Operator`s and Service Manual
Contents
1. and the extinction coefficients are known the concen trations and can be computed from this set of equations Ex A1Cxt Equation 1 gt Ex 7 42 Equation 2 33 Equation 3 Conventional whole blood oximeters use only two wavelengths to measure the relative concentrations of two hemoglobin species oxy and deoxyhemoglobin Thus for a con ventional whole blood oximeter the oxyhemoglobin saturation is defined as x 100 Equation 4 where the total hemoglobin concentration is assumed to consist entirely of oxy and deoxy hemoglobin Consequently if other hemoglobin species such as met or carboxyhemoglo bin are present in substantial concentrations the conventional two wavelength oximeter s measurements of O2Hb would be in error 35 THEORY OF MEASUREMENT The AVOXimeter 4000 uses multiple wavelengths to obtain accurate measurements of O2Hb even if bilirubin and four different hemoglobin species are present in sample Thus for AVOXimeter 4000 the value reported on the display for 2 is defined as 7oO5Hb 100 Equation 5 HHb MetHb COHb Similar equations apply to and MetHb The AVOXimeter 4000 reports a value for the total hemoglobin concentration that is the sum of the concentrations of2. wv ow S AVOXimeter Wiee 4 000 Operator s and Service Manual U S Patent No 5 430 542 6 262 798 and 6 519 025 and Euro UK Patent 0663070 Table of Contents Topic Page General Precautions 3 Introduction to the AVOXimeter 4000 4 System Components 5 Getting Started 7 Keypad Overview 8 Installation and Operation 9 Software Features 10 Sample Collection and Preparation 12 Sample Analysis 13 Sample Printouts 15 Settings 16 Computer key Settings 16 Main Menu key Settings 23 Calibration and Quality Control 28 Optical QC Filters 28 Liquid QC 30 Proficiency Testing 31 Maintenance 32 Theory of Measurement 35 Troubleshooting of Specifications 42 Appendix A Printer Information 43 Appendix B Menu Flowcharts 44 Appendix C ASTM Output 51 Warranty and Service 55 Appendix D Circuit Diagrams 56 Index 61 Rev 9 06 General Precautions Do not allow untrained or an unauthorized personnel to use this instru ment This instrument will give accurate readings only if the cuvettes are at room temperaure and the temperature probe is near the cuvettes Do not attempt to use this instrument outside the recommended tempera ture range 15 C 30 C 59 F 86 F Do not place this instrument in air currents or thermally unstable surroundings Do not warm the cuvettes in your hand Do not allow blood water or other liquids to enter the instrument itself Cuvettes are not sterile Blood e
3. 912979 Mn 5161 13105 ist 6414 01140 11 11 183840 LII n 1288 agenti Index A AC adapter 3 7 Air bubbles 13 14 B Batteries Charging 32 Conservation 21 33 Replacement 3 Baud Rate 11 25 43 Bilirubin 36 40 C Calibration Menu 23 Temperature Probe 34 Verification 28 29 Optical Filters Carboxyhemoglobin 35 36 40 Cardio Green See indocyanine green dye Cleaning 33 Categorization 4 Computer key 8 16 45 Controls See Quality Control Cuvette Cal Code 23 Lot Number 23 Injection Technique 12 14 D Data Entry 7 8 Data Management 16 20 Data Transfer 16 17 Default Settings 11 Deoxyhemoglobin 35 36 40 Desiccant 3 Device Settings 20 E Enter On key 8 9 F Fetal hemoglobin 40 Filters See Optical QC Filters Front Panel 7 G General Precautions 3 Getting Started 7 H Hemolysis 36 40 IL s Multi 4 28 Indocyanine green dye See Cardio Green Installation 9 Introduction 4 6 IRMA Capillary Collection Device 12 K Keypad 8 L Light scattering 36 Liquid QC 30 31 Main Menu 23 27 Main Menu key 8 Maintenance 32 34 Methemoglobin 35 36 40 0 Optical Absorbance 35 36 Contamination 29 38 Density 35 QC 28 29 QC Filters 5 6 9 10 28 29 Oxyhemoglobin 36 Oxyhemoglobin saturation 40 P Patient ID 19 48 Printer 6 43 Print
4. Information Backlight OFF Backlight LOW Backlight MEDIUM Backlight HIGH Bom tHb Units g dL 1 OK 2 Select mmol L Standby Delay in Minutes 60 1 OK 2 Enter New Value HHMM Time 1816 24 hr 1 OK 2 Enter New Value MMDDYY Date 042996 1 OK 2 Enter New Value Temperature Battery 24 0C 75 2F OK ENTER When Done 45 APPENDIX B coNT D Security Measures after User ID 1 16666666 1951 991 1 1 01 JUBA BINS ay 1 330 uo 4950 eseeld 50192 ou 9 dn ODORE 195 191343 5141 19 9 2 nuaAeid 110195 01 666666 1951 AAO NO 1611 49501 144 PPY 9jojog mel eH 30 2 NO 1 5 330 NO 1981 46 APPENDIX B coNT D Stored QC Lot Information J91U3 1 191 90 1913 1 30120 21021 GANISSGNN 101 129195 61 J91U3 1 30120 21021
5. caret character 0 5 Records are variable length Records conform to the ASTM standard 1394 91 Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems Transmission conforms to ASTM standard 1381 91 Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems Records are transmitted from the AVOXimeter 4000 in reverse sample number sequence Record Types Used Message Header Record Patient Record Order Record Manufacturer Record Result Record Terminator Record Record Types Not Used Comments Request Information Scientific IV Record Hierarchy Header Record Patient 1 Record Order 1 Record Manufacturer Record Analyte 1 Result Record Analyte 2 Result Record Order 2 Record Order Record Manufacturer Record Analyte 1 Result Record Analyte 2 Result Record Patient n Record Order 1 Record Manufacturer Record Analyte 1 Result Record Analyte 2 Result Record Terminator Record 51 APPENDIX C CONT D V ASTM FORMATS Field No 1 2 AJAJ Field No 1 2 Field Label Record Type Delimiters Message Control Access Password Sender Information see below Sender Name ID Software Version Serial Number Sender Street Reserved Sender Phone Sender Characteristics Receiver ID Comments Processing ID E1394 Version No Message Date Time Field Label
6. system is not ready to receive data the transfer process will out and display a message that the transfer process has terminated Verify the connection port configuration on both systems the readiness of the receiving system and attempt the transfer again No Terminates the data transfer and returns to the Stored Data menu Selecting this function powers down the AVOXimeter 4000 27 Calibration and Quality Control GENERAL Quality Control Materials OPTICAL QC Recommendation for Optical QC The initial calibration of the AVOXimeter 4000 is set at the factory Recalibration is required only if the daily functional checks with the yellow and orange optical filters do not meet the established specifi cations Recalibration if necessary will be performed at ITC The most frequent cause of error messages or erroneous readings is not loss of calibration but contamination of the optical detector with blood or other debris The optical filters are used to quickly and conveniently determine whether the optics have been contaminated and to verify that the calibration has not changed Because they verify calibration these procedural checks meet the requirement 8493 1202 which states that the user must per form and document calibration procedures at least once every six months These procedural checks not only verify that the instrument is prop erly calibrated but also confirm the optical detector
7. LCD Units Standby Delay This feature allows the operator to adjust the brightness of the LCD backlighting Selection of this option from the Device Settings menu displays the following backlighting options 1 Backlight OFF 2 Backlight LOW 3 Backlight MEDIUM 4 Backlight HIGH Enter the selection number and press Enter On to adjust the back lighting to the operating environment The screen immediately ad justs to the brightness selected Continue to adjust the backlight via number selection until the desired backlighting is achieved Press Cancel from the backlight options menu to return to the Device Set tings menu This feature allows the operator to change the current tHb units displayed The options are g dL or mmol L Selection of this option displays the current status and allows the operator to leave the status as currently displayed or select the alternate status Standby mode allows you to minimize the drain on the batteries yet keep the AVOXimeter 4000 turned on so it can quickly resume analy sis This mode draws very little power and thus extends the operat ing time to several days with a fully charged battery The AVOXimeter 4000 will automatically go into Standby Mode after n minutes of inactivity where is the value defined The AVOXimeter 4000 will not go into Standby Mode when perform ing analyses or executing functions unless the battery voltage is critically low If the battery voltage is
8. Manual not shown AVOXimeter 4000 rear view showing handle serial port AC adapter port and temperature probe connected SYSTEM COMPONENTS CONT D Cuvettes Optical QC filters Optional printer Getting Started Precautions 1 Use only the AC adapter battery charger supplied by ITC PN 9692 110 VAC or PN 9671 220 VAC 2 The instrument should not be used in the presence of flammable agents 3 For accurate readings the cuvettes must be stored at room tem perature 15 30 C near the temperature probe connected to the instrument Do not place the instrument in air currents or thermal ly unstable surroundings 4 Do not allow blood or other liquids to enter the instrument itself 5 Blood exposed to the cuvette should never be returned to the patient because the cuvettes are not sterile Front Panel A Slot for cuvette 3 Sakai insertion B Keypad for data 2 ks entry No C Liquid crystal dis AVO Imeter 8 play or 4000 i eos The display has four ux lines each with 20 char Mns dr acters Data Entry Sample analysis does not require use of the numeric keypad until af ter the sample analysis is complete and prior to display of the results After the analysis is complete the software allows Sample Identifica tion through selection or entry of numeric values Keypad Overview Data E Other keys on the keypad are utilized as follows cont d Main Menu prov
9. Name Patient ID A VOX Systems Inc 15 Settings Computer Data Management Data Transfer ON The Computer and Main Menu keys activate the configuration and data access features of the AVOXimeter 4000 The following section describes the options available from these keys For a quick refer ence Appendix B contains a hierarchy of the configuration menu structure Options under the Main Menu key begin on page 23 When the Computer key is pressed the following menu is dis played 1 Data Management 2 Device Settings 3 Time Date Temp Selection of choice 1 from the Computer menu displays the Data Management menu options 1 Data TransferON OFF 2 User ID ON OFF 3 Patient ID ON OFF 4 QC Lot The purpose of this feature is to provide the option to send the AVOXimeter s data out the serial port using both the ASTM format and communication protocol Selection of this option displays the current status On or Off and allows the operator to leave the status as currently displayed or select the alternate status When ON option 3 Transfer Data appears on the Stored Data menu Selecting the Transfer Data option from the Stored Data menu sends result records out the serial port via the attached RS 232 cable using the ASTM Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems E1394 91 as it applies to the specific data generated by the AVOXimeter 40
10. This function configures the serial port for compatibility with the external printer Both the baud rate and parity can be adjusted However the data bits are fixed at 8 and the stop bits are fixed at 1 When the Printer Parameters are selected from the Printer Mode menu the currently defined baud rate and parity are displayed Pressing Cancel leaves the values as currently displayed chang es can be made as described below The default baud rate is 9600 bps The available baud rates are 110 300 600 1200 4800 9600 and 19200 bps Enter On leaves the baud rate as displayed and moves the cur sor to the parity value Yes displays the next available baud rate No displays the previous available baud rate The default parity is NONE The available parity options are NONE EVEN ODD Enter On leaves the parity as displayed and presents a confirma tion screen for both baud rate and parity values Yes displays the next available parity value No displays the previous available parity value If you change the serial port configuration for the printer and also use the Transfer Data function verify that the receiving system can accommodate the current serial port configuration If not change the serial port configuration before and after executing the Transfer Data function The Stored Data function displays and prints existing AVOXimeter 4000 results Upon selection of the Stored Data option from the Main Menu the follow
11. critical the AVOXimeter will im mediately enter Standby Mode and prompt the operator to plug in the charger To resume operation hold down any key for approximately one second Selecting this option displays the current Standby Delay in minutes and allows the operator to leave the status as currently displayed or enter a new Standby Delay The valid entries are 10 to 180 minutes Use 0 to disable the Standby Delay feature Entry of a value greater than O but less than 10 automatically defaults to 10 21 COMPUTER SETTINGS CONT D Time Date Temp Set amp View Time Set amp View Date Temp amp Battery Selecting choice 3 from the Computer menu displays the follow ing Time Date Temp menu 1 Set amp View Time 2 Set amp View Date 3 Temp amp Battery This feature allows viewing and changing the AVOXimeter s internal clock Selection of this option displays the current time and allows the operator to leave the time as currently displayed or set the clock to a new time The operator is not required to enter leading zeros but must enter trailing zeros the AVOXimeter 4000 automatically adds leading zeros to create the time in the format HHMM For ex ample entry of 1 automatically defaults to 0001 The AVOXimeter 4000 does not automatically adjust for Day Light Savings Time This feature allows viewing and changing the AVOXimeter s internal calendar Selection of this option displays the current da
12. into the AVOXimeter 4 Insert the filter into the cuvette slot and enter the sample information at the prompt 5 Verify that each of the results is within the established range for the filter Proceed with the other filter if each value is within range NOTE Discontinue using the device for clinical purposes if any of the val ues are outside of the specified range and refer to the Troubleshoot ing section of the manual or contact Technical Support Optical QC Ranges Analyte Range for Yellow Filter Range for Orange Filter tHb g dL 7 8 to 8 2 16 7 to 17 3 tHb mmol L 48 to 5 1 10 4 to 10 7 O2Hb 93 7 to 96 3 37 8 to 402 COHb 0 6 to 3 4 200 to 230 MetHb 0 4 to 2 4 0 2 to 1 8 29 Liquid QC LIQUID QC Recommendation for Liquid QC Liquid QC Procedure The purpose of liquid controls is to serve as another means to verify that the AVOXimeter 4000 system is functioning properly Control materials compatible with the AVOXimeter 4000 are the IL Multi 4 CO Oximeter Controls levels 1 2 and 800 955 9525 781 861 0710 or www ilww com and RNA CC 527 levels 1 to 3 or CVC 223 levels 1 to 5 800 533 6162 978 772 9070 or www rnamedical com Other controls may give erroneous results The Multi 4 controls are assayed hemoglobin solutions that require refrigeration The RNA controls are dye based liquid controls that can be stored at room temperature When ordering request a lot with best dating to ensure t
13. the screws The baud rates of both the printer and the AVOXimeter 4000 are preset at the factory to 9600 bps To verify or change the baud rate settings on the AVOXimeter 4000 refer to page 25 Pin Out for the AVOXimeter 4000 Serial Port The following diagram explains the pin out for the rear connector DB9 male of the AVOX imeter 4000 serial port The connector is shown as viewed from the back of the instrument Pin 1 NC Pin 2 RXD Input Pin 3 TXD Output Pin 4 DTR Data Term Ready Pin 5 Signal Ground Pin 6 NC Pin 7 RTS Ready to Send Pin 8 CTS Clear to Send Pin 9 NC 00000 00 43 Appendix B Screens under MAIN MENU key Cuvette Cal Code Calibration Menu remo P is 1 OK res the MAIN MENU 1 Cuvette Cal Code Senter Now value key 2 Cuvette Lot Number 3 H fner s 1 30 1 39 Cuvette Lot ici 66 6 6 6 6 1 OK 2 Enter New Value Main Menu H fner s Number 1 Calibration 81 pod 02 g Hb E 2 Printer Mode 2 Enter New Value 3 Stored Data 4 Turn Off Auto Print OFF Printer Mode Menu 1 OK 2 Turn ON 1 Auto Print ON OFF 2 2 Print Stored Data 3 Printer Parameters Printing 4216 E Please Wait CANCEL to Terminate Instructions Baud 9600 To make a selection ole ca ee ata Bits ixe from any menu press Stop Bits 1 Fixe
14. 00 and the ASTM Specification for Low Level Proto col to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems E1381 91 16 COMPUTER SETTINGS CONT D Data Transfer Cont d ON OFF User ID ON OFF Security Please refer to Appendix C for output format specific to data gener ated by the AVOXimeter 4000 The output contains a flag indicating that a record has been previously sent When OFF option 3 Transfer Data no longer appears on the Stored Data menu and disables the ability to transfer results to another device such as a computer The purpose of this feature is to allow optional entry of the operator ID in either a secure or non secure mode Selection of this option displays the current status and allows the operator to leave the sta tus as currently displayed or select the alternate status When User ID is turned ON or the current ON status is acknowl edged the operator is presented with the Security ON OFF menu Please see the following section for a discussion of the Security options When the User ID is ON and Security is OFF the opera tor of the AVOXimeter is prompted for entry of the User ID at the completion of sample analysis but prior to the results display In this configuration the AVOXimeter 4000 accepts either a validated or non validated User ID or no User ID Leaving the User ID blank displays USR Not Ent on the Stored Data result display Leaving the U
15. 1 107 109 96 21 19497 2 120 96 21021 L 107 199195 11 47 APPENDIX B coNT D Entry of Patient amp QC Information Part 1 ued 20 1uened ees 50192 ou 6 01 dn aae OO 1955 19443 20 ed ejduies 199125 Hed uoneuuoju 20 ees 10 9 uesu AO 9 106098 9 uesu AQV3H AQV3H 50192 ou 6 01 1955 49103 jueuinujsu 48 APPENDIX B coNT D Entry of Patient amp QC Information Part 2 96 96 1p 6 998 1266 0 21 qHi9 N L 9 72 T soJez ou 01 dn HEH 19103 ____ uo 49 APPENDIX B coNT D Entry of Patient amp QC Information Part 3 96 96 1p 6 999 266 041 GHOD L MO Jojues e
16. 7 Abnormal Flags Null 8 Nature of Abnormal Null Testing 9 Hesult Status or H not previously sent If previously sent R Terminator Record Field No Field Label Values Additional Comments 1 Record Type 2 Sequence 1 3 Termination Code N or T Normal N Sender aborted T Warranty and Service ITC declares to the original purchaser that each instrument manufactured and sold by ITC or sold by an authorized ITC dealer shall be free from defects in material and workmanship and under normal and proper use conditions warrants it for a period of one year from installation and no more than 13 months from the shipping date except as otherwise provided in writing ITC s obligation is limited to repairing replacing or modifying at ITC s undisputed judgment at ITC s factory or elsewhere the material whose defects have been verified on condition that the purchaser has informed ITC of any defects found within 15 days from receipt Damages caused by or connected to trans port 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 These replacements repairs or alterations will in no case determine extension to the above specified warranty period The warranty does not cover those parts that deteriorate or which in any case considered consumables or those parts or items which
17. Cal Code instructions p 23 Follow Cuvette Cal Code instructions p 23 3 Contact Technical Support 4 Analyze optical QC filters if values are within specifica tions detector is OK Verify user is using proper cuvette handling and sampling tech nique If values are outside of specification contact Technical Support Contact Technical Support 38 TROUBLESHOOTING SYMPTOM Message on LCD Reads ERROR tHb lt gt or ERROR 2 lt gt XX X or ERROR COHb lt gt XX X or ERROR MetHb lt gt XX X or ERROR lt gt XX X or ERROR Scat lt gt XX X or followed by See Troubleshooting Section of Manual ENTER to Continue Note If any of these errors the sample data will not be stored ERROR tHb 4 0 g dL Note The sample data will not be stored ERROR tHb gt 25 0 g dL Note The sample data will not be stored tHb O2Hb or MetHb reading for optical filter is out of range POSSIBLE CAUSE 1 No sample in cuvette 2 Cuvette is not properly filled 2 3 Detector surface is contami nated with blood or other debris 4 LED intensities too low tHb may actually be low In this case 2 4 MetHb values may be curate tHb may actually be high In this case tHb 2 amp MetHb values may be inac curate Detector surface is contaminated wit
18. H 1 je2ndo XXXXXX XXXXXXX 101 XXXXXXX 107 9 91 L 19 9 XXXXXXX ou 5 o1 dn XXXXXXX 4 129 1 1291098 jeondo pinbr L 50 P S 19497 19497 12925 50 Appendix C The AVOXimeter 4000 features an ASTM output using the single RS 232 serial port This allows transfer of the AVOximeter 40005 results to an information system capable of receiving data utilizing the ASTM standard 1394 91 Standard Specification for Transferring Information Between Clinical Laboratory Instruments and Computer Systems and ASTM sta Instrumen ASTM Output ndard 1381 91 Specification for Low Level Protocol to Transfer Messages Between Clinical Laboratory ts and Computer Systems The following is a brief description of the formatting of these data General Output Notes Moo 9 ASTM Ill ASTM Q S Each record consists of fields separated by the vertical bar character 0 7 Each record will end with the lt CR gt character 0 00 Fields may contain components separated with the
19. Number 393 User ID 975310 Optical Filter Orange Measured tHb 17 0 g dL O2Hb 39 3 96 COHb 21 3 96 MetHb 1 0 96 Calculated O2Ct 9 3 mL dL A VOX Systems Inc Liquid QC with User ID Off Patient ID On amp User ID On AVOXimeter 4000 Optical QC Test S N 41017 Tested on 05 24 05 07 43 Test Number 392 User ID Not Entered Optical Filter Yellow Measured tHb 8 0 g dL O2Hb 95 2 COHb 1 6 MetHb 0 7 Calculated O2Ct 10 5 mL dL User ID A VOX Systems Inc Patient ID Off amp User ID On AVOXimeter 4000 Liquid QC Test S N 41017 Tested on 05 24 05 07 43 Test Number 391 User ID Not Entered Control Level 2 QC Lot Number 754191 Measured tHb 14 1 g dL O2Hb 94 5 COHb 23 MetHb 1 0 Calculated O2Ct 18 6 mL dL Cal Code 41878 Cuvette Lot 103095 User ID A VOX Systems Inc AVOXimeter 4000 Patient Test S N 41017 Printed on 05 27 05 09 03 Tested on 05 24 05 07 43 Test Number 394 User ID 864201 Patient ID 357912468035 Measured tHb 12 5 g dL O2Hb 95 0 96 COHb 23 96 MetHb 0 3 96 Calculated O2Ct 16 5 mL dL Cal Code 41878 Patient Name A VOX Systems Inc AVOXimeter 4000 Patient Test S N 41017 Tested on 05 24 05 07 43 Test Number 395 User ID 975310 Patient ID Not Entered Measured tHb 12 4 g dL O2Hb 95 4 1 9 MetHb 0 2 Calculated O2Ct 16 5 mL dL Cal Code 41878 Patient
20. Record Type Sequence No Patient ID Primar Lab ID Header Record Values Null Null VX X X XXXXX 5 digits Null Null Null Null IDMS Null YYYYMMDDHHMMSS Patient Record Values 1 4 Null Q C Test Patient ID up to 12 digits or Null Additional Comments Repeat delimiter component delimiter escape character respectivel AVOX software version Analyzer serial number Current Date and Time Additional Comments nth patient record in this transmission set between and L records If sample type patient then patient ID entered or Null if left blank If sample type QC then literal string Q C Test 52 APPENDIX C CONT D Order Record 1 Record Type Q 2 Sequence No 1 nth order record in this patient set between P and P or P and L record sets 4 instrument ID CO XXXXXX upto 6 digits Analyzer sample ID 1 5 Universal Test ID 888080 7725 L 51 _______ Test ID Pati Nul 434444 L 52 Univ Test ID Part L 53 JUnivTestlD 5 4 Universal Test ID Part4 AO if not Optical Filter Yellow Optical QC 1 a 1 M HH us CR 2 Order Dateffi Null ine xe Tesi date O O Collection V Null 11 Collector ID or Null ID of operator up to 9 digits per
21. Then dry off the detector surface making sure that it is clean Remove any other debris inside the optical unit 13 Reassemble the two halves of the optical unit making sure that the shutter door and torsion spring are installed correctly the 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 14 Reverse steps 1 through 10 to reassemble the AVOXimeter 15 Turn on the instrument The AVOXimeter should run its self test and display its READY screen Reset time and date see Time Date menu p 22 16 Ifthe AVOXimeter fails its self test or displays error messages the most likely cause of the problem is improper re assembly particularly cables not connected to the correct pins on their sockets see Troubleshooting 41 Specifications Measurements and Operating Ranges total hemoglobin concentration tHb 4 to 25 g dL oxyhemoglobin O2Hb 0 to 100 96 carboxyhemoglobin COHb 0 to 75 9 methemoglobin MetHb 0 to 85 96 Calculated oxygen content O2Ct 0 to 35 mL dL Accuracy Precision total hemoglobin concentration 10 g dL 0 45 g dL 0 3 g dL 10 g dL 0 35 g dL 0 3 g dL oxyhemoglobin O2Hb 1 6 96 0 8 96 carboxyhemoglobin COHb 2 9 1 methemoglobin MetHb 1 5 0 7 96 type whole blood volume 50 ul Time per Sample 10 sec Number of Wavelengths 7 Data Display 4 lines X 20 char
22. This section describes how to perform the following maintenance procedures on the AVOXimeter 4000 system Charging the battery Cleaning the analyzer Cleaning the optical QC filters Inserting printer paper Temperature probe calibration verification The AVOXimeter 4000 can be powered either from its internal batter ies or from the wall transformer that serves as a battery charger and AC adapter It can analyze blood samples and perform all of its other functions using either power source When the AC adapter is the power source the batteries will charge at the same time that blood samples are analyzed To maximize the operating time from a battery charge the AVOXimeter 4000 has two modes of operation Sample Analysis Mode and Standby Mode When the AVOXimeter 4000 is displaying its READY screen itis in the Sample Analysis Mode This is the usual mode of operation foranalyzing samples using various menus and printing stored data If a sample is not analyzed or a key is not pressed within a user defined time period the AVOXimeter will go into Standby Mode to conserve its battery charge The Standby Delay can be set by pressing the Com puter Key selecting Device Settings and selecting Standby Delay Standby Mode conserves battery power and extends the battery op erating time without turning off the AVOXimeter 4000 Testing may resume shortly after exiting Standby Mode To exit hold down any key for approximately one secon
23. Ximeter 4000 automatically compares it with an internal table of acceptable codes After entering a five digit numeric Cal Code the operator must confirm the entry in a subsequent display Upon acceptance the AVOXimeter verifies that the entry is a valid Cal Code and presents an error message if the Cal Code entered does not match one of those defined by the manufacturer The Cuvette Lot Number is stored with the liquid QC results to facilitate regulatory compliance and the recall of Stored Data Selecting the Cuvette Lot Number option from the Calibration Menu displays the Cuvette Lot Number currently defined Press Cancel or OK to leave the Cuvette Lot Number as currently dis played or change the current value The Cuvette Lot Number can also be changed following completion of analysis during collection of sample information When entered during sample information entry the new Cuvette Lot Number re displays the existing Cuvette Lot Number stored in the AVOXimeter 4000 s non volatile memory Entry of a one to seven digit numeric Cuvette Lot Number redis plays the entry for confirmation 2 Main Menu SETTINGS CONT D Hufner s Number Printer Mode Auto Print ON OFF Print Stored Data H fner s Number the constant k in the following equation is used to compute the oxygen content O2Ct of each sample O2Ct k x tHb x 2 100 Selecting the H fner s Number option from the Calibration Menu displays the cu
24. acters Interference tHb 9002 _ 9eCOHb MetHb bilirubin 11mg dL none none lt 1 lt 1 hemolysis none none lt 1 lt 1 fetal hemoglobin 13 5 g dL HbF 100 0 45g dL 196 0 06 HbF lt 1 indocyanine green dye 10mg L 0 45g dL 196 lt 1 lt 1 methemoglobin 0 2 g dL lt 1 tHb 16 g dL MetHb 1096 7 1 pH 7 8 Dimensions 10X8X3 75 inches 25 4 x 20 3 x 9 5 cm Weight 4 lbs 1 8 kg Serial Port RS232C Battery Ni Cad Battery Charger PN 9692 110VAC PN 9671 220 VAC Approvals UL 544 CE mark for EMC directive Data Storage 100 samples in non volatile memory Accuracy data were obtained by comparing the AVOXimeter 4000 with a reference co oximeter Specifications for accuracy are Sy x standard error of the estimate for the best fit line determined by the method of least squares Precision specification is based on the standard deviation of repeated analysis of the same sample 42 Appendix A PRINTER Installation Serial Port The Dymo SE300 printer is a small convenient thermal printer which attaches to AVOXimeter 4000 via a custom 089 to RJ 11 modular plug cable The printer is powered by an AC adapter Do not operate the printer with any adapter other than the one provided Connect the cable supplied with the Dymo printer to the printer using the RJ11 modular plug Connect the DB9 connector to the serial port on the rear panel of the AVOXimeter 4000 Secure the cable with
25. attery cable at the circuit board JP301 6 Tilt the top half of the case backward to gain access to the front of the circuit board 7 Find the keypad cable that runs from the keypad to the circuit board Disconect the keypad cable at the circuit board J101 8 Find the flat LCD cable that runs from the LCD to the circuit board connector J102 Discon nect the LCD cable at the circuit board CAU TION Grasp the connector only and gently rock in an upward direction 9 Disconnect the LED cable that runs from the black optical unit to the circuit board J203 un plugging it at the circuit board Disconnect the coaxial detector cable that runs from the black optical unit to the small circuit board J1XX unhooking it at the circuit board end 40 TROUBLESHOOTING 10 Now turn the top half of the AVOXimeter s case upside down so that you are looking directly at the black optical unit Using the 5mm nutdriver remove the four nuts and washers if applicable that hold the optical unit to the front panel and completely remove the optical unit from the instrument 11 Using the 1 4 nutdriver remove the four screws and four nuts Take care when separating the two halves of the optical unit Do not lose the small torsion spring or the shutter door Set them aside in a safe place for reassembly 12 Clean the exposed detector with gauze pads dampened with detergent Do not use abra sives
26. by their nature are normally required to be replaced periodically consistent with normal maintenance It is also understood that following the purchase and delivery of the instrument 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 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
27. d If the battery voltage becomes critical the AVOXimeter 4000 will im mediately go into Standby Mode and will prompt the user to plug in the charger 32 Maintenance Cont d Battery Charge Conservation Battery Status Analyzer Cleaning If the batteries are fresh and fully charged the AVOXimeter 4000 can analyze blood samples continuously for 10 12 hours when the display backlighting is set at MEDIUM However the operating time per battery charge depends on a number of user selectable factors The following tips will help the user maximize the number of samples that can be analyzed from a single battery charge 1 Turning the display backlight off will conserve battery energy and thus increase the operating time per battery charge If the backlight is needed the LOW backlight setting is the next best choice Press the Computer key select Device Settings and select LCD to set the level of backlighting 2 Setting the Standby Delay to the shortest time 10 minutes will conserve battery energy by putting the AVOXimeter 4000 into Standby Mode if it is not used for 10 minutes Press the Com puter key select Device Settings and select Standby Delay to change the setting 3 Ni Cad batteries suffer from a memory effect if they are charged before being completely discharged To prevent memory effect let batteries discharge completely before recharging Batteries are almost completely discharged when the battery cri
28. d the desired number and then the Enter On key Stored Data Menu Show Sample 1 Select Sample Valid Range Press Cancel to return 2 Newest Sample L 117 to 216 t revi menu 3 Transfer Data O A previetis MENU Use to Scroll Sample 214 This line shown only if Data tHb O2Hb COHb MetHb Transfer turned on under Data 17 0 35 4 225 0 6 Management menu 96 96 9 Transfer Data Y N Turn Off POWERING DOWN Note This selection does not require pressing Enter On to confirm APPENDIX B coNT D Screens under COMPUTER key Press the COMPUTER key Computer Menu 1 Data Management p 2 Device Settings 3 Time Date Temp Instructions To make a selection from any menu press the desired number and then the Enter On key Press Cancel to return to a previous menu 1 DataTransferON OFF 2 User ID ON OFF 3 Patient ID ON OFF 4 QC Lot Device Settings Menu Data Management Menu 1 LCD 2 2 Units 3 Standby Delay Time and Date Menu 1 Set amp View Time 73 2 Set amp View Date 3 Battery Status Data Transfer ON 1 OK 2 Turn OFF User ID ON 1 OK 2 Turn OFF Patient ID ON 1 OK 2 Turn OFF Select Level 1 Level 1 2 Level 2 3 Level 3 See Security Measures After User ID See Stored QC Lot
29. e analysis yet provide optional features to assure result integrity for patient reporting and to facilitate regulatory com pliance All operating parameter settings are stored in non volatile memory and are retained when the AVOXimeter 4000 is powered down Enabling the Security feature requires entry of a valid numeric User ID before performing tests or accessing data in the AVOXimeter 4000 These numeric User IDs must be predefined by the QA User through the Data Management Menu User ID option Enabling the Security feature also provides the option to suppress printing of the User ID on the result printout When the option to print the User ID is disabled a labeled line on the printout provides space for writing in the User ID manually When Security is disabled a User ID option allows entry of a non validated numeric operator ID This eliminates the need to enter a valid User ID before accessing functions on the AVOXimeter 4000 and satisfies regulatory requirements for recording the operator who performed the test Because these IDs are not secure using this mode for recording operator IDs automatically includes the User ID on the printout Disabling the User ID completely bypasses the User ID entry option The software requires the operator to distinguish between a patient and QC sample prior to result display When Security is disabled following completion of sample analysis the AVOXimeter 4000 guides the operator through entry or se
30. edged entry of a valid numeric User ID is no longer required to oper ate the AVOXimeter 4000 When Security is turned Off User IDs will be printed on the result printout for both new and recalled tests The purpose of this feature is to allow optional entry of the patient ID Selection of this option displays the current status and allows the operator to leave the status as currently displayed or select the alternate status When Patient ID is ON the operator of the AVOXimeter is prompted to enter the Patient ID at the completion of sample analysis but prior to the results display In this configuration the AVOXimeter 4000 ac cepts entry of a one to twelve digit numeric Patient ID Leaving the Patient ID blank displays Pt ID Not Entered on the Stored Data result display prints Patient ID Not Entered on the result printout and provides a write on capability at the bottom When Patient ID is OFF the operator is not given the option to enter Patient ID following the completion of sample analysis A sample analyzed with Patient ID OFF displays Pt ID Not Entered on the Stored Data result display prints Patient ID Not Entered on the re sult printout and provides a write on capability at the bottom COMPUTER SETTINGS CONT D QC Lot Select Level Select Lot Device Settings The purpose of this feature is to allow definition of the Lot Number s associated with Levels 1 2 or 3 once they have b
31. een accepted for use within the organization Following comple tion of sample analysis but before result display the operator is asked to identify the sample type If the sample type is Liquid QC the screen for Level selection appears followed by the Lot Numbers predefined using this feature for the selected level This feature allows for definition of three lot numbers per level During sample identification only those previously defined will appear for operator selection Following selection of the QC Lot option the following menu ap pears Select Level 1 Level 1 2 Level 2 3 Level 3 The lot numbers defined for the level selected are displayed Select the Lot number to be changed or deleted The QC Lot confirmation screen displays the Lot Number selected Option 1 Cancel or OK to accept the Lot Number displayed Option 2 Enter New Value presents a Lot Number entry screen Enter a new Lot Number from one to seven numeric dig its in length or press Enter On to delete the previous Lot Num ber Entry of a new Lot Number requires confirmation Deletion of a Lot Number automatically shifts the remaining Lot Numbers up one selection on the Select Lot screen When specifying Lot Numbers ignore leading letters and leading zeroes Selection of choice 2 from the Computer menu displays the fol lowing Device Settings menu 1 LCD 2 Units 3 Standby Delay 20 COMPUTER SETTINGS CONT D Device Settings Cont d
32. en times faster than standard co oximeters and eliminate the extensive care associated with their use No sample preparation is required Analysis is quickly accomplished by injecting the whole blood sample into a disposable cuvette and inserting the cuvette into the instru ment The AVOXimeter 4000 then illuminates the sample with multiple wavelengths records the optical absorbance of the sample at each wavelength and computes the results In 10 seconds the total hemoglobin concentration and the relative concentra tions of oxy carboxy and methemoglobin are shown in appropriate units on the liquid crystal display on the front panel The total hemoglobin concentration measured by the AVOXimeter 4000 includes oxy deoxy met and carboxyhemoglobin tHb OjHb HHb MetHb COHb Accordingly the percentage of oxyhemoglobin reported by the AVOXimeter 4000 is O5Hb x 100 HHb MetHb COHb The fractions of carboxy and methemoglobin are defined in a similar manner In the U S the AVOXimeter is classified as moderately complex under the CLIA test categorization System Components The AVOXimeter 4000 system consists of the following components AVOXimeter 4000 AC adapter e Single use cuvette ordered separately Temperature probe Optical QC filters Operator s Manual yellow and orange Printer optional AVOximeter 4000 front view Includes AC adapter and Operator s
33. er Mode 24 25 Printer paper 34 Proficiency Testing 31 Q Quality Control 28 31 Lot 20 R Ready Screen 13 CC 527 Controls 28 30 S Sample Collection 12 Screen Backlighting 20 21 Security 10 17 18 Self test 9 Service 55 Standby Delay 20 21 Standby Mode 32 33 Stored Data 25 27 System Components 5 6 T Table of Contents 2 Technical Support 37 Temperature Probe 5 9 13 34 Temperature Operating Range 3 Theory of Measurement 35 Time Date Temp 22 Total hemoglobin 4 35 36 40 Troubleshooting 37 41 Turn OFF 9 27 U Units 21 User ID V Vent Patch W Warranty 55 Wavelengths 36 40 10 17 13 14 61 8 Olsen Avenue Edison 08820 USA tel 732 548 5700 fax 732 248 1928 www itcmed com a subsidiary of Thoratec Corporation Emergo Europe Molenstraat 15 2513 BH The Hague The Netherlands Tel 31 70 345 8570 Fax 31 70 346 7299
34. erials the AVOXimeter can still give spurious readings on whole blood if blood or other debris has got ten onto the light detector To rule out this possibility perform the Optical QC Procedure with the yellow and orange filters Proficiency testing is a system by which laboratories can compare the accuracy of their testing procedures and the proficiency of their users with other laboratories Federal regulations at this time require that only the test system assay or examination used as the primary method for patient testing participate in the proficiency testing 8493 801 A full description of the proficiency testing process may be found in Subpart H 42 CFR Feb 28 1992 CLIA 88 In the case of ancillary testing if a testing facility performs the same test using different methodologies or instruments or per forms the same test at multiple testing sites the testing facility must have a system that evaluates and defines the relationship between test results biannually 8493 1709 The primary instru ment enrolled in proficiency testing is used to compare all other instruments The following proficiency surveys are compatible with the AVOX imeter American Proficiency Institute API Blood Oximetry 114 94 800 333 0958 College of American Pathologists CAP Blood Oximetry Survey SO 800 323 4040 Other proficiency surveys may give erroneous results 31 Maintenance MAINTENANCE Battery Power Standby Mode
35. forming test Null if left blank Manufacturer Record Field N Field Label Val A dditi 1 Record Type 2 Sequence 3 Calibration Code XXXXX 5 digits or Null Null if Optical Filter 4 Cuvette Lot up to 7 digits Null if Patient Data or Optical Loo or Filter ____________ 5 Control Level Null or 1 2 or 3 record field 4 does not 6 Material Lot i e up to 7 digits Null if Patient Data or Po Control Lot Number orNul Value BX 09 8 Optical QC Status Null PASS or FAIL PASS or FAIL if Optical Filter Null otherwise 53 APPENDIX C Result Record Field No Field Label Values Additional Comments 1 Record Type 2 Sequence 1 nth result record in this order set between O and O or O and L record Sets 3 Universal Test ID see below 3 1 Univ Test ID Part 1 Null 3 2 Univ Test ID Part 2 3 3 Univ Test ID Part 3 3 4 Universal Test ID tHb O2Hb Analyte test ID Part 4 MetHb HHb O2Ct predefined by the analyzer 3 5 Universal Test ID M or Measured value for tHb Part 5 O2Hb COHb MetHb HHb Calculated value C for O2Ct 4 Data or HHH HHH Measurement Value 5 Units Null g dL mmol L 6 Reference Range Null
36. h blood or other debris 2 Calibration of instrument has drifted REMEDY Fill cuvette with sample Make sure sample reaches vent patch Analyze optical QC filters If values are within specifica tions detector is OK Verify proper cuvette handling and sampling technique is being used If values are outside of specification contact Tech nical Support Turn off on to see if Self Test fails If failure occurs then contact Technical Support Not Applicable Not Applicable 1 Contact Technical Support 2 Contact Technical Support 39 TRouBLESHOOTING Disassembling the AVOXimeter and Cleaning the Detector If you suspect that the optical unit has been contaiminated with blood you may clean the detector of the AVOXimeter by following these instructions You need the following tools for this procedure a phillips screwdriver b 5mm nutdriver c 1 4 nutdriver 1 Disconnect the wall transformer from the AVOXimeter and turn the unit off 2 Turn the AVOXimeter upside down and remove the four screws using the 0 phillips screwdriver 3 Hold the upper and lower parts of the case together and turn the AVOXimeter right side up again with the keypad to your right 4 Slowly and carefully lift the upper part of the case slightly keeping it parallel with the lower part 5 Find the battery cable that runs from the battery pack to the circuit board Disconnect the b
37. he longest shelf life possible If QC ranges for the AVOXimeter 4000 are not listed on the insert sheet of the IL Multi 4 or the RNA CC 527 or 223 controls call Technical Support 800 225 2869 210 696 4149 The manufacturer recommends periodic quality control testing with liquid controls to verify proper storage of cuvettes weekly verify proper shipping conditions before a new lot or shipment of cuvettes is put into use verify the performance of the cuvettes as required To conduct periodic QC and calibration verification with liquid con trols Prior to analyzing liquid controls QC lot information must be defined refer to page 20 1 Observe the manufacturer s recommendations for storage prepa ration and handling of the control material 2 Ensure that the temperature probe is firmly plugged into the AVOxXimeter 4000 3 If the AVOXimeter 4000 is not powered up press the Enter On key and wait for the Ready screen 30 PROFICIENCY TESTING Recommended Surveys 4 Verify cuvette Cal Code page 23 fill cuvette with the control and insert the cuvette into the instrument 5 Verify that results are within your facility s established ranges If values are not within range follow your facility s protocol Even if the AVOXimeter s readings with liquid QC materials fall within the acceptable ranges specified on the insert sheets sup plied with the liquid QC mat
38. ides access to a series of menus or options to configure Calibration specify Printing options view Stored Data or Power Down the AVOXimeter 4000 Computer provides access to a series of menus or options to enable Data Management features and configure Device Settings Enter On accepts selections When the screen presents a menu press the appropriate number key to make your selection followed by the Enter On key to accept your selection and proceed to the next screen D Backspace lt erases the character immediately to the left of the cursor This key should be used when changing an operator en tered numeric string of characters E Print prints a hard copy of the results to the attached external printer F X No moves back one record or setting in select functions Yes moves ahead one record or setting in select functions Cancel returns to the previous menu 3 Cancel Print bias Keypad Main Com Menu puter Enter On 35554 gt m Installation and Operation Installation Operation Powering Down 1 Place the AVOXimeter 4000 on a stable surface away from drafts Plug the AC adapter PN 9692 for 110 VAC 60 Hz or PN 9671 for 220 VAC 50 Hz into an appropriate electrical outlet Plug the external temperature probe into the designated socket on the rear panel see page 5 Ensure that the plug is firmly seated Place the box
39. ing menu is displayed 1 Select Sample 2 Newest Sample 3 Transfer Data if Data Transfer is ON Use to Scroll 25 Main Menu SETTINGS Stored Data cont d Select Sample Newest Sample Yes Key No Key Result Display This function allows reviewing and printing selected results by speci fying the sample number The AVOXimeter 4000 automatically incre ments the sample number by one for each new successful sample analysis The sample number will increment to 999999 before it must be reset Upon selection of this function the AVOXimeter 4000 dis plays the currently available range of sample numbers This function automatically displays results for the most recent suc cessful sample analysis Pressing this key automatically displays the results for the first old est sample stored in the AVOXimeter 4000 Pressing this key automatically displays results for the last newest sample stored in the AVOXimeter 4000 The result display is the same as the display following sample analy sis and entry of sample information However because the result display does not provide sample information the Enter On key tog gles between two display modes results and sample information The sample information display contains the following information Display line one contains Sample number and User ID Display line two contains Patient ID if sample type Patient Optical filter if sample type O
40. is not contami nated by any debris Two types of controls are available for use on the AVOXimeter 4000 1 Optical QC filters yellow and orange 2 Liquid control materials such as IL s Multi 4 CO Oximeter Con trols or RNA Medical s RNA CC 527 or CVC 223 Each AVOXimeter 4000 is equipped with cuvette shaped yellow and orange optical QC filters that can be inserted into the instrument to simulate a blood sample of known composition Each filter has a se rial number that matches the serial number of the AVOXimeter 4000 with which it is used If you have two or more AVOXimeter 4000 analyzers their optical fil ters cannot be used interchangeably Each set of yellow and orange optical QC filters can be used only with the AVOXimeter 4000 of the same serial number The manufacturer recommends that quality control testing with both optical filters be performed oneach analyzer once each day of patient testing when an analyzer is brought from a hot to a cold temperature or vice versa whenever the performance of the analyzer requires verification 28 OPricAL Optical QC conduct the daily QC and calibration verification with optical filters Procedure 1 Confirm that the filters have the same serial number as the AVOxXimeter 4000 2 Wait until the READY message appears on the display 3 Remove any debris from the surface of the optical filters by wiping them with dry gauze prior to inserting them
41. lection of the following infor mation about the sample just analyzed A Operator ID if User ID is enabled B Sample type either Patient or QC 1 If sample type is patient the patient ID if enabled 2 If the sample type is QC the type of QC either optical or liquid a If the QC type is optical the Yellow or Orange filter b If the QC type is liquid the level the material lot s predefined for the level and verification of the predefined Cuvette Lot number or entry of the new Cuvette Lot number SOFTWARE FEATURES CONT D Default Settings The AVOXimeter 4000 is shipped from the factory with the following default settings User ID Off Security Off Patient ID Off Data Transfer Off Auto Print Off Printer Baud Rate 9600 Printer Parity None Standby Delay 30 min Backlight MEDIUM tHb units g dL Hufners Number 1 39 Please refer to the Settings section of this manual for additional op tions and instructions to modify the above settings or define values for data entry that cannot be established at the factory such as Cu vette Lot number QC Material Lot numbers and Cuvette Cal Code Sample Collection and Preparation Sample Collection Collection Sources of error Sample Preparation Preparation Sources of error Toobtain accurate measurements collect blood samples in a sodium or lithium heparinized plastic syringe Collect and handle the specimens according to medically accepted sterile techni
42. les Ignore bubbles outside of the light path see page 13 7 Remove any blood on cuvette s exterior surfaces before insert ing cuvette into the AVOXimeter 4000 Do not overpressure the cuvette or cause the vent patch to bulge outward 8 Insert cuvette within 10 seconds of filling it Never inject blood or any other material into the instrument itself 9 Observe the LCD display At the screen prompt remove the cu vette and select the sample type 10 After the sample information is entered the results will be displayed as follows Sample 1 tH b O 2H b COHb MetHb 17 0 39 7 56 6 1 1 g dL 11 After the results appear the data will stay on the display until the Enter On key is pressed Data will be stored in non volatile memory 100 samples and may be recalled using the Stored Data menu 12 To analyze the next sample obtain a fresh cuvette from the bag next to the instrument and repeat the previous eleven steps ample Printouts Liquid QC with User ID On Optical QC with User ID On Optical QC with User ID Off AVOXimeter 4000 Liquid QC Test S N 41017 Tested on 05 24 05 07 43 Test Number 390 User ID 975310 Control Level 2 QC Lot Number 754191 Measured tHb 14 1 g dL O2Hb 94 5 COHb 2 3 96 MetHb 1 0 96 Calculated O2Ct 18 6 mL dL Cal Code 41878 Cuvette Lot 103095 A VOX Systems Inc AVOXimeter 4000 Optical QC Test S N 41017 Tested on 05 24 05 07 43 Test
43. lutions Finally at wavelengths used by AVOXimeter 4000 indocyanine green dye absorbs relatively little light Thus diagnostic concentrations 10 mg L of indo cyanine green dye produce minimal error see Specifications 36 Troubleshooting If necessary contact Technical Support 800 225 2869 or 210 696 4149 for service assistance SYMPTOM AVOXimeter fails to turn on AVOXimeter does not re spond to cuvette insertion or key presses or Display is blank with cursor flashing Self Test fails on power up Cuvette Inserted shows on LCD screen External printer not printing Message on LCD Reads ERROR Temp lt 15 0 C or ERROR Temp 30 0 C POSSIBLE CAUSE Battery is discharged and AC adapter is not plugged into AC outlet Microprocessor is locked up 1 Cuvette is inserted in instrument 2 no cuvette is in instru ment then the intensities may be out of range 1 No power to printer 2 Printer not connected to AVOxXimeter 4000 3 Auto Print not selected or baud rate or parity is wrong 4 Printer does not respond or prints unintelligible characters 5 AVOXimeter 4000 is locked up i e fails to re spond to cuvette insertion or key presses 1 Temperature probe absent or not plugged in firmly 2 Temperature is outside op erating range of 15 30 59 86 F REMEDY Connect AC adapter to AVOXimeter 4000 and to AC outlet Contact Tech
44. ndards in Technology NIST standards The ther mometer should be accurate to at least 0 5 2 Use rubber bands or adhesive tape to attach the bulb end of the thermometer to the circular disk at the end of the AVOXimeter temperature probe 3 Make sure the probe and the thermometer are in a thermally stable environment and not in air currents 4 Wait 10 minutes 5 Press the Computer key and select the Time Date Temperature option Then select the Temp amp Battery op tion to display the temperature measured by the AVOX imeter 6 Record the temperatures measured by the AVOXim eter and the thermometer 7 If the AVOXimeter s reading is within 3 of the NIST thermometer the AVOXimeter is properly calibrat ed If the AVOXimeter differs from the thermometer by more than 3 call Technical Support 800 225 2869 or 210 696 4149 34 Theory of Measurement According to Beer s Law if several light absorbing compounds are present in a solution the concentration of each compound can be deduced if the compounds differ in their opti cal absorbances and if optical density is measured at as many wavelengths as there are compounds present For example if three compounds X Y and Z are present and if the optical density OD is measured at three different wavelengths A the result is a set of simultaneous equations with as many equations as there are unknown concentrations c Thus if the optical pathlength
45. nical Support 2 Remove cuvette turn power off and restart Contact Technical Support Firmly plug cord into printer con nect to power and turn on Connect cable both to printer and to AVOXimeter 4000 Set baud rate and or par ity on AVOXimeter 4000 and on printer to same values See p 24 25 Contact Technical Support Contact Technical Support Turn unit off plug temperature probe in firmly turn on unit and retry Bring environment to proper temperature range If error is persistent then contact Technical Support 37 TROUBLESHOOTING SYMPTOM POSSIBLE CAUSE REMEDY 2 Detector surface is contaminated 1 Analyze optical filters If val MetHb measurements with blood or other debris are inaccurate tHb measurements are 4 New box of cuvettes is being inaccurate used but cuvette Cal Code has not been updated 2 Incorrect Cal Code for cur rent box of cuvettes was entered 3 Detector surface is con taminated with blood or other debris 4 tHb calibration has changed Message on LCD Reads Microprocessor error ERROR Uninitialized Vector Service Required ues are within specifications detector is OK Verify op erator is using proper cuvette handling and sampling tech nique Analyze optical filters If val ues are outside of specifica tion contact Technical Sup port Follow Cuvette
46. o delete this ID results in an error message Cancel or option 1 Return to PrevMenu returns to the previous menu Option 2 Delete This ID presents a confirmation screen to confirm deletion of the ID unless it belongs to the QA User displays the next secure numeric User ID displays the previous secure numeric User ID This option allows entry of a new numeric User ID from one to nine digits in length If the User ID entered already exists a message is displayed and the User ID is not added If the User ID does not already exist it is added to the list of secure User IDs The AVOXimeter 4000 allows definition of 50 secure User IDs An attempt to add more than 50 secure User IDs results in an error message If an external printer is connected this option prints a list of secured User IDs currently defined in the AVOXimeter 4000 COMPUTER SETTINGS CONT D Print ID ON OFF Patient ID ON OFF This feature determines if the secured User IDs print on the result printout Selection of this option displays the current status and al lows the operator to leave the status as currently displayed or select the alternate status When ON the secured User ID prints on the printout When OFF and Security is ON the secured User ID does not print on the printout rather the printout includes User ID write on capabil ity at the bottom When Security is turned OFF or the current OFF status is acknowl
47. observance of the regulations relevant to installation power supply and operation of the instruments with particular regard to the regulations for accident prevention THIS WARRANTY IS GIVEN EXPRESSLY AND IN LIEU OF ALL OTHER WARRANTIES EXPRESS OR IMPLIED PURCHASER AGREES THAT THERE IS NO WARRANTY OR MERCHANTABILITY AND THAT THERE ARE NO OTHER REMEDIES OR WARRANTIES EXPRESS OR IMPLIED WHICH EXTEND BEYOND THE CONTENTS OF THIS AGREEMENT No agent or employee of is authorized to extend any other warranty or to assume for any liability except as above set forth Please contact Technical Support if any malfunction is discovered Emergo Europe Molenstraat 15 2513 8 Olsen Avenue Edison 08820 USA tel 732 548 5700 fax 732 248 1928 Netherlands www itcmed com Tel 31 70 345 8570 a subsidiary of Thoratec Corporation Fax 31 70 346 7299 55 ircuit Diagrams e 2 2 m 88 5 0151035 35885 858 1999102 581230 SIINI NI 031317395 351903910 22201 8883 persere 40114142533 MEN ae SY 21 Deui eS 0 meum Umm 2 DN NIGO 14301 3005 UI Thy 96 1060 Dry WE
48. of disposable cuvettes next to the instrument s tem perature probe Prior to use the bag of cuvettes must be stored near the temperature probe for a minimum of one hour at ambient room temperature Refer to Appendix A for printer information Turn on the instrument by pressing the Enter On key Upon power up the AVOXimeter 4000 executes a self test to confirm the proper operation of its light sources If the self test fails the AVOXimeter 4000 will assist you in diagnosing the prob lem For additional help consult the Troubleshooting section of this manual If the AVOXimeter 4000 passes the self test then the yellow and orange optical filters may be analyzed to verify that its calibra tion has not changed Each optical filter should be analyzed at a minimum once each day the AVOXimeter 4000 is used to report patient results If the optical filter readings are all within the established ranges then the system is ready to analyze patient samples refer to page 13 for details If any of the values are outside of the ranges refer to the Troubleshooting section To turn the AVOXimeter 4000 off press the Cancel and Main Menu keys simultaneously The AVOXimeter 4000 can also be turned off by pressing the Main Menu key and selecting the Turn Off option Software Features Security User ID Sample Identification The software in the AVOXimeter 4000 has been specifically designed to facilitate sampl
49. oxy de oxy met and carboxyhemoglobin O5Hb HHb MetHb Equation 6 Conventional whole blood oximeters do not measure the total hemoglobin concentration because whole blood does not really obey Beer s Law Whole blood does not simply absorb light the red blood cells also scatter the light Thus conventional oximeters are unable to measure the total hemoglobin concentration accurately The AVOXimeter 4000 makes an assessment of the amount of light scattering in each sample employs proprietary optics and mathematical algorithms to correct its measurements and thus obtains accurate measurements of total hemoglobin concentration and percent carboxy and methemoglobin In conventional whole blood oximeters the following can constitute major sources of error a hemolysis which changes the amount of light scattering in the sample b other light absorbing compounds such as indocyanine green dye and bilirubin c other hemoglobin species including carboxyhemoglobin and methemoglobin By using additional wavelengths the AVOXimeter 4000 is able to measure four hemoglobin species and to eliminate interference due to bilirubin By making appropriate corrections for the light scattering in each sample the AVOXimeter 4000 yields accurate measure ments regardless of the extent of hemolysis Thus the AVOXimeter 4000 is capable of analyzing samples of whole blood partially hemolyzed blood and even hemoglobin so
50. ptical QC Level and Lot if sample type Liquid QC Display line three contains Cuvette Lot Number if the sample type Liquid QC Blank if the sample type is Patient or Optical QC Display line four contains Cal Code if the sample type Patient or Liquid QC Sample type Q for QC or P for Patient on the right side if Data Transfer is ON Transfer status also on the right side S for sent and N for not sent if Data Transfer is ON 26 Main Menu SETTINGS Result Display cont d Transfer Data Turn OFF Enter On Toggles to the alternate display mode Pressing this key automatically displays either results or sample information for the next sample number The display mode is determined by the display mode of the last sample number No Pressing this key automatically displays either results or sample information for the previous sample number The display mode is determined by the display mode of the last sample number Cancel Returns to the Stored Data menu If the Data Transfer option is turned ON see page 16 this func tion transfers results in an ASTM format via the serial port to the connected information system Each result contains a flag indicat ing if it has previously been sent Upon selection of this function a confirmation screen is displayed Begins data transfer If the cable is not connected prop erly or the port is not configured accurately or the receiving
51. ques including the use of universal precautions 1 When drawing blood samples with a syringe from a saline filled catheter withdraw the saline first and make sure that only whole blood is sampled Citrate is known to change the pH of the blood and cause errors in spectrophotometric measurements Similarly fluoride and oxalate should be avoided Excessive volumes of anticoagulant or saline may oxygenate the sample or cause dilution errors Roll the tightly sealed syringe between your palms to keep the red blood cells and plasma well mixed Poorly mixed samples or those containing clots may cause inaccurate results When handling cuvettes hold them only by their black caps To avoid warming the cuvette do not pick it up until you are ready to fill it and analyze the sample Always fill cuvette prior to inserting it into the instrument Always store cuvettes in the sealed bag with a desiccant pouch or erroneous results may occur Check the desiccant prior to using cuvettes to ensure that the color indicator has not changed from blue to pink If the color indicator has changed do not use cuvettes until a new desiccant pouch can be added to the bag Prior to use verify indicator is blue When filling a cuvette do not use excessive pressure or cause the vent patch to bulge outward If the vent patch protrudes discard the cuvette To avoid contaminating the optics never insert a cuvette with a prot
52. rrently defined value of H fner s Number Press Cancel or OK to leave H fner s Number as currently displayed or enter a new value To eliminate keying errors the AVOXimeter 4000 allows entry of only the final digit Entry of 0 to 9 redisplays the entry for confirmation Selecting the Printer Mode option from the Main Menu displays the following menu 1 Auto Print ON OFF 2 Print Stored Data 3 Printer Parameters The AVOXimeter 4000 includes a feature to automatically print results following sample analysis Selecting the Auto Print ON OFF option from the Printer Mode menu displays the current status Press Cancel or OK to leave the status as currently displayed or change the status to the alternate value When Auto Print is ON the AVOXimeter 4000 automatically prints results upon completion of sample analysis and collection of sam ple information When Auto Print is OFF the AVOXimeter 4000 prints results only when the Print key is pressed This function prints all results stored in the AVOXimeter 4000 beginning with the most recent sample Upon selection of the function the Printing XXXXXX displays where XXXXXX is the sample number currently printing Press the Cancel key to stop printing When Cancel is pressed before all samples have printed a message will be displayed stat ing that not all results have printed 24 Main Menu SETTINGS CONT D Printer Parameters Baud Rate Parity Stored Data
53. ruding vent patch into the instrument If the sample in the cuvette is poorly mixed or contains clots then discard the cuvette to prevent erroneous results Sample Analysis 1 Confirm that the temperature probe is plugged firmly into its socket on the rear panel of the instrument Press the Enter On key to turn on the AVOXimeter 4000 and confirm that the self test was successful The instrument is ready to analyze samples when the display reads READ Y Insert Cu vette Ready Screen Cal Code 44445 2 Verify that the Cal Code is correct for the cuvette bag in use If not refer to page 23 3 Collect and prepare the heparinized blood sample as described on page 12 or prepare the control sample as described on the pack age insert for the control Hold cuvette by black cap Bubble here is OK Light Path Vent patch gt Side View Do not let patch bulge 13 SAMPLE ANALYSIS CONT D CAUTION 4 Expel one drop of sample from syringe and connect sample filled plastic syringe to a new disposable cuvette 5 Hold cuvette downward at 45 angle and inject sample into cuvette until sample reaches the vent patch at the opposite end Leave the syringe attached to the cuvette Never force sample into cuvette If cuvette does not fill easily discard it and use another one 6 Confirm that the light path at the widest portion of the sample chamber is free of debris or air bubb
54. ser ID blank prints User ID Not Entered on the result printout and provides a blank line for writing in the User ID manually When User ID is OFF the operator is not given the option to enter User ID following the completion of sample analysis A sample ana lyzed with User ID OFF displays USR Not Ent on the Stored Data result display prints User ID Not Entered on the result printout and provides a write on capability at the bottom The purpose of this feature is to require entry of a valid numeric User ID before allowing access to the AVOXimeter 4000 functions Selec tion of this option displays the current status and allows the opera tor to leave the status as currently displayed or select the alternate status Following five minutes of inactivity the AVOXimeter 4000 automati cally returns to the Enter User ID screen when Security is ON COMPUTER SETTINGS CONT D Security Cont d ON Review Delete Add User Print User List When Security is turned ON or the current ON status is acknowl edged the following menu is displayed 1 Review Delete 2 Add User 3 Print User List 4 Print ID ON OFF This option displays a list of secure User IDs The numeric User ID for the QA User which never displays or prints is 123456 The literal QAUSER prints or displays in place of 123456 Though the screen display includes the option to Delete This ID the ID for the QA User cannot be deleted An attempt t
55. te and allows the operator to leave the date as currently dis played or enter a new date in the format MMDDYY The AVOX imeter 4000 presents an error message when the day entered is greater than 31 The AVOXimeter 4000 automatically adjusts for leap year This feature presents the current power or battery status and temperature in both and F If the AVOXimeter is connected to the battery charger the battery status will not be shown Instead Connected to AC will appear Pressing Cancel or Enter On from the status display returns to the previous menu 22 Main Menu Settings Main Menu Calibration Cuvette Cal Code Cuvette Lot Number Pressing the Main Menu key on the keypad displays the following menu 1 Calibration 2 Printer Mode 3 Stored Data 4 Turn Off Selecting the Calibration option from the Main Menu displays the following Calibration menu 1 Cuvette Cal Code 2 Cuvette Lot Number 3 H fner s 1 30 1 39 Each package of cuvettes is labeled with a cuvette Calibration Code used by the AVOXimeter 4000 to obtain correct measure ments The currently defined Cuvette Cal Code is displayed on the Ready screen for visual verification each time a sample is analyzed Selecting the Cuvette Cal Code option from the Calibration Menu displays the Cal Code currently defined Press Cancel or OK to leave the Cal Code as currently displayed or change the current value When a new Cal Code is entered the AVO
56. tical status screen is displayed Battery status can be checked by pressing the Computer key se lecting Time Date Temp and selecting Temp amp Battery The battery charge status will fall into one of four categories High OK Low or Critical When the AVOXimeter 4000 15 in the Sample Analysis Mode the status of the battery will be displayed on the LCD display when it becomes critical When the battery status becomes critical the AVOXimeter 4000 will immediately go into Standby Mode and will prompt the user to plug in the battery charger Clean the analyzer surface and screen with a soft cloth dampened with isopropyl alcohol distilled water or 1096 bleach solution Immediately wipe off any excess alcohol or accidental liquid spill A cotton swab may also be used to clean the outside of the cuvette slot as needed do not insert cotton swab into the analyzer Do not use excessive force strong detergent concentrated bleach or abrasive cleaning solution because they can scratch or damage the surface 33 Maintenance Cont d Optical Filter Cleaning Printer Paper Temperature Probe Calibration Verification Clean the surface of the optical filters with dry gauze to prevent scratching Follow the printer manufacturer s directions for insertion of printer paper The calibration of the temperature probe should be checked once every six months 1 Obtain a thermometer calibrated to National Institute for Sta
57. xposed to the cuvette should not be returned to the patient Do not re use the cuvettes discard after each use Always keep cuvettes in sealed bag with desiccant When filling cuvette do not use excessive pressure or cause the vent patch to bulge outward Do not insert a cuvette if the vent patch pro trudes discard it Do not leave a cuvette in the oximeter Remove the cuvette as soon as the sample has been analyzed For proper calibration use only the hemoglobin controls recommended in this manual Controls from other sources yield erroneous results Use this instrument only with the AC adapter battery charger supplied by ITC Do not use this instrument in the presence of flammable agents or anes thetics Operator should take appropriate precautions when handling potentially infectious blood samples Introduction The AVOXimeter 4000 is intended for professional use in settings in which rapid ac curate measurements are needed of the total hemoglobin concentration and the rela tive concentrations of oxy carboxy and methemoglobin Direct analyte values are obtained in 10 seconds In addition oxygen content O2Ct is automatically calculated and available on the printout and data output The AVOXimeter 4000 is a light weight portable instrument that is calibrated at the factory prior to shipment Optical technology patent pending and disposable cuvettes enable the AVOXimeter 4000 to make its measurements six to t
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