Accu-Chek Inform 2 Operator'S Manual Download Page 54

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Glucose Control Testing

4 Glucose Control Testing

Information regarding glucose control tests

Observe the applicable regulations and directives of the

responsible regulatory agencies when performing

glu cose control tests.
Accurately testing known levels of glucose ensures that

the system and your technique used in testing give

accu rate results on patient tests. Glucose control

solutions have defined (known) values. The results for

these solu tions must first fall within a certain acceptable

range in order to allow valid patient testing.

The system may be configured to require in-range

glu cose control testing before patient testing is allowed.

This is called

QC Lockout

, and the system actually

prevents patient and proficiency testing when the control

results are not within the accepted range.

Summary of Contents for Inform 2

Page 1: ...ACCU CHEK Inform II BLOOD GLUCOSE MONITORING SYSTEM Operator s Manual ...

Page 3: ......

Page 4: ...critically ill statement Version 3 0 2013 03 Update cleaning and disinfecting chapter Version 4 0 2014 02 Transition to new meter hardware 2D barcode scanner modifications to wireless LAN option separate insertable RF card replaced by integrated WLAN component new battery pack Update to SW 04 00 misc editorial revisions ...

Page 5: ... respective owners The Wi Fi CERTIFIED Logo is a certification mark of the Wi Fi Alliance On the packaging on the identification plate of the meter the battery pack the base unit or the code key reader you may encounter the following symbols shown here with their meaning Caution consult accompanying documents Refer to safety related notes in the instruction for use accompanying this instrument Tem...

Page 6: ...work protection from unauthorized access 20 Wired network connection 20 Wireless network connection 20 Radiofrequency radiation exposure information 21 System components 24 Overview of the meter 25 Overview of the code key reader 26 Overview of the base unit 27 Overview of the ACCU CHEK Inform II Base Unit HUB 28 Overview of the accessory box 29 Reagents and consumables 29 Instructions for initial...

Page 7: ... Testing 53 Information regarding glucose control tests 53 Glucose control testing intervals 54 Information stored during glucose control testing 55 Control solutions 55 Preparing to run a glucose control test 55 Performing glucose control tests 56 Overview of test procedure 56 Starting a glucose control test 57 Confirming or selecting the lot number for control solutions 58 Confirming or selectin...

Page 8: ...als 83 Information stored during linearity testing 84 Linearity test kit 84 Preparing to run a linearity test 84 Performing a linearity test 85 Overview of test procedure 85 Starting a linearity test 85 Confirming or selecting the lot number for linearity test kits 86 Confirming or selecting the test strip lot 86 Inserting test strips 87 Applying a linearity test sample 88 Results screen 89 8 Prof...

Page 9: ...8 Creating a setup password 119 Setting the date and time 120 Beeper options 121 10 Maintenance and Care 122 Conditions for storage and shipping 122 General operating conditions 122 Storage 123 Cleaning and disinfecting the ACCU CHEK Inform II system 123 Guide to cleaning and disinfecting the ACCU CHEK Inform II system 124 Cleaning and disinfecting the meter 124 Acceptable cleaning disinfecting ag...

Page 10: ...liminary note 161 Background 161 Technical implementation 162 RF specific functionalities and effective performance specifications 164 C Supplement for Other Test Entry 167 Before you start 167 Description 167 Overview of Other Test Entry 168 Introduction 168 Recording Other Test Entries 170 Recording Other Control Test Entries 176 Introduction 176 Other Control Testing Intervals 176 Stored Contro...

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Page 12: ...nosis or screening of diabetes mellitus nor for testing neonate cord blood samples The ACCU CHEK Inform II Blood Glucose Monitoring System is intended for testing outside the body in vitro diagnostic use and is intended for multiple patient use in professional healthcare settings This system should only be used with single use auto disabling lancing devices The multiple patient use ACCU CHEK Infor...

Page 13: ... the meter for on meter configuration Refer to Appendix A for configuration via a data manage ment system Be sure to read the Important safety instructions and additional information section in this chapter before operating the system The FDA CDC and CMS recommend that Point of Care blood testing devices such as the ACCU CHEK Inform II meter should be used only on one patient and not shared If ded...

Page 14: ...CU CHEK Inform II meter its serial number this manual and all related consumables when you call If you suspect a communication error beyond the meter also have your ACCU CHEK Inform II Base Unit serial number ready to help assist our customer care group in troubleshooting Note on the use of base unit in this manual Unless otherwise specified the term base unit refers to both the ACCU CHEK Inform I...

Page 15: ... which includes Time and date of test IDs for operator patient and samples Information about control solutions test strips and linearity Test results and comments n Record patient test results quality control test results and reagent information for certain off meter manual tests n For purposes of quality assurance information on the following areas can be collected stored and transferred Meters T...

Page 16: ...ic or directs the reader to related safety information WARNING WARNING Indicates a hazardous situation which if not avoided could result in death or serious injury CAUTION CAUTION Indicates a hazardous situation which if not avoided could result in minor or moderate injury NOTICE NOTICE Indicates a hazardous situation which if not avoided may result in damage to the system Important information th...

Page 17: ...essionals n Use gloves Wear a new pair of clean gloves for testing each patient n Wash hands thoroughly with soap and water before putting on a new pair of gloves and performing the next patient test n Use an auto disabling single use lancing device for each patient n Dispose of used lancets in a sturdy sharps container with lid n Dispose of used test strips from patient and proficiency tests acco...

Page 18: ...o IEC 60529 General care NOTICE To avoid damaging the system use only solutions recommended to clean and disinfect the system Using other solutions may result in incorrect operation and possible failure of the system Accessory box NOTICE Carry the accessory box carefully by the handle for easy transport Dropping or hitting the box may damage it Meter n Dispose of the meter in accordance with appli...

Page 19: ...he ACCU CHEK Inform II sys tem it must be deemed as potentially biohazardous Treat it accordingly See Disposal of the system on page 17 n When storing or disposing of the battery pack use the manufacturer s original packaging Save or download data from the meter prior to replacing the battery pack to prevent loss of data see Chapter 9 n Always power off the meter before removing the battery pack n...

Page 20: ...26 2 6 The system s emissions of the energy used are low and not likely to cause interference in nearby electronically driven equip ment Electrostatic discharge ESD is an electrical charge at rest most commonly known as static electricity If the ACCU CHEK Inform II meter experiences a form of ESD before or after running a blood glucose test the test result will be stored in the meter memory and tr...

Page 21: ...II Base Unit or ACCU CHEK Inform II Base Unit HUB must be protected against unauthorized access For additional information about the ACCU CHEK Inform II Base Unit or ACCU CHEK Inform II Base Unit HUB refer to the ACCU CHEK Inform II Base Unit HUB Operator s Manual Wireless connectivity If the meter is equipped with WLAN functionality Wireless connectivity allows the meter to send data test results...

Page 22: ...crowave ovens heaters and other non communication devices While these types of devices usually pose no threat of interference as they are low powered devices the possibility exists that some indus trial high power systems may wipe out any attempted communication use of a WLAN Therefore perform a site survey and interference analysis with a spectrum analyzer to view the entire spectrum looking for ...

Page 23: ...ed with mini mum distance of 8 inches 20 cm between the radiator and your body This transmitter must not be co located or operated in conjunction with any other antenna or transmitter Changes or modifications made to this equipment not expressly approved by Roche Diagnostics may void the FCC authorization to operate this equipment This device complies with Part 15 of the FCC Rules and with RSS 210...

Page 24: ... there is no guarantee that interference will not occur in a particular installation If this equipment does cause harmful interference to radio or television reception which can be determined by turning the equipment off and on the user is encouraged to try to correct the interference by one or more of the following measures n Reorient or relocate the receiving antenna n Increase the separation be...

Page 25: ...gement system Note Not all options can be configured using the Setup function on the meter The meter performs the following tasks within the system n Serves as the primary operator interface through the touchscreen and on off button n Performs glucose tests n Scans barcodes test strip lots controls patient and operator IDs in a variety of supported formats n Displays test results from patient test...

Page 26: ...ply touch the button on the screen 3 On Off button Press this button to power off the meter on or off 4 Barcode scanner The integrated barcode scanner can be used to read operator and patient IDs and patient information 5 Battery compartment cover Remove to insert the battery pack 6 Charging contacts These contacts are used to charge the battery pack when the meter is in the base unit 7 Infrared w...

Page 27: ...lot 9 LED green for displaying status 10 Infrared window for transmitting the code file to the meter Do not exchange code keys while the Code Key Reader LED status light is still flashing green If the Code Key Reader is still flashing green it will continue to transmit the previously loaded code file and ignore the code file on the newly inserted code key You may get an error message on the meter ...

Page 28: ... window for communication with the meter 13 Status LED lights up when power is connected Lights up red Power supply is connected application is starting up ACCU CHEK Inform II Base Unit only Lights up green Ready Flashes red Error Lights up blue Configuration mode ACCU CHEK Inform II Base Unit only 14 Jack for the power supply unit provided 15 Removable mount for wall installation The ACCU CHEK In...

Page 29: ...The HUB also provides power for the ACCU CHEK Inform II Base Unit Light When connected to a HUB an ACCU CHEK Inform II Base Unit Light does not require a separate power supply The LED colors of the HUB are the same as for the ACCU CHEK Inform II Base Unit Light 18 Status LED lights up when power is connected 19 Jack for the power supply unit provided 20 Network connection LAN Ethernet RJ45 21 USB ...

Page 30: ...e contains the Level 1 Lo control while the other bottle contains the Level 2 Hi control n ACCU CHEK Linearity Kit if required by your facility guidelines Available for purchase separately contains six 2 5 mL bottles These bottles span the glucose range in six levels L1 to L6 Your facility provides additional consumables such as blood collection supplies Observe the current rules and safety guidel...

Page 31: ...ation using the Setup Menu see Chapter 9 as well as Appendix A In addition to this option the meter can be configured using a data man agement system Suitable data management systems provide a range of functions for configuring the meter that go beyond what is possible with the meter based configuration feature For questions about using data management systems contact your Roche representative see...

Page 32: ...ns for updating these settings in Chapter 9 Contrast Power Up 12 48 pm 09 18 13 Performing self checks n If during self check an error is detected the appropriate error message appears on screen n If the QC Lockout feature is enabled and glucose control is required a corresponding message is displayed The battery icon shows the current battery level A completely filled icon indicates a fully charg...

Page 33: ...onditions 1 In the Power Up screen touch Contrast The Display screen appears 2 Touch or to make the display lighter or darker 3 Touch to confirm the setting After 30 seconds without any activity e g without a screen touch the meter automatically dims the display backlight to conserve energy Low Power Mode Display Lighter Darker 12 48 pm 09 18 13 ...

Page 34: ...work connection touch RF OFF in the Power Up screen The icon then changes to RF ON n To temporarily enable the wireless network connection touch RF ON in the Power Up screen The icon then changes to RF OFF The RF ON RF OFF button always displays the option you currently have The current communication status is dis played in the status bar bottom line of the display in all menus and screens n The i...

Page 35: ...t If an operator name matching the entered operator ID is available on the meter this name will be displayed in the Main Menu shown here as Maria S There are a number of options for entering operator IDs and these depend on the configuration of the system n Via barcode scanner only a list of supported barcode symbologies can be found in Appendix A2 n Manually or optionally via barcode scanner Oper...

Page 36: ...3 1 Press and release The button now appears with a black background during the scan 2 Hold the meter so that the window of the barcode scanner is approximately 4 8 inches above the barcode you wish to read The meter beeps once the barcode has been read suc cessfully The barcode information appears in the opera tor ID field The barcode scanner turns off after 10 seconds if a barcode is not scanned...

Page 37: ...haracters A O for letters A O P Z for letters P Z 123 for numbers 0 9 3 Touch to backspace and delete a character entered incorrectly Touch to delete the whole entry Touch to enter a space 4 Touch to confirm If the operator ID you have entered is not valid or the operator is not stored in the meter an error message is displayed Confirming the message allows you to enter the ID again Entering a pas...

Page 38: ...egulations and directives for disposing of potentially infectious samples and materials n Refer to the section Important information regarding safety starting on page 16 of this manual in particular Protection against infection and blood borne pathogens n Use gloves Wear a new pair of clean gloves for testing each patient n Wash hands thoroughly with soap and water before putting on a new pair of ...

Page 39: ...tion whether glucose control tests are necessary is displayed in the Power Up screen n If configured the meter may require downloading stored data to the data management system within defined time intervals If such a download either via WLAN or by docking the meter in a base unit does not happen within the specified time the meter is locked Download Lockout and cannot be used for testing If a gluc...

Page 40: ...ol proficiency or linearity the meter will power off after 10 minutes of inactivity no screen touches independently of configured automatic power off time If a result is already present the meter will emit three warning beeps every minute after 5 minutes of inactivity and will save the result before powering off after 10 minutes of activity n Observe the applicable regulations and directives for h...

Page 41: ...completed login by selecting and the Main Menu screen is displayed Entering or selecting the patient ID After preparing the meter as described you can proceed to the steps directly related to testing A B C D E F G H I J K L M N O P Z 123 Patient ID 123456789 12 48 pm 09 18 13 D 503 Patient ID 123456789 Name Mary Jane Miller DOB 12 03 56 Is this correct Patient Confirmation Main Menu Review Results...

Page 42: ...eriod or hyphen may be used n Enter patient ID via barcode scanner n Select a patient from a list The following options are available for validating patient IDs n Manual entries can be validated based on an downloaded list n Confirmation of patient name date of birth and ID can be required n Barcode masking can be used to eliminate any characters not belonging to the Patient ID See information on ...

Page 43: ...or letters A O P Z for letters P Z 123 for numbers 0 9 3 Touch to backspace and delete a character entered incorrectly Touch to delete the whole entry Touch to enter a space 4 Touch to confirm or touch to cancel this procedure and return to the Main Menu If the patient ID you have entered is not valid or the patient is not found in the downloaded list an error mes sage is displayed Confirming the ...

Page 44: ...he list If one of the buttons is hidden you have reached the top or bottom of the list 2 Touch the desired entry to select a patient or 3 Touch to cancel this procedure and return to the Main Menu Depending on the DMS you are using this feature may be disabled Patient ID Keyboard ID 2222222222 Name Jane Doe ID 3333333333 Name John Doe ID 4444444444 Name Jenny Doe ID 5555555555 Name James Doe 12 48...

Page 45: ...444444444 Name Jenny Doe ID 5555555555 Name James Doe 12 48 pm 09 18 13 1 Press and release The button now appears with a black background during the barcode scan 2 Hold the meter so that the window of the barcode scanner is approximately 4 8 inches above the barcode you wish to read The meter beeps once the barcode has been read suc cessfully The barcode information appears in the patient ID fiel...

Page 46: ...sired lot number from the list 2 Touch to confirm the selected test strip lot number The meter can be configured so that manual confirmation is not necessary In this setup only the lot number is displayed Additional options are not available The meter can be configured so that lot numbers are entered via barcode scanner only see note below For additional information about storing lot numbers for t...

Page 47: ...the test strip vial and close the vial with the cap 2 Hold the test strip so the lettering ACCU CHEK is facing upward 3 Slide the test strip into the test strip port as far as it goes in the direction indicated by the arrows on the test strip The meter beeps The meter beeps The hourglass icon appears and indicates that the meter is checking the test strip Do not apply blood while it is displayed P...

Page 48: ...shing drop appears in the display before applying the blood The meter beeps 2 Apply the drop of blood to the front edge yellow dosing area of the test strip Blood is pulled into the test strip by capillary action Do not apply the blood to the top of the strip Blood on top of the test strip is not available for testing because it will not be pulled into the strip Once a sufficient blood sample has ...

Page 49: ...also appear depending on system configuration notify ing you if the result exceeds the specified limit values Additionally a red flashing arrow see Patient Test screen below next to the test result indicates that a result is out of range the value is above the normal critical upper range the value is below the normal critical lower range These limit values define ranges that can either be con figu...

Page 50: ...ent 123456789 Date 09 18 13 12 48 pm mg dL 09 18 13 12 48 pm Patient Test Out of Critical Range 34 Patient 123456789 Date 09 18 13 12 48 pm mg dL 12 48 pm 09 18 13 Patient Test Out of Critical Range 305 Patient 123456789 Date 09 18 13 12 48 pm mg dL 09 18 13 12 48 pm Patient Test Out of Reportable Range RR HI Patient 123456789 Date 09 18 13 12 48 pm 12 48 pm 09 18 13 ...

Page 51: ... be quantified properly n Glucose results above or below the Reportable Range as defined by the institution or local regulatory body are above the highest or below the lowest numerical results to be reported Results outside this range must not be used for intervention decisions n Glucose results above or below the Critical Range as defined by the institution require immediate action as defined by ...

Page 52: ...ed during setup This message is then displayed with the corresponding test results Instructions on how to add comments are provided in the following section If comments are not set as required and you do not wish to add a comment to the test result touch to return to the Main Menu Test results are also saved when the meter is powered off in the results screen or when it powers off automatically Re...

Page 53: ...tient Test Out of Normal Range 220 Patient 123456789 Date 09 18 13 12 48 pm mg dL New Strip Lot Doctor Notified Will Repeat Test 09 18 13 12 48 pm Patient Test Out of Normal Range 220 Patient 123456789 Date 09 18 13 12 48 pm mg dL 09 18 13 12 48 pm To add comments 1 In the Patient Test screen touch 2 Select up to three desired predefined comment s from the display list if configured or 3 Touch to ...

Page 54: ...r technique used in testing give accu rate results on patient tests Glucose control solutions have defined known values The results for these solu tions must first fall within a certain acceptable range in order to allow valid patient testing The system may be configured to require in range glu cose control testing before patient testing is allowed This is called QC Lockout and the system actually...

Page 55: ...en using a new test strip lot for the first time and as a result a new test strip code n If a test strip vial was left open n If questionable test results are displayed repeatedly n If you wish to test the performance of the system In addition the following events can be specified during setup as a reason for a glucose control test n If a previous control test is out of range n If glucose control ...

Page 56: ...s Control solutions For blood glucose test strips control solutions have two levels n Level 1 L1 Lo low values in test results n Level 2 L2 Hi high values in test results Preparing to run a glucose control test Aside from special preparations see the following sec tion a glucose control test is run in the same manner as a patient test n At least one code file for test strips must be stored in the ...

Page 57: ...ber of the test strips n Perform the test with the control solution As mentioned previously the following steps must be completed already 1 The meter is switched on 2 You have entered your operator ID 3 You have completed login by selecting and the Main Menu screen is displayed The result must fall within the specified range as shown on the label of the test strip vial or defined per configuration...

Page 58: ...iew Results Control Test Patient Test 12 48 pm 09 18 13 1 From the Main Menu screen touch Control Test In the Control Test screen the levels available for the control solution are displayed To the right of the buttons the word Required identifies the level at which a glucose control test must be run to remove QC Lockout 2 Touch Level 1 Lo or Level 2 Hi to select the level for the following test In...

Page 59: ...n To use the preselected number displayed by the meter touch to confirm n To use a different number than the lot number displayed touch to open the keypad and enter the number manually 2 Touch to confirm the selected control lot number The meter can be configured so that manual confirmation is not necessary In this setup only the lot number is displayed Additional options are not available The met...

Page 60: ... number other than the one displayed touch to open the keypad and enter the number manually or to display a list of stored lot numbers and then select the desired lot number from the list 2 Touch to confirm the selected test strip lot number The meter can be configured so that manual confirmation is not necessary In this setup only the lot number is displayed Additional options are not available T...

Page 61: ...rom the test strip vial and close the vial with the cap 2 Hold the test strip so the lettering ACCU CHEK is facing upward 3 Slide the test strip into the test strip port as far as it goes in the direction indicated by the arrows on the test strip The meter beeps The hourglass icon appears and indicates that the meter is checking the test strip Do not apply control solution while it is displayed Co...

Page 62: ...4 12 48 pm 09 18 13 1 Wait until the flashing drop appears in the display before applying the control solution The meter beeps 2 Apply a drop of glucose control solution to the front edge of the test strip Do not apply the control solution to the top of the strip The control solution is pulled into the test strip by capillary action Once sufficient control solution has been detected the meter beep...

Page 63: ...further testing until all the required glucose control levels are successfully run QC Lockout When the results are displayed as a value the results screen contains a button that changes its name based on the result Range or Out of Range Touch this button to display the minimum and maximum target values for the control levels You can add comments to a test result as with blood glucose tests see pag...

Page 64: ...dministrator has enabled the STAT test option during setup n The number of STAT tests available has not been exceeded If these conditions are fulfilled two buttons appear in the warning message that allow you to choose the next step n Touch Run QC to run the required control test instead of a patient test n Touch Run STAT to perform a patient test even if a glucose control test is required The sta...

Page 65: ...Glucose Control Testing 64 This page intentionally left blank ...

Page 66: ...re added List of results stored in the memory To display the results from the memory as a list Glucose Results Patient QC All 04 19 13 mg dL Time Rslt 7 15 pm 74 123456789ABC 5 32 pm 229 123456789ABC 2 25 pm FAIL QC L2 12 15 pm 79 56789ABC1234 11 46 am PASS QC L1 10 01 am 74 Linearity L3 ID 09 18 13 12 48 pm Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 1 From the main menu ...

Page 67: ... view you will be asked to enter the patient ID manually or via barcode scanner The list now contains only the results for the selected patient If you touch Patient in the Patient Result view middle screen above the list of test results for this patient will be displayed 5 Touch QC if you wish to display a list of glucose control tests 6 Touch All in the Glucose Results screen to remove the Patien...

Page 68: ...system from where it can be sent to all the meters used in your facility Make sure with each test that the code stored and selected by you matches the lot number of the test strips in use Aside from the unchangeable data directly linked to the lot specific properties some of the information from the code key can be modified depending on your meter setup This information includes n Expiration date ...

Page 69: ...14 855732 11 21 14 845678 Strip 11 21 14 845723 Type Exp Date Lot Num Strip 12 48 pm 09 18 13 1 Touch to open the Main Menu 2 screen 2 Touch Strip Lots to open the related menu 3 Touch Add if you want to add the information for a new test strip lot from a new code key The Add Strip Lot screen opens 4 Insert the new code key in the opening of the code key reader The LED light starts flashing green ...

Page 70: ...you get an error message that the download was not successful re insert the same code key and try again n Do not exchange code keys while the code key reader is still flashing If the code key reader is still flashing it will continue to transmit the previously loaded code file and ignore the code file on the newly inserted code key You may get an error message on the meter Once the connection is m...

Page 71: ...he current lot number The current lot number is provided automatically for use with subsequent tests 3 Touch to confirm that you want this lot number to be the lot number currently in use or touch to store the entries without making the lot number the current lot number 4 Continue entering additional lot numbers or touch to return to the Main Menu Add Strip Lot Strip Lot Confirmation D 530 Do you ...

Page 72: ...he keypad to enter the desired expiration date use two digits and leading zero if necessary It is not possible to enter a date beyond the expiration date stored in the key 2 Touch to accept the modified date and continue to the value ranges Add Strip Lot Strip Lot Confirmation D 530 Do you want to use the suggested values for strip 545603 Use by 02 10 14 L1 Lo 43 74 mg dL L2 Hi 288 389 mg dL 12 48...

Page 73: ...12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Control L1 Min 31 mg dL 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Strip Expiration 11 30 13 12 48 pm 09 18 13 3 Use the keypad to enter the desired values one after another Minimum limit value for Level 1 Maximum limit value for Level 1 Minimum limit value for Level 2 Maximum limit value for Level 2 4 Touch to confirm each separate entry and continue to the next e...

Page 74: ...The current lot number is provided automatically for use with subsequent tests 5 Touch to confirm that you want this lot number to be the lot number currently in use or 6 Touch to store the entries without making the lot number the current lot number 7 Continue entering additional lot numbers or 8 Touch to return to the Main Menu 1 2 3 Control L2 Max 353 mg dL D 314 Do you want to make Strip lot 5...

Page 75: ... list Entering the lot number of the control solution The following description assumes that the meter is pow ered on and the main menu is displayed Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Control Lots Add QC L2 11 21 13 777678 12 31 13 777732...

Page 76: ...1 30 13 12 48 pm 09 18 13 4 Select the level L1 Lo or L2 Hi 5 Use the keypad to enter the lot number Touch to confirm the entered lot number or 6 Press and release to read the lot number from the control solution bottle via barcode scanner Follow the instructions for barcode scanning IDs see page 35 7 Use the keypad to enter the expiration date as stated on the control solution bottle 8 Touch to c...

Page 77: ...ber is provided automatically for use with subsequent tests 9 Touch to confirm that you want this control lot number to be the lot number currently in use or 10 Touch to store the entries without making the lot number the current lot number 11 Continue entering additional control lot numbers or 12 Touch to return to the Main Menu 1 2 3 Control Expiration 11 30 13 12 48 pm 09 18 13 4 5 6 D 312 Do y...

Page 78: ... Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Control Lots Add QC L2 11 21 13 777678 12 31 13 777732 11 21 13 777723 QC L1 QC L2 Type Exp Date Lot Num 12 48 pm 09 18 13 1 Touch in the main menu to open the Main Menu 2 screen 2 Touch Control Lots to open the related menu The curren...

Page 79: ... 13 Make Current 12 48 pm 09 18 13 Control Lots Add QC L2 11 21 13 777678 12 31 13 777732 11 21 13 777723 QC L1 QC L2 Type Exp Date Lot Num 12 48 pm 09 18 13 3 Touch the lot number you wish to select as the current lot number This opens the related detail view 4 Touch Make Current to make the lot number the current lot number The information Current is then also displayed in the detail view 5 Touc...

Page 80: ...g description assumes that the meter is pow ered on and the main menu is displayed Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Linearity Lots Add Lin 12 31 13 777732 03 15 14 777723 Lin Type Exp Date Lot Num 12 48 pm 09 18 13 1 Touch to open the M...

Page 81: ...shed updating the linearity test informa tion you can use the next screen to select the lot number you are currently editing as the current lot number The current lot number is provided automatically for use with subsequent tests 7 Touch to confirm that you want this lot number to be the lot number currently in use or 8 Touch to store the entries without making the lot number the current linearity...

Page 82: ...t Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Linearity Lots Add Lin 11 21 13 777678 12 31 13 777732 11 21 13 777723 Lin Lin Type Exp Date Lot Num 12 48 pm 09 18 13 1 Touch in the main menu to open the Main Menu 2 screen 2 Touch Linearity Lots to open the related menu The current line...

Page 83: ...e Exp Date Lot Num 12 48 pm 09 18 13 Linear Lot Details Edit Delete Linearity Lot 777732 Use by 12 31 13 Make Current 12 48 pm 09 18 13 3 Touch the linearity lot number you wish to select as the current lot number This opens the related detail view 4 Touch Make Current to make this lot number the current lot number The Current information is then also displayed in the detail view 5 Touch to return...

Page 84: ...aintain a constant accuracy over the full range of spec ified values If test results were plotted against reference values as a curve over the full range of these values the ideal high linearity would be a straight line Linearity is the range of values from the lowest to the highest for which an instrument is proven capable of giving accurate results Linearity testing intervals The linearity of th...

Page 85: ... solutions in six levels 6 vials 2 5 mL each For additional information about the contents and handling of the kit refer to the package insert Preparing to run a linearity test Aside from special preparations see the following sec tion a linearity test is run the same as a patient test Please check the following n At least one code file for test strips must be stored in the meter and match the lot...

Page 86: ...arity test The following description assumes that the meter is powered on and the main menu is displayed Linearity Test 12345678 Use Linearity Lot 12 48 pm 09 18 13 Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 1 Touch in the Main Menu to open the M...

Page 87: ...ou are asked to choose the test strip lot number Compare the number displayed by the meter to the number on the label of the test strip vial Select the test strip lot number as follows To read the test strip lot number from the test strip vial via barcode scanner press and release Follow the instructions for scanning IDs To use the preselected test strip lot number displayed by the meter touch to ...

Page 88: ...he test strip from the test strip vial and close the vial again with the cap 2 Hold the test strip so the lettering ACCU CHEK is facing upward 3 Slide the test strip into the test strip port as far as it will go in the direction indicated by the arrows on the test strip The meter beeps The hourglass icon appears and indicates that the meter is checking the test strip Do not apply linearity solutio...

Page 89: ...545794 12 48 pm 09 18 13 1 Wait until the flashing drop appears in the display before applying the solution The meter beeps 2 Apply a drop of the linearity solution to the front edge of the test strip Do not apply the solution to the top of the strip The linearity solution is pulled into the test strip area by capillary action Once sufficient linearity solution has been detected the meter beeps an...

Page 90: ...1 L5 L3 L6 L4 L2 Linearity 12345678 Strip Lot 545794 12 48 pm 09 18 13 You can add comments to a test result as with blood glucose tests see page 52 If you do not wish to add a comment to the test result touch to continue to the next level of the linearity test Remove the test strip and dispose of it in accordance with applicable regulations and directives Repeat the above steps for all levels of ...

Page 91: ...Linearity Testing 90 This page intentionally left blank ...

Page 92: ...ng the test The supplied samples are treated in the same manner as regular patient samples Blood glucose proficiency testing provides another means to verify that your technique reagents system and testing performance are as they should be Some regulatory agencies require that these proficiency sam ples be tested as part of an institution s quality assurance program before certification of the ins...

Page 93: ...ficiency tests the sample ID instead of patient ID must be stored as identification Sample IDs with up to 20 characters can be entered Preparing a proficiency test To perform a proficiency test you need the following n At least one code file for test strips must be stored in the meter and match the lot number of the test strips used see Chapter 6 n The proper test strips must be available n An ope...

Page 94: ...h the proficiency sample Starting a proficiency test The following description assumes that the meter is powered on and the main menu is displayed Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 1 Touch in the Main Menu to open the Main Menu 2 screen ...

Page 95: ...he test strip lot Once you have entered and confirmed the sample ID you will be asked to choose the test strip lot number Com pare the number displayed by the meter to the number on the label of the test strip vial 3 If you want to use the preselected number displayed by the meter touch to confirm To use a different number than the lot number displayed touch to select the number from a list enter ...

Page 96: ...test strip vial and close the vial with the cap 2 Hold the test strip so the lettering ACCU CHEK is facing upward 3 Slide the test strip into the test strip port as far as it will go in the direction indicated by the arrows on the test strip The meter beeps The hourglass icon appears and indicates that the meter is checking the test strip Do not apply the proficiency sample while it is displayed P...

Page 97: ...23456789 Strip Lot 545794 12 48 pm 09 18 13 1 Wait until the flashing drop appears in the display before applying the sample The meter beeps 2 Apply a drop of sample to the front edge of the test strip Do not apply the sample to the top of the test strip The sample is pulled into the test strip area by capillary action Once sufficient sample has been detected the meter beeps and the measurement be...

Page 98: ... The result is displayed as a numerical value unless it falls outside the system measurement range In this case the message HI or LO is displayed You can add comments to a test result as with blood glucose tests see page 52 If you do not wish to add a comment to the test results touch to complete the test and store the result Test results are also saved when the meter is powered off in the results...

Page 99: ...Proficiency Testing 98 This page intentionally left blank ...

Page 100: ...t if in use 2 Connect the power cord to the proper outlet 3 If you want to connect the ACCU CHEK Inform II Base Unit in a wired environment Connect the Ethernet RJ45 cable or the USB cable to the respective outlet Use only the USB cable provided with the ACCU CHEK Inform II system 4 Slide the base unit back onto the wall mount if in use For details on configuring the ACCU CHEK Inform II Base Unit ...

Page 101: ...the icon is displayed This icon shows that power is available and the meter can charge if necessary Make sure that the allowable temperature range for charging the battery pack 37 104 F or 3 40 C is maintained during installation and initial setup Replace the battery pack within approximately 10 minutes to retain the date and time settings Beyond this period of time you may have to re enter the da...

Page 102: ...partment cover in place 4 Remove the battery compartment cover from the meter The battery pack now visible is connected to the meter by a plug 5 Carefully lift the battery pack and remove the plug connector Disposal of used batteries Do not dispose of the batteries with normal domestic waste Dispose of used batteries in accordance with applicable local regulations and directives and your facility ...

Page 103: ...tery pack in your hand with the wires and the plug pinched between your thumb and index finger 3 Plug the connector plug into the socket 4 Place the battery pack inside the battery compartment as shown above To position the battery pack correctly always align the ridges on the side of the battery pack with the ridges on the inside of the battery compartment ...

Page 104: ...may appear informing you that the date and time settings have been lost due to power loss n The screens for entering the date and the time appear 7 Enter the date and time After you have entered the correct information confirm each screen with n Unless your QC configuration is Always OK the meter will now be in QC Lockout due to the manually entered date time 8 Synchronize the meter s date time wi...

Page 105: ...lowing displays appear on the meter when it is docked in an ACCU CHEK Inform II Base Unit or an ACCU CHEK Inform II Base Unit Light and communicating The same displays appear whether the meter is transferring data via base unit or via wireless connection Docked Connecting 12 48 pm 09 18 13 Docked Synchronizing Database 12 48 pm 09 18 13 Docked Transferring 50 Results to Transmit 12 48 pm 09 18 13 ...

Page 106: ...display is visible when software updates are trans ferred to the meter Note n If the meter transfers data wirelessly immediately after a test this communication is not visible on the display The display remains unchanged usually in the Main Menu view after a test n If a meter is in standby but not docked and communicating wirelessly this communication is not visible on the display Docked Busy 12 4...

Page 107: ...nfiguration options on the meter may be disabled to avoid conflicts in the settings These options then appear grayed out on the display The meter is delivered with preconfigured default set tings The following settings can be configured on the meter n Date and time format n Date and time editing enabled n Units n Test types n Lot information editing enabled n Methods for verifying lot information ...

Page 108: ...t basic settings Main Menu Observer Log in Enter Observer ID Enter Observer Password Patient Test Enter Patient ID Verify Test Strip Lot Insert Test Strip Apply Blood Sample View Test Results Add Comments Control Test Select Level Verify Control Lot Verify Test Strip Lot Insert Test Strip Apply Control Solution View Test Results Add Comments Review Results View All Test Results ...

Page 109: ... Lots View Lot List Select Control Level Add Lot Enter Expiration Date Make Lot Current Edit Delete Lot Linearity Lots View Lot List Add Lot Enter Expiration Date Make Lot Current Edit Delete Lot Linearity Verify Linearity Lot Verify Test Strip Lot Select Linearity Level Insert Test Strip Apply Linearity Solution View Test Results Add Comments Beeper Set Beeper Volume Diagnostics List Software Ver...

Page 110: ...isplay Options Result Unit Enable Tests Number of STAT Tests if enabled Reagent Options Reagent Editing Lot Verification Mode QC Frequency Control Frequency Test Ranges Normal Critical Reportable Operator ID Entry Operator Entry Operator Validation Barcode Patient ID Patient Entry Patient Validation Barcode Setup Password Change Setup Password Delete Patient Delete all patient related data patient...

Page 111: ...ip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Admin Menu Date Time Language Selection Setup Menu 12 48 pm 09 18 13 Setup Menu Date Time QC Test Display Password Test Ranges Reagents Operator ID Patient ID Unlock Delete Pat 12 48 pm 09 18 13 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Admin to open the Admin Menu 3 Touch Set...

Page 112: ...ntering a password n Time Format 12 hour AM PM 24 hour n Date Format mm dd yy The date is displayed in two digit month day year format dd mm yy The date is displayed in two digit day month year format 2 Touch to save the settings or 3 Touch to exit this menu without saving any changes The display returns in both cases to the Setup Menu When using a data management system for configuration it is po...

Page 113: ...layed in the Main Menu 2 screen Proficiency is displayed in the Main Menu 2 screen Maintenance is displayed in the Main Menu 2 screen 2 Touch to save the settings If the STAT option is enabled enter the number of STAT tests allowed or 3 Touch to exit this menu without saving any changes The display returns in both cases to the Setup Menu after entering the number of STAT tests allowed Test Disp Op...

Page 114: ... The lot number is shown on screen but the operator cannot confirm it or select a different lot number Confirmation The operator must confirm the lot number displayed and can enter alternative lot numbers manually or via barcode scanner List selection The operator can also select from a list of stored lot numbers Scan only Lot numbers can be verified via barcode scanner only 2 Touch to change to t...

Page 115: ... enter the lot number Scan only Lot numbers can be verified via barcode scanner only n Linearity Lot Verification Display only The lot number is shown on screen but the operator cannot confirm it or select a different lot number Confirmation The operator must confirm the lot number displayed and can enter alternative lot numbers manually or via barcode scanner Lot entry The operator must enter the...

Page 116: ...un successfully the counter is reset to 0 Strip Count QC Lockout is activated after reaching the specified number of tests When a glucose control test is run successfully the test strip counter is reset to 0 Shift QC Lockout is activated per shift Time Of Day QC Lockout is activated at the specified time of day Up to six times per day can be configured Rotating QC QC tests require alternating use ...

Page 117: ...48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Critical Range Lo 40 mg dL 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Report Range Hi 600 mg dL 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Normal Range Hi 200 mg dL 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Critical Range Hi 301 mg dL 12 48 pm 09 18 13 Values for range limits are entered one directly after the other in the following order n Normal low high limit value n Critic...

Page 118: ...h up to 20 characters Enter the minimum and maximum lengths after selecting this option List The operator ID must be on a list received from the DMS List with password The operator ID must be on a list received from the data management system DMS Additionally a password must be entered 2 Touch to save the settings If the Length option is enabled enter the desired numbers or 3 Touch to exit this me...

Page 119: ...ient IDs are validated for their length Alphabetic patient IDs are not validated List must be on list The patient ID must be on a list received from the DMS List allowed to add new The patient ID will be checked against a list received from the DMS However it is allowed to create a new patient ID using the meter 2 Touch to save the settings If the Length option is enabled enter the desired numbers...

Page 120: ...tion is required to access the Setup Menu Store your password in a safe place 1 Use the keypad to enter the password 2 Touch to save the password and enable password protection Password protection will take effect only after the next power on The display returns to the Setup Menu or 3 Touch to exit this screen without saving any changes The display returns to the Main Menu To disable password prot...

Page 121: ... Date Time Language Selection Setup Menu 12 48 pm 09 18 13 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Admin to open the Admin Menu 3 Touch Date Time to begin entering the date 1 2 3 4 5 6 7 8 9 0 Date 09 18 13 09 30 13 12 48 pm 1 2 3 4 5 6 7 8 9 AM PM 0 Time 12 48 pm 09 18 13 12 15 pm Admin Menu Date Time Language Selection Setup Menu 12 15 pm 09 18 13 4 Enter the date first t...

Page 122: ...Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Beeper Setup Medium Low High Beeper Volume 12 48 pm 09 18 13 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Beeper to set the volume 3 Touch the button with the desired volume When you touch a button the meter will beep at the corresponding volume 4 Touch to save the setting and return to the Main Men...

Page 123: ...ng it n Protect the base unit from dripping liquid n Do not immerse the meter or base unit in any liquid n Follow the instructions for cleaning and disinfecting beginning on page 123 Observe the following safety information to ensure the system functions properly Improper handling can lead to erroneous test results n Do not expose the meter to excessive sources of heat for prolonged periods of tim...

Page 124: ... and not shared If dedicating blood glucose meters to a single patient is not possible the meters must be properly cleaned and disinfected after every use following the guidelines given in this section 3 For technical assistance or questions on cleaning and disinfecting please contact ACCU CHEK Customer Care at 1 800 440 3638 1 FDA Public Health Notification Use of Fingerstick Devices on More than...

Page 125: ... disinfecting should be removed and hands washed thoroughly with soap and water before performing the next patient test Cleaning and disinfecting the meter n Clean the meter to remove visible soil and organic material prior to disinfecting 3 n Disinfect the meter to destroy pathogenic and other types of microorganisms Disinfection destroys most recognized pathogenic microorganisms but not necessar...

Page 126: ...th Germicidal Disposable Wipes EPA reg no 9480 4 Pre moistened disinfecting cloths active ingredient 0 5 quaternary ammonium chlorides and up to 60 isopropanol n Cleaners and disinfectants were validated separately and only one cleaning disinfecting solution should be used on the device as the effect of using more than one cleaner disinfectant interchangeably has not been evaluated NOTE Always use...

Page 127: ...eter surface Technical Assistance If you notice any of the following signs of deterioration after cleaning or disinfecting of your meter system stop using the system component and contact ACCU CHEK Customer Care at 1 800 440 3638 for assistance clouding of the touchscreen display on off button button malfunction clouding of the infrared data port and or barcode scanner or quality control results o...

Page 128: ...n Do Not get any moisture in the test strip port n Do Not spray anything onto the meter n Do Not immerse the meter in liquid If you suspect that moisture may have entered the test strip port perform a glucose control test NOTICE Do not allow liquid to enter the test strip port or allow pooling of liquid on the touchscreen If liquid does get into the test strip port immediately dry the components w...

Page 129: ... surface of the meter 3 Use a Clorox Germicidal Wipe or Super Sani Cloth Germicidal Disposable Wipe to clean by gently wiping the outside of the meter and carefully wipe around the test strip port area making sure that no liquid enters the test strip port and then wipe dry with a tissue 4 Dry the meter thoroughly with a dry cloth or gauze Visually verify that no solution is seen anywhere on the me...

Page 130: ...the outside of the meter three times horizontally and three times vertically and carefully wipe around the test strip port area making sure that no liquid enters the test strip port 2 Allow the surface of the meter to remain damp with the recommended disinfecting solution The recommended contact times are as follows Clorox Germicidal Wipes a 1 minute contact time and Super Sani Cloth Germicidal Di...

Page 131: ... 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Add Comments 09 18 13 Cleaned Meter 12 48 pm 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Maintenance to open the screen for adding comments 3 Select the desired comment s from the list or touch to enter your own comment via keypad 4 Once you ...

Page 132: ...here are for illustration purposes only Information shown on your meter may differ Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Diagnostics S W Version 04 00 00 BSP Version 05 00 00 Last Download 09 16 13 Battery Voltage 3 976 V Battery Percent 83 ...

Page 133: ...ion 9 None Operator Validation 0 Configuration Page 3 Hours 24 QC Freq Strip Limitations Warning Used Disabled Enabled Allowed Allowed 12 48 pm 09 18 13 Diagnostics Test Authenticated RF activated Associated Configured IP IP Subnet Gateway DNS Contacted DMS Connected to DMS Completed Wireless Status 12 48 pm 09 18 13 3 Touch or to scroll between screens 4 Touch Log to display stored error messages...

Page 134: ...cess to the data management system Since unlocking is a function of the Setup Menu it is restricted to persons who know the setup password The following description assumes that the meter is powered on and the main menu is displayed Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 09 18 13 Admin Menu Date Time Language Selection...

Page 135: ... L M N O P Z 123 D 201 Delete Data Are you sure you want to delete all patients and all results from this meter This operation cannot be undone Patient Confirmation 12 48 pm 09 18 13 To ensure deleted data is not transferred back through an unwanted automatic synchronization with the DMS remove the battery pack immediately after deleting patient data Be aware that the function Delete Patient irrev...

Page 136: ... further assistance is required contact ACCU CHEK Customer Care Errors and unusual behavior without error messages Some conditions may arise that have no associated error message Refer to the following table if such a condition arises on the ACCU CHEK Inform II system Display symptom Possible solution No message or unusual behavior Meter display does not power on Wait 10 seconds and try turning on...

Page 137: ...ed according to the requirements of your facility Meter displays Strip defect Error The test strip is defective or the blood glucose result is extremely low and below the meter s measurement range Refer to the package insert for the test strips Check that you are performing the test correctly see Chapter 3 Run a glucose control test with a new test strip see Chapter 4 Repeat the test or proceed ac...

Page 138: ...ter 2 Check whether the data transfer icon shows that the last attempt at data transfer was successful see Chapter 2 Dock the RF enabled meter into a hard wired base unit to transfer the data see Chapter 9 Check the meter WLAN performance in Diagnostic Screen 7 on the meter Reset the meter by pressing the On Off button for 12 seconds If the error persists contact ACCU CHEK Customer Care Base unit ...

Page 139: ...ess the On Off button on the meter Battery Low Charge the battery by placing the meter in the base unit Battery Critically Low Charge the battery by placing the meter in the base unit Check that the battery pack is correctly installed and connected Replace the defective battery pack Follow the instructions in Chapter 9 to avoid data loss when replacing the battery pack ...

Page 140: ...lem The different message types are illustrated in the following table Sample message type Description Linearity Lots D 311 Do you want to make Linearity lot 777678 the current lot Make Current 12 31 13 777732 Lin 03 15 14 777723 Lin Exp Date Lot Num Type 12 48 pm 09 18 13 D Decision To confirm touch To reject touch Patient Test Patient 123456789 Date 09 18 13 12 48 pm 150 L22 12 48 pm 09 18 13 Ra...

Page 141: ... Please see your System Administrator Invalid Scan 12 48 pm 09 18 13 1 2 3 E Error touch to confirm To resolve the problem take the actions suggested Patient Test 09 18 13 Out of Crit Range 12 48 pm Patient 123456789 Date 09 18 13 12 48 pm 310mg dL W 511 Out of Critical Range Out of Critical Range W Warning touch to confirm ...

Page 142: ...check the Versions screen appears for a few seconds then disappears The Versions screen shows the version numbers of the meter components The Versions screen shown here is for illustration purposes only Version numbers on your meter may differ n A message appears informing you that the date and time settings have been lost due to the meter reset 3 Confirm the message Loss of Date Time SP HUQHO 5RR...

Page 143: ...reen with n Unless your QC configuration is Always OK the meter will now be in QC Lockout due to the manually entered date time 5 Meter may have to be docked in the base unit for synchronization of the meter s date time with the date time of your facility 1 2 3 4 5 6 7 8 9 0 Date 09 18 13 09 30 13 12 48 pm 1 2 3 4 5 6 7 8 9 AM PM 0 Time 12 48 pm 09 18 13 12 15 pm ...

Page 144: ... 573 g with wall mount N A User interface Touchscreen and barcode scanner LED tricolor red green blue LED green Display resolution touchscreen 320 x 240 pixel N A N A Memory 1 000 Results 5 000 Operator IDs 4 000 Patient IDs 300 Predefined comments 20 Code Files test strip lots 100 Reagent Lots control linearity N A N A Measurement temperature 61 to 95 F 16 to 35 C N A N A Storage temperature long...

Page 145: ...ode 128 Code 39 Code 93 EAN 13 Interleaved 2 of 5 Codabar GS1 DataBar Limited QR Code DataMatrix PDF417 N A N A Not applicable to ACCU CHEK Inform II Base Unit Light EAN 13 barcodes are not recommended for identification of operators and patients Interleaved 2 of 5 codes can only be decoded if they contain a check digit Specification Accessory box Code key reader Base unit HUB Height 3 35 in 85 mm...

Page 146: ...Meter only 05060311001 ACCU CHEK Inform II Meter Meter equipped with WLAN functionality 05060303001 ACCU CHEK Inform II Base Unit Equipped with charging and connectivity functionality 05060290001 ACCU CHEK Inform II Base Unit Light Equipped with charging functionality 05920353001 ACCU CHEK Inform II Base Unit Wall Mount Wall Mount for Base Unit Base Unit Light 05404878001 ACCU CHEK Inform II Base ...

Page 147: ...equested on a standard data exchange medium from the manufacturer at the following address Roche Diagnostics GmbH Sandhofer Str 116 68305 Mannheim Germany The complete license agreements are stored as a text file file name license PDF on the ACCU CHEK Inform II Base Unit of the ACCU CHEK Inform II system The file License PDF is located in the same folder as the file ROCHE HBU BU Technical Note pdf...

Page 148: ...tive If you do not already have contact details visit our website on www roche com Select Roche in your country at the top of the page and then select your country to find the appropriate local office contact infor mation The ACCU CHEK Inform II system is manufactured for and distributed by In the United States Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 ...

Page 149: ...General Product Information 148 This page intentionally left blank ...

Page 150: ...tor using a data management system the configuration options on the meter may be disabled to avoid conflicts in the settings This option is indicated by the use of parentheses e g Y DMS Configuration options may vary depending on available DMS settings Configuration options Subject Attribute Range Default Device DMS Timer Shutdown timeout meter powers off if no activity 30 3 600 s 300 N Y Beeper B...

Page 151: ...Y Control result display 0 value numeric 1 PASS FAIL 0 N Y Critical range display 0 value numeric 1 HI LO 0 N Y Critical range HI limit 10 600 mg dL 0 6 33 3 mmol L 600 mg dL 33 3 mmol L Y Y Critical range LO limit 10 600 mg dL 0 6 33 3 mmol L 10mg dL 0 6 mmol L Y Y Critical range message enabled Whether to display the out of critical range warning message 1 or not 0 1 N Y Critical range text 0 10...

Page 152: ...message Whether to display a reportable range message 1 or not 0 1 N Y Reportable range message text 0 100 characters N Y Strip limitations warning Configuration whether to display the strip limitations warning 1 or not 0 0 Y Y Strip lot verification 0 display only 1 yes no confirmation 2 list selection 3 scan only 1 Y Y Linearity lot verification 0 display only 1 yes no confirmation 2 prompt for ...

Page 153: ...enabled maintenance comments are allowed 0 disabled 1 enable 1 Y Y Main menu 2 Proficiency allowed if enabled proficiency tests are allowed 0 disabled 1 enable 0 Y Y Admin menu Setup if enabled access to setup screens is possible 0 disabled 1 enable 1 Y Y Setup password 0 20 characters Y Y Reagent editing allowed 1 Allowed 2 Password needed 0 Not allowed 1 Y Y Operator ID Operator ID entry control...

Page 154: ...parate table at the end of this chapter 0 300 characters N Y The number of characters in the unmasked barcode may not exceed 20 Patient ID Patient ID confirmation 0 disabled 1 name 2 date of birth DOB 3 name DOB 0 N Y Depends on available DMS settings Patient ID entry mode 0 Keyboard Scan 1 List Keyboard Scan 2 Scan only 3 Prompt numeric 0 Y Y Patient ID validation mode Allowed characters a z 0 9 ...

Page 155: ...t to Shift or Shift rotate 1 2 3 4 6 8 12 24 hours 8 N Y QC shift start time of the shift start if the QC algorithm is set to Shift or Shift rotate 0 23 hours 6 N Y QC strip count number of tests a PASS control remains valid 1 999 50 Y Y QC time of day 6 POCT1 A data fields 00 00 23 59 06 00 09 00 12 00 15 00 18 00 22 00 N Y QC time of day set 6 POCT1 A data fields 0 or 1 1 0 0 0 0 0 N Y Result de...

Page 156: ...HCP is used the DHCP subnet mask will be used 0 0 0 0 255 255 255 255 0 0 0 0 N Y Use DNS 0 disabled 1 enabled 0 N Y DMS host the host s DNS name if DNS is used 0 20 characters N Y DMS IP address the host s IP address if no DNS is used 0 0 0 0 255 255 255 255 0 0 0 0 N Y DMS port the port number to request open socket from the DMS Roche recommends use of port numbers 1024 0 65 535 0 N Y DNS IP IP ...

Page 157: ...e EAP type TLS PEAP or TTLS and the diverse EAP configuration settings have to be configured SSID 0 32 characters N Y WEP key 40 or 104bits NUL terminated string of 10 or 26chs HEX 00000 00000 N Y WEP authentication 0 open system authentication 1 shared key authentication 0 N Y WPA Key Type 0 Passphrase 1 Key 0 N Y WPA Key string of 64 characters HEX 0000000000 0000000000 0000000000 0000000000 000...

Page 158: ...passphrase 0 open 0 none 1 WEP 4 WEP40 0 open 1 shared 10 characters HEX 1 WEP 5 WEP104 0 open 1 shared 26 characters HEX 2 WPA_PSK 1 AES WPA2 0 passphrase 8 63 characters 2 WPA_PSK 1 AES WPA2 1 key 64 characters HEX 2 WPA_PSK 2 TKIP WPA 0 passphrase 8 63 characters 2 WPA_PSK 2 TKIP WPA 1 key 64 characters HEX 2 WPA_PSK 3 AES TKIP WPA2 WPA 0 passphrase 8 63 characters 2 WPA_PSK 3 AES TKIP WPA2 WPA...

Page 159: ... data character in this position must be a number 0 9 and it is not kept as part of the ID If the scan data character is not a number the scan data is not a valid ID Plus The scan data character in this position must be an alpha character A Z and it is not kept as part of the ID If the scan data character is not an alpha character the scan data is not a valid ID Caret This mask character denotes t...

Page 160: ...3 barcodes although widely used in retail are less recommendable for patient operator barcodes If used they demand the very highest quality standards of barcode creation and reproduction The barcode samples shown here are for illustration purposes only If printed out they can be used to check the barcode scanner However they are not meant to be used as a reference for size or resolution of real pa...

Page 161: ...Appendix 160 Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2 of 5 can only be decoded if they contain a check digit GS1 DataBar Limited PDF417 DataMatrix QR Code ...

Page 162: ...smit data3 The ACCU CHEK Inform II system adheres to IEEE Standard 802 11b 2 4 GHz range 4 The system is backwards compatible to 802 11b During wireless communication to an Access Point AP the ACCU CHEK Inform II meter recog nizes the existent AP WLAN protocol configuration 802 11b or 802 11g and automatically transmits data using the appropriate communication protocol5 1 The ACCU CHEK Inform II s...

Page 163: ...or to connecting any wireless device to a wireless net work it is recommended that a WLAN site survey be per formed The goal of a WLAN site survey is to ensure that Access Points will provide enough coverage and perfor mance to support any new radio frequency RF applica tion or device The survey will also detail RF signals including all existing WLANs along with any competing RF signals and interf...

Page 164: ...y WEP security mechanisms with Temporal Key Integrity Protocol TKIP and Advanced Encryption Standard AES In addition the system supports the extensible authentication protocol EAP with EAP TLS EAP TTLS MSCHAPv2 and PEAPv0 EAP MSCHAPv2 The ACCU CHEK Inform II meter interoperability Wi Fi certificate can be accessed at http certifications wi fi org search_products php Further information including a...

Page 165: ...new protocol As described above the ACCU CHEK Inform II meter sup ports the 802 11g standard This translates into the fol lowing RF specific performance claims n The ACCU CHEK Inform II meter is capable of trans ferring to a suitable DMS via WLAN a data set of up to 1000 result records 100 reagent records and 500 operator ID records in less than 15 minutes when operated in a typical WLAN environme...

Page 166: ...ce between WLAN device and AP within which communication can be guaranteed The ACCU CHEK Inform II system is designed such that it coexists with other wirelessly communicating devices The ACCU CHEK Inform II system does NOT include any real time or even time critical wireless functionality It communicates exclusively single digital data fields It does NOT communicate continuous waveform data Note ...

Page 167: ...Appendix 166 This page intentionally left blank ...

Page 168: ...ation to a data management system DMS The availability of OTE tests may vary by DMS functionality The activation of this feature is only possible via a suitable DMS Activating this feature permanently adds an additional step to the Patient Test or a Control Test sequence Once this feature is activated you will have to select the type of test Glucose Test Other Test or Glucose Control Test Other Co...

Page 169: ...allows you to add information about prescribed insulin type and number of units n Rapid Acting Insulin n Regular Insulin n Intermediate Acting Insulin n Long Acting Insulin n Insulin Mixtures In the Review Result listing the test names for the above tests will be abbreviated as follows n Pregnancy Preg n Visual UA VUA n Rapid Strep Strep n Rapid DAT DAT n Fecal Occult F Occ n Gastric Occult G Occ ...

Page 170: ... n Enter the date and time the test was performed n Enter or confirm the test strip kit and or other reagent lot numbers This can be done either manually or by using the barcode scanner if a barcode is available n Enter the test strip kit and or other reagent expiration date the first time a lot number is entered n Enter the onboard control result s if available n Enter the test result s n Select ...

Page 171: ...ew Results Control Test Patient Test 12 48 pm 09 18 13 Other Patient Tests Pregnancy Visual UA MS Visual UA CS Rapid Strep Rapid DAT 09 18 13 12 48 pm Patient Test Menu Glucose Test Other Test 09 18 13 12 48 pm 1 From the Main Menu screen touch Patient Test 2 From the Patient Test Menu touch Other Test 3 Touch or to scroll up or down in the list 4 Select the desired test from the display list If y...

Page 172: ...more information Touch to proceed to the next screen 1 2 3 4 5 6 7 8 9 0 Date Tested 09 18 13 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 0 Time Tested AM PM 12 48 pm 09 18 13 12 48 pm 6 Use the keypad to enter the date the test was performed For single digit numbers add a leading zero Touch to proceed to the next screen 7 Use the keypad to enter the time the test was performed For single digit numbers ad...

Page 173: ...nner to enter the Fecal Card Lot number and touch to proceed to the next screen OR if configured n Touch to confirm that you want to use the preselected lot number displayed by the meter n Touch to enter a new lot number if you want to use a different lot number than the one displayed If you touch to confirm the displayed lot number the meter will not prompt for expiration date 9 Use the keypad to...

Page 174: ...code is available to enter the Fecal Developer Lot number and touch to proceed to the next screen Or if configured n Touch to confirm that you want to use the preselected lot number displayed by the meter n Touch to enter a new lot number if you want to use a different lot number than the one displayed If you touch to confirm the displayed lot number the meter will not prompt for expiration date 1...

Page 175: ...t acceptable 09 18 13 12 48 pm Fecal Occult Pat ID 150 88 256 Result Select a Fecal Occult result positive negative 09 18 13 12 48 pm 12 Select the result of the Positive Control as acceptable or not acceptable by touching the appropriate button 13 Select the result of the Negative Control as acceptable or not acceptable by touching the appropriate button 14 Select the patient test result as posit...

Page 176: ...Pat result screen is displayed 15 To change an entry or a result touch the appropriate button To add comments refer to Adding Comments in this manual for more information 16 In the result screen touch 17 Select the desired predefined comment from the display list if configured or 18 Touch to enter your own custom comment Use the keypad as with login to enter your comment 19 Once you have selected ...

Page 177: ...trol solutions should be used on a reg ular basis as established by your institution s quality control protocols The results for these solutions should be within a certain acceptable range in order to ensure valid OTE testing Other Control Testing Intervals Intervals between running control tests are determined by your institution Quality control lockout is not available for Other Test Entry Store...

Page 178: ...onfirm the kit or test strip lot number This can be done either manually or by using the barcode scanner if a barcode is available n Enter the kit or test strip expiration date n Enter or confirm the control lot number n Enter the control lot expiration date n Select the control result s The control solution results must fall into the acceptable range indicated on the test kit or reagent packaging...

Page 179: ...A CS Rapid Strep Rapid DAT 09 18 13 12 48 pm Control Test Menu Glucose Control Test Other Control Tests 09 18 13 12 48 pm 1 From the Main Menu screen touch Control Test 2 From the Control Test Menu touch Other Control Tests Other Control Tests Pregnancy Visual UA MS Visual UA CS Rapid Strep Rapid DAT 09 18 13 12 48 pm Pregnancy Control Positive Liquid Control Negative Liquid Control 09 18 13 12 48...

Page 180: ... 6 Use the keypad to enter the Pregnancy Ctrl Lot expiration date Touch to proceed to the next screen 1 2 3 4 5 6 7 8 9 0 Date Tested 09 18 13 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 0 Time Tested AM PM 12 48 pm 09 18 13 12 48 pm 7 Use the keypad to enter the date the test was performed For single digit numbers add a leading zero Touch to proceed to the next screen 8 Use the keypad to enter the time t...

Page 181: ...le to enter the Pregnancy Kit Lot number Touch to proceed to the next screen 10 Use the keypad to enter the Pregnancy Kit Lot expiration date Touch to proceed to the next screen 1 2 3 4 5 6 7 8 9 A O 0 Pregnancy Kit Lot 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 0 Expiration Date 07 30 14 09 18 13 12 48 pm ...

Page 182: ...riate button 12 Select the result of the liquid control test Ctrl Result as acceptable or not acceptable by touching the appropriate button Once the results are entered the Pregnancy Control result screen is displayed 13 To change an entry or a result touch the appropriate button To add comments refer to Adding Comments in this manual for more information 14 In the result screen touch 15 Select th...

Page 183: ...esult is in ques tion These screens are important flags as they caution that test information may not be valid or accurate See Pop Up Messages section of this manual When entering other patient and other control test results the user may be prompted to enter a control test control bar result as either acceptable or not acceptable If the result is entered as not acceptable subse quent patient resul...

Page 184: ...e following steps to Review Other Test result s Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Other Test Results Patient QC All 09 18 13 Type ID 12 15 pm 12 25 pm Strep VUA Positive Ctrl 10 32 am 9 12 am VUA F Occ Negative Ctrl 8 20 am DAT 54344478 8 31 am Preg 150 88 256 Time 150 88 256 150 88 256 09 18 13 12 48 pm Test Result Menu Review Glucose Test Review Other Test 09 1...

Page 185: ...C Patient ID 150 88 256 Dev Lot Card Lot Name Helen Schneider 45233 11 30 13 1283 12 30 13 09 18 13 9 12 am Page 1 2 09 18 13 12 48 pm Fecal Occult Pat QC Patient ID 150 88 256 Doctor Notified Negative Ctrl Positive Ctrl Page 2 2 acceptable negative Result acceptable 09 18 13 12 48 pm 3 Touch or to scroll up or down in the list The results are grouped by date 4 Touch an entry in the list to displa...

Page 186: ...lts Patient All QC 09 18 13 Type ID 12 15 pm Strep Positive Ctrl 8 20 am DAT Negative Ctrl Time 09 18 13 12 48 pm 6 Touch Patient if you wish to display results for a specific patient only If you touch Patient from the full list view you will be asked to enter the patient ID manually or via barcode scanner The list now contains only the results for the selected patient 7 Touch QC if you wish to di...

Page 187: ...Configuration Options Other Test Entry options can only be configured using a DMS The availability of electronic configuration options will thus vary according to the data management soft ware utilized by your institution Consult your system administrator ...

Page 188: ...er with the glucose test result and any desired comments This function needs to be configured by the system administrator and depends on available DMS settings Electronic configuration options will thus vary according to the data management software utilized by your institution If so configured the operator may receive a message from the DMS when he or she tries to log in to the meter This message...

Page 189: ... the Patient Test Menu the Glucose Test button is grayed out disabled until the observer has logged in 2 Touch Observer Login 3 Wait until the Observer ID screen is displayed Enter your operator ID or scan your operator ID barcode Enter the optional password in the Observer Password screen and touch to log in The Patient Test Menu is displayed again The Glucose Test button is now available 5 Hand ...

Page 190: ...plete OTS Valid Glucose Result No Yes OTS Pass Fail 12 48 pm 09 18 13 Patient Test OTS Range 150 Patient 123456789 Date 09 18 13 12 48 pm mg dL 09 18 13 12 48 pm Observer 8 Touch to log in again 9 After you enter your password touch to proceed with the assessment 10 Assess the test result validity by touching Yes or No 11 Assess the operator s performance by touching Pass or Fail 12 Touch if you w...

Page 191: ...Supplement for Observed Test Sequence 190 This page intentionally left blank ...

Page 192: ... a replacement meter whichever period is longer The purchaser s sole and exclusive remedy with respect to the ACCU CHEK Inform II meter shall be repair or replacement in Roche Diagnostics sole discretion An optional wireless card is made available for use in the ACCU CHEK Inform II system These wireless cards have been validated for use with the ACCU CHEK Inform II meter Use of a matched or unmatc...

Page 193: ...I METER NO WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE IF ANY IS IMPLIED FROM THE SALE OF THE METER SHALL EXTEND FOR A LONGER DURATION THAN 1 YEAR FROM THE DATE OF PURCHASE Some states do not allow limitations on how long an implied warranty will last or the exclusion of incidental or consequential damages so the above limitation and exclusion may not apply to you This warranty...

Page 194: ...Menu overview 106 108 Contrast 32 Control frequency 114 Control lots Editing control lot data 70 75 Selecting 56 Storing information 65 80 Control solution Lot number 56 Critical range 49 115 CR LO HI 49 D Date and time 119 Date and time format 110 Diagnostics 120 Disinfecting 124 129 Disinfecting agents 126 Display options 111 Disposal 19 Docking the meter 103 Download lockout 39 61 Unlocking 122...

Page 195: ...w 106 108 N Normal range 49 115 O Observed test sequence 179 180 Operating conditions general 123 Operator ID 34 36 Barcode Scanner 35 Entering manually 36 Options 116 Password 36 Ordering 141 P Password 118 Patient glucose testing 37 50 Performing a test 39 49 Preparing 38 Results 47 Patient ID 39 43 Barcode scanner 43 Entering manually 41 Options 117 Powering up 31 Product information 143 146 Pr...

Page 196: ...rage 124 Strip lot Selecting 44 57 System Cleaning 124 129 Components 25 Disinfecting 124 129 General information 143 152 Initial startup 97 122 Maintenance 124 129 Overview accessory box 29 Overview base unit 28 Overview code key reader 27 Overview meter 26 Technical data 139 Troubleshooting 130 136 T Technical data 139 Test strip lots Storing information 65 79 Test strip options 112 Test strips ...

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Page 199: ...che Manufactured for and distributed in the U S A by Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www accu chekinformii com www roche com www accu chek com 05234646003 2014 02 USA ...

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Accu-Chek Inform 2, Operator'S Manual

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