ITC AVOXimeter 4000 Operator's Manual
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ITC AVOXimeter 4000 Operator's Manual

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Whole Blood Oximeter
Operator's Manual

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Summary of Contents for ITC AVOXimeter 4000

  • Page 1 ® AVOXimeter 4000 Whole Blood Oximeter Operator’s Manual...
  • Page 2 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.

  • Page 3: Table Of Contents

    Table of Contents INTRODUCTION .......................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 DESCRIPTION ......................5 Front Panel ........................ 5 Keypad ........................
  • Page 5 ERATION......................319 Startup ........................31 mple Collection and Preparation ................. 32 Sample Collection..................32 Sample Preparation ..................32 nning a Test......................33 Running a Test on a Patient Sample ............33 Using the Printer ...................... 35 Prin ing th e Current Test R esults..............
  • Page 6 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...

  • Page 9: Introduction

    The ITC AVOXimeter 40 then illuminat es the sample with multiple wavelengths, records the optical density of the samp...

  • Page 10: Glossary Of Abbreviation Equivalents

    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.

  • Page 11: Operating Precautions And Warnings

    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...

  • Page 12: Limitations

    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 zed in light of a specific patient’s condition and therapy. Any results exhibiting incon sistency with t he patient’s...

  • Page 13: Description

    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 xyhemoglobin satur...

  • Page 14: Keypad

    ITC AVOXimeter 4000 Operator’s Manual Test Chamber Number Keys (Blue) Action Keys (White) Enter/On Key Display (Red) Panel Menu Keys (White) Figure 2. Front Panel Keypad The routine analysis of blood samples does not require the use of menus or the numeric keypad.

  • Page 15: Menus

    ITC AVOXimeter 4000 Operator’s Manual Menus The pri pal m enus, their commands, and the procedure to access each menu are summarize below: Note: ss the button at any time to return to the previous menu. Menu Commands Access Main Menu...

  • Page 16: Test Cuvettes

    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 d as bioh azardous include used cuvettes.

  • Page 17: Connections

    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...

  • Page 18: Instrument Specifications

    Nickel Cadmium (NiCad) Battery Type Approximately 8 hours (constant run) or 10 complete test cycles per charge. Tests may also be run while the ITC AVOXimeter Operating Time On Battery 4000 is plugged into the AC/DC power module. Approximately 500 charge / discharge cycles...

  • Page 19: Interference

    OXimeter 4000 is factory-cali brated and employs highly stable state-of-the-art light sources. Sho uld recalibrati on be required please contact an ITC technical support represe ati Proper calibration also req uires entry of the co rrect cuvette pathlength by the user (see page 26)
  • Page 20 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 21: Getting Started

    ITC AVOXimeter 4000 Operator’s Manual Getting Started Unpacking and Inspection Note: Inspect each component for d amage when unpacking. If damage is observed, contact your shipping representative immediately. Remove any protectiv e packaging that may be present around the instrument.

  • Page 22: Optional Materials

    This eliminates the risk of the instrument powering down during a test. Fully charged batteries will allow the ITC AVOXimeter 4000 to analyze blood samples contin uously for up to 8 hours when the display is set at medium brigh tness.

  • Page 23: Setting Up The Instrument

    ITC AVOXimeter 4000 Operator’s Manual Press to display the time, date, and battery menu again. Press to return to the previous menu, if desired. etting Up the Instrument The user can specify the display brightness, specify the units that are us...

  • Page 24: Enabling Or Disabling Display Of [So2], [O2Ct], And [O2Cap]

    ITC AVOXimeter 4000 Operator’s Manual nabling or Disabling Display of SO Ct, and O Display of calculated oxygen content (0 Ct), percent saturation (SO ) and oxygen carrying capacity (O2Cap) of the blood sample can be enabled or disabled. Oxygen content (0...

  • Page 25: Changing The Date And Time

    ITC AVOXimeter 4000 Operator’s Manual Changing the Date and Time Changing the Time: Display the “Time, Date, and Temperature” menu (a submenu of , see page 7). Press followed by to display the current time: Press followed by to change the time: Use the number keys to enter the new time, then press .

  • Page 26: Setting The Standby Delay

    ITC AVOXimeter 4000 Operator’s Manual Use the number keys to enter the new date, then pres . The new date is displayed. Press followed by The “Time, Date, and Battery” menu is again displayed. Press to return to the previous menu, if desired.

  • Page 27: Specifying Entry Of User Id And/Or Patient Id

    ITC AVOXimeter 4000 Operator’s Manual Specif ying Entry of User ID and/or Patient ID A Use r ID and/or Patient ID can be entered for any test. The User ID and/or Patient ID i s included the results record for tests that are run and can be included in the printed results.
  • Page 28 ITC AVOXimeter 4000 Operator’s Manual Press to display the “Data Management” menu.
  • Page 29 ITC AVOXimeter 4000 Operator’s Manual Disabling the Requirement to Enter an Authorized User ID: Display the “Data Management” menu (a submenu of see page 7). Press followed by to display the current User ID setting: Press followed by . A confirmation p rompt is displayed, and the “User...
  • Page 30 ITC AVOXimeter 4000 Operator’s Manual Press to return to the previous menu, if desired.
  • Page 31 ITC AVOXimeter 4000 Operator’s Manual Reviewing and/or Deleting Authorized User IDs: Display the “Data Management” menu (a submenu of , see page 7). Press followed by to display the current User ID setting: Note: User ID: must be ON to proceed.
  • Page 32 ITC AVOXimeter 4000 Operator’s Manual Printing a List of Authorized User IDs: Prepare the printer (see page 35). Display the “Data Management” menu (a submenu of see page 7). Press followed by to display the current User ID setting: Note: User ID: must be ON to proceed.
  • Page 33 ITC AVOXimeter 4000 Operator’s Manual Specifying Whether Authorized User IDs are Included on Results Printouts: Display the “Data Management” menu (a submenu of , see page 7). Press followed by to display the current User ID setting: Note: User ID: must be ON to proceed.

  • Page 34: Specifying Optional Entry Of A User Id Whenever A Test Is Run

    ITC AVOXimeter 4000 Operator’s Manual Specifying Optional Entry of a User ID Whenever a Test is Enabling Optional Entry of User IDs: Display the “Data Management” menu (a submenu of , see page 7). Press followed by to display the current User ID setting:...

  • Page 35: Specifying Optional Entry Of A Patient Id Whenever A Test Is Run

    ITC AVOXimeter 4000 Operator’s Manual Specifying Optional Entry of a Patient ID Whenever a Test is Run Enabling Optional Entry of Patient IDs: Display the “Data Management” menu (a submenu of , see page 7). Press followed by to display the current Patient ID setting:...

  • Page 36: Specifying A Different Value For Hüfner's Number

    (see page 1). Although Hüfner’s number is generally 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.

  • Page 37: Calibration

    Re-C alibration 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.
  • Page 38 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 39: 4 Operation

    ITC AVOXimeter 4000 Operator’s Manual 4 Operation Startup If Entry of an Authorized User ID is Not Required: (see page 19) Press . The instrument starts and performs a series of self-tests. and “ are displayed when a test can be run: “RE...

  • Page 40: Sa Mple Collection And Preparation

    ITC AVOXimeter 4000 Operator’s Manual ample Collection and Preparation Sample Collection Collect whole blood samples in a sodium or lithium heparinized syringe. Do not use samples that contain excessive volumes of anticoagulant or are diluted with saline. Refer to CLSI document H18-A3, en titled “Procedures for the Handling and...

  • Page 41: Running A Test

    ITC AVOXimeter 4000 Operator’s Manual Running a Test Running a Test on a Patient Sample Verify that the instrument is ready to run a test and that the “ READY” - “Insert Cuvette” screen is displayed: Holding the cuvette by the finger grip on the black cap, insert the cuvette (with the syringe still attached) into the test cham ber.
  • Page 42 ITC AVOXimeter 4000 Operator’s Manual The screen fo r specifying the sample type is displayed: Press followed by If optional entry of Patient IDs is enabled (see page 26), the screen for entering a Patient ID is displayed: To bypass entry of a Patient ID, press...

  • Page 43: Using The Printer

    (see page Contact your ITC representative to purchase the optional printer. Printing the Current Test Results When the test results are displayed on the screen, press...

  • Page 44: Data Management

    ITC AVOXimeter 4000 Operator’s Manual Data Management Stored results can be reviewed, printed, and purged (if desired). CAUTION: Once the in strument database contains the results of 100 tests, the results from the oldest test are automatical ly deleted when a test is run. Use the Data Transfer function to transfer data to an information system.

  • Page 45: Locating, R Eviewing, And/Or Printing Any Sample

    ITC AVOXimeter 4000 Operator’s Manual ocating, Reviewing, and/or Printing any Sample (If needed) Turn on the printer. Display the “Stored Data” menu (a submenu of , see page 7). Press followed by . A screen to specify the test record number is...

  • Page 46: Quality Control

    Verify that the serial number on each filter matches the serial number of the instrument when performing optical quality control. Each set of yellow and orange filters can only be used only with the ITC AVOXimeter 4000 of the same serial number and cannot be shared be een different instruments.
  • Page 47 ITC AVOXimeter 4000 Operator’s Manual The screen for specifying the sample type is displayed: Press followed by . The screen for specifying QC type is displayed: Press followed by . The screen for specifying filter type is displayed: Press the number key corresponding to the filter being run, followed by...

  • Page 48: Run Ng L Ni Iquid Controls

    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., ●...
  • Page 49 ITC AVOXimeter 4000 Operator’s Manual Press the number key co rresponding to the liquid control level being run, followed . A menu for selection of the liquid control lot number is displayed: Select the previously entered (see page 38) lot number and press...

  • Page 50: Entering Liquid Control Lot Numbers

    ITC AVOXimeter 4000 Operator’s Manual Entering Liquid Co ntrol Lot Numbers Three lot numbers for each of three levels of liquid control can be entered into the instrument for later refe rence. Display the “Data Management” menu (a submenu of , see page 7).

  • Page 51: Entering Cuvette Lot Numbers

    ITC AVOXimeter 4000 Operator’s Manual Entering Cuvette Lot Numbers The lot number of cuvettes can be entered int o the instrumen t for later reference Display the “Ca libration” menu (a submenu , see page 7). Press followed by to display the cuvette lot number screen:...

  • Page 52: Shutdown

    ITC AVOXimeter 4000 Operator’s Manual Shutdown (see page 7). Press followed by . The instrument will shut down. ultaneously press . The instrume nt will shut down.

  • Page 53: Troubleshoo Ng

    2. The printer is not connected 2. Connect the printer to the ITC to the instrument. AVOXimeter 4000 (see page 9). 3. The wrong print mode, 3. Specify the proper values for baud rate, or parity is the printer (see page 35).
  • Page 54 ITC AVOXimeter 4000 Operator’s Manual Symptom Possible Cause Action Required Measurements of 1. The optical detector may be 1. Run optical quality control. If %HbO are not contaminated by blood or needed, clean the optical accurate foreign material. detector (see page 49).
  • Page 55 ITC AVOXimeter 4000 Operator’s Manual Symptom Possible Cause Action Required The following ERROR: 1. Microprocessor error. 1. Press the keys message is displayed: simultaneously to turn the instrument off, then turn the “Uninitialized Vector instrument back on. Service Required“ 2. If the problem persists, contact ITC Technical Support (see page ii).
  • Page 56 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 57: Maintenance

    ITC AVOXimeter 4000 Operator’s Manual 5 Maintenance 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.

  • Page 58: Cleaning The Optical Detector

    Materials Needed: 2. 5 mm nutdriver 3. 1/4 inch nutdriver Disconnect the ITC AVOXimeter 4000 from the AC Adapter. Remove the four screws from the bottom of the instrument, using the #0 Phillips screwdriver. Holding the upper and lower covers together, place the...
  • Page 59 ITC AVOXimeter 4000 Operator’s Manual Keypad Cable Display Cable 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. Locate the coaxial cable that runs from the black optical unit to the small circuit board.
  • Page 60 ITC AVOXimeter 4000 Operator’s Manual ITC AVOXimeter 4000 Operator’s Manual Using the 1/4" nutdriver, remove the four screws and four nuts that secure the two halves of the black optical unit. Take care when separating the two halves of the optical unit.
  • Page 61 Sh ould this occur, disconnect the AC adapter and confirm that all connections have been made properly. Should the problem persist, contact ITC Technical Support. Reset the time and date (see page 16), and run optical quality control (see page...
  • Page 62 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 63: Replacing The Battery

    Record the temperatures displayed on the battery status screen. Then read the thermometer and record it as well. 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...
  • Page 64 ITC AVOXimeter 4000 Operator’s Manual Plastic Tie Blue and White Battery Cable Plastic Tie 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.
  • Page 65 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 –...
  • Page 66 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 67: 6 Quality Control Logs

    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.
  • Page 68 ITC AVOXimeter 4000 Operator’s Manual...
  • Page 69 ITC AVOXimeter 4000 Operator’s Manual...
  • Page 70 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 71: Warranty

    15 days from receipt. Damages caused by or connected to transport are excluded. Transport to and from ITC facility will be at purchaser’s charge and risk, and shall also be prepaid for reshipment, except as otherwise provided in writing.
  • Page 72 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.

  • Page 73: Safety St Ndard A S

    ITC AVOXimeter 4000 Operator’s Manual 8 Safety Standards The ITC AVOXimeter 40 00 instrumen t co mplies with the follo wing safety standard requirements d directives: A C22.2. 601. Medical Electrical Equipment –Gen eral Requirements for Safety N 60601-1/ Medical El...

  • Page 74: Guidance And Manufacturer's Declaration - Electromagnetic Emissions

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

  • Page 75: Guidance An Ma D Nufacturer's Declaration - Electromagnetic Immunit Y

    Immu nity 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. IEC 60601 Compliance Electromagnetic Environment -...
  • Page 76 ITC AVOXimeter 4000 Operator’s Manual...

  • Page 77: Index

    ITC AVOXimeter 4000 Operator’s Manual I ndex backlighting............15 labels and symbols..........v batteries limitations ............4 charging ............14 liquid controls ..........38 checking ............14 entering lot numbers ........40 calculations ............2 lockout ............... 9 calibration ............27 menus..............
  • Page 78 ITC AVOXimeter 4000 Operator’s Manual AP4001 10/07...

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