AVL 9180 User manual

9180 Electrolyte Analyzer
Operator's Manual
MEDICAL INSTRUMENTS

ii
2nd Edition
June 1996
Copyright, 1996, AVL Scientific Corporation. All rights reser ed. Unless otherwise noted, no part of
this publication may be reproduced, transmitted, transcribed, stored in a retrie al system, or translated
into any language in any form without the written permission of AVL Scientific Corporation.
For information contact:
AVL Scientific Corporation AVL MEDICAL INSTRUMENTS AG AVL LIST GmbH
50 Mansell Court Stettemerstrasse 28 Kleiststrasse 48
P.O. Box 337 CH-8207 Schaffhausen A-8020 Graz
Roswell, Georgia USA 30077 Switzerland Austria
1-800-526-2272 41-848-800-885 43-316-987
Printed in USA
PD5006 REV B

This Operator´s Manual contains important warnings and safety information to be observed by the
user.
This instrument is only intended for one area of application which is described in the instruc-
tions. The most important prerequisites for application, operation and safety, are explained to
ensure smooth operation. o warranty or liability claims will be covered if the instrument is
applied in areas other than those described or if the necessary prerequisites and safety mea-
sures are not observed.
The instrument is only to be operated by qualified personnel capable of observing these
prerequisites.
Only accessories and supplies either delivered by or approved by AVL are to be used with the
instrument.
Due to this instrument operating principle, analytical accuracy not only depends on correct
operation and function, but also upon a variety of external influences beyond the manufactur-
ers control. Therefore, the test results from this instrument must be carefully examined by an
expert, before further measures are taken based on the analytical results.
Instrument adjustment and maintenance with removed covers and connected power mains are
only to be performed by a qualified technician who is aware of the dangers involved.
Instrument repairs are only to be performed by the manufacturer or qualified service personnel.
Symbol Explanation
Attention symbol - Refer to the Operator's Manual or Service
Manual for further instructions. This symbol is located on the
inside of the instrument.
Type B instrument symbol - An instrument of the B type falls
under safety categories I, II, or III, or has an internal power
supply providing the required insulation against discharge current
and reliable ground connections.
Important Information!
Important Information!
iii
!

iv
This instrument falls under Safety Category I.
This instrument is a Class B instrument.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions: (1) this device may not cause harmful interferences, and (2) this device must accept
any interference received, including interference that may cause undesired operation.
Warning: Changes or modifications to this unit not expressly approved by the party
responsible for compliance could void the users authority to operate the equipment.
ote: This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference in a residential installation. This
equipment generates, uses, and can radiate radio frequency energy and, if not installed and
used in accordance with the instructions, may cause harmful interference to radio commu-
nication. However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does not cause harmful interference to radio or television
reception, which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna
Increase the separation between the equipment and receiver
Connect the equipment into an outlet on a circuit different from that to which
the receiver is connected.
Consult the dealer or an experienced radio TV technician for help
Caution:
The instrument is designed as a conventional device (closed, not waterproof type).
Do not operate the instrument in an explosive environment or in the vicinity of
explosive anesthetic mixtures containing oxygen or nitrous oxide.
This instrument is suitable for continuous operation.
The power plug is to be plugged into a ground socket only. When using an extension
cord, make sure that it is of the proper size and is properly grounded.
Any breakage of the ground lead inside or outside the instrument or a loose ground
connection can cause a hazardous condition when operating the instrument. Intentional
disconnection of the grounding is not permitted.
When replacing the fuses, make sure that they are of the same type and rating as the
original fuses. ever use repaired fuses or short-circuit the fuse holders.
Operating Safety Information
Operating Safety Information

v
METHOD SHEET
Intended Use
The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potas-
sium, chloride, ionized calcium and lithium in samples of hole blood, serum, plasma, urine, dialy-
sate and aqueous standard solutions.
Clinical Significance1,2
Sodium
Sodium is the major cation of extracellular fluid. Its primary functions in the body are to chemically
maintain osmotic pressure and acid-base balance and to transmit nerve impulses. Sodium functions
at the cell membrane level by creating an electrical potential bet een different cell membranes
causing the transmission of nerve impulses and neuromuscular excitability to be maintained. Sodium
is involved in some enzyme catalyzed reactions as a cofactor. The body has a strong tendency to
maintain a total base content, and only slight changes are found even under pathologic conditions.
Lo sodium values, hyponatremia, usually reflect a relative excess of body ater rather than a lo
total body sodium. Reduced sodium levels may be associated ith: lo sodium intake; sodium losses
due to vomiting or diarrhea ith adequate ater and inadequate salt replacement, diuretics abuse, or
salt-losing nephropathy; osmotic diuresis, metabolic acidosis; adrenocortical insufficiency; congeni-
tal adrenal hyperplasia; dilution type due to edema, cardiac failure, hepatic failure; and
hypothyroidism.
Elevated sodium values, hypernatremia, are associated ith conditions ith ater loss in excess of
salt loss through profuse s eating, prolonged hyperpnea, severe vomiting or diarrhea, diabetes
insipidus or diabetic acidosis; increased renal sodium conservation in hyperaldosteronism, Cushings
syndrome; inadequate ater intake because of coma or hypothalamic diseases; dehydration; or
excessive saline therapy.
The sodium value obtained may be used in the diagnosis or monitoring of all disturbances of the
ater balance, infusion therapies, vomiting, diarrhea, burns, heart and kidney insufficiencies, central
or renal diabetes insipidus, endocrine disturbances and primary or secondary cortex insufficiency of
the adrenal gland or other diseases involving electrolyte imbalance.
1 Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W. .Saunders, Co., 1990)
p.98-99, 118-119, 456-459, 510-511, 720-721.
2 urtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W. .Saunders, Co.,
1994) pp.1354-1370.

vi
Potassium
Potassium is the major cation in the intracellular fluid and functions as the primary buffer ithin the
cell itself. Ninety percent of potassium is concentrated ithin the cell, and damaged cells release
potassium into the blood. Potassium plays an important role in nerve conduction, muscle function, and
helps maintain acid-base balance and osmotic pressure.
Elevated potassium levels, hyperkalemia, can be found in oliguria, anemia, urinary obstruction, renal
failure due to nephritis or shock, metabolic or respiratory acidosis, renal tubular acidosis ith the K+/
H+ exchange and hemolysis of the blood. Lo potassium levels, hypokalemia, can be found in exces-
sive loss of potassium through diarrhea or vomiting, inadequate intake of potassium, malabsorption,
severe burns and increased secretion of aldosterone. High or lo potassium levels may cause changes
in muscle irritability, respiration and myocardial function.
The potassium value obtained may be used to monitor electrolyte imbalance in the diagnosis and
treatment of infusion therapies, shock, heart or circulatory insufficiency, acid-base imbalance, therapy
ith diuretics, all kinds of kidney problems, diarrhea and hyper- and hypo-function of adrenal cortex
and other diseases involving electrolyte imbalance.
Chloride
Chloride is an anion that exists predominantly in extracellular spaces. It maintains cellular
integrity through its influence on osmotic pressure. It is also significant in monitoring acid-base
balance and ater balance. In metabolic acidosis, there is a reciprocal rise in chloride concentra-
tion hen the bicarbonate concentration drops.
Decreased levels are found in severe vomiting, severe diarrhea, ulcerative colitis, pyloric obstruction,
severe burns, heat exhaustion, diabetic acidosis, Addisons disease, fever and acute infections such as
pneumonia.
Increased levels are found in dehydration, Cushings syndrome, hyperventilation, eclampsia, anemia,
cardiac decompensation.
Ionized Calcium
Calcium in blood is distributed as free calcium ions (50 %), bound to protein, mostly albumin
(40 %) and 10 % bound to anions such as bicarbonate, citrate, phosphate and lactate. Ho ever,
only ionized calcium can be used by the body in such vital processes as muscular contraction,
cardiac function, transmission of nerve impulses and blood clotting. The AVL 9180 Analyzer
measures the ionized portion of the total calcium. In certain disorders such as pancreatitis and
hyperparathyroidism, ionized calcium is a better indicator for diagnosis than total calcium.

vii
Elevated calcium, hypercalcemia, may be present in various types of malignancy, and calcium
measurements may serve as biochemical markers. In general, hile ionized calcium may be slightly
more sensitive, either ionized or total calcium measurements have about equal utility in the detection
of occult malignancy. Hypercalcemia occurs commonly in critically ill patients ith abnormalities in
acid-base regulation and losses of protein and albumin, hich gives a clear advantage to monitoring
calcium status by ionized calcium measurements.
Patients ith renal disease caused by glomular failure often have altered concentrations of calcium,
phosphate, albumin, magnesium and pH. Since these conditions tend to change ionized calcium
independently of total calcium, ionized calcium is the preferred method for accurately monitoring
calcium status in renal disease3.
Ionized calcium is important for diagnosis or monitoring of: hypertension management,
parathyroidism, renal diseases, inadequate calcium intake, vitamin D monitoring, dialysis patients,
cancer, pancreatitis, effect of diuretics, malnutrition, kidney stones, multiple myeloma and diabetes
mellitus.
Lithium
Lithium is a monovalent alkali metal hich is usually absent in the human body. It is used in the
treatment of manic depression psychosis. The drug has proven highly effective in its intended use but
some clinically significant complications have been associated ith its use. Lithium binding to the
plasma proteins is less than 10% and its half life is 7 - 35 hrs. It is mainly eliminated from the body by
urine (95%).
Lithium has a very narro therapeutic range. Initial dosing is aimed at bet een 0.80 to 1.20 mmol/L
and the long-term maintenance level is 0.60 to 0.80 mmol/L. The concentration of lithium in serum
during therapy is closely monitored, because lithium is acutely toxic ith concentrations that are
slightly higher than the above therapeutic range.
Urine Electrolytes
The electrolytes present in the human body and also ingested daily from food are excreted from the
body in a natural circulation via the renal system, into the urine. Measurement of electrolytes in
excreted urine gives important information about the efficiency of the kidneys and other pathological
situations. Urine examinations can be made on a random urine sample or for a quantitative determina-
tion on a 24 hour collected urine sample. The quantity of electrolytes excreted per day can be deter-
mined by multiplying the measured concentration (mmol/L) ith the total quantity of urine excreted in
one day.
3 urritt MF, Pierides AM, Offord KP: Comparative studies of total and ionized serum calcium values in normal
subjects and in patients with renal disorders. Mayo Clinic Proc. 55:606, 1980.

viii
Dialysate Electrolytes
In the dialyzer, arterial blood and suitable dialysate liquids are led to a dialysis membrane in opposite
directions. The structure of the membrane is such that it prevents the diffusion of proteins and red
blood cells through the membrane. Since the composition of the blood and the dialysate are different,
a gradient ill be formed at the membrane and thus smaller molecules are activated to diffuse
through the membrane. This method is effectively used to remove substances like urea, uric acid
hich are unable to excrete from the blood because of renal insufficiency.
When the concentration of the electrolytes bet een the blood and dialysate liquid deviates signifi-
cantly, the electrolytes diffuse in the direction to ards the lo er concentration (i.e. from blood into
the dialysis liquid or vice versa). Analysis of electrolytes in dialysis is of immense clinical signifi-
cance and provides useful information to the clinician. The use of ISE's in dialysis are:
 To control the patient's electrolyte balance before, during and after the dialysis for fast
recognition of deviations and also for making early corrections.
 To control the electrolyte concentrations in the dialysis liquid. Normally they are prepared
by mixing appropriate concentrations of the substances ith a defined quantity of distilled
ater.
Principles of Procedures
The AVL 9180 Analyzer methodology is based on the ion-selective electrode (ISE) measurement
principle to precisely determine the measurement values.
There are six different electrodes used in the AVL 9180 Electrolyte Analyzer: sodium, potassium,
chloride, ionized calcium, lithium and a reference electrode. Each electrode has an ion-selective
membrane that undergoes a specific reaction ith the corresponding ions contained in the sample
being analyzed. The membrane is an ion exchanger, reacting to the electrical charge of the ion
causing a change in the membrane potential, or measuring voltage, hich is built up in the film
bet een the sample and the membrane.
A galvanic measuring chain ithin the electrode determines the difference bet een the t o potential
values on either side of the membrane. The galvanic chain is closed through the sample on one side
by the reference electrode, reference electrolyte and the "open terminal". The membrane, inner
electrolyte and inner electrode close the other side.
A difference in ion concentrations bet een the inner electrolyte and the sample causes an electro-
chemical potential to form across the membrane of the active electrode. The potential is conducted
by a highly conductive, inner electrode to an amplifier. The reference electrode is connected to
ground as ell as to the amplifier.
The ion concentration in the sample is then determined by using a calibration curve determined by
measured points of standard solutions ith precisely kno n ion concentrations.

ix
Specimen Collection and Handling
Safety
Universal precautions must be observed hen collecting blood specimens. It is recommended that all
blood specimens be handled as potentially infectious specimens capable of transmitting human
immunodeficiency virus (HIV), hepatitis B virus (HBV), or other bloodborne pathogens. Proper
blood collection technique must be follo ed in order to minimize risk to the laboratory staff. Gloves
should al ays be orn hen handling blood and other body fluids.
Please refer to NCCLS document, M29-T2, Protection of Laboratory Workers from Infectious
Disease Transmitted by Blood, Body Fluids, and Tissue - Second dition; Tentative Guideline for
further information on safe handling of these specimens.
Sample Requirements
Refer to NCCLS document, H11-A2, Percutaneous Collection of Arterial Blood for Laboratory
Analysis - Second dition; Approved Standard, May 1992, for detailed information on sample
collection, storage and handling.
Blood sampling for analysis must be performed under proper supervision ith details of collection,
including sampling devices, site selection, sample handling and documentation approved by the
personnel responsible. Specific procedures used should follo NCCLS guidelines.
Anticoagulants and Sample Collection De ices
The AVL 9180 Electrolyte Analyzer ill accept samples directly from syringes, collection tubes,
samples cups and, ith the use of an adapter, from capillary tubes or the AVL Microsampler.
For hole blood and plasma samples, a balanced heparin that does not affect the electrolyte values is
the recommended anticoagulant of choice. Sodium heparin is also an acceptable anticoagulant for
electrolyte analysis, ho ever, heparin binds ionized calcium to a certain extent falsely decreasing the
measurement values.
Other anticoagulants such as EDTA, citrate, oxalate and fluoride have a significant effect on blood
electrolytes and should not be used.
For serum samples, containers ithout additives are recommended.

x
Handling and Storage of Samples
For ionized calcium values, anaerobic conditions should be follo ed for all sample types. Contact
ith ambient air ill cause a loss of CO2 in the sample and the subsequent rise in pH ill cause a
reduction in ionized calcium.
Whole Blood
Whole blood samples should be collected in a heparinized syringe, AVL Microsampler or capillary
and analyzed as soon as possible after collection. The sample container should be filled as much as
possible, leaving minimal residual air space. If brief storage is required, do not cool the sample, as
the erythrocytes could burst and release the intracellular potassium, creating an inaccurate potassium
value in the sample.
Plasma
Plasma samples should be obtained by immediately centrifuging heparinized hole blood, separating
the plasma from red cells and capping the sample tube. Analyze as soon as possible. If storage is
required, the samples should be capped and refrigerated at 4 to 8 °C. Refrigerated samples should be
allo ed to arm to room temperature (15 to 30 °C) prior to analysis. If storage exceeds one hour,
the plasma sample must be recentrifuged to remove additional fibrin clots.
Serum
Serum samples should be obtained by collecting blood in an untreated blood collecting tube. The
sample should stand for 30 minutes to allo the clot to form prior to centrifugation. After centrifuga-
tion, remove the serum from the clot, and cap or seal the sample tube. If storage is required, the
sample should be stored, tightly capped, under refrigeration at 4 to 8 °C, and allo ed to return to
room temperature, 15 to 30 °C, prior to analysis.
Each laboratory should determine the acceptability of its o n blood collection syringes, capillaries
and tubes and the serum or plasma separation products. Variations in these products exist bet een
manufacturers, and at times, from lot to lot.

xi
Reagents
ISE SnapPakTM (BP5186) containing the follo ing reagents:
Standard A
Use: For calibration of sodium, potassium, chloride, ionized calcium and
lithium in the AVL 9180 Electrolyte Analyzer
Contents: 350 mL
Active Ingredients: Na+150 mmol/L
K+5.0 mmol/L
Cl-115 mmol/L
Ca++ 0.9 mmol/L
Li+0.3 mmol/L
Additives: Germicides
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.
Standard B
Use: For calibration of sodium, potassium, chloride, ionized calcium and
lithium in the AVL 9180 Electrolyte Analyzer
Contents: 85 mL
Active Ingredients: Na+100 mmol/L
K+1.8 mmol/L
Cl-72 mmol/L
Ca++ 1.5 mmol/L
Li+0.3 mmol/L
Additives: Germicides
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.

xii
Standard C
Use: For calibration of sodium, potassium, chloride, ionized calcium and
lithium in the AVL 9180 Electrolyte Analyzer
Contents: 85 mL
Active Ingredients: Na+150 mmol/L
K+5.0 mmol/L
Cl-115 mmol/L
Ca++ 0.9 mmol/L
Li+1.4 mmol/L
Additives: Germicides
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.
Reference Solution
Use: A salt bridge for calibration and measurement in the AVL 9180 Electrolyte
Analyzer
Contents: 85 mL
Active Ingredients: Potassium chloride 1.2 mol/L
Additives: Germicides
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.
Separately Packaged Reagents:
Cleaning Solution A (BP1025)
Use: For cleaning the AVL 9180 Analyzer measuring system.
Contents: Each dispensing bottle contains 100 mL of solution
Active Ingredients: Neodisher MA (detergent) 3.5 g/L
Additives: none
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.

xiii
Conditioning Solution (BP0380)
Use: For daily conditioning of the sodium electrode and sample sensor in the
AVL 9180 Analyzer.
Contents: Each dispensing bottle contains 100 mL of solution (U.S. market)
Active Ingredients: Ammonium bifluoride 100 mmol/L
Additives: none
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.
Urine Diluent (BP0344)
Use: For use as a diluent for the measurement of urine samples in AVL electro-
lyte system.
Contents: Each bottle contains 500 mL of solution
Active Ingredients: Sodium chloride 120 mmol/L
Additives: germicides
Storage: Temperature: 5 - 30 °C (41 - 86 °F)
Stability: Expiration Date & Lot Number are printed on each container label.
PRECAUTIONS:
Use of calibration solutions or electrodes not manufactured for AVL could void t e warranty.
A waste container is provided wit t e ISE SnapPakTM w ic , w en used, olds uman body fluids
w ic may be potentially infectious; andle wit appropriate care to avoid skin contact or ingestion.
FOR IN-VITRO DIAGNOSTIC USE.
Procedure
Materials Needed
Description Part Number
ISE SnapPakTM BP5186
Cleaning Solution A BP1025
Conditioning Solution BP0380
Urine Diluent BP0344
Printer Paper (5 rolls) HP5025

xiv
The AVL 9180 Analyzer allo s the operator to select one of the follo ing measuring modes: hole
blood, serum, urine, standard, Q.C. material, acetate or bicarbonate depending on the sample type to
be analyzed. The analyzer automatically processes the sample through the necessary steps, then
prints and displays the results.
In the blood, serum and Q.C. measuring modes, the results for sodium and potassium are reported by
default as flame photometry equivalent values; chloride, ionized calcium, and lithium are reported as
ISE direct potentiometry values. The urine mode allo s for the measurement of prediluted urine
samples for sodium, potassium and chloride. The acetate, bicarbonate and standard mode allo s for
the measurement of aqueous solutions and reports as ISE direct potentiometry values. For details of
this operation, please refer to the Operator's Manual.
Test Conditions
Sample Size: 95 µL
Sample Types: Whole blood, serum, plasma, urine, acetate and bicarbonate
dialysate solutions
Sample Container: capillary, AVL Microsampler, syringe, collection tube, sample
cup.
Ambient Temperature: +15 to +32 °C ( 60 to 90 °F)
Relative Humidity: 5% to 85% (non-condensing)
Type of Measurement: direct potentiometry
Measured Parameters
Parameter Measurement Range Display Resolution
Whole blood, serum, plasma, dialysate and aqueous solutions:
Sodium 40 - 205 mmol/L 1 or 0.1 mmol/L
Potassium 1.5 - 15 mmol/L 0.1 or 0.01 mmol/L
(0.8 - 15mmol/L dialysate)
Chloride 50 - 200 mmol/L 1 or 0.1 mmol/L
ionized Cal ium 0.2 - 5.0 mmol/L 0.01 or 0.001 mmol/L
Lithium 0.1 - 6.0 mmol/L 0.01 or 0.001 mmol/L
(Lithium is not measured in dialysate samples)
Urine
Sodium 1 - 300 mmol/L 1 mmol/L
Potassium 4.5 - 120 mmol/L 0.1 mmol/L
(60-120 with additional dilution)
Chloride 1 - 300 mmol/L 1 mmol/L
(Cal ium and Lithium are not measured in urine samples)

xv
Calibration
The analyzer contains soft are hich permits one of six parameter configurations: Na+/K+/Ca++,
Na+/K+/Cl-, Na+/K+/Li+, Na+/K+, Na+/Li+, Li+. Each of these configurations uses the same calibration
solutions.
A 2-point calibration is performed automatically every 4 hours in READY mode and a 1-point calibra-
tion is automatically performed ith every measurement.
An automatic calibration procedure is also performed shortly after po er-on or reset. A calibration
cycle can also be initiated manually at times hen no sample measurements are performed.
Quality Control
AVL recommends that at least once daily or in accordance ith local regulations, quality control
solutions ith kno n Na+, K+, Cl-, Ca++ and Li+ values should be analyzed at t o levels (normal and
lo or high). For further details, please revie the Quality Control section of the Operator's Manual.
Results obtained should fall ithin limits defined by the day-to-day variability of the system as mea-
sured in the users laboratory. If the results fall outside the laboratorys acceptable limits, refer to the
Troubleshooting Section of the Operator's Manual.
Reference Inter al
Specimen Reference Ranges
Na+ K+ Ca++ Cl- Li+
(mmol/l) (mmol/L) (mmol/L) (mmol/L) (mmol/L)
serum, plasma,
hole blood 136-14513.5-5.111.12-1.32197-11140.6-1.201
urine
(mmol/24hrs) 40-220125-1251N/A 110-2501N/A
The ranges are provided for reference only. Each laboratory should establish its o n reference interval
for Na+, K+ , Cl-, Ca++ and Li+ as performed on the AVL 9180 Electrolyte Analyzer.
4 Henry, R.J., Clinical Chemistry - Principles and Technics, (New York: Harper and Row, 1974)

xvi
Limitations of the Procedure
A number of substances have been reported to cause physiological changes in blood, serum, and
plasma analyte concentrations. A comprehensive discussion concerning these and other interfering
substances, their blood, serum or plasma concentrations and their possible physiological involvement
is beyond the scope of this method sheet. No significant effect on serum and urine has been demon-
strated from bromide, ammonium and iodide.
As ith any clinical reaction, users must be alert to the possible effect on results due to unkno n
interference from medications or endogenous substances. All patient results must be evaluated by
the laboratory and the physician in light of the total clinical status of the patient.
Opening and closing the fist ith a tourniquet in place results in an increase in potassium levels by as
much as 10 to 20%. It is recommended that the blood sample be obtained ithout a tourniquet, or
that the tourniquet be released after the needle has entered the vein and 2 minutes elapsed before the
sample is dra n.
Since the concentration of potassium inside erythrocytes is much greater than that in extracellular
fluid, hemolysis should be avoided, and the serum should be separated from the cells as soon as
possible after collection.
The lithium electrode response is dependent on the actual sodium concentration of the sample. The
AVL 9180 Analyzer reports lithium in the range of 105 - 180 mmol/L Na+.
Interferences
Salicylate, in extremely high levels, is kno n to interfere ith the chloride electrode and results in a
positive bias of the chloride result. At therapeutic levels of salicylate concentration, the influence on
chloride is clinically insignificant.
The lithium electrode sho s a slight sensitivity to the ionized calcium present in the sample and
results in a negative bias of the lithium result. At normal physiological ionized calcium concentra-
tions, the influence of ionized calcium is clinically insignificant.
5 Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p.890-95

xvii
Relationship of ionized Calcium to total Calcium
The ratio of ionized calcium to total calcium in a healthy population is around 0.50 or 50% 1,5. These
relationships may be altered hen using citrate in blood, or hen the acid-base metabolism is dis-
turbed.
Specific Performance Characteristics
Reproducibility
Typical Within-Run (Swr) Bet een-Day (Sdd) and Total (ST) Precision is determined from 2 runs per
day ith 2 replicates per run for 20 days on t o AVL 9180 analyzers in each of its three configura-
tions. Values for sodium and potassium are average of all six instruments, hile values for chloride,
ionized calcium and lithium are determined from the measurement of t o of each respective unit
configuration. All values are reported in mmol/L.
Material: ISE-trol Protein Based Aqueous Control Material - Level 1
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 114.6 0.48 0.42% 0.76 0.66% 0.89 0.78%
Potassium 2.82 0.025 0.87% 0.035 1.24% 0.041 1.44%
Chloride 76.7 0.29 0.38% 0.52 0.67% 0.72 0.94%
ionized Calcium 2.07 0.015 0.72% 0.024 1.18% 0.034 1.66%
Lithium 0.40 0.010 2.40% 0.018 4.57% 0.026 6.41%
Material: ISE-trol Protein Based Aqueous Control Material - Level 2
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 141.2 0.40 0.28% 0.30 0.21% 0.46 0.33%
Potassium 4.35 0.024 0.55% 0.023 0.53% 0.036 0.82%
Chloride 102.4 0.18 0.18% 0.20 0.20% 0.32 0.31%
ionized Calcium 1.35 0.016 1.21% 0.021 1.55% 0.042 3.10%
Lithium 1.04 0.012 1.19% 0.035 3.36% 0.045 4.31%

xviii
Material: ISE-trol Protein Based Aqueous Control Material - Level 3
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 158.8 0.51 0.32% 0.76 0.48% 0.90 0.56%
Potassium 5.74 0.027 0.48% 0.026 0.45% 0.036 0.62%
Chloride 123.2 0.36 0.29% 0.89 0.72% 1.17 0.95%
ionized Calcium 0.63 0.010 1.52% 0.007 1.07% 0.014 2.29%
Lithium 2.59 0.025 0.97% 0.063 2.44% 0.082 3.18%
Material: RNA EQUIL Reduced Bovine Hemoglobin Solution - Level 2
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 134.8 0.53 0.40% 0.45 0.33% 0.63 0.47%
Potassium 4.89 0.039 0.79% 0.021 0.42% 0.043 0.88%
Chloride 100.4 0.43 0.43% 0.42 0.41% 0.58 0.57%
ionized Calcium 1.10 0.008 0.75% 0.004 0.40% 0.011 0.95%
Lithium N/A
Material: Aqueous Standard Solution - Level 1
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 150.0 0.55 0.37% 0.34 0.23% 0.57 0.38%
Potassium 4.97 0.022 0.44% 0.018 0.36% 0.029 0.57%
Chloride 115.0 0.11 0.09% 0.08 0.07% 0.16 0.14%
ionized Calcium 0.96 0.004 0.41% 0.004 0.39% 0.007 0.76%
Lithium 0.30 0.004 1.27% 0.005 1.60% 0.008 2.48%
Material: Aqueous Standard Solution - Level 2
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 113.2 0.51 0.45% 0.96 0.85% 1.07 0.95%
Potassium 1.82 0.033 1.88% 0.043 2.36% 0.053 2.92%
Chloride 82.9 0.27 0.33% 0.67 0.80% 0.87 1.05%
ionized Calcium 2.43 0.014 0.56% 0.032 1.33% 0.043 1.76%
Lithium 5.42 0.043 0.78% 0.155 2.86% 0.196 3.62%

xix
Material: Pooled Human Serum
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 138.8 0.30 0.22% 0.36 0.28% 0.47 0.34%
Potassium 4.49 0.034 0.75% 0.041 0.92% 0.051 1.13%
Chloride 106.8 0.18 0.17% 1.00 0.93% 1.24 1.16%
ionized Calcium 1.19 0.007 0.55% 0.031 2.64% 0.039 3.29%
Lithium 0.17 0.011 6.19% 0.015 8.40% 0.023 13.28%
Material: Acetate Dialysate Solution
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 86.1 0.85 0.98% 1.81 2.10% 1.78 2.07%
Potassium 2.09 0.029 1.41% 0.041 1.94% 0.049 2.32%
Chloride 107.8 0.25 0.24% 0.23 0.21% 0.40 0.37%
ionized Calcium 1.77 0.020 1.13% 0.092 5.20% 0.115 6.50%
Lithium N/A
Material: Bicarbonate Dialysate Solution
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 135.2 0.45 0.33% 0.59 0.44% 0.72 0.54%
Potassium 1.58 0.023 1.46% 0.031 1.95% 0.037 2.37%
Chloride 107.3 0.37 0.35% 0.63 0.59% 0.86 0.80%
ionized Calcium 1.68 0.012 0.72% 0.016 0.96% 0.027 1.63%
Lithium N/A
Material: Urine
Parameter mean Swr (CV%) Sdd (CV%) ST(CV%)
Sodium 51.5 1.98 3.84% 3.06 5.94% 3.65 7.08%
Potassium 48.4 0.65 1.34% 0.97 2.00% 1.11 2.29%
Chloride 85.9 0.53 0.62% 0.66 0.76% 0.99 1.16%
ionized Calcium N/A
Lithium N/A

xx
Linearity in Aqueous Standard Solutions
Aqueous linearity standards ere gravimetrically prepared from N.I.S.T. traceable salts and mea-
sured on each of six AVL 9180 instruments, t o of each configuration: Na/K/Cl, Na/K/iCa and Na/
K/Li.
Correlation
Parameter Slope Intercept Coefficient Sy*x Range n
Sodium 0.99993 0.0128 0.99995 0.666 51-196 300
Potassium 0.99838 0.0119 0.99919 0.194 2.0-12.6 300
Chloride 0.97556 -0.1775 0.99994 0.674 56-194 100
ionized Calcium 1.01552 -0.0078 0.99980 0.037 0.4-3.3 100
Lithium 0.99850 0.0087 0.99985 0.038 0.3-5.3 100
Linearity in Serum
Linearity in serum as established ith the analysis of t o specimen sets in non-clinical tests:
commercially prepared serum linearity standards for sodium, chloride and potassium ith normal
protein content, and a group of random patient serum samples. All samples ere analyzed in pairs on
each of t o of AVL 9180 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and
in pairs on each of the follo ing instrument types for comparision to various methods:
Direct ISE, not flame correlated AVL 983 Na/K/Cl Analyzer
(listed as 98X) AVL 984 Na/K/iCa Analyzer
AVL 985 Na/K/Li Analyzer
Direct ISE, flame correlated AVL 9130 Na/K/Cl Analyzer
(listed as 91XX) AVL 9140 Na/K/iCa Analyzer
Flame Absorbance Emission Spectroscopy IL 943 Flame Photometer
Chloridometry Labconco Digital Chloridometer