Accu-Chek Inform II Operator'S Manual Download Page 115

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Proficiency Testing •

115

08424705001 (01) 2017-04 USA • Accu-Chek Inform II Operator’s Manual Version 6

Inserting test strips

After confirming the test strip lot, a flashing green arrow

appears on screen and prompts you to insert the test

strip.

Remove the test strip from the test strip vial and

close the vial with the cap.

Hold the test strip so the lettering “ACCU-CHEK” is

facing upward.

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.

Profi ciency Test

Sample 123456789
Strip Lot 545794

12:48 pm

03/17/17

Profi ciency Test

Sample 123456789
Strip Lot 545794

12:48 pm

03/17/17

Summary of Contents for Inform II

Page 1: ...Accu Chek Inform II BLOOD GLUCOSE MONITORING SYSTEM Operator s Manual for meters with a serial number greater than or equal to UU14000000 ...

Page 2: ...ion 3 0 2013 03 Update cleaning and disinfecting chapter Version 3 1 2017 04 Add Rx only to Version 3 0 Operator s Manual 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 Version 5 0 2015 03 Correct two typographi...

Page 3: ...08424705001 01 2017 04 USA Operator s Manual Version 6 0 A ACCU CCU CHEK HEK Inform II System ...

Page 4: ...iagnostics Roche Diagnostics has made 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 If you have questions or comments about this manual please contact Accu Chek Customer Care ACCU CHEK ACCU CHEK INF...

Page 5: ...umber In vitro diagnostic medical device Global Trade Item Number Serial Number 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 Base Unit Light Power supply connection Base Unit Rx only Caution Federal law restricts this device to sale by or on the order of a physician This device complies wit...

Page 6: ...y between activation of the scan ner and reading a barcode PreAimer Delay See section Barcode Configuration on page 190 More barcode types supported See section Barcode Configuration on page 190 Additional information regarding lithium ion Li ion batteries Avoidance of electrical shock fire and explosions Possible hazards posed by the battery pack See section 1 2 Information regarding shipping See...

Page 7: ...lete Patient Information function has been moved to a new Service Menu See page 159 OTS workflow the assessment buttons on the dis play are bigger and easier to use See page 227 Workflow for replacing the battery pack has been modified See page 122 Support of isolation room workflows Scan the test strip vial before scanning the patient ID See Supplement E Supplement for Enhanced Work flows Blood s...

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Page 9: ...nformation regarding safety 20 Disposal of the system 21 Product safety 21 General care 22 Accessory box 22 Meter 22 Power off meter 22 Automatic power off 22 Shut down meter 23 Automatic shutdown 23 Battery Pack 23 Touchscreen 26 Electromagnetic compatibility EMC 26 Electrostatic discharge ESD 27 Wireless connectivity 28 Radiofrequency radiation exposure information 28 Local Area Network protecti...

Page 10: ...ient ID from a list 54 Entering a patient ID with barcode scanner 55 Confirming or selecting the test strip lot 56 Patient identification information 58 Inserting test strips 59 Obtaining a blood sample 60 Applying a blood sample 61 Results screen 62 Adding comments 65 Additional Patient Test 67 4 Glucose Control Testing 69 4 1 Information regarding glucose control tests 69 Glucose control testing...

Page 11: ... lot number 101 7 Linearity Testing 103 7 1 Information regarding linearity tests 103 Linearity testing intervals 104 Information stored during linearity testing 104 Linearity test kit 105 Preparing to run a linearity test 105 7 2 Performing a linearity test 106 Overview of test procedure 106 Starting a linearity test 106 Confirming or selecting the lot number for linearity test kits 107 Confirmin...

Page 12: ...ting the date and time 143 9 15 Beeper options 144 10 Maintenance and Care 145 10 1 Conditions for storage and shipping 145 General operating conditions 145 Shipping 146 Storage 147 10 2 Cleaning disinfecting the Accu Chek Inform II system 147 Guide to cleaning and disinfecting the Accu Chek Inform II system 148 Cleaning and disinfecting the meter 148 Acceptable cleaning disinfecting agents 149 Wh...

Page 13: ... Test Entry 203 C 1 Before you start 203 Description 203 C 2 Overview of Other Test Entry OTE 204 Introduction 204 C 3 Recording Other Patient Tests 207 C 4 Recording Other Control Tests 214 Introduction 214 Other Control Testing Intervals 214 Stored Control Information 214 Warning messages 220 C 5 Reviewing Other Test Results 221 C 6 Other Test Entry Configuration Options 224 D Supplement for Obs...

Page 14: ...14 08424705001 01 2017 04 USA Accu Chek Inform II Operator s Manual Version 6 G Limited Warranty 239 Accu Chek Inform II meter LIMITED WARRANTY 239 Index 241 ...

Page 15: ...control The system is not for use in diagnosis 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...

Page 16: ...fer to Chapter 9 Initial setup on 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 ...

Page 17: ...oubleshooting please have ready your Accu 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 Note on illustrations in this manual Unless ...

Page 18: ...nd 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 strips Glucose control solutions Linearity solutions Test results Test principle An enzyme on the test strip converts the glucose in the blood sample t...

Page 19: ...t symbol alone without a signal word promotes awareness to hazards which are generic or directs the reader to related safety information WARNING Indicates a hazardous situation which if not avoided could result in death or serious injury CAUTION Indicates a hazardous situation which if not avoided could result in minor or moderate injury NOTICE Indicates a hazardous situation which if not avoided ...

Page 20: ...ts 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 on a new pair of gloves and performing the next patient test Use an auto disabling single use lancing device for each patient Dispose of used lancets in a sturdy sharps container with lid Dispose of used test strips from patient and proficienc...

Page 21: ...ecome damaged Do not use loose power sockets or damaged power supply units cables plugs or battery packs Do not short circuit the power supply unit the base unit charging contacts or the battery pack Do not drop the Accu Chek Inform II meter the power supply unit or the battery pack and protect these against shaking and vibrations WARNING Infection by a potentially biohazardous instrument The Accu...

Page 22: ...wer after 5 minutes of inactivity e g no screen touches strip insertions In measurement mode only If you are performing a test patient control 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 pres ent the meter will emit three warning beeps every minute after 5 minutes of i...

Page 23: ...ter is shut down Use meter shutdown when you want to remove or replace the battery pack see page 122 Automatic shutdown In case of a Download Lockout see page 157 or if the battery pack is critically low see page 165 the meter willl shut down automatically Battery Pack The meter contains a rechargeable battery pack that begins charging as soon as it is placed in an active base unit i e one connect...

Page 24: ...it that leads to overheating Do not place either the battery pack or the Accu Chek Inform II meter on or in heating appliances such as a microwave conventional oven or radiator Avoid prolonged exposure to direct sunlight e g when the meter is docked in the base unit Keep this in mind when positioning the base unit Battery fluid or materials leaking from damaged battery packs can irritate your skin...

Page 25: ...eter must be returned immediately to the base unit for recharging No more tests can be performed Disposal of used batteries Do not dispose of the battery pack with normal domestic waste As a component of the Accu Chek Inform II system it must be deemed as potentially biohazardous Treat it accordingly See Disposal of the system on page 21 Save or download data from the meter prior to replacing the ...

Page 26: ...e designed to provide reasonable protection against harmful interfer ence in a residential installation This equipment gener ates uses and can radiate radio frequency energy and if not installed and used in accordance with 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 equ...

Page 27: ... II system complies with the elec trostatic discharge ESD immunity requirements as specified in IEC 61326 2 6 Electrostatic discharge ESD is an electrical charge at rest most commonly known as static electricity If the meter experiences ESD during a blood glucose test an error message is displayed and no blood glucose result is displayed by the meter or stored in the meter s memory The blood gluco...

Page 28: ... appendix B Radiofrequency radiation exposure information The Industrial Scientific and Medical ISM radio frequencies may contain emissions from microwave ovens heaters and other noncommunication devices While these types of devices usually pose no threat of interference as they are low powered devices the possi bility exists that some industrial high power systems may wipe out any attempted commu...

Page 29: ...abil ity testing programs to ensure that 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 ...

Page 30: ...olled networks as well as measures that ensure that the connected network is free of malicious code Wired network connection If connected to a local area network the Accu Chek Inform II Base Unit or Accu Chek Inform II Base Unit Hub must be protected against unauthorized access by means of a strong password management For additional information about the Accu Chek Inform II Base Unit or Accu Chek ...

Page 31: ...ngth Passwords must contain characters from at least three of the following four categories English uppercase alphabetic characters A through Z English lowercase alphabetic characters a through z Numeric characters 0 through 9 Non alphabetic characters for example Examples of weak passwords uhxwze11 contains no upper case letter UHXW13SF contains no lower case letter uxxxxx7F contains the same cha...

Page 32: ...r see Chapter 9 2 Configuration via data management system Note 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 barcodes test strip lots controls patient and operator IDs in a variety of supported formats Di...

Page 33: ...esults To select any of these 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 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...

Page 34: ...ry pack Powers the device 9 Wireless 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 35: ...r has the following elements 12 Code 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 flashing the code key reader will continue to transmit the pre...

Page 36: ...ation with a data management system 1 communication with a computer Both versions of the base unit have the following elements 15 Charging contacts 16 Infrared 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...

Page 37: ...22 USB configuration switch Base Unit for System Administrator use only The following additional elements are provided with the base units 23 Power supply unit for Base Unit Base Unit Light not shown here 24 USB cable for Base Unit USB A to USB micro B For instructions on connecting the base unit see Chapter 9 Illustration on the left shows the Accu Chek Inform II Base Unit above the Accu Chek Inf...

Page 38: ...n Ethernet RJ45 port 21 USB port 24 Connections for up to 4 Accu Chek Inform II Base Units Light RJ25 data transfer and power 25 RJ25 cable connects the hub to an Accu Chek Inform II Base Unit Light 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 or the Technical Note stored on ...

Page 39: ...ek Inform II Test Strips Accu Chek Inform II Control Solutions Available for purchase separately consists of two 2 5 mL bottles One bottle contains the Level 1 Lo control while the other bottle contains the Level 2 Hi control 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 leve...

Page 40: ... can perform these settings on 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...

Page 41: ...ectly If necessary refer to the instructions 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 par...

Page 42: ...disable this functionality 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 display backlight to conserve energy Low Power Mode Display Lighter Darker 12 48 pm 03 17 17 WARNING If you suspect that ...

Page 43: ... connectivity is enabled Signal strength is shown by 4 bars next to the icon in the status bar Signal strength can range from poor to excellent 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...

Page 44: ...nctions ID dependent 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 Via barcode scanner only a list of supported barcode symbologies can be found in Appendix A 2 Manually or optionally via barc...

Page 45: ...nce 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 03 17 17 The meter can be configured so that there is a small delay between activating the barcode scanner green beam and reading the barcode red beam The delay is adjustable and...

Page 46: ... 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 password Once the operator ID has been entered correctly a screen for entering a password may appear if config ured Enter the password manually in the same manner as described above for the o...

Page 47: ...ng blood samples Observe the applicable regulations and directives for disposing of potentially infectious samples and mate rials Refer to the section Important information regarding safety starting on page 20 of this manual in particu lar Protection against infection and blood borne pathogens Use gloves Wear a new pair of clean gloves for testing each patient Wash hands thoroughly with soap and w...

Page 48: ...ust 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 by docking the meter in a base unit does not happen within the specified time the m...

Page 49: ...he meter being in QC Lockout or Download Lockout see page 81 Depending on how your meter is configured see page 137 QC Lockout occurs when patient testing is attempted and controls have not been run in the time interval or frequency estab lished by your facility controls have been run but the control values were not in range new software has been installed a test strip lot other than the current l...

Page 50: ... test procedure A patient glucose test comprises the following steps Enter the patient ID This can be done either 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 225 ...

Page 51: ...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 03 17 17 D 503 Patient ID 123456789 Name Mary Jane Miller DOB 12 03 56 Is this correct Patient Confirmation Main Menu Review Results ...

Page 52: ...Z and 0 9 additionally period 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 down loaded 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 I...

Page 53: ... 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 does not match configured max min length an error message is displayed Confirming the error mes sage allows you to enter the ID again If the patient is not found in the downloaded list a decision message may be displayed depending on configuration see Appendix A 1 Cancell...

Page 54: ... 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 2 Touch the desired entry to select a patient or touch to cancel this procedure and return to the Main Menu 1 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 12345...

Page 55: ...o that the window of the barcode scanner is approx 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 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 03 17 17 Patient ID Keyboard ID 2222222222 Name Jane ...

Page 56: ... played by the meter touch to confirm To use a different lot number than 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 or scanned lot number The meter can be configured so that no QC lockout occurs when you switch between stored test strip lots However the selected test strip lot must already have passed...

Page 57: ... 344654 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 A O 0 Patient ID 12 48 pm 03 17 17 The meter can be configured so that manual confirma tion 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 Note Barcodes on control solutions may not be availa ble in all...

Page 58: ...he screen The display cycles every second between displaying patient ID and if available patient name In a second line the date of birth DOB is displayed If no DOB is available a dash is shown instead See illustrations below Patient Test Patient John Doe Strip Lot 545794 12 48 pm 03 17 17 DOB 12 05 70 Patient Test Patient 123456789 Strip Lot 545794 12 48 pm 03 17 17 DOB 12 05 70 Patient Test Patie...

Page 59: ... 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 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 1...

Page 60: ...e lancing device for each 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 fi...

Page 61: ...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 been detected the meter beeps and the measurement begins Patient Test Patient 123456789 Strip Lot 545794 12 48 pm DOB 12 05 70 03 17 17 Whe...

Page 62: ...l lower range These limit 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 ...

Page 63: ... Results outside this range must not be used 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 0...

Page 64: ...easurement Range LO below 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 alway...

Page 65: ...provide 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 saved automa...

Page 66: ...ypad as with login to enter 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 New Strip Lot Will Repeat Test RN Notified Doctor Notified 12 48 pm 03 17 17 Patient Test Out of Normal Range 220 Patient 123456789 Date 03 17 17 12 48 pm mg dL New Strip Lot Doctor Notified Will Repeat Test 12 48 pm 03 17 1...

Page 67: ...is function is enabled only possible via DMS a pop up dialog allows the operator to perform another test for the same patient immediately after the first test result is displayed This function is also available for OTS and OTE workflows Patient Test Range 150 Patient 123456789 Date 03 17 17 12 48 pm mg dL 12 48 pm 03 17 17 D 531 Perform additional Patient Test for Patient ID 123456789 Additional P...

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Page 69: ...f 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 ...

Page 70: ...r 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 the system In addition the following events can be specified during setup as a reason for a glucose control test If a previous control test is out of range If glucose...

Page 71: ...ose 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 of the test strips Time and date of test Comments if applicable Out of range measurements ...

Page 72: ...sults 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 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 applicabl...

Page 73: ...es the following steps Select the desired 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 ...

Page 74: ... 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 the example above Level 2 Hi is marked Control Test Level 2 Hi Level 1 Lo Required 12 48 pm 03 17 17 Mai...

Page 75: ...ing IDs see page 45 If you want to use the preselected number dis played by the meter touch to confirm If you want to use a different number than the lot number displayed touch to open the keypad and enter the number manually or 2 Touch to confirm the selected test strip lot number For additional information about storing lot numbers for control solutions see page 94 The meter can be configured so...

Page 76: ...rm To use a different lot number than the one dis played 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 For additional information about storing lot numbers for test strips see page 87 The meter can be configured so that manual confirmation i...

Page 77: ... 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 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 ...

Page 78: ... solution to the front edge 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 03 17 17 When applying the control solution position the meter so that...

Page 79: ...o disallow 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 Control Test PASS Control L2 Hi 123456 Date 03 17 17 12 48 pm ...

Page 80: ...Menu Remove the test strip and dispose of it in accordance with applicable regulations and directives For control tests comments are only required if the result is outside the specified range whether this is displayed as a value or as FAIL If the result is within the specified range displayed as a value or as PASS comments are optional Test results are saved automatically if the meter is pow ered ...

Page 81: ...ol intervals or other conditions The 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 ...

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Page 83: ... the data record for stored test results 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 ...

Page 84: ...esults are grouped by date Glucose Results Patient QC All 01 19 17 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 12 48 pm 03 17 17 Main Menu Review Results Control Test Patient Test 12 48 pm 03 17 17 Glucose Results Patient QC All 01 19 17 mg dL Time Rslt 7 15 pm 74 123456789ABC 5 32 pm 2...

Page 85: ...ent in the Patient Result view middle screen above the list of test results for this patient will be displayed Glucose Results Patient QC All 01 19 17 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 12 48 pm 03 17 17 Patient Result ID 123456789ABCDEFG Name Joe M Doe Strip Lot 400433 229 mg ...

Page 86: ...return to the previous menu screen 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 01 19 17 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...

Page 87: ...be stored centrally in the data management 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 T...

Page 88: ...e 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 03 17 17 Strip Lots Add Strip 06 31 17 855732 05 21 17 845678 Strip 06 21 17 84572...

Page 89: ...the code key is removed After the LED 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 fil...

Page 90: ...umber 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 the ...

Page 91: ...e ranges for control solutions 1 Use the 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 12 10 17 L1 L...

Page 92: ...fter 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 353 mg dL 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 0 Control L2 Min 261 mg dL 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 0 Strip Expiration 05 30 17 12 48 pm 03 17 17...

Page 93: ...tly editing as the current lot number 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 353 mg dL 12 ...

Page 94: ...st 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Bee...

Page 95: ... lot number or press and release to read the lot number from the control solution bottle via barcode scan ner Follow the instructions for scanning IDs see page 45 6 Use the keypad to enter the expiration date as stated on the control solution bottle 7 Touch to confirm the entered expiration date 1 2 3 4 5 6 7 8 9 0 Control Lot 12 48 pm 03 17 17 Add Control Lot Level 2 Hi Level 1 Lo 12 48 pm 03 17 ...

Page 96: ...onfirm 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 05 30 17 12 48 pm 4 5 6 03 17 17 D 312 Do you want to make ...

Page 97: ...umber 1 Touch in the Main Menu to open 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 03 17 17 Control Lots Add QC L2 05 21 17 777678 06 31...

Page 98: ...nt 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 10 11 17 Current 12 48 pm 03 17 17 Control Lot Details Edit Delete Control Lot 777732 Control Level 1 Use by 10 11 17 Make Current 12 48 pm 03 17 17 Control Lots Add QC L2 05 21 17 777678 06 31 17 777...

Page 99: ...number of the linearity test 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 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagno...

Page 100: ...e current lot num ber 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 03 17 17 1 2 3 4 5 6 7 8 9 0 Linearity Expiration 03 31 17 12 48 pm 03 17 17 The c...

Page 101: ... number 1 Touch in the Main Menu to open 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 03 17 17 Linearity Lots Add Lin 06 21 17 777678 0...

Page 102: ... 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 17 Current 12 48 pm 03 17 17 Linearity Lots Add Lin 06 21 17 777678 07 31 17 777732 06 21 17 777723 Lin Lin Type Exp Date Lot Num 12 48 pm 03 17 17 Linear Lot Details Edit Delete Linearity Lo...

Page 103: ...s should be treated in exactly the same manner as previously described for control 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 straight l...

Page 104: ...ests are determined by the facility 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 stri...

Page 105: ...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 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 ent...

Page 106: ...y solutions Starting a linearity 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 03 17 17 Main Menu Review Results Control Test Patient Test 12 48 pm 03 17 17 Main...

Page 107: ...d 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 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 ...

Page 108: ...lose 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 indi cates that the meter is checking the test strip Do not apply linearity solution while it is displayed Linearity Test L1 L...

Page 109: ...arity 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 and the measurement begins Linearity Test Linearity 12345678 L1 Strip Lot 545794 12 48 pm 03 17 17 When applying the linearity solution position the met...

Page 110: ...inearity 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 45 Linearity 12345678 L1 Date 03 17 17 12 48 pm mg dL 12 48 pm 03 17 17 Linearity Test Linearity 12345678 L1 Strip Lot 545794 12 48 pm 03 17 17 Linearity Test L1 L5 L3 L6 L4 L2 Linearity 12345678 Strip Lot 545794 1...

Page 111: ... to the appro priate source after completing 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 assuran...

Page 112: ...red Preparing a proficiency 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 ...

Page 113: ...est strips Perform the actual test with 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 03 17 17 Main Menu 2 Maintenance Strip Lots Profi...

Page 114: ...ID Confirming or selecting 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 ...

Page 115: ...ial 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 indi cates that the meter is checking the test strip Do not apply the proficiency sample while it is displayed Proficiency Test Sample 1234567...

Page 116: ...y a drop of sample to the front 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 03 17 17 When applying the proficiency sample position the meter so that the test strip...

Page 117: ... not wish 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 03 17 17 12 48 pm 12 48 pm 03 17 17 Proficiency Test 150 Sample 123456789 Date 03 17 17 12 48 pm mg dL 12...

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Page 119: ...ersion 6 9 Initial Startup 9 1 Connecting the base unit Accu Chek Inform II Base Unit Accu Chek Inform II Base Unit Light 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 175 ...

Page 120: ...base unit back onto the wall mount if in use For details on configuring the Accu Chek Inform II Base Unit contact Accu Chek Customer Care for technical assistance Note for System Administrator For further technical information on setting up and configuring the Accu Chek Inform II Base Unit consult the package insert accompanying the device and the Technical Note stored on the Accu Chek Inform II B...

Page 121: ...n the base unit before testing 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 37 108 F or 3 42 C is maintained during installation and initial setup Replace the battery pack within approximately 10 minutes to retain the date and ti...

Page 122: ...ent damage to the meter or potential data loss 1 To shut down the meter press the the On Off button for about 5 seconds and release the On Off button as soon as the Roche logo is dis played and the meter beeps 2 Place the meter face down on a level surface If you press the On Off button for too long a meter reset will be triggered after about 12 seconds see section Meter reset on page 168 ...

Page 123: ...ttery 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 s guidelines on the disposal of electro...

Page 124: ...bout 2 10 inch 2 Hold the 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 125: ...ar If the meter has been without 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 137 the meter will now be in QC Lockout due t...

Page 126: ...m II Base Unit or 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 Data Management System DMS Docked Connecting 12 48 pm 03 17 17 ...

Page 127: ...erred to the meter 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 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 03 17 17 Docked Updating Soft...

Page 128: ... 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 management system the configuration options on the meter may be disab...

Page 129: ...nalysis UA Rapid Streptococcus Rapid Drugs 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 Contr...

Page 130: ... Current Edit Delete Lot Control 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 Di...

Page 131: ...rmat Test Display 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 Service Menu1 Delete Patient Information De...

Page 132: ...dmin to open the Admin Menu 3 Touch Setup Menu to open the Setup Menu 4 Enter the Setup password if requested see Creating a setup password on page 142 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 03 17 17 Admin Menu Date Time Language Selection Setup Menu 12 48 pm Service Menu 03 17 17 Setup Menu Date Time QC Test Display P...

Page 133: ...to edit the date and time only after entering a password Not Allowed The operator cannot edit date or time 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 case...

Page 134: ... the settings Linearity is displayed 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 ST...

Page 135: ...ator cannot edit reagent information Strip 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 List selection The operator can also select from a list of stored lot numbers Scan only Lot...

Page 136: ...arcode scanner Lot entry The 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 operat...

Page 137: ... running glucose control tests Last QC 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 t...

Page 138: ...f day Up to six times per day 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 139: ...n the following order Normal low high limit 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 11 mg dL 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 0 Normal Range L...

Page 140: ...r ID must be a specified length 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 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...

Page 141: ...ing this option Length if numeric Only numeric patient 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 ...

Page 142: ...and enable pass word protection 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 passw...

Page 143: ...ll values are two digit with a 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 03 17 17 Admin Menu Date Time Language Selection Setup Menu 12 48 pm Service M...

Page 144: ...lume 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 Menu 2 screen Main Menu Review Results Control Test Patient Test 12 48 pm 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics Linearity Lots Admin 12 48 pm 03 17 17 Beeper Setup Mediu...

Page 145: ...re placing in base unit Follow the instructions for cleaning beginning on page 147 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 ope...

Page 146: ... that it cannot move around in the packaging Also observe any other applicable national regulations When shipping via third parties e g by air or parcel service work with the carrier to check whether specific requirements need to be met in relation to the lithium ion battery packs on the basis of national or international laws on hazardous goods and where applicable if special packaging and labeli...

Page 147: ...rs should be used only on one patient 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 fol lowing the guidelines given in this section 3 1 FDA Public Health Notification Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens Initial Communication 201...

Page 148: ... the next patient test Cleaning and disinfecting the meter Clean the meter to remove visible soil and organic material prior to disinfecting 1 Disinfect the meter to destroy pathogenic and other types of microorganisms Disinfection destroys most recognized pathogenic microorganisms but not necessarily all microbial forms e g bacterial spores 1 NOTE The meter should be cleaned and disinfected betwe...

Page 149: ...ient 1 or less solution of sodium hypochlorite in water Super Sani Cloth Germicidal Disposable Wipes EPA reg no 9480 4 Pre moistened disinfecting cloths active ingredient 0 5 quaternary ammonium chlorides and up to 60 isopropanol Cleaners and disinfectants were validated sepa rately and only one cleaning disinfecting solution should be used on the device as the effect of using more than one cleane...

Page 150: ...n The meter housing entire meter 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 ...

Page 151: ... performing a blood glucose or control test Do Not get any moisture in the test strip port Do Not spray anything onto the meter 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...

Page 152: ...olution before cleaning the 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...

Page 153: ... 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 D...

Page 154: ...ment 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 All logged maintenance comments can be reviewed later on the Review Results screen of the meter see page 83 Main Menu Review Results Control Test Patient Test 12 48 pm 03 17 17 Main Men...

Page 155: ...WLAN option The Diagnostics screens shown 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 03 17 17 Main Menu 2 Maintenance Strip Lots Proficiency Control Lots Beeper Linearity Diagnostics ...

Page 156: ...0000740 12 48 pm 03 17 17 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 03 17 17 Diagnostics List allowed to add new Reagent Editing Date Time Editing STATs Patient Validation 9 None Operator Validation 0 Configuration Page 3 Hours QC Freq Strip Limitations Warning Used Disabl...

Page 157: ...ned period of time If a download lockout 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 withou...

Page 158: ...sword if requested 5 Touch Unlock to reset the lockout timer The meter shuts down 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 03 17 17 Admin Menu Date Time Language Selection Setup Menu 12 48 pm Service Menu 03 17 17 Setup Menu Date Time QC Test Display Password Test Ranges R...

Page 159: ...e in the preconfig ured default setting The Service Menu can only be acti vated via DMS Service Menu Delete Patient Information 12 15 pm 03 17 17 Admin Menu Date Time Language Selection Setup Menu 12 48 pm Service Menu 03 17 17 Delete Patient Information Service Menu 12 15 pm QC Test Display Password Test Ranges Operator ID Patient ID Unlock Delete Pat 03 17 17 Confirm Deletion D 201 Delete Data A...

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Page 161: ...e column header Possible Solution If 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 o...

Page 162: ...see Chapter 4 Repeat the test or 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...

Page 163: ... is unable to communicate with the Data 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 wireless 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...

Page 164: ... as described in the following Power 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 Repla...

Page 165: ...cated by a single red segment that grows gradually until the required threshold for booting the meter is reached Avoid using the meter in case of low power to guarantee full functionality The On Off button cannot be used If not docked the meter will shut down automatically after 1 minute Flashing icon in status bar If the meter is not properly docked a short humming noise sporadically occurs and t...

Page 166: ... on screen to resolve the problem The different message types are illustrated in the following 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 17 777732 Lin 01 15 17 777723 Lin Exp Date Lot Num Type 12 48 pm 03 17 17 Patient Test Patient ...

Page 167: ...the actions suggested Sample message type Description W 1302 D T settings lost due to meter reset or loss of power Before performing further tests Enter D T manually and synchronize meter OR Ask System Admin for help Loss of Date Time 1 2 3 Operator ID 12 48 pm 03 17 17 E 314 Invalid Scan The scan returned an entry 20 characters Please see your System Administrator Invalid Scan ...

Page 168: ... 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 Before performing any further tests you must now either enter date time manually and then synchronize the meter or contact your syst...

Page 169: ...tion is Always OK see page 137 the meter will now be in QC Lockout 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...

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Page 171: ...8 mm max 2 01 in 51 mm Length 7 60 in 193 mm max Base Unit 5 12 in 130 mm max Base Unit Light 4 06 in 103 mm max 3 43 in 87 mm Weight approx 347 g with rechargeable battery Base Unit 671 g with wall mount Base Unit Light 573 g with wall mount 170 g User interface Touchscreen and barcode scanner Base Unit LED tricolor red green blue Base Unit Light LED bicolor red green LED green Display resolution...

Page 172: ... temperature Test strip dependent Refer to the test strip package insert Storage conditions long term storage 41 to 104 F 5 to 40 C at 10 85 RH non condensing Remove battery pack from meter for long term storage Humidity operating 10 90 RH non condensing Air pressure 0 7 to 1 06 bar 70 to 106 kPa 0 7 to 1 06 bar 70 to 106 kPa N A Specification Meter Base unit Power supply unit ...

Page 173: ...ing1 N A N A Interfaces Charging contacts IR port Barcode scanner WLAN Channel 1 11 only Charging contacts IR port RJ45 Ethernet Base Unit RJ25 Base Unit Light USB type B DC connector Replaceable AC input contacts Data transfer rate WLAN up to 54 Mbps IR 9 6K 115K bps Ethernet 10 100 Mbps auto negotiate full duplex USB 12 Mbps N A Supported barcodes Code 128 Code 39 Code 93 EAN 13 Interleaved 2 of...

Page 174: ...in 70 7 mm 5 in 127 mm Weight 1100 g 28 g 470 g Operating temperature N A 37 to 122 F 3 to 50 C 37 to 122 F 3 to 50 C Storage temperature short term 13 to 158 F 25 to 70 C 37 to 122 F 3 to 50 C 13 to 158 F 25 to 70 C 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 Inpu...

Page 175: ...artment Cover Replacement cover for meter battery compartment for meters with serial no above UU14000000 06869823001 Accu Chek Inform II Base Unit Light Equipped with charging functionality 05920353001 Power Supply Power supply for Base Unit Light legacy Base Unit REF 05060290001 North America 05388805001 Accu Chek Inform II Base Unit Equipped with charging and connectivity functionality 076717171...

Page 176: ... Base Unit Hub North America 03868133001 Accu Chek Inform II Code Key Reader 04884671001 Accu Chek Inform II Accessory Box 05060281001 Accu Chek Inform II Battery Pack Rechargeable battery pack consumable for meters with older hardware and serial no below UU14000000 04882326001 Accu Chek Inform II RF Card Kit Wi Fi card replacement accessory for meters with older hardware and serial no below UU140...

Page 177: ...perator s Manual and the Accu Chek Inform II Quick Reference Guide are available on the Roche Diagnostics USA website at https usdiagnostics roche com Reagents and Solutions Supplies are available through Roche Diagnostics Contact Accu Chek Customer Care Product Limitations Read the information in the package insert supplied with the reagents and solutions for detailed product data and limitations...

Page 178: ...ile 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 PDF file ROCHE BU Technical Note UDS5 1 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 the Base Unit included...

Page 179: ...t are not answered in this manual contact Accu Chek Customer Care If you do not already have contact details visit our website at www roche com Click on Menu then select Worldwide 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 ...

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Page 181: ...ailable using the respective configuration method Configuration options DEVICE If the meter is configured by a system admin istrator using a data management system the configu ration 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 Attribute...

Page 182: ... 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 0 100 characters Out of Critical Range N Y Normal range HI limit 10 600 mg dL 0 6 33 3 ...

Page 183: ...a patient test series 0 disabled 1 enabled 0 N Y Blood sample type selection 0 disabled 1 enabled 0 N Y Isolation Room 0 disable selectpatientID before strip lot selection 1 enable select strip lot before patient ID selection 0 N Y Linearity lot verification 0 display only 1 yes no confirmation 2 prompt for lot entry 1 Y Y Display Contrast 0 15 7 Y Y Formats and Language Date format 1 MM DD YY 2 D...

Page 184: ... the setuppasswordisrequired to 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 possibl...

Page 185: ...ed to validate an operator ID if operator ID validation mode is set to Length 0 20 0 Y Y Operator ID timeout determines the time in sec before the operator is logged out after power off 0 immediately logged out 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...

Page 186: ... validation 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 or List allowed to add new 0 20 20 Y Y Patient ID minimum length used to vali date a patient ID if patient ID validation mode is set to Length or List allowed...

Page 187: ...m is set to Hours or hours rotate 1 9 999 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 ...

Page 188: ... A command 30 3 600 s 60 N Y WLAN settings general WLAN enabled 0 disabled 1 enabled 0 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 enab...

Page 189: ...re listed below see table Allowed combinations of cipher and security type Note 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...

Page 190: ...ode 39 0 disabled 1 enabled 1 N Y Code 93 0 disabled 1 enabled 1 N Y EAN 13 0 disabled 1 enabled 1 N Y Interleaved 2 of 5 0 disabled 1 enabled 1 N Y Codabar 0 disabled 1 enabled 1 N Y GS1 DataBar Limited 0 disabled 1 enabled 1 N Y QR Code 0 disabled 1 enabled 1 N Y DataMatrix 0 disabled 1 enabled 1 N Y PDF417 0 disabled 1 enabled 1 N Y Aztec 0 disabled 1 enabled 1 N Y PreAimer Delay in millisecond...

Page 191: ... open 0 none 1 WEP 4 WEP40 0 open 1 shared 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 6...

Page 192: ... as part of the ID Tilde The scan 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 Ca...

Page 193: ... content WARNING Risk of barcode read errors If a barcode is read incorrectly this may lead to patient misidentification and therefore to inappropriate therapy decisions 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 15416 a...

Page 194: ...arcodes contact Accu Chek Customer Care see Chapter 12 EAN 13 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 It is possible to selectively enable or disable the barcode types used for scanning Patient IDs or Operator IDs Barcode types that are not used can be di...

Page 195: ...method and configu ration the substrate material on which the barcode is printed and the resulting print quality Recommended Specification Remarks Print resolution 300 dpi preferred 200 dpi minimum At 200 dpi issues with the wide to narrow ratio may exist Reflective contrast 70 or greater Matte finish is preferred over gloss finish Symbol grade Grade C or above Grade B is preferred Symbol grades a...

Page 196: ... Codabar Code 39 Code 93 Code 128 EAN 13 GS1 DataBar Limited Interleaved 2 5 without checksum Interleaved 2 5 with checksum PDF417 Aztec DataMatrix QR Code Roche Professional Diagnostics Roche Professional Diagnostics Roche Professional Diagnostics Roche Professional Diagnostics ...

Page 197: ... GHz frequency range to wirelessly transmit 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 municatio...

Page 198: ...ey 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 interferences building structure related and other wireless equipment devices As part of an RF implementa...

Page 199: ...pports 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 glossary of terms frequently asked questions and other topics related to Wi Fi technology can be found on the Wi Fi Alli ance sit...

Page 200: ... and data transfer capabilities 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 ...

Page 201: ...cation 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 however the meter will respond within a few seconds An Accu Chek Inform II meter with wireless ...

Page 202: ...teed 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 The Accu Chek Inform II meter monitors the Quality of Service QoS of t...

Page 203: ...rols are entered in the Control Test 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 additio...

Page 204: ...nter patient results 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 205: ...view Results listing the test names for 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 206: ...rip 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 1 Note The display of date of birth DOB is not available for OTE workflows This can be done ...

Page 207: ...or ID You have completed login by selecting 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 03 17 17 Other Patient Tests Pregnancy Visual UA MS Visual UA CS Rapid Strep Rapid DAT 12 48 pm 03 17 17 Patient Test ...

Page 208: ...er Patient Tests Pregnancy Visual UA MS Visual UA CS Rapid Strep Rapid DAT 12 48 pm 03 17 17 Other Patient Tests Intermediate Acting Insulin Insulin Mixtures Long Acting Insulin 12 48 pm 03 17 17 Other Patient Tests Fecal Occult Ketones Gastric Occult Rapid Acting Insulin Regular Insulin 12 48 pm 03 17 17 If you need to change an entry touch to return to the previous screen ...

Page 209: ...e next screen 7 Use the keypad to enter 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 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 A O 0 Patient ID 12 48 pm 03 17 17 1 See also section Entering or selecting the patient ID in Chapter 3 1 2 3 4 5 6 7 ...

Page 210: ... Touch to enter a new 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 17 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 A O 0 Fecal Card Lot 111363 12 48 pm 03 17 17 Fecal Card Lot Use card 131163 ID 150 88 256 12 19 17 9 12 am 12 48 pm 03 17 ...

Page 211: ...number displayed by the meter Touch to 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 17 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 A O 0 Fecal Developer Lot 12 48 pm 03 17 17 Fecal Developer Lot Use developer 131163 ID 1...

Page 212: ...y touching the appropriate 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 12 48 pm 03 17 17 Fecal Occult Pat ID 150 88 256 Negative Ctrl Select a negative control result acceptable not acceptable 12 48 pm 03 17 17 Fecal Occult Pat ID 150 88 25...

Page 213: ...d as with login to enter your comment 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 03 17 17 9 12 am 45233 07 30 18 1283 12 30 17 12 48 pm 03 17 17 Fecal Occult Pat Result ID 150 88 256 negative 12 48 pm 03 17 17 Fe...

Page 214: ...ommer cially prepared 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 fo...

Page 215: ...time tested if required Enter or confirm 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 succes...

Page 216: ...sts 3 Select the desired 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 03 17 17 Other Control Tests Pregnancy Visual UA MS Visual UA CS Rapid Strep Rapid DAT 12 48 pm 03 17 17 Control Test Menu Glucose Control Test Other Control Tests 12 48 pm 03 17 17 Other Control ...

Page 217: ... the next screen 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 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 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 0 Expiration Date 12 30 17 1...

Page 218: ... a bar code is available 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 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 0 Expiration Date 01 30 18 12 48 pm 03 17 17 ...

Page 219: ...ntered the Pregnancy Control result screen 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 12 48 pm 03 17 17 Pregnancy Control Positive Liquid Control Ctrl Result Select a Pregnancy liquid control result acceptable not acceptable 12 48 pm 03 17 17 Pregna...

Page 220: ...r Other Patient Tests 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 acceptabl...

Page 221: ... Main Menu screen is displayed Perform 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 03 17 17 Other Test Results Patient QC All 03 17 17 Type ID 12 15 pm 12 25 pm Strep VUA...

Page 222: ... QC All 03 17 17 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 12 48 pm 03 17 17 Fecal Occult Pat QC Patient ID 150 88 256 Dev Lot Card Lot Name Helen Schneider 45233 11 30 17 1283 12 30 17 03 17 17 9 12 am Page 1 2 12 48 pm 03 17 17 Fecal Occult Pat QC Patient ID 150 88 256 Doctor ...

Page 223: ...st Results screen to remove the Patient 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 03 17 17 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 12 48 pm 03 17 17 Other Test Res...

Page 224: ...rsion 6 C 6 Other Test 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 225: ...perator This assessment is saved together 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 purp...

Page 226: ...r your operator 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 available 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 03 17 17 1 2 3 4 5 6 7 8 9 A O 0 Obse...

Page 227: ...uch 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 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 com...

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Page 229: ... workflows The Accu Chek Inform II system offers enhanced config uration options for adapting the default patient testing workflow described in chapter 3 Patient Glucose Testing to meet a facility s specific requirements or needs See Appendix A 1 Table of configuration options The activation of these features is only possible via a suitable data management System DMS ...

Page 230: ...ed the test strip lot see page 56 or Patient ID in case of the Isolation Room Workflow described below the blood sample type selec tion screen appears Or Patient Test Patient 123456789 Use Strip Lot 12 48 pm 123456 03 17 17 Patient Test Sample Type Arterial Capillary Venous Heel Stick 12 48 pm 03 17 17 1 2 3 4 5 6 7 8 9 A O 0 Patient ID 12 48 pm 03 17 17 Patient Test Sample Type Arterial Capillary...

Page 231: ...d blood type a flashing green arrow appears on screen and prompts you to insert the test strip 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 Patient Test Sample Type Arterial Capillary Venous Heel Stick 12 48 pm 03 17 17 Patient Test Patient 123456789 Strip Lot 545794 12 48 pm 03 17 17 DOB 12 05 70 Patient Test Sample T...

Page 232: ... allows you to test a patient in an isolation room without having to take the test strip vial to the patient Test procedure for patients in an isolation room 1 Confirm or select the test strip lot For more details see page 56 2 Take the meter and the test strip to the isolation room 1 2 3 4 5 6 7 8 9 A O 0 Patient ID 12 48 pm 03 17 17 Patient Test Patient 123456789 Use Strip Lot 12 48 pm 123456 03...

Page 233: ...D 123456789 12 48 pm 03 17 17 D 503 Patient ID 123456789 Name Mary Jane Miller DOB 12 03 56 Is this correct Patient Confirmation Patient Test Patient 123456789 Strip Lot 545794 12 48 pm 03 17 17 DOB 12 05 70 The test strips should be used immediately after remov ing them from the test strip vial see package insert However where this is not possible due to an altered workflow example Isolation Room...

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Page 235: ...rm II Base Unit This chapter describes the elements and technical data of the legacy base unit version with older hardware F 1 Overview of the base unit with older hardware The Accu Chek Inform II Base Unit legacy version can charge the meter battery pack communicate with a data management system communicate with a computer The base unit has the following elements 1 Charging contacts 2 Infrared wi...

Page 236: ...6 Electrical connections are located on the back of the base unit 4 Removable mount for wall installation 5 Network connection Ethernet RJ45 port 6 USB port 7 Jack for the power supply unit provided 8 USB configuration switch for System Administrator use only 4 5 6 7 8 7 5V 1 7A ...

Page 237: ...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 NOTICE To ensure continuous safe and reliable operation use only the power supply unit provided for the Accu Chek Inform II system for o...

Page 238: ...er interface LED tricolor red green blue LED green Operating temperature 37 to 122 F 3 to 50 C 32 to 104 F 0 to 40 C Storage conditions long term storage 41 to 104 F 5 to 40 C at 10 85 RH non condensing Humidity operating 10 90 RH non condensing Air pressure 0 7 to 1 06 bar 70 to 106 kPa N A Input voltage 7 5 V DC 100 to 240 V AC Input frequency DC 50 to 60 Hz Input current 1 7 A max 350 to 150 mA...

Page 239: ... discretion This warranty does not apply to the performance of an Accu Chek Inform II meter that has been damaged by accident or has been altered misused tampered with or abused in any way THE ABOVE WARRANTY IS EXCLUSIVE OF ALL OTHER WARRANTIES AND ROCHE DIAGNOSTICS MAKES NO OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING WITHOUT LIMITATION THE IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PA...

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Page 241: ...ation 128 144 181 192 Menu overview 129 131 Control frequency 137 Control lots Editing control lot data 94 98 Selecting 75 Storing information 87 102 Control solution Lot number 75 CR LO HI 64 Critical range 64 139 D Date and time 143 Date and time format 133 Delete patient 159 Diagnostics 155 Display options 134 Disposal 21 Docking the meter 126 Download lockout 48 81 Unlocking 157 E Error messag...

Page 242: ...y 46 Options 140 Password 46 Ordering 175 Other Test Entry OTE 203 223 P Password 142 Patient glucose testing 48 67 Performing a test 50 65 Preparing 48 Results 63 Patient ID 51 55 Barcode scanner 55 Entering manually 53 Options 141 Powering off 22 Powering up 41 Power off automatic 22 Product information 171 178 Proficiency test Preparing 112 Proficiency testing 111 117 Performing a test 113 117 ...

Page 243: ...32 General information 171 178 Initial startup 120 156 Maintenance 145 159 Overview accessory box 39 Overview base unit hub 38 Overview base unit 36 Overview code key reader 35 Overview meter 33 Technical data 171 238 Troubleshooting 161 169 T Technical data 171 238 Telephone number information service 179 Test strip lots Storing information 87 102 Test strip options 135 Test strips Applying blood...

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Page 245: ...245 Notes ...

Page 246: ...246 Notes ...

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Page 248: ...FORM and COBAS are trademarks of Roche M Roche Diagnostics GmbH Sandhofer Strasse 116 68305 Mannheim Germany Manufactured for and distributed in the U S A by Roche Diagnostics 9115 Hague Road Indianapolis IN 46256 Rx only https usdiagnostics roche com ...

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