AVL COMPACT 3 PH Blood Gas Analyzer Operators Manual Rev 2.0 June 1998

Manufactured by: AVL LIST GmbH MEDIZINTECHNIK Hans-List-Platz 1 8020 Graz / Austria

Distributed by: AVL MEDICAL INSTRUMENTS AG Stettemerstraße 28 8207 Schaffhausen / Switzerland AVL MEDIZINTECHNIK GMBH Norsk-Data-Straße 1 Postfach 1142 61281 Bad Homburg / Germany AVL LIST GmbH MEDIZINTECHNIK Hans-List-Platz 1 8020 Graz / Austria AVL SCIENTIFIC CORPORATION Roswell, GA 30077 / USA

Local AVL representative:

Copyright  1998 AVL List GmbH, all rights reserved The contents of this document may not be reproduced in any form or communicated to any third party without the prior written consent of AVL. While every effort is made to ensure its correctness, AVL assumes no responsibility for errors or omissions which may occur in this document. Subject to change without notice.

First Edition: 17. Juli 1996

- Important Information! - Important Information! -

This Operator´s Manual contains important warnings and safety instructions 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 manufacturers control. Therefore the test results from this instrument must be carefully examined by 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.

Explanation:

!

This symbol is located on the inside of the instrument: "Refer to the Operator’s Manual / Service Manuals".

Symbol for instrument type B: An instrument of the B-type falls under safety categories I, II or III, or has an internal power supply, providing the required insulation against discharge current and reliable ground connections.

- Important Information! - Important Information! -

- Operating Safety Information • The instrument falls under Safety Category I. • The instrument belongs to Type B. • The instrument is designed as a conventional device (of 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. • The instrument is suitable for continous operation.

CAUTION: • The mains plug may be plugged only into a grounded socket. When using an extension cord, make sure it is properly grounded. • Any rupture of the ground lead inside or outside the instrument or a loose ground connection can render hazardous operation of the instrument. Intentional disconnection of the grounding is not permitted. • While changing the fuses, make sure that the fuses used, are of the specified type and rating in every case. Never use repaired fuses or short-circuit the fuse holders.

- Operating Safety Information -

Contents

Contents METHOD SHEET Intended Use ...1 Clinical Significance ...1 Principles of Procedure ...2 Reagents ans Accessories ...5 Specimen Collection and Handling... ...9 Handling and Storage of Samples ... 11 Materials Needed ... 12 Test Conditions ... 13 Calculated Values ... 14 Specific Performance Characteristics ... 17 Bibliography ... 26

1 INTRODUCTION Analyzer Description ...1-1 Intended Use ...1-1 Clinical Significance ...1-2 Handling the Analyzer ...1-3 Handling Blood and Blood Products ...1-3 Handling AVL Reagents...1-4 Decontamination ...1-5 Handling the Electrodes ...1-8

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

I

Contents

2 DESCRIPTION OF THE ANALYZER Main Features... 2-1 Analyzer Components ... 2-2 Description of the Sample Path... 2-6 Operator Interface... 2-12

3 INSTALLATION, SHUTDOWN Installation ... 3-1 Shutdown ... 3-11

4 PATIENT TESTING Sample Preparation ... 4-1 Sample Measurement ... 4-2 Password Option... 4-10 Parameter and Data Input ... 4-12 Printout ... 4-19

5 QUALITY CONTROL QC Measurement ... 5-1 QC Edit Function... 5-3 QC Statistics ... 5-7

II

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Contents

6 CALIBRATION Automatic Calibrations ...6-1 Conditioning ...6-2 Operator-Initiated Calibrations...6-2

7 DATA MANAGER

8 SYSTEM FUNCTIONS Manual Standby ...8-3 Automatic Standby...8-4 Timings ...8-5 Parameter ...8-9 Language...8-13 Interface ...8-14 Password ...8-19 Device Lock...8-21 Report ...8-22 Display ...8-27 Mini Sample ...8-28

9 MAINTENANCE Introduction ...9-1 Decontamination ...9-1 Daily Maintenance ...9-5 Weekly Maintenance ...9-8

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

III

Contents

Every 6 Month ... 9-9 Yearly Maintenance... 9-10 As needed... 9-11

10 TROUBLESHOOTING Displayed and Printed Warning... 10-1 Displayed and Printed Alarms ... 10-1 Error Messages and Instructions for Elimination... 10-3 Printed Warnings and Error Messages ... 10-8 Insufficient Wash and Dry Cycle ... 10-8 Clogged Sample Path ... 10-9 Test Programs... 10-13

11 INTERFACE General Description ... 11-1 Hardware... 11-1 Baud Rate ... 11-2 Transmission Format ... 11-2 Transmission Report... 11-3 Reports ... 11-3 Connection Cable AVL COMPACT 3 - PC (Terminal / Printer) ... 11-5 Barcode Scanner ... 11-6 Datalink ... 11-8 Telelink ... 11-23

IV

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Contents

12 APPENDIX Specification of the Analyzer ...12-1 Description of Various Reports ...12-4 Parameters and Equations ... 12-15 Care and Maintenance of Remembranable Blood Gas Electrodes... 12-28 Operating Principles ... 12-44 Analytical Performance ...12-4/ Options ... 12-59 User Programs ... 12-63 Fluidics ... 12-64

13 PREANALYTICAL REQUIREMENTS FOR BLOOD GAS ANALYSIS Introduction ...13-1 Sample Types ...13-1 Sampling Procedures...13-2 Treatment of Sample before Analysis... 13-9 Summary ... 13-10

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

V

Contents

Figures CHAPTER 2 Fig. 2-1: Display ... 2-2 Fig. 2-2: Thermal printer... 2-2 Fig. 2-3: View with open top cover ... 2-3 Fig. 2-4: Reagents ... 2-3 Fig. 2-5: Sample fill module ... 2-5 Fig. 2-6: Measuring chamber module ... 2-7 Fig. 2-7: Measuring capillary ... 2-7 Fig. 2-8: Electrodes... 2-8 Fig. 2-9: Peristaltic pump ... 2-8 Fig. 2-10: Rear panel ... 2-9 Fig. 2-11: Warning and identification plates ... 2-9 Fig. 2-12: Interface ... 2-10 Fig. 2-13: Gas connections ... 2-10 Fig. 2-14: Power switch module ... 2-11

CHAPTER 3 Fig. 3-1: Solenoid valve relief clamps - fill module ... 3-2 Fig. 3-2: Solenoid valve relief clamps - peristaltic pump ... 3-3 Fig. 3-3: Solenoid valve relief clamps - bottle compartment ... 3-3 Fig. 3-4: Peristaltic pump tubes ... 3-3 Fig. 3-5: Gas connection ... 3-5 Fig. 3-6: Position of calibration gas cylinder ... 3-5 Fig. 3-7: Removal of transport housing ... 3-6

VI

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Contents

Fig. 3-8: pH Reference Electrode - yellow marking ...3-6 Fig. 3-9: pH Reference Electrode - droplet ...3-9 Fig. 3-10: Paper insertion ...3-10 Fig. 3-11: Transport housing ...3-13 Fig. 3-12: Solenoid valve relief clamps - fill module...3-13 Fig. 3-13: Solenoid valve relief clamps - peristaltic pump...3-14 Fig. 3-14: Solenoid valve relief clamps - bottle compartment...3-14

CHAPTER 4 Fig. 4-1: AVL Microsampler ...4-1 Fig. 4-2: Syringe measurement ...4-2 Fig. 4-3: Capillary measurement ...4-4

CHAPTER 8 Fig. 8-1: Password-codecards with different access codes...8-20 Fig. 8-2: Password...8-21

CHAPTER 9 Fig. 9-1: Paper insertion ...9-6 Fig. 9-2: Position of the gas cylinders ...9-6 Fig. 9-3: pH Reference Electrode ...9-8 Fig. 9-4: Peristaltic pump tubes ...9-10 Fig. 9-5: Pump spool ...9-11 Fig. 9-6: Zero-maintenance pH / Blood Gas Electrodes ...9-12 Fig. 9-7: pH Reference Electrode (1)...9-12

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

VII

Contents

Fig. 9-8: pH Reference Electrode... 9-14 Fig. 9-9: Remove pH Reference Electrode housing ... 9-14 Fig. 9-10: O-ring (pH Reference Electrode) ... 9-15 Fig. 9-11: pH Reference Electrode housing... 9-15 Fig. 9-12: Remembranable pH / Blood Gas Electrode ... 9-16 Fig. 9-13: Electrode check (1) - PCO 2 / PO 2 Electrode... 9-16 Fig. 9-14: Electrode Check (2) - PCO 2 / PO 2 Electrode... 9-17

CHAPTER 10 Fig. 10-1: Remove glass splinters (1) ... 10-11 Fig. 10-2: Remove glass splinters (2) ... 10-11 Fig. 10-3: Remove glass splinters (3) ... 10-12 Fig. 10-4: Remove glass splinters (4) ... 10-12

CHAPTER 11 Fig. 11-1: COM 1 / COM 2 - pinning ... 11-1 Fig. 11-2: COM 3 - pinning... 11-2 Fig. 11-3: Barcode scanner ... 11-6 Fig. 11-4: 9-pin SUBMIN D / M ... 11-6 Fig. 11-5: Types of barcode ... 11-7 Fig. 11-6: Interface AVL 988-3 ... 11-8 Fig. 11-7: Interface AVL 9180 ... 11-14 Fig. 11-8: Interface AVL 912 ... 11-20 Fig. 11-9: Telelink... 11-23

VIII

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Contents

CHAPTER 12 Fig. 12-1: Remembranable pH / Blood Gas Electrode ... 12-28 Fig. 12-2: pH Electrode ... 12-29 Fig. 12-3: Pull out the pH Electrode ... 12-29 Fig. 12-4: Remove pH Electrode housing ... 12-30 Fig. 12-5: Inner electrode - O-Ring ... 12-30 Fig. 12-6: pH Electrode: fix new housing (1)... 12-30 Fig. 12-7: pH Electrode: fix new housing (2)... 12-31 Fig. 12-8: pH Electrode: immerse into Buffer 1 ... 12-31 Fig. 12-9: pH Electrode: cleaning procedure (1) ... 12-32 Fig. 12-10: pH Electrode: cleaning procedure (2) ... 12-32 Fig. 12-11: pH Electrode: cleaning procedure (3) ... 12-33 Fig. 12-12: pH Electrode: immerse into Buffer 1 ... 12-33 Fig. 12-13: PCO 2 Electrode ... 12-34 Fig. 12-14: PCO 2 Electrode: remove Inner element ... 12-35 Fig. 12-15: PCO 2 Electrode: Inner element ... 12-35 Fig. 12-16: PCO 2 Electrode.: cleaning shaft ... 12-35 Fig. 12-17: PCO 2 Electrode: inner shaft ... 12-36 Fig. 12-18: PCO 2 Electrode: cleaning procedure (1) ... 12-36 Fig. 12-19: PCO 2 Electrode: cleaning procedure (2) ... 12-37 Fig. 12-20: PCO 2 Electrode: cleaning procedure (3) ... 12-37 Fig. 12-21: PO 2 Electrode... 12-38 Fig. 12-22: PO 2 Electrode: cleaning procedure (1) ... 12-39 Fig. 12-23: PO 2 Electrode: cleaning procedure (2) ... 12-39 Fig. 12-24: PO 2 Electrode: cleaning procedure (3) ... 12-39 Fig. 12-25: Electrode housing with protective cap ... 12-41 Fig. 12-26: Filling electrode housing with electrolyte ... 12-41

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

IX

Contents

Fig. 12-27: Remove air bubbles ... 12-42 Fig. 12-28: Insert inner part ... 12-42 Fig. 12-29: Insert inner part ... 12-42 Fig. 12-30: Close overflow hole of the electrode housing ... 12-43 Fig. 12-31: Silicon grease of the tip of the electrodes... 12-43 Fig. 12-32: Operating principles - pH Electrode ... 12-44 Fig. 12-33: pH Electrode... 12-45 Fig. 12-34: pH Reference Electrode ... 12-45 Fig. 12-35: Operating principles - PCO 2 Electrode ... 12-46 Fig. 12-36: PCO 2 Electrode... 12-46 Fig. 12-37: Operating principles - PO 2 Electrode ... 12-47 Fig. 12-38: PO 2 Electrode ... 12-47 Fig. 12-39: Linearity of pH, PCO 2 and PO 2 in tonometered whole blood ... 12-57 Fig. 12-40: Comparison study with AVL 995 ... 12-58 Fig. 12-41: Barcode scanner ... 12-59 Fig. 12-42: External waste container ... 12-60 Fig. 12-43: User programs - AVL COMPACT 3 ... 12-63 Fig. 12-44: Fluidics ... 12-64

CHAPTER 13 Fig. 13-1: AVL Microsampler ... 13-2 Fig. 13-2: Main arteries in the arm... 13-4 Fig. 13-3: Main arteries in the body ... 13-5 Fig. 13-4: Use of AVL Microsampler ... 13-6 Fig. 13-5: Puncture of the heel (newborn) ... 13-7 Fig. 13-6: Capillary puncture at the earlobe... 13 -7

X

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Method Sheet

Method Sheet Intended Use ...1 Clinical Significance ...1 pH ...1 P CO 2 ...1 P O 2 ...2 Principles of Procedure ...2 Reagents and Accessories ...5 Specimen Collection and Handling... ...9 Safety ...9 Sample Requirements ...9 Anticoagulants ...9 Sample Collection Devices ...9 Handling and Storage of Samples ... 11 Whole Blood ... 11 Plasma ... 11 Serum ... 12 Materials Needed ... 12 Reagents ... 12 Test Conditions ... 13 Sample Size ... 13 Sample Type ... 13 Sample Application ... 13 Ambient Temperature ... 13 Relative Humidity ... 13 Type of Measurement ... 13 Measured Values ... 13 Input Values... 14 Calculated Values... 14 Types of Calibration ... 15 Quality Control ... 15

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

I

Method Sheet

Specific Performance Characteristics ... 17 Limitations ... 17 Reproducibility ... 17 Precision and Linearity... 20 Precision and Recovery on Whole Blood ... 21 Correlation to Other Methods ... 23 Precision of Measurement in Whole Blood ... 23 Bibliography ... 26

II

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Method Sheet

Method Sheet Intended Use The AVL COMPACT 3 pH/Blood Gas Analyzer is intended to be used for the measurement of pH, P CO 2 and P O 2 in samples of whole blood.

Clinical Significance1 pH

The pH value of the blood, serum or plasma, may be the single most valuable factor in the evaluation of the acid-base status of a patient. The pH value is an indicator of the balance between the buffer (blood), renal (kidney) and respiratory (lung) systems, and one of the most tightly controlled parameters in the body. The causes of abnormal blood pH-values are generally classified as: a) primary bicarbonate deficit - metabolic acidosis b) primary bicarbonate excess - metabolic alkalosis c) primary hypoventilation - respiratory acidosis d) primary hyperventilation - respiratory alkalosis An increase in blood, serum or plasma pH (alkalemia) may be due to increased plasma bicarbonate, or a feature of respiratory alkalosis due to an increased elimination of CO 2 due to hyperventilation. A decreased pH value (acidemia) in blood, serum or plasma may occur due to an increased formation of organic acids, an increased excretion of H + -ions in certain renal disorders, an increased acid intake such as in salicylate poisoning or loss of alkaline body fluids. Respiratory acidosis is the result of a decreased alveolar ventilation and may be acute; as the result of pulmonary edema, airway obstruction or medication, or maybe be chronic; as the result of obstructive or restrictive respiratory diseases.

PCO 2

The P CO 2 value of arterial blood is used to assess how well the body eliminates carbon dioxide in relation to the metabolic rate of CO 2 production. A P CO 2 below the normal range is termed respiratory alkalosis and indicates hypocapnia, a condition caused by increased alveolar ventilation such as hyperventilation. An arterial P CO 2 above the normal range is termed respiratory acidosis and indicates hypercapnia, a sign of hypoventilation and failure, resulting from cardiac arrest, chronic obstructive lung disease, drug overdose, or chronic metabolic acid-base disturbances.

1

Teitz, Norbert W., Ed., Clinical Guide to Laboratory Tests, 2nd Ed., (Philadelphia: W.B.Saunders, Co., 1990) p.436.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

1

Method Sheet

PO 2

The P O 2 value of arterial blood has become the primary tool for the evaluation of arterial oxygenation status. Values below the normal arterial P O 2 (arterial hypoxemia) are usually caused by pulmonary, circulatory, or respiratory abnormalities (e.g. bronchial obstruction, vascular problems, decreased cardiac output, increased oxygen demand, anatomical heart defect, low inspired O 2 content). Generally, P O 2 levels above 100 mmHg do not contribute significantly to the oxygen content since, with normal hemoglobin concentrations, 80 - 100 mmHg P O 2 provides a 97% saturation level, and a level greater than 100% cannot be achieved.

Principles of Procedure There are 4 electrodes used in the AVL COMPACT 3 pH/Blood Gas Analyzer; a pH Electrode, a pH reference electrode, a P CO 2 Electrode and a P O 2 Electrode.

pH Measurement

pH of a solution is defined by the negative logarithm of the activity of Hydrogen ions, and described by the equation: pH = -log [ H + ] A single measurement of the electric potential of a solution, under proper conditions, can be directly related to the concentration of Hydrogen ions. In pH measurement systems, a bulb of special glass is filled with a conductive buffer solution of known pH in contact with the measuring instrument through a conductive, metallic electrode. When this special electrode is immersed in an aqueous solution, water molecules diffuse into the structure of the glass and form a hydrated layer. A potential difference develops between the solution inside the glass electrode and the solution being measured for [H + ]. The magnitude of this difference depends solely on the concentration of Hydrogen ions in the solution. This difference is measured by combining the glass electrode with standard, calomel, reference electrode and measuring the voltage of the system. Calibration of the system is accomplished by using buffer solutions with known pH values traceable to buffers with values assigned by the National Institute of Standard Technology. The pH of the unknown solution is compared to known buffer solution by electric potential measurement by the instrument using specially designed electrodes arranged as a special type of concentration cell which is described by a modification of the Nernst equation:

E = E0 + where:

RT lna H + (mv) nF

E0

=

standard potential in mV

R

=

gas constant (8.3143 joule × K -1 × mol -1 )

T

=

temperature degrees Kelvin (310.15 °K = 37 °C)

n

=

number of electrons in electrochemical reaction

F

=

value of the Faraday constant (96487 coulomb × mol -1 )

aH+ =

2

Hydrogen ion activity

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Method Sheet

pH Electrode

pH Reference Electrode

PCO 2

The pH Electrode consists of a single glass tube with a special pH-sensitive glass membrane at its tip. Hydrogen ions in a sample at the time diffuse into the hydrated glass layer and generate an electric potential. This potential is conducted through a gelled buffer solution of constant pH to the instrument through an AgCl coated silver pin immersed in the buffer and connected to the instrument with a cable and plug. The electrical circuit is completed through the sample path to the pH Reference Electrode and a second instrument input. The potential difference (measuring voltage) is amplified for easier processing. With the help of a calibration curve determined by calibration points near 7.38 and 6.84, and by using the measured voltage of the sample, the ion concentration of the sample is determined and converted to pH for display.

The pH Reference Electrode consists of a glass tube filled with calomel paste (mercurous chloride) in contact with mercury surrounding a platinum wire. This mixture is kept moist with a cotton plug at the end of the glass tube immersed in a solution of potassium chloride (KCl) and contained in a disposable housing. The mixture of metals in the electrode generates a constant voltage. A porous membrane at the tip of the housing provides a liquid junction with the sample and the KCl solution serves as a salt bridge, establishing contact between the instrument, calomel element and pH Electrode through the sample in contact with the KCl at the housing tip.

The P CO 2 Electrode consists of a pH-glass electrode and an Ag/AgCl reference electrode that forms the outer part that is surrounded by a common electrolyte solution. They are separated from the sample or calibration gas by a CO2 permeable but not ion-permeable membrane. Carbon dioxide diffuses in both directions through the membrane until an equilibrium is established between the CO 2 partial pressure of the sample and the CO 2 partial pressure of the very thin electrolyte layer between the membrane and the glass electrode. At this time, the pH-value of the electrolyte solution has been changed by a chemical reaction, which occurs as carbon dioxide gas dissolves in the electrolyte and produces hydrogen ions.

CO 2 + H 2 O ⇔ H 2 CO 3 ⇔ H + + HCO 3 − This pH change is measured and amplified and is indicated as the P CO 2 value. Methodology is a modification of the galvanometric pH measurement.

PO 2

The P O 2 Electrode consists of a glass electrode body containing the cathode (4 platinum wires) and a silver anode, an electrode housing containing an O 2 permeable membrane and inner electrolyte that enables the chemical reaction and transports the charges. The O 2 diffuses through the membrane, depending on the O 2 partial pressure of the sample, and continuously replaces the O 2

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

3

Method Sheet

molecules of the electrolyte layer consumed during the cathode reaction. A very small constant current, representing the oxygen partial pressure P O 2 of the samples passes through the electrode. Methodology is polarographic. At the cathode, oxygen diffused through the membrane is reduced through a series of reactions producing current between the cathode and anode proportionate to the oxygen tension:

O 2 + 2H 2 O + 4e − → 4OH − 4NaCl + 4OH − → 4NaOH + 4Cl −

Cathode Reaction Electrolyte Reaction

4Ag → 4Ag + + 4e − → 4Cl − + 4Ag + → 4AgCl + 4e −

Anode Reaction

The electrons in the initial reaction are supplied by a constant voltage of -0.7 V. In this series of equations, it is apparent that for the reduction of each oxygen molecule, 4 electrons are consumed.

4

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998