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

Operators Manual

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Operator’s Manual

AVL COMPACT 3 pH / Bloodgas Analyzer

CH3581 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

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

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

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

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

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

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

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

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

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.

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

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

standard potential in mV

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

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

number of electrons in electrochemical reaction

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

aH+ =

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

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.

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

Method Sheet

Reagents and Accessories Buffer Type 1 (pH=7.383)

Buffer Type 2 (pH=6.841)

pH Reference Solution

Order number:

BP0136

Use:

For calibration of pH in AVL pH/Blood Gas instruments

Contents:

1 package contains 3 ready to use containers with 90 mL each

Composition:

Potassium dihydrogen phosphate, 13.619 mmol/L Disodium hydrogen phosphate, 53.14 mmol/L Lithium carbonate, 0.25 mmol/L

Additives:

Germicides

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label

Order number:

BP0137

Use:

For calibration of pH in AVL pH/Blood Gas instruments

Contents:

1 package contains 3 ready to use containers with 90 mL each

Composition:

Potassium dihydrogen phosphate, 25.0 mmol/L Disodium hydrogen phosphate, 25.0 mmol/L

Additives:

Germicides

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label

Order number:

BP0134

Use:

For calibration of pH in AVL pH/Blood Gas instruments

Contents:

1 package contains 3 ready to use containers with 90 mL each

Composition:

Potassium chloride, 600 mmol/L

Additives:

Germicides

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label

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

Method Sheet

Rinse

Cleaning Solution

Deproteinizer

Order number:

BP1890

Use:

For calibration of pH in AVL pH/Blood Gas instruments

Contents:

1 package contains 6 ready to use containers with 430 mL each

Composition:

Dehydran 241,0.065 g/L Dehydol 100, 0.0065 g/L

Additives:

Germicides

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each package

Order number:

BP1889

Use:

For the daily cleaning of the AVL COMPACT 3 measuring system

Contents:

1 package contains 3 ready to use containers with 90 mL each

Composition:

Sodium bicarbonate, 4.1 g/L Sodium chloride, 2.5 g/L Antarox BL344, 1.0 g/L 2-phenylethanol, 0.1 g/L Hyamine 1622, 0.05 g/L

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each package

Order number:

BP0521

Use:

For periodic cleaning of the measuring system after lipemic samples or as required for decontamination.

Contents:

Each dispensing bottle contains 100 mL of solution.

Composition:

Sodium hypochlorite, 16.0 g/L

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label.

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

Method Sheet

PCO 2 Filling Solution

PO 2 Filling Solution

Calibration Gas 1

Order number:

BP1286

Use:

Electrolyte solution used in remembranable P CO 2 Electrodes.

Contents:

Each dispensing bottle contains 100 mL of solution.

Composition:

Potassium chloride, 25.0 mmol/L Sodium bicarbonate, 10.0 mmol/L

Additives:

Germicides

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label.

Order number:

BP1414

Use:

Electrolyte solution used in remembranable P O 2 Electrodes.

Contents:

Each dispensing bottle contains 100 mL of solution.

Composition:

Ethylene glycol: 1000 g/L Regent grade water: 100 g/L Disodium hydrogen phosphate: 5.34 g/L Potassium dihydrogen phosphate: 2.45 g/L Sodium chloride: 0.58 g/L

Additives:

Germicides

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label.

Order number:

HL0020

Use:

For the calibration of P O 2 and P CO 2 in the AVL COMPACT 3 pH/Blood Gas Analyzer

Contents:

Each disposable cylinder contains 3.15 L at 2200 PSI at 70 °F (150 bar at 21°C)

Composition:

Oxygen: 20.0% ± 0.03% Carbon Dioxide: 5.5% ± 0.03% Nitrogen: balance

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label

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

Method Sheet

Calibration Gas 2

Capillary Tubes

Order number:

HL0021

Use:

For the calibration of P O 2 and P CO 2 in the AVL COMPACT 3 pH/Blood Gas Analyzer

Contents:

Each disposable cylinder contains 3.15 L at 2200 PSI at 70 °F (150 bar at 21°C)

Composition:

Carbon Dioxide: 10.0% ± 0.03 % Nitrogen: balance

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are printed on each container label

Order number:

MG0002

Use:

For collection and transport of capillary blood specimens for pH/Blood Gas and Electrolyte analysis. Not to be used for collection of samples for analysis of Lithium

Contents:

Each package contains 250 capillary tubes

Composition:

Each tube is coated to contain 6 I.U. Sodium heparin and 9 I.U. Lithium heparin per 100 µL tube volume. Each tube has a minimum volume of 115µL

Storage:

Temperature: 5 - 30 °C (41 - 86 °F)

Stability:

Expiration date and lot number are labeled on the bottom of each container

Precautions: Use of calibration solutions or electrodes not manufactured for AVL could void the warranty. A waste container is provided. Once used, the waste container holds human body fluids which may be potentially infectious; handle with appropriate care to avoid skin contact or ingestion. For in-vitro diagnostic use.

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

Method Sheet

Specimen Collection and Handling Safety

Sample Requirements

Anticoagulants

Universal precautions must be observed when collecting blood specimens. It is recommended that all blood specimens be handled as if capable of transmitting human immunodeficiency virus (HIV), hepatitis B virus (HBV), or other bloodborne pathogens. Proper blood collection techniques must be followed in order to minimize risk to the laboratory staff, and gloves should be worn. 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.

Refer to NCCLS document H11-A2, Percutaneous Collection of Arterial Blood for Laboratory Analysis - Second Edition; Approved Standard, May 1992, for detailed information of sample collection, storage and handling. Blood sampling for analysis must be performed under proper medical supervision with details of collection, including sampling devices, site selection, sample handling, documentation and specific procedures used approved by the personnel responsible.

Lithium heparin, Sodium heparin or balanced heparin salts (as often used for samples taken also for electrolyte analysis) are the only acceptable anticoagulants for blood gas analysis. Other anticoagulants such as EDTA, citrate, oxylate and fluoride have a significant effect on blood pH and should not be used. Lithium heparin should not be used for samples taken also for analysis of Lithium.

Sample Collection Devices Syringes

If liquid heparin is used as an anticoagulant, collection devices should be no larger than the amount of blood required minimizing the effects of dilution of the blood by the anticoagulant solution. Although plastic syringes are commonly used for collection of blood specimens for blood gas analysis, there have been reports in the literature regarding the use of plastic syringes when P O 2 values higher than normal are expected. Particular attention should be paid to cooling blood samples in ice water, because of the CO 2 and oxygen solubility in some plastics. If blood specimens are expected to have very high P O 2 values, care should be taken to analyze the specimen as quickly as possible following collection to avoid the need for cooling.

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

Method Sheet

Capillary Tubes

Capillary blood specimens should be collected using AVL capillary tubes, which have a minimum volume, filled, of 115 µL and are ideally suited for use with the AVL COMPACT 3. The AVL capillary tubes for pH and blood gas analysis should not be used for samples taken for the analysis of Lithium. Samples may be collected in capillary tubes after warming the area or otherwise stimulating it to promote arterial circulation before the puncture. The puncture should be made deeply enough to ensure a free and rapid flow of blood. Do not use clay-capped capillary tubes as the rough, broken edge left when the capillary is cut may cause damage to the AVL COMPACT 3 fill port. Use only capillary tubes with fire-polished ends to prevent damage to the instrument. If a mixing flea is used, as required in some capillary tubes, take care to remove the flea prior to sample introduction to avoid damage to the AVL COMPACT 3. Specimens collected in capillary tubes are stable at room temperature for up to 30 minutes after collection because of the rapid cooling of the sample accomplished during filling.

AVL Microsampler

Blood may be collected for analysis on the AVL COMPACT 3 with the AVL Microsampler to provide two filled capillary tubes which may be used for analysis on separate instruments for split-sampling, for CO-Oximetry measurement or for the analysis of electrolytes other than Lithium. After collection, the AVL Microsampler should be capped and transported in a horizontal position to the instrument for analysis within 30 minutes, as with all specimens collected in capillary tubes.

Vacuum Tubes

Venous specimens collected in vacuum tubes containing Lithium or Sodium heparin may be used. Ensure that the tube is completely filled and that the sample is thoroughly mixed immediately after collection by gentle inversion. Blood gas values reported from venous specimens should be clearly identified as such to allow for correct interpretation. Each laboratory should determine the acceptability of its own blood collection syringes and capillaries. Variations in these products exist between manufacturers, and at times, from lot to lot.

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

Method Sheet

Handling and Storage of Samples Please refer to NCCLS Document C27-A, Blood Gas Pre-Analytical Considerations: Specimen Collection, Calibration and Controls; Approved Guideline, April 1993 for a detailed discussion of guidelines for the collection of acceptable specimens, instrument calibration, and quality control in pH and blood gas analysis; including details of many potential sources of error which may cause inaccurate results.

Whole Blood

Arterial Specimens Whole blood samples should be collected in a heparinized syringe, AVL Microsampler or capillary and analyzed as soon as possible after collection. Immediately after collection, check the syringe or other device for air bubbles and carefully expel any trapped bubbles, following the manufacturer’s recommended procedure. Extreme caution should be used to avoid needle stick injury. Mix the specimen collected in a syringe thoroughly with anticoagulant by gentle inversion or by rolling the syringe between both hands. Properly identify the specimen, following usual procedures for such documentation. Place the syringe containing the specimen in an ice slurry. Blood gases and pH will change if the specimen remains at room temperature in a syringe for more than 5 minutes due to cellular metabolism. P O 2 changes due to oxygen consumption may be influenced by several factors, including white blood cell count, reticulocyte count, storage temperature and initial P O 2 value. At a storage temperature of 1 to 5 °C, the results obtained are valid up to 2 hours. Samples expected to have high white blood cell count, reticulocyte count, or high P O 2 values initially should be analyzed as soon as possible after collection. Errors in blood gas analysis on properly collected samples may result from improper mixing of the sample after collection and before measurement; contamination with room air resulting from failure to expel trapped bubbles after collection; and from metabolic changes in the sample. Venous Specimens Whole blood samples should be collected in a heparinized syringe, vacuum tube 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 storage for more than 5 minutes or up to 1 hour is required, the sample should be stored, cooled in an ice slurry (1 to 4 ºC) prior to analysis.

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 32 °C / 50 to 90 °F) prior to analysis. Plasma samples more than one hour old must be centrifuged again to remove additional fibrin clots.

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

Method Sheet

Serum

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 (39 to 46 °F), and allowed to return to room temperature, 15 to 32 °C (59 to 90 °F), 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.

Materials Needed

Reagents

Description

Part Number

pH Buffer Type 1

BP0136

pH Buffer Type 2

BP0137

pH Reference Solution

BP0134

Rinse

BP1890

Cleaning Solution

BP1887

Deproteinizer

BP0521

Calibration Gas 1

HL0020

Calibration Gas 2

HL0021

Printer Paper

HP0070

The AVL COMPACT 3 pH/Blood Gas Analyzer automatically processes the sample through the necessary steps, then prints and displays the results. For details of this operation, please refer to the Operator’s Manual.

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

Method Sheet

Test Conditions Sample Size

50 µ L, capillary 100 µ L, syringe 25 µ L, microsample mode

Sample Type

whole blood

Sample Application

syringe, capillary or AVL Microsampler

Ambient Temperature

15 - 32º C (59 - 89.6º F)

Relative Humidity

20% to 90% (non-condensing)

Type of Measurement

Measured Values

pH, P CO 2 PO2

galvenometric polarographic

Parameter

Range

Display Resolution

6.0 to 8.0 pH units

0.001 pH units

P CO 2

0 to 200 mmHg

0.1 mmHg

0.5 - 26.7 kPa

0.01 kPa

-10 to 742 mmHg

0.1 mmHg

-1.33 to 98.7 kPa

0.01 kPa

300 to 800 mmHg

0.1 mmHg

0.0 to 106.0 kPa

0.01 kPa

PO2

Barometric Pressure

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

Method Sheet

Input Values

Parameter

Range

Display Resolution

Patient temperature, T

14.0 to 44.0 °C

0.1 °C

57.1 to 111.2 °F

0.1 °F

1 to 26 g/dL

0.1 g/dL

10 to 260 g/L

1.0 g/L

0.7 to 16.1 mmol/L

0.01 mmol/L

Total Hemoglobin, tHb

Hemoglobin type

adult or fetal

P 50 adult

15 to 40 mmHg

0.1 mmHg

2.0 to 5.33 kPa

0.01 kPa

10 to 40 mmHg

0.1 mmHg

1.34 to 5.33 kPa

0.01 kPa

Respiratory Quotient, RQ

0.71 to 1.99

0.01

Fraction of Inspired Oxygen F IO 2

0.11 to 0.99

0.01

Patient number

0 to 9999999999

Patient age

0 to 99 years

Patient sex

male or female

P 50 fetal

Calculated Values

Parameter -

1 year

Range

Display Resolution

1 to 100 mmol/L

0.1 mmol/L

Actual Bicarbonate

HCO 3

Base Excess,

-40 to +40 mmol/L

0.1 mmol/L

Base Excess ecf,

BE ecf

-40 to +40 mmol/L

0.1 mmol/L

Base Excess at actual oxygen saturation BE act

-40 to +40 mmol/L

0.1 mmol/L

Total CO 2 ,

ctCO 2

1 to 100 mmol/L

0.1 mmol/L

Standard Bicarbonate, -

HCO 3 st

1 to 100 mmol/L

0.1 mmol/L

Standard pH,

pH st

6.5 to 8.0

0.001 pH units

Hydrogen ion concentration

10 to 1000 nmol/L

0.1 nmol/L

Functional Oxygen saturation,

SO2

0 to 100 %

0.1%

Oxygen content,

ctO 2

0 to 56 mL/dL

0.1 mL/dL

Alveolar arterial oxygen partial pressure difference,

AaDO 2

0 to 742 mmHg

0.1 mmHg

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

Method Sheet

Parameter Standardized ionized Calcium niCa (at Datalink with pH=7.4 AVL 988-3)

Range

Display Resolution

0.1 ... 6.0 mmol/L

0.1mmol/L

P O 2 at patient temperature

PO2t

0 ... 742 mmHg

0.1 mmol/L

P CO 2 at patient temperature

P CO 2 t

0 ... 200 mmHg

0.1 mmol/L

pH at patient temperature

pH t

6 ... 8

0.1 mmol/L

Shunt

& Qs & Qt

0 to 100 %

0.1%

Types of Calibration

The AVL COMPACT 3 automatically performs a one-point gas calibration with each sample measurement. In addition, the AVL COMPACT 3 automatically performs a one-point pH calibration based upon user programmed intervals; either fixed at every half hour or one hour intervals or flexible at 1, 2, or 3 hour intervals based on the drift of the pH Electrode. The programmed interval may vary from site to site depending on usage and regulatory requirements. A two-point main calibration can be programmed to occur automatically at intervals from 2 to 12 hours in normal operation if no analysis is in progress. Automatic calibration also occurs shortly after power-on or reset. A calibration cycle can also be manually initiated any time a sample measurement is not being performed.

Quality Control

At least once daily or according to local regulations, run solutions at three levels (low, normal, high) of a quality control solution with known pH, P CO 2 and P O 2 values. For further details, review the Quality Control Section of the Operator’s Manual. The result 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.

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

Method Sheet

Reference Interval

Laboratory normal ranges for arterial carbon dioxide tension, P aCO 2 and pH are well documented and widely accepted: Parameter

Mean

± 2 SD

7.40

7.35 - 7.45

P aCO 2 (mmHg)

35 - 45

Arterial oxygen tension, P aO 2 is dependent upon the inspired oxygen tension, as well as various physiologic variables, and the administration of oxygen is common in the treatment of patients in need of blood gas analysis. Hypoxemia is defined as an arterial P O 2 below an acceptable range while breathing room air, with about 21% oxygen, at sea level. Increasing altitudes above sea level will produce lower inspired oxygen tensions and therefore, lower arterial P O 2 values. Below are listed acceptable arterial oxygen tensions at sea level, while breathing room air: P aO 2 Adult and Child Normal Acceptable range Hypoxemia

97 mmHg > 80 mmHg < 80 mmHg

Newborn Acceptable range

40 - 70 mm Hg

Aged Acceptable range

60 years old 70 years old 80 years old 90 years old

> 80 mmHg > 70 mmHg > 60 mmHg > 50 mmHg

Each laboratory should establish its own reference interval for pH, P CO 2 and P O 2 as performed on the AVL COMPACT 3 Analyzer and at their laboratory altitude.

Shapiro BA, Harrison RA, Cane RD, Kozlowski-Templin R: Clinical Application of Blood Gases, 4th ed., (Chicago: Year Bood Medical Publishers, Inc.,1991) pp 79-83.

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

Method Sheet

Specific Performance Characteristics All performance data in this section was generated on AVL COMPACT pH/Blood Gas systems with default calibration frequencies: continuous 1 point gas calibration, 1 point pH calibration at 1, 2 or 3 hour intervals determined automatically by the instrument based on calibration drift, and complete 2 point calibration every 12 hours, and without any correlation factors. The operating environment during the collection of this data was typical, varying from 22 to 26 °C (70 to 80 °F).

Limitations

The performance characteristics are affected by the following sample considerations: The preferred test liquid is whole, human blood for all parameters. It is necessary to tonometer blood to obtain values to evaluate accuracy of P O 2 and P CO 2 because patient samples must be considered to be unknown. Tonometry of blood introduces potential errors unrelated to the blood gas system being evaluated, including: accuracy of the gas values used, temperature control and thermostatting of the tonometer, humidification of the tonometry gases, duration of tonometry and transfer of the sample from the tonometer to the instrument for analysis. pH of blood cannot be predicted in tonometry. All tonometered samples analyzed in these studies were analyzed in duplicate on an AVL 995 to establish correlation. Precision of P O 2 and P CO 2 measurement, as well as pH was evaluated over a 20 day period using 2 AVL COMPACT pH/Blood Gas Analyzers with 2 replicates per run and 2 runs per day using a commercially available solution of reduced bovine hemoglobin which has been demonstrated to be comparable to tonometered whole blood. 3 Precision and accuracy of pH was evaluated using commercially available precision pH buffer solutions with values traceable to N.I.S.T. and precision of pH, P CO 2 and P O 2 was evaluated using aqueous control materials.

Reproducibility

Typical Within-Run (S wr ) and Total (S T ) imprecision data was collected from 2 runs per day with 2 replicates per run on three AVL COMPACT pH/Blood Gas Analyzers over twenty days following the protocol of NCCLS document number EP5-T2.

Material: AVL CONFITEST III Aqueous pH/Blood Gas Control, Level 1 Parameter

Mean

S wr

pH P CO 2 PO2

240 240 240

7.207 18.8 148.7

0.0020 0.20 0.92

0.0043 0.27 1.72

Mahoney JJ, Wong RJ, Van Kessel AL: Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas Quality-Control Material. Clin.Chem.39/5, 874-879 (1993).

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

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