ITC AVOXimeter 4000 User manual

AVOXimeter®4000
Whole Blood Oximeter
Operator’s Manual

Manufacturing Company Location
International Technidyne Corp
8 Olsen Avenue, Edison, New Jersey USA
Phone: [phone]
Fax: [phone]
web site: www.itcmed.com
Copyright and Trademarks
Copyright© 2007 International Technidyne Corporation (ITC). All rights reserved. This material
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 [phone] or [phone], or by e-mail at
[e-mail].
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Table of Contents
1INTRODUCTION .......................................................................................................1
Intended Use of the ITC AVOXimeter 4000............................................................... 1
Summary and Explanation of the Test....................................................................... 1
Glossary of Abbreviation Equivalents ……………………………………………………2
Operating Precautions and Warnings ........................................................................ 3
Limitations.................................................................................................................. 4
2DESCRIPTION ..........................................................................................................5
Front Panel ................................................................................................................ 5
Keypad....................................................................................................................... 6
Menus ....................................................................................................................... 7
Test Cuvettes............................................................................................................. 8
Connections ............................................................................................................... 9
Automatic Standby and Shutdown............................................................................. 9
Instrument Lockouts................................................................................................... 9
Instrument Specifications......................................................................................... 10
Reportable Range........................................................................................ 10
Accuracy ...................................................................................................... 10
Precision ...................................................................................................... 10
Interference.................................................................................................. 11
Calibration................................................................................................................ 11
3GETTING STARTED...............................................................................................13
Unpacking and Inspection........................................................................................ 13
Materials Provided ....................................................................................... 13
Materials Required But Not Provided .......................................................... 13
Optional Materials........................................................................................ 14
Charging the Batteries ............................................................................................. 14
Setting Up the Instrument ........................................................................................ 15
Setting Display Backlighting ........................................................................ 15
Specifying Units for Total Hemoglobin (THb) .............................................. 15
Enabling or Disabling Display of [sO2], [O2Ct], and [O2Cap]...................... 16
Enabling or Disabling Suppression of Negative Values............................... 16
Changing the Date and Time....................................................................... 17
Setting the Standby Delay ........................................................................... 18
Specifying Entry of User ID and/or Patient ID.......................................................... 19
Specifying Mandatory Entry of an Authorized User ID................................. 19
Specifying Optional Entry of a User ID Whenever a Test is Run................. 26
Specifying Optional Entry of a Patient ID Whenever a Test is Run ............. 27
Specifying a Different Value for Hüfner’s Number ................................................... 28
Calibration................................................................................................................ 29
Cuvette Calibration Code............................................................................. 29
Re-Calibration.............................................................................................. 29
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iv

4OP .....................................................319
Startup ..................................................................................................................... 31
Sa
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, R ....................................... 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
5MAINTENANCE ......................................................................................................49
Verification 49
Cleaning the Opti
Replacing the B ................................................................................... 55
6QUALITY CONTR .................................59
7WARRANTY............................................................................................................63
Certification, arranty and Service Warranty, and Service ..................................... 63
8SAFETY ST NDARD 65
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions .................... 66
Guidance an Ma y ................. 67
INDEX ......
ERATION..................................................... 29
mple Collection and Preparation ......................................................................... 32
Sample Collection........................................................................................ 32
Sample Preparation ..................................................................................... 32
nning a Test.................................................................
...................................................................................................... 35
e Current Test Rt
t.................................
and/or Printing the Law
eviewing, and/or Printing any Sample
ll Stored Datan ..............................
trol
ni iquid Controls .....................................................................
rin uvette Lot Numbers ......
ti
of Instrument Temperature....................................................................
cal Detector .................................................................................. 50
tterya ............
OL LOGS ..................................................
W
A S ...........................................................................................
d nufacturer’s Declaration – Electromagnetic Immunit
......................................................................................................69
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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
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ITC AVOXimeter 4000 Operator’s Manual
1 Introduction
Int imeter 4000
The ITC
individual poi
(%0
heparin ([02Ct]), percent
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
ended Use of the ITC AVOX
AVOXimeter 4000 is a battery-operated desktop whole blood oximeter that performs
nt-of-care measurements of total hemoglobin (tHb), oxyhemoglobin saturation
2Hb), carboxyhemoglobin (%COHb), and methemoglobin (%MetHb) on freshly-drawn or
- or EDTA-anticoagulated whole blood samples. Oxygen content
O2) and oxygen carrying capacity (O2Cap) of the blood sample are automatically
ulated from the %Hb02and THb measurements.
reparation is required, and analysis is quickly accomplished by injecting the sample
osable cuvette and inserting the cuvette into the instrument. The ITC AVOXimeter 40
es the sample with multiple wavelengths, records the optical density of the samp
wavelengths, an
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
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 (O2Hb), reduced hemoglobin
(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.
and Explanation of the Test
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
as
re
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ITC AVOXimeter 4000 Operator’s Manual
The measured values are used to calculate total hemoglobin (tHb) and percent oxyhemoglobin
ample, using the fractional method described below:
tHb) + (COHb)
saturation [%02Hb] of the s
(tHb) = (O2Hb) + (HHb) + (Me
(O2Hb) x 100
%O2Hb = (tHb)
Oxygen content [O2Ct] of the sample is then calculated:
1.39 x tHb x % O2Hb
O2Ct = 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 AVOXimeter 4000
Display Conventional Equivalent
Total Hemoglobin tHb tHb
Fractional O2 Saturation sO2SO2
Oxygen Content O2Ct O2CT
Carboxyhemoglobin COHb COHb
Methemoglobin MetHb MetHb
Oxyhemoglobin Saturation %O2Hb %O2Hb
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ITC AVOXimeter 4000 Operator’s Manual
Operating Precautions and Warnings
ostic use.
●Do not allow blood, water, or other liquids to enter the instrument.
●The ITC AVOXimeter 4000 instrument is designed for use only with ITC AVOXimeter
or dot on the desiccant pack indicates the presence of mositure.
use the
ation verification, use only the controls recommended
a
NOT perform testing while carrying or holding the
instrument.
r 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.
●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
that does not comply with either the equivalent
ipment or UL/IEC 60601-1 or IEC 60601-1-2, may
lead to a reduced level of safety with the resulting system.
●For in vitro Diagn
4000 cuvettes.
●Do not re-use test cuvettes.
●Always keep cuvettes in sealed bag with desiccant, and replace desiccant if the
indicat
●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
●In orde
ged in
ower cor
ctrical serv
e AC/DC p
d affect the perform
to open and perfo
pulling on the cord.
either in the patient vicinity, or
safety requirements of this equ
Any items ex
biohazardous
local regulatio
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
r
t
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.
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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
zed in light of a
sistency with t
st data.
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ITC AVOXimeter 4000 Operator’s Manual
2
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
( 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.
The concentration of total hemoglobin (tHb), the relative f
(%COHb) and methemoglobin (%MetHb), and the ox 2
then automatically calculated and reported.
Eac eter 4000 is calibrated at the factory. The ITC A 00 ca
oper om its internal batteries or from the AC charged
whenever the AC Adapter is connected.
Description
c
HHb), o ation (%02Hb)
e operator
globin (CO
st cu
ractions of carboxyhemoglobin
ntent (0 ) of the blood sample areygen co
h ITC AVOXim
ated either fr VOXimeter 40 n be adapter. The batteries are
Figu imeter 4000 Oximeter
Fro
The front panel (Figure 2) contains the test chamber, ke
re 1. ITC AVOX
nt Panel
a ypad with the key, action and
nsmenu keys, number keys, and a display panel. Opera or instructio are shown on the display
pane r enters commands and information using the keypad.
Whe mpleted, the results are shown on the
mem ent or future printing.
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.
Test Cuvette
t
l, and the operato
n the test is co
ory for curr
display panel and stored in system
Finger Grip
Display
Panel
Ke
yp
ad
Test Cuvettes
Optical QC
ersFilt
Test Chamber
Tempera
Prob
ture
e
Printer
(
O
p
tional
)
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ITC AVOXimeter 4000 Operator’s Manual
Figure 2. Front 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
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.
to Enter characters for Operator IDs or Patient IDs. Enter a
character for selection of a command.
Chamber Number Keys (Blue)Test
Action Keys
(
White
)
Enter/On Key
Display
Panel
(
Red
)
Menu Keys
(
White
)
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ITC AVOXimeter 4000 Operator’s Manual
Menus
The pri pal m d
below:
Note: Pre
nci enus, their commands, and the procedure to access each menu are summarize
ss the button at any time to return to the previous menu.
Menu Commands Access
Main Menu
Press the
key when a test is not
Calib
Submenu
running or another menu is not active.
ration
Press followed by while the
main menu is displayed.
Printer Mode
Submenu
Press followed by while the
main menu is displayed.
Stored Data
Submenu
Press followed by while the
main menu is displayed.
Computer Menu
Press the
key when a test is not
running or another menu is not active.
Data Man
Submenu
agement
Press followed by while the
computer menu is displayed.
Device Settings
Submenu (Page 1)
Press followed by while the
computer menu is displayed.
Device Settings
Submenu (Page 2) followed byPress
while
u is
Submenu
Page 1 of the device settings men
displayed.
Time, Date, and
Temperature
Press followed by while the
computer menu is displayed.
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ITC AVOXimeter 4000 Operator’s Manual
Tests are performed with single- ette
contains a finger gri ort, , and a vent patch.
Test Cuvettes
use disposable test cuvettes (Figure 3). Each test cuv
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
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
details).
Note: 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.
uvette
d sample is ins d into a test cuvette by conne
d then gently pressing
oximately 50 µL of whole loo
end of the test cuvette w
syringe still attached) is
o handle cuvette eith
insert acc panying th
●Rem y rom the exterior of the test cuvette before
inserting it into the test chamber.
●After filling the cuvette with blood, inspect the vent patches to ensure they
lgi nt patch protrudes, discard the cuvette. Do not
uv rotruding vent patch into the test chamber.
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.
illing Port
F
Light Path
Vent Patch
Optical
Window
Finger Grip
ove an blood or debris f
are not bu ng out. If a ve
insert a c ette with a p
HAZARD
st be hand RNIN cautio
oratory sa practice
d as
dispose of the
azardous
se
8

ITC AVOXimeter 4000 Operator’s Manual
HAZARD WARNING: Any items exposed to human blood, plasma or serum
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
Connections to the power supply and an optional printer (or a comp e at the rear of
BIO
sly as
s and
ardous m
nd local
in accordan
ions. Fede
ith
te and
ified as bioh
spose of the
ous inc cuvett portan s be
uter) are mad
the instrument (Figure 4).
Use only the power supply provided with the instrument.
Serial Number
Label
Carrying
AC Adapter
Connector
Printer or Computer Temperature Sensor
Figure 4. Rear Panel Components
Handle
Auto
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 also enters standby if the battery charge becomes
critically low.
The ITC AVOXimeter 4000 shuts down after it has been in standby for 4 hours.
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.
Connector Connector
matic Standby and Shutdown
VOXimeter 4000 enters a low-power standby mode after the instrument has been idle
9

ITC AVOXimeter 4000 Operator’s Manual
Instrument Specifications
Size 20.3 cm (8.0 in) x 25.4 cm (10.0 in) x 9.5 cm (3.8 in)
Weight 1.8 kg (4 lbs)
Operating Temperature Room temperature (15°C to 30°C, 59°F to 86°F)
Battery Type Nickel Cadmium (NiCad)
Operating Time On Battery Approximately 8 hours (constant run) or 10 complete test cycles 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 Input: 100 / 240 VAC, 50 / 60 Hz
Output: 12 VDC, 800 mA
Serial Data Port RS232C
Sample Type Whole blood
Sample Volume 50 µL
Analysis Time 7 to 10 seconds per sample
Analysis Wavelengths 5
Reportable Range
tHb 4 to 25 g/dL
%O2Hb 0 to 100%
%COHb 0 to 75%
%MetHb 0 to 85%
[O2] 0 to 35 mL O2/dL
Accuracy
tHb (>10 g/dL) ±0.45 g/dL
tHb (<10 g/dL) ±0.35 g/dL
%O2Hb ±1.6%
%COHb ±2%
%MetHb ±1.5%
Precision
tHb 0.3 g/dL
%O2Hb 0.8 % O2Hb
%COHb 1 % COHb
%MetHb 0.7 % MetHb
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ITC AVOXimeter 4000 Operator’s Manual
Interferences
tHb %O2Hb %COHb %MetHb
Bilirubin
(11 mg/dL) None None < 1% < 1%
(tHb < 0.45 g/dL < 1% < 1%
Indocyanine Green Dye
< 0.45 g/dL < 1% < 1% < 1%
Methemo
(tHb = 16 g/dL, MetHb <10%,
7.8) < 0.2 g/dL < 1%
Calibrat
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).
Hemolysis None None < 1% < 1%
Fetal Hemoglobin < 0.6% per
= 13.5 g/dL, HbF = 100% %HbF
(<10 mg/L)
globin
7.1 < pH <
ion
OXimeter 4000 is factory-cali
uld recalibrati
nt ve.
uires entry of the co
customary value for
Crol results are not acceptable, errone s are
encountered, or error messages are displayed, the most likely cause may be
contam
re
AUTION:If quality cont ous result
ination of the optical detector by blood or debris, which cannot be resolved by
-calibration. Consult the Troubleshooting section for additional information.
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ITC AVOXimeter 4000 Operator’s Manual
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