Roche 9180 User manual

MEDICAL INSTRUMENTS

9180 Electrolyte Analyzer

Operator's Manual

2nd Edition June 1996

Copyright, 1996, AVL Scientific Corporation. All rights reserved. Unless otherwise noted, no part of this publication may be reproduced, transmitted, transcribed, stored in a retrieval 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

Important Information!

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 instructions. The most important prerequisites for application, operation and safety, are explained to ensure smooth operation. No 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 measures 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 manufacturers 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!

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Operating Safety Information

 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.

Note: 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 communication. 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. Never use repaired fuses or short-circuit the fuse holders.

Operating Safety Information

METHOD SHEET

Intended Use

The AVL 9180 Electrolyte Analyzer is intended to be used for the measurement of sodium, potassium, chloride, ionized calcium and lithium in samples of whole blood, serum, plasma, urine, dialysate and aqueous standard solutions.

Clinical Significance

1,2

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 between 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.

Low sodium values, hyponatremia, usually reflect a relative excess of body water rather than a low total body sodium. Reduced sodium levels may be associated with: low sodium intake; sodium losses due to vomiting or diarrhea with adequate water and inadequate salt replacement, diuretics abuse, or salt-losing nephropathy; osmotic diuresis, metabolic acidosis; adrenocortical insufficiency; congenital adrenal hyperplasia; dilution type due to edema, cardiac failure, hepatic failure; and hypothyroidism.

Elevated sodium values, hypernatremia, are associated with conditions with water loss in excess of salt loss through profuse sweating, prolonged hyperpnea, severe vomiting or diarrhea, diabetes insipidus or diabetic acidosis; increased renal sodium conservation in hyperaldosteronism, Cushings syndrome; inadequate water 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 water 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.

Tietz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1990)

p.98-99, 118-119, 456-459, 510-511, 720-721.

Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B.Saunders, Co.,

1994) pp.1354-1370.

Potassium

Potassium is the major cation in the intracellular fluid and functions as the primary buffer within the cell itself. Ninety percent of potassium is concentrated within 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 with the K

H+ exchange and hemolysis of the blood. Low 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 low 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 with 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 water balance. In metabolic acidosis, there is a reciprocal rise in chloride concentration when 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. However, 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.

Elevated calcium, hypercalcemia, may be present in various types of malignancy, and calcium measurements may serve as biochemical markers. In general, while 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 with abnormalities in acid-base regulation and losses of protein and albumin, which gives a clear advantage to monitoring calcium status by ionized calcium measurements.

Patients with 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 disease

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 which 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 with 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 narrow therapeutic range. Initial dosing is aimed at between 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 with 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 determination on a 24 hour collected urine sample. The quantity of electrolytes excreted per day can be determined by multiplying the measured concentration (mmol/L) with the total quantity of urine excreted in one day.

Burritt 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.

vii

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 will 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 which are unable to excrete from the blood because of renal insufficiency.

When the concentration of the electrolytes between the blood and dialysate liquid deviates significantly, the electrolytes diffuse in the direction towards the lower concentration (i.e. from blood into the dialysis liquid or vice versa). Analysis of electrolytes in dialysis is of immense clinical significance 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 with a defined quantity of distilled water.

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 with 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, which is built up in the film between the sample and the membrane.

A galvanic measuring chain within the electrode determines the difference between the two 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 between the inner electrolyte and the sample causes an electrochemical 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 well 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 with precisely known ion concentrations.

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Specimen Collection and Handling

Safety

Universal precautions must be observed when 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 followed in order to minimize risk to the laboratory staff. Gloves should always be worn when 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 Edition; 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 Edition; Approved Standard, May 1992, for detailed information on sample

collection, storage and handling.

Blood sampling for analysis must be performed under proper supervision with details of collection, including sampling devices, site selection, sample handling and documentation approved by the personnel responsible. Specific procedures used should follow NCCLS guidelines.

Anticoagulants and Sample Collection Devices

The AVL 9180 Electrolyte Analyzer will accept samples directly from syringes, collection tubes, samples cups and, with the use of an adapter, from capillary tubes or the AVL Microsampler.

For whole 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, however, 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 without additives are recommended.

Handling and Storage of Samples

For ionized calcium values, anaerobic conditions should be followed for all sample types. Contact with ambient air will cause a loss of CO 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 whole 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 allowed to warm 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

in the sample and the subsequent rise in pH will cause a

Serum samples should be obtained by collecting blood in an untreated blood collecting tube. The sample should stand for 30 minutes to allow the clot to form prior to centrifugation. After centrifugation, 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 allowed to return to room temperature, 15 to 30 °C, prior to analysis.

Each laboratory should determine the acceptability of its own blood collection syringes, capillaries and tubes and the serum or plasma separation products. Variations in these products exist between manufacturers, and at times, from lot to lot.

Reagents

ISE SnapPak

(BP5186) containing the following reagents:

Standard A

Use: For calibration of sodium, potassium, chloride, ionized calcium and

lithium in the AVL 9180 Electrolyte Analyzer

Contents: 350 mL

K Cl Ca Li

150 mmol/L

5.0 mmol/L 115 mmol/L

0.9 mmol/L

0.3 mmol/L

Active Ingredients: Na

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

K Cl Ca Li

100 mmol/L

1.8 mmol/L 72 mmol/L

1.5 mmol/L

0.3 mmol/L

Active Ingredients: Na

Additives: Germicides Storage: Temperature: 5 - 30 °C (41 - 86 °F) Stability: Expiration Date & Lot Number are printed on each container label.

Standard C

Use: For calibration of sodium, potassium, chloride, ionized calcium and

lithium in the AVL 9180 Electrolyte Analyzer

Contents: 85 mL

K Cl Ca Li

150 mmol/L

5.0 mmol/L 115 mmol/L

0.9 mmol/L

1.4 mmol/L

Active Ingredients: Na

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.

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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 the warranty.

A waste container is provided with the ISE SnapPak

which, when used, holds human body fluids

which may be potentially infectious; handle with appropriate care to avoid skin contact or ingestion.

FOR IN-VITRO DIAGNOSTIC USE.

Procedure

Materials Needed

Description Part Number

ISE SnapPak

Cleaning Solution A BP1025 Conditioning Solution BP0380 Urine Diluent BP0344 Printer Paper (5 rolls) HP5025

BP5186

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The AVL 9180 Analyzer allows the operator to select one of the following measuring modes: whole 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 allows for the measurement of prediluted urine samples for sodium, potassium and chloride. The acetate, bicarbonate and standard mode allows 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 - 15 mmol/L dialysate) Chloride 50 - 200 mmol/L 1 or 0.1 mmol/L ionized Calcium 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 (Calcium and Lithium are not measured in urine samples)

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Calibration

The analyzer contains software which 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 calibration is automatically performed with every measurement.

An automatic calibration procedure is also performed shortly after power-on or reset. A calibration cycle can also be initiated manually at times when no sample measurements are performed.

Quality Control

AVL recommends that at least once daily or in accordance with local regulations, quality control solutions with known Na+, K+, Cl-, Ca++ and Li+ values should be analyzed at two levels (normal and low or high). For further details, please review the Quality Control section of the Operator's Manual. Results obtained should fall within limits defined by the day-to-day variability of the system as measured 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 Interval

Specimen Reference Ranges

(mmol/l) (mmol/L) (mmol/L) (mmol/L) (mmol/L)

serum, plasma, whole blood 136-145

3.5-5.1

1.12-1.32

97-111

0.6-1.20

urine (mmol/24hrs) 40-220

25-125

N/A 110-250

N/A

The ranges are provided for reference only. Each laboratory should establish its own reference interval for Na+, K+ , Cl-, Ca++ and Li+ as performed on the AVL 9180 Electrolyte Analyzer.

Henry, R.J., Clinical Chemistry - Principles and Technics, (New York: Harper and Row, 1974)

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 demonstrated from bromide, ammonium and iodide.

As with any clinical reaction, users must be alert to the possible effect on results due to unknown 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 with 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 without a tourniquet, or that the tourniquet be released after the needle has entered the vein and 2 minutes elapsed before the sample is drawn.

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 known to interfere with 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 shows 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 concentrations, the influence of ionized calcium is clinically insignificant.

Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p.890-95

xvi

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% relationships may be altered when using citrate in blood, or when the acid-base metabolism is disturbed.

1,5

. These

Specific Performance Characteristics

Reproducibility

Typical Within-Run (Swr) Between-Day (Sdd) and Total (ST) Precision is determined from 2 runs per day with 2 replicates per run for 20 days on two AVL 9180 analyzers in each of its three configurations. Values for sodium and potassium are average of all six instruments, while values for chloride, ionized calcium and lithium are determined from the measurement of two 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%

xvii

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%

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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

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Linearity in Aqueous Standard Solutions

Aqueous linearity standards were gravimetrically prepared from N.I.S.T. traceable salts and measured on each of six AVL 9180 instruments, two 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 was established with the analysis of two specimen sets in non-clinical tests: commercially prepared serum linearity standards for sodium, chloride and potassium with normal protein content, and a group of random patient serum samples. All samples were analyzed in pairs on each of two of AVL 9180 instruments in each configuration: Na/K/Cl, Na/K/iCa and Na/K/Li. and in pairs on each of the following 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

Correlation to Flame

IL 943 Flame Photometer

Parameter Slope Intercept Coefficient Sy*x Range n

Sodium 0.9617 5.83 0.9908 2.04 104-178 50

normalized to Na = 140 0.47

Potassium 1.0249 0.015 0.9991 0.075 1.8-11.5 50

normalized to K = 4.0 0.11

Lithium 0.9803 0.011 0.9822 0.028 0.11-0.71 15

0.9720 0.016 0.9957 0.019 0.23-1.13 15

Correlation to Direct ISE - not flame correlated

AVL 98X Electrolyte Analyzers

Parameter Slope Intercept Coefficient Sy*x Range n

Sodium 0.9895 -6.35 0.9992 0.61 110-186 50

normalized to Na = 140 -7.83

Correlation

Potassium 1.0223 -0.25 0.9996 0.05 2.0-11.6 50

normalized to K = 4.0 -0.164

Chloride 0.9631 -1.01 0.9995 0.51 70-152 50

normalized to Cl = 105 -4.88

ionized Calcium 0.8898 0.107 0.9960 0.021 0.67-1.66 50

normalized to iCa = 1.1 -0.014

Lithium 0.9923 0.008 0.9985 0.010 0.11-0.71 15

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Correlation to Direct ISE - flame correlated

AVL 91XX Electrolyte Analyzers

Correlation

Parameter Slope Intercept Coefficient Sy*x Range n

Sodium 0.9856 -2.02 0.9856 1.21 104-179 50

normalized to Na = 140 0.006

Potassium 0.9992 0.02 0.9994 0.05 1.9-11.8 50

normalized to K = 4.0 0.02

Chloride 1.0026 -5.31 0.9989 0.73 70-152 50

normalized to Cl = 105 -5.04

ionized Calcium 1.0023 0.040 0.9954 0.022 0.62-1.54 50

normalized to iCa = 1.1 0.042

Correlation to Chloridometry

Labconco Digital Chloridometer

Correlation

Parameter Slope Intercept Coefficient Sy*x Range n

Chloride 1.0222 2.75 0.9923 2.03 66-145 50

normalized to Cl = 105 0.00

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Bibliography

Bishop ML, Duben-Engelkirk JL, Fody EP. Clinical Chemistry Principles Procedures Correlations, 2nd Ed., (Philadelphia: J.B.Lippincott Co.),1992,p.281.

Burritt 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.

Burtis C, Ashwood E (Eds.), Tietz Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co.,1994) pp.1354-1360,2180-2206.

Calbreath, Donald F., Clinical Chemistry A Fundamental Textbook, (Philadelphia: W.B. Saunders Co.,

1992) pp.371, 376, 390-395.

Henry, R.J., Clinical Chemistry - Principles and Technics, (New York, Harper and Row, 1974)

Kost GJ.Arch.Path.Lab.Med., Vol.117, Sep.1993, p.890-95

National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Infectious Disease Transmitted by Blood, Body Fluids and Tissue, Second Edition; Tentative Guideline. NCCLS Document M29-T2, (1992).

National Committee for Clinical Laboratory Standards. Additives for Blood Collection Devices: Heparin; Tentative Standard; NCCLS Document H24-T, (1988).

National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical Chemistry Devices, Second Edition; Tentative Guideline. NCCLS Document EP5-T2, (1992).

Rose, Burton David, Clinical Physiology of Acid-Base and Electrolyte Disorders, 4th Ed., (New York: McGraw-Hill, Inc., 1993) pp. 346-348, 432, 797-798.

Schoeff, Larry E & Williams, Robert H. (Eds.) Principles of Laboratory Instruments, (St. Louis: Mosby Year Book Inc., 1993) pp. 150-157, 161-164.

Snyder John R., Senhauser Donald A, (Eds.), Administration and Supervision in Laboratory Medicine, 2nd Ed, (Philadelphia: J.B.Lippincott Co., 1989) pp.262-284.

Tietz, Norbert W.,Ed.,Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B. Saunders Co.,

1990), pp.98-99, 118-119, 456-459, 510-511, 720-721

Tietz, Norbert W.,Ed., Textbook of Clinical Chemistry, 2nd Ed., (Philadelphia: W.B. Saunders, Co.,1986), pp.1816, 1837, 1840-1842, 1845.

Toffaletti J, Gitelman JH, Savory J: Separation and quantification of serum constituents associated with calcium by gel filtration. Clin Chem 22: 1968-72, 1976.

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Preface

Welcome

Your AVL Electrolyte Analyzer is a powerful tool

designed to help you quickly, accurately and effi-

ciently conduct basic electrolyte testing in the conve-

nience of your own laboratory.

This manual will help guide you through setting up

your analyzer and will help you start analyzing

samples. As you become familiar with the operation

of the unit, you may use the manual as a reference

for day-to-day routines and as a guide for mainte-

nance and troubleshooting.

How to use this manual

If you have an analyzer that is not yet set up, you

should begin by reading Chapters 1 and 2. For

programming and quality control functions, read

Chapters 3 and 4. Information on analyzer opera-

tion and maintenance is contained in Chapters 5

and 6. Detailed service information and operating

principles can be found in Chapters 7 and 8.

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Contents

Chapter 1: Getting to Know Your AVL

Electrolyte Analyzer ......................................................... 1

Chapter 2: Installation ...................................................................... 11

Chapter 3: Programming .................................................................. 25

Chapter 4: Quality Control ............................................................... 41

Chapter 5: Operation ....................................................................... 47

Chapter 6: Maintenance ................................................................... 55

Chapter 7: Troubleshooting and Service Functions ......................... 75

Chapter 8: Principles of Operation ................................................... 95

Chapter 9: Supplies, Service, and Warranty Registration ............... 109

Appendix A: Technical Specifications ............................................... 114

Appendix B: Program Flow Chart..................................................... 116

Appendix C: Maintenance Log Master.............................................. 117

Appendix D: Correlation Factor Worksheet Master .......................... 118

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