i2a SIRscan 2000 automatic User Manual
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i2a SIRscan 2000 automatic User Manual

Software version: v101.4 or newer.
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SIRscan® 2000 Automatic
User Manual
Software version: V101.4 or
newer.
MU-0387
Validé : 28/11/18
i2a
Parc Eurêka 401, avenue du Walhalla
34060 Montpellier Cedex 2
Tel. +33 4 67 50 48 05
Fax. +33 4 67 17 09 06
email : i2a@i2a.info
www.i2a-diagnostics.com
Ref. Doc : MU-0387
Validé : 28/11/18
 CS83406
France

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  • Page 1   CS83406 Parc Eurêka 401, avenue du Walhalla  34060 Montpellier Cedex 2 France MU-0387  Tel. +33 4 67 50 48 05 Fax. +33 4 67 17 09 06 Validé : 28/11/18  email : i2a@i2a.info www.i2a-diagnostics.com...

  • Page 2: Table Of Contents

    Routine use ............................ 16   CS83406 Parc Eurêka 401, avenue du Walhalla  34060 Montpellier Cedex 2 France MU-0387  Tel. +33 4 67 50 48 05 Fax. +33 4 67 17 09 06 Validé : 28/11/18  email : i2a@i2a.info www.i2a-diagnostics.com...
  • Page 3 SIRscan® 2000 automatic Client ..................49   CS83406 Parc Eurêka 401, avenue du Walhalla  34060 Montpellier Cedex 2 France MU-0387  Tel. +33 4 67 50 48 05 Fax. +33 4 67 17 09 06 Validé : 28/11/18  email : i2a@i2a.info www.i2a-diagnostics.com...
  • Page 4 Contact support ......................... 62   CS83406 Parc Eurêka 401, avenue du Walhalla  34060 Montpellier Cedex 2 France MU-0387  Tel. +33 4 67 50 48 05 Fax. +33 4 67 17 09 06 Validé : 28/11/18  email : i2a@i2a.info www.i2a-diagnostics.com...

  • Page 5: Reference Table

    Reference table All the referenced documents are available online on the i2a website: https://www.i2a-diagnostics.fr/acces- docs PR-0004: SIRScan®2000 Automatic EU Declaration of Conformity MU-0373: SIRScan®2000 User manual MU-0376: SIRweb® AST settings MU-0676: SIRscan® Temperature SIR MU-1336: i2a Disc Abbreviation Recognition MU-1155: Dispenser Management - Antibiotic lot traceability ...

  • Page 6: Modifications

    Page 58: renew the plate support detailed.   CS83406 Parc Eurêka 401, avenue du Walhalla  34060 Montpellier Cedex 2 France Réf : MU-0430  Tel. +33 4 67 50 48 05 Fax. +33 4 67 17 09 06 Draft  email : i2a@i2a.info www.i2a-diagnostics.com...

  • Page 7: Foreword

    1 - SIRweb application must be installed on computers provided or approved by i2a. 2 - The application/device is operated under the instructions of this manual. 3 - Only software or hardware specified by i2a shall be installed on the system. This software must be the original copyrighted version.

  • Page 8: Safety Precautions

    If this device was supplied to you by anyone other than i2a or an i2a authorized representative, i2a cannot guarantee this product in terms of specification, latest revision and latest documentation. Further information may be obtained from your i2a authorized representative.

  • Page 9: Chemical Risk

    3.1 Environment The operation of the SIRweb application installed on a computer is restricted for indoor location use only. Please contact your local i2a representative for any information regarding the operation location when it does not comply with the recommended specifications.

  • Page 10: Disposal Application/Device

    Prior to the shipping of a device by transporter, whatever the destination, an external decontamination of the device must be carried out. 4 Unpacking and Installation Unpacking, Installation and any relocation of device should be performed by an i2a representative. MU-0387 Page 10 of 62 ...

  • Page 11: Sirscan® 2000 Automatic General Introduction

    It is therefore necessary to take the following space requirements into account when considering location: Printer (if necessary) Temporary storage of petri dishes waiting to be read and already read Access for maintenance interventions MU-0387 Page 11 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 12: Electrical Features

    SIRcan 2000® AST reader is a subunit of SIRscan® 2000 Automatic. This machine alone allows manual reading of Kirby-Bauer AST. There is a specific user manual for this unit (Ref. MU-0373). MU-0387 Page 12 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 13: Incubator

    Automatic uses barcodes to identify the plates as they are loaded into the incubator. The AST Panel settings are presented in a specific manual provided in the starter pack of documents (ref. MU-0376). MU-0387 Page 13 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 14: Bench Settings

    The right side of the window is reserved to the edition of the Benches (reading zone). The different buttons are described below: Add a new bench Edit the name of a bench Delete a bench Once all the benches are created, click on to validate. MU-0387 Page 14 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 15: Additional Settings

    Complete (automatic): complete expertise (consistency rules, interpretation rules and users rules) is triggered after reading.  User rules (automatic): Only the user rules are triggered.  Delayed: The expertise is delayed. MU-0387 Page 15 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 16: Routine Use

    © Windows operating system will load (this step may take several minutes). © A Windows log in screen appears; default user "i2a" and password default "i2a”. Press “Enter” and the © Windows desktop is displayed. MU-0387 Page 16 of 62 ...

  • Page 17: Sirweb® Pilote Start Up

    To start SIRweb® application, click the icon on the desktop. Enter the username and password to access the SIRweb® main menu. If another session was started, the system displays a message similar to the following example: MU-0387 Page 17 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 18: Barcode Printing

    The system then requests the authentication information 7.5 Barcode printing Note: If the laboratory uses i2a antibiotics with lot traceability, barcode printing is necessary before reading a plate to associate the dispenser antibiotics lot numbers and the plate being read. Barcode label printing is done via the « Dispensers management » menu, detailed in the manual Ref.
  • Page 19 If the laboratory uses benches (see section 1.3.2), tick « Printing by zone » then select the bench with the drop down menu. Then click on to launch the printing. MU-0387 Page 19 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 20: Rack Management

    Lower part is a general panel with control elements and information for all 4 racks together. Manual launch of the reading without incubation. Stop the reading process. Traffic light indicating the reading process status. MU-0387 Page 20 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 21 Printing the rack details (per rack or per bench). Incubator communication journal (i2a support). Activation/deactivation of detailed traceability for the communication (i2a support). Return to the SIRweb® main menu. There is also a screen on the bottom right indicating the position of the racks and plate information.

  • Page 22: Rack Management

    The temperature indicated is the temperature set in the rack. When the temperature is at temperature, the symbol with orange waves on a black background appears. The hour displayed is the hour when the reading will be triggered automatically. MU-0387 Page 22 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 23: Setting The Set Temperature Of The Racks

    7.6.2 Setting the set temperature of the racks The temperatures are pre-set by i2a during the installation, but it can be useful to know where it is set. Each rack is temperature regulated individually and each rack has 4 temperature probes.

  • Page 24: Rack Loading

    Position 1 of each rack is dedicated to the humidifier (it is mandatory to check if the option « humidifier in position 1 » is ticked), all the other positions will be used for the reading plates. MU-0387 Page 24 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 25 If the request is not complete or if there is missing or incorrect information e.g. miscellaneous, it is possible to edit the patient information by clicking on An edit screen appears. It is possible to edit all the fields of the request. MU-0387 Page 25 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 26 AST to be linked to one of the ID analysis. If you want to see all the AST in progress appears (AST type), the option needs to be activated (see section 6.3). MU-0387 Page 26 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 27 The organism appears in the species box. If you select same strain, the isolate number field is not editable. It is possible to change the organism in the dropdown menu. MU-0387 Page 27 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 28 Once back on the rack management menu, click on to end the loading and start the incubation of the plates. If the organism is not planned for the panel: the following message appears : MU-0387 Page 28 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 29: Cancel The Rack Loading

    SIRscan® 2000 Automatic can only incubate in an aerobic atmosphere but can automatically read all AST. Load the pre-incubated AST into the SIRscan® 2000 Automatic (see section 7.6.4), then untick the option incubation and click on to manually start the automatic reading process. MU-0387 Page 29 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 30: Re-Reading

    3. The AST with specific atmosphere are put in their specific atmosphere incubator. 4. Next morning, all the read plates on the machine are unloaded. 5. The AST incubated in another incubator are loaded into SIRscan® 2000 Automatic for reading without incubation. MU-0387 Page 30 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 31: Special Case : Ast Prelud

    7.7 Special case : AST PreLUD® PreLUD® is a plate streaker from i2a. It allows automated culture streaking, slide preparation, AST streaking and dynamic disc dispensing. In a laboratory using PreLUD® to streak the AST plate with or without the disc dispensing, the loading of the plates will be different.

  • Page 32: Prelud® Streaking (Automatic Streaking / Manual Disc Dispensing)

    The red cross of the dish tray should be orientated to the right of the incubator. To add a new plate, repeat these steps. MU-0387 Page 32 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 33: Prelud® Ast (Automatic Streaking And Disc Dispensing)

    It is also possible to access of all the plates prepared by PreLUD® waiting to be loaded, by clicking on the magnifying glass in the prelud section: If the request is known, then SIRweb® displays patient data as below and will automatically enter the organism for this plate. MU-0387 Page 33 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 34: Mhr-Sir® (Rapid Müeller Hinton Sir)

    Then, if after 8 hours of incubation the reading is still not sufficient, the reading will be done according to a standard MH protocol. Once the plate is correctly read, the processus continues after batch validation. MU-0387 Page 34 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 35: Ast Validation

    8 AST validation Laboratories using i2a antibiotic discs with activated disc recognition should refer to the disc recognition user manual as this contains an additional step of validation (Ref: MU-1336). If the automatic expertise hasn’t been defined in the additional settings, the interpretation can be done from any client computer using batch validation menu The first AST appears on the screen.

  • Page 36: Ast Expertise And Results Display

    8.1 AST expertise and results display When the reading of the AST is correct, click on to select the analysis then click on to launch the expertise of the AST. MU-0387 Page 36 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 37 The organism and each antibiotic are preceded by a question mark. Double clicking on it shows information about the selected item. This information can be modified in the thesaurus of the item. MU-0387 Page 37 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 38 Display tests and phenotypes of the analysis Traceability details of the plate Display the pictures of the antibiogram. Display the expert rules Help for symbols used in « State » column MU-0387 Page 38 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 39: Manual Reading (Batch Reading)

    It is possible to do a manual reading with SIRscan® 2000 Automatic using “batch reading” menu from SIRweb® main menu. The following window appears: Enter the request number. Once the request is identified, patient demographic data appears. MU-0387 Page 39 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 40 If there is an ID analysis (identification only) attached to the request, the software will display a window enabling the AST to be linked to one of the ID analysis. MU-0387 Page 40 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 41 Click on to launch the acquisition and the image treatment. Laboratories using i2a antibiotic discs with activated disc recognition should refer to the disc recognition user manual as this contains an additional step of validation (Ref: MU-1336). MU-0387 Page 41 of 62 ...
  • Page 42 At this step, as in batch validation, it is possible to edit the diameter of the antibiotics. Clicking zoom, the full screen image is shown: MU-0387 Page 42 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 43: Display Options

    Color display: It is also possible to adjust the inhibition zone thickness by selecting the circle button and then editing the value with the increase and decrease buttons. MU-0387 Page 43 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 44: Further Actions

    During the expertise, the expert system can request diameter checks and it is possible to review the pictures taken by SIRscan® 2000 Automatic by clicking on the button When the expertise is complete, SIRweb® displays the results. MU-0387 Page 44 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 45 Cancel (or un-cancel) an antibiotic: select the antibiotic and click on the icon. Edit an interpreted result: select the antibiotic and click on the icon. Edit the report order of this antibiogram. MU-0387 Page 45 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 46 Display tests and phenotypes of the analysis Traceability details of the plate Display the pictures of the antibiogram. Display the expert rules Help for symbols used in « State » column MU-0387 Page 46 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 47: Maintenance

    10 Maintenance Frequency of the maintenance operations detailed in the sections below is found in parentheses. REF. I2A TIME OPERATION FREQUENCY REQUIRED. CONSUMMABLES Fill humidifier N /A daily 1 min Renewing humidifier 311225 Quarterly 1 min Electrical shut down N /A...

  • Page 48: Humidifier (Daily)

    Caution: to prevent water spillage, do not overfill the humidifier. Spillage may cause damage to the electrical components located in the bottom part of the incubator. The humidifiers are to be replaced quarterly and are available (pack of 4) from i2a using reference 311225.

  • Page 49: Sirscan® 2000 Automatic Client

    Windows® taskbar. The rack management window appears with the exit button (door) available to close it. Click on to quit the program. The incubator icon will disappear from the Windows® taskbar. MU-0387 Page 49 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 50: Sirscan® Computer Components Cleaning (Monthly)

    10.4 SIRscan® 2000 Automatic measurement calibration (quarterly) SIRscan® measurement calibration is a maintenance operation to be performed quarterly. Each SIRscan® is delivered with a standard plate (i2a ref: ZN152) which is linked to national calibration standards (certificate available on request).
  • Page 51 » to do a new measurement. The « » button enables you to delete one line in case of error. The following screen appears. Check the operator name (it is possible to edit it). MU-0387 Page 51 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 52 Once the diameter is adjusted, click on the button to go to the next step and start the process again with the next diameter. MU-0387 Page 52 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 53: Caliper Test (Quarterly)

    If the three diameters are correct, the result of the check will be Correct and if not, it will be Not Correct. In the case of a Not Correct result, repeat the reading. If it remains Not Correct, contact i2a or your local i2a representative support.
  • Page 54 The following screen displays the COM port on which the caliper is connected. Confirm the currently selected port. The system then initialises a reading test. The following screen appears: MU-0387 Page 54 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 55: Cleaning Dishtray (4 Months Or 1 Rack Per Month)

    Pull out, lifting slightly, the drawer containing the keyboard. Take it out of its rail. Unscrew the two black screws located under the and pull out the filter support. SIRscan® MU-0387 Page 55 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 56: Mechanical Set Filter

    Once the new filter is on, SIRscan®. 10.8.2 Mechanical set filter Use the SIRscan® key to open the top panel Remove the gutter by unscrewing the 2 side screws A and B. MU-0387 Page 56 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...
  • Page 57 Open the filter grid and change the filter. Place the grid in position below the fan. Fix the grid on the top of the fan by pushing firmly. One click indicates that the filter is in position. MU-0387 Page 57 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 58: Lid Clamp Sterilization (Annually Or In Case Of Contamination)

    Once the rack is dry, it may be returned to the incubator. 10.11 Lamp replacement (as required) The lamps used in the SIRscan 2000® are EKE 150 W 21 Volts (i2a code: :MC303001). These lamps are provided by i2a and alternatives must NEVER be used.
  • Page 59 Take off the gutter by unscrewing the 2 side screws A and B Unscrew the C screw to open the G grill of the lamp box. Push back the arm of the lamp holder to remove the lamp from its housing. MU-0387 Page 59 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 60: Fuse Replacement (As Required)

    Check if a spillage of water in the humidifier (water visible in the bottom of the rack) has caused a short circuit on the cards or power supply. Shut down incubator and SIRscan® 2000 then switch back on. 11.5 Pictures are dark Check the lamps and replace them if needed. MU-0387 Page 60 of 62  Validé : 28/11/18 www.i2a-diagnostics.com...

  • Page 61: Lid Is Misplaced After A Reading

    At the rack, check the arms interior laser (cleaning with a dry swab) If the laser is not well aligned with the receiving diode, contact your i2a authorized representative. Check the reading table laser (cleaning with a dry swab) The laser is not well aligned with the receiving diode;...

  • Page 62: A Door On The Incubator Makes A Noise When It Is Opened Or Closed

    11.14 A door on the incubator makes a noise when it is opened or closed Check the door is properly closed. Do not use this rack. Contact your i2a authorized representative to schedule an intervention. 11.15 The temperature of the racks does not correspond to the set temperature Switch off the incubator for a few minutes to reset the temperature management charts.

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