Humalyte 3-5 Plus

HumaLyte Plus5
HumaLyte Plus3
| User Manual
REF 17470/1
REVISION LIST OF THE MANUAL
Rev. /DATE. REVISION DESCRIPTION
01/2010-02 First Edition
02/2010-08 Correction of typing errors
03/2011-09 Correction dimension
04/2012-05 Chap. 2.1, 2.2, 2.4, 2.6, 2.7, 2.8, 2.9, 2.12, 2.13, 3.2, 3.2.1, 3.3.2, 3.7.3,
3.7.5, 3.7.7, 3.8, 3.9, 5.1, 5.6, 6.2, 7.1, 8.1-8.5
05/2014-01 Software 5.5HE, iCa and pH, pre-analytics. Chap. 1.2, 2.1, 2.2, 2.15,
2.16, 3.3, 3.3.3, 3.4, 3.7.3, 3.7.6, 3.7.11, 3.9, 3.9.3, 4.1, 8.3, 8.4
06/2017-07 pH intended use change. Chap. 2.1, 2.2, 2.14, 2.16, 3.3.5, 3.3.6,
3.7.11, 8.4 and Cal descrip Chap. 3.4
07/2019-10 Change of Safety Notes; Addition of Chapter 4.2.1 & 4.2.2; added
information regarding urine samples; correction of normal slope
ranges; article numbers supplemented; smaller corrections
08/2022-04 Update of Indended Purpose according to IVDR
09/2023-05 Minor text adjustments
SYSTEM VERSION
Software 5.5HE
COPYRIGHT
Copyright 2023, Human Gesellschaft für Biochemica und Diagnostica mbH, Wiesbaden,
Germany. All rights reserved.
No part of this documentation may be reproduced in any form, nor processed, copied or
distributed by means of electronic systems, without prior permission of HUMAN in
writing. Since all precautionary measures were taken into account in producing these operating
instructions, the manufacturer accepts no responsibility for any errors or omissions. This
includes any liability for damage that could arise from possible incorrect operation based on this
information. Subject to changes without notice as result of technical development.
SERVICE AND SUPPORT

CONTENTS
TABLE OF CONTENTS
1 SAFETY INSTRUCTIONS 5
1.1 INTRODUCTION 5
1.2 USER WARRANTY 5
1.3 USE OF THE INSTRUMENT 5
1.4 GENERAL SAFETY WARNINGS 6
1.5 DISPOSAL MANAGEMENT CONCEPT 6
1.6 BIOHAZARD WARNING 7
1.7 INSTRUMENT DISINFECTION 7
2 SYSTEM DESCRIPTION 9
2.1 BRIEF DESCRIPTION OF THE INSTRUMENT 9
2.2 SCOPE OF APPLICATION 10
2.3 SYSTEM STRUCTURE 11
2.3.1 Front panel 11
2.3.2 Rear panel 11
2.4 UNPACKING 12
2.5 ENVIRONMENT REQUIREMENT 13
2.6 INSTALLATION OF THE REAGENTS 13
2.7 INSTALLATION OF THE ELECTRODES 13
2.8 FILLING SOLUTIONS 15
2.9 INSTALLATION OF THE AUTOSAMPLER (FOR AUTOSAMPLER MODELS
ONLY) 15
2.10 INSTALLATION OF THE PRINTING PAPER 15
2.11 INSTALLATION OF THE TUBES 16
2.12 CONNECTING TO THE POWER SUPPLY 16
2.13 INSTRUMENT CONSTRUCTION 16
2.14 ISE THEORY 17
2.15 MEASURING PRINCIPLES 17
2.16 EXPLANATION OF THE DIFFERENT PARAMETERS FOR CALCIUM AND PH
(HUMALYTE PLUS 5 ONLY) 18
3 METHOD OF OPERATION 21
3.1 FLOW CHART OF THE OPERATING PROCEDURE 21
3.2 STARTUP AND SELF-TEST 22
3.2.1 First start up 24
3.3 SAMPLE MEASUREMENT 25
3.3.1 Operation without autosampler 25
3.3.2 Urine testing method 28
3.3.3 Operation with autosampler 30
3.3.4 Pre-analytics: Sample collection and handling 31
3.3.5 Measurement of ionized calcium and pH (HumaLyte Plus 5 only) 31
3.3.6 Stability of iCa and pH in specimen 32
3.3.7 Acceptable patient samples and anticoagulant 33
3.4 CALIBRATION 35
3.5 W. LIST 37
3.6 MEASURE STD 38
3.7 SERVICE 39
3.7.1 Change date and time 39
3.7.2 Position 39
3.7.3 Quality control 40
3.7.4 Printer 42
3.7.5 Cleaning the instrument and Na-conditioner 42
3.7.6 Factor 44
3.7.7 Data transfer 45
3.7.8 Voltage 46
3.7.9 Feed paper 46
3.7.10 Reagent 47
3.7.11 Choosing the parameters you want to display (HumaLyte Plus 5
only) 48
3.7.12 Result review 48
3.8 REAGENT CONSUMPTION 50
4 PRECAUTIONS 53
4.1 OPERATION PRECAUTIONS 53
4.2 SAFETY PRECAUTIONS 54
4.2.1 Hazard statements 54
4.2.2 Precautionary statements 54
CONTENTS
5 MAINTENANCE 57
5.1 DAILY MAINTENANCE 57
5.2 WEEKLY MAINTENANCE 57
5.3 SPARE PARTS REPLACEMENT 57
5.4 CHECK THE TUBING SYSTEM 58
5.5 REPLACE THE ELECTRODE 58
5.6 REPLACE THE REFERENCE MEMBRANE 59
6 ERROR CODE 65
6.1 PRINTED ERROR CODE 65
6.2 DISPLAYED ERROR CODE 65
7 TROUBLESHOOTING 67
7.1 SLOPE UNSTABLE 67
7.2 SLOPE ABNORMAL 68
7.3 ASPIRATION ABNORMAL 68
8 APPENDIX 69
8.1 CONSUMABLES AND ACCESSORIES 69
8.2 AUTOSAMPLER (REF 17470/30) 70
8.3 SHELF LIFE AND CONSUMPTION 70
8.4 SPECIFICATIONS 71
8.5 REAGENT 74
8.6 LIST OF REFERENCES 75
Safety Instructions 5
1 SAFETY INSTRUCTIONS
1.1 Introduction
This manual is considered part of the instrument and must be available to the
operator and the maintenance personnel. For accurate installation, use and
maintenance, please read the following instructions carefully.
In order to avoid damage to the instrument or personal injury, carefully read
the ”GENERAL SAFETY WARNINGS”, describing the appropriate operating pro-
cedures. Please contact your HUMAN authorised local Technical Service in the
event of instrument failure or other difficulties with the instrument.
1.2 User warranty

HUMAN warrants that instruments sold by one of its authorised representa-
tives 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 within this
warranty period 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, 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.
1.3 Use of the instrument

The instrument must be used for its intended purpose (see chapter 2). It must
be operated in perfect technical conditions, by qualified personnel, in such [IVD]
working conditions and maintained as described in this manual, in the GENERAL
SAFETY WARNINGS. This manual contains instructions for qualified professional
operators.
6
1.4 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 ven-
tilation.
The instrument should be installed on a flat, stationary working surface, that is
free of vibrations.
Do not operate in area with excessive dust.
Operate at temperature and at a humidity level in accordance with the specifi-
cations listed in this manual .
Do not operate this instrument with covers and panels removed.
Use only 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 instru-
ment.
The 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 instru-
ment.
Do not power the instrument in environments that are potentially explosive or
at risk of fire.
Prior to cleaning and/or performing maintenance on the instrument, switch off
the instrument and remove the power cord.
Only cleaning materials described in this manual may be used, as other mate-
rials may damage parts. It is recommended to always wear protective clothing
and eye protection while using this instrument.
All warning symbols that appear in this manual must be carefully observed.
For users in the European Union only: Please report any serious incident that has
occurred in relation to the device to the manufacturer and the competent au-
thority of the Member State in which the user and/or the patient is established.
1.5 Disposal Management Concept

The applicable local regulations governing disposal must be observed. It is the
user‘s responsibility to arrange for proper disposal of the individual components.
All parts which may contain potentially infectious materials must be disinfect-
ed by suitable, validated procedures (autoclaving, chemical treatment) prior to
disposal. Applicable local regulations for disposal must be carefully observed.
The instruments and electronic accessories (without batteries, power packs etc.)
must be disposed of according to the applicable local regulations for the dispos-
al of electronic components.
HumaLyte Plus5 / HumaLyte Plus3 | User manual

Safety Instructions 7
Batteries, power packs and similar power sources must be removed from elec-
tric/electronic parts and disposed of in accordance with applicable local regu-
lations.
1.6 Biohazard Warning

Analytical instruments for in vitro diagnostic application involve the handling of
human samples and controls which should be considered at least potentially in-
fectious. 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.
The „BIOHAZARD“ warning label must be affixed to the instrument prior to first
use with biological material!
Figure 1
Biological Hazard Symbol
1.7 Instrument Disinfection

Before performing any servicing on the instrument it is very important to thor-
oughly disinfect all possibly contaminated parts. Before the instrument is re-
moved from the laboratory for disposal or servicing, it must be decontaminated.
Decontamination must be performed by authorised well-trained personnel, and
in observance of all necessary safety precautions.
8

System Description 9
2 SYSTEM DESCRIPTION
2.1 Brief description of the instrument

Intended purpose HumaLyte Plus3
HumaLyte Plus3 is a semi-automated ion selective electrode (ISE) analyzer and
closed system for the quantitative determination of sodium (Na+), potassium
(K+) and chloride (Cl-) levels in human serum, plasma (lithium heparin), urine,
or whole blood. In combination with HUMAN’s clinical chemistry reagents, it
may be used as an aid to diagnosis or monitoring of sodium, potassium and
chloride imbalances, depending on the used reagent. For laboratory profession-
al use only.
Intended purpose HumaLyte Plus5

HumaLyte Plus5 is a semi-automated ion selective electrode (ISE) analyzer and
closed system for the quantitative determination of sodium (Na+), potassium
(K+), chloride (Cl-) and calcium (ionized Ca2+, total Ca2+) levels in human serum,
plasma (lithium heparin), whole blood and urine (Na+, K+ and Cl- only). In com-
bination with HUMAN’s clinical chemistry reagents, it may be used as an aid to
the diagnosis or monitoring of sodium, potassium, chloride and calcium imbal-
ances, depending on the used reagent. For laboratory professional use only.
Potassium, sodium, chloride and calcium make up the bulk of body electrolytes.
It is a priority of all medical treatment to maintain the proper electrolyte bal-
ance. It is therefore very important to measure the levels of potassium, sodium,
chloride and calcium in patients’ body fluids. In the past, the flame luminosity
was the method most widely used to measure potassium and sodium levels.
In recent years, Ion Selective Electrode (ISE) technology has been become prom-
inent with the application of sensor technology and microcomputer technology.
The flame luminosity method not only requires the use of flammable gas and
compressed air, it also requires that samples be centrifuged in order to obtain
patient serum for dilution and testing.
The Ion Selective Electrode method can measure the serum directly without any
dilution. It therefore shortens the measuring time significantly. In addition, the
Ion Selective Electrode method has several other advantages: it is more accu-
rate and less sample material is needed. For these reasons, it has become the
mainstream technology for electrolyte analysis.
10
The HumaLyte Plus line of electrolyte analyser is specially designed for clinical
analysis. The main features include:
High precision: Guaranteed by the use of long-life, high performance

electrodes and advanced automatic control software.
Unique calibration programs eliminate systematic
errors. Wide linear range.
Low sample volume: Only 150μl per test.
High throughput: Result obtained in less than 60 seconds.
High automation: Automatic aspiration, washing and calibration. Re-

sults display and print out automatically. All models
can be easily upgraded with an autosampler.
Easy operation: User friendly software, large LCD display, touch
screen. 24–hour, non-stop working mode, suitable for
emergency samples.
Large memory: Up to 200 patient results stored on board, easy to

review.
Easy maintenance: Advanced hardware design, fluid tubing system

and self-diagnosis software make maintenance and
troubleshooting simple.
2.2 Scope of application

The electrolyte analysers HumaLyte Plus 5 and HumaLyte Plus 3 are automat-
ed, microprocessor-controlled analytical instruments that use ISE (Ion Selective
Electrode) technology for the in vitro diagnostic measurement of ionized po-
tassium (K), sodium (Na), chloride (Cl) and ionized calcium (iCa) in serum, plas-
ma and whole blood (heparin between 10 and 20 U/ml, see chapter 3.3.7) pH
results are used only for the correction of iCa. Potassium (K), sodium (Na), and
chloride (Cl) can also be measured in diluted urine.
The instrument is only accurate for the measurement of ionized calcium (iCa),
total calcium (tCa) is a calculated value derived from iCa using the formula: tCa=
1.95 x iCa. iCa(7.4) and pH(37) are mathematically calculated on the basis of iCa
and pH (software version 5.5HE or above).

2.3 System structure
2.3.1 Front panel
Figure 2
3
1 Sample probe
2 Wash block
3 LCD, touch screen
4 Reagent pack compartment
1
4 5 Front door
2
5
2.3.2 Rear panel
Figure 3
1 Power switch
2 Power socket and voltage
selector
3 Grounding
4 RS232 port
5 Barcode reader
1 2 3
12
2.4 Unpacking
When unpacking the instrument, please make sure that the following items are
included. In case of any damage or missing items, please contact the supplier
immediately.
Table 1 [REF] Qty Unit Description Comment

17470/10 1 pcs. HumaLyte Plus 3 analyser
17470/20 1 pcs. HumaLyte Plus 5 analyser
17470/1 1 pcs. User Manual
17470/82 1 pcs. Reagent Pack Plus 3 only!
17470/83 1 pcs. Reagent Pack Plus 5 only!
18999 1 pcs. Power Cord
1 pcs. Grounding wire
1 Set Set of electrodes
17470/17 1 pcs. - Reference electrode

17470/12 1 pcs. - Sodium (Na) electrode
17470/11 1 pcs. - Potassium (K) electrode
17470/13 1 pcs. - Chloride (Cl) electrode
17470/15 1 pcs. - pH electrode Plus 5 only!
17470/14 1 pcs. - Calcium (Ca) electrode Plus 5 only!
1 Set - Accessories to hold electrodes
17470/70 1 pcs. QC solution

17470/79 1 pcs. Na conditioner
17470/76 1 pcs. Ca filling solution Plus 5 only!
17470/75 1 pcs. Na/Cl/pH filling solution
17470/74 1 pcs. K filling solution
17470/78 1 pcs. Reference filling solution
17470/72 1 pcs. Weekly cleaning solution
17470/86 1 pcs. Urine diluent
18144/5 1 Set Thermal paper (3 pcs.)
1 Set Accessories
1 pcs. - Tweezers
1 pcs. - Screwdriver
1 pcs. - Cleaning needle
17470/19 1 Set - Reference membrane (10 pcs.)
2 pcs. - O-ring
1 pcs. - Ref. membrane fitting tool
17470/18 1 pcs. - Internal electrode
17470/42 2 pcs. - Peristaltic pump tube
17470/61 1 Set - Fuse (F2AL250V) (2 pcs.)

2.5 Environment requirement

1. The instrument should be installed on a stable, solid platform away from any
vibration source.
2. The environment should be as free as possible from dust, corrosive gas, loud
noises and electrical interference.
3. Avoid placing the instrument in direct sunlight or near any source of heat or
vents.
4. Ambient temperature: 15…32°C, relative humidity: <85%.
5. The power supply should be 220/110Vac ± 10%, 50/60 Hz
6. Power supply and grounding must be connected correctly.
2.6 Installation of the reagents

1. Remove the reagent pack.
2. Remove the red cap on the connectors.
3. Insert the reagent pack into the compartment.
The Reagent Pack is identified by the instrument using an RFID chip inside the
Reagent Pack. The instrument will display an error when the chip is not present,
damaged, or not in the correct position.
1. After removing the Reagent Pack, Standard, Quality Control,

Filling solutions or other reagents from the refrigerator,
! allow them to warm to room temperature to achieve

accurate results and prevent any damage of the electrodes.
2. Be careful not to contaminate the reagents during installation
or replacement.
2.7 Installation of the electrodes

1. Assemble the electrodes with the rubber gaskets according to Figure 4. Slide
them onto the axis rod, then tighten the nuts firmly.
2. Check the filling solution levels. If necessary, remove the internal electrodes
and add the corresponding filling solution (K filling solution for the K elec-
trode, Ca filling solution for the Ca electrode, Na/Cl/pH filling solution for
the Na, Cl and pH electrodes, and reference filling solution for the reference
electrode).
14
3. Clean and dry the electrodes with a soft tissue.

4. Install the whole electrode assembly into the electrode holder.
5. Connect the electrode lead wires and the grounding wire to the correspond-
ing plugs according to figure Figure 5.
Due to the high electrolyte concentration (“salt”) inside the solution, there
might be salt crystals on the electrodes or other parts of the instrument (spilling).
As long as there is no leakage, salt crystals will not influence the instruments
function. Just turn of the instrument and use a wet cloth to clean.
! Do not mix up the electrodes!
Figure 4
HumaLyte Plus 5 only 4 5
1 “O”-Ring
2 Gasket 1
3 Sample mount
4 Internal electrode 2
5 Axis 3
Figure 5
K Na Ca PH Cl Ref
1
1 Plug
2 Lead wire
2
3 Sample mount
3
K Na Ca PH Cl Ref

2.8 Filling solutions

Filling Solutions are necessary for the function of the electrode. The “internal
electrode” (metal wire, see picture) has to be at least 2/3 emerged into the
Filling Solution. During weekly maintenance check if the filling level is sufficient
and refill if necessary. Filling Solution also has to be replaced if the calibration
of the respective parameter fails or the QC results are out of range. The approx-
imate filling volume for each electrode is stated in the table below.
Because you rarely have to completely refill the electrodes, one 100ml bottle is
more than sufficient until the end of usage time (see chapter 8.3 Shelf life and
consumption).
Figure 6
Item Approximate filling volume

K filling solution 300 ± 20µl per filling
Na/Cl/pH filling solution Na: 1170 ± 30µl, Cl: 300±20µl, pH: 730±20µl
Ca filling solution 300 ± 20µl
Ref. filling solution 650 ± 30µl
2.9 Installation of the autosampler (for autosampler models only)

Turn off the instrument and place the main unit and the autosampler onto the
junction panel. Connect the data cable correctly. When unplugging the cable, do
not pull the wires, only pull the clip.
2.10 Installation of the printing paper

1. Insert the paper roll into the printer
2. Insert the paper into the guide slot.
3. Make sure the thermal side of the paper faces downward.
4. Pull up the lever on the right and rotate the knob until the end of the paper
comes out of the printer, then push the lever down; or press Paper in the
service menu until the paper feeds correctly.
16
2.11 Installation of the tubes

Connect the tubes according to Figure 7.
Figure 7
7 8 9 9
1 Pump
2 Pump tube
3 Probe
4 Optical coupler
5 Wash block 1
6 Liquid distribution valve 2 waste

7 Aspirating tube 3
8 Electrodes
9 Connecting tubes
4 Std B
5
6
Std A
2.12 Connecting to the power supply

1. Make sure the input voltage selector is set to correct voltage.
2. Make sure the power switch is in the OFF position.
3. Connect the instrument to the power supply with the power cable.
!
The instrument must be grounded properly! Use the supplied
grounding cable if necessary.
2.13 Instrument construction

The instrument consists of electrochemical sensors (ISE), liquid and position
sensors, a microprocessor control system, a peristaltic pump, a 3-way valve, a
movable aspiration probe, an auto sampling system (optional), an auto calibra-
tion system and a Reagent Pack (including standard A, standard B, and a waste
container).

2.14 ISE theory

The HumaLyte Plus uses a method called ion-selective electrode (ISE) for the
determination of the concentration of electrolytes (K, Na, Cl, iCa) which are used
for diagnosis, treatment, and monitoring of patients. The pH results are used for
the correction of iCa only.
HumaLyte Plus 3 can directly measure 3 parameters: K, Na, Cl. HumaLyte

Plus 5 can directly measure 5 parameters: K, Na, Cl, iCa and pH. Based on the
parameters measured directly HumaLyte Plus 5 can derive 3 more calculated
parameters. These calculated parameters are iCa(7.4), tCa, pH(37). The para-
meters iCa(7.4) and pH(37) are only available on instruments featuring soft-
ware version 5.5HE or above.
An Ion Selective Electrode is a type of electrochemical sensor. It converts ion

activity into the electric potential of the electrode. This relation conforms to
the Nernst equation, which shows the linear relation of the logarithm of the
ion activity to the electrode potential. In addition, different electrodes are
sensitive to different ions. For example, the sodium electrode is only sensitive to
Na ions, and the potassium electrode is only sensitive to K ions. If the potassium
electrode, sodium electrode, and chloride electrode are combined, the K ions, Na
ions, and chloride ions in the sample can be measured at the same time.
The key part of the electrode is the sensitive membrane. On one side it is in
contact with the sample and responds to the change in concentration of certain
ions in the sample. On the other side, it is in contact with the internal filling
solution and converts the ionic conduction to electronic conduction through a
silver filament, i.e. internal electrode. In addition, there is a reference electrode
that indicates the reference potential and forms a complete measuring circuit.
Inside the reference electrode there is also an internal electrode. Its potential
remains constant when the concentration of the solution changes, so it
provides a reference point to measure the potential differences.
2.15 Measuring principles

The instrument measures the electrode potentials, and the data is processed
by the microprocessor to obtain the concentration of a given ion. The measure
method is called “standard comparison”.
18
It uses two kinds of standard solutions, one for the calibration of the base point,
and the other for the calibration of the slope. The result is obtained from the
potentials of the sample and two standard solutions. Both standards (standard
A and standard B) are contained within the reagent pack.
The following equations are used:
CX = CA * EXP [(EX-EA) / S] (1)
EB - EA
S= (2)
Log (CB / CA)
! Note:
•
•
Cx, Ex: the concentration and potential of the sample
CA, EA: the concentration and potential of standard A
• CB, EB: the concentration and potential of standard B
• S: the slope of electrode
In order to improve the precision, the contents of the standard solutions are
similar to ion concentration in a normal blood sample.
2.16 Explanation of the different parameters for calcium and pH

(HumaLyte Plus 5 only)
iCa (software version 5.5HE or above)
iCa is the actual concentration of ionized calcium measured directly by the in-
strument using a calcium ISE under the conditions which are present in the sam-
ple at that moment.
iCa(7.4) (software version 5.5HE or above)

Only about 50% of the “total” blood Calcium (tCa) is free ionized Calcium (iCa).
The remaining approximately 50% are bound to proteins or other complexes. An
alteration of the pH will change the ratio of iCa to tCa, thus changing the result
of the measurement of ionized Calcium. Once the sample has been collected pH
will inevitably change depending on the pre-analytical conditions (see require-
ments in chapter 3.3.4).
iCa(7.4) is the calculated concentration of a sample normalized to pH 7.4 and is

similar to the old iCa of software version 5.4HE. The iCa of version 5.4HE is also
corrected to a pH of 7.4. Software version 5.4HE only uses pH instead of pH(37)
for the calculation.

The version 5.5HE uses the formula
iCa(7.4)= iCa + [pH(37)-7.4]/1.89 [1]
where iCa is the actual concentration of ionized calcium measured by the

instrument, and pH(37) is the calculated pH of the sample at 37°C. The
mathematical approximation is only valid in the range of pH 7.2 to 7.6.
tCa
tCa is the calculated concentration of total calcium in the sample including both
free ionized calcium, which can be measured as described above, and protein
bound calcium using the formula
tCa=1.95*iCa(7.4) [2]
pH - used for correction of iCa only

pH is measured by the instrument directly at room temperature and under the
conditions which are present in the sample at that moment. Since standard A
and B inside the reagent pack have been adjusted to 25°C, the pH measured by
the instrument always represents the pH at 25°C.
pH(37) (software version 5.5HE or above)

The actual pH of the sample rises linearly with the fall of temperature. pH(37)
is the calculated pH corresponding to a temperature of 37°C (thus simulating
patient body temperature) using the following formula
pH(37)=pH - 0.0146*(37-25) [3]

20

Method of Operation 21
3 METHOD OF OPERATION
3.1 Flow chart of the operating procedure
Start- up

Self test

Positioning

Calibration

Main menu
Sample Cal. W. list
STD Service Results
Sample Cal. W. list

  
Measure sample Calibration Input work list
STD Service Results

 
Measure STD  Result review
Time Position QC
Printer Cleaning Factor
Send Voltage Paper
Reagent
22
3.2 Startup and self-test

After the instrument has been correctly installed, turn on the power and boot
up the instrument. The screen displays:
Initialization…
The instrument carries out a self-test for the positioner (liquid sensor on the left
side of the electrodes), printer and autosampler. The sample probe will lift, and
the screen displays:
Figure 8
!

Note:
1. For autosampler models, the screen will show “Sample tray OK” if
the autosampler is correctly installed.
2. The initialization will halt if any error is detected in the liquid distri-
bution valve, elevator switch or optical couplers.
When the initialization finishes successfully, the sample probe will lower. A few
seconds later, the screen displays:
Measure ISE STD……
This indicates that the instrument is carrying out a calibration. The system
checks the positioner’s voltage, pump pulse numbers and electrode potentials.
The screen displays:
(the positioner’s voltage (in mV) when calibrating with

1032 …
out liquid, up to 3 readings)
(the positioner’s voltage (in mV) when calibrating with
127 …
liquid, up to 3 readings)
(the pump pulse number corresponding to the sample
2094 2100 …
volume, up to 4 readings)
70.36 68.08 73.77 (the potential of each electrode when Standard B is
33.75 69.1 aspirated)
53.98 73.56 66.59 (the potential of each electrode when Standard A is
26.15 95.1 aspirated)

(The potentials with standard B and standard A are displayed in turn, up to 3

times). When the calibration is finished, the screen displays:
Figure 9
The results will also be printed out as below:
TIME: 2009-09-30 10:08

SLOPE
K:
Na:
Cl:
54.5
52.3
51.6
(27…67)
(27…67)
(27…60)
! Note: If the slope of an elec-
trode is unstable, “Fluc.” will
be displayed on the right. If the
Ca: 25.5 (15…34) slope of an electrode is abnormal
PH: 55.6 (26…70) “X” will be displayed on the right.
The normal ranges of the slopes are:

K: 27…67 mV/dec Ca: 15…34 mV/dec
Na: 27…67 mV/dec pH: 26…70 mV/dec
Cl: 27…60 mV/dec
After the calibration, the screen will display the main menu:
Figure 10
24
3.2.1 First start up

When a new instrument is started for the first time or has not been used for
one or more days there are some problems you may encounter but solve easily.
Due to the concentration of electrolytes in the solutions there might be crystal-

lizations inside the instrument preventing the good functioning of the instru-
ment. This problem is common to ISE-instruments and can easily be solved. The
first thing, you always should do, is to turn off and back on the instrument two
times.
Problems you may encounter and their solution:
- No liquid moving inside the tubing

• Try to locate the position where the tubing is blocked. Disconnect the
tubing and rinse the tubing using distilled water and a pipette.
- Abnormal or unstable calibration

• Refer to the trouble shooting section of this manual. Usually this
problem can be solved by replacing the filling solutions or the reference
membrane.
• If all parameters are concerned the problem is likely to be caused by
the reference electrode. If only one parameter is concerned there is a
problem with this specific electrode.
- “Sensor Error” 1#
• Crystallization inside the valve blocks the movement of the valve. Check
if the black disc inside the valve is turning (difficult to see, because there
is only one small slot in the disc). If the valve is not turning, open the valve
(two screws) and rinse it with distilled water. Make sure not to lose any
joints and put them back into the correct position.
- Crystallization on the outside of the electrodes

• Use a wet cloth to clean from the outside.
- Brown or black color on the bottom of the electrodes

• This will not prevent the instrument from working.

3.3 Sample measurement
3.3.1 Operation without autosampler

Press Sample to enter the sample measurement menu; the screen displays:
Figure 11
To change the sample number, press the corresponding button.

The screen then displays:
Figure 12
Enter the patient number and press Yes to save.

Once the system date changes, the sample number will restart from 001 and
increase until 999 (maximum) automatically.
26
To change the patient ID number using a barcode reader, scan the barcode on
the sample tube. The ID will be displayed after “ID”:
Figure 13
To change the patient ID number manually, press the button Get ID ; the screen
displays:
Figure 14
Enter the ID number and press Yes to save.

Place the sample under the sample probe and press Aspirate . The sample will
be aspirated into the system. Remove the sample from the sample probe when
the system emits a beep and the screen shows “Remove sample”. The results
will be displayed within 60 seconds:
Figure 15
When the instrument beeps, the sample should be removed
! from the sample probe immediately!

Printout
The results will also be printed out as below:
TIME: 2009-09-30 10:12

SAMPL-No: 001
PAT ID: 123456789012345678
K 5.09 mmol/l 3.5…5.2

Na 145.5 mmol/l 135…145 H
Ca 1.31 mmol/l 1.1…1.4
Cl 105.3 mmol/l 98…108
TCa 2.55 mmol/l 2.2…2.9
! Note:
•
•
“H” indicates the result is higher than the normal range.
“L” indicates the result is lower than the normal range.
• “?” indicates the slope is abnormal or the electrode has not been
calibrated properly.
Normal ranges
Many studies and clinical experience have proven that results of different in-
struments and different patient populations are not necessarily comparable.
Laboratories have to determine local reference ranges for all parameters using
the local instrument, specimen type, collection protocol, and reference subjects
representative of their patient population.
28
3.3.2 Urine testing method

“U/C” without backlight signifies that the sample is serum.
The screen displays:
Figure 16
For urine testing, press “U/C” and it will switch to “Urine”, indicating that the
sample is urine. The screen displays:
Figure 17
Press “Urine” again to switch to “CHYLE B”, which indicates that the sample is
whole blood or lipemic serum.
Figure 18
Pressing “CHYLE B” again will switch back to “U/C”.

The default type is "U/C" (serum). In "Urine" mode you have to pre-dilute the
urine sample 1+1 and the instrument will calculate and print out the correct
concentration itself.

In "Chyle B" mode the instrument will turn off the liquid positioner (sensor on
left side of the electrodes). In this case you will have to position the liquid inside
the tubing manually. Position the liquid in a way that there is no air inside elec-
trode pathway, only liquid.
!

Note:
1. Urine testing is possible for Na, K and Cl only. For clinically significant
analyses, 24 h urine is required.
2. For urine testing, only HUMAN urine diluent can be used, mixed with
the urine sample in a 1+1 ratio.
3. For fully automated operation, the specimen types (serum, urine,
chylous blood) can be pre-defined in the “W.list” menu.
4. For urine testing, the instrument aspirates 240 µl (after dilution) of
sample. The testing time will be 6 seconds longer than for serum.
If the instrument is not operated for more than X minutes (depending on the
setup), the screen will display Wake up , and the sample probe will lower. A
few seconds later, the instrument will enter standby mode. To begin measuring
samples again, press Wake up to activate the instrument.
If the standby time is over 30 minutes, the instrument will perform a calibra-
tion automatically when it is called out of standby mode. The electrodes will be
maintained during the standby time by automatic priming.
Figure 19
30
3.3.3 Operation with autosampler

Press Sample to enter the sample measurement menu; the screen displays:
Figure 20
Press the button after Tray Num and input the tray number. Input the first
sample number and last sample number in the same way. The first number can
be any number between 1 and 20, while the last number should be between the
first number and 20.
To measure controls, press QC 1 and/or QC 2 . The screen will show QC 1√

and/or QC 2√ . Before or after testing the samples, the instrument will measure
the controls placed in positions “QC 1”or “QC 2” automatically. For example, if
only QC 1 is pressed, the instrument will measure the control in position “QC 1”
before testing the samples. If only QC 2 is pressed, the instrument will measure
the control in position “QC 2” after testing the samples.
If emergency samples must be tested during the regular measurement

procedure, they should be placed in position “E 1” or “E 2”on the sample tray. If
there is only one emergency sample, it must be placed in position “E 1”. Pressing
E 1 or E 2 will display E 1√ or E 2√ . After measuring the current sample, the
instrument will measure the emergency samples. When the measurement of the
emergency samples finishes, “√” will disappear from the screen and the
instrument will return to the measurement of the regular samples.
During the sample measuring procedure, Exit can be pressed at any time to
quit. After finishing the measurement for the current sample, the instrument
will return to the main menu. Should the autosampler fail power off the instru-
ment and disconnect the autosampler from the main unit. When the instru-
ment is powered on again, it will automatically switch to stand-alone working
mode. The instrument can then continue to operate without the autosampler.

3.3.4 Pre-analytics: Sample collection and handling

Sample collection and handling must be carried out by the professionals. Al-
ways avoid haemolysis. In addition, the following points should be noted:
1. The serum, plasma or urine can be stored in the refrigerator, but they must
be warmed to the room temperature before testing.
2. When preparing samples, do not add any materials such as surfactants that
may interfere with the measurement or even damage the sensor.
3.3.5 Measurement of ionized calcium and pH (HumaLyte Plus 5 only)

General comments on the measurement of iCa and pH
In contrast to Sodium, Potassium, and Chloride, ionized Calzium and pH do not
remain stable within patient- and artificial samples. Thus for measuring iCa and
pH it is absolutely essential to respect pre-analytical steps and measuring con-
ditions. Without these pre-conditions the concentration of iCa and pH in the
sample will inevitably change and it is impossible to achieve meaningful results.
Blood collection procedure, pre-analytical handling, sample matrix, anti-coagu-

lant, medication and other analytes have a significant influence on the concen-
tration of iCa and pH in the sample and the ISE response. Centrifugation and
measurement should be performed immediately after blood collection, contact
of the sample with air should be avoided, and tubes are to remain tightly closed.
[2] [4] [5] [6] [7]
Comparability of the results

HumaLyte Plus 5 is measuring the pH and iCa in the sample under the actual
conditions during the measurement (e.g. temperature). Many Blood Gas Ana-
lyzers pre-heat the sample to 37°C before the measurement. This is not the case
for Humalyte Plus 5, which is an ISE analyzer for the clinical laboratory which
operates at room temperature.
HumaLyte Plus 5 with software version 5.5HE or above features additional

mathematical functions that make results between the two different types of
analyzers more comparable.
Laboratories anyway have to determine local reference ranges for all parame-
ters using the local instrument, specimen type, collection protocol, and refer-
ence subjects representative of their patient population.
32
Quality control
Human recommends using Human QC Solution (REF 17470/70 and 17470/110)
for the quality control of the instrument. Artificial control sera, including Huma-
trol N, Humatrol P, Serodos, and Serodos Plus, which do not have defined and
stable concentrations of iCa are not suitable for the control of iCa. Though they
may well be used for Na, K and Cl.
Results for ionized calcium using the new software 5.5HE (or above) will change
slightly compared to 5.4HE. Target values for Human QC Solution (REF 17470/70
and 17470/110) will thus also change slightly.
New target values for ionized calcium for software version 5.5HE (or above):
The target value on the label of REF 17470/70 and 17470/110 corresponds to
software version 5.4HE. The following table shows the unchanged target value
for version 5.4HE and the new target values for version 5.5HE (or above). In both
cases the range +/-0.1 mmol/l remains unchanged.
Table 2
Target in mmol/l 5.4HE 5.5HE or above
iCa 1.3 1.33
iCa(7.4) - 1.24
Please use these modified target values and the range indicated above in order
to release the instrument for measurements of patient samples.
3.3.6 Stability of iCa and pH in specimen

Stability of pH (used for the correction of iCa results only)
Influencing factors that change the pH of the sample in-vitro are for example:
- pH rises linearly with the fall of temperature [3]

- Exposure of the sample to air (loss of CO2) [2] [5]
- Glycolysis [5]
- Sample collection, handling, transport and storage (e.g. refrigeration, time)

Stability of ionized calcium

Only 50% of the “total” blood Calcium (tCa) is free ionized Calcium (iCa). 5%
are complex-bound (citrate, lactate, phosphate, bicarbonate), and 45% are
protein-bound (albumin, globulin). [5] A change of the concentration of the
mentioned substances, but also the pH and added anticoagulants will change
the ratio of iCa to tCa, thus changing the result of the measurement of ionized
Calcium.
Influencing factors that change the concentration of iCa in the sample in-vitro
are for example [2] [5]:
- pH alterations (and indirectly temperature, contact with air) [7]
- Binding of calcium by anticoagulant
- Sample dilution by anticoagulant
- Metabolism of blood cells or damage to the cells (hemolysis: K and iCa)
- Sample collection, handling, transport and storage (e.g. refrigeration, time)
3.3.7 Acceptable patient samples and anticoagulant

The instrument is designed for clinical diagnosis of patient specimen in
heparinized whole blood, plasma and serum samples. Sodium and lithium
heparin can be used [6]. Sodium heparin cannot be used for the evaluation of
patient sodium level. The heparin concentration in a blood sample should be
between 10 and not more than 20 IU per mL.
Specimen containers
Blood can be collected in glass or plastic tubes. Glass is an inert material imper-
meable to gases, thus glass tubes are suitable for sampling, storage, and trans-
port of specimens for electrolyte determinations. Plastic materials are perme-
able to gases, thus plastic syringes cannot be considered as perfectly gas-tight.
The permeability may cause a shift of the original values of pCO2 and further
affect the pH and iCa values.
The degree of this shift is dependent on the material and the syringe design such
as thickness of the wall, surface to volume relationship, and fitting of plunger
and stopper, etc. Plastic syringes with tightly fitting plungers and stoppers are
suitable for the determination of acid-base status (pH) and electrolytes if the
storage interval is less than 30 min. To avoid remixing of the blood cells, it is
recommended to use a gel separator tube (e.g. HumaTube Serum Gel-C/A (Z)
Cat. No. 73030/12).
34
General requirements for sampling

Blood may be collected for electrolyte determinations under the following
requirements:
- The sample has to be drawn and handled without contact with air in
order to keep the gas tensions, pH, and the concentration of ionized calcium
unchanged. Sample must be collected without air spaces or gaps in capillary.
Pouring the liquid from one tube to another is not suitable [2].
- The sample must be anti-coagulated immediately and sufficiently in order to
avoid the formation of clots which may obstruct the analytical instrument.
- Damage to the cells (hemolysis) must be avoided since hemolysis may cause
an increase in potassium, and a decrease in ionized calcium.
- Immediate centrifugation (shift of Na-K-relation may occur) [7]
Storage of samples
The following limitations to storage time and conditions apply for the
mentioned parameters. It is always recommended that the sample should be
refrigerated at 4°C or ice-water is used if the measurement of ionized calcium
and pH is included. [6] [2] [8]
Whole blood
Table 3 Temperature Glass tube Plastic tube
Room temperature Na, K: 2 hours Na, K: 2 hours
(21°C) Calcium, pH: 15 minutes Calcium, pH: 15 minutes
K: 1 hour K: 1 hour
4°C
Calcium, pH: 2 hours Calcium, pH: 30 minutes
K: 1 hour K: 1 hour
Ice-water bath
Calcium, pH: 2 hours Calcium, pH: 30 minutes
Serum and plasma

Table 4 Temperature Glass or plastic tube
Room temperature (21°C) Na, K, Calcium, pH: 12 hours
4°C Na, K, Calcium, pH: 24 hours
Table 5 Urine
Temperature Glass or plastic tube
2-8°C Na, K, Calcium, pH: 12 hours

Aspirate sample
Samples need to reach room temperature before starting the measurement. It
is always recommended to aspirate sample from the middle of the solution in
the tube for measurements.
3.4 Calibration
When systematic bias errors (results are always too low or too high) exist,
the factors can be adjusted using the Cal. function.
! Note: All system malfuntions should be excluded before using the function.
A calibration will be performed using an external calibrator and the calcula-
ted factors will be stored automatically. It is not necessary to use this funtion
on a daily base, as the system automatically calibrates in fixed intervals using
the internal calibrators.
Press Cal. in the main menu; the screen displays:
Figure 21
Press the button after K; the screen displays:
Figure 22
36
Enter the target value for K and press Yes to save. Enter the Na and Cl target
values in the same way. When all target values have been entered, press Cal ;
the screen displays:
Figure 23
Place the control under sample probe and press Aspirate , the instrument
aspirates the control and tests it. After a few moments, the screen displays:
Figure 24
The values displayed on the screen are calibrated values (calibrated value =
actual measuring value * current factor). If necessary, press Cal. to calibrate and
obtain other factors; otherwise press Exit to quit. After calibration, the screen
displays the new factors:
Figure 25
The new factors will also be printed out if printing is activated.

3.5 W. List
To input the work list, press W. List in the Main Menu; the screen displays:
Figure 26
Press Num▲ or Num▼ to increase or decrease the sample number. The num-
ber can also be changed by pressing the button after Num. The screen displays:
Figure 27
Enter the sample number and press Yes to save.
To change the patient ID number using a barcode reader, scan the barcode on
each sample tube, one by one. After each tube is scanned, the ID will be dis-
played after “ID”, and the number will be increased automatically.
! Note: In the definition of the type and number of samples in the “W.list”
menu, you should first select the type of sample (if necessary - the default
sample setting is serum), and then enter or scan the sample number. When the
number changes, the instrument will automatically switch to the next sample.
38
To change the patient ID number manually, then press the button Get ID ; the
screen displays:
Figure 28
Enter the ID number and press Yes to save.
3.6 Measure STD

This program calibrates the slope of the electrode. The procedure is same as for
“section 3.2 Startup and Self-Test”.
Press STD ; the screen displays:
Figure 29
Press Sel. ISE to calibrate the slope of the K/Na/Cl/Ca electrode. The calibration
procedure is same as for “chapter 3.2 Startup and Self-Test.

3.7 Service
The instrument has a comprehensive set of service programs. Press Service in
the main menu; the screen displays:
Figure 30
3.7.1 Change date and time

Press Time ; the screen displays:
Figure 31
Enter the value for “Year”. Press Yes to save. Set the month, date and time in
the same way.
3.7.2 Position
This program is to set up the correct aspiration volume. Press Position and the
instrument will aspirate the liquid. The screen displays:
Figure 32
40
Check for the correct liquid level: the liquid surface should be about 2cm away
from the inlet of the electrode assembly. Press ▲ to increase the aspirating
volume if the liquid level is too low, press ▼ to decrease the aspirating volume
if the liquid level is too high.
This program should be run after any service performed. The above operation
can be skipped if the instrument has a positioner (fluid position sensor) installed.
However, if the positioner is defective, the instrument will use the parameter
obtained with the above operations. For this reason, running this program is
recommended whenever a new instrument is installed.
3.7.3 Quality control

Quality Control Solution (see chapter 8.1 Consumables and accessories) is used
to verify the good function of the instrument. It is very sensitive to contamina-
tion or evaporation. If you are using the 100ml bottle of QC Solution, work with
a clean pipette, close the lid immediately after use, do not aspirate directly from
the bottle, store the open bottle in a refrigerator, and respect the usage time.
To avoid these problems we suggest using QC Solution supplied in 2ml am-

poules. Target values are marked on the packaging of the QC Solution. See also
chapters 3.3.5 and 4 for information concerning quality control of iCa and pH.
To run the QC program, press QC ; the screen displays:
Figure 33

To enter a new Lot number, press Lot No. ; the screen displays:
Figure 34
Enter the new lot number (8 digits, e.g. 0000H023), press Yes to save.
Place the control under sample probe and press Aspirate . The control will be
aspirated into the system for measuring. (For autosampler models, the control
should be placed in position “QC1” on the sample tray.) The result will be dis-
! Note: All QC data stored in
the instrument will be deleted
automatically when a new lot
played and printed out within 60 seconds. When there are 5 or more QC results number is entered!
(up to 220), a statistical report can be obtained. Press Stat. ; the screen displays:
Figure 35
Press By Day to display a statistical report including mean value (Mean),

standard deviation (SD) and coefficient of variation (CV %).
Figure 36
42
The report will also be printed out as below:

STATISTIC REPORT
TIME: 2009-09-30 11:23
Lot No: 00000000000020050330 (only the last 8 digitals are valid)
ITEM Mean SD CV(%)

K 5.01 0.03 0.60
Na 145.2 0.15 0.41
Cl 105.5 0.35 0.30
Ca 1.31 0.03 0.29
N=10
Press By Month to print out a statistical report for all of the last QC results of
each day.
3.7.4 Printer
Press Printer ; the screen displays:
Figure 37
Press Print ON to enable the printer, press Print OFF to disable the printer.
3.7.5 Cleaning the instrument and Na-conditioner

This chapter explains the use of the Daily Cleaning Solution, the Weekly
Cleaning Solution and the Na-Conditioner. Under normal condition it is
sufficient to clean the instrument using the Weekly Cleaning Solution once a
week.
The Daily Cleaning Solution should only be used if you are measuring whole
blood or lipemic samples. For Daily and Weekly Cleaning Solution you use the
option “Deprotein” in the “Service”-“Cleaning”-menu. The Na-Conditioner has
to be used if the slope of Sodium is below 50. Please use the option “Na Adjust”
for this purpose.

The procedure takes only a few minutes and is very similar for all three
solutions. You press the respective cleaning option in the menu and the needle
will aspirate the respective solution and clean the instrument automatically.
The consumption of the respective solution is stated in the table below.
Press Cleaning ; the screen displays:
Figure 38
For autosampler models, the cleaning solution should be placed in the position
“Calib” on the sample tray.
For Daily and Weekly Cleaning Solution use Deprotein .
Press Deprotein to display Aspirate on the screen. Place the cleaning solu-
tion under sample probe. Press Aspirate to aspirate the cleaning solution into
the instrument. After aspiration, Aspirate disappears from the screen and the
percentage progress is displayed:
Figure 39
The whole process will take about 5 minutes.

To “re-condition” the Na filling solution inside the electrode use Na-Conditioner
and the option Na Adjust .
Press Na Adjust , the screen displays Aspirate . Place the Na conditioner under
sample probe. Press Aspirate to aspirate the Na conditioner into the instru-
ment. After aspiration, Aspirate disappears from the screen and the percentage
progress is displayed.
44
! Note: Run the “Na adjust”

program when the Na slope is
less than 50.
It takes about 1 minute to finish the “Na Adjust” program. The Na slope should
be above 50 for the electrode to be in the best working condition which can
prolong the using time of the electrode.
Table 8
Item Approximate consumption
Na conditioner 430µl per conditioning cycle
Daily Cleaning Solution 1300µl per cleaning cycle
Weekly Cleaning Solution 1300µl per cleaning cycle
If you are planning not to use the instrument for more than one week, you
should drain the fluidic system. Please pull out the Reagent Pack approxima-
tely 2cm and perform a “STD” calibration (option “STD” in the main menu).
The instrument will aspirate air instead of standard solution from the Reagent
Pack, thus draining the fluidic system.
! Falsely using the Weekly Cleaning Solution for everyday clean-

ing will lead to a deterioration of the life time of the electrodes!
3.7.6 Factor
You can manually define a slope (a) and an intercept (b) to achieve correlation to
a reference instrument. The slope can also be changed by using the “Cal.”-func-
tion in the main menu.
To change the calibration factors manually, press Factor ; the screen displays:
Figure 40
! Note:
a – slope,
b – intercept

Select the item to be changed, for example K; the screen displays:
Figure 41
Enter the new slope value (a) and press Yes to save; the screen displays:
Figure 42
Enter the new intercept value (b). Press Yes to save.
3.7.7 Data transfer

Press Send ; the patient results will be transferred using the serial port on the
back of the instrument. Be aware that this is not a standardised protocol and no
program is provided by Human to be installed on a host computer. If you wish to
use this data, please ask a computer specialist to provide help with the RS-232
data received from the instrument.
46
3.7.8 Voltage
Press Voltage to check the potential of each electrode:
Figure 43
Press Aspirate to aspirate a sample and check the voltages. For autosampler
models, place the sample in the position “Calib” on the sample tray.
The screen displays the voltages (in mV) every two seconds:
Figure 44
Press Exit to quit.

Check the performance of the electrodes using this program. For standard A or
control, the normal values of K, Na and Cl should be approx. 50. If the values of
K, Na and Cl are all smaller than 20, the most likely causes are a too-low level of
reference filling solution or an aging reference membrane. Add filling solution
or replace the reference membrane.
3.7.9 Feed paper

Press Paper to feed the printing paper.

3.7.10 Reagent
To check the residual volume of the reagents, press Reagent . The screen dis-
plays:
Figure 45
The residual volume of the reagents will be displayed on the screen. When load-
ing a new reagent pack, press Refill . The screen displays:
Figure 46
Enter the password: 123 and press Yes to confirm or Exit to quit; then the
screen displays:
Figure 47
48
! 1.
Note:
When the icon appears on the main menu screen, this indicates
that the remaining reagents are sufficient to run approx. 150 samples.
2. When the icon appears on the main menu screen, the
remaining reagents are sufficient to run only approx. 20 samples.
3. When the icon appears on the main menu screen, the reagents
have run out.
3.7.11 Choosing the parameters you want to display (HumaLyte Plus 5 only)
With software version 5.5HE and the standard settings of the instrument
iCa(7.4) and pH (used for correction of iCa results only) will be displayed and
printed. The iCa(7.4) actually is comparable to the old iCa of software version
5.4HE. If you wish to also display and print iCa, pH(37) and tCa, contact your
local distributor to set up the instrument accordingly.
3.7.12 Result review

The instrument stores patient results for review.
Press Results ; the screen displays:
Figure 48
The residual volume of the reagents will be displayed on the screen. When
loading a new reagent pack, press Refill . The screen displays:

Figure 49
To review the results by sample number, press Num 001 , the screen displays:
Figure 50
Input the sample number and press Yes ; the corresponding result will be dis-
played on the screen. You can also press ▲ or ▼ to change the sample number.
Press Print to print out the sample results.
! Note: To print out results,
the printer should be enabled
first. Refer to section 3.7.4.
Press All to print out all sample results. If there is no data stored, the screen will
display “No data”.
The printing format is the following:
001 PAT ID: 000000000000000000

5.09 145.3 105.3 1.31 7.56 0.1
002 PAT ID: 000000000000000001
5.09 145.3 105.3 1.31 7.56 0.1
003 PAT ID: 000000000000000002
5.09 145.3 105.3 1.31 7.56 0.1
50
3.8 Reagent consumption

Reagent consumption of the HumaLyte Plus greatly depends on the use of
the instrument. The “Reagent” Pack contains two solutions that are used to
calibrate the instrument: Standard A (Std. A, 650ml) and Standard B (Std. B,
350ml)
In order to assure valid results, the instrument has to calibrate regularly. The
number of calibrations the instrument has to perform will determine the
number of samples you can measure with one Reagent Pack, because the
calibration will also consume reagent.
A. When turning on the instrument, it will perform a triplet of two point

(Std. A and Std. B) calibrations. This Start-Up-Calibration will consume
7.26ml of Std. A and 3ml of Std. B.
B. When the instrument is not used it will fall into a sleeping mode (*). If you
wake up the instrument within the next 30 minutes, the Small-Wake-
Up-Calibration will consume 0.19ml of Std. A.
C. If you wake up the instrument later than 30 minutes after going into
sleeping mode, the Big-Wake-Up-Calibration will consume 2.13ml of Std.
A and 1.39ml of Std. B.
D. During sleeping mode (stand-by) the instrument will automatically rinse

the electrodes every 4 hours. This maintenance of the electrodes will con-
sume 2.3ml of Std. A and 1.4ml of Std. B.
E. When you perform a manual calibration by pressing the “STD” option in

the main menu, the Manual-Calibration will also consume 2.13ml of Std.
A and 1.39ml of Std. B.
F. The measurement of a sample will consume 0.45ml of Std. A and 0ml of

Std. B (one point calibration with every measurement).
(*) You may change the time before the instrument falls into sleeping mode
(please refer to your local service engineer in order to do this).

Based on the numbers given above, the following table gives an approximation
of how many samples you can measure with one Reagent Pack.
Number of samples per day Number of samples per reagent pack Table 9
5 100-190
10 200-350
20 350-550
50 600-850
100 850-1050
What will most influence the consumption of reagent is:
- The number of samples you measure per day

- The number of samples you measure in one batch (e.g. 30 samples in the
morning and 30 samples in the afternoon will consume a lot less reagent
than measuring 20 times a day but only 3 samples per batch)
52

Precautions 53
4 PRECAUTIONS
4.1 Operation precautions

1. The analyzer is designed to work continuously for 24 hours a day. There
is no need to shut down the machine every day. It is important that the
membranes of the electrodes are humidified regularly by the automatic
rinse function of the analyzer. Shutting off the analyzer during the night or
during a weekend will result in a decrease of the electrodes life time and
usage time.
2. Do not use standard solutions intended for use with flame luminosity. They
contain strong acid and other supplements that may damage the electrodes.
3. Not all commercial controls are suitable for ISE measurement. Some contain
too many chemical additives that may interfere with the measurement.
Especially HumaTrol N, HumaTrol P, Serodos, and Serodos Plus, which do not
have defined and stable concentrations of pH and iCa are not suitable for
the control of iCa and pH. Though they may well be used for Na, K and Cl.
Please refer to the leaflet of the respective control.
4. Bubbles should be prevented during sample aspiration; otherwise the

results will be unreliable.
5. When the sample reaches the testing point, make sure there are no bubbles
in it; otherwise the sample should be run again.
6. If the ambient temperature fluctuates by more than 5°C, the instrument

should be calibrated again.
7. The pH value of the standard solutions and the samples should be within a
range of 6 to 9, otherwise the measurement of sodium ions may be inaccu-
rate.
8. Discard the reagent if it becomes mouldy or a deposit forms.
9. Perform the routine maintenance according to the instructions.

54
4.2 Safety precautions

1. The electric voltage inside the instrument is hazardous. Do not open the in-
strument before disconnecting it from the power supply.
2. Because the samples may contain pathogenic bacteria or viruses, all replaced
tubes, electrodes and waste containers should be discarded according to the
safe laboratory procedures and government regulations.
3. Always wear proper personal protective equipment (as gloves, lab coat etc.)
and follow safe laboratory procedures when working with instrument and
reagents in the laboratory.
4.2.1 Hazard statements

The following hazard statements are valid for the respective REF numbers.
17470/79 Na conditioner (100ml/bottle)

Warning
H315 Causes skin irritation
H319 Causes serious eye irritation
4.2.2 Precautionary statements

The following precautionary statements apply to the following REF numbers.
[REF] 17470/79 Na conditioner (100ml/bottle)
P280 Wear protective gloves/protective clothing/eye protec-

tion/face protection.
P305+P351+P338 IF IN EYES: Rinse cautiously with water for several min-
utes. Remove contact lenses, if present and easy to do.
Continue rinsing.
P321 Specific treatment (see ... on this label)
P332+P313 If skin irritation occurs: Get medical advice/attention.
P337+P313 If eye irritation persists: Get medical advice/attention.

Precautions 55
The following precautionary statements apply to the following REF numbers.
[REF] 17470/82 Reagent Pack HumaLyte Plus 3 (1000ml/pcs)

[REF] 17470/83 Reagent Pack HumaLyte Plus 5 (1000ml/pcs)
[REF] 17470/70 QC solution (100ml/bottle)
[REF] 17470/110 QC solution (10 x 2ml ampoules)
[REF] 17470/71 Daily Cleaning Solution (100ml/bottle)
[REF] 17470/72 Weekly Cleaning Solution (100ml/bottle)
[REF] 17470/74 K filling solution (100ml/bottle)
[REF] 17470/75 Na/Cl/pH filling solution (100ml/bottle)
[REF] 17470/76 Ca filling solution (100ml/bottle)
[REF] 17470/78 Ref. filling solution (100ml/bottle)
[REF] 17470/86 Urine diluent (100ml/bottle)
P234 Keep in original container.

P260 Do not breathe dust / fume / gas / mist / vapours / spray.
P262 Do not get in eyes, on skin or on clothing.
P281 Use personal protective equipment as required.
IF ON SKIN (or hair): Take off immediately all contami-
P303+P361+P353
nated clothing. Rinse skin with water/shower.
IF IN EYES: Rinse cautiously with water for several min-
P305+P351+P338 utes. Remove contact lenses, if present and easy to do.
Continue rinsing.
P337+P313 If eye irritation persists: Get medical advice/attention.
Store in accordance with local / regional / national /
P401
international regulations.
Dispose of contents / container in accordance with local /
P501
regional / national / international regulations.
56

Maintenance 57
5 MAINTENANCE
5.1 Daily maintenance

Monitor the residual reagent volume and replace the reagent pack when
necessary. Run the cleaning program in the service menu every day, using “Daily
Cleaning Solution”, if you measure whole blood or lipemic samples. Please refer
to section 3.7.2.
5.2 Weekly maintenance

1. Check to ensure that the internal filling solution level of each electrode is
sufficient. Add filling solution if the level is less than 2/3 of the total volume.
2. Check if there is a salty crust on the electrode, if so, remove it with a moist
cloth.
3. Check if the sample aspiration volume is correct. If necessary, adjust the
pump according to section 3.7.2.
4. Run the cleaning program in the service menu once a week if more than
25 samples are measured every day. If fewer than 20 samples are measured
per day, the cleaning program needs to be run only every 2-3 weeks. Please
refer to section 3.7.5.
5. Run the “Na adjust” program if the slope of Na electrode is less than 50.
Please refer to section 3.7.5.
6. Check the voltage of each electrode. If necessary, replace the reference fill-
ing solution or reference membrane. Please refer to section 3.7.8.
5.3 Spare parts replacement

Check the following parts periodically:
1. Pump tube
2. Aspirating tube
3. Connecting tubes
4. Valve
5. Internal electrodes
Replace worn parts.

58
5.4 Check the tubing system

If the aspirating speed and volume is abnormal, check the tubing system to see
if there is any leakage.
1. Run the calibration program.

2. Check the flow inside the electrode assembly.
3. Check the flow inside the tubing system.
4. The normal condition is a long section of air followed by a long section of
liquid. If the tubing connection is loose, bubbles can be found near the
connector. Reconnect the tubing.
5. If there is a leak anywhere between the electrodes, disassemble the
electrodes and check the gaskets (O-rings).
6. If the tubes are tightly connected, check if there is any blockage.
7. Replace the pump tube if it is seriously distorted, otherwise the aspiration
volume will not be sufficient.
5.5 Replace the electrode

1. Pull out all of the electrode wires from the plugs. Remove the tubes from the
inlet and outlet of the electrode assembly.
2. Loosen the fixing nuts of the electrode assembly.
3. Disassemble the whole electrode assembly.
4. Discard the electrode to be replaced.
5. Take a new electrode and add the filling solution.
6. Assemble the electrodes in the correct order. Make sure that the rubber
gaskets are in right position.
7. Tighten the fixing nuts of the electrode assembly.
8. Connect the tubing. Insert the electrode wires back to the plugs.
9. Calibrate the instrument.

Maintenance 59
5.6 Replace the reference membrane

If you experience a problem (e.g. unstable or abnormal slopes) for all
parameters, it is probably due to the reference electrode. It is usually not
necessary to replace the complete electrode, because you can maintenance
the electrode yourself. First check the cable connection and replace the filling
solution of the electrode. If unsuccessful replace the reference membrane as
described in the user manual. In most cases this will solve the problem and you
don’t have to replace the whole electrode.
1 Figure 51
2
1 Internal electrode
3
2 Screw cap
4
3 Internal interface
5
4 Reference menbrane
5 "O"- Ring
6 Ref
7
7 "O"- Ring
6 8
8 Referance membrane
9 9 Interface
Reference electrode components are shown in the following figure:
1 2 3 4
Figure 52
1 Ref-block
2 Screw cap
3 Reference membrane (REF 17470/19)
4 Internal electrode (REF 17470/18)
5 Internal interface
6 O-ring fitting tool (REF 17470/200)
7 O-Ring
5 6 7
60
1. Open the instrument front door and pull out all the electrode wires from the
plugs. Remove the tubes from the inlet and outlet of the electrode assembly.
See the following figure:
Figure 53
2. Loose the fixing nuts of the electrode assembly and take out the reference
electrode. See the following figures:
Figure 54
Figure 55
3. Disassemble the reference electrode: Loosen the screw cap, take out the
internal electrode, and remove the filling solution, the O-ring and the old
reference membrane. Clean the internal interface and Ref with distill water,
and wipe it with clean cotton or tissue.

Maintenance 61
4. Soak a new reference membrane in the distilled water.

5. Place the O-ring on the interface as shown in the following figure.
Figure 56
6. Place the new reference membrane evenly on the internal interface See the
following figure:
Figure 57
7. Connect the interface with the internal interface and pull the ‘O’ ring onto
the internal interface. See the following figure:
Figure 58
62
8. Remove the interface. Make sure that the reference membrane is smooth
and not damaged. See the following figure:
Figure 59
9. Insert the internal interface into Ref-block without damaging the new refer-
ence membrane. Tighten the screw cap. See the following figure:
Figure 60
10. Fill the internal interface with reference filling solution (REF 17470/78) us-
ing a pipette or syringe (up to 2/3 of the total volume avoiding to damage
the membrane and without any bubbles on the bottom)
11. Screw in the internal electrode. If there is any filling solution overflowing,
wipe it with clean tissue. Otherwise, it will produce white salt crystals after
evaporation of water.
12. Re-assemble the electrodes in correct order, tighten the fixing nuts, and
then connect the tubing to inlet and outlet. Insert all the wires into the plugs.
Run calibration again.

Maintenance 63
! Note: The instrument may give “Error” signals in the first calibration after
replacement of the membrane. In this case, perform calibrations for several
more times and the results will be good. If the results are still not good after
several calibrations, check as following:
1. Check whether the reference membrane is properly replaced. Replace it

again if necessary.
2. Check whether the reference filling solution is invalid or contaminated. Re-

place with new reference filling solution if necessary.
3. Check whether there are bubbles at the bottom of the reference electrode.
Get rid of the bubble if there is any on the bottom.
4. Check the internal electrode and make sure its coating doesn’t flake off.
Change it if necessary (REF 17470/18).
64

Error Code 65
6 ERROR CODE
6.1 Printed error code
Code Description Table 10

Error 0# Liquid positioning failed
Error 1# Liquid detection failed
Warn 2# Bubbles detected
Error 3# Too much or too little sample aspirated
Error 4# Slope abnormal
Error 5# Slope unstable
6.2 Displayed error code
Code Description Table 11

Liquid distribution valve failed. Please check
if the black disk inside the distribution valve is
1# (“Sensor Error”) turning. In case it is not turning please ask an en-
gineer to clean the valve from the inside using
distilled water.
2# Elevator switch failed
3# Optical coupler for the sample tray home failed
4# Optical coupler for the sample tray cup failed
66

Troubleshooting 67
7 TROUBLESHOOTING
7.1 Slope unstable

Table 12
Cause Recommended solution
Unreliable grounding Check the connection of the ground-
ing wire
No standard A or standard B Check and replace Standard A or B;
aspirated Check the tubing connection
Incorrect positioning of the standard Adjust position again
solution
The reference filling solution or If the problem (unstable or abnor-
reference membrane is not working mal) occurs for all parameters there
is a problem with the reference elec-
trode. Check cable connection and re-
place filling solution. If unsuccessful
replace the reference membrane as
described above.
The internal electrode turns gray Replace when necessary
Poor connection of the electrode wire Check and connect again
Electrode membrane leaks Replace when necessary
Power supply voltage fluctuates Use UPS or power stabilizer
Humidity too high Lower the humidity or move the in-
strument to a dryer place
Bubbles inside the tubing Check the tubing system
Liquid leakage inside the valve Replace gasket or valve when neces-
sary
The electrode is not activated or Activate the electrode first
the activating time is insufficient
Reference membrane defective Replace the reference membrane
68
7.2 Slope abnormal
Table 13 Cause Recommended solution

Too many organic deposits on Clean the instrument with Weekly and/or
the electrode membrane Daily Cleaning Solution
Reagent contaminated Replace the reagent
Insufficient filling solution Add filling solution
Electrode does not work Replace the failed electrode
Bubble at the bottom of the If an air bubble is stuck at the bottom of an
electrode electrode, remove the complete electrode
set and tap it carefully on the table.
Dust or moisture around the Clean and dry the electrode and plug
electrode or plug
Tubing blocked Crystallization may block the tubing.
Please watch and check if the liquid is
flowing in all tubes. If a tube is blocked,
disconnect and clean it using a pipette and
distilled water.
7.3 Aspiration abnormal
Table 14 Cause Recommended solution

Aspirating tube loose or broken Connect again or replace
Pump tube sticks Replace the tubing
Pump tube broken Replace the tube
Pump tube blocked Clear the blockage
The gasket between the elec- Align the gasket properly or replace if nec-
trodes is not aligned properly or essary
is missing
The electrode assembly leaks Tighten the assembly again
Dust on the liquid sensor or sen- Clean or replace
sor is damaged

Appendix 69
8 APPENDIX
8.1 Consumables and accessories
Description Table 15
[REF]
17470/11 K - electrode
17470/12 Na - electrode
17470/13 Cl - electrode
17470/14 Ca - electrode
17470/15 pH - electrode
17470/17 Reference electrode
17470/18 Internal electrode
17470/19 Reference membrane (10 pcs)
17470/82 Reagent Pack HumaLyte Plus 3 (1000ml/pcs)
17470/83 Reagent Pack HumaLyte Plus 5 (1000ml/pcs)
17470/70 QC solution (100ml/bottle)
17470/110 QC solution (10 x 2ml ampoules)
17470/71 Daily Cleaning Solution (100ml/bottle)
17470/72 Weekly Cleaning Solution (100ml/bottle)
17470/74 K filling solution (100ml/bottle)
17470/75 Na/Cl/pH filling solution (100ml/bottle)
17470/76 Ca filling solution (100ml/bottle)
17470/78 Ref. filling solution (100ml/bottle)
17470/79 Na conditioner (100ml/bottle)
17470/86 Urine diluent (100ml/bottle)
17470/41 Aspirating tube
17470/42 Peristaltic pump tube
17470/91 Connection tube
18144/5 Thermal paper (5 pcs.)
17470/30 Autosampler for 20 sample cups
17470/59 Sample cup 2.0 ml for Autosampler (500 pcs)
70
8.2 Autosampler (REF 17470/30)

The autosampler is an optional accessory that has to be ordered separately. The
following items are included in the delivery of the optional autosampler.
Table 16 [REF] Qty Unit Description Comment

- 1 pcs. Main unit
17470/31 2 pcs. Autosampler tray
- 1 pcs. Connection cable
17470/32 1 pcs. Bottom plate
17470/59 1 Set Sample cups (60 pcs. only)
17470/71 1 pcs. Daily cleaning solution
8.3 Shelf life and consumption
Table 17
Storage Usage
Item REF Unit conditions time (*)
Sodium Electrode 17470/12 1 pc 5 … 30˚C 12 months
Potassium Electrode 17470/11 1 pc 5 … 30˚C 6 months
Chloride Electrode 17470/13 1 pc 5 … 30˚C 6 months
Calcium Electrode 17470/14 1 pc 5 … 30˚C 6 months
pH Electrode 17470/15 1 pc 5 … 30˚C 12 months
Reference Electrode 17470/17 1 pc 5 … 30˚C 12 months
Reference membrane 17470/19 10 pcs 5 … 35˚C 6 months
QC Solution 17470/70 100ml 5 … 8˚C open 2 months
5 … 35˚C closed
QC Solution 17470/110 10x2ml 5 … 8˚C open 1 day
5 … 35˚C closed
K Filling Solution 17470/74 100ml 5 … 35˚C 12 months
Na/Cl/pH Filling Solu- 17470/75 100ml 5 … 35˚C 12 months
tion
Ca Filling Solution 17470/76 100ml 5 … 35˚C 12 months
Ref. Filling Solution 17470/78 100ml 5 … 35˚C 12 months
Na Conditioner 17470/79 100ml 5 … 35˚C 12 months
Urine Diluent 17470/86 100 ml 5 … 35˚C 12 months
Daily Cleaning Solution 17470/71 100ml 5 … 35˚C 12 months
Weekly Cleaning Solution 17470/72 100ml 5 … 35˚C 12 months
Reagent Pack 17470/82 1 pc 5 … 35˚C 4 months
(Plus3)
17470/83
(Plus5)

Appendix 71
(*) Usage Time is the estimated minimum time you are able to use the item,
starting from the point of time when you install/open the item. (For Filling Solu-
tions the Usage Time specifies the time you can use an open bottle to refill the
electrodes.) In any case, the items are only usable until the end of their expiry.
!
Falsely using the Weekly Cleaning Solution for everyday clean-
ing will lead to a deterioration of the life time of the electrodes!
8.4 Specifications
System
overview Analyzer type: Stand-alone ISE Electrolyte Analyzer
Principle: Direct measurement by Ion Selective Table 18
Electrode (ISE)
Measured HumaLyte Plus 3
parameters: Na+ (sodium)
K+ (potassium)
Cl- (chloride)
HumaLyte Plus 5:
Na+ (sodium)
K+ (potassium)
Cl- (chloride)
iCa++ (ionized calcium)
pH (used for correction of iCa results only)
tCa (calculated value)
iCa(7.4) (calculated value)
ph(37) (calculated value, used for correction of
iCa results only)
Sample type: Serum, plasma (heparin 10 – 20 U/ml),
whole blood (heparin 10 – 20 U/ml), diluted
urine
Throughput: Up to 60 samples/hour
Sampling: Manually through aspiration needle or option-
al Autosampler (with STAT)
Operation Standard mode: Daily use operation;
Modes: QC mode: QC measurement for statistical
interpretation (two levels)
72
Table 19 Measurement Sample volume: 150 µL

Measuring range (serum, plasma, whole blood):
K+ 0.50 – 15.00 mmol/L
Na+ 30.0 – 200.0 mmol/L
Cl- 30.0 – 200.0 mmol/L
iCa++ 0.10 – 5.00 mmol/L
pH 4.00 – 9.00 units
Measuring range (urine):

K+ 10 - 100 mmol/l
Na+ 50 - 250 mmol/l
Cl- 50 - 250 mmol/l
iCa++ n.a.
pH n.a.
Precision within run (CV%, for serum):

K+ ≤1.5%
Na+ ≤1.0%
Cl- ≤1.5%
iCa++ ≤3.0%
pH ≤2.0%
Carryover: <1.5% sample to sample
Calibration: Automatic 2-point calibration
every 4 hours or on demand.
1-point calibration with each
sample for temperature and
drift compensation.
Sample positions: 1 aspiration position, (20 sample
positions with Autosampler)
Sample tubes: All regular tubes/cups up to 50
mm length.
Sample cups (17470/59) for
Autosampler.

Appendix 73
Operation Data storage: Sample results (for 200 patients with patient ID), Table 20
QC results
Reports: QC (Mean, SD, CV%), patient results
Warnings: Analytical limits (high/low), calibration criteria
User interface: LCD touch screen (110 x 62 mm, with LED back
light)
Printer: Build-in thermal printer, 32 characters per line;
Printing Width: 58 mm;
Printing Speed: 46 characters per second
Connectivity: RS-232 serial port (uni-directional)
Periphery: Barcode reader can be connected via RS-232
Language: English
General Operating Table 21
temperature: 15 – 32°C
Relative ≤85%, non-condensing
humidity: (at 30°C)
Input voltage: 110/220 V AC ± 10%, 50/60 Hz
Power 60 VA
consumption:
Dimensions Instrument without any
(WxDxH): components: 38 x 35 x 44 cm
Space required for routine use: 63 x 61 x 52 cm
Packaging: 49 x 45 x 56 cm
Space required for use with
autosampler: 69 x 61 x 52 cm
Weight: HumaLyte Plus 3: Gross: 13.3 kg, Net 7.8 kg
HumaLyte Plus 5: Gross: 13.9 kg, Net 7.8 kg
Autosampler (option): Net 1.3 kg
Fuse: F2AL250V
Usage Pump: Peristaltic pump Table 22

Valve: Rotary valve
Sensor: Optical liquid sensor for positioning
Reagent: Only one Reagent Pack necessary for all para-
meters. Closed system, only usable with Human
Reagent Pack.
Disposal of Contaminated waste, container integrated in
waste: Reagent Pack
74
8.5 Reagent
Table 23 HumaLyte Plus 3 Reagent Pack Standard A 650ml

KCl 4.00 mmol/l
NaCl 96.0 mmol/l
Na acetate 44.0 mmol/l
Standard B 350ml
KCl 8.00 mmol/l
NaCl 59,9 mmol/l
HumaLyte Plus 5 Reagent Pack Standard A 650ml
KCl 4.00 mmol/l
NaCl 94.0 mmol/l
CaCl2 1.0 mmol/l
Standard B 350ml
KCl 8.00 mmol/l
NaCl 58,0 mmol/l
CaCl2 2.0 mmol/l
Table 24
Na/Cl/pH filling solution 100ml < 1% NaCl
< 1% N-(2-hydroxyethyl) piperazine-
(2-ethanesulfonic acid)
< 1% Tris(hydroxymethyl)aminomethane
K filling solution 100ml < 1% Potassium chloride
Ca filling solution 100ml < 1% Calcium chloride
Reference filling solution 100ml < 1.5% Potassium chloride
Na conditioner 100ml < 1% Ammonium hydrogenfluoride
QC solution KCl 5.0 mmol/l
Target values (software 5.4HE) NaCl 97.6 mmol/l
K: 5.0 ± 0.1 mmol/L Na acetate 47.4 mmol/l
Na: 145.0 ± 2.0 mmol/L CaCl2 1.2 mmol/l
Cl: 105.0 ± 2.0 mmol/L
iCa: 1.3 ± 0.1 mmol/L
Weekly cleaning solution 100ml < 1% Sodium hypochlorite
Daily cleaning solution 100ml < 1% Pepsin
< 1% Trypsinase
< 1% Papain
Urine diluent < 0.3% Magnesium acetate
< 0.2% Trishydroxymethyl-aminomethane
(TRIS)
< 0.2% N-(2-Hydroxyethyl)- piperazine -
N-2-ethanesulfonic acid (HEPES)
< 0.2% Triton X-100

Appendix 75
8.6 List of references

For further information kindly refer to the following list of references. Many of
the cited references are available online (e.g. [2] [6] [3] [1]).
1. Sachs, „Anomalies in pH 7.40 correction in ionized calcium analyzers,“ Ann.

Clin. Biochem., Nr. 26, 1989.
2. Boink, Buckley und Christiansen, „IFCC Recommendation on Sampling,
Transport and Storage for the Determination of the Concentration of Ion-
ized Calcium in Whole Blood, Plasma and Serum,“ Eur. J. Clin. Chem. Clin.
Biochem., Nr. 29, pp. 767-772, 1991.
3. Rosenthal, „The effect of temperature on the pH of blood and plasma in vit-
ro,“ J. Biol. Chem., Nr. 173, pp. 25-30, 1948.
4. G. Dimeski and T. Badrick, "Ion Selective Electrodes (ISEs) and interferences -
A review," Clinica Chimica Acta, no. 411, pp. 309-317, 2010.
5. L. Thomas, Labor und Diagnose, Frankfurt: TH-Books, 2008.
6. Burnett, Covington und Fogh-Andersen, „Approved IFCC Recommendations
on Whole Blood Sampling, Transport and Storage for Simultaneous Determi-
nation of pH, Blood Gases and Electrolytes,“ Eur. J. Clin. Chem. Clin. Biochem.,
Nr. 33, pp. 247-253, 1995.
7. Burtis, Ashwood und Bruns, TIETZ Textbook of clinical chemistry and molec-
ular diagnostics, St. Louis: Elsevier Saunders, 2006.
8. A. Kallner, „Preanalytical Procedures in the Measurement of Ionized Calcium
in Serum and Plasma,“ Eur J Clin Chem Clin Biochem, Nr. 34, pp. 53-58, 1996.
76

HUMAN
Gesellschaft für Biochemica und Diagnostica mbH
Max-Planck-Ring 21 • 65205 Wiesbaden • Germany
Tel.: +49 6122/9988 0 • Fax: +49 6122/9988 100
eMail: human@human.de • www.human.de

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HumaLyte Plus5

SERVICE AND SUPPORT

1.2 User warranty

1.3 Use of the instrument

1.4 General Safety Warnings

1.5 Disposal Management Concept

HumaLyte Plus5 / HumaLyte Plus3 | User manual

1.6 Biohazard Warning

1.7 Instrument Disinfection

HumaLyte Plus5 / HumaLyte Plus3 | User manual

2.1 Brief description of the instrument

Intended purpose HumaLyte Plus5

High precision: Guaranteed by the use of long-life, high performance

Low sample volume: Only 150μl per test.

High throughput: Result obtained in less than 60 seconds.

High automation: Automatic aspiration, washing and calibration. Re-

Large memory: Up to 200 patient results stored on board, easy to

Easy maintenance: Advanced hardware design, fluid tubing system

2.2 Scope of application

HumaLyte Plus5 / HumaLyte Plus3 | User manual

2.3 System structure

2.3.1 Front panel

2.3.2 Rear panel

Table 1 [REF] Qty Unit Description Comment

17470/17 1 pcs. - Reference electrode

17470/70 1 pcs. QC solution

HumaLyte Plus5 / HumaLyte Plus3 | User manual

2.5 Environment requirement

2.6 Installation of the reagents

1. After removing the Reagent Pack, Standard, Quality Control,

! allow them to warm to room temperature to achieve

2.7 Installation of the electrodes

3. Clean and dry the electrodes with a soft tissue.

! Do not mix up the electrodes!

HumaLyte Plus5 / HumaLyte Plus3 | User manual

2.8 Filling solutions

Item Approximate filling volume

2.9 Installation of the autosampler (for autosampler models only)

2.10 Installation of the printing paper

2.11 Installation of the tubes

6 Liquid distribution valve 2 waste

2.12 Connecting to the power supply

2.13 Instrument construction

HumaLyte Plus5 / HumaLyte Plus3 | User manual

2.14 ISE theory

HumaLyte Plus 3 can directly measure 3 parameters: K, Na, Cl. HumaLyte

An Ion Selective Electrode is a type of electrochemical sensor. It converts ion

2.15 Measuring principles

CX = CA * EXP [(EX-EA) / S] (1)

2.16 Explanation of the different parameters for calcium and pH

iCa(7.4) (software version 5.5HE or above)

iCa(7.4) is the calculated concentration of a sample normalized to pH 7.4 and is

HumaLyte Plus5 / HumaLyte Plus3 | User manual

The version 5.5HE uses the formula

iCa(7.4)= iCa + [pH(37)-7.4]/1.89 [1]

where iCa is the actual concentration of ionized calcium measured by the

pH - used for correction of iCa only

pH(37) (software version 5.5HE or above)

pH(37)=pH - 0.0146*(37-25) [3]