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

Page 2

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

Page 3

- 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! -

Page 4

- 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 -

Page 5

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

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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

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

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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

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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

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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

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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

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

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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

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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

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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

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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

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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

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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

Page 17

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

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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

Page 19

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

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Page 20

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

Page 21

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

5

Page 22

Method Sheet

Rinse

Cleaning Solution

Deproteinizer

6

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

Page 23

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

7

Page 24

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.

8

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

Page 25

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

9