Humalyte User

HumaLyte
| User Manual
|
Cat.No. 17400/1
Revision List of the Manual
No. DATE / Rev. REVISION DESCRIPTION
1 02/2004-04 First edititon
2 03/2005-08 Update for software version 4.3
3 04/2007-09 Correction of typing errors, adaptation to new corporate design
i
ii
1 INTRODUCTION
This manual is considered as a part of the instrument; it has to be at the operators hand as well as at the
maintenance operators availability. For accurate installation, use and maintenance, please read the following
instructions carefully. In order to avoid instrument or personal damages, carefully read the GENERAL SAFETY
WARNINGS, describing the suitable operating procedures. In case of breakdowns or any troubles with the
instrument, apply to the local Technical Service.
2 USER WARRANTY
HUMAN warrants that instruments sold by one of its authorised representatives shall be free of any defect in
material or workmanship, provided that this warranty shall apply only to defects which become apparent within
one year from the date of delivery of the new instrument to the purchaser.
The HUMAN representative shall replace or repair any defective item at no charge, except for transportation
expenses to the point of repair.
This warranty excludes the HUMAN representative from liability to replace any item considered as expendable in
the course of normal usage, e.g.: lamps, valves, syringes, glassware, fuses, diskettes, tubing etc.
The HUMAN representative shall be relieved of any liability under this warranty if the product is not used in
accordance with the manufacturer's instructions, altered in any way not specified by HUMAN, not regularly
maintained, used with equipment not approved by HUMAN or used for purposes for which it was not designed.
HUMAN shall be relieved of any obligation under this warranty, unless a completed installation / warranty
registration form is received by HUMAN within 15 days of installation of this product.
This warranty does not apply to damages incurred in shipment of goods. Any damage so incurred shall be re-ported
to the freight carrier for settlement or claim.
3 INTENDED USE OF THE INSTRUMENT [IVD]

The instrument has to be used for the expected purposes and in perfect technical conditions, by qualified
personnel, in working conditions and maintenance operations as described in this manual, according to the
GENERAL SAFETY WARNINGS. This manual contains instructions for professional qualified operators.
4 GENERAL SAFETY WARNINGS

Use only chemical reagents and accessories specified and supplied by HUMAN and/or mentioned in this manual.
Place the product so that it has proper ventilation.
The instrument should be installed on a stationary flat working surface, free from vibrations.
Do not operate in area with excessive dust.
Work at room temperature and humidity, according to the specifications listed in this manual.
Do not operate this instrument with covers and panels removed.
Only use the power cord specified for this product, with the grounding conductor of the power cord connected to
earth ground.
Use only the fuse type and rating specified by the manufacturer for this instrument, use of fuses with improper
ratings may pose electrical and fire hazards.
To avoid fire or shock hazard, observe all ratings and markings on the instrument.
Do not power the instrument in potentially explosive environment or at risk of fire.
Prior to cleaning and/or maintaining the instrument, switch off the instrument and remove the power cord.
For cleaning use only materials specified in this manual, otherwise parts may become damaged.
It is recommended always to wear protective apparel and eye protection while using this instrument.
Respective warning symbols, if appearing in this manual, should be carefully considered.
I
5 DISPOSAL MANAGEMENT CONCEPT
The currently valid local regulations governing disposal must be observed. It is in the responsibility of the user to
arrange proper disposal of the individual components.
All parts which may comprise potentially infectious materials have to be disinfected by suitable validated
procedures (autoclaving, chemical treatment) prior to disposal. Applicable local regulations for disposal have to be
carefully observed.
The Instruments and electronic accessories (without batteries, power packs etc.) must be disposed of according to
the regulations for the disposal of electronic components.
Batteries, power packs and similar power source have to be dismounted from electric/electronic parts and disposed
off in accordance with applicable local regulations.
6 INSTRUMENT DISINFECTION
Analytical instruments for in vitro diagnostic involve the handling of human samples and controls which should be
considered at least potentially infectious. Therefore every part and accessory of the respective instrument which
may have come into contact with such samples must equally be considered as potentially infectious.
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be
decontaminated/disinfected. Decontamination/disinfection should be performed by a authorised well-trained
personnel, observing all necessary safety precautions. Instruments to be returned have to be accompanied by a
disinfection certificate completed by the responsible laboratory manager. If a disinfection certificate is not
supplied, the returning laboratory will be responsible for charges resulting from non-acceptance of the instrument
by the servicing centre, or from authoritys interventions.
7 NOTICE
Every effort has been made to avoid errors in text and diagrams, however, HUMAN GmbH assumes no
responsibility for any errors which may appear in this publication. It is the policy of HUMAN GmbH to improve
products as new techniques and components become available. HUMAN GmbH therefore has to reserve the right
to change specifications if necessary in the course of such improvements.
II
NOTICE
Analytical instruments for in vitro diagnostic application involve the handling of human samples and controls
which should be considered at least potentially infectious. Therefore every part and accessory of the respective
instrument which may have come into contact with such samples must equally be considered as potentially
infectious.
BIOHAZARD
The BIOHAZARD warning label must be affixed to instrument prior to first use with biological material !
Servicing Note:
Before doing any servicing on the instrument it is very important to thoroughly disinfect all possibly contaminated
parts. Before the instrument is removed from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination should be performed by authorised well-trained personnel only, observing all necessary safety
precautions. Instruments to be returned have to be accompanied by a decontamination certificate completed by
the responsible laboratory manager. If a decontamination certificate is not supplied, the returning laboratory will
be responsible for charges resulting from non-acceptance of the instrument by the servicing centre, or from
authoritys interventions.
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: human@human.de www.human.de
a
b
Contents
1 Preface 3
2 Description 4
3 Setup 24
4 Operation 37
5 Maintenance 59
6 Quality Control 85
7 Troubleshooting 99
8 Theory 155
9 Appendix 161
10 List of Consumables and Reagents 175
Contents
1 Preface .............................................................................................................................................................................................................. 3
1.1 Intended Use ...................................................................................................................................................................................... 3
1.2 Chapters and Contents................................................................................................................................................................... 3
1.3 Conventions........................................................................................................................................................................................ 3
1.4 Ordering Information...................................................................................................................................................................... 4
1.5 Technical Assistance........................................................................................................................................................................ 4
2 Description...................................................................................................................................................................................................... 4
2.1 Introduction........................................................................................................................................................................................ 4
2.2 Installing the HumaLyte................................................................................................................................................................. 5
2.3 Features..............................................................................................................................................................................................12
2.4 Analytes..............................................................................................................................................................................................13
2.5 Main Components..........................................................................................................................................................................14
2.5.1 Tubing .................................................................................................................................................................................................14
2.5.2 Flow Controller ................................................................................................................................................................................15
2.5.3 Pump ...................................................................................................................................................................................................15
2.5.4 Waste Valve and Reference Valve ............................................................................................................................................15
2.5.5 Waste Valve ......................................................................................................................................................................................16
2.5.6 Reference Valve ...............................................................................................................................................................................16
2.5.7 Sampler ..............................................................................................................................................................................................16
2.5.8 Electrode Carrier..............................................................................................................................................................................17
2.5.9 Measuring Electrodes....................................................................................................................................................................17
2.5.10 Reference Electrode ............................................................................................................................................................17
2.5.11 Air Detector (AD)..................................................................................................................................................................18
2.5.12 Input/Output Devices ........................................................................................................................................................18
2.5.13 Keypad .....................................................................................................................................................................................18
2.5.14 Liquid Crystal Display (LCD) .............................................................................................................................................19
2.5.15 Alarm........................................................................................................................................................................................20
2.5.16 Printer ......................................................................................................................................................................................20
2.6 Acceptable Samples.......................................................................................................................................................................20
2.6.1 Sample Handling Requirement .................................................................................................................................................20
2.6.2 Serum ..................................................................................................................................................................................................20
2.6.3 Plasma.................................................................................................................................................................................................21
2.6.4 Whole Blood .....................................................................................................................................................................................21
2.6.5 Urine21
2.7 Acceptable Anticoagulants .........................................................................................................................................................22
2.7.1 Interfering Substances .................................................................................................................................................................22
2.7.2 Drugs Showing No Lithium Interference...............................................................................................................................22
2.8 Reference Intervals.........................................................................................................................................................................23
2.9 Display Range for Analytes .........................................................................................................................................................23
3 Setup ...............................................................................................................................................................................................................24
3.1 Introduction......................................................................................................................................................................................24
3.2 Setup Options in Menu ................................................................................................................................................................24
3.2.1 Selecting Electrodes.......................................................................................................................................................................24
3.2.2 Selecting Units of Measurement..............................................................................................................................................25
3.2.3 Setting Resolution Values ...........................................................................................................................................................26
3.2.4 Setting Two-point Calibration Interval ..................................................................................................................................27
3.2.5 Setting Date and Time..................................................................................................................................................................28
3.2.6 Setting Results/Printer .................................................................................................................................................................29
3.2.7 Setting Reference Values.............................................................................................................................................................30
3.2.8 Setting Panic Values ......................................................................................................................................................................31
3.2.9 Setting Offsets Values ..................................................................................................................................................................32
3.3 Setting Operation Options..........................................................................................................................................................33
2
1 Preface
1.1 Intended Use
The HumaLyte is intended for in vitro diagnostic use by healthcare professionals for the quantitative determination
of sodium and potassium, and either chloride or lithium (option) in whole blood, serum, and plasma. Sodium,
potassium and chloride can be determined in whole blood, serum, plasma, urine and CSF.
All data reported by the HumaLyte are for clinical reference; if abnormal clinical data occur, further study and
evaluation of these data is suggested to ensure clinical accuracy.
The HumaLyte User Manual is written for the healthcare professionals who will operate the HumaLyte. Users do
not need prior experience with HUMAN products, but should have been trained on the instrument by HUMANs
designated personnel.
This manual describes the HumaLyte and explains how to test samples with the instrument.
1.2 Chapters and Contents
The HumaLyte User Manual includes the following chapters:
Chapter 1, Description, gives instructions on installation, lists the Humalyte operating features, describes its
operating components and specimen handling requirements.
Chapter 2, Setup, describes the instruments Setup 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 maintenance procedures on the instrument.
Chapter 5, Quality Control, explains how to monitor the performance of the instrument with quality control
standards.
Chapter 6, Troubleshooting, describes error codes and explains how to repair the HumaLyte.
Chapter 7, Theory, describes the theory of ion-selective electrodes and the process of electrode calibration. This
chapter also includes the equations that the instrument uses to calculate the concentration for each analyte.
Chapter 8, Appendix, includes all of the HumaLyte system specifications, warning messages, labels on the
HumaLyte, description of IEC letter symbols, consumables information, error codes, reference list and parts list.
1.3 Conventions
This manual uses the following conventions:

Bulleted lists contain itemised or summarised information.
Numbered lists contain procedural steps.
Notes are written in Italics and provide important or helpful operating information.
WARNINGS are written in italicised capital letters and provide information that is important for the safety of the
user or instrument.
Initial Capital Letters begin the name of software screens & menu options.
Framed letters are used for the names of the keys on the HumaLyte keypad.
3 Human HumaLyte User Manual

Captions in bold type 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
1.4 Ordering Information
Users can order additional copies of the HumaLyte User Manual (Cat.-No.: 17410/01), from their local HUMAN
representative.
When any questions arise regarding the different language versions, the English version will be the principal
reference.
1.5 Technical Assistance
For technical assistance call HUMAN or your local HUMAN representative.
2 Description
2.1 Introduction
This chapter lists the HumaLyte testing parameters and specimen requirements, describes its main operating
components, and provides an overview of major software functions. The HumaLyte appears in Figure 2-1.
Note: References to lithium and chloride are only applicable to analyzers equipped with these electrodes.
Figure 2-1. HumaLyte
4
2.2 Installing the HumaLyte
Those unfamiliar with the HumaLyte should read chapter 1 before proceeding. Users must complete the following
steps to install the HumaLyte. Some procedures may not apply to all instruments.
Unpacking the HumaLyte 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 HumaLyte weighs approximately 12 kg (without reagent pack). HUMAN recommends that at least 2 persons
help to remove the instrument from its shipping carton and place it on the table. Complete the following steps to
install and assemble the instrument:
Unpacking the HumaLyte and Start Up Kit
Inspect the boxes for any shipping damage. Contact your local HUMAN representative if damage is discovered.
Place the box facing up. Open the top of the top. Take out the accessory box.
Open the accessory box and check its contents against the enclosed packing list before proceeding with the
installation. Contact your HUMAN representative if parts are missing.
Remove the top foam end cap. Gently remove the HumaLyte from the box and place it on the counter.
Remove the reference manual and the power cord from the box.

Confirming Voltage Range
The power input module permits the HumaLyte to run at 0.6A/100-120VAC or 0.35A/200-220VAC.
Confirm that the voltage range of the laboratory corresponds with the HumaLyte specifications. Turn the
instrument around in order to view the back. The power cord should be connected to the power input module
located on the back of the instrument.
Once replaced, proceed to reset cycle counter in
Power Switch
(OFF Position)
Fuse Socket
Power Input
Module
Figure 2-2. Power Input Module and Fuse Socket
Confirm that the correct fuse has been installed for the available mains voltage. See Table 2-1 below for the
correct fuse. Install the fuse according to the instructions in Chapter 4, Maintenance.
Table 2-1. Fuse for Various Line Voltages.

V A Fuse Requirement
100-120 0.6 2.0A SB (T2.0A/250V)
200-240 0.35 2.0A SB (T2.0A/250V)
6
Assembling and Installing Electrodes
Remove the electrodes and electrode carrier from the packing material.
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 2-3).
Press the Locking Lever Down to Open Position
Figure 2-3. Open Position.
Insert each electrode into the electrode carrier as follows:

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.
Align the lip of the electrode with the guide rails at the side of the electrode train. Slide the electrodes into the
electrode train from bottom to top.
Install the electrodes and other parts in the following order: Spacer, Reference Electrode, Chloride Electrode or
Lithium Electrode, Sodium Electrode, Potassium Electrode, and Air Detector (see Figure 2-4).
The electrodes are keyed so they cannot be installed upside down.

Note: Make sure there is a sealing gasket between each of the electrodes in the carrier.
W-port
Electrode Spacer with the W-port inserted

through the top hole of the electrode
carrier
Reference Electrode with the R-port
R-port
pointing to the right
Chloride Electrode or Lithium Electrode
Sodium Electrode

Potassium Electrode
Air Detector
Figure 2-4. Electrode Carrier with Installed Electrodes.
Engage the locking lever at the bottom of the carrier to secure all of the electrodes in the carrier. The lever should
be in its Closed position.
Align the connector pins on the electrode and the electrode carrier with the receptacles on the instrument.
Gently push the electrode carrier into place on the HUMALYTE, pressing from the bottom and the top
simultaneously.
Note: Align the guiding ground rod on the electrode train with the hole in the analyzer. Make sure that you push
the guiding ground rod in first
8
Installing the Septum
Remove a septum from the reagent pack.
Lift the sampler into 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.
Septum
Figure 1-5. Install the Septum
Note: it is recommended to replace the Septum when a new Reagent pack is installed.

Installing the Probe
Open the analyzer door.
Unscrew the locking screw from the top of the sampler arm.
Insert the long end of the probe through the sampler arm and into the septum.
Slip the locking screw over the short end of the probe. Finger tighten the locking screw onto the sampler arm.
Probe
Figure 2-6
10
Installing the Tubing
Figure 2-7 shows the location of the tubing.
Connect one end of the S-line (Sample Tubing) to the bottom end of the electrode carrier and thread the other
end onto the probe.
Loosen the pump. Insert the W-line (Waste Tubing) into the pump. The yellow collar must be retained by the left
pump bracket. Fasten the pump. 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 to the reagent harness.
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 to the reagent harness.
Connect the A-line (STD-A Tubing) and B-line (STD-B Tubing) to the septum. Attach the fitting to the reagent
harness
Figure 2-7. Install tubing.

Installing the Reagent pack
Unscrew the bottle caps of all reagents and the waste bottle.
Place a reagent pack half-way onto the fluid deck.
Insert the tubing harness straws into the appropriate bottles.
Push the reagent pack all the way in.
Check all tubing connections. Incorrect installation may result in backward flow and contamination of reagent
packs.
Plug the RMS (Reagent Management System) into the RMS port (See Figure 2-8 for the location of the RMS port).
Replace the Septum every time the reagent pack is changed.
Powering on the Instrument

Insert the female end of the power cord into the Power Input Module plug receptacle. Plug the other end of the
cord into a wall socket.
Switch the power button ON. It is located on top of the Power Input Module. The instrument is now powered
on.
The instrument screen should now display the system initialisation procedure.
Preparing the Printer

Install the printer paper according to the instructions in Chapter 4, Maintenance.
Conditioning Electrodes and Flow Path

Perform the conditioning procedure for the sodium electrode as described in Chapter 4, Maintenance.
Perform the conditioning procedure for the flow path as described in Chapter 4, Maintenance.
Performing Instrument Calibration
From the Menu screen, press 6 to access the Maintenance screen. Select the Prime option. Select the Full Prime
option, then press the Enter key to initiate a full prime of all fluids.
Press the Calibrate key to initiate a manual calibration. Repeat this procedure at least one more time. Refer to
Chapter 6, Troubleshooting, in the event of error codes.
The user may now proceed to Chapter 2, Setup Options, followed by the analysis of specimens as described in
Chapter 3, Operation.
2.3 Features
The HumaLyte is a state-of-the-art electrolyte analyzer that tests serum, plasma, CSF, whole blood, and urine. The
HumaLyte uses a microcomputer-based operating system to measure analytes, calculate results, and rapidly
perform state analyses. The HumaLyte quantitated analytes are listed according to sample type and analysis mode
in Table 2-2. The HumaLyte is a highly flexible laboratory instrument and includes many operating features that
can be modified to accommodate users changing work environment. Users can adapt the HumaLyte to fit their
laboratory testing needs and define its operating parameters for the technicians who will use it.
12
2.4 Analytes
Table 2-2. Available HumaLyte Analytes by Analysis Mode and Sample Type.
Analysis Mode Analytes Sample Type
Serum/Plasma Urine Whole Blood
MANUAL
Sodium

Potassium

Chloride

Lithium*
SEMI-AUTO
Sodium

Potassium

Chloride

Lithium*
* Indicates that this part is optional.

2.5 Main Components
The HumaLyte Main Components (Figure 2-8) include tubing and flow controller to aspirate fluids, an electrode
carrier to analyze samples and several communication devices to receive and display information. The HumaLyte
also includes a replaceable reagent pack that contains all of the reagents to calibrate the instrument and analyze
samples.
Figure 2-8. Main Components.
Note: Instruments may vary according to the options ordered.
2.5.1 Tubing
A series of plastic tubes transports fluids through the HumaLyte. These include all tubing that extends from the
reagent pack to the analytical components on the front of the HumaLyte.
Note: The flow path is the route travelled by fluids in the HumaLyte.
Single tubing, called the W-line, carries fluids out of the analytical components and back into the reagent pack. Any
fluids that exit the HumaLyte 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.
14
2.5.2 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 HumaLyte 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 HumaLyte 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.
2.5.3 Pump
The pump (Figure 2-9) is mounted inside the front panel of the HumaLyte and consists of a roller cage that is
connected to a stepping motor.
Figure 2-9. Pump.
When the microcomputer turns the stepping motor on, the roller cage rotates to aspirate fluids through the W-
line, which is stretched across the pumps roller cage. As the pump rotates, it creates a vacuum inside of the tubing
and pushes reference solution through the R-line into the reference electrode, transports 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 speeds, controlled by the
microcomputer, so that fluids are aspirated at the proper times.
2.5.4 Waste Valve and Reference Valve

The waste valve and reference valve help control the flow of fluids during the instruments operating cycles. All
instruments include a waste valve and a reference valve.

2.5.5 Waste Valve
The waste valve is located inside the front panel of the instrument, above the reference valve.
2.5.6 Reference Valve

The reference valve is located on the front of the instrument and below the waste valve.
Figure 2-10. Location of Waste Valve and Reference Valve.
2.5.7 Sampler
The sampler, which is located inside the front panel of the HumaLyte, controls which fluids are aspirated into the
electrode carrier for analysis. The 2 main components of the sampler are the septum (Figure 2-5) and the probe
(Figure 2-6).
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 piece of blunt-ended metal tubing that aspirates fluids into the HumaLyte. 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 Manual Mode (Figure 3-27B), the sampler aspirates 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.
16
2.5.8 Electrode Carrier
The electrode carrier (Figure 2-11) 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 2-11. Electrode Carrier.
Sealing gaskets, which prevent any fluid leakage, connect the electrodes and the air detector.
2.5.9 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.
2.5.10 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 HumaLyte uses constant voltage supplied by the reference
electrode to measure the potential produced by each measuring electrode.

2.5.11 Air Detector (AD)
The air detector is located below the potassium electrode and has 2 functions: it detects 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 both air and fluids.
2.5.12 Input/Output Devices

Use the following input and output devices to communicate with the HumaLyte:
Keypad
Liquid Crystal Display (LCD)
Alarms
Printer
2.5.13 Keypad
The keypad (Figure 2-12) is located on the left front of the HumaLyte and contains both numeric and function keys.
KEYPAD ISE UNIT
1 2 3 Start/
Standby
4 5 6 Sample
Type
7 8 9
Calibrate
Status Menu . 0
Flowpath QC Esc Enter ANALYZE
Figure 2-12. Keypad.
18
The function keys are described in Table 2-3.
Table 2-3. The Function Keys.
Key Function
Analyze Initiates a specimen analysis or restart an interrupted analysis.
Calibrate Initiates a 2-point calibration.
Deletes characters on an input screen.
Enter Selects highlighted data, initiates sequences, and selects options. The Enter key
transfers the data shown on 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 of 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 HumaLyte Status screen.
Start/Standby Switches the HumaLyte screen to Standby Mode. Press again to return to the
Main screen.
2.5.14 Liquid Crystal Display (LCD)

The HumaLyte LCD screen has 40 characters and 4 lines. The HumaLyte main screen is shown in Figure 2-13.
2000/05/04 <<HumaLyte>> 11:20:51

--------------------------------------
* Sample Type : Serum/Plasma
* Status Not ready
Figure 2-13. Main Screen.
The main screen contains the following information: current date and time, sample type, and status.

2.5.15 Alarm
The HumaLyte sounds an alarm in response to input errors or problems that occur during automatic operation. The
HumaLyte 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 HumaLyte 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 the user shuts them off by pressing any key on the keypad or by accessing another
procedure.
2.5.16 Printer
The thermal printer provides hard copies of test results, calibration information, maintenance information, and
error messages.
2.6 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
Lithium Serum, plasma, whole blood
2.6.1 Sample Handling Requirement

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 HumaLyte.
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.
2.6.2 Serum
Collect blood for serum samples in plain vacuum tubes or serum separator tubes. Allow the sample to clot for
approximately one half-hour. Following clot retraction, centrifuge at 1000 RCF for 10 to 15 minutes, uncap the
tube, 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 22C (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 8C. 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 -20C.
20
2.6.3 Plasma
Collect whole blood for plasma samples with minimal stasis, without moving the arm, in vacuum tubes 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 heparinised 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 8C. 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 20C
2.6.4 Whole Blood

Blood samples should be collected with minimal stasis, without exercise of the arm. Collect blood for analysis on
the HumaLyte 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 HumaLyte.
2.6.5 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. HUMAN GmbH 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 8C for extended periods to prevent the growth and metabolism of
micro-organisms. Urine allowed to sit at room temperature for extended periods of time before analysis 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.
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

2.7 Acceptable Anticoagulants
Sodium and lithium heparin are the recommended anticoagulants for plasma specimens. EDTA, citrate, oxalate
and sodium chloride are 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 lyophilised 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. HumaLyte users should take careful note of these
considerations when establishing reference intervals and interpreting results.
2.7.1 Interfering Substances

The following substances at the concentrations indicated have been shown to produce an approximately 2%
increase in the chloride concentration:
-hydroxybutyrate (25 mmol/L)
acetoacetate (25 mmol/L)
formate (10 mmol/L)
lactate (25 mmol/L)
salicylate (50 mg/dl)
citrate (10 mmol/L)
2.7.2 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 non-prescription medications commonly
administered, some combinations of drugs, their metabolites or both may be encountered, which will affect
22
2.8 Reference Intervals
Each laboratory should establish and maintain its own reference intervals based on its patient population.
Table 2-4. Reference Intervals
Serum Urine (24hr.) Whole Blood

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
Lithium 0.5-1.20 mmol/L
2
(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.
2.9 Display Range for Analytes
The following display ranges are used by the HumaLYte 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 2-5. Display Range by Sample Type.
Analytes Serum, Plasma, Whole Blood Urine

Sodium 60-200 mmol/L 4-400 mmol/L
Potassium 1.0-10.0 mmol/L 10-300 mmol/L
Chloride 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.

3 Setup
3.1 Introduction
The HumaLyte setup options let users define the instruments operating parameters to accommodate users
laboratorys testing needs. To access the Setup screen (Figure 3-1), from the Menu screen (Figure 3-16), input 1 and
press the 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 3-1. Setup Screen.
To select a setup option, input the number of the option and press the Enter key.
3.2 Setup Options in Menu

3.2.1 Selecting Electrodes
Use this function to turn each electrode ON or OFF. Figure 3-2 shows the Test Select screen.
The flowchart on this page is the step-by-step procedure for Selecting Electrodes.
<< TEST SELECT >> 11:20:51

1. Na+ : ON 2. K+ : ON
3. Cl- : ON 4. Li+ : OFF
>>Press Enter key to change. (ON,OFF)
Figure 3-2. Test Select Screen.
Use the keys to move the cursor, and press the Enter key to turn the test electrode to ON or OFF.
After setting the test electrode, press the Esc key twice to return to the Menu screen.
Procedure
TEST SELECT
MENU SETUP
1 1 Screen
Screen Screen
24
3.2.2 Selecting Units of Measurement
The Units Setting option lets users select the units of measurement for the analysis report of each test. Figure 3-3
shows the Units Setting screen, which lists all of the system tests and the units of measurement that users can
select for each one.
The flowchart on this page is the step-by-step procedure for Selecting Units of Measurement.
<< UNITS SETTING >> 08:30:32

1. Na+ : mmol/L 2. K+ : mmol/L
3. Cl- : mmol/L 4. Li+ : mmol/L
>>Press Enter key to change. (mmol/L,mEq/L)
Figure 3-3. Units Setting Screen.
Use the keys to move the cursor, and press the Enter key to change the units of measurement.
After setting the units of measurement, press the Esc key twice to return to the Menu screenScreen.
+ +
Note: Only Na and K can be set to mmol/L or mEq/L.
Procedure
UNITS
MENU SETUP
1 2 SETTING
Screen Screen
Screen

3.2.3 Setting Resolution Values
The Resolution Set Option lets users specify the number of decimal places that the HUMALYTE reports for sodium,
potassium, chloride, and lithium results. Figure 3-4 shows the Resolution Set screen with the alternate resolution
values.
The flowchart on the left side of this page is the step-by-step procedure for Setting Resolution Values.
<< RESOLUTION SET >> 08:30:32

1. Na+ : 123 2. K+ : 12.3
3. Cl- : 123 4. Li+ : 1.23
>>Press Enter key to change. (123,12.3)
1. Cl-
Figure 3-4. Resolution Set Screen.
Use the keys to move the cursor, and press the Enter key to change the number of decimal places.
After setting the resolution values, press the Esc key twice to return to the Menu screen.
Table 3-1. 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
Procedure
RESOLUTION SET
MENU 3 Screen
1 SETUP
Screen
Screen
26
3.2.4 Setting Two-point Calibration Interval
The 2-Pt Calibration Setup Option lets users specify the two-point calibration interval for the HUMALYTE. Figure 3-5
shows the 2-Pt Calibration Setup screen.
The flowchart on the left side of this page is the step-by-step procedure for Setting two-point Calibration
Interval.
<< 2-PT CALIBRATION SETUP >> 11:20:51

* Calibration interval : 2 hour
>>Range : 1 - 4 hour
Figure 3-5. 2-Pt Calibration Setup Screen.
Input a number from 1~4, and press the Enter key to set the two-point calibration interval.
After setting the two-point calibration interval, press the Esc key twice to return to the Menu screen.
If the input number is larger than 4, the HumaLyte will sound an alarm and return to the previous value.
Procedure
2-Pt
MENU SETUP
1 4 CALIBRATION
Screen Screen SETUP
Screen

3.2.5 Setting Date and Time
The HumaLyte 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; date and time can be changed at any time. The internal clock has a
battery that will maintain the correct date and time during long power outages. Figure 3-6 shows the Date/Time
Set screen.
Complete the following steps to change the date and time:
Note: The HumaLyte displays time in military units (i.e. 1:00PM. = 13:00).
The flowchart on the left side of this page is the step-by-step procedure for Setting Date and Time.
<< DATE/TIME SET >> 11:08:08

************************************
* 2000/03/30 15:46:20 *
************************************
Figure 3-6. Date/Time Set screen.
On the Date/Time Set screen, a blinking cursor appears next to the first date field.
At the cursor, input a digit. Once it has been entered the 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).
Procedure
DATE/TIME SET
MENU SETUP
1 5 Screen
Screen Screen
28
Use the keys to move cursor to the desired position, and use numerical keys to input date or time. When the
date and time have been set correctly, press the Esc key twice to return to the Menu screen.
If the entered date or time is invalid, the system will display a warning message Invalid! on line 1 of the LCD (see
Figure 3-7).
<< DATE/TIME SET >> Invalid! 11:08:08

************************************
* 2000/02/30 15:46:20 *
************************************
Figure 3-7. Date/Time Set Invalid Screen.
Users must reset if Invalid appears.
3.2.6 Setting Results/Printer

The Results-Set Option lets users define the reference values, panic values, and offsets values. Figure 3-8 shows the
Results Set screen.
The flowchart on the left side of this page is the step-by-step procedure for accessing the Results Set screen.
<< RESULTS SET >> Input No.? 1 11:20:51

1. Reference set 4.Printer:OFF
2. Panic set
3. Offsets
Figure 3-8. Results Set Screen.
Input 1~4 and press the Enter key to select function or press the Esc key twice to return to the Menu screen.
The default value of printer is OFF. Please input 4 and press the Enter key to turn printer on.
The printer OFF function is designed for end-users who need to be able to analyze samples even if the printer is
defective. This is a temporary solution; please replace related parts as necessary.
Procedure
RESULTS SET
MENU SETUP
1 6 Screen
Screen Screen

3.2.7 Setting Reference Values
The Reference-Set option lets users define the reference values of the HumaLyte. Figure 3-9 shows the Reference
Set screen.
The flowchart on the left side of this page is the step-by-step procedure for Setting Reference Values.
<< REFERENCE SET >> 11:20:51

<Blood> Low High Low High
1. Na+: 136 146 2. K+ : 3.5 5.0
3. Cl-: 98 106 4. Li+ : 0.50 1.20
Figure 3-9. Reference Set Screen.
Press the Samp.Type key to change sample types.
Note: <Blood> means serum/plasma or whole blood.
Use the keys to move the cursor.
Input the number (0.00~999), and press the Enter key to set the reference values.
After setting the reference values, press the Esc key 3 times to return to the Menu screen.
If the input number is larger than 1000, the HumaLyte will sound an alarm and return to the previous value.
If the analysis data is out of the range of the reference values, the HumaLyte will automatically mark the data
<Ref or >Ref.
The resolution of the reference values depends on Resolution Set.
Procedure
MENU
Screen
RESULTS REFERENCE
SETUP SET
1 6 SET 1
Screen Screen
Screen
30
3.2.8 Setting Panic Values
The Panic-Set option lets users define the panic values of the HUMALYTE. Figure 3-10 shows the Panic Set screen.
The flowchart on the left side of this page is the step-by-step procedure for Setting Panic Values.
<< PANIC SET >> 11:20:51

<Blood> Low High Low High
1. Na+: 60 200 2. K+ : 1.0 10.0
3. K+ : 60 200 4. Li+ : 0.10 5.00
Figure 3-10. Panic Set Screen.
Note: 1. <Blood> means serum/plasma or whole blood.

2. Only the panic values of serum/plasma and whole blood can be set.
Input the number (0.00~999), and press the Enter key to set the panic values.
After setting the panic values, press the Esc key 3 times to return to the Menu screen.
If the input number is larger than 1000, the HumaLyte will sound an alarm, and return to the previous value.
If the analysis data is out of the range of panic values, the HumaLyte will automatically mark the data
<Pan or >Pan.
The Resolution of the panic values depends on Resolution Set.
Procedure
MENU
Screen
RESULTS
SETUP SET PANIC SET
1 6 2
Screen Screen Screen

3.2.9 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 HumaLyte with other instruments in users lab. Figure 3-11 shows the Offsets screen.
The flowchart on the left side of this page is the step-by-step procedure for Setting Offsets.
<< OFFSETS >> 11:20:51

<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
Figure 3-11. Offsets Screen.
Press the Samp. Type key to change sample types.
Note: <Serum> indicates for both serum and plasma samples and <WB> indicates for whole blood samples.
Input the figures for slope and intercept.
Press the Enter key to change the sign (+/-) of the intercept.
After setting the slope and intercept, press the Esc key 3 times to return to the Menu screen.
Table 3-2 shows the range of slope & 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
MENU
Screen
RESULTS
SETUP SET OFFSETS
1 6 3
Screen Screen Screen
32
3.3 Setting Operation Options
The Operation options allow users to set the analysis result and alarm option. Figure 3-12 shows the Operation
screen.
The flowchart on the left side of this page is the step-by-step procedure for Setting Operation Options.
<< OPERATION >> 11:20:51

1.Patient copy :OFF 2.ID required:OFF
3.Calib. print :ON 4.MV print :OFF
5.Mess. print :ON 6.Alarm :ON
Figure 3-12. Operation Screen.
Use the keys to move the cursor, and press the Enter key to switch the operation options ON or
OFF.
After setting the operation options, press the Esc key to return to the Menu screen.
Table 3-3 shows the description of the operation options.
Table 3-4 shows the description of the message.
Procedure
MENU OPERATION
2
Screen Screen

Table 3-2. Description of the Operation Options.
Option Default Set Description

Patient copy OFF The HumaLyte will print two analysis results copies
if this option is set to ON.
ID required OFF Users must input ID before the analysis procedure
if this option is set to ON.
Calib. print ON The HumaLyte will print the calibration results
after calibration if this option is set to ON.
MV Print OFF The HumaLyte will print the results of analysis &
calibration including voltage of signals if this
option is set to ON.
Mess. Print ON The HumaLyte will print results including worry
message if occurred if this option is set to ON.
Table 3-3 shows the error messages.
Alarm ON The system will sound an alarm if an error occurs
and this option is set to ON.
Table 3-3. Description of the Message.
Message Description
< Ref Assay concentration is less than reference low limit.
> Ref Assay concentration is greater than reference high limit.
< Pan Assay concentration is less than panic low limit.
> Pan Assay concentration is greater than panic high limit.
Drift E_0 drift is greater than E_0 drift limit.
NC The electrode isnt calibrated.
34
Contents
4 Operation.......................................................................................................................................................................................................37
4.1 Introduction......................................................................................................................................................................................37
4.2 Software Description.....................................................................................................................................................................37
4.2.1 Main Screen ......................................................................................................................................................................................37
4.2.2 Setup Options ..................................................................................................................................................................................47
4.2.3 Operation Options..........................................................................................................................................................................47
4.2.4 Data Options ....................................................................................................................................................................................47
4.2.5 Data Recall.........................................................................................................................................................................................48
4.2.6 Data Transfer....................................................................................................................................................................................49
4.2.7 R-Time Trans: off.............................................................................................................................................................................49
4.2.8 Data Clear ..........................................................................................................................................................................................50
4.2.9 Software Version ............................................................................................................................................................................51
4.2.10 Diagnostic...............................................................................................................................................................................51
4.2.11 Maintenance .........................................................................................................................................................................51
4.2.12 QC function Key ...................................................................................................................................................................51
4.3 HumaLyte Operation.....................................................................................................................................................................52
4.3.1 Shortcut Procedures ......................................................................................................................................................................52
4.4 Power On............................................................................................................................................................................................53
4.4.1 Selecting Electrodes.......................................................................................................................................................................53
4.4.2 Set Sample Type ..............................................................................................................................................................................53
4.4.3 Selecting Analysis Modes ............................................................................................................................................................53
4.4.4 Calibration.........................................................................................................................................................................................54
4.4.5 Manual Calibration ........................................................................................................................................................................54
4.4.6 Auto-Calibration .............................................................................................................................................................................54
4.4.7 Analysis: Serum/Plasma ..............................................................................................................................................................54
4.4.8 Analysis: Whole Blood ..................................................................................................................................................................54
4.4.9 Analysis: Urine .................................................................................................................................................................................55
36
4 Operation
4.1 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.
4.2 Software Description

4.2.1 Main Screen
Switch the power switch to the ON position to turn the HumaLyte on. The power switch is located on the rear
panel of the HumaLyte (see Figure 1-2).
After the system has initiated, the screen will change to the Main screen.
System Initial... 11:20:45
1999/05/04 <<Humalyte>> 11:20:51

--------------------------------------
* Sample Type : Serum/Plasma
* Status : Not ready
Figure 4-1. System Initial Screen and Main Screen.
TAble 4-1 describes the status in the Main screen.
TAble 4-1. Status Description in the Main Screen.

Status Description
Parameter ready Indicates that the electrode(s) is ready and

In the Main screen,
analysis can proceed. the following
function keys are
Not ready Must perform calibration before proceeding to available:
Start/Standby,
analysis.
Samp. Type,
Flow path Must perform Flow Path procedure before Calibrate, Analyze,
Menu, QC, Status,
proceeding to other options. Flowpath.

Start/Standby Function Key
Users can press the Start/Standby key in the Main screen. Figure 4-2 shows the Standby screen.
<< STANDBY >> 10:06:12

z~
Z
>>Press START key to continue.
Figure 4-2. Standby Screen.
In the Standby screen, only the Start/Standby function key is available.
In Standby Mode, during auto-calibration, no calibration is carried out. Instead, the system will rinse with STD-A
for 5 seconds and with REF for 2 seconds.
1. After pressing the Start/Standby key, system will run the flush procedure, then return to the Main
screen.
Note: After a power failure, when the electricity returns the instrument will return to the previous mode, standby
or normal.
38
Samp. Type Function Key
Users can press the Samp. Type key in the Main screen. Figure 4-3 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 4-3. Sample Type Set Screen.
>>Sample Type: Serum/Plasma means the selected sample type at present.
Input 1~4 and press the Enter key to change sample type, or press the Esc key to return to the Main screen.
When the sample type is changed, the calibration status of the HumaLyte will change to NC. A recalibration must
be done before proceeding to the analysis procedure.
When the sample type is changed to urine, the system will display the HELP FOR URINE SAMPLE screen for
urine sample analyses (Figure 4-4):
<< HELP FOR URINE SAMPLE >> 11:20:51

1.Dilute one part urine sample with two
parts diluent(Cat. No.: U0050).
2.Use diluted sample to run ANALYZE.
Figure 4-4. Help for Urine Sample Screen.

Calibrate Function Key
The Calibrate function is started by pressing the Calibrate key in the Main screen. Figure 4-5 shows 4 screens of the
Calibration screen.
<< CALIBRATION >> 10:06:12

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

* 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 4-5. Calibration Screens.
The system will start to calculate calibration time when the Calibrate key has been pressed.
During the calibration procedure, press the Status key to switch among the four Calibration screens.
At the end of calibration, the system will set and calculate the next auto-calibration time.
If the calibration procedure is interrupted, the system will rinse the flow path with STD-A and REF.
At the end of the calibration the system will print out Figure 4-6 (To set the calibration printout form, see Setting
Operation Options in chapter 2, Setup, for details)
40
1999/04/28 13:23:12
================================
<< Calibration >>
--------------------------------
Item Slope Range Mess.
---- ------ ------------- ------
Na+ 50.0 50.7 - 66.8 NC
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
K+ 56.28 98.58
Cl- 123.45 78.02
================================
Figure 4-6. Printout of Calibration.
NC: Means that the sensor is not calibrated.

MV Print must be set to ON in the Operation Options for the system to print this message (See Setting
Operation Options in chapter 2, Setup, for details).
Analyze Function Key

Users can press the Analyze key in the Main screen. Figure 4-7 shows the Sample Data screen.
<< SAMPLE DATA >> QC-run control 10:06:12

1. ID : 2. Sequence # :
3. Accession # :
4. Name : <.-start set -change char.>
Figure 4-7. Analysis Screen.
The system will clear the error message from the last analysis and begin calculating analysis time when the
Analyze key is pressed.
Calibration must be done before the analysis procedure. If the selected electrode status is NC, the screen will
show Figure 4-8. Press any key to quit analysis procedure.
<< ANALYSIS >> 10:06:12

>>No calibration data.
>>Please run calibration first.
>>Press any key to continue.
Figure 4-8. NC Analysis Screen.

TAble 4-2 shows the description of the Analysis screen options.
Option Description
ID 10 characters (number or letter)
Sequence # 0-999 (auto count by system)
Accession # 0-9999999999
20 characters (letter, [-], [.], [ ], [])
Patient Name Press key to move cursor, then input information if desired.
To input letters under the ID and Patient Name options, press . and key to select the desired letter.
If a bar code reader has been installed, users can read the bar code of the ID or SSN with the bar code reader by
moving the cursor to the position of the ID or SSN. If the read data is out of range, the system will sound an
alarm.
The bar code reader model is CCD600, and the serial port interfaces are made by GIGA-TMS INC in TAIWAN. There
is more information on the operation of the CCD bar code reader in the programming manual.
Press the Analyze key to return to the analysis procedure.
If the operation option ID input is set to ON (see Setting Operation Options in chapter 2, Setup, for details), the
ID must be input. If the ID has not been entered when the Analyze key is pressed, the system will show Figure 4-
9.
<< SAMPLE DATA >> QC-run control 10:06:12

>>You must input ID.
Figure 4-9. Analysis Warning Screen.
42
Figure 4-10 shows 4 screens of the Analysis screen.
<< ANALYSIS >> 10:06:12

Remaining 48sec. Rinse STD-A
* Na+ : ON * K+ : ON
* Cl- : ON * Li+ : OFF
<< ANALYSIS >> 10:06:12

* 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
Figure 4-10. Analysis Screens.
During the analysis procedure, press the Status key to switch among the four Analysis screens.
Once sample analysis is finished, the printer will automatically print the results. During printing, the Analysis
Concentration screen (Figure 4-11) will appear. Once printing is finished, the system remains in the Analysis
Concentration screen for 5 seconds. Press any key to immediately 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 4-11. Analysis Concentration Screen.
Units and resolution depend on (Set Up set) the values entered under Setup. (See Setting Electrolyte Resolution
Values in chapter 2, Setup, for details.).
OFF: Means that the sensor has not been selected.

If the analysis procedure is interrupted, the system will rinse the flow path with STD-A and REF.
At the end of analysis, the system will print the results as shown in Figure 4-12. (To set the analysis printout
format, see Setting Operation Options in chapter 2, Setup, for details.)
Note: For QC analysis, press QC instead of the Analyze key.
1999/04/28 13:23:12
================================
<< Analysis >>
SAMPLE ID : A122113994
Access # : 1221159940
Name : S-M WU
Sequence # : 1
Analyze Date: 1999/04/28 (1)
Analyze Time: 13:24:10
Sample Type : Serum/Plasma (2)
--------------------------------
(2)
Item Concentration Message (3)
---- -------------- -----------
Na+ NC (4)
K+ 3.12 mmol/L
Cl- 100.2 mEq/L Drift
================================
================================
Item STD-A [mV] Sample [mV]
---- ------------ --------------
Na+ -120.55 75.26
K+ 56.28 98.58
Figure 4-12. Printout of Analysis.
(1) Message Print must be set to ON in the Operation Options for the system to print this message (See Setting
(2) NC: Means that the sensor is not calibrated.
(3) Drift: Means that the voltage of STD-A taken during analysis is too high compared with the voltage of STD-A
during calibration.
(4) MV Print must be set to ON in the Operation Options for the system to print this message (See Setting
44
Status Function Key
The Status screen can be called up in any screen by pressing the Status key.
Figure 4-13A, B, C shows the Status screens.
Press Status key to change the Status screens or press the Enter key to print all status information.
Status screen 1 (Figure 4-13A) 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 4-13A. Status Screen 1.
Status screen 2 (Figure 4-13B) shows the voltage values of each sensor that has been selected. All signals are
updated once per second.

* Na : -120.55 mV * K+ : 12.54 mV
* Cl- : 123.45 mV * AIR : 880.45 mV
Figure 4-13B. Status Screen 2.
Status screen 3 (Figure 4-13C) shows the flow rate of the calibration and analysis procedures. All signals are
updated once per second (?)..

Figure 4-13C. Status Screen 3.
Press the Esc key to quit the Status screen.

Flowpath Function Key
Press the Flowpath key in the Main screen. The system will pump air into the analyzer until the S-line, electrode
train, and W-line are empty. Once empty, the screen will display Flowpath screen 1 (Figure 4-14).
<< FLOWPATH >> 11:20:51
>> Press FLOWPATH key to continue.
Figure 4-14. Flowpath Screen 1.
Either press the Flowpath key again while in Flowpath screen 1 to prime the tubing with all fluids and return to the
Main screen (Figure 4-1), or system will automatically prime all fluids after one hour of idling. Before priming the
tubing with all fluids , the system will beep 10 times (once per second) and display Flowpath screen 2 (Figure 4-15).
To stay in flowpath mode (or clear the tubing), press the ESC key during these 10 seconds.
<< FLOWPATH >> 11:20:51
>> Press ESC key to stay in flowpath mode.

>> Press FLOWPATH key to continue.
Figure 4-15. Flowpath Screen 2.
46
Menu Function Key
Press the Menu key in the Main screen to enter the Menu screen. Figure 4-16 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 4-16. Menu Screen.
Input 1~6 and press the Enter key to select a function, or press Esc to return to the Main screen.
4.2.2 Setup Options

When the Menu key in the Main screenis pressed, the system will enter the Menu screen. Input 1 and press the
Enter key to run the set up procedures (see Setup Options in chapter 2, Setup, for details).
4.2.3 Operation Options

When users press the Menu key in the Main screen, system will enter the Menu screen. Input 2 and press the Enter
key to run operation procedures (see Setting Operation Options in chapter 2, Setup, for details).
4.2.4 Data Options

When users press the Menu key in the Main screen, system will enter the Menu screen. Input 3 and press the Enter
key to call up the data options. Figure 4-17 shows the Data screen.
<< DATA >> Input No.? 1 10:06:12

1. Recall 4. Clear
2. Transfer
3. R-Time Trans: off
Figure 4-17. Data Screen.
Input 1~4 and press the Enter key to select a function, or press Esc to return to the Menu screen.

4.2.5 Data Recall
Input 1 and press the Enter key in the Data screen to enter the Data Recall screen. Figure 4-18 shows the Data
Recall screen.
<< RECALL >> ID : NONE 10:06:12
>> Press ENTER to seek.

>> Press ESC key to quit.
Figure 4-18. Data Recall Screen.
For searches, users can input an ID and press the Enter key or read the ID using the bar code reader. If users dont
input an ID, press the Enter key to search for all data (Figure 4-17). (NONE: means search for all IDs)
Press the Esc key to return to the Data screen.
Figure 4-19 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 4-19. Data Seek Screen.
Press the keys to search for data (maximum of 250 data).
Press the keys to browse the data found in the search.
Press the Enter key to print the data found in the search.
Press the Esc key to return to the Data screen.
48
4.2.6 Data Transfer
Input 2 and press the Enter key in the Data screen to enter the Transfer Data screen. Figure 4-20 shows the
Transfer Data screen.
<< TRANSFER DATA >> 10:06:12

(1 ) ID: A123456789 Date: 1999/04/24
>> Transferring...
>> Press ESC key to interrupt.
Figure 4-20. Transfer Data Screen.
To run this function, users must connect the analyzer to a PC by serial port and use the ASTM protocol (see
Service Manual for details).
When the HumaLyte is transferring data, the screen shows Figure 4-18. Line 2 of the screen will display the file
currently being transferred.
After transferring, system will automatically return to the Data screen.
4.2.7 R-Time Trans: off

1. The default value for R-Time Transfer is OFF. Input 3 and press the Enter key to turn this function on, if
necessary.
2. The purpose of this function is for users who wish to transfer analysis data to a computer in real time.

4.2.8 Data Clear
Input 3 and press the Enter key in the Data screen to enter the Clear Data screen. Figure 4-21 shows the Clear Data
screen.
<< CLEAR DATA >> 10:06:12

>>Are you sure to clear data? ENTER
>>Press ESC key to quit.
Figure 4-21. Clear Data Screen.
Press the Enter key to clear the saved data to memory, or press the Esc key to return to the Data screen.
Figure 4-22 shows the system running the clearing data procedure.
<< CLEAR DATA >> 10:06:12

>>Clearing.......
Figure 4-22. Clearing Data Screen.
Figure 4-23 shows the Data Clear OK screen. Press any key to return to the Data screen.
<< CLEAR DATA >> 10:06:12

>>Data clear ok!
Figure 4-23. Data Clear OK Screen.
If the system shows Figure 4-24, press any key to return to the Data screen and contact your local HUMAN
representative.
<< CLEAR DATA >> 10:06:12

>>Data clear error!
Figure 4-24. Data Clear Error Screen.
50
4.2.9 Software Version
When the Menu key is pressed in the Main screen, system will enter the Menu screen. Input 4 and press the Enter
key in the Menu screen to enter the Software Version screen. Figure 4-25 shows the Software Version screen.
<< SOFTWARE VERSION >> 10:06:12

* Main program version : 3.1
* Test program version : 3.1
Figure 4-25. Software Version Screen.
Press any key to return to the Menu screen.
4.2.10 Diagnostic
When the Menu key is pressed in the Main screen, system will enter the Menu screen. Input 5 and press the Enter
key to run diagnostic procedures (for details, see Diagnostic in chapter 6, Troubleshooting).
4.2.11 Maintenance
When the Menu key is press in the Main screen, system will enter the Menu screen. Input 6 and press the Enter key
to run maintenance procedures (for details, see chapter 4, Maintenance).
4.2.12 QC function Key

Press the QC key in the Main screen to run a QC analysis (for details, see chapter 5, QC).

4.3 HumaLyte Operation
This prologue contains basic instructions for running samples.
The HumaLyte is a sophisticated instrument with many operating functions and convenient user features. This
chapter explains in detail how to operate the HumaLyte. However, the HumaLyte 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 instruments set-up
parameters.
Note:
Reference to chloride or lithium or both are only applicable to instruments with these electrodes.
In order to test lithium, both sodium and potassium should also be tested at the same time.
4.3.1 Shortcut Procedures

The shortcut procedures are as shown on Figure 4-26.
POWER
Analysis
ON
Selecting Calibration
Electrodes
Selecting
Set Sample
Analysis
Type
Mode
Figure 4-26. Shortcut Procedures.
Note:
The Shortcut Procedures are for reference use only. For more detailed information, please refer to the
corresponding sections in this Reference Manual.
52
4.4 Power On
See Powering on the Instrument (in Chapter 1, Description) for details.
4.4.1 Selecting Electrodes

See Selecting Electrodes (in Chapter 2, Setup) for details.
4.4.2 Set Sample Type

See Samp. Type Function key (in Chapter 2, Setup) for details.
4.4.3 Selecting Analysis Modes

There are 2 analysis modes built in: Manual Mode and Semi-Auto Mode. Users can position the arm vertically to
operate in Semi-Auto Mode or lift up the arm to operate in Manual Mode. The instrument has an auto-sensor to
distinguish the 2 modes automatically. (Figure 4-27A, B)
Figure 4-27A. Semi-Auto Mode. Figure 4-27B. Manual Mode.
Note: Place the sample cup carefully to avoid possible spills when using the Semi-Auto Mode.

4.4.4 Calibration
Press the Calibrate key in the Main screen to run calibration procedures. There are two modes of calibration built
into the HumaLyte, Manual Calibration and Auto Calibration.
4.4.5 Manual Calibration

To initiate a manual calibration on the HumaLyte, press the Calibrate key while the system is idling.
4.4.6 Auto-Calibration
The HumaLyte 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 the two-point calibration interval, see Setting
Two-point Calibration Interval in chapter 2, Setup, for details.
4.4.7 Analysis: Serum/Plasma

All installation and calibration procedures must be done before running samples.
TAble 4-3 shows the procedures for running samples on the two analysis modes.
TAble 4-3. Procedures of the Two Analysis Modes.
Procedure Semi-Auto Manual

1 Press the Analyze key so that the probe remains in the
outside position.
2 Place sample cup in Sample Holder. Place a sample cup underneath the probe.
3 Press the Analyze key to analyze the Press the Analyze key to analyze the sample.
sample.
4 After analysis, the probe will automatically return to

the inside position.
Note: If the Analyze key is not pressed when the probe is in the outside position, the HUMALYTE will automatically
sound an alarm after 10 seconds and the probe will return to the inside position after 20 seconds.
The HumaLyte will print results and save the data to memory automatically at the end of each analysis and
display the results on the screen.
After printing the results, the screen will return to the Analysis screen (Figure 4-7).
4.4.8 Analysis: Whole Blood

All procedures for running whole blood are the same as for running serum/plasma. The sample type must be
selected as Whole Blood (for details, see Set Sample Type in chapter 3, Operation).
The Humalyte will print the results and save the data to memory automatically at the end of each analysis,
showing the results on the screen.
54
4.4.9 Analysis: Urine
Before analyzing urine samples, the samples must be diluted with Urine Diluent for HumaLyte (Cat. No.: U0050).
Dilute one part urine sample with two parts diluent and mix well. After diluting the urine sample, it may be
analyzed. All procedures for running urine are the same as for running serum/plasma. Sample type must be
selected as Urine (for details, see Set Sample Type in chapter 3, Operation).
HumaLyte will print the results and save the data to memory automatically at the end of each analysis, showing
the results on the screen.
Note: If the printed results of a urine sample report Too low, analyze the undiluted sample directly, then divide
the result by 3 to obtain the correct result.

56
Contents
5 Maintenance ................................................................................................................................................................................................59
5.1 Introduction......................................................................................................................................................................................59
5.2 Maintenance Function .................................................................................................................................................................59
5.2.1 Condition ...........................................................................................................................................................................................60
5.2.2 Condition Na ....................................................................................................................................................................................60
5.2.3 Condition f_path.............................................................................................................................................................................63
5.2.4 Clean Flow Path...............................................................................................................................................................................65
5.2.5 Reagent Information .....................................................................................................................................................................67
5.2.6 Prime ...................................................................................................................................................................................................67
5.2.7 Probe Adjustment...........................................................................................................................................................................68
5.2.8 Calibrate Pump Frequency ..........................................................................................................................................................69
5.3 Daily Maintenance .........................................................................................................................................................................69
5.3.1 Checking the Reagent Pack Level..............................................................................................................................................70
5.3.2 Cleaning the Sample Inlet Port..................................................................................................................................................70
5.3.3 Conditioning Na Electrode ..........................................................................................................................................................70
5.3.4 Conditioning the Flow Path with Serum ...............................................................................................................................70
5.3.5 Checking Slope & Flow Time ......................................................................................................................................................70
5.3.6 Checking the Electrode Slope.....................................................................................................................................................70
5.3.7 Checking the Flow Time ...............................................................................................................................................................70
5.4 Periodic Maintenance ...................................................................................................................................................................71
5.4.1 Flow Path Maintenance Cycle....................................................................................................................................................71
5.4.2 Replacing the W-line .....................................................................................................................................................................71
5.4.3 Replacing the R-line .......................................................................................................................................................................72
5.4.4 Replacing the S-line .......................................................................................................................................................................73
5.4.5 Replacing the A-line/B-line .........................................................................................................................................................74
5.4.6 Replacing the Probe .......................................................................................................................................................................75
5.4.7 Replacing the Electrodes..............................................................................................................................................................76
5.5 Non-routine Maintenance ..........................................................................................................................................................77
5.5.1 Cleaning the Sample Inlet Port..................................................................................................................................................77
5.5.2 Cleaning the Probe.........................................................................................................................................................................77
5.5.3 Standby Mode..................................................................................................................................................................................77
5.6 Replacing the Reagent Pack........................................................................................................................................................78
5.7 Installation of Thermal Paper ....................................................................................................................................................80
5.8 Shutdown ..........................................................................................................................................................................................81
58
5 Maintenance
5.1 Introduction
This chapter explains how to maintain the HumaLyte. 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 analyzers with these electrodes.
5.2 Maintenance Function
HumaLyte maintenance functions should be performed as described below.
Input 6 and press the Enter key in the Menu screen to enter the Maintenance screen. Figure 5-1 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
<< MAINTENANCE >> Input No.?1 10:06:12
1. Condition Na 2. Condition f_path
Figure 5-1. Maintenance Screen.
Input 1~6 and press the Enter key to select a function or press the 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 Runs procedures for conditioning sodium electrode and flow path.
Clean Flow Path Runs procedures for cleaning flow path.
Reagent information Shows information on the reagent pack.
Prime Runs procedures for priming with the selected solution or air.
Probe adjustment Adjusts the probe position.
Cal. pump frequency Calibrates the pump frequency.

5.2.1 Condition
Input 1 and press the Enter key in the Maintenance screen to enter the Condition screen. Figure 5-2 shows the
Condition screen.
<< CONDITION >> Input No.?1 10:06:12

1. Condition Na 2. Condition flow path
Figure 5-2. Condition Screen.
Input 1 or 2 and press the Enter key to select a function or press the Esc key to return to the Menu screen.
5.2.2 Condition Na
Note: When this procedure is performed, be sure to condition the sodium electrode first, then condition the flow
path with serum.
During the sodium conditioning cycle, CONDITIONING Na SOLUTION (Cat. No.: 17422) is aspirated from a sample
cup into the electrode carrier. After the electrodes are conditioned, the Conditioning Na Solution is flushed into the
waste bottle.
Instructions:
The sampler must be pulled out (raise the sample arm) for sampling Conditioning Na Solution.
Fill the sample cup with 1ml CONDITIONING Na SOLUTION (Cat. No.: 17422).
From the Menu screen, press 6 and the 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. The calibration procedures must be done before running an analysis.
Condition Na Screen 1
Input 1 and press the Enter key in the Condition screen to enter the Condition Na screen. Figure 5-2A, B, C, D, E
shows the Condition Na screens.
<< CONDITION Na >> 10:06:12

>>Pull the sampler out, then press ENTER
key to start.
Figure 5-2A. Condition Na Screen 1.
60
Press the Enter key to move the probe out, or press the Esc key to return to the Condition screen.
Press the Enter key in Condition Na screen 1 to switch to Condition Na screen 2 (Figure 5-2B).

>>Hold condition solution under probe,
then press ANALYZE key to prime soln.
Figure 5-2B. Condition Na Screen 2.
Hold the Conditioning Na Solution under the probe for priming.

Press the Analyze key to prime Conditioning Na Solution, or press the Esc key to enter Condition
Na screen 6 (Figure 5-2F). Then, press the Esc key to return to the Condition screen.
Press the Analyze key in Condition Na screen 2 to switch to Condition Na screen 3 (Figure 5-2C).

>>Priming...
Figure 5-2C. Condition Na Screen 3.
Press the Esc key once for Figure 5-2F, or press the Esc key twice to return to the Condition screen.

After priming with the Conditioning Na Solution, the screen switches to Condition Na screen 4 (Figure 5-2D).

>>Wait for 60 sec.
Figure 5-2D. Condition Na Screen 4.
Wait for the Conditioning Na Solution to condition the Na electrode for 60 seconds.
Press the Esc key once for Figure 5-2E, or press the Esc key twice to return to the Condition screen.
After the Na electrode has been conditioned, the screen will change to Condition Na screen 5 (Figure 5-2E).

>>Condition Na+ was finished.
Figure 5-2E. Condition Na Screen 5.

Press the Esc key to return to the Condition screen.
62
5.2.3 Condition f_path
Note: Always condition the flow path with serum after the sodium electrode has been conditioned.
Instructions:
The sampler must be pulled out (raise the sample arm) for sampling serum.
Fill the sample cup with serum.
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. Calibration must be performed before running an analysis.
Condition f_path Screen 1
Input 2 and press the Enter key in the Condition screen to enter the Condition f_path screen. Figures 4-3A, B, C, D,
E, F show the Condition f_path screens.
<< CONDITION FLOW PATH >> 10:06:12

key to start.
Figure 5-3A. Condition f_path Screen 1.
Press the Enter key to move the probe out, or press the Esc key to return to the Condition screen.
Press the Enter key in Condition f_path screen 1 to switch to Condition f_path screen 2 (Figure 5-3B).

>>Hold serum under probe, then press
ANALYZE key to prime serum.
Figure 5-3B. Condition f_path Screen 2.

Hold serum under the probe for priming.
Press the Analyze key to prime serum, or press the Esc key to enter Condition f_path screen 6
(Figure 5-3F). Then press the Esc key to return to the Condition screen.

Press the Analyze key in Condition f_path screen 2 to switch to Condition f_path screen 3 (Figure 5-3C).

>>Priming...
Figure 5-3C. Condition f_path Screen 3.
Press the Esc key once for Figure 5-3F, or press the Esc key twice to return to the Condition screen.
After priming with serum, the screen will change to Condition f_path screen 4 (Figure 5-3D).

>>Wait for 60 sec.
Figure 5-3D. Condition f_path Screen 4.
Wait for the serum to condition the flow path for 60 seconds.
Press Esc key once for Figure 5-3F, or press Esc key twice to return to the Condition screen.
After the flow path has been conditioned, the screen will change to Condition f_path screen 5 (Figure 5-3E).

>>Condition flow path was finished.
Figure 5-3E. Condition f_path Screen 5.
Press the Esc key to return to the Condition screen.
64
5.2.4 Clean Flow Path
Instructions:
The sampler must be pulled out (raise the sample arm) for sampling Cleaning Solution.
Fill the sample cup with CLEANING SOLUTION (Cat. No.:17421).
Select the Clean Flow Path option (select 2 to access this option).
After cleaning the flow path, run the Condition f_path procedures and calibration again before
analyzing a sample.
The cycle takes about 1 minute. When the cycle is finished, all electrodes will be uncalibrated and the status will
display NC. The calibration procedures must be run before running an analysis.
Clean Flow Path Screen 1
Input 2 and press the Enter key in the Maintenance screen to enter the Clean Flow Path screen. Figures 4-4A, B, C,
D, E, F show the Clean Flow Path screens.
<< CLEAN FLOW PATH >> 10:06:12

key to start.
Figure 5-4A. Clean Flow Path Screen 1.
Press the Enter key to move the probe out, or press the Esc key to return to the Maintenance screen.
Press the Enter key in Clean Flow Path screen 1 to switch to Clean Flow Path screen 2 (Figure 5-4B).

>>Hold clean solution under probe, then
press ANALYZE key to prime clean soln
Figure 5-4B. Clean Flow Path Screen 2.
Hold the Cleaning Solution under the probe for priming.

Press the Analyze key to prime with Cleaning Solution, or press the Esc key to enter Clean Flow
Path screen 6 (Figure 5-4F). Then press the Esc key to return to the Maintenance screen.

Press the Analyze key in Clean Flow Path screen 2 to switch to Clean Flow Path screen 3 (Figure 5-4C).

>>Priming...
Figure 5-4C. Clean Flow Path Screen 3.
Press the Esc key once for Figure 5-4F, or press the Esc key twice to return to the Maintenance
screen.
After priming with Cleaning Solution, the screen switches to Clean Flow Path screen 4 (Figure 5-4D).

>>Wait for 60 sec.
Figure 5-4D. Clean Flow Path Screen 4.
Wait for the Cleaning Solution to clean the flow path for 60 seconds.
Press the Esc key once for Figure 5-4F, or press the Esc key twice to return to the Maintenance
screen.
After cleaning the flow path, the screen will change to Clean Flow Path screen 5 (Figure 5-4E).

>>Clean flow path was finished.
Figure 5-4E. Clean Flow Path Screen 5.
Press the Esc key to return to the Maintenance screen.
66
5.2.5 Reagent Information
Input 3 and press the Enter key in the Maintenance screen to enter the Reagent Information screen. Figure 5-5
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 5-5. Reagent Information Screen.
Press the keys to change among screens.
5.2.6 Prime
Input 4 and press the Enter key in the Maintenance screen to enter the Prime screen. Figure 5-6 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 5-6. Prime Screen

Input 1~6 and press t
he Enter key to select a prime option.
The system will prime with each fluid 20 seconds each time, then return to the Prime screen.
The FULL option: The system will prime each fluid, STD-B, STD-A, and REFERENCE, for 20
seconds .
Figure 5-7 shows the Priming screen. Press the Esc key to interrupt the prime procedure and screen will show
Figure 5-6.
<< PRIME STD-A >> 10:06:12
>>Priming...
Figure 5-7. Priming Screen

Press the Esc key to return to the Prime screen when screen shows Figure 5-8.
<< PRIME STD-A >> 10:06:12

>>Prime error or interrupt.
Figure 5-8. Interrupt Priming Screen.
Note: When using the full prime function to empty the tubing, it is normal that the system will sound an alarm
three times.
5.2.7 Probe Adjustment

Input 5 and press the Enter key in the Maintenance screen to enter the Prime screen. Figure 5-9A shows Probe
Adjustment screen 1.
<< PROBE ADJUSTMENT >> Input No.?1 10:06:12

1. AIR
2. SAMPLE
Figure 5-9A. Probe Adjustment Screen 1.
Input 1 or 2 and press the Enter key to enter Probe Adjustment screen 2 (Figure 5-9B) or 3 (Figure 5-9C).
Option 2. SAMPLE: Refers to the probe position in Semi-Auto Mode (when the sampler is inside)
<< PROBE ADJUSTMENT >> 10:06:12

* AIR : 500 (Default : 500)
>> Press key to move probe.
Figure 5-9B. Probe Adjustment Screen 2.
<< PROBE ADJUSTMENT >> 10:06:12

* SAMPLE : 1420 (Default : 1420)
>> Press key to move probe.
Figure 5-9C. Probe Adjustment Screen 3.

Press the keys to adjust the probe position.
68
5.2.8 Calibrate Pump Frequency
Input 6 and press the Enter key in the Maintenance screen to enter Calibrate Pump Frequency screen 1 (Figure 5-
9D).
>> Setting the flow rate... 10:06:12
Figure 5-9D. Calibrate Pump Frequency Screen 1.
After Calibrating pump frequency, the screen will change to Calibrate Pump Frequency screen 2 (Figure 5-9E).
<< CAL. PUMP FREQUENCY >> 10:06:12

* Pump frequency = 105
* Flow rate = 2.10 sec
Figure 5-9E. Calibrate Pump Frequency Screen 2.
5.3 Daily Maintenance
The following maintenance procedures must be performed before using HUMALYTE for the first time each day:
Check the reagent pack level.
Clean the sample inlet port.
Condition the Na electrode.
Condition the flow path with serum.
Check the slope and flow time.
Note: 1. HUMAN recommends conditioning the Na electrode and flow path before daily operation. The instrument
must also be calibrated after electrode conditioning has been performed.
2. All fluids in tubing are infectious and thus must be handled with care! Wear gloves if necessary!
Perform the following steps to complete the daily maintenance procedures:

5.3.1 Checking the Reagent Pack Level
Press Status then press the keys repeatedly until Status screen 2 appears (Figure 3-13B). This screen shows
the amount of fluid that is left in the reagent pack for the most-consumed fluid. 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 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.
5.3.2 Cleaning the Sample Inlet Port

Raise the sampler into the manual position.
Clean the sample inlet port with a cotton swab moistened with deionised water.
Note: If whole blood is analyzed frequently, clean the sample inlet port more often.
5.3.3 Conditioning Na Electrode

See Condition Na in the earlier section of this chapter for details.
5.3.4 Conditioning the Flow Path with Serum

See Condition f_path in the earlier section of this chapter for details.
5.3.5 Checking Slope & Flow Time

Calibrate the instrument if electrode conditioning has just been performed. Calibration is initiated by pressing the
Calibrate key.
5.3.6 Checking the Electrode Slope

Press Status then press the keys until 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.
5.3.7 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 then press the keys until 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.
70
5.4 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 maintains the instrument in an idle state while
it is being serviced.
5.4.1 Flow Path Maintenance Cycle

To initiate the Flow Path Maintenance Cycle, press the Flowpath key once in the Main screen. Users can also use
the Prime function and select AIR to empty the 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.
5.4.2 Replacing the W-line

Figure 5-10 shows the location of the W-line. Replace the W-line according to the following procedure:
Figure 5-10. Location of the W-line.

Use the Prime function or press the Flowpath key to empty the W-line.
Detach the fitting on the W-line for the reagent harness tubing.
Loosen the pump by lifting the lock.
Remove the W-line from the waste valve.
Remove the W-line from the pump.
Disconnect the W-line from the top of the electrode carrier and discard the used W-line.
Insert a new W-line into the pump.
Fasten the pump by pushing down the lock.
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.
Insert the straw into the waste bottle.
Close the analyzer door.
Prime the HumaLyte with fluids.
Perform a calibration.
5.4.3 Replacing the R-line

Figure 5-11 shows the location of the R-line. Replace the R-line according to the following procedure:
Figure 5-11. Location of the R-line.

Use the Prime function to empty the R-line.
Detach the fitting on the R-line for the reagent harness tubing.
Remove the R-line from the reference valve.
Disconnect the R-line from the left-hand side of the electrode carrier and discard the used R-line.
Connect a new R-line 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.
Insert the straw into the reference bottle.
72
5.4.4 Replacing the S-line
Figure 5-12 shows the location of the S-line. Replace the S-line according to the following procedure:
S-line
Figure 5-12. Location of the S-line.

Use the Prime function or press the Flowpath key to empty the S-line.
Detach the S-line fitting on the probe.
Remove the S-line.
Disconnect the S-line from the bottom of the electrode carrier and discard the used S-line.
Connect a new S-line to the bottom of the electrode carrier.
Thread the S-line into the probe.
Prime fluids into the HumaLyte.

5.4.5 Replacing the A-line/B-line
Figure 5-13 shows the location of the A-line and B-line. Replace the A-line and B-line according to the following
procedure:
B-line
A-line
Figure 5-13. Location of the A-line and B-line.
74
5.4.6 Replacing the Probe
Figure 5-14 shows the location of Probe. Replace the Probe according to the following procedure:
Probe
Figure 5-14. Location of the Probe.

Use the Prime function or press the Flowpath key to empty the probe.
Detach the S-line fitting on the of the probe.
Unscrew the probe cap and take off the probe.
Discard the used probe.
Insert a new probe into the probe cap.
Screw the probe cap on tightly.
Connect the S-line to the probe.

5.4.7 Replacing the Electrodes
Figure 5-15 shows the Electrode Carrier. Replace the electrodes according to the following procedure:
Figure 5-15. Electrode Carrier.

Use the Prime function or press the Flowpath key to empty the electrodes.
Disconnect the W-line, R-line and S-line.
Remove the electrode carrier.
Unlock the electrodes in the carrier by pushing down the Locking lever.
Remove the old electrodes by sliding them out of the carrier.
Install the new electrodes by sliding them into the electrode carrier with the sealing gasket oriented toward the
top.
Engage the locking lever above the air detector to lock the electrodes into place.
Replace the electrode carrier on its mounting bracket on the HUMALYTE. Make sure the electrode spacer is at the
top.
Note: Align the guiding ground rod on the electrode train with the hole on the analyzer. Make sure that you push
in the guiding ground rod first.
Connect the W-line, R-line and S-line.
If the sodium electrode was replaced, perform a condition Na cycle and condition flow path cycle, in that order.
Each of these procedures is explained earlier in this chapter. If other electrodes were replaced, perform only a
condition flow path cycle with serum.
Calibrate the instrument twice.
76
5.5 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.
5.5.1 Cleaning the Sample Inlet Port

See Cleaning the Sample Inlet Port in the earlier section of this chapter for details.
5.5.2 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:
Raise the sampler into manual position.
Fill the sample cup with 1ml of CLEANING SOLUTION (Cat. No.: C0060).
See Clean Flow Path earlier in this chapter for details.
Recondition the flow path with serum (see Daily Maintenance Procedures), and recalibrate before proceeding to
control and specimen assays.
5.5.3 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 small amounts of STD-A and REF through the flow path.
Note: In order to conserve fluids, the HumaLyte does not perform recalibration while it is in Standby Mode.
See Start/Standby Function Key in chapter 2, Setup, for details.

5.6 Replacing the Reagent Pack
Replace the reagent pack and septum when the reagent pack has expired or is empty.
Note:
All fluids in tubing are infectious and thus must be handled with care! Wear gloves if necessary!
The septum must be replaced together with the reagent pack.
Replacing the reagent pack

When the reagent pack has expired or is empty, the system will show Figure 5-16A and start emptying all
standard solutions.
<< CHANGE REAGENT PACK >> 10:06:12

* Reagent pack has expired!
>> Emptying all standard solutions...
Figure 5-16A. Change Reagent Pack Screen 1.
After emptying all standard solutions, the system will show Figure 5-16B.

>> Please disconnect tubing (A, B, R),
then press ENTER key to empty tubing.
Figure 5-16B. Change Reagent Pack Screen 2.

Remove the 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.
Press the Enter key to empty the tubing and system will show Figure 5-16C.

>> Emptying tubing...
Figure 5-16C. Change Reagent Pack Screen 3.
78
After emptying all tubing, system will show Figure 5-16D.

>> Please replace a new reagent pack,
then press CALIBRATE key to start.
Figure 5-16D. Change Reagent Pack Screen 4.
Remove the W-straw from the waste bottle. Wipe it dry with a tissue.
Remove the old reagent pack.
Place the new reagent pack onto the fluids deck.
Replacing the septum

Disconnect the A-line and B-line from the old septum.
Turn the septum counter-clockwise 1/4-turn, and remove it from the sampler (as shown in Figure 5-17, left).
Discard the old septum.
Slide the new septum over the probe and turn it clockwise 1/4-turn to lock it into place (as shown in Figure 5-17,
right).
Connect the A-line and B-line to the new septum.
Insert the tubing harness straws into the appropriate bottles of the reagent pack.
Septum
Figure 5-17. Replacing the Septum.

Press the Calibrate key to start full priming and the system will show Figure 5-16E.

* New reagent pack
>> Full priming...
After full priming, the system will do an auto-calibration.

5.7 Installation of Thermal Paper
This section not only explains installation of the thermal paper but also explains the replacement of thermal paper.
Users can install/replace thermal paper according to the following procedure.
Open the printer cover.

Gently remove the old roll.
Install a new roll of paper into the chamber.
Insert the tip of the thermal paper into the paper inlet of the printer.
Press the ON LINE key on the top of the HumaLyte once to turn off the ON LINE light indicator, then press the
Feed key several times until the tip of the paper roll extends through the outlet.
Pull the paper and center it.
Press the ON LINE key once to turn on the ON LINE light indicator.
Close the printer cover.
If the printer fails to print after a new roll of paper is installed, investigate the following possible causes:
If the loose end feeds from the top of the roll, the roll of paper is installed upside down. Remove the roll, turn it
around, and install it so the loose end feeds from the bottom of the roll.
The printer paper is jammed. Check that the part number of the paper (Cat. No.: 18144/5) is correct for the
HumaLyte printer.
After installing the thermal paper, check the ON LINE light indicator. If the ON LINE light indicator is off, press the
ON LINE key once to turn on the ON LINE light indicator.
If the above-mentioned points have been checked and none of them is the cause of the printer failure, try powering
off the HumaLyte and powering it on again.
If the printer fails to print after a new roll of paper is installed, investigate the following possible causes:
80
5.8 Shutdown
Use the following shutdown procedure to prevent salt buildup in the flow path when the HumaLyte is turned off or
unplugged.
Note: All fluids in tubing are infectiousand thus must be handled with care! Wear gloves if necessary!

Remove the 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.
Leave the A, B and R straws exposed to the air.
From the Menu screen, press 6 to access the Maintenance screen.
Select the Prime function,then select the Full Prime option.
Press the Enter key to purge the fluids from all the tubes.
At the conclusion of the full prime cycle, immerse the ends of the A, B, and R straws into a beaker of deionised
water.
Press the Enter key to fill the tubes with deionised water.
At the conclusion of the prime cycle, remove the straws from the beaker of water and leave them exposed to air.
Perform 2 full prime cycles with air to purge all water from the tubing.
At the conclusion of the second full prime cycle, remove the W straw from the waste bottle and wipe the straw.
If the reagent pack has a reasonable amount of reagent left, tape the holes on top of the bottles or cover them
with parafilm to prevent evaporation of the fluids.
Release the collars of the W-line from the pump bracket.
Switch the power button to OFF and unplug the HumaLyte.

82
Contents
6 Quality Control (QC) ..................................................................................................................................................................................85

6.1 Introduction......................................................................................................................................................................................85
6.2 Analyze Control ...............................................................................................................................................................................85
6.3 QC Setup ............................................................................................................................................................................................88
6.4 Statistics.............................................................................................................................................................................................91
6.4.1 Browse QC Data ..............................................................................................................................................................................91
6.4.2 Print QC Data....................................................................................................................................................................................92
6.4.3 Print L-J Chart ...................................................................................................................................................................................92
6.4.4 Browse Statistics.............................................................................................................................................................................93
6.4.5 Print Statistics ..................................................................................................................................................................................94
6.5 Clear QC Data...................................................................................................................................................................................95
84
6 Quality Control (QC)
6.1 Introduction
Monitor the performance of the HumaLyte by analyzing quality control samples. The HumaLyte can track up to 7
QC levels and store the results in the instruments memory. These results are used to calculate any requested
statistics data. 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 an error is
reported, the HumaLyte will sound an 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 function from the Main screen by pressing the QC key on the instrument.
<< QC >> Input No.? 1 10:06:12

1. Analyze control 2. QC setup
3. Print W-R violn 4. Statistic
5. Clear QC data
Figure 6-1. QC Screen.
Input 1~5 and press the Enter key to select a function or press the Esc key to return to the Main screen.
6.2 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 6-2. Analyze Control Screen.
Input the level number of QC samples and select which test items to analyze. Perform the usual analysis
procedures. Finally, the results will be printed automatically and a message will be displayed on screen asking the
user to confirm acceptance of the record.
Instruction
From the QC screen, press 1, Analyze Control, to access this option.
Press the keys to move the cursor.
Use the numerical keys to input the level numbers of the QC samples, and use the Enter key to turn the test
items on or off.
Press the Analyze key to start the analysis.
Check the analysis results (as shown in Figure 6-3, on the following page).

1999/04/28 13:23:12
==============================
<< Control Analysis >>
Level : 1
Lot No. : 12345678
Expiry Date : 1
Analyze Date: 1999/04/28 (1)
Analyze Time: 13:24:10 (2)
-------------------------------
Item Concentration Message (3)
---- -------------- -----------
Na+ NC (4)
K+ 3.12 mmol/L
Cl- 100.2 mEq/L Drift
===============================
===============================
Item STD-A [mV] Sample [mV]
---- ------------ -------------
Na+ -120.55 75.26
K+ 56.28 98.58
Cl- 123.45 78.02
================================
Figure 6-3. Printout of Control Analysis.
(1) Message Print must be set to ON in the Operation Options for the system to print this message (See
Setting Operation Options in chapter 2, Setup, 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 to ON in the Operation Options for the system to print this message (See
Setting Operation Options in chapter 2, Setup, for details).
After printing the analysis results, the screen will change to the Accept screen (Figure 6-4).
<< ANALYZE CONTROL >> 10:06:12

>>Accept this record : 1 (1:Yes 2:No)
>>Concentration out of range.
Figure 6-4. 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.
86
If users input 1, the screen will change to Save QC Data screen 1 (Figure 6-5). If users input 2, the screen will return
to the Analyze Control screen (Figure 6-2).
<< SAVE QC DATA >> 10:06:12

>>Saving.......
Figure 6-5. Save QC Data Screen 1.
If the QC data save is OK, the screen will change to Save QC Data screen 2 (Figure 6-6).
<< 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 6-2).
If there is not enough memory, the screen will change to Save QC Data screen 3 (Figure 6-7).
<< SAVE QC DATA >> 0:06:12

>>No memory to save. Please run CLEAR!
Press any key to return to the Analyze Control screen (Figure 6-2).
Use the Clear QC data function to clear all of the old data before saving the new data (See later in this chapter for
details).

6.3 QC Setup
The HumaLyte can check the results of the QC test by comparing the QC setup. The QC setup includes QC sample
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 6-8. QC Setup Screen.
Instructions:
From the QC screen, press 2, QC Setup, to access this option.
Use the numerical keys to input the level number, lot number and expiry date.
Press the Enter key to set range, mean & SD, and Westgard rule setting.
Press Esc to return to the QC screen.
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 6-9. QC Range Screen.

Instructions:
Use the numerical keys and the 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 in the settings (see Setting Electrolyte Resolution Values in chapter 2, Setup, for details).
Press Esc to return to the QC Setup screen.
88
If the concentration range has been changed, screen will display a warning message (Save QC Data screen 4, shown
as Figure 6-10) 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.

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 6-11. QC Mean & SD Screen.

Instructions:
AUTO means that the values of mean and SD are determined by the pervious QC data.
Press the QC key, then use the 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 6-12. QC Westgard Rule Screen.

Instructions:
Press the Enter key to switch ON or OFF.
Print Westgard Rules Violation

This option allows users to print the Westgard Rules violation chart. There are 5 rules which can be applied to the
QC sample.
(1) 1-2S: One sample with a result greater than 2 standard deviations (SD) from the mean.
(2) 1-3S: One sample with a result greater than 3 SDs from the mean.
(3) 2-2S: Two consecutive samples with results greater than 2SDs 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 6-13 shows the Wastgard Rules Violation Printing screen.
<< WESTGARD RULES VIOLATION >> 10:06:12

>>Printing...
Figure 6-13. Westgard Rules Violation Printing Screen.
Figure 6-14 shows the Westguard Rules Violation Chart Format as printed by the HUMALYTE.
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+ -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 6-14. Westguard Rules Violation Chart Format.
(1) The numbers (1-7): indicate the level in which a violation for at least one data set has occurred.
(2) *: Means no violation.
(3) Blank: means that not enough data has been checked.
90
6.4 Statistics
This function group allows users to process, calculate, and print QC results. Once selected, the screen displays the
the information below. Users may input the desired function number to access that 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 6-15. Statistics Screen.
Input 1~5 and press the Enter key to select a function or press the Esc key to return to the QC screen.
6.4.1 Browse QC Data

With this function, users can browse all data stored in the memory.
<< 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 6-16. Browse QC Data Screen 1.
Instructions:
From the Statistics screen, press 1, Browse QC Data, to access this option.
Use numerical key to set the date interval.
Use the keys to move cursor to proper fields and use the Enter key to turn off the test items on or off.
Press the QC key to switch to QC Data Browse screen 2 (Figure 6-17).
<< 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 6-17. Browse QC Data Screen 2.
Press the keys to change level & sensor.

Press the keys to change date.
Press the Esc key twice to return to the Statistics screen.

6.4.2 Print QC Data
Use this function to print QC test data from the memory.
<< 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 6-18. Print QC Data Screen.
Instructions:
From the Statistics screen, press 2, Print QC data, to access this option.
Use numerical keys to set the date interval.
Use the keys to move the cursor to specific fields and use Enter key to turn the test items on or off.
Press the QC key to print the data table (Figure 6-19 on the following page).
Press Esc to return to the Statistics screen.
Figure 6-19 shows the QC Data Format printed by the HumaLyte.
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
==============================
6.4.3 Print L-J Chart

When the Levey-Jennings 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 6-20. Print L-J Chart Screen.
92
Instructions:
From the Statistics screen, press 3, Print L-J Chart, to access this option.
Use the numerical keys to set the date interval.
Use the keys to move the cursor to specific fields and use the Enter key to turn off the test items on
or.
Press the QC key to print a L-J chart (Figure 6-21 on the following page).
Figure 6-21 shows the L-J Chart Print Format printed by the HUMALYTE.
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 6-21. L-J Chart Print Format.

0 means that the result is located at the mean value.
1 means that the result is located between mean value and 1SD.
2 means that the result is located between 1SD and 2SD.
3 means that the result is located between 2SD and 3SD.
4 means that the result is located out of 3SD.
6.4.4 Browse Statistics

The HumaLyte 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
3.Select level: 1 2 3 4 5 6 7
Figure 6-22. Browse Statistics Data Screen.

<< 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 6-23. Statistics Result Screen.
Press the keys to change level & sensor.

6.4.5 Print Statistics
<< PRINT 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 6-24. Print Statistics Data Screen.
Instructions:
From the Statistics screen, Press 5, Print Statistics Data, to access this option.
Use the numerical keys to set the date interval.
Use the keys to move cursor to specific fields and use the Enter key to turn the test items on or off.
Press the QC key to print statistics data (Figure 6-25).
Press the Esc to return to the Statistics screen.
Figure 6-25 shows the statistics data printout format printed by the HUMALYTE.
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
================================
94
6.5 Clear QC Data
When the memory for stored data is full, the memory must be cleared before more QC data can be saved.
<< CLEAR QC DATA >> 1999/04/29

* Select level: 1 2 3 4 5 6 7
>>Press QC key to clear QC data.
Figure 6-26. Clear QC Data Screen 1.
Instructions:
From the QC screen, press 5, Clear QC data, to access this option.
Press 5 again to confirm.
Note: Once cleared, data will be lost forever.
Use the keys to move cursor to the specific fields and use the Enter key to select a level.
Press the QC key to clear the data (Figure 6-27) or press the 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 the QC data clear is OK, the screen will change to Clear QC Data screen 3 (Figure 6-28).
<< CLEAR QC DATA >> 10:06:12

>>QC data clear ok
Press any key to return to the QC screen.

96
Contents
7 Troubleshooting..........................................................................................................................................................................................99
7.1 Introduction......................................................................................................................................................................................99
7.2 Troubleshooting Theory...............................................................................................................................................................99
7.2.1 Troubleshooting Procedure ........................................................................................................................................................99
7.2.2 Solving Flow Problems............................................................................................................................................................... 100
7.2.3 Indicator of Flow Related Problem........................................................................................................................................ 100
7.2.4 Flow Times ..................................................................................................................................................................................... 100
7.2.5 Air and Fluid Readings ............................................................................................................................................................... 101
7.2.6 Confirming a Flow Problem ..................................................................................................................................................... 101
7.2.7 Possible Sources of Flow Problem ......................................................................................................................................... 102
7.2.8 Flow Path Check ........................................................................................................................................................................... 102
7.3 W-line Check.................................................................................................................................................................................. 103
7.3.1 S-line/Electrode Carrier Check ................................................................................................................................................ 103
7.3.2 Probe Check ................................................................................................................................................................................... 104
7.3.3 A-line & B-line Check.................................................................................................................................................................. 105
7.3.4 R-line Check.................................................................................................................................................................................... 105
7.3.5 Septum Check ............................................................................................................................................................................... 106
7.4 Diagnostic....................................................................................................................................................................................... 106
7.4.1 Device Exercise ............................................................................................................................................................................. 107
7.4.2 Valve Exercise................................................................................................................................................................................ 107
7.4.3 Pump Exercise............................................................................................................................................................................... 108
7.4.4 Probe Exercise ............................................................................................................................................................................... 108
7.4.5 Device Test ..................................................................................................................................................................................... 109
7.4.6 Speaker Test................................................................................................................................................................................... 109
7.4.7 Printer Test..................................................................................................................................................................................... 110
7.4.8 LCD Test........................................................................................................................................................................................... 110
7.4.9 Keypad Test.................................................................................................................................................................................... 111
7.4.10 Sampler Sensor Test ........................................................................................................................................................ 111
7.4.11 Serial Port Test................................................................................................................................................................... 111
7.4.12 Air Detector Test ............................................................................................................................................................... 112
7.4.13 Error Log ............................................................................................................................................................................... 113
7.4.14 View Error Log .................................................................................................................................................................... 113
7.4.15 Print Error Log .................................................................................................................................................................... 113
7.4.16 Clear Error Log.................................................................................................................................................................... 114
7.4.17 System Test......................................................................................................................................................................... 115
7.4.18 Probe Position .................................................................................................................................................................... 115
7.4.19 Pump Movement .............................................................................................................................................................. 115
7.4.20 Valves Set............................................................................................................................................................................. 116
7.4.21 Sensor mV Data................................................................................................................................................................. 116
7.5 Error Code ....................................................................................................................................................................................... 117
7.5.1 Introduction to Error Codes ..................................................................................................................................................... 117
7.5.2 Display Error Code ....................................................................................................................................................................... 117
7.5.3 Problem Solving Procedures .................................................................................................................................................... 117
7.5.4 Interpreting Error Codes............................................................................................................................................................ 118
7.5.5 Error Code Reference.................................................................................................................................................................. 118
98
7 Troubleshooting
7.1 Introduction
This chapter describes the troubleshooting procedure for the HumaLyte and provides instructions on how to use
error codes and the Diagnostics screen.
7.2 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 a flow problem in the HumaLyte 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 HumaLyte. 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 a flow problem has been corrected
must be investigated individually.
Do not replace any flow path components until you have 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 may encounter with your HumaLyte.
7.2.1 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:
Eliminate obvious causes.
Troubleshoot 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:

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

If the preceding troubleshooting procedure fails to resolve the HumaLyte malfunction, call your local HUMAN
representative.
7.2.2 Solving Flow Problems

The flow path consists of the probe, septum, electrode train, all tubing, and the reagent pack (all of 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 a 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.
7.2.3 Indicator of Flow Related Problem
The HumaLyte monitors flow during every calibration and analysis cycle and provide 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.
7.2.4 Flow Times

Press the Status key; then use the keys 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 HumaLyte begins measuring the time it takes for the air detector to
detect the end of the Standard B stream.
The analysis flow rate is the time (in seconds) it takes for a sample to pass through the air detector. When the
sample first reaches the air detector, the HumaLyte begins measuring the time it takes for the air detector to detect
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 a slightly slower flow rate.
It is possible for the instrument to have a good analysis flow time while at the same time 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 HumaLyte 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 build-
up 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.
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.
100
7.2.5 Air and Fluid Readings
Press the Menu key in the Main screen. The system will enter the Menu screen. Input 5 and press the Enter key to
run diagnostic procedures. Then press 3 and press the 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 detector takes the air reading when it expects air
to be passing through it. Likewise, the air detector takes a fluid reading when it expects fluid to be passing through
it.
Flow readings like these usually generate error code 0400, Air Detector Uncalibration, for calibration sequence, or
1400, Cant 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, it 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.
7.2.6 Confirming a Flow Problem

If the flow indicators suggest a flow problem, confirm its existence by performing the flow test with deionised
water. The procedure requires a small beaker or similar container of deionised 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:

Pull the sampler up into manual position.
From the Menu screen, select the Maintenance menu. Select Prime Options to access the priming function. Select
Sample to initiate the sequence. The probe extends and the pumps turn on.
Immerse the probe in the beaker of deionised 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.
If there are no new problems, press the Esc key to terminate the new test.
If a flow problem has been confirmed, continue as follows:
Disconnect the S-line from the probe. Repeat Step 4 starting at the S-line.
Disconnect the S-line from the air detector and connect the new S-line. Repeat Step 4 starting at
the new S-line.
Press the Esc key to terminate the flow test.
Since the 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.
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:

Flush the flow path with deionised water. Refer to Priming the Flow Path in Chapter 4, Maintenance, for detailed
instructions.
If flow is now unrestricted, close the door and perform a calibration to confirm that the flow problem has been
resolved.
If the flow problem persists, proceed to the flow path check.
7.2.7 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-related errors:
W-line: The W-line is the only component that comes in direct contact with the pump. Damaged, blocked, or
improperly installed pump tubing can hinder suction.
Probe/S-Line: Clots, salt, or protein build-up in the probe and/or S-line can hinder suction.
Electrode Carrier: Clots, salt, or protein build-up in the electrodes can block the electrodes and cause instabilities.
Missing or damaged gaskets between electrodes can cause loss of suction.
Septum: The constant movement of the probe can eventually wear out the septum and cause it to leak.
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.
7.2.8 Flow Path Check

For troubleshooting purposes, the flow path has been divided into the following 6 sections:
W-line Check
S-line/Electrode Carrier Check
Probe Check
A-line & B-line Check
R-line Check
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.
102
7.3 W-line Check
Disconnect the W-line from the top of the electrode carrier.

From the Menu screen, input 6 to access the Maintenance function.
Select the Prime option.
Select the Full option.
Immerse the free end of the W-line into a beaker of deionised water and try to aspirate water into the W-line.
Watch for leaks and obstructions.
If there is no leak or blockage in the W-line, proceed to the S-line/Electrode Carrier Check.
If the flow is slow or completely blocked, there is a leak or obstruction in the W-line.
Detach the fitting on the W-line of the reagent harness tubing.
Remove the W-line from the pump.
Remove the tubing from the blunt syringe needle. Fill the syringe with deionised water and connect
the W-line to the needle.
Flush the W-line to clear any obstructions.
Reinstall the W-line into the pump.
Reconnect the W-line to the top of the electrode carrier.
Repeat step 2 and step 3.
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 has been resolved.
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 has been resolved.
If the problem still persists, proceed to the S-line/Electrode Carrier Check.
7.3.1 S-line/Electrode Carrier Check

Disconnect the S-line from the top of the probe and from the side of the electrode carrier.
Remove the tubing from the blunt syringe needle. Fill the syringe with deionised water and connect the S-line to
needle.
Flush the S-line to clear any obstruction.
If the S-line is blocked or damaged and cannot be cleared, perform the following procedure:
Discard the S-line and install a new S-line.
Perform a Calibration to see if the flow problem has been resolved.
If the S-line is not blocked, reconnect the S-line to the side of the electrode carrier.
Immerse the free end of the S-line into a beaker of deionised water and try to aspirate water into the S-line.
If it primes well, connect the S-line to the top of the probe and perform a calibration to see if the flow problem
has been resolved.
If the problem still persists, flush the electrode flow train as follows:
Disconnect the R, W, and S lines from the electrode carrier and remove the carrier from the
HumaLyte.
Reattach the tubing to the blunt needle on the probe cleaning syringe and fill the syringe with
deionised water.

Connect the syringe to the W-port at the top of the electrode carrier.
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.
If the electrode carrier is not leaking or blocked, dry and reinstall it and the R, W, and S lines. Proceed to Probe
Check.
If the electrode carrier is leaking or blocked, proceed to the appropriate problem:
(1) Leakage:
Replace the sealing gasket at the leak site.
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:
Remove all components from the electrode carrier.
Flush each component individually with deionised 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 deionised water.
Reassemble the electrodes in the carrier in the order shown on the side of the carrier.
Reuse any components that are not blocked or damaged. Discard any components that are blocked or damaged
and install new ones.
Replace the carrier on the HumaLyte and reconnect the R, W, and S lines.
Perform a calibration to see if the flow problem has been eliminated.
If the problem still persists, proceed to the Probe Check.
7.3.2 Probe Check
Warning: Be careful not to place your hands on or near the septum when extending the probe.
Pull the sampler up into manual position.

Put a cup of deionised water underneath the probe.
Select the Sample option.
Try to aspirate water into the probe. Watch for leaks and obstructions.
If there is no leak or blockage in the probe, proceed to the Septum Check.
If the flow is slow or completely blocked, there is a leak or obstruction in the probe.
Detach the fitting on the S-line of the probe.
Unscrew the probe cap and take off the probe.
the probe to needle.
Flush the probe to clear any obstruction.
Reinstall the probe into the probe cap.
Screw the probe cap on tightly.
Reconnect the S-line to the top of the probe.
Repeat steps 2 to 4.
If the probe is blocked or damaged and cannot be cleared, perform the following procedure:
Discard the probe and install a new one.
Perform a calibration to see if the flow problem has been resolved.
104
If there is no leak or blockage, perform a calibration to see if the flow problem has been resolved.
If the problem still persists, proceed to the Septum Check.
7.3.3 A-line & B-line Check

Select the Standard A or Standard B option.
If there is no leak or blockage in the A-line or B-line, proceed to the Septum Check.
If the flow is slow or completely blocked, there is a leak or obstruction in the A-line or B-line.
Detach the fitting on the A-line or B-line of the reagent harness tubing and the septum.
the A-line or B-line to needle.
Flush the A-line or B-line to clear any obstructions.
Reinstall the A-line or B-line.
Repeat step 1 and step 2.
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 has been resolved.
7.3.4 R-line Check

Disconnect the R-line from the reference electrode.
Select the Reference option.
Immerse the free end of the R-line into a beaker of deionised water and try to aspirate water into the R-line.
If there is no leak or blockage in the R-line, proceed to the Septum Check.
If the flow is slow or completely blocked, there is a leak or obstruction in the R-line.
Detach the fitting on the R-line of the reagent harness tubing.
Remove the tubing from the blunt syringe. Fill the syringe with deionised water and connect the R-
line to needle.
Flush the R-line to clear any obstruction.
Reconnect the R-line to the left-hand side of the electrode carrier.
Repeat steps 1 and 2.
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 has been resolved.

7.3.5 Septum Check
Pull the sampler into manual position (remove the sampler cover if necessary).
Make sure that the probe is centred 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.
Observe each line during a prime cycle to see if the reagent is being aspirated.
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 have failed to resolve the flow problem, contact your local HUMAN
representative.
If one or more of the reagents are not priming, there may be a problem in the septum or reagent harness.
Proceed as follows:
Verify that the septum is correctly seated:
Check the fit of the septum on the sampler and tighten it if needed.
Reprime the reagents as before to see if the flow problem has been resolved.
If the flow problem persists, install a new septum (see Chapter 4, Maintenance) and prime the
reagents as before. During the prime observe whether the probe moves to the correct positions in
the septum chambers.
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.
If the reagents are not priming with the new septum and the probe is improperly positioned, contact your local
HUMAN representative.
If reagents are not priming with the new septum, but the probe is properly positioned, the flow problem lies in
the tubing harness.
The septum is now eliminated as a cause of the flow problem.
7.4 Diagnostic
Press the Menu key in the Main screen. The system will enter the Menu screen. Input 5 and press the Enter key to
run diagnostic procedures. Figure 7-1 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 7-1. Diagnostic Screen.
Input 1~6 and press the Enter key to select this function, or press the Esc key to return to the Menu screen.
106
7.4.1 Device Exercise
Input 1 and press the Enter key in the Diagnostic screen to enter the Device Exercise screen. Figure 7-2 shows the
Device Exercise screen.
<<DEVICE EXERCISE>>Input No.?1 10:06:12

1. Valve exercise
2. Pump exercise
3. Probe exercise
Figure 7-2. Device Exercise Screen.
Input 1~3 and press the Enter key to select this function, or press the Esc key to return to the Diagnostic screen.
7.4.2 Valve Exercise

Input 1 and press the Enter key in the Device Exercise screen to enter the Valve Exercise screen. Figure 7-3 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 7-3. Valve Exercise Screen
Valve Exercise Procedure (25 times):

Valve status: Valve 1 OPEN Valve 1 CLOSE Valve 2 OPEN Valve 2 CLOSE.
(Valve exercise procedure 2 seconds/time)
Press Esc key to interrupt this procedure and return to the Device Exercise screen.
Figure 7-4 shows the Valve Exercise Finish screen. Press the Esc key to return to the Device Exercise screen.
<< VALVE EXERCISE >> 10:06:12

>>Exercise finished
>>Reference Valve : CLOSE
Figure 7-4. Valve Exercise Finish Screen.

7.4.3 Pump Exercise
Input 2 and press the Enter key in the Device Exercise screen to enter the Pump Exercise screen. Figure 7-5 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 7-5. Pump Exercise Screen.
Pump Exercise Procedure (25 times):

Pump speed: HI LO
(Pump exercise procedure 2 seconds/time)
Press the Esc key to interrupt this procedure and return to the Device Exercise screen.
Figure 7-6 shows the Pump Exercise Finish screen. Press the Esc key to return to the Device Exercise screen.
<< PUMP EXERCISE >> 10:06:12

>>Exercise finished
>>Pump speed : LO
Figure 7-6. Pump Exercise Finish Screen.
7.4.4 Probe Exercise

Input 3 and press the Enter key in the Device Exercise screen to enter the Probe Exercise screen. Figure 7-7 shows
the Probe Exercise screen where exercise times and probe position are displayed.
<< PROBE EXERCISE >> 10:06:12

>>Exercise 25 times
>>Probe position : 1 (STANDARD B)
Figure 7-7. Probe Exercise Screen.
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.
Press the Esc key to interrupt this procedure and return to the Device Exercise screen.
The probe returns to initial position and the Probe Exercise Finish screen (Figure 7-8) appears. Press the Esc key to
return to the Device Exercise screen.
108
<< PROBE EXERCISE >> 10:06:12
>>Exercise finished
>>Probe position : 6 (SAMPLE 2)
Figure 7-8. Probe Exercise Finish Screen.Figure 5-3. Printout of Control Analysis.
7.4.5 Device Test

Input 2 and press the Enter key in the Diagnostic screen to enter the Device Test screen. Figure 7-9 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 7-9. Device Test Screen.

Input 1~6 and press the Enter key to select this function or press the Esc key to return to the Diagnostic screen.
7.4.6 Speaker Test

Input 1 and press the Enter key in the Device Test screen to enter the Speaker Test screen. Figure 7-10 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 7-10. Speaker Test Screen.
Press the keys to move the cursor, then press the Enter key to test beep or alarm.
Press the Esc key to return to the Device Test screen.

7.4.7 Printer Test
Input 2 and press the Enter key in the Device Test screen to enter the Printer Test screen. Figure 7-11 shows the
Printer Test screen.
<< PRINTER TEST >> 10:06:12

>>Printing...
Figure 7-11. Printer Test Screen.
After printing all of the characters, the system will automatically return to the Device Test screen.
Press the Esc key to interrupt printing and return to the Device Test screen.
Figure 7-12 shows the finished printout format.
<< PRINTER TEST >>

(all characters)
<< PRINT FINISH >>
Figure 7-12. Print Test Printout Format.
If the Esc key is pressed to interrupt the printer test,<<PRINT INTERRUPT>> will be printed instead of <<PRINT
FINISH>>.
7.4.8 LCD Test

Input 3 and press the Enter key in the Device Test screen to enter the LCD Test screen. Figures 6-13 and 6-14 show
the LCD Test screen.
Figure 7-13. LCD Test Screen 1, Clear Screen.

Figure 7-14. LCD Test Screen 2, All Black Screen.
Press the Esc key to change screens and return to the Device Test screen.
110
7.4.9 Keypad Test
Input 4 and press the Enter key in the Device Test screen to enter the Keypad Test screen. Figure 7-15 shows the
Keypad Test screen.
<< KEYPAD TEST >> 10:06:12

>>The key pressed : Menu
>>Press any key to test.
Figure 7-15. Keypad Test Screen.
Press any key except the Esc key. While a key is being pressed, the system will display the key pressed on line 2 of
the LCD screen.
7.4.10 Sampler Sensor Test

Input 5 and press the Enter key in the Device Test screen to enter the Sampler Sensor Test screen. Figure 7-16
shows the Sampler Sensor Test screen.
<< SAMPLER SENSOR TEST >> 10:06:12

>>Sampler position : INSIDE
>>Move sampler to test.
Figure 7-16. Sampler Sensor Test Screen.
If sampler is inside, system will display INSIDE on line 2 of the LCD.

If sampler is outside, system will display OUTSIDE on line 2 of the LCD.
Move sampler manually to test.
7.4.11 Serial Port Test

Input 6 and press the Enter key in the Device Test screen to enter the Serial Port Test screen. Figure 7-17 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 7-17. Serial Port Test Screen.

Press the keys to move cursor.
Press the Esc key to return to the Device test screen.
To test the RS232C port:
Short pins 2 and 3, pins 4 and 5, and pins 6 and 20 on the RS232 port on the rear panel of the
HumaLyte (see Appendix VII).
Press the Enter key to begin the test.
If the RS232 port is normal, the system will display PASS.
If the RS232 port is abnormal, system will display FAIL.
BarCode port test:
Plug the bar code reader into the BarCode port on the rear panel of the HumaLyte (see Appendix VII).
Scan an appropriate bar code (less than 10 characters) using the bar code reader.
If the bar code is read correctly, the bar code number will be displayed on the screen.
If the bar code is read incorrectly, a FAIL message will be displayed on the screen instead.
7.4.12 Air Detector Test

Press 3 and press the Enter key in the Diagnostic screen to access the Air Detector Test function. Figure 7-18 shows
the Air Sensor Test screen and Figure 7-19 shows the Test Result screen.
<<AIR DETECTOR TEST>> 10:06:12

>>Testing...
Figure 7-18. Air Detector Test Screen.
<<AIR DETECTOR TEST>> 10:06:12

* Air : 1000 mV * Fluid : 1200 mV
* Test result : PASS
Figure 7-19. Test Result Screen.
Air and Fluid: Means the reading from the air detector.
Press the Esc key to return to the Diagnostic screen.
112
7.4.13 Error Log
Input 4 and press the Enter key in the Diagnostic screen to enter the Error Log screen. Figure 7-20 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 7-20. Error Log Screen.
Input 1~3 and press the Enter key to select a function, or press the Esc key to return to the Diagnostic screen.
7.4.14 View Error Log

Input 1 and press the Enter key in the Error Log screen to enter the View Error Log screen. Figure 7-21 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 7-21. Error Log Screen.
Press the keys to view more error logs or press the Esc key to return to the Error Log screen.
7.4.15 Print Error Log

Input 2 and press the Enter key in the Error Log screen to enter the Print Error Log screen. Figure 7-22 shows the
Print Error Log screen.
<< PRINT ERROR LOG >> 10:06:12

>> Printing.......
>> Press any key to continue.
Figure 7-22. Print Error Log Screen.

While the system is printing the error log, printing can be stopped by pressing the Esc key.
Figure 7-23 shows the printout format of Print Error Log. The system will print the log results from the last error
to the first error (to a maximum of 50 errors in memory).

================================
Error Log
--------------------------------
1999/04/24 09:45:35
0105 Na+ Slope Too Low
1999/04/24 09:45:35
0205 K+ Slope Too Low
1999/04/22 10:35:12
1400 Cant Tell Air from Fluid
1999/04/20 16:54:03
2000 Illegal Probe Position
================================
Figure 7-23. Print Error Log Printout Format.
After printing, the system will display Figure 7-24. Press any key to return to the Error Log screen.
<< PRINT ERROR LOG >> 10:06:12

>>Print ok!
Figure 7-24. Print OK Screen.
7.4.16 Clear Error Log

Input 3 and press the Enter key in the Error Log screen to enter the Clear Error Log screen. Figure 7-25 shows the
Clear Error Log screen.
<< CLEAR ERROR LOG >> 10:06:12

>>Clear ok!
Figure 7-25. Clear Error Log Screen.
After clearing, press any key to return to the Error Log screen.
114
7.4.17 System Test
Input 5 and press the Enter key in the Diagnostic screen to enter the System Test screen. Figure 7-26 shows the
System Test screen.
<< SYSTEM TEST >> Input No.? 1 10:06:12

1.Probe position
2.Pump movement
3.Valves set
Figure 7-26. System Test Screen.
Input 1~3 and press the Enter key to select this function, or press the Esc key to return to the Diagnostic screen.
7.4.18 Probe Position

Input 1 and press the Enter key in the System Test screen to enter the Probe Position screen. Figure 7-27 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 7-27. Probe Position Screen.
Input 1~6 and press the Enter key to move the probe to the selected position.
Option 5. SAMPLE (IN): Refers to the probe position in Semi-Auto Mode (when the sampler is
inside). If the sampler is in the OUT position, the system will sound an alarm when this option is
selected.
Option 6. SAMPLE (OUT): Refers to the probe position in Manual Mode (when the sampler is
outside). If the sampler is in the IN position when this option is selected, the system will sound an
alarm.
Press the Esc key to return to the System Test screen.
7.4.19 Pump Movement

Input 2 and press the Enter key in the System Test screen to enter the Pump Movement screen. Figure 7-28 shows
the Pump Movement screen.
<< PUMP MOVEMENT >> 10:06:12

* Pump : Stop

7.4.20 Valves Set
Input 3 and press the Enter key in the System Test screen to enter the Valves Set screen. Figure 7-29 shows the
Valves Set screen.
<< VALVES SET >> 10:06:12

* Waste valve : Close
* Reference valve : Close
Figure 7-29. Probe Position Screen.
Use the keys to move cursor between the Waste Valve and Reference Valve, then press the Enter key to
close or open the valve.
Press the Esc key to return to the System Test screen.
7.4.21 Sensor mV Data

Input 6 and press the Enter key in the Diagnostic screen to enter the Sensor mV Data screen. Figure 7-30 shows the
Sensor mV Data screen.
<< SENSOR MV DATA >> Input No.? 1 10:06:12

1.Calibration mV data
2.Analysis mV data
Figure 7-30. Sensor mV Data Screen.
Input 1 or 2 and press the Enter key to select this function, or press the Esc key to return to the Diagnostic screen.
Figure 7-31 shows the Calibration mV Data screen and Figure 7-32 shows the Analysis mV Data screen. They show
the voltage values from 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 7-31. Calibration mV Data Screen.
116
7.5 Error Code
This section describes error codes and explains how to display, interpret, and use them while troubleshooting.
7.5.1 Introduction to Error Codes

In order to troubleshoot the HumaLyte successfully, it is necessary 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 malfunctions, which are 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 HumaLyte is malfunctioning; rather they describe how the HumaLyte is
affected by a malfunction.
7.5.2 Display Error Code

When a malfunction generates one or more error codes, an E is displayed in 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.
7.5.3 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 instruments 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.
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 given here do not resolve an instrument
problem, contact your local HUMAN representative for troubleshooting assistance.
Note: It is helpful to record the HumaLyte error codes, flow times, and slope performance numbers before
contacting your HUMAN representative.

7.5.4 Interpreting Error Codes
An error code consists of 4 characters.
The characters mean:
X X XX
Class Location Particular
0- Calibrate error Cl- Channel Two digits between 01 and 19
Na+ Channel
K+ Channel
Li+ Channel
Others
1- Analyze error Cl- Channel Two digits between 01 and 19
Na+ Channel
K+ Channel
Li+ Channel
Other
2- System error Operation Two digits between 01 and 19
Device
Software
QC & Communication
Others
7.5.5 Error Code Reference

Code Message Page
0001 Na+ Instability STD-A 145
0002 Na+ Instability STD-B
0003 Na+ Overload STD-A
0004 Na+ Overload STD-B
0005 Na+ Slope Too Low
0006 Na+ Slope Too High
0101 K+ Instability STD-A 148
0102 K+ Instability STD-B
0103 K+ Overload STD-A
0104 K+ Overload STD-B
0105 K+ Slope Too Low
0106 K+ Slope Too High
0201 Cl- Instability STD-A 142
0202 Cl- Instability STD-B
0203 Cl- Overload STD-A
0204 Cl- Overload STD-B
0205 Cl- Slope Too Low
0206 Cl- Slope Too High
0301 Li+ Instability STD-A 151
0302 Li+ Instability STD-B
118
Code Message Page
0303 Li+ Overload STD-A
0304 Li+ Overload STD-B
0305 Li+ Slope Too Low
0306 Li+ Slope Too High
0400 Air Detector Uncalibrated 154
0401 No STD-A
0402 No STD-B
0403 No Sample
0404 Flow Rate Too Short 146
0405 Flow Rate Too Long
0406 ADC Not Ready 173
0407 Sampler Error
0408 Math Error
1001 Na+ Instability STD-A 145

1005 Na+ Conc. Too Low
1006 Na+ Conc. Too High
1007 Na+ E-0 Drift
1008 Na+ Instability Sample
1009 Na+ Overload Sample
1101 K+ Instability STD-A 148
1105 K+ Conc. Too Low
1106 K+ Conc. Too High
1107 K+ E-0 Drift
1108 K+ Instability Sample
1109 K+ Overload Sample
1201 Cl- Instability STD-A 142
1203 Cl- Overload STD-A
1204 Cl- Overload STD-B
1205 Cl- Conc. Too Low
1206 Cl- Conc. Too High
1207 Cl- E-0 Drift
1208 Cl- Instability Sample
1209 Cl- Overload Sample
1301 Li+ Instability STD-A 151

Code Message Page
1305 Li+ Conc. Too Low
1306 Li+ Conc. Too High
1307 Li+ E-0 Drift
1308 Li+ Instability Sample
1309 Li+ Overload Sample
1400 Cant Tell Air from Fluid 168
1401 No STD-A
1402 No STD-B
1403 No Sample
1404 Short Sample
1405 Flow Rate Too Long
1406 ADC Not Ready 173
1407 Sampler Error
1408 Math Error
120
2000 Illegal Probe Position 173
2001 Illegal Probe Speed
2002 Illegal Pump Speed
2003 Illegal Command
2004 Illegal Parameter
2005 Illegal Error Code
2006 Can't Tell Air from Fluid 168
2007 No STD-A
2008 No STD-B
2009 No Sample
2100 Sampler Error
2101 Printer Time Out
2102 Printer Out of Paper
2103 Printer Error 170
2104 Printer Off-Line
2106 ADC Error
2200 EEP Erase Error
2201 EEP Write Error
2202 Memory Write Error
2203 Memory Clear Error
2204 Value Over Flow
2300 Westgard Rule 1-2s 171
2301 Westgard Rule 1-3s
2304 Westgard Rule 1x
2305 Control Outside Range
Error Code 0201 Cl- Instability STD-A

1201 Cl- Instability STD-A
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
Repeat the analysis or calibration to see if the error recurs.
Verify that the attachment of the electrode carrier to the HUMALYTE is secure.
If the error persists, there may be bubble caught in the electrode. Perform a flow path conditioning cycle with
serum. Perform a calibration.
If the error persists, enter flow path maintenance.

Clean the electrode pins and connectors on the sensor board with alcohol to eliminate any salt bridges.
Remove the chloride and reference electrodes and flush them with deionised water.
Verify that sealing gaskets are present between all electrodes and that tight seals are formed.
Reinstall the chloride and reference electrodes, exit flow path maintenance, and perform a calibration.
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.
If the error persists, there may be an obstruction. Perform a flow path check (Chapter 6, Troubleshooting).
If the error persists, continue to Solution Block B.
Solution Block B
Replace the chloride electrode (Chapter 4, Maintenance). Perform a flow path conditioning cycle with serum.
Perform two calibrations.
If the error persists, replace the reference electrode (Chapter 4, Maintenance). Perform two calibrations.
If these solutions do not resolve the problem, call your local HUMAN representative.
Notes:
If the instability error code is accompanied by flow error codes or slope error codes, resolve these error codes first,
and the instability error codes should disappear.
Instabilities with patient samples may occur randomly as a result of interfering substances in the sample.
If all channels are showing instability, either the electrode carrier is not attached correctly, or there is a flow
problem, or the reagent pack is empty.
If the sodium, potassium, and chloride channels are showing instability, check the reference electrode.
Error Code 0201 Cl- Instability STD-A

1201 Cl- Instability STD-A
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
Clean the electrode pins and connectors on the sensor board with alcohol to eliminate any salt
bridges.
Remove the chloride and reference electrodes and flush them with deionised water.
122
Reinstall the chloride and reference electrodes, exit flow path maintenance, and perform a
calibration.
Solution Block B
Notes:
Instabilities with patient samples may occur randomly as a result of interfering substances in the sample.
If the sodium, potassium, and chloride channels are showing instability, check the reference electrode.
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
Repeat the calibration to see if the error recurs. Note the slope before and after conducting the calibration.
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.
If the error persists, perform a flow path conditioning cycle with serum to eliminate any bubbles that may be
caught. Perform a calibration.
If the error persists, enter flow path maintenance and remove the reference and chloride electrodes. Flush both
with deionised water. Reinstall the electrodes. Verify that sealing gaskets are present between all electrodes. Exit
flow path maintenance and perform a calibration.
Solution Block B

Notes:
If the slope error is accompanied by other error codes, resolve the other error codes first.
Normal but negative slopes on all channels indicate Standard A and B are mixed up.
High negative slopes indicate that the reagent pack may have been exposed to freezing temperatures.
If all channels have Slope Low or High errors, it is usually due to one or more of the following:
Flow problems
Incorrectly installed reagent pack
Contaminated reagent pack
Reference electrode problem
Error Code 0001 Na+ Instability STD-A

1001 Na+ Instability STD-A
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
Verify that the electrode carrier is securely attached to the HumaLyte.
bridges.
Remove the sodium and reference electrodes and flush them with deionised water.
Reinstall the sodium and reference electrodes, exit flow path maintenance and perform a
calibration.
124
Solution Block B
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 two calibrations.
Notes:
If the instability error code is accompanied by flow error codes or slope error codes, resolve these error codes first
Instabilities in patient samples may occur randomly as a result of interfering substances in the sample.
If more than 1 electrode channel is showing instability, check the reference electrode.
Error Code 0003 Na+ Overload STD-A

1009 Na+ Overload Sample
Description: A Sodium Overload error occurs when the millivolt readings for standard A, standard B, or the
sample exceed the acceptable operational limits of the sodium electrode.
Solution Block A
Verify that the attachment of the electrode carrier to the h is secure.
If the error persists, troubleshoot this error first.
Remove the sodium and reference electrode and flush them with deionised water.
Reinstall the electrodes
Exit flow path maintenance.
Check the tubing harness for air leaks near the straw connections.
Solution Block B
Clean the electrode pins and connectors on the sensor board with alcohol. Salt bridges on pins can cause
overloads.
Replace the sodium electrode (Chapter 4, Maintenance).
Perform a sodium conditioning cycle with Conditioning Na Solution and then perform a flow path conditioning
cycle with serum. Perform two calibrations.

Notes:
Electrode slope error codes will also appear when an electrode overload condition exists. Once the electrode
overload error has been resolved, the electrode slope error codes should disappear.
If an electrode overload exists on more than 1 electrode, the problem may stem from an improperly attached
electrode carrier.
Electrode overload errors typically stem from either a faulty electrode or an electrical problem.
If overload errors occur on more than 1 electrode channel, investigate the reference electrode.
Math errors will also appear if overload errors occur. Once the electrode overload error has been resolved, the
math errors should disappear.
Error Code 0005 Na+ Slope Too Low

0006 Na+ Slope Too High
Description: A Sodium Slope Low or High error occurs during a calibration cycle when the difference (delta)
sodium electrode.
Solution Block A
Repeat the calibration to see if the error recurs. Note the slope before and after calibrating.
(Chapter 4, Maintenance). If contamination is suspected, replace the reagent pack. Perform two calibrations.
If the error persists, perform a sodium conditioning cycle with Conditioning Na Solution. Perform a flow path
conditioning cycle with serum. Perform two calibrations.
If the error persists, enter flow path maintenance and remove the reference and sodium electrodes. Flush both
Solution Block B
Na Solution. Perform a flow path conditioning cycle with serum. Perform two calibrations.
Notes:
Flow problems
126
Error Code 0101 K+ Instability STD-A
1101 K+ Instability STD-A
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
If the error persists, there may be a bubble caught in the electrode. Perform a flow path conditioning cycle with
bridges.
Remove the potassium and reference electrodes and flush them with deionised water.
Reinstall the potassium and reference electrodes, exit flow path maintenance and perform a
calibration.
Solution Block B
Replace the potassium electrode (Chapter 4, Maintenance). Perform a flow path conditioning cycle with serum.
Notes:
Instabilities on patient samples may occur randomly as a result of interfering substances in the sample.

Error Code 0103 K+ Overload STD-A
1109 K+ Overload Sample
Description: A Potassium Overload error occurs when the millivolt readings for standard A, standard B, or the
sample exceed the acceptable operational limits of the potassium electrode.
Solution Block A
Verify that the attachment of the electrode carrier to the HumaLyte is secure.
Remove the potassium and reference electrodes and flush them with deionised water.
Solution Block B
Clean the electrode pins and connectors on sensor board with alcohol. Salt bridges on pins can cause overloads.
Replace the potassium electrode (Chapter 4, Maintenance).
Perform a flow path conditioning cycle with serum. Perform two calibrations.
Notes:
electrode carrier.
If overload errors occur on more than 1 electrode channel, investigate the reference electrode.
Math errors will also appear if overload errors occur. Once the electrode overload error has been resolved, the
128
Error Code 0105 K+ Slope Too Low
0106 K+ Slope Too High
Description: A Potassium Slope Low or High error occurs during a calibration cycle when the difference (delta)
potassium electrode.
Solution Block A
trapped. Perform a calibration.
If the error persists, enter flow path maintenance and remove the reference and potassium electrodes. Flush
both with deionised water. Reinstall the electrodes. Verify that sealing gaskets are present between all
electrodes. Exit flow path maintenance and perform a calibration.
Solution Block B
Notes:
Flow problems

Error Code 0301 Li+ Instability STD-A
1301 Li+ Instability STD-A
1308 Li+ Instability Sample
Description: A Lithium Instability error occurs during a calibration or analysis cycle when the response of the
lithium electrode fluctuates while the electrode response is being measured.
Solution Block A
1. Repeat the analysis or calibration to see if the error recurs.
If the error persists, there may be a bubble caught in the electrode. Perform a flow path conditioning cycle with
bridges.
Remove the lithium and reference electrodes and flush them with deionised water.
Reinstall the lithium and reference electrodes, exit flow path maintenance, and perform a
calibration.
Solution Block B
Replace the lithium electrode (Chapter 4, Maintenance). Perform a flow path conditioning cycle with serum.
Notes:
The sodium and potassium channels must be calibrated for lithium to work.
and the instability error code should disappear.
Instabilities on patient samples may occur randomly as a result of interfering substances in the sample.
130
Error Code 0303 Li+ Overload STD-A
1309 Li+ Overload Sample
Description: A Lithium Overload error occurs when the millivolt readings for standard A, standard B, or the
sample exceed the acceptable operational limits of the lithium electrode.
Solution Block A
Verify that the attachment of the electrode carrier to the HumaLyte is secure.
Remove the lithium and reference electrode and flush them with deionised water.
Solution Block B
Clean electrode pins and connectors on sensor board with alcohol. Salt bridges on pins can cause overloads.
Replace the lithium electrode (Chapter 4, Maintenance).
Perform a flow path conditioning cycle with serum. Perform two calibrations.
Notes:
The sodium and potassium electrodes must be calibrated for lithium to work.
electrode carrier.
If more than 1 electrode overload error occurs, investigate the reference electrode.
Math errors will also appear if overload error occurs. Once the electrode overload error has been resolved, the

Error Code 0305 Li+ Slope Too Low
0306 Li+ Slope Too High
Description: A Lithium Slope Low or High error occurs during a calibration cycle when the difference (delta)
lithium electrode.
Solution Block A
caught. Perform a calibration.
If the error persists, enter flow path maintenance and remove the reference and lithium electrodes. Flush both
Solution Block B
Perform 2 calibration.
Notes:
The sodium and potassium channels must be calibrated for lithium analysis to work.
Flow problems
132
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
From the Menu screen, input 5 to access the Diagnostic function.
Select the Air detector test option.
If the Test result shows PASS, perform a calibration.
If the Test result shows FAIL, press the Flowpath key to remove the bubble in the air detector. Perform a
calibration.
Repeat step 3 several times.
If the error persists, replace the air detector (Chapter 4, Maintenance). Perform a flow path conditioning cycle
with serum. Perform two calibrations.
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
Troubleshoot the reagent pack:
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. Perform a calibration.
If there is insufficient Standard A in the bottle, replace the reagent pack (Chapter 4, Maintenance).
If the error persists, perform a flow path check (Chapter 6, Troubleshooting).
Check the reagent straw and the tubing harness for correct installation.
Verify that the probe is positioned in the centre of the septum chambers when performing the
flow path check.
If the probe position is incorrect, contact your local HUMAN representative.
If the probe position is correct, perform a calibration.
If an obstruction is found, clean the appropriate components with deionised water. Perform a
calibration.
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
calibration.
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
Troubleshoot the reagent pack:
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. Perform a calibration.
If there is insufficient Standard B in the bottle, replace the reagent pack (Chapter 4, Maintenance).
Check the reagent straw and the tubing harness for correct installation.
Make sure the probe is positioned in the centre of the septum chambers when performing the
flow path check.
If the probe position is incorrect, contact your local HUMAN representative.
If the probe position is correct, perform a calibration.
If an obstruction is found, clean the appropriate components with deionised water. Perform a
calibration.
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
calibration.
Notes:
If the flow error #0400 (Air Detector Uncalibrated) appears along with the error No Standard B, change the
septum.
134
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
Check the amount of sample. If it is sufficient, continue to Solution Block B.
Solution Block B
calibration.
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
If the pump tubing has been replaced recently, release the 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 centre of the septum chambers when performing the septum check
part of the flow path check.
Solution Block B
Replace the S-line. Make sure correct part number is installed (Chapter 4, Maintenance).
If the error persists and the pump tubing has not been recently replaced, replace the pump tubing (Chapter 4,
Maintenance).
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.

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
times, and reposition it around the pump. Replace the tubing in the bracket without twisting it.
Check that the probe is positioned in the centre of the septum chambers when performing the septum check
part of the flow path check.
Solution Block B
Maintenance).
Notes:
136
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
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.
septum check part of the flow path check.
Solution Block B
Maintenance).
Notes:

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
If a flow error appears, resolve the flow problem first. Perform a flow path check (Chapter 6, Troubleshooting).
If the samples concentration is too low or too high, the sample cannot be assayed for chloride.
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.
Notes:
The analytical range for chloride is 60-200 mM for serum, plasma, whole blood, and CSF. The urine range is 40-400
mM.
No chloride results are available on samples that generate these 2 error codes.
138
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
If flow errors also appear, resolve the flow problems first.
Enter flow path maintenance.
Verify that sealing gaskets are present between all electrodes and that all seals are tight.
Reinstall the electrodes.
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
Perform two calibrations and repeat the analysis.
If the error persists, replace the reference electrode (Chapter 4, Maintenance). Perform two calibrations and
repeat the analysis.
Notes:
If all channels are showing E-0 Drift errors, the reagent pack may be empty. Troubleshoot the reagent pack before
flow errors.

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
If the samples concentration is too low or too high, the sample cannot be assayed for sodium.
sodium concentration to check the electrode performance. Repeat the analysis.
Notes:
The analytical range for sodium is 60-200 mM for serum, plasma, and whole blood. The urine range is 40-400 mM.
No sodium results are available on samples that generate these 2 error codes.
140
Error Code 1007 Na+ E-0 Drift
Description: A Sodium 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 sodium
electrode.
Solution Block A
Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Replace the R-line if necessary (Chapter 4,
If the error persists, perform a sodium conditioning cycle with Conditioning Na Solution. Perform a flow path
conditioning cycle with serum. Perform two calibrations and repeat the analysis.
Solution Block B
Na Solution, then a flow path conditioning cycle with serum. Perform two calibrations and repeat the analysis.
Notes:
If all channels are giving E-0 Drift errors, the reagent pack may be empty. Troubleshoot the reagent pack before
flow errors.

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
If the samples concentration is too low or too high, the sample cannot be assayed for potassium.
potassium concentration to check the electrode performance. Repeat the analysis.
Notes:
The analytical range for potassium is 1.0-10.0 mM for serum, plasma, and whole blood. The urine range is 10-300
mM.
No potassium results are available on samples that generate these 2 error codes.
142
Error Code 1107 K+ E-0 Drift
Description: A Potassium 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
potassium electrode.
Solution Block A
Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Replace the R-line if necessary (Chapter 4,
Solution Block B
Notes:
flow errors.

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
If the samples concentration is too low or too high, the sample cannot be assayed for lithium.
lithium concentration to check the electrode performance. Repeat the analysis.
Notes:
The analytical range for lithium is 0.1-5.0 mM for serum, plasma, and whole blood.
No lithium results are available on samples that generate these 2 error codes.
144
Error Code 1307 Li+ E-0 Drift
Description: A Lithium 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 lithium
electrode.
Solution Block A
Check the fluid delivery rate of the R-line (Chapter 6, Troubleshooting). Change the R-line if necessary (Chapter 4,
Solution Block B
Notes:
flow errors.
The sodium and potassium channels must be calibrated for lithium to work.

Error Code 1400, 2006 Cant Tell Air from Fluid
Description: The Cant 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
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 has been resolved, the Cant Tell Air from Fluid error will disappear.
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 deionised water. Reinstall the air detector, exit flow path
maintenance, and perform a calibration. Repeat the analysis.
Solution Block B
Replace the air detector (Chapter 4, Maintenance). Perform a flow path conditioning cycle with serum. Perform
two calibrations.
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
Check the sample for clots. Repeat the analysis.
If the error persists and the pump tubing has recently been replaced, release the 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.
septum check part of the flow path check.
Solution Block B
If the pump tubing has not been recently replaced, replace the pump tubing (Chapter 4, Maintenance).
Notes:
error, resolve the flow problem first, and the other errors should disappear.
146
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
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.
Press the QC key, then input 3 (Print Westgard Rule Violation function) to reactivate the printer.
Error Code 2300 Westgard Rule 1-2s

2301 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
Make sure the correct QC standard is being analyzed.
Notes:
If other error codes appear along with the QC error, resolve those errors first.

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
Make sure the correct QC standard is being analyzed.
Notes:
If other error codes appear along with the QC error, resolve those errors first.
Error Code 0406, 1406 ADC Not Ready

0407, 1407, 2100 Sampler Error
0408, 1408 Math Error
2000 Illegal Probe Position
2001 Illegal Probe Speed
2002 Illegal Pump Speed
2003 Illegal Command
2004 Illegal Parameter
2005 Illegal Error Code
2101 Printer Time Out
2103 Printer Error
2104 Printer Off-Line
2106 ADC Error
2200 EEP Erase Error
2201 EEP Write Error
2202 Memory Write Error
2203 Memory Clear Error
2204 Value Over Flow
Description: These error codes usually come from a hardware problem.
Solution Block A
Contact your local HUMAN representative.
148
Contents
8 Theory .......................................................................................................................................................................................................... 151

8.1 Introduction................................................................................................................................................................................... 151
8.2 Origin of the Potential Measurement.................................................................................................................................. 152
8.3 Calculation of Na, K, Cl, and Li Concentration .................................................................................................................. 155
8.4 Electrode Calibration.................................................................................................................................................................. 156
8.4.1 Two-Point Calibration................................................................................................................................................................ 156
8.4.2 Two-Point Calibration Sequence ........................................................................................................................................... 156
8.4.3 One-point Calibration ................................................................................................................................................................ 157
8.5 Direct vs. Indirect Methodologies.......................................................................................................................................... 157
8.5.1 Plasma Volume Displacement Error..................................................................................................................................... 157
8.5.2 Bicarbonate.................................................................................................................................................................................... 157
8.5.3 Protein Binding ............................................................................................................................................................................. 157
8.5.4 Combined Effects......................................................................................................................................................................... 157
8.5.5 Halogen Effects on Chloride Determination ..................................................................................................................... 158

150
8 Theory
8.1 Introduction
The evolution of the ion selective electrode (ISE) as a measuring device began in 1875 with the recognition that
1
glass is an electrolytic conductor. 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
2
gas electrodes developed in the 1950s by the the laboratories of MacInnes and Dole, and Severinghaus and
3
Bradley.

8.2 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 8-1). 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 8-1 Ionic diffusion.
At equilibrium, the ratio of the ion concentrations in the two solutions is
Cl Na K 1

Cl Na K
o o o

Equation 1
i i i
the subscripts o and i denote ions on either side of the membrane.
152
In Figure 8-2, 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.
Figure 8-2 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:
RT ao
Em ln Equation 2
nF ai
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 Faradays 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 8-2 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:
RT
E m Eo ln ao Equation 3
nF
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:
RT
Em Eo 2.303 log ao Equation 4
nF

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 8-3. 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
potential from the ion selective electrode, Em, the reference electrode, Er, and the junction potential, Ej.
Figure 8-3 Electrode measuring circuit.
E cell E m E r E j Equation 5
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 minimises the magnitude of the liquid
junction potential (that is, have similar ionic mobilities in solution).
RT
By setting S 2.303 and substituting Equation 4 for Em, Equation 5 can be rewritten:
nF
E cell E m S log ao E r E j Equation 6
154
O
S is called the electrode slope. Under ideal conditions at 37 C, 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.
E StdB E StdA
S Equation 7
B
log
A
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:
E X EO S log a X E r E j Equation 8
E Std EO S log a Std E r E Equation 9
aX
E E X E Std S log Equation 10
a Std
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.
8.3 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:
fC O
E E X E Std S log Er E j Equation 11
fC i
The ionic strength of whole blood, plasma and serum tends to remain relatively constant over the physiological
4
range. 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 ions 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:
E cell E S log F C O , C i Equation12
Where,
fO
E E O S log Er E j Equation13
fi
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 E cell E :
E X E S log X
C
Equation 14
minus
Ci
E Std E S log Std

C
Equation 15
Ci
E E X E Std S log X
C
C Std
Equation 16

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:
C X C Std 10 E / s Equation 17
The microcomputer uses Equation 17 to calculate the concentration of sodium, potassium, and chloride ions in the
sample.
8.4 Electrode Calibration
There are 2 major methods of electrode calibration: 2-point calibration, and 1-point calibration. 2-point calibration,
also called full calibration, is used to establish the electrode slopes for each sensor, and to verify electrode
performance. 1-point calibration is used to monitor and correct the instrument for electrode drift.
The HumaLyte is programmed to initiate calibration cycles at regular intervals. This is called auto-calibration.
Calibration can also be initiated manually at any time by pressing the Calibrate key.
8.4.1 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.
8.4.2 Two-Point Calibration Sequence

The 2-point calibration sequence includes the following steps:
The pump aspirates Standard B through the sensor block.

The electrodes take Standard B millivolt readings for Na, K, Cl, or Li.
The pump aspirates Standard A and air through the sensor block to wash out the Standard B.
The pump aspirates Standard A through the sensor block.
The electrodes take Standard A millivolt readings for Na, K, Cl, or Li.
The microprocessor calculates the slopes for Na, K, Cl, or Li using the millivolt readings taken in steps 2 and 5.
156
8.4.3 One-point Calibration
Electrode drift is a gradual change in electrode potential that can adversely affect electrode performance. The
HumaLyte 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:

Standard A is pumped through the sensor block during analysis. The electrode takes Standard A millivolt
readings for Na, K, Cl, or Li.
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.
8.5 Direct vs. Indirect Methodologies
This section compares direct and indirect methodologies for the measurement of analytes and explains how the
HumaLyte electrode offset values were determined.
8.5.1 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 errors 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 and/or protein content increases, as with certain pathological states, the
error increases and can produce significantly low electrolyte results, (e.g., pseudohyponatremia). The HumaLyte is
unaffected by this problem because it measures sodium, potassium, chloride, and lithium (where applicable) in
serum and plasma directly, with no dilution.
8.5.2 Bicarbonate
Sodium and potassium ions tend to bind to bicarbonate ions in solution to a small but measurable degree. Because
the HumaLyte does not sense bound ions, this bicarbonate binding introduces a normal sample. Citrate and
acetate binding also occur but normally with very little effect.
8.5.3 Protein Binding

Proteins are large molecules whose quaternary structures are associated with varying charge densities. This
property causes proteins to act as zwitterions; that is, they can exhibit anionic and cationic behaviour as a function
of pH. At physiological pH, albumin and the globulin exhibit anionic behaviour and therefore tend to bind sodium
and potassium ions to a small but measurable degree. This protein binding influence the sodium and potassium on
normal samples. Other serum protein molecules exhibit cationic behaviour at physiological pH and tend to bind
chloride and bicarbonate. This tendency lowers direct ISE measurements of chloride and bicarbonate by
approximately 1.5% on normal samples.
8.5.4 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. HumaLyte direct potentiometric instruments exhibit a negative bias
of 3-4% due to ion binding. For this reason, HumaLyte electrolyte results tend to run 2-3% 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
Combined Effect +2% +4.5%
8.5.5 Halogen Effects on Chloride Determination

Therapeutic levels of bromide and iodide in serum can cause significant errors in the chloride levels determined by
colorimeter and conventional chloride electrodes. Both methods tend to recognise 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 HumaLyte chloride electrodes theoretical values for bromide and iodide are 1.8 to 1 and approximately 4 to 1,
respectively.
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.
158
Contents
9 Appendix..................................................................................................................................................................................................... 161
9.1 Appendix I: Warranty of Products ......................................................................................................................................... 161
9.2 Appendix II: HumaLyte Specifications ................................................................................................................................. 161
9.3 Appendix III: Performance of HumaLyte............................................................................................................................. 164
9.4 Appendix IV: Warning Messages........................................................................................................................................... 164
9.5 Appendix V: Labels on the HumaLyte .................................................................................................................................. 165
9.6 Appendix VI: Description of IEC Letter Symbols............................................................................................................... 165
9.7 Appendix VII: Location of Serial Ports .................................................................................................................................. 166
9.8 Appendix VIII: Error Codes........................................................................................................................................................ 167
9.9 Appendix IX: List of consumables.......................................................................................................................................... 171
9.10 Appendix X: List of spare parts ............................................................................................................................................... 171
160
9 Appendix
9.1 Appendix I: Warranty of Products
The warranty of the Human products is regulated in our General Terms and Conditions.
9.2 Appendix II: HumaLyte Specifications
Measured Parameters:
Sodium, Potassiumand either Chloride or Lithium.
Sample Type:
Primary: Serum, Plasma, Whole Blood (Vacutainer, Syringe)
Secondary : Urine (Manual Pre-dilution Required)
Sample Volume:
120 L blood for measurement of sodium, potassium, and chloride or lithium
120 L urine for measurement of sodium, potassium, and chloride
Carryover:
Less than 1% sample to sample
Analysis Time / Throughput

45 seconds / 80 samples per hour (maximum)
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)
Operation Modes:
STANDARD MODE : Daily Use Operation (automatic calibration at user selectable intervals,
always ready)
STANDBY MODE : Nights / Weekends (idle only, flush on start-up)

LCD Screen:
Character Format: 40 chars. x 4 lines
Character Font: 5 x 8 dot + cursor
Character Colour: Green
Viewing Area: 148.0 mm x 30.3 mm
Viewing Angle 30 - 150 o
Type: Transreflective with LED back light
Built-in Thermal Printer:

Character Format: 32 characters per line
Character Font: 7 x 5 dot
Printing Width: 58 mm
Printing Speed : 46 characters per second
User Interface:
RS232 Serial Interface: uses ASTM protocol for connection capability to personal computer and HUMAN's PUM
system
Bar Code Reader Port : for bar code reader, such as CCD 600 with RS232 interfacing capabilities manufactured by
GIGATMS Inc., Taiwan
On-Board QC Software Package:

QC data storage and reporting
On-Board Patient Data Storage:

Last 450 patient samples
Data Power Protection:

Time, date, last 2-point calibration parameters, last patient ID, set-up parameters and QC data are stored in non-
volatile memory chips. These data are unaffected by power outages.
Power Requirement:
100-120 V50-60 Hz 0.6A
200-240 V50-60 Hz 0.35A
Equipment Electrical Ratings:

100-120 V 50-60 Hz 0.6A
200-240 V 50-60 Hz 0.35A
Main supply voltage fluctuations not to exceed +/- 10% of the nominal voltage.
Equipment Pollution Degree:

Pollution degree 2
162
Equipment Installation Category:
Installation category II
Maximum Relative Humidity:

Maximum relative humidity of 85% for temperatures up to 30 C decreasing linearly to 50% relative humidity at
40C
20. Operating Temperature Range:

15... 40C
Recommended max. altitude:

up to 2000 m
Physical & Environmental:

Height: 410 mm (16.1 inches)
Width: 270 mm (10.6 inches)
Depth: 245 mm (9.6 inches)
Weight: 12 kg (26 lb)
No hazardous waste, all disposable are landfill acceptable.
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
Interrupt Rating: 35A at 250V (500mA 3.15A), 10x In at 250V (4A 6.3A)
Current Rating Available: 2A
Regulatory Approvals:
CE Mark ( IEC61010-1 for safety & IEC 601-1-2 for EMC)
Warranty:
The Products manufactured by HUMAN GmbH are warranted against defects in materials and
workmanship.

9.3 Appendix III: Performance of HumaLyte
Recommended operating range and general imprecision for Serum, Plasma, Whole Blood
Analyte Range C.V.s Within Run, C.V.s Day-To-Day, Resolution
[mmol/L] n=20 n=20 [mmol/L]
Sodium 60-200 1.0% or 1.0 mmol/L 2.0% or 1.0 mmol/L 0.1
Potassium 1.0-10.0 1.5% or 0.15 mmol/L 3.0% or 0.15 mmol/L 0.01
Chloride 60-200 1.5% or 2.0 mmol/L 2.0% or 2.0 mmol/L 0.1
Lithium 0.1-5.0 3.0% or 0.03 mmol/L 5.0% or 0.05 mmol/L 0.01
Recommended operating range and general imprecision for Urine

Analyte Range C.V.s Within Run, C.V.s Day-To-Day, Resolution
[mmol/L] n=20 n=20 [mmol/L]
Sodium 40-400 3.0% or 1.0 mmol/L 4.0% or 1.5 mmol/L 0.1
Potassium 10-300 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 ----- -------- -------- -----
9.4 Appendix IV: Warning Messages
The HumaLyte is for indoor use only.

Do not use the HumaLyte in a manner not specified by HUMAN GmbH.
Do not use the HumaLyte with flammable substances.
The HumaLyte should not be mounted on a surface made of flammable material.
Keep the HumaLyte away from possible hazards such as explosion, implosion or release of toxic or flammable
gases arising from materials being heated.
Use only a fuse and a power supply cord with the same type and rating as specified in Appendix II.
It is the users responsibility to carry out appropriate decontamination (e.g. cleaning with a 75% alcohol solution)
if hazardous material is spilt on or inside the HumaLyte. To prevent shock hazard, disconnect the power supply
before cleaning of the unit.
Before using any cleaning or decontamination method except those recommended by HUMAN GmbH, users
should check with HUMANs local distributor to ensure that the proposed method will not damage the
HumaLyte.
Do not use the service program; its use is for service engineers only.
When the HumaLyte sounds an alarm or displays an error message, stop operation and investigate the cause.
164
9.5 Appendix V: Labels on the HumaLyte
Label Name Label Classification Label Note

Fuse Specification Label Replace the fuse only with one of the
same type and ratings.
FUSE : T2 H250 Disconnect power before changing the

fuse.
Peristaltic Pump Keep fingers away from the peristaltic

Warning Label pump.
Grounding Label Make sure the power outlet is

grounded
Warning Label Electric shock hazard!

! CAUTION Disconnect from power before
opening.
ELECTRIC SHOCK HAZARD !
DISCONNECT FROM POWER
BEFORE OPENING
9.6 Appendix VI: Description of IEC Letter Symbols
Symbol Description Symbol Description

V Voltage ! Power On
Alternating Current O Power Off
A Current
Protective Conductor
Terminal ! Attention, Consult Accompanying
Documents

9.7 Appendix VII: Location of Serial Ports
Bar Code Reader Port

(D-SUB 25-pin male)
RS-232 Port
(D-SUB 25-pin female)
166
9.8 Appendix VIII: Error Codes
Interpreting Error Codes:

* Error code: 4 characters
* Character means:
X X XX
Class Location Particular
-
0- Calibrate error 0- Cl Channel Two digits between 01 and 19
+
1- Na Channel
+
2- K Channel
+
3- Li Channel
4- Others
-
1- Analyze error Cl Channel Two digits between 01 and 19
+
Na Channel
+
K Channel
+
Li Channel
Other
2- System error 1- Operation Two digits between 01 and 19
2- Device
3- Software
4- QC & Communication
5- Others

Error Codes Table:
Code Message Description
0001 Na+ Instability STD-A See 0201
0002 Na+ Instability STD-B See 0201
0003 Na+ Overload STD-A See 0203
0004 Na+ Overload STD-B See 0203
0005 Na+ Slope Too Low See 0205
0006 Na+ Slope Too High See 0206
0101 K+ Instability STD-A See 0201
0102 K+ Instability STD-B See 0201
0103 K+ Overload STD-A See 0203
0104 K+ Overload STD-B See 0203
0105 K+ Slope Too Low See 0205
0106 K+ Slope Too High See 0206
0201 Cl- Instability STD-A The Cl electrode signal is out of range
0202 Cl- Instability STD-B See 0201
0203 Cl- Overload STD-A The Cl electrode signal is out of range
0204 Cl- Overload STD-B See 0203
0205 Cl- Slope Too Low The calibration slope of the electrode is below the acceptable
operational range
0206 Cl- Slope Too High The calibration slope of the electrode is above the acceptable
operational range
0301 Li+ Instability STD-A See 0001
0302 Li+ Instability STD-B See 0001
0303 Li+ Overload STD-A See 0003
0304 Li+ Overload STD-B See 0003
0305 Li+ Slope Too Low See 0005
0306 Li+ Slope Too High See 0006
0400 Air Detector Uncalibrated The air detector cant 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 AD converter error
0407 Sampler Error Probe position error or other error
0408 Math Error Software error
1001 Na+ Instability STD-A See 0201
1002 Na+ Instability STD-B See 0201
1003 Na+ Overload STD-A See 0203
1004 Na+ Overload STD-B See 0203
1005 Na+ Conc. Too Low See 1205
1006 Na+ Conc. Too High See 1206
168
1007 Na+ E-0 Drift See 1207
1008 Na+ Instability Sample See 0201
1009 Na+ Overload Sample See 0203
1101 K+ Instability STD-A See 0201
1102 K+ Instability STD-B See 0201
1103 K+ Overload STD-A See 0203
1104 K+ Overload STD-B See 0203
1105 K+ Conc. Too Low See 1205
1106 K+ Conc. Too High See 1206
1107 K+ E-0 Drift See 1207
1108 K+ Instability Sample See 0201
1109 K+ Overload Sample See 0203
1201 Cl- Instability STD-A See 0201
1202 Cl- Instability STD-B See 0201
1203 Cl- Overload STD-A See 0203
1204 Cl- Overload STD-B See 0203
1205 Cl- Conc. Too Low The concentration of sample below the acceptable linearity range.
1206 Cl- Conc. Too High The concentration of sample above the acceptable linearity range.
1207 Cl- E-0 Drift The standard A millivolt drift between the last 2-point calibration and
the 1-point analysis calibration exceeds the acceptable operational
limits.
1208 Cl- Instability Sample See 0001
1209 Cl- Overload Sample See 0003
1301 Li+ Instability STD-A See 0001
1302 Li+ Instability STD-B See 0001
1303 Li+ Overload STD-A See 0003
1304 Li+ Overload STD-B See 0003
1305 Li+ Conc. Too Low See 1005
1306 Li+ Conc. Too High See 1006
1307 Li+ E-0 Drift See 1007
1308 Li+ Instability Sample See 0001
1309 Li+ Overload Sample See 0003
1400 Cant 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 the sample to travel from the probe tip to the air
detector is greater than the allotted time.
1406 ADC Not Ready See 0406
1407 Sampler Error See 0407
1408 Math Error See 0408
2000 Illegal Probe Position The probe position value 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.
2003 Illegal Command The command is not acceptable in this screen.
2004 Illegal Parameter The parameter out of its limitation.
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
2100 Sampler Error See 0409
2101 Printer Time Out Printer ready wait time was too long.
2102 Printer Out of Paper No printer paper to print.
2103 Printer Error Printer error excluding 2101 &2102
2104 Printer Off-Line Printer is off line.
2106 ADC Error See 0406
2200 EEP Erase Error An error occurred when erasing the data in EEPROM.
2201 EEP Write Error An error occurred when writing the data to EEPROM.
2202 Memory Write Error An error occurred when writing the data to flash_rom.
2203 Memory Clear Error An error occurred when erasing the data in flash_rom.
2204 Value Over Flow Print data out of format
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 Control Outside Range The concentration of control sample out of acceptable limit.
170
9.9 Appendix IX: List of consumables
EMERGENCY KIT 1 UNIT/INSTRUMENT 17450

Electrodes
Sodium Ion-selective Electrode 17411
Potassium Ion-selective Electrode 17412
Lithium Ion-selective Electrode 17413/2
Chloride Ion-selective Electrode 17414/2
Reference Electrode 17415
Accessories
Spacer 17416
Air Detector 17417
Septum 17418
Printer Paper (5 rolls) 18144/5
Solutions
Reagent Pack complete 17420
Na/pH Condition Solution (100ml) 17422
Urine Diluent (100ml) 17423
Clean Solution(50ml) 17421
9.10 Appendix X: List of spare parts
17410/10 ADC PCB

17410/11 Adhesive Backed Rubber Foot
17410/12 AMP Module
17410/13 AMP Module without Valve
17410/14 Base PCB
17410/15 Program Update Module (PUM)
17410/16 Chain
17410/17 CPU PCB
17410/18 Driver PCB
17410/19 Electrode Carrier
17410/20 Electrode Carrier Cover
17410/21 Front Panel
17410/22 Front Panel Bank Board
17410/23 Fuse, 2A
17410/24 I/O PCB
17410/25 Keypad
17410/26 Keypad Flat Cable
17410/27 Keypad PCB
17410/28 LCD Flat Cable
17410/29 LCD Module (English & European)
17410/30 Left Side Panel

17410/31 Magnet Latch
17410/32 Motor Step
17410/33 Pinch Valve
17410/34 Pinch Valve Fixture
17410/43 Power Supply
17410/44 Power Supply Cable
17410/45 Printer Control Cable
17410/46 Printer Control PCB
17410/47 Printer Cover
17410/48 Printer Extended PCB
17410/49 Printer Flat Cable
17410/50 Printer PCB
17410/51 Probe, Sampler
17410/52 Probe Screw
17410/53 Pump, M Type
17410/54 Pump Flat Cable, M Type Pump
17410/55 Pump Front Plate, M Type
17410/56 Pump Roller, M Type
17410/57 Pump Twist Spring, M Type
17410/58 Right Side Panel
17410/59 RMS Flat Cable
17410/60 Sampler Module
17410/61 Sampler Module Front Panel
17410/62 Sampler Module Spring
17410/63 Screw Servicing Part
17410/64 Thermal Printer Head
17410/65 Top Cover
17410/66 Tubing Set
172
Contents
10 List of Consumables and Reagents................................................................................................................................................... 175

10.1 Intended Use ................................................................................................................................................................................. 175
10.2 Method ............................................................................................................................................................................................ 175
10.3 Preparation, Maintenance........................................................................................................................................................ 175
10.4 Reference Range........................................................................................................................................................................... 175
10.5 Solutions ......................................................................................................................................................................................... 175
10.6 Intended use.................................................................................................................................................................................. 175
10.7 Contents.......................................................................................................................................................................................... 175
10.8 Preparation, Storage, Stability ................................................................................................................................................ 176
10.9 Accessories ..................................................................................................................................................................................... 176
174
10 List of Consumables and Reagents
[REF]
Emergency Kit 1 Unit/Instrument 17450
Electrodes:
Sodium Ion-selective Electrode 17411
Potassium Ion-selective Electrode 17412
Lithium Ion-selective Electrode 17413/2
Chloride Ion-selective Electrode 17414/2
Reference Electrode 17415
10.1 Intended Use

For the quantitative determination of electrolytes in whole blood, serum, plasma and urine with the HumaLyte
instrument.
10.2 Method
Ion selective electrodes (ISE) typically consist of a selective membrane, an internal electrolyte solution and an
internal reference electrode. ISE measure the potential of a particular ion in solution in the presence of other ions.
Cells, particles, or colloids in the sample are ignored and do not influence the measurement. Equipped to the
HumaLyte analyzer the signal of the ISE is converted to the particular ion's concentration.
10.3 Preparation, Maintenance

The ion selective electrodes are ready for use. No refilling is required during the shelf life. For proper maintenance
please refer to the HumaLyte User Manual. Do not try to open the electrode!
10.4 Reference Range

While each laboratory should establish its own reference range, the following table may be used for orientation:
Analyte Reference range

+
K 3.5 5.0 mmol/l
+
Na 136 146 mmol/l
-
Cl 96 106 mmol/l
+
Li 0.75 1.20 mmol/l
10.5Solutions
[REF]
Reagent Pack complete 17420
Standard A 400 ml
Standard B 150 ml
Reference 200 ml
10.6 Intended use
For calibration and the quantitative determination of ionised sodium, potassium, chloride and lithium in human
blood, serum, plasma and urine using the HumaLyte Analyzer equipped with the appropriate electrodes.
10.7 Contents
1 RMS (Reagent Management System)
Concentrations of electrolytes (Na+, K+, Cl-,Li+)for [STD A] , [STD B] [REF] 17420 are indicated on the individual label

10.8 Preparation, Storage, Stability
All reagents are ready for use and stable until the expiration date stated on the label, when stored at 15...30C.
Contamination after opening should be carefully avoided. Shake well before opening.
[REF]
Cleaning Solution 50 ml 17421
Sodium hypochlorite solution 0.2 mol/l
Na+ Conditioner 100 ml 17422
Ammonium hydrogendifluoride solution 0.05 mol/l
Xi R: 25 34 (S: 22 26 37 45)
Urine-Diluent 250 ml 17423
Buffer
10.9 Accessories
[REF]
Spacer 17416
Air detector 17417
Septum 17418
Printer Paper (5 rolls) 18144/5
176
HUMAN
Gesellschaft fr Biochemica und Diagnostica mbH
| Max-Planck-Ring 21 65205 Wiesbaden Germany
| Tel.: +49 61 22/99 88-0 Fax: +49 61 22/99 88-100
| e-Mail: human@human.de www.human.de

Humalyte User

Hochgeladen von

Dokumentinformationen

Copyright

Verfügbare Formate

Dieses Dokument teilen

Dokument teilen oder einbetten

Freigabeoptionen

Stufen Sie dieses Dokument als nützlich ein?

Sind diese Inhalte unangemessen?

Copyright:

Verfügbare Formate

Humalyte User

Hochgeladen von

Copyright:

Verfügbare Formate

HumaLyte

3 INTENDED USE OF THE INSTRUMENT [IVD]

4 GENERAL SAFETY WARNINGS

1.1 Intended Use

1.2 Chapters and Contents

The HumaLyte User Manual includes the following chapters:

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

This manual uses the following conventions:

3 Human HumaLyte User Manual

1.4 Ordering Information

1.5 Technical Assistance

For technical assistance call HUMAN or your local HUMAN representative.

Figure 2-1. HumaLyte

5 Human HumaLyte User Manual

Figure 2-2. Power Input Module and Fuse Socket

Table 2-1. Fuse for Various Line Voltages.

Press the Locking Lever Down to Open Position

Figure 2-3. Open Position.

Insert each electrode into the electrode carrier as follows:

7 Human HumaLyte User Manual

Electrode Spacer with the W-port inserted

Figure 2-4. Electrode Carrier with Installed Electrodes.

Figure 1-5. Install the Septum

9 Human HumaLyte User Manual

Figure 2-7. Install tubing.

11 Human HumaLyte User Manual

Powering on the Instrument

Preparing the Printer

Conditioning Electrodes and Flow Path

Analysis Mode Analytes Sample Type

Serum/Plasma Urine Whole Blood

* Indicates that this part is optional.

13 Human HumaLyte User Manual

Note: Instruments may vary according to the options ordered.

Figure 2-9. Pump.

2.5.4 Waste Valve and Reference Valve

15 Human HumaLyte User Manual

2.5.6 Reference Valve

Figure 2-10. Location of Waste Valve and Reference Valve.

Figure 2-11. Electrode Carrier.

2.5.9 Measuring Electrodes

2.5.10 Reference Electrode

17 Human HumaLyte User Manual

2.5.12 Input/Output Devices

KEYPAD ISE UNIT

Flowpath QC Esc Enter ANALYZE

Figure 2-12. Keypad.

Table 2-3. The Function Keys.

Analyze Initiates a specimen analysis or restart an interrupted analysis.

Calibrate Initiates a 2-point calibration.

Deletes characters on an input screen.

Menu Displays the Main screen of the sensor Status screen.

Samp. Type Displays the Sample-Type Set screen.

2.5.14 Liquid Crystal Display (LCD)

2000/05/04 <<HumaLyte>> 11:20:51

Figure 2-13. Main Screen.

19 Human HumaLyte User Manual

The HumaLyte sounds an alarm to inform users of the following conditions:

2.6 Acceptable Samples

PARAMETER SPECIMEN MATRIX

Sodium Serum, plasma, whole blood, or urine

Potassium Serum, plasma, whole blood, or urine

Chloride Serum, plasma, whole blood, urine

Lithium Serum, plasma, whole blood