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V2 Reference Manual
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 2000 12
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 34
2. 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
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
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
4. 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 Probe 93
Standby Mode 93
Replacing the Reagent Pack 94
Installation of Thermal Paper 97
Shutdown 98
5. 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
Print Statistics 116
Clear QC Data 117
6. 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 151
7. 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 209
8. Appendix 211
Appendix I : Warranty of Products 212
Appendix II : Specifications of Biolyte 2000 215
Appendix III : Performance of Biolyte 2000 219
Appendix IV : Warning Messages 220
Appendix V : Labels on the Biolyte 2000 221
Appendix VI : Description of IEC Letter Symbols 221
Appendix VII : Location of Serial Ports 222
Appendix VIII : Error Codes 222
Appendix IX : Spare Parts List of Biolyte 2000 227
Appendix X : Consumable List of Biolyte 2000 228
A. Preface
A. Preface 5
Intended Use 7
Intended Audience 7
Chapters and Contents 7
Conventions 9
Ordering Information 9
Technical Assistance 9
5
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V2 Reference Manual
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 2000. 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
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with quality control standards.
Chapter 6, Troubleshooting, describes error codes and explains how to repair the Biolyte
2000.
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.
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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.: 9010157),
from BioCare Corporation Marketing Department at +886 -3-2616678 or e-mail 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 +886-3-2616678.
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1. Description
Introduction 11
Installing the Biolyte 2000 12
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 34
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V2 Reference Manual
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 2000.
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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 2000. 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.
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• Confirming Voltage Range
6. The power input module permits the Biolyte 2000 to run at 0.6A/100-240VAC.
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 power-
input module is located where the power cord connects to the Biolyte 2000.
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 2000. Change the fuse according
to the instructions in Chapter 4, Maintenance.
Table 1-1. Fuse for Various Line Voltages.
V A Fuse Requirement
100-240 0.6 2.0A SB (T2.0A/250V)
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• 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.
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V2 Reference Manual
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.
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• 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.
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• 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.
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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.
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V2 Reference Manual
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.
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Tubing
A series of plastic tubing transports fluids throughout the Biolyte 2000. These tubing
include all tubing that extends from the reagent pack to the analytical components on the
front of the Biolyte 2000.
Note: The flow path is the route that fluids travel in, throughout the Biolyte 2000.
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.
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V2 Reference Manual
• 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.
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• 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 1-10. Location of Waste Valve and Reference Valve.
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• 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 2000. 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.
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• 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 1-11. Electrode Carrier.
Sealing gaskets, which prevent any fluid leakage, connects

the electrodes and the air detector.
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V2 Reference Manual
• 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.
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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 1-12. Keypad.
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V2 Reference Manual
The function keys are described in Table 1-3.
Table 1-3. The Function Keys.
Key Function
Analyze Initiates a specimen analysis or restart an interrupted

analysis.
Calibrate Initiates a 2-point calibration.
Delete characters on an input screen.
Enter A select highlighted number of data, initiates sequences,

and selects options. The Enter key transfers data from the
screen to the microcomputer.
Esc Aborts procedures and calls up the previous screen.

Accesses the Main Screen.
Interrupts an analysis.
Flowpath Begins and ends a flow path maintenance sequence.
Menu Displays the Main Screen from the sensor Status Screen.
QC Accesses QC functions.
Samp. Type Displays the Sample Type Set Screen.
Status Displays the Full Sensor Status Screen and the

Biolyte 2000Status Screen.
Start/Standby Makes the screen of Biolyte into “Standby Mode”. Press

again to return to Main Screen.
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• Liquid Crystal Display (LCD)
The Biolyte 2000 uses 40 characters * 4 lines LCD screen. The Biolyte 2000’s main screen is
shown in Figure 1-13.
1999/05/04 <<Biolyte>> 11:20:51

--------------------------------------
* Sample Type : Serum/Plasma
* Status : Not ready
Figure 1-13. 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.
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Acceptable Samples
The following chart lists acceptable sample types for the different parameters measured:
PARAMETER SPECIMEN MATRIX
Sodium Serum, plasma, whole blood, or urine

Potassium Serum, plasma, whole blood, or urine
Chloride Serum, plasma, whole blood, urine or CSF
Lithium 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 2000.
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.
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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 22oC (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 8oC. 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 -20oC.
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 8oC. 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 -20oC.
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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 2000.
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 8oC 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. 1990. Laboratory Test Handbook. Lexi-Comp Inc.
Tietz, N.W., ed. 1986. Textbook of Clinical Chemistry. W.B. Saunders Co.
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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)
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V2 Reference Manual
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
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 136-146 mmol/L 60-220 mmol/day 136-146 mmol/L

Potassium 3.5-5.0 mmol/L 1.0-10.0 mmol/day 3.5-5.0 mmol/L
Chloride 98-106 mmol/L 60-200 mmol/day 98-106 mmol/L 118-132 mmol/L
Lithium 0.5-1.20 mmol/L
(Therapeutic range )
1
Tietz. Norbert W., Ed. 1986 Textbook of Clinical Chemistry. W.B. Saunders Co.
2
Statland. Bernaid. 1987. 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, CSF Urine

Whole Blood
Sodium 60-200 mmol/L --- 40-400 mmol/L
Potassium 1.0-10.0 mmol/L --- 3-300 mmol/L
Chloride 60-200 mmol/L 60-200 mmol/L 40-400 mmol/L
Lithium 0.1-5.0 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
2. Set Up
Introduction 36
Set Up Options in Menu 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
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.
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V2 Reference Manual
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
MENU Screen
3. Cl- : ON 4. Li+ : OFF
>>Press Enter key to change. (ON,OFF) ↓
1
↓
Figure 2-2. Test Select Screen.
SETUP
Screen
2.Use keys to move the cursor, and press Enter key to turn “ON”
↓
or “OFF” the test electrode.
1
↓
3.After setting the test electrode, press Esc key twice to return to the Menu
TEST SELECT
Screen.
Screen
37
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
MENU Screen
<< UNITS SETTING >> 08:30:32
1. Na+ : mmol/L 2. K+ : mmol/L ↓
3. Cl- : mmol/L 4. Li+ : mmol/L 1
>>Press Enter key to change. (mmol/L,mEq/L) ↓
SETUP
Figure 2-3. Units Setting Screen. Screen
↓
2. Use keys to move the cursor, and press Enter key to change the 2
units of measurement. ↓
UNITS SETTING
3. After setting the units of measurement, press Esc key twice to return to Screen
the Menu Screen.
Note: Only Na+ and K+ can be set to mmol/L or mEq/L.
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V2 Reference Manual
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.
Procedure
<< RESOLUTION SET >> 08:30:32
1. Na+ : 123 2. K+ : 12.3
MENU Screen
3. Cl- : 123 4. Li+ : 1.23
>>Press Enter key to change. (123,12.3) ↓
1
↓
Figure 2-4. Resolution Set Screen. SETUP Screen
↓
2.Use keys to move the cursor, and press Enter key to change the 3
number of decimal places. ↓
RESOLUTION SET
3.After setting the resolution values, press Esc key twice to return to the Screen
Menu Screen.
Table 2-1. Resolution Options for Analytes

Resolution :
Analyte 1 mmol/L 0.1 mmol/L 0.01 mmol/L
Na+ x x
K+ x x
Cl- x x
Li+ x
39
Setting Two-point Calibration Interval
The 2-Pt Calibration Setup Option lets users specify the two-point
calibration interval for Biolyte 2000. Figure 2-5 shows the 2-Pt Calibration
Setup Screen.
for Setting two-point Calibration Interval.
Procedure
<< 2-PT CALIBRATION SETUP >> 11:20:51
* Calibration interval : 2 hour
MENU Screen
>>Range : 1 - 12 hour ↓
1
Figure 2-5. 2-Pt Calibration Setup Screen. ↓
SETUP Screen
↓
2.Input the number 1~12 , and press Enter key to set the two-point 4
calibration interval. ↓
2-Pt CALIBRATION
3.After setting the two-point calibration interval, press Esc key twice to SETUP Screen
return to the Menu Screen.
4.If the input number is larger than 4, Biolyte 2000 will alarm, and return
to the previous value.
40
V2 Reference Manual
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 :

Procedure
Note: The Biolyte 2000 displays time in military units (i.e. 1:00PM. = 13:00).
MENU Screen
1.The flowchart on the left side of this page is the step- ↓
by-step procedure for Setting Date and Time. 1
↓
<< DATE/TIME SET >> 11:08:08 SETUP Screen
************************************
↓
* 1999/03/30 15:46:20 *
************************************
5
↓
Figure 2-6. Date/Time Set Screen. DATE/TIME SET
Screen
On the Date/Time Set screen, a blinking cursor appears next to the first
date field.
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
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
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.
for accessing the Results Set Screen.
<< RESULTS SET >> Input No.? 1 11:20:51 Procedure

1. Reference set 4.Printer:OFF
2. Panic set
3. Offsets MENU Screen
↓
Figure 2-8. Results Set Screen. 1
↓
2.Input 1~4 and press Enter key to select function or press Esc key twice SETUP Screen
to return to the Menu Screen. ↓
6
3.The default value of printer is OFF. Please input 4 and press Enter key ↓
to turn printer on. RESULTS SET
Screen
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.
43
Setting Reference Values
The Reference Set Option lets users define the reference values of Biolyte
2000. Figure 2-9 shows the Reference Set Screen.
for Setting Reference Values.
<< REFERENCE SET >> 11:20:51 Procedure

<Blood> Low High Low High
1. Na+ : 136 146 2. K+ : 3.5 5.0
3. Cl : 98 106 4. Li+ : 0.50 1.20 MENU Screen
↓
Figure 2-9. Reference Set Screen. 1
↓
2. Press Samp.Type key to change sample types. SETUP Screen
↓
Note: <Blood> means serum/plasma or whole blood. 6
↓
3. Use keys to move the cursor. RESULTS SET
Screen
4. Input the number (0.00~999), and press Enter key to set the reference ↓
values. 1
↓
5. After setting the reference values, press Esc key 3 times to return to the REFERENCE SET
Menu Screen. 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.
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V2 Reference Manual
Setting Panic Values
The Panic Set Option lets users define the panic values of Biolyte 2000.
Figure 2-10 shows the Panic Set Screen.
for Setting Panic Values.
<< PANIC SET >> 11:20:51 Procedure

<Blood> Low High Low High
1. Na+ : 60 200 2. K+ : 1.0 10.0
3. K+ : 60 200 4. Li+ : 0.10 5.00 MENU Screen
↓
Figure 2-10. Panic Set Screen. 1
↓
Note: 1. <Blood> means serum/plasma or whole blood. SETUP Screen
2. Only the panic values of serum/plasma and whole blood can be set. ↓
6
2. Use keys to move the cursor. ↓
RESULTS SET
3. Input the number (0.00~999), and press Enter key to set the panic values. Screen
↓
4.After setting the panic values, press Esc key 3 times to return to the Menu 2
Screen. ↓
REFERENCE
5.If the input number is larger than 1000, Biolyte 2000 will alarm, and return SET Screen
to the previous value.
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
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.
for Setting Offsets.
Procedure
<< OFFSETS >> 11:20:51

Main Menu Screen
<Serum> Slope Int. Slope Int.
* Na+ : 1.00 +0.00 * K+ : 1.00 +0.00 ↓
* Cl- : 1.00 +0.00 * Li : 1.00 +0.00 1
↓
Figure 2-11. Offsets Screen. SETUP Screen
↓
2.Press Samp. Type key to change sample types. 6
↓
Note: <Serum> indicates for both serum and plasma samples and <WB> indicates for RESULTS SET
whole blood samples. Screen
↓
3.Use keys to move the cursor. 3
↓
4.Input the number of slope or intercept. 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.
Slope Intercept
Cl- 0.8~1.2 ±8.0

Na+ 0.7~1.3 ±10.0
K+ 0.8~1.2 ±0.5
Li+ 0.7~1.3 ±1.0
46
V2 Reference Manual
Setting Operation Options
The Operation Options allow users to set the analysis result and
alarm option. Figure 2-12 shows the Operation Screen.
for Setting Operation Options.
<< OPERATION >> 11:20:51 Procedure

1.Patient copy : OFF 2.ID required :OFF
3.Calib. print : ON 4.MV print :OFF
5.Mess. print : ON 6.Alarm :ON MENU Screen
↓
Figure 2-12. Operation Screen. 2
↓
2.Use keys to move the cursor, and press Enter key to switch the OPERATION Screen
operation options “ON” or “OFF”.
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
Table 2-2. Description of the Operation Options.
Option Default Set Description
Patient copy OFF Biolyte 2000 will print two analysis results if it were set “ON”.
ID required OFF Users must input ID before analysis
procedure if it were set “ON”.
Calib. print ON Biolyte 2000 will print the calibration result
after calibration if it were set “ON”.
MV Print OFF Biolyte 2000 will print results of analysis & calibration
including voltage of signals if it were set “ON”.
Mess. Print ON 1. Biolyte 2000 will print results including worry
message if “occurred” if it were set “ON”.
Alarm 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 Description
< Ref Means assay concentration is less than reference low limit.
> Ref Means assay concentration is greater than reference high limit.
< Pan Means assay concentration is less than panic low limit.
> Pan Means assay concentration is greater than panic high limit.
Drift Means E_0 drift is greater than E_0 drift limit.
NC Means the electrode isn’t calibrated.
48
V2 Reference Manual
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
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
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

key to start.
<< CALIBRATION >> 10:06:12

Remaining 48 sec. Rinse STD-A
* Na+ : ON * K+ : ON
* Cl- : ON * Li+ : OFF
50
V2 Reference Manual
1999/05/04 <<Biolyte>> 11:20:51
--------------------------------------
* 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 Description
“Parameter Indicates that the electrode(s) is ready and
ready” analysis can proceed.
Not ready Must perform calibration before proceeding to
analysis.
Flow path 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
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.: 1030072).
2.Use diluted sample to run ANALYZE.
Figure 3-4. Help for Urine Sample Screen.
52
V2 Reference Manual
Calibrate Function Key
Users can press Calibrate key in the Main Screen. Figure 3-5 shows 4 screens of the Calibration
Screen.

Remaining 48sec. Rinse STD-A
* Na+ : ON * K+ : ON

* Next auto-calibration time = 109 min.
* Na+ : 156.42 mV * K+ : 12.54 mV
* Cl- : 123.45 mV * AIR : 880.45 mV

* Calibration flow rate = 1.6 sec.
* Analysis flow rate = 1.6 sec.
* Remaining reagent = 100 %

Na+ K+ Cl- Li+
* Slope 50.00 50.00 -50.00 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
1999/04/28 13:23:12
================================
<< Calibration >>
--------------------------------
Item Slope Range Mess.
---- ------ ------------- -------
Na+ 50.0 50.7 - 66.8 NC
1
K+ 50.0 48.4 - 64.5
Cl- -50.0 -59.9 - -39.1
================================
================================
Item STD-A [mV] STD-B [mV]
---- ------------ ------------
Na+ -120.55 -75.26 2
K+ 56.28 98.58
Cl- 123.45 78.02
================================
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).
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V2 Reference Manual
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).

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 # 0-999 (auto count by system)
Acc. (Accession #) 0-9999999999
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
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.

>>You must input ID.
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
<< ANALYSIS >> 10:06:12

* Na+ : -120.55 mV * K+ : 12.54 mV
* Cl- : 123.45 mV * AIR : 880.45 mV
<< ANALYSIS >> 10:06:12

<< ANALYSIS >> 10:06:12

Na+ K+ Cl- Li+
* Slope NC 50.00 -50.00 OFF
56 Figure 3-10. Analysis Screens.

V2 Reference Manual
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- : 100.2 mEq/L * Li+ : OFF
Figure 3-11. 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
1999/04/28 13:23:12
================================
<< Analysis >>
SAMPLE ID : A122113994
Access # : 1221159940
Name : S-M WU
Sequence # : 1
Analyze Date: 1999/04/28
Analyze Time: 13:24:10
Sample Type : Serum/Plasma
--------------------------------
Item Concentration Message 1
---- -------------- -----------
Na+ NC 2
K+ 3.12 mmol/L
Cl- 100.2 mEq/L Drift 3
================================
================================
Item STD-A [mV] Sample [mV] 4
---- ------------ ------------
Na+ -120.55 -75.26
K+ 56.28 98.58
Cl- 123.45 78.02
================================
Figure 3-12. 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
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 50.00 -50.00 OFF
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.

* Na : -120.55 mV * K+ : 12.54 mV
* Cl- : 123.45 mV * AIR : 880.45 mV
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.

Figure 3-13C. Status Screen 3.

5.Press Esc key to quit the Status Screen.
59
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 3-14. 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 3-15. Flowpath Screen 2.
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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 3-16. 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
Input 2 and press Enter key to run operation procedures (see Setting Operation
Options in chapter 2, Set Up for details).
• Data Options
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 3-17. 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.
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• 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 3-18. 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 : A123456789 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 3-19. 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.
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• 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: A123456789 Date: 1999/04/24
>> Transferring...
>> Press ESC key to interrupt.
Figure 3-20. 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 3-18. 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
Figure 3-21. 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 3-22. Clearing Data Screen.
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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!
Figure 3-23. 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!
Figure 3-24. Data Clear Error Screen.
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• 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 3-25. 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).
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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
2000. 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.
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Shortcut Procedures
The shortcut procedures are as shown on Figure 3-26.
POWER ON → Selecting Electrodes → Set Sample Type → Selecting Analysis Mode
→ Calibration → Analysis
Figure 3-26. 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.
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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

Press Analyze key so that the probe
1
remains at the outside position.
Put sample cup at Put sample cup underneath the probe.
2
Sample Holder.
Press Analyze key to Press Analyze key to analyze sample.
3
analyze sample.
After analysis, the probe will automatically
4
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).
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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.
Analysis : Urine
1.Before analyzing urine samples, urine samples must be diluted with Urine Diluent
for Biolyte 2000 (Part. No.: 1030072). 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).
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).
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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
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 Probe 93
Standby Mode 93
Replacing the Reagent Pack 94
Installation of Thermal Paper 97
Shutdown 98
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Introduction
This chapter explains how to maintain Biolyte 2000. 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 Description
Condition Running procedures for conditioning
sodium electrode and flow path.
Clean flow path Running procedures for cleaning flow path.
Reagent info Showing the information of the reagent pack.
Prime Running procedures for priming the selected solution or air.
Probe adjustment Adjusting the probe position.
Cal. pump frequency Calibrating pump frequency.
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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.: 1030019) 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.: 1030019).
• 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.
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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.

key to start.
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.
Press Enter key in the Condition Na Screen 1 to switch
to the Condition Na Screen 2 (Figure 4-3B).

>>Hold condition solution under probe,
then press ANALYZE key to prime sol'n.
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.
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Press Analyze key in the Condition Na Screen 2 to switch
to the Condition Na Screen 3 (Figure 4-3C).

>>Priming...
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.
After priming Conditioning Na Solution, screen switches
to the Condition Na Screen 4 (Figure 4-3D).

>>Wait for 60 sec.
Figure 4-3D. Condition Na Screen 4.
• Waiting Conditioning Na Solution to condition Na electrode for 60 seconds.

Maintenance Screen.
After condition Na electrode, screen will change to
the Condition Na Screen 5 (Figure 4-3E).

>>Condition Na+ has been finished.
Figure 4-3E. Condition Na Screen 5.

• Press Esc key to return to the Maintenance Screen.
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• 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.
Screen.
• Select the Condition option (select 1 to access this option).
• Select the Condition f_path option (select 2 to access this option).
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.
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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.

key to start.
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.

Press Enter key in the Condition f_path Screen 1 to switch to the Condition f_path
Screen 2 (Figure 4-4B).

>>Hold serum under probe, then press
ANALYZE key to prime serum.
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.
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Press Analyze key in the Condition f_path Screen 2 to switch to the Condition f_path
Screen 3 (Figure 4-4C).

>>Priming...
Figure 4-4C. Condition f_path Screen 3.
Maintenance Screen.

After priming serum, screen will change to the Condition f_path Screen 4 (Figure
4-4D).

>>Wait for 60 sec.
Figure 4-4D. Condition f_path Screen 4.
• Waiting serum to condition flow path for 60 seconds.

Maintenance Screen.

After condition flow path, screen will change to the Condition f_path Screen 5 (Figure
4-4E).

>>Condition flow path has been finished.
Figure 4-4E. Condition f_path Screen 5.

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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.: 1030012).
Screen.
• Select the Clean Flow Path option (select 2 to access this option).
• 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.
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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

key to start.
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.

Press Enter key in the Clean Flow Path Screen 1 to switch to the Clean Flow Path
Screen 2 (Figure 4-5B).

>>Hold clean solution under probe, then
press ANALYZE key to prime clean sol'n
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.
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Press Analyze key in the Clean Flow Path Screen 2 to switch to the Clean Flow Path
Screen 3 (Figure 4-5C).

>>Priming...
Figure 4-5C. Clean Flow Path Screen 3.
Maintenance Screen.

After priming Cleaning Solution, screen switches to the Clean Flow Path Screen 4
(Figure 4-5D).

>>Wait for 60 sec.
Figure 4-5D. Clean Flow Path Screen 4.

• Waiting Clean Solution to clean flow path for 60 seconds.
Maintenance Screen.

After clean flow path, screen will change to the
Clean Flow Path Screen 5 (Figure 4-5E).

>>Clean flow path has been finished.
Figure 4-5E. Clean Flow Path Screen 5.
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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. : LP8B001
2. Expire date : 06/2001
3. Remaining use life : 32 days
<< REAGENT INFORMATION >> 10:06:12

<mmol>STD-A STD-B STD-A STD-B
* Na+ : 140 60.0 * K+ : 4.0 10.0
* Cl- : 114.5 46.0 * Li+ : 0.5 5.0
Figure 4-6. Reagent Information Screen.
• Press key to change screen.
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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...
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.
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.
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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
1. AIR
2. SAMPLE
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).
• 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.
Figure 4-10B. Probe Adjustment Screen 2.
<< PROBE ADJUSTMENT >> 10:06:12

* SAMPLE : 1420 (Default : 1420)
>> Press key to move probe.
Figure 4-10C. Probe Adjustment Screen 3.
• Press key to adjust the probe position.
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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
Figure 4-11B. Calibrate Pump Frequency Screen 2.
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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.
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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.
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Replacing the W-line
Figure 4-12 shows the location of the W-line. Replace the W-line according to the
following procedures:
Figure 4-12. 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 2000.
14.Perform a calibration.
87
Replacing the R-line
Figure 4-13 shows the location of the R-line. Replace the R-line according to the
Figure 4-13. Location of the R-line.

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.
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Replacing the S-line
Figure 4-14 shows the location of the S-line. Replace the S-line according to the
Figure 4-14. Location of the S-line.

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.
89
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 4-15. Location of the A-line and B-line.

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.
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Replacing the Probe
Figure 4-16 shows the location of Probe. Replace the Probe according to the
Figure 4-16. Location of the Probe.

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.
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Replacing the Electrodes
Figure 4-17 shows the Electrode Carrier. Replace the electrodes according to the
Figure 4-17. Electrode Carrier.

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.
13.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.
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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 :

2.Fill the sample cup with 1ml of CLEANING SOLUTION (Part. No.: 1030012).
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.
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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...
Figure 4-18A. Change Reagent Pack Screen 1.
2.After emptying all standard solutions, system will show Figure 4-18B.

>> Please disconnect tubing (A, B, R),
then press ENTER key to empty tubing.
Figure 4-18B. Change Reagent Pack Screen 2.

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.

>> Emptying tubing...
Figure 4-18C. Change Reagent Pack Screen 3.
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6.After emptying all tubing, system will show Figure 4-18D.

>> 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 4-19. Replacing the Septum.
95
16.Press Calibrate key to start full priming and system will show Figure 4-18E.

* New reagent pack
>> Full priming...
Figure 4-18E. Change Reagent Pack Screen 5.
17.After full priming, system will do auto-calibration.

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Installation of Thermal Paper
This section does not only explain installation of thermal paper but also explain the
replacement of thermal paper. Users can install/replace thermal paper according to
the following procedures.
1.Pull the printer cover.

2.Gently remove the old roll of paper.
3.Install a new roll of paper into the chamber.
4.Pull the tip of the thermal paper outside and close the printer cover.
5.If the printer cover is not closed, the power light will flash.
If the printer fails to print after a new roll of paper is installed, investigate the
following causes:
☉ The printer paper is jammed. Check that the part number of the paper
(Part. No.: 5020097) is correct for the Biolyte 2000's printer.
☉ After installing the thermal paper, check the power light indicator. If the
power light indicator flashes, press the printer cover into the case.
If the above-mentioned are checked and none of them is the cause of the printer
failure, power off the Biolyte 2000 and try power on again.
97
Shutdown
Use the following shutdown procedures to prevent salt buildup in the flow path
when the Biolyte 2000 is turned off or unplugged.
Note: All fluids in tubing are infectious. Thus, they must be handled with care! Wear gloves if
necessary!
1. Open the analyzer door.

2. Remove A, B, and R straws from their reagent bottles in the reagent pack.
Leave the W-tubing in the waste container. Wipe each straw dry as it
is lifted out of the bottles to prevent cross contamination.
3. Leave A, B and R straws exposed to the air.
4. From the Menu Screen, press 6 to access the Maintenance Screen.
5. Select the Prime function. Then select the Full Prime option.
6. Press Enter key to purge fluids from all the tubes.
7. At the conclusion of the full prime cycle, immerse the ends of A, B, and R
straws into a beaker of deionized water.
8. Press Enter key to fill the tubes with deionized water.
9. At the conclusion of the prime cycle, remove the straws from the beaker of
water and leave them exposed to air.
10. Perform 2 full prime cycles with air to purge all water from the tubing.
11. At the conclusion of the second full prime cycle, remove the W straw from
the waste bottle and wipe the straw.
12. If the reagent pack has a reasonable of reagent left, tape the holes on top
of the bottles or cover them with parafilm to prevent evaporation of the
fluids.
13. Release the collars of the W-line from the pump bracket.
14. Close the analyzer door.
15. Switch the power button OFF and unplug the Biolyte 2000.
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5. Quality Control (QC)
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
Print Statistics 116
Clear QC Data 117
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Introduction
Monitor the performance of Biolyte 2000 by analyzing quality control samples.
Biolyte 2000 can track up to 7 QC levels and store the results in instrument’s
memory. These results will be used to calculate any statistics data that users regret.
Reports of historical data, including Levey-Jennings charts, can be printed when
necessary.
This package can check whether the QC test Results obey the 5 Westgard Rules. If
any rule is violated and error is reported, the Biolyte 2000 will alarm. Results that
fall outside the QC assay ranges will require verification by the users before they
become part of the historical data.
Access any QC functions from the Main Screen by pressing the QC key on
instrument.
<< QC >> Input No.? 1 10:06:12

1. Analyze control 2. QC setup
3. Print W-R viol'n 4. Statistic
5. Clear QC data
Figure 5-1. QC Screen.
Input 1~5 and press Enter key to select function or press Esc key to return to the
Main Screen.
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Analyze Control
When this option is selected from the QC Screen, the screen displays the following:
<< ANALYZE CONTROL >> 10:06:12

* Input level : 1 (from 1 to 7)
1. Na+ : ON 2. K+ : ON
3. Cl- : ON 4. Li+ : OFF
Figure 5-2. Analyze Control Screen.
Input the level number of QC samples and select which test items to
analyze. Operate as normal analysis procedures. Finally, the results will
be printed automatically and a message will be displayed on screen
asking users to confirm whether to accept the record or not.
Instruction
•From the QC Screen, press 1 , Analyze control, to access this option.
•Press key to move cursor.
•Use numerical key to input level numbers of QC samples, and use Enter key to turn
on or off the test items.
•Press Analyze key to start analysis.
•Check analysis results (as shown in Figure 5-3, on the following page).
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1999/04/28 13:23:12
================================
<< Control Analysis >>
Level : 1
Lot No. : 12345678
Expiry Date : 1
Analyze Date: 1999/04/28
Analyze Time: 13:24:10
--------------------------------
Item Concentration Message 1
---- -------------- -----------
Na+ NC 2
K+ 3.12 mmol/L
Cl- 100.2 mEq/L Drift 3
================================
================================
Item STD-A [mV] Sample [mV] 4
---- ------------ ------------
Na+ -120.55 75.26
K+ 56.28 98.58
Cl- 123.45 78.02
================================
Figure 5-3. Printout of Control 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)Voltage 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).
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After printing the analysis results, screen will change to the Accept Screen (Figure
5-4).
<< ANALYZE CONTROL >> 10:06:12

>>Accept this record : 1 (1:Yes 2:No)
>>Concentration out of range. *
Figure 5-4. Accept Screen.
• Input 1 to accept or 2 to quit this record.

＊ This message will appear when the concentration of the analyzed
control is out of range.
If users input 1, screen will change to the Save QC Data Screen 1 (Figure 5-5). If users
input 2, screen will return to the Analyze Control Screen (Figure 5-2).
<< SAVE QC DATA >> 10:06:12

>>Saving.......
Figure 5-5. Save QC Data Screen 1.
103
If saving QC data is OK, screen will change to the Save QC Data Screen 2 (Figure 5-6).
<< SAVE QC DATA >> 10:06:12

>>Data save ok!
>>4025 data storage space remains.
• Press any key to return to the Analyze Control Screen (Figure 5-2).
If there is not enough memory, screen will change to the Save QC Data Screen 3
(Figure 5-7).
<< SAVE QC DATA >> 10:06:12

>>No memory to save. Please run CLEAR!
• Press any key to return to the Analyze Control Screen (Figure 5-2).
• Use the Clear QC data function to clear all the old data before saving this data (See
later section in this chapter for details).
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QC Setup
Biolyte 2000 can check the results of QC test by comparing the QC setup. The
QC setup includes QC samples levels, expiry date, lot number, and theoretical
concentration ranges.
<< QC SETUP >> 10:06:12

1. Level : 0
2. Lot number : 0
3. Expiry date : 1998/01/01
<< QC SETUP >> 10:06:12

4. Range : Press ENTER to set
5. Mean & SD : Press ENTER to set
6. W-R setting : Press ENTER to set
Figure 5-8. QC Setup Screen.
Instruction
• From the QC Screen, press 2 , QC setup, to access this option.
• Press key to move cursor.
• Use numerical key to input level number, lot number and expiry date.
• Press Enter key to set range, mean & SD, and Westgard rule setting.
• Press Esc to return to the QC Screen.
105
QC Range Screen
<< QC RANGE >> Level 1 10:06:12

<mmol/L> Low High Low High
1.Na+ : 0.0 0.0 2.K+ : 0.00 0.00
3.Cl- : 0.0 0.0 4.Li+ : 0.00 0.00
Figure 5-9. QC Range Screen.
Instruction
• Use numerical key and Enter key to input the QC range.
Note: Analytes for which no ranges are entered or are missing will not be tracked. The resolution
depends on the Resolution Set (see Setting Electrolyte Resolution Values in chapter 2, Set Up for
details).
• Press Esc to return to the QC Setup Screen.

If the concentration range was changed, screen will display a warning message (the
Save QC Data Screen 4, shown as Figure 5-10) before clearing data.
<< SAVE QC DATA >> 10:06:12

>>When concentration range is modified,
QC data for this level will be lost.
>>Are you sure? 2 (1:Yes 2:No)
• Input 1 to clear data or 2 to return to the QC setup Screen.
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QC Mean & SD Screen
<< QC MEAN & SD >> Level 1 10:06:12

<mmol/L> Mean SD Mean SD
1.Na+: AUTO AUTO 2.K+ : AUTO AUTO
3.Cl- : AUTO AUTO 4.Li+ : AUTO AUTO
Figure 5-11. QC Mean & SD Screen.
Instruction
• “AUTO” means that the values of Mean and SD are determined by the
pervious QC data.
• Press QC key, then use numerical key and Enter key to input the QC range.
QC Westgard Rule Screen
<< QC WESTGARD RULE >> Level 1 10:06:12

1-2s 1-3s 2-2s 1-4s 10x
1.Na+ : OFF OFF OFF OFF OFF
2.K+ : OFF OFF OFF OFF OFF
<< QC WESTGARD RULE >> Level 1 10:06:12

1-2s 1-3s 2-2s 1-4s 10x
3.Cl- : OFF OFF OFF OFF OFF
4.Li+ : OFF OFF OFF OFF OFF
Figure 5-12. QC Westgard Rule Screen.
Instruction
• Press Enter key to switch ON or OFF.
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Print Westgard Rules Violation
This option provides users to print Westgard Rules violation chart. There are 5 rules
which can be applied to the QC sample.
(1) 1-2S: One sample with result greater than 2 standard deviations (SD) from
the Mean.
(2) 1-3S: One sample with result greater than 3 SD’s from the Mean.
(3) 2-2S: Two consecutive samples with results greater than 2SD’s from the
Mean.
(4) 4-1S: Four consecutive samples with result greater than 1 SD from the
Mean.
(5) 10X: Ten consecutive samples with result that fall on the same side of the
Mean.
Figure 5-13 shows the Wastgard Rules Violation Printing Screen.
<< WESTGARD RULES VIOLATION >> 10:06:12

>>Printing...
Figure 5-13. Westgard Rules Violation Printing Screen.
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Figure 5-14 shows the Westguard Rules Violation Chart
Format as printed by the Biolyte 2000.
1999/04/28 13:23:12
=================================
Westgard Rules Violation
--------- Level: 1234567---------
-
Cl 1-2S 1 3 *
1-3S * * *
2-2S * 3 *
4-1S * * *
10X * *
--------------------------------
+
Na 1-2S 1 3 *
1-3S * * *
2-2S * 3 *
4-1S * * *
10X * *
--------------------------------
+
K 1-2S 1 3 *
1-3S * * *
2-2S * 3 *
4-1S * * *
10X * *
--------------------------------
+
Li 1-2S
1-3S
2-2S
4-1S
10X
=================================
Figure 5-14. Westguard Rules Violation Chart Format.
(1)Number (1-7): means the level in which violation for at least one data has
occurred.
(2) * : Means no violation.
(3)Blank: means that not enough data has been checked.
109
Statistics
This function group provides users to process, calculate, and print QC results. Once
selected, the screen displays the following. Users may input the desired function
number to access the function.
From the QC Screen, press 4, Statistics, to access this option.
<< STATISTICS >> Input No.? 1 10:06:12

1. Browse QC data 2. Print QC data
3. Print L-J chart 4. Browse statistics
5. Print statistics
Figure 5-15. Statistics Screen.
Input 1~5 and press Enter key to select function or press Esc key to return to the QC
Screen.
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Browse QC Data
By this function, user can browse every historical data.
<< BROWSE QC DATA >> 10:06:12

1.Select date : 1999/04/01 - 1999/04/24
2.Select test : □ Na+ □ K+ □ Cl- □ Li+
3.Select level : □ 1 □ 2 □ 3 □ 4 □ 5 □ 6 □ 7
Figure 5-16. Browse QC Data Screen 1.
Instruction
• From the Statistics Screen, press 1 , Browse QC Data, to access the option.
• Use numerical key to set date interval.
• Use key to move cursor to proper fields and use Enter key to
turn on or off the test items.
• Press QC key to switch screen to the QC Data Browse Screen 2 (Figure 5-17).
<< QC DATA FOR Cl- LEVEL 1 >> 10:06:12

1999/04/02 12:52:12 132.5 mmol/L
>>Press key to change level & sensor
>>Press key to change date
Figure 5-17. Browse QC Data Screen 2.
• Press key to change level & sensor.

• Press key to change date.
• Press Esc key twice to return to the Statistic Screen.
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Print QC Data
Use this function to print the historical QC test data.
<< PRINT QC DATA >> 10:06:12

1.Select date : 1999/04/01 -1999/04/24
3.Select level : □ 1 □ 2 □ 3 □ 4 □ 5 □ 6 □ 7
Figure 5-18. Print QC Data Screen.
Instruction
• From the Statistics Screen, press 2 , Print QC data, to access the option.
• Use key to move cursor to specific fields and use Enter key to
• Press QC key to print data table (Figure 5-19 on the following page).
• Press Esc to return to the Statistics Screen.
Figure 5-19 shows the QC Data Format printed by Biolyte 2000.
1999/04/29 12:32:45
================================
<< QC DATA FOR Cl- LEVEL 1 >>
From 1999/04/01 to 1999/04/24
--------------------------------
Date Concentration
1999/04/02 132.5 mmol/L
1999/04/02 132.4 mmol/L
: : :
1999/04/24 132.0 mmol/L
================================
Figure 5-19. QC Data Format.
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Print L-J Chart
When the Levey-Jenings charts option is selected, the screen displays the following:
<< PRINT L-J CHART >> 10:06:12

1.Select date : 1999/04/01 - 1999/04/24
3.Select level : □ 1 □ 2 □ 3 □ 4 □ 5 □ 6 □ 7
Figure 5-20. Print L-J Chart Screen.
Instruction
• From the Statistics Screen, press 3, Print L-J chart, to access this option.
• Press QC key to print L-J chart (Figure 5-21 on the following page).
113
Figure 5-21 shows the L-J Chart Print Format printed by Biolyte 2000.
1999/04/29 12:32:45
================================
<< L-J CHARTS FOR Cl- LEVEL 1 >>
From 1999/04/01 to 1999/04/24
Date ---------------------------
04/02 0
04/02 1 |
04/03 | 4
04/04 |
04/10 |1
04/10 1 |
04/15 3 |
04/16 3 |
04/17 2 |
04/18 | 1
04/20 | 1
04/24 0
04/24 | 2
================================
Figure 5-21. L-J Chart Print Format.
Number 0 means that the result is located at mean value.

Number 1 means that the result is located between mean value and 1SD.
Number 2 means that the result is located between 1SD and 2SD.
Number 3 means that the result is located between 2SD and 3SD.
Number 4 means that the result is located out of 3SD.
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Browse Statistics
Biolyte 2000 helps users to calculate results such as mean value, SD and %CV.
<< BROWSE STATISTICS DATA >> 10:06:12

1.Select date : 1999/04/01 - 1999/04/24
+
2.Select test : □ Na+ □ K+ □ Cl- □ Li
3.Select leve : □1 □2 □3 □4 □5 □6 □7
Figure 5-22. Browse Statistics Data Screen.
Instruction
•From the Statistics Screen, press 4 , Browse Statistics data, to access the
option.
•Use key to move cursor to proper fields and use Enter key to
• Press QC key to browse statistics data (Figure 5-23).
<< STATISTICS DATA FOR Cl- >> 10:06:12

Control n Mean[mmol/L] SD CV%
Level 1 13 132.4 1.52 1.23
>>Press key to change level & sensor
Figure 5-23. Statistics Result Screen.
• Press key to change level & sensor.

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Print Statistics
<< BROWSE STATISTICS DATA >> 10:06:12

1.Select date : 1999/04/01 - 1999/04/24
3.Select level : □ 1 □2 □3 □4 □5 □6 □7
Figure 5-24. Print Statistics Data Screen.
Instruction
• From the Statistics Screen, Press 5, Print Statistics data, to access the
option.
• Press QC key to print statistics data (Figure 5-25).
Figure 5-25 shows the Statistics Data Printout Format printed by the Biolyte 2000.
1999/04/29 12:32:45
================================
<< STATISTICS DATA FOR Cl- >>
From 1999/04/01 to 1999/04/24
Unit : mmol/L
--------------------------------
Control n Mean SD CV%
--------------------------------
Level 1 13 132.4 1.52 1.23
Level 3 13 102.4 0.95 0.89
Level 5 13 80.2 -0.62 0.51
================================
Figure 5-25. Statistics Data Printout Format.
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Clear QC Data
When the data stored in memory are full, users have to clear the
QC data in order to save more test results in the future.
<< CLEAR QC DATA >> 1999/04/29

* Select level: □ 1 □ 2 □ 3 □ 4 □ 5 □6 □7
>>Press QC key to clear QC data.
Figure 5-26. Clear QC Data Screen 1.
Instruction
• From the QC Screen, press 5 , Clear QC data, to access the option.
• Ensure the decision again.
Note: Once cleared, data will be lost forever.
• Use key to move cursor to specific fields and use Enter key to select
level.
• Press QC key to clear data (Figure 5-27) or press Esc key to quit.
• Press Esc to return to the QC Screen.
<< CLEAR QC DATA >> 1999/04/29

* Select level: □ 1 □ 2 □ 3 □4 □5 □6 □7
>>Clearing.......

If QC data cleared OK, screen will change to the Clear QC Data Screen 3 (Figure 5-28).
<< CLEAR QC DATA >> 10:06:12

>>QC data clear ok!
• Press any key to return to the QC Screen.
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6. Troubleshooting
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
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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 151
119
Introduction
This chapter describes troubleshooting procedure for the Biolyte 2000 and provides
instructions on how to use error codes and the Diagnostics Screen.
Troubleshooting Theory
The most efficient troubleshooting procedures focus on the simplest and fastest
way to resolve error codes. Since most error codes are due to flow problem in the
Biolyte 2000’s flow path, it is logical to investigate flow problems first. It is helpful
while troubleshooting to view the system as a whole and to consider how the flow
path components interact to transport fluids throughout the Biolyte 2000. When
multiple error codes occur, resolve the flow problems before troubleshooting the
remaining error codes. In most cases, the accompanying errors are resolved along
with the flow problems. Error codes that remain unresolved after flow problem has
been corrected must be investigated individually.
Do not replace any flow path components until you resolved the flow problems,
unless instructed to do so during the flow path check.
The information in this chapter and an understanding of the flow path components
and their functions are all you need to resolve most of the problems you will
encounter with your Biolyte 2000.
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Troubleshooting Procedure
The recommended troubleshooting procedure consists of a series
of steps that are designed to resolve a malfunction in the most
direct and logical way. The following approach is used:
1. Eliminate obvious causes.
2. Troubleshooting individual error codes and groups of error codes by first
eliminating flow problems. Then resolve any remaining error codes.
Proceed as follows to troubleshoot malfunction:

1.First eliminate all obvious problems that may have caused the malfunction.
a.Investigate and correct, if necessary, the following possibilities :
• Unplugged electrode
• Disconnected tubing or septum
• Empty reagent pack
• Incorrectly connected reagent pack
b.Perform a calibration to determine if all calibration errors have disappeared.
c.If the calibration errors have disappeared, perform an analysis to determine
if the analysis errors have also been resolved.
d.If resolved, the troubleshooting procedure is now completed. If either
calibration or analysis errors codes persist, proceed to Step 2 to continue.
2.Troubleshoot individual error codes. Refer to numerical list of error codes in
Error Codes Table (see Appendix VIII). If a flow problem is suspected, you will be
instructed to perform the flow path check at appropriate time. Special emphasis
will be given to flow path components that are the most likely cause of the flow
problem. Refer to flow path check later in this chapter for detailed instruction on
how to perform this procedure.
After the corrective action in each step has been completed, perform a
calibration or analysis or both to determine if the errors have been resolved.
If the proceeding troubleshooting procedure failed to resolve the
Biolyte 2000 malfunction, call BioCare Customer Service Center.
Solving Flow Problems

The flow path consists of the probe, septum, electrode train, all tubing, and reagent
pack (which are linked together to form an airtight unit). The vacuum, created
when the peristaltic pump turns the pump tubing, produces suction that pulls fluids
through the flow path at a specified rate. Flow problems are caused by partial or
complete loss of suction due to leaks or obstructions in any portion of the flow path.
Since the accuracy of analytical results is flow-dependent, it is essential that you
resolve flow problems before attempting to troubleshoot other errors.
121
• Indicator of Flow Related Problem
The Biolyte 2000 monitors flow during every calibration and analysis
cycle and provides the following useful flow indicators :
☉ Flow times
☉ Air and fluid readings
These flow indicators can help you to determine if a problem is flow related.
• Flow Times
Press Status key repeatedly to view the last calibration and analysis flow rate.
The calibration flow rate is the time (in seconds) it takes for Standard B to pass
through the air detector. When Standard B first reaches the air detector, the Biolyte
2000 begins measuring the time it takes for the air detector to see the end of the
Standard B stream.
Analysis flow rate is the time (in seconds) it takes for a sample to pass through the
air detector. When sample first reaches the air detector, the Biolyte 2000 begins
measuring the time it takes for the air detector to see the end of the sample stream.
The analysis flow rate of aqueous standards should be close to the calibration flow
rate. More viscous samples (such as whole blood) will have slightly longer flow rate.
It is possible for the instrument to have a good analysis flow time while it has a bad
calibration flow time, since each measures the flow rate of a different fluid. Because
a calibration flow time measures the flow rate of standard B, a problem such as
insufficient standard B in the reagent pack or a problem in the B-line can cause a
poor calibration flow time without affecting the analysis flow time.
The Biolyte 2000 performs most efficiently when the flow times fall within their
optimal ranges. Flow times that fall just outside of these ranges indicate a subtle
flow problem that will worsen over time (such as minor protein buildup in the flow
path, slightly worn tubing, or a slightly worn septum). You should investigate a flow
problem as soon as the flow times deviate from their optimal ranges.
Flow times that fall outside of their acceptable limits generate error codes 0404 (Flow
Time Too Short) or 0405 and 1405 (Flow Time Too Long). Error codes 0404 and 0405
refer to the calibration flow times, and error code 1405 refers to the analysis flow
times. Each of these errors indicates a more significant flow problem and precludes
accurate analytical results.
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A calibration or analysis flow time of zero indicates that no calibration or analysis
has been performed since the instrument was powered down; therefore, data is
unavailable.
• Air and Fluid Readings

Press Menu key in the Main Screen. System will enter the Menu Screen. Input 5 and
press Enter key to run diagnostic procedures. Then press 3 and press Enter key in
the Diagnostic Screen to access the Air Detector Test function (see Air Detector Test
in the later section of this chapter for details).
The air reading is the signal reading from the air detector when air should be
passing through it. The fluid reading is the signal reading from the air detector
when fluid should be passing through it.
The calibration or analysis cycle is a series of timed events. The air detected takes
the air reading when it expects air to be passing through it. Likewise, the air
detector takes a fluid reading when if expects fluid to be passing through it.
Flow readings like these usually generate error code 0400, Air Detector
Uncalibration, for calibration sequence, or 1400, Can’t Tell Air from Fluid, for analysis
sequence. These errors indicate a flow problem such as an obstruction or an air
leak.
If the air detector does become defective, if will gradually degenerate over time. As
the air detector accumulates protein buildup, it becomes less able to distinguish
between air and fluid readings; fluid readings increase while air readings decrease
so that the 2 readings become closer.
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• Confirming a Flow Problem
If the flow indicators suggest a flow problem, confirm its existence by
performing the flow test with deionized water. The procedure requires a
small beaker or similar container of deionized water and a new S-line. Test
the entire flow path first. Then disconnect components where indicated
and retest in order to isolate the portion of the flow path in which the flow
problem is located. Complete the following steps to perform the Flow Test:

2.Pull the sampler into the manual position.
3.From the Menu Screen, select the Maintenance Menu. Select prime option
to access priming function. Select the Sample to initiate the sequence. The
probe extends, and the pumps turn on.
4.Immerse the probe in the beaker of deionized water then remove it to
introduce air. Repeat this step several times to determine if water is moving
freely through the system.
☉ Unrestricted flow indicates that there is no flow problem.
☉ Restricted or no flow confirms the existence of a flow problem.
5.If there are no new problems, press Esc key to terminate the new test.
6.If a flow problem has been confirmed, continue as follows:
a.Disconnect the S-line from the probe. Repeat Step 4 starting at the
S-line.
b.Disconnect the S-line from the air detector and connect the new
S-line. Repeat Step 4 starting at the new S-line.
c.Press Esc key to terminate the flow test.
7.Since flow path components were eliminated one at a time, you should
have been able to determine if the flow problem was located in the probe,
S-line, electrode train, or W-line.
8.Reconnect all loose tubing. Reuse the old S-line if it is not blocked or use a
new one.
If you were able to locate the source of the flow problem while conducting
the flow test, proceed directly to the flow path check to determine the
appropriate corrective action for the problem you have diagnosed.
If you have confirmed but were unable to diagnose a specific flow problem,
perform the following steps before proceeding to the flow path check :
1.Flush the flow path with deionized water. Refer to Priming the Flow Path in
Chapter 4, Maintenance, for detailed instructions.
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2.If flow is now unrestricted, close the door and perform a calibration to
confirm that the flow problem has been resolved.
3.If the flow problem persists, proceed to the flow path check.
• Possible Sources of Flow Problem

The turning action of the peristaltic pump on the W-line creates a vacuum
that produces suction to pull fluids through the flow path. Flow problems are
caused by the loss of suction when the vacuum is disrupted. The following
flow path components are possible sources of flow–rated errors:
1.W-line: The W-line is the only components that come in direct contact
with the pump. Damaged, blocked, or improperly installed pump tubing
can hinder suction.
2.Probe/S-Line: Clots, salt, or protein buildup in the probe and S-line can
hinder suction.
3.Electrode Carrier: Clots, salt, or protein buildup in the electrodes can
block the electrodes and cause instabilities. Missing or damaged gaskets
between electrodes can cause loss of suction.
4.Septum: The constant movement of the probe can eventually wear out
the septum and cause it to leak.
5.A-line, B-line and R-line: Damaged or blocked tubing in the harness can
cause loss of suction.
Detailed instructions for identifying and correcting these problems
are given in the following flow path check procedure.
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• Flow Path Check
For troubleshooting purposes, the flow path has been
divided into the following 6 sections :
1.W-line Check
2.S-line/Electrode Carrier Check
3.Probe Check
4.A-line & B-line Check
5.R-line Check
6.Septum Check
If you have determined the exact location of a flow problem, troubleshoot only that
section of the flow path in which the problem originates.
If you have been unable to locate the source of the problem, troubleshoot the flow
path in the recommended order to avoid duplicating steps. Investigate and correct
each section completely before proceeding to the next one. Discontinue the flow
path check as soon as the flow problem has been eliminated.
• W-line Check
1.Disconnect the W-line from the top of the electrode carrier.
2.From the Menu Screen, input 6 to access the Maintenance function.
Select the “Prime” option.
Select the “Full” option.
3.Immerse the free end of the W-line into a beaker of deionized water and try
to aspirate water into the W-line. Watch for leaks and obstructions.
4.If there is no leak or blockage in the W-line, proceed to S-line/Electrode
Carrier Check. If the flow is slow or completely blocked, there is a leak or
obstruction in the W-line.
a.Detach the fitting on the W-line of the reagent harness tubing.
b.Remove the W-line from the pump.
c.Remove the tubing from the blunt syringe needle. Fill the syringe
with deionized water and connect the W-line to needle.
d.Flush the W-line to clear any obstruction.
e.Reinstall the W-line into the pump.
f.Reconnect the W-line to the top of the electrode carrier.
g.Repeat step 2 and step 3.
h.If the W-line is blocked or damaged and cannot be cleared, discard
the W-line and install a new one, then perform a calibration to see
if the flow problem is resolved.
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i.If there is no leak or blockage, connect the W-line to the top of
the electrode carrier and perform a calibration to see if the flow
problem is resolved.
j.If the problem still persists, proceed to S-line/Electrode Carrier
Check.
• S-line/Electrode Carrier Check

1.Disconnect the S-line from the top of the probe and from the side of the
electrode carrier.
2.Remove the tubing from the blunt syringe needle. Fill the syringe with
deionized water and connect the S-line to needle.
3.Flush the S-line to clear any obstruction.
4.If the S-line is blocked or damaged and cannot be cleared, perform the
following procedure:
a.Discard the S-line and install a new S-line.
b.Perform a Calibration to see if the flow problem is resolved.
5.If the S-line is not blocked, reconnect the S-line to the side of the
electrode carrier.
7.Immerse the free end of the S-line into a beaker of deionized water and
try to aspirate water into the S-line. Watch for leaks and obstructions.
8.If it primes well, connect the S-line to the top of the probe and perform a
calibration to see if the flow problem is resolved.
9.If the problem still persists, flush the electrode flow train as following :
a.Disconnect the R, W, and S lines from the electrode carrier and
remove the carrier from the Biolyte 2000.
b.Reattach the tubing to the blunt needle on the probe cleaning
syringe and fill the syringe with deionized water.
c.Connect the syringe to the W-port at the top of the electrode
carrier.
d.Flush water through the electrodes in the carrier, while
alternately blocking (with a finger) the reference electrode port,
and the air detector port. Watch for a blockage, or for leaks
between electrodes.
e.If the electrode carrier is not leaking or blocked, dry and reinstall
it and the R, W, and S lines. Proceed to Probe Check.
f.If the electrode carrier is leaking or blocked, proceed to the
appropriate problem :
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(1) Leakage :
(a).Replace the sealing gasket at the leak site.
(b).Retest the carrier for leaks as before. If the leak persists,
it may be due to a damaged or broken electrode. Proceed
with the blockage procedure.
(2) Blockage : Flush the electrodes as follows:
(a). Remove all components from the electrode carrier.
(b). Flush each component individually with deionized water
to dislodge any obstructions and to spot leaks.
☉ The reference electrode has an additional port; alternately block each
with a finger while flushing.
☉ If the air detector is blocked, flush it with Cleaning Solution. Allow
Cleaning Solution to soak inside the air detector for 5 minutes, then flush
with deionized water.
(3) Reassemble the electrodes in the carrier in the order shown on the side
of the carrier.
(4) Reuse any components that are not blocked or damaged. Discard any
components that are blocked or damaged and install new ones.
(5) Replace the carrier on the Biolyte 2000 and reconnect the R, W, and S
lines.
(6) Perform a calibration to see if the flow problem has been eliminated.
(7) If the problem still persists, proceed to Probe Check.
• Probe Check
Warning: Be careful not to place your hands on or near the septum when extending the probe.
2.Put a cup of deionized water underneath the probe.
Select the “Sample” option.
4.Try to aspirate water into the probe. Watch for leaks and obstructions.
5. If there is no leak or blockage in the probe, proceed to Septum Check.
6. If the flow is slow or completely blocked, there is a leak or obstruction in
the probe.
a.Detach the fitting on the S-line of the probe.
b.Unscrew the probe cap and take off the probe.
c.Remove the tubing from the blunt syringe needle. Fill the
syringe with deionized water and connect the probe to needle.
d.Flush the probe to clear any obstruction.
e.Reinstall the probe into the probe cap.
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f.Screw the probe cap tightly.
g.Reconnect the S-line to the top of the probe.
h.Repeat step 2 to step 4.
i. If the probe is blocked or damaged and cannot be cleared,
perform the following procedure :
(1) Discard the probe and install a new one.
(2) Perform a calibration to see if the flow problem is resolved.
j. If there is no leak or blockage, perform a calibration to see if the
flow problem is resolved.
k. If the problem still persists, proceed to Septum Check.
• A-line & B-line Check

Select the “Standard A” or “Standard B” option.
2.Watch for leaks and obstructions.
3.If there is no leak or blockage in the A-line or B-line, proceed to Septum
Check.
4.If the flow is slow or completely blocked, there is a leak or obstruction in
the A-line or B-line.
a. Detach the fitting on the A-line or B-line of the reagent harness
tubing and the septum.
b. Remove the tubing from the blunt syringe needle. Fill the
syringe with deionized water and connect the A-line or B-line to
needle.
c. Flush the A-line or B-line to clear any obstruction.
d. Reinstall the A-line or B-line.
e. Repeat step 1 and step 2.
f. If the A-line or B-line is blocked or damaged and cannot be
cleared, discard the A-line or B-line and install a new one, then
perform a calibration to see if the flow problem is resolved.
g. If there is no leak or blockage, perform a calibration to see if the
h. If the problem still persists, proceed to Septum Check.
• R-line Check
1.Disconnect the R-line from the reference electrode.
Select the “Reference” option.
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3.Immerse the free end of the R-line into a beaker of deionized water and
try to aspirate water into the R-line. Watch for leaks and obstructions.
4.If there is no leak or blockage in the R-line, proceed to Septum Check.
5.If the flow is slow or completely blocked, there is a leak or obstruction in
the R-line.
a. Detach the fitting on the R-line of the reagent harness tubing.
b. Remove the tubing from the blunt syringe. Fill the syringe with
deionized water and connect the R-line to needle.
c. Flush the R-line to clear any obstruction.
a.Reconnect the R-line to the left-hand side of the electrode
carrier..
e. Repeat step 1 and step 2.
f. If the R-line is blocked or damaged and cannot be cleared,
discard the R-line and install a new one, then perform a
calibration to see if the flow problem is resolved.
(1) If there is no leak or blockage, perform a calibration to see if the
(2) If the problem still persists, proceed to Septum Check.
• Septum Check
1.Pull the sampler up to the manual position (remove the sampler cover if
necessary).
3.Make sure that the probe is centered in the correct chamber of the
septum during each prime cycle.
Note: It is easier to see a reagent aspirating through the tubing harness if you create an air bubble in
the tubing. While pumping, withdraw and reinsert the straw into the reagent pack to create the air
bubble.
4.Observe each line during a prime cycle to see if reagent is being
aspirated.
5.If all of the reagents prime well, the septum is eliminated as a cause of the
flow problem. The flow path check is complete. If the preceding steps
failed to resolve the flow problem, contact BioCare Corporation’s
Customer Service Center.
6.If one or more of the reagents are not priming, there may be a problem in
the septum or reagent harness. Proceed as follows :
a.Verify the fitness of the septum :
(1)Check the fit of the septum on the sampler and tighten it if
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needed.
(2)Reprime the reagents as before to see if the flow problem is resolved.
b.If the flow problem persists, install a new septum (see Chapter 4,
Maintenance) and prime the reagents as before. During the
prime observe that the probe moves to the correct positions in
the septum chambers.
7.If all the reagents are priming and the probe is properly positioned, the
septum and the tubing harness are now eliminated as a cause of the flow
problem.
8.If the reagents are not priming with the new septum and the probe is
improperly positioned, contact BioCare Corporation’s Customer Service
Center.
9.If reagents are not priming with the new septum, but the probe is
properly positioned, the flow problem lies in the tubing harness.
10.The septum is now eliminated as a cause of the flow problem.
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Diagnostic
Press Menu key in the Main Screen. System will enter the Menu Screen. Input 5
and press Enter key to run diagnostic procedures. Figure 6-1 shows the Diagnostic
Screen.
<< DIAGNOSTIC >> Input No.? 1 10:06:12

1. Device exercise 2. Device test
3. Air detector test 4. Error log
5. System test 6. Sensor mV data
Figure 6-1. Diagnostic Screen.
Input 1~6 and press Enter key to select function, or press Esc key to return to the
Menu Screen.
Device Exercise
Input 1 and press Enter key in the Diagnostic Screen to enter the Device
Exercise Screen. Figure 6-2 shows the Device Exercise Screen.
<<DEVICE EXERCISE>>Input No.?1 10:06:12

1. Valve exercise
2. Pump exercise
3. Probe exercise
Figure 6-2. Device Exercise Screen.
Diagnostic Screen.
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• Valve Exercise
Input 1 and press Enter key in the Device Exercise Screen to enter the Valve Exercise
Screen. Figure 6-3 shows the Valve Exercise Screen where exercise times and valve
status are displayed.
<< VALVE EXERCISE >> 10:06:12

>>Exercise 25 times
>>Waste Valve : OPEN
Figure 6-3. Valve Exercise Screen.
1.Valve Exercise Procedure (25 times) :

Valve status: Waste Valve OPEN → Waste Valve CLOSE → Reference Valve
OPEN → Reference Valve CLOSE (Valve exercise procedure 2 seconds/time)
2.Press Esc key to interrupt this procedure and return to the Device Exercise Screen.
3.Figure 6-4 shows the Valve Exercise Finish Screen. Press Esc key to return to the
Device Exercise Screen.
<< VALVE EXERCISE >> 10:06:12

>>Exercise finished
>>Reference Valve : CLOSE
Figure 6-4. Valve Exercise Finish Screen.
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• Pump Exercise
Input 2 and press Enter key in the Device Exercise Screen to enter the Pump Exercise
Screen. Figure 6-5 shows the Pump Exercise Screen where exercise times and pump
speed are displayed.
<< PUMP EXERCISE >> 10:06:12

>>Exercise 25 times
>>Pump speed : HI
Figure 6-5. Pump Exercise Screen.
1. Pump Exercise Procedure (25 times):

Pump speed: HI → LO
(Pump exercise procedure 2 seconds/time)
2. Press Esc key to interrupt this procedure and return to the Device Exercise Screen.
3. Figure 6-6 shows the Pump Exercise Finish Screen. Press Esc key to return to the
Device Exercise Screen.

>>Exercise finished
>>Pump speed : LO
Figure 6-6. Pump Exercise Finish Screen.
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• Probe Exercise
Input 3 and press Enter key in the Device Exercise Screen to enter the Probe Exercise
Screen. Figure 6-7 shows the Probe Exercise Screen where exercise times and probe
position are displayed.

>>Exercise 25 times
>>Pump speed : HI
Figure 6-7. Probe Exercise Screen.
1. Probe Exercise Procedure (25 times):

Probe position: 1 (STD-B) → 2 (STD-A) → 3 (AIR) → 4 (REFER) → 5 (SAMP1) → 6
(SAMP2)
SAMPLE 1: Means the probe position of sample when sampler is inside.
SAMPLE 2: Means the probe position of sample when sampler is outside.
2. Press Esc key to interrupt this procedure and return to the Device Exercise Screen.
3. Probe returns to initial position and the Probe Exercise Finish Screen (Figure 6-8)
appears. Press Esc key to return to the Device Exercise Screen.
<< PROBE EXERCISE >> 10:06:12

>>Exercise finished
>>Probe position : 6 (SAMPLE 2)
Figure 6-8. Probe Exercise Finish Screen.
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Device Test
Input 2 and press Enter key in the Diagnostic Screen to enter the Device Test Screen.
Figure 6-9 shows the Device Test Screen.
<< DEVICE TEST >> Input No.? 1 10:06:12

1. Speaker 2. Printer
3. LCD 4. Keypad
5. Sampler sensor 6. Serial Port
Figure 6-9. Device Test Screen.
Diagnostic Screen.
• Speaker Test
Input 1 and press Enter key in the Device Test Screen to enter the Speaker Test
Screen. Figure 6-10 shows the Speaker Test Screen.
<< SPEAKER TEST >> 10:06:12

1. Beep : Press ENTER key to test
2. Alarm : Press ENTER key to test
Figure 6-10. Speaker Test Screen.
• Press key to move cursor, then press Enter key to beep or alarm.
• Press Esc key to return to the Device Test Screen.
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• Printer Test
Input 2 and press Enter key in the Device Test Screen to enter the Printer Test Screen.
Figure 6-11 shows the Printer Test Screen.
<< PRINTER TEST >> 10:06:12

>>Printing...
Figure 6-11. Printer Test Screen.
• After printing all character, system will automatically return to the Device
Test Screen.
• Press Esc key to interrupt printing and return to the Device Test Screen.
• Figure 6-12 shows the “finished” printout format.
<< PRINTER TEST >>

(all characters)
<< PRINT FINISH >>
Figure 6-12. Print Test Printout Format.
• If Esc key is pressed to interrupt the printer test, on the printout, “<<PRINT
INTERRUPT>>” will be printed instead of “<<PRINT FINISH>>”.
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• LCD Test
Input 3 and press Enter key in the Device Test Screen to enter the LCD Test Screen.
Figure 6-13 and Figure 6-14 shows the LCD Test Screen.
Figure 6-13. LCD Test Screen 1, Clear Screen.
▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊
▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊
▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊
▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊
▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊▊
Figure 6-14. LCD Test Screen 2, All Black Screen.
• Press Esc key to change screen, and to return to the Device Test Screen.
• Keypad Test
Input 4 and press Enter key in the Device Test Screen to enter the Keypad Test
Screen. Figure 6-15 shows the Keypad Test Screen.
<< KEYPAD TEST >> 10:06:12

>>The key pressed : Menu
>>Press any key to test.
Figure 6-15. Keypad Test Screen.
• Press any key except Esc key. When a key is being pressed, system will display
the key pressed on line 2 of LCD screen.
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• Sampler Sensor Test
Input 5 and press Enter key in the Device Test Screen to enter the Sampler Sensor
Test Screen. Figure 6-16 shows the Sampler Sensor Test Screen.
<< SAMPLER SENSOR TEST >> 10:06:12

>>Sampler position : INSIDE
>>Move sampler to test.
Figure 6-16. Sampler Sensor Test Screen.
• If sampler is inside, system will display INSIDE on line 2 of LCD.

• If sampler is outside, system will display OUTSIDE on line 2 of LCD.
• Move sampler manually to test.
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• Serial Port Test
Input 6 and press Enter key in the Device Test Screen to enter the Serial Port Test
Screen. Figure 6-17 shows the Serial Port Test Screen.
<< SERIAL PORT TEST >> 10:06:12

1. RS232C : press ENTER to test
2. BarCode : Scan using barcode reader
Figure 6-17. Serial Port Test Screen.

• Press Esc key to return to the Device test screen.
• To test the RS232C port :
a.Short pin 2 and 3, pin 4 and 5, and pin 6 and 20 on the RS232 port at
the backside of the Biolyte 2000 (see Appendix VII).
b.Press Enter key to begin test.
c.If the RS232 port is normal, system will display “PASS”.
d. If the RS232 port is abnormal, system will display “FAIL”.
• BarCode port test :
a. Plug the bar code reader to the BarCode port at the backside of the
Biolyte 2000 (see Appendix VII).
b. Scan an appropriate bar code (less than 10 characters) using the bar
code reader.
c. If the bar code is read correctly, the bar code number will be
displayed on the screen.
d. If the bar code is read incorrectly, a “FAIL” message will be displayed
on the screen instead.
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Air Detector Test
Press 3 and press Enter key in the Diagnostic Screen to access the Air Detector Test
function. Figure 6-18 shows the Air Sensor Test Screen and Figure 6-19 shows the
Test Result Screen.
<<AIR DETECTOR TEST>> 10:06:12

>>Testing...
Figure 6-18. Air Detector Test Screen.
<<AIR DETECTOR TEST>> 10:06:12

* Air : 1000 mV * Fluid : 1200 mV
* Test result : PASS *
Figure 6-19. Test Result Screen.
• Air and Fluid: Means the reading of air detector.

• Press Esc key to return to the Diagnostic Screen.
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Error Log
Input 4 and press Enter key in the Diagnostic Screen to enter the Error Log Screen.
Figure 6-20 shows the Error Log Screen.
<< ERROR LOG >> Input No.? 1 10:06:12

1.View error log
2.Print error log
3.Clear error log
Figure 6-20. Error Log Screen.
Diagnostic Screen.
• View Error Log

Input 1 and press Enter key in the Error Log Screen to enter the View Error Log
Screen. Figure 6-21 shows the View Error Log Screen.
<< VIEW ERROR LOG >> 10:06:12

>>Press ▲ ▼ to change, ESC key to quit.
(1) 1999/04/24 16:36:33 1403 No Sample
Figure 6-21. Error Log Screen.
Press key to view more error log or press Esc key to return to the Error Log
Screen.
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• Print Error Log
Input 2 and press Enter key in the Error Log Screen to enter the Printer Error Log
Screen. Figure 6-22 shows the Printer Error Log Screen.
<< PRINT ERROR LOG >> 10:06:12

>> Printing.......
>> Press any key to continue.
Figure 6-22. Print Error Log Screen.
1.When system is printing error log, users can press Esc key to stop printing.
2.Figure 6-23 shows printout format of Print Error Log. System will print the log
results from the last error to the first error (to a maximum of 50 errors in memory).
================================
Error Log
--------------------------------
(1) 1999/04/24 09:45:35
0105 Na+ Slope Too Low
(2) 1999/04/24 09:45:35
0205 K+ Slope Too Low
(3) 1999/04/22 10:35:12
1400 Can t Tell Air from Fluid
(4) 1999/04/20 16:54:03
2000 Illegal Probe Position
================================
Figure 6-23. Print Error Log Printout Format.
3.After printing, system will display Figure 6-24. Press any key to return to the Error
Log Screen.
<< PRINT ERROR LOG >> 10:06:12

>>Print ok!
Figure 6-24. Print OK Screen.
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• Clear Error Log
Input 3 and press Enter key in the Error Log Screen to enter the Clear Error Log
Screen. Figure 6-25 shows the Clear Error Log Screen.
<< CLEAR ERROR LOG >> 10:06:12

>>Clear ok!
Figure 6-25. Clear Error Log Screen.
After clearing, users can press any key to return to the Error Log Screen.
System Test
Input 5 and press Enter key in the Diagnostic Screen to enter the System Test Screen.
Figure 6-26 shows the System Test Screen.
<< SYSTEM TEST >> Input No.? 1 10:06:12

1.Probe position
2.Pump movement
3.Valves set
Figure 6-26. System Test Screen.
Diagnostic Screen.
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• Probe Position
Input 1 and press Enter key in the System Test Screen to enter the Probe Position
Screen. Figure 6-27 shows the Probe Position Screen.
<<PROBE POSITION>> Input No.? 1 10:06:12

1. SATANDARD A 2. STANDARD B
3. AIR 4. REFERENCE
5. SAMPLE(IN) 6. SAMPLE(OUT)
Figure 6-27. Probe Position Screen.
1. Input 1~6 and press Enter key to move the probe to selected position.
☉ Option “5. SAMPLE (IN)”: Means the probe position of the Semi-Auto
Mode (when the sampler is inside). If the sampler is at the “OUT” position
when users select this option, system will alarm.
☉ Option “6. SAMPLE (OUT)”: Means the probe position of the Manual Mode
(when the sampler is outside). If the sampler is at the “IN” position when
users select this option, system will alarm.
2. Press Esc key to return to the System Test Screen.
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• Pump Movement
Input 2 and press Enter key in the System Test Screen to enter the Pump Movement
Screen. Figure 6-28 shows the Pump Movement Screen.
<< PUMP MOVEMENT >> 10:06:12

* Pump : Stop

• Press Enter key to start or stop.
• Press Esc key to return to the System Test Screen.
• Valves Set
Input 3 and press Enter key in the System Test Screen to enter the Valves Set Screen.
Figure 6-29 shows the Valves Set Screen.
<< VALVES SET >> 10:06:12

* Waste valve : Close
* Reference valve : Close
• Use key to move cursor between Waste Valve and Reference Valve, then
press Enter key to close or open.
• Press Esc key to return to the System Test Screen.
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Sensor mV Data
Input 6 and press Enter key in the Diagnostic Screen to enter the Sensor mV Data
Screen. Figure 6-30 shows the Sensor mV Data Screen.
<< SENEOR MV DATA >> InputNo.? 1 10:06:12

1.Calibration mV data
2.Analysis mV data
Figure 6-30. Sensor mV Data Screen.
Input 1 or 2 and press Enter key to select function, or press Esc key to return to the
Diagnostic Screen.
Figure 6-31 shows the Calibration mV Data Screen and Figure 6-32 shows the
Analysis mV Data Screen. They show the voltage values in the last calibration or
analysis procedure.
<< CALIBRATION MV DATA >> 10:06:12

<mV> Std-A Std-B Std-A Std-B
1.Na+ : 38.48 17.76 2.K+ : 6.92 29.03
3.Cl- : 60.29 79.12 4.Li+ : OFF OFF
Figure 6-31. Calibration mV Data Screen.
<< ANALYSIS MV DATA >> 10:06:12

<mV> Std-A Sample Std-A Sample
1.Na+ : 39.08 17.42 2.K+ : 6.86 29.53
3.Cl- : 62.76 82.17 4.Li+ : OFF OFF
Figure 6-32. Analysis mV Data Screen.
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Error Code
This section describes error codes and explains how to display, interpret, and use
them while troubleshooting.
Introduction to Error Codes

In order to troubleshoot the Biolyte 2000 successfully, you have to be able to interpret
and use its self-diagnosing capabilities. The system monitors itself during every
calibration and analysis sequence to detect and to diagnose system malfunction
that is expressed as numerically coded messages called error codes. Depending on
when they occur, error codes are classified as analysis, calibration, or system related.
Error codes do not state what part of the Biolyte 2000 is malfunction; rather they
describe how the Biolyte 2000 is affected by a malfunction.
Display Error Code

When a malfunction generates one or more error codes, a E is displayed on
the upper right corner of the LCD. At the same time, the error message will
automatically be displayed on the screen. After reading the error message, press the
Esc key to return to the previous screen. To print the cumulative error codes, access
the Error Log under the Diagnostic option.
Problem Solving Procedures

Error codes sometimes stem from more than 1 system fault. When several error
codes appear together, you should consider what they mean as a group.
First troubleshoot the error codes that are flow related. Many flow problems
generate numerous slope and instability errors, which you should resolve before
you address any individual channel errors.
Do not try to change any electrodes or troubleshoot slope errors until you have
resolved the instrument’s flow problems.
Before you troubleshoot error codes, it is best to
☉ Check the flow time
☉ Perform the flow path check as described earlier in this chapter
If these 2 procedures yield positive results, repeat the calibration or analysis

sequence. Otherwise, troubleshoot the error codes according to the instructions in
this chapter.
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This section identifies possible causes of error codes and includes instructions on
how to remedy them. When referring to the error code sheet outlining corrective
action, we recommend performing corrective actions in Solution Block A before
going to Solution Block B. If the recommendations giving here do not resolve an
instrument problem, contact BioCare Corporation’s Customer Service Center for
troubleshooting assistance.
Note: It is helpful to record the Biolyte 2000’s error codes, flow times, and slope performance
numbers before contacting BioCare Corporation’s Customer Service Center.
149
Interpreting Error Codes
☉ Error code consists of 4 characters.
☉ Character means :
X X XX
Class Location Particular
0- Na+ Channel
1- K+ Channel
0- Calibrate error Two digits between 01 and 19
2- Cl- Channel
3- Li+ Channel
4- Others
0- Na+ Channel
1- K+ Channel
1- Analyze error 2- Cl- Channel Two digits between 01 and 19
3- Li+ Channel
4- Others
0- Operation
1- Device
2- System error 2- Software Two digits between 01 and 19
3- QC &
Communication
4- Others
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Error Code Reference
Code Message Page
0001 Na+ Instability STD-A 161
0002 Na+ Instability STD-B 161
0003 Na+ Overload STD-A 163
0004 Na+ Overload STD-B 163
0005 Na+ Slope Too Low 165
0006 Na+ Slope Too High 165
0101 K+ Instability STD-A 167
0102 K+ Instability STD-B 167
0103 K+ Overload STD-A 169
0104 K+ Overload STD-B 169
0105 K+ Slope Too Low 171
0106 K+ Slope Too High 171
0201 Cl- Instability STD-A 155
0202 Cl- Instability STD-B 155
0203 Cl- Overload STD-A 157
0204 Cl- Overload STD-B 157
0205 Cl- Slope Too Low 159
0206 Cl- Slope Too High 159
0305 Li+ Slope Too Low 173
0306 Li+ Slope Too High 173
0307 Li+ Slope Can’t Calculate 175
0400 Air Detector Uncalibrated 176
0401 No STD-A 177
0402 No STD-B 178
0403 No Sample 179
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Code Message Page
0404 Flow Rate Too Short 180
0405 Flow Rate Too Long 181
0406 ADC Not Ready 197
1001 Na+ Instability STD-A 161
1002 Na+ Instability STD-B 161
1003 Na+ Overload STD-A 163
1004 Na+ Overload STD-B 163
1005 Na+ Conc. Too Low 184
1006 Na+ Conc. Too High 184
1007 Na+ E-0 Drift 185
1008 Na+ Instability Sample 161
1009 Na+ Overload Sample 163
1101 K+ Instability STD-A 167
1102 K+ Instability STD-B 167
1103 K+ Overload STD-A 169
1104 K+ Overload STD-B 169
1105 K+ Conc. Too Low 186
1106 K+ Conc. Too High 186
1107 K+ E-0 Drift 187
1108 K+ Instability Sample 167
1109 K+ Overload Sample 169
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Code Message Page
1201 Cl- Instability STD-A 155
1202 Cl- Instability STD-B 155
1203 Cl- Overload STD-A 157
1204 Cl- Overload STD-B 157
1205 Cl- Conc. Too Low 182
1206 Cl- Conc. Too High 182
1207 Cl- E-0 Drift 183
1208 Cl- Instability Sample 155
1209 Cl- Overload Sample 157
1305 Li+ Conc. Too Low 188
1306 Li+ Conc. Too High 188
1307 Li+ E-0 Drift 189
1310 Li+ Cannot Calculate 175
1400 Can’t Tell Air from Fluid 190
1401 No STD-A 177
1402 No STD-B 178
1403 No Sample 179
1404 Short Sample 179
1405 Flow Rate Too Long 192
1406 ADC Not Ready 197
1410 Unreachable Pump Speed 191
2000 Illegal Probe Position 197
2001 Illegal Probe Speed 197
2002 Illegal Pump Speed 197
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Code Message Page
2002 Illegal Pump Speed 197
2005 Illegal Error Code 197
2006 Can't Tell Air from Fluid 190
2007 No STD-A 177
2008 No STD-B 178
2009 No Sample 179
2010 LCD Over Flow 197
2102 Printer Out of Paper 193
2103 Printer Error 197
2104 Printer Off-Line 197
2106 ADC Error 197
2205 RMS I/O Error 194
2206 RMS Write Error 194
2210 RMS Analyzer Type Error 194
2211 RMS Pack Type Error 194
2212 Pack Lot Expired 195
2213 Pack Uselife Expired 195
2214 Standard A Empty 195
2215 Standard B Empty 195
2216 Reference Empty 195
2300 Westgard Rule 1-2s 193
2304 Westgard Rule 1x 193
2305 QC Control Outside Assay Range 196
2306 Transmit to PC Time-out 195
2307 Too Many NAKs from PC 195
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Error Code
0201 Cl- Instability STD-A
0202 Cl- Instability STD-B
1201 Cl- Instability STD-A
1202 Cl- Instability STD-B
1208 Cl- Instability Sample
Description: A “Chloride Instability” error occurs during a calibration or analysis cycle

when the response of the chloride electrode fluctuates while the electrode response
is being measured.
Solution Block A
1. Repeat the analysis or calibration to see if the error recurs.
☉ Verify that the attachment of the electrode carrier to the Biolyte 2000 is secure.
2. If the error persists, there may be bubble hang-up in the electrode.
Perform a flow path conditioning cycle with serum. Perform a calibration.
3. If the error persists, enter flow path maintenance.
☉ Clean electrode pins and connectors on sensor board with alcohol to eliminate
salt bridges.
a. Remove the chloride and reference electrodes and flush them with
deionized water.
b. Verify that sealing gaskets are present between all electrodes and that
tight seals are formed.
c. Reinstall the chloride and reference electrodes, exit flow path maintenance,
and perform a calibration.
5. If the error persists, check the fluid delivery rate of the R-line (Chapter 6,
Troubleshooting). Change the R-line if necessary (Chapter 4, Maintenance).
Perform a calibration.
6. If the error persists, there may be an obstruction. Perform a flow path check
(Chapter 6, Troubleshooting). Perform a calibration.
7. If the error persists, continue to Solution Block B.
Solution Block B
1. Replace the chloride electrode (Chapter 4, Maintenance). Perform a flow path
conditioning cycle with serum. Perform calibration twice.
2. If the error persists, replace the reference electrode (Chapter 4,
155
If these solutions do not resolve the problem, call BioCare Corporation’s Customer
Service Center.
Notes:
1. Electrode slope error codes will also appear when an electrode overload condition exists.
Once the electrode overload error is resolved, the electrode slope error codes should disappear.
2. If an electrode overload exists on more than 1 electrode, the problem may stem from
an improperly attached electrode carrier.
3. If the sodium, potassium, or chloride overload errors occur, investigate the reference electrode.
4. Math errors will also appear if overload errors occur. Once the electrode overload error
is resolved, the math error should disappear.
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Error Code
0203 Cl- Overload STD-A
0204 Cl- Overload STD-B
1203 Cl- Overload STD-A
1204 Cl- Overload STD-B
1209 Cl- Overload Sample
Description: A “Chloride Overload” error occurs when the millivolt readings for
standard A, standard B, or the sample exceed the acceptable operational limits of
the chloride electrode.
Solution Block A
2. If the error persists, troubleshoot this error first.
a. Verify that sealing gaskets are present between all electrodes and that
b. Remove the chloride and reference electrode and flush them with
deionized water.
c. Reinstall the electrodes
d. Exit flow path maintenance.
5. Check the tubing harness for air leaks near the straw connections.
6. Perform a calibration.
Solution Block B
1. Clean electrode pins and connectors on sensor board with alcohol. Salt bridges
on pins can cause overloads.
2. Replace the chloride electrode (Chapter 4, Maintenance).
3. Perform a flow path conditioning cycle with serum. Perform calibration twice.
4. If the error persists, replace the reference electrode (Chapter 4, Maintenance).
Perform calibration twice.
157
Notes:
1. If the slope error is accompanied, resolve these error codes first.
2. Normal but negative slopes on all channels indicate Standard A and B are mixed up.
3. High negative slopes indicate that the reagent pack may have been exposed to freezing
temperatures.
4. If all channels have Slope Low or High errors, it is usually due to one or more of the following :
a. Flow problems
b. Incorrectly installed reagent pack
c. Contaminated reagent pack
d. Reference electrode problem
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Error Code
0205 Cl- Slope Too Low
0206 Cl- Slope Too High
Description : A “Chloride Slope Low or High” error occurs during a calibration

cycle when the difference (delta) between the Standard A and Standard B millivolt
readings is not within the acceptable operational limits of the chloride electrode.
Solution Block A
1. Repeat the calibration to see if the error recurs. Note the slope before and after
conducting the calibration.
2. Check the level of Standard A and Standard B in the reagent pack. If levels are
low, replace the reagent pack (Chapter 4, Maintenance). If contamination is
suspected. Replace the reagent pack. Perform a calibration.
3. If the error persists, perform a flow path conditioning cycle with serum to
eliminate any bubble hang-up. Perform a calibration.
5. If the error persists, enter flow path maintenance and remove the reference and
chloride electrodes. Flush both with deionized water. Reinstall the electrodes.
Verify that sealing gaskets are present between all electrodes. Exit flow path
maintenance and perform a calibration.
6.If the error persists, continue to Solution Block B.
Solution Block B
2.If the error persists, replace the reference electrode (Chapter 4, Maintenance).
Service Center.
Notes:
temperatures.
159
4.If all channels have Slope Low or High errors, it is usually due to one or more of the following :
a. Flow problems
d.Reference electrode problem
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Error Code
0001 Na+ Instability STD-A
0002 Na+ Instability STD-B
1001 Na+ Instability STD-A
1002 Na+ Instability STD-B
1008 Na+ Instability Sample
Description : A “Sodium Instability” error occurs during a calibration or analysis

cycle when the response of the sodium electrode fluctuates while the electrode
response is being measured.
Solution Block A
2. If the error persists, there may be bubble hang-up in the electrode. Perform a
flow path
conditioning cycle with serum. Perform a calibration.
salt bridges.
a. Remove the sodium and reference electrodes and flush them with
deionized water.
c. Reinstall the sodium and reference electrodes, exit flow path maintenance,
and perform a calibration.
Troubleshooting).
Change the R-line if necessary (Chapter 4, Maintenance). Perform a calibration.
Solution Block B
1.Replace the sodium electrode (Chapter 4, Maintenance). Perform a sodium
conditioning cycle with Conditioning Na Solution, then a flow path conditioning
cycle with serum. Perform calibration twice.
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Perform calibrationtwice.
Service Center.
Notes:
1. If the stability error code is accompanied by flow error codes or slope error codes, resolve these
error codes first, and the instability error codes should disappear.
2. Instabilities on patient samples may occur randomly as a result of interfering substances in the
sample.
3. If all channels are giving instabilities, either the electrode carrier is not attached correctly, or there
is a flow problem, or the reagent pack is empty.
4. If more than 1 electrode channel is giving instabilities, check the reference electrode.
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Error Code
0003 Na+ Overload STD-A
0004 Na+ Overload STD-B
1003 Na+ Overload STD-A
1004 Na+ Overload STD-B
1009 Na+ Overload Sample
Description : A “Sodium Overload” error occurs when the millivolt readings for
the sodium electrode.
Solution Block A
b. Remove the sodium and reference electrode and flush them with
deionized water.
Solution Block B
2. Replace the sodium electrode (Chapter 4, Maintenance).
3. Perform a sodium conditioning cycle with Conditioning Na Solution and then
perform a flow path conditioning cycle with serum. Perform calibration twice.
Service Center.
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Notes:
1. Electrode slope error codes will also appear when an electrode overload condition exists. Once
the electrode overload error is resolved, the electrode slope error codes should disappear.
2. If an electrode overload exists on more than 1 electrode, the problem may stem from an
improperly attached electrode carrier.
3. Electrode overload errors typically stem from either a faulty electrode or an electrical problem.
4. If overload errors occur on more than 1 electrode channel, investigate the reference electrode.
5. Math errors will also appear if overload errors occur. Once the electrode overload error is
resolved, the math error should disappear.
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Error Code
0005 Na+ Slope Too Low
0006 Na+ Slope Too High
Description : A “Sodium Slope Low or High” error occurs during a calibration

readings is not within the acceptable operational limits of the sodium electrode.
Solution Block A
calibrating.
low,replace the reagent pack (Chapter 4, Maintenance). If contamination is
suspected. Replace the reagent pack. Perform calibration twice.
3. If the error persists, perform a sodium conditioning cycle with Conditioning Na
Solution. Perform a flow path conditioning cycle with serum. Perform calibration
twice.
sodium electrodes. Flush both with deionized water. Reinstall the electrodes.
Solution Block B
1. Replace the sodium electrode (Chapter 4, Maintenance). Perform a sodium
conditioning cycle with Conditioning Na Solution.
Perform a flow path conditioning cycle with serum. Perform calibration twice.
Service Center.
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Notes:
1.If the slope error is accompanied, resolve these error codes first.
2.Normal but negative slopes on all channels indicate Standard A and B are mixed up.
3.High negative slopes indicate that the reagent pack may have been exposed to freezing
temperatures.
4.If all channels have Slope Low or High errors, it is usually due to one or more of the following:
a.Flow problems
b.Incorrectly installed reagent pack
c.Contaminated reagent pack
d.Reference electrode problem
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Error Code
0101 K+ Instability STD-A
0102 K+ Instability STD-B
1101 K+ Instability STD-A
1102 K+ Instability STD-B
1108 K+ Instability Sample
Description : A “Potassium Instability” error occurs during a calibration or analysis

cycle when the response of the potassium electrode fluctuates while the electrode
response is being measured.
Solution Block A
1 Repeat the analysis or calibration to see if the error recurs.
2. If the error persists, there may be bubble hang-up in the electrode. Perform a flow
path conditioning cycle with serum. Perform a calibration.
salt bridges.
a. Remove the potassium and reference electrodes and flush them with
deionized water.
c. Reinstall the potassium and reference electrodes, exit flow path
maintenance, and perform a calibration.
5. If the error persists, check the fluid delivery rate of the R-line (Chapter 6
, Troubleshooting). Change the R-line if necessary (Chapter 4, Maintenance).
Solution Block B
1. Replace the potassium electrode (Chapter 4, Maintenance). Perform a flow path
2. If the error persists, replace the reference electrode (Chapter 4,
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Maintenance). Perform calibration twice.
Service Center.
Notes:
1. If the stability error code is accompanied by flow error codes or slope error codes, resolve these
error codes first, and the instability error codes should disappear.
2. Instabilities on patient samples may occur randomly as a result of interfering substances in the
sample.
3. If all channels are giving instabilities, either the electrode carrier is not attached correctly, or there
is a flow problem, or the reagent pack is empty.
4. If more than 1 electrode channel is giving instabilities, check the reference electrode.
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Error Code
0103 K+ Overload STD-A
0104 K+ Overload STD-B
1103 K+ Overload STD-A
1104 K+ Overload STD-B
1109 K+ Overload Sample
Description : A “Potassium Overload” error occurs when the millivolt readings for
the potassium electrode.
Solution Block A
1.Repeat the analysis or calibration to see if the error recurs.
b. Remove the potassium and reference electrode and flush them with
deionized water.
Solution Block B
2. Replace the potassium electrode (Chapter 4, Maintenance).
3. Perform a flow path conditioning cycle with serum. Perform calibration twice.
169
Service Center.
Notes:
1. Electrode slope error codes will also appear when an electrode overload condition exists.
Once the electrode overload error is resolved, the electrode slope error codes should disappear.
2. If an electrode overload exists on more than 1 electrode, the problem may stem from an
improperly attached electrode carrier.
3. Electrode overload errors typically stem from either a faulty electrode or an electrical problem.
4. If overload errors occur on more than 1 electrode channel, investigate the reference electrode.
5. Math errors will also appear if overload errors occur. Once the electrode overload error is
resolved, the math error should disappear.
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Error Code
0105 K+ Slope Too Low
0106 K+ Slope Too High
Description : A “Potassium Slope Low or High” error occurs during a calibration

readings is not within the acceptable operational limits of the potassium electrode.
Solution Block A
calibrating.
low, replace the reagent pack (Chapter 4, Maintenance). If contamination is
potassium electrodes. Flush both with deionized water. Reinstall the electrodes.
Solution Block B
Service Center.
171
Notes:
temperatures.
4. If all channels have Slope Low or High errors, it is usually due to one or more of the following:
a. Flow problems
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Error Code
0305 Li+ Slope Too Low
0306 Li+ Slope Too High
Description A “Lithium Slope Low or High” error occurs during a calibration

readings is not within the acceptable operational limits of the lithium electrode.
Solution Block A
calibrating.
2. Check the level of Standard A and Standard B in the reagent pack. If levels are low
, replace the reagent pack (Chapter 4, Maintenance). If contamination is
4.If the error persists, check the fluid delivery rate of the R-line (Chapter 6
, Troubleshooting). Change the R-line if necessary (Chapter 4, Maintenance).
5.If the error persists, enter flow path maintenance and remove the reference and
lithium electrodes. Flush both with deionized water. Reinstall the electrodes.
6.If the error persists, continue to Solution Block B.
Solution Block B
1.Replace the lithium electrode (Chapter 4, Maintenance). Perform a flow path
conditioning cycle with serum. Perform 2 calibration.
Service Center.
Notes:
1.The sodium and potassium channels must be calibrated for lithium analysis to work.
173
temperatures.
5. If all channels have Slope Low or High errors, it is usually due to one or more of the following :
a. Flow problems
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Error Code
0307 Li+ Slope Can’t Calculate
1310 Li+ Can’t Calculate
Description : A “Lithium Slope Can’t Calculate” error and “Lithium Can’t Calculate”
error occurs during a calibration cycle or analysis cycle when sodium and potassium
electrodes are unable to obtain a proper slope or reading.
Solution Block A
1. Check and resolve any error related to sodium and potassium channels. This error
will be solved automatically.
Notes:
1. The sodium and potassium channels must be calibrated for lithium analysis to work.
2. Normal but negative slopes on all channels indicate that Standard A and B are switched.
3. If the slope errors occur, resolve these error codes first.
temperatures.
175
Error Code
0400 Air Detector Uncalibrated
Description : The “Air Detector Uncalibrated” error occurs during a calibration cycle
when the air detector cannot distinguish air from fluid by their signals.
Solution Block A
1. From the Menu Screen, input 5 to access the Diagnostic function.
Select the “Air detector test” option.
2. If the “Test result” shows “PASS”, perform a calibration.
3. If the “Test result” shows “FAIL”, press Flowpath key to remove the bubble in the
air detector. Perform a calibration.
4. Repeat step 3 several times.
5. If the error persists, replace the air detector (Chapter 4, Maintenance). Perform a
flow path conditioning cycle with serum. Perform calibration twice.
Service Center.
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Error Code
0401, 1401, 2007 No STD-A
Description : A “No Standard A” error occurs during an analysis cycle when the air
detector does not see Standard A at the appropriate time.
Solution Block A
1. Troubleshoot the reagent pack :
a. Check the level of Standard A in the bottle. If there is sufficient Standard
A, perform a Prime A cycle to confirm that Standard A is being pumped.
b. If there is sufficient Standard A in the bottle, replace the reagent pack
(Chapter 4, Maintenance). Perform a calibration.
2. If the error persists, perform a flow path check (Chapter 6, Troubleshooting).
a. Check the reagent straw and the tubing harness for correct installation.
b. Verify that the probe is positioned in the center of the septum chambers
when performing the flow path check.
☉ If the probe position is incorrect, contact BioCare Corporation’s Customer
Service Center.
☉ If the probe position is correct, perform a calibration.
c. If an obstruction is found, clean the appropriate components with
deionized water. Perform a calibration.
3. If any damaged tubing is found during the flow path check, replace the reagent
harness or the pump tubing or both as needed (Chapter 4, Maintenance). Perform
a calibration.
Solution Block B
3.If the “Test result” shows “FAIL”, press Flowpath key to remove the bubble in the air
4.Repeat step 3 several times.
5.If the error persists, replace the air detector (Chapter 4, Maintenance). Perform a
Service Center.
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Error Code
0402, 1402, 2008 No STD-B
Description : A “No Standard B” error occurs during an analysis cycle when the air
detector does not see Standard B at the appropriate time.
Solution Block A
1. Troubleshoot the reagent pack :
a. Check the level of Standard B in the bottle. If there is sufficient Standard
B, perform a Prime B cycle to confirm that Standard B is being pumped
b. If there is sufficient Standard B in the bottle, replace the reagent pack
(Chapter 4, Maintenance). Perform a calibration.
a. Check the reagent straw and the tubing harness for correct installation.
b. Make sure the probe is positioned in the center of the septum chambers
when performing the flow path check.
☉ If the probe position is incorrect, contact BioCare Corporation’s Customer
Service Center.
☉ If the probe position is correct, perform a calibration.
c. If an obstruction is found, clean the appropriate components with
deionized water. Perform a calibration.
3. If any damaged tubing is found during the flow path check, replace the reagent
harness or the pump tubing or both as needed (Chapter 4, Maintenance). Perform
a calibration.
Solution Block B
Service Center.
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Notes :
If the flow error #0400 (Air Detector Uncalibrated) appear along with the error No Standard B,
change the septum.
Error Code
0403, 1403, 2009 No Sample
1404 Short Sample
Description :
A “No Sample” error code occurs during an analysis cycle when the air detector does
not see the sample within the allotted time.
A “Short Sample” error occurs during an analysis when an insufficient amount of
sample is seen by the air detector.
Solution Block A
1. Check the amount of sample. If it is sufficient, continue to Solution Block B.
Solution Block B
Service Center.
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Error Code
0404 Flow Time Too Short (Calibration Only)
Description :
A “Flow Time Too Short” error occurs during a calibration when the time required
for Standard A to travel from the probe tip (in the septum) to the air detector is less
than the allotted time.
Solution Block A
1. If the pump tubing was just replaced, release each tubing from the bracket, let it
relax, stretch it several times, and reposition it around the pump. Replace the
tubing in the bracket without twisting it.
☉ Check that the probe is positioned in the center of the septum chambers when
performing septum of the flow path check.
Solution Block B
1. Replace a S-line. Make sure correct part number is installed (Chapter 4,
Maintenance).
2. If the error persists and the pump tubing was not recently replaced, replace the
pump tubing (Chapter 4, Maintenance).
Service Center.
Notes:
A flow error code has the highest priority in troubleshooting. If other electrode error codes appear
with the flow error, resolve the flow problem first, and the other errors should disappear.
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Error Code
0405 Flow Time Too Long (Calibration Only)
Description :
A “Flow Time Too Long” error occurs during a calibration when the time required for
Standard A to travel from the probe tip (in the septum) to the air detector is greater
than the allotted time.
Solution Block A
1. If the pump tubing was just replaced, release each tubing from the bracket, let it
relax, stretch it several times, and reposition it around the pump. Replace the
tubing in the bracket without twisting it. Perform a calibration.
☉ Check that all sealing gaskets are in place.
☉ Verify that the probe is positioned in the center of the septum chambers when
performing septum check of the flow path check.
Solution Block B
1. Replace the S-line. Make sure correct part number is installed (Chapter 4,
Maintenance).
2. If the error persists and the pump tubing was not recently replaced, replace the
pump tubing (Chapter 4, Maintenance).
Service Center.
Notes:
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Error Code
1205 Cl- Conc. Too Low
1206 Cl- Conc. Too High
Description :
A “Chloride Concentration Too Low or Too High” error occurs when an analysis is
performed on a sample and the chloride is calculated to be above or below the
acceptable linearity range of the chloride electrode.
Solution Block A
1. If a flow error appears, resolve the flow problem first. Perform a flow path check
(Chapter 6, Troubleshooting).
2. If the sample’s concentration is too low or too high, the sample cannot be assayed
for chloride.
3. If there is no flow problem, perform a flow path conditioning cycle with serum.
Run a control with adequate chloride concentration to check the electrode
performance. Repeat the analysis.
Service Center.
Notes:
1. The analytical range for chloride is 60-200 mM for serum, plasma, whole blood, and CFS. The
urine range is 40-400 mM.
2. No chloride results are available on samples that generate these 2 error codes.
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Error Code
1207 Cl- E-0 Drift
Description :
A “Chloride E-0 Drift” error occurs during an analysis when the Standard A millivolt
drift between the last 2-point calibration and the 1-point analysis calibration
exceeds the acceptable operational limits of the chloride electrode.
Solution Block A
1. If flow errors also appear, resolve the flow problems first.
2. Enter flow path maintenance.
tight seals are found.
b. Remove the sodium and reference electrodes and flush them with
deionized water.
c. Reinstall the electrodes.
3. Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Change
the R-line if necessary (Chapter 4, Maintenance). Perform a calibration and repeat
the analysis.
Solution Block B
conditioning cycle with serum. Perform calibration twice and repeat the analysis.
Perform calibration twice and repeat the analysis.
Service Center.
Notes:
If all channels are giving E-0 Drift errors, the reagent pack may be empty. Troubleshoot reagent pack
before flow errors.
183
Error Code
1005 Na+ Conc. Too Low
1006 Na+ Conc. Too High
Description :
A “Sodium Concentration Too Low or Too High” error occurs when an analysis is
performed on a sample and the sodium is calculated to be above or below the
acceptable linearity range of the sodium electrode.
Solution Block A
for sodium.
3. If there is no flow problem, perform a flow path conditioning cycle with
serum. Run a control with adequate sodium concentration to check the electrode
Service Center.
Notes:
1. The analytical range for sodium is 60-200 mM for serum, plasma, and whole blood. The urine
range is 40-400 mM.
2. No sodium results are available on samples that generate these 2 error codes.
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Error Code
1007 Na+ E-0 Drift
Description :
A “Sodium E-0 Drift” error occurs during an analysis when the Standard A millivolt
exceeds the acceptable operational limits of the sodium electrode.
Solution Block A
deionized water.
3. Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Replace
the analysis.
4. If the error persists, perform a sodium conditioning cycle with Conditioning Na
Solution. Perform a flow path conditioning cycle with serum. Perform calibration
twice and repeat the analysis.
Solution Block B
1. Replace the sodium electrode (Chapter 4, Maintenance). Perform a sodium
conditioning cycle with Conditioning Na Solution, then a flow path conditioning
cycle with serum. Perform calibration twice and repeat the analysis.
Service Center.
Notes:
before flow errors.
185
Error Code 1105 K+ Conc. Too Low
1106 K+ Conc. Too High
Description :
A “Potassium Concentration Too Low or Too High” error occurs when an analysis is
performed on a sample and the potassium is calculated to be above or below the
acceptable linearity range of the potassium electrode.
Solution Block A
for potassium.
3. If there is no flow problem, perform a flow path conditioning cycle with serum.
Run a control with adequate potassium concentration to check the electrode
Service Center.
Notes:
1. The analytical range for potassium is 1.0-10.0 mM for serum, plasma, and whole blood. The urine
range is 3-300 mM.
2. No potassium results are available on samples that generate these 2 error codes.
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Error Code
1107 K+ E-0 Drift
Description :
A “Potassium E-0 Drift” error occurs during an analysis when the Standard A millivolt
exceeds the acceptable operational limits of the potassium electrode.
Solution Block A
deionized water.
3. Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Replace
the analysis.
Solution Block B
Service Center.
Notes:
before flow errors.
187
Error Code
1305 Li+ Conc. Too Low
1306 Li+ Conc. Too High
Description :
A “Lithium Concentration Too Low or Too High” error occurs when an analysis is
performed on a sample and the lithium is calculated to be above or below the
acceptable linearity range of the lithium electrode.
Solution Block A
for lithium.
3. If there is no flow problem, perform a flow path conditioning cycle with
serum. Run a control with adequate lithium concentration to check the electrode
Service Center.
Notes:
1. The analytical range for lithium is 0.1-5.0 mM for serum, plasma, and whole blood.
2. No lithium results are available on samples that generate these 2 error codes.
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Error Code
1307 Li+ E-0 Drift
Description :
A “Lithium E-0 Drift” error occurs during an analysis when the Standard A millivolt
exceeds the acceptable operational limits of the lithium electrode.
Solution Block A
deionized water.
3. Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Change
the analysis.
Solution Block B
1. Replace the lithium electrode (Chapter 4, Maintenance). Perform a flow path
Service Center.
Notes:
1. If all channels are giving E-0 Drift errors, the reagent pack may be empty. Troubleshoot reagent
pack before flow errors.
2. The sodium and potassium channels must be calibrated for lithium to work.
189
Error Code
1400, 2006 Can’t Tell Air from Fluid
Description :
The “Can’t Tell Air from Fluid” error occurs during an analysis cycle if the measured
signal difference between fluid and air did not fall within acceptable limits.
Solution Block A
1. Perform a calibration. If during the calibration the error #0400 (Air Detector
Uncalibrated) occurs, troubleshoot that error first (Chapter 6, Troubleshooting).
☉ When the Air Detector Uncalibrated error is resolved, the “Can’t Tell Air from
Fluid” error will disappear.
2. Enter flow path maintenance and remove the air detector. Flush it with Cleaning
Solution, allowing the solution to soak inside the air detector for 5 minutes. Flush
with deionized water. Reinstall the air detector, exit flow path maintenance, and
perform a calibration. Repeat the analysis.
Solution Block B
1. Replace the air detector (Chapter 4, Maintenance). Perform a flow path
Service Center.
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Error Code
1410 Unreachable Pump Speed
Description :
The instrument can auto-calibrate the speed of the peristaltic pump to optimize
the flow rate in the tubing set. If the instrument makes 3 attempts to calibrate the
peristaltic pump and still cannot adjust the flow rate to an acceptable range. Then
this warning message will be shown.
Solution Block A
1. Check that the tubing set, especially the W-line, is installed properly.
2. Run the “Calibrate Pump Frequency” again to properly set the pump speed.
Solution Block B
1. If the tubing set was not replaced for a period of time, replace the tubing set
(Chapter 4, Maintenance).
Service Center.
Notes:
This error message is only a warning signal. It means the instrument is not ready to be used.
191
Error Code
1405 Flow Time Too Long (Analysis Only)
Description :
A “Flow Time Too Long” error occurs during an analysis (after the sample has already
reached the air detector) if the time required for the air detector to see the end of
the sample is greater than the allotted time.
Solution Block A
1. Check the sample for clots. Repeat the analysis.
2. If the error persists and the pump tubing was just replaced, release each tubing
from the bracket, let it relax, stretch it several times, and reposition it around the
pump. Replace the tubing in the bracket without twisting it. Perform
a calibration. Repeat the analysis.
☉ Check that all sealing gaskets are in place.
☉ Verify that the probe is positioned in the center of the septum chambers when
performing septum check of the flow path check.
Solution Block B
1. If the pump tubing was not recently replaced, replace the pump tubing (Chapter 4,
Maintenance).
Service Center.
Notes:
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Error Code
2102 Printer Out of Paper
Description :
A “Printer Out of Paper” error code occurs when the printer runs out of paper during
an analysis or calibration or when the printer cover is open.
Solution Block A
1. If there is sufficient paper or if the paper has just been changed, check the printer
cover. If it is open (lever forward), close it by pushing the lever back.
2. Press QC key, then input 3 (Print Westgard Rule Violation function) to reactivate
the printer.
Service Center.
Error Code
2300 Westgard Rule 1-2s
2304 Westgard Rule 1x
Description :
These error codes indicate that a Westgard Rule has been violated on a QC standard.
An explanation of the Westgard Rules is found in Chapter 5, Quality Control. These
errors do not necessarily indicate that there is anything wrong with the instrument.
Solution Block A
1. Make sure the correct QC standard is being analyzed.
Service Center.
Notes:
If other error codes appear along with the QC error, resolve those errors first.
193
Error Code
2205 RMS I/O Error
2206 RMS Write Error
Description :
The error means that the “Reagent Management System (RMS)” cannot access the
RMS or the RMS is missing.
Solution Block A
1. Check whether the RMS is installed.
2. Check the cable and the connection around the RMS plug.
Service Center.
Error Code
2210 RMS Analyzer Type Error
2211 RMS Pack Type Error
Description :
These error codes indicate that the reagent pack and the instrument are not
supposed to be used with each other.
Solution Block A
1. Check the type of the reagent pack and confirm its type with the supplier.
Service Center.
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Error Code
2212 Pack Lot Expired
2213 Pack Uselife Expired
2214 Standard A Empty
2215 Standard B Empty
2216 Reference Empty
Description :
These error codes indicate that the reagent pack is expired, out of date, or has been
used up.
Solution Block A
1. Please change to a new reagent pack.
Service Center.
Error Code
2306 Transmit to PC Time-out
2307 Too Many NAKs from PC
Description :
The errors indicate that a problem occurs during the communication between a PC
and the instrument. Error Code 2306 means that the instrument does not receive
any response from the PC and the initial handshake was not established correctly.
Error Code 2307 means that the information received by the PC does not correspond
to the information sent by the instrument.
Solution Block A
1. Check the cable’s connections and check that the type of cable being used is
correct.
2. Check that the settings of the PC are correct according to ASTM 1394 and ASTM
1381 protocol.
Service Center.
195
Error Code
2305 QC Control Outside Assay Range
Description :
These error codes indicate that an analyte in a QC standard was outside the
specified range. An explanation of the QC package is found in Chapter 5, Quality
Control. This error does not necessarily indicate that there is anything wrong with
the instrument.
Solution Block A
1. Make sure the correct QC standard is being analyzed.
Service Center.
Notes:
If other error codes appear along with the QC error, resolve those errors first.
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Error Code
0406, 1406 ADC Not Ready
2000 Illegal Probe Position
2001 Illegal Probe Speed
2002 Illegal Pump Speed
2005 Illegal Error Code
2010 LCD Over Flow
2103 Printer Error
2104 Printer Off-Line
2106 ADC Error
Description :
These error codes usually stem from a hardware problem.
Solution Block A
1. Contact BioCare Corporation’s Customer Service Center.
197
7. Theory
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 209
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Introduction
The evolution of the ion selective electrode (ISE) as a measuring device began in
1875 with the recognition that glass is an electrolytic conductor.1 Initially, studies
were conducted using whatever kinds of glass were readily available, such as
laboratory glass tubing. As knowledge in the field increased, these glasses were
analyzed and their compositions altered to measure the effects of such change on
their diffusion rates and selectivity. Complex multi-component lithe glass and non-
glass materials that can function as ion selective membranes as they were identified
replaced the simple trioxide glasses originally used. In particular, ion exchange
resins with high selectivity were developed. When these resins were embedded
in structural matrices, their selectivity was further increased and their utility for
potentiometric measurement was enhanced. Ion selective electrodes like the pH
electrode are now commonly found in every clinical chemistry laboratory.
Regardless of the specific type of sensor used, all the ISE devices operate in the
same way as do the pH and blood gas electrodes developed in the 1950s by the
laboratories of MacInnes and Dole,2 and Severinghaus and Bradley.3
199
Origin of the Potential Measurement
To help understand the ion exchange phenomena that occur at the membrane
of the ion selective electrode, consider first the ion exchange taking place at
the surface of a simple permeable membrane, such as a dialysis membrane, in a
concentration cell between 2 salt solutions, A and B (Figure 7-1). Because solution B
has a smaller concentration of the ions in both solutions, a concentration gradient
is set up at the membrane. The concentration gradient creates a driving force to
send ions in solution from the cell where they are most concentrated across the
membrane to the cell where they are less concentrated. This force decreases, as
the concentration becomes more equal on both sides of the membrane. This
equilibration process results in equal salt concentrations on both sides of the
membrane and equal rates of migration both ways across the membrane.
Figure 7-1 Ionic diffusion.
At equilibrium, the ratio of the ion concentrations in the two solutions

Is :
Where subscripts o and i denote ions on either side of the membrane. In Figure
7-2, the dialysis membrane is replaced with an ion-selective membrane that can
differentiate among ions. For purposes of discussion, a K+ selective membrane is
used. This means the membrane can differentiate potassium ions from all other
ions in solution. As the ions in solutions A and B move about, the K+ ions enter into
the ion-selective sites on the membrane surface and leave behind the negatively
charged Cl- ions.
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Figure 7-2 Establishment of membrane potential.
The chloride ions line up adjacent to the membrane and set up a potential that
prevents further movement across the membrane surface. At equilibrium, a
potential difference, or membrane potential, is established on the membrane
surface and the area adjacent to the membrane can be compared to a miniature
battery with the voltage equal to the potential difference of the membrane. The
membrane potential is dependent on the activities of the potassium ions on either
side of the membrane and was described by Nernst :
Where Em is the membrane potential, a is the activity of the potassium ions, R is the
universal gas constant, T is the temperature in degrees Kelvin, F is Faraday’s constant
and n is the charge of the measured ion:
+1 for sodium, potassium, and ammonium, -1 for chloride.
When the glass tubing in Figure 7-2 is filled with a salt solution of constant
composition, called the internal filling solution, (IFS) the electric potential of the
membrane depends only on the solution outside the membrane as follows :
Where Eo is a constant that includes a term for a0, the activity of the ion in the IFS.
We can convert from the natural log (ln) in Equation 3 to a base 10 log and device an
equivalent equation:
201
In order to measure the potential on the ion selective membrane; a complete
electrical circuit is needed. A typical ion selective electrode measuring circuit is
shown in Figure 7-3. There are 2 electrodes here: a reference electrode and the
ion selective electrode. The potential of the reference electrode is maintained
constant; that of the ISE varies, depending on the activity of the ion if interest in the
test solution. A voltmeter is used to measure the potential difference between the
ion selective electrode and the reference electrode.
The potential difference of the entire electrode measuring circuit, Ecell, is equal to
the algebraic sum of the potenial from the ion selective electrode, Em, the reference
electrode, Er, and the junction potential, Ej.
Figure 7-3 Electrode measuring circuit.
The junction potential is the potential developed at the liquid/liquid

junction between the reference electrode and the test solution. Using high
concentrations of salts that are equitransferent minimizes the magnitude of
the liquid junction potential (that is, have similar ionic mobilities in solution).
By setting and substituting Equation 4 for Em,
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Equation 5 can be rewritten :
S is called the electrode slope. Under ideal conditions at 37OC, it is theoretically

equal to 30.8 mV per decade change in activity for a divalent ion, and 61.5mV for a
univalent ion. It is the slope of the line obtained by graphing potential, E, vs. the log
of the concentration (or activity). Such a line is described by the Nernst equation.
Where B is the activity of Standard B and A is the activity of Standard A.
When the unknown activity of the ion of interest is measured in a test solution, the
potential of the test solution, Ex is compared with that of a known. Most of the terms
cancel out as follows :
Thus, the difference in potential between the 2 solutions, E, is dependent only on

the ratio of the activity of the ion of interest in the test solution, ax, and the activity
of the ion of interest in the standard solution, a std.
203
Calculation of Na, K, Cl, and Li
Concentration
The activity of an ion is a measure of its “effective” concentration in solution. It
is equal to the product of C, its concentration in solution, and f, its ionic activity
coefficient. a=(f)(C). The activity coefficient relates concentration to activity, and
is a function of ionic strength. Thus, Equation 10 can be rewritten in terms of
concentration as follows :
The ionic strength of whole blood, plasma and serum tends to remain relatively
constant over the physiological range. 4 As a result, the activity coefficient of
sodium and potassium can be assumed to be constant. The internal standards are
formulated to reflect the same ionic strength as that of serum. Therefore, a given
ion’s activity coefficient can be assumed to be equal in the standard and sample.
Equation 11 can be rewritten to terms of concentration only as follows :
Where,
Thus, when Ecell, the potential of the test solution, is measured against that of a
standard solution in which the concentration of the ion of interest is known, the
potential difference between the 2 solutions is dependent only on the difference
between the concentrations of the ion of interest in the test and standard solutions :
Letting
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By holding CStd in Equation 16 constant, E is dependent on only one variable, Cx, the
concentration of the ion of interest in the sample. Equation 16 can be rearranged to
isolate this variable :
The microcomputer uses Equation 17 to calculate the concentration of sodium,

potassium, and chloride ions in the sample.
205
Electrode Calibration
There are 2 major methods of electrode calibration: a 2-point calibration, and a
1-point calibration. A 2-point calibration, also called a full calibration, is used to
establish the electrode slopes for each sensor, and to verify electrode performance.
A 1-point calibration is used to monitor and correct the instrument for electrode
drift.
The Biolyte 2000 is programmed to initiate calibration cycles at regular intervals.

This is called auto-calibration. Calibration can also be initiated manually, by pressing
Calibrate key at any time.
Two-Point Calibration
During a 2-point calibration, solutions of known ion concentrations are flushed
through the flow path. Each electrode of the sensor block measures the chemical
activity, in millivolt, of a particular ion in the solutions in order to obtain an electrode
slope. When samples with unknown ion concentrations are aspirated into the flow
path, each electrode takes a millivolt reading of chemical activity. To obtain the ion
concentration of the solution, these readings are compared to the electrode slopes
established during calibration.
Two-Point Calibration Sequence

The 2-point calibration sequence includes the following steps :
1. The pump aspirates Standard B through the sensor block.
2. The electrodes take Standard B millivolt readings for Na, K, Cl, or Li.
3. The pump aspirates Standard A and air through the sensor block to wash out
the Standard B.
4. The pump aspirates Standard A through the sensor block.
5. The electrodes take Standard A millivolt readings for Na, K, Cl, or Li.
6. The microprocessor calculates the slopes for Na, K, Cl, or Li using the millivolt
readings taken in step 2 and 5.
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• One-point Calibration
Electrode drift is a gradual change in electrode potential that can adversely affect
electrode performance. The Biolyte 2000 performs a 1-point calibration during
every analysis to determine if the drift for any electrode falls outside its acceptable
range. Detection of excessive drift generates the appropriate error codes,
depending on the analysis mode.
The 1-point calibration sequence has the following steps :

1. Standard A is pumped through the sensor block during analysis. The
electrode takes Standard A millivolt readings for Na, K, Cl, or Li.
2. For a stat analysis, the drift for each electrode is determined by
comparing the Standard A readings taken in step 1 to the standard A
reading taken during the last 2-point calibration.
207
Direct vs. Indirect Methodologies
This section compares direct and indirect methodologies for the measurement
of analytes and explains how the Biolyte 2000 electrode offset values were
determined.
Plasma Volume Displacement Error

Insoluble lipids and plasma proteins cause the small differences in sodium,
potassium, chloride, and lithium results obtained by direct potentiometer and
indirect methods in normal samples. With an indirect method, these insoluble
materials occupy space in the sample and introduce error in the dilution factor
used in calculating the results. The dilution factor assumes 100% of the sample
is diluted (as the aqueous standard is), when in fact, normal samples have a 6-7%
portion of the plasma that is insoluble and does not participate in the dilution.
This well known plasma volume displacement error causes flame photometers,
dilution ISE instruments, chloride titration, and other diluting methods to produce
results approximately 6-7% lower than the theoretically expected values on
normal samples. As the lipid or protein or both content increases, as with certain
pathological states, the error increases and can produce significantly low electrolyte
results, (e.g., pseudohyponatremia). The Biolyte 2000 is unaffected by this problem
because it measures sodium, potassium, chloride, and lithium (where applicable) in
serum and plasma directly, with no dilution.
Bicarbonate
Sodium and potassium ions tend to bind to bicarbonate ions in solution to a small
but measurable degree. Because the Biolyte 2000 does not sense bound ions, this
bicarbonate binding introduces a normal sample. Citrate and acetate binding also
occur but normally with very little effect.
Protein Binding
Proteins are large molecules whose quaternary structures are associated with
varying charge densities. This property causes proteins to be zwitterions; that is,
they can exhibit anionic and cationic behavior as a function of pH. At physiological
pH, albumin and the globulin exhibit anionic behavior and therefore tend to bind
sodium and potassium ions to a small but measurable degree. This protein binding
introduces of sodium and potassium on normal samples. Other serum protein
molecules exhibit cationic behavior at physiological pH and tend to bind chloride
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V2 Reference Manual
and bicarbonate. This tendency lowers direct ISE measurements of chloride and
bicarbonate by approximately 1.5% on normal samples.
Combined Effects
Serum electrolyte results from flame photometers and diluting instruments exhibit
a negative bias of 6-7% on normal samples, due to plasma volume error. Biolyte
2000 directs potentiometric instruments exhibit a negative bias of 3-4% due to ion
binding. For this reason, Biolyte 2000 electrolyte results tend to run 2-2% higher
than flame photometry or dilution ISE results for sodium and potassium.
Table 7-1. Typical Difference in Direct vs. Indirect Electrolyte Values.
DIRECT ISE VALUE COMPARED TO :
Individual Effect Flame Photometer Chloridometer
Plasma Volume
+6% +6%
(Na+, K+, Cl-)
Protein Binding -1.5% —
Bicarbonate Binding -2.5 +6%
Combined Effect +2% +4.5%
Halogen Effects on Chloride Determination

Therapeutic levels of bromide and iodide in serum can cause significant error in
chloride levels determined by colorimeter and conventional chloride electrodes.
Both methods tend to recognize these other halogens as chloride. The conventional
solid state Ag/AgCl electrode is especially prone to this, with a theoretical value of
105 to 1 for iodide and 300 to 1 for bromide (that is, it “reads” 1 mole of bromide as
300 moles of chloride). In contrast, the Biolyte 2000 chloride Electrodes’ theoretical
values for bromide and iodide are 1.8 to 1 and approximately 4 to 1, respectively.
209
1. Eisenmann, G., ed. Glass Electrodes for Hydrogen and Other Cations: Principles
and Practice. New York: Marcel Dekker, Inc. 1967.
2. D.A. MacInnes and M.Dole. The Behavior of Glass Electrodes of Different
Compositions. J Am Chem Soc Vol51. 1930:pp.29-36.
3. J.W. Severinghaus and A.F. Bradley. Electrodes for Blood pO2 and pCO2
Determination. J Appl Physiol Vol12. 1958:pp.515-520.
4. MS. Mohan and R.G. Bates Blood pH, Gases and Electrolytes. NBS Special
Publication 450,U.S Government Printing Office. 1977:p.293.
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8. Appendix
Appendix I : Warranty of Products 212
Appendix II : Specifications of Biolyte 2000 215
Appendix III : Performance of Biolyte 2000 219
Appendix IV : Warning Messages 220
Appendix V : Labels on the Biolyte 2000 221
Appendix VI : Description of IEC Letter Symbols 221
Appendix VII : Location of Serial Ports 222
Appendix VIII : Error Codes 222
Appendix IX : Spare Parts List of Biolyte 2000 227
Appendix X : Consumable List of Biolyte 2000 228
211
Appendix I : Warranty of Products
The Products manufactured by BioCare Corporation (hereinafter called "BioCare")
are warranted against defects in materials and workmanship prior their expiration
date. The Instrument of Products is covered by a Warranty Period of 12 months
warranty from the date of delivery. BioCare's liability under this warranty is
limited, at the option of BioCare, for repair or replacement of the product. Item
expendable through normal use is not covered by this warranty. All warranty repair
or replacement of parts shall be limited to instrument malfunction, which, in the
sole opinion of BioCare, is due or traceable to defects in the original materials or
workmanship. All obligations of BioCare under this warranty shall cease in the event
of abuse, accident, alteration, misuse, or neglect of the Products. In warranty repair
or replacement, all parts are warranted for only the remaining unexpired portion
of the original Warranty Period, applicable to the repaired or replaced parts. After
expiration of the applicable Warranty Period, the customer will be charged at the
current prices for parts, labor and transportation.
Reasonable care must be used to avoid hazards to the Products. BioCare expressly
disclaims responsibility for loss or damage caused by the use of its ways other than
in accordance with proper operating procedures.
EXCEPT AS STATED HEREIN, BioCare, MAKES NO WARRANTY, EXPRESSED OR

IMPLIED OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE OR
OTHERWISE. Statements made by any person, including representatives of BioCare,
which are inconsistent or in conflict with the terms of this warranty shall not be
binding upon BioCare unless specified in writing and approved by BioCare.
All claims under this warranty must be made promptly after the occurrence of
circumstances giving rise thereto, and must be received by BioCare or its authorized
representative within fifteen (15) days after the instrument malfunction. Such
claims should include the Products serial number, the date of purchase, and a full
description of the circumstances giving rise to the claim. Before any Products are
returned for repair and/or adjustment, written authorization from BioCare or its
authorized representative for the return and instruction as to how and where these
Products should be returned, must be obtained. Any Products returned to BioCare
for examination shall be sent freight prepaid via the means of transportation
indicated as acceptable to BioCare.
BioCare reserves the right to reject any warranty claim not promptly reported and
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V2 Reference Manual
any warranty claim on any item that has been altered or has been returned by non-
acceptable means of transportation. When any product is returned for examination
and/or inspection, or for any other reason, the customer shall be responsible for
all damage resulting from improper packing or handling, and for loss in transit,
notwithstanding any defector nonconformity in the product. In all cases, BioCare
has the sole responsibility for determining the cause and nature of the failure;
BioCare's determination with regard thereto shall be final.
If it has been found that the Products has been returned without cause and is still
serviceable, the customer will be notified and the Products returned at its expense;
in addition, a charge for testing and examination may be made to the Products so
returned.
Neither BioCare nor anyone else involved in the development, production, or

delivery of Products shall be liable for any indirect, incidental special, consequential,
exemplary, or punitive damages, including lost profits, arising from the use of or
inability to use the Products, even if advised of the possibility of such damages.
BioCare reserves the right to change, alter, modify or improve any of its Products
without any obligation to make corresponding changes to any Products previously
sold or shipped.
WHEN ENCOUNTERING ANY QUESTION ARISING FROM DIFFERENT LANGUAGE

VERSIONS, THE ENGLISH VERSION WILL BE THE PRINCIPAL REFERENCE.
ALL THE DATA REPORTED FROM BIOLYTE ARE FOR CLINICAL REFERENCE, IF
ABNORMAL CLINICAL DATA OCCUR, THE USERS ARE SUGGESTED TO TAKE
FURTHER STUDIES AND EVALUATION OF THESE DATA TO ENSURE CLINICAL
SAFETY.
Assistance from this warranty is available through BioCare Corporation’s Customer

Service Center during normal business hours, Monday through Friday.
Customer Service Center

BioCare Corporation
Tel: +886-3-2616678 | Fax: +886-3-2616679
E-mail : Service@biocare.com.tw
213
PLEASE FILL OUT YOUR REGISTRATION CARD (MANUFACTURER COPY),
CERTIFIED BY AUHORIZED SIGNATURE, THEN SENT IT BACK TO BioCare.
YOUR WARRANTY WITH BioCare CORPORATION FOR THE PRODUCTS WILL BE
ACTIVATED IMMEDIATELY AFTER THIS REGISTRATION.
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Appendix II :
Specifications of Biolyte 2000
1. Measured Parameters :
☉ Sodium, Potassium, Chloride or Lithium.
2. Sample Type :
☉ Primary : Serum, Plasma, Whole Blood (Vacutainer, Syringe)
☉ Secondary : Urine (Manual Pre-dilution Required)
3. Sample Volume :
☉ 150 μL blood for measurement of sodium, potassium, and chloride or
lithium.
☉ 150 μL urine for measurement of sodium, potassium, and chloride.
4. Carryover :
☉ Less than 1% sample to sample
5. Analysis Time / Throughput
☉ 49 seconds / 73 samples per hour (maximum)
6. Calibration :
☉ Automatic 2-point calibration : User selectable intervals of 1-4 hours,
☉ 1-point calibration with each sample,
☉ Idle only in STANDBY MODE (i.e. no calibration)
7. Operation Modes :
☉ STANDARD MODE : Daily Use Operation (automatic calibration at user
selectable intervals, always ready).
☉ STANDBY MODE : Nights / Weekends Operation (idle only, flush on
startup).
8. LCD Screen :
☉ Character Format : 40 chars. x 4 lines
☉ Character Font 5 x 8 Dot + Cursor
☉ Character Color : Yellow Green
☉ Viewing Area : 148.0 mm x 30.3 mm
o
☉ Viewing Angle 30 C 150 o
☉ ype : Tranreflective with LED Back Light
9. Build-in Thermal Printer :
☉ Character Format : 32 characters per lines (32 Max)
☉ Character Font : 12 x 24 Dot
☉ Printing Width : 58 mm
☉ Printing Speed : 80 mm/s
215
10. User Interface :
☉ Data Transmission Port (RS232) Serial Interface : using ASTM protocol for
connection capabilities to personal computer
☉ Barcode Reader Port (PS/2 Port)
11. On-Board QC Software Package :
☉ QC data storage and reporting.
12. On-Board Patient Data Storage :
☉ Last 450 patient samples.
13. Data Power Protection :
☉ Time, date, last 2-point calibration parameters, last patient ID, setup
parameters and QC data are stored in nonvolatile memory chips. These
data are unaffected by power outages.
14. Power Requirement :
☉ 100-240 V~50-60 Hz 0.6A
15. Main supply voltage fluctuations not exceeding +/- 10% of the nominal voltage.
16. Equipment Pollution Degree :
☉ Pollution Degree 2
17. Equipment Installation Category :
☉ Installation Category II
18. Operation Condition :
o
☉ Relative humidity of 95% for temperatures up to 15~40 C at atmospheric
pressure 10.2~15.4 Psi.
19. Storage Condition :
o
☉ Relative humidity of 0-95% for temperatures up to -10~60 C at
atmospheric pressure 7.3~15.4 Psi.
20. Shipping :
☉ up to 2000m
21. Physical & Environmental :
☉ Height : 410 mm (16.1 inches)
☉ Width : 270 mm (10.6 inches)
☉ Depth : 245 mm (9.6 inches)
☉ Weight : 11 kg (24 lb)
☉ No hazardous waste, all disposable are land fill acceptable.
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V2 Reference Manual
22. Power Supply Cords :
Countries Length (cm) Cord Color Wire Color Plug Power Rating Connector Power Rating Cable Type
Black
USA, etc 183 Black White WS-001;10A/125V WS-002;10A/125V STV 18AWG
Green
Brown H05VV-F 3G
UK, etc 183 Black Blue WS-012A;13A/250V WS-002;10A/250V 0.75MM
Green/Yellow SQ N.M
Blue H05VV-F 3G
French, etc 183 Black Brown WS-010;16A/250V WS-002;10A/250V 0.75MM
Green/Yellow SQ
Blue
Australia, 183 Pearl White Brown WS-015;10A/250V WS-002;10A/250V LTSA 3G
etc Green/Yellow 0.75MMSQ
Blue H05VV-F 3G
Italy, etc 183 Black Brown WS-013;10A/250V WS-002;10A/250V 0.75MM
Green/Yellow SQ
Blue H05VV-F 3G
Swiss, etc 183 Black Brown WS-014;10A/250V WS-002;10A/250V 0.75MM
Green/Yellow SQ
Blue H05VV-F 3G
South 183 Black Brown WS-016;10A/250V WS-002;10A/250V 0.75MM
Africa, etc Green/Yellow SQ
Blue H03VV-F 3G
Israel, etc 183 Black Brown WS-020;10A/250V WS-002;10A/250V 0.75MM
Green/Yellow SQ
23. Fuse :
☉ Time-Delay
☉ Low Breaking Capacity
☉ Physical Size: 0.197” x 0.788” (5mm x 20mm)
☉ Construction: glass tube, end caps: nickel plated brass
☉ Voltage Rating: 250V AC or less
☉Interrupting Rating: 35A at 250V (500mA – 3.15A), 10x In at 250V (4A – 6.3A)
☉ Current Rating Available: 2A
24. Regulatory Approvals :
☉ CE Mark ( EN/IEC61010-1, EN/IEC 61010-2-101 for safety & EN 61326-1, EN
61326-2 for EMC)
☉ FDA
217
25. Consumables and Accessories :
□ Na+ ISE 1 pc per pack (CRT type)

□ K+ ISE 1 pc per pack (CRT type)
□ Cl- ISE 2 pcs per pack (CRT type)
□ Li+ ISE 2 pcs per pack (CRT type)
□ Ref. Electrode 1 pc per pack (CRT type)
□ Air Detector 1 pc per pack
□ Reagent Pack 1 set per box, Standard A 400 ml, Standard B 150 ml,
Reference Solution 200 ml, Waste Bottle 1000 ml, RMS
□ Septum 1 pc per pack
□ Chem Set Levels Na/K/Cl/Li, 5-Level Controls (50 ml/Bottle)
□ Na Conditioning Solution 100 ml/Bottle
□ Cleaning Solution 50 ml/Bottle
□ Urine Diluent 250 ml/Bottle
□ Printer Paper 2 rolls per pack, 11 x 3000 cm per roll
□ Reference Manual 1 pc per pack
26.Warranty:
☉ The Products manufactured by BioCare Corporation are warranted
against defects in materials and workmanship.
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V2 Reference Manual
Appendix III :
Performance of Biolyte 2000
1. Recommend operating range and general imprecision for Serum, Plasma, Whole
Blood
Range [mmol/L] Range [mmol/L] C.V.s Within Run,n=20 C.V.s Day-To-Day,n=20 Resolution [mmol/L]
60-200 60-200 1.0% or 1.0 mmol/L 2.0% or 1.0 mmol/L 0.1
1.0-10.0 1.0-10.0 1.5% or 0.15 mmol/L 3.0% or 0.15 mmol/L 0.01
60-200 60-200 1.5% or 2.0 mmol/L 2.0% or 2.0 mmol/L 0.1
0.1-5.0 0.1-5.0 3.0% or 0.03 mmol/L 5.0% or 0.05 mmol/L 0.01
2. Recommend operating range and general imprecision for Urine

Analyte Range [mmol/L] C.V.s Within Run, n=20 C.V.s Day-To-Day, n=20 Resolution [mmol/L]
Sodium 40-400 3.0% or 1.0 mmol/L 4.0% or 1.5 mmol/L 0.1
Potassium 3-300 3.0% or 0.5 mmol/L 4.0% or 0.5 mmol/L 0.1
Chloride 40-400 4.0% or 2.0 mmol/L 5.0% or 2.5 mmol/L 0.1
Lithium ----- -------- -------- -----
219
Appendix IV: Warning Messages
1. The Biolyte 2000 is for indoor use only.
2. Do not use the Biolyte 2000 in a manner not specified by BioCare Corporation.
3. Do not use the Biolyte 2000 with flammable substances.
4. The Biolyte 2000 should not be mounted on a surface of flammable material.
5. Take any possible hazards of explosion, implosion or release of toxic or flammable

gases arising from the materials being heated away from the Biolyte 2000.
6. Use only a fuse and a power supply cord with the same type and rating as
specified in the Appendix II.
7. User has the responsibility for carrying out appropriate decontamination (eg.
scrubbing with 75% alcohol) if hazardous material is spilt on or inside the Biolyte
2000. To prevent shock hazard, disconnect power supply before cleaning of the
unit.
8. Before using any cleaning or decontamination method except those
recommended by BioCare Corporation, users should check with BioCare
Corporation that the proposed method will not damage the Biolyte 2000.
9. Do not use the service program, which is for service engineers only.
10. When the Biolyte 2000 alarms or there is any error message shown, stop
operating and check.
11. The electromagnetic environment should be evaluated prior to operation of the
device.
12. Use of this instrument in a dry environment and don’t use this instrument
in close proximity to sources of strong electromagnetic radiation, as these may
interfere with the proper operation.
13. User’s should ensure that a compatible electromagnetic environment for the
equipment can be maintained in order that the device will perform as intended.
14. This equipment complies with the emission and immunity requirements
described in this part of the EN 61326 series.
220
V2 Reference Manual
Appendix V :
Labels on the Biolyte 2000
Label Classification Label Name
Fuse Specification Label
Peristaltic Pump Warning Label
Grounding Label
Biological Risks Label
In vitro Diagnostic Medical Device Label
Use By Label
Batch Code Label
Manufacturer Label
Authorized Representative in
the European Community Label
Warning Label
Appendix VI :
Description of IEC Letter Symbols
Symbol Description Symbol Description
V Voltage | Power On
~ Alternating Current O Power Off
A Current
Protective Conductor Attention, Consult

Terminal Accompanying Documents
221
Appendix VII : Location of Serial Ports
Appendix VIII: Error Codes

1. Interpreting Error Codes :
* Error code: 4 characters
* Character means :
X X XX
Class Location Particular
0- Na+ Channel
0- Calibrate error 1- K+ Channel Two digits between 01 and 19
2- Cl- Channel
3- Li+ Channel
4- Others
0- Na+ Channel
1- Analyze error 1- K+ Channel Two digits between 01 and 19
2- Cl- Channel
3- Li+ Channel
4- Others
2- System error 1- Operation Two digits between 01 and 19
2- Device
3- Software
4- QC & Communication
5- Others
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V2 Reference Manual
2. Error Codes Table :
Code Message Description

0001 Na+ Instability STD-A The range of electrode signal is out of its limits.
0002 Na+ Instability STD-B See 0001
0003 Na+ Overload STD-A The signal of electrode is out of its limits.
0004 Na+ Overload STD-B See 0003
0005 Na+ Slope Too Low The calibration slope of an electrode is blew
the acceptable operational range.
0006 Na+ Slope Too High The calibration slope of an electrode is above
the acceptable operational range.
0101 K+ Instability STD-A See 0001
0102 K+ Instability STD-B See 0001
0103 K+ Overload STD-A See 0003
0104 K+ Overload STD-B See 0003
0105 K+ Slope Too Low See 0005
0106 K+ Slope Too High See 0006
0201 Cl- Instability STD-A See 0001
0202 Cl- Instability STD-B See 0001
0203 Cl- Overload STD-A See 0003
0204 Cl- Overload STD-B See 0003
0205 Cl- Slope Too Low See 0005
0206 Cl- Slope Too High See 0006
0305 Li+ Slope Too Low See 0005
0306 Li+ Slope Too High See 0006
0307 Li+ Slope Can't Calculate The calibration slope of an electrode cannot be established
due to the improper calibration of other electrodes.
0400 Air Detector Uncalibrated The air detector can’t distinguish air from fluid by their signals.
0401 No STD-A The air detector does not see Standard A at the appropriate time.
0402 No STD-B The air detector does not see Standard B at the appropriate time.
0403 No Sample The air detector does not see Sample at the appropriate time.
0404 Flow Time Too Short The time required for Standard A to travel from the probe
tip to the air detector is less than the allotted time.
0405 Flow Time Too Long The time required for Standard A to travel from the probe
tip to the air detector is greater than the allotted time.
0406 ADC Not Ready The AD converter error
223
1001 Na+ Instability STD-A See 0001
1002 Na+ Instability STD-B See 0001
1003 Na+ Overload STD-A See 0003
1004 Na+ Overload STD-B See 0003
1005 Na+ Conc. Too Low The concentration of a sample is below
the acceptable linearity range.
1006 Na+ Conc. Too High The concentration of sample is above the acceptable linearity range.
The standard A millivolt drifts between the last
1007 Na+ E-0 Drift 2-point calibration and the 1-point analysis calibration
exceeds the acceptable operational limits.
See 0001
1008 Na+ Instability Sample See 0003
1009 Na+ Overload Sample See 0001
1101 K+ Instability STD-A See 0001
1102 K+ Instability STD-B See 0003
1103 K+ Overload STD-A See 0003
1104 K+ Overload STD-B See 1005
1105 K+ Conc. Too Low See 1006
1106 K+ Conc. Too High See 1007
1107 K+ E-0 Drift See 0001
1108 K+ Instability Sample See 0003
1109 K+ Overload Sample See 0001
1201 Cl- Instability STD-A See 0001
1202 Cl- Instability STD-B See 0003
1203 Cl- Overload STD-A See 0003
1204 Cl- Overload STD-B See 1005
1205 Cl- Conc. Too Low See 1006
1206 Cl- Conc. Too High See 1007
1207 Cl- E-0 Drift See 0001
1208 Cl- Instability Sample See 0003
1209 Cl- Overload Sample See 1005
1305 Li+ Conc. Too Low See 1006
1306 Li+ Conc. Too High See 1007
1307 Li+ E-0 Drift The reading of the electrode cannot be interpolated to a
1310 Li+ Cannot Calculate meaningful value due to the improper reading of other electrodes.
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V2 Reference Manual
1400 Can’t Tell Air from Fluid See 0400
1401 No STD-A See 0401
1402 No STD-B See 0402
1403 No Sample See 0403
1404 Short Sample The air detector detected an insufficient amount of sample.
1405 Flow Time Too Long The time required for sample to travel from the probe tip
to the air detector is greater than the allotted time.
1406 ADC Not Ready See 0406
1410 Unreachable Pump Speed The peristaltic pump is not calibrating within
an acceptable range of speed.
2000 Illegal Probe Position The probe position value is out of its range.
2001 Illegal Probe Speed The probe speed value is not an acceptable value.
2002 Illegal Pump Speed The pump speed value is not an acceptable value.
2005 Illegal Error Code The error code is not acceptable.
2006 Can't Tell Air from Fluid See 0400
2007 No STD-A See 0401
2008 No STD-B See 0402
2009 No Sample See 0403
2010 LCD Over Flow The display on the LCD screen is over flow.
2102 Printer Out of Paper The printer has run out of paper.
2103 Printer Error Printer error exclude 2101 &2102
2104 Printer Off-Line Printer is on off line status new.
2105 - -
2106 ADC Error See 0406
2108 - -
2204 Value Over Flow Print data out of format
2205 RMS I/O Error Cannot initialize the communication and handshake with RMS.
2206 RMS Write Error Unable to write data into RMS.
2207 - -
2208 - -
2209 - -
2210 RMS Analyzer Type Error The reagent pack is used in the wrong type of the analyzer.
2211 RMS Pack Type Error The analyzer with the current settings does
not use this kind of reagent pack.
225
2212 Pack Lot Expired The reagent pack has passed it shelf life.
2213 Pack Uselife Expired The reagent pack has reached its open useful lifespan.
2214 Standard A Empty Standard A is used up.
2215 Standard B Empty Standard B is used up.
2216 Reference Empty Reference solution is used up.
2300 Westgard Rule 1-2s A Westgard Rule has been violated on a QC standard.
2301 Westgard Rule 1-3s See 2300
2304 Westgard Rule 1x See 2300
2305 QC Control Outside The concentration of control sample is out of acceptable limit.
Assay Range
2306 Transmit to PC Timed-out No response from the PC.
2307 Too Many NAKs from PC The checksum calculated by the PC does not
match the checksum sent by the analyzer.
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V2 Reference Manual
Appendix IX :
Spare Parts List of Biolyte 2000
Part. No. Description
1010159 Main PCB
1010162 Keypad PCB
1010167 Peripheral PCB
1010161 Driver PCB
1040549 AMP Module
1040008 Electrode Carrier
2160015 Pinch Valve (Waste Valve or Reference Valve)
3010189 Keypad
3020070 Adhesive Backed Rubber Foot
2080191 Keypad Flat Cable
2080053 LCD Flat Cable
1990030 LCD Module (English & European)
2080079 Power Cord (Australia)
2080078 Power Cord (French)
2080083 Power Cord (Israel)
2080080 Power Cord (Italy)
2080082 Power Cord (South Africa)
2080081 Power Cord (Swiss)
2080077 Power Cord (UK)
2040011 Power Supply
2040038 Fuse
2080195 Printer Cable
1040508 Probe
3010192 Probe Screw
1040552 Pump M type
1040546 Sampler Module
1990001 Sampler Position Sensor
2990079 Thermal Printer Module
9010157 Biolyte 2000 V2 Reference Manual
227
Appendix X :
Consumable List of Biolyte 2000
Part. No. Description
1030033 Biolyte Na Electrode
1030031 Biolyte K Electrode
1030030 Biolyte Cl Electrode
1030032 Biolyte Li Electrode
1030034 Biolyte Ref Electrode
1030035 Biolyte Assay Electrode Spacer
1040010 Air Detector
1030108 Reagent Pack with septum
1030019 Conditioning Na Solution
1030012 Cleaning Solution
1030013 Chem Set A Level 1
3010193 Sample Cup
1040530 Septum
3030040 Septum Mainfold
5020097 Thermal Printer Paper
1030072 Urine Diluent
1990040 W-LINE
1040509 Tubing Set
228
V2 Reference Manual
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V2 Reference Manual

5. Quality Control (QC) 99

Chapters and Contents

Chapter 4, Maintenance, explains how to perform the instrument maintenance procedures.

Note: Reference to lithium is only applicable to analyzers with this electrode.

Figure 1-1. Biolyte 2000.

• Unpacking the Biolyte 2000 and accessory boxes.

• Unpacking the Biolyte 2000 and Accessory Boxes

Figure 1-2. Power Input Module and Fuse Socket.

Table 1-1. Fuse for Various Line Voltages.

100-240 0.6 2.0A SB (T2.0A/250V)

Figure 1-3. “Open” Position.

11. Insert each electrode into the electrode carrier as follows:

Figure 1-4. Electrode Carrier with Installed Electrodes.

• Installing the Probe

Figure 1-5. Probe.

Figure 1-6. Install the Septum.

Figure 1-7. Install tubing.

• Powering on the Instrument

• Preparing the Printer

• Conditioning Electrodes and Flow Path

• Performing Instrument Calibration

Analysis Mode Analytes Sample Type

“*” Remarks that this part is optional.

Figure 1-8. Main Components.

Note: Instruments may vary according to the options ordered.

Figure 1-9. Pump.

Figure 1-10. Location of Waste Valve and Reference Valve.

Figure 1-11. Electrode Carrier.

Sealing gaskets, which prevent any fluid leakage, connects

Figure 1-12. Keypad.

Table 1-3. The Function Keys.

Analyze Initiates a specimen analysis or restart an interrupted

Calibrate Initiates a 2-point calibration.

Delete characters on an input screen.

Enter A select highlighted number of data, initiates sequences,

Esc Aborts procedures and calls up the previous screen.

Flowpath Begins and ends a flow path maintenance sequence.

Samp. Type Displays the Sample Type Set Screen.

Status Displays the Full Sensor Status Screen and the

Start/Standby Makes the screen of Biolyte into “Standby Mode”. Press

1999/05/04 <<Biolyte>> 11:20:51

Figure 1-13. Main Screen.

PARAMETER SPECIMEN MATRIX

Sodium Serum, plasma, whole blood, or urine

Sample Handling Requirement

DRUG DOSAGE(G/ML) DRUG DOSAGE(G/ML)

Table 1-4. Reference Intervals

Serum Urine (24hr.) Whole Blood CSF

Sodium 136-146 mmol/L 60-220 mmol/day 136-146 mmol/L

Display Range for Analytes

Table 1-5. Display Range by Sample Type.

Analytes Serum, Plasma, CSF Urine

<< SETUP >> Input No.? 1 10:06:12

Figure 2-1. Set Up Screen.

1. The flowchart on the left side of this page is the step-by-step

Note: Only Na+ and K+ can be set to mmol/L or mEq/L.

Table 2-1. Resolution Options for Analytes

Complete the following steps to change the date and time :

4. When the input date or time is invalid, system will display a

<< DATE/TIME SET >> Invalid! 11:08:08

Figure 2-7. Date/Time Set Invalid Screen.