Page 1 HemoCue 201 DM Analyzer ® & HemoCue 201 DM Docking Station ® Reference Manual...
Page 2: Table Of Contents
CONTENTS PART I Introduction..................1 Introduction ..................2 Abbreviations/glossary ..............3 Designated Terminology ............6 Functional description ...............8 1.3.1 System Components ...............8 1.3.2 Analyzer overview ................9 1.3.3 Docking station – General ............12 1.3.4 Docking Station overview ............14 1.3.5 Functions and features ..............19 General operations ................20 How to operate the Display ..........
Page 3 PART II Settings .....................36 Settings ..................... 37 Activating the Settings procedure .........37 Define Lists ................40 3.2.1 Liquid Controls ................41 3.2.2 Cuvette Batches ................47 3.2.3 Define Operators ................51 3.2.4 Define Comments ................ 56 3.2.5 Define Log Notes ................58 Basic Settings ................
Page 4 PART III Routine use ..................103 Patient Test procedure ..............104 Patient Test ................104 4.1.1 Patient Test Result ................110 4.1.2 Verify/Duplicate sampling ............112 4.1.3 Entering Comments ..............115 4.1.4 Entering Comments – Verified sample ........119 STAT Test procedure ..............121 STAT Test ..................121 5.1.1 STAT Test Result ................124 QC Test procedure ................
Page 5 Delete Stored Data ..............162 Review Latest Download ............. 164 Log Input ................. 165 Data communications ..............166 Interaction Application – Analyzer ........166 Docking station setup ............167 Data transfer ................173 PART IV Other actions ................176 Troubleshooting ................177 PART V Miscellaneous ................
Page 6: Part I
PART I Introduction...
Page 7: Introduction
Docking Station. Usage Disclaimer The HemoCue 201 DM system has flexible settings to meet different user needs. The setting options are configured in the settings menu, requiring a pin code. The selected settings are the responsibility of the local administrator. HemoCue AB does not take responsibility for user configurations that may cause system conflicts, loss of data or prevent the end-user to perform tests.
Page 8: Abbreviations/Glossary
POC devices and electronic medical records and laboratory information systems. Data Management Data Management Server HemoCue A physical connecting device A hub is a place of convergence where data arrives from one or more directions and is forwarded in one or more other directions.
Page 9 Light Emitting Diode A semiconductor device that emits visible light when an electric current passes through it. In most LEDs the light is monochromatic, i.e. occurring at a single wavelength. Lab Identification (ID) or lab number ID of a test, unique within a user site.
Page 10 QC Test A measurement of control material, providing evidence of the stability of the System Secondary Docking Station Secondary Docking Station (Unlabelled) STAT Short Turn Around Time STAT Test A test mode that allows a patient test to be performed without entering information required in the routine patient test mode.
Page 11: Designated Terminology
(irrespective of primary or secondary) HemoCue 201 DM - DMS Software DMS Software HemoCue Hb 201 Microcuvette Cuvette HemoCue Glucose 201 Microcuvette HemoCue Glucose 201 RT Microcuvette Documentation HemoCue 201 DM Analyzer & HemoCue 201 DM Reference Manual Docking Station Reference Manual...
Page 12 HemoCue Hb 201 DM Instructions for Use Instructions for Use HemoCue Glucose 201 DM Instructions for Use HemoCue Glucose 201 DM RT Instructions for Use HemoCue 201 DM - DMS Software User’s Guide (on DMS Software Manual Spare parts HemoCue recommended Power Adapter...
Page 13: Functional Description
1.3 Functional description 1.3.1 System Components FIGURE 1-1 The System consists of a specially designed Analyzer (1), specially designed Cuvettes, and a specially designed Docking Stations (2). The System is intended for In Vitro diagnostic use only. Analyzer The Analyzer (1) is only to be used together with the respective Cuvette (see relevant Instructions for Use and Package insert).
Page 14: Analyzer Overview
1.3.2 Analyzer overview Front panel FIGURE 1-2 The Analyzer (1) is started when the On/Off button (2) is pressed. The screen images will be visible on the Display (3). All navigation and information handling is performed by pressing the appropriate touch buttons directly on the Display (3). For information on how to operate the Display, see section 2.1 How to operate the Display.
Page 15 Back panel FIGURE 1-3 The following items are found on the back panel of the Analyzer. • Power inlet (1) for the Power Adapter • Power + USB signal inlet (2) for connection to the Docking Station • Built-in Barcode Scanner (3) • IR Transmitter/Receiver (4) for data transfer to/from the Docking Station Data can be transmitted between the Analyzer and the Docking Station in different...
Page 16 FIGURE 1-4 Settings can be transmitted between two Analyzers via the IR Transmitter/Receiver (see section 3.6 Infra Red). The Analyzers have to be out of the Docking Stations and positioned with the IR Transmitter/ Receivers (4) facing each other. The Power inlet (1) for the Power Adapter can only be used when the Analyzer is separated from the Docking Station.
Page 17: Docking Station - General
1.3.3 Docking station – General Single Docking Station FIGURE 1-5 A Docking Station not connected to other Docking Stations, is referred to as a Single Docking Station. Multiple Docking Stations FIGURE 1-6 Up to five Docking Stations can be connected to each other. These are referred to as Multiple Docking Stations.
Page 18 FIGURE 1-8 A Secondary Docking Station cannot be connected to a LAN. In order to communicate via a LAN it must be connected to a Primary Docking Station. A Secondary Docking Station can communicate directly to a PC via a USB connection.
Page 19: Docking Station Overview
1.3.4 Docking Station overview Front FIGURE 1-9 The Docking Station consists of the following items: • Tracks (1) for the Analyzer • Power + USB signal outlet (2) for the Analyzer • IR Transmitter/Receiver (3) for data transmission to/from the Analyzer • LED (4) The combined Power + USB signal outlet (2) is not a standard USB port, but a special connector which fits the corresponding...
Page 20 Back panel – Primary Docking Station FIGURE 1-10 The following items are located on the back panel: • Power inlet (1) for the Power Adapter • USB port (2) for setting up the Primary Docking Station (different from the USB port in the Secondary Docking Station) •...
Page 21 Data Communication Connectors FIGURE 1-12 The male connector (1) for data communication between Multiple Docking Stations is positioned under the Side Trim (2). A Torx screwdriver size T10 is needed to remove the Side Trim. Note that the Side Trim (2) on the Docking Station should always be used to protect the Connector (1).
Page 22 FIGURE 1-13 The female connector (3) is positioned under the Bottom Trim (4). There is no female connector (3) on a Primary Docking Station. Note that the Bottom Trim (4) on the Docking Station should always be used to protect the Connector (3). Female Connector 4 Bottom Trim...
Page 23 Placing the Analyzer in the Docking Station FIGURE 1-14 Always slide the Analyzer into and out of the Docking Station by means of the Tracks (1). Make sure that the Analyzer is fully inserted. Tracks FIGURE 1-15 Never try to lift the Analyzer out of the Docking Station or press the Analyzer downwards into the Docking Station.
Page 24: Functions And Features
1.3.5 Functions and features HemoCue 201 DM system is a powerful data management system for decentralized testing. It can be customized by the user allowing the activation or deactivation of the following functions: • Operator ID input, with lockout function if the Operator ID is not recognized •...
Page 25: General Operations
2 General operations This chapter describes the general operations necessary for Analyzer use. 2.1 How to operate the Display 2.1.1 Display buttons FIGURE 2-16 The Buttons (1) appearing on the Display (2) activate the specific functions symbolized by the image on the button. The Buttons (1) should only be pressed using the fingertip.
Page 26 Activating a function FIGURE 2-17 a) When a Button (1) is pressed, it will appear highlighted as long as it is kept pressed. b) When the Button is released, the function indicated by the button is activated. An audible signal will sound if the audio function has been activated in the Settings, see section 3.3.3 Audible Signals.
Page 27 Changing a function FIGURE 2-18 a) Keep pressing while moving the fingertip over to another button. FIGURE 2-19 b) The original button will cease to appear highlighted and the new button will appear highlighted. c) When the new Button is released, the new function will be activated.
Page 28 Cancelling a function FIGURE 2-20 a) Keep pressing while moving the fingertip over to an area without Buttons. FIGURE 2-21 b) No Button will appear highlighted. c) When the finger is released from the Display, the first Button choice will be ignored and no action will be activated.
Page 29: Operating The Analyzer
Analyzer 2.2.1 Start up FIGURE 2-22 a) Turn the Analyzer on (see 1.3.2 Analyzer overview). The Start Image, beginning with the HemoCue logo, will be displayed. The Start Image includes the following Glucose 201 DM RT information: Analyzer type (1), Software version (2) and the unique Serial number (3)
Page 30: Login Image
For information on how to operate the Display, see section 2.1 How to operate the Display. For instructions on how to perform tests, see section 4 Patient Test procedure, section 5 STAT Test procedure and section 6 QC Test procedure. 2.2.2 Login image FIGURE 2-23 08/09/03 10:55 AM...
Page 31: Main Menu And Help
2.2.3 Main Menu and Help FIGURE 2-24 08/09/03 10:55 AM FIGURE 2-24 is referred to as the Main Menu. JAMES SMITH It is displayed as the Startup Image for all Tests, Setting procedures, etc. The Help button (1) may be used to display information about other buttons, procedures, etc.
Page 32: Display Buttons And Symbols
Display buttons and symbols 2.3.1 Navigation buttons Button Designation Function Erase button Erases the last input. Previous image Returns to the previous image button Note that Inputs/changes made in the current image will not be saved. Text mode button Switches to text input mode. Numeric mode Switches to the numeric input mode.
Page 33: Procedure Buttons
2.3.2 Procedure buttons Button Designation Function Patient test button Activates the Patient Test procedure. STAT test button Activates the STAT (Short Turn Around Time) Test procedure. QC test button Activates the QC (Quality Control) Test procedure. Stored data button Activates the Stored Data function. Settings button Activates the Settings menu.
Page 34: Other Display Buttons
2.3.3 Other display buttons Button Designation Function Help button Displays help regarding other buttons, procedures, etc. Confirm button Saves text or numbers and/or displays the next screen image. All inputs/changes will be saved. Log Out button Logs out the operator. The Log Out button is only displayed if the Operator ID is required.
Page 35 Allows input of a digit. Dilution button* Allows measurement of a diluted sample. The Dilution button is only displayed if activated in the Settings menu. *only applicable for HemoCue Glucose 201 DM Analyzer The Dilution function is not available in all markets. Add button Allows addition of a comment to a result, an item to a list, etc.
Page 36 Button Designation Function Reject button Rejects a result. Reject Reject A rejected result will be saved and flagged as rejected. Save button Stores the entered information. Save No button The entered information will not be stored. Continue button Continues the current operation. Continue Statistics button Displays statitics on the chosen subject.
Page 37: Display Symbols
2.3.4 Display symbols Symbol Designation Function Battery Indicates the voltage status of the Battery in four levels. The furthest to the left is fully charged, the one to the right is almost empty. Date Indicates the Date format chosen (from three 03/03/04 possibilities) in the Settings Menu.
Page 38: Entering Information With Letters And Digits
2.3.5 Entering information with letters and digits 08/09/03 10:55 AM FIGURE 2-25 Inputs to the Analyzer such as Operator ID, Patient ID, etc. can be made via the display Enter or via the Barcode Scanner (see section 2.3.6 Operator ID Entering information from barcodes).
Page 39 Text mode FIGURE 2-26 Operator ID Only capital letters and a few special characters can be used in the text mode. Lower-case letters can only be entered into the Analyzer by means of the Barcode Scanner. a) In the text mode, inputs are made using the Letter buttons (1) and the Special Character button (2).
Page 40: Entering Information From Barcodes
2.3.6 Entering information from barcodes 08/09/03 10:55 AM FIGURE 2-28 Inputs to the Analyzer such as Operator ID, Patient ID, etc. can be made via the built-in Enter Barcode Scanner or via the display (see 2.3.5 Operator ID Entering information with letters and digits). Use of the Barcode Scanner eliminates manual input errors.
Page 41: Settings
PART II Settings...
Page 42: Settings
3 Settings This chapter guides you through the process of setting and configuring the Analyzer and the Docking Station. 3.1 Activating the Settings procedure FIGURE 3-1 08/09/03 10:55 AM Access to the Settings function is dependent JAMES SMITH on the setting for Operator ID entry and on the operator’s user level.
Page 43 FIGURE 3-2 Enter Only displayed if the Operator ID Settings Password requirement at startup is set to “Not used” (see 3.4.1 General Settings) c) Enter the Settings Password (default value is “0000”), either directly on the Display via the Text mode (2) and Numeric mode (3) buttons, or with the Barcode Scanner via the Barcode Scanner button (4).
Page 44 FIGURE 3-4 Settings The Settings menu with the following Setting categories (7) is displayed: • Define Lists (see 3.2 Define Lists) Define Lists Define Lists • Basic Settings (see 3.3 Basic Settings) • Advanced Settings (see 3.4 Advanced Basic Settings Basic Settings Settings) •...
Page 45: Define Lists
3.2 Define Lists Define FIGURE 3-5 When the Define Lists button is pressed in Lists the Settings menu (see FIGURE 3-4), the following Define Lists categories (1) are displayed: Liquid Controls Liquid Controls • Liquid Controls (see 3.2.1 Liquid Controls) Cuvette Batches Cuvette Batches •...
Page 46: Liquid Controls
3.2.1 Liquid Controls A Liquid Control is a liquid with a known concentration, intended for checking the accuracy of the System. Results from Liquid Controls can only be stored as QC measurements if the Liquid Control specifications have been entered. Liquid Controls FIGURE 3-6 When the Liquid Controls button is pressed in...
Page 47 FIGURE 3-8 Control Name The control level (2) and the currently used (Level 1) name (3) of the Liquid Control are displayed. If no information had been entered GlucoTrol NG previously, the Liquid Control name (3) will not appear. If the Confirm button is repeatedly pressed through FIGURE 3-8 to FIGURE 3-11, no changes will be effected.
Page 48 FIGURE 3-9 Control Lot f) Enter the Lot No. for the Liquid Control (Level 1) either directly on the Display via the Text mode and Numeric mode buttons, or by 1 2 3 4 5 6 7 8 9 the Barcode Scanner via the Barcode Scanner button.
Page 49 QC Level 1 FIGURE 3-11 The warning limits define the range of Unit:mg/dL results for QC testing that must be obtained Warning Min (0) to prevent a warning from being displayed. Warning Max (500) j) Enter min. value (10) and max. value (11) for the warning interval.
Page 50 QC Level 1 FIGURE 3-12 All settings for the Control are shown in a summary display. GlucoTrol NG n) Press Save to store the setting Lot: 12345678 information or press No to cancel. Exp.: 08/10/03 13 Control Liquid name 14 Control Liquid Lot No. 15 Control Liquid expiration date (mg/dL) 16 Warning interval min.
Page 51 View/Change Liquid Control specification Liquid Controls FIGURE 3-14 a) To choose the Liquid Control specification that is to be viewed/ changed, highlight the Liquid Control L2 123456789 specification by pressing the Scroll bar L2 123456789 arrows (1). Press the View button (2). By L3 123456789 pressing repeatedly on the confirm L1 123456789...
Page 52: Cuvette Batches
3.2.2 Cuvette Batches A Cuvette Batch is a set of Cuvettes manufactured in one series under the same conditions. Information entered for a specific batch will apply to all Cuvettes within that batch. Five distinct Cuvette Batches with corresponding information can be stored in the Analyzer.
Page 53 FIGURE 3-16 Add Cuvette Batch b) Enter the Cuvette Batch No., either directly on the Display via the Text mode and Numeric mode buttons, or with the Barcode Scanner via the Barcode Scanner button. c) If the Batch No. was entered via the Barcode Scanner from the barcode on the Cuvette vial, FIGURE 3-18 will be displayed, otherwise FIGURE 3-17 will be...
Page 54 FIGURE 3-18 g) Press Save to store the information or Cuvette Batch press No to cancel. h) The updated Cuvette Batch list will be Cuvette batch: displayed. Press the Confirm button in 123456789 this display to return to the Define List Expiration Date: menu (see FIGURE 3-5).
Page 55 View Cuvette Batch Information Cuvette FIGURE 3-20 a) To choose the Cuvette Batch information Batches that is to be viewed, highlight the Cuvette Batch No. by pressing the Scroll bar 123456789 arrows (1). Press the View button (2). A 234567891 summary of the stored information will 345678912 be displayed.
Page 56: Define Operators
3.2.3 Define Operators A list of Operators that can log in and use the System can be stored in the Analyzer. Add Operator Define FIGURE 3-21 When the Define Operators button is pressed Operators in the Define Lists menu (see FIGURE 3-5), the Define Operators list (1) will be displayed.
Page 57 FIGURE 3-23 Activate d) Enter the date from which the Operator will have access to the Analyzer. Operator: JDO1943 Date e) Press the Confirm button (6). FIGURE 08/09/03 3-24 will be displayed. 6 Confirm button FIGURE 3-24 Deactivate f) Enter the date after which the Operator will be denied access to the Analyzer.
Page 58 Access Level FIGURE 3-25 h) The following Access Level options (8) are available: • Supervisor Supervisor Supervisor • Key Operator • Trusted User Key Operator Key Operator • User • Training Trusted User Trusted User i) Press the Scroll bar arrow (9) to view options not initially visible on the screen.
Page 59 Access Level FIGURE 3-26 j) Select an Access Level option (8) by pressing it. k) A summary of the entered information is Supervisor Supervisor displayed. Press Save to store the information or press No to cancel. Key Operator Key Operator l) The updated Define Operators list will be displayed.
Page 60 View Operator Define FIGURE 3-28 a) To choose the Operator information that Operators is to be viewed, highlight the Operator ID by pressing the Scroll bar arrows (1). Press HBJ2926 the View button (2). A summary of the FJO1819 stored information will be displayed. KSV1315 Press the Confirm button (3).
Page 61: Define Comments
3.2.4 Define Comments A comment is a short piece of text that can be added to a result. Add Comment Define FIGURE 3-29 When the Define Comments button is Comments pressed in the Define Lists menu (see FIGURE 3-5), the Define Comments list (1) Wrong Patient will be displayed.
Page 62 Delete Comment Define FIGURE 3-31 a) To choose the Comment that is to be Comments deleted, highlight the Comment (1) by pressing the Scroll Bar Arrows (2). Press Wrong Patient the Delete button (3). Wrong QC Level b) A confirm dialogue is displayed. Press Old Cuvette Delete to delete the Comment or press Old Liquid Control...
Page 63: Define Log Notes
3.2.5 Define Log Notes A log note is a short text, used to define specific actions performed on the Analyzer. Add Log FIGURE 3-33 Define When the Define Log button is pressed in the Define Lists menu (see FIGURE 3-5), the Define Log list (1) will be displayed.
Page 64 Delete Log Notes FIGURE 3-35 Define a) To choose the Log note that is to be deleted, highlight the Log note (1) by pressing the Scroll bar arrows (2). Press Cleaned Touch pad the delete button (3). Calibrated LCD b) A confirm dialogue is displayed. Press Delete to delete the Log or press No to cancel.
Page 65: Basic Settings
3.3 Basic Settings Basic FIGURE 3-37 When the Basic Settings button is pressed in Settings the Settings menu (see FIGURE 3-4), the following Basic Settings categories (1) are displayed: Date/Time Date/Time • Date/Time (see 3.3.1 Date/Time) Power Saver Power Saver • Power Saver (see 3.3.2 Power Saver) •...
Page 66: Date/Time
3.3.1 Date/Time Adjust Date FIGURE 3-38 When the Date/Time button is pressed in the Basic Settings menu (see FIGURE 3-37), the Format: MM/DD/YY date setting function is displayed first. 02/02/02 a) Select the Date format (1) with the Date format button (3). The formats available are: •...
Page 67 Adjust Time FIGURE 3-39 The time setting function is now displayed. a) Select the Time format (5) with the Time Format: 12h format button (6). The following formats 10:55 AM are available: • 24hours • 12hours Time format 6 Time format button AM/PM AM/PM Adjust Time...
Page 68: Power Saver
3.3.2 Power Saver A detailed description of the Power Saver mode can bew found in 2.2.4 Power saver mode. FIGURE 3-41 Power Saver When the Power Saver button is pressed in the Basic Settings menu (see FIGURE 3-37), the Power Saver settings function is displayed.
Page 69: Audible Signals
3.3.3 Audible Signals Audible FIGURE 3-42 When the Audible Signals button is pressed Signals in the Basic Settings menu (see FIGURE 3-37), the following Audible Signal setting Button Click Button Click choices are displayed: • Button Click Test Ready Test Ready •...
Page 70: Language
3.3.4 Language An Analyzer is delivered with two predefined language options. FIGURE 3-44 Language When the Language button is pressed in the Basic Settings menu (see FIGURE 3-37), the Language settings function is displayed. The two language options are displayed as English English Language buttons (1).
Page 71: Advanced Settings
3.4 Advanced Settings Advanced FIGURE 3-45 When the Advanced Settings button is Settings pressed in the Settings categories menu (see FIGURE 3-4), the following Advanced General Settings General Settings Settings categories (1) are displayed: • General Settings (see 3.4.1 General Patient test Patient test Settings) •...
Page 72: General Settings
3.4.1 General Settings FIGURE 3-46 General When the General Settings button is pressed Settings in the Advanced Settings menu (see FIGURE 3-45), the following General Settings categories are displayed: Units Operator ID • Operator ID (See FIGURE 3-47) Operator ID Password •...
Page 73 Operator ID requirement Operator ID FIGURE 3-47 When the Operator ID button is pressed in the General Settings menu (see FIGURE 3-46), the settings for Operator ID requirement are displayed. Not Used Not Used The options available are displayed as buttons (1).
Page 74 If Entry Required or Approved Only was selected, FIGURE 3-48 will be displayed for setting the Operator ID specifications. If Not Used was selected, the General Settings menu, FIGURE 3-46, will be displayed. Operator ID FIGURE 3-48 The settings for the min. and the max. number of characters for the Operator ID Min Character are displayed.
Page 75 Password for protected functions Some Analyzer functions are password protected. The password protection function is only activated when the Operator ID requirement is set to “Not Used”. FIGURE 3-49 Password When the Password button is pressed in the General Settings menu (see FIGURE 3-46), Old Password (1 - 10) the settings for Password are displayed.
Page 76 Cuvette Batch requirement FIGURE 3-51 Cuvette Batch When the Cuvette Batch button is pressed in the General Settings menu (see FIGURE 3-46), the settings for Cuvette Batch requirements are displayed. Not Used Not Used The options available are displayed as buttons (1).
Page 77 Patient List setting A Patient List is a list containing Patient ID’s and corresponding Patient names. If an OR supports the sending of Patient Lists to the Analyzer, the Analyzer can display the name of a patient after the patient ID has been entered, allowing for positive patient identification.
Page 78 Full Memory Options Patient FIGURE 3-53 Up to 4000 Patient/STAT tests can be stored Memory Full in the Analyzer. When the Memory button is pressed in the General Settings menu (see FIGURE 3-46), the options for when the patient memory is full are displayed. Lockout Lockout The options available are displayed as...
Page 79 FIGURE 3-54 The options for QC Memory full will be Memory Full displayed. The option currently in use is indicated by the selected Radio button (5). c) To change the setting, press the button Lockout Lockout for the desired option (4). d) Press the Confirm button (6) to return to Overwrite Overwrite the General Settings menu, FIGURE 3-46.
Page 80: Patient Test Settings
Select a Patient Test Settings category (2) by pressing it. Scroll bar arrow Patient Test Settings categories * Only available for HemoCue Glucose 201 DM Analyzer. The Dilution function is not available in all markets.
Page 81 Critical Limits The Critical Limits define the range of values outside of which the patient test results will be listed as critical. Critical Limits FIGURE 3-56 When the Critical Limits button is pressed in the Patient Test Settings menu (see FIGURE Min (0) 80 mg/dL 3-55), the settings for Critical Limits are...
Page 82 Patient ID Patient ID FIGURE 3-57 When the Patient ID button is pressed in the Patient Test Settings menu (see FIGURE 3-55), the settings for the Patient ID requirements are displayed. Not Used Not Used The options available are displayed as buttons (1).
Page 83 If Optional or Required was selected, FIGURE 3-58 will be displayed for setting the Patient ID specifications. If Not Used was selected, the General Settings menu, FIGURE 3-55, will be displayed. Patient ID FIGURE 3-58 Numbers in brackets show the lowest and the highest allowable number of characters.
Page 84 Clear FIGURE 3-59 The setting for clearing the Patient ID is Patient ID displayed. The options available are displayed as buttons (8). The option currently in use is Used Used indicated by the selected Radio button (9). Used: The previous Patient ID will be cleared Not Used Not Used when a new test is initiated.
Page 85 Lab Number (LID) requirement FIGURE 3-60 Lab Number When the Lab Number (LID) button is (LID) pressed in the Patient Test Settings menu (see FIGURE 3-55), the settings for Lab ID requirement are displayed (1). Not Used Not Used The option currently in use is indicated by the selected Radio button (2).
Page 86 If Optional was selected, FIGURE 3-61 will be displayed for setting the Lab Number specifications. If Not Used was selected, the Patient Test Settings menu, FIGURE 3-55, will be displayed. The settings for the min. and the max. length of the Lab Number are displayed. FIGURE 3-61 Lab Number Numbers in brackets show the lowest and...
Page 87 STAT Test usage FIGURE 3-62 STAT Test When the STAT button is pressed in the Patient Test Settings menu (see FIGURE 3-55), the settings for STAT Tests are displayed. Used Used The options available are displayed as buttons (1). The option currently in use is indicated by the selected Radio button (2).
Page 88 If Used was selected, FIGURE 3-63 will be displayed for setting the STAT Test specifications. If Not Used was selected, the General Settings menu, FIGURE 3-55, will be displayed. FIGURE 3-63 STAT Test The numbers in brackets show the lowest and the highest number of tests that can be set.
Page 89 Duplicate sampling In order to minimize errors due to preanalytical factors, local recommendations might involve measurements in duplicates when capillary blood is used. The Duplicate sampling function is used to facilitate these recommendations. FIGURE 3-64 Duplicate sampling When Duplicate sampling is pressed in the Max.
Page 90 If Used was selected, FIGURE 3-65 will be displayed for setting the Duplicate Sampling specifications. If Not Used was selected, the General Settings menu, FIGURE 3-55, will be displayed. FIGURE 3-65 Duplicate sampling c) To change the maximum difference Max. Difference allowed between two samples (1), press the arrows (2) for the desired value.
Page 91 Dilution possibilities Dilution function is only applicable for HemoCue Glucose 201 DM Analyzer. The function is not available in all markets. Whole Blood: Results above 400 mg/dL (22.2 mmol/L) will be displayed as overrange. The measuring range may be extended to 800 mg/dL (44.4 mmol/L) by dilution with saline, 1+1.
Page 92: Qc Test Settings
3.4.3 QC Test Settings QC Test FIGURE 3-67 When the QC test button is pressed in the Settings Advanced Settings menu (see FIGURE 3-45), the following QC Test Settings options are Level 1 displayed: • Level 1 (see FIGURE 3-68) Normal Level 2 •...
Page 93 QC Test settings for distinct concentration levels An Analyzer can be set to perform a lockout if the required QC test is not performed within a pre-defined time or after a pre- defined number of measurements. The Analyzer will be unlocked when an approved QC test at the required concentration level has been performed.
Page 94 QC Level 1 FIGURE 3-69 a) To change the setting, press the button Lockout for the desired option (1). b) Press the Confirm button (3). Not Used Not Used If “Not Used” is selected, the QC Test Settings Menu, FIGURE 3-67, is displayed. Time Time If “Time”...
Page 95 Lockout FIGURE 3-71 The QC lockout interval may be set in either Interval Hours or Days (4). The options are displayed as buttons. The option currently in use is indicated by the Hours Hours selected Radio button (5). The number of Hours or Days is also Days Days displayed (6).
Page 96 FIGURE 3-72 Lockout d) To adjust the reminder time to fit the new Interval QC lockout time, press Adjust. After adjusting to an acceptable reminder time Note! (see FIGURE 3-76), FIGURE 3-73 will be New Lockout Time displayed. To return to FIGURE 3-71, press No. The Requires Adjusted selected time interval until the next QC Reminder Time...
Page 97 QC lockout determined by number of measurements FIGURE 3-74 Lockout If Measurements was selected in the QC Interval lockout menu (see FIGURE 3-68), the setting Measurements (2 - 200) for the QC lockout based on the number of 1 0 0 patient or STAT test measurements performed is displayed.
Page 98 QC Test Reminder settings FIGURE 3-76 When the Reminder Time button is pressed Reminder in the QC Test menu (see FIGURE 3-67), the settings for the QC reminder based on time is displayed. A reminder message will be shown at this set time, prior to QC lockout. Hours The Reminder time can be set to no more than half the shortest of the QC lockout...
Page 99 FIGURE 3-77 The settings for the QC reminder based on Reminder Reminder the number of Patient or Stat tests Measurements (1 - X) Measurements (1 - 50) performed is displayed. A reminder message will be shown when this number of tests are remaining, prior to QC lockout.
Page 100 QC Result Presentation Options QC Result FIGURE 3-78 When the QC Result Option button is Options pressed in the QC Test menu (see FIGURE 3-67), two options are displayed. Numeric Numeric QC Test results can be presented either as quantitative (numerical) or qualitative Passed/Failed Passed/Failed (“Passed”/”Failed”) values.
Page 101 Failed QC Comment Failed QC FIGURE 3-79 When the Failed QC Comment button is Comment pressed in the QC Test menu, two options are displayed. Numeric Not Used When Failed QC Comment is set to Entry Required it forces the operator to enter at Passed/Failed Entry Required least one comment to a QC Test that has...
Page 102: Linearity Test Settings
3.4.4 Linearity Test Settings For a description of linearity tests, see 6.2.2 Linearity Test. FIGURE 3-80 Linearity When the Linearity test button is pressed in the Advanced Settings menu (see FIGURE 3-45), options for the number of concentration levels for the linearity test are 3 Levels 3 Levels displayed.
Page 103: Default Settings
3.5 Default Settings Default FIGURE 3-82 When the Default Settings button is pressed Settings in the Settings menu (see FIGURE 3-4), confirmation or cancellation of the Are You Sure You requested change to the Analyzer default Want to Change to setting is required.
Page 104: Infra Red
3.6 Infra Red Settings (but not measurements) can be transmitted between two Analyzers when the IR-ports are facing each other. 3.6.1 The transmitting Analyzer FIGURE 3-83 Infra Red When the Infra Red button is pressed in the Settings menu (see FIGURE 3-4), the categories (1) that can be transferred are displayed All Settings...
Page 105 Infra Red FIGURE 3-84 Confirmation or cancellation of the transfer All Settings of the desired setting (3) is required. c) To initiate data transfer of the category indicated (3) to the receiving Analyzer, Are You Sure You press Continue. To cancel, press No. Want to Send the d) If the process was initiated, the Settings?
Page 106: The Receiving Analyzer
3.6.2 The Receiving Analyzer Infra Red FIGURE 3-85 Confirmation or cancellation of the Transmission transmitted setting information (1) is required on the receiving Analyzer. a) To accept data transfer of the category Update indicated (1) from the sending Analyzer, All Settings? press Continue. All current To cancel, press No.
Page 107: Docking Station Settings
3.7 Docking Station Settings The settings of a Docking Station consist of network parameters necessary to enable communication with a LAN, such as the IP address of the Docking Station. Settings can only be made on Primary Docking Stations, not on Secondary, see Primary and Secondary Docking Stations.
Page 108: Part Iii Routine Use
PART III Routine use...
Page 109: Patient Test Procedure
4 Patient Test procedure This chapter guides you through the process of performing a Patient Test. 4.1 Patient Test The Patient Test procedure may vary, depending on which information requirements have been activated in the Settings, see section 3.4.2 Patient Test Settings. The following information may be required: •...
Page 110 FIGURE 4-2 Enter Note that FIGURE 4-2 will not be displayed if Cuvette Batch the Cuvette Batch No. requirement is set to “Not Used” in the Settings (see 3.4.1 General Settings). c) Enter Cuvette Batch No. either directly on the Display via the Text mode and Numeric mode buttons, or with the Barcode Scanner via the Barcode Scanner button.
Page 111 FIGURE 4-3 Cuvette Batch This will only be displayed if the Cuvette Batch: 123456789 Batch No. requirement when inserting a Cuvette is set to “Entry required” (see 3.4.1 Expiration Date General Settings), and Cuvette Batch No. 09/12/03 was not entered via the Barcode Scanner using the barcode from Cuvette vial.
Page 112 FIGURE 4-5 Patient ID (PID) This will not be displayed if the Patient List setting is set to “Not Used” (see 3.4.1 General Settings), or the Patient ID requirement is set to “Not Used”. If the Patient List setting is set to “Used” and there is a Patient List on the Analyzer that 123456789 contains the Patient ID and corresponding...
Page 113 FIGURE 4-7 Verify j) A display will be shown where it is possible to verify all entered information. If some of the entered information is wrong, press the back arrow to go back Cuvette Batch: 6789 and re-enter the information, otherwise PID: 123456789 press OK to continue.
Page 114 Diluted sample FIGURE 4-9 Patient Test Dilution function is only applicable for HemoCue Glucose 201 DM Analyzer. The function is not available in all markets. Please Fill Note that the Dilution button (6) and the Help button (7) will only be displayed if the...
Page 115: Patient Test Result
4.1.1 Patient Test Result FIGURE 4-11 Patient Test Position numbers (1) to (3) are explained in Result the position list below. The Result (4) is presented in bold print. The Note (6) Critical will be displayed if the PID: 123456789 result is outside the critical limits that are LID: 123456789 defined in the Settings (see 3.4.2 Patient Test Settings).
Page 116 FIGURE 4-12 Patient Test To add comments to the result, press the Comment input button (6). See 4.1.3 Result Entering Comments. The Verify/Duplicate sampling button (7) PID: 123456789 allows the verification of the result by LID: 123456789 measuring a new sample from the patient (see 4.1.2 Verify/Duplicate sampling).
Page 117: Verify/Duplicate Sampling
4.1.2 Verify/Duplicate sampling FIGURE 4-13 Patient Test Results may be verified by obtaining a second sample from the same patient and Result performing a new measurement. Depending on whether the Duplicate sampling function PID: 750629-3694 (see Duplicate sampling) has been activated or not the outcome of this procedure may LID: 12345 vary.
Page 118 Result Verification FIGURE 4-15 Patient Test 1) indicates the result from the first Result Verify measurement (1). 2) indicates the result from the second PID: 750629 - 3694 measurement (2). LID: 12345 ¯ indicates the Mean value (3) for these two measurements. = 64 mg/dL If the Duplicate sampling function is used 63 mg /dL and the two results differ more than the...
Page 119 When the Duplicate sampling function is used, predefined comments will automatically be added to the two results, pairing them together. This will enable OR’s to see that the two results belong together and make it possible to calculate a mean value.
Page 120: Entering Comments
4.1.3 Entering Comments FIGURE 4-18 Patient Test Comments may be entered prior to saving the result. Result a) When the result is displayed, press the Comment input button (1). PID: 750629-3694 FIGURE 4-19 will be displayed. LID: 12345 Comment input button 63 mg/dL FIGURE 4-19 Comments...
Page 121 Add Comment FIGURE 4-20 This list will be empty if no comments have been pre-defined in the Settings menu, see Free Text Free Text 3.2.4 Define Comments. Expired cuvette c) Press the Scroll bar arrows (4) to select a Air bubble Comment (5).
Page 122 Comments FIGURE 4-22 All added comments are displayed. In this example, Air bubble and Expired Cuvette are displayed. Air bubble g) Press the Scroll bar arrows (11) to select a Expired Cuvette Expired Cuvette Comment, in this example Expired Cuvette. h) Press the Delete button (12) 11 Scroll bar arrows Delete Delete...
Page 123 FIGURE 4-24 Acceptance k) The result may now be accepted or rejected, by means of the Accept button (16) or Reject button (17) respectively. Accept or Reject Both accepted and rejected results will be the Current stored. Measurement l) If the Reject button (17) is pressed without any comments being added, this text will be displayed: To Reject a Sample, Enter at least one...
Page 124: Entering Comments - Verified Sample
4.1.4 Entering Comments – Verified sample FIGURE 4-26 Patient Test Comments may be added to the results of Result Verify verified samples before saving. a) When the results are presented, press the PID: 750629-3694 Comment input button (1). LID: 12345 b) This text will be displayed: Comment Cuvette Number 1.
Page 125 FIGURE 4-27 Patient Test The dotted Comment input button (2) Result Verify indicates that comments have been added. In this example the Waste bin (3) indicates PID: 750629-3694 that the result for the first Cuvette has been LID: 12345 rejected. g) Press the Confirm button (4). = 64 mg/dL The Main menu, FIGURE 4-1, will be 1) 63 mg/dL...
Page 126: Stat Test Procedure
5 STAT Test procedure This chapter guides you through the process of performing a STAT Test. The STAT Test fulfills the same function as a Patient Test but a predefined number of STAT tests can be performed by overriding the requirement of performing any type of QC Test. When performing a STAT Test, it is optional whether or not to enter Cuvette Batch, Patient ID or Lab Number in order to make the measuring procedure quicker.
Page 127 b) Enter the information for the 3 following images: Enter Cuvette Batch Enter Patient ID (PID) Enter Lab Number (LID) (see section 4 Patient Test procedure) or just press the Confirm button if no data is to be added. FIGURE 5-2 will be displayed.
Page 128 Diluted sample FIGURE 5-3 STAT Test The Dilution function is only applicable for HemoCue Glucose 201 DM Analyzer. The function is not available in all markets. Note that the Dilution button (2) and Help Please Fill button (3) will only be displayed if the...
Page 129: Stat Test Result
5.1.1 STAT Test Result FIGURE 5-5 STAT Test The result (4) is presented in bold print. Result To add a comment to the result, press the Comment input button (5). The procedure is the same as for a Patient Test, see 4.1.3 PID: 750629-3694 Entering Comments.
Page 130: Qc Test Procedure
6 QC Test procedure This chapter describes the process of performing QC Tests, Linearity Tests and Proficiency Tests. 6.1 Events necessitating QC Tests 6.1.1 QC Reminder Based on the settings made for the QC Test Reminder, the Reminder icon (1) will be displayed to warn of an impending QC lockout.
Page 131 FIGURE 6-2 08/09/03 10:55 AM If the required QC Test is performed after the JAMES SMITH reminder is displayed, but before the QC 2h 47min (QC1) lockout, the time/measurement counter is 100 cuv (QC2) reset to the max. time/number of measurements until the next QC lockout.
Page 132: Qc Lockout
6.1.2 QC Lockout If the required QC Test is not performed within the time or number of measurements indicated by the QC Reminder, FIGURE 6-1, the Analyzer will perform a QC lockout. FIGURE 6-3 will be displayed. FIGURE 6-3 The QC Lockout (1) indicates that the Analyzer has performed a QC lockout.
Page 133: Supervisory Lockout
6.1.3 Supervisory Lockout FIGURE 6-4 The Analyzer has been locked out by the Supervisor. This can only be performed via 08/09/03 10:55 AM the DMS Software or an Observation JAMES SMITH Reviewer (OR). The Analyzer can only be Supervisory unlocked by the Supervisor via the DMS Lockout Software or an OR.
Page 134: Performing A Qc Test
6.2 Performing a QC Test FIGURE 6-5 08/09/03 10:55 AM a) In the Main Menu, press the QC Test JAMES SMITH button (1). FIGURE 6-6 will be displayed. QC Test button...
Page 135 FIGURE 6-6 QC Test There are 7 QC Test options (1): • Level 1 (See 6.2.1 QC Tests at a specific concentration level) Level 1 • Level 2 • Level 3 Normal Level 2 • Level 4 • Level 5 • Linearity (see 6.2.2 Linearity Test) High Level 3 •...
Page 136: Qc Tests At A Specific Concentration Level
6.2.1 QC Tests at a specific concentration level QC Level 1 FIGURE 6-7 The QC Tests procedure for Level 1, Level 2, Level 3, Level 4 and Level 5 are identical, and therefore only one, Level 1, is described. Please Fill The concentration level of the QC Test (1) is displayed.
Page 137 FIGURE 6-8 Enter c) Enter the Cuvette Batch No. either Cuvette Batch directly on the Display via the Text mode and Numeric mode buttons, or with the Barcode Scanner via the Barcode Scanner button. FIGURE 6-9 will be displayed. If the Cuvette Batch No. requirement is set to Approved only (see 3.4.1 General Settings), and a Cuvette Batch No.
Page 138 FIGURE 6-10 QC Level 1 The Numeric Test Result (5) and the Result Qualitative Test Result (6) are displayed in bold text. Lot No: 234567 For a result within the Approved area (2) (the blank area), the Qualitative Test Result (6) will indicate “Pass”. For a result within the Warning area (3) (the 50 mg/dL dotted area), the Qualitative Test Result (6)
Page 139 QC Level 1 FIGURE 6-11 Result g) If the Failed QC Comment setting is set to “Entry Required” (see 3.4.3 QC Test Settings) and the QC Test has failed, then Enter at Least FIGURE 6-11 will be displayed when the Confirm button shown in FIGURE 6-10 is one Comment for pressed.
Page 140 FIGURE 6-12 QC Level 1 The diagram shows the trend for the most recent QC measurements performed on the Recent Trend control lot. h) To continue to the statistics image, FIGURE 6-13, press the Confirm button (9). 10 Confirm button FIGURE 6-13 QC Level 1 The All Statistics report shows statistical data for all QC Tests for the level of control and...
Page 141: Linearity Test
6.2.2 Linearity Test A linearity test consists of replicate testing of different concentrations of the desired analyte within the measuring range of the Analyzer. The purpose of the test is to make sure that the relationship between the analyte concentration and the System output is linear. Enter FIGURE 6-14 a) To perform a Linearity Test, press the...
Page 142 FIGURE 6-15 Linearity d) To resume a previously interrupted linearity test, press Yes. FIGURE 6-17 will be displayed. Otherwise press No. Resume FIGURE 6-14 will be displayed. Interrupted Yes button Linearity Test? No button FIGURE 6-16 Kit Name If a kit name was entered previously, it will be displayed (3).
Page 143 FIGURE 6-17 Linearity If there are any already completed levels within the linearity test, the buttons for these will have bold text (5). Level 1 Level 1 Continue testing until all levels have been completed. Level 2 Level 2 g) The levels not visible initially are available by pressing the Scroll bar arrow (7).
Page 144 FIGURE 6-18 Kit Lot The Kit Lot is the Lot No. of the material (Level 1) used at the designated concentration level. k) Enter the Lot No. either directly on the Display via the Text mode and Numeric mode buttons, or with the Barcode Scanner via the Barcode Scanner button.
Page 145 Level 1 FIGURE 6-20 The level of the linearity material and it’s Unit:mg/dL concentration unit are displayed. Range Min (0 - 500) If levels with known concentration ranges Range Max (0 - 500) are used, the ranges should be entered. Numbers in brackets show the lowest and the highest allowable value.
Page 146 Level 1 FIGURE 6-21 The previously entered values for the linearity material at the designated level are GlucoLin displayed for confirmation. Lot: 56489754 p) To confirm the displayed values and to Exp.: 08 /09/03 save them for future comparisons to the measured value, press Save.
Page 147 FIGURE 6-23 22 23 The result will be displayed. Level 1 Continue testing the designated level until the number of required measurements have Result been completed. If the result is beyond the upper measuring Cuvette 1 (3) range of the Analyzer, the display will read: Overrange and a Confirm button will be shown.
Page 148 s) If the result is within range and the Previous image button is pressed, the following message will be displayed: Do You wish to Reject all Cuvettes Measured for this Level? To reject all measurements at the current level press Yes. FIGURE 6-17 will be displayed.
Page 149 Linearity FIGURE 6-25 Result When all levels have been completed, an image containing all results is displayed. N = 15 If the mean result (29) for each level is within mg/dL the concentration range (30) for the level, 1 = 75 (70 - 80) the Qualitative test result (31) will indicate “Within range”.
Page 150: Proficiency Test
6.2.3 Proficiency Test Proficiency testing is performed on samples from external sources. The expected value is unknown to the site performing the test. The purpose of the test is to ensure that the systems enrolled in the proficiency testing all have the same level of calibration.
Page 151 FIGURE 6-29 Enter The Specimen ID is the ID of the proficiency Specimen ID sample. e) Enter the Specimen ID either directly on the Display via the Text mode and Numeric mode buttons, or with the Barcode Scanner via the Barcode Scanner button.
Page 152: Reviewing Stored Data
7 Reviewing stored data This chapter describes the process of reviewing stored data. 7.1 Activating the Stored Data procedure FIGURE 7-1 08/09/03 10:55 AM Access to the Stored Data functions is JAMES SMITH dependent on the operator’s user level and on the existing requirement for an Operator ID.
Page 153 FIGURE 7-2 Enter Stored Only displayed if the Operator ID Data Password requirement is set to “Not used” (see 3.4.1 General Settings). c) Enter the Password (default value is “0000”) for protected functions, either directly on the Display via the Text mode (2) and Numeric mode (3) buttons, or with the Barcode Scanner via the Barcode Scanner button (4).
Page 154 FIGURE 7-4 Stored Data The following options are displayed: • Review (see 7.2 Review Stored Data) Liquid Controls Review • Delete (see 7.3 Delete Stored Data) • Latest Download (see 7.4 Review Latest Download) Cuvette Batches Delete • Log Input (see 7.5 Log Input) The Stored Data options (7) are explained in Define Operators Lastest Download...
Page 155: Review Stored Data
7.2 Review Stored Data FIGURE 7-5 Review When the Review button is pressed in the Stored Data menu (see FIGURE 7-4), the following options are displayed: Liquid Controls All Data • All Data (see 7.2.1 Review All Data) • PAT/STAT (see 7.2.2 Review PAT/STAT) Cuvette Batches PAT/STAT •...
Page 156: Review All Data
7.2.1 Review All Data FIGURE 7-6 All Data Press the All Data button in the Review menu, FIGURE 7-5. From 07/10/03 The From date (1) and To date (2) displayed 02/01/04 represent the earliest and latest stored records. It is possible to change the date interval.
Page 157: Review Pat/Stat
7.2.2 Review PAT/STAT FIGURE 7-7 PAT/STAT Press the PAT/STAT button in the Review menu, FIGURE 7-5. From: 07/10/03 The From date (1) and To date (2) displayed 02/01/04 represent the earliest and latest stored Patient Tests and STAT tests. It is possible to change the date interval.
Page 158 Patient/STAT test FIGURE 7-8 Patient Test a) To browse through the available records, use the scroll bar arrows (4). 07/10/03 10:24 AM b) Depending on the operator’s user level, OP: Chris comments can either be added, deleted or changed or just viewed, by pressing PID: 670317- 4987 the Comment input button (8).
Page 159: Review Qc Tests
7.2.3 Review QC Tests QC Test FIGURE 7-9 Press the QC Test button in the Review menu, FIGURE 7-5. From 07/10/03 The From date (1) and To date (2) displayed 02/01/04 represent the earliest and latest stored QC tests. It is possible to change the date interval.
Page 160 QC Test FIGURE 7-11 The categories Level 1, Level 2, Level 3, Level 4 and Level 5, refer to the different concentration levels of Liquid Controls used All QC Data All QC Data in a QC test. Linearity and Proficiency define other types of tests.
Page 161 All QC Data All categories of QC data within the defined date interval will be available. The different images possible are described in FIGURE 7-12, FIGURE 7-15 and FIGURE 7-17. QC tests at a specific concentration level FIGURE 7-12 a) To browse through the available records, QC Level 1 use the scroll bar arrows (4).
Page 162 FIGURE 7-13 QC Level 1 The diagram shows the trend for the most Recent Trend recent QC measurements at the defined concentration level. No consideration is given Lot No: 1413-1245 to the defined date interval. e) Press the Confirm button (15). FIGURE 7-14 will be displayed.
Page 163 Linearity tests For a description, see 6.2.2 Linearity Test. FIGURE 7-15 Linearity [L5] a) To browse through the available records, 08/11/03 10:24 AM use the scroll bar arrows (4). b) To view statistics for the linearity test, OP: Chris press the Statistics button (7). FIGURE Lot: 142387 7-16 will be displayed.
Page 164 Proficiency tests For a description, see 6.2.3 Proficiency Test. Proficiency FIGURE 7-17 a) To browse through the available records, use the scroll bar arrows (4). 01/05/03 11:43 AM b) Press the Confirm button (6). FIGURE 7-10 will be displayed. OP: Emma Spec: 1435-3425 Date and time of test Operator performing the test 248 mg/dL...
Page 165: Review Analyzer Log
7.2.4 Review Analyzer Log Press the Analyzer Log button in the Review menu, FIGURE 7-5. An individual Analyzer Log can be either an error message or a log note. Analyzer Log FIGURE 7-18 The From date (1) and To date (2) displayed represent the earliest and latest stored Logs.
Page 166 Analyzer Log FIGURE 7-19 The individual Analyzer Logs can have different degrees of severity. 09/23/03 09:47 AM • Critical (error messages) OP: Tom • Warning (error messages) • Note (log notes) Warning d) To browse through the available records QC Buffer Full use the scroll bar arrows (7).
Page 167: Delete Stored Data
7.3 Delete Stored Data Delete FIGURE 7-20 When the Delete button is pressed in the Stored Data menu (see FIGURE 7-4), the following options for deleting data are All Data All Data displayed: • All Data PAT/STAT PAT/STAT • PAT/STAT •...
Page 168 Delete FIGURE 7-22 c) To cancel the request to delete the data, press No (7). All Data To confirm the request to delete the data, press Yes (8) From: 01/09/03 The Delete menu, FIGURE 7-20, will be displayed. 01/11/03 Data Will Be 6 The type of data requested for deletion Permanently Lost.
Page 169: Review Latest Download
7.4 Review Latest Download Latest FIGURE 7-23 When the Latest Download button is pressed Download in the Stored Data menu, FIGURE 7-4, data regarding the latest information exchange with an OR is displayed. 09/11/03 02:45 PM a) To transfer the Data again, press the Patient Data: Resend Data button (3).
Page 170: Log Input
7.5 Log Input Log Input FIGURE 7-24 When the Log Input button is pressed in the Stored Data Menu, FIGURE 7-4, data for reviewing or adding logs to the Analyzer log Free Text Free Text list is displayed. Cleaned Cuv. Holder It is possible to enter free text or to choose Cleaned Opt.
Page 171: Data Communications
8 Data communications This chapter briefly describes the data communication between the Analyzers and the DMS Software. 8.1 Interaction Application – Analyzer Specially developed DMS Software or an OR with an interface for the Analyzers is necessary to provide full data management for the Analyzers.
Page 172: Docking Station Setup
8.2 Docking station setup Single Primary Docking FIGURE 8-1 A Single Primary Docking Station must be connected to a LAN (1) to which the PC hosting the DMS Software (2), or an OR, is also connected. The communication Analyzer - DMS Software is two-way: •...
Page 173 Single Secondary Docking Station FIGURE 8-2 A Single Secondary Docking Station must be connected via a USB (1) to the PC hosting the DMS Software (2). A Secondary Docking Station is only connected to a PC for data communication. No settings can be made on the Secondary Docking Station.
Page 174 Set of Multiple Docking Stations containing a Primary FIGURE 8-3 In a set of Multiple Docking Stations containing a Primary (1), the Primary is connected to a LAN (3) to which the PC hosting the DMS Software (4), or the OR, is also connected. The communication between the Analyzer and the DMS Software is two-way.
Page 175 FIGURE 8-4 For Analyzer in Secondary Docking Station (2), the following applies: • Analyzer Data is transmitted via the Secondary Docking Stations to the Primary Docking Station (1), see Arrow (7). The Primary Docking Station (1) transmits the Data to the PC (4), see Arrows (5). •...
Page 176 Multiple set consisting solely of Secondary Docking Stations FIGURE 8-5 In a multiple set consisting solely of Secondary Docking Stations, each Docking Station (1) must, for data communication, be connected separately to a USB port (4) on the PC hosting the DMS Software (5). If the PC doesn’t have enough USB ports, a USB hub can be used.
Page 177 FIGURE 8-6 • Analyzer Data is transmitted directly from the Analyzers in the Secondary Docking Station (1) via a USB cable (2) and (3) through the USB hub (4) on to the PC (5) according to Arrows (6) and (7). • Analyzer Settings are transmitted directly from the PC (5) via a USB (3) and (2) through the USB hub (4) on to the Analyzer in the Secondary Docking Station (1) according to Arrows (8) and (9).
Page 178: Data Transfer
8.3 Data transfer Analyzers can be administered by the DMS Software from a central PC. The central PC can communicate with several Analyzers at the same time. The communication between the DMS Software and the Analyzer is two-way, using the POCT1-A standard (also known as the CIC standard).
Page 179 FIGURE 8-8 During data transfer, FIGURE 8-8 will be displayed until the process is completed or interrupted. Data Exchange ... FIGURE 8-9 When an Analyzer is removed from the docking station, FIGURE 8-9 will be displayed. After removing the Analyzer from the Data Exchanged docking station it can take up to 20 seconds before FIGURE 8-9 is displayed.
Page 180 FIGURE 8-10 When the data transfer process is being activated, but the connection is not established successfully, FIGURE 8-10 will be displayed. No Connection to One of the following errors has occured: Server - The Docking Station is not properly connected to the network.
Page 181: Other Actions
PART IV Other actions...
Page 182: Troubleshooting
This chapter describes the Error Codes that may be displayed while using the Analyzer. If you are unable to resolve the problem by following this troubleshooting guide, please contact your local HemoCue distributor or HemoCue AB. Customers in the US should contact HemoCue America, Technical Support. There are no serviceable parts inside the Analyzer.
Page 183 Symptom Explanation Action The absorbance is too high. a) Check that the Analyzer and Light blocking item in the Cuvettes are used according to Cuvette holder. the Instructions for Use. b) Analyzer needs service. Contact the distributor. Hardware Error Analyzer needs service. Contact distributor.
Page 184 Symptom Explanation Action The QC memory is full. No more Save test results by placing the QC data can be saved. Analyzer in a Docking Station connected to DMS Software or OR. For the following, supervisory authority is needed. a) Delete all or part of the QC Tests stored in the Analyzer (see 7.3 Delete Stored Data) b) Change Analyzer settings...
Page 185 Fill a new Cuvette and perform a measurement. * this error code is only displayed If the error code appears again, use a in HemoCue Glucose 201 DM suitable laboratory reference method Anlyzer and HemoCue Glucose to analyze the specimen.
Page 186 Symptom Explanation Action HemoCue Hb 201 DM: HemoCue Hb 201 DM and HemoCue Overrange Glucose 201 DM RT: Measured value exceeds 25.6 g/ dL (256 g/L, 15.9 mmol/L). The result is above the measuring range. HemoCue Glucose 201 DM: HemoCue Glucose 201 DM:...
Page 187 Symptom Explanation Action No characters 1) The Analyzer is not receiving 1a) Check that the Power Adapter is on the display power. connected to the power supply. 2) If on battery power, the 1b) Check that the Power Adapter is Battery needs to be securely connected to the recharged.
Page 188 2) Steady red light - internal 2a) Disconnect and then reconnect error in the Docking Station. the Power Adapter. 2b) Contact HemoCue AB or the distributor. No transfer of No USB-communication. a) Check that the Analyzer is data via USB properly docked.
Page 189 Symptom Explanation Action No transfer of 1) No network communication 1a) Check that the LED on the data with OR or PC. Docking Station does not show a 2) Communication error. flashing red light. 3) No communication. 1b) Check the network configuration 4) No communication between of PDS/PDS the first and second Docking...
Page 190 Cuvette. distributor or HemoCue AB. Use another HemoCue analyzer or a * this error code is only displayed suitable laboratory reference method in HemoCue Glucose 201 DM to analyze the specimen. Analyzer and HemoCue Glucose 201 DM RT Analyzer...
Page 191 40 5) Clean the optical parts as seconds (for Glucose 201 DM described in relevant section of and Glucose 201 DM RT) or Instructions for Use. 10 minutes (for Hb 201 DM) 6) Fill a new Cuvette and perform a after filling the Cuvette.
Page 192: Miscellaneous
PART V Miscellaneous...
Page 193: Specifications
FW7556M/06: 6 V /2500 mA FW8001/06: 5.9 V /3000 mA Battery HemoCue Li-Ion rechargeable power battery 201 DM 3.6V 2.6Ah Battery capacity ≥ 120 tests/100 hours using the Barcode Scanner and a power save setting of 5 minutes Battery charging time 75% of its capacity <...
Page 194: Docking Station
10.1.2 Docking station Dimensions 206 × 135 × 61 mm (8.10 × 5.30 × 2.40 inches) Weight 566 g (1.24 pounds) Network communication : 100Mbps speed: PDS: 10Mbps System operating temperature See relevant Instructions for Use Docking station storage and 0 - 50 °C (32 - 122 °F) transport temperature Docking station operating and...
Page 195: Ivd Medical Device Directive
Prior to service and disposal the Analyzer and Docking Stations should be cleaned as recommended in Instructions for Use. Consult your local environmental authorities for proper disposal. 10.6 Spare parts • Power Adapter • HemoCue 201 DM Battery • Cuvette holder 10.7 Optional items • Software applications • USB cable •...
Page 196: Symbols Used
10.8 Symbols used Consult instructions for Caution CE mark Biological risk In Vitro diagnostic medical Temperature limitation device Manufacturer Humidity limitation Alternating current Catalogue number Serial number Ethernet DC inlet Lithium-ion Battery. Only valid within the Danger of explosion. European Community. Replace the battery with Indicates separate the same type...
Page 197 Laser radiation – Do not Warning - Laser beam stare into the beam. Class 2 Laser Product. Maximum output: 1 mW; Emitted Wavelength: 657 nm; This product meets the requirements of IEC/ EN 60825-1:2014. Do not expose to fire For indoor use only Do not expose to any liquids Efficiency Level...
Page 198: Default Settings
Appendix A – Default Settings Analyzer Serial Number: Date: Section Identifier Available options Default value Customer Settings Basic Settings Date format MM/DD/YY MM/DD/YY DD.MM.YY YY-MM-DD Time format 12 AM/PM 12 AM/PM 24 H Power saver time 5-30 min. 15 min. Audible signals (volume) Button Click...
Page 199 0-25.6 g/dL 0-256 g/L 0.0-15.9 mmol/L Glucose 201 DM: Glucose 201 DM: 0-400 mg/dL 0-400 mg/dL 0.0-22.2 mmol/L Glucose 201 DM RT: Glucose 201 DM RT: 0-500 mg/dL 0-500 mg/dL 0.0-27.8 mmol/L Critical Limits Glucose 201 DM: Glucose 201 DM: (Plasma Equiv.)
Page 200 0 mg/dL Max. Difference 4.0 g/dL 40 g/L 2.5 mmol/L Glucose 201 DM: 0 mg/dL 0-40 mg/dL 0-2.2 mmol/L Glucose 201 DM RT: 0 mg/dL 0-40 mg/dL 0-2.2 mmol/L Dilution Not Used Not used Optional function only available in Glucose...
Page 201 Section Identifier Available options Default value Customer Settings Start of First Workshift Free choice of time 12:00 AM Lockout Interval, time 1, 2, 3, 4, 6, 8, 12, 24 8 hours hours, 2-7 days Lockout Interval, 2-200 measurement QC Level 2 Lockout Not Used Not Used Time...
Page 202 Section Identifier Available options Default value Customer Settings QC Level 5 Lockout Not Used Not Used Time Measurement Start of First Workshift Free choice of time 12:00 AM Lockout Interval time 1, 2, 3, 4, 6, 8, 12, 24 8 hours hours, 2-7 days Lockout Interval, 2-200...
Page 203 Manufacturer HemoCue Distributor USA HemoCue AB HemoCue America Kuvettgatan 1 250 South Kraemer Boulevard SE - 262 71 Ängelholm, Sweden Brea, CA, 92821, USA Phone: + 46 77 570 02 10 Phone (General): 800.881.1611 Fax: + 46 77 570 02 12 Orders: 800.323.1674...

HemoCue 201 DM Reference Manual

Quick Links

Related Manuals for HemoCue 201 DM

Summary of Contents for HemoCue 201 DM

Table of Contents