Roche 9180 User manual

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MEDICAL INSTRUMENTS

9180 Electrolyte Analyzer

Operator's Manual

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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

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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

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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

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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.

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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.

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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.

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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.

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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.

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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.

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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)

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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

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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%

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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

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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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Page 23

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.

xxiii

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xxiv

Page 25

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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xxvi

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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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xxviii

Page 29

Page 30

Page 31

Chapter 1

Getting to Know Your AVL Electrolyte Analyzer

Important safety instructions

Before you begin installing your AVL Electrolyte Ana-

lyzer, carefully read the overview information in this

chapter.

For your own safety and the proper operation of your

equipment, always follow these precautions when working

with your AVL Electrolyte Analyzer:

 Keep the analyzer away from all sources of liquids

such as sinks and wash basins.

 Dont use ammonia-based or alcohol-based cleaners,

which can chemically react with plastic, on or around the analyzer.

 Always handle blood samples and collection devices

with care.



Use approved protective gloves to avoid direct con with sample.

 Aseptic procedures are required when cleaning the

sampling probe to avoid contamination.

 Dispose of ISE SnapPakTM according to local regu-

lations.

tact

Page 32

Control Panel Display

Control Panel Keypad

Front Door

ISE SnapPak

1-1. 9180 Electrolyte Analyzer Major Components (external)

Sample Probe Mechanism

Page 33

Analyzer components

The AVL Electrolyte Analyzer is a fully automatic, microprocessor-controlled medical instrument that measures:

Na+: Sodium K+: Potassium

plus one of the following:

Cl¯: Chloride Ca++: Calcium Li+: Lithium

The analyzer consists of several major components that are important for you to know and understand while becoming familiar with the unit. See Illustration 1-1.

1-2. Control panel keypad

Na K Cl READY

1-3. Control panel display

You communicate with the analyzer through a keypad with YES and NO keys. With these keys you can perform all analyzer functions, including: sample measurement, data input, programming and quality control testing. See Illustration 1-2.

The analyzer communicates to you through a dot matrix display. This two line, alpha-numeric read-out allows up to 16 characters per line, displaying the activities of the analyzer, sample results and other programmed information.

See Illustration 1-3.

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Thermal Printer

Peristaltic Pump

Measuring Chamber

Fluid Control Valves

1-4. 9180 Electrolyte Analyzer Major Components (internal)

Sample Probe Mechanism

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Inside the unit are other components which are

accessible by opening the main door.

See illustration 1-4 and 1-5.

1-5. Opening the main door

1-6. Measuring chamber

The measuring chamber consists of the movable

left locking device that holds the electrodes in

place, the electrodes, the right electrode holder

with sample sensor connector, and the measuring

chamber base. Electrodes are labeled:

Ref : Reference Na+: Sodium

K+: Potassium Cl¯: Chloride Ca++: Calcium Li+: Lithium

See illustration 1-6.

A peristaltic pump is used to transport all liquids

within the analyzer.

See illustration 1-7.

1-7. Peristaltic pump

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1-8. Fluid control valves

1-9. Sample probe mechanism

Valves control the movement of the liquid within the

analyzer.

See illustration 1-8.

The sample probe mechanism is located behind the

small door at the front of the unit.

See illustration 1-9.

1-10. ISE SnapPak

The self-contained ISE SnapPakTM uses an integral

check-valve to ensure that waste cannot spill out of

the package.

See illustration 1-10.

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The thermal printer uses heat-sensitive paper to

output information in 16 columns. The analyzer will

print measured values, calibration values, electrode

voltages, and amount of liquid remaining in the ISE

SnapPak

as well as cleaning and maintenance

information. The unit is configured to allow conve-

nient storage of a second roll of paper in the paper

tray.

1-11. Thermal printer

U18-005

9180

1-12. Model - Serial No. plate

See illustration 1-11.

The model and serial number is located on an identifi-

cation plate above the probe mechanism.

See illustration 1-12.

The rear panel of the unit contains a serial number

plate, as well as the power switch/power receptacle

module and an RS232 interface port.

See illustration 1-13.

1-13. Rear panel

Congratulations

Youve just learned the basic components of the

analyzer and are now ready to install your system.

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Chapter 2

Installation

Choosing a location for the AVL Electrolyte Analyzer

Location is important for trouble-free operation of

your analyzer. Before you begin setup, choose a site

that is convenient for your sampling needs and meets

the following physical requirements of the unit:

 Grounded electrical outlet

 Away from direct sunlight

 Room temperature between 15° C and 32° C

(60° F and 90° F)

13 3/8"

13 3/4"

2-1. Space requirements

 Maximum relative humidity of 85%

 Ample room to allow air to circulate freely

around the unit. See illustration 2-1.

 Away from strong electromagnetic fields, such as

those created by electric motors and x-ray equipment.

 Away from explosive gases or vapors.

13"

Page 42

Now its time to unpack your AVL Electrolyte Ana-

lyzer. Carefully remove the unit from the box. DO

NOT lift the analyzer by the foam packaging materi-

als, which are provided for shipping only.

Before you begin installing your system, take a mo-

ment to look over the contents to ensure that you have

everything you need to get your analyzer up and

running.

Check for these items:

Power cord Electrodes Printer paper

ISE SnapPak

Cleaning Solution A Electrode Conditioning Solution ISE-trol Electrolyte Control

You will also need a supply of lint-free tissues and

disposable sample cups, which should be kept in a

location convenient to the analyzer.

Setting up

Now youre ready to get your AVL Electrolyte

Analyzer prepared to operate. Prior to beginning the

actual installation, it is a good idea to completely read

through this chapter to develop an understanding of the procedures that are required.

Page 43

Begin by placing the analyzer on a secure table top

that allows plenty of working space and is convenient

to a power connection.

Open the analyzer main door. Locate and carefully

remove the five red relief clamps from the valves by

sliding out the clamps. Save the clamps for reuse to

prevent damaging the tubes in the event the analyzer is

2-2. Removing relief clamps

2-3. Installing the pump windings

later shut down for any reason. See illustration 2-2.

Slip the two pump windings around the analyzer pump

rollers, making sure not to overstretch the tubing.

See illustration 2-3.

Electrodes and measuring chamber

The next procedure involves preparing and installing

the electrodes in the measuring chamber.

Remove the reference housing and electrodes from

their protective boxes and place them on a soft, clean

surface. Check that each electrode has an o-ring in

the left side of the electrode.

2-4. Electrode o-ring

See illustration 2-4.

Page 44

Unscrew the red transport housing from the reference

electrode and check that the o-ring on the electrode is

properly seated. Save the transport housing for

storage of the reference electrode in the event the

analyzer is turned off or taken out of service for any

reason.

See illustration 2-5.

2-5. Transport housing removal

reference electrode housing

2-6. Installing reference electrode

reference electrode

red transport housing

Carefully screw the reference electrode into the

reference electrode housing and place it with the other

electrodes.

See illustration 2-6.

Slide the measuring chamber forward until it locks in

the front position. Unclamp the left electrode holder

by moving the clamp forward.

See illustrations 2-7 and 2-8.

2-7. Slide chamber forward 2-8. Unclamping electrode holder

Page 45

2-9. Sample sensor cable & o-ring

2-10. Installing electrodes

Locate the sample sensor cable and ensure that it is securely inserted into the receptacle above the measuring chamber. Check that an o-ring is present in the right electrode holder. See illustration 2-9.

Now install the electrodes in the measuring chamber, beginning on the right and working to the left (the reference electrode will be installed last).

Note: The electrode on the right may be one of the following: chloride, ionized calcium, lithium or a dummy electrode, if no third test is needed. If sodium and lithium are selected, the K+ electrode is replaced by a dummy electrode.

Check to make sure that the lettering on the measuring chamber matches the lettering on the electrode. Also, note that all electrodes have a lip on the bottom that rests on the flat edge of the measuring chamber to aid in proper positioning. See illustration 2-10.

2-11. Closing electrode clamp

Close the clamp on the left electrode holder by lifting it upward until it locks in the back position, and ensure that the electrodes are properly seated. See illustration 2-11.

Page 46

2-12. Slide chamber backward

2-13. Reference connector

Slide the measuring chamber back until it snaps into position. See illustration 2-12.

Plug the tubing connector of the reference housing assembly into the receptacle below the left side of the measuring chamber. See illustration 2-13.

Preparing the analyzer for operation

Before the analyzer is powered on, the language setting must be selected. The factory-set language is English; to select a different language setting, remove the paper tray and use a pen to set the switch to the desired language position as indicated on the label.

Now, locate the power switch on the back of the unit and make sure that it is in the OFF (O) position. Next, plug the power cord into the power receptacle module on the back of the unit, then plug the cord into a grounded electrical outlet. See illustration 2-14.

2-14. Power cord installation

Note: If you decide to change the language after the unit is powered on, you must cycle the power to activate the new language.

Page 47

Push the power switch to the ON (I) position. The unit will automatically begin to operate. See illustration 2-15.

Now that the AVL Electrolyte Analyzer is functioning, you will begin using the keypad interface to communicate with the instrument. Use the NO key to make changes, the YES key to accept the displayed values or information.

2-15. Turning power on

The analyzer will display a default date and time and will allow you to input the correct date and time.

Date: 01-JAN -80 Time: 00:00

Enter the correct date as follows:

1. Press the NO key until the correct day is displayed. Press YES. The cursor will move to the month.

Note: By keeping the NO key depressed, the analyzer will automatically scroll through the numbers, first slowly, then fast.

2. Press NO until the correct month is displayed. Press YES.

3. Press NO until the correct year is displayed. Press YES. The correct date should now be displayed.

4. Follow the same procedure to enter the correct time.

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2-16. Removing protective strip

2-17. Installing ISE SnapPak

5. After entering the time, the analyzer will prompt: OK? Press YES, if the date and time you

entered is correct, or press NO to make a change.

6. After entering YES, the following prompt appears in the display : STATUS: NO SnapPak.

Install the ISE SnapPakTM. Record the installation date on the label on the pack. Remove the protective strip and slide the ISE SnapPakTM into position on the left side of the analyzer. See illustration 2-16 and 2-17.

Note: Once the protective strip is removed, be sure to keep the ISE SnapPakTM upright to avoid spillage. Save the protective strip to use to close the nipples on the pack prior to disposing.

At the prompt New SnapPak Installed?, press YES. Press YES again to the question Are you sure?

2-18. Inserting printer paper

Install the thermal printer paper into the printer by placing the printer paper into the paper tray and threading it into the feeder slot, as shown in the diagram underneath the paper holder on the analyzer. See illustration 2-18.

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2-19. Paper advance button

Press the paper advance button to bring the paper completely through the feeder. See illustration 2-19.

Note: By pressing and releasing the paper advance button, the paper will automatically advance 10 lines.

Your AVL Electrolyte Analyzer is now prepared for

initial daily maintenance.

Initial daily maintenance

Prior to performing your first calibration or running your first sample, the AVL Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure that the unit will perform properly. This procedure is called daily maintenance, because it must be performed each day the analyzer is used to conduct sampling.

The process involves cleaning and conditioning the sample path and electrodes, which prepares the AVL analyzer for calibration. You should have ready the bottles containing Cleaning Solution A and Electrolyte Conditioning Solution, along with a package of lintfree tissues that will be used to dry the probe.

Note: Check expiration date on bottles.

Note: In some cases, when the unit prompts you for an action and you do not respond within a set period of time, an alarm will sound and the unit will discontinue its current operation.

Page 50

To perform daily cleaning, you will communicate through the keypad interface. The prompt Perform Daily Cleaning? will be displayed. Press YES to accept.

The prompt Open Sample Door Introduce Sample will be displayed. Pour a small amount of AVL Cleaning Solution A into a clean sampling container.

Lift the sample door. The prompt Introduce Sample will be displayed and the pump will begin to

aspirate. Introduce the cleaning solution to the probe. See illustration 2-20.

Hold the solution under the probe until the prompt Wipe Probe Close Sample Door is displayed.

Use a lint-free tissue to remove the cleaning solution

2-20. Introducing cleaning solution

2-21. Cleaning probe

from the probe, then close the door. See illustration 2-21.

The analyzer will now display Thank You! and a

brief countdown will begin, indicated by the clock in

the lower right of the display. While the countdown is

running, open the bottle of AVL Electrode Conditioning Solution and pour a small amount into a clean

container.

After the countdown is completed, the system will prompt Perform Daily Conditioning? Press YES.

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2-22. Introducing conditioner

2-23. Cleaning probe

The prompt Open Sample Door Introduce Sample will be displayed. Lift the sample door. The

prompt Introduce Sample will be displayed and the pump will begin to aspirate. Now, introduce the conditioning solution to the probe. See illustration 2-22.

Hold the solution under the probe until the prompt Wipe Probe Close Sample Door is displayed. Use a lint-free tissue to remove the conditioning solution from the probe and close the door. See illustration 2-23.

The analyzer will now display Thank You! and a brief countdown will begin. Upon completion of the countdown, the prompt Remain in Daily Mainte- nance? will be displayed. Press NO.

The unit will display Calibration in Process while the analyzer prepares for automatic calibration. A countdown will be displayed as soon as the actual calibration cycle starts.

Note: Calibration is an automatic process. During this time, the analyzer is conducting measurement operations to ensure the accuracy of the instrument. Occasionally, extended calibration is required.

Note: It is very important that the main door is closed during calibration, since it provides shielding from sources of electromagnetic interference.

When calibration is completed, the analyzer will display READY, indicating that the instrument is now prepared for quality control sampling.

Page 52

Selecting Parameter Configuration

After completion of the daily maintenance procedure, the analyzer starts an automatic calibration for sodium and potassium.

To select a different parameter configuration, interrupt the calibration by pressing NO. Continue pressing NO, until OPERATOR FUNCTIONS is displayed. Press YES followed by NO, until the analyzer displays Select Parameter Configuration? Press YES to display the current configuration. The default configuration is displayed:

Selected Param.: [ Na ] [ K ] [ ] ok?

Press NO until the desired configuration is displayed, then press YES to accept your selection.

Note: If ([ Na ]) [ ] [ Li ] is selected, only lithium is reported. Install the Na electrode and calibrate for lithium.

Congratulations! Your AVL Electrolyte Analyzer is ready for operation.

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Page 55

Chapter 3

Programming

Your AVL Electrolyte Analyzer comes preset to

easily and accurately perform sampling operations.

Through the programming menu, you have the capa-

bility to input additional information or parameters to

tailor the instruments performance to match the

particular needs of your lab.

Programming the analyzer allows you to select the

third testing channel and to modify quality control

ranges, normal values and correlation factors. You

can also program the operation of the printer.

Note: For safety and security, the analyzer can only be programmed or have existing parameters changed by entering the correct password via the control panel keypad.

Accessing programming functions

From the READY display, press NO until the prompt

PROGRAM INSTRUMENT? is displayed. Press

YES.

Page 56

The analyzer will display Enter Code: AAA. To program your AVL Electrolyte Analyzer, you must now enter the code K-E-Y as follows:

1. Press NO until the character K is displayed.

2. Press YES and the cursor will advance to the

second position.

3. Press NO until E is displayed, then press YES.

The cursor will advance to the last character.

4. Press NO until Y is displayed.

Note: If you pass the desired letter, continue pressing NO until the letter is displayed again.

If you have entered the code correctly, press YES. The analyzer is prepared for operator programming and will display Program QC Level 1 Ranges?

Note: If you inadvertently enter an incorrect code, the analyzer will display CODE ERROR! RETRY? Enter YES and you will be returned to the Enter Code prompt. To exit this menu, press NO.

Programming QC Level ranges

When you open a new box of AVL ISE-trol Electrolyte Controls, the lot number should be entered into the analyzer, along with the target ranges. Each level has its own lot number, which is printed on the informational sheet contained inside the ISE-trol box.

Page 57

Note: AVL ISE-trol Electrolyte Controls are spe-

cially designed for your AVL Electrolyte Analyzer

and should be used exclusively to ensure absolute

quality and consistency of your patient samples.

To enter the lot number, proceed from the display Program QC Level 1 Ranges? Enter YES and the analyzer will prompt Current Lot: 0000

Change Lot#?

Note: The first time QC lot number information is

entered, the AVL Electrolyte Analyzer will display a

default lot number. Thereafter, the current lot num-

ber will appear.

Note: If you do not desire to change current lot information, but wish to verify current programmed QC ranges, press NO.

Press YES and Print old Values and Statistics? will be displayed. Select YES to receive a printout

that contains information including the mean, standard deviation (SD) and coefficient of variation (CV) of stored data, or press NO to decline.

The analyzer will display New Lot! Delete Old Data? Select YES to continue entering new lot number information or press NO, if you decide to keep the current lot number and data.

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Note: If you enter YES, all stored statistics for this QC level will automatically be deleted from memory.

To enter a new lot number, press NO until the correct number is displayed above the cursor, and YES to accept. Repeat until all four digits have been entered.

After entering the new lot number, the analyzer will ask you to confirm that the entry is correct. To proceed with QC programming, press YES.

Note: If you have entered an incorrect lot number, enter NO and you will return to the Enter Lot Number prompt.

The analyzer will now sequentially display high and low ranges for the electrolytes that correspond with the QC level and lot number, such as:

Na low = 040 Na high = 205

Note: You may find this information printed on the data sheet contained inside the box of ISE-trol.

Press YES and the next electrolyte range will be displayed. After all activated parameters have been programmed, the display prompts: Additional Param- eters?. Pressing YES will allow you to program the deactivated parameters as well.

After each range has been displayed, QC Level 1 programming will be completed. The AVL Electrolyte Analyzer will prompt Program QC Level 2 Ranges?

Page 59

To continue programming, repeat the above procedure for QC Level 2 and QC Level 3.

At the completion of QC Level 3 programming, the analyzer will prompt Program Normal Ranges? This programming feature allows you to customize the normal ranges that the AVL Electrolyte Analyzer will use to flag abnormal patient measurement values on

both the display and printed report.

Programming normal ranges

The AVL Electrolyte Analyzer is preset to standard direct normal ranges (Na+/K+ - flame photometry):

Na+: 136 - 145 mmol/L

K Cl

: 3.5 - 5.1 mmol/L

: 97 - 111 mmol/L

Ca++: 1.12 - 1.32 mmol/L

: 0.6 - 1.20 mmol/L

These parameters can be changed through the programming menu to tailor the normal ranges to your lab specifications. To change the normal ranges, follow the steps at the beginning of this chapter that explain the PROGRAM INSTRUMENT? display.

1. Tietz, Norbert W., Ed. Clinical Guide to Laboratory Tests, 2nd edition (Philadelphia: W.B. Saunders Company, 1990), pp. 98, 456, 510, 720.

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

Page 60

Press NO until Program Normal Ranges? is displayed. Press YES and the current Na+ low and high values will be displayed as such:

Na low = 136 Na high = 145 ok?

If the standard Na+ ranges are acceptable for your lab, press YES. If you wish to change the ranges to conform to your specific requirements, press NO. You may now adjust the high and low values by using the NO key to change the number, the YES key to accept the number.

The analyzer will now display the current K+ low and high values as such:

K low = 3.5 K high = 5.1 ok?

If the standard K+ ranges are acceptable for your lab, press YES. If you wish to change the ranges to conform to your specific requirements, press NO. You may now adjust the high and low values by using the NO key to change the number, the YES key to accept the number.

The analyzer will now display the current Cl- (if activated) low and high values as such:

Cl low = 97 Cl high = 111 ok?

If the standard Cl- ranges are acceptable for your lab, press YES. If you wish to change the ranges to conform to your specific requirements, press NO.

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You may now adjust the high and low values by using the NO key to change the number, the YES key to accept the number.

The analyzer will now display the current Ca++ (if activated) low and high values as such:

Ca low = 1.12 Ca high = 1.32 ok?

If the standard Ca++ ranges are acceptable for your lab, press YES. If you wish to change the ranges to conform to your specific requirements, press NO. You may now adjust the high and low values by using the NO key to change the number, the YES key to accept the number.

Note: If the units for Ca++ were switched to mg/dL (for MGL Code, see 'Service Codes'), the low and high values are displayed in mg/dL units.

The analyzer will now display the current Li+ (if activated) low and high values as such:

Li low = 0.60 Li high = 1.20 ok?

If the standard Li+ ranges are acceptable for your lab, press YES. If you wish to change the ranges to conform to your specific requirements, press NO. You may now adjust the high and low values by using the NO key to change the number, the YES key to

accept the number.

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Programming correlation factors

Correlation factors allow you to correlate results from your AVL Electrolyte Analyzer to other electrolyte analyzers. Activated correlation values are taken into consideration when sampling whole blood, serum, plasma and QC samples. They are not used for standard samples analyzed in the QC/STD/DIALYSATE/URINE SAMPLE mode. A separate set of correlation factors is available for dialysate and urine samples.

Note: In case the QC samples were switched to report direct ISE values (Code QCC, see 'Service Codes'), the values are NOT affected by correlation factors.

Note: The measurement range as well as normal and QC ranges are ALWAYS checked against the DISPLAYED values. Therefore, you may have to adjust the QC and normal ranges to your correlation factors.

The correlation factors can be changed through the programming menu. Follow the steps at the beginning of this chapter that explain the PROGRAM INSTRUMENT? display and enter the password.

Press NO until Program Corr. Factors? is displayed. Press YES and the analyzer will prompt Reset Corr. Factors (Default)?. Pressing YES to this prompt will cancel all correlation factors programmed and will return to the default values. The analyzer will then advance to the printer programming functions.

Press NO to the prompt Reset Corr. Factors (de-

fault)? and the analyzer will display Input/Verify Corr Factors? Pressing NO will allow you to exit the correla-

tion factor section and proceed to the printer programming functions.

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Pressing YES to the prompt Input / Verify Corr Factors? will allow you to input your own correlation factors or to verify or change correlation factors already programmed.

The current values will be displayed, such as:

Na(b) = +00.0 Na(m) = 1.000 ok?

If the Na+ intercept (b) and the slope (m) are correct, press YES. If you wish to change the values, press NO. You may now adjust the intercept and slope values by using the NO key to change the number, the YES key to accept the number.

The programmed factors are automatically applied to blood/serum and QC samples.

Follow the same procedure for the intercept (b) and slope (m) for K+, Cl¯ , Ca++ , and Li+ .

Note: Only activated parameters can be programmed.

If Na+/K+, Na+/K+/Cl

or Na+/K+/Ca++ are activated, a

separate set of bicarbonate and acetate correlation factors can be programmed. Press YES to Program

Bicarb.Corr Factors? and/or Program Acetate Corr Factors?. Program these factors as described

above. The programmed factors are automatically applied to acetate and bicarbonate measurements.

A separate set of correlation factors is availabe for urine samples. Press YES to Program Urine Corr Factors? Note that there are no urine correlation factors available for Ca++ and Li+ since these parameters are not measured in urine mode.

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AVL electrolyte analyzer

reference analyzer

3-1. Regression diagram

d m = c

y = mx +b

Calculating correlation factors

If the analyzer you wish to correlate with does not compare to flame photometer values, you may need to determine correlation factors. This may be done using one of the following two methods:

a) Correlation Factor Worksheet.

1. Measure the AVL ISE-trol level 1 and level 3, three times each on the AVL Electrolyte Analyzer and the reference analyzer. The three measured values for each device should not differ by more than 2.0 mml/L for Na+, 0.2 mmol/L for K+, and 2.0 mmol/L for Cl-,

0.04 mmol/L for Ca++, and 0.04 mmol/L for Li+.

2. Fill out a Correlation Factor Worksheet for each parameter. Follow the arrows and calculations to determine the intercept (b) and slope (m). (See appendix for blank worksheets.)

b) Calculator with Regression Function.

1. Analyze at least 20 lipid-free serum samples or samples with normal lipids on the AVL Electrolyte Analyzer and on the reference analyzer. Select samples with different concentrations in order to provide determination points from the lowest point to the highest point of the measurement range. See illustration 3-1.

2. Use a calculator with a linear regression function to determine the intercept (b) and slope(m).

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Programming the printer

The AVL Electrolyte Analyzer allows convenient operator programming of the printing functions for automatic printing of patient sample reports, printing two copies of the sample report, and automatic calibration reports.

The analyzer printing default is set to automatically print one sample report after conducting an analysis, but not to automatically print the calibration reports. To change the default setting, enter the programming menu. Follow the steps at the beginning of this chapter that explain the PROGRAM INSTRU- MENT? display and enter the operator code.

Press NO until Program Printer Setup? appears. Press YES and the analyzer will prompt Patient Report Off?. Select NO if you want the analyzer to automatically print a sample report after each analysis, or YES if an automatic report is not required.

Note: If you select YES, you will advance to the Automatic Cal Report? prompt.

If you select NO, the analyzer will display Print two Patient Reports?. Press YES if you want the AVL

Electrolyte Analyzer to automatically produce two reports, NO to decline.

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The analyzer will display Automatic Cal Report? Select YES if you want a printed calibration report after each calibration, or NO if an automatic report is not required.

Note: The PRINT FUNCTIONS menu allows you to print a copy of the last sample report as well as the last calibration report.

The analyzer displays Program Comment Line? In this menu, a comment (up to 16 characters) can be programmed which will be printed after the header on each report. After pressing YES to the Program

Comment Line? display, the prompt Enter Com- ment appears. Press NO to scroll through the letters

of the alphabet and numbers 0 - 9, press YES to accept your selection. Press NO to move the cursor to the next character.

After completing printing programming functions, the menu Program Interface? will be displayed. Press YES and the prompt Activate Data link? appears. Press YES if you wish to interface the AVL 9180 with an AVL Compact 2 blood gas analyzer. The data link with the AVL Compact 2 blood gas analyzer allows you to combine ISE results with pH/blood gas results on one printout. If Ca++ is activated on the 9180, a pH-corrected Ca++ value will be calculated and printed on the combined sample report.

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For connection of the 9180 analyzer to the Compact 2 analyzer, the optional Interface Kit (BP5202) is required. To install the kit, first turn both instruments off. Connect the interface filter provided in the kit to the RS232 port on the 9180. Then connect one end of the cable to the interface filter, the other end to the COM 2 port on the Compact 2. On the Compact 2, select 9180 under the COM2 interface options. See Compact 2 Operator's Manual for Details.

The analyzer will then display Remain in Program

Func? Pressing YES will return you to the Pro- gram QC Level 1 Ranges? menu, while NO will return the analyzer to READY.

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Chapter 4

Quality Control

Running a QC sample

To monitor the performance of your AVL Electrolyte Analyzer, you should run daily quality control samples using AVL ISE-trol Electrolyte Control (HC0033). These protein-based ISE controls allow you to monitor the analysis of sodium, potassium, chloride, ionized calcium and lithium, and have been specially formulated for use with your AVL Electrolyte Analyzer.

Note: You can store in memory up to 35 QC measurements per level. You can print the values stored and view the statistics at any time.

ISE-trol is provided in three levels to produce expected values that are low, normal and high, allowing thorough evaluation of the analyzers performance. Whenever a new box of ISE-trol is opened, be sure to enter the lot number information into the analyzer as detailed in Chapter 3.

Note: ISE-trol should be stored in the refrigerator at 2-8° C and brought to room temperature before use.

From the READY display, press NO until the prompt QC / STD / DIALYSATE / URINE SAMPLE? appears. Press YES. The prompt QC Level 1 Sample? will be displayed.

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4-1. Introducing Level 1 control

Press YES. The prompt Open Sample Door Introduce Sample will be displayed.

Remove a Level 1 ampule from the box of ISE-trol and mix carefully. Gently tap the head of the ampule with your fingernail to remove any liquid.

Carefully open the ampule by breaking off the top.

Note: Protect your fingers by using gloves or tissue while breaking ampule.

Lift the sample door and the prompt Introduce Sample will be displayed. Introduce the control to

the sample probe. See illustration 4-1.

Note: It is very important that the main door is closed during sampling, since it provides shielding from sources of electromagnetic interference.

4-2. Cleaning probe

Hold the ampule under the probe until the prompt Wipe Probe Close Sample Door is displayed. Use a lint-free tissue to remove the control from the probe, then close the door. See illustration 4-2.

Note: It is very important that the sample probe is carefully cleaned each time following a sample introduction.

The instrument will display QC Level 1 in process and a countdown will begin, during which the control will be analyzed. Upon completion, the results will briefly be displayed, such as:

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Na K ¯ Cl

125.1 3.05 77.8

Note: The AVL Electrolyte Analyzer flags values that are above or below the programmed target ranges by using an up or down arrow.

The analyzer will automatically prompt Store Values in Memory? To save the values in memory,

press YES. To reject the values, press NO. If the values are rejected, the analyzer will return to the QC Level 1 Sample? display, allowing you to repeat level 1 by pressing YES and repeating the sampling procedure, or to skip to level 2 by pressing NO.

Note: In case the value is outside the measurement

range ( ↑↑↑↑, ↓↓↓↓ or ERR.), it will automatically

be rejected.

If the values have been saved, the analyzer will display

VAL

UES ACCEPTED!, followed by the prompt

QC Level 2 Sample? To continue with QC mea-

surement, press YES and follow the instructions as outlined for QC Level 1 Sample, being sure to use a Level 2 ISE-trol.

After storing values for QC Level 2, the analyzer will display VALUES ACCEPTED!, followed by the prompt QC Level 3 Sample? To continue with QC measurement, press YES and follow the instructions as outlined for QC Level 1 Sample, being sure to use a Level 3 ISE-trol.

Note: If you wish to discontinue QC testing, press NO until READY is displayed.

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At the completion of QC Level 3 testing, the analyzer will prompt, Remain in QC/Std/ Urine Sample? If all level testing has been completed, press NO and the analyzer will return to READY.

Note: Responding YES to the Remain in QC / Std/ Urine Sample? prompt will return the analyzer to the QC Level 1 Sample? display.

Printing a QC report

The analyzer will store in memory the last 35 measurement values for each of the three levels of control. To print a report of these values along with their mean, standard deviation (1SD) and coefficient of variation (CV), press the NO key until PRINT FUNCTIONS? is displayed.

Press YES and the prompt Print last Sample Report? will be displayed. Press NO.

The analyzer will now display Print Cal Report? Press NO and Print QC Values and Statistics? will appear. Press YES and instrument will begin printing all values grouped by configuration. For the statistics, all values available for each parameter are used.

After printing, the AVL Electrolyte Analyzer will return to READY.

Note: If correlation factors are changed or QC values switched to direct ISE, ALL values in memory are recalculated and printed in the new setting.

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Chapter 5

Operation

The AVL Electrolyte Analyzer provides fast, convenient analysis of whole blood, serum, plasma, aqueous solutions, dialysate solutions and urine for:

Na K Cl-Chloride Ca++Calcium Li

The analyzer will accept specimens directly from most common containers, including collection tubes, syringes, sample cups and capillary tubes.

Note: Always follow proper safety procedures when handling biological samples.

Sodium

Potassium

Lithium (Ca++ and Li+ are not measured in urine samples)

All parameters are reported in mmol/L. However, Ca++ (if activated) can be switched to mg/dL (see 'Service Codes').

Whole blood samples

Collect the blood in a green top tube or heparinized syringe, preferably with sodium heparin anticoagulant.

Note: Lithium heparin may also be used, if lithium is not installed.

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Whole blood samples should be analyzed as soon as possible within one hour after collecting the sample. If a brief storage is required, do not cool the sample as the erythrocytes could burst and release the intracellular potassium, creating an inaccurate value of

potassium in the sample.

Plasma samples

Collect the blood in a green top tube, preferably with lithium or sodium heparin anticoagulant.

Note: Lithium heparin may be used, if lithium is not installed.

Centrifuge the sample and separate plasma into a different test tube or sample cup as soon as possible.

Plasma can be stored longer than whole blood samples. If storage is required, plasma samples should be capped and placed in the refrigerator. Prior to analysis, always allow sample to warm to room temperature.

Note: For whole blood and plasma samples, the proper amount of anticoagulant must be used to prevent the sample from clotting. DO NOT use anticoagulants such as EDTA, citrate, oxalate, etc.

Serum samples

Collect the blood in a red top tube containing no anticoagulant. Allow the blood to clot and then centrifuge. Separate the serum into a different test tube or sample cup as soon as possible. Serum can be stored longer than whole blood, though preferably capped and placed in the refrigerator.

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Prior to measurement, always bring the sample to room temperature.

Aqueous Samples

Aqueous samples, such as Standard A, have to be measured in the Standard Mode.

Note: The Standard Mode ALWAYS reports direct ISE values and is not affected by correlation factors or the setting of QCC (see 'Service Codes').

Dialysate Samples

Either acetate or bicarbonate dialysate fluids may be analyzed. Dialysate samples can be stored longer than whole blood, though preferably capped and placed in the refrigerator. Prior to measurement, always bring the sample to room temperature.

Note: If lithium is activated, the dialysate mode is not available.

Running a sample with the AVL Electrolyte Analyzer

The AVL Electrolyte Analyzer provides fast, easy operation. Whenever READY appears on the display, the unit is prepared to conduct sampling measurements. To analyze a Standard Sample, press

NO to get to QC/STD/DIALYSATE/URINE SAMPLE?. Press YES. Then press NO until the prompt Standard Sample? appears. Press YES.

Note: Urine samples require dilution, and must be analyzed in the urine mode. Instructions for analyzing urine samples are provided later in this chapter.

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To analyze a sample, lift the sample door. The prompt, Introduce Sample will be displayed and the pump will begin to aspirate. Introduce the sample to the probe. See illustration 5-1.

Note: It is very important that the main door is closed during sampling, since it provides shielding from sources of electromagnetic interference.

5-1. Introducing a sample

5-2. Cleaning probe

* AVL 9180 * ELECTROLYTE ISE NA - K - LI 01MAR96 07:20

Name: . . . . . . .

. . . . . . . .

Sample: SERUM

Sample No. 4 Na = 190 ↑ mmol/L

K = 5.2 mmol/L Li = *** mmol/L

*** Li calculation not possible

Hold the sample under the probe until Wipe Probe Close Sample Door is displayed. Use a lint-free

tissue to clean the probe, then close the sample door when prompted. See illustration 5-2.

Note: It is very important that the sample probe is carefully cleaned each time following a sample introduction.

The analyzer will display Thank You! and a brief countdown will begin. Upon completion of analysis, the test results will be displayed and printed. See illustration 5-3.

Note: Values that are higher or lower than the programmed normal range will be indicated by an arrow pointing up or down.

Note: If the Na+ result is above 180 mmol/L (above

169.5 mmol/L for blood/serum) or below 95 mmol/L (below 89.6 mmol/L for blood/serum), the Li+ value cannot be derived.

5-3. Sample report

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If an additional sample report is desired or the automatic sample report is turned off, the results may be printed by following these steps:

1. Press NO.

2. The prompt PRINT FUNCTIONS? will be displayed.

3. Press YES to accept.

4. Print Last Sample Report? will be displayed.

5. Press YES to accept.

6. The test results will be displayed, and the report will print.

7. The analyzer will return to READY.

Dialysate samples

Dialysate samples are measured in the dialysate mode. In the default analyzer setting, the dialysate mode provides measurements identical to those performed in the standard mode. Separate correlation factors for bicarbonate and acetate permit optimization of absolute measurement, which may be necessary for certain dialysate compositions (see Chapter 3, Correlation Factors).

To access the dialysate mode, press NO until

QC/STD/DIALYSATE/URINE SAMPLE? appears. Press YES, then NO until Bicarbonate Sample? or Acetate Sample? appears.

Note: If lithium is selected, the dialysate mode is not available.

Due to interfering substances inherent in some dialysate solutions, you may need to establish correlation factors to obtain correct results.

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* AVL 9180 * ELECTROLYTE ISE NA - K - CL 25MAR96 16:55

Name: . . . . . . .

. . . . . . . .

Sample: URINE

Sample No. 1

Na = 263 mmol/L K = 18.3 mmol/L Cl = 118 mmol/L

5-4. Urine sample report (no additional dilution required).

Urine samples

Before measuring urine, accurately dilute the sample with AVL Urine Diluent (BP0344) in the ratio of 1 part urine to 2 parts diluent (e.g., 1 mL urine and 2 mL urine diluent). Thoroughly mix the sample, and analyze in the urine mode.

Whenever READY appears on the display, the unit is prepared to conduct sampling measurements. However, urine samples, diluted with urine diluent, are analyzed in the urine mode. To access this mode, press NO until QC / STD / DIALYSATE / URINE SAMPLE? appears on the display.

* AVL 9180 * ELECTROLYTE ISE NA - K - CL 02MAR96 10:07

Name: . . . . . . .

. . . . . . . .

Sample: URINE

Sample No. 5

Na = 142 mmol/L

↑↑↑↑ mmol/L

K =

5-5. Urine sample report (additional dilution required).

Press YES and then NO until Urine Sample? appears. Press YES and follow the prompts. Upon completion of analysis, the analyzer will calculate the final test results which will be displayed and printed. See illustration 5-4.

Note: Ca++ and Li+ are not measured in urine.

Note: If the result of the urine sample is given with

↑↑↑↑, the K

value of the sample is higher than 45 mmol/L, and outside the measurement range of the analyzer. The measurement must be repeated using the following procedure.

1. Record the value of Na (and Cl- , if activated) of

the first urine measurement.

2. Redilute the diluted urine (already diluted 1:2 with urine diluent) with distilled water in

the ratio of 1:2 (e.g., 1 mL of diluted urine and 2

mL distilled water).

3. Thoroughly mix the sample.

4. Run a second urine measurement with the twice diluted urine sample.

5. Ignore the Na+ value (and Cl-, if activated).

6. Multiply the K+ value by 3 and record.

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Chapter 6

Maintenance and Operator Functions

Scheduled Maintenance: Performing daily maintenance

Prior to running your first sample of the day, the AVL Electrolyte Analyzer needs to undergo a simple cleaning and conditioning procedure that helps ensure the unit will perform properly. This procedure is called daily maintenance, because it must be performed once each day the analyzer is used to conduct sampling.

Note: In case cleaning and/or conditioning has not been performed within the last 24 hours, the analyzer will automatically print on each sample report

Perform Daily Maintenance.

The process involves cleaning and conditioning the sampling path, including the probe and electrodes. You will need to have ready the bottles of Cleaning Solution A and Electrolyte Conditioning Solution, and a package of lint-free tissues to use in drying the sample probe. Check the bottles to ensure that the

expiration date has not been reached.

Note: If fewer than 5 samples are analyzed each day, cleaning should be performed once a week instead of daily (see weekly maintenance).

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To begin daily maintenance, press NO until the

prompt DAILY MAINTENANCE? is displayed.

Press YES to accept. Perform Cleaning? will be

displayed. Press YES to start the cleaning procedure.

6-1. Introducing Cleaning Solution A

6-2. Cleaning probe

The prompt

Sample

Open Sample Door Introduce

will appear. At this time, pour a small

amount of AVL Cleaning Solution A into a clean

container.

Lift the sample door and the pump will begin to

aspirate. Introduce the cleaning solution to the sample

probe.

See illustration 6-1.

Continue holding the solution under the sample probe

until the prompt Wipe Probe and Close Sample

Door is displayed. Use a lint-free tissue to remove

the cleaning solution from the probe and close the door

See illustration 6-2.

The analyzer will now display Thank You!, and a

brief countdown will begin. While the countdown is

running, open the bottle of AVL Electrode Condition-

ing Solution and pour a small amount into a clean

container.

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After the countdown is completed, the system will

prompt, Perform Daily Conditioning? To con-

tinue with the procedure, press YES.

The prompt

Sample

the pump will begin to aspirate. Introduce the condi-

tioning solution to the sample probe.

Continue holding the solution under the sample probe

until the prompt Wipe Probe and Close Sample

Door is displayed. After wiping the probe and closing

the sample door, the analyzer will display Thank

You! . Upon completion of the countdown, the

prompt Remain in Daily Maintenance? will be

displayed. Press NO, and the AVL Electrolyte Ana-

lyzer will automatically initiate a calibration cycle.

Note: It is very important that the main door is closed during calibration, since it provides shielding from sources of electromagnetic interference.

Open Sample Door Introduce

will be displayed. Lift the sample door and

When calibration is completed, the analyzer will

display READY, indicating that the instrument is

prepared to conduct electrolyte sampling.

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6-3. Fill port

Performing weekly maintenance

On a weekly basis, or whenever necessary, you should clean the sample fill port and sample probe (illustration 6-3), as well as the exterior analyzer surfaces. Cleaning should also be performed on a weekly basis, if fewer than five samples are analyzed a day.

To clean the sample fill port and probe, open the sample door and clean the fill port, probe and surrounding area with a damp cotton swab. When finished, close the sample door. If the analyzer attempts to perform a sample analysis, NO Sample will be briefly displayed, and the unit will return to READY. The exterior surfaces should be wiped clean with a soft, damp cloth.

Note: Never use strong or abrasive cleaners on the AVL Electrolyte Analyzer. Use a slightly damp cloth to avoid getting fluid inside the analyzer.

6-4. Removing reference connector

Performing monthly maintenance

Monthly maintenance involves cleaning the reference electrode housing, and should be performed prior to daily maintenance. To complete this procedure, you will need a small amount of household bleach.

Begin monthly maintenance by pressing NO until DAILY MAINTENANCE? is displayed. Press YES and Perform Daily Cleaning? will appear. Do not press any keys.

Open the front cover of the analyzer. Unplug the tubing of the reference electrode from the receptacle below the left side of the measuring chamber.

See illustration 6-4.

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6-5. Sliding measuring chamber to front locked position

Slide the measuring chamber forward until it locks in the front position. See illustration 6-5.

Unclamp the left electrode holder by moving the clamp forward. See illustration 6-6.

Remove the reference electrode assembly from the analyzer. Unscrew the reference electrode from the reference housing. Store the reference electrode in the red transport housing filled with reference solution

that has been poured from the electrode housing.

Note: It is important that reference electrode always be stored in reference solution and never allowed to become dry.

Pour some bleach into a small container, and submerge the reference housing into the bleach, ensuring that no air bubbles remain in the housing.

6-6. Unclamping left electrode holder

Note: The reference connector and tubing do not need to be submerged.

After a period of 15 minutes, remove the reference housing from the bleach, thoroughly rinse the housing with tap water and dry.

Unscrew the red transport housing from the reference electrode and check that the o-ring on the electrode is

properly seated. Save the transport housing.

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6-7. Installing reference electrode

Carefully screw the reference electrode into the

reference electrode housing and place the assembly

into the left side of the measuring chamber. Note that

the reference electrode has a lip on the bottom that

rests on the flat edge of the measuring chamber.

See illustration 6-7.

Close the clamp on the left electrode holder by lifting

it upward until it locks in the back position. Ensure

the electrodes are seated properly.

See illustration 6-8.

6-8. Closing electrode holder clamp

6-9. Installing ref. electrode connector

Plug the tubing of the reference electrode into the

receptacle below the left side of the measuring

chamber.

See illustration 6-9.

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6-10. Installing measuring chamber

6-11. Removing pump windings

Slide the measuring chamber back until it snaps into position, and close the front cover of the analyzer. See illustration 6-10.

At this time, you may perform daily maintenance by pressing YES. If daily maintenance is not needed, press NO until CALIBRATION? is displayed. Press YES and a complete calibration cycle will be performed.

Performing 6-month maintenance

Every six months, the peristaltic pump tubing needs to be replaced.

Note: To make sure that the pump does not turn on during this procedure, press NO until DAILY

MAINTENANCE? is displayed. Press YES and Perform Daily Cleaning? will appear. Then, do not

press any keys.

6-12. Pump winding plate

To change the tubing, open the analyzer front cover and slip the two pump windings from the analyzer pump rollers. See illustration 6-11.

Next, disconnect one tube at a time from the old pump

winding plate and reconnect to the same place on the

new pump winding plate.

See illustration 6-12.

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Install the new pump winding plate and slip the new

pump windings over the analyzer pump rollers, being

careful not to cross the tubes.

Press NO until CALIBRATION? is displayed. Press

YES to initiate a calibration cycle.

6-13. Slide chamber forward

6-14. Unclamp electrodes

Unscheduled Maintenance:

Changing electrodes

Slide the measuring chamber forward until it locks in

the front position.

See illustration 6-13.

Unclamp the left electrode holder by moving the

clamp forward.

See illustration 6-14.

Remove the used electrode from the measuring

chamber.

6-15. Remove used electrode

See illustration 6-15.

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6-16. Electrode o-ring

6-17. Installing new electrode

Remove the new electrode from its protective box and

check for the presence of an o-ring in the left side of

the electrode.

See illustration 6-16.

Install electrode in its labeled position in the measur-

ing chamber. Note that the electrode has a lip on the

bottom that rests on the flat edge of the measuring

chamber to aid in proper positioning.

See illustration 6-17.

6-18. Closing electrode clamp

Close the clamp on the left electrode holder by lifting

it upward until it locks in the back position. Ensure

that the electrodes are seated properly.

See illustration 6-18.

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6-19. Slide measuring chamber back

Slide the measuring chamber back until it snaps into position. See illustration 6-19.

After installing a new electrode, the AVL Electrolyte Analyzer needs to undergo Daily Maintenance, Calibration and QC Measurement to verify the performance of the electrode.

Operator Functions

Checking reagent fluid level and changing the

ISE SnapPak

The AVL Electrolyte Analyzer monitors the level of solutions in the ISE SnapPakTM and displays the amount remaining. To check the status of fluid remaining in the pack:

6-20. Removal of used ISE SnapPak

1. Press NO until the prompt, OPERATOR FUNCTIONS? is displayed. Press YES.

2. The prompt Change SnapPak? will be displayed.

3. Press YES. The analyzer will display the amount of fluid remaining.

4. To change the ISE SnapPakTM, it is not necessary to go to a special menu, just grasp the extended portion of the pack and slide it out. If removal is difficult, press on the end of the ISE

SnapPakTM guide pin (protruding from the

connector located to the left of the measuring chamber inside the front door).

See illustration 6-20.

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As soon as the analyzer detects that the pack has been removed, the display prompts Status: No SnapPak. In addition, the printer will print the

current status of the ISE SnapPak

Note: Do not remove the pack during a calibration or measurement procedure.

6-21. Installing ISE SnapPak

Note: The ISE SnapPak

must be treated as medical waste and disposed of in accordance with local regulations.

5. Prepare the new ISE SnapPakTM by carefully

removing the protective strip. Save this cover to close the connectors prior to disposal of the used pack. Write the installation date on the label of the new pack.

Note: Once the protective strip is removed, be sure to keep the pack upright to avoid spillage.

6. Slide the new ISE SnapPakTM into position on

the left side of the analyzer. The analyzer will prompt New SnapPak installed?

See illustration 6-21.

7. Press YES to indicate that a new ISE

SnapPakTM is installed. Press NO if you reinstall the pack that was removed.

8. Press YES, and the AVL Electrolyte Analyzer

will automatically reset the fluid pack counter to 100% and commence system calibration.

Standby mode

The AVL Electrolyte Analyzer is designed to calibrate automatically every four hours during normal tion. If sampling will be delayed for an ex

opera-

tended period of time, such as evenings and weekends, you may place the analyzer into Standby mode to suspend automatic calibration.

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Note: Your analyzer can be programmed to automatically enter Standby mode. For instructions see "Service Codes" in Chapter 7.

To access this mode, follow the steps below:

1. Press NO until the prompt, OPERATOR FUNCTIONS? is displayed. Press YES.

2. Press NO until the prompt Go to Standby Mode? is displayed and press YES.

3. The analyzer will display STANDBY! YES -> READY to confirm that it has entered Standby mode.

To leave Standby and resume normal operation:

1. Press NO. The prompt Leave Standby Mode?

will be displayed.

2. Press YES.

Note: If less than four hours have elapsed since the last calibration, the analyzer will return to READY. If more than four hours have elapsed, the analyzer will exit to the daily maintenance menu. If cleaning / conditioning has not occurred in the past 24 hours perform the daily maintenance now. If cleaning / conditioning is not needed, press NO to start calibration.

Setting date and time

The date and time of the AVL Electrolyte Analyzer can be easily changed as necessary. To change the date and time, enter the OPERATOR FUNC-

TIONS? menu and press NO until Set Time / Date? is displayed.

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1. Press YES to enter the time/date setting menu.

2. The current time/date is displayed with the ques-

tion OK? Respond with NO, if you want to change the time/date. Press YES to exit.

3. Press NO until the correct day is displayed. Press YES. The cursor will move to the month.

4. Press NO until the correct month is displayed. Press YES.

5. Press NO until the correct year is displayed. Press YES. The correct date should now be displayed.

6. Follow the same procedure to enter the correct time. The analyzer will prompt: OK? Press YES if the date and time you entered is correct, or press NO to continue making changes.

Changing Parameter Configuration

Your analyzer is designed to allow easy change of parameter configuration. To change the current parameter configuration, enter the OPERATOR FUNCTIONS? menu. Press YES followed by NO until Select Parameter Configuration? appears. Press NO, until the desired configuration is displayed.

Note: The ([Na]) in parenthesis indicates that the Na result is not displayed, the Na+ parameter, however, has to be present to allow for lithium calibration.

After confirming the desired parameter configuration by pressing YES, the instrument returns to READY, if no new parameter has been activated. If one or several new parameters have been selected, the analyzer will enter the maintenance menu, where a cleaning and conditioning routine has to be performed

followed by an automatic calibration.

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Resetting the sample number

Each time a sample is analyzed, the analyzer will automatically advance the sample counter. If for any reason you wish to reset the counter, you can do so by entering the OPERATOR FUNCTIONS? menu and press NO until Reset Sample Number? is displayed.

To reset the sample number to zero (0), press YES. The analyzer will prompt Are you sure? Press YES and the sample number will be reset to zero. Press NO to decline.

Take out of operation

The take-out-of-operation routine assists you in performing a complete shutdown of the analyzer. A complete shutdown may be indicated to prepare the analyzer for shipping or in case the analyzer is not being used for an extended period of time. For this procedure, you will need a special shutdown kit BP5014 (not supplied with the analyzer).

Note: Never attempt to turn the power off for an extended period of time without performing a complete shutdown of the analyzer.

Note: In case the analyzer is not being used for several days only, it is not recommended to perform a complete shutdown, but to put the analyzer in Standby Mode.

To perform the shutdown, you will need the following items:

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6-22. Shutdown plug and containers installed

 Two containers, one filled with at least 100 mL of

water, the other one empty.

 Five solenoid relief clamps (supplied with analyzer

and shutdown kit)

 Two reference electrode transport housings

(supplied with shutdown kit)

 One shutdown plug (supplied with shutdown kit)  Protective strip for ISE SnapPakTM (supplied

with shutdown kit)

To get started, go to OPERATOR FUNCTIONS. Press YES, then NO until

Take Out of Operation?

appears. Press YES.

Next the analyzer prompts Shutdown Plug and Water Installed?. First remove the ISE SnapPak

and push the protective strip firmly onto the fluid pack connector. Insert the shutdown plug carefully into the fluid pack receptacle. Next, place the blue marked line into the disposable container filled with water. The line with the red mark is inserted into the empty container. Press YES. See illustration 6-22.

The analyzer will prompt Transport Ref Housing Installed? Pull the electrode holder forward and remove the reference electrode assembly.

Carefully unscrew the reference electrode from the reference electrode housing. Temporarily place the reference electrode on a clean, soft cloth. Next, pour the remaining reference solution in the reference housing into a transport housing. Then carefully screw the reference electrode into the filled transport housing.

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Now the second transport housing is screwed into the

reference housing. Place the reference housing back

into the electrode holder and move the lever backwards,

making sure all electrodes are seated properly. The

electrode holder remains in the forward position. Press YES. See illustration 6-23 and 6-24.

6-23. Installing the second transport housing

6-24. Reclamp electrode assembly

The analyzer will take approximately one minute to

flush all lines with water. Upon completion, you will

receive the prompt

Remove Water and Press Yes

Remove the line with the blue mark from the water and

place it on a cloth, making sure it is not obstructed. The

line with the red mark remains in its container. Press

YES. During this cycle, all lines are purged of water.

Upon completion, the prompt All Electrodes & Plug

Removed? will appear.

See illustration 6-25.

Unplug the reference connector below the left side of

the electrode holder. Then move the lever on the left

side forward and remove all electrodes, placing them on

a soft cloth. Next, move the lever back and push the

empty electrode holder into its back position.

6-25. Blue line removed for purge cycle