Biolyte Service Manual 4.2A
Biolyte Service Manual 4.2A
Biolyte Service Manual 4.2A
1. Safety ......................................................................................................................... 5
Introduction ............................................................................................................ 6
Biological Safety .................................................................................................... 6
Electrical Safety ..................................................................................................... 7
Mechanical Safety .................................................................................................. 7
Chemical Safety ..................................................................................................... 7
2. System Description .................................................................................................... 9
Introduction .......................................................................................................... 10
Main Controller Module ...................................................................................... 10
CPU PCB ..................................................................................................... 10
I/O PCB ........................................................................................................ 10
ADC PCB..................................................................................................... 11
Base PCB ..................................................................................................... 12
Cable Connections ....................................................................................... 12
Test Points .................................................................................................... 13
RS232 Port ................................................................................................... 13
Driver PCB........................................................................................................... 14
Power Supply ....................................................................................................... 14
Sampler Module ................................................................................................... 14
AMP Module........................................................................................................ 15
AMP PCB .................................................................................................... 15
Electrode Signal Circuit ....................................................................... 16
Air Detector ......................................................................................... 16
A/D Converter ...................................................................................... 16
Waste Valve and Reference Valve ................................................................ 17
Pump Module ....................................................................................................... 17
Printer Module ..................................................................................................... 18
Keypad and Keypad PCB .................................................................................... 18
LCD Module ........................................................................................................ 18
3. Replacement Procedures .......................................................................................... 20
Right and Left Side Panels Replacement ............................................................. 21
LCD Module Replacement .................................................................................. 22
Keypad PCB Replacement ................................................................................... 24
I/O PCB, CPU PCB and ADC PCB Replacement ............................................... 25
Base PCB Replacement ....................................................................................... 27
Driver PCB Replacement ..................................................................................... 29
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Power Supply Replacement ................................................................................. 30
Pump Module Replacement ................................................................................. 31
AMP Module Replacement .................................................................................. 33
Sampler Module Replacement ............................................................................. 35
Printer Module Replacement ............................................................................... 37
4. Troubleshooting ....................................................................................................... 40
First Initiate .......................................................................................................... 41
Instability Error Codes ......................................................................................... 42
Overload Error Codes .......................................................................................... 43
Drift Error Codes ................................................................................................. 44
Slope Error Codes ................................................................................................ 45
Flow Error Codes ................................................................................................. 46
Sampler Error Codes ............................................................................................ 48
Pump Error Codes ................................................................................................ 49
Printer Error Codes .............................................................................................. 50
Math Error Codes ................................................................................................. 51
Software Error Codes ........................................................................................... 52
Analog to Digital Converter Error Codes ............................................................ 53
Westgard Rule Violation Error Codes .................................................................. 54
Out of Range Error Codes.................................................................................... 56
Sodium Results .................................................................................................... 57
Potassium Results ................................................................................................ 58
Chloride Results ................................................................................................... 59
Lithium Results .................................................................................................... 60
Urine Result Problems ......................................................................................... 61
Instrument Correlation ......................................................................................... 62
5. Circuit Diagrams ...................................................................................................... 64
I/O PCB Block Diagram ...................................................................................... 65
CPU PCB Block Diagram .................................................................................... 66
ADC PCB Block Diagram ................................................................................... 67
Base PCB Block Diagram .................................................................................... 68
AMP PCB Block Diagram ................................................................................... 69
Driver PCB Block Diagram ................................................................................. 70
6. Appendix .................................................................................................................. 72
Appendix I: Software Structure ........................................................................... 73
Appendix II: Initial Data Value ............................................................................ 74
Appendix III: Flow Chart of Calibration ............................................................. 76
Appendix IV: Flow Chart of Analysis.................................................................. 77
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Appendix V: Program Download Procedure ....................................................... 78
Appendix VI: Data Transfer Protocol .................................................................. 80
Appendix VII: All Characters of Printer .............................................................. 87
Appendix VIII: LCD Characters .......................................................................... 88
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1. Safety
Contents
Introduction ............................................................................................................ 6
Biological Safety .................................................................................................... 6
Electrical Safety ..................................................................................................... 7
Mechanical Safety .................................................................................................. 7
Chemical Safety ..................................................................................................... 7
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Introduction
The Biolyte 2000 is designed for safety and convenience. For continuing safe
operation, the instrument should be properly maintained by knowledgeable
service personnel who are familiar with the safety warning in this manual.
Biological Safety
The waste bottle included in the reagent pack collects all blood, serum, plasma
and urine samples aspirated through the instrument. Thus, reagent packs
should be disposed of in a manner which will prevent possible spread of
disease by waste.
Gloves should be worn when handling any part of the external flow path that
comes in contact with serum, plasma, whole blood and urine. Hands and other
skin surfaces should be washed immediately and thoroughly if contaminated
with blood or other body fluids.
Hands should also be washed immediately after gloves are removed. Engineers
should take precautions to prevent injuries caused by sharp objects or devices
used during troubleshooting when servicing and cleaning used instruments.
Parts that have come in contact with any type of biological fluids and have been
removed from an instrument should be flushed with bleach and distilled water.
These parts should be sealed in a plastic bag or packaged in the original box and
identified with appropriate labeling.
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Electrical Safety
The instrument line voltage, fuse specifications, and frequency are specified on
the serial number plate on the backside of the instrument near the power cord.
The instrument should only be operated at the specified voltage and frequency.
Line Voltage may be as high as 240 VAC. Caution should be observed when
handling the capacitor banks, power supplies, and the LCD.
To remove the line voltage, unplug the line cord at the wall outlet. Do not
attempt to remove the fuse without disconnecting the line cord.
Mechanical Safety
The sampler mechanism found on the instrument can exert extremely high
pressure. Fingers and other objects should be kept away from the sampler
mechanism whenever the system is performing a task. The sampler
mechanisms are controlled by optical detectors. The analytical processor reads
these switches and prevents computer controlled probe motion, which may cause
injury to the operator or damage to the probe. These sensors should be checked
periodically.
Chemical Safety
The chemicals provided with the instrument itself require no special handling,
beyond that of normal laboratory reagents.
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2. System Description
Contents
Introduction .......................................................................................................... 10
Main Controller Module ...................................................................................... 10
CPU PCB ..................................................................................................... 10
I/O PCB ........................................................................................................ 10
ADC PCB..................................................................................................... 11
Base PCB ..................................................................................................... 12
Cable Connections ....................................................................................... 12
Test Points .................................................................................................... 13
RS232 Port ................................................................................................... 13
Driver PCB........................................................................................................... 14
Power Supply ....................................................................................................... 14
Sampler Module ................................................................................................... 14
AMP Module........................................................................................................ 15
AMP PCB .................................................................................................... 15
Electrode Signal Circuit ....................................................................... 16
Air Detector ......................................................................................... 16
A/D Converter ...................................................................................... 16
Waste Valve and Reference Valve ................................................................ 17
Pump Module ....................................................................................................... 17
Printer Module ..................................................................................................... 18
Keypad and Keypad PCB .................................................................................... 18
LCD Module ........................................................................................................ 18
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Introduction
The main modules of the Biolyte 2000 are as follows:
◎ Main Controller Module
◎ Driver PCB
◎ Power Supply
◎ Sampler Module
◎ AMP Module
◎ Pump Module
◎ Printer Module
◎ Keypad & Keypad PCB
◎ LCD Module
CPU PCB
A 16bit 80186 processor combined with the watch dog timer (W. D. T) function
as the core of the CPU PCB. Through 因為 the execution 執行 of the program
in the Two 128K Byte ROM, the CPU PCB performs various functions,
such as sequence and input/output information.
Two 32K Byte RAM are used to store variables and perform operational
functions. A real time clock provides the time and date for the system.
I/O PCB
The I/O PCB consists of two UARTs (Universal Asynchronous 非同步 Receiver
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Transmitters 發射器) and one programmable input/output circuit.
The other UART is a 25pin D-sub male connector. It can be a barcode reader
interface or a PUM (Program Update Module) interface.
detects the printer status, such as paper out and printer error. It also controls the
printer module to print data.
ADC PCB
The serial-to-parallel circuit receives the output serial signals from the AMP
Module and converts them to 16bit parallel signals, which is then read off by the
CPU PCB. It also provides four A/D channel select signals and various control
signals to the AMP module.
The LCD/keypad control interface regulates 控製 the display of the LCD and
receives the keypad inputs.
The programmable input/output circuit reads off standby signals and outputs
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The Biolyte 2000’s RMS (Reagent Management System) verifies that a correct,
unexpired fluid pack is being used. At the same time, it monitors the fluid
volume in each fluid pack bottle and displays the volume of the least full bottle.
Base PCB
I/O PCB, CPU PCB, and ADC PCB. There are four slots on the
Base PCB: I/O PCB slot, CPU PCB slot, ADC PCB slot, and
a spare slot. The Base PCB also provides the connectors for signals from
Cable Connections
The following cable connections are located on the Base PCB:
Name Connect To
CON2 Printer Module
CON4 Power Supply
CON5 AMP Module
CON6 Driver PCB
Name Connect To
J2 Keypad PCB
Name Connect To
CON1 Sampler Module
CON2 CON6 on the Base PCB
CON3 Sampler Location Detector on the Sampler Arm
CON4 Tilt Location Detector on the Sampler Arm
CON5 Power Supply
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CON6 Pump Module
CON7 Pinch Valve
Name Connect To
J4 LCD Module
J6 J2 on the ADC PCB
Test Points
The following test points are located on the Base PCB:
RS232 Port
The RS232 interface port is a 25pin D-sub female connector, and is located at the
backside of the Biolyte 2000. The RS232 port can be used to connect to PC.
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Start bit: 1 bit
Stop bit: 1 bit
Data bit: 8 bits
Pinouts are as follows:
Driver PCB
The Driver PCB receives the control signals from ADC PCB and then regulates
these signals to control the actions of the pump module and pinch valves. It
drives the sampler module, pump module and pinch valves, and detects the
sampler location and the tilt of the sampler arm.
Power Supply
The input specifications of the Power Supply are as follows:
Input Voltage Range : 85VAC ~ 264VAC
Input Frequency Range : 47HZ ~ 63 HZ
Maximum Input Current : 1A RMS (115VAC) or 0.6A RMS (230VAC)
Sampler Module
The function of the Sampler Module is to vertically move the sampler arm and
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probe to a specific position predetermined by the software. The Sampler
Module consists of a stainless steel sample probe attached to an arm, driven by a
stepping motor. Optical detectors are used to monitor both the home and probe
positions.
The sampler tilts up for Manual Mode and down for Semi-Auto Mode. The
driver PCB monitors two in position tilt sensors to verify correct positioning.
The sampler has one optical position sensor which is interrupted by a flag on the
sample arm. The position is used as an absolute position reference (HOME)
and as a probe down signal. The probe down signal is linked by an interrupt to
the driver PCB. Sampler motion is controlled by a step timer, step counter and a
direction bit. All sampler positions are found by counting the number of steps
from the home position.
AMP Module
The AMP Module measures the analyte voltages and sends the data to the Main
Controller Module. It consists of one AMP PCB and two pinch valves (a Waste
Valve and a Reference Valve).
AMP PCB
The AMP PCB contains the circuits for the following:
◎ Electrode Signal Circuit
◎ Air Detector
◎ A/D Converter
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Electrode Signal Circuit
The voltages from the electrodes are measured with respect to a reference
electrode. The electrode signal is fed from through a differential amplifier and
sent to the analog multiplexer, which then selects the signal to be sent to the A/D
converter.
Air Detector
The Air Detector detects the presence or the absence of fluid in the electrode
train during analytical sequence. It does this by sensing changes in the photo
diode 感光二極體 response between air and fluids, and, serum and whole blood.
The light source is one red LED with one photo diode as the detector.
A/D Converter
The A/D Converter changes the analog input voltages to digital signals. It is a
dual slope integrating converter with a four channel input muliplexer. The
AMP PCB adapts a 16 bits A/D converter.
The valves control the flow of the fluids through the tubing, from the reagent
pack into the electrode carrier. They are normally in the open position when
fluid is being drawn to the electrode carrier. Once the fluid fills the electrode
carrier completely and the slope readings are being taken, the valves will close to
prevent back flow of fluids into the electrode carrier. After the reading are
taken, the Waste Valve opens and the fluid is drawn out through the W-line.
Pump Module
The Pump Module controls the flow of the fluids through the W-line. The
Pump consists of a rotating roller cage mounted directly on the shaft of a
stepping motor. Tubing is stretched around the roller cage to accomplish
aspiration. The Pump can be operated at different speeds and tested via the
software. The specifications of the Pump are as follows:
Input Voltage : 12V
Input Current : 0.8A (maximum)
Control Signal : motor ON/OFF
motor direction
High/Low speed selection
Half/Full step selection
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Printer Module
The Printer PCB directs the printer functions. It receives the signals from the
ADC PCB and drives the printer to print, feed paper, and read off the printer
status.
The Printer is a 32 column thermal printer with graphic and column print
capability. The specifications of the Thermal Printer are as follow:
Paper width : 58mm
Printing Columns : 32
Printing Speed : 46cps
Character Matrix : 8-dot high*6-dot wide
Character Set : 256
Operating Voltage : 4.6~5.5V
Current Consumption : Standby 5.5mA max, Printing 4.0A max.
There are many keys and key control circuits on the Keypad PCB. It connects
with the ADC PCB through the J6 connector and with the LCD Module through
the J4 connector.
LCD Module
The LCD (Liquid Crystal Display) Module is on the front panel of the Biolyte
2000. The electrical specifications of the LCD Module are as follows:
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Input Voltage VI ----- 4.7 5.0 5.3 V
Input High Vol. VIH ----- 2.2 ----- VDD V
Input Low Vol. VH ----- 0 ----- 0.6 V
Output High Vol. VOH ----- 2.4 ----- ----- V
Output Low Vol. VOI ----- ----- ----- 0.4 V
Supply Current IDD VDD =5V 4.0 10.0 mA
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3. Replacement Procedures
Contents
Right and Left Side Panels Replacement ............................................................. 21
LCD Module Replacement .................................................................................. 22
Keypad PCB Replacement ................................................................................... 24
I/O PCB, CPU PCB and ADC PCB Replacement ............................................... 25
Base PCB Replacement ....................................................................................... 27
Driver PCB Replacement ..................................................................................... 29
Power Supply Replacement ................................................................................. 30
Pump Module Replacement ................................................................................. 31
AMP Module Replacement .................................................................................. 33
Sampler Module Replacement ............................................................................. 35
Printer Module Replacement ............................................................................... 37
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Right and Left Side Panels Replacement
Right Side
Left Side
Panel
Panel
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LCD Module Replacement
Back Board
Screws
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LCD Module Installation
1. Orient the LCD module so the low profile header is on the right side.
2. Install the LCD module into the Biolyte 2000.
3. Install the four screws on the LCD module (Figure 3-3).
4. Reconnect the LCD flat cable to the LCD module.
5. Reconnect the Keypad flat cable to the Keypad PCB.
6. Fasten the four screws on the front panel back board (Figure 3-2).
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Keypad PCB Replacement
Keypad
Screw
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I/O PCB, CPU PCB and ADC PCB
Replacement
I/O PCB
CPU PCB
ADC PCB
Figure 3-5. I/O PCB, CPU PCB and ADC PCB Replacement.
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I/O PCB, CPU PCB and ADC PCB Installation
1. To install the I/O PCB,
a. Install the I/O PCB into the Biolyte 2000.
b. Fasten the screw on the left side of the I/O PCB.
c. Reconnect the connector to the J1 of the I/O PCB.
2. To install the CPU PCB,
a. Install the CPU PCB into the Biolyte 2000.
b. Fasten the screw on the left side of the CPU PCB.
3. To install the ADC PCB,
a. Install the ADC PCB into the Biolyte 2000.
b. Fasten the screw on the left side of the ADC PCB.
c. Reconnect the connectors to the J1 and J2 of the ADC PCB.
4. Reinstall the left side panel (Figure 3-1).
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Base PCB Replacement
Base PCB
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4. Reconnect the connectors to the CON1, CON4, CON5, and CON6 of the Base
PCB.
5. Install the I/O PCB, CPU PCB and ADC PCB (Figure 3-5).
6. Install the left side panel (Figure 3-1).
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Driver PCB Replacement
Driver PCB
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Power Supply Replacement
Power Supply
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Pump Module Replacement
Pump
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3. Reconnect the connector to the CON6 of the Driver PCB.
4. Reinstall the right and left side panels (Figure 3-1).
Note: If it is difficult to install the Pump Module, remove the I/O PCB, CPU PCB,
and ADC PCB first. Connect the connector to the CON6 of the Driver
PCB, then reinstall the I/O PCB, CPU PCB, and ADC PCB back to their
slots.
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AMP Module Replacement
Connection
AMP Module
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AMP Module Installation
1. Reconnect the connector to the location indicated in Figure 3-10.
2. Install the AMP module from the Biolyte 2000.
3. Fasten the four screws on the AMP module (Figure 3-10).
4. Install the left side panel (Figure 3-1).
5. Install the electrode carrier and all tubing.
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Sampler Module Replacement
Spring
Sampler Module
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5. Install the right side panel (Figure 3-1).
6. Install the S-line to the probe, and install the septum to the sampler module.
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Printer Module Replacement
Top Cover
Printer Module
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b. Remove the four screws on the thermal printer head.
c. Remove the thermal printer head from the printer module.
11. To remove the printer PCB/printer extended PCB,
a. Disconnect the connector from the CN2 of the printer extended PCB.
b. Disconnect the connector from the CN3 of the printer PCB.
c. Remove the four screws on the backside of the printer PCB (Figure 3-12,
medium).
d. Remove the printer PCB/printer extended PCB from the printer module.
12. To remove the printer control PCB,
a. Remove the four screws on the printer control PCB (Figure 3-12, upper).
b. Disconnect the connector from the J1 of the printer control PCB.
c. Remove the printer control PCB from the printer module.
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Figure 3-12. Printer Module Replacement 2.
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4. Troubleshooting
Contents
First Initiate .......................................................................................................... 41
Instability Error Codes ......................................................................................... 42
Overload Error Codes .......................................................................................... 43
Drift Error Codes ................................................................................................. 44
Slope Error Codes ................................................................................................ 45
Flow Error Codes ................................................................................................. 46
Sampler Error Codes ............................................................................................ 48
Pump Error Codes ................................................................................................ 49
Printer Error Codes .............................................................................................. 50
Math Error Codes ................................................................................................. 51
Software Error Codes ........................................................................................... 52
Analog to Digital Converter Error Codes ............................................................ 53
Westgard Rule Violation Error Codes .................................................................. 54
Out of Range Error Codes.................................................................................... 56
Sodium Results .................................................................................................... 57
Potassium Results ................................................................................................ 58
Chloride Results ................................................................................................... 59
Lithium Results .................................................................................................... 60
Urine Result Problems ......................................................................................... 61
Instrument Correlation ......................................................................................... 62
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First Initiate
Power on. Press the Enter key twice before the screen finishes showing the
System Initial Screen (Figure 4-1). Then, screen will switch to the First Initiate
Warning Screen (Figure 4-2).
System Initial...
Input 1 or 2, then press the Enter key to initiate system or not. If yes, system
will reset all parameters to the default values (see Appendix II).
At the end of the first initiate procedure, system will printout the following:
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Instability Error Codes
0001 Na+ Instability STD-A 0002 Na+ Instability STD-B
0101 K+ Instability STD-A 0102 K+ Instability STD-B
0201 Cl- Instability STD-A 0202 Cl- Instability STD-B
0301 LI+ Instability STD-A 0302 Li+ Instability STD-B
1001 Na+ Instability STD-A 1002 Na+ Instability STD-B
1008 Na+ Instability Sample 1101 K+ Instability STD-A
1102 K+ Instability STD-B 1108 K+ Instability Sample
1201 Cl- Instability STD-A 1202 Cl- Instability STD-B
1208 Cl- Instability Sample 1301 LI+ Instability STD-A
1302 Li+ Instability STD-B 1308 Li+ Instability Sample
Instabilities are detected when the electrode’s response curve fails to reach a
steady state plateau prior to the electrode millivolt reading.
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Overload Error Codes
0003 Na+ Overload STD-A 0004 Na+ Overload STD-B
0103 K+ Overload STD-A 0104 K+ Overload STD-B
0203 Cl- Overload STD-A 0204 Cl- Overload STD-B
0303 LI+ Overload STD-A 0304 Li+ Overload STD-B
1003 Na+ Overload STD-A 1004 Na+ Overload STD-B
1009 Na+ Overload Sample 1103 K+ Overload STD-A
1104 K+ Overload STD-B 1109 K+ Overload Sample
1203 Cl- Overload STD-A 1204 Cl- Overload STD-B
1209 Cl- Overload Sample 1303 LI+ Overload STD-A
1304 Li+ Overload STD-B 1309 Li+ Overload Sample
An electrode overload error occurs when the millivolt readings for a standard of
the sample exceeds the operational limits of the electrode.
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Drift Error Codes
1007 Na+ E-0 Drift 1107 K+ E-0 Drift
1207 Cl- E-0 Drift 1307 Li+ E-0 Drift
An E-Zero Drift error code is generated when the millvolt reading for the one
point calibration has drifted, beyond a preset software limit, from the reading of
the past two point calibration.
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Slope Error Codes
0005 Na+ Slope Too Low 0006 Na+ Slope Too High
0105 K+ Slope Too Low 0106 K+ Slope Too High
0205 Cl- Slope Too Low 0206 Cl- Slope Too High
0305 Li+ Slope Too Low 0306 Li+ Slope Too High
A Slope error is generated when the difference between the electrode millivolts
for the calibration standards during the two point calibration is either above or
below the predefined software limits. Slope values can be obtained from Status
Screen
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Flow Error Codes
0400 Air Detector Uncalibrated 0401 No STD-A
0402 No STD-B 0403 No Sample
0404 Flow Rate Too Short 0405 Flow Rate Too Long
1400 Can’t Tell Air from Fluid 1401 No STD-A
1402 No STD-B 1403 No Sample
1404 Flow Rate Too Short 1405 Flow Rate Too Long
2400 Air Detector Uncalibrated 2401 No STD-A
2402 No STD-B 2403 No Sample
Flow problems can be subtle and generate error codes such as Flow Time Too
Long even though Fluid flow is visible throughout the flowpath. Flow
problems can also be the result of complete blockages in the flowpath that result
in air detector related error codes of No Standard when required error codes.
A “No Standard” error code is generated when the Air Detector detected the
presence of air in the flowpath, at a point in time when a calibration or analysis
standard should be on the flowpath.
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8. Replace the septum assembly.
9. Verify that the reagent pack is installed correctly.
10. Verify that the tubing harness has been installed correctly, if it has just been
replaced.
11. Verify that all dummy tubing segments if necessary.
12. Replace the pump tubing segment if necessary.
13. Replace the S-line.
14. Replace the probe.
15. Replace the Air Detector.
16. Replace the reagent pack.
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Sampler Error Codes
0407 Sampler Error 0409 Probe Position Error
1407 Sampler Error 1409 Probe Position Error
2000 Illegal Probe Position 2001 Illegal Probe Speed
2100 Sampler Error
Sampler errors may be the result of a sampler of optical position sensor failure.
Sampler errors may also be due to system voltage problems therefore, all
voltages and cable connections should be tested/reseated. Sampler Tilt and
Illegal Sampler Position errors result from having the Sampler Module in the
wrong position when trying to perform certain functions.
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Pump Error Codes
2002 Illegal Pump Speed
Pump error may be the result of a pump or optical position sensor failure. If a
Pump was just replaced on a system and errors are occurring, verify that the
correct Pump has been installed. Pump errors may also be due to system
voltage problems there, all voltages and cable connections should be
tested/reseated.
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Printer Error Codes
2101 Printer Time Out 2102 Printer Out of Paper
2103 Printer Error 2104 Printer Off-Line
Printer Error Codes are generated when an error condition occurs during the
printing process due to a paper jam, software communication breakdown or a
hardware failure.
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Math Error Codes
0408 Math Error 1408 Math Error
Math errors are the result of a software error that is detected during calibration or
analysis. When the software problem is detected the cause could be due to a
transient spike on the power line and may not reoccur of could be the result of a
hardware problem within the system. When this error code occurs all
calibrations of analysis fail for that particular sequence. Unless the problem
reoccurs, no intervention is required on the part of the operator.
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Software Error Codes
2003 Illegal Command 2004 Illegal Parameter
2005 Illegal Error Code 2200 EEP Erase Error
2201 EEP Write Error 2202 Memory Write Error
2203 Memory Clear Error
Software errors are the result of a minor software problem that is detected during
a sequence. When the software problem is detected, the cause could be due to a
transient spike on the hardware problem within the system. When these error
codes occur, all calibrations of analysis fail for that particular sequence. Unless
the problem reoccurs, no intervention is required on the part of the operator.
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Analog to Digital Converter Error Codes
0406 ADC Not Ready 1406 ADC Not Ready
2106 ADC Error
A/D Converter errors are due to a variety of reasons. Overloads may be due to
a hardware problem. Other A/D errors are usually the direct result of a software
or hardware error condition.
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Westgard Rule Violation Error Codes
2300 Westgard Rule 1-2s 2301 Westgard Rule 1-3s
2302 Westgard Rule 2-2s 2303 Westgard Rule 4-1s
2304 Westgard Rule 10x 2305 Control Outside Range
A Westgard Rule error is generated when results for one or more parameters on
the laboratory quality control material have violated one or more of the Westgard
rules that have been enabled.
Westgard Rules are set up to alert the operator to various trends within the
quality control data. Depending upon the laboratories quality control
requirements, possibly all of the Westgard Rules may be active on a system.
The Westgard Rules and a general interpretation of each violation are noted
below. Corrective actions to be taken by the laboratory will vary depending
upon the individual laboratories Quality Control practices:
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QC Westgard Rule Violation 10x
This error code means that ten consecuiive QC results for at least one analyte are
on the same side of the mean.
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Out of Range Error Codes
1005 Na+ Conc. Too Low 1006 Na+ Conc. Too High
1105 K+ Conc. Too Low 1106 K+ Conc. Too High
1205 Cl- Conc. Too Low 1206 Cl- Conc. Too High
1305 Li+ Conc. Too Low 1306 Li+ Conc. Too High
Out of Range Error occur during an analysis sequence only. The error is
generated when the measured result exceeds the measurement range of the
individual electrode. The result is displayed with a Greater than (>) or Less
Than (<) sign. No action is required on the operators part. The sample should
be repeated on another instrument within the laboratory that may have a greater
measurement range.
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BIOLYTE SERVICE MANUAL
Sodium Results
The sodium electrode is a high impedance electrode. Result variations can be
attributed to static electricity, flow, and grounding problem. The electrode
warranty is nine months, therefore, if the electrode is beyond the warranty,
replace the electrode, otherwise reference the solutions below.
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Potassium Results
The potassium electrode is an organic membrane exchanger electrode. Result
variations can be attributed to static electricity, sample hemolysis, and
plasma/serum difference. The electrode warranty is six months, therefore, if the
electrode is beyond the warranty, replace the electrode, otherwise reference the
solutions below.
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Chloride Results
The chloride electrode is an organic membrane exchanger electrode. The
electrode warranty is one month, therefore, if the electrode is beyond the
warranty, replace the electrode, otherwise reference the solutions below.
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Lithium Results
The lithium electrode is an organic membrane exchanger electrode. The
electrode warranty is one month, therefore, if the electrode is beyond the
warranty, replace the electrode, otherwise reference the solutions below.
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Urine Result Problems
The urine sample is placed in the cup and a dilution of the sample is made with
the Biolyte 2000 Urine Diluent. In addition to the suggestions outlined under
the results related problems portion of this section, the following is a
recommended series of steps to solve urine result problems.
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Instrument Correlation
Correlation between the Biolyte 2000 and other instrumentation may be biased
due to differences in measurement technologies, for example, direct versus
indirect measurement. Performance of the Biolyte 2000 should be based upon
the followings:
1. The instrument ability to recover the assayed control values on the Biolyte
2000 Biomedical Stat Control material.
2. The instruments ability to meet Biolyte 2000 Biomedical’s stated
specifications for with-in run and day to day precision.
3. The laboratory’s own historical correction data between the Biolyte 2000
and the other instrument.
If the Biolyte 2000’s performance meets the first two criteria and a bias stall
exists, the bias can be eliminated by calculation and implementation of slope and
intercept correction factors.
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5. Circuit Diagrams
Contents
I/O PCB Block Diagram ...................................................................................... 65
CPU PCB Block Diagram .................................................................................... 66
ADC PCB Block Diagram ................................................................................... 67
Base PCB Block Diagram .................................................................................... 68
AMP PCB Block Diagram ................................................................................... 69
Driver PCB Block Diagram…………………………………………………….70
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BIOLYTE SERVICE MANUAL
I/O PCB Block Diagram
Address &
Data Bus PIO
DIN 64 PRINTER
Solt Control
J6 Control Bus
&
N.V RAM
URAT 1 URAT 1
RS-232 RS-232
Driver Driver
circuit circuit
RS-232 RS-232
interface interface
Connector Connector
J3 J1
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BIOLYTE SERVICE MANUAL
CPU PCB Block Diagram
chip select
Address & chip select
Data Bus Control Bus
32K*16bits
SRAM
Reset & 80186
W.D.T
Circuit CPU
DIN 64
Slot
Address &
J1
Reset
Data Bus
R.T.C
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BIOLYTE SERVICE MANUAL
ADC PCB Block Diagram
Address &
Data Bus
DIN 64
Slot Control Bus
PIO
AMP, K/B
Data Bus PUMP, Valve
Serial-parallel & LCD control
Control Bus
AMP interface
LCD
interface Control Bus
TxD
RMS
interface RxD
Connector
J1
Connector
J2
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Base PCB Block Diagram
DIN 64 PRINTER
I/O Slot CONNECTOR
Solt1 CON2
DIN 64
CPU Slot
Solt2
PUMP
CONNECTOR
DIN 64 CON6
A/D Slot
Solt3 AMP.
CONNECTOR
CON5
DIN 64
Reserve Slot
Solt4
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AMP PCB Block Diagram
CONNECTOR
J1
Isolator
16 bit Control
A/D converter Bus
Channels
Multiplexer
4 TO 1
Cl/Li Na K AIR
Pre.AMP Pre.AMP Pre.AMP detector
AMP
Cl/Li Na K AIR
Electrode Electrode Electrode detector
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Driver PCB Block Diagram
Photo Sampler
Sensor 20 PIN Control Bus
CON1
Connector Motor
To Sampler
CON3 DRIVER
CON4 CON2 Motor
Valve
CON7
DRIVER
To Valve
PUMP
Oscillator
DRIVER
CON6
To PUMP
Motor
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6. Appendix
Contents
Appendix I: Software Structure ........................................................................... 73
Appendix II: Initial Data Value ............................................................................ 74
Appendix III: Flow Chart of Calibration ............................................................. 76
Appendix IV: Flow Chart of Analysis.................................................................. 77
Appendix V: Program Download Procedure ....................................................... 78
Appendix VI: Data Transfer Protocol .................................................................. 80
Appendix VII: All Characters of Printer .............................................................. 87
Appendix VIII: LCD Characters………………………………………………..88
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Appendix I: Software Structure
Power ON Function Key Sub-Function 1 Sub-Function 2 Sub-Function 3
Main Start/Standby
Sample Type
Calibrate
Analyze
Status
Flowpath
Menu 1. Setup 1. Test select
2. Units setting
3. Resolution set
4. 2-Pt cal setup
5. Date/Time set
6. Results settings 1. Reference Set
2. Panic Set
3. Offsets
2. Operation
3. Data 1. Recall
2. Transfer
3. Clear
4. Software version
5. Diagnostic 1. Device exercise 1. Valve exercise
2. Pump exercise
3. Probe exercise
2. Device test 1. Speaker
2. Printer
3. LCD
4. Keypad
5. Sampler sensor
6. Serial port
3. Air detector test
4. Error log 1. View error log
2. Print error log
3. Clear error log
5. System test 1. Probe position
2. Pump movement
3. Valves set
6. Sensor mV data
6. Maintenance 1. Condition Na 1. Condition Na
2. Condition f-path
2. Clean flow path
3. Reagent info
4. Prime
5. Probe adjustment
6. Cal. pump frequency
QC 1. Analyze control
2. QC setup
3. Print W-R viol’n
4. Statistics 1. Browse QC data
2. Print QC data
3. Print L-J chart
4. Brows statistics
5. Print statistics
5. Clear QC Data
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Appendix II: Initial Data Value
1. Save in RTC:
• Date/Time: auto-count
• Tests set: ON(Na+, K+, Cl-), OFF(Li+)
• Unit set: mmol/L (for 4 sensors)
• Resolution set: 123(Na+, Cl-), 12.3(K+), 1.23(Li+)
• Operator set: ON(3, 5, 6), OFF(1, 2, 4)
• Pump speed: LO
• Dilute ratio: 3
• Print more: OFF
2. Save in EEPROM:
• Reference limit: [mmol/L]
Na+ K+ Cl- Li+
Blood 136-146 3.5-5.0 96-106 1.75-1.20
Urine 27-287 25-120 170-250 -
CSF - - 120-130 -
• Panic limit:[mmol/L]
Cl- Na+ K+ Li+
Range 60-200 60-200 1.0-10.0 0.10-5.00
• Slope of last calibration: NC
• STD-A Volt. of last calibration: 0 (for 4 sensors) [mV]
• Control sample expiration date: 1998/01/01 (for 7 levels)
• Control sample lot number: 0 (for 7 level)
• Control sample concentration range: 0 (for 7 levels & 4 sensors) [mmol/L]
• Flow time of calibration & analysis procedure: [sec.]
Flowtime 0 1 2 3 4 5 6 7
Serum/Plasma 0 0 7 0.5 0.5 5 1 0
Whole Blood 0 0 10 1 1 8 1 0
Urine 0 0 10 0.5 0.5 5 1 0
CSF 0 0 7 0.5 0.5 5 1 0
• Probe speed: 1500
• Air sensor range: 65 [mV]
• Air limit: 200 [mV]
• Analysis test number: 0
• Correction factor: slope=1.00, intercept=0.00
• Error code of 50 error log: 0
• Probe position: AIR=500, STD-A=380, STD-B=260, REF=620, Sample
(IN)=1420, Sample (OUT)=1900, AIR (OUT)=750
• QC: Control Mean=0, Control SD=AUTO, Control W-R=OFF
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• Analysis result: * SAMPLE ID: “ “
* Access #: 0
* Name: “ “
* Sequence #: 0
* Analyze Date: 2000/00/00
* Analyze Time: 00:00:00
* Sample type: Serum/Plasma
* Concentration: 0 (for 4 sensors)
• Control sample result: * Level: 0
* Analysis Date: 20000/00/00
* Analysis Time: 00:00:00
* Concentration: 0 (for 4 sensors)
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Appendix III: Flow Chart of Calibration
Rinse REF :
START END Flowtime[6] sec.
Rinse AIR :
Rinse AIR : Air to Air Detector
Air to Air Detector
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Appendix IV: Flow Chart of Analysis
END
START
Rinse REF :
Rinse AIR : Flowtime[6] sec.
Flowtime[4] sec.
Sensing :
Rinse REF : Flowtime[2] sec.
Flowtime[6] sec.
Rinse AIR :
Rinse SAMPLE : Flowtime[1] sec.
Sample to Air Detector
Waiting :
Rinse SAMPLE : Flowtime[0] sec.
Flowtime[7] sec.
Rinse AIR :
Rinse AIR : Air to Air Detector
Air to Air Detector
2. Plug the PUM (Program Update Module) onto the barcode reader port of the
Biolyte 2000.
3. Power on. Press the Flowpath key while and the screen finishes displaying
the Power On Screen (Figure 8-1). Once the Flowpath key is pressed, the
system will display the Select Test Item Screen (Figure 8-2).
4. Press ← key to download program. At this time, screen will show the
Download Program Screen (Figure 8-3).
Download program
....
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5. The screen will display “ . . . .” when the new software is being downloaded.
8. Remove the PUM from the barcode port of the Biolyte 2000.
10. Enter the Menu Screen and input 4 to access the Software Version Screen to
check whether the software version has been updated.
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Appendix VI: Data Transfer Protocol
1. Object
This document describes how the Biolyte 2000 transmits data to an external
computer.
2. Low-level Protocol (Transfer Link)
This protocol used by Biolyte 2000 is designed according to ASTM E1381-91.
There are three distinct phases in transferring information between the instrument
and a computer system. The three phases are establishment, transfer, and
termination
Note: Biolyte 2000 is always the sender; it cannot be the receiver.
2.1 Establishment phase
Biolyte 2000 transmits the <ENQ> transmission control character to the
intended receiver.
The receiver has 15 seconds to reply with an <ACK> (if ready) or
<NAK> (if not ready) after receiving an <ENQ> character.
If the receiver responds with an <ACK> character, Biolyte 2000 will
proceed to transfer phase.
If the receiver responds with an <NAK> or any other character (except
<ACK>), Biolyte 2000 will proceed to Termination phase.
If the receiver does not respond within 15 seconds period, Biolyte 2000
will send another <ENQ> character.
If the receiver does not respond within 15 seconds period again, Biolyte
2000 will proceed to Termination phase.
2.2 Transfer phase
Biolyte 2000 has 30 seconds to transmit the first frame. If no frame or
<EOT> is received within 30 seconds, the receiver will proceed to the
Termination phase.
The receiver has 15 seconds to respond with an acknowledgment control
character (<ACK> or <NAK>).
If the receiver responds with an <ACK> character, Biolyte 2000 will
transmit next frame within 30 seconds.
If the receiver responds with an <NAK> character, Biolyte 2000 will
transmit the same frame again within 30 seconds period. If Biolyte
2000 has transmit the same frame 6 times, it will proceed to Termination
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BIOLYTE SERVICE MANUAL
phase.
After all frames have been send, Biolyte 2000 will proceed to
Termination phase.
2.3 Termination phase
Biolyte 2000 transmits an <EOT> character and then regards the data link
to be in a neutral state. Upon receiving <EOT>, the receiver also regards
the data link to be in the neutral state.
For more details in time and data link between two systems please refer to ASTM
E1381-91.
3. High-level Protocol (Transfer Information)
This protocol used by Biolyte 2000 is designed according to ASTM E1394-91.
This protocol is intended to apply to the structure of messages exchanged between
clinical instruments and computer systems.
The structure of records is described in Table I. The column “ASTM REF” lists
the sections of the ASTM E1394-91. The column “ ASTM NAME” lists the
field names that is defined in ASTM E1394-91. The column
“IMPLEMENTATION” lists the data formats of the field.
The frame structure is illustrated as follows:
<STX> FN test <ETX> C1 C2 <CR> <LF>
where: <STX> - Start of Text transmission control character
FN - single digit Frame Number 0 to 7
text - Data Content of Message
<ETX> - End of Text transmission control character
C1 - most significant character of checksum 0 to 9 and A to F
C2 - least significant character of checksum 0 to 9 and A to F
<CR> - Carriage Return ASCII character
<LF> - Line Feed ASCII character
Checksum: The checksum is initialized to zero with the <STX> character. The
first character used in computing the checksum is the frame number
and the last character is <EXT> character.
4. Reference
4.1 ASTM E1381-91 “Specification for Low-Level Protocol to Transfer Messages
Between Clinical Laboratory Instruments and Computer Systems”
4.2 ASTM E1394-91 “Standard Specification for Transferring Information
Between Clinical Instruments and Computer Systems”
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BIOLYTE SERVICE MANUAL
Header Record
ASTM REF ASTM NAME IMPLEMENTATION
7.1.1 Record Type ID Single character: “H”
7.1.2 Delimiter Definition Standard delimiters: |\^&
7.1.3 Message Control ID Not used
7.1.4 Access Password Not used
7.1.5 Sender Name or ID BioCare^Biolyte^mm..mm^dd..dd
“mm..mm” – version of software
“dd..dd” – analyzer serial No.
7.1.6 Sender Street Address Not used
7.1.7 Reserved Field Not used
7.1.8 Sender Telephone Not used
Number
7.1.9 Characteristics of Sender Not used
7.1.10 Receiver ID Not used
7.1.11 Comment or Special Not used
Instruction
7.1.12 Processing ID Not used
7.1.13 Version No. This value identifies the version level of the
ASTM specification.
Single character : “1”
7.1.14 Data and Time of Date and time at which message was
Message transmitted. (This is not the time of the
analysis.)
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8.1.17 Patient Height Not used
8.1.18 Patient Weight Not used
8.1.19 Patient’s Known or Not used
Suspected Diagnosis
8.1.20 Patient Active Not used
Medications
8.1.21 Patient’s Diet Not used
8.1.22 Practice Field No. 1 Not used
8.1.23 Practice Field No. 2 Not used
8.1.24 Admission and Not used
Discharge Dates
8.1.25 Admission Status Not used
8.1.26 Location Not used
8.1.27 Nature of Alternative Not used
Diagnostic Code and
Classifiers
8.1.28 Alternative Diagnostic Not used
Code and Classification
8.1.29 Patient Religion Not used
8.1.30 Marital Status Not used
8.1.31 Isolation Status Not used
8.1.32 Language Not used
8.1.33 Hospital Service Not used
8.1.34 Hospital Institution Not used
8.1.35 Dosage Category Not used
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Received
9.4.16 Specimen Descriptor “Serum/Plasma”, “Whole Blood”, Urine”
9.4.17 Ordering Physician Not used
9.4.18 Physician’s telephone Not used
Number
9.4.19 User Field No. 1 Not used
9.4.20 User Field No. 2 Not used
9.4.21 Laboratory Field No. 1 Not used
9.4.22 Laboratory Field No. 2 Not used
9.4.23 Date/Time Results Not used
Reported or Last
Modified
9.4.24 Instrument Charge to Not used
Computer System
9.4.25 Instrument Section ID Not used
9.4.26 Report Types “P” – preliminary results(Results require
remote review)
9.4.27 Reserved Field Not used
9.4.28 Location or Ward of Not used
Specimen Collection
9.4.29 Nosocomial Infection Not used
Flag
9.4.30 Specimen Service Not used
9.4.31 Specimen Institution Not used
Result Record
ASTM REF ASTM NAME IMPLEMENTATION
10.1.1 Record Type ID Single character: “R”
10.1.2 Sequence Number Counts the items sent for this order; ‘1’ for
the first items, ‘2’ for the second, etc.
10.1.3 Universal Test ID Five parts
The first three parts are not used (see
sections 6.6.1.1-6.6.1.3 of ASTM
E1394-91).
The fourth part is item name assigned by
BioCare. Which are defined below:
“Cl-” - chloride concentration
“Na+” - sodium concentration
“K+” - potassium concentration
“Li+” - lithium concentration
The fourth part is item type; it will be one
of the following:
M – measured
C - Calculated
10.1.4 Data or Measurement Value of the parameter as an ASCII string.
Value “±###.##” – if too many digits
10.1.5 Units Concentration unit
“mmol/L”
“mEq/L”
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10.1.6 Reference Ranges Not used
10.1.7 Result Abnormal Flags Not used
10.1.8 Nature of Abnormality Not used
Testing
10.1.9 Result Status Not used
10.1.10 Date of Change of Not used
Instrument Normative
Values or Units
10.1.11 Operator Identification Not used
10.1.12 Date/Time Test Started Date and time at which the analysis started.
(This field will be used only in the first
result record.)
10.1.13 Date/Time Test Not used
Completed
10.1.14 Instrument Identification Not used
Example
This example includes both low-level and high-level protocol.
The responses from computer are shown as <ACK>.
Example data:
Instrument: Biolyte
Software version: 2.1.1.1
Analyzer serial No.: 5
Patient ID: 123456789
Sample type: Serum/Plasma
Sample serial No.: 12
Date and time analyzed: Oct 29, 1999 08:50:59
Date and time transmitted: Oct 29, 1999 10:36:31
Item result:
Na+ : 167 mmol/L
K+ : 7.2 mmol/L
Cl- : 151 mmol/L
Transmit format:
<ENQ>
<ACK>
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<STX>1H|\^&|||BioCare^Biolyte^1.2.1.1^5||||||||1|19991029103631<CR><ETX>c3
<CR><LF>
<ACK>
<STX>2P|1||123456789 <CR><ETX>34<CR><LF>
<ACK>
<STX>3O|1||12||||||||||||Serum/Plasma||||||||||P<CR><ETX>2b<CR><LF>
<ACK>
<STX>4R|1|^^^Na+^M| 167
|mmol/L|||||||19991029085059<CR><ETX>ea<CR><LF>
<ACK>
<STX>5R|2|^^^K+^M| 7.2 |mmol/L<CR><ETX>30<CR><LF>
<ACK>
<STX>6R|3|^^^Cl-^M| 151 |mmol/L<CR><ETX>21<CR><LF>
<ACK>
<STX>7L|1|N<CR><ETX>09<CR><LF>
<ACK>
<EOT>
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Appendix VII: All Characters of Printer
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Appendix VIII: LCD Characters
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