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
vi
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 disp00
then illuminatle
at each of thed computes the results. In less than 10 seconds, the total
hemogl
methemo
front panel.
Data mand with the instrument. These capabilities include
stora
tagging
AVOXimeter4000 is a battery-operated desktop whole blood oximeter that performs
Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb) on freshly-drawn or
2
- 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
O
2
and THb measurements.
2
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
2
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 caas 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.
1
AVOXimeter4000 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.
as
liquid control lot numbers for each level of Liquid Quality Control (LQC) can be stored
re
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
2
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) =
(O
2
(O
Hb) x 100
%O
Hb=
2
2
(tHb)
Oxygen content [O
Ct] of the sample is then calculated:
2
1.39 x tHb x % O
O
Ct=
2
2
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 AVOXimeter4000 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.
● 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 plugto an eleice outlet and the AC/DC power module while the
DC pd from thower 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 coulance 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
a
●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 AVOXimete4000 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
r
t
3
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 inconhe patient’s
clinical status should be repeated or supplemented with additional te
sistency with t
st data.
zed in light of a
4
ITC AVOXimeter 4000 Operator’s Manual
)
2
Description
The ITC AVOXimeter 4000 (Figure 1) is a tabletop device for use at the bedside. It contains a test
c
hamber which performs all operations to measure the concentrations of reduced oxyhemoglobin
HHb), oation (%0
(xyhemoglobin satur, carboxyhemoHb), and methemoglobin
(MetHb) of a whole blood sample after th inserts a tevette containing the sample
into the test chamber.
Hb)
2
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.
Eaceter 4000 is calibrated at the factory. The ITC A00 ca
h ITC AVOXim
operom 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
e
Finger Grip
2
VOXimeter 40n be
Test Cuvette
Figuimeter 4000 Oximeter
re 1. ITC AVOX
Fro
5
nt Panel
The front panel (Figure 2) contains the test chamber, ke
paner enters commands and information using the keypad.
l, and the operato
Whempleted, the results are shown on the
n the test is co
mement 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.
aypad with the key, action and
t
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
to
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.
6
Menus
ITC AVOXimeter 4000 Operator’s Manual
The pripal md
below:
ncienus, 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 bywhile the
followed bywhile the
followed bywhile 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 bywhile the
followed byPress
followed bywhile the
while
u is
7
ITC AVOXimeter 4000 Operator’s Manual
Test Cuvettes
Tests are performed with single-ette
contains a finger griort,, and a vent patch.
Optical
Window
p, filling p optical window
Figure 3. Test C
A whole blooertecting a small syringe containing the
whole blood sample to the filling port an the syringe plunger to dispense
appr bd into the test cuvette. Air escapes from the vent patch at the
oximately 50 µL of wholeloo
end of the test cuvette w
syringe still attached) is
details).
Note:
d sample is insd 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 tthe er by the edges or by the finger grip. Refer to the
packageome test cuvettes for storage and handling instructions.
o handle cuvette eith
insert accpanying th
use disposable test cuvettes (Figure 3). Each test cuv
F
illing Port
Finger Grip
Light Path
Vent Patch
uvette
d then gently pressing
● Remyrom the exterior of the test cuvette before
● After filling the cuvette with blood, inspect the vent patches to ensure they
BIO WAG: Any items exposed to human blood, plasma or serum
muledusly as a biohazardous material in accordance with
labfetys 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
classifiebioh include used cuvettes. It is important that steps be
taken tomaterials in accordance with the prevailing regulations
in your location.
ove an blood or debris f
inserting it into the test chamber.
are not bung out. If a ve
insert a cette with a p
HAZARD
st be hand
oratory sa practice
lgint patch protrudes, discard the cuvette. Do not
uvrotruding vent patch into the test chamber.
RNIN
cautio
d as
dispose of the
azardous
se
8
BIO
must be handled cautiou a biohazaterial ce w
laboratory safety practice federal aregulatral, 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
classazardlude usedes. It is imt that step
taken to dise 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 cuvettportans be
ardous m
nd local
in accordan
ions. Fede
ith
te and
Connections to the power supply and an optional printer (or a compe 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.
9
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
The ITC AVbrated and employs highly stable state-of-the-art light
sources. Shoon be required please contact an ITC technical support
represe ati
Proper calibration also reqrrect 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
ntve.
uires entry of the co
customary value for
Crol results are not acceptable, errones are
AUTION: If quality contous 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.
11
ITC AVOXimeter 4000 Operator’s Manual
12
ITC AVOXimeter 4000 Operator’s Manual
3
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
ow1
Per 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
e:
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
1
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
13
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
contintness.
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)
e270) As NeePrinter Papded
r (Part No. 30
1
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
cre
cha
rging them. The message “Battery Critical – Connect Charger” will be displaye
battery is completely discharged.
the
The me
the stand
be used for acharged.
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
h
l
followed by to display the battery status:
d when
, see page 7).
14
ITC AVOXimeter 4000 Operator’s Manual
S
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 baer
k
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. Pressto 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
15
ITC AVOXimeter 4000 Operator’s Manual
E
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.
(O
2
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
2.
of calculated (0
3. Select the appropriate option by pressing the corresponding number key followed
by
4. Press
followed by
2
. 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
2
Oxygen content (02Ct), percent satuon (sO2), and oxygen carrying capacity
rati
d
, %COHb, and %
2
Ct), percent saturation (SO2), and oxygen carrying
Cap) for each test:
2
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
e
16
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