ITC Avoximeter 4000 User Manual

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AVOXimeter® 4000

Whole Blood CO-Oximeter

Operator’s Manual

Manufacturing Company Location

International Technidyne Corp

8 Olsen Avenue, Edison, New Jersey USA

Phone: 1-732-548-5700 Fax: 1-732-248-1928 web site: www.itcmed.com

may not be reproduced or copied, in whole or in part, without the written permission of ITC.

ITC and AVOXimeter are registered trademarks of International Technidyne Corporation in the United States and other jurisdictions.

U.S. Patents. 5,430,542 and 6,262,798. Euro/UK Patent 0663070. Other patents pending.

Technical Support

Contact ITC Technical Support at (800) 631-5945 or (732) 548-5700, or by e-mail at

techsupport@itcmed.com

Table of Contents

1 INTRODUCTION ....................................................................................................... 1

Intended Use of the ITC AVOXimeter 4000...............................................................

Summary and Explanation of the Test.......................................................................

Glossary of Abbreviation Equivalents ……………………………………………………2

Operating Precautions and Warnings ........................................................................ 3

Limitations..................................................................................................................

1 1

2 DESCRIPTION ..........................................................................................................

Front Panel ................................................................................................................

Keypad .......................................................................................................................

Menus .......................................................................................................................

Test Cuvettes.............................................................................................................

Connections ...............................................................................................................

Automatic Standby and Shutdown.............................................................................

Instrument Lockouts...................................................................................................

Instrument Specifications.........................................................................................

Reportable Range........................................................................................

Accuracy ......................................................................................................

Precision ......................................................................................................

Interference..................................................................................................

Calibration................................................................................................................

3 GETTING STARTED...............................................................................................

Unpacking and Inspection........................................................................................

Materials Provided .......................................................................................

Materials Required But Not Provided ..........................................................

Optional Materials........................................................................................

Charging the Batteries .............................................................................................

Setting Up the Instrument ........................................................................................

Setting Display Backlighting ........................................................................

Specifying Units for Total Hemoglobin (THb) ..............................................

Enabling or Disabling Display of [sO2], [O2Ct], and [O2Cap]......................

Enabling or Disabling Suppression of Negative Values...............................

Changing the Date and Time.......................................................................

Setting the Standby Delay ...........................................................................

Specifying Entry of User ID and/or Patient ID..........................................................

Specifying Mandatory Entry of an Authorized User ID.................................

Specifying Optional Entry of a User ID Whenever a Test is Run.................

Specifying Optional Entry of a Patient ID Whenever a Test is Run .............

Specifying a Different Value for Hüfner’s Number ...................................................

Calibration................................................................................................................

Cuvette Calibration Code.............................................................................

Re-Calibration..............................................................................................

5 6 7 8 9 9 9

10 10 10 10 11

13 13

14 14 15

15 15 16 16 17

18 19

19 26 27

iii

4 OP .....................................................319

ERATION.....................................................

Startup ..................................................................................................................... 31

mple Collection and Preparation ......................................................................... 32

Sample Collection........................................................................................ 32

Sample Preparation ..................................................................................... 32

nning a Test.................................................................

Ru ........................................ 33

Running a Test on a Patient Sample ........................................................... 33

Using the Printer

Prin ing th esults................................................................. 35

Specifying Automatic Printing of Results ..................................................... 35

Changing the Serial Port Baud Rate and Parity .......................................... 35

Data Managemen .................................................................. 36

Revie ing st Sample................................................. 36

Locating, Reviewing, and/or Printing any Sample ....................................... 37

Printi g a .................................................. 37

Aborting Printing of Results ......................................................................... 37

Quality Con ......................................................................................................... 38

Performing Optical Quality Control .............................................................. 38

Run ng L ......... 40

Entering Liquid Control Lot Numbers........................................................... 42

Ente g C .............................................................. 43

Shutdown ................................................................................................................. 44

Troubleshoo ng ....................................................................................................... 45

...................................................................................................... 35

e Current Test Rt

t .................................

and/or Printing the Law

n ll Stored Data..............................

trol

ni iquid Controls .....................................................................

rin uvette Lot Numbers ......

5 MAINTENANCE ......................................................................................................49

Verification Ins ............................................................ 49

Cleaning the Opti

Replacing the B ................................................................................... 55

6 QUALITY CONTR .................................59

7 WARRANTY ............................................................................................................63

Certification, arranty and Service Warranty, and Service ..................................... 63

8 SAFETY ST ND ...............................................65

Guidance and Manufacturer’s Declaration – Electromagnetic Emissions.................... 66

Guidance an Ma y ................. 67

INDEX ......

of trument Temperature........

cal Detector .................................................................................. 50

tterya ............

OL LOGS ..................................................

A ARDS ............................................

d nufacturer’s Declaration – Electromagnetic Immunit

......................................................................................................69

Important Labels and Symbols

Before using the ITC AVOXimeter 4000, it is essential that the contents of this Operator’s Manual, any labels on the instrument or its packaging, and instructions accompanying ITC AVOXimeter 4000 cuvettes are read and understood by the operator. These materials make

reference to additional symbols that are explained below:

Product Conforms to Directive 98/79, 27 October 1998 on In-Vitro Diagnostic

Medical Devices

Serial Number of Instrument

Lot Number of Cuvettes

ITC Catalogue Number of Devices

Do Not Reuse– Single Use Only

Upper and Lower Temperature Limitations (For Storage or Use)

For in vitro Diagnostic Use

Attention - Read Accompanying Documentation or Instructions

Consult Instructions for Use

Input Port for DC Power Cord from AC/DC Power Module - Polarity, VDC and A Input

Serial Output Port for Data Transfer – RS232C

Temperature Probe Input

Name and Address of Manufacturer

Warning - Biohazard

Medical Equipment per Annex 1A, Item 8 Directive 2002/96/EC For Electronic Equipment Waste – Contact ITC Technical Support @ 1-800-631-5945

vii

1 Introduction

ITC AVOXimeter 4000 Operator’s Manual

Int

ended Use of the ITC

The ITC individual poi (%0 heparin ([0 saturation (S calc

No sample p

into a disp 00

then illuminat le at each of the d computes the results. In less than 10 seconds, the total hemogl methemo front panel.

Data man d with the instrument. These capabilities include stora tagging

AVOXimeter 4000 is a battery-operated desktop whole blood oximeter that performs

Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb) on freshly-drawn or

- or EDTA-anticoagulated whole blood samples. Oxygen content

ulated from the %Hb0

osable cuvette and inserting the cuvette into the instrument. The ITC AVOXimeter 40

obin concentration and the percentages of oxyhemoglobin, carboxyhemoglobin, and

globin in the sample are shown in appropriate units on the liquid-crystal display on the

agement capabilities are include

ge of up to 100 patient or QC results, designation of quality control levels and lot numbers,

of test results with date, time, Patient ID and/or Operator ID, and printing of results.

Summary

AVOX

nt-of-care measurements of total hemoglobin (tHb), oxyhemoglobin saturation

) and oxygen carrying capacity (O2Cap) of the blood sample are automatically

and THb measurements.

reparation is required, and analysis is quickly accomplished by injecting the sample

es the sample with multiple wavelengths, records the optical density of the samp

wavelengths, an

imeter 4000

Ct]), percent

and Explanation of the Test

The ITC disposable a whole blood sample into a cuvette, the cuvette is in results will pressed, cle

The result ca as run, the Patient ID, Operator ID, and othe which h th

Up to th e

in the ITC A

numbers ca authorized o run.

The ITC AVOXimeter 4000 measures oxygenated hemoglobin (O

(HHb), methemoglobin (MetHb), and carboxyhemoglobin (COHb) directly, using novel optics and multiple wavelengths. This reduces interference from dyshemoglobins and other interfering substances such as fetal hemoglobin and bilirubin and minimizes the effects of hemolysis.

AVOXimeter 4000 measures whole blood tHb, %02Hb, %COHb, and %MetHb using

single-use cuvettes. The operator inserts

serted into the test chamber on the instrument, and the results are displayed. The

remain on the display after the cuvette is removed from the instrument until any key is

aring the screen.

n be automatically printed along with the time and date the test w

r information entered. The result is also saved in an internal database,

e capability to store up to 100 results.

liquid control lot numbers for each level of Liquid Quality Control (LQC) can be stored

VOXimeter 4000 and must be tagged to the stored or printed records. Cuvette lot

n also be tagged to the LQC records. The instruments can be configured so that only

perators can operate the system and that patient IDs can be entered for each test

Hb), reduced hemoglobin

ITC AVOXimeter 4000 Operator’s Manual

The measured values are used to calculate total hemoglobin (tHb) and percent oxyhemoglobin saturation [%02Hb] of the s

ample, using the fractional method described below:

Hb) + (HHb) + (Me

(tHb) =

Hb) x 100

Hb =

(tHb)

Oxygen content [O

Ct] of the sample is then calculated:

1.39 x tHb x % O

Ct =

100

where 1.39 is the amount of oxygen assumed to be carried by one gram of oxygenated hemoglobin (Hϋfner’s Number). Depending on your facility protocols, the Hϋfner’s Number stored

in the ITC AVOXimeter 4000 can be set at any value in the range of 1.30 to 1.39 (see page 28).

Glossary of Abbreviation Equivalents

In some cases, the display screen of the ITC AVOXimeter 4000 does not show the most

commonly used format for a specific constituent’s abbreviation. Below is a glossary of

abbreviation equivalents to ensure that users fully understand each reading on the ITC AVOXimeter 4000 display.

Constituent

Total Hemoglobin tHb tHb Fractional O2 Saturation sO2 SO2 Oxygen Content O2Ct O2CT Carboxyhemoglobin COHb COHb Methemoglobin MetHb MetHb Oxyhemoglobin Saturation %O2Hb %O2Hb

AVOXimeter 4000

Display

tHb) + (COHb)

Conventional

Equivalent

Operating Precautions and Warnings

ITC AVOXimeter 4000 Operator’s Manual

● For in vitro Diagn

● Do not allow blood, water, or other liquids to enter the instrument.

ostic use.

● The ITC AVOXimeter 4000 instrument is designed for use only with ITC AVOXimeter

4000 cuvettes.

● Do not re-use test cuvettes.

● Always keep cuvettes in sealed bag with desiccant, and replace desiccant if the

indicat

or dot on the desiccant pack indicates the presence of mositure.

● When filling cuvette, do not use excessive pressure on the syringe or ca

vent patch to bulge outward by overfilling the cuvette.

● For proper calibration and calibr

in this manual. Controls from other sources may yield erroneous results.

● The ITC AVOXimeter 4000 instrument is designed to be used for testing in

stationary position. DO instrument.

● In order to charge the ITC AVOXimeter 4000 instrument, the AC power cord should

be plug to an ele ice outlet and the AC/DC power module while the DC p d from th ower module is plugged into the DC port in the back of the instrument.

● DO NOT expose the ITC AVOXimeter 4000 instrument to extreme temperature

(above 35°C, 95°F). Such exposure coul ance of any type of electronic instrumentation.

ged in

ower cor

NOT perform testing while carrying or holding the

ctrical serv

e AC/DC p

ation verification, use only the controls recommended

d affect the perform

use the

● DO NOT drop the ITC AVOXimeter 4000 instrument, and do not use the results if

the instrument is dropped during a test.

● Only properly qualified personnel should attempt rm work on the

ITC AVOXimeter 4000 instrument as identified in this manual.

● DO NOT remove the AC/DC power module from the ITC AVOXimeter 4000

instrument by

● The use of accessory equipment (e.g., printers, etc.) not identified in this manual

either in the patient vicinity, or safety requirements of this equ

lead to a reduced level of safety with the resulting system.

Any items ex biohazardous local regulatio

waste be disposed of in a specific manner. Waste material from the ITC AVOXimete 4000 which may be classified as biohazardous include used cuvettes. It is importan

that steps be taken to dispose of these materials in accordance with the prevailing

regulations in your location.

pulling on the cord.

that does not comply with either the equivalent

ipment or UL/IEC 60601-1 or IEC 60601-1-2, may

posed to human blood, plasma or serum must be handled cautiously as a

material in accordance with laboratory safety practices and federal and

ns. Federal, state and local laws and regulations require that hazardous

to open and perfo

ITC AVOXimeter 4000 Operator’s Manual

Limitations

Do not disturb the instrument while a test is in progress.

As with all diagnostic tests, ITC AVOXimeter 4000 test results should be scrutini

specific patient’s condition and therapy. Any results exhibiting incon he patient’s clinical status should be repeated or supplemented with additional te

sistency with t

st data.

zed in light of a

ITC AVOXimeter 4000 Operator’s Manual

)

Description

The ITC AVOXimeter 4000 (Figure 1) is a tabletop device for use at the bedside. It contains a test

hamber which performs all operations to measure the concentrations of reduced oxyhemoglobin

HHb), o ation (%0

( xyhemoglobin satur , carboxyhemo Hb), and methemoglobin (MetHb) of a whole blood sample after th inserts a te vette containing the sample into the test chamber.

Hb)

e operator

globin (CO

st cu

The concentration of total hemoglobin (tHb), the relative f (%COHb) and methemoglobin (%MetHb), and the ox then automatically calculated and reported.

Eac eter 4000 is calibrated at the factory. The ITC A 00 ca

h ITC AVOXim

oper om its internal batteries or from the AC charged

ated either fr

whenever the AC Adapter is connected.

Printer (Optional

Optical QC

ers Filt

Display

Panel

Test Chamber

Keypad

Test Cuvettes

Tempera

ractions of carboxyhemoglobin

ntent (0 ) of the blood sample are ygen co

adapter. The batteries are

ture

Prob

Finger Grip

VOXimeter 40 n be

Test Cuvette

Figu imeter 4000 Oximeter

re 1. ITC AVOX

Fro

nt Panel

The front panel (Figure 2) contains the test chamber, ke

pane r enters commands and information using the keypad.

l, and the operato

Whe mpleted, the results are shown on the

n the test is co

mem ent or future printing.

ory for curr

The display panel is illuminated to enhance visibility in low light conditions. The illumination can be adjusted (or turned off) to conserve power during battery operation.

a ypad with the key, action and

display panel and stored in system

nsmenu keys, number keys, and a display panel. Opera or instructio are shown on the display

ITC AVOXimeter 4000 Operator’s Manual

(

)

(

)

(

)

Chamber Number Keys (Blue) Test

Action Keys

White

Display

Panel

Keypad

The routine analysis of blood samples does not require the use of menus or the numeric keypad. However, these enable the user to take advantage of many useful features.

The purpose of each key is summarized below:

Key Purpose

Enter/On Key

Red

Menu Keys

White

Figure 2. Front Panel

Switch the instrument on. Select a command.

Display a menu of commands for calibration, printing, stored data, and shutdown.

Display a menu of commands for entering hemodynamic variables, entering device settings, entering the time and date, viewing battery status and temperature, and managing data.

Print the results that are displayed.

and

Respond to questions that are displayed.

Backspace over a numerical entry (such as a QC lot number) so that it can be corrected.

Return to the previous menu.

Enter characters for Operator IDs or Patient IDs. Enter a character for selection of a command.

Menus

ITC AVOXimeter 4000 Operator’s Manual

The pri pal m d below:

nci enus, their commands, and the procedure to access each menu are summarize

Note:

Pre

ss the

Menu Commands Access

Main Menu

Calib Submenu

Printer Mode Submenu

Stored Data Submenu

ration

button at any time to return to the previous menu.

Press the running or another menu is not active.

Press

main menu is displayed.

Press main menu is displayed.

Press

main menu is displayed.

key when a test is not

followed by while the

Computer Menu

Data Man Submenu

Device Settings Submenu (Page 1)

Device Settings Submenu (Page 2)

Time, Date, and Temperature Submenu

agement

Press the running or another menu is not active.

Press

computer menu is displayed.

Press computer menu is displayed.

Page 1 of the device settings men displayed.

Press

computer menu is displayed.

key when a test is not

followed by while the

followed by Press

followed by while the

while

u is

ITC AVOXimeter 4000 Operator’s Manual

Test Cuvettes

Tests are performed with single- ette contains a finger gri ort, , and a vent patch.

Optical

Window

p, filling p optical window

Figure 3. Test C

A whole bloo erte cting a small syringe containing the whole blood sample to the filling port an the syringe plunger to dispense appr b d into the test cuvette. Air escapes from the vent patch at the

oximately 50 µL of whole loo end of the test cuvette w syringe still attached) is details).

Note:

d sample is ins d into a test cuvette by conne

hile the whole blood sample is being inserted. The test cuvette (with the

then inserted into the test chamber of the instrument (see page 32 for

Be sure t the er by the edges or by the finger grip. Refer to the

package om e test cuvettes for storage and handling instructions.

o handle cuvette eith

insert acc panying th

use disposable test cuvettes (Figure 3). Each test cuv

illing Port

Finger Grip

Light Path

Vent Patch

uvette

d then gently pressing

● Rem y rom the exterior of the test cuvette before

● After filling the cuvette with blood, inspect the vent patches to ensure they

BIO WA G: Any items exposed to human blood, plasma or serum

mu led usly as a biohazardous material in accordance with lab fety s and federal and local regulations. Federal, state and local laws and regulations require that hazardous waste be disposed of in a

specific manner. Waste material from the ITC AVOXimeter 4000 which may be

classifie bioh include used cuvettes. It is important that steps be taken to materials in accordance with the prevailing regulations in your location.

ove an blood or debris f

inserting it into the test chamber.

are not bu ng out. If a ve

insert a c ette with a p

HAZARD

st be hand oratory sa practice

lgi nt patch protrudes, discard the cuvette. Do not

uv rotruding vent patch into the test chamber.

RNIN

cautio

d as dispose of the

azardous

BIO

must be handled cautiou a biohaz aterial ce w laboratory safety practice federal a regulat ral, sta local laws and regulations require that hazardous waste be disposed of in a

specific manner. Waste material from the ITC AVOXimeter 4000 which may be

class azard lude used es. It is im t that step taken to di se materials in accordance with the prevailing regulations

in your location.

Connections

ITC AVOXimeter 4000 Operator’s Manual

HAZARD WARNING: Any items exposed to human blood, plasma or serum

ified as bioh

spose of the

sly as

s and

ous inc cuvett portan s be

ardous m

nd local

in accordan

ions. Fede

ith

te and

Connections to the power supply and an optional printer (or a comp e at the rear of the instrument (Figure 4).

Carrying

AC Adapter

Connector

Auto

uter) are mad

Use only the power supply provided with the instrument.

Serial Number

Label

Handle

Printer or Computer Temperature Sensor Connector Connector

Figure 4. Rear Panel Components

matic Standby and Shutdown

The ITC A for a specified period of time (the standby delay). The instrument is factory preset for a standby delay time of 60 minutes, but a time of 10 to 180 minutes can be specified (see page 18). To

resume normal operation when the instrument is in standby, press and hold down any key for one second.

Note:

The ITC AVOXimeter 4000 shuts down after it has been in standby for 4 hours.

VOXimeter 4000 enters a low-power standby mode after the instrument has been idle

The ITC AVOXimeter 4000 also enters standby if the battery charge becomes

critically low.

Instrument Lockouts

The instrument can be configured to allow use only by authorized operators and/or to allow use only if optical QC has been performed.

ITC AVOXimeter 4000 Operator’s Manual

Instrument Specifications

Size

Weight

Operating Temperature

Battery Type

20.3 cm (8.0 in) x 25.4 cm (10.0 in) x 9.5 cm (3.8 in)

1.8 kg (4 lbs)

Room temperature (15°C to 30°C, 59°F to 86°F)

Nickel Cadmium (NiCad)

Approximately 8 hours (constant run) or 10 complete test cycles

Operating Time On Battery

per charge. Tests may also be run while the ITC AVOXimeter 4000 is plugged into the AC/DC power module.

Anticipated Battery Life Approximately 500 charge / discharge cycles

Power Supply/Chargers

Serial Data Port

Sample Type

Sample Volume

Analysis Time

Analysis Wavelengths

Input: 100 / 240 VAC, 50 / 60 Hz Output: 12 VDC, 800 mA

RS232C

Whole blood

50 µL

7 to 10 seconds per sample

Reportable Range

tHb

%COHb

4 to 25 g/dL

0 to 100%

0 to 75%

Accuracy

Precision

%MetHb

tHb (>10 g/dL) tHb (<10 g/dL)

%COHb

%MetHb

tHb

%COHb

%MetHb

]

0 to 85%

0 to 35 mL O

±0.45 g/dL

±0.35 g/dL

±1.6%

±2%

±1.5%

0.3 g/dL

0.8 % O

1 % COHb

0.7 % MetHb

/dL

ITC AVOXimeter 4000 Operator’s Manual

Interferences

tHb %O2Hb %COHb %MetHb

= 13.5 g/dL, HbF = 100%

(tHb

Indocyanine Green Dye

(tHb = 16 g/dL, MetHb <10%,

Calibrat

Bilirubin

(11 mg/dL)

Hemolysis

Fetal Hemoglobin

(<10 mg/L)

Methemo

7.1 < pH <

globin

ion

7.8)

None None < 1% < 1%

< 0.45 g/dL < 1% < 1%

< 0.45 g/dL < 1% < 1% < 1%

< 0.2 g/dL < 1%

< 0.6% per

%HbF

The ITC AV brated and employs highly stable state-of-the-art light

sources. Sho on be required please contact an ITC technical support represe ati

Proper calibration also req rrect cuvette pathlength by the user (see page 26) and use of a Hüfner’s number (see page 26).

OXimeter 4000 is factory-cali

uld recalibrati

nt ve.

uires entry of the co

customary value for

C rol results are not acceptable, errone s are

AUTION: If quality cont ous result

encountered, or error messages are displayed, the most likely cause may be contam re

ination of the optical detector by blood or debris, which cannot be resolved by

-calibration. Consult the Troubleshooting section for additional information.

ITC AVOXimeter 4000 Operator’s Manual

Getting Started

Unpacking and Inspection

Note: Inspect each component for d

your shipping representative immediately.

1. Remove any protectiv

2. Examine the packaging material to be sure that the AC Adapter, temperature

probe, connecting cables, or other components have been removed. The materials that are provided are listed below.

Note:

Do not discard the packaging material. It should be preserved

e use, in the event that it is necessary to re-pack the instrument for

futur

ping or transport.

ship

e packaging that may be present around the instrument.

amage when unpacking. If damage is observed, contact

for

Materials Provided

Item Quantity

ITC AVOXimeter 4000 Instrument 1

ow 1

P er Supply

Temperature Probe

Operator’s Manual 1

Quality Control Filters 2

Not

An AC power cord is supplied only for the 110VAC version of the US/Canada/Japan

instrument. For all othe that is compatible with an IEC 320 connection at the power supply AC inlet and any other local requirements.

rs, the customer must obtain a 3 conductor AC power cord

Materials Required But Not Provided

Item Quantity

ITC AVOXimeter 4000 Cuvettes As Needed

Liquid Controls (Manufactured by IL or RNA) See page 39 for additional information

As Needed

ITC AVOXimeter 4000 Operator’s Manual

Optional Materials

Item Quantity

Charging

Charge the batteries before the system is used for the first time.

1. Plug the AC Adapter into an electrical service outlet.

2. Connect the AC Adapter cord to the power connector on the rear of the instrument.

3. Allow the battery to charge for at least eight hours.

4. To ensure adequate charge, leave the instrument connected to the AC Adapter

Fully charged batteries will allow the ITC AVOXimeter 4000 to analyze blood samples

contin tness.

uously for up to 8 hours when the display is set at medium brigh

Dymo Printer

• 110 V (Part No. SE300-110)

• 220 V (Part No. SE300-220)

• UK (Part No. SE300-UK)

e 270) As NeePrinter Pap ded

r (Part No. 30

the Batteries

The AC Adapter can remain connected all the time.

Note:

for a minimum of eight hours. This eliminates the risk of the instrument powering down during a test.

Battery power can be conserved by:

● Reducing (or turning off) display backlighting (see page 15).

● Reducing the standby delay (see page 18).

Note:

The batteries can suffer from a “memory effect” if they are charged before being completely

dis

harged. For optimal battery performance, discharge completely when possible befo

c re

cha

rging them. The message “Battery Critical – Connect Charger” will be displaye battery is completely discharged.

the

The me the stand be used for a charged.

ssage “Battery Critical – Connect Charger” is displayed and the instrument reverts to

by mode if t e battery power is insufficient to complete the test. The AC Adapter must

dditiona tests until the battery is re

Checking the Battery:

1. Display the “Time, Date, and Temperature” menu (a submenu of

2. Press

followed by to display the battery status:

d when

, see page 7).

ITC AVOXimeter 4000 Operator’s Manual

The user ed for reporting total hemoglobin (THb), change the date and time, and specify the length of time that the instrument is idle before it enters the standby mode.

Setting Display Backlighting

Lighting of th or increased to improve visibility.

3. Press

4. Press

to display the time, date, and battery menu again.

to return to the previous menu, if desired.

etting Up the Instrument

can specify the display brightness, specify the units that are us

e display can be reduced to conserve battery power

1. Display the “Device Settings” menu (a submenu of

2. Press

backlighting:

followed by to display the screen for changing the LCD

, see page 7).

3. Select the ba er

Specif Total Hemoglobin (THb)

Measured val /dL.

ying Units for

ues of total hemoglobin can be expressed in units of mmol/L or gm

1. Display the “Dev , see page 7).

2. Press

hemoglobin:

3. Press

when the desired units are displayed. The “Device Settings” menu is again displayed.

4. Press

cklighting level (or turn it off) by pressing the corresponding numb

ed by ey follow

4. Press to display the “Device Settings” menu again.

followed by to display the screen for changing the units fo tot

followed by followed by to cha ge the units, or pressn

to return to the previous menu, if desired.

. The backlighting changes accordingly.

ice Settings” menu (a submenu of

r al

ITC AVOXimeter 4000 Operator’s Manual

nabling or Disabling Display of SO2, O2Ct, and O2Cap

Display of calculated oxygen content (02Ct), percent saturation (SO2) and oxygen carrying capacity (O2Cap) of the blood sample can be enabled or disabled.

Note:

Cap) are automatically calculate for each test.

When display of these values is enabled, these values are displ ayed on the second page (of three p (see page 36), and they are included in printed test results.

Only measured values of tHb, %HbO instrument display panel after a test is run, regardless of whether display of calculated oxygen o capacity (O2Cap) of

1. Display the second page of the “Device Settings” menu (a submenu of ).

Press to display the screen for enabling or disabling display

of calculated (0

3. Select the appropriate option by pressing the corresponding number key followed

4. Press

followed by

. A corresponding confirmation prompt is displayed.

to return to the previous menu, if desired.

ages) when results are reviewed in the ‘stored data’ menu

c ntent (0

the blood sample is enabled.

Ct), (SO2), and (O

Oxygen content (02Ct), percent satu on (sO2), and oxygen carrying capacity

rati

, %COHb, and %

Ct), percent saturation (SO2), and oxygen carrying

Cap) for each test:

MetHb are displayed on the

Enabling or Disabling Suppression of Negative Values

Users ca

n choose to display or suppress negative values.

Note:

Negative values may occur becaus e in some cases, due to instrument precision ranges, a very low Met- or Carboxyhemoglobin value may read as a negative value. Users can choose to suppress negative values, and have them read as ‘0’.

1. Display the second page of the “Device Settings” menu (a submenu of , se

page 7).

2. Press

of negative values:

3. Select the appropriate option by pressing the corresponding number key followed

by to the previous menu, if desired.

followed by to display the screen for enabling or disabling display

. A corresponding confirmation prompt is displayed. Press to return

ITC AVOXimeter 4000 Operator’s Manual

Changing the Date and Time

Changing the Time:

1. Display the “Time, Date, and Temperature” menu (a submenu of , see page 7).

2. Press

3. Press

4. Use the number keys to enter the new time, then press . The new time is

displayed.

Note: The time is displayed in 24-hour format. For example, 3:3

5. Press

displayed.

followed by

followed by to change the time:

to display the current time:

0 pm is

displayed as 1530.

followed by

The “Time, Date, and Battery” menu is again

6. Press

Changing the Date:

1. Display the “Time, Date, and Battery” menu (a submenu of

2. Press

3. Press

to return to the previous menu, if desired.

followed by

followed by to change the date:

to display the current date:

, see page 7).

ITC AVOXimeter 4000 Operator’s Manual

4. Use the number keys to enter the new date, then press

displayed.

5. Press The “Time, Date, and Battery” menu is again

displayed.

6. Press

followed by

to return to the previous menu, if desired.

. The new date is

Setting the Standby Delay

The instru mode after being inactive for a specified length of time (the Standby Del preset for a standby delay time of 60 minutes, bu

t a time of 10 to 180 minutes can be specified.

ment enters a low-power Standby

ay). The instrument is factory

1. Display the “Device Settings” menu (a submenu of , see page 7).

2. Press

factory default value):

followed by to display the standby delay (60 minutes is the

3. Press

4. U y delay (or disable the standby

se the number keys to enter the new standb

delay), then press

5. Press The “Device Settings” menu is again displayed.

6. Press

followed by to display the screen for changing the standby delay:

. The new standby delay is displayed.

followed by

to return to the previous menu, if desired.

ITC AVOXimeter 4000 Operator’s Manual

Specify

A User ID and/or Patient ID can be entered for any test. The User ID and/or Patient ID is included in the results record for tests that are run and can be included in the printed results. Three alternatives are available for entry of User ID:

● Authorized User ID with Security:

users is required in order to start the instrument and is not again prompted for until the instrument is restarted. The User ID that is entered to operate the instrument is included on all test records and can also be included on printed test results if specified.

● Authorized User ID without Security: Entry of a numeric User ID is prompted for

whenever a test is run. The operator can enter any numeric User ID (up to nine digits, with no leading zeros) or the operator can bypass entering a User ID for that test. If a User ID is entered, that User ID is included on the test record and can be printed with test results.

● Authorized User ID Disabled: A User ID cannot be entered.

A prompt can also be enabled for optional entry of a Patient ID whenever a test is run.

Specifying Mandatory Entry of an Authorized User ID

ing Entry of User ID and/or Patient ID

Entry of an authorized User ID from a list of authorized

Enabling the Requirement to Enter an Authorized User ID:

1. Display the “Data Management” menu (a submenu of

, see page 7).

2. Press

3. Press . A confirmation prompt is displayed, and the

“Security” menu is displayed:

4. Press . A confirmation prompt is displayed, and the

“Authorized User ID” menu is displayed:

Note:

5. If needed, review the list of authorized users, add or delete authorized users, print

the authorized user list, and/or specify whether authorized User IDs are included in the results printout (see below).

followed by to display the current User ID setting:

followed by

The authorized User ID must be re-entered if the instrument is idle for

longer than 15 minutes or is turned off.

ITC AVOXimeter 4000 Operator’s Manual

6. Press

to display the “Data Management” menu.

ITC AVOXimeter 4000 Operator’s Manual

Disabling the Requirement to Enter an Authorized User ID:

2. Press

u (a submenu of

followed by to display the current User ID setting:

,1. Display the “Data Managemen ent” m see page 7).

3. Press . A confirmation prompt is displayed, and the “User

followed by

and Patient ID” menu is again displayed.

4. Press

to return to the previous menu, if desired.

Adding an Authorized User ID:

1. Display the “Data Management” menu (a submenu of

2. Press

followed by to dis urrent User ID setting: play the c

, see page 7).

Note: User ID: must be ON to proceed.

3. Press

followed by . The “Security” menu is displayed:

Note: Security: must be ON to proceed.

Press4.

followed by to display the “Authorized User ID” menu:

followed by 5. Press to display the screen for entering a new User ID:

6. Enter the new User ID, using the number keys, then press

screen is displayed.

7. Press

followed by to confirm the new User ID. The “User ID” menu is

again displayed.

. A confirmation

ITC AVOXimeter 4000 Operator’s Manual

8. Press

to return to the previous menu, if desired.

ITC AVOXimeter 4000 Operator’s Manual

Reviewing and/or Deleting Authorized User IDs:

1. Display the “Data Management” menu (a submenu of

2. Press

Note:

3. Press

Note: Security: must be ON to proceed.

4. Press

followed by to display the current User ID setting:

User ID: must be ON to proceed.

followed by . The “Security” menu is displayed:

followed by to display the “Authorized User ID” menu:

, see page 7).

5. Press

6. Press to scroll through the list of users. To delete a user, display that user, press followed by

Note:

7. Press

8. Press

followed by to display the first User ID in the list:

, and respond to the confirmation prompt.

The default QA Use

deleted.

followed by to display the “Authorized User ID” menu.

to return to the previous menu, if desired.

r ID is 123456. The default QA User ID cannot be

ITC AVOXimeter 4000 Operator’s Manual

Printing a List of Authorized User IDs:

1. Prepare the printer (see page 35).

,2. Display the “Data Management” menu (a submenu of see page 7 ).

3. Press

Note:

4. Press

Note: Security: must be ON to proceed.

5. Press

6. Press to print the list. A message is displayed after the list

has printed:

followed by to display the current User ID setting:

User ID: must be ON to proceed.

followed by . The “Security” menu is displayed:

followed by to dis r ID” menu: play the “Authorized Use

followed by

7. Press to display the “User ID” menu.

8. Press

to return to the previous menu, if desired.

ITC AVOXimeter 4000 Operator’s Manual

Specifying Whether Authorized User IDs are Included on Results Printouts:

1. Display the “Data Management” menu (a submenu of

2. Press

Note:

3. Press . The “Security” menu is displayed:

Note: Security: must be ON to proceed.

4. Press

followed by to display the current User ID setting:

User ID: must be ON to proceed.

followed by

followed by to display the “Authorized User ID” menu:

, see page 7).

5. Press

6. Press

displayed, and the “Authorized User ID” menu is displayed.

7. Press

followed by to display the “User ID on Printout” menu:

followed by to change the setting. A confirmation prompt is

to return to the previous menu, if desired.

ITC AVOXimeter 4000 Operator’s Manual

Specifying Optional

Enabling Optional Entry of User IDs:

1. Display the “Data Management” menu (a submenu of

2. Press

3. Press

“Security” menu is displayed:

Note:

User ID: must be ON to display the Security menu.

4. Press . The “Data Management” menu is displayed.

Entry of a User ID Whenever a Test is Run

, see page 7).

followed by to display the current User ID setting:

followed by . A confirmation prompt is displayed, and the

followed by

Disabling Optional Entry of User IDs:

1. Display the “Data Management” menu (a subm

2. Press

3. Press

“Security” menu is displayed:

Note:

4. Press

followed by to display the current User ID setting:

followed by . A confirmation prompt is displayed, and the

User ID: must be ON to display the Security menu.

followed by . The “Data Management” menu is displayed.

enu of

, see page 7).

ITC AVOXimeter 4000 Operator’s Manual

Specifying Optional Entry of a Patient ID Whenever a Test is Run

Enabling Optional Entry of Patient IDs:

1. Display the “Data Management” menu (a submenu of

2. Press

3. Press . The “Data Management” menu is displayed.

Disabling Optional Entry of Patient IDs:

1. Display the “Data Management” menu (a submenu of

2. Press

3. Press . A confirmation prompt is displayed, and the “Data

Management” menu is displayed.

followed by to display the current Patient ID setting:

followed by

followed by to display the current User ID setting:

followed by

, see page 7).

ITC AVOXimeter 4000 Operator’s Manual

Specifying a Different Value for Hüfner’s Number

Hüfner’s number (the volume o to calculate the oxygen conten assumed to be 1.39 mL/gm, facilities may use a different value and may wish to set the ITC

AVOXimeter 4000 to match other instruments in the facility.

1. Display the “Calibration” menu (a submenu of

2. Press

value used for Hüfner’s number:

3. Press to display the screen for entering a different value:

4. Press the number key (e.g.,

Note:

A default value of 1.39 is entered at the factory. Values ranging from

f oxygen that can be carried by one gram of hemoglobin) is used

t of a sample (see page 1). Although Hüfner’s number is generally

, see page 7).

followed by

1.30 to 1.39 can be entered.

to display the screen for accep g tin or changing the

) corresponding to the new value:

5. Check that the new Hüfner’s numb r is correctly displayed, then press

followed by

6. Press to return to the previous menu, if desired.

. The “Calibration” menu is again displayed.

Calibration

The ITC AVOXimeter 4000 is factory-calibrated and employs highly stable state-of-the-art light

sources.

ITC AVOXimeter 4000 Operator’s Manual

Cuvettcy Calibration Code

Accura code (see cuvette calibration code whenever using a different lo

Note:

of total hemoglobin measurements depends on using the correct cuvette calibration page 1). The user must check the

t number of cuvettes.

for each

The lot number and calibration code are included on the carton label and bag lot of cuvettes.

Entering a Different Cuvette Calibration Code:

“Calibration” menu (a submenu of

2. Press

3. Press

cuvette calibration code is displayed:

4. Enter the new calibration code, using the number keys, then pre

confirmation

followed by to display the cuvette calibration code screen:

followed by to enter a new value. A screen for entering a new

screen is displayed.

,1. Display the see page 7).

ss . A

5. Press

menu is again displayed.

6. Press

followed by to confirm the new calibration code. The “Calibration”

to return to the previous menu, if desired.

Re-Calibration

If the ITC AVOXimeter 4000 results are out of range with either blood samples or controls and

troubleshooting does not resolve the issue, re-calibration may be necessary. Please contact ITC Technical Support for more information on re-calibration.

ITC AVOXimeter 4000 Operator’s Manual

4 Operation

ITC AVOXimeter 4000 Operator’s Manual

tartup

If Entry of an Authorized Us

If Entry of an Authorized User ID is Required: (see page 19)

er ID is Not Required: (see page 19)

1. Press

2. “READY” and “Insert Cuvette” a displayed when a test can be run: re

3. Confirm that the Cal Code is the same as the one marked on the package of

cuvettes. If not, change the Cal Code (see page 28).

Run the quality control test(s) for the day (see page 36).

1. Press

2. The screen for entering the User ID is displayed:

. The instrument starts and performs a series of self-tests.

3. Enter the User ID, then press

4. Press followed by . “READY” and “Insert Cuvette” are displayed when

e run: a test can b

5. Confirm that the Cal Code is the same as the one marked on the package of

cuvettes. If not, change the Cal Code (see page 28).

6. Run the quality control test(s) for the day (see page 36).

. A confirmation screen is displayed:

ITC AVOXimeter 4000 Operator’s Manual

Sample Collection

Collec ht w c x

ontain e

Note: Refer to CLSI document H18-A3, entitled “Pro cedures for the Handling and

ample Preparation

ole blood samples in a sodium or lithium heparinized syringe. Do not use samples that

cessive volumes of anticoagulant or are diluted with saline.

Processing of Blood Specimens – information on sample collection.

CAUTION

processing samples. Spills should be imme disinfectant solution to avoid spreading contamination to laboratory personnel or equipment.

1. If the sample was not infused into the cuvette immediately after blood d

2. Connect a syringe containing the sample to an unused cuvette. Hold the cuvette

: Universal safety precautions should be taken when handling and

the whole blood sample by rolling the syringe between the palms of your hands.

by means of the finger grip on the black cap (see below).

and Preparation

Approved Guideline, Third Edition” for additional

diately disinfected with an appropriate

raw, mix

3. Firmly holding the syringe and cuvette at a 45 degree angle, fill the cuvette by

gently pressing the syringe plung

CAUTION: Never force sample into the cuvette. If a cuvette does not fill easily, discard it and use a new one.

4. Stop filling the cuvette when the sample reach

to fill the cuvette and cause the vent patch to bulge.

CAUTION: Carefully review the additional precautions on

5. Verify that the light path area is free of bubbles.

6. Remove any blood from the exterior of the cuvette before pla

syringe still attached) into the test chamber.

er.

es the vent patch. Do not continue

page 8.

cing the cuvette (with

Running a Test

Running a Test on a Patient Sample

1. Verify that the instrument is ready to run a test and that the “READY” - “Insert Cuvette” screen is displayed:

2. Holding the cuvette by the finger grip on the black cap, insert the cuvette (with the

syringe still attached) into the test chamber.

ITC AVOXimeter 4000 Operator’s Manual

Important: Always keep the syringe attached when inserting the cuvette into the

3. If optional entry of User IDs is enabled (see page 26), the screen for entering a

User ID is displayed:

test chamber. Removing the syringe may cause in

CAUTION: Never inject sample directly into the test chamber.

CAUTION: Carefully review the additional precautions on page 8.

accurate results.

Enter the User ID, then press

press

Note:

followed by .

To bypass entry of a Use , enter a zero and then press

ID is displayed.

, or simply press

. When the confirmation screen is displayed,

r ID, either press

when the screen for entering a User

ITC AVOXimeter 4000 Operator’s Manual

layed: 4. The screen for specifying the sample type is disp

5. Press

6. If optional entry of Patient IDs is enabled (see page 26), the screen for entering a

Patient ID is displayed:

Note:

● If the Patient ID that was previously entered during the current session is to

followed by .

To bypass entry of a Patient ID, press .

be used, press

screen for entering a Patient ID is displayed:

Enter the Patient ID, then press displayed .

, press

followed by . A confirmation screen is displayed.

followed by

. When the confirmation screen is

followed by ● If a new Patient ID is to be entered, press . The

ten seconds: 7. Test results are displayed within

Note:

8. Holding the cuvette by the finger grip on the black cap, remove the cuvette from

the test chamber.

The oxygen content (O2Ct) of the sample is calculated and included in the test record. The (O the stored data record, but is not displayed.

Ct) result is included in the results printout and in

Using the Printer

ITC AVOXimeter 4000 Operator’s Manual

An optional printer can be connected by means of the serial port at the rear of the instrument ( page 9).

Contact your ITC representative to purchase the o

ptional printer. Note:

Printing the Current Test Results

1. When the test results are displayed on the screen, press .

Specifying Automatic Printing of Results

test. The instrument can be configured so that results are automatically printed at the end of a

1. Display the “Printer Mode” menu (a submenu of

2. Press

3. Press

Mode” menu is again displayed.

followed by to display the automatic printing screen:

followed by . A confirmation prompt is displayed, and the “Printer

, see page 7).

see

4. Press

to return to the previous menu, if desired.

Changing the Serial Port Baud Rate and Parity

If a computer is being connected to the ITC AVOXimeter 4000, the baud rate and parity of the

seri mmunication. al port on the instrument may need to be changed to optimize co

1. Display the “Printer Mode” menu (a submenu of , see page 7).

2. Press

3. Press

displayed, press

4. Press

correct va press

5. Press

followed by to display the port parameters:

and/or to change the baud rate. When the correct value is

to advance the cursor to the “Parity” field.

and/or to toggle between NE,” “ODD,” and “EVEN.” When the

lue is displayed,

to confirm the new values. The “Printer Mode” menu is again displayed.

“NO

6. Press

to return to the previous menu, if desired.

ITC AVOXimeter 4000 Operator’s Manual

Stored results can be reviewed, printed, and purged (if desired).

Reviewing and/or Printing the Last Sample

ata Management

CAUTION: Once the instrument database contains the results of 100 tests, the results from the oldest test are automatically deleted when a test is run. Use the Data Transfer function to transfer data to an information system.

1. (If needed) Turn on the printer.

2. Display the “Stored Data” menu (a submenu of , see page 7).

3. Press

4. Press

● The second and/or third page(s) of results for a Patient sample contains

followed by . The last test record is displayed:

either th se U

again to display the second page of results for that sample.

er ID, Patient ID, and calibration code, or if

If SO

is ‘on’ (see page 16), SO

Note:

● cond p fo ua t con

The se age of results r an optical q lity control tes tains the User ID and filter color:

● The second page of results for a liquid quality control test contains the

User ID, liquid control lot number, cuvette lot number, and calibration code:

5. Press

6. Press

to print the test record.

to return to the previous menu, if desired.

and O page the patient re Patient ID and calib cod shown o rd page.

capacity will be shown

of cord, ser ID

ration

n the thi

, O2 content,

on the second

and the U

e will be

ITC AVOXimeter 4000 Operator’s Manual

Locating, Reviewing, and/or Printing any Sample

1. (If needed) Turn on the printer.

menu (a submenu of

3. Press

displayed:

4. Enter the desired record number and press

sample record:

5. Press

sample.

6. If needed, press (to view the previous record).

7. Press

8. Press

followed by . A screen to specify the test record number is

again to display the second and/or third page of results for that

(to view the next record) or

to print a test record while it is displayed.

to return to the previous menu, if desired.

,2. Display the “Stored Data” see page 7).

to view the first page of the

Printing all Stored

1. (If needed) Turn on the printer.

2. Display the “Printer Mode” menu (a submenu of

3. Press

test. The record number is displayed as each record is printed:

4. When printing is completed, the “Printer Mode” menu is again displayed.

5. Press

Data

followed by . All test records are printed, beginning with the latest

to return to the previous menu, if desired.

Aborting Printing of Results

1. Press while results are printing to discontinue printing of additional results. A

confirmation prompt is displayed, indicating that all samples were not printed.

2. Press

to return to the main menu.

, see page 7).

ITC AVOXimeter 4000 Operator’s Manual

Quality

Routine quality control testing should be part of a comprehensive quality assurance program.

Quality control testing of the ITC AVOXimeter 4000 consists of the following operations:

● Daily optical quality control.

● Weekly testing of one level of liquid controls.

In addition, the heck” to verify that the light source is operating properly every time it is turned on.

If quality control results are out of range, refer to the Troubleshooting section for

Note:

Performin

The yellow and orange optical filters supplied with the ITC AVOXimeter 4000 provide a

convenient m instrument is ing a blood sample of known composition and has a serial number that matches the serial number of the instrument.

Control

ITC AVOXimeter 4000 performs a “self-c

instructions. If the “self-check” fails, con chnical Support (see page ii).

g Optical Quality Control

eans of verifying that the optics are not obscured by blood or debris and that the properly calibrated. Each filter simulates a cuvette contain

CAUTION: Each filter is labeled with a serial number that matches the serial num ber of the instrument. Verify that the serial n mber on each filter matches the serial number of the instrument when perform ical quality control. Each set of yellow and orange f serial number and struments.

ilters can only be used only with the ITC AVOXimeter 4000 of the same

cannot be shared between different in

tact ITC Te

ing opt

1. Verify that the instrument is ready to run a test and that the “READY” - “Insert Cuvette” screen is displayed:

2. Insert the yellow optical filter into the test chamber.

3. If optional entry of User IDs is enabled (see page 26), the screen for entering a

User ID is displayed:

Enter the User ID, then press

press

Note:

followed by .

To bypass entry of a User ID, either press , enter a zero and then press

ID is displayed.

, or simply press

. When the confirmation screen is displayed,

when the screen for entering a User

ITC AVOXimeter 4000 Operator’s Manual

4. The screen for specifying the sample type is displayed:

5. Press

6. Press

7. Press the number key corresponding to the filter being run, followed by .

Press displayed, and test re sults are displayed within ten seconds.

8. Record the THb, %O

test (see page 35).

9. Press any key to clear the results, then repeat steps 2 through 8 using the orange

filter.

10. Verify that the results for each filter are within the expected ranges listed bel

Optical Filter

followed by . The screen for specifying QC type is displayed:

followed by . The screen for specifying filter type is displayed:

followed by

tHb (g/dL) %O2Hb %COHb %MetHb

to confirm your selection. A confirmation screen is

Hb, %COHb, and %MetHb results, or print the results of the

ow:

Expected Range

Yellow 7.8 to 8.2 93.7 to 96.3 0.6 to 3.4 -0.4 to 2.4

Orange

The Expected Range is also shown on a sticker on the side of each filter.

Note:

11. If desired, plot the optical filter results on daily logs such as the ones shown in the

Quality Control Logs section on page 57.

16.7 to 17.3 37.8 to 40.2 20.0 to 23.0 0.2 to 1.8

ITC AVOXimeter 4000 Operator’s Manual

Running Liquid Controls

ITC recommends either of the following Liquid Quality Controls (LQC):

● RNA CO-Oximeter controls, available from RNA Medical, Devens, MA., phone 978 772-

9070 or toll-free 800-533-6162.

● Multi-4™ CO-Oximeter controls, available from Instrumentation Laboratory, Inc.,

Lexington, MA., phone toll-free 800-955-9525.

1. Verify that the instrument is ready to run a test and that the “READY” - “Insert Cuvette” screen is displayed:

2. Fill a test cuvette with a liquid control (see page 32).

3. Insert the test cuvette into the test hamber (see page 33). c

4. If optional entry of User IDs is enabled (see page 26), the screen for entering a

User ID is displayed:

Enter the User ID, then press

press

Note:

5. The screen for specifying the sample type is displayed:

7. Press . The screen for specifying the control level is

displayed:

followed by .

To bypass entry of a User ID, either press , enter a zero and then press

ID is displayed.

followed by 6. Press . The screen for specifying QC type is displayed:

followed by

, or simply press

. When the confirmation screen is displayed,

when the screen for entering a User

ITC AVOXimeter 4000 Operator’s Manual

8. Press th

e number key corresponding to the liquid control level being run, followed

. A menu for selection of the liquid control lot number is displayed:

9. Select the previously entered (see page 38) lot number and press . A

cuvette lot number screen is displayed:

followed by

● If a new lot number must be entered, press followed by . A

. A confirmation screen is displayed.

screen for entry of the cuvette lot number is displayed:

Enter the new cuvette lot number, using the number keys, then press

. A confirmation screen is displayed.

● If the previously entered cuvette lot number is to be used, press

10. Press

followed by to confirm the cuvette lot number. A screen for final

confirmation of the liquid control lot number and cuvette lot number is displayed:

11. Press to confirm the lot numbers. Test results are displayed

followed by

within ten seconds.

12. Record the THb, %O

Hb, %COHb, and %MetHb results, or print the results of the

test (see page 35).

13. Verify that the results are within the expected range of values for the liquid control.

14. If desired, plot the liquid control results on daily logs such as the ones shown in

the Quality Control Logs section on page 57.

ITC AVOXimeter 4000 Operator’s Manual

Entering Li

T ch of three levels of liquid control ca e instrument for

hree lot numbers for ea n be entered into th

ater reference.

quid Control Lot Numbers

1. Display the “Da ubme

2. Press

3. Select the level for which a lot number is to be . A menu added and press

for selection of a lot number is displayed:

4. Select the lot to be changed and press

is displayed:

ta Management” menu (a s nu of

followed by to display a menu for selection of a control level:

. A screen for entry of the lot number

, see page 7).

5. Press to enter a new value

6. Enter the ne k

confirmation sc

7. Press

Management” m

8. Press

followed by

w lot number, using the number eys, then press

reen is displayed.

followed by to confirm th

enu is again displayed.

to re if d ired.

turn to the previous menu, es

e ne

w lot number. The “Data

. A

ITC AVOXimeter 4000 Operator’s Manual

Entering Cuvette Lot

T uvettes n

he lot number of c can be entered into the instrume t for later reference.

1. Display the f

2. Press

displayed:

Enter the ne ing the n4. w cuvette lot number, us umber keys, then press

confirmation

5. Enter the w lot number, using the number

Numbers

“Calibration” menu (a submenu o

followed by to display the cuvette lot number screen:

3. Press followed by . A screen for entry o te lot number is

screen is displayed.

ne key

n scconfirmatio reen is displayed.

, see page 7).

f the etcuv

s, then press

. A

6. Press

menu is again displayed.

followed by to confirm the new l ”

ot number. The “Calibration

ITC AVOXimeter 4000 Operator’s Manual

Shutdown

1. Press (see page 7).

2. Press

Or:

1. Simultaneously press

followed by

The instrument will

and

The instrument will shut down.

shut down.

Troubleshooting

Symptom Possible Cause Action Required

ITC AVOXimeter 4000 Operator’s Manual

The instrument does not turn on.

The instrument does not respond to keystrokes or cuvette insertion.

Self-Test fails on power-up. The following error message is displayed:

"Cuvette Inserted???"

2. Intensities are out of range.

1. The battery is discharged, and the AC Adapter is not connected to an AC outlet and/or the instrument.

1. The microprocessor is locked up.

1. A cuvette is inserted in the instrument. If a cuvette is not inserted in the instrument, see #2 below:

1. Connect the AC Adapter to an AC outlet and the ITC

AVOXimeter 4000.

1. Press the simultaneously to turn the instrument off, then turn the instrument back on.

2. If this fails, contact ITC Technical Support (see page ii).

1. Remove cuvette, turn unit off and restart.

2. At "Cuvette Inserted???"

screen, press Diagnostic M ss any

key and then adjust light sources. When program finishes, turn the instrument off and then on.

and keys

twice for

ode. Pre press

to re-

3. The cable from the detector to the circuit board is disconnected.

4. There is no power to the LEDs. The LED cable may be loose, disconnected or improperly placed on the connector at one or both ends.

5. One or more LEDs is defective.

6. The cuvette door is partially open

The external printer is not printing.

2. The printer is not connected

3. The wrong print mode,

4. The microprocessor is

1. There is no power to the printer.

to the instrument.

baud rate, or parity is selected.

locked up.

3. Open the case and check that the cables are properly connected.

4. Open the case and check that the cables are properly connected.

5. Contact ITC Technical Support (see page ii).

6. Contact ITC Technical Support (see page ii).

1. Connect the printer to an AC outlet and turn on the printer.

2. Connect the printer to the ITC AVOXimeter 4000 (see page 9).

3. Specify the proper values for the printer (see page 35).

4. See above.

ITC AVOXimeter 4000 Operator’s Manual

Symptom Possible Cause Action Required

Measurements of %HbO

are not

accurate

Measurements of THb are not accurate

One of the following ERROR: messages is displayed:

“%HbO2<> XX.X%“ or “%HbCO<> XX.X%“ or “%HbMet<

> XX.X%“ or

“%RHb<> XX.X%“

1. The optical d contam foreign

etector may be

inated by blood or

material.

2. The instrument may require calibration.

1. The wrong cuvette calibration code is entered

1. Run optical quality control. If needed, clean the optical detector (see page 49).

2. Re-calibrate the instrument (see page 29).

1. Obtain the correct cuvette calibration code from the

into the instrument. cuvette carton and enter the

value (see page 29).

2. The optical detector may be 2. Clean the optical de contaminated by blood or

page 49).

tector (see

foreign material.

3. The instrument may require calibration.

1. A cuvette without a sample was inserted.

2. The cuvette was not properly filled.

3. The optical detector may be contaminated by blood or for n material. 3. Run optical quality control.

eig

3. Re-calibrate the instrument (see page 29).

1. Test a new cuvette that contains the sample.

2. Ensure that the sample reaches the vent patch when filling and that there are no air bubbles in the optical window.

needed, clean the optical detector (see page 49

4. LED intens

ities are too low. 4. Remove cuvette, turn unit off,

and resta

rt. Verify that the self

test passes.

5. The sample is lipemic. 5. If possible, obtain a replacement sample that is n lipemic.

The followi messag

ng ERROR: 1. THb may

e is displayed: this cas

“THb < 4.0 g/dL“

he following ERROR:

messag

“T

THb an readi oran rang

e is displayed:

Hb > 25.0 g/dL“

d/or %HbO2

ngs for yellow or ge filter are out of e.

actually be low. In

e, values of THb

and %H

urate.

acc

not likely to be

1. THb may actually be high In this case, values of TH and %HbO

not likely to be

accurate.

1. The optical detector may be contaminated by blood or foreign material.

2. The instrument may require calibration.

1. Contact ITC Technical Support (see page ii).

1. Contact ITC Technical Support

(see page ii).

1. Clean the optical detector (see page 49).

2. Re-calibrate the instrument (see page 29).

ITC AVOXimeter 4000 Operator’s Manual

Symptom Possible Cause

The following ERROR: 1. Microprocesso message is

“Uninitializ d Vector Service Re uired“

displayed:

r error.

Action Required

1. Press the imultaneously to turn the

and keys

instrument off, then turn the instrument back on.

2. If the problem persists, contact

ITC Technica

l Support (see

page ii).

ITC AVOXimeter 4000 Operator’s Manual

5 M

Periodic maintenance procedures must be performed on the ITC AVOXimeter 4000 in order to

assure consistent efficient performance or to repair/replace user-serviceable components.

Inspect and clean the exterior of the instrument as required. Remove residual dried blood or other foreign matter using a water-dampened cloth.

Only qualified personnel should perform maintenance as described in t

All maintenance procedures performed on the instrument should be documented in order to comply with requirements for laboratory quality assurance.

aintenance

his manual.

CAUTION: Maintenance procedures involving opening the instrument are only to be conducted after assuring that the AC adapter has been disconnected from both the instrument and a source of AC power.

Verification of Instrument Temperature

Materials Needed: 1. A thermometer that is calibrated a

National Institute of Standards and Technology (NIST) standards (or other national standards). The

thermometer should be accurate to ±0.5 °C

nd traceable to

1. Using rubber bands or adhesive tape, attach the bulb end of the thermometer to

the circular disk at the end of the ITC AVOXimeter 4000 temperature probe.

2. Ensure that the probe and the thermometer are in a thermally stable environment

and not in air currents.

3. Start the instrument.

4. Wait ten minutes.

5. Display the battery status screen (page 14).

6. Record the temperatures displayed on the battery status screen. Then read the

thermometer and record it as well.

7. If the ITC AVOXimeter 4000 temperature reading is within ± 3°C of the NIST traceable thermometer, the ITC AVOXimeter 4000 is properly calibrated. If the ITC AVOXimeter 4000 differs from the thermometer by more than 3°C, call ITC

Technical Support (800) 631-5945.

2. Rubber bands or adhesive ta

ITC AVOXimeter 4000 Operator’s Manual

Cleaning the Optical Detector

Materials Needed: 1. # 0 Phillips screwdriver

1. Disconnect the ITC AVOXimeter 4000 from the AC Adapter.

2. Remove the four screws from the bottom of the instrument, using the #0 Phillips

screwdriver.

3. Holding the upper and lower covers together, place the instrument in the upright

position, with the keypad to your right.

4. Slowly and carefully lift the upper cover, keeping it parallel with the lower part of

the instrument, until the upper cover is free of the rear panel.

5. Locate the cable that runs from the battery pack to the main circuit board (see below). Disconnect the cable from the J302 connector on the main

2. 5 mm nutdriver

3. 1/4 inch nutdriver

circuit board.

Battery Cable

6. Tilt the

circuit board on the lower part of the instrument.

7. Locate the flat keypad cable Disconnect the cable from the Keyboard (J101) connector on the main circuit board.

8. Locate the flat LCD cable that runs from the LCD to the main

Disco ct the cabl b

upper cover backward to fully expose the main circuit board and small

that runs from the keypad to the main circuit board.

circuit board.

oard.

Note:

nne

Grasp only the conn connector in an upward direction to remove it.

e from the Display (J102) connector on the main circuit

ector at the end of the cable. Gently rock the

ITC AVOXimeter 4000 Operator’s Manual

Keypad Cable

Display Cable

9. Locate the flat cable that runs from the black optical unit to the main circuit board. Disconnect the cable from the J203 connector on the main circuit board.

10. Locate the coaxial cable that runs from the black optical unit to the small circuit board. Disconnect the cable from the J1XX connector on the small circuit board.

11. The upper cover containing the black optical unit can now be rested on a table

with the front panel facing down.

12. Using the 5mm nutdriver, remove the four nuts (and washers, if applicable) that

secure the black optical unit to the front panel. Then remove the black optical unit from the instrument.

Black Optical Unit

ITC AVOXimeter 4000 Operator’s Manual

13. Using the 1/4" nutd

halves of the black optical unit. Do not los aside in a safe pla

river, remove the four screws and four nuts that secure the two

optical unit. Take care when separating the two halves of the

e the small torsion spring or the

ce r

for eassembly.

shutter door. Set them

Black Optical Unit

14. Clean the exposed detector with gauze pads dampened with detergent. Do not

use abrasives. Then d Remove any other de

ry off the detector surface, making sure that it is clean.

bris inside the optical unit.

15. Reassemble the two halve

and torsion spring are installed correctly (the

s of the optical unit, making sure that the shutter door

two door ribs will face outward). One

leg of the spring fits into a hole in the door slot, the other leg rests behind the shutter door. Bolt the optical unit back together.

Long End of

Torsion Spring

Short End of Torsion Spring

ITC AVOXimeter 4000 Operator’s Manual

16. Place the optical unit back on the front panel. Using the 5mm nutdriver, secure the

black optical unit to the front panel with the four nuts (and washers, if applicable).

Optical Unit

17. Position the upper cover (containing the black optical unit) in an upright position

over the lower part of the instrument, with the keypad to the right.

18. Connect the coaxial cable from the optical unit to the J1XX connector on the small

circuit board.

19. nect the flat cable from the optical unit to the J203 connector on the main

Con circuit bo

20. Connect the flat cable from the LCD to the Display (J102) connector on the main

circ

21. m the keypad to the Keyboard (J101) connector on the

Connect the flat cable fro main circuit board.

22. Connect the cable from the battery pack to the J302 connector on the main circuit

board.

23. Slowly and carefully lower the upper cover onto the lower part of the instrument,

ensuring that the metal rear panel slides into the center slot at the rear of the upper cover.

Note:

24. Using the #0 Phillips screwdriver, secure the bottom of the instrument to the upper

cover with the four screws.

25. Connect the AC adapter and turn on the instrument. The self-test should run and the “Ready – Insert Cuvette” screen should be displayed.

Note:

ard.

uit board.

Ensure that the cables are not snagged or crimped between components

when lowering the upper cover onto the lower part of the instrument.

If the self-test fails or an error message is displayed, the most likely

cause is improper reassembly or incorrect connections. Should this occur, disconnect the AC adapter and confirm that all connections have been made properly. Should the problem persist, contact ITC Technical Support.

26. Reset the time and date (see page 16), and run optical quality control (see page

36)

ITC AVOXimeter 4000 Operator’s Manual

Replacing the Battery

Materials Needed: 1. # 0 Phillips screwdriver

ITC AVOXimeter 4000 Operator’s Manual

1. Steps 1 Materials Needed:

2. Using rubber bands or adhesive tape, attach the bulb end of the thermometer to

the circular disk at the end of the ITC AVOXimeter 4000 temperature probe.

3. Ensure that the probe and the thermometer are in a thermally stable environment

and not in air currents.

4. Start the instrument.

5. Wait ten minutes.

6. Display the battery status screen (page 14).

7. Record the temperatures displayed on the battery status screen. Then read the

thermometer and record it as well.

through 11 of the Verification of Instrument Temperature

2. Diagonal cutting pliers

3. Replacement battery with cable (E4-BATP)

4. Securing cording (packaged with replacement battery)

1. A thermometer that is calibrated and traceable to

National Institute of Standards and Technology (NIST) standards (or other national standards). The thermometer should be accurate to ±0.5 °C

2. Rubber bands or adhesive tape

8. If the ITC AVOXimeter 4000 temperature reading is within ± 3°C of the NIST

traceable thermometer, the ITC AVOXimeter 4000 is properly calibrated. If the ITC AVOXimeter 4000 differs from the thermometer by more than 3°C, call ITC

Technical Support (800) 631-5945.

9. Cleaning the Optical Detector procedure on page 49 Must be performed before

moving to step 2 of “Replacing the Battery”, below.

The battery is housed in the lower cover.

Note:

10. Using the diagonal cutting pliers, cut the plastic ties that secure the battery to the

frame.

Be sure to cut only the white plastic ties that are wrapped around the

Note:

battery and secure it to the lower cover. Do not cut the blue and white power cables that are connected to the top of the battery.

ITC AVOXimeter 4000 Operator’s Manual

Plastic Tie

11. Remove the battery, being careful not to snag any components when pulling the

cable out from underneath the main circuit board. If the battery well contains tape, remove the tape.

12. Remove the liner from the tape on the bottom of the new battery, and place the

new battery in the battery well with the tape side down, ensuring that the blue and white cables are facing up, then route the new plastic ties (packaged with the replacement battery) underneath the battery well.

Blue and White Batter

Cable

New Plastic Tie

New Battery

ITC AVOXimeter 4000 Operator’s Manual

13. Secure the new battery in the battery well, using the new white plastic ties.

When securing the battery to the battery well, be sure that the plastic ties

Note:

are routed underneath the battery well. Cut the excess length from the plastic ties using the diagonal cutting pliers.

14. Thread the blue and white battery cable of the new battery under the main circuit

board.

15. Re-connect the cables, replace the upper cover of the ITC AVOXimeter, connect the AC adapter, and turn on the instrument.as outlined in Steps 17 through 25 of the Cleaning the Optical Detector procedure on page 49. The self-test should run and the “Ready – Insert Cuvette” screen should be displayed.

Be sure to connect the blue and white battery cable last.

Note:

The new battery is not charged. To ensure adequate charge, leave the instrument connected to the AC Adapter for a minimum of eight hours. Tests can be run while the instrument is charging.

16. Reset the time and date (see page 16).

ITC AVOXimeter 4000 Operator’s Manual

6 Quality Control Logs

Quality control logs for the yellow and orange filters are shown on the following pages.

ITC AVOXimeter 4000 Operator’s Manual

7 Warranty

Certification, Warranty and Service Warranty, and Service

ITC, declares to the origina

by ITC, or sold by an a

sold material an nship

for a period of one year from

it shipping date, except as otherwise prov

s obliga ited to repairing, replacing, or modifying (at ITC's undisputed

ITC' tion is lim

dgment) a ctory, or elsewhere, the material whose defects have been

rified, on condition that the purchaser has informed ITC of any defects found

ithin 15 days from receipt. Damage

cluded. Tra

ex and shall al Thes the above specified warran

warranty does not cover those parts that deteriorate, or which are in any case

The consid norma

also understood that, following the purchase and delivery of the instrument,

It is the purchaser shall be deemed liable for any losses, damages, or complaints concerning persons or things incurred by the use, or misuse of the instrument, on behalf of the purchaser, its employees, co-operators, or others. ITC does not assume any obligation or warranty engagement concerning precision and/or accuracy of the measurements, as well as for any damage to the instrument, directly or indirectly resulting from the use of reagents and/or consumables different from those produced by ITC specifically for its own instruments, and for the same properly tested.

d workma

t ITC's faju

nsport to and

so be pre

e replacements, repair

ered les, or those parts or “items”, which by their nature are

consumab

lly requ aced periodically consistent with normal maintenance.

ired to be repl

l purchaser that each instrument manufactured and

uthorized ITC dealer, shall be free from defects in

and, under normal and proper use conditions, warrants

installation and no more than 13 months from the

ided in writing.

s caused by or connected to transport are

from ITC facility will be at purchaser’s charge and risk,

paid f

or reshipment, except as otherwise provided in writing.

s, or alterations will in no case determine extension to

ty period.

Warranty will not apply to those defective instruments or materials showing defects or damage arising from the following causes:

1. Insufficient or negligent care by the purchaser.

2. Insufficient or negligent maintenance by the purchaser in relation to the instructions contained in the manuals prepared by ITC for this purpose; tampering or alterations of the instruments, or in any case interventions or repairs made by any person not duly authorized by ITC.

3. Misuse due to carelessness, negligence, or inexperience.

4. Employment of materials under heavier conditions than those for which they have been designed and manufactured, and use of the same in combination with incompatible or dangerous products.

5. Non-observance of the regulations relevant to installation, power supply, and operation of the instruments (with particular regard to the regulations for accident prevention).

ITC AVOXimeter 4000 Operator’s Manual

THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER WARRANTIES, EXPRESS OR IMPLIED. PURCHASER AGREES THAT THE

NO WARRANTY OR MERCHANTABILITY AND THAT THERE ARE NO

IS OTHER REMEDIES OR WARRANTIES, EXPRESS OR IMPLIED, WHICH EXTEND BEYOND THE CONTENTS OF THIS AGREEMENT.

No agent or employee of ITC is authorized to extend any other warranty or to assume for ITC any liability except as above set forth.

se c chn any m

Plea ontact ITC Te ical Support if alfunction is discovered.

8 Safety Standards

The ITC AVOXimeter 4000 instrument complies with the following safety standard requirements

and directives:

CSA C22.2. 601.1. Medical Electrical Equipment –General Requirements for Safety

ITC AVOXimeter 4000 Operator’s Manual

EN 60601-1/ UL/IEC 60601-1

EN 60601-1-2 / IEC 60601-1-2

Directives: 89/336/EEC and as amended by 91/263/EEC, 92/31/EEC, 93/68/EEC and 98/13/EC, 98/79/EC

Equipment Classifications As Defined Per UL 60601-1:2003/ IEC60601-1 2nd Edition

Protection against electrical shock: Class II, Internally Powered Equipment with no applied parts

Protection against ingress of liquids: Ordinary (no protection as defined by IEC 529)

Product cleaning and disinfection: Only according to recommendations of the manufacturer’s accompanying documentation

Mode of operation of equipment: Continuous

Degree of safety of application in the presence of flammable anesthetic mixture with air, oxygen or nitrous oxide: Not Suitable

Note:

As defined in the above standards, the classification of “Not Suitable” DOES

NOT MEAN that the instrument is not suitable for use in an Operating Room (OR) environment. Rather, it is intended to indicate that the instrument is not suitable for use in the direct presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide.

Medical Electrical Equipment – General Requirements for Safety

Medical Electrical Equipment – Part 1-2 – General Requirements for Safety – Collateral Standard: Electromagnetic Compatibility – Requirements and Tests

All relevant documentation is kept on file at ITC.

ITC AVOXimeter 4000 Operator’s Manual

Guidance and Manufacturer’s Declaration – Electromagnetic

Emis

sions

The ITC

below. The customer or the user of the ITC AVOXimeter 4000 should assure that it is used in

such an environment.

AVOXimeter 4000 is intended for use in the electromagnetic environment specified

Emissions Test Compliance E

RF Emissions

Group 1

CISPR 11

RF Emissions

Class B

CISPR 11

Harmonic

Emissions

IEC 61000-3-2

Voltage

Fluctuations/

Flicker Emissions

IEC 61000-3-3

Class A

Complies

lectromagnetic Environment - Guidance

The IT

C AVO 0 uses RF energy only for its Ximeter 400

intern

al function. Therefore, its RF emissions are very

low

and are not likel

nearby electronic equipment.

The ITC AVOXimeter 4000 is suitable for use in all

establish

power s

ments, including domestic establishments and

those

directly connected to the public low-voltage

upply network that supplies buildings used for

y to cause any interference in

domestic purposes.

ITC AVOXimeter 4000 Operator’s Manual

Guidance and Manufacturer’s Declaration – Electromagnetic

Immunity

The ITC AVOXimeter 4000 is intended for use in the electromagnetic environment specified below. The customer or the user of the ITC AVOXimeter 4000 should assure that it is used in

such an environment.

Immunity Test

Electrostatic

Discharge (ESD)

IEC 61000-4-2

Electrical fast

transient / Burst

IEC 61000-4-4

Surge

IEC 61000-4-5

Voltage dips, short

interruptions, and voltage variations

on power supply

input lines

IEC 61000-4-11

IEC 60601 Compliance Electromagnetic Environment -

Test Level Level Guidance

Floors should be wood, concrete or

6 kV contact

8 kV air

6 kV contact

8 kV air

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30 %.

2 kV for

power supply

lines

2 kV for

power supply

lines

Mains power quality should be that of a

typical domestic, commercial or

1 kV for

input/output

lines

1 kV

differential

mode

2 kV

common

mode

<5 % U

(>95 % dip in

for 0.5

cycle)

40 % U

(60 % dip in

) for 5

cycles

70 % U

(30 % dip in

) for 25

cycles

<5 % U

(>95 % dip in

) for 5 sec

1 kV for

input/output

lines

1 kV

differential

mode

2 kV common

mode

<5 % U

(>95 % dip in

for 0.5

cycle)

40 % U

(60 % dip in

) for 5 cycles

70 % U

(30 % dip in

) for 25

cycles

<5 % U

(>95 % dip in

) for 5 sec

hospital environment.

Mains power quality should be that of a

typical domestic, commercial or

hospital environment.

Mains power quality should be that of a

typical domestic, commercial or

hospital environment.

If the user of the ITC AVOXimeter

4000 System requires continued

operations during power mains

interruptions, it is recommended that

the ITC AVOXimeter 4000 System be

powered from an uninterruptible power

supply or battery.

Power frequency

(50/60 Hz)

magnetic field

3 A/m 3 A/m

IEC 61000-4-8

Power frequency magnetic fields

should be at levels characteristic of a

typical location in a typical domestic, commercial or hospital environment.

ITC AVOXimeter 4000 Operator’s Manual

8BIndex

ITC AVOXimeter 4000 Operator’s Manual

backlighting...................................................... 15

batteries

charging ....................................................... 14

checking ....................................................... 14

calculations ........................................................ 2

calibration ........................................................ 27

changing

date and time ............................................... 17

units for total hemoglobin............................. 15

connections........................................................ 9

cuvettes ............................................................. 8

cal code........................................................ 27

data management............................................ 34

display panel...................................................... 5

handling

cuvettes.......................................................... 8

samples........................................................ 30

Hüfner’s number ........................................ 11, 26

instrument

calibration............................................... 11, 27

connections .................................................... 9

description...................................................... 5

front panel ...................................................... 5

keypad............................................................ 6

limitations ....................................................... 4

lockout............................................................ 9

maintenance................................................. 47

menus ............................................................ 7

precautions and warnings .............................. 3

safety standards........................................... 63

setup ............................................................ 15

shutdown.................................................. 9, 42

specifications................................................ 10

standby........................................................... 9

startup .......................................................... 29

unpacking and inspection ............................ 13

warranty ....................................................... 61

intended use ...................................................... 1

keypad ............................................................... 6

labels and symbols.............................................v

limitations .......................................................... 4

liquid controls .................................................. 38

entering lot numbers.................................... 40

lockout ............................................................... 9

menus................................................................ 7

optical detector

cleaning ....................................................... 48

optical quality control....................................... 36

precautions........................................................ 3

printer .............................................................. 33

connection ................................................... 33

printing

aborting........................................................ 35

any sample .................................................. 35

last sample................................................... 34

stored data................................................... 35

quality control logs........................................... 57

running a test................................................... 31

safety standards .............................................. 63

sample preparation.......................................... 30

setting

standby delay............................................... 18

shutdown ........................................................... 9

specifications................................................... 10

standby.............................................................. 9

summary and explanation ................................. 1

symbols ..............................................................v

test cuvettes ...................................................... 8

tests

running......................................................... 31

troubleshooting................................................ 43

unpacking and inspection................................ 13

user ID

deleting ........................................................ 21

printing list.................................................... 22

warnings ............................................................ 3

warranty

........................................................... 61

ITC AVOXimeter 4000 Operator’s Manual

AP4001 10/07

ITC Avoximeter 4000 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual

1 Introduction

Glossary of Abbreviation Equivalents

Operating Precautions and Warnings

Limitations

Description

Keypad

Menus

Test Cuvettes

Connections

Instrument Lockouts

Instrument Specifications

Reportable Range

Accuracy

Precision

Interferences

Getting Started

Unpacking and Inspection

Materials Provided

Materials Required But Not Provided

Optional Materials

Setting Display Backlighting

Enabling or Disabling Suppression of Negative Values

Changing the Date and Time

Setting the Standby Delay

Specifying Mandatory Entry of an Authorized User ID

Specifying Optional Entry of a Patient ID Whenever a Test is Run

Specifying a Different Value for Hüfner’s Number

Calibration

Re-Calibration

4 Operation

Sample Collection

Running a Test

Running a Test on a Patient Sample

Using the Printer

Printing the Current Test Results

Specifying Automatic Printing of Results

Changing the Serial Port Baud Rate and Parity

Reviewing and/or Printing the Last Sample

Locating, Reviewing, and/or Printing any Sample

Aborting Printing of Results

Running Liquid Controls

Shutdown

Verification of Instrument Temperature

Cleaning the Optical Detector

Replacing the Battery

6 Quality Control Logs

7 Warranty

Certification, Warranty and Service Warranty, and Service

8 Safety Standards