Roche OMNI C Instructions For Use Manual
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Roche OMNI C Instructions For Use Manual

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Roche OMNI
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Instructions for Use

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Summary of Contents for Roche OMNI C

  • Page 1 P O I N T C A R E T E S T I N G Roche OMNI Instructions for Use...
  • Page 2 The contents of this document may not be reproduced in any form or communicated to any third party without the prior writ- ten consent of Roche Diagnostics. While every effort is made to ensure its correctness, Roche Diagnostics assumes no respon- sibility for errors or omissions which may appear in this document.
  • Page 3 Instrument repairs are to be performed only by the manufacturer or qualified service personnel. Only accessories and supplies either delivered by or approved by Roche are to be used with the instrument. These items are manufactured especially for use with this instrument and meet the highest quality require- ments.
  • Page 4 Intentional disconnection of the grounding is not permitted. • The instrument is not suitable for operation with a direct current power supply. Use only the original mains plug delivered with the Roche OMNI C. – Operating safety information –...
  • Page 5 1 Introduction 2 Specifications 3 Calibration 4 Measurement 5 Quality Control 6 Maintenance 7 Trouble shooting 8 Operating Modes 9 Index...

  • Page 7: Table Of Contents

    Pump ................................1-13 1.7.6 Flap .................................. 1-13 1.7.7 Bottle compartment........................... 1-13 1.7.8 Power supply..............................1-13 Position of the mains switch ........................... 1-13 1.7.9 Reverse side ..............................1-14 Interface ..................................1-14 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 8 10. Remove the printer paper ..........................1-33 11. Remove the tube under V1 and V2 ....................... 1-33 12. Shutting down the AutoQC module ......................1-34 13. Uninstall the AutoQC module ......................... 1-34 1-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 9 1 Introduction Introduction Fig. 1 The Roche OMNI C is a modular analyzer for measuring blood gases, electrolytes, total hemoglobin, oxygen saturation and hematocrit in whole blood, serum, plasma, acetate and bicarbonate containing dialysis solutions, and QC materials. It is possible to complete database procedures or to make simultaneous adjustments during measurement or calibration.

  • Page 10: General Notes

    Complete at least one quality control test every day (please see chapter 5, "Quality Control", for more information) in order to quickly recognize error functions in the Roche OMNI C. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 11: Symbols

    Danger of sensitization during contact with skin (when classified with R 43). Caution: Avoid contact with eyes and skin, do not inhale vapours. "GreenDot" (in Germany) Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 12: Used In The Instructions For Use

    All sections / passages that are marked with this symbol describe procedures and/or indicate conditions or dangers that could damage or lead to a malfunction in the Roche OMNI C, and which therefore should never be attempted. TIP: All sections / text locations marked with "TIP" describe safe procedures that are intended to provide the user with additional "Help."...

  • Page 13: Measurement And Calibration Procedure

    Measurement evaluation The validity of the test results from the Roche OMNI C must be carefully examined by a clin- ical-medical specialist who will take the patient's clinical condition into consideration before any clinical decisions are reached based on the test results.

  • Page 14: Safety Instructions For Specific Dangers

    For more detailed information about decontamination, please see chapter 6, "Mainte- nance." Handling solutions Store the OMNI C solutions according to the specified packaging requirements. The solu- tions should be adapted to the ambient temperature before use. The shelf life of the solutions is limited.

  • Page 15: Handling Electrodes

    Pump flap reverse side measurement chamber with electrodes and tHb/SO module power pack / mains switch unlocking knob bottle compartment for the AutoQC cover module Fig. 2 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 16: Screen

    Parameter temporarily deactiva- Parameter permanently deactiva- ted with QC warning ted (under "Setup") * Pressing the parameter button produces a status report (see chapter 7, "Trouble shooting", section "Electrode status"). Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 17 Difference of oxygen concentration between alveolar and mixed venous blood 50 (c) Oxygen partial pressure at 50% oxygen saturation calculated with SO as meas- urement value 1. Details and calculation, see Reference Manual Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 18 Sample type Blood type Specimen ID Puncture site ALLEN test A/F (adult/fetal) Pat ID Last name First name Middle initials Date of birth Gender Pract. Pat ID Height Weight 1-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 19 Remark Input values—measurement information Physisian Remark Acceptor Date drawn Time drawn Place drawn Danger code Clinic info Container 24 hr. urine Ventilation mode SRATE ARATE PEEP Flow rate 1-11 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 20: Buttons

    / right, additional selection possibilities select the marked entry move one level up / back activate / deactivate confirm cancel go to additional views print remove password data input details start 1-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 21: Printer

    The calibration solutions and the waste container are located behind the bottle compart- ment cover. 1.7.8 Power supply This unit contains the mains power switch and the mains power connector. Position of the mains switch Fig. 4 1-13 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 22: Reverse Side

    This interface can be assigned as serial interface to ASTM. For an exact description of the assignment, see the section "Settings > Interfaces > COM 2" in chapter 3, "Operating modes," of the Reference Manual. 1-14 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 23: Barcode Scanner

    IMPORTANT: Press the button on the underside to activate the scanner! A beeping sound and a brief illumination of the LED on the upper side indicate the successful scanning of the barcode. Warning and identification labels Fig. 7 Fig. 8 1-15 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 24: Installation

    • Check for the correct voltage: 100 to 240 VAC (±10%) After setting up the Roche OMNI C analyzer at a location that meets the necessary condi- tions, execute the following steps to ensure the instrument is ready for operation: •...

  • Page 25: Attach Power Cord And Barcode Scanner

    Plug the power cord into the power supply (Fig. 9/1). Connect the barcode scanner and, if necessary, the network cable (Fig. 9/2) to the respective interface(s) (Fig. 9/3) on the reverse side of the Roche OMNI C. Fig. 9 •...

  • Page 26: Installing The Autoqc Module (Automatic Quality Control Module)

    Fig. 12 • On the right side of the Roche OMNI C, remove the gray plastic cover from the AutoQC docking port. Close the AutoQC cover and push the AutoQC module into the tracks on the Roche OMNI C until it locks into place.
  • Page 27 1 Introduction The module's docking part will slide into the opening on the side wall on the Roche OMNI C and lock into place. Roche OMNI C AutoQC module AutoQC module docking part Fig. 13 • Connect both tube ends in the bottle compartment to the docking part according to Fig.

  • Page 28: Switch On

    7. Checking the AutoQC module and "Instrument > AutoQC" • If the AutoQC module is not activated, press Changes will be accepted after reboot. Press "Yes". 1-20 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 29: Installation

    Check the bottle compartment's back wall to make sure that the air mixture tube (valve V2) and the ventilation tube (valve V9) are in the guides (see Fig. 17). air mixture valve tube V2 ventilation tube V9 Fig. 17 1-21 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 30: Insert Fms Tubes

    • Close the clear plastic cover (tension lever). The tubing holder is then pressed into the sealer. tension lever pump head linear clamp pump open pump closed Fig. 19 1-22 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 31: Insert Needle And Fill Port Holder

    The printer paper is heat sensitive on one side only. Please make sure that you insert the paper roll correctly. Open the printer cover. • • Place the new paper roll into the holder. 1-23 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 32: Insertion Of Bottles

    Press the grips together and press the transparent disk downward (Fig. 24/2). • Rotate the transparent disk in the clockwise direction. Stop when you notice (after a short distance) resistance (Fig. 24/3). Fig. 24 1-24 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 33: Insert Electrodes

    C3 fluid pack (exception: the waste water bottle, which does not have a bar- code) (see Fig. 25/1). • The Roche OMNI C recognizes the correct solution and checks the expiration date. On the screen, the respective bottle starts blinking. If the bottle has passed the expiration date, the screen displays a warning.

  • Page 34: Insertion Of The Reference Electrode

    Push all electrodes slightly to the right so that they are lined up together without gaps. 17. Insertion of the reference electrode • Insert the new reference electrode. Fig. 28 1-26 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 35 Inspect the electrical contact of the electrodes by checking if they fit tightly. The correct position of the various electrodes is easy to recognize by looking at the colours of the contact strips or at their labels. Fig. 31 1-27 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 36: Begin Installation Routines

    Scan the barcodes located on the inner packaging of each electrode or enter the bar- codes manually with the help of TIP: Always save the inside packaging materials! Whenever the Roche OMNI C is taken out of service and then brought back into service, the barcodes of the remaining functional electrodes must be scanned again! Fig.

  • Page 37: Shutdown

    "System > Tools > Software shutdown" and switch the instrument OFF. 1.9.2 Longer than 24 hours If the Roche OMNI C will be shut down for longer than 24 hours, perform the following procedure. TIP: Before shutting down the instrument, backup the data to a PCMCIA card or an inter- face (see chapter 8, "Operating modes", section "Database").

  • Page 38: Insert The Shutdown Kit And Connect It

    Fill the shutdown kit about halfway with distilled water. • Insert the shutdown kit into space C3. • Connect the tubes of the set with the connectors from C1 and C2. Fig. 35 1-30 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 39: Remove The Shutdown Kit

    7. Remove the pump tube • Open the instrument cover. • Open the peristaltic pump's clear plastic cover (tension lever). Push the linear clamp (white plastic piece) upwards (see Fig. 37). 1-31 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 40: Remove The Electrodes

    It will come out of the axis and snap out of place (see Fig. 39/1) CAUTION: Do not bend the needle! • Carefully remove the fill port holder from the needle (see Fig. 39/2). Remove the needle. 1-32 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 41: Remove The Printer Paper

    Slide the feed tube of the C2 solution under the tube clip (valve V2) and out. feed tube: C2 solution feed tube C1 solution Fig. 40 • Pressure is removed from the tubes. 1-33 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 42: Shutting Down The Autoqc Module

    Unlock the AutoQC module by pulling the unlocking knob (see Fig. 41) on the reverse side of the instrument and remove the AutoQC module from the tracks on the Roche OMNI C. 1-34 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 43 If you plan to transport the instrument, be sure to unplug the power cord, the scanner, and the network cable. Then install the transport safety device for the AutoQC module. Fig. 44 • Use the original packaging when transporting the instrument! 1-35 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 44 1 Introduction 1-36 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 45 Electrical data ..............................2-7 2.7.2 Classification ..............................2-7 2.7.3 Dimensions ..............................2-7 Instrument ..................................2-7 AutoQC module ................................2-7 2.7.4 Weight ................................2-7 2.8 Printer ..........................2-8 2.9 Screen ..........................2-8 2.10 Barcode scanner ......................2-8 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 46 2 Specifications 2-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 47: Measured Parameters

    2.4048 - 6.0120 mg/dL SD < 0.1202 mg/dL SD < 0.2004 mg/dL ± 0.4008 mg/dL > 6.0120 - 16.0320 mg/dL S D < 0.6012 mg/dL S D < 1.0020 mg/dL ± 2.0040 mg/dL Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 48 B ..whole blood A ..dialysis solutions containing acetate S ..serum or plasma Q ... aqueous QC material D ..dialysis solutions containing bicarbonate Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 49: Sample Throughput

    Activated / volume volumes the sample sensor installed electrodes [µl] [µl] [µl] BG – ISE – tHb/SO Sample types Whole blood, serum, plasma, dialysis solutions containing acetate and bicarbonate, QC material Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 50: Calibrations

    12 hours (alternatively 4, 6, 8 or 12 hours) <7 Warm-up phase ..<25 when turning ON Warm-up phase ..power failure < 1 minute <2 Electrode exchange as needed <27 incl. calibration Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 51: Environmental Parameters

    -5 °C to +40 °C ..............over a period of 3 days Humidity 20 - 80 % (not condensed) ................over a period of 3 days Shock resistance < 50 g .............. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 52: Solutions

    4, up to 6 (depending on the remaining volume) C2 calibration solution 2 Calibration solution min. 4, up to 6 (depending on the remaining volume) C3 fluid pack Solution pack Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 53: Qc-Material

    Stability during operation Temperature COMBITROL TS < +28 °C up to 3 months AUTO-TROL TS < +28 °C up to 3 months (incl. up to one month on the AutoQC module) Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 54: Product Data

    Height closed ........19.8 cm (open: 38.7 cm) Depth ..........39.5 cm 2.8.4 Weight Roche OMNI C (instrument) ....about 17 kg (without calibration solutions!) Roche OMNI C ready for shipment ..about 23 kg AutoQC module ......... 5,9 kg (without ampoule mats)

  • Page 55: Printer

    Reading width ....... up to 9 cm Preprogrammed code types: ... Full code 39 / code 39 EAN/UPC, Codabar Interleaved 2 of 5 Code 11 EAN-13 UPC-A Code 128 MSI / Plessey Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 56 2 Specifications 2-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 57 3.2.1 Calibration for "Ready"..........................3-2 3.2.2 System calibration............................3-2 3.2.3 Conductivity calibration ..........................3-3 3.2.4 1P calibration ..............................3-3 3.2.5 2P calibration incl. O2..........................3-3 3.2.6 2P O2 calibration ............................3-3 3.2.7 2P calibration without O2...........................3-3 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 58 3 Calibration 3-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 59 TIP: The user can set a permanent start time for the system calibration. This enables com- pletion of calibration tasks while the Roche OMNI C is not in use or when the workload in the laboratory or station is smaller (see Reference Manual, chapter 8, "Operating modes", section "Setup").
  • Page 60 Using the "up / down" buttons you may now select the desired calibration. Start the selected calibration by pressing the button. 3.2.1 Calibration for "Ready" The Roche OMNI C automatically selects the calibration that is required to transfer all parameters to the "Ready" status. 3.2.2 System calibration See page 3-1!
  • Page 61 3.2.6 2P O calibration This calibration is a 2 point calibration for the electrode. 3.2.7 2P calibration without O This calibration is a 2 point calibration of all parameters except Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 62 3 Calibration Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 63 Whole blood ..................................4-4 Serum ....................................4-4 Plasma ....................................4-4 4.2 Measuring procedure ....................4-5 4.2.1 Syringe mode ..............................4-6 4.2.2 Capillary mode..............................4-8 4.2.3 Data input.................................4-9 4.2.4 Results display / measurement report ....................4-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 64 4 Measurement 4-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 65: Preanalytics

    Acceptable anticoagulants The only clot inhibitors that may be used for analyses in the Roche OMNI C are heparin salts. Other clot inhibitors, such as EDTA, citrate, oxalate, fluoride, and ammonium-based materials have significant influence on the blood's pH and other parameters and may not be used for this reason.

  • Page 66: Sample Collection Containers

    Capillary tubes with ceramic sealing caps should not be used because the fracture that forms when opening the capillary can damage the fill port of the Roche OMNI C. Use only capillary tubes with heat-treated ends to avoid damage to the instrument. When using stirring rods like those offered by a few manufacturers, remove these rods before inserting the sample in order to avoid clogging the Roche OMNI C.

  • Page 67: Clot Catcher

    The clot catcher prevents blood clots and tissue particles from entering the Roche OMNI C. The clot catcher cannot be used in "Syringe mode" and not be connected in "Cap- illary mode."...

  • Page 68: Sample Handling

    8 °C. If a sample has been cooled, warm it to room temperature (15 - 33 °C) before analysis. Plasma samples older than 1 hour must be re-centrifuged in order to remove fibrin clumps that may have formed. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 69: Measuring Procedure

    Danger of personal injuries (for detailed information see chapter "Quality Control")! In order to start a measurement, the Roche OMNI C must be "Ready" and in the "Analyzer" operating mode. Depending on the settings the entry of a password or a mandatory input (input value) may be required (see Reference Manual, chapter 3 "Operating modes"...

  • Page 70: Syringe Mode

    The sharp edge can cause damage to the fill port. The clot catcher cannot be used in "Syringe mode!" Fig. 3 • The sample is automatically aspirated (it is unnecessary to press any buttons). Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 71 Upon display of the instruction "Close flap", remove the syringe and close the flap. • The measurement starts. TIP: Never open the flap during measurement. Doing this will result in rejection of the sample! Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 72: Capillary Mode

    The clot catcher cannot be connected in "Capillary mode". The capillary with attached clot catcher must be held in position! Never inject the sample into the instrument! Danger of infection! Fig. 6 The sample is aspirated automatically into the analyzer. • Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 73: Data Input

    (see Reference Manual, chapter 3, "Operating Modes" – "Setup"). Press the "More func- tions" button to select the predefined form. This form remains the standard until a new form is selected. More functions Fig. 8 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 74: Results Display / Measurement Report

    4.2.4 Results display / measurement report After the measurement is complete and all parameters have been entered, the Roche OMNI C displays the results on a standardized or user-specific form on the screen before printing the results. Use the menu selection "Setup - Displays & reports - Measuring data - Result screen" to create a user-specific results display (see Reference Manual, chapter "Operating modes -...
  • Page 75 You can complete or edit additional entries in the database. For more information, refer to chapter 8, "Operating modes", section "Database" in these Instructions for Use and to the respectively titled chapters in the Reference Manual! 4-11 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 76 4 Measurement 4-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 77 5.7 QC consequences ......................5-13 5.8 QC unlock ........................5-14 5.8.1 QC warning..............................5-14 5.8.2 QC error ................................. 5-14 Automatic correction ..............................5-14 Manual correction ..............................5-14 Exchange the electrode ............................5-14 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 78 5 Quality control 5-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 79: General Qc Concept

    COMBITROL, AUTO-TROL, etc., are offered to ensure that the Roche OMNI C provides measurements of high quality to protect customers or its patients. In order to ensure the quality of the measurement results, complete a quality control test on 3 levels (low, normal, high) after each electrode exchange and after startup of the instru- ment at least once daily or more often in accordance with local regulations.

  • Page 80: Important Information Concerning The Analysis Of Qc Measurement Results

    If the result of the repeated measurement is larger than target value ± 2σ, but smaller than target value ± 3σ, the parameter must not be used for additional patient measurements. If the error persists, replace the electrode and/or contact customer support!! Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 81: Material Setup

    Roche OMNI C automatically assigns these. Manual entry Use the button to manually enter batch number, expiration date, sample type and target values. Complete and save the entry by pressing twice Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 82: Inserting Autoqc Mats

    Close the cover of the AutoQC module. 5.4.1 Material assignment - AutoQC materials Before beginning an AutoQC measurement, the selected AutoQC material must be assigned. Fig. 3 to select the mat to be defined (A-F). Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 83 Fig. 4 This screen shows detailed information about the AutoQC material placed on this mat. Press the button again to change to the mat assignment screen. Fig. 5 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 84: Setting Qc Times

    Setting start time(s) Select the day from the "Day of Week" list on which the QC measurement should be performed. Add a new time entry (you can remove it again with Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 85 Select another day of the week and press – the copied time entry will be entered for the new weekday. These entries can be transferred to as many other weekdays as required. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 86 5 Quality control "More functions" Measurement retries The number of repeated measurements (none=0, 1, 2) that are allowed in the case of an incorrect measurement can be adjusted here. Fig. 8 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 87: Qc Measurement

    TIP: Suction the QC material directly from the ampoule! • Insert the needle into the ampoule. The needle should be inserted deep enough into the fluid to avoid air bubbles. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 88: Autoqc Measurement

    The AutoQC measurement can be retrieved programmatically or manually. For this purpose, activate the corresponding AutoQC material (AUTO-TROL TS) and the selected level (e.g. level 1). Start the AutoQC measurement by pressing 5-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 89: Multirules

    2. Elsa F. Quam BS, Lorene K. Haessig BS, Marlene J. Koch BS: A Comprehensive Statistical Quality Control Program for Blood Gas Analyzers. Journal of Medical Technology 2:1 January 1985 5-11 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 90: Overview Of The Multirules

    ≥ 9 2SD range Defined target values (ranges) TIP: The Multirule process is applied after each individual measurement. Multirules are only applied to the corresponding control material (e.g. COMBITROL TS). 5-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 91: Qc Consequences

    Ready screen, but remains ready for measurement QC error: the parameter will be blocked if one of the adjusted rules is broken. The parameter will be identified accordingly in the Ready screen. 5-13 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 92: Qc Unlock

    Pressing removes the block for all parameters. Exchange the electrode See chapter 6, "Maintenance", section "Exchanging the Electrodes and the MCon". 5-14 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 93 Replacement of the electrodes and the MCon ................6-16 6.6.5 Replacement of the reference electrode ................... 6-18 6.6.6 Cleaning the measurement chamber ....................6-20 6.6.7 Cleaning the screen ..........................6-20 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 94 6 Maintenance 6.6.8 Surfaces ................................. 6-20 6.6.9 Adjusting the screen ..........................6-21 6.7 Additional maintenance procedures ................ 6-22 6.8 Maintenenance overview .................... 6-23 6.9 Maintenance scheduler ....................6-23 6-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 95: Decontamination

    6 Maintenance Maintenance After use, components of the Roche OMNI C, including tubing, waste container, fill port, etc., contain biological fluids and represent therefore a possible infectious risk. Handle these components with care and according to regulations surrounding poten- tially infectious material. Avoid contact with skin.

  • Page 96: Tubing Paths

    Re-insert the bottles C1, C2, and C3 [see section Exchanging the solutions C1 calibra- tion solution 1, C2 calibration solution 2, and C3 fluid packs, page 6-7]. Close the bottle compartment cover. • Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 97: Recommended Decontaminant

    After skin contact: wash with generous amounts of water, remove contaminated cloth- After eye contract: rinse eyes with generous amounts of water, contact an eye doctor After drinking: drink large amounts of water, avoid vomiting, contact a doctor. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 98: Daily

    (paper is sufficient for about 200 measurements with 15 cm / measurement) (see section Replacing printer paper, page 6-15). TIP: The printer paper is heat sensitive on one side only. Please make sure that you insert the paper roll correctly. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 99: Weekly

    (see Fig. 4/1+2). • Close the flap to the syringe position (half-opened position). • Clean the tip of the needle (see Fig. 4/3). Fig. 4 • Close the flap. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 100: Semi Annual

    Close the acrylic glass cover (tension lever). This presses the tubing holder into the sealer. • Close the top cover. The tubes may drip after disconnection. Remove excess fluids with a clean, absorbent cloth. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 101: Sample-Dependent Maintenance Procedures

    • Solution for conditioning the Na electrode • • Cleaning solution • Reference solution Implementation: • Open the bottle compartment cover. The following screen appears: enter fill level Fig. 6 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 102 If a barcode scanner is not available, enter the correct barcode with the numerical key- board and confirm your entry. • The Roche OMNI C recognizes the correct solution and checks the expiration date. The respective bottle blinks on the screen. If the bottle has passed the expiration date, the screen displays a warning.

  • Page 103: Waste Material

    Dispose of the waste container according to local regulations (hazardous waste!). Empty the waste container Always wear gloves! Danger of infection! • Place the bottle tool on the screw cap (Fig. 9). Fig. 9 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 104 Empty the waste material and decontaminate the container according to local regulations (hazardous waste material!). • Screw the cap back onto the bottle. The cap must be screwed shut until completely closed! 6-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 105: Using The Empty C1 Calibration Solution 1 Bottle As W Waste Container

    Close the bottle compartment cover. CAUTION! If the W waste container is mistakenly reused as C1 calibration solution 1, a section of the tubing must be exchanged! Please contact customer service immediately! 6-11 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 106: Exchanging The Fill Port Holder

    Place the new fill port holder (with integrated fill port) over the needle. It is easier if you turn the holder around so that the bottom side is showing on top (see Fig. 14). Fig. 14 6-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 107 Snap the fill port holder evenly onto the axis (do not bend the needle!). Fig. 15 • Close the flap. Dispose of the used fill port holder in accordance with local regulations (hazardous waste!). 6-13 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 108: Unscheduled

    Always wear gloves! Danger of infection! While in the "Analyzer" operating mode, press: > System > Wash and clean > Clean sample port module Sample drip tray Wash plate Fig. 16 6-14 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 109: Replacing Printer Paper

    Make sure that the printer lever is in the "down" position (see Fig. 18). • Feed in the beginning of the paper according to the sticker on the inside of the printer cover (see Fig. 18). printer lever Fig. 18 6-15 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 110: Replacement Of The Electrodes And The Mcon

    6.6.4 Replacement of the electrodes and the MCon • Open the top cover and measurement chamber cover. The following image appears on the screen: Fig. 20 locking lever MCon Fig. 21 6-16 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 111 Inspect the electrical contact of the electrodes by checking if they fit tightly. • Scan the barcodes located on the inner packaging of each electrode or enter the bar- codes manually with the help of Fig. 23 6-17 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 112: Replacement Of The Reference Electrode

    Open the top cover and measurement chamber cover. • The following image appears on the display: Fig. 24 • Open locking lever. • Remove the reference electrode. locking lever reference electrode Fig. 25 6-18 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 113 Scan the barcode on the packaging of the inserted electrodes or enter it manually with the help of The corresponding electrode begins blinking on the screen. • Confirm with the button. • Close the measurement chamber and the top cover. 6-19 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 114: Cleaning The Measurement Chamber

    Always respect the time necessary for proper effects. IMPORTANT: Never spray parts that cannot be removed or that are inside the instrument! 6-20 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 115: Adjusting The Screen

    Use this test function to test the functionality of the touch screen and to adjust the screen. Fig. 28 By pressing the "Test" button, you can check if the entire (black) area is active as a touch- sensitive surface (see Fig. 29). Fig. 29 6-21 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 116: Additional Maintenance Procedures

    • Yearly service Check the baro value • • Fill level measurement – waste material: check / correct accuracy • Pump head • Replacement of the entire tubing system 6-22 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 117: Maintenenance Overview

    > Times & intervals > Maintenance scheduler starting with the top level of the analyzer mode For the exact description, see the section "Settings" in chapter 3, "Operating modes," of the Reference Manual! 6-23 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 118 6 Maintenance 6-24 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 119 7.2.19 3024 Flash memory full ..........................7-9 7.2.20 3025 PCMCIA memory full.........................7-9 7.2.21 3026 Data object error..........................7-9 7.2.22 3028 Hardware error ..........................7-10 7.3 Electrode status ......................7-11 7.3.1 Sensor status..............................7-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 120 7 Trouble shooting 7-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 121: System Stops

    7 Trouble shooting Trouble shooting After use, components of the Roche OMNI C, including tubing, waste container, fill- ing port, etc., contain biological fluids and represent therefore a possible infectious risk. Handle these components with care and avoid contact with skin.
  • Page 122 Fill the AutoQC wash tube • Fill the FMS reservoir • Wash • Wash AutoQC • Conductivity calibration • System calibration • Waste container fill level measurement • Aspirate Mix1 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 123: List Of System Stops

    C2 changed: prepare solution C2, fill FMS reservoir, conductivity calibration • C3 changed resp. C3 docking mechanism micro switch operated: prepare C3 solutions • Waste container changed resp. micro switch operated: Waste container fill level meas- urement Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 124: 3003 Flap Open

    Wash 7.2.5 3005 Memory error Cause • Fundamental software functions can not be performed (memory problems, file system problems), the correct operation of the Roche OMNI C can not be guaranteed Remedy • Press the "Reboot" button • In case of recurrence, call customer service (the electronics is defective, change compo- nents if necessary)! Instructions for Use, Roche OMNI C, Rev.

  • Page 125: 3006 Temperature Error

    • Check the AutoQC cover sensor ("More functions > System > Test > Control sensors > Monitoring Sensors"). • In case of recurrence, call customer service (change components if necessary)! Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 126: 3012 User System Stop

    C2 changed: prepare solution C2, fill FMS reservoir, conductivity calibration • C3 changed resp. C3 docking mechanism micro switch operated: prepare C3 solutions • Waste container changed resp. micro switch operated: Waste container fill level measurement Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 127: 3015 Waste Container Full

    If the displayed values are outside of the limits, perform a FMS volume determination and correct the FMS volume value. • In case of recurrence, call customer service! Consequence actions • Aspirate Mix1 • Conductivity calibration Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 128: 3018 Sample Detection Failed

    The waste container fill level must be set roughly (+/- 4 cm) corresponding to the actual fill level in the waste container • In case of recurrence, call customer service! Consequence actions • Wash • Waste container fill level measurement Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 129: 3024 Flash Memory Full

    - insert the card into a PC that has a suitable port, export the data, and then delete the data from the card - reformat the card in the Roche OMNI C (see Reference Manual, chapter 3, "Operating modes", section "System – Test – PC Components – PCMCIA card) 7.2.21 3026 Data object error...

  • Page 130: Electrode Status

    Exchange electrode, see chapter 6, "Maintenance", section "Exchanging the Electrodes and the MCon." • Please see the Reference Manual, chapter 5, "Error Correction", for a detailed descrip- tion of the short texts! 7-10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 131: Sensor Status

    Press "line up/line down" and select a sensor from the list on the left. You receive the following information about the selected sensor: Abb. 4 By pressing , you can start the printout of the report. 7-11 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 132 7 Trouble shooting 7-12 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 133 Instrument data............................8-11 8.4 Info ........................... 8-11 8.4.1 Roche info ..............................8-12 8.4.2 Version numbers............................8-12 8.4.3 Fill levels................................. 8-12 8.4.4 Help ................................. 8-12 8.4.5 Sensor status..............................8-12 8.4.6 Counter overview............................8-13 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 134 8 Operating modes 8-II Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 135: Analyzer

    8 Operating modes Operating modes The Roche OMNI C is a combined bloodgas, electrolyte, and tHb/SO analyzer. It is possi- ble to complete database procedures or to make simultaneous adjustments during measure- ment or calibration. The individual, mutually independent operating modes are defined as follows: •...
  • Page 136 "Complete mandatory inputs" or "Close flap and enter password." The system section can be reached directly and only from the "Ready" screen. This occurs by pressing the button. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 137: System

    8.1.3 System The following main menus are available: Fig. 5 Select the appropriate function. Activate the marked entry. Back to the top level of the analyzer mode (= "Ready" screen). Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 138: Quick Access

    8.1.5 QC measurement This function helps start a quality control measurement. For more detailed information, see chapter 5, Quality control. Setup Use this function to make the following settings: Fig. 7 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 139: Database

    TIP: You can activate the desired database directly by pressing the respective line on the screen. The following query criteria are possible: • Today • Last week • Last month • All patient, measurement, calibration, QC, and instrument data Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 140 QC statistics Only for QC data: The marked ranged is depicted as a Levey Jennings chart. Only for patient data: The measurement data associated with the selected entry is shown. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 141: Data Export - Pcmcia Card (For Example)

    Measuring data > Measurement > DB - Overview"). Optimize database The database is optimized. More disc-space is available. Data export – PCMCIA card (for example) • Open the printer cover. Printer cover Fig. 10 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 142 Fig. 12 • After completing all entries, press The data is exported. Please see the Reference Manual, chapter 3, "Operating modes", section "Database" for an exact description of this operating function! Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 143: Patient Data

    Select the marked entry - the patient's data is shown. 8.3.2 Measuring data Fig. 14 Press these buttons to scroll through all parameters. Select the marked entry - the results screen associated with this measurement is then displayed. Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 144: Calibration Data

    QC data Fig. 16 When you start this function, the Roche OMNI C displays an overview of the saved QC data. This screen shows you, based on selected query criteria, all QC materials that were meas- ured up to this point, the level, lot numbers, and the date on which the QC files were begun.

  • Page 145: Instrument Data

    Press these buttons to scroll through all parameters. Select the marked entry - details about the entry are displayed. Info Use this function to retrieve the following information: Fig. 18 8-11 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

  • Page 146: Roche Info

    8 Operating modes 8.4.1 Roche info This displays the name, address, telephone number, and e-mail address that you defined under: "Setup – Instrument – Roche info" (see Reference Manual, chapter 3, "Operating modes", section "Setup"). 8.4.2 Version numbers This lists the software version.

  • Page 147: Counter Overview

    Fig. 20 Lifetime sample counter: Number of all measured samples since initial startup Sample counter: Number of measurements QC counter: Number of QC measurements Cleaning counter: Number of internal cleanings 8-13 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 148 8 Operating modes 8-14 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 149 ........6-1 Insert suction tube and filling port holder .. 1-23 Cleaning of the needle and fill port ......6-5 Insertion of bottles ..........1-24 Cleaning the measurement chamber ..... 6-20 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 150 Replacement of the electrodes and the MCon ... 6-16 Overview of the Multirules .........5-12 Replacing printer paper ..........6-15 Parameter Sample acquisition ............4-1 Display on the "Ready" screen ......1-8 Sample collection ............. 4-1 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 151 Waste water bottle 3001 Measuring chamber cover open ........... 6-9 ..... 7-3 Weight 3002 Bottle compartment cover open .................. 2-8 .... 7-3 Whole blood 3003 Flap open ............... 4-4 ............7-4 Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...
  • Page 152 Index Instructions for Use, Roche OMNI C, Rev. 4.0, December 2002...

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