Accriva avoximeter 1000E User manual

Operator’s Manual

ii
Manufacturing Company Location
Accriva Diagnostics, Inc.
6260 Sequence Drive, San Diego, CA USA
Phone: [phone]
Fax: [phone]
web site: www.accriva.com
Copyright and Trademarks
Copyright© 2015 Accriva Diagnostics, Inc. All rights reserved. This material may not be
reproduced or copied, in whole or in part, without the written permission of Accriva.
Accriva and AVOXimeter are registered trademarks of Accriva Diagnostics, Inc. 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 Technical Support at [phone] or [phone], or by e-mail at
[e-mail].

iii
Table of Contents
1INTRODUCTION......................................................................................................1
Intended Use of the AVOXimeter 1000E..................................................................1
Summary and Explanation of the Test......................................................................1
Hemodynamic Calculations..........................................................................2
Saturation Step-Ups.....................................................................................3
Operating Precautions and Warnings.......................................................................5
Limitations................................................................................................................5
2DESCRIPTION.........................................................................................................6
Front Panel...............................................................................................................6
Keypad.....................................................................................................................7
Menus .....................................................................................................................8
Test Cuvettes...........................................................................................................9
Connections...........................................................................................................10
Automatic Standby and Shutdown..........................................................................10
Instrument Lockouts...............................................................................................10
Instrument Specifications .......................................................................................11
Reportable Range......................................................................................11
Accuracy....................................................................................................11
Precision ....................................................................................................11
Interference................................................................................................11
Calibration..............................................................................................................12
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
Changing the Date and Time......................................................................16
Setting the Standby Delay..........................................................................17
Specifying Mandatory Entry of User ID and/or Patient ID .......................................18
Changing the QA User ID...........................................................................21
Requiring Entry of a Patient ID...................................................................22
Specifying Oximetry Site Prompts..........................................................................23
Specifying Use of Oximetry Sites ...............................................................24
Entering a Different Value for Hüfner’s Number..........................................25

iv
4OPERATION.........................................................................................................27
Startup ...................................................................................................................27
Entering a User ID (Optional)..................................................................................27
Entering a Patient ID (Optional)..............................................................................27
Sample Collection and Preparation.........................................................................28
Sample Collection.......................................................................................28
Sample Preparation....................................................................................28
Running a Test.......................................................................................................29
Using the Printer.....................................................................................................30
Printing the Current Test Results................................................................30
Specifying Automatic Printing of Results.....................................................30
Changing the Serial Port Baud Rate and Parity..........................................30
Data Management..................................................................................................31
Printing all Stored Data...............................................................................31
Printing All Optical Quality Control Data......................................................31
Reviewing and/or Printing the Last Sample ................................................32
Locating, Reviewing, and/or Printing any Sample.......................................32
Aborting Printing of Results ........................................................................33
Purging all Test Records.............................................................................33
Quality Control........................................................................................................34
Performing Optical Quality Control..............................................................34
Running Liquid Controls..............................................................................35
Entering Liquid Control Lot Numbers..........................................................36
Tagging a Liquid Control Test with a Lot Number.......................................37
Enabling QC Lockout..................................................................................38
Calibration ..............................................................................................................39
Cuvette Pathlength.....................................................................................39
Re-Calibration.............................................................................................39
Shutdown ...............................................................................................................40
Hemodynamic Calculations ....................................................................................41
Entering the Patient Age, Height, Weight, and Sex.....................................41
Oxygen Uptake Rate ..................................................................................43
Body Surface Area......................................................................................44
Saturation Step-Ups ...................................................................................45
Flow Calculations........................................................................................46
Systemic and Pulmonary Resistances........................................................50
Stroke Volume and Stroke Index ................................................................52
Printing Hemodynamic Values....................................................................54
Troubleshooting......................................................................................................55
5MAINTENANCE.................................................................................................... 59
Cleaning the Optical Detector.................................................................................59
Replacing the Battery .............................................................................................63

v
6QUALITY CONTROL LOGS..................................................................................65
7WARRANTY ..........................................................................................................68
Certification, Warranty and Service Warranty, and Service ....................................68
8SAFETY STANDARDS..........................................................................................70
Guidance and Manufacturer’s Declaration – Electromagnetic Emissions....................70
Guidance and Manufacturer’s Declaration – Electromagnetic Immunity.................72
INDEX ..........................................................................................................73

vi
Important Labels and Symbols
Before using the AVOXimeter 1000E, it is essential that the contents of this Operator’s Manual,
any labels on the instrument or its packaging, and instructions accompanying AVOXimeter
1000E 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/EC, 27 October 1998 on In-Vitro Diagnostic
Medical Devices
Expiration Date of Cuvettes
Serial Number of Instrument
Lot Number of Cuvettes
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 (AVOXimeter 4000 Only)
Name and Address of Manufacturer
Warning - Biohazard
Medical Equipment per Annex 1A, Item 8 Directive 2002/96/EC For Electronic
Equipment Waste – Contact Technical Support @ 1-800-579-2255

AVOXimeter 1000E Operator’s Manual
1
1 Introduction
Intended Use of the AVOXimeter 1000E
The AVOXimeter 1000E is a battery-operated bedside whole blood oximeter that performs
individual point-of-care measurements of oxyhemoglobin saturation (%Hb02) and total
hemoglobin concentration [THb] on lithium/sodium or heparin or EDTA anticoagulated whole
blood samples. Oxygen content [02] of the blood sample is automatically calculated from the
%Hb02and THb measurements.
No sample preparation is required, and analysis is quickly accomplished by injecting the sample
into a disposable cuvette and inserting the cuvette into the instrument. The AVOXimeter 1000E
then illuminates the sample with multiple wavelengths, records the optical density of the sample
at each of the wavelengths, and computes the results. In less than 10 seconds, the
oxyhemoglobin fraction, the total hemoglobin concentration, and the oxygen content of the
sample are shown in appropriate units on the liquid-crystal display on the front panel.
Data management capabilities are included with the instrument. These capabilities include a
combined storage of up to 500 patient, and/or QC results, designation of quality control levels and
lot numbers, tagging of test results with date, time, Patient ID and/or Operator ID, entry of
oximetry site and subsite, and printing of results.
The instrument also can calculate ten hemodynamic variables (such as body surface area,
estimated oxygen consumption rate, and cardiac output using the Fick principle) from data that
are entered by the operator. It can also calculate differences in oxygen saturation between
adjacent anatomical sites from which blood samples were taken (saturation step-ups), to aid in
diagnosing intracardiac and great vessel shunts.
In vitro diagnostic use, For Professional Use, Rx Only
Summary and Explanation of the Test
The AVOXimeter 1000E measures whole blood %Hb02 and [THb] using disposable single-use
cuvettes. The operator inserts a whole blood sample into a cuvette, the cuvette is inserted into
the test chamber on the instrument, and the results are displayed. The results will remain on the
display while the cuvette remains in the instrument.
The result can be automatically printed along with the time and date the test was run, the Patient
ID, Operator ID, and other information entered. The result is also saved in an internal database,
which has the capability to store up to 500 results.
Individual AVOXimeter 1000E instruments can be customized so that optical quality control tests
must be performed whenever a specified period of time has elapsed. In addition, up to three liquid
control lot numbers for each level of liquid QC can be stored in the AVOXimeter 1000E and can
be tagged to the stored or printed liquid QC records. The instruments can also be configured so
that only authorized operators can operate the system and that patient IDs are required for each
test run.
The AVOXimeter 1000E measures oxygenated hemoglobin [HbO2], deoxyhemoglobin [HHb],
methemoglobin [MetHb], and carboxyhemoglobin [COHb] directly, using novel optics and multiple

AVOXimeter 1000E Operator’s Manual
2
wavelengths. This reduces interference from dyshemoglobins and other interfering substances
such as fetal hemoglobin and bilirubin and minimizes the effects of hemolysis.
The measured values are used to calculate total hemoglobin [THb] and percent oxyhemoglobin
saturation [%Hb02] of the sample, using the fractional method described below:
[THb] = [HbO2] + [HHb] + [MetHb] + [COHb]
[%HbO2] =
[HbO
2
] x 100
[HbO2] + [HHb] + [MetHb] + [COHb]
Oxygen content [O2] of the sample is then calculated:
[O2] =
1.39 x [THb] x [%HbO
2
]
100
where 1.39 is the ml 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
AVOXimeter 1000E can be set at any value in the range of 1.30 to 1.39 (see page 25).
Note: Below is a legend for oxygen saturation terminology used throughout this
document:
Abbreviation Term Units Displayed
THb Total Hemoglobin g/dl
HbO2Oxyhemoglobin g/dl
MetHb Methemoglobin g/dl
COHb Carboxyhemoglobin g/dl
HHb Reduced Hemoglobin g/dl
%HbO2Percent Oxyhemoglobin Saturation
(Fractional Oxygen Saturation) n/a
[O2]Oxygen Content ml/dl
Hemodynamic Calculations
Based on the results, hemodynamic calculations are performed as described below.
Cardiac Output
ml/min =
Oxygen Uptake
[O2] arterial -[O2] venous
Note: Oxygen uptake rate can either be measured from expired gases, or it can be
estimated from the patient’s age, height, weight, and sex (see below).

AVOXimeter 1000E Operator’s Manual
3
Body Surface Area
m2= 0.007185 (Weight kg)0.425 (Height cm)0.725
Oxygen Uptakemales
ml/min = 157.3 BSA + 10– (10.5 * age + 4.8)
Oxygen Uptakefemales
ml/min = 157.3 x BSA –(10.5 * age + 4.8)
Cardiac Index
L/min/ m2 =
Cardiac Output
BSA
Stroke Volume
ml/beat =
Cardiac Output
Heart rate
Stroke Index
ml/beat/m2=
Stroke Volume
BSA
Pulmonary
Blood Flow
ml/min
=
Oxygen Uptake
[02] Pulmonary Arterial – [02] pulmonary venous
Total Systemic
Resistance
mmHg/ml/min
= Arterial Pressure – Right Atrial Pressure
Cardiac Output
Total Pulmonary
Resistance
mmHg/ml/min
= Pulmonary Arterial Pressure –Left Atrial Pressure
Cardiac Output
Pulmonary to
Systemic Flow Ratio = Pulmonary Flow
Systemic Flow
Pulmonary to
Systemic Flow Ratio = %Hb02Arterial – %Hb02Venous
%Hb02Pulmonary Venous – %Hb02Pulmonary Arterial
Saturation Step-Ups
Saturation step-ups are the differences in oxyhemoglobin saturation [%Hb02] between adjacent
anatomical sites. These values are used as an aid in diagnosing intracardiac and great vessel
shunts. The AVOXimeter 1000E calculates saturation step-ups between the following anatomical
sites:
●Right atrium and superior vena cava
●Right ventricle and right atrium
●Pulmonary artery and right ventricle
●Pulmonary vein and left atrium
●Left atrium and left ventricle

AVOXimeter 1000E Operator’s Manual
4
●Left ventricle and aorta
When calculating saturation step-ups, the AVOXimeter 1000E searches the database for all
results for each main oximetry site for that patient (sub-sites are ignored), averages the results for
each site, and then calculates the saturation step-ups from the average result for each main site.
This information can then be printed from the AVOXimeter 1000E.
Note: Use of average readings rather than individual values improves the precision of saturation
step-up calculations.