Roche AVL Compact 3 User manual

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Operator’s Manual

AVL COMPACT 3

pH / Bloodgas Analyzer

CH3581 Rev. 2.0, June 1998

Manufactured by:

AVL LIST GmbH MEDIZINTECHNIK Hans-List-Platz 1

8020 Graz / Austria

Distributed by:

AVL MEDICAL 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

Method Sheet

Parameter Range Display Resolution

Standardized ionized Calcium (at Datalink with AVL 988-3)

O2 at patient

niCa

pH=7.4

0.1 .......6.0 mmol/L 0.1mmol/L

0 .......... 742 mmHg 0.1 mmol/L

temperature

CO2 at patient

0 .......... 200 mmHg 0.1 mmol/L

temperature pH at patient

6 .......... 8 0.1 mmol/L

temperature

Types of Calibration

Quality Control

Shunt

0 to 100 % 0.1%

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

At least once daily or according to local regulations, run solutions at three levels

(low, normal, high) of a quality control solution with known pH,

CO2 and PO

values. For further details, review the Quality Control Section of the Operator’s Manual. The result obtained should fall within limits defined by the day to day variability of the system as measured in the user’s laboratory. If the results fall outside the laboratory’s acceptable limits, refer to the Troubleshooting Section of the Operator’s Manual.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 15

Method Sheet

Reference Interval

Laboratory normal ranges for arterial carbon dioxide tension, PaCO2 and pH are well documented and widely accepted:

Parameter Mean pH

aCO2 (mmHg)

7.40 7.35 - 7.45 40 35 - 45

± 2 SD

Arterial oxygen tension, PaO2 is dependent upon the inspired oxygen tension, as well as various physiologic variables, and the administration of oxygen is common in the treatment of patients in need of blood gas analysis.

Hypoxemia is defined as an arterial

O2 below an acceptable range while breathing room air, with about 21% oxygen, at sea level. Increasing altitudes above sea level will produce lower inspired oxygen tensions and therefore, lower

arterial

O2 values.

Below are listed acceptable arterial oxygen tensions at sea level, while breathing room air:

Adult and Child

Normal 97 mmHg Acceptable range > 80 mmHg Hypoxemia < 80 mmHg

Shapiro BA, Harrison RA, Cane RD, Kozlowski-Templin R: Clinical Application of Blood Gases, 4th ed., (Chicago:

Year Bood Medical Publishers, Inc.,1991) pp 79-83.

Newborn

Acceptable range 40 - 70 mm Hg

Aged

Acceptable range 60 years old > 80 mmHg

70 years old > 70 mmHg 80 years old > 60 mmHg 90 years old > 50 mmHg

Each laboratory should establish its own reference interval for pH,

CO2 and PO

as performed on the AVL COMPACT 3 Analyzer and at their laboratory altitude.

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

Specific Performance Characteristics

All performance data in this section was generated on AVL COMPACT pH/Blood Gas systems with default calibration freque ncies: continuous 1 p oint gas calibration, 1 point pH calibra tion at 1, 2 or 3 ho ur intervals determined automatically by the instrument based on calibration drift, and complete 2 point calibration every 12 hours, and without any correlation factors. The op erating environment during the collection of this data was typical, varying from 22 to 26

C (70 to 80 °F).

Method Sheet

Limitations

Reproducibility

The performance characteristics are affected by the following sample considerations:

The preferred test liquid is whole, human blood for all parameters. It is necessary

to tonometer blood to obtain values to evaluate accuracy of

O2 and PCO

because patient samples must be considered to be unknown. Tonometry of blood introduces potential errors unrelated to the blood gas system being evaluated, including: accuracy of the gas values used, temperature control and thermostatting of the tonometer, humidification of the tonometry gases, duration of tonometry and transfer of the sample from the tonometer to the instrument for analysis.

pH of blood cannot be predicted in tonometry. All tonometered samples analyzed in these studies were analyzed in duplicate on an AVL 995 to establish correlation.

Precision of

O2 and PCO2 measurement, as well as pH was evaluated over a 20 day period using 2 AVL COMPACT pH/Blood Gas Analyzers with 2 replicates per run and 2 runs per day using a commercially available solution of reduced bovine hemoglobin which has been demonstrated to b e comparable to tonometered whole

blood. Precision and accuracy of pH was evaluated using commercially available

precision pH buffer solutions with values traceable to N.I.S.T. and precision of

CO2 and PO2 was evaluated using aqueous contro l materials.

pH,

Typical Within-Run (S

) and Total (ST) imprecision data was collected from 2 runs

per day with 2 replicates per run on three AVL COMPACT pH/Blood Gas Analyzers over twenty days following the protocol of NCCLS document number EP5-T2.

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

Parameter n Mean Swr ST

pH 240 7.207 0.0020 0.0043

240 18.8 0.20 0.27 240 148.7 0.92 1.72

Mahoney JJ, Wong RJ, Van Kessel AL: Reduced Bovine Hemoglobin Solution Evaluated for Use as a Blood Gas

Quality-Control Material. Clin.Chem.39/5, 874-879 (1993).

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 17

Method Sheet

Material: AVL CONFITEST III Aqueous pH/Blood Gas Control, Level 2

Parameter n Mean Swr ST

pH 240

240 240

7.410 0.0017 0.0047

37.4 0.23 0.42

110.9 0.93 1.38

Material: AVL CONFITEST III Aqueous pH/Blood Gas Control, Level 3

Parameter n Mean Swr ST

pH 240

240 240

7.630 0.0021 0.0051

63.4 0.34 0.50

74.1 0.78 1.42

Material: AVL CONFITEST III Aqueous pH/Blood Gas Control, Level 4

Parameter n Mean Swr ST

pH 240

240 240

7.406 0.0012 0.0045

44.3 0.25 0.29

288.6 1.93 5.43

Material: RNA Medical QUALIDATA pH/Blood Gas Electrolyte

Control Level 1

Parameter n Mean Swr ST

pH 240

240 240

7.144 0.0016 0.0043

70.3 0.55 0.87

72.3 0.70 1.13

Material: RNA Medical QUALIDATA pH/Blood Gas Electrolyte

Control Level 2

Parameter n Mean Swr ST

pH 240

240 240

7.395 0.0016 0.0065

44.5 0.24 0.34

110.8 0.89 1.54

Material: RNA Medical QUALIDATA pH/Blood Gas Electrolyte

Control Level 3

Parameter n Mean Swr ST

pH 240

240 240

7.596 0.0013 0.0073

23.0 0.18 0.38

150.3 0.93 1.59

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

Method Sheet

Mate r ial: RNA Medical EQUIL Reduced Bovine Hemoglobin Blood Tonometry Material Level 1:

11.0% CO2, 20.93% O2, balance N

Parameter n Mean Swr ST

pH 240

240 240

Level 2: :5.13% CO2, 7.80% O2, balance N

7.178 0.0015 0.0087

74.2 0.58 1.08

149.2 1.19 1.95

Parameter n Mean Swr ST

pH 240

240 240

Level 2: :1.50% CO2, 2.91% O2, balance N

7.422 0.0017 0.0047

34.6 0.28 0.41

56.5 0.75 1.25

Parameter n Mean Swr ST

pH 240

240 240

7.732 0.0016 0.0048

11.0 0.09 0.24

20.5 0.49 0.46

Aliquots of Reduced Bovine Hemoglobin material were tono metered at 37°C. For each level, two replicates were run

in two runs on three AVL COMPACT 3 pH/Blood Gas Analyzers for twenty days.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 19

Method Sheet

Precision and Linearity

Precision and Linearity of pH on Phosphate Buffer Solution

Ampoules of precision pH buffer solutions, with values traceable to N.I.S.T., were analyzed in random order in sets of 10 measurements on each of 6 AVL COMPACT pH/Blood Gas Analyzers.

Precision

Linearity of pH on Whole Blood

pH Value @ 37 °C

6.841 ± 0.005

7.100 ± 0.005

7.383 ± 0.005

7.600 ± 0.005

Linearity

Number of pairs (n): 240 slope (m): 0.9974 ± 0.0010 y-intercept (b): 0.0179 ± 0.0073 correlation coefficient (r): 1.0000

180 runs were made on two AVL COMPACT pH/Blood Gas Analyzers and on 1 AVL 995 after being tonometered to various concentrations of CO 37°C.

n Mean WRSD

60 6.8409 0.0023 60 7.0993 0.0025 60 7.3823 0.0024 60 7.5976 0.0019

and O2 gas at

Number of pairs (n): 180 slope (m): 0.9979 ± 0.0016 y-intercept (b): 0.0118 ± 0.0114 correlation coefficient (r): 0.9998

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

Precision and Recovery on Whole Blood

Method Sheet

Whole blood was tonometered at 37°C to various levels of gravimetrically prepared gases with CO the manufacturer. Expected and observed values for

and O2 concentrations certified to ± 0.03% absolute by

CO2 and PO2 were corrected to 760 mmHg. For each tonometered level, 10 replicates were run on two AVL COMPACT pH/Blood Gas Analyzers:

Analyte type n Expected Observed S

1.00% CO

syringe 20 7.1 5.9 0.06 90

% Recovery

capillary 20 7.1 6.4 0.07 86

1.50% CO

syringe 20 10.7 10.8 0.14 101

capillary 20 10.7 10.6 0.23 99

2.97% CO

syringe 20 19.5 19.2 0.16 98

capillary 20 19.5 19.1 0.11 98

4.00% CO

syringe 20 28.5 28.7 0.12 101

capillary 20 28.5 28.2 0.19 99

6.00% CO

syringe 20 42.8 42.8 0.22 100

capillary 20 42.8 42.7 0.35 100

8.00% CO

syringe 20 57.0 57.5 0.28 101

capillary 20 57.0 57.0 0.60 100

10.00% CO2syringe 20 71.3 72.1 0.52 101 capillary 20 71.3 72.5 0.19 102

14.00% CO2syringe 20 99.8 100.9 0.45 101 capillary 20 99.8 100.7 0.63 101

18.00% CO2syringe 20 128.3 131.1 0.89 102 capillary 20 128.3 129.7 0.55 101

Linearity

Number of pairs (n): 180 slope (m): 1.0205 ± 0.0010 y-intercept (b): -0.7408 ± 0.0637 correlation coefficient (r): 0.9999

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 21

Method Sheet

Analyte type n Expected Observed S

2.93% O

syringe 20 20.9 20.9 0.30 100

% Recovery

capillary 20 20.9 20.8 0 .43 99

4.00% O

syringe 20 28.5 28.3 0.37 99

capillary 20 28.5 28.0 0 .23 98

8.00% O

syringe 20 57.0 56.6 0.44 99

capillary 20 57.0 56.7 0 .39 99

13.97% O2syringe 20 99.6 99.1 0.58 99 capillary 20 99.6 99.6 0 .46 100

16.00% O2syringe 20 114.1 113.9 0.58 100 capillary 20 114.1 115.2 0.84 101

20.00% O2syringe 20 142.6 144.2 1.16 101 capillary 20 142.6 140.8 1.56 99

30.00% O2syringe 20 213.9 213.2 0.72 100 capillary 20 213.9 210.8 2.62 99

50.00% O2syringe 20 356.5 352.6 2.13 99 capillary 20 356.5 350.4 2.73 98

80.00% O2syringe 20 570.4 565.3 5.97 99 capillary 20 570.4 562.9 2.82 99

Linearity

Number of pairs (n): 180 slope (m): 0.9872 ± 0.0008 y-intercept (b): 0.7362 ± 0.1920 correlation coefficient (r): 0.9999

All specific performance characteristics tests were run with default instrument calibration and after normal recommended equipment quality control checks were

performed (see Operator’s Manual). Specimens at each level were analyzed in replicates of two for 20 days. The

within-run and between-day standard deviations were calculated by the analysis of variance method.

Model equation for regression statistics is: [re sults of AVL COMPACT 3 Analyzer] = slope(m) x [comparative method results] + intercept(b).

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

Correlation to Other Methods

Method Sheet

Whole Blood

Precision of Measurement in Whole Blood

Specimens were collected for blood gas analysis by traditional operators of blood gas equipment. The specimens were analyzed on existing instrumentation operated and controlled by hospital procedur es. If any specimen remained after the initial run on the hospital system, the remainder was then run on the AVL COMPACT. The results of the AVL COMPACT analysis follows:

Comparative Method: AVL 995, Blood Gas Analyzer

Correlation

Parameter Slope Intercept Coefficient Range n

pH 0.9862 0.108 0.9920 6.96-7.63 141 normalized to pH=7.4 0.006

0.9886 0.516 0.9967 18 - 90 141

0.9712 3.453 0.9976 1.7 - 376 141

Following is the summary of the expected performance specifications for the Normal, Capillary, Mini sample and Micro sample modes.

Measuring Range (mmHg) SD

pH 6.000-8.000

0-40 0-0.8 mmHg

≤

0.005

40-200 0.8-3.0 mmHg

0-143

≤

1.2 mmHg

143-742 1.2-15.0 mmHg

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 23

Method Sheet

Precision on Whole Blood

The standard deviation for pH in whole blood is not easily specified, because the pH value in-vitro can either be controlled or kept constant. T he following data was obtained thro ugh timed record ing of the pH values, the curve was fitted with a straight line and the mean deviation from this line was calculated.

-Measurements

PCO

1SD

yx)

and O2 concentrations. Five measurements

Mini Micro

1SD

pH Standard Deviation (1 S

pH 6.000-8.000 0.005

CO2 and PO2, whole blood was tonometered at 37°C to various levels of

For gravimetrically prepared gases with CO were obtained at each of 10 levels of gas and Mean and SD were calculated for each of the four sample modes available on the AVL COMPACT pH/Blood Gas Analyzer: Syringe, Capillary, Mini, and Micro Sample. Measurement was also performed on the AVL OMNI Analyzer.

Syringe Capillary Sample Sample TOTAL

Target

17.8 18.1 0.23 18.0 0.27 17.8 0.45 17.9 0.27 18.0 0.32

20.6 20.9 0.34 20.9 0.26 20.9 0.28 20.6 0.35 20.8 0.31

27.5 28.1 0.37 28.2 0.23 27.6 0.26 27.8 0.25 27.9 0.28

1SD

27.5 27.9 0.38 28.0 0.55 27.7 0.46 27.7 0.42 27.8 0.46

37.7 38.2 1.07 38.0 0.78 38.7 0.35 38.3 0.18 38.3 0.69

41.2 42.07 0.35 41.8 0.58 41.6 0.88 41.8 0.43 41.8 0.59

67.8 37.6 1.55 68.6 0.55 68.8 0.58 69.7 0.57 68.7 0.92

68.8 70.5 0.60 70.4 0.42 69.7 1.05 70.7 0.73 70.3 0.73

103.1 102.9 0.76 103.5 0.90 104.0 1.54 104.0 1.68 103.6 1.28

139.5 139.5 1.64 140.0 1.99 137.6 2.80 140.8 4.17 139.5 2.82

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

PO2-Measurements

Method Sheet

Mini Micro

Syringe Capillary Sample Sample TOTAL

Target

0.0 1.07 0.47 0.89 0.47 0.83 0.36 0.70 0.57 0.87 0.47

21.0 20.9 0.53 21.1 1.50 20.7 0.60 20.6 1.05 20.8 1.00

44.7 44.4 1.00 44.4 1.12 43.3 0.64 43.3 1.68 43.8 0.93

76.0 67.6 1.55 68.6 0.55 68.8 0.58 69.7 0.57 68.7 0.92

96.2 95.7 0.70 96.7 0.96 97.5 0.88 97.1 1.10 96.7 0.92

135.6 137.3 3.25 136.3 1.24 137.4 1.38 137.8 1.14 137.2 1.95

300.7 290.8 3.60 295.1 1.87 294.12 8.18 293.7 3.06 293.4 4.81

344.0 336.9 6.65 342.1 4.07 343.6 3.48 343.6 9.93 341.5 6.55

501.2 492.1 11.11 489.1 7.19 486.7 8.39 494.3 9.30 490.5 9.11

659.5 640.1 12.61 647.7 11.80 644.6 12.22 641.6 20.55 643.5 14.75

1SD

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 25

Method Sheet

Bibliography

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

2. Shapiro BA, Harrison RA, Cane RD, Kozlowski-Templin R: Clinical Application of Blood Gases, 4th ed.,

(Chicago: Year Book Medical Publishers, Inc., 1991).

3. Mahoney JJ, Wo ng RJ, Van Kessel AL: Re duced Bo vine Hemoglobin So lution Evaluated fo r Use as a B lood

Gas Quality Control Material. Clin.Chem.1991; 39(5): 874-879.

4. Mahoney JJ, et al. Changes in Oxygen Measurements when Whole Blood is Stored in Iced Plastic or Glass

Syringes, Clin.Chem. 1991; 37(7): 1244-1248.

5. National Committee for Clinical Laboratory Standards. Blood Gas Pre-Analytical Considerations: Specimen

Collection, Calibration and Controls; Approved Guideline. NCCLS Document C27-A, (1993).

6. National Committee for Clinical Laboratory Standards. Protection of Laboratory Workers from Infectious

Disease Transmitted by Blood, Body Fluids and Tissue - Second Edition; Tentative Guideline. NCCLS Document M29-T2, (1992).

7. National Committee for Clinical Laboratory Standards. Percutaneous Collection of Arterial Blood for

Laboratory Analysis - Second Edition; Approved Standard. NCCLS Document H11-A, (1992).

8. National Committee for Clinical Laboratory Standards. Additives for Blood Collection Devices: Heparin;

Tentative Standard; NCCLS Document H24-T, (1988).

9. National Committee for Clinical Laboratory Standards. Evaluation of Precision Performance of Clinical

Chemistry Devices - Second Edition; Tentative Guideline. NCCLS Document EP5-T2, (1992).

10. Snyde r John R., Senhauser Dona ld A, (ed s), Administration a nd Supervisio n in Laborat ory Medici ne, 2

(Philadelphia: J.B.Lippincott Co., 1989).

ed,

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

1 Introduction

1 INTRODUCTION

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

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

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

pH ............................................................................................................................. .............. 1-2

CO2....................................................................................................................................... 1-2

O2......................................................................................................................................... 1-2

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

Location................................................................................................................................... 1-3

General Information .................................................................................................................1-3

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

Hygienic Handling of Blood.....................................................................................................1-3

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

Precaution..................................................................................................................... ........... 1-4

Storage ....................................................................................................................................1-4

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

Reagents.................................................................................................................................. 1-5

AVL Deproteinizer................................................................................................................ 1-5

Disinfectant.......................................................................................................................... 1-6

Fill port area............................................................................................................................ 1-6

Sample drip tray.................................................................................................................... 1-6

Fill port...................................................................................................................... .......... 1-6

Flap........................................................................................................................... ........... 1-7

Keyboard .................................................................................................................................1-7

Surfaces ...................................................................................................................................1-7

Sample path / Measuring chamber ............................................................................................1-8

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

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 1-I

1 Introduction

Analyzer Description

1 Introduction

Intended Use

Fig. 1-1: AVL COMPACT 3

•

The AVL COMPACT 3 is an automatic microprocessor controlled pH /

Blood Gas Analyzer with an integral thermal printer.

•

High safety, zero risk sample port and waste level control eliminate

contamination and infection hazard.

•

A complete pH / Blood Gas analysis is performed on only 55 µ l of whole

blood with obvious benefits in neonatology, pediatrics and geriatrics.

•

An optimized user interface reduces the requirement for extensive user

training.

•

AVL zero-maintenance electrodes fit perfectly to the low maintenance

concept of the AVL COMPACT 3.

•

Quick and pr ecise analysis is completed within 20 seconds from sample

introduction to results.

•

Lowest consumables and calibration gas requirement of any comparable

analyzer, ensures continued cost savings.

•

Pro duct design and AVL quality combine to ensure ultimate performance,

reliability and economy.

•

Extensive self-diagnostic software, as featured on all AVL analyzers.

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

measurement of pH,

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 1-1

CO2 and PO2 in samples of whole blood.

1 Introduction

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 o f the most tightly controlled para meters in the body. The causes of abnormal blood pH-values are generally classified as:

pH < 7.4

•

primary bicarbonate deficit - metabolic acidosis

•

primary hypoventilation - respiratory acidosis

pH > 7.4

•

primary bicarbonate excess - metabolic alkalosis

•

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

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

due to hyperventilation.

-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.

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

PCO

The eliminates carbon dioxide in relation to the metabolic rate of CO

CO2 below the normal range is termed respiratory alkalosis and indicates

production.

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 car diac arre st, chronic o bstructive lung dise ase, drug overdose, or chronic metabolic acid-base disturbances.

O2-value of arterial blood has become the primary tool for the evaluation

The of arterial oxygenation status. Values below the normal arterial

O2 (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

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.

1-2 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Handling the Analyzer

1 Introduction

Location

General Information

For correct, trouble-free operation, the following environmental specifications must be observed:

• Ambient temperature: +15 °C to + 32 °C (50 °F to 90 °F).

• Avoid direct sunlight.

• Avoid hazardous gases and vapors.

• Relative humidity: 20 - 90 %.

• Avoid locations beside strong electromagnetic fields (electric motors,

transformers, X-ray apparatus etc.). Avoid the use of cellular telephones close to the device.

• Avoid vibration, use a solid surface.

• Allow sufficient space (at least 20 cm / 8 Inch minimum) around the

analyzer for air circulation and electrical supply.

The AVL COMPACT 3 should be switched on at all time. For switch-off periods of more than 12 hours, the "shutdown procedure" described in chapter 3 must be performed.

• Do not place liquids on top of the analyzer.

• P erform regular quality control tests (for further information, please refer

to chapter 5).

Handling Blood and Blood Products

Hygienic Handling of Blood

Always handle blood with caution, as it may contain hazardous biological substances.

WARNING: Waste liquids must be disposed of in accordance with local

regulations (biohazard).

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 1-3

1 Introduction

Handling AVL Reagents

NOTE: AVL Medical Instruments cannot guarantee the performance of the

analyzer if any of the following situations occur:

• Reagents other than those recommended are used.

• Expiration dates of reagents have been exceeded.

• Reagents are not used according to AVL´s recommendations.

• The procedures described in this manual are not followed.

Precaution

Storage

AVL Deproteinizer contains sodium hypochlorite (≤ 2.0 % active chlorine). Do not swallow the solution, avoid eyes and skin contact. In case of contact wash the affected area with plenty of water. In case of eye contact consult a physician as soon as possible.

Store AVL reagents in accordance with the information displayed on the package label, allow reagents to stabilize at ambient temperature before use.

1-4 Operator's Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Decontamination

1 Introduction

AVL recommends the following decontamination procedures. Decontamination should be performed in accordance with typical laboratory regulations. This decontamination should be performed periodically to minimize the risk of infections (incl. hepatitis virus and HIV). The purpose of this procedure is to minimize the risk when replacing items that were in direct contact with blood.

NOTE: Always used approved, protective gloves!

The following parts of the device have to be decontaminated:

Daily

• Fill port area

• Keyboard

• Surfaces

As needed

• Sample path

Reagents

AVL Deproteinizer

NOTE: Use liquid disinfectants only.

Do not use sprays!

Composition

Aqueous solution of NaOCl containing ≤ 2.0 % active chlorine.

Hazards identification

Due to the basic and oxidizing character of the reagent ("Deproteinizer") local irritations after contact with eyes, skin or mucous membranes cannot be excluded.

First aid measures

After inhalation: fresh air, drink plenty of water After skin contact: rinse with plenty of water, remove contaminated

clothes

After eye contact: rinse with plenty of water, consult a doctor If swallowed: drink plenty of water, avoid vomiting, and consult a

doctor

NOTE: When Deproteinizer is handled and used properly, no ecological

problems are to be expected.

Operator's Manual, AVL COMPACT 3, Rev. 2.0, June 1998 1-5

1 Introduction

Disinfectant

Fill port area

Sample drip tray

A commercially available alcoholic disinfectant containing aldehyde should be used (e.g.: Meliseptol). Please refer to the product description of the surface disinfectant.

NOTE: Do not use the disinfectant for internal decontamination of the sample

path!

For decontamination AVL Deproteinizer is especially recommended. You may also use a commercially available alcoholic disinfectant containing aldehyde.

The sample drip tray prevents contamination of the bottle compartment (in case of improper sample introduction). Decontaminate a dirty sample drip tray with a cloth or gauze pad saturated in disinfectant.

Procedure

1. Open bottle co mpartment cover.

2. Pull sample drip tray out.

3. Clean and decontaminate or replace it.

4. Close bottle compartment cover.

Fill port

Decontaminate fill port with a cloth or gauze pad saturated in disinfectant.

Procedure

1. Activate:

7UGTRTQITCOU! oZm

5[UVGOVGUV! o

'NGEVTQFGU! o

2. Open flap.

3. Decontaminate fill port.

4. Close flap.

5. Press the key k twice upon completion of this maintenance procedure.

The system performs a washing/drying procedure and will return to the "4'#&;" screen.

1-6 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

1 Introduction

Flap

Keyboard

Decontaminate the inside and outside of the flap with a cloth or gauze pad saturated in disinfectant.

Procedure

1. Activate:

7UGTRTQITCOU! oZm

5[UVGOVGUV! o

'NGEVTQFGU! o

2. Open flap.

3. Decontaminate the inside and outside of the flap and wait until

disinfectant has dried.

4. Close flap only after disinfectant has dried completely to avoid damaging

the lacquer when reopening the flap.

5. Press the key k twice upon completion of this maintenance procedure.

The system performs a washing/drying procedure and will return to the "4'#&;" screen.

Decontaminate the keyboard with a cloth or gauze pad saturated in disinfectant.

Surfaces

NOTE: Decontaminate with damp cloth only using a disinfectant.

Do not use sprays!

Decontaminate all outside surfaces and cover with a cloth or gauze pad saturated in disinfectant.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 1-7

1 Introduction

Sample path / Measuring chamber

Cleaning with AVL Deproteinizer should be performed only when the measuring capillary is contaminated (protein residue) or if components of the measuring path are being replaced.

Such cleaning process basically interferes with the measuring system and the electrodes. They must be conditioned afterwards.

The decontamination agent is introduced via the fill port. If necessary decontaminate the measuring chamber specially the connecting

pieces with a cloth saturated in disinfectant.

Procedure

Activate:

7UGTRTQITCOU! oZm

/CKPVGPCPEG! oZm

%NGCPKPI ! o

Perform cleaning according instructions on the display.

NOTE: After reinstalling of the decontaminated electrodes at a later time or

Handling the Electrodes

Handle the electrodes with great care to prolong their operation life.

• Avoid contact between the electrode tip and hard surfaces.

• Never allow the electrodes to dry out, or store them unprotected.

For details, please refer to chapter 9, section "Care and Maintenance of pH / Blood Gas Electrodes", and chapter 12, section "Care and Maintenance of Remembranable pH / Blood Gas Electrodes".

a new electrode perform two measurements with a wetting agent (e.g. whole blood) to moisten the system.

1-8 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

2 Description of the Analyzer

2 DESCRIPTION OF THE ANALYZER

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

Measurements ................................................................................................................... ....... 2-1

Calibration ...............................................................................................................................2-1

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

Display and Keys......................................................................................................................2-2

Thermal Printer........................................................................................................................2-2

Cover.......................................................................................................................................2-3

Bottle Compartment..................................................................................................................2-3

Waste...................................................................................................................................2-4

Rinse .......................................................................................................................... .......... 2-4

Buffer Type 1 (pH = 7.383) ..................................................................................................2- 4

Buffer Type 2 (pH = 6.841) ..................................................................................................2- 4

pH Reference Solution ..........................................................................................................2-4

Cleaning Solution..................................................................................................................2-4

Sample Fill Module.................................................................................................................. 2-5

Flap........................................................................................................................... ........... 2-5

Fill Port and Tube............................................................................................................. .... 2-5

Sample Drip Tray.................................................................................................................. 2-5

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

Fill Port ................................................................................................................................2-6

Sample Inlet Path ..................................................................................................................2-6

Measuring Capillary .............................................................................................................. 2-6

Measuring Chamber Valve ..................................................................................................... 2-6

Measuring Chamber Module ..................................................................................................... 2- 7

Measuring Capillary .............................................................................................................. 2-7

Measuring Chamber Block ..................................................................................................... 2-8

Measuring Chamber Valve ..................................................................................................... 2-8

Electrodes............................................................................................................................. 2-8

Peristaltic Pump....................................................................................................................... 2-8

Rear Panel ............................................................................................................................... 2-9

Interfaces............................................................................................................................2-10

Gas Connections .................................................................................................................2-10

Power Switch Module.......................................................................................................... 2-11

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

Display..................................................................................................................................2-12

Keypad ......................................................................................................................... .........2-12

Timeout ........................................................................................................................ ......2-13

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

2 Description of the Analyzer

Main Features

The AVL COMPACT 3 is a fully automatic microprocessor-controlled analyzer for quantitative "in-vitro" measurement of whole blood of the following analytes:

pH hydrogen ion activity

CO2partial pressure of carbon dioxide

partial pressure of oxygen

BP actual barometric pressure Based on measured parameters, in conjunction with patient temperature, ctHb

IO2, the following parameters can be calculated:

and BE base excess

ecf

act

BB buffer base

HCO

cHCO ctCO

AaDO

cH SO

ctO

Shunt measurement for the direct mixture venous blood in the

base excess of extra cellular fluid base excess at actual oxygen saturation

actual bicarbonate

standard bicarbonate at a

CO2 of 40 mmHg standard pH value at a PCO2 of 40 mmHg arterial-alveolar oxygen partial pressure difference

hydrogen ion concentration oxygen saturation oxygen content

oxygenated circulatory system

2 Description of the Analyzer

CO2 = 40 mmHg

Measurements

The AVL COMPACT 3 analyzer is equipped with a sample detection system, which identifies air bubbles in a sample, controls the positioning of a sample in the instrument, and determines the volume of a sample. With a blood sample

volume of at least 55 µl in place, an automatic Blood Gas measurement is performed. With a blood sample volume of > 25 to 55 µl (Microsampler) a semi-automatic

CO2 and PO2 will be performed.

automatically:

Calibration

measurement of pH,

The following calibrations are initiated and performed

• Main calibration

• pH 1P calibration

The following calibrations are operator-initiated calib rations and will be performed automatically:

• pH 2P calibration

• Gas 2P calib rations

For details, please refer to chapter 6, " Calibrations".

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 2-1

2 Description of the Analyzer

Analyzer Components

Display and Keys

numeric keypad

Fig. 2-1: Display

Measured results, calculated parameters, and diagnostic informations appear on a four-line alphanumeric LCD display.

The keys and the numeric keypad in conjunction with the display provide control of all analyzer functions:

•

measurements

•

data input

•

programming

•

maintenance

•

system test

Display

Keys

Thermal Printer

Fig. 2-2: Thermal printer

The analyzer is equipped with a 24-column thermal printer using special (58 mm) wide paper with one heat-sensitive surface.

The following data can be printed out:

• measured values

• calculated values

• calib ration data

• electrode voltage

• system messages

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

2 Description of the Analyzer

Cover

It is essential to ensure the cover of the analyzer is closed during measurements and calibrations to prevent electrical interference and maintain temperature stability of the measuring system. The cover can be held in an open position using the door rod to secure the door.

Fig. 2-3: View with open top cover

Bottle Compartment

In the bottle compartment the following reagents / containers are required

•

Waste

•

Rinse

•

B uffer T ype 1

•

Bu ffer Typ e 2

•

pH Reference So lution

•

Cleaning Solution

Cleaning Solution Buffer Type 2

Fig. 2-4: Reagents

NOTE: The ambient temperature for storing all reagents ranges from

5 °C to 30 °C (41 °F to 86 °F).

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

2 Description of the Analyzer

Waste

Rinse

Buffer Type 1 (pH = 7.383)

Buffer Type 2 (pH = 6.841)

All liquids used by the analyzer are collected in the Waste container.

CAUTION: A trouble-free wash and dry cycle can be ensured only if the

system is completely sealed. The Waste container lid must be tightly closed.

The Rinse is used:

•

to wash out the sample;

•

to wash out the calibratio n solution.

The Buffer Type 1 is used to determine the first point of a pH calibration.

The bottle is placed behind the Buffer Type 1 bottle inside the bottle compartment. The Buffer Type 2 solution is used to deter mine the second point of a pH calibration.

pH Reference Solution

Cleaning Solution

This solution is pumped into the pH-reference electrode by means of a KCl pressure circulation system and the sample. The pH Reference Solution is transported only if the bottle cap is closed tightly.

The bottle is placed behind the pH Reference Solution inside the bottle compartment. A cleaning cycle is automatically performed after 50 samples during the next main calibration.

CAUTION: Do not mix or refill reagents.

Use only AVL reagents.

2-4 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

2 Description of the Analyzer

Sample Fill Module

This module consists of the following parts:

•

Flap

•

Fill por t and tube

•

Sample drip tray

Flap

Fill port

Sample drip tray

Fig. 2-5: Sample fill module

Flap

Fill Port and Tube

Sample Drip Tray

The flap has to be opened for a sample input.

CAUTION: If the flap is opened by mistake, the running action will be

interrupted. The analyzer prompts the operator to close the flap and a wash/dry cycle will be performed.

The fill port (see Fig. 2-5) allows samples to be injected or aspirated from

•

syringes,

•

AVL Microsampler and

•

capillaries without the need of adapters.

The sample drip tray is placed on the lower end of the fill module to avoid sample spilling. The tray is replaced as part of the scheduled maintenance procedures or when it becomes very soiled.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 2-5

2 Description of the Analyzer

Description of the Sample Path

Fill Port

Sample Inlet Path

Measuring Capillary

The sample is injected or aspirated into the fill port of the AVL COMPACT 3 using a syringe, capillary or AVL Microsampler.

The fill port is made of soft PVC and serves as an interface between the sample container and the sample path. The fill port is designed so those samples can be injected or aspirated via syringe, capillary or Microsampler without the need of an adapter.

The sample flows through the pre heating tube.

The metal sample inlet path heats the sample up to 37° C. The sample inlet path is also the first contact for sample detection and the first contact path (K

The analyzer aspirates the sample from the sample inlet path into the measuring capillary. In the measuring capillary, the sample contacts the electrodes. Before the sample reaches the measuring chamber valve it passes the second electrical contact for sample detection. In the measuring capillary, an electrical contact for sample detection is positioned between the The AVL COMPACT 3 detects the sample and controls the filling of the measuring capillary by means of contact paths.

After the pH blood gas measurement is completed, the sample is moved into the waste bottle.

- Mini Sample).

O2 and PCO2 Electrode.

Measuring Chamber Valve

2-6 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

The electromagnetic measuring chamber valve closes the measuring chamber and avoids the direct filling of a syringe sample into the measuring chamber. The sample is pushed into a bypass tube. This construction ensure s a continuous and bubble-free filling of the measuring chamber. It also prevents electrode damage from excessive pressure.

Measuring Chamber Module

2 Description of the Analyzer

The measuring chamber module consists of the following parts:

Fig. 2-6: Measuring chamber m odule

Measuring Capillary

measuring capillary

measuring chamber block

measuring chamber valve

electrodes

Fig. 2-7: Measuring capillary

In the measuring capillary the Blood Gas Electrodes and the pH Electrode are in direct contact with the sample to measure the Blood Gas parameters and the pH-value. The measuring capillary is permanently illuminated so that the entire aspiration cycle can be observed.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 2-7

2 Description of the Analyzer

Measuring Chamber Block

Measuring Chamber Valve

The entire module is thermostated at 37 °C.

The measuring chamber solenoid valve is located at the right end of the measuring chamber block. This valve prevents direct access from the pre-induction tube (i.e. syringe injection) to the measuring chamber module to avoid damage of the electrodes.

Electrodes

The electrodes are inserted into the measuring chamber block from the rear. The electrode tips proj ect into the measuring capillary thus come into contact with the sample material. The electrodes are color-coded for easy identification. Listed from left to right:

white gray green blue

pH Reference pH

Fig. 2-8: Electrodes

Peristaltic Pump

The peristaltic pump is used to transport all samples and liquid s inside the analyzer.

Fig. 2-9: Peristaltic pump

2-8 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

2 Description of the Analyzer

Rear Panel

Warning and identification plates with model and serial numbers are located on the rear panel of the unit.

NOTE: Only a trained service engineer is authorized to open the rear panel.

Fig. 2-10: Rear panel

Fig. 2-11: Warning and ident ification plat es

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 2-9

2 Description of the Analyzer

Interfaces

COM 3: 25-pin (female)

COM 2: 9-pin (female)

COM 1: 9-pin (female)

Gas Connections

Fig. 2-12: Interface

The standard bi-directional interface (RS232 C, Submin. D-connector) enables the user to connect the analyzer with a Host Computer, an external printer or ticket printer. In addition, the unit is provided with an interface option for a Bar code scanner and for data link with an AVL Oximeter or an AVL Electrolyte Analyzer and / or with an external service modem.

Gas 2 (10 % CO2, balanced N2)

Gas 1 (5.5 % CO2, 20 % O2, balanced N2)

Fig. 2-13: Gas connections

Connections for gas tubing are located in the lower right corner of the rear panel.

2-10 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Power Switch Module

2 Description of the Analyzer

Fig. 2-14: Power switch module

This module consists of a power switch, power input, fuses, and a power line filter.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 2-11

2 Description of the Analyzer

Operator Interface

Display

Keypad

The display helps you to operate the analyzer. When the unit is ready for measurement, the display reads as follows:

4'#&; (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

First line: current status of the analyzer, actual time. Second and third line: display instructions, alarms and measuring values. Fourth line: indicates user programs and questions; selection,

activation and data input.

The keypad in conjunction with the display provides control of all analyzer functions

Keys Function Data input

•

activates user programs

•

answers indicated questions

•

confirms indicated values

•

negates indicated questions

•

selects next function

•

negates indicated questions

•

selects previous function

•

interrupts the program sequence

•

interrupts all actions

•

exits user programs

•

jumps to previous menu

EXCEPT: calibrations and measurements: an interruption by

pressing k must be confirmed by pressing o .

•

confirms / completes data

input

•

input of time/date

•

input time/date

•

aborts data input

•

input of all numerical values

Except: time / date

• input of signs

• at each key touch the cursor

will be placed back for one digit, without deleting other digits

EXCEPT: patient number

2-12 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

2 Description of the Analyzer

Timeout

If no key was pressed, the analyzer automatically returns within 30 sec from each user program to 4'#&;. Exception: the user program "System Test".

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 2-13

2 Description of the Analyzer

2-14 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

3 Installation, Shutdown

3 INSTALLATION / SHUTDOWN

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

Location................................................................................................................................... 3-2

Solenoid Valve Relief Clamps ................................................................................................... 3-2

Peristaltic Pump Tube............................................................................................................... 3-3

Filling and Connecting the Bottles ............................................................................................3-4

Waste Bottle......................................................................................................................... 3-4

Rinse, pH Reference Solution, Buffer Type 1, Buffer Type 2, Cleaning Solution..................... 3-4

Calibration Gas Connection ......................................................................................................3-5

Electrodes ..................................................................................................................... ........... 3-6

pH Reference Electrode (white)............................................................................................. 3-6

Inserting Printer Paper............................................................................................................3-10

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

Longer than 3 Days.................................................................................................................3-11

Rinse and Dry the Tubes...................................................................................................... 3-11

Electrode Care....................................................................................................................3-12

Releasing the Peristaltic Pump Tube ....................................................................................3-13

Releasing the Tubes ............................................................................................................3-13

Storage, Transportation.......................................................................................................3-14

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

3 Installation / Shutdown

This chapter describes the installatio n and shutdown procedures.

Installation

After the AVL COMPACT 3 has been unpacked and placed in a location according to the requirements described in chapter 1, the following steps should be performed:

Check whether analyzer and accessories are complete and undamaged. Check contents against the supplied packing list.

If parts are missing inform your AVL representative. In case of damage inform your carrier immediately. Keep analyzer and packing material until any queries have been addressed.

NOTE: Packing may vary by country and slight variation from the accessories

list. Contact your AVL representative for your specific list.

3 Installation, Shutdown

Description

1 set dummy electrodes (four pieces) 1 pcs. lamp 28 V 1 pcs. 80 mAT / 250 V (F1/F2) 1 pcs. 1.6 AT / 250 V (F3 / mains fuse) 2 pcs. 3.2 AT / 250 V (F4) 1 pcs. nozzle cleaning needle 1 pcs. tub ing set for peristaltic pump 1 pcs. fill po rt 1 pcs. quad r ing seal for pH Reference Solution bo ttle

(28.17 x 3.53 mm)

1 pcs. quad ring seal for measuring chamber

(1.06 x 1.25 mm) 1 pcs. quad ring seal for waste (50.4 x 3.53 mm) 1 pcs. leak proof adapter (measuring chamber valve)

1 pcs. power cable (∅ = 1.5 mm 1 pcs. sample drip tray 1 pcs. operator’s manual

; length = approx. 2 m)

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 3-1

3 Installation, Shutdown

Location

Solenoid Valve Relief Clamps

For correct, trouble-free operation, the following environmental specifications must be observed:

• Ambient temperature: +15 °C to + 32 °C (50 °F to 90 °F).

• Avoid direct sunlight.

• Avoid hazardous gases and vapors.

• Relative humidity: 20 - 90 %.

• Avoid locations beside strong electromagnetic fields (electric motors,

transformers, X-ray apparatus etc.). Avoid the use of cellular telephones near the device.

• Avoid vibrations, use a solid surface.

• Allow sufficient space (at least 20 cm / 8 Inch minimum) around the

analyzer for air circulation and electrical supply.

In the AVL COMPACT 3 analyzer, relief clamps are inserted under the solenoid valves to prevent tube damage. Before installing the analyzer remove the relief clamps and reinsert it during shutdown procedur e.

NOTE: Do not forget to remove the relief clamps, otherwise no proper start

up operation will occur. The clamps designed for this pu rpose can easily be removed b y lifting the solenoid fixtures. Slightly pull the armature of the va lves when removing the relief clamps. Take care for the solenoid valve relief cla mps, you will need it for a possible later shutdown.

Open the cover of the analyzer to gain access to the solenoid valves relief clamps. Six of them (V3, V4, V5, V7, V11, V12) are located to the right of the measuring chamber (see Fig. 3-1), one to the right of the peristaltic pump (see Fig. 3-2). Open the bottle compartment cover (transparent gray plastic) and r emove the three solenoid valve red relief clamps from the solenoid valves (V6, V8 , V10) in the bottle compartment (see Fig. 3-3).

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

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

Fig. 3-2: Solenoid valve relief cl amps - peristal tic pump

3 Installation, Shutdown

Peristaltic Pump Tube

Fig. 3-3: Solenoid valve relief cl amps - bottle c ompartment

Fig. 3-4: Peristaltic pump tubes

Procedure

• Push end of tension lever to the r ight and slightly against the pump plate

until it locks with a click.

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

3 Installation, Shutdown

Filling and Connecting the Bottles

Located under the measuring chamber and the fill module, the reagent compartment houses the fluid containers. The screw-on caps with tubing for the containers are connected to the liquid circulation system which projects from the rear wall of the reagent compartment.

NOTE: Ensure to place the caps to the corresponding reagent bottles and pay

attention, that no tube is folded.

Waste Bottle

Rinse, pH Reference Solution, Buffer Type 1, Buffer Type 2, Cleaning Solution

Before screwing the cap on the Waste bottle, ensure that the ring seal is properly in place. If the seal is in place, screw the cap onto the empty Waste container and insert the bottle into its socket in the bottle compartment.

NOTE: Ensure that the Waste bottle is completely airtight to a llow a

trouble-free operation.

The necks of the bottles are sealed with aluminum foil. Remove the foil by cutting along the edge of the bottleneck.

NOTE: When removing the foil, make sure that the fluid s are not

contaminated.

NOTE: If you do not use the Rinse reagen t, fill the bottle with distilled water

and add one ampoule of Rinse Additive.

Screw the caps on the bottles and place them in their sockets in the bottle compartment.

NOTE: Before screwing on the cap of the pH Reference Solu tion bottle,

ensure that the ring seal is properly in place. Ensure that the cap is screwed on finger tight otherwise the pH Reference Electrode will not function p roperly. After installing the pH Reference Solution, do not switch on the analyzer before a pH Reference Electrode has been installed!

3-4 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Calibration Gas Connection

3 Installation, Shutdown

The AVL COMPACT 3 needs two different calibration gases.

Gas 2 (10 % CO2, balanced N2)

Gas 1 (5.5 % CO2, 20 % O2, balanced N

Fig. 3-5: Gas connection

Fig. 3-6: Position of c alibration gas cylinder

Procedure

•

Install the pressure regulators on the new gas cylinders.

•

Insert the new cylinders in the holder and secure them.

•

Connect the tube s to the outlet of the gas reduction valve.

•

Connect the tubes to the connector nipples on the rear panel of the

AVL COMPAC T 3.

•

Open the valves of the gas cylinders again.

NOTE: Do not mix up bottles and tubes.

NOTE: The length of the gas tube is limited at 1m (3 ft). Avoid large distances

between analyzer and gas cylinder. Please contact your AVL customer support if larger distances are necessary.

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

3 Installation, Shutdown

Electrodes

NOTE: Zero maintenance pH / Blood Gas Electrodes do not require any

preparation.

Fig. 3-7: Removal of transport housing

Before installing the remembranable electrodes r emove transport housing

(1) and pull (2)) and fit them with a new electrode housing (see

(twist chapter 12, "Care and Maintenance of Remembranable pH / Blood Gas Electrodes ").

NOTE: Save transport housing for possible storage or transport.

The electrodes do not require cleaning with electrode paste at this stage. Install the electrodes from right to left in the following sequence:

•

O2 Electrode (blue)

•

CO2 Electrode (green)

pH-Reference Electrode (white)

•

pH Electrode (gray)

Pull out the electrode clips and insert the electrodes into the measuring chamber block. Secure the electrodes with the clips and connect the electrode cables.

1. Carefully remove the protective caps from the pH Reference Electrode

nipples. Connect the unmarked tube to the lower nipple and the yellowcoded tube to the yellow-coded upper nipple.

Yellow marking

Fig. 3-8: pH Reference Electrode - yel low marking

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

3 Installation, Shutdown

Replace the pH Reference Electrode housing with a new one. Fill the pH Reference Electrode with pH Reference Solution, before inserting into the measuring chamber block.

2. P lug the power cord into an electrical outlet and switch on the analyzer.

3. The following display appears:

%1/2#%6

2NGCUGYCKV

When the correct temperature is reached, the following display with the correct temperature appears.

9#4/72 /%VGOR% 52VGOR%

During the warm up there is a conditioning of the PO2- and PCO2electrode.

9#4/72 

2NGCUGYCKV

4. Check the automatic filling function of the pH Reference Electro de housing

(see chapter 9). If the pH Reference Electrode is filled, continue with item 5.

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

3 Installation, Shutdown

If the pH Reference Electrode was not filled:

Take pH Reference Electrode out of the measuring chamber.

NOTE: Do NOT disconnect cable and tubes!

Activate:

/CKPVGPCPEG! oZm

4GHg'NGEVTQFG! o

75'4241)4#/5 4GHgGNGEVTQFG

(KNNGNGEVTQFG!

Press o . This function activates the automatic filling of the pH Reference Electrode

housing. On completion of the filling procedure, the following display appears:

75'4241)4#/5 4GHgGNGEVTQFG

(KNNGNGEVTQFG!

5. P ress n when the electrode is filled.

The permeability of the pH Reference Electrode diaphragm should be tested. Carefully touch the electrode tip with a clean dry tissue.

75'4241)4#/5 4GHgGNGEVTQFG

%JGEMRGTOGCDKNKV[!

Press o to confirm. Observe the electrode tip for the formation of a small droplet of pH

Reference Solution.

75'4241)4#/5 4GHgGNGEVTQFG

%JGEMRGTOGCDKNKV[!

3-8 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

3 Installation, Shutdown

If no droplet has formed on the tip, press o to confirm and repeat this procedure, otherwise exit this program by pressing k .

If again no droplet has formed replace the pH Reference Electrode housing in accordance with the instructions given in chapter 9, "Maintenance".

Fig. 3-9: pH Reference Electrode - dropl et

If the droplet has formed, wipe it off carefully, insert the electrode into the measuring chamber and secure with the clip.

Press k to exit the program.

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

3 Installation, Shutdown

Inserting Printer Paper

1. Push the paper roll holder slightly to the side

2. Put a new roll of paper into the mounting support.

3. Insert the paper in the feeder.

4. Press the paper feed (black) button until the paper ap pears at the outside of

the cover.

1 / 2

Fig. 3-10: Paper insertion

NOTE: The paper is heat-sensitive on one side only. Make sure that it is

inserted correctly.

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

Shutdown

3 Installation, Shutdown

If the AVL COMPACT 3 is to be put out of use for a longer period of time, it is possible to activate the economy standby mode. During this time, the analyzer does not need Buffer Type 1 or Buffer Type 2, but the electrodes have the optimal conditioning. If necessary, a "Manual Standby" or "Automatic Standby" can be activated. For details, see chapter 8 "Settings" section " Manual Standby" or "Automatic Standby". This economy standby mode can be canceled at any time. After performing the necessary calibration the analyzer is 4'#&;.

Longer than 3 Days

Rinse and Dry the Tubes

If your AVL COMPACT 3 is to be shut down completely for more than 3 days, you have to empty the tubes, remove the electrodes from the measuring chamber and secure some of the tube valves with the relief clamps.

Procedure

4'#&; (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

1. Take both tubes off the pH Reference Electrode and connect them with

each other by means of a nipple. Close the two nipples of the pH Reference Electrode with the two supplied red stoppers.

NOTE: A capillary tube may also be used instead of a n ipple.

Do not insert the ends of the capilla ry into the tubes deeper th an 10 mm.

2. Empty Buffer Type 1, Buffer Type 2, pH Reference Solution and Cleaning

Solution, rinse them, fill them with distilled water and put them back into the analyzer.

3. Activate:

7UGTRTQITCOU! oZm

/CKPVGPCPEG! oZm

5JWVFQYP! o

75'4241)4#/5 5JWVFQYP

4KPUG!

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

3 Installation, Shutdown

Press o. A rinsing cycle is now activated during which the entire reagent inlet and

outlet tubing system is rinsed. Empty the bottles of Buffer Type 1, Buffer Type 2, pH Reference Solution, Cleaning Solution and Rinse.

75'4241)4#/5 5JWVFQYP

&T[!

Press o.

75'4241)4#/5 5JWVFQYP &T[CEVKXCVGF

Electrode Care

The liquids are aspirated and the tubing system is dried.

75'4241)4#/5 5JWVFQYP 5YKVEJQHHCPCN[\GT

4. Switch off the power supply.

5. Close the valve of the calibration gas cylinders.

6. I nsert the solenoid valve relief clamps.

7. Empty, decontaminate and dry the waste bottle and put it back into the

analyzer.

Disconnect the electrode cables and lift the electrode clips. The electrodes may now be removed.

NOTE: Reinsert the electrode clips to avoid losing them.

Storage for only one day

To prevent the electrodes from drying out fill the protective caps with:

• pH Electrode: Buffer Type 1

CO2 Electrode:

•

O2 Electrode: do not fill

CO2/TCO2 Filling Solution

• pH Reference Electrode: pH Reference Solution

and seal them with Parafilm

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

Releasing the Peristaltic Pump Tube

3 Installation, Shutdown

Transport (only for Remembranable Electrodes)

•

Remove the electrode housing from the corresponding electrode.

•

Fill the transpo rt housing with the corresponding electr olyte (Exception:

O2 Electrode):

•

Remove the o utside O-ring fro m the transport housing fo r opening the

discharge pore

Fig. 3-11: Transport housing

•

Fit the electrodes with the filled transport ho using

Unlock tension lever. Push on hook-shaped until tensio n lever moves left and pump tube tension is released.

Releasing the Tubes

To prevent tube damage in the AVL COMPACT 3 analyzer during transport, relief clamps are inserted under the solenoid valves to.

NOTE: The clamps designed for this p urpose can easily be removed by lifting

the solenoid fixtures.

Six of them (V3, V4, V5, V7, V11, V12) are inserted to the right of the measuring chamber (see Fig. 3-12), one to the right of the peristaltic pump (see Fig. 3-13).

The remaining three red solenoid valve relief clamps have to be inserted (V6, V8, V10) in the bottle compartment (see Fig. 3-14).

Fig. 3-12: Solenoid valve relief clamps - fill module

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

3 Installation, Shutdown

Fig. 3-13: Solenoid valve relief cl amps - peristal tic pump

Storage, Transportation

Fig. 3-14: Solenoid valve relief cl amps - bottle c ompartment

Protect the AVL COMPACT 3 with a dust cover during storage. For transportation purposes use the original shaped parts packing material.

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

4 Patient Testing

4 PATIENT TESTING

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

Important when Storing Blood .................................................................................................. 4 -1

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

Syringe Measurement ...............................................................................................................4-2

Capillary or Microsampler Measurement ................................................................................... 4-4

Micro sample ................................................................................................................... ........ 4-6

Printout of Results.................................................................................................................... 4-9

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

Password - OFF......................................................................................................................4-10

Password - ON (Measurement - ON)........................................................................................4-10

Password - ON (Measurement - OFF) ......................................................................................4-11

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

Parameter Input ......................................................................................................................4-12

Modification of Patient’s Temperature.................................................................................. 4-13

Modification of tHb Value...................................................................................................4-14

Modification of tHb Type for Fetal and Adult Blood.............................................................4-14

Modification of Fraction of Inspired Oxygen (

Modification of Respiratory Quotient (RQ) .......................................................................... 4-15

Modification of Half- Saturation Pressure ............................................................................4-15

Modification of Sample Type............................................................................................... 4-16

Input of Patient- Related Data................................................................................................. 4-17

Entering Patient’s Number (Manual).....................................................................................4-18

Entering Patient’s Number (Barcode) ...................................................................................4-18

Entering Patient’s Sex ..........................................................................................................4-18

Entering Patient’s Age .........................................................................................................4-18

IO2).............................................................4-14

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

Measurement Reports .............................................................................................................4-20

Data Input...........................................................................................................................4-20

Reports ...............................................................................................................................4-20

Calibration Reports ................................................................................................................ 4-21

Error Report................................................................................................................... ........4-21

System Status.................................................................................................................. .......4-22

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-I

4 Patient Testing

This chapter describes routines used to o perate of AVL COMPACT 3.

Sample Preparation

NOTE: Always observe the laboratory regulations, when collecting blood.

For capillary blood samples, it is advisable to use AVL capillary tubes, which contain a special Heparin coating. The most advanced and user-friendly device for collecting arterial blood is the AVL Microsampler.

4 Patient Testing

Important when Storing Blood

Fig. 4-1: AVL Microsampler

The use of very thin needles prevents common complications such as hematoma, thrombosis etc. which may occur after an arterial puncture.

NOTE: When the Microsampler needle punctures an artery, a pulsating blood

flow filling of the capillary tube ca n be observed. Continuous flow indicates that a vein has been punctured.

CAUTION: The higher the temperature of a sample, the faster and more

intensive its metabolism (means change of Blood Gas and pH values).

The ideal temperature for long-term storing of blood is approx. 4° C (39 °F). At this temperature the metabolism of a sample and, as a consequence, its oxygen consumption are lowest. At a temperature of 4° C, a sample may be kept for up to two hours without significant changes of its Blood Gas and pH values. When using an AVL Microsampler, the sample does not require icing for up to 30 min. For details, please refer to chapter 13!

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-1

4 Patient Testing

Sample Measurement

Syringe Measurement

Before a measurement can be performed, the analyzer must be in 4'#&; mode.

NOTE: Before measurement, turn the syringe in your hand for about 10

Open the flap.

4'#&; (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

seconds to mix the sample and remove any air by injecting it onto a cotton swab.

/'#574'/'06 +PLGEVUCORNGQT UGNGEVCURKTCVKQP #URKTCVKQP!

Insert the syringe into the fill port and inject the sample slowly.

Fig. 4-2: Syringe measurem ent

As soon as the requisite sample volume is injected, an acoustic signal will sound and the following display appears:

/'#574'/'06 4GOQXGU[TKPIG ENQUGVJGHNCR

Remove the syringe from the fill port and close the flap.

4-2 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

4 Patient Testing

NOTE: If the flap is opened again while the sample is being aspirated and not

closed before the countdown reaches 000, a continuous beep will sound until the flap is closed. If the flap is opened during the measurement, the measurement will be aborted.

NOTE: Do not open the cover during measurements!

/'#574'/'06

'FKVRCVKGPVFCVC!

The analyzer performs a fully automatic measurement. The transparent, illuminated measuring channel enables the user to observe the movement of a sample and to identify blockages or air bubbles. During measurement, data input (input patient or sample related data) is possible.

Please refer to chapter 8 "Settings", section "Interfaces" for further information.

The countdown running in the upp er right co rner of the disp lay during the

measurement ends with the display of measured pH,

CO2 and PO2 and one of the calculated values (for details, please refer to chapter 8, section " Settings" "Display") and printout of the results.

%10&+6+10+0) R*g2%1g 21g$'g 'FKVRCVKGPVFCVC!

On completion of the measurement, the results are displayed and printed out, and a gas conditioning is started. As soon as the countdown reaches 20 seconds, an asterisk (*020) appears to indicate that the flap can now be opened for further measurement (max. 4 times) before the end of the conditioning cycle is reached. If the flap is not opened before completion of the countdown, the analyzer returns to 4GCF[ and the display will read as follows:

4'#&; (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-3

4 Patient Testing

Capillary or Microsampler Measurement

Before a measurement can be performed, the analyzer must be in the 4'#&; mode.

Fig. 4-3: Capillary measurement

4'#&; (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

Open the flap.

/'#574'/'06 +PLGEVUCORNGQT UGNGEVCURKTCVKQP #URKTCVKQP!

Press owhe n " #URKTCVKQP!" is indicated. Carefully insert the capillary into the fill port.

NOTE: At least 55µ l sample volu me is required!

If under "Settings" the function "Mini sample" was activated, the following display appears:

/'#574'/'06 5CORNG KUCURKTCVGF /KPKUCORNG!

4-4 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

4 Patient Testing

Press o and only 60 µ l sample will be aspirated. As soon as an acoustic signal will sound, remove the capillary and close the flap. The remaining sample volume can be used for measurements in another analyzer (oximeter or ISE). If the displayed "Mini sample" was not confirmed by o, the sample will be aspirated as long as the measuring chamber is completely filled. After the acoustic signal will sound, remove the capillary and close the flap.

NOTE: If the flap is opened again, while the sample is being aspirated and

not closed before the countdown reaches 000, a continuous beep will sound until the flap is closed. If the flap is opened during the measurement, the measurement will be aborted.

NOTE: Do not open the cover during measurements!

/'#574'/'06

'FKVRCVKGPVFCVC!

The analyzer performs a fully automatic measurement. The transparent, illuminated measuring channel enables the user to observe the movement of the sample and to identify blockages or air bubbles. During measurement, data input is possible.

Please refer to chapter 8 "Settings", section "Interfaces" for further information.

The countdown running in the upp er right co rner of the disp lay during the

measurement ends with the display of measured pH,

CO2 and PO2 and one of the calculated values (for details, please refer to chapter 8, " Settings", section "Display") and printout of the results.

%10&+6+10+0) R*g2%1g 21 g$'g 'FKVRCVKGPVFCVC!

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-5

4 Patient Testing

On completion of the measurement, the results are displayed and printed out, and a gas conditioning is activated. As soon as the countdown reaches 20 seconds, an asterisk (*020) appears to indicate that the flap can now be opened for further measurement (max. 4 times) before the end of the conditioning cycle is reached. If the flap is not opened before completion of the countdown, the analyzer returns to 4GCF[ and the display will read as follows:

4'#&; (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

Micro sample

The micro sample is only offered as a measurement variation for capillary samples, smaller than 55µl and with a minimal volume of 25 µl. The micro sample will automatically be identified during aspiration of the capillary sample. If the sample volume is greater than 25 µl, the operator can choose micro sample measurement. If the question /+%415#/2.'! is answered with n or the time out has expired, the sample will be rejected with the error signal 0Q5CORNG Thereafter, the analyzer carries out a wash-/dry cycle and conditioning process and returns to 4'#&;.

O2, PCO2 and pH parameters can be

The chosen and measured individually, according to the order of the electrodes in the measuring chamber.

NOTE:The

If a parameter ( the sample by pressing l over the desired sample. The sensor must be completely covered by the sample. Press o to confirm the actual measurement.

If the parameter is in alarm, this particular parameter cannot be selected and is automatically passed without appearing on the display. The micro sample measurement is shown as /+%41 on the display.

O2-measurement begins immediately after a micro sample has been detected (in this case, the sample is properly positioned as a result of the defined minimum volume) and the sample is then either disregarded or measured, depending on the chosen variation.

CO2 or PO2) is chosen with o , the operator must position

Procedure

4'#&;  (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

Open the flap.

4-6 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

4 Patient Testing

/'#574'/'06 +PLGEVUCORNGQT UGNGEVCURKTCVKQP #URKTCVKQP!

Press o when #52+4#6+10! is shown on the display. The sample will be aspirated.

A micro sample measurement is automatically performed when the sample volume is less than 55 µl. If the sample is greater than 25 µl, the following appears on the display:

/'#574'/'06 4GOQXGECRKNNCT[ ENQUGVJGHNCR /KETQUCORNG!

Close the flap and the following is shown:

/'#574'/'06 

/KETQUCORNG!

Confirm with o . If n is pressed or after conclusion of time out, the sample will be washed

out and the analyzer returns to the 4'#&; mode.

/'#574'/'06 

21OGCUWTGOGPV!

Press o to perform the PO2 measurement. If the PO2 measurement is not selected, the already scanned in values will also be canceled.

After the

O2 measurement, or when this is not selected by pressing n, the

following appears on the display:

/'#574'/'06 

2%1OGCUWTGOGPV!

Press o to perform the PCO2 measurement.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-7

4 Patient Testing

/'#574'/'06  2QUgYKVJ72

5CORNGRQUKVKQPGF!

By pressing l you can position the sample. The sample should be positioned uninterrupted. The sample should reach at least to the middle of the

connecting capillary between the pH- and Confirm the correct position and start the measurement by pressing o .

After completion of the offered. At the pH-measurement the pH-reference electrode as well as the pHelectrode have to be completely covered by the sample.

CO2 measurement, the pH-measurement will be

CO2-electrodes.

4-8 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

4 Patient Testing

Printout of Results

Immediately after the results are displayed, the results are printed on the thermal printer.

For a detailed description of reports, see chapter 12, "Appendix", section "Description of Various Reports".

AVL COMPACT 3

BLOOD GAS

header

ACID BASE REPORT

Pat.Name: Age: 36 F Pat.no.: 18 Sample: CAPILLARY cap.

Mo,17-Nov-97 15:54

No.: 30 Baro 724.8 mmHg

#tHb A 15.2 g/dL #Temp 37.0 38.2 ÀC

...........actual date / time

...........sample number

...........air pressure

patient data

input values

pH 7.200 7.184 PCO2 17.0 17.9 mmHg

BE - 19.3 mmol/l BEecf - 19.8 mmol/l BB 28.7 mmol/l HCO3 6.4 mmol/l

PO2 126.3 133.4 mmHg O2sat 97.4 %

Op.ID.:

#Input values

...........measured value

...........calculated value

...........operator identity

measured values

calculated values

NOTE: For details, please refer to chapter 8, “Settings“.

To set the layout of this report, activate the program “Settings“ "Report" - "Report Editor“.

Operator's Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-9

4 Patient Testing

Password Option

Password - OFF

If the function "Password" is activated in the progra m function "Settings" (for details see chapter 8, section "Barcode Scanner", or "Password"), the following condition for measurement is given:

4'#&;  (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

The measurement can be performed as usual. If a barcode scanner is installed, it is possib le to scan in the patient number during measurement (within the sample stop time and before the measurement and calculated values appear on the display), as well as during the "Data input" function. Please refer to chapter 8 "Settings", section "Interfaces" for further information.

Password - ON (Measurement - ON)

/'#574'/'06  (QTOGCUWTGOGPV QRGPVJGHNCR 2CUUYQTF!

The measurement can be performed without scanning in the password. In order to activate the program functions, either password-code 1 or password-code 2 must be scanned in.

The operator identification (OP . ID) can only be scanned in during the 4'#&; mode, with the use of the barcode scanner.

Details pertaining to the use of password-codecards can be found in chapter 8, "Settings", section " Password" .

4-10 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Password - ON (Measurement -OFF)

4 Patient Testing

4'#&;  +PRWVRCUUYQTF

2CUUYQTF!

A measurement can only be started, if a password-codecard is scanned in.

Scanning in the passw ord-codecard 3

4'#&;  (QTOGCUWTGOGPV QRGPVJGHNCR 2CUUYQTF!

The operator is only able to perform a measurement, but has no access to the program functions.

Scanning in the passw ord-codecard 1 and 2

4'#&;  (QTOGCUWTGOGPV QRGPVJGHNCR 7UGTRTQITCOU!

The operator is able to perform measurements and can also activate program functions.

CAUTION: If a barcode scanner is installed, it is possible to scan in the

patient number during measurement (from sample stop up to reaching 4'#&;) as well as during the function "Data input"

- "Patient number". The operator identification (OP. ID) can o nly be read in with the barcode scanner during the 4'#&; mode.

Details pertaining to the use of password code cards can be found in

chapter 8, "Settings", section " Password“.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-11

4 Patient Testing

Parameter and Data Input

During and after a measurement, the user may enter or reset various parameters and patient-related data (e.g. the patient temperature). This can be done only for the current measurement.

If a barcode scanner is installed, it is possib le to scan in the patient number during measurement (from sample stop up to reaching 4'#&;) as well as during the function "Data input" - "P atient number". Further it is po ssible to scan in the OP ID before a measurement (before the flap will be opened). Standard values (e.g. the patient’s temperature, which may be modified if necessary.

IO2 etc.) are default settings,

Parameter Input

The input of patient-related and sample-specific data overwrites the preset default values for the current measurement. The data input is possible during measurement or immediately thereafter, as long as the results are displayed.

During the measurement

/'#574'/'06

'FKVRCVKGPVFCVC!

Press o .

75'4241)4#/5 'FKVRCVKGPVFCVC

2CTCOGVGTUKPRWV!

Press o.

Select the desired parameter with m or l and confirm by pressing o.

After the measurement

%10&+6+10+0) R*g2%1g 21g$'g 'FKVRCVKGPVFCVC!

Press o .

4-12 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

4 Patient Testing

NOTE: If none of the following parameters is selected before the measurement

is finished, the analyzer automatically returns to the highest menu level %10&+6+10+0) or 4'#&;).

75'4241)4#/5 'FKVRCVKGPVFCVC

2CTCOGVGTUKPRWV!

Press o and select the desired parameter with m or l and confirm the selected parameter by pressing o.

The following parameters can be modified:

• Pa tient’s temperature

• tHb value

• Hb-type for fetal and adult blood

• Fractio n of inspired oxygen (

IO2)

• Respiratory quotient (RQ)

• Half-saturation pressur e (

50)

• Sample Type (cap. / art. / venous)

Modification of Patient’s Temperature

Activate:

2CTCOGVGTUKPRWV! o

2CVg6GORGTCVWTG! o

The displayed temperature may now be varied with the numeric keypad.

Available input range: 14 °C ... 44 °C (57.2 °F ... 111.2 °F). Preset value: 37 °C

When you confirm the selected temperature with o , the display will fade out.

At this point, you may select another parameter with mor l exit from the program by pressing k.

Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998 4-13

4 Patient Testing

Modification of tHb Value

Modification of tHb Type for Fetal and Adult Blood

Activate:

2CTCOGVGTUKPRWV! oZm

V*D! o

The displayed tHb value may now be varied with the numeric keypad.

Available input range: 1.0 ... 26.0 g/dL Preset value: 15 g/dL

When you confirm the selected tHb value with o , the display will fade out. At this point, you may select another parameter with m or l or exit the

program by pressing k.

Activate:

2CTCOGVGTUKPRWV! oZm

Modification of Fraction of Inspired Oxygen (FIO

)

#FWNVHGVCN*D! o

The analyzer calculates the oxygen saturation values on the basis of a standard ODC (Oxygen Dissociation Cur ve).

This ODC is, however, different for normal adult blood and for children’s blood. On the display appears "adult" and "fetal"; the selected parameter is blinking.

Select either "adult" or "fetal" by pressing mor l. When you activate the blinking parameter with o , the display will fade out. At this point, you may select another parameter with mor lor exit the

program by pressing k.

Activate:

2CTCOGVGTUKPRWV! oZm

(+1! o

This parameter is used to calculate the alveolar-arterial oxygen partial pressure difference (AaDO

The displayed

IO2 value may now be varied with the numeric keypad.

Available input range: 0.11 ... 0.99 Preset value: 0.21

When you confirm the selected

IO2 value with o , the display will fade

out. At this point, you may select another parameter with mor l or exit the

program by pressing k.

4-14 Operator’s Manual, AVL COMPACT 3, Rev. 2.0, June 1998

Roche AVL Compact 3 User manual

Specifications and Main Features

Frequently Asked Questions

User Manual