GEM Hemochron 100 Operator's Manual
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GEM Hemochron 100 Operator's Manual

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000GH100
Operator Manual • 000HZ6006EN.US • 02 • 02/2022
English
Accriva Diagnostics, Inc. - 6260 Sequence Drive, San Diego, CA 92121 USA
Tel: +1-858-263-2300 • www.instrumentationlaboratory.com
MDSS GmbH - Schiffgraben 41, 30175 Hannover, Germany
1 / 112

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  • Page 1 000GH100 Operator Manual • 000HZ6006EN.US • 02 • 02/2022 English Accriva Diagnostics, Inc. - 6260 Sequence Drive, San Diego, CA 92121 USA Tel: +1-858-263-2300 • www.instrumentationlaboratory.com MDSS GmbH - Schiffgraben 41, 30175 Hannover, Germany 1 / 112...
  • Page 2 (This page intentionally left blank)

  • Page 3: Table Of Contents

    Sleep Mode ......................21 2.2.6 Automatic Shutdown ..................21 2.3 Display Screen .......................22 2.3.1 Selecting Items on the Screen ................22 2.3.2 Scrolling the Screen ...................22 2.3.3 Back and Home Icons ..................22 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 3 / 112...
  • Page 4 3.5 Wi‑Fi Signal Strength ....................45 Patient Testing 4.1 Considerations About Patient Testing ..............46 4.2 Specimen Collection ....................46 4.3 Run a Patient Test....................47 4.4 Patient Test Results Data ..................49 4.5 Test Interval Timer Feature (Optional) ..............49 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 4 / 112...
  • Page 5 8.3 Administrative Settings ...................74 8.3.1 Logging into CCM for the First Time ..............75 8.3.2 Create CCM User Accounts .................76 8.3.3 Configure CCM Software Settings ...............77 8.3.3.1 Configure Miscellaneous Settings ..............77 8.3.3.2 Configure Network Settings ................77 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 5 / 112...
  • Page 6 8.4.6 Update Wi‑Fi Enterprise Certificate ..............98 8.4.7 Download Instrument Log Files .................100 Regulatory Compliance 10 Legal Notices and Licenses Ordering Information Technical Support Trademarks Index = Change Identifier: Change(s) to section since previous revision. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 6 / 112...

  • Page 7: Copyright

    The manufacturer reserves the right to make technical improvements to this equipment and documentation without prior notice as part of a continuous program of product development. Warranty The manufacturer declares to the original purchaser that each GEM Hemochron™ 100 system manufactured and ®...

  • Page 8: Preface

    Cross-references to other information are in italic : Example: See “Patient Testing” (page 46) . Paragraphs containing important information are in italic : Example: NOTE: Supervisors have access to User Settings and Supervisor Settings. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 8 / 112...

  • Page 9: Product Labeling, Symbols, And Icons

    Quality Control – Level 2 (Abnormal) Conformity to European Directives/Regulations Authorized Representative in the European Biological Risks Community Not Made with Natural Rubber Latex Manufacturer Device for Near-Patient Testing TÜV 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 9 / 112...

  • Page 10: Icons On The Display Screen

    Wi-Fi Connection is Good. drawing the sample into the test channel. Wi-Fi Connection is Excellent. Checking Test Cartridge. Network connection is active. Network connection is inactive, previous connection was successful. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 10 / 112...

  • Page 11: Symbols Used In This Manual

    BIOHAZARD: This symbol alerts the user of potential biological risks associated with the medical device. NOTE: A note is supplementary information. Change Indicator: Change(s) to section since previous revision. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 11 / 112...

  • Page 12: Definitions And Terms

    Point Of Care Connectivity approved standard published by CLSI (Clinical and Laboratory Standard Institute). Quality Control Transmission Control Protocol Test Cartridge/Test Cuvette Instrument Consumables Wi-Fi RSSI Wi-Fi Signal Quality WLAN Wireless Local Area Network 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 12 / 112...

  • Page 13: Introduction

    The type of activator used will affect the degree of prolongation of the ACT to a given heparin dose. The GEM Hemochron 100 ACT+ test uses a mixture of silica, kaolin, and phospholipids as an activator to create a rapid and highly sensitive alternative to existing ACT tests. This test demonstrates linearity at heparin concentrations ranging from 1.0–6.0 units of heparin per mL of blood, and it is not affected by high dose...

  • Page 14: Principles Of Operation

    1 - Introduction 1.4 Principles of Operation The GEM Hemochron 100 system measures whole blood activated clotting time using single‑use disposable test cartridges. Each test cartridge contains all of the reagents necessary for a specified test. The Operator inserts a test cartridge into the instrument and then (optional) enters information about the sample either manually or by scanning the barcode using the barcode scanner.

  • Page 15: Description Of The System

    1 - Introduction 1.5 Description of the System The GEM Hemochron 100 system consists of the instrument, Centralized Configuration Manager (CCM), a power supply, Liquid Quality Control (LQC) products, and the test cartridges for ACT+ and ACT-LR assays. 1.5.1 Instrument Components Instrument components are shown in Figure 2 and described in Table 1 .

  • Page 16: Test Cartridges

    1 - Introduction 1.5.2 Test Cartridges GEM Hemochron 100 test cartridges are single‑use disposable test devices with a sample well for application of samples. NOTE: Test cartridges are not supplied with the system. They must be ordered separately. See “Materials Required, but Not Provided”...

  • Page 17: Operational Warnings And Precautions

    Strictly adhere to the institution’s policies for the proper handling and disposal of biohazardous materials. ● The materials included as part of the GEM Hemochron 100 system are not made with natural rubber latex. ● Deleted test results cannot be recovered.

  • Page 18: Limitations

    As with all diagnostic tests, GEM Hemochron 100 test results should be evaluated in the context of a specific patient’s condition and anticoagulant therapy. Any test results exhibiting inconsistency with the patient’s clinical status should be repeated or supplemented with additional test data.

  • Page 19: Preparing The Instrument

    Optional Materials: Table 4: Optional Materials Description Catalog # Centralized Configuration Manager (CCM) Software for GEM Hemochron 100 000GCCM NOTE: Refer to “Ordering Information” (page 106) for additional product information on all materials listed above. Unpack and Inspect the Instrument: NOTE: Do not discard the packaging material.

  • Page 20: Instrument Power And Charging

    The instrument can be used while it is being charged. NOTE: The battery charge indicator is displayed in the status bar at the top of the screen. For more information, see “Battery Power Icons” (page 10). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 20 / 112...

  • Page 21: Power On The Instrument

    The default period of time for automatic shutdown is 1 hour. Supervisors can specify a different period of time or specify that the instrument never shuts down. See “Set the Shutdown Interval” (page 32) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 21 / 112...

  • Page 22: Display Screen

    2.3.3 Back and Home Icons Back and Home icons are always displayed at the bottom of the screen ( Figure 9 ). Back Home Figure 9 : Back and Home Icons 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 22 / 112...

  • Page 23: Entering Information Into The Instrument

    To move the cursor, touch the text in the text field to display the cursor and then move the cursor horizontally ( Figure 12 ). Figure 12 : Cursor in a Text Field 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 23 / 112...

  • Page 24: Using The Barcode Scanner

    An audible beep will be heard when the barcode scanner reads the barcode. Verify that the information was entered into the dialog box. Select Save to save the information or Cancel to exit without saving. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 24 / 112...

  • Page 25: Δ 3 Instrument Settings

    3.2.1 Rotate Screen Select (Settings) > User Settings > Rotate Screen. Tap Rotate Screen ( Figure 14 ) and the screen will rotate 180°. Figure 14 : Rotate Screen 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 25 / 112...
  • Page 26 Rotating the screen 180° allows Operators to use the instrument with the test cartridge insertion chamber positioned on either end of the instrument ( Figure 15 ). This accommodates left-handed and right-handed Operators . Figure 15 : Rotating the Screen 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 26 / 112...

  • Page 27: Interval Timer

    Test Interval Timer feature. See “Test Interval Timer Feature (Optional)” (page 49) . 3.2.3 Adjust the Display Brightness Select (Settings) > User Settings. Drag the Brightness slider horizontally to the desired level ( Figure 17 ). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 27 / 112...

  • Page 28: Adjust The Beep Volume

    (Settings) > User Settings > Font Size. Select In the dialog box ( Figure 19 ), select the preferred size (Normal or Large). Figure 19 : Adjusting Font Size 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 28 / 112...

  • Page 29: Δ 3.3 Supervisor Settings (Advanced Settings)

    Supervisors are required to log into the instrument. The factory default setting Supervisor account password should be changed, recorded, and stored in a safe place. To change the password, use CCM. See “GEM Hemochron 100 System User Accounts” (page 71) . To Log into the Factory Default Setting Supervisor Account: Select (Settings) >...
  • Page 30 Erase all patient test results from the instrument. See “Clear All Patient Test Results” Results (page 42) . Barcode Scanner Test Check the barcode scanner. See “Test the Barcode Scanner” (page 43) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 30 / 112...

  • Page 31: Reset Counters

    Supervisors can set the sleep mode interval. Select (Settings) > Supervisor Settings > Instrument Settings > Display > Sleep. In the dialog box, select the desired interval. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 31 / 112...

  • Page 32: Set The Shutdown Interval

    (Toggle Off). Select Set Date. In the dialog box ( Figure 24 ), scroll the values for the month, day, and year. Figure 24 : Set Date Select OK. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 32 / 112...

  • Page 33: View Battery Usage Information Based On System Resource

    (page 35) . POCT1-A Using Ethernet or Wi‑Fi, Supervisors can connect the instrument to a POCT1-A-compliant network for use with middleware. See “Configure a POCT1‑A Network” (page 37) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 33 / 112...
  • Page 34 Connect an Ethernet cable between a network access point and the Ethernet port on the instrument. (Settings) > Supervisor Settings > Instrument Settings > Ethernet > Mode. Select 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 34 / 112...
  • Page 35 Is the desired wireless network on the list of available networks? ● No – Go to the next step. ● Yes – Go to step 7 (page 36) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 35 / 112...
  • Page 36 NOTE: While Wi-Fi is connected, select Advanced Options > IP Settings and change the setting from Static to DHCP mode on each GEM Hemochron 100 instrument to maintain a fixed IP address. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual...

  • Page 37: Language

    (Settings) > Supervisor Settings > POCT1-A Network Settings. Select In the dialog box ( Figure 31 ), enter the IP Address and the Port. Figure 31 : Configuring POCT1‑A Network Settings 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 37 / 112...

  • Page 38: Set Port Number And Encryption Mode For Ccm

    Select Done. NOTE: Supervisors can consult the IP Address and MAC Address in Instrument Settings. See “View Instrument Information” (page 37). Figure 34 : IP Address and MAC Address 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 38 / 112...

  • Page 39: Automatically Send Test Results To The Network (Auto Send)

    OID. They can scan a compatible barcode or manually enter the OID. Scan Only – Before Operators run a test, they are required to enter their OID by scanning a ● compatible barcode. Figure 35 : OID Entry Preference 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 39 / 112...

  • Page 40: Reuse An Oid (Automatic Entry Of The Most Recent Oid)

    NOTE: After a period of instrument inactivity, the OID reuse duration is automatically reset to 0 (zero). NOTE: OID reuse will not go into effect until the Supervisor specifies the period of time the feature is to remain enabled. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 40 / 112...

  • Page 41: Patient Id (Pid) Settings

    (Settings) > Supervisor Settings > PID Reuse (During Patient Test). Select On to enable PID reuse: ● (Toggle Off) – Disabled. ● (Toggle On) – Enabled (the PID will automatically be entered into the dialog box). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 41 / 112...

  • Page 42: Clear Test Results

    Clear All Patient Test Results: (Settings) > Supervisor Settings > Clear All Patient Test Results. Select In the dialog box, select Delete to delete all patient test results. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 42 / 112...

  • Page 43: Test The Barcode Scanner

    (page 90) in CCM. Select Cancel to return to the Supervisor Settings menu. For more information about using the barcode scanner, see “Using the Barcode Scanner” (page 24) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 43 / 112...

  • Page 44: Run A Demo Test

    (Apply Sample to Test Cartridge), indicating the instrument is ready for the sample to be applied ( Figure 43 ). Figure 43 : Demo – Add Sample and Press Start 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 44 / 112...

  • Page 45: Wi-Fi Signal Strength

    (Settings) > Wi-Fi Signal Strength. NOTE: Signal Strength is the Wi-Fi RSSI. The indicator is a relative indication (Figure 46). Figure 46 : Wi-Fi Signal Strength (Wi-Fi RSSI) 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 45 / 112...

  • Page 46: Patient Testing

    For more information, see “QC Lockout” (page 53) . Test Cartridges: Only use GEM Hemochron 100 test cartridges. Use the appropriate test cartridge for the type of test that will be performed. Test cartridges are for single-use only, do NOT reuse.

  • Page 47: Run A Patient Test

    Displays the test result. Test results are displayed as Celite equivalent ACT value in seconds, not real-time seconds. If the test result is out of range, repeat the test. If the test result is still out of range, see “Troubleshooting” (page 65) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 47 / 112...
  • Page 48 ( Figure 49 ). Figure 49 : Patient Test Result Details NOTE: Patient test results are stored in the instrument database. To view them, see “Database” (page 63). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 48 / 112...

  • Page 49: Patient Test Results Data

    4.4 Patient Test Results Data As a complementary feature, during an active singular procedure, the GEM Hemochron 100 instrument can display up to 10 sequential patient test results on the left side of the display screen. To access these test results, select (Information) ( Figure 50 ).
  • Page 50 Operator ). (Toggle Off) – Disabled (the audible beep is NOT repeated). – Figure 55 : Test Interval Timer – Beep Options Select Ok. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 50 / 112...

  • Page 51: Quality Control (Qc)

    This requirement can be accomplished by conducting internal EQC or external LQC testing. QC of the GEM Hemochron 100 Test Cartridges: Performance of each lot of GEM Hemochron 100 test cartridges should be validated with 2 levels (Level 1 [Normal] and Level 2 [Abnormal]) of LQC using directCHECK Whole Blood Quality Controls: ●...

  • Page 52: Electronic Quality Control (Eqc) Testing

    3 seconds 120 seconds Configured for 500 seconds, total time = 380 Total elapsed time to perform an EQC test is approximately 5 or 8.5 minutes (configuration dependent) 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 52 / 112...

  • Page 53: Liquid Quality Control (Lqc) Testing

    LQC Products: directCHECK Whole Blood Quality Controls are the recommended LQC products for the GEM Hemochron 100 instrument. The LQC product and test cartridge must match the type of LQC test that needs to be run.

  • Page 54: Patient Test Lockout

    To specify the number of additional failed QC tests that Operators can run after the first QC test fails, the Supervisor must log into CCM. See “Configure Instruments (Instrument Settings)” (page 83) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 54 / 112...

  • Page 55: Clearing A Lockout

    Select Yes in the Clear LQC Level 2 Failure Count drop-down list. Select Yes in the Clear Number of Patient Tests Used After LQC Expiration drop-down list. Select OK. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 55 / 112...
  • Page 56 Figure 57 : Clear an EQC Lockout in CCM Select Yes in the Clear EQC Failure Count drop-down list. Select Yes in the Clear Number of Patient Tests Used After EQC Expiration drop-down list. Select OK. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 56 / 112...

  • Page 57: Run An Eqc Test

    Select this icon to abort the test at any time. Figure 60 : EQC Test in Progress NOTE: By pressing (Home) or (Back), the test can be canceled. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 57 / 112...
  • Page 58 NOTE: If Auto Send is enabled, the instrument will automatically send the test result to the network (Test Result Transmission Sent) will be displayed indicating the transmission was successful (Figure 64). Figure 64 : Test Result Transmission Sent 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 58 / 112...

  • Page 59: Run An Lqc Test

    Compare the LQC lot information in the dialog box with the human-readable LQC lot information on Acceptable Performance Range label to verify it was entered correctly. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 59 / 112...
  • Page 60 Displays the test result. Test results are displayed as Celite equivalent ACT value in seconds, not real-time seconds. If the test result is out of range, repeat the test. If the test result is still out of range, see “Troubleshooting” (page 65) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 60 / 112...
  • Page 61 NOTE: If Auto Send is enabled, the instrument will automatically send the test result to the network (Test Result Transmission Sent) will be displayed indicating the transmission was successful (Figure 68). Figure 68 : Test Result Transmission Sent 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 61 / 112...
  • Page 62 ( Figure 70 ). Figure 70 : LQC Result Details NOTE: LQC test results are stored in the instrument database. To view them, see “Database” (page 63). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 62 / 112...

  • Page 63: Database

    (Status), then select All, Sent, Unsent, or Fail. The selection criteria will be displayed on the screen. To exit, select or select other tab. This search is available for Patient, LQC, and EQC test results. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 63 / 112...

  • Page 64: View/Send Test Results

    Table 9: Options on the Database Menu Option Description Number of Results Display the total number of test results in the database. Send All Send all test results to the network. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 64 / 112...

  • Page 65: Service, Maintenance, And Troubleshooting

    7.2 Instrument Repair In the unlikely event that the GEM Hemochron 100 system requires repair; the instrument may have to be sent to your authorized service center. Contact Technical Support to determine if the instrument requires repair.

  • Page 66: Error Messages

    Run a successful EQC or LQC. Test Limit Reached. are not allowed. For more information on QC expiration, go to QC, and select the tab that contains a (Testing Failed). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 66 / 112...
  • Page 67 The test cartridge lot was not recognized. Verify that the test cartridge lot used is Cartridge Lot valid. Remove the test cartridge and insert a new one. If error persists, contact Technical Support. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 67 / 112...
  • Page 68 LIS settings. If error persists, contact Technical Support. POCT1-A Error Database error. Power the instrument off and back on. If Database Access. error persists, contact Technical Support. Contact Technical Support. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 68 / 112...

  • Page 69: Changes In Performance Characteristics

    If during the use of this device or as a result of its use, a serious incident has occurred or a product performance issue has been observed, please report it to the manufacturer and/or its authorized representative or, your local affiliate, and to your national authority. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 69 / 112...

  • Page 70: Disposing Of Products

    Use caution when handling and disposing of any sharp device. Strictly adhere to the institution's policies for the proper handling and disposal of biohazardous materials. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 70 / 112...

  • Page 71: Δ 8 Centralized Configuration Manager (Ccm) Software

    NOTE: Users log into each module separately. Users must log out of 1 module before logging into the other module. 8.1.1 GEM Hemochron 100 System User Accounts There are 4 types of accounts are associated with the GEM Hemochron 100 system. 2 accounts are for the CCM software application and 2 accounts are for instrument(s): CCM Accounts: ●...

  • Page 72: Overview For Using Ccm Software

    To see a tooltip that displays the error message, place the cursor over the text field. NOTE: To import the configuration settings from an instrument, see “Import Configuration Data” (page 96). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 72 / 112...

  • Page 73: Installing, Updating, And Uninstalling Ccm Software

    Click Next several times until the installer starts. When installation is complete, click Close. Click the Windows Start button. The GEM Hemochron 100 Configuration Manager application shortcut is available in the Start menu under Instrumentation Laboratory > CCM: Configure Firewalls – Before using CCM, configure all firewalls so they will not prevent the instrument from communicating over the network with the computer using the CCM software ( Table 11 ).

  • Page 74: Uninstall Ccm Software

    This setting needs to match the encryption setting of the instrument and CCM. For the instrument encryption setting, see Figure 33 (page 38) . NOTE: Only CCM Admins are allowed to access this module; CCM Supervisors cannot. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 74 / 112...

  • Page 75: Logging Into Ccm For The First Time

    NOTE: The password must contain at least 7 characters. At least 1 character must be a special character (period, comma, &, @, *, $, etc.) (e.g., @mypassword). The Administrative Settings module ( Figure 75 (page 74) ) is displayed. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 75 / 112...

  • Page 76: Create Ccm User Accounts

    NOTE: To edit or delete an account, select the account from the list (Figure 79) and the appropriate button (Edit or Delete). List of user accounts. Figure 79 : CCM – List of User Accounts 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 76 / 112...

  • Page 77: Configure Ccm Software Settings

    NOTE: Verify that the Remote Poke Port setting on CCM matches the Port setting on the instrument. For the Encryption and Port settings on the instrument, see “Set Port Number and Encryption Mode for CCM” (page 38) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 77 / 112...

  • Page 78: Δ 8.4 Configuration Settings

    Before an instrument can be configured over the network, the instrument must be added to CCM so it can be recognized. Instrument groups allow users to perform operations on all of the instruments in a group. Figure 83 : CCM – Configuration Settings Title Bar 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 78 / 112...

  • Page 79: Add An Instrument

    In the list of instruments, select the instrument to add to the group. Click Edit. In the Group drop-down list, select the group and click OK. To return to the Home screen, click (Home) in the upper left corner. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 79 / 112...

  • Page 80: Configure Instruments

    ● Go Back – Go back to the session so the data can be sent to an instrument or exported. Figure 84 : CCM – Unsaved Changes Message 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 80 / 112...

  • Page 81: Create Configuration Data

    Figure 86 : CCM – Cartridge Lots Dialog Box Click New. The Adding New Cartridge Lot dialog box ( Figure 87 ) is displayed. Figure 87 : CCM – Adding New Cartridge Lot 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 81 / 112...

  • Page 82: Configure Lqc Lots Data

    NOTE: When editing an LQC lot, if the test type is changed, the Range Low and Range High values will be reset to 0 (zero). Please ensure the appropriate values are entered in this text field before saving. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 82 / 112...

  • Page 83: Δ 8.4.2.1.3 Configure Instruments (Instrument Settings)

    No – Operators cannot see the number of patient tests allowed. The number is not shown. OID/PID Automatic The number of hours (0:00–720:00) before Operators are automatically logged Logout Hours out. (HHH:MM 0:00–720:00) 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 83 / 112...
  • Page 84 Pre-stored Only been registered in (added to) CCM: • Yes – Operators must only use registered test cartridge lots. • No – Operators can use any test cartridge lot. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 84 / 112...
  • Page 85 After the first LQC test fails, the counter is incremented each time an additional LQC test fails. For more information, see the description for the field labeled “Number of LQC Failures Allowed Before Assay Lockout (0–9)” . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 85 / 112...
  • Page 86 Expiration” will be cleared (reset) when configuration data is sent to the instrument. NOTE: It is recommended to run a successful LQC test to clear the value in the field labeled “Number of Patient Tests Used After LQC Expiration”. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 86 / 112...
  • Page 87 EQC test (e.g., Configured time: 9 am, interval 8 hr. User start EQC at 8 am, next EQC will be required to run at 4 pm ). 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 87 / 112...
  • Page 88 Level 2 Range The expected low range for Level 2. This value is read-only. Level 2 Range The expected high range for Level 2. This value is read-only. High 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 88 / 112...
  • Page 89 Expiration” will be cleared (reset) when configuration data is sent to the instrument. NOTE: It is recommended to run a successful EQC test to clear the value in the field labeled “Number of Patient Tests Used After EQC Expiration”. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 89 / 112...
  • Page 90 Click OK again to save the changes and return to the Home screen. Send the configuration data to the instrument. For more information, see “Send Configuration Data to Instruments” (page 95) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 90 / 112...
  • Page 91 Send the configuration data to the instrument. For more information, see “Send Configuration Data to Instruments” (page 95) . 10 Initiate a patient test to confirm that the Patient ID displayed on the instrument screen contains the appropriate barcode parsing. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 91 / 112...
  • Page 92 The name of the configuration file (.cfg) that was imported into the current session. Config Revision The revision number of the configuration file (.cfg). It contains the date and time stamp: YYYYMMDDHHMMSS 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 92 / 112...

  • Page 93: Create Instrument Operators And Supervisors

    NOTE: If using an Operator list from other middleware (e.g., GEMweb Plus 500), the limitation on Operator ID (character length and/or password) will be determined by the middleware software. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 93 / 112...

  • Page 94: Configure Institution Data

    The Institution dialog box ( Figure 96 ) is displayed. Figure 96 : CCM – Institution Dialog Box Add data about the institution. Click OK to save the changes. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 94 / 112...

  • Page 95: Send Configuration Data To Instruments

    Apply – The configuration data will be applied immediately. If Postpone or Apply are not selected within 2 minutes, the configuration data will be applied when the countdown timer expires. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 95 / 112...

  • Page 96: Export Configuration Data

    NOTE: To import the configuration settings from an existing instrument, first read from the instrument, edit the configuration data, and then send to the instruments or to a group of instruments. 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 96 / 112...

  • Page 97: Generate A Configuration Report

    CCM. Technical Support can use the information in the event that a problem with the instrument occurs. Time‑stamped versions of this file are located in the following folder: C:\ProgramData\InstrumentationLaboratory\CCM 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 97 / 112...

  • Page 98: Update Instrument Software

    Select the Wi‑Fi Enterprise Certificate file, click Open, and then select OK in the Update Certificate dialog box ( Figure 99 ) to upload the certificate onto the instrument. Figure 99 : CCM – Update Certificate 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 98 / 112...
  • Page 99 To view and/or modify stored credentials, select User Credentials. To remove all certificates, select Clear Credentials. To configure Wi‑Fi, see “Connect to a Wireless Network (Wi-Fi)” (page 35) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 99 / 112...

  • Page 100: Download Instrument Log Files

    NOTE: If requested, send to Technical Support. Technical Support can use the information in the event that a problem with the instrument occurs. Figure 102 : CCM – Download Log Results 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 100 / 112...

  • Page 101: Regulatory Compliance

    9 - Regulatory Compliance Regulatory Compliance The GEM Hemochron 100 instrument complies with the following safety standard requirements and directives: CAN/CSA‑C22.2 No. 61010‑1:2012 + U1:2015‑07 + U2:2016‑04 CAN/CSA-C22.2 No. 61010-2-010:2015 CAN/CSA-C22.2 No. 61010-2-101:2015 EN 61010‑1:2010 EN 61010‑2‑010:2014 EN 61010‑2‑101:2017 UL 61010‑1:2012 + R:2015‑07 + R:2016‑04 UL 61010-2-010:2015 IEC 61010‑1:2012...
  • Page 102 Inadequate QoS will result in a communications error flagged to the Operator through the instrument user interface. For an indicator of the network quality, see “Connectivity Icons” (page 10) . 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 102 / 112...
  • Page 103 9 - Regulatory Compliance Cybersecurity: Refer to the GEM Hemochron 100 Cybersecurity and Privacy Guide (P/N: 000HZ7003). Addressing Wireless Connectivity Problems / Coexistence: This instrument is able to provide essential performance (assay analysis) without the use of a network connection. In the event of a perceived or actual communications failure, relocate the instrument closer to the desired wireless access point and/or identify and eliminate any wireless interference.
  • Page 104 (Eudamed) at https://ec.europa.eu/tools/eudamed. Currently, it is available on the manufacturer’s website. RoHS Compliance: The manufacturer certifies that the GEM Hemochron 100 instrument is in compliance with the Directive 2011/65/EU of the European Parliament and of the Council of June 8, 2011 on the restriction of the use of certain hazardous substances in electrical and electronic equipment (RoHS 3).

  • Page 105: Legal Notices And Licenses

    Licensed under Apache License Version 2.0 Original license LGPL Details of the Apache License, Version 2.0 can be found at: http://www.apache.org/licenses/ Apache License Version 2.0, January 2004 http://www.apache.org/licenses/ 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 105 / 112...

  • Page 106: Ordering Information

    000DCGLR‑2 Centralized Configuration Manager (CCM) Software for GEM Hemochron 100 000GCCM Technical Support This manual is published by the manufacturer for use with the GEM Hemochron 100 instrument. ● Inside US or Canada, contact +1‑800‑678‑0710 for Technical Support. ● Outside US or Canada, please contact your local Instrumentation Laboratory (IL) representative or Werfen/IL distributor for Technical Support.

  • Page 107: Index

    Requiring LQC Lot Entry ..........84 Update Instrument Software ........78, 98 Update Wi‑Fi Enterprise Certificate ......... 98 Version Info..............92 Connect Instrument to Network ..........34 Copyright ................7 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 107 / 112...
  • Page 108 Serial Number Label ............... 9 QC Test Lockout ............53, 54 Service.................. 65 Log Files Shutdown..............21, 29, 32 Audit Log File..............97 Debug Log File ..............97 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 108 / 112...
  • Page 109 Test Cartridge Lot ......... 16, 72, 81, 84, 95 Test Cartridge Lot Number Entry ......16, 81, 84 Test Interval Timer Feature ........... 49 Test Timeout ............. 47, 60, 67 000HZ6006EN.US • 02 • GEM Hemochron 100 Operator Manual 109 / 112...
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  • Page 111 (This page intentionally left blank)
  • Page 112 Operator Manual • 000HZ6006EN.US • 02 • 02/2022 English Accriva Diagnostics, Inc. - 6260 Sequence Drive, San Diego, CA 92121 USA Tel: +1-858-263-2300 • www.instrumentationlaboratory.com MDSS GmbH - Schiffgraben 41, 30175 Hannover, Germany 112 / 112...

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