Na+ : ON * K+ : ON * Cl- : ON * Li+ : OFF 50 V2 Reference Manual

52 1999/05/04 <<Biolyte>> 11:20: * Sample Type : Serum/Plasma * Status : Na, K, Cl Ready Figure 3-1. From System Initial Screen to Main Screen. Table 3-1 describes the status in the Main Screen. Status Parameter ready Not ready Flow path Description Indicates that the electrode(s) is ready and analysis can proceed. Must perform calibration before proceeding to analysis. Must perform Flow Path procedure before proceeding to other options. In the Main Screen, users can use the waiting function keys as following : Start/Standby, Samp. Type, Calibrate, Analyze, Menu, QC, Status, Flowpath. Start/Standby Function Key Users can press Start/Standby key in the Main Screen. Figure 3-2 shows the Standby Screen. << STANDBY >> 10:06:12 z~ Z >>Press START key to continue. Figure 3-2. Standby Screen. 1.In the Standby Screen, users only can use Start/Standby function key. 2.Under the Standby Mode, during auto-calibration, no calibration is carried out, instead system will rinse STD-A for 5 seconds and REF for 2 seconds. 3.After pressing the Start/Standby key, system will run flush procedure, then return to the Main Screen. Note: After a power failure, when the electricity return, reload back to the previous standby or normal mode. 51

53 Samp. Type Function Key Users can press Samp. Type key in the Main Screen. Figure 3-3 shows the Sample Type Set Screen. << SAMPLE TYPE >> Input No.? 1 11:20:51 1. Serum/Plasma 2. Whole blood 3. Urine 4. CSF >>Sample Type : Serum/Plasma Figure 3-3. Sample Type Set Screen. >>Sample Type : Serum/Plasma means the selected sample type at present. Input 1~4 and press Enter key to change sample type, or press Esc key to return to the Main Screen. When sample type is changed, the calibration status of Biolyte 2000 will change to NC. Recalibrate must be done before proceeding to analysis procedure. When sample type change to urine, system will display the HELP FOR URINE SAMPLE screen for analyze urine sample analyses (Figure 3-4) << HELP FOR URINE SAMPLE >> 11:20:51 1.Dilute one part urine sample with two parts diluent(part. No.: ). 2.Use diluted sample to run ANALYZE. Figure 3-4. Help for Urine Sample Screen. 52 V2 Reference Manual

54 Calibrate Function Key Users can press Calibrate key in the Main Screen. Figure 3-5 shows 4 screens of the Calibration Screen. << CALIBRATION >> 10:06:12 Remaining 48sec. Rinse STD-A * Na+ : ON * K+ : ON * Cl- : ON * Li+ : OFF << CALIBRATION >> 10:06:12 * Next auto-calibration time = 109 min. * Na+ : mv * K+ : mv * Cl- : mv * AIR : mv << CALIBRATION >> 10:06:12 * Calibration flow rate = 1.6 sec. * Analysis flow rate = 1.6 sec. * Remaining reagent = 100 % << CALIBRATION >> 10:06:12 Na+ K+ Cl- Li+ * Slope OFF * Analysis test number : 1 Figure 3-5. Calibration Screens. 1.System will start to calculate calibration time when Calibrate key has been pressed. 2.During calibration procedure, press Status key to switch between the four Calibration Screens. 3.At the end of calibration, system will set and calculate next auto-calibration time. 4.If calibration procedure is interrupted, system will rinse the flow path with STD-A and REF. 5.At the end of calibration, system will printout Figure 3-6 (To set the calibration printout form, see Setting Operation Options in chapter 2, Set Up for details). 53

55 1999/04/28 13:23:12 ================================ << Calibration >> Item Slope Range Mess Na NC K Cl ================================ ================================ Item STD-A [mv] STD-B [mv] Na K Cl ================================ 1 2 Figure 3-6. Printout of Calibration. (1) NC: Means that the sensor is not calibrated. (2) MV Print must be set ON in the Operation Option, for system to print this message (See Setting Operation Options in chapter 2, Set Up for details). 54 V2 Reference Manual

56 Analyze Function Key Users can press Analyze key in the Main Screen. Figure 3-7A and Figure 3-7B shows the Sample Data Screen. << SAMPLE DATA >> QC-run control 10:06:12 1. ID : 2. Sequence # : 3. Acc.: 4. Name : <.-start set -change char.> Figure 3-7A. Sample Data Screen (for Serum/Plasma, Whole Blood and CSF). << SAMPLE DATA >> QC-run control 10:06:12 1. ID : 2. Sequence # : 3. Acc.: 4. Diluted urine: Yes 5. Name : <.-start set -change char.> Figure 3-7B. Sample Data Screen (for Urine). 1.System will clear error message of last analysis and begin calculating analysis time when users press Analyze key. 2.Calibration must be done before analysis procedure. If the selected electrode statuses are NC, the screen will show Figure 3-8. Press any key to quit analysis procedure. << ANALYSIS >> 10:06:12 >>No calibration data. >>Please run calibration first. >>Press any key to continue. Figure 3-8. NC Analysis Screen. 3. Table 3-2 shows description options of the Sample Data Screen. Option Description ID 12 characters (number or letter) Sequence # (auto count by system) Acc. (Accession #) Diluted urine Press Enter key to select Yes or No. Patient Name 20 characters (letter, [-], [.], [ ], [ ]) Press key to move cursor, then input information if desired. To input alphabets under the ID and Patient Name options, press. and key to select the desired alphabet. 55

57 4. If barcode reader has been installed, users can read bar code of ID or Acc. by barcode reader, when the cursor is at position of ID or Acc. When read data is out of range, system will alarm. 5. The barcode reader model is CCD600 Serial Port interfaces made by GIGA-TMS INC in TAIWAN. There is more operation information in the programming manual of CCD Barcode Reader. 6. Press Analyze key to return to analysis procedure. 7. If operation option ID input is set ON (see Setting Operation Options in chapter 2,Set Up for details), ID must be input. If ID is not input when Analyze key is pressed, system will show Figure 3-9. << SAMPLE DATA >> QC-run control 10:06:12 >>You must input ID. >>Press any key to continue. Figure 3-9. Analysis Warning Screen. 8. Figure 3-10 shows 4 screens of the Analysis Screen. << ANALYSIS >> 10:06:12 Remaining 48sec. Rinse STD-A * Na+ : ON * K+ : ON * Cl- : ON * Li+ : OFF << ANALYSIS >> 10:06:12 * Next auto-calibration time = 109 min. * Na+ : mv * K+ : mv * Cl- : mv * AIR : mv << ANALYSIS >> 10:06:12 * Calibration flow rate = 1.6 sec. * Analysis flow rate = 1.6 sec. * Remaining reagent = 100 % << ANALYSIS >> 10:06:12 Na+ K+ Cl- Li+ * Slope NC OFF * Analysis test number : 1 56 Figure Analysis Screens. V2 Reference Manual

58 9.During analysis procedure, press Status key to switch between the four Analysis Screens. 10.Once sample analysis is finished, the printer will automatically print the results. During printing, an Analysis Concentration Screen (Figure 3-11) will appear. Once printing is finished, the system remains in the Analysis Concentration Screen for 5 seconds, or otherwise press any key to automatically return to the Analysis Screen. << ANALYSIS >> 10:06:12 Item conc. Item conc. * Na+ : NC * K+ : 3.12 mmol/l * Cl- : meq/l * Li+ : OFF Figure Analysis Concentration Screen. Unit and resolution depend on Set Up set (See Setting Electrolyte Resolution Values in chapter 2, Set Up for details). OFF: Means that sensor is not being selected. 11. If the analysis procedure is interrupted, system will rinse the flow path with STD-A and REF. 12. At the end of analysis, system will print results as shown in Figure 3-12 (set analysis printout format, see Setting Operation Options in chapter 2, Set Up for details). Note: For QC analysis, press QC instead of Analyze key. 57

59 1999/04/28 13:23:12 ================================ << Analysis >> SAMPLE ID : A Access # : Name : S-M WU Sequence # : 1 Analyze Date: 1999/04/28 Analyze Time: 13:24:10 Sample Type : Serum/Plasma Item Concentration Message Na+ NC K mmol/l Cl meq/l Drift ================================ ================================ Item STD-A [mv] Sample [mv] Na K Cl ================================ Figure Printout of Analysis. (1) Message Print must be set ON in the Operation Option, for system to print this message (See Setting Operation Options in chapter 2, Set Up for details). (2) NC: Means that the sensor is not calibrated. (3) Drift: Means that the voltage of STD-A taken during analysis is too large compared with the voltage of STD-A during calibration. (4) MV Print must be set ON in the Operation Option, for system to print this message (See Setting Operation Options in chapter 2, Set Up for details). 58 V2 Reference Manual

60 Status Function Key The Status Screen can call up in any screen by pressing the Status key. Figure 3-13A, B, C shows the Status Screens. 1.Press Status key to change the Status Screens or press the Enter key to print all status information. 2.The Status Screen 1 (Figure 3-13A) shows the last-conducted calibration slopes of each sensor. The analysis test number will auto-count from 1 to 10,000. <<STATUS>> Press ENTER to print. 10:06:12 Na+ K+ Cl- Li+ * Slope NC OFF * Analysis test number : 1 Figure 3-13A. Status Screen 1. 3.The Status Screen 2 (Figure 3-13B) shows voltage values of each sensor that has been selected. All signals change per second. <<STATUS>> Press ENTER to print. 10:06:12 * Na : mv * K+ : mv * Cl- : mv * AIR : mv * Next auto-calibration time = 109 min. Figure 3-13B. Status Screen 2. 4.The Status Screen 3 (Figure 3-13C) shows the flow rate of calibration and analysis procedure. All signals change per second. <<STATUS>> Press ENTER to print. 10:06:12 * Calibration flow rate = 1.6 sec. * Analysis flow rate = 1.6 sec. * Remaining reagent = 100 % Figure 3-13C. Status Screen 3. 5.Press Esc key to quit the Status Screen. 59

61 Flowpath Function Key Press Flowpath key in the Main Screen. System will prime air into the analyzer until S-line, electrode train, and W-line are empty. Once empty, screen will display to the Flowpath Screen 1 (Figure 3-14). << FLOWPATH >> 11:20:51 >> Press FLOWPATH key to continue. Figure Flowpath Screen 1. Either press Flowpath key again while in the Flowpath Screen 1 to prime all fluids into the tubing and return to the Main Screen (Figure 3-1), or, system will automatically prime all fluids after one hour of idling. Before priming all fluids into the tubing, system will beep 10 times (once per second) and display the Flowpath Screen 2 (Figure 3-15). To stay at flowpath mode (or empty tubing), press ESC key during these 10 seconds. << FLOWPATH >> 11:20:51 >> Press ESC key to stay at flowpath mode. >> Press FLOWPATH key to continue. Figure Flowpath Screen V2 Reference Manual

62 Menu Function Key Press Menu key in the Main Screen to enter Menu Screen. Figure 3-16 shows the Menu Screen. << MENU >> Input No.? 1 11:20:51 1. Setup 2. Operation 3. Data 4. Software version 5. Diagnostic 6. Maintenance Figure Menu Screen. Input 1~6 and press Enter key to select function, or press Esc to return to the Main Screen. Set Up Options When users press Menu key in the Main Screen, system will enter the Menu Screen. Input 1 and press Enter key to run set up procedures (see Set Up Options in chapter 2, Set Up for details). Operation Options When users press Menu key in the Main Screen, system will enter the Menu Screen. Input 2 and press Enter key to run operation procedures (see Setting Operation Options in chapter 2, Set Up for details). Data Options When users press Menu key in the Main Screen, system will enter the Menu Screen. Input 3 and press Enter key to call up data options. Figure 3-17 shows the Data Screen. << DATA >> Input No.? 1 10:06:12 1. Recall 4. Clear 2. Transfer 3. R-Time Trans:OFF Figure Data Screen. Input 1~4 and press Enter key to select function, or press Esc to return to the Menu Screen. The default value for R-Time Transfer is OFF. The purpose of this function is for users who wish to real-time transfer analysis data to the computer. 61

63 Data Recall Input 1 and press Enter key in the Data Screen to enter the Data Recall Screen. Figure 3-18 shows the Data Recall Screen. << RECALL >> ID : NONE 10:06:12 >> Press ENTER to seek. >> Press ESC key to quit. Figure Data Recall Screen. 1.For seeks, users can input ID and press Enter key or read ID by barcode reader. If users don t input ID, press Enter key to seek all data (Figure 3-17). (NONE: means for all ID) 2.Press Esc key to return to the Data Screen. 3.Figure 3-19 shows the Data Seek Screen. << RECALL >> ID : NONE 10:06:12 (1) ID : A Date: 1999/04/24 SSN: 456 Sequence # : 2 >> -Next data -Other info ENTER-Print << RECALL >> ID : NONE 10:06:12 (1) Na+ : NC K+ : 5.2 mmol/l Cl- : NC Li+ : OFF >> -Next data -Other info ENTER-Print Figure Data Seek Screen. 4.Press key to seek data (maximum of 450 data). 5.Press key to browse the data that you recall. 6.Press Enter key to print the data that you recall. 7.Press Esc key to return to the Data Screen. 62 V2 Reference Manual

64 Data Transfer Input 2 and press Enter key in the Data Screen to enter the Transfer Data Screen. Figure 3-20 shows the Transfer Data Screen. << TRANSFER DATA >> 10:06:12 (1 ) ID: A Date: 1999/04/24 >> Transferring... >> Press ESC key to interrupt. Figure Transfer Data Screen. 1.To run this function, users must connect analyzer to PC by serial port and use ASTM protocol (see Service Manual for details). 2.When Biolyte 2000 is transferring data, screen shows Figure The line 2 of screen will display the data being transferred at the time. 3.After transferring, system will automatically return to the Data Screen. Data Clear Input 4 and press Enter key in the Data Screen to enter Clear Data Screen. Figure 3-21 shows the Clear Data Screen. << CLEAR DATA >> 10:06:12 >>Are you sure to clear data? ENTER >>Press ESC key to quit. Figure Clear Data Screen. 1.Press Enter key to clear the saved data in memory, or press Esc key to return to the Data Screen. 2.Figure 3-22 shows system running the clearing data procedure. << CLEAR DATA >> 10:06:12 >>Clearing... Figure Clearing Data Screen. 63

65 3.Figure 3-23 shows the Data Clear OK Screen. Press any key to return to the Data Screen. << CLEAR DATA >> 10:06:12 >>Data clear ok! >>Press any key to continue. Figure Data Clear OK Screen. 4.If system shows Figure 3-24, press any key to return to the Data Screen and contact BioCare Customer Service Center. << CLEAR DATA >> 10:06:12 >>Data clear error! >>Press any key to continue. Figure Data Clear Error Screen. 64 V2 Reference Manual

66 Software Version When Menu key was pressed in the Main Screen, system will enter the Menu Screen. Input 4 and press Enter key in the Menu Screen to enter the Software Version Screen. Figure 3-25 shows the Software Version Screen. << SOFTWARE VERSION >> 10:06:12 * Main program version : B5.0A * Test program version : 0.3 Figure Software Version Screen. Press any key to return to the Menu Screen. Diagnostic When Menu key was pressed in the Main Screen, system will enter the Menu Screen. Input 5 and press Enter key to run diagnostic procedures (for details, see Diagnostic in chapter 6, Troubleshooting). Maintenance When Menu key was press in the Main Screen, system will enter the Menu Screen. Input 6 and press Enter key to run maintenance procedures (for details, see chapter 4, Maintenance). QC function Key Press QC key in the Main Screen to run QC analysis (for details, see chapter 5, QC). 65

67 Biolyte 2000 Operation This prologue contains shortcut instructions for running samples. The Biolyte 2000 is a sophisticated instrument with many operating functions and convenient user features. This chapter explains in detail how to operate the Biolyte However, the Biolyte 2000 is also designed to accommodate users need to run analyses quickly and simply without using all of the offered functions. The following operation shortcuts allow users to analyze samples quickly without altering the instrument s set-up parameters. Note: 1. Reference to chloride or lithium or both are only applicable to instruments with these electrodes. 2. In order to test lithium, both sodium and potassium should also be tested at the same time. 66 V2 Reference Manual

68 Shortcut Procedures The shortcut procedures are as shown on Figure POWER ON Selecting Electrodes Set Sample Type Selecting Analysis Mode Calibration Analysis Figure Shortcut Procedures. Note: The Shortcut Procedures are for reference use only. For more detailed information, please refer to the respective sections in this Reference Manual. Power On See Powering on the Instrument (in Chapter 1, Description) for details. Selecting Electrodes See Selecting Electrodes (in Chapter 2, Set Up) for details. Set Sample Type See Samp. Type Function key (in Chapter 2, Set Up) for details. Selecting Analysis Modes There are 2 analysis modes build in: Manual Mode and Semi-Auto Mode. User can position the arm straight to operate Semi-Auto Mode; lift up the arm to operate Manual Mode. The instrument has auto-sensor to distinguish the 2 modes automatically. (Figure 3-27A, B) Figure 3-27A. Semi-Auto Mode. Figure 3-27B. Manual Mode. Note: Place the sample cup carefully to avoid any possible spills when using the Semi-Auto Mode. 67

69 Calibration Press Calibrate key in the Main Screen to run calibration procedures. There are two modes of calibration build in Biolyte 2000, Manual Calibration and Auto-calibration. Manual Calibration To initiate a manual calibration on the Biolyte 2000, press Calibrate key in the Main Screen. Auto-Calibration The Biolyte 2000 automatically initiates a calibration sequence 30 minutes after POWER ON and approximately every 2 hours thereafter, or 2 hours after the last manual calibration. To set two-point calibration interval, see Setting Two-point Calibration Interval in chapter 2, Set Up for details. Analysis : Serum/Plasma 1.All installation and calibration procedures must be done before running samples. 2.Table 3-3 shows the procedures for running samples on the two analysis modes. Table 3-3. Procedures of Two Analysis Modes. Procedure Semi-Auto Manual Put sample cup at Sample Holder. Press Analyze key to analyze sample. Press Analyze key so that the probe remains at the outside position. Put sample cup underneath the probe. Press Analyze key to analyze sample. After analysis, the probe will automatically return to the inside position. Note: If users don t press Analyze key when the probe is at the outside position, Biolyte 2000 will automatically alarm after 10 seconds and the probe will return to the inside position after 20 seconds. 3.Biolyte 2000 will print results and save data into memory automatically at the end of each analysis, and show result on the screen. 4.After printing result, screen will return to the Analysis Screen (Figure 3-7). 68 V2 Reference Manual

70 Analysis : Whole Blood 1.All procedures for running whole blood are the same as running serum/plasma. Sample type must be selected as Whole Blood (for details, see Set Sample Type in chapter 3, Operation). 2.Biolyte 2000 will print result, save data into memory automatically at the end of each analysis, and show result on the screen. 3.After printing result, screen will return to the Analysis Screen (Figure 3-7). Analysis : Urine 1.Before analyzing urine samples, urine samples must be diluted with Urine Diluent for Biolyte 2000 (Part. No.: ). Dilute one part urine sample with two parts diluent and mix well. After diluting urine sample, users can analyze urine sample. All procedures of running urine are the same as running serum/plasma. Sample type must be selected as Urine (for details, see Set Sample Type in chapter 3, Operation). 2.Biolyte 2000 will print result, save data into memory automatically at the end of each analysis, and show result on the screen. 3.After printing result, screen will return to the Analysis Screen (Figure 3-7). Note: If the printed result of urine sample shows Too low, press Enter key to select Diluted urine item as No in the Analysis Screen (Figure 3-7B), then analyze undiluted sample directly. Analysis : CSF Note: Only the concentration of chloride can be measured in CSF. 1.All procedures for running CSF are the same as running serum/plasma. Sample type must be selected as CSF (for details, see Set Sample Type in chapter 3, Operation). 2.Biolyte 2000 will print result, save data into memory automatically at the end of each analysis, and show result on the screen. 3.After printing result, screen will return to the Analysis Screen (Figure 3-7). 69

71 4. Maintenance Introduction 71 Maintenance Function 71 Condition 72 Condition Na 72 Condition f_path 75 Clean Flow Path 78 Reagent Information 81 Prime 82 Probe Adjustment 83 Calibrate Pump Frequency 84 Daily Maintenance 85 Checking the Reagent Pack Level 85 Cleaning the Sample Inlet Port 85 Conditioning Na Electrode 85 Conditioning the Flow Path with Serum 85 Checking Slope & Flow Time 86 Checking the Electrode Slope 86 Checking the Flow Time 86 Periodic Maintenance 86 Flow Path Maintenance Cycle 86 Replacing the W-line 87 Replacing the R-line 88 Replacing the S-line 89 Replacing the A-line/B-line 90 Replacing the Probe 91 Replacing the Electrodes 92 Non-routine Maintenance 93 Cleaning the Sample Inlet Port 93 Cleaning the Probe 93 Standby Mode 93 Replacing the Reagent Pack 94 Installation of Thermal Paper 97 Shutdown V2 Reference Manual

72 Introduction This chapter explains how to maintain Biolyte Maintenance includes both daily and periodic maintenance procedures, as well as component replacement, non-routine maintenance and instrument shutdown/start up procedures. The daily maintenance procedures should be performed before operating the instrument for the first time each day. The periodic maintenance procedures should be also performed according to users scheduled timetables. Note: References to chloride or lithium or both are only applicable to analyzer with these electrodes. Maintenance Function Biolyte 2000 maintenance functions shall be operated as described below. Input 6 and press Enter key in the Menu Screen to enter the Maintenance Screen. Figure 4-1 shows the Maintenance Screen. << MAINTENANCE >> Input No.?1 10:06:12 1. Condition 2. Clean flow path 3. Reagent info 4. Prime 5. Probe adjustment 6. Cal. pump frequency Figure 4-1. Maintenance Screen. Input 1~6 and press Enter key to select function or press Esc key to return to the Menu Screen. Table 4-1 shows the description of Maintenance Options. Table 4-1. Description of Maintenance Options. Option Condition Clean flow path Reagent info Prime Probe adjustment Cal. pump frequency Description Running procedures for conditioning sodium electrode and flow path. Running procedures for cleaning flow path. Showing the information of the reagent pack. Running procedures for priming the selected solution or air. Adjusting the probe position. Calibrating pump frequency. 71

73 Condition Input 1 and press Enter key in the Maintenance Screen to enter the Condition Screen. Figure 4-2 shows the Condition Screen. << CONDITION >> Input No.?1 10:06:12 1. Condition Na 2. Condition flow path Figure 4-2. Condition Screen. Input 1 or 2 and press Enter key to select function or press Esc key to return to the Menu Screen. Condition Na Note: When users perform this procedure, be sure to condition the sodium electrode first, then condition the flow path with serum. During the sodium conditioning cycle, CONDITIONING Na SOLUTION (Part. No.: ) is aspirated from a sample cup into the electrode carrier. After the electrodes are conditioned, the Conditioning Na Solution flushes into the waste bottle. Instruction The sampler must be pulled out (push sample arm up) for sampling Conditioning Na Solution. Fill the sample cup with 1ml CONDITIONING Na SOLUTION (Part. No.: ). From the Menu Screen, press 6 and Enter key to access the Maintenance Screen. Select the Condition option (select 1 to access this option). Select the Condition Na option (select 1 to access this option). Follow the directions on the screen. The cycle takes about 1 minute. When the cycle is finished, all electrodes will be uncalibrated, and the status will display NC. Users must run calibration procedures before running analysis. 72 V2 Reference Manual

74 Condition Na Screen 1 Input 1 and press Enter key in the Condition Screen to enter the Condition Na Screen. Figure 4-3A, B, C, D, E, F shows the Condition Na Screens. << CONDITION Na >> 10:06:12 >>Pull the sampler out, then press ENTER key to start. >>Press ESC key to quit. Figure 4-3A. Condition Na Screen 1. Press Enter key to move the probe out, or press Esc key to return to the Maintenance Screen. Condition Na Screen 2 Press Enter key in the Condition Na Screen 1 to switch to the Condition Na Screen 2 (Figure 4-3B). << CONDITION Na >> 10:06:12 >>Hold condition solution under probe, then press ANALYZE key to prime sol'n. >>Press ESC key to quit. Figure 4-3B. Condition Na Screen 2. Hold Conditioning Na Solution under the probe for priming. Press Analyze key to prime Conditioning Na Solution, or press Esc key to enter the Condition Na Screen 6 (Figure 4-3F). Then, press Esc key to return to the Maintenance Screen. 73

75 Condition Na Screen 3 Press Analyze key in the Condition Na Screen 2 to switch to the Condition Na Screen 3 (Figure 4-3C). << CONDITION Na >> 10:06:12 >>Priming... >>Press ESC key to quit. Figure 4-3C. Condition Na Screen 3. Press Esc key once for Figure 4-3F, or press Esc key twice to return to the Maintenance Screen. Condition Na Screen 4 After priming Conditioning Na Solution, screen switches to the Condition Na Screen 4 (Figure 4-3D). << CONDITION Na >> 10:06:12 >>Wait for 60 sec. >>Press ESC key to quit. Figure 4-3D. Condition Na Screen 4. Waiting Conditioning Na Solution to condition Na electrode for 60 seconds. Press Esc key once for Figure 4-3F, or press Esc key twice to return to the Maintenance Screen. Condition Na Screen 5 After condition Na electrode, screen will change to the Condition Na Screen 5 (Figure 4-3E). << CONDITION Na >> 10:06:12 >>Condition Na+ has been finished. >>Press ESC key to quit. Figure 4-3E. Condition Na Screen 5. Press Esc key to return to the Maintenance Screen. 74 V2 Reference Manual

76 Condition f_path Note: Always condition the flow path with serum if sodium electrode has been conditioned. Instruction The sampler must be pulled out (push sample arm up) for sampling serum. Fill the sample cup with serum. From the Menu Screen, press 6 and Enter key to access the Maintenance Screen. Select the Condition option (select 1 to access this option). Select the Condition f_path option (select 2 to access this option). Follow the directions on the screen. The cycle takes about 1 minute. When the cycle is finished, all electrodes will be uncalibrated, and the status will display NC. Users must run calibration procedures before running analysis. 75

77 Condition f_path Screen 1 Input 2 and press Enter key in the Condition Screen to enter the Condition f_path Screen. Figure 4-4A, B, C, D, E, F show the Condition f_path Screens. << CONDITION FLOW PATH >> 10:06:12 >>Pull the sampler out, then press ENTER key to start. >>Press ESC key to quit. Figure 4-4A. Condition f_path Screen 1. Press Enter key to move the probe out, or press Esc key to return to the Maintenance Screen. Condition f_path Screen 2 Press Enter key in the Condition f_path Screen 1 to switch to the Condition f_path Screen 2 (Figure 4-4B). << CONDITION FLOW PATH >> 10:06:12 >>Hold serum under probe, then press ANALYZE key to prime serum. >>Press ESC key to quit. Figure 4-4B. Condition f_path Screen 2. Hold serum under the probe for priming. Press Analyze key to prime serum, or press Esc key to enter the Condition f_path Screen 6 (Figure 4-4F). Then press Esc key to return to the Maintenance Screen. 76 V2 Reference Manual

78 Condition f_path Screen 3 Press Analyze key in the Condition f_path Screen 2 to switch to the Condition f_path Screen 3 (Figure 4-4C). << CONDITION FLOW PATH >> 10:06:12 >>Priming... >>Press ESC key to quit. Figure 4-4C. Condition f_path Screen 3. Press Esc key once for Figure 4-4F, or press Esc key twice to return to the Maintenance Screen. Condition f_path Screen 4 After priming serum, screen will change to the Condition f_path Screen 4 (Figure 4-4D). << CONDITION FLOW PATH >> 10:06:12 >>Wait for 60 sec. >>Press ESC key to quit. Figure 4-4D. Condition f_path Screen 4. Waiting serum to condition flow path for 60 seconds. Press Esc key once for Figure 4-4F, or press Esc key twice to return to the Maintenance Screen. Condition f_path Screen 5 After condition flow path, screen will change to the Condition f_path Screen 5 (Figure 4-4E). << CONDITION FLOW PATH >> 10:06:12 >>Condition flow path has been finished. >>Press ESC key to quit. Figure 4-4E. Condition f_path Screen 5. Press Esc key to return to the Maintenance Screen. 77

79 Clean Flow Path Instruction The sampler must be pulled out (push sample arm up) for sampling Cleaning Solution. Fill the sample cup with CLEANING SOLUTION (Part. No.: ). From the Menu Screen, press 6 and Enter key to access the Maintenance Screen. Select the Clean Flow Path option (select 2 to access this option). Follow the directions on the screen. After cleaning flow path, run Condition f_path procedures and calibration again before analyzing sample. The cycle takes about 1 minute. When the cycle is finished, all electrodes will be uncalibrated, and the status will display NC. Users must run calibration procedures before running analysis. 78 V2 Reference Manual

80 Clean Flow Path Screen 1 Input 2 and press Enter key in the Maintenance Screen to enter the Clean Flow Path Screen. Figure 4-5A, B, C, D, E, F shows the Clean Flow Path Screens. << CLEAN FLOW PATH >> 10:06:12 >>Pull the sampler out, then press ENTER key to start. >>Press ESC key to quit. Figure 4-5A. Clean Flow Path Screen 1. Press Enter key to move the probe out, or press Esc key to return to the Maintenance Screen. Clean Flow Path Screen 2 Press Enter key in the Clean Flow Path Screen 1 to switch to the Clean Flow Path Screen 2 (Figure 4-5B). << CLEAN FLOW PATH >> 10:06:12 >>Hold clean solution under probe, then press ANALYZE key to prime clean sol'n >>Press ESC key to quit. Figure 4-5B. Clean Flow Path Screen 2. Hold Cleaning Solution under the probe for priming. Press Analyze key to prime Cleaning Solution, or press Esc key to enter the Clean Flow Path Screen 6 (Figure 4-5F). Then press Esc key to return to the Maintenance Screen. 79

81 Clean Flow Path Screen 3 Press Analyze key in the Clean Flow Path Screen 2 to switch to the Clean Flow Path Screen 3 (Figure 4-5C). << CLEAN FLOW PATH >> 10:06:12 >>Priming... >>Press ESC key to quit. Figure 4-5C. Clean Flow Path Screen 3. Press Esc key once for Figure 4-5F, or press Esc key twice to return to the Maintenance Screen. Clean Flow Path Screen 4 After priming Cleaning Solution, screen switches to the Clean Flow Path Screen 4 (Figure 4-5D). << CLEAN FLOW PATH >> 10:06:12 >>Wait for 60 sec. >>Press ESC key to quit. Figure 4-5D. Clean Flow Path Screen 4. Waiting Clean Solution to clean flow path for 60 seconds. Press Esc key once for Figure 4-5F, or press Esc key twice to return to the Maintenance Screen. Clean Flow Path Screen 5 After clean flow path, screen will change to the Clean Flow Path Screen 5 (Figure 4-5E). << CLEAN FLOW PATH >> 10:06:12 >>Clean flow path has been finished. >>Press ESC key to quit. Figure 4-5E. Clean Flow Path Screen 5. Press Esc key to return to the Maintenance Screen. 80 V2 Reference Manual

82 Reagent Information Input 3 and press Enter key in the Maintenance Screen to enter the Reagent Information Screen. Figure 4-6 shows the Reagent Information Screen. << REAGENT INFORMATION >> 10:06:12 1. Lot No. : LP8B Expire date : 06/ Remaining use life : 32 days << REAGENT INFORMATION >> 10:06:12 <mmol>std-a STD-B STD-A STD-B * Na+ : * K+ : * Cl- : * Li+ : Figure 4-6. Reagent Information Screen. Press key to change screen. 81

83 Prime Input 4 and press Enter key in the Maintenance Screen to enter the Prime Screen. Figure 4-7 shows the Prime Screen. << PRIME >> Input No.? 1 10:06:12 1. SATANDARD A 2. STANDARD B 3. REFERENCE 4. AIR 5. SAMPLE 6. FULL Figure 4-7. Prime Screen. Input 1~6 and press Enter key to select prime option. System will prime each fluid 20 seconds each time, then return to the Prime Screen. The FULL option: System will prime STD-B, STD-A, and REFERENCE 20 seconds of each fluid. Figure 4-8 shows the Priming Screen. Press Esc key to interrupt prime procedure, and screen will show Figure 4-9. << PRIME STD-A >> 10:06:12 >>Priming... >>Press ESC key to quit. Figure 4-8. Priming Screen. Press Esc key to return to the Prime Screen when screen shows Figure 4-9. << PRIME STD-A >> 10:06:12 >>Prime error or interrupt. >>Press ESC key to quit. Figure 4-9. Interrupt Priming Screen. Note: When users use the full prime function to empty the tubing, it is normal that the system alarms three times. 82 V2 Reference Manual

84 Probe Adjustment Input 5 and press Enter key in the Maintenance Screen to enter the Prime Screen. Figure 4-10A shows the Probe Adjustment Screen 1. << PROBE ADJUSTMENT >> Input No.?110:06:12 1. AIR 2. SAMPLE >> Press ESC key to quit. Figure 4-10A. Probe Adjustment Screen 1. Input 1 or 2 and press Enter key to enter the Probe Adjustment Screen 2 (Figure 4-10B) or 3 (Figure 4-10C). Press Esc key to return to the Maintenance Screen. Option 2. SAMPLE : Means the probe position of the Semi-Auto Mode (when the sampler is inside). << PROBE ADJUSTMENT >> 10:06:12 * AIR : 500 (Default : 500) >> Press key to move probe. >> Press ESC key to quit. Figure 4-10B. Probe Adjustment Screen 2. << PROBE ADJUSTMENT >> 10:06:12 * SAMPLE : 1420 (Default : 1420) >> Press key to move probe. >> Press ESC key to quit. Figure 4-10C. Probe Adjustment Screen 3. Press key to adjust the probe position. 83

85 Calibrate Pump Frequency Input 6 and press Enter key in the Maintenance Screen to enter the Calibrate Pump Frequency Screen 1 (Figure 4-11A). >> Setting the flow rate... 10:06:12 Figure 4-11A. Calibrate Pump Frequency Screen 1. After Calibrating pump frequency, screen will change to the Calibrate Pump Frequency Screen 2 (Figure 4-11B). << CAL. PUMP FREQUENCY >> 10:06:12 * Pump frequency = 105 * Flow rate = 2.10 sec >> Press ESC key to quit. Figure 4-11B. Calibrate Pump Frequency Screen 2. Press Esc key to return to the Maintenance Screen. 84 V2 Reference Manual

86 Daily Maintenance The following maintenance procedures must be performed before users use Biolyte 2000 for the first time each day: Check the reagent pack level. Clean the sample inlet port. Condition the flow path with serum. Check the slope and flow time. Note: 1. BioCare recommends conditioning flow path before daily operation. Users must calibrate the instrument if electrode conditioning has just been performed. 2. All fluids in tubing are infectious, thus, must be handled with care! Wear gloves if necessary! Perform the following steps to complete the daily maintenance procedures. Checking the Reagent Pack Level Press Status key repeatedly until the Status Screen 2 appeared (Figure 3-13B). This screen shows the amount of the most consumed fluid that is left in the reagent pack. When it shows that the reagent pack is empty, replace the reagent pack according to the instructions that appear later in this chapter. Note: The amount of the reagent shown in the Status Screen 2 is approximate. In some cases a zero indicator can appear with some reagent remaining, or in other cases the reagent will be entirely consumed and the indicator will show some reagent remaining. Cleaning the Sample Inlet Port 1.Pull the sampler up to the manual position. 2.Clean the sample inlet port with a cotton swab moistened with deionized water. Note: If whole blood is analyzed frequently, clean the sample inlet port more often. Conditioning Na Electrode See Condition Na in the earlier section of this chapter for details. Conditioning the Flow Path with Serum See Condition f_path in the earlier section of this chapter for details. 85

87 Checking Slope & Flow Time Calibrate the instrument if electrode conditioning has just been performed. Calibration is initiated by pressing Calibrate key. Checking the Electrode Slope Press Status key repeatedly until the Status Screen 3 (Figure 3-13C) appears. This screen displays the slope of the last calibration. If any electrode slope is not within the acceptable range, perform the appropriate corrective procedures in Chapter 6, Troubleshooting. Checking the Flow Time Flow time measures the time it takes for fluid to travel from the tip of the probe to the air detector. Press Status key repeatedly until the Status Screen 2 (Figure 3-13B) appears. This screen displays the flow times during the last calibration and analysis cycles, as well as their acceptable ranges. If either flow time is not within the acceptable range, perform the appropriate corrective procedures in Chapter 6, Troubleshooting. Periodic Maintenance Periodic maintenance procedures must be performed according to users scheduled timetables to assure optimal instrument performance. Unless otherwise indicated, the flow path maintenance cycle must be initiated before the start of any maintenance procedures. The flow path maintenance cycle purges the flow path of fluid and holds the instrument in an idle state while it is being serviced. Flow Path Maintenance Cycle To initiate the Flow Path Maintenance Cycle, press the Flowpath key once in the Main Screen. Or users can use Prime function and select AIR to empty flow path (see Prime in the earlier section of this chapter for details). Note: Unless otherwise indicated, the Flow Path Maintenance Cycle must be initiated before any component of the flow path is disconnected for maintenance or troubleshooting procedures. 86 V2 Reference Manual

88 Replacing the W-line Figure 4-12 shows the location of the W-line. Replace the W-line according to the following procedures: Figure Location of the W-line. 1.Open the analyzer door. 2.Use Prime functions or press Flowpath key to empty the W-line. 3.Detach the fitting on the W-line of the reagent harness tubing. 4.Loosen the pump by lifting the locket. 5.Remove the W-line from the pump side. 6.Pushing down the locket, and remove the W-line from the waste valve side Disconnect the W-line from the top of the electrode carrier and discard the used W-line. 7.Insert a new W-line into the pump. 8.Connect the W-line to the top of the electrode carrier. 9.Thread the W-line into place inside of the waste valve. 10.Attach the fitting on the reagent harness. 11.Insert the straw into the waste bottle. 12.Close the analyzer door. 13.Prime fluids into Biolyte Perform a calibration. 87

89 Replacing the R-line Figure 4-13 shows the location of the R-line. Replace the R-line according to the following procedures: Figure Location of the R-line. 1.Open the analyzer door. 2.Use Prime functions to empty the R-line. 3.Detach the fitting on the R-line of the reagent harness tubing. 4.Remove the R-line from the reference valve. 5.Disconnect the R-line from the left-hand side of the electrode carrier and discard the used R-line. 6.Connect a new R-line to the left-hand side of the electrode carrier. 7.Thread the R-line into place inside of the reference valve. 8.Attach the fitting on the reagent harness. 9.Insert the straw into the reference bottle. 10.Close the analyzer door. 11.Prime fluids into Biolyte Perform a calibration. 88 V2 Reference Manual

90 Replacing the S-line Figure 4-14 shows the location of the S-line. Replace the S-line according to the following procedures: Figure Location of the S-line. 1.Open the analyzer door. 2.Use Prime functions or press Flowpath key to empty the S-line. 3.Detach the fitting on the S-line of the probe. 4.Remove the S-line. 5.Disconnect the S-line from the down side of the electrode carrier and discard the used S-line. 6.Connect a new S-line to the down side of the electrode carrier. 7.Thread the S-line to the probe. 8.Close the analyzer door. 9.Prime fluids into Biolyte Perform a calibration. 89

91 Replacing the A-line/B-line Figure 4-15 shows the location of the A-line and B-line. Replace the A-line and B-line according to the following procedures: Figure Location of the A-line and B-line. 1.Open the analyzer door. 2.Use Prime functions to empty the A-line or B-line. 3.Detach the fitting on the A-line or B-line of the reagent harness tubing and the septum. 4.Discard the old A-line or B-line. 5.Connect a new A-line or B-line to the reagent harness tubing and the septum. 6.Close the analyzer door. 7.Prime fluids into Biolyte Perform a calibration. 90 V2 Reference Manual

92 Replacing the Probe Figure 4-16 shows the location of Probe. Replace the Probe according to the following procedures: Figure Location of the Probe. 1.Open the analyzer door. 2.Use Prime functions or press Flowpath key to empty the probe. 3.Detach the fitting on the S-line of the probe. 4.Remove the septum Unscrew probe cap and take off the probe. 5.Discard the used probe. 6.Insert a new probe into the probe cap. 7.Screw probe cap tightly. 8.Connect the S-line to the probe. 9.Install the septum Close the analyzer door. 10.Prime fluids into Biolyte Perform a calibration. 91

93 Replacing the Electrodes Figure 4-17 shows the Electrode Carrier. Replace the electrodes according to the following procedures: Figure Electrode Carrier. 1.Open the analyzer door. 2.Use Prime functions or press Flowpath key to empty the electrodes. 3.Disconnect the W-line, R-line and S-line. 4.Remove the electrode carrier. 5.Unlock the electrodes in the carrier by pushing down the Locking lever. 6.Remove the old electrodes by sliding them out of the carrier. 7.Place the new electrodes by sliding them into the electrode carrier with the sealing gasket oriented toward the top. 8.Engage the locking lever above the air detector to lock the electrodes into place. 9.Replace the electrode carrier on its mounting bracket on the Biolyte 2000 Make sure the electrode spacer is at the top. Note: Align the guiding ground rod on the electrode train to the hole on the analyzer. Make sure that you push in the guiding ground rod in first. 10.Connect the W-line, R-line and S-line. 11.Close the analyzer door. 12.Prime fluids into Biolyte If the sodium electrode was replaced, perform a condition Na cycle and condition flow path cycle, in the respective orders. Each of these procedures is explained earlier in this chapter. If other electrodes were replaced, only perform a condition flow path cycle with serum. 14.Calibrate the instrument twice. 92 V2 Reference Manual

94 Non-routine Maintenance Non-routine maintenance procedures are performed in response to trends in instrument operation that may generate error codes if left uncorrected, or as corrective actions in response to inappropriate or incorrect procedures. Cleaning the Sample Inlet Port See Cleaning the Sample Inlet Port in the earlier section of this chapter for details. Cleaning the Probe The probe cleaning procedure is recommended when a gradual increase in flow times is observed. This cycle takes place with the sampler in the manual position. During the probe cleaning cycle, Cleaning Solution is aspirated from a sample cup into the electrode carrier. At the end of the cycle, the Cleaning Solution flushes into the waste bottle. Complete the following steps to clean the probe : 1.Pull the sampler up to the manual position. 2.Fill the sample cup with 1ml of CLEANING SOLUTION (Part. No.: ). 3.See Clean Flow Path in the earlier section of this chapter for details. 4.Recondition the flow path with serum (see Daily Maintenance Procedures), and recalibrate before proceeding to control and specimen assays. Standby Mode The Standby mode is designed to keep the instrument in a functional state indefinitely while conserving fluids during long periods of inactivity. In this mode recalibration is suspended; however, an idle sequence is performed periodically to advance a small segment of STD-A and REF through the flow path. Note: In order to conserve fluids, the Biolyte 2000 does not perform recalibration while it s in Standby Mode. See Start/Standby Function Key in chapter 2, Set Up for details. 93

95 Replacing the Reagent Pack Replace the reagent pack and septum when the reagent pack has expired or is empty. Note: 1. All fluids in tubing are infectious, thus, must be handled with care! Wear gloves if necessary! 2. Septum must be replaced together with the reagent pack. Replacing the reagent pack and RMS 1.When the reagent pack has expired or is empty, system will show Figure 4-18A and start emptying all standard solutions. << CHANGE REAGENT PACK >> 10:06:12 * Reagent pack has expired! >> Emptying all standard solutions... >> Press ESC key to quit. Figure 4-18A. Change Reagent Pack Screen 1. 2.After emptying all standard solutions, system will show Figure 4-18B. << CHANGE REAGENT PACK >> 10:06:12 * Reagent pack has expired! >> Please disconnect tubing (A, B, R), then press ENTER key to empty tubing. Figure 4-18B. Change Reagent Pack Screen 2. 3.Open the analyzer door. 4.Remove A, B, and R straws from their reagent bottles in the reagent pack. Leave the W-line in the waste bottle. Wipe each straw dry as it is lifted out of the bottles to prevent cross contamination. Leave A, B and R straws exposed to the air. 5.Press Enter key to empty tubing and system will show Figure 4-18C. << CHANGE REAGENT PACK >> 10:06:12 * Reagent pack has expired! >> Emptying tubing... >> Press ESC key to quit. Figure 4-18C. Change Reagent Pack Screen V2 Reference Manual

96 6.After emptying all tubing, system will show Figure 4-18D. << CHANGE REAGENT PACK >> 10:06:12 * Reagent pack has expired! >> Please replace a new reagent pack, then press CALIBRATE key to start. Figure 4-18D. Change Reagent Pack Screen 4. 7.Remove the W-straw from the waste bottle. Wipe it dry with a tissue. 8.Turn off the power, then remove the old reagent pack and the old RMS. 9.Place the new reagent pack onto the fluids deck and plug the new RMS into the RMS port. Replacing the septum 10.Disconnect the A-line and B-line from the old septum. 11.Turn the septum counterclockwise 1/4-turn, and remove it from the sampler (as shown in Figure 4-19, left). 12.Discard the old septum. 13.Slide the new septum over the probe and turn it clockwise 1/4-turn to lock it into place (as shown in Figure 4-19, right). 14.Connect the A-line and B-line to the new septum. 15.Insert the tubing harness straws into the appropriate bottles of the reagent pack. Figure Replacing the Septum. 95