Roche AVL Compact 3 User manual

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 I NSTRUM ENT S 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:

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 w arnings 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:

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.

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

Symbol for instrument type B:

- 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

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

Contents

Test Conditions...............................................................................................................................13

Calculated Values ........................................................................................................................... 14

Specific Performance Characteristics ............................................................................................. 17

Bibliography .................................................................................................................. ................. 26

1 INTRODUCTION

Analyzer Description .....................................................................................................................1-1

Intended Use ..................................................................................................................................1-1

Clinical Significance ......................................................................................................................1-2

Handling the Analyzer...................................................................................................................1-3

Handling Blood and Blood Products..............................................................................................1-3

Handling AVL Reagents.................................................................................................................1-4

Decontamination............................................................................................................... .............1-5

Handling the Electrodes .................................................................................................................1-8

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

Contents

2 DESCRIPTION OF THE ANALYZER

Main Features................................................................................................................................2-1

Analyzer Components ....................................................................................................................2-2

Description of the Sample Path...................................................................................................... 2-6

Operator Interface.......................................................................................................................2-12

3 INSTALLATION, SHUTDOWN

Installation .................................................................................................................................... 3-1

Shutdown ...................................................................................................................... ...............3-11

4 PATIENT TESTING

Sample Preparation....................................................................................................................... 4-1

Sample Measurement.....................................................................................................................4-2

Password Option..........................................................................................................................4-10

Parameter and Data Input...........................................................................................................4-12

Printout ....................................................................................................................................... 4-19

5 QUALITY CONTROL

QC Measurement ................................................................................................................ ........... 5-1

QC Edit Function........................................................................................................................... 5-3

QC Statistics ................................................................................................................. ................. 5-7

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

6 CALIBRATION

Automatic Calibrations........................................................................................................ ..........6-1

Conditioning ..................................................................................................................................6-2

Operator-Initiated Calibrations.....................................................................................................6-2

7 DATA MANAGER

8 SYSTEM FUNCTIONS

Manual Standby .............................................................................................................................8-3

Contents

Automatic Standby.........................................................................................................................8-4

Timings..........................................................................................................................................8-5

Parameter ..................................................................................................................... .................8-9

Language...................................................................................................................................... 8-13

Interface ...................................................................................................................................... 8-14

Password ...................................................................................................................... ................ 8-19

Device Lock.................................................................................................................................. 8-21

Report.......................................................................................................................................... 8-22

Display....................................................................................................................... .................. 8-27

Mini Sample ................................................................................................................... .............. 8-28

9 MAINTENANCE

Introduction ...................................................................................................................................9-1

Decontamination............................................................................................................... .............9-1

Daily Maintenance .........................................................................................................................9-5

Weekly Maintenance......................................................................................................................9-8

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

Contents

Every 6 Month................................................................................................................. .............. 9-9

Yearly Maintenance .....................................................................................................................9-10

As needed.....................................................................................................................................9-11

10 TROUBLESHOOTING

Displayed and Printed Warning................................................................................................... 10-1

Displayed and Printed Alarms .....................................................................................................10-1

Error Messages and Instructions for Elimination........................................................................ 10-3

Printed Warnings and Error Messages ........................................................................................10-8

Insufficient Wash and Dry Cycle.................................................................................................10-8

Clogged Sample Path................................................................................................................... 10-9

Test Programs............................................................................................................................10-13

11 INTERFACE

General Description .....................................................................................................................11-1

Hardware...................................................................................................................... ...............11-1

Baud Rate....................................................................................................................................11-2

Transmission Format........................................................................................................... ........11-2

Transmission Report....................................................................................................................11-3

Reports ........................................................................................................................................11-3

Connection Cable AVL COMPACT 3 - PC (Terminal / Printer) .................................................11-5

Barcode Scanner ..........................................................................................................................11-6

Datalink ...................................................................................................................... .................11-8

Telelink...................................................................................................................................... 11-23

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

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

Contents

13 PREANALYTICAL REQUIREMENTS FOR BLOOD GAS

ANALYSIS

Introduction ................................................................................................................................. 13-1

Sample Types...............................................................................................................................13-1

Sampling Procedures....................................................................................................................13-2

Treatment of Sample before Analysis........................................................................................... 13-9

Summary....................................................................................................................... ............. 13-10

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

Contents

Figures

CHAPTER 2

Fig. 2-1: Display ............................................................................................................................. 2-2

Fig. 2-2: Thermal printer................................................................................................................ 2-2

Fig. 2-3: View with open top cover ............................................................................................. .... 2-3

Fig. 2-4: Reagents............................................................................................................. .............. 2-3

Fig. 2-5: Sample fill module............................................................................................................2-5

Fig. 2-6: Measuring chamber module .............................................................................................2-7

Fig. 2-7: Measuring capillary ......................................................................................................... 2-7

Fig. 2-8: Electrodes.........................................................................................................................2-8

Fig. 2-9: Peristaltic pump............................................................................................................... 2-8

Fig. 2-10: Rear panel......................................................................................................................2-9

Fig. 2-11: Warning and identification plates ..................................................................................2-9

Fig. 2-12: Interface........................................................................................................... ............2-10

Fig. 2-13: Gas connections............................................................................................................2-10

Fig. 2-14: Power switch module................................................................................................. ...2-11

CHAPTER 3

Fig. 3-1: Solenoid valve relief clamps - fill module.........................................................................3-2

Fig. 3-2: Solenoid valve relief clamps - peristaltic pump ................................................................3-3

Fig. 3-3: Solenoid valve relief clamps - bottle compartment........................................................... 3-3

Fig. 3-4: Peristaltic pump tubes......................................................................................................3-3

Fig. 3-5: Gas connection ....................................................................................................... .......... 3-5

Fig. 3-6: Position of calibration gas cylinder..................................................................................3-5

Fig. 3-7: Removal of transport housing..........................................................................................3-6

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

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

Contents

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

Fig. 9-14: Electrode Check (2) - PCO

/ PO2 Electrode..................................................................9-16

/ PO2 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............................................................................................1 1-1

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

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

Contents

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

Fig. 12-14: PCO

Fig. 12-15: PCO

Fig. 12-16: PCO

Fig. 12-17: PCO

Fig. 12-18: PCO

Fig. 12-19: PCO

Fig. 12-20: PCO

Fig. 12-21: PO

Fig. 12-22: PO

Fig. 12-23: PO

Electrode.........................................................................................................12-34

Electrode: remove Inner element ....................................................................12-35

Electrode: Inner element.................................................................................12-35

Electrode.: cleaning shaft................................................................................12-35

Electrode: inner shaft ..................................................................................... 12-36

Electrode: cleaning procedure (1)................................................................... 12-36

Electrode: cleaning procedure (2)................................................................... 12-37

Electrode: cleaning procedure (3)................................................................... 12-37

Electrode............................................................................................................ 12-38

Electrode: cleaning procedure (1)......................................................................12-39

Electrode: cleaning procedure (2)......................................................................12-39

Fig. 12-24: PO

Electrode: cleaning procedure (3)......................................................................12-39

Fig. 12-25: Electrode housing with protective cap......................................................................12-41

Fig. 12-26: Filling electrode housing with electrolyte ................................................................. 12-41

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

Contents

Fig. 12-27: Remove air bubbles ..................................................................................................12-42

Fig. 12-28: Insert inner part....................................................................................................... 12-42

Fig. 12-29: Insert inner part....................................................................................................... 12-42

Fig. 12-30: Close overflow hole of the electrode housing............................................................12-43

Fig. 12-31: Silicon grease of the tip of the electrodes..................................................................12-43

Fig. 12-32: Operating principles - pH Electrode......................................................................... 12-44

Fig. 12-33: pH Electrode....................................................................................................... ...... 12-45

Fig. 12-34: pH Reference Electrode............................................................................................ 1 2-45

Fig. 12-35: Operating principles - PCO

Fig. 12-36: PCO

Electrode......................................................................................................... 12-46

Fig. 12-37: Operating principles - PO

Fig. 12-38: PO

Fig. 12-39: Linearity of pH, PCO

Electrode ........................................................................................................... 12-47

Electrode..................................................................... 12-46

Electrode ....................................................................... 12-47

and PO2 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.......................................................................................... 1 2-60

Fig. 12-43: User programs - AVL COMPACT 3......................................................................... 12-63

Fig. 12-44: Fluidics........................................................................................................... .......... 12-64

CHAPTER 13

Fig. 13-1: AVL Microsampler .......................................................................................................13-2

Fig. 13-2: Main arteries in the arm...............................................................................................13-4

Fig. 13-3: Main arteries in the body ............................................................................................. 13-5

Fig. 13-4: Use of AVL Microsampler............................................................................................13-6

Fig. 13-5: Puncture of the heel (newborn) ....................................................................................13-7

Fig. 13-6: Capillary puncture at the earlobe.................................................................................13 -7

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

Method Sheet

Intended Use ...................................................................................................................................... 1

Clinical Significance ..........................................................................................................................1

pH................................................................................................................................................... 1

CO2...............................................................................................................................................1

O2.................................................................................................................................................2

Principles of Procedure...................................................................................................................... 2

Reagents and Accessories....................................................................................................... ............5

Specimen Collection and Handling............................................................................................... ......9

Safety..............................................................................................................................................9

Sample Requirements .......................................................................................................................9

Anticoagulants.................................................................................................................................9

Sample Collection Devices ............................................................................................................... 9

Handling and Storage of Samples ................................................................................................ .... 11

Whole Blood .................................................................................................................... .............. 11

Plasma...........................................................................................................................................11

Serum.......................................................................................................................... .................. 12

Materials Needed .............................................................................................................................12

Reagents....................................................................................................................... ................. 12

Test Conditions................................................................................................................................13

Sample Size ...................................................................................................................................13

Sample Type.................................................................................................................................. 13

Sample Application........................................................................................................................ 13

Ambient Temperature.....................................................................................................................13

Relative Humidity.......................................................................................................................... 13

Type of Measurement............................................................................................................ ......... 13

Measured Values ................................................................................................................ ............ 13

Input Values................................................................................................................................... 14

Calculated Values........................................................................................................................... 14

Types of Calibration.......................................................................................................................15

Quality Control.............................................................................................................................. 15

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

Method Sheet

Specific Performance Characteristics .............................................................................................. 17

Limitations.................................................................................................................................... 17

Reproducibility ................................................................................................................ .............. 17

Precision and Linearity...................................................................................................................20

Precision and Recovery on Whole Blood......................................................................................... 2 1

Correlation to Other Methods ......................................................................................................... 23

Precision of Measurement in Whole Blood......................................................................................23

Bibliography.................................................................................................................................... 26

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

Method Sheet

Intended Use

Method Sheet

The AVL COMPACT 3 pH/Blood Gas Analyzer is intended to be used for the

measurement of pH,

CO2 and PO

in samples of whole blood.

Clinical Significance

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 par ameters 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) pr imary hypoventilation - respiratory acidosis d) pr imary 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

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 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.

due to hyperventilation.

-ions in certain

PCO

CO2 value of arterial blood is used to assess how well the body eliminates

The carbon dioxide in relation to the metabolic rate of CO

production. A PCO2 below

the normal range is termed respiratory alkalosis and indicates hypocapnia, a condition caused by increased alveolar ventilation such as hyperventilation. An

arterial

CO2 above the normal range is termed respiratory acidosis and indicates hypercapnia, a sign of hypoventilation and failure, resulting from cardiac arrest, chronic obstructive lung d isease, drug o verdose, or chronic metabolic a cid-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 1

Method Sheet

The PO2 value of arterial blood has become the primary tool for the evaluation of arterial oxygenation status. Values below the normal arterial hypoxemia) are usually caused by pulmonary, circulatory, or respiratory abnormalities (e.g. bronchial obstruction, vascular problems, decreased card iac output, increased oxygen demand, anatomical heart defect, low inspired O content). Generally, PO2 levels above 100 mmHg do not contribute significantly to the oxygen content since, with normal hemoglobin concentrations, 80 - 100 mmHg

O2 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

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 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 thro ugh 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 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 Tec hnology. The p H of the unknown solution is compar ed 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:

[H+]

O2 (arterial

CO2 Electrode and a PO2 Electrode.

]. The magnitude of this

lna (mv)

where: 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

= Hydrogen ion activity

-1

)

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

Method Sheet

pH Electrode

pH Reference Electrode

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 consta nt pH to the instrument through a n AgCl coated silver pin immersed in the buffer and connected to the instrument with a cable and plug. T he electrical c ircuit is completed thro ugh 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 chlorid e) in contact with mercury surro unding a platinum wire. T his 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 co nstant voltage. A p orous 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 Electro de through the sample in co ntact with the KCl at the housing tip.

PCO

CO2 Electrode consists of a pH-glass electrode and an Ag/AgCl reference

The 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 CO

permeable but not ion-permeable membrane. Carbon dioxide diffuses in both directions through the membrane until an e quilibrium is established b etween the

partial pressure of the sample and the CO2 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 HO HCO H HCO

+⇔ ⇔+

22 23 3

−

This pH change is measured and amplified and is indicated as the PCO2 value. Methodology is a modification of the galvanometric pH measurement.

The PO2 Electrode consists of a glass electrode body containing the cathode (4 platinum wires) and a silver anode, an electrode housing containing an O

permeable membrane and inner electrolyte that enables the chemical reaction and transports the charges. The O on the O

partial pressure of the sample, and continuously replaces the O

diffuses through the membrane, depend ing

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

Method Sheet

molecules of the electrolyte layer consumed during the cathode reaction. A

very small constant current, representing the oxygen partial pressure

O2 of the

samples passes through the ele ctrode. Methodology is polarographic. At the cathode, oxygen diffused through the

membrane is reduced through a series of reactions producing curr ent between the cathode and anode proportionate to the oxygen tension:

O 2H O 4e 4OH

++→

−−

Cathode Reaction

4NaCl 4OH 4NaOH 4Cl

+→ +

4Ag 4Ag 4e 4Cl 4Ag 4AgCl 4e→+→+→ +

−−

+− − + −

Electrolyte Reaction

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

Reagents and Accessories

Method Sheet

Buffer Type 1 (pH=7.383)

Buffer Type 2 (pH=6.841)

Order number: Use: For calibration of pH in AVL pH/Blood Gas instruments Contents: 1 package contains 3 ready to use containers with 90 mL

Composition: Potassium dihydrogen phosphate, 13.619 mmol/L

Additives: Germicides Storage:

Stability: Expiration date and lot number are printed on each container

Order number:

Use: For calibration of pH in AVL pH/Blood Gas instruments Contents: 1 package contains 3 ready to use containers with 90 mL

BP0136

each

Disodium hydrogen phosphate, 53.14 mmol/L Lithium carbonate, 0.25 mmol/L

Temperature: 5 - 30 °C (41 - 86 °F)

label

BP0137

each

pH Reference Solution

Composition: Potassium dihydrogen phosphate, 25.0 mmol/L

Disodium hydrogen phosphate, 25.0 mmol/L Additives: Germicides Storage:

Stability: Expiration date and lot number are printed on each container

Order number: Use: For calibration of pH in AVL pH/Blood Gas instruments Contents: 1 package contains 3 ready to use containers with 90 mL

Composition: Potassium chloride, 600 mmol/L Additives: Germicides Storage:

Stability: Expiration date and lot number are printed on each container

Temperature: 5 - 30 °C (41 - 86 °F)

label

BP0134

each

Temperature: 5 - 30 °C (41 - 86 °F)

label

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 5

Method Sheet

Rinse

Cleaning Solution

Order number: Use: For calibration of pH in AVL pH/Blood Gas instruments Contents: 1 package contains 6 ready to use containers with 430 mL

Composition: Dehydran 241,0.065 g/L

Additives: Germicides Storage:

Stability: Expiration date and lot number are printed on each package

Order number: Use: For the daily cleaning of the AVL COMPACT 3 measuring

Contents: 1 package contains 3 ready to use containers with 90 mL each Composition: Sodium bicarbonate, 4.1 g/L

BP1890

each

Dehydol 100, 0.0065 g/L

Temperature: 5 - 30 °C (41 - 86 °F)

BP1889

system

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

Deproteinizer

Storage: Stability: Expiration date and lot number are printed on each package

Order number: Use: For periodic cleaning of the measuring system after lipemic

Contents: Each dispensing bottle contains 100 mL of solution. Composition: Sodium hypochlorite, 16.0 g/L Storage:

Stability: Expiration date and lot number are printed on each container

Temperature: 5 - 30 °C (41 - 86 °F)

BP0521

samples or as required for decontamination.

Temperature: 5 - 30 °C (41 - 86 °F)

label.

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

Method Sheet

PCO2 Filling Solution

PO2 Filling Solution

Order number:

Use: Electrolyte solution used in remembranable

Contents: Each dispensing bottle contains 100 mL of solution. Composition: Potassium chloride, 2 5.0 mmol/L

Additives: Germicides Storage:

Stability: Expiration date and lot number are printed on each container

Order number: Use: Electrolyte solution used in remembranable Contents: Each dispensing bottle contains 100 mL of solution. Composition: Ethylene glycol: 1000 g/L

BP1286

Electrodes.

Sodium bicarbonate, 10.0 mmol/L

Temperature: 5 - 30 °C (41 - 86 °F)

label.

BP1414

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

O2 Electrodes.

Calibration Gas 1

Additives: Germicides Storage:

Stability: Expiration date and lot number are printed on each container

Order number: Use: For the calibration o f

Contents:

Composition:

Storage: Stability: Expiration date and lot number are printed on each container

Temperature: 5 - 30 °C (41 - 86 °F)

label.

HL0020

O2 and PCO2 in the AVL COMPACT 3

pH/Blood Gas Analyzer

Each disposable cylinder contains 3.15 L at 2200 PSI at 70 °F

(150 bar at 21°C)

Oxygen: 20.0% ± 0.03%

Carbon Dioxide: 5.5% ± 0.03%

Nitrogen: balance

Temperature: 5 - 30 °C (41 - 86 °F)

label

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 7

Method Sheet

Calibration Gas 2

Capillary Tubes

Order number: Use: For the calibration o f

Contents: Each disposable cylinder contains 3.15 L at 2200 PSI at

Composition:

Storage: Stability: Expiration date and lot number are printed on each container

Order number: Use: For collection and transport of capillary blood specimens for

Contents: Each package contains 250 capillary tubes Composition: Each tube is coated to contain 6 I.U. Sodium heparin and

HL0021

O2 and PCO2 in the AVL COMPACT

3 pH/Blood Gas Analyzer

70 °F (150 bar at 21°C) Carbon Dioxide: 10.0% ± 0.03 %

Nitrogen: balance Temperature: 5 - 30 °C (41 - 86 °F)

label

MG0002

pH/Blood Gas and Electrolyte analysis. Not to be used for collection of samples for analysis of Lithium

9 I.U. Lithium heparin per 100 µL tube volume. Each tube has

a mini mum vo lume of 1 15µL Storage: Stability: Expiration date and lo t number are labeled on the bottom of

Precautions: Use of calibration solutions or electrodes not manufactured for AVL

Temperature: 5 - 30 °C (41 - 86 °F)

each container

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

Specimen Collection and Handling

Method Sheet

Safety

Sample Requirements

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 ot her 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 infor mation 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.

Anticoagulants

Sample Collection Devices

Syringes

Lithium heparin, Sodium hepari n or balance d heparin sa lts (as often used fo r 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.

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 ar e commonly used for collection of blood specimens for blood gas analysis, there have been reports in the literature re garding the use of plastic syringes

when be paid to cooling blood samples in ice water, because of the CO solubility in some plastics. If blood specimens are expected to have very high

possible following collection to avoid the need for cooling.

O2 values higher than normal are expected. Particular attention should

and oxygen

O2 values, care should be taken to analyze the specimen as quickly as

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 9

Method Sheet

Capillary Tubes

AVL Microsampler

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 dee ply enough to ensure a fr ee and rap id flow of blood.

Do not use clay-capped c apillary tubes as the ro ugh, broken edge left when the capillary is cut may cause damage to the AVL COMPACT 3 fill por t. 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 COMPAC T 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.

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

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

Venous specimens collect ed in vacuum tubes conta ining 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.

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.

Method Sheet

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 thor oughly with anticoagulant by gentle inversion or by rolling the syringe between both hands. Prope rly 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. several factors, including white blood cell count, reticulocyte count, storage temperature and initial

results obtained a re valid up to 2 hours. Samples e xpected to ha ve high white blood cell count, reticulocyte count, or high 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

O2 changes due to oxygen consumption may be influence d by

O2 value. At a storage temperature of 1 to 5 °C, the

O2 values initially should be

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 b e stored, cooled in an ice slurry (1 to 4 ºC) prior to analysis.

Plasma

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 11

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.

Method Sheet

Serum

Materials Needed

Reagents

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.

Description Part Number pH Buffer Type 1

pH Buffer Type 2 pH Reference Solution Rinse Cleaning Solution Deproteinizer Calibration Gas 1 Calibration Gas 2 Printer Paper

BP0136 BP0137 BP0134 BP1890 BP1887 BP0521 HL0020 HL0021 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 Operato r’s Manual.

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

Test Conditions

Method Sheet

Sample Size

Sample Type

Sample Application

Ambient Temperature

Relative Humidity

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

whole blood

syringe, capillary or AVL Microsampler

15 - 32º C (59 - 89.6º F)

20% to 90% (non-condensing)

Type of Measurement

Measured Values

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 13

pH, PCO

Parameter Range Display Resolution

pH 6.0 to 8.0 pH units 0.001 pH units

Barometric Pressure 300 to 800 mmHg 0.1 mmHg

galvenometric polarographic

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

0.0 to 106.0 kPa 0.01 kPa

Method Sheet

Input Values

Parameter Range Display Resolution

Patient temperature, T

14.0 to 44.0 °C0.1

57.1 to 111.2 °F0.1

Total Hemoglobin, tHb 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

Hemoglobin type adult or fetal

50 adult 15 to 40 mmHg 0.1 mmHg

2.0 to 5.33 kPa 0.01 kPa

50 fetal 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

0.11 to 0.99 0.01

Patient number 0 to 9999999999 Patient age 0 to 99 years 1 year Patient sex male or female

Calculated Values

Parameter Range Display Resolution

Actual Bicarbonate HCO

1 to 100 mmol/L 0.1 mmol/L Base Excess, BE -40 to +40 mmol/L 0.1 mmol/L Base Excess ecf, B E

ecf

-40 to +40 mmol/L 0.1 mmol/L

Base Excess at actual oxygen saturation BE

act

Total CO2, ctCO Standard

Bicarbonate,

Standard pH, pH Hydrogen ion

HCO3

concentration Functional Oxygen

-40 to +40 mmol/L 0.1 mmol/L

1 to 100 mmol/L 0.1 mmol/L

6.5 to 8.0 0.001 pH units

10 to 1000 nmol/L 0.1 nmol/L

0 to 100 % 0.1% saturation,

Oxygen content, ctO

0 to 56 mL/dL 0.1 mL/dL Alveolar arterial

oxygen partial

AaDO

0 to 742 mmHg 0.1 mmHg

pressure difference,

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

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