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HemoCue 201 DM, Reference Manual

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130

FIGURE 6-6 

There are 7 QC Test options (1):

•  Level 1 (See 

6.2.1 QC Tests at a specific 

concentration level

)

•  Level 2
•  Level 3
•  Level 4
•  Level 5
•  Linearity (see 

6.2.2 Linearity Test

)

•  Proficiency (see 

6.2.3 Proficiency Test

)

a)  View options (1) not initially visible by 

pressing the Scroll bar arrow (2).

b)  Select a QC Test option by pressing it.

Level 1, Level 2, Level 3, Level 4 and Level 5, 
refer to the different concentration levels of 
Liquid Controls used in QC tests. The 
procedure for performing a QC test is the 
same for all the concentration levels. 
Therefore only one, Level 1, is described.

1  QC Test options
2  Scroll bar arrow

Normal

Level 2

High

Level 3

Other Level

Level 4

QC Test

Low

Level 1

2

1

Summary of Contents for 201 DM

Page 1: ...HemoCue 201 DM Analyzer HemoCue 201 DM Docking Station Reference Manual ...

Page 2: ...ons and features 19 2 General operations 20 2 1 How to operate the Display 20 2 1 1 Display buttons 20 2 2 Operating the Analyzer 24 2 2 1 Start up 24 2 2 2 Login image 25 2 2 3 Main Menu and Help 26 2 2 4 Power saver mode 26 2 3 Display buttons and symbols 27 2 3 1 Navigation buttons 27 2 3 2 Procedure buttons 28 2 3 3 Other display buttons 29 2 3 4 Display symbols 32 2 3 5 Entering information w...

Page 3: ...Define Log Notes 58 3 3 Basic Settings 60 3 3 1 Date Time 61 3 3 2 Power Saver 63 3 3 3 Audible Signals 64 3 3 4 Language 65 3 4 Advanced Settings 66 3 4 1 General Settings 67 3 4 2 Patient Test Settings 75 3 4 3 QC Test Settings 87 3 4 4 Linearity Test Settings 97 3 5 Default Settings 98 3 6 Infra Red 99 3 6 1 The transmitting Analyzer 99 3 6 2 The Receiving Analyzer 101 3 7 Docking Station Setti...

Page 4: ...lt 124 6 QC Test procedure 125 6 1 Events necessitating QC Tests 125 6 1 1 QC Reminder 125 6 1 2 QC Lockout 127 6 1 3 Supervisory Lockout 128 6 2 Performing a QC Test 129 6 2 1 QC Tests at a specific concentration level 131 6 2 2 Linearity Test 136 6 2 3 Proficiency Test 145 7 Reviewing stored data 147 7 1 Activating the Stored Data procedure 147 7 2 Review Stored Data 150 7 2 1 Review All Data 15...

Page 5: ...sfer 173 PART IV Other actions 176 9 Troubleshooting 177 PART V Miscellaneous 187 10 Specifications 188 10 1 Technical Specifications 188 10 1 1 Analyzer 188 10 1 2 Docking station 189 10 2 EMC and Electrical Safety 189 10 3 IVD Medical Device Directive 190 10 4 Warranty 190 10 5 Service and Disposal 190 10 6 Spare parts 190 10 7 Optional items 190 10 8 Symbols used 191 Default Settings i ...

Page 6: ...PART I Introduction ...

Page 7: ...lation of the Docking Stations see Hemocue 201 DM Docking Station Manual For information on the HemoCue 201 DM DMS Software see the separate User s Guide on the DMS Software CD Instructions for everyday routine use including sampling procedure and maintenance have been provided in Instructions for Use for the respective Analyzer This chapter gives a brief overview of the functions and features of ...

Page 8: ...necting 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 IP address A number that identifies each sender or receiver of information that is sent in packets across the Internet IR Infra Red light Electromagnetic radiation with wavelengths longer than those of visible light but shorter than those of radio waves IrD...

Page 9: ...int of care diagnostic devices connect These services facilitate the collection of test results and quality data from as well as the management of these devices In addition services hosted by an OR may exchange data with already existing information systems in the hospital or laboratory e g Laboratory Information Systems LIS PAT Patient Test PC Personal Computer PDS Primary Docking Station PDS Pri...

Page 10: ...t entering information required in the routine patient test mode Testing is also possible in this mode if the routine patient testing mode of the Analyzer is locked out TCP IP Transmission Control Protocol Internet Protocol USB Universal Serial Bus A plug and play interface between a computer and peripheral devices e g keyboards scanners printers With USB a new device can be added to the computer ...

Page 11: ...moCue Hb 201 DM Analyzer HemoCue Glucose 201 DM Analyzer HemoCue Glucose 201 DM RT Analyzer Analyzer HemoCue 201 DM Primary Docking Station Primary Docking Station HemoCue 201 DM Secondary Docking Station Secondary Docking Station HemoCue 201 DM Docking Station irrespective of primary or secondary Docking Station HemoCue 201 DM DMS Software DMS Software HemoCue Hb 201 Microcuvette HemoCue Glucose ...

Page 12: ...emoCue Glucose 201 DM Instructions for Use HemoCue Glucose 201 DM RT Instructions for Use Instructions for Use HemoCue 201 DM DMS Software User s Guide on CD DMS Software Manual Spare parts HemoCue recommended Power Adapter Power Adapter HemoCue 201 DM Battery Battery ...

Page 13: ...ion Full data management is possible when the Analyzer is placed in the Docking Station 3 which is connected via USB or LAN to a PC hosting the DMS Software The Analyzer Battery is recharged while in the Docking Station Analyzer must always be fully inserted in the Docking Station to ensure connectivity and charging of the Battery Remove the Analyzer if there is no communication between the Analyz...

Page 14: ...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 To perform a measurement the Cuvette is filled with sample material and placed in the Cuvette holder 4 The Cuvette holder is inserted into the Analyzer To turn off the Analyzer 1 press the On Off button 2 1 Analyzer 2 On Off button 3 Display 4 Cu...

Page 15: ...s depending on which version of Docking Station is used and how the Docking Station is connected to Software Via USB using the Power USB signal inlet 2 if the Docking Station communicates with the DMS Software via USB or if the Docking Station is labelled and communicates with the DMS Software via LAN By means of IR light using the IR Transmitter Receiver 4 if the Docking Station is NOT labelled a...

Page 16: ...alyzer is placed in a Docking Station this inlet will be blocked and the Analyzer receives power via the Power USB signal inlet 2 The combined Power USB signal inlet 2 is not a standard USB port but a special connector which fits the corresponding connector on the Docking Station The IR Transmitter Receiver 4 is located inside the casing of the Analyzer Do not cover or block the items on the back ...

Page 17: ...the other Analyzers through this connection Primary and Secondary Docking Stations 1 2 FIGURE 1 7 Primary and Secondary Docking Stations are two physically different products A Primary Docking Station can be connected to a LAN and both receive send data itself and pass data from to a Secondary Docking Station that is connected to the Primary When a Primary Docking Station is connected via a USB co...

Page 18: ...condary Docking Stations or of only Secondary Docking Stations If a Primary is included it must be positioned furthest to the left 1 when facing the front of the Docking Station Two Primary Docking Stations must not be connected together Primary Docking Stations labelled PDS shall only be connected to a Secondary Docking Station labelled SDS Secondary Docking Stations labelled SDS shall only be co...

Page 19: ...o 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 connector on the Analyzer The IR Transmitter Receiver 3 is located inside the casing Do not cover or block the items on the back panel doing so may result in malfunction 1 Tracks 2 Power outlet 3 IR Transmitter Receiver not in Docking Stations labelled PD...

Page 20: ...ry Docking Station Network port 3 for data communication via a LAN 1 Power inlet for the Power Adapter 2 USB port 3 Network port Back panel Secondary Docking Station FIGURE 1 11 The following items are located on the back panel Power inlet 1 for the Power Adapter USB port 2 for data communication directly with the PC different from the USB port in the Primary Docking Station 1 Power inlet for the ...

Page 21: ...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 1 Male Connector 2 Side Trim 1 2 ...

Page 22: ... 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 3 Female Connector 4 Bottom Trim 4 3 ...

Page 23: ...ocking Station by means of the Tracks 1 Make sure that the Analyzer is fully inserted 1 Tracks FIGURE 1 15 Never try to lift the Analyzer out of the Docking Station or press the Analyzer downwards into the Docking Station This may damage the casing and power outlets of the Analyzer and or the Docking Station ...

Page 24: ...t functions Linearity and proficiency testing STAT tests The Analyzer stores Approximately 4000 Patient STAT test results and 500 QC test results incl ID date time comments etc Approximately 500 Analyzer log entries Error messages maintenance etc The Analyzer also has the following features Touchscreen Display Built in Barcode Scanner Powered either by a rechargeable lithium ion battery Power Adap...

Page 25: ...he Display 2 1 1 Display buttons Enter Settings Password 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 Do not use sharp edged objects as these can damage the Display 1 Buttons 2 Display ...

Page 26: ...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 1 Button highlighted ...

Page 27: ...ep pressing while moving the fingertip over to another button Enter Settings Password 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: ... Keep pressing while moving the fingertip over to an area without Buttons Enter Settings Password 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: ... measuring position the following text will be displayed Please Pull Out the Cuvette Holder Pull the Cuvette holder out to the loading position When the Cuvette holder is in the loading position the Analyzer will perform a self test No function can be activated for approximately 20 seconds during the selftesting c If the requirement for Operator ID is set to Not Used see section 3 Settings the Mai...

Page 30: ...to Not Used see section 3 Settings a Enter Operator ID either directly on the Display via the Text mode 1 and Numeric mode 2 buttons or by the Barcode Scanner via the Barcode Scanner button 3 Use of the Barcode Scanner eliminates manual input errors Refer to Instructions for Use for information on the Barcode Scanner b When a valid Operator ID is entered the Main Menu will be displayed see FIGURE ...

Page 31: ...aver mode When no procedures have been performed within the time predefined in the Analyzer settings see section 3 3 2 Power Saver the Analyzer will switch to power save mode If the Analyzer is powered via the Power Adapter the user will be logged off the image on the display will disappear but the power will remain on Touch the Display to reactivate it If the Analyzer is powered via the Battery t...

Page 32: ...mage will not be saved ABC ABC Text mode button Switches to text input mode 123 123 Numeric mode button Switches to the numeric input mode Barcode Scanner button Activates the Barcode Scanner Scroll bar arrow Up Scrolls upwards in a list of different options or in a text Scroll bar arrow Down Scrolls downwards in a list of different options or in a text Next image button Continues to the next imag...

Page 33: ...ored data button Activates the Stored Data function Settings button Activates the Settings menu Verify Duplicate sampling button Allows for the performance of a second test on the same patient using a new Cuvette without the need for re entering the Patient ID and other information Comment input button Allows a comment to be added to the current result Comment input button dotted Button appearance...

Page 34: ...ut the operator The Log Out button is only displayed if the Operator ID is required STU YZ VWX JKL PQR MNO ABC GHI DEF 123 Special Character button Enters a special character see explanations below Other special characters can only be loaded into the Analyzer by means of the Barcode Scanner See above Space press once See above Period press twice See above Hyphen press three times View button Provi...

Page 35: ...2 ABC Digit buttons 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 Add button Allows addition of a comment to a result an item to a list etc Delete Delete button Allows deletion of a com...

Page 36: ...ton The entered information will not be stored Continue Continue button Continues the current operation Statistics button Displays statitics on the chosen subject Date format button Switches between the following date formats YYMMDD DD MM YY MM DD YY Time format button Switches between the following time formats 12 hours 24 hours AM PM AM PM button Enables adding AM PM only 12 hour format ...

Page 37: ...s rotating when displayed Small hourglass When the small hourglass is displayed the instrument is in a measuring or blanking state When displayed in the Main Menu only Settings and Stored Data functions are available It is also possible to log out Waste bin Indicates that a result has been rejected The result is stored in the Analyzer QC Reminder Reminder that a QC Test will be required within sta...

Page 38: ... be set to two different modes text mode for entering letters including a few special characters and numeric mode for entering digits a Press the Text mode button 1 or the Numeric mode button 2 depending on if the first character that is to be entered is a letter or a digit b Depending on the mode chosen follow the description for FIGURE 2 26 or FIGURE 2 27 1 Text mode button 2 Numeric mode button...

Page 39: ...ll information has been entered press the Confirm button 5 1 Letter button 2 Special Character button 3 Erase button 4 Numeric mode button 5 Confirm button Numeric mode FIGURE 2 27 a In the numeric mode inputs are made using the Digit buttons 1 b The Erase button 2 erases the last input c If a letter or a special character is to be entered switch to the text input mode by pressing the Text mode bu...

Page 40: ...via the display see 2 3 5 Entering information with letters and digits Use of the Barcode Scanner eliminates manual input errors Special characters can be entered into the Analyzer by means of the Barcode Scanner For more information on how to use the Barcode Scanner see Instructions for Use 1 Barcode scanner button Enter Operator ID 08 09 03 10 55 AM 123 ABC 1 ...

Page 41: ...PART II Settings ...

Page 42: ...elivered with the Operator ID set to Not Used a In the Main Menu press the Settings button 1 b If the requirement for Operator ID entry is set to Not Used see 3 4 1 General Settings FIGURE 3 2 will be displayed as this is a password protected function Two other screens may be displayed dependent on the setting for entry of the Operator ID If the operator s user level does not permit access to Sett...

Page 43: ...ered FIGURE 3 4 will be displayed 2 Text mode button 3 Numeric mode button 4 Barcode Scanner button Settings Incorrect Password or User Level No Changes to the Settings will be Saved 6 5 FIGURE 3 3 e Pressing the Previous image button 5 will result in a return to either the Main Menu if the operator s user level does not permit access to the Settings or FIGURE 3 2 if the Operator ID is set to Not ...

Page 44: ...tting categories 7 is displayed Define Lists see 3 2 Define Lists Basic Settings see 3 3 Basic Settings Advanced Settings see 3 4 Advanced Settings Default Settings see 3 5 Default Settings Infra Red see 3 6 Infra Red f Press the Scroll bar arrow 8 to view categories 7 not initially visible on the Display g Select a Settings category 7 by pressing it 7 Settings categories 8 Scroll bar arrow ...

Page 45: ...d Controls see 3 2 1 Liquid Controls Cuvette Batches see 3 2 2 Cuvette Batches Define Operators see 3 2 3 Define Operators Define Comments see 3 2 4 Define Comments Define Log see 3 2 5 Define Log Notes Define Operators may only be activated if the operator is designated as Supervisor or if the correct password has been entered a View Define Lists categories 1 not initially visible by pressing the...

Page 46: ...nt Liquid Control specifications When pressing the Add button 2 to add a new Liquid Control specification the following Liquid Controls options 1 are displayed Level 1 Level 2 Level 3 Level 4 Level 5 FIGURE 3 7 Level 1 Level 2 Level 3 Level 4 and Level 5 refer to the different concentration levels of Liquid Controls The settings procedure is the same for all concentration levels For this reason on...

Page 47: ...ar If the Confirm button is repeatedly pressed through FIGURE 3 8 to FIGURE 3 11 no changes will be effected d Enter Liquid Control name 3 either directly on the Display via the Text mode 4 and Numeric mode 5 buttons or with the Barcode Scanner via the Barcode Scanner button 6 e Press the Confirm button 7 2 Liquid Control concentration level 3 Liquid Control name 4 Text mode button 5 Numeric mode ...

Page 48: ... or by the Barcode Scanner via the Barcode Scanner button g Press the Confirm button 8 8 Confirm button QC Level 1 Lot 123456789 Expiration Date 1 5 2 8 7 4 6 9 3 0 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 08 10 03 9 FIGURE 3 10 h The Expiration Date of the specific control Lot can be entered or changed using the numeric buttons if desired i Press the Confirm button 9 9 Confirm button ...

Page 49: ...g displayed j Enter min value 10 and max value 11 for the warning interval k Press the Confirm button 12 A similar image for the lockout limits will be displayed The lockout limits define the range for QC testing that must be obtained to prevent the Analyzer from performing a lockout l In the image for the lockout limits enter min value 10 and max value 11 for the lockout interval m Press the Conf...

Page 50: ...x value Delete a Liquid Control specification Liquid Controls L2 123456789 L2 123456789 L3 123456789 L1 123456789 Delete Delete Add Add 1 2 3 FIGURE 3 13 a To choose the Liquid Control specification that is to be deleted highlight the Liquid Control specification 1 by pressing the Scroll Bar Arrows 2 Press the Delete button 3 b A confirm dialogue is displayed Press Delete to delete the Liquid Cont...

Page 51: ...d changed highlight the Liquid Control specification by pressing the Scroll bar arrows 1 Press the View button 2 By pressing repeatedly on the confirm button FIGURE 3 8 to FIGURE 3 12 will be displayed Press the Save button to store any changes made and return to the Liquid Controls List b Press the Confirm button 3 to return to the Define Lists menu see FIGURE 3 5 1 Scroll bar arrows 2 View butto...

Page 52: ...tch Information Cuvette Batches 123456789 234567891 345678912 456789123 Delete Delete Add Add 2 1 FIGURE 3 15 When the Cuvette Batches button is pressed in the Define Lists menu see FIGURE 3 5 the Cuvette Batch list 1 will be displayed In the initial settings the Cuvette Batch list 1 will be empty When trying to enter more than five Batches the following text will be displayed Maximum Five Batches...

Page 53: ...e Cuvette vial FIGURE 3 18 will be displayed otherwise FIGURE 3 17 will be displayed 0 7 9 8 4 6 5 1 3 2 0 0 7 7 9 9 8 8 4 4 6 6 5 5 1 1 3 3 2 2 Cuvette Batch Batch 123456789 Expiration Date 08 09 03 3 ABC ABC FIGURE 3 17 This screen will not be displayed if the Cuvette Batch No was entered via the Barcode Scanner from the barcode on the Cuvette vial d Enter the Expiration Date for the Cuvette Bat...

Page 54: ... 123456789 234567891 345678912 456789123 567891234 Delete Delete Add Add 2 1 3 FIGURE 3 19 a To choose the Cuvette Batch information that is to be deleted highlight the Cuvette Batch No 1 by pressing the Scroll Bar Arrows 2 Press the Delete button 3 b A confirm dialogue is displayed Press Delete to delete the Cuvette Batch or press No to cancel c The updated Cuvette Batch list will be displayed Pr...

Page 55: ... that is to be viewed highlight the Cuvette Batch No by pressing the Scroll bar arrows 1 Press the View button 2 A summary of the stored information will be displayed Press the Confirm button 3 The Cuvette Batch List will be displayed b Press the Confirm button 3 in the new display to return to the Define Lists menu see FIGURE 3 5 1 Scroll bar arrows 2 View button 3 Confirm button ...

Page 56: ...ings the Define Operators list 1 will only contain the default name SUPERVISOR a To add an Operator to the list press the Add button 2 1 Define Operators list 2 Add button Add Operator ID 123 123 ABC ABC 4 5 3 FIGURE 3 22 b Enter the Operator ID either directly on the Display via the Text mode 3 and Numeric mode 4 buttons or with the Barcode Scanner via the Barcode Scanner button 5 c A similar ima...

Page 57: ...access to the Analyzer e Press the Confirm button 6 FIGURE 3 24 will be displayed 6 Confirm button 0 7 9 8 4 6 5 1 3 2 0 0 7 7 9 9 8 8 4 4 6 6 5 5 1 1 3 3 2 2 Deactivate Operator JDO1943 Date 7 08 09 04 FIGURE 3 24 f Enter the date after which the Operator will be denied access to the Analyzer g Press the Confirm button 7 FIGURE 3 26 will be displayed 7 Confirm button ...

Page 58: ... view options not initially visible on the screen Each operator belongs to only one Access Level 8 Access Level options 9 Scroll bar arrow The different Access Levels give the Operator the following authority Operator category Authority description Supervisor Full Access to system Key Operator Same as Supervisor Trusted User Patient and QC function access only User Same as Trusted User Training Pa...

Page 59: ...e List menu see FIGURE 3 5 Delete Operator Define Operators HBJ2926 FJO1819 KSV1315 MSV5566 Delete Delete Add Add 2 1 3 4 FIGURE 3 27 a To choose the Operator information that is to be deleted highlight the Operator ID 1 by pressing the Scroll bar arrows 2 Press the delete button 3 b A confirm dialogue is displayed Press Delete to delete the Operator information or press No to cancel c The updated...

Page 60: ...ewed highlight the Operator ID by pressing the Scroll bar arrows 1 Press the View button 2 A summary of the stored information will be displayed Press the Confirm button 3 The Define Operator List will be displayed b Press the Confirm button in the new display to return to the Define Lists menu see FIGURE 3 5 1 Scroll bar arrows 2 View button 3 Confirm button ...

Page 61: ...to enter more than 30 Comments the following text will be displayed Maximum 30 Comments are Allowed in the List a To add a Comment to the list press the Add button 2 1 Define Comments list 2 Add button Add Comment 123 123 ABC ABC 4 5 3 FIGURE 3 30 b Enter the Comment either directly on the Display via the Text mode 3 and Numeric mode 4 buttons or with the Barcode Scanner via the Barcode Scanner bu...

Page 62: ...t to be deleted 2 Scroll bar arrows 3 Delete button 4 Confirm button View Comment Define Comments Wrong Patient Wrong QC Level Old Cuvette Old Liquid Control Delete Add Add 2 3 1 FIGURE 3 32 A Comment that requires more space than is available in the current display can be viewed by pressing the View button a To choose the comment that is to be viewed highlight the Comment by pressing the Scroll b...

Page 63: ... more than 30 Log notes the following text will be displayed Maximum 30 Log Notes are Allowed in the List a To add a Log note to the list press the Add button 2 1 Define Log list 2 Add button Add Log 123 123 ABC ABC 4 5 3 FIGURE 3 34 b Enter the Log note either directly on the Display via the Text mode 3 and Numeric mode 4 buttons or with the Barcode Scanner via the Barcode Scanner button 5 c The ...

Page 64: ...IGURE 3 5 1 Log to be deleted 2 Scroll bar arrows 3 Delete button View Log Define Log Cleaned Touch pad Calibrated LCD Delete Add Add 2 3 1 FIGURE 3 36 A Log note that requires more space than is available in the current display can be viewed by pressing the View button a To choose the Log note that is to be viewed highlight the Log note by pressing the Scroll bar arrows 1 Press the view button 2 ...

Page 65: ...When the Basic Settings button is pressed in the Settings menu see FIGURE 3 4 the following Basic Settings categories 1 are displayed Date Time see 3 3 1 Date Time Power Saver see 3 3 2 Power Saver Audible Signals see 3 3 3 Audible Signals Language see 3 3 4 Language a Select a Basic Settings category 1 by pressing it 1 Basic Settings categories ...

Page 66: ...d first a Select the Date format 1 with the Date format button 3 The formats available are MM DD YY default format DD MM YY press once YY MM DD press twice MM symbolizes the month as two digits DD symbolizes the day of the month as two digits YY symbolizes the year as two digits b Enter the current date with the Digit buttons 2 c Press the Confirm button 4 FIGURE 3 39 will be displayed 1 Date form...

Page 67: ...format 6 Time format button Format 12h 10 55 AM Adjust Time 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 AM PM AM PM 8 9 7 FIGURE 3 40 b If the 12h format is selected select AM or PM by means of the AM PM button 7 The AM PM button 7 will only be displayed if the 12h format is selected c Enter the current time with the Digit buttons 8 d Press the Confirm button 9 The Basic Settings menu will be displaye...

Page 68: ...is pressed in the Basic Settings menu see FIGURE 3 37 the Power Saver settings function is displayed a To change the Power Saver time 1 press the Scroll bar arrows 2 The Power Saver time is set in five minute intervals from 5 30 minutes b Press the Confirm button 3 c The Basic Settings menu will be displayed see FIGURE 3 37 1 Power Saver time 2 Scroll bar arrows 3 Confirm button ...

Page 69: ...t Ready Error a To adjust the volume of an audible signal press one of the Audible Signal buttons 1 In this example the Button Click button is pressed 1 Audible Signal buttons Button Click 2 Volume 3 2 4 4 FIGURE 3 43 b Set the Volume 2 from 0 4 by means of the Scroll bar arrows 3 To turn an Audible Signal off set the Volume 2 to value 0 c Press the Confirm button 4 d The Audible Signal settings w...

Page 70: ...enu see FIGURE 3 37 the Language settings function is displayed The two language options are displayed as Language buttons 1 The language currently in use is indicated by the selected Radio button 2 a To change the language press the desired Language button 1 b Press the Confirm button 3 c The Basic Settings menu will be displayed see FIGURE 3 37 1 Language buttons 2 Radio button 3 Confirm button ...

Page 71: ...ries menu see FIGURE 3 4 the following Advanced Settings categories 1 are displayed General Settings see 3 4 1 General Settings Patient test see 3 4 2 Patient Test Settings QC test see 3 4 3 QC Test Settings Linearity test see 3 4 4 Linearity Test Settings a Select one of the Advanced Settings categories 1 by pressing the button The Advanced Settings categories are explained on the following pages...

Page 72: ...Settings menu see FIGURE 3 45 the following General Settings categories are displayed Operator ID See FIGURE 3 47 Password See FIGURE 3 49 Cuvette Batch See FIGURE 3 51 Patient List See FIGURE 3 52 Memory See FIGURE 3 53 a Press the Scroll bar arrow 2 to view categories not initially visible on the display b Select a General Settings function 1 by pressing it 1 General Settings categories 2 Scroll...

Page 73: ...Operator may perform all functions except the password protected functions see FIGURE 4 49 Entry required An Operator ID must be entered at startup Any operator not verified against the Operator List will be considered as belonging to the user category see FIGURE 3 22 Approved Only An Operator ID must be entered at startup Any operator not verified against the operator list will be denied access t...

Page 74: ...er of characters for the Operator ID are displayed Numbers in brackets show the lowest and the highest allowable number of characters To allow only an exact number of characters enter the same value in the Min and Max settings c Enter the min No of characters 4 for the Operator ID via the Digit 6 buttons Press the Confirm button 7 d Enter the max No of characters 5 for the Operator ID via the Digi...

Page 75: ...nter the Old Password using the Digit buttons 1 and the Letter buttons that are displayed when the Text Mode button 2 is pressed The default password is 0000 b Press the Confirm button 3 1 Digit button 2 Text mode button 3 Confirm button New Password 1 10 Password 1 5 2 8 7 4 6 9 3 0 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 ABC ABC 4 FIGURE 3 50 c Enter the New Password d Press the Confirm button 4...

Page 76: ...he selected Radio button 2 Not Used The Cuvette Batch No cannot be entered Entry required The Cuvette Batch No must be entered The Cuvette Batch No entered is not verified against the predefined list Approved Only The Cuvette Batch No must be entered and verified against the predefined Cuvette Batch list in the Analyzer for the result to be displayed a To change the setting press the button for th...

Page 77: ...n is pressed in the General Settings menu see FIGURE 3 46 the Patient List settings are displayed The options available are displayed as buttons 1 The option currently in use is indicated by the selected Radio button 2 Not Used The Patient List feature is not used Used The Patient List feature is used when running a Patient test See chapter 4 Patient Test procedure for more information a To change...

Page 78: ...e option currently in use is indicated by the selected Radio button 2 Lockout The Analyzer is locked out when the patient memory is full No patient tests can be performed until the stored results have been deleted from the Patient Memory function Overwrite When the patient memory is full the Analyzer stores the new patient test result by overwriting the oldest result a To change the setting press ...

Page 79: ...use is indicated by the selected Radio button 5 c To change the setting press the button for the desired option 4 d Press the Confirm button 6 to return to the General Settings menu FIGURE 3 46 The option selected for QC Memory Full will automatically be selected for Log Memory Full 4 Memory Full option buttons 5 Selected option 6 Confirm button ...

Page 80: ... displayed Critical Limits see FIGURE 3 56 Patient ID see FIGURE 3 57 Lab Number LID see FIGURE 3 60 STAT see FIGURE 3 62 Duplicate Sampling see FIGURE 3 64 Dilution see FIGURE 3 66 a Press the Scroll bar arrow 1 to view categories not initially visible on the display b Select a Patient Test Settings category 2 by pressing it 1 Scroll bar arrow 2 Patient Test Settings categories Only available for...

Page 81: ... button is pressed in the Patient Test Settings menu see FIGURE 3 55 the settings for Critical Limits are displayed The numbers in brackets show the lowest and the highest values for the critical limits a Enter the min value 1 via the Digit buttons 3 Press the Confirm button 4 b Enter the max value 2 via the Digit buttons 3 Press the Confirm button 4 The Patient Test Settings menu FIGURE 3 55 will...

Page 82: ...e displayed The options available are displayed as buttons 1 The option currently in use is indicated by the selected Radio button 2 Not Used The Patient ID cannot be entered Optional The Patient ID can be entered or left blank Required The Patient ID must be entered a To change the setting press the button for the desired option 1 b Press the Confirm button 3 1 Options for Patient ID requirement ...

Page 83: ... 9 3 3 0 0 5 4 6 7 FIGURE 3 58 Numbers in brackets show the lowest and the highest allowable number of characters To allow only an exact number of characters enter the same value in the Min and Max options c Enter the min No of characters 4 via the Digit buttons 6 Press the Confirm button 7 d Enter the max No of characters 5 via the Digit buttons 6 Press the Confirm button 7 FIGURE 3 59 will be di...

Page 84: ...d by the selected Radio button 9 Used The previous Patient ID will be cleared when a new test is initiated Not Used The previous Patient ID will be displayed until a new Patient ID is entered e To change the setting press the button for the desired option 8 f Press the Confirm button 10 to return to the Patient Test Settings menu see FIGURE 3 55 8 Clear Patient ID options 9 Selected option 10 Conf...

Page 85: ...ttings for Lab ID requirement are displayed 1 The option currently in use is indicated by the selected Radio button 2 Not Used The Lab No cannot be entered Optional The Lab No can be entered or left blank Required The Lab No must be entered a To change the setting press the button for the desired option 1 b Press the Confirm button 3 1 Options for Lab Number requirement 2 Selected option 3 Confirm...

Page 86: ... 2 Lab Number LID 1 5 2 8 7 4 6 9 3 0 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 5 4 6 7 FIGURE 3 61 Numbers in brackets show the lowest and the highest allowable number of characters c Enter the min No of characters 4 via the Digit buttons 6 Press the Confirm button 7 d Enter the max No of characters 5 via the Digit buttons 6 Press the Confirm button 7 The Patient Test Settings menu FIGURE 3 55 will...

Page 87: ... The options available are displayed as buttons 1 The option currently in use is indicated by the selected Radio button 2 Used STAT tests are permitted even when the Analyzer has performed a QC lockout Not Used STAT tests are not permitted a To change the setting press the button for the desired option 1 b Press the Confirm button 3 1 Options for STAT test usage 2 Selected option 3 Confirm button ...

Page 88: ... 9 3 0 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 5 4 6 FIGURE 3 63 The numbers in brackets show the lowest and the highest number of tests that can be set c Enter the max No of STAT tests that will be allowed after the Analyzer has performed a QC lockout via the Digit buttons 5 Press the Confirm button 6 The Patient Test Settings menu FIGURE 3 55 will be displayed 4 Max number of STAT tests 5 Digit ...

Page 89: ...sed in the Patient Test Settings menu see FIGURE 3 55 the setting to enable the use of the duplicate sampling function is displayed The options available are displayed as buttons 1 The option currently in use is indicated by the selected Radio button 2 Not Used The duplicate sampling function is not activated on the Analyzer Used The duplicate sampling function is activated on the Analyzer a To ch...

Page 90: ...isplayed FIGURE 3 65 c To change the maximum difference allowed between two samples 1 press the arrows 2 for the desired value d Press the Confirm button 3 to return to the Patient Test Settings menu FIGURE 3 55 1 Max allowed difference between samples 2 Arrows for increasing decreasing the Difference 3 Confirm button Duplicate sampling Max Difference 3 2 0 2 0 2 0 2 mmol L 1 ...

Page 91: ...ly be multiplied by a factor of 2 Dilution of the sample may reduce the accuracy of the result Not Used Not Used Optional Optional Dilution Dilution with NaCl 1 1 4 1 3 2 FIGURE 3 66 When the Dilution button is pressed in the Patient Test Settings menu see FIGURE 3 55 the setting to enable the use of diluted samples is displayed The options available are displayed as buttons 1 The option currently...

Page 92: ...inder Time see FIGURE 3 76 QC Result Options see FIGURE 3 78 Failed QC Comment see FIGURE 3 79 Level 1 Level 2 Level 3 Level 4 and Level 5 refer to the different concentration levels of Liquid Controls used in QC tests The settings procedure is the same for all concentration levels For this reason only one of these is described a Press the Scroll bar arrow 2 to view options 1 not initially visible...

Page 93: ...ements QC Level 1 Lockout 3 1 2 FIGURE 3 68 When the Level 1 button is pressed in the QC Test Settings menu see FIGURE 3 67 the settings for QC lockout at this level are displayed The options available are displayed as buttons The option currently in use is indicated by the selected radio button Not Used No QC lockout will be performed Time The QC lockout will be activated if the required QC test ...

Page 94: ...urements is selected FIGURE 3 74 is displayed 1 Options for QC lockout criteria 2 Selected option 3 Confirm button QC lockout determined by time Format 12h 10 55 AM Start of First Workshift 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 AM PM AM PM 1 2 3 FIGURE 3 70 If Time was selected in the QC lockout menu the setting for the QC lockout based on time is displayed a Enter the start time 1 for the begin...

Page 95: ...ton 5 The number of Hours or Days is also displayed 6 a To change the setting press the button for the desired option 4 b To change the length of the time interval use the Scroll bar arrows 7 c Press the Confirm button 8 If the reminder time needs to be adjusted FIGURE 3 72 will be displayed Otherwise FIGURE 3 73 will be displayed 4 Time interval options 5 Selected option 6 Selected time interval ...

Page 96: ...splayed To return to FIGURE 3 71 press No The selected time interval until the next QC lockout will then need to be adjusted QC Level 1 Lockout Next lockout 09 12 03 04 00 PM 10 11 9 12 FIGURE 3 73 The date and time of the next QC lockout for the chosen QC level will be displayed e Press the Confirm button 12 to return to the QC Test Settings menu FIGURE 3 67 9 Concentration level of QC test 10 Da...

Page 97: ...inder value needs to be adjusted FIGURE 3 75 will be displayed Otherwise there will be a return to FIGURE 3 67 1 No of measurements after which QC lockout occurs 2 Digit button 3 Confirm button Lockout Interval No No Adjust Adjust Note New Lockout Value Requires Adjusted Reminder Value Adjust FIGURE 3 75 c To adjust the number of measurements for the reminder so that it corresponds with the new va...

Page 98: ... lockout The Reminder time can be set to no more than half the shortest of the QC lockout times irrespective as to which level this refers The current value of the reminder time 2 expressed in the given unit 1 is displayed a Set the reminder time using the Scroll bar arrows 3 To turn the Reminder Time function off set the value 2 to 0 b Press the Confirm button 4 FIGURE 3 78 will be displayed 1 Un...

Page 99: ...respective as to which level this refers The numbers in brackets show the lowest and the highest number of tests that can be set a Enter the number of measurements for the reminder 5 via the Digit buttons 6 b Press the Confirm button 7 FIGURE 3 67 will be displayed 5 No of measurements for reminder 6 Digit button 7 Confirm button Measurements 1 X 1 0 QC Reminder 1 5 2 8 7 4 6 9 3 0 1 1 5 5 2 2 8 8...

Page 100: ...ative Passed Failed values The options are displayed as buttons 1 The option currently in use is indicated by the selected Radio button 2 a To change the setting press the button for the desired option 1 b Press the Confirm button 3 to return to the QC Test Settings menu FIGURE 3 67 1 Options for presentation of test results 2 Selected option 3 Confirm button Numeric Numeric Passed Failed Passed F...

Page 101: ...t to a QC Test that has failed The options are displayed as buttons 1 The option currently in use is indicated by the selected Radio button 2 a To change the setting press the button for the desired option 1 b Press the Confirm button 3 to return to the QC Test Settings menu FIGURE 3 67 1 Options for Failed QC Comment 2 Selected option 3 Confirm button Numeric Not Used Passed Failed Entry Required...

Page 102: ...the button for the desired option 1 b Press the Confirm button 3 FIGURE 3 81 will be displayed 1 Options for number of levels 2 Selected option 3 Confirm button FIGURE 3 81 The numbers in brackets show the lowest and the highest number of tests that can be set c Enter the number of Cuvettes 4 for each level via the Digit buttons 5 d Press the Confirm button 6 FIGURE 3 45 will be displayed 4 Number...

Page 103: ...rators Comments or Logs will not be affected For a list of default values see Appendix A Default Settings a If all the settings in the Analyzer are to be changed to Default settings press Continue Otherwise press No FIGURE 3 4 will be displayed If the choice was to change all settings to default the following text will be displayed for a few seconds Settings have Now Changed to Default Settings b ...

Page 104: ...te Batches see 3 2 2 Cuvette Batches Liquid Controls see 3 2 1 Liquid Controls Operator List see 3 2 3 Define Operators Comment List see 3 2 4 Define Comments Log List see 3 2 5 Define Log Notes 1 Settings options 2 Scroll bar arrow All options are transfered by the Analyzer in the same manner therefore only one of these All Settings is described a Press the Scroll bar arrow 2 to view options not ...

Page 105: ...r see FIGURE 3 85 the same text will continue to be displayed during data transfer When the transfer is completed the following text will be displayed for a few seconds Transmission OK and a beep will be heard if the audible signal is enabled FIGURE 3 83 will be displayed f If no connection was established or transfer was rejected by the receiving Analyzer the following text will be displayed No C...

Page 106: ...nue To cancel press No b If the transfer is accepted while data is being received the following text will be displayed Receiving via IR port with slight variations depending on the category of settings information c When the transfer is completed the following text will be displayed for a few seconds Transmission OK 1 Settings to receive Infra Red Transmission No No Continue Continue Update All Se...

Page 107: ... Docking Station Settings can only be made on Primary Docking Stations not on Secondary see Primary and Secondary Docking Stations The setting of a Docking Station is made from a software application In order to perform the settings the Docking Station must be connected to the PC hosting the DMS Software or the PDS Configuration Tool see section 8 2 Docking station setup ...

Page 108: ...PART III Routine use ...

Page 109: ...b ID A Patient Test procedure may be initiated in two different ways The first way is described below The other way is by filling and inserting a Cuvette then closing the Cuvette holder allowing required information to be entered while the sample is being analyzed 08 09 03 10 55 AM JAMES SMITH 1 2 2 3 FIGURE 4 1 a In the Main Menu press the Patient Test button 1 b FIGURE 4 2 will be displayed 1 Pa...

Page 110: ...nd a Cuvette Batch No that has not previously been stored in the Analyzer see 3 2 2 Cuvette Batches is entered or the Cuvette Batch is expired the following text will be displayed Invalid Cuvette Batch If the Previous image button 4 is pressed the Main Menu will be displayed see 2 2 3 Main Menu and Help d If Cuvette Batch No requirement is set to Entry required see 3 4 1 General Settings and the C...

Page 111: ...Cuvette vial e Enter the Expiration Date for the Cuvette Batch via the Numeric mode buttons f Press the Confirm button 5 5 Confirm button Enter Patient ID PID 123 ABC FIGURE 4 4 This will not be displayed if the Patient ID requirement is set to Not Used see 3 4 2 Patient Test Settings g Enter the Patient ID PID via the Text mode and Numeric mode buttons or with the Barcode Scanner via the Barcode ...

Page 112: ...esponding Patient Name as a means of positive patient identification If the Patient List doesn t contain a Patient Name corresponding to the entered Patient ID then the text Unknown Patient Name will be displayed h Press OK to continue or the back arrow to go back and re enter the Patient ID Enter Lab Number LID 123 ABC FIGURE 4 6 This will not be displayed if the Lab ID requirement is set to Not ...

Page 113: ...and re enter the information otherwise press OK to continue For a diluted sample follow FIGURE 4 9 otherwise continue with step k FIGURE 4 8 k Obtain a blood sample according to the procedure described in relevant Instructions for Use l Place the filled Cuvette in the Cuvette holder and gently insert it into the measuring position m When the measurement is ready FIGURE 4 11 will be displayed Pleas...

Page 114: ...od and one part NaCl n If the sample is diluted press the Dilution button 6 FIGURE 4 10 will be displayed 6 Dilution button 7 Help button FIGURE 4 10 o Confirm with Yes or No FIGURE 4 9 will then be displayed again p Obtain a blood sample according to the procedure described in relevant Instructions for Use q Place the filled Cuvette in the Cuvette holder and gently insert it into the measuring po...

Page 115: ...isplayed if the result is outside the critical limits that are defined in the Settings see 3 4 2 Patient Test Settings The Comment Diluted 5 will automatically be displayed and added to the results Comment list see 4 1 3 Entering Comments if the sample was diluted and the result was calculated 1 Type of test 2 Patient ID 3 Lab Number ID 4 Result 5 Comment to mark diluted sample 6 Critical Note 7 C...

Page 116: ...2 Verify Duplicate sampling Do not press the Confirm button 8 in this screen if the result is to be verified Never re measure a Cuvette a Press the Confirm button 8 to store the information The Main Menu FIGURE 4 1 will be displayed The result will remain on the display even if the Cuvette holder is pulled out allowing for examination of the Cuvette before comments are made 1 Type of test 2 Patien...

Page 117: ...t result is displayed press the Verify Duplicate Sampling button 1 FIGURE 4 14 will be displayed 1 Verify Duplicate sampling button Patient Test PID 750629 3694 LID 12345 Cuv 123456 Verify Press OK to Accept 2 FIGURE 4 14 b Accept the information for the new measurement by pressing the Confirm button 2 c The following text will be displayed Please Fill and Insert a Cuvette d When the new Cuvette i...

Page 118: ...er more than the maximum difference set in the settings see FIGURE 3 65 the results will automatically be rejected and instead of the mean value the following text will be displayed Difference too large When the confirm button is pressed FIGURE 4 16 is displayed When pressing the confirm button 1 in FIGURE 4 16 the Main Menu will be displayed 1 Result from first measurement 2 Result from second me...

Page 119: ... The result will remain on the display even if the Cuvette holder is pulled out allowing for examination of the Cuvette before comments are made Patient Test PID 750629 3694 LID 12345 64 mg dL 1 63 mg dL 2 65 mg dL Result Verify 5 1 3 2 4 FIGURE 4 17 The Comment input button 4 indicates that there are no comments added to the result To add comments press the Comment input button 4 see 4 1 4 Enteri...

Page 120: ...ll be displayed 1 Comment input button Comments Delete Delete Add Add 3 2 FIGURE 4 19 The Comment list 2 is empty prior to the addition of any comments Note that the only exception is the auto generated comment Diluted displayed in the results Comment list 2 if the Dilution button has been pressed earlier see FIGURE 4 9 b To add a comment press the Add button 3 FIGURE 4 20 will be displayed 2 Resu...

Page 121: ...21 will be displayed If information is to be added as text and numbers or via the Barcode Scanner press the Free text button 7 4 Scroll bar arrows 5 Selected comment 6 Add button 7 Free text button Comments Delete Delete Add Add 9 Expired cuvette 8 10 FIGURE 4 21 The added comment is displayed in the Comment list 8 e If more comments are to be added press the Add button 9 again and repeat the proc...

Page 122: ...d cuvette 13 15 FIGURE 4 23 i When all comments that are to be added are displayed in the Comment list 13 press the Confirm button 14 If the Previous image button 15 is pressed this text will be displayed If you continue no comment changes will be saved Continue If Continue is pressed again all changes entered in the Comment list 13 will be lost If an attempt is made to add more than four comments...

Page 123: ...ng added this text will be displayed To Reject a Sample Enter at least one Comment 16 Accept button 17 Reject button Patient Test PID 750629 3694 LID 12345 63 mg dL Result 18 20 19 FIGURE 4 25 The dotted Comment input button 18 indicates that there are comments added to the result The Waste bin 19 indicates that the result has been rejected see FIGURE 4 24 m Press the Confirm button 20 The Main me...

Page 124: ...s text will be displayed Comment Cuvette Number 1 c To add comments to the result from the first Cuvette follow the same procedure as in 4 1 3 Entering Comments FIGURE 4 19 to FIGURE 4 23 d When the comments for the first Cuvette are made this text will be displayed Comment Cuvette Number 2 e To add comments to the result from the second Cuvette follow the same procedure as in 4 1 3 Entering Comme...

Page 125: ...tted Comment input button 2 indicates that comments have been added In this example the Waste bin 3 indicates that the result for the first Cuvette has been rejected g Press the Confirm button 4 The Main menu FIGURE 4 1 will be displayed 2 Comment input button 3 Indicator for rejected test result 4 Confirm button ...

Page 126: ... 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 5 1 STAT Test STAT tests are only available if enabled during the configuration of the Analyzer settings see 3 4 2 Patient Test Settings 08 09 03 10 55 AM JAMES SMITH 1 FIGURE 5 1 a In the Main Menu press the STAT Test butto...

Page 127: ...eneral Settings the Patient ID requirement see 3 4 2 Patient Test Settings and the Lab ID requirement see 3 4 2 Patient Test Settings are set to Not Used For a diluted sample follow FIGURE 5 3 otherwise continue with step c FIGURE 5 2 c Obtain a blood sample according to the procedure described in the respective Instructions for Use d Place the filled Cuvette in the Cuvette holder and gently inser...

Page 128: ...ilution function the sample must be diluted with NaCl Saline one part blood and one part NaCl f If the sample is diluted press the Dilution button 2 FIGURE 5 4 will be displayed 2 Dilution button 3 Help button Dilution No No Yes Yes Sample Diluted with NaCl 1 1 FIGURE 5 4 g Confirm with Yes or No FIGURE 5 3 will then be displayed again h Obtain a blood sample according to the procedure described i...

Page 129: ...llows the verification of the result by measuring a new sample from the same patient The procedure is the same as for a Patient Test see 4 1 2 Verify Duplicate sampling Never re measure a Cuvette a Press the Confirm button 7 to store the information The result will remain on the display even if the Cuvette holder is pulled out allowing for the examination of the Cuvette before comments are made 1 ...

Page 130: ...r Number of measurements 3 remaining before the QC Lockout The number of measurements remaining refer only to Patient Tests and STAT tests The text inside the brackets indicates the types of QC Tests 4 that must be performed in order to avoid a QC lockout QC1 QC Test Level 1 QC2 QC Test Level 2 QC3 QC Test Level 3 QC4 QC Test Level 4 QC5 QC Test Level 5 1 QC Reminder 2 Time remaining before QC Loc...

Page 131: ...t before the QC lockout the time measurement counter is reset to the max time number of measurements until the next QC lockout a To enter the QC Test procedure press the QC Test button 5 FIGURE 6 6 will be displayed 5 QC Test button 08 09 03 10 55AM JAMES SMITH 2h 47min QC1 100 cuv QC2 5 ...

Page 132: ... and Proficiency Tests are not allowed when the Analyzer has performed a QC lockout STAT Tests are not allowed when the Analyzer has performed a QC lockout if usage of STAT Tests is set to Not Used see 3 4 2 Patient Test Settings or if the number of STAT Tests performed has reached the max limit allowed The Information text 2 indicates the types of QC Tests required to unlock the QC Lockout a To e...

Page 133: ...t by the Supervisor This can only be performed via the DMS Software or an Observation Reviewer OR The Analyzer can only be unlocked by the Supervisor via the DMS Software or an OR 1 QC Lockout 2 Supervisory Lockout Text 08 09 03 10 55 AM JAMES SMITH Supervisory Lockout 1 2 ...

Page 134: ...129 6 2 Performing a QC Test FIGURE 6 5 a In the Main Menu press the QC Test button 1 FIGURE 6 6 will be displayed 1 QC Test button 08 09 03 10 55AM JAMES SMITH 1 ...

Page 135: ...y visible by pressing the Scroll bar arrow 2 b Select a QC Test option by pressing it Level 1 Level 2 Level 3 Level 4 and Level 5 refer to the different concentration levels of Liquid Controls used in QC tests The procedure for performing a QC test is the same for all the concentration levels Therefore only one Level 1 is described 1 QC Test options 2 Scroll bar arrow Normal Level 2 High Level 3 O...

Page 136: ...herefore only one Level 1 is described The concentration level of the QC Test 1 is displayed a Fill a Cuvette with the appropriate level of Liquid Control 1 b Place the Cuvette in the Cuvette holder and gently insert it into the measuring position FIGURE 6 8 will be displayed 1 Concentration level of QC Test Please Fill and Insert a Cuvette QC Level 1 1 ...

Page 137: ... stored in the Analyzer see 3 2 2 Cuvette Batches is entered or the Cuvette Batch has expired the following text will be displayed Invalid Cuvette Batch Enter Control Lot 123 ABC ABC FIGURE 6 9 d Enter the Lot No for the Liquid Control used either directly on the Display via the Text mode and Numeric mode buttons or with the Barcode Scanner via the Barcode Scanner button FIGURE 6 10 will be displa...

Page 138: ...for two consecutive results within the Warning area 3 the Qualitative Test Result will 6 indicate Fail To avoid or unlock a QC lockout the Qualitative Test Result must indicate Pass e To view a graphic presentation of the most recent QC Tests press the Statistics button 7 FIGURE 6 12 will be displayed f Press the Confirm button 8 FIGURE 6 6 or FIGURE 6 11 will be displayed 2 Approved area 3 Warnin...

Page 139: ...Test Settings and the QC Test has failed then FIGURE 6 11 will be displayed when the Confirm button shown in FIGURE 6 10 is pressed Use the Previous Image button 9 to go back and add at least one comment 9 Previous Image button QC Level 1 Result a Failed QC Enter at Least one Comment for 9 ...

Page 140: ...7 09 10 03 09 11 03 N 30 52 mg dL SD 0 76 mg dL CV 1 5 11 12 13 14 15 16 17 FIGURE 6 13 The All Statistics report shows statistical data for all QC Tests for the level of control and Lot No displayed i Press the Confirm button 16 FIGURE 6 10 will be displayed 11 Lot No of Liquid Control used in QC tests 12 Date interval of test results 13 No of test results on which statistics are based 14 Mean va...

Page 141: ... be used either directly on the Display via the Text mode and Numeric mode buttons or with the Barcode Scanner via the Barcode Scanner button If the Cuvette Batch No requirement is set to Approved only see 3 4 1 General Settings and a Cuvette Batch No that was not previously stored in the Analyzer see 3 2 2 Cuvette Batches is entered or the Cuvette Batch has expired the following text will be disp...

Page 142: ...ll be displayed 1 Yes button 2 No button Kit Name 123 123 ABC ABC 4 3 GlucoLin FIGURE 6 16 If a kit name was entered previously it will be displayed 3 e If desired change the kit name 3 either directly on the Display via the Text mode and Numeric mode buttons or with the Barcode Scanner via the Barcode Scanner button f Press the Confirm button 4 FIGURE 6 17 will be displayed 3 Kit name 4 Confirm b...

Page 143: ...ton for it 6 i If testing for the selected level has been completed 5 the following will be displayed Chosen Level has been completed Do You Wish to Retest this Level j Press No to return to the current image or press Yes to continue to image FIGURE 6 18 If testing for the selected level 6 is not complete FIGURE 6 18 is displayed 5 Buttons for already completed levels 6 Buttons for non completed l...

Page 144: ...Barcode Scanner via the Barcode Scanner button When finished FIGURE 6 19 will be displayed Level 1 Lot 56489754 Expiration Date 0 8 0 9 0 3 1 5 2 8 7 4 6 9 3 0 1 1 5 5 2 2 8 8 7 7 4 4 6 6 9 9 3 3 0 0 8 9 10 11 FIGURE 6 19 The Lot No 8 is displayed l Enter the Expiration Date 9 for the current Lot via the Digit buttons 10 m Press the Confirm button FIGURE 6 20 will be displayed 8 Lot No 9 Expiratio...

Page 145: ...he remaining levels If a range is entered for the first level ranges must be entered for the remaining levels n Enter the min value for the concentration range 13 via the Digit buttons Press the Confirm button 15 o Enter the max value for the concentration range 14 via the Digit buttons Press the Confirm button 15 FIGURE 6 21 will be displayed 12 Unit for concentration 13 Concentration range min v...

Page 146: ...Otherwise press No FIGURE 6 17 will be displayed 16 Kit name 17 Lot No 18 Expiration Date 19 Concentration range max value 20 Concentration range min value Please Fill and Insert a Cuvette Level 1 21 FIGURE 6 22 The level of linearity material to be tested 21 is shown on the display q Fill a Cuvette from the previously designated batch with the appropriate level of linearity material r Place the C...

Page 147: ...d a Confirm button will be displayed When Confirm is pressed the following message will be displayed Error All Cuvettes for this Level will be Rejected When Confirm is pressed all measurements for the designated level are rejected but still kept in memory and FIGURE 6 17 is displayed 22 Measurement No 23 Total No of measurements required 24 Concentration range min value 25 Concentration range max ...

Page 148: ...Fill a Cuvette from the previously designated batch with the appropriate level of linearity material u Place the Cuvette in the Cuvette holder and gently insert it into the measuring position If additional tests are required FIGURE 6 23 will be displayed again If no additional tests are required FIGURE 6 24 will be displayed FIGURE 6 24 v Press the Confirm button If other levels of the linearity m...

Page 149: ...est 28 Unit for analyte concentration 29 Mean result at the level 30 Concentration min and max value at the level 31 Qualitative Test Result 32 Confirm button FIGURE 6 26 If no ranges are specified for the concentration levels see FIGURE 6 20 only the mean results at each level 34 are listed and no range limits will be displayed No Qualitative test result is given a Press the Confirm button 35 FIG...

Page 150: ...tte holder and gently insert it into the measuring position FIGURE 6 28 will be displayed Enter Cuvette Batch 123 123 ABC ABC FIGURE 6 28 d Enter the Cuvette Batch No of the Cuvette used either directly on the Display via the Text mode and Numeric mode buttons or with the Barcode Scanner via the Barcode Scanner button FIGURE 6 29 will be displayed If the Cuvette Batch No requirement is set to Appr...

Page 151: ...r directly on the Display via the Text mode and Numeric mode buttons or with the Barcode Scanner via the Barcode Scanner button When finished FIGURE 6 30 will be displayed FIGURE 6 30 f Press the Confirm button 3 to return to FIGURE 6 27 1 Specimen ID 2 Test Result 3 Confirm button Proficiency Spec ID 234567 138 mg dL Result 1 2 3 ...

Page 152: ...sult or add comments a In the Main Menu press the Stored Data button 1 b If the entry requirement for an Operator ID is set to Not Used see 3 Settings FIGURE 7 2 will be displayed as this is a password protected function Otherwise the Analyzer can respond in two different ways If the operator s user level does not permit access to the Stored Data see FIGURE 3 22 FIGURE 7 3 will be displayed If the...

Page 153: ...f the correct password is entered FIGURE 7 4 will be displayed 2 Text mode button 3 Numeric mode button 4 Barcode Scanner button Stored Data Incorrect Password or User Level No Changes to the Stored Data will be Saved 6 5 FIGURE 7 3 e Pressing the Previous image button returns the user to FIGURE 7 2 and allows entry of the correct password By pressing the Confirm button Stored Data can be viewed b...

Page 154: ...displayed Review see 7 2 Review Stored Data Delete see 7 3 Delete Stored Data Latest Download see 7 4 Review Latest Download Log Input see 7 5 Log Input The Stored Data options 7 are explained in the pages that follow f Select an option by pressing it g To return to the previous image press the Previous image button 8 7 Stored Data options 8 Previous image button ...

Page 155: ...s are displayed All Data see 7 2 1 Review All Data PAT STAT see 7 2 2 Review PAT STAT QC Test see 7 2 3 Review QC Tests Analyzer Log see 7 2 4 Review Analyzer Log a Select an option by pressing it 1 Review option buttons Liquid Controls All Data Cuvette Batches PAT STAT Define Operators QC Test Review Define Comments Analyzer Log 1 ...

Page 156: ...ns 3 Press Confirm 4 b Repeat the instruction a to change the To date 2 1 From date 2 To date 3 Digit button 4 Confirm button c All stored data Patient tests STAT tests QC tests and Analyzer Logs within the date interval will be available for review The latest record is displayed first The different images possible are described in FIGURE 7 8 FIGURE 7 12 FIGURE 7 15 FIGURE 7 17 FIGURE 7 19 If no d...

Page 157: ... next display a Patient ID No can be entered to view specific patient data Otherwise press the Confirm button 4 to view all Patient and STAT data 1 From date 2 To date 3 Digit button 4 Confirm button d All Patient Tests and STAT tests within the defined date interval will be available for review Initially the latest record is displayed For Patient tests and STAT tests see FIGURE 7 8 e If no data w...

Page 158: ...by pressing the Comment input button 8 See 4 1 3 Entering Comments c Press the Confirm button 9 FIGURE 7 5 will be displayed 1 Date and time of test 2 Operator ID 3 Patient ID 4 Scroll bar arrows 5 Lab Number 6 Indicator for rejected test result 7 Result 8 Comment input button 9 Confirm button Patient Test 07 10 03 10 24 AM OP Chris PID 670317 4987 LID 124 4456 Diluted Critical 198 mg dL 4 1 2 3 5...

Page 159: ...te 1 via the Digit buttons 3 When finished press the Confirm button 4 b Repeat instruction a to change the To date 2 c FIGURE 7 10 will be displayed 1 From date 2 To date 3 Digit button 4 Confirm button FIGURE 7 10 There are different categories of QC Test data The following options are available All QC Data Level 1 Level 2 Level 3 Level 4 Level 5 Linearity Proficiency From 07 10 03 To 02 01 04 QC...

Page 160: ...gory by pressing it c All QC tests within the selected category and the defined date interval will be available for review The latest test is displayed first For Level 1 Level 2 Level 3 Level 4 and Level 5 see FIGURE 7 12 For Linearity see FIGURE 7 15 For Proficiency see FIGURE 7 17 If no data within the date interval is found the following message will be displayed No Records Found The Previous i...

Page 161: ...g the Comment input button 8 See 4 1 3 Entering Comments c To view a graphic presentation of the most recent QC tests at the defined concentration level press the Statistics button 9 FIGURE 7 13 will be displayed d To return to the QC Test categories image FIGURE 7 10 press the Confirm button 10 1 Date and time of test 2 Operator ID 3 Lot No of Liquid Control 4 Scroll bar arrows 5 Indicator for re...

Page 162: ...il area 13 Warning area 14 Pass area 15 Confirm button QC Level 1 All Statistics Lot No 234567 N 30 52 mg dL SD 0 76 mg dL CV 1 5 16 18 19 21 09 10 03 09 11 03 17 22 20 FIGURE 7 14 The image shows statistical data for all stored QC tests with the current Lot No f Press the Confirm button 22 FIGURE 7 12 will be displayed 16 Lot No of Liquid Control 17 Date interval of test results 18 Number of test...

Page 163: ... of test 2 Operator ID 3 Lot No of Linearity material 4 Scroll bar arrows 5 Indicator for rejected test result 6 Result 7 Statistics button 8 Confirm button Linearity Result N 15 mg dL 1 75 70 80 2 143 140 150 3 209 210 220 4 278 280 290 5 354 354 360 Out of Range 9 11 12 10 13 FIGURE 7 16 The image shows statistical data For more information on the image see FIGURE 6 25 d Press the Confirm button...

Page 164: ... the available records use the scroll bar arrows 4 b Press the Confirm button 6 FIGURE 7 10 will be displayed 1 Date and time of test 2 Operator performing the test 3 Specimen ID 4 Scroll bar arrows 5 Result 6 Confirm button Proficiency 01 05 03 11 43 AM OP Emma Spec 1435 3425 248 mg dL 4 1 2 3 5 6 ...

Page 165: ...atest stored Logs It is possible to change the date interval If no change is required press Confirm 4 FIGURE 7 19 will then be displayed a If required change the From date 1 via the Digit buttons 3 Press Confirm 4 b Repeat the step a for the To date 2 c FIGURE 7 19 will be displayed 1 From date 2 To date 3 Digit button 4 Confirm button From 09 23 03 To 11 05 03 Analyzer Log 1 5 2 8 7 4 6 9 3 0 1 1...

Page 166: ...og notes d To browse through the available records use the scroll bar arrows 7 e Press the Confirm button 10 FIGURE 7 5 will be displayed 5 Date and time of test 6 Operator ID 7 Scroll bar arrows 8 Degree of severity of the Analyzer Log 9 Log note 10 Confirm button Analyzer Log OP Tom Warning QC Buffer Full 7 5 6 9 8 09 23 03 09 47 AM 10 ...

Page 167: ...the earliest and latest stored records of the selected type It is possible to alter the To date but not the From date If no change is required press Confirm 5 FIGURE 7 22 will be displayed b If required enter a new To date 3 via the Digit buttons 4 When finished press Confirm 5 FIGURE 7 22 will be displayed 2 From date 3 To date 4 Digit button 5 Confirm button PAT STAT PAT STAT QC Test QC Test Ana...

Page 168: ...To confirm the request to delete the data press Yes 8 The Delete menu FIGURE 7 20 will be displayed 6 The type of data requested for deletion 7 No button 8 Yes button Delete No No Yes Yes Data Will Be Permanently Lost Are You Sure All Data From 01 09 03 To 01 11 03 8 6 7 ...

Page 169: ...formation exchange with an OR is displayed a To transfer the Data again press the Resend Data button 3 b Press the Confirm button 4 FIGURE 7 4 will be displayed 1 Date and time of transfer 2 No of transferred records 3 Resend Data button 4 Confirm button Latest Patient Data 53 QC Data 13 Analyzer Log 5 1 2 09 11 03 02 45 PM Resend Data 4 3 Download ...

Page 170: ...Log and FIGURE 7 4 will be displayed If the Free Text option 1 was selected FIGURE 7 25 will be displayed 1 Free text option 2 Selected Log Note 3 Scroll bar arrows 4 Add button FIGURE 7 25 d Enter a free text notation either directly on the Display via the Text mode 5 and Numeric mode 6 buttons or with the Barcode Scanner via the Barcode Scanner button 7 e Press the Confirm button 8 FIGURE 7 4 wi...

Page 171: ... for storage and evaluation Settings in an Analyzer can be updated from the DMS Software or an OR The Analyzer must be placed in a Docking Station that is connencted to a PC or to an Observation Reviewer OR to facilitate communication with the DMS Software or OR Remove the Analyzer if there is no communication between the Analyzer and the Docking Station and then re dock the Analyzer in the Dockin...

Page 172: ...ings are transmitted from the PC 2 to the Analyzer see Arrow 4 To make settings on a Primary Docking Station e g IP address it must be connected to a PC via a USB the same type of connection a Secondary Docking Station uses for data communication see FIGURE 8 2 When a Primary Docking Station is connected via a USB connection only the TCP IP settings can be changed No other information can be sent ...

Page 173: ...tion No settings can be made on the Secondary Docking Station The communication between the Analyzer and the DMS Software is two way Analyzer Data is transmitted from the Analyzer to the PC 2 for Data Management see Arrow 3 Analyzer Settings are transmitted from the PC 2 to the Analyzer see Arrow 4 1 USB connection 2 PC hosting the DMS Software 3 Analyzer Data to DMS Software 4 Analyzer Settings f...

Page 174: ...DMS Software is two way For the Analyzer in the Primary Docking Station 1 the following applies Analyzer Data is transmitted from the Analyzer in the Primary Docking Station 1 to the PC 4 for Data Management see Arrow 5 Analyzer Settings are transmitted from the PC 4 to the Analyzer in the Primary Docking Station 1 see Arrow 6 1 Primary Docking Station 2 Secondary Docking Station 3 LAN 4 PC hostin...

Page 175: ...reason for this type of configuration For Secondary Docking Stations labelled SDS in such a set the Analyzer needs to be restarted or re docked to establish connection to PC via USB To restore the LAN connection for the Secondary Docking Station labelled SDS remove the USB cable and restart or re dock the Analyzer in the Docking Station To make settings on the Primary Docking Station in such a set...

Page 176: ...doesn t have enough USB ports a USB hub can be used Only electrical power can be transferred between Docking Stations in this configuration A secondary Docking Station cannot be directly connected to a LAN Analyzers in a multiple set consisting solely of Secondary Docking Stations communicate with the DMS Software according to FIGURE 8 6 1 Secondary Docking Station 2 USB connection Docking Station...

Page 177: ... 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 1 Secondary Docking Stations 2 USB connection Docking Station to hub 3 USB connection hub to PC 4 USB hub 5 PC hosting the DMS Software 6 Analyzer Data to PC via hub 7 Analyzer Data to PC via hub 8 Analyzer Settings from PC via hub 9 Analyzer Settings fr...

Page 178: ... a docking station containing an Analyzer to the PC or by placing an Analyzer in a docking station already connected to the PC If the Analyzer is busy with a measurement when the connection is established data transfer will start as soon as the measurement is completed Data transfer from an Analyzer to the PC will always contain measurement results not already transferred During the activation and...

Page 179: ...until the process is completed or interrupted Data Exchanged with server OK FIGURE 8 9 When an Analyzer is removed from the docking station FIGURE 8 9 will be displayed After removing the Analyzer from the docking station it can take up to 20 seconds before FIGURE 8 9 is displayed ...

Page 180: ...twork The network server is not available There is a fault in the Docking Station a Press the Confirm button 2 to return to the Main Menu FIGURE 2 24 1 Confirm button Communication Error E31 2 FIGURE 8 11 If during data transfer an error or malfunction between the Analyzer and the recieving computer is detected FIGURE 8 11 will be displayed Refer to the section 8 Data communications a Press the Co...

Page 181: ...PART IV Other actions ...

Page 182: ...or codes below E00 No stable endpoint found within the time range 1 The Cuvette is faulty 2 The circuit board is out of order 1a Check the expiration date for the Cuvettes 1b Take a new Cuvette and repeat the measurement 2 Analyzer needs service Contact the distributor E01 E02 1 Dirty optical parts 2 Analyzer too hot cold 3 Magnet missing in cuvette holder 1 Clean optical parts as described in Ins...

Page 183: ...l Time Clock backup battery has been drained The backup battery needs to be replaced Contact distributor E25 Analyzer not calibrated Analyzer needs service Contact distributor E26 The Patient test memory is full No more patient data can be saved Save test results by placing the Analyzer in a Docking Station connected to DMS Software or OR For the following supervisory authority is needed a Delete ...

Page 184: ... saved Save test results by placing the Analyzer in a Docking Station connected to DMS Software or an OR For the following supervisory authority is needed a Delete all or part of the Analyzer logs stored in the Analyzer see 7 3 Delete Stored Data b As the Analyzer settings regarding full memory for Analyzer logs is the same as the setting for full memory of QC tests change Analyzer behaviour for Q...

Page 185: ...a Check that the LED on the Docking Station does not show a red light stable or flashing See Symptom Docking Station LED red b See Symptom No transfer of data If problems remain contact distributor E70 E71 The Cuvette is faulty or the sample might be grossly lipemic this error code is only displayed in HemoCue Glucose 201 DM Anlyzer and HemoCue Glucose 201 DM RT Analyzer Check that the system is u...

Page 186: ...mg dL 31 mmol L HemoCue Hb 201 DM and HemoCue Glucose 201 DM RT The result is above the measuring range HemoCue Glucose 201 DM Whole blood The measuring range may be extended to 800 mg dL 44 4 mmol L by using the Dilution function Plasma Equivalent The measuring range may be extended to 888 mg dL 49 2 mmol L by using the Dilution function Note that the Dilution function is not available in all mar...

Page 187: ...characters 1 The display is out of order 2 The microprocessor is out of order 1 2 Analyzer needs service Contact distributor Scanner is malfunc tioning 1 The incorrect barcode is being scanned 2 The product has expired 3 The Analyzer is too close or too far from the barcode 4 The barcode is indinstinct 5 The Scanner glass is dirty 6 The barcode is not compatible with the Scanner 7 The Scanner is b...

Page 188: ...a via USB No USB communication a Check that the Analyzer is properly docked b Check the cable connections in both the Docking Station and the PC c Check that the Docking Station is not a Primary Docking station d Check that all Docking Stations that should communicate are connected with a USB cable to the PC e Check that the DMS Software is properly installed and that the USB driver is installed f...

Page 189: ...ions are docked together 2b If multiple Docking Stations are used make sure not to mix Docking Stations labelled PDS SDS with unlabelled Docking Stations 3a Check that a USB connection is not used for communication in a Primary Docking Station 3b If multiple Docking Stations are used make sure not to mix Docking Stations labelled PDS SDS with unlabelled Docking Stations 4 Check that two Primary St...

Page 190: ...res primarily empty Cuvettes not under filled Cuvettes 2 No chemical reaction is identified in the blood filled Cuvette this error code is only displayed in HemoCue Glucose 201 DM Analyzer and HemoCue Glucose 201 DM RT Analyzer 1 2 Fill a new Cuvette and perform a measurement as described in relevant sections of Instructions for Use If the Empty Cuvette message appears again contact your local dis...

Page 191: ...vant section in Instructions for Use 2 Check the expiry date and the storage conditions of the Cuvettes 3 Fill a new Cuvette and perform a new measurement 4 Check the Cuvette for air bubbles Remeasure the control sample with a new Cuvette 5 Clean the optical parts as described in relevant section of Instructions for Use 6 Fill a new Cuvette and perform a new measurement 7 Fill a new Cuvette and pe...

Page 192: ...PART V Miscellaneous ...

Page 193: ... 8 EAN 13 Code 128 USS 128 UCC EAN 128 ISBT 128 Code 39 Interleaved 2 of 5 Codabar Pollution degree 2 Overvoltage category II Altitude up to 2000 m above sea level Power Adapter Input FW7556M 06 100 240V 50 60 Hz 400 200 mA FW8001 06 100 240V 50 60 Hz 400 200 mA Power Adapter Output 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 B...

Page 194: ...dapter Output FW7556M 06 6 V 2500 mA FW8001 06 5 9 V 3000 mA 10 2 EMC and Electrical Safety The System is tested and complies with IEC 61010 1 IEC EN 61010 2 101 and IEC EN 61326 2 6 including applicable parts of IEC EN 61326 1 The System has been tested for indoor use When using the Analyzer standalone or together with one Primary Docking Station it has been designed and tested to CISPR 11 Class ...

Page 195: ...tended 10 3 IVD Medical Device Directive The System complies with the IVD Medical Device Directive 98 79 EC and carries the CE mark 10 4 Warranty The Analyzer and Docking Stations carry a 24 month warranty from the day of receipt After the warranty period service repair is carried out at fixed prices Any other use of the System than recommended by the manufacturer including opening the cover of th...

Page 196: ...nufacturer Humidity limitation Alternating current Catalogue number USB Serial number Ethernet DC inlet Lithium ion Battery Danger of explosion Replace the battery with the same type recommended by the equipment manufacturer Only valid within the European Community Indicates separate collection for waste of electrical and electronic equipment ...

Page 197: ...ss 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 Do not expose to temperatures above 50 C Class II equipment ...

Page 198: ...M DD MM DD YY Time format 12 AM PM 24 H 12 AM PM Power saver time 5 30 min 15 min Audible signals volume Button Click 0 4 4 Audible signals volume Test Ready 0 4 4 Audible signals volume Error 0 4 4 Language Language 1 Language 2 Language 1 Advanced Settings General Settings Operator ID Not Used Entry Required Approved Only Not Used Min Max characters in Operator ID 1 15 3 12 ...

Page 199: ...Overwrite Overwrite Patient Test settings Critical Limits Whole Blood Hb 201 DM 0 0 25 6 g dL 0 256 g L 0 0 15 9 mmol L Hb 201 DM 0 25 6 g dL Glucose 201 DM 0 400 mg dL 0 0 22 2 mmol L Glucose 201 DM 0 400 mg dL Glucose 201 DM RT 0 500 mg dL 0 0 27 8 mmol L Glucose 201 DM RT 0 500 mg dL Critical Limits Plasma Equiv Glucose 201 DM 0 444 mg dL 0 0 24 6 mmol L Glucose 201 DM 0 444 mg dL Glucose 201 D...

Page 200: ...12 STAT Test Used Not Used Used STAT Tests Allowed 1 100 10 Duplicate sampling Not Used Used Not Used Duplicate sampling Max Difference Hb 201 DM 4 0 g dL 40 g L 2 5 mmol L 0 mg dL Glucose 201 DM 0 40 mg dL 0 2 2 mmol L 0 mg dL Glucose 201 DM RT 0 40 mg dL 0 2 2 mmol L 0 mg dL Dilution function only available in Glucose 201 DM Analyzer Not Used Optional Not used QC Test Settings QC Level 1 Lockout...

Page 201: ...2 00 AM Lockout Interval time 1 2 3 4 6 8 12 24 hours 2 7 days 8 hours Lockout Interval measurement 2 200 100 QC Level 3 Lockout Not Used Time Measurement Not Used Start of First Workshift Free choice of time 12 00 AM Lockout Interval time 1 2 3 4 6 8 12 24 hours 2 7 days 8 hours Lockout Interval measurement 2 200 100 QC Level 4 Lockout Not Used Time Measurement Not Used Start of First Workshift F...

Page 202: ...12 00 AM Lockout Interval time 1 2 3 4 6 8 12 24 hours 2 7 days 8 hours Lockout Interval measurement 2 200 100 QC Reminder time 0 30 min 1 2 3 4 hours 1 hour QC Reminder measurements 1 50 20 QC Result Options Numeric Passed Failed Numeric Failed QC Comment Not Used Entry Required Not Used Linearity Settings Linearity 3 4 5 Levels 5 Levels Linearity Cuvettes level 1 20 3 ...

Page 203: ...den Phone 46 77 570 02 10 Fax 46 77 570 02 12 E mail info hemocue se www hemocue com HemoCue America 250 South Kraemer Boulevard Brea CA 92821 USA Phone General 800 881 1611 Orders 800 323 1674 Tech support 800 426 7256 Fax Cust service 800 333 7043 E mail info hemocue com 901041 180503 ...

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