Roche ACCU-CHEK Inform II Operator'S Manual Download

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Accu-Chek

Inform II

BLOOD GLUCOSE MONITORING SYSTEM

Operator’s Manual

Summary of Contents for ACCU-CHEK Inform II

Page 1: ...Accu Chek Inform II BLOOD GLUCOSE MONITORING SYSTEM Operator s Manual ...

Page 2: ... version 03 00 Version 4 0 2012 11 Update new SW version 03 04 OTS OTE revision Cleaning Disinfection section misc editorial revisions Version 5 0 2013 09 Transition to new meter hardware 2D barcode scan ner modifications to wireless LAN option separate insertable RF card replaced by integrated WLAN com ponent new battery pack Update to SW 04 00 misc editorial revisions ...

Page 3: ...0 4807839001 05 2013 09 EN Operator s Manual Version 5 0 A ACCU CCU CHEK HEK Inform II System ...

Page 4: ...de every reasonable effort to ensure that all the information contained in this manual is correct at the time of printing However Roche Diagnostics reserves the right to make any changes necessary without notice as part of ongoing product development Please send questions or comments about this manual to your local Roche representative ACCU CHEK ACCU CHEK INFORM ACCU CHEK PERFORMA and COBAS are tr...

Page 5: ...edical device This product fulfills the requirements of the European Directives 98 79 EC on in vitro diagnostic medical devices and 1999 5 EC on radio and telecommunications terminal equipment R TTE The system fulfills the Canadian and U S safety requirements UL LISTED in accordance with UL 61010 1 and CAN CSA C22 2 No 61010 1 Power supply connection This device complies with Part 15 of the FCC Ru...

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Page 7: ...k protection from unauthorized access 22 Wired network connection 22 Wireless connectivity 23 Radiofrequency radiation exposure information 24 1 3 System components 27 1 4 Overview of the meter 28 1 5 Overview of the code key reader 30 1 6 Overview of the base unit 31 1 7 Overview of the Accu Chek Inform II Base Unit Hub 32 1 8 Overview of the accessory box 33 1 9 Reagents and consumables 33 1 10 ...

Page 8: ...l tests 61 Overview of test procedure 61 Starting a glucose control test 62 Confirming or selecting the lot number for control solutions 63 Confirming or selecting the test strip lot 64 Inserting test strips 65 Applying the control solution 66 Results screen 67 Performing a STAT test 68 5 Review Results 69 5 1 Displaying test results from the memory 69 Information stored in data records for test r...

Page 9: ...ency test 99 Overview of test procedure 99 Starting a proficiency test 99 Entering the proficiency sample ID 100 Confirming or selecting the test strip lot 100 Inserting test strips 101 Applying a proficiency sample 102 Results screen 103 9 Initial Startup 105 9 1 Connecting the base unit 105 9 2 Installing or replacing the battery pack 106 Removing the battery pack 107 Installing the battery pack...

Page 10: ... 10 4 Diagnostics view 140 10 5 Unlocking a Download Lockout 142 10 6 Deleting patient data 144 11 Troubleshooting 145 Errors and unusual behavior without error messages 145 Pop up messages 149 Meter reset 151 12 General Product Information 153 12 1 Technical data 153 12 2 Further Information 156 Ordering 156 Accu Chek Inform II Operator s Manual and Quick Reference Guide 157 Reagents and Solution...

Page 11: ...er Patient Tests 185 C 4 Recording Other Control Tests 192 Introduction 192 Other Control Testing Intervals 192 Stored Control Information 192 Warning messages 198 C 5 Reviewing Other Test Results 199 C 6 Other Test Entry Configuration Options 202 D Supplement for Observed Test Sequence 203 Observed Test Sequence OTS 203 Using the OTS function 204 Index 207 ...

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Page 13: ...ecord keeping associated with blood glucose and glucose control tests Important information regarding use Read this operator s manual as well as the package inserts for all relevant consumables before using the system for the first test You must configure the Accu Chek Inform II system according to your needs before initial use You can con figure the system either directly on the meter or by using...

Page 14: ...ts serial number this manual and all related consumables when you call If you suspect a com munication 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 Note on illustrations in this manual Unless otherwise specified the term base unit refers to both the Accu ...

Page 15: ...n 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 Record patient test results quality control test results and reagent information for certain off meter manual tests For purposes of quality assurance information on the following areas can be collected stored and transferred Meters Test...

Page 16: ...neric 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...

Page 17: ...n Operators need to adhere to Standard Precautions when handling or using the Accu Chek Inform II system All parts of this system should be considered potentially infectious and are capable of transmitting blood borne pathogens between patients and healthcare professionals Use gloves Wear a new pair of clean gloves for testing each patient Wash hands thoroughly with soap and water before putting o...

Page 18: ...g disinfection solution comes into contact with your skin wash it off immediately with water Follow all health and safety regulations in force locally WARNING Infection by a potentially biohazardous instrument The Accu Chek Inform II system or its components must be treated as potentially biohazardous waste Decontam ination i e a combination of processes including clean ing disinfection and or ste...

Page 19: ...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 inactivity NOTICE The system is not protected against the harmful ingress of fluids IP X0 rating according to IEC 60529...

Page 20: ... as soon as possible to the base unit for recharging The Battery Critically Low warning indicates that the meter must be returned immediately to the base unit for recharging NOTICE Use only the specially designed battery pack provided by Roche Diagnostics Using any other type of battery may damage the system Disposal of used batteries Do not dispose of the batteries with normal domestic waste Disp...

Page 21: ...pecified in IEC 61000 4 2 and complies with applicable electromagnetic emissions requirements according to EN 61326 1 and EN 61326 2 6 The system s emissions of the energy used are low and not likely to cause interference in nearby electronically driven equipment NOTICE Use only your finger to touch the screen elements Using a sharp edged object e g tip of a pen can damage the touchscreen Do not u...

Page 22: ...s or near electronic equipment that is a source of electromagnetic radiation Local Area Network protection from unauthorized access If this product is connected to a local area network this network must be protected against unauthorized access In particular it must not be linked directly to any other network or the Internet Customers are responsible for the security of their local area network esp...

Page 23: ...ins no lower case letter uxxxxx7F contains the same character more than four times x12useridF contains a substring of the user ID longer than four characters Wireless connectivity If the meter is equipped with WLAN functionality Wireless connectivity allows the meter to send data test results patient IDs operator IDs etc to the data man agement system without the need to return the meter to the ba...

Page 24: ...industrial 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 signals that might not only be within the fre quency range of the intended WLAN but also could be near or at the same frequency and cause interference Glossary FCC stands for Federal Communica...

Page 25: ...hat wireless devices work together and support secure connections The Accu Chek Inform II system complies with FCC radi ation exposure limits set forth for an uncontrolled envi ronment This equipment should be installed and operated with minimum distance of 20 cm 8 inches between the radiator and your body This transmitter must not be co located or operated in conjunction with any other antenna or...

Page 26: ...ith the instruc tions may cause harmful interference to radio communi cations However 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 powering the equipment off and on the user is encouraged to try to correct the interference by one or more of the follow...

Page 27: ...te Not all options can be configured using the Setup function on the meter The meter performs the following tasks within the system Serves as the primary operator interface through the touchscreen and on off button Performs glucose tests Scans barcodes1 test strip lots controls patient and operator IDs in a variety of supported formats Displays test results from patient tests and control tests Tra...

Page 28: ...hese functions simply touch the button on the screen 3 On Off button Press this button to power the meter on or off 4 Barcode scanner The integrated barcode scanner can be used to read operator and patient IDs 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 window Faci...

Page 29: ...reless LAN label If the meter supports wireless connectivity This label displays registration numbers that are specific to the meter RF hardware 10 Interface For manufacturer s use only 11 Battery pack connector socket Connect battery pack here 8 9 10 11 8 ...

Page 30: ...key slot 13 LED green for displaying status 14 Infrared window for transmitting the code file to the meter 1 The code key is also frequently referred to as a code chip The terms are synonymous Do not replace code keys while the code key reader is still flashing If the green LED status light is still flash ing the code key reader will continue to transmit the previously loaded code file and ignore ...

Page 31: ...nfrared window for communication with the meter 17 Status LED lights up when power is connected Lights up red Power supply is connected applica tion 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 18 Jack for the power supply unit provided 19 Removable mount for wall installation The Accu...

Page 32: ...ts communication to a data management system via Ethernet RJ45 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 17 Status LED lights up when power is connected 18 Jack for the power suppl...

Page 33: ...nd consumables You need the following reagents to perform patient tests and glucose control tests Accu Chek Inform II Test Strips Accu Chek Performa Control Solutions Accu Chek Linearity Kit if required by your facility guidelines Your facility provides additional consumables such as blood collection supplies Observe the current rules and safety guidelines for collecting and handling blood samples...

Page 34: ...a limited basis directly in the Setup Menu of the meter For more information about configuration 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 feat...

Page 35: ...ctions for updating these settings in Chapter 9 If during self check an error is detected the appro priate error message appears on screen 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 charged battery and a partial charge is displayed as a partiall...

Page 36: ...tionality as required Wireless connectivity is automatically reactivated the next time you power on the meter You can then disable it again temporarily if required After 30 seconds without any activity e g without a screen touch the meter automatically dims the dis play backlight to conserve energy Low Power Mode Display Lighter Darker 12 48 pm 09 18 13 WARNING If you suspect that the RF emissions...

Page 37: ... displayed if wireless connectivity is enabled The icon is displayed if the last attempt to com municate with the data management system was successful and was terminated according to the communication protocol The icon is displayed if the last attempt to communicate with the data management system was not successful or was unintentionally termi nated If this icon persists contact your system admi...

Page 38: ...he 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 Via barcode scanner1 only Manually or optionally via barcode scanner 1 A list of supported barcode symbologies can be found in Appendix A 2 Operator IDs can consist of up to 20 alphanumeric characters Alphanumeric characters are any combination of A Z and 0...

Page 39: ...lack background during the scan 2 Hold the meter so that the window of the barcode scanner is approx 10 20 cm 4 8 in above the bar code 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 1 2 3 4 5 6 7 8 9 A O 0 Operator ID 12 48 pm 09 18 13...

Page 40: ...f 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 password Once the operator ID has been entered correctly a screen for entering a password may appear if config ured Enter the password in the same manner as described above for the operator ID Once all entries ar...

Page 41: ...configured for login Glucose control tests specified in the system con figuration must be run and completed successfully before running patient tests Information whether glucose control tests are necessary is displayed in the Power Up screen 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 ...

Page 42: ...man ually or by using the barcode scanner Confirm that the test strip lot matches the test strips in use if configured Perform the test Optionally a test may be categorized as an Observed Test Sequence see page 203 Depending on how your meter is configured see page 121 QC Lockout occurs when patient testing is attempted and controls have not been run in the time interval or frequency estab lished ...

Page 43: ...o testing 1 From the Main Menu screen touch Patient Test 2 Enter or select the Patient ID as described on the following pages 3 If the function Patient Confirmation is enabled verify and confirm the displayed patient informa tion after you entered or selected the ID 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 ...

Page 44: ...riod or hyphen may be used Enter patient ID via barcode scanner 1 Select a patient from a list 2 The following options are available for validating patient IDs Manual entries can be validated based on an downloaded list Confirmation of patient name date of birth and ID can be required 2 Barcode masking can be used to eliminate any characters not belonging to the Patient ID See information on Opera...

Page 45: ...atient is not found in the downloaded list an error mes sage is displayed Confirming the message allows you to enter the ID again Selecting the patient ID from a list Choose the patient ID from a list1 if a list has been down loaded to the meter from the data management system 1 Touch or to scroll up or down in the list If one of the buttons is hidden you have reached the top or bottom of the list...

Page 46: ...is approx 10 20 cm 4 8 in above the bar code you wish to read The meter beeps once the barcode has been read suc cessfully The barcode information appears in the patient ID field The barcode scanner turns off after 10 seconds if a barcode is not scanned A B C D E F G H I J K L M N O P Z 123 Patient ID 12 48 pm 09 18 13 Patient ID Keyboard ID 2222222222 Name Jane Doe ID 3333333333 Name John Doe ID ...

Page 47: ...ctions for scanning IDs see note below 2 Touch to confirm the selected or scanned lot number For additional information about storing lot numbers for test strips see page 73 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 barco...

Page 48: ... 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 indi cates that the meter is checking the test strip Do not apply blood while it is displayed Patient Test Patient 123456789 Strip Lot 545794 12 48 pm 09 18 13 Patient ...

Page 49: ...h patient The lancing device must be intended for use by healthcare professionals in a multiple patient setting Follow the manufacturer s instructions for use We recommend obtaining the capillary blood sample from the side of the fingertip as this part is the least sensitive to pain WARNING Potential risk of incorrect results due to residues on skin Traces of food on the fingers or fatty residues ...

Page 50: ...ed 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 been detected the meter beeps and the measurement begins Patient Test Patient 123456789 Strip Lot 545794 12 48 pm 09 18 13 When applying the sample position the meter so ...

Page 51: ...it values define ranges that can either be con figured individually by the system administrator in line with facility guidelines or are the technical limits of the system The characteristics of these ranges are explained on the following page 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 configured limit values...

Page 52: ...ed for intervention decisions Glucose results above or below the Critical Range as defined by the institution require immediate action as defined by hospital policy Glucose results within the Normal Range as defined by the institution are considered normal and require no therapeutic action Patient Test Out of Reportable Range RR HI Patient 123456789 Date 09 18 13 12 48 pm 12 48 pm 09 18 13 Patient...

Page 53: ...w the System Measurement Range HI above the System Measurement Range Instructions on how to add comments are provided in the following section 1 Results that are below or above the Critical Range thresh old but within the Reportable Range can be configured to display as either numeric results or as CR LO or CR HI All other results exceeding specified limit values will always be displayed as RR LO ...

Page 54: ... for example additional information about the test conditions or the patient The meter can be configured so that comments are always required required depending on the result range optional or disabled You can call up the function for adding comments directly in the results screen If com ments are set as required the meter will not accept an empty comment field Test results are also saved when the...

Page 55: ... your comment s 3 Once you have selected the desired comment s touch to return to the results screen 4 Touch to return to the Main Menu Add Comments 09 18 13 New Strip Lot Will Repeat Test RN Notified Doctor Notified 12 48 pm Patient Test Out of Normal Range 12 2 Patient 123456789 Date 09 18 13 12 48 pm mmol L New Strip Lot Doctor Notified Will Repeat Test 09 18 13 12 48 pm Patient Test Out of Nor...

Page 56: ...applicable regulations and directives for disposal of potentially infectious samples and materials Test results are also saved when the meter is powered off in the results screen or automatically powers off after 10 minutes of inactivity no screen touches See Automatic power off on page 19 ...

Page 57: ...own 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 allo...

Page 58: ... cumstances Before using the meter for patient testing the first time At the glucose control intervals established by your facility When using a new test strip vial for the first time When using a new test strip lot for the first time and as a result a new test strip code If a test strip vial was left open If questionable test results are displayed repeatedly If you wish to test the performance of...

Page 59: ... perform a limited number of blood glucose tests if circumstances require despite the meter being in QC Lockout see page 68 Information stored during glucose control testing The following information is stored for every glucose con trol test using control solution Glucose control test result Lot number of the control solution Operator ID if configured Level of control solution L1 or L2 Lot number ...

Page 60: ... 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 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 The proper test strips must be available An operator ID must be entered with password if applicable if the meter is config...

Page 61: ...ired level of control solution for the test Check the lot number of the control solution Check the lot number of the test strips Perform the test with the control solution The result must fall within the specified range as shown on the label of the test strip vial or defined per configura tion for the control test to be completed successfully Patient tests can now be performed again ...

Page 62: ...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 the example above Level 2 Hi is marked Control Test Level 2 Hi Level 1 Lo Required 12 48 pm 09 18 13 Main Menu Review Results Con...

Page 63: ... or To read the lot number from the control solution bottle via barcode scanner press and release Follow the instructions for scanning IDs see page 39 2 Touch to confirm the selected test strip lot number For additional information about storing lot numbers for control solutions see page 80 Barcodes on control solutions may not be available in all countries see page 47 The meter can be configured ...

Page 64: ...han the one dis played touch to display a list of stored lot numbers Select the desired lot number from the list 2 Touch to confirm the selected test strip lot number For additional information about storing lot numbers for test strips see page 73 Barcodes on control solutions may not be available in all countries see page 47 The meter can be configured so that manual confirmation is not necessary...

Page 65: ...t 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 indi cates that the meter is checking the test strip Do not apply control solution while it is displayed Control Test Control L2 Hi 123456 Strip Lot 545794 12 48 pm 09 18 13 Co...

Page 66: ...dge of the test strip Do not apply the con trol 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 beeps and the measurement begins Control Test Control L2 Hi 123456 Strip Lot 545794 12 48 pm 09 18 13 When applying the control solution position the meter so that the test strip port is ...

Page 67: ...tton 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 page 54 If you do not wish to add a comment to the test result touch to continue to the next level of the control test if necessary or to return to the Main Menu Remove the test strip and dispose of it in accordance with applicable regulations and direc...

Page 68: ...administrator has enabled the STAT test option during setup 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 Touch Run QC to run the required control test instead of a patient test Touch Run STAT to perform a patient test even if a glucose control test is required The status a...

Page 69: ...ts the following information is displayed Patient ID glucose control or sample ID The test result The lot numbers of the reagents used for glucose control and linearity tests Date and time of the test Comments entered at the time the test was per formed Maintenance results for documentation of maintenance activities are stored and displayed with date and time only if comments were added ...

Page 70: ...Results Patient QC All 04 19 13 mmol L Time Rslt 7 15 pm 4 1 123456789ABC 5 32 pm 12 7 123456789ABC 2 25 pm FAIL QC L2 12 15 pm 4 4 56789ABC1234 11 46 am PASS QC L1 10 01 am 4 1 Linearity L3 ID 09 18 13 12 48 pm Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Glucose Results Patient QC All 04 19 13 mmol L Time Rslt 7 15 pm 4 1 123456789ABC 5 32 pm 12 7 123456789ABC 2 25 pm 16 ...

Page 71: ...n above the list of test results for this patient will be displayed Glucose Results Patient QC All 04 19 13 mmol L Time Rslt 7 15 pm 4 1 123456789ABC 5 32 pm 12 7 123456789ABC 2 25 pm FAIL QC L2 12 15 pm 4 4 56789ABC1234 11 46 am PASS QC L1 10 01 am 4 1 Linearity L3 ID 09 18 13 12 48 pm Patient Result ID 123456789ABCDEFG Name Joe M Doe Strip Lot 400433 12 7 mmol L 04 19 13 05 32 pm Comment 1 Comme...

Page 72: ...een or touch to return to the Main Menu If the meter is configured to show PASS FAIL instead of a numerical QC result you can use the list to check whether a meter lockout is due to a failed or overdue control test Glucose Results Patient QC All 04 19 13 mmol L Time Rslt 7 15 pm 4 1 123456789ABC 5 32 pm 12 7 123456789ABC 2 25 pm FAIL QC L2 12 15 pm 4 4 56789ABC1234 11 46 am PASS QC L1 10 01 am 4 1...

Page 73: ...ement 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 Expiration d...

Page 74: ...w code key into the opening of the code key reader The LED starts flashing green and signals that the reader is ready to transfer data 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 Strip Lots Add Strip 12 31 14 855732 11 21 14 845678 Strip 11 21 14 ...

Page 75: ...ED stops flashing remove the code key and insert a new code key for download if required If you get an error message that the download was not successful re insert the same code key and try again Do not replace 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 n...

Page 76: ...t number 2 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 3 Continue entering additional lot numbers or touch to return to the Main Menu The current lot number is provided automatically for use with subsequent tests Add Strip Lot Strip Lot Confirmation D 530 Do you want to use t...

Page 77: ...e 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 con tinue 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 2 4 4 1 mmol L L2 Hi 16 21 6 mmol L 1...

Page 78: ...e 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 entry 1 2 3 4 5 6 7 8 9 0 Control L2 Max 19 6 mmol L 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Control L2 Min 14 5 mmol L 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Strip Expiration 11 30 13 12 48 pm 0...

Page 79: ...5 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 6 Continue entering additional lot numbers or touch to return to the Main Menu The current lot number is provided automatically for use with subsequent tests 1 2 3 Control L2 Max 19 6 mmol L 12 48 pm 09 18 13 4 5 6 D 314 Do you wa...

Page 80: ...Lot list Entering the lot number of the control solution The following description assumes that the meter is powered on and the Main Menu is displayed 1 Touch to open the Main Menu 2 screen 2 Touch Control Lots to open the related menu 3 Touch Add to enter a new lot number Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Main Menu 2 Maintenance Strip Lots Proficiency Control Lo...

Page 81: ...ution bottle via barcode scanner Follow the instructions for scanning IDs see page 39 6 Use the keypad to enter the expiration date as stated on the control solution bottle 7 Touch to confirm the entered expiration date Barcodes on control solutions may not be available in all countries see page 47 1 2 3 4 5 6 7 8 9 0 Control Lot 12 48 pm 09 18 13 Add Control Lot Level 2 Hi Level 1 Lo 12 48 pm 09 ...

Page 82: ... 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 9 Continue entering additional lot numbers or touch to return to the Main Menu The current lot number is provided automatically for use with subsequent tests 1 2 3 Control Expiration 11 30 13 12 48 pm 09 18 13 4 5 6 D 312 Do you want to ...

Page 83: ...n the Main Menu 2 screen 2 Touch Control Lots to open the related menu The current lot number is indicated by an asterisk 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 11 21 13 777723 QC L1 QC L...

Page 84: ... Current is then also displayed in the detail view 5 Touch to return to the list of lot numbers or touch to return to the Main Menu Control Lot Details Edit Delete Control Lot 777732 Control Level 1 Use by 12 31 13 Current 12 48 pm 09 18 13 Control Lot Details Edit Delete Control Lot 777732 Control Level 1 Use by 12 31 13 Make Current 12 48 pm 09 18 13 Control Lots Add QC L2 11 21 13 777678 12 31 ...

Page 85: ...wing description assumes that the meter is powered on and the Main Menu is displayed 1 Touch to open the Main Menu 2 screen 2 Touch Linearity Lots to open the related menu 3 Touch Add to enter a new lot number 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...

Page 86: ...as the current lot number 7 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 8 Continue entering additional lot numbers or touch to return to the Main Menu 1 2 3 4 5 6 7 8 9 A O 0 Linearity Lot 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Linearity Expiration 09 30 13 12 48 pm 09 18 13 T...

Page 87: ...en the Main Menu 2 screen 2 Touch Linearity Lots to open the related menu The current lot number is indicated by an asterisk 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 11 21 13 777678 12 31 13 777732 11 21 13 777723 Lin Lin...

Page 88: ...r The Current information is then also displayed in the detail view 5 Touch to return to the list of lot numbers or touch to return to the Main Menu Linear Lot Details Edit Delete Linearity Lot 777732 Use by 12 31 13 Current 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 Linear Lot Details Edit Delete Lineari...

Page 89: ...samples should be treated in exactly the same manner as previously described for con trol solutions used in glucose control testing The term Linearity describes the ability of the system to maintain 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 str...

Page 90: ...acility that operates the system Linearity testing can also be run when you want to check the overall performance of the system Information stored during linearity testing The following information is stored for every linearity test Test result Lot number of the linearity solution Level of linearity solution L1 to L6 Operator ID if configured Lot number of the test strips Time and date of test Com...

Page 91: ...ing 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 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 The proper test strips must be available An operator ID must be entered with password if applicable if th...

Page 92: ...rity test The following description assumes that the meter is powered on and the Main Menu is displayed 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Linearity to start the linearity test The Line arity Test screen opens 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 Lo...

Page 93: ...rming or selecting the test strip lot Once you have entered and confirmed the lot number of the linearity test kit you are asked to choose the lot number of the test strips Compare the number displayed by the meter to the number on the label of the test strip vial 4 If you want to use the preselected number dis played by the meter touch to confirm To use a different number than the lot number dis ...

Page 94: ... 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 indi cates that the meter is checking the test strip Do not apply linearity solution while it is displayed Linearity Test L1 L5 L3 L6 L4 L2 Linearity 1234...

Page 95: ...e 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 and the measurement begins Linearity Test Linearity 12345678 L1 Strip Lot 545794 12 48 pm 09 18 13 When applying the linearity solution position the meter so that the test strip port is alwa...

Page 96: ... 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 the linearity test Linearity Test 2 5 Linearity 12345678 L1 Date 09 18 13 12 48 pm mmol L 12 48 pm 09 18 13 Linearity Test Linearity 12345678 L1 Strip Lot 545794 12 48 pm 09 18 13 Linearity Test L1 L5 L3 L6 L4 L2 Linearity 12345678 Strip Lot 5457...

Page 97: ...leting 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...

Page 98: ... test To perform a proficiency test you need the following 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 The proper test strips must be available An operator ID must be entered with password if applicable if the meter is configured for login For blood glucose proficiency tests the sample ID instead of patient ID mu...

Page 99: ...h the proficiency sample Starting a proficiency test The following description assumes that the meter is powered on and the Main Menu is displayed 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Proficiency to start the proficiency test 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 D...

Page 100: ...the test strip lot Once you have entered and confirmed the sample ID you will be 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 3 If you want to use the preselected number dis played by the meter touch to confirm To use a different number than the lot number dis played touch to select the number from a list ente...

Page 101: ...p 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 indi cates that the meter is checking the test strip Do not apply the proficiency sample while it is displayed Proficiency Test Sample 123456789 Strip Lot 545794 12 48 pm 09 18 13...

Page 102: ...ront edge of the test strip Do not apply the sample to the top of the 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 begins Proficiency Test Sample 123456789 Strip Lot 545794 12 48 pm 09 18 13 When applying the proficiency sample position the meter so that the test strip port is always higher or o...

Page 103: ...sh to add a comment to the test results touch to complete the test and store the result Remove the test strip and dispose of it in accordance with applicable regulations and directives for disposal of potentially infectious samples and materials Proficiency Test HI Sample 123456789 Date 09 18 13 12 48 pm 09 18 13 12 48 pm Proficiency Test 8 3 Sample 123456789 Date 09 18 13 12 48 pm mmol L 09 18 13...

Page 104: ...8 Proficiency Testing 104 This page intentionally left blank ...

Page 105: ...ment 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 NOTICE To ensure continuous safe and reliable operation use only the power supply unit provided for the Accu Chek Inform II system for ordering information see page 156 For details on configuring ...

Page 106: ...sting Whenever the meter is in the base unit 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 3 40 C or 37 104 F is maintained during installation and initial setup Replace the battery pack within approximately 10 minutes to retain the date and time settings Beyond this p...

Page 107: ...mpartment 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 108: ...battery 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 compart ment 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 109: ...thout power for too long a message may appear informing you that the date and time settings have been lost due to power loss 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 Unless your QC configuration is Always OK see page 121 the meter will now be in QC Lockout due to the manually entered date...

Page 110: ... an Accu Chek Inform II Base Unit Light and communi cating The same displays appear whether the meter is transferring data via base unit or via wireless connection This display is visible when communication is still active but the meter is busy processing the data received or waiting for the next data message from the DMS Docked Connecting 12 48 pm 09 18 13 Docked Synchronizing Database 12 48 pm 0...

Page 111: ...fers 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 If a meter is in standby but not docked and commu nicating wirelessly this communication is not visible on the display The display remains blank Docked Idle 12 48 pm 09 18 13 Docked Updating Software 12 48 pm 09 18 13 ...

Page 112: ...ettings can be configured on the meter Date and time format Date and time editing enabled Units Test types Lot information editing enabled Methods for verifying lot information Enable barcode scanner Normal critical and reportable ranges Operator ID options Patient ID options Settings for glucose controls and QC Lockout Beeper If the meter is configured by a system administrator using a data manag...

Page 113: ...rugs of Abuse Tests DAT Fecal Occult Gastric Occult Ketones Rapid Acting Insulin Regular Insulin Intermediate Acting Insulin Long Acting Insulin Insulin Mixtures Control Test Glucose Control Test Select Level Verify Control Lot Verify Test Strip Lot Insert Test Strip Apply Control Solution View Test Results Add Comments Other Control Tests Select Type of Control Enter Date Time tested Enter Confir...

Page 114: ...rol 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 Strip Lot Select Linearity Level Insert Test Strip Apply Linearity Solution View Test Results Add Comments Beeper Set Beeper Volume Diagnostics List Software Versi...

Page 115: ...splay 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 116: ... 3 Touch Setup Menu to open the Setup Menu 4 Enter the Setup password if requested see Creating a setup password on page 126 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 Setup Menu 12 48 pm 09 18 13 Setup Menu Date Time QC Test Display Password Test Ranges Reagents Operator ID...

Page 117: ... after entering a password Time Format 12 hour AM PM 24 hour 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 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 configu ration it is...

Page 118: ...splayed 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 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 119: ...y 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 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 chang...

Page 120: ...operator must enter the lot number Scan only Lot numbers can be verified via barcode scanner only 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 Lot entry The operator must enter the lot number ...

Page 121: ... OK QC Lockout is activated only when the last glucose control test is out of range or a control test is not available e g when changing the test strip lot Hours QC Lockout is activated after the specified time When a glucose control test is run success fully the counter is reset to 0 Strip Count QC Lockout is activated after reaching the specified number of tests When a glucose con trol test is r...

Page 122: ... can be configured Rotating QC QC tests require alternating use of L1 and L2 controls instead of requiring both controls when performing a QC test 2 Touch to save the settings If the Hours or Strip Count option is enabled enter the desired number or touch to exit this menu without saving any changes The display returns in both cases to the Setup Menu ...

Page 123: ...value Critical low high limit value Reportable low high limit value 1 Use the keypad to enter the first value 2 Touch to enter the following value or touch to return to the previous view 3 After entering the last value touch to save all the previous settings 1 2 3 4 5 6 7 8 9 0 Report Range Lo 0 6 mmol L 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Normal Range Lo 3 9 mmol L 12 48 pm 09 18 13 1 2 3 4 5 6...

Page 124: ...0 characters Enter the minimum and maximum lengths after selecting this option List The operator ID must be on a list received from the data management system 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 touch to ...

Page 125: ...atient 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 numbe...

Page 126: ...on or touch to exit this screen without saving any changes The display returns to the Main Menu Password protection will take effect only after the next power on To disable password protection 1 Open the Setup Menu you must enter the current password 2 Touch Password 3 Delete the current password by touching 4 Touch to disable password protection Please note that password protection can only be re...

Page 127: ...leading zero if necessary by touching If the time format is 12h touch am pm to select the correct time 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 Admin Menu Date Time Language Selection Setup Menu 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 0 Date 09 18 ...

Page 128: ...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 Menu 2 screen 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 Beeper Setup Medium Low High Beeper Volume 12 4...

Page 129: ...0 Do not expose the meter to excessive sources of heat for prolonged periods of time when perform ing a test Potential sources of heat can be but are not limited to Leaving the meter under a bilirubin light or photo therapy light Leaving the meter on a bed warmer Leaving the meter in an isolette See Chapter 12 for operating and storage temperature ranges All information given on maintenance and ca...

Page 130: ...so safety messages Protection against infection and blood borne pathogens on page 17 and Allergy or injury caused by reagents and other working solutions on page 18 The gloves worn during cleaning and disinfecting should be removed and hands washed thoroughly with soap and water before performing the next patient test Dispose of acceptable cleaning and disinfection solutions per facility guideline...

Page 131: ...low Recommended cleaning agents mild soapy water 70 or less solution of isopropyl alcohol in water 0 625 or less solution of sodium hypochlorite in water Recommended disinfecting agents 0 625 or less solution of sodium hypochlorite in water bleach quaternary ammonium compounds up to 0 5 single compound or mixture in isopropyl alcohol isopropanol up to 55 0 05 solution of a phenol compound in water...

Page 132: ...idelines WARNING Avoid getting liquid into the test strip port Moisture in the strip port may lead to incorrect blood glucose results Do Not clean disinfect the meter while performing a blood glucose or control test Do Not get any moisture in the test strip port Do Not spray into the test strip port Do Not immerse the meter in liquid If you suspect that moisture may have entered the test strip por...

Page 133: ...er 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 with a dry cloth or gauze If solution is allowed to collect in any meter opening severe damage to the system can occur ...

Page 134: ...commercially available pre moistened cleaning disinfection wipes squeeze off excess solution or blot on a dry paper towel to remove any excess solution before wiping the surface of the meter 5 Carefully wipe over the test strip port area making sure that no liquid enters the test strip port If spraying the meter place it on a flat surface or table Wear gloves Be aware that the meter may become sli...

Page 135: ...ution is seen anywhere on the meter at the completion of cleaning Always ensure that the meter is thoroughly dried after cleaning disinfecting If you notice streaks on the housing or touchscreen or the touchscreen surface becomes slightly cloudy wipe clean immediately with a soft lint free cloth slightly dampened with water ...

Page 136: ... base unit 3 Dry the base unit thoroughly after cleaning disin fecting Visually verify that no solution is seen in the base unit connectors at the completion of disin fecting If fluid is allowed to collect in any connector severe damage can occur to the meter and the base unit 4 Plug in the base unit NOTICE Ensure meter base unit including connectors are thoroughly dried after cleaning or disinfec...

Page 137: ...he accessory box place it on a flat sur face or table Ensure that it is completely empty 2 Allow the accessory box to air dry for the recom mended contact time according to the cleaning disinfecting solution product labeling Do not place the meter in the accessory box until all cleaning disinfecting steps are completed 3 Dry the accessory box thoroughly with a dry cloth or gauze and visually verif...

Page 138: ...ing the Accu Chek Inform II Base Unit Hub The hub should be cleaned as necessary 1 Unplug the power supply unit and detach all other cables from the hub before cleaning 2 Wipe over the surfaces with a clean and soft lint free cloth slightly dampened with water wring out any excess 3 Dry the hub with a dry cloth or gauze and visually verify that it is completely dry and no moisture is left on the s...

Page 139: ...ents 3 Select the desired comment s from the list or touch to enter your own comment via keypad 4 Once you have entered your comments touch to save the maintenance comments The Mainte nance Test screen opens up 5 Touch to return to Main Menu 2 You can add up to three comments For details see section Adding comments on page 54 Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Mai...

Page 140: ...own here are for illustration purposes only Information shown on your meter may differ 1 Touch in the Main Menu to open the Main Menu 2 screen 2 Touch Diagnostics to call up the main screen for this menu 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...

Page 141: ...attery Percent 83 Scan Log Serial No 10000740 12 48 pm 09 18 13 Diagnostics Test Authenticated RF activated Associated Received IP IP Subnet Gateway DNS Contacted DMS Connected to DMS Completed 192 168 4 117 Wireless Status 12 48 pm 09 18 13 Diagnostics List allowed to add new Reagent Editing Date Time Editing STATs Patient Validation 9 None Operator Validation 0 Configuration Page 3 Hours 24 QC F...

Page 142: ...ut occurs the operator may use a STAT test to temporarily override the lockout If no STAT test is configured or left the meter cannot be used until the stored data is downloaded via network either wire less or by docking the meter In cases of e g network failures which make a download impossible or other emergencies it may be necessary to unlock a meter without access to the data management system...

Page 143: ... Unlock to reset the lockout timer The meter switches off and is ready for testing after powering up again 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 Setup Menu 12 48 pm 09 18 13 Setup Menu Date Time QC Test Display Password Test Ranges Reagents Operator ID Patient ID Unlock...

Page 144: ... Display Password Test Ranges Reagents Operator ID Patient ID Unlock Delete Pat 12 48 pm 09 18 13 Confirm Deletion D 201 Delete Data Are you sure you want to delete all patients and all results from this meter This operation cannot be undone Setup Menu Date Time QC Test Display Password Test Ranges Reagents Operator ID Patient ID Unlock Delete Pat 12 48 pm 09 18 13 Be aware that the function Delet...

Page 145: ...ther assistance is required call your local Roche representative 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 powering ...

Page 146: ...r proceed according to the requirements of your facility Meter displays Strip defect Error The test strip is defective 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 according to the requirements of your facility If the error persists contact you...

Page 147: ...ata Management System Check whether WLAN is activated on the meter see Chapter 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 See page 140 Reset the meter by pressing the On Of...

Page 148: ...er off after time specified by system administrator default is 5 minutes configurable by system administrator Press 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 Foll...

Page 149: ... The different message types are illustrated in the fol lowing table Sample message type Description D Decision To confirm touch To reject touch I Information touch to confirm 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 Patient Test Patient 123456789 Date 09 18 13 12 48 pm...

Page 150: ...ple message type Description Patient Test 09 18 13 Out of Critical Range 12 48 pm Patient 123456789 Date 09 18 13 12 48 pm 17 2mmol L W 511 Out of Critical Range Out of Critical Range 1 2 3 Operator ID 12 48 pm 09 18 13 E 314 Invalid Scan The scan returned an entry 20 characters Please see your System Administrator Invalid Scan ...

Page 151: ... for a few seconds then disappears The Versions screen shows the version numbers of the meter compo nents The Versions screen shown here is for illus tration purposes only Version numbers on your meter may differ 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 Kernel RootFS App Boot Build 04 00 00 Version...

Page 152: ...t due to the manually entered date time 5 Synchronize the meter s date time with the date time of your facility via base unit or if working wire lessly wait at least ten minutes for the next WLAN synchronization before performing any further tests Even if your configuration does not require it we recommend always performing a QC test after a meter reset 1 2 3 4 5 6 7 8 9 0 Date 01 01 05 09 18 13 1...

Page 153: ...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 OTE N A N A Operating temperature 3 to 50 C 37 to 122 F 3 to 50 C 37 to 122 F 0 to 40 C 32 to 104 F Mea...

Page 154: ...7 A max 1 7 A max 350 to 150 mA Battery capacity 100 subsequent measurements possible after 120 min of charging N A N A Interfaces Charge contacts IR port Barcode scanner WLAN Channel 1 11 only Charge contacts IR port RJ45 Ethernet USB type B DC connector Replaceable AC input contacts Data transfer rate WLAN up to 54 Mbps IR 9 6K 115K bps Ethernet 10 Mbps USB 12 Mbps N A Supported barcodes Code 12...

Page 155: ...7 mm 2 78 in 127 mm 5 in Weight 1100 g 28 g 470 g Operating temperature N A 3 to 50 C 37 to 122 F 3 to 50 C 37 to 122 F Storage temperature short term 25 to 70 C 13 to 158 F 3 to 50 C 37 to 122 F 25 to 70 C 13 to 158 F Relative humidity short term storage 93 93 93 Battery voltage type N A Not replaceable N A Interfaces N A IR port Code key socket LED red green blue Input voltage N A N A 12 V DC In...

Page 156: ...quipped with power and connectivity function ality for the Accu Chek Inform II Base Unit Light 05888760001 Accu Chek Inform II Battery Pack Rechargeable battery pack 06869904001 Accu Chek Inform II Battery Compartment Cover Replacement cover for meter battery compartment 06869823001 Accu Chek Inform II Code Key Reader 04884671001 Power Supply Power supply for Base Unit international edition 048056...

Page 157: ...ence Guide For additional copies of the Accu Chek Inform II Operator s Manual and Quick Reference Guide or copies in other languages please contact your local Roche organization Reagents and Solutions Supplies are available through Roche Diagnostics Contact your local Roche representative ...

Page 158: ...s 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 You can access these files by connecting the Accu Chek Inform II Base Unit to a PC with the USB cable For detailed instructions on how to do this see the instruction sheet Setting Up t...

Page 159: ...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 information The Accu Chek Inform II system is manufactured for and distributed by In the United States Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 In Australia Roche Diagnostics Australia Pty Limited ABN 29 003 001 205 31 Victoria Av...

Page 160: ...12 General Product Information 160 This page intentionally left blank ...

Page 161: ...ot available using the respective configuration method Configuration options DEVICE If the meter is configured by a system admin istrator using a data management system the config uration 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 Subject Attr...

Page 162: ...ical 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 0 100 characters N Y Normal range HI limit 10 600 mg dL 0 6 33 3 mmol L 600 mg dL 33 3 mmol L Y Y Normal range LO limit 10 600 mg dL 0 6 33 3 mmol L 10mg dL 0 6 mmol L Y Y STAT tests allowed 0 no 1 y...

Page 163: ... yes no confirmation 2 prompt for lot entry 1 Y Y Display Contrast 1 15 7 Y Y Formats and Language Date format 1 MM DD YY 2 DD MM YY 1 Y Y Time format 1 24 hours 2 12 hours 2 Y Y Language setting 1 German 3 French 4 Spanish 5 Italian 6 Dutch 7 Swedish 8 English USA 9 Danish 11 Portuguese 8 Y Y Glucose result units 0 mg dL 1 mmol L 0 Y Y Other languages For the availability of languages not listed ...

Page 164: ...set date and time 1 N Y Main menu 2 Linearity if enabled linear ity tests are allowed 0 disabled 1 enable 1 Y Y Main menu 2 Maintenance if enabled maintenance comments are allowed 0 disabled 1 enable 1 Y Y Main menu 2 Proficiency allowed if ena bled 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 Setu...

Page 165: ...erator ID validation mode is set to Length 0 20 0 Y Y Operator ID timeout determines the time in sec that an operator remains logged in after power off 0 feature disabled 0 3 600sec 0 N Y Operator password length 4 20 characters only a z 0 9 allowed N A N N Operator certification expiry warning 0 90 days 0 off N Y Operator Name length 0 25 characters N A N N Operator ID and patient ID barcode mask...

Page 166: ...dation Allowed characters a z 0 9 period hyphen 0 none 1 length 2 list 3 list allowing entry if not on list 4 length if numeric 0 Y Y Patient ID maximum length used to validate a patient ID if patient ID validation mode is set to Length 0 20 20 Y Y Patient ID minimum length used to validate a patient ID if patient ID validation mode is set to Length 0 20 0 Y Y Patient name length 0 25 characters N...

Page 167: ...999 hours 24 Y Y QC shift length a PASS control remains valid for twice this amount in time after shift start if the QC algorithm is set 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 da...

Page 168: ...N settings general WLAN enabled 0 disabled 1 enabled 1 N Y Use DHCP 0 disabled 1 enabled 0 N Y IP the meter s static IP address if no DHCP is used 0 0 0 0 255 255 255 255 0 0 0 0 N Y Subnet Mask subnet mask to be used by the meter if static IP is used Note if DHCP 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 DN...

Page 169: ...te When using option 4 ensure that an appropriate WLAN EAP package has already been downloaded from the DMS to the meter Within this EAP container the appropriate 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 104 bits NUL terminated string of 10 or 26chs HEX 0000000000 N Y WEP authentication 0 open system authenti ...

Page 170: ...A Appendix 170 Subject Attribute Range Default Device DMS Other Test Entry OTE OTE functionality 0 disabled 1 enabled 0 N Y Depends on available DMS settings ...

Page 171: ...hared 10 charac ters HEX 1 WEP 5 WEP104 0 open 1 shared 26 charac ters HEX 2 WPA_PSK 1 AES WPA2 0 passphrase 8 63 characters 2 WPA_PSK 1 AES WPA2 1 key 64 charac ters HEX 2 WPA_PSK 2 TKIP WPA 0 passphrase 8 63 characters 2 WPA_PSK 2 TKIP WPA 1 key 64 charac ters HEX 2 WPA_PSK 3 AES TKIP WPA2 WPA 0 passphrase 8 63 characters 2 WPA_PSK 3 AES TKIP WPA2 WPA 1 key 64 charac ters HEX 3 4 EAP ...

Page 172: ...n 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 ...

Page 173: ...ution require ments when creating patient or operator barcodes When creating patient or operator barcodes always adhere to the applicable international IEC ISO standards for the respective barcode symbology In particular ensure that barcode size and print quality as defined in ISO IEC 15421 are adequate Inadequate print size and or quality may lead to erroneous decoding EAN 13 barcodes although wi...

Page 174: ...A Appendix 174 Codabar Code 39 Code 93 Code 128 EAN 13 Interleaved 2 5 GS1 DataBar Limited PDF417 DataMatrix QR Code ...

Page 175: ...ansmit data3 The Accu Chek Inform II system adheres to IEEE Standard 802 11g 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 recognizes the existent AP WLAN protocol configuration 802 11b or 802 11g and automatically transmits data using the appropriate com munication protocol5 1 The Accu Chek Inform II...

Page 176: ...rior 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 per formance to support any new radio frequency RF appli cation or device The survey will also detail RF signals including all existing WLANs along with any competing RF signals and inte...

Page 177: ...ecurity mecha nisms 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 gloss...

Page 178: ...Wireless connectivity can help to ensure that updates to informa tion in the DMS are sent immediately to all networked meters Meters with an integrated and activated wireless option use the base unit for recharging and or as a redundant communication option to exchange data with the DMS The meter also has to be docked if the hospital changes security protocols When this change occurs it may lock o...

Page 179: ... Accu Chek Inform II meter will attempt to connect to the DMS In line with the industry communication standard POCT1 A the DMS must acknowledge the meter s request for connection and actively query for the result Only upon receipt of this DMS query the meter will send the result Hence the effective time for transmitting results depends on infrastructure DMS workload etc Once the DMS sends a query ...

Page 180: ...em 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 The Accu Chek Inform II meter monitors the Quality of Service QoS of the WLAN communication connection ...

Page 181: ...section The meter facilitates the transfer of this information to a data management system DMS The examples in this manual are for illustration purposes only Consult the instructions that come with the DMS for details and configuration options The activation of this feature is only possible via a suit able DMS Activating this feature permanently adds an additional step to the Patient Test or a Con...

Page 182: ... for the following tests Pregnancy Visual Urinalysis UA Rapid Streptococcus Rapid Drugs of Abuse Tests DAT Fecal Occult Gastric Occult Ketones The Other Test Entry feature also allows you to add information about prescribed insulin type and number of units Rapid Acting Insulin Regular Insulin Intermediate Acting Insulin Long Acting Insulin Insulin Mixtures ...

Page 183: ...r the above tests and insulin information will be abbreviated as follows Pregnancy Preg Visual UA VUA Rapid Strep Strep Rapid DAT DAT Fecal Occult F Occ Gastric Occult G Occ Ketones Ket Rapid Acting Rap I Regular Reg I Intermediate Acting Int I Long Acting Long I Insulin Mixtures Mix I ...

Page 184: ...firm the test strip kit and or other reagent lot numbers Enter the test strip kit and or other reagent expira tion date the first time a lot number is entered Enter the onboard control result s if available Enter the test result s Select appropriate comments This can be done either manually or by using the barcode scanner This can be done either manually or by using the barcode scanner if a barcod...

Page 185: ...ecting and the Main Menu screen is displayed 1 From the Main Menu screen touch Patient Test 2 From the Patient Test Menu touch Other Test The Other Patient Tests menu list is displayed Main Menu Review 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...

Page 186: ...nancy Visual UA MS Visual UA CS Rapid Strep Rapid DAT 09 18 13 12 48 pm Other Patient Tests Intermediate Acting Insulin Insulin Mixtures Long Acting Insulin 09 18 13 12 48 pm Other Patient Tests Fecal Occult Ketones Gastric Occult Rapid Acting Insulin Regular Insulin 09 18 13 12 48 pm If you need to change an entry touch to return to the previous screen ...

Page 187: ...er the time the test was per formed For single digit numbers add a leading zero Touch to proceed to the next screen Other Patient Tests Fecal Occult Ketones Gastric Occult Rapid Acting Insulin Regular Insulin 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 A O 0 Patient ID 12 48 pm 09 18 13 1 See also section Entering or selecting the patient ID in Chapter 3 1 2 3 4 5 6 7 8 9 0 Date Tested 09 18 13 09 18 13 1...

Page 188: ...lot number if you want to use a different lot number than the one displayed 9 Use the keypad to enter the Fecal Card Lot expira tion date Touch to proceed to the next screen 1 2 3 4 5 6 7 8 9 0 Expiration Date 12 30 13 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 A O 0 Fecal Card Lot 11 13 63 09 18 13 12 48 pm Fecal Card Lot Use card 131163 ID 150 88 256 11 19 13 9 12 am 09 18 13 12 48 pm If you touch to c...

Page 189: ... enter a new lot number if you want to use a different lot number than the one displayed 11 Use the keypad to enter the Fecal Developer Lot expiration date Touch to proceed to the next screen 1 2 3 4 5 6 7 8 9 0 Expiration Date 12 30 13 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 A O 0 Fecal Developer Lot 09 18 13 12 48 pm Fecal Developer Lot Use developer 131163 ID 150 88 256 09 18 13 9 12 am 09 18 13 12...

Page 190: ...riate button 14 Select the patient test result as positive or negative by touching the appropriate button Fecal Occult Pat ID 150 88 256 Positive Ctrl Select a positive control result acceptable not acceptable 09 18 13 12 48 pm Fecal Occult Pat ID 150 88 256 Negative Ctrl Select a negative control result acceptable not acceptable 09 18 13 12 48 pm Fecal Occult Pat ID 150 88 256 Result Select a Fec...

Page 191: ... 18 Once you have selected the desired comment s touch to return to the results screen 19 Touch to return to the Main Menu Fecal Occult Pat Card Lot D T Tested Dev Lot ID 150 88 256 Positive Ctrl Negative Ctrl acceptable acceptable 11 19 13 9 12 am 45233 07 30 14 1283 12 30 13 09 18 13 12 48 pm Fecal Occult Pat Result ID 150 88 256 negative 09 18 13 12 48 pm Fecal Occult Pat Doctor Notified Result...

Page 192: ... control solutions should be used on a regular 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 St...

Page 193: ...irm the kit or test strip lot number Enter the kit or test strip expiration date Enter or confirm the control lot number Enter the control lot expiration date Select the control result s The control solution results must fall into the acceptable range indicated on the test kit or reagent packaging or as defined by your institution before being considered successful This can be done either manually...

Page 194: ...red test from the display list Pregnancy control will be used as the example 4 Select the type level of control being used Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 Other Control Tests Pregnancy Visual UA MS Visual UA 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 Other Control Tests Pregnancy Visua...

Page 195: ...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 the test was performed For single digit numbers add a leading zero Touch to proceed to the next screen 1 2 3 4 5 6 7 8 9 A O 0 Pregnancy Ctrl Lot 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 0 Expiration Date 12 30 13 09 18 13 12 48 pm 1 2 3 4 5 6 7 8 9 0 ...

Page 196: ...able 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 197: ...creen is displayed 13 To change an entry or a result touch the appropriate button Pregnancy Control Positive Liquid Control Control Bar Select a Pregnancy control bar result acceptable not acceptable 09 18 13 12 48 pm Pregnancy Control Positive Liquid Control Ctrl Result Select a Pregnancy liquid control result acceptable not acceptable 09 18 13 12 48 pm Pregnancy Control Control Lot D T Tested Ki...

Page 198: ...s and Other Control Tests These error or warning messages occur when the validity of the recorded result is questionable These messages caution that test information may not be valid or accurate See also Pop up messages in Chapter 11 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 accepta ble...

Page 199: ...m the following steps to Review Other Test result s 1 From the Main Menu screen touch Review Results 2 From the Test Result Menu touch Review Other Test All stored OTE test results are displayed in a sequential list 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...

Page 200: ...e 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 Fecal Occult Pat QC 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 Ct...

Page 201: ...t or QC selection and display all results 9 Touch to return to the previous menu screen or touch to return to the Main Menu 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 Other Test Results QC All ID 150 88 256 Type 12 25 p...

Page 202: ...st Entry Configuration Options Other Test Entry options can only be configured using a DMS The availability of configuration options will thus vary according to the data management software utilized by your institution Consult your system administrator ...

Page 203: ...her with the glucose test result and any desired comments 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 informs the operator that they have to renew their certification The contents of the message is created on the DMS and may vary The screen message shown here is for illustration purposes only This function needs to be co...

Page 204: ...ID or scan your operator ID bar code 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 active 5 Hand the meter to the operator who can now perform the patient test under supervision Main Menu Review Results Control Test Patient Test 12 48 pm 09 18 13 1 2 3 4 5 6 7 8 9 A O 0 Observer ID 12 48 pm 09...

Page 205: ...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 want to add a comment 13 Touch to return to the Main Menu screen The OTS information is saved together with the test result Observer Login I 301 Observer Alan Smithee please log in to proceed Otherwise the OTS test will not be complete OTS Valid Glucose Result No Yes ...

Page 206: ...D Supplement for Observed Test Sequence 206 This page intentionally left blank ...

Page 207: ... 128 161 172 Menu overview 113 115 Control frequency 121 Control lots Editing control lot data 80 84 Selecting 63 Storing information 73 88 Control solution Lot number 63 CR LO HI 53 Critical range 53 123 D Date and time 127 Date and time format 117 Delete patient 144 Diagnostics 140 Disinfecting 130 138 Display options 118 Disposal 18 Docking the meter 110 Download lockout 41 68 Unlocking 142 E E...

Page 208: ...40 Options 124 Password 40 Ordering 156 Other Test Entry OTE 181 201 P Password 126 Patient glucose testing 41 56 Performing a test 42 54 Preparing 41 Results 52 Patient ID 43 46 Barcode scanner 46 Entering manually 45 Options 125 Powering up 35 Power off automatic 19 Product information 153 158 Proficiency test Preparing 98 Proficiency testing 97 103 Performing a test 99 103 Results 103 Q QC lock...

Page 209: ...itial startup 105 141 Maintenance 129 144 Overview accessory box 33 Overview base unit hub 32 Overview base unit 31 Overview code key reader 30 Overview meter 28 Technical data 153 Troubleshooting 145 152 T Technical data 153 Telephone number information service 159 Test strip lots Storing information 73 88 Test strip options 119 Test strips Applying blood sample 50 Applying control solution 66 Ap...

Page 210: ...Index 210 This page intentionally left blank ...

Page 211: ...211 ...

Page 212: ...07839001 05 2013 09 EN c ACCU CHEK ACCU CHEK INFORM ACCU CHEK PERFORMA and COBAS are trademarks of Roche M Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany www roche com www accu chek com ...

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