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Lifescan SureStep Pro User's Manual

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1. Alternatively scan the barcode on the test strip Ta bottle label 64 A configuration option may have been selected which would allow you to enter a new test strip lot number at the bedside unit If you do not see the lot number in the list and the Enter Strip Lot button appears on the screen press the button and manually enter the test strip lot number and CTL code A CAUTION To obtain accurate results you must enter the correct test strip lot number and code for each new test ae ey Q SureStepPro 2 0 users press Ok to perform the test for the OC q linearity level and replicate 2 i Lin Level 1 indicated Run Rep 1 Menu Ne fI ox Ne O Apply the linearity solution to the test strip A CAUTION Applying too much or too little linearity solution may cause out of range results e Gently shake the linearity solution vial 65 Special Tests e Touch a drop of linearity solution to the center of the pink test square If the white pad becomes completely saturated you have applied too much linearity solution Repeat the application with a new test strip Check the confirmation dot on the back of the test strip to verify it has turned completely blue indicating an adequate amount of solution was applied If white patches or streaks are visible you have not applied enough linearity solution Repeat the appli
2. See Depending on the configuration option setting you may or may not be required to enter your operator ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after the bedside unit is turned off If your ID appears at the operator screen press Ok to confirm it is correct If the ID is not correct simply enter your ID and it will replace the existing ID 70 Select an option to identify your unknown solution for example Unkn A 5 Select the solution lot or identification number from the list displayed Lin Unkn Test Select a test Lin Lin Lin 1 2 3 Lin Lin 4 5 iia Unkn Unkn A B C Unkn Unkn D Menu oC q Select Lot Unknown A CAP15 Enter UnkA Lot Menu Scan ea N EE Depending on the configuration option setting you may be required to enter the unknown solution lot number If you are not required to enter the lot number the Select Lot screen will not appear 71 Special Tests If you are required to enter the unknown solution lot number a configuration option may have been selected which would allow you to enter a new unknown solution lot number at the bedside unit If you do not see the lot number in the list an
3. If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 89 e Troubleshooting MESSAGE POSSIBLE CAUSE SOLUTION Shake vial and apply High Normal Low control Bedside unit is ready for control solution application Gently shake vial Touch a drop of solution to center of pink test square e If white pad becomes satu rated you have applied too much solution Repeat application with new strip e If white patches or streaks appear on confirmation dot you have not applied enough solution Repeat application with new strip test type Strip Lot Test strip lot Enter and use new test strip Expired expired lot Discard any remaining expired test strips This QC Test QC solution level Do not perform QC test using Not Required was not selected as this level unless you required test by understand that if test is Continue administrator performed and fails and QC lockout mode was selected bedside unit will lock out users until this test and all required QC tests are performed and pass Upload Data transfer not Transfer data Overdue performed within specified time Wrong Type of reagent Check reagent type low Reagent solution entered normal high linearity or Type does not match unknown and re enter information If you cannot resolve a problem call LifeScan Healthcare Professi
4. Start by selecting Lin 1 ai oC q Lin Unkn Test Select a test ume Lin Lin 1 2 3 Lin Lin Unkn Unkn Unkn A B c Unkn Unkn D E Menu 5 Select the Linearity Solution lot number from the list o q displayed Select Lot Linearity 1 Alternatively scan the LIN4002 barcode on the linearity solution vial r Menu Scan Nee 63 Special Tests Depending on the configuration option setting you may be required to enter the linearity solution lot number If you are not required to enter the lot number the Select Lot screen will not appear If you are required to enter the linearity solution lot number you may be allowed to enter a new linearity lot number at the bedside unit If you do not see the lot number in the list and the Enter Lin Lot button appears on the screen press the button and manually enter the linearity solution lot number and expiration date 6 Select the test strip lot number and code from the OC q list displayed The last test Select Strip Lot strip lot number selected Lot CODE Jiono a 8 appears at the top of the list oe Use the arrows to scroll mens o 1015500 6 Enter STRIP Lot t Menul Scan 4 through the list if necessary
5. SureSter Professional Blood Glucose Management System Bedside Unit Operator s Guide LIFESCAN a fohwmonafohwon company The SureStep Pro Bedside Unit is for in vitro diagnostic use for the quantitative measurement of glucose in venous capillary arterial and neonatal whole blood samples It should not be used for the diagnosis of diabetes A CAUTION This product contains a barcode scanner It is a class II laser which operates at 680 nm and uses 0 88 mW of energy This product meets 21 CFR Code of Federal Regulations 1040 10 laser light when activated Do not stare into the laser beam Refer to page 8 of this guide for information and instructions on barcode scanner operation CAUTION Laser light when open DO NOT STARE INTO BEAM AVOID EXPOSURE Laser light is emitted from this aperture 2002 1996 LifeScan Inc All rights reserved The system described herein is covered by one or more of the following US patents D392 740 D367 109 5 418 142 5 515 170 5 526 120 5 563 031 5 605 837 5 780 304 5 789 255 5 922 530 5 968 836 and 6 335 203 Use of the system described herein is protected under US patent 4 935 346 Purchase of the system described herein does not act to grant a license under these patents Such a license is granted only when the device is used with SureStepPro or OneTouch SureStep Test Strips No test strip supplier other than LifeScan is authorized to grant such a l
6. Messages Messages that appear at a QC result screen when the test fails These messages offer possible reasons why the test failed Failed QC Message Entry Required O Yes ONo Ifa QC test result fails you may be required to select a comment that corresponds to the failed test result Specifications The performance of the system has been evaluated under the conditions listed below Refer to the SwreStepPro Test Strips package insert for typical accuracy and precision data Bedside Unit Specifications power supply result range display sample type calibration hematocrit range meter size meter weight operating temperature two size C 1 5 V alkaline batteries 0 500 mg dL liquid crystal whole blood plasma equivalent 25 60 neonatal 25 65 height 18 9 cm 7 4 in width 8 8 cm 3 5 in depth 6 5 cm 2 6 in 1 2 lb 18 30 C 64 86 F 97 Specifications operating humidity 30 70 relative humidity noncondensing altitude up to 10 000 ft 3048 m For more information read the SureStepPro Test Strip package insert class II laser 680 nm barcodes Barcode 39 Barcode 128 Example of Code 39 Example of Code 128 Barcode Specifications e Black and white only no color background e 1 4 in border surrounding barcode symbol optimal e Accepts the first 14 alphanumeric characters in a barcode that contains a maximum
7. Patient Test a 11 Press Enter Notes and choose 1 to 3 comments that OC q correspond to the patient s Select Comment current situation Press Ok SS Procedure Err Pre Meal Or press Menu and continue Post Meal Fasting testing Nocturnal Ok Me T Depending on the configuration option setting you may be required to select comments when a patient test result falls outside the limits of the range If Enter Notes is the only option available at the Patient Result screen you are required to select at least one comment The comments that appear at the Select Comment screen have been selected by your system administrator E NOTE Results tagged with the comment Procedure Err are not included in any patient reports generated by the system administrator If you have problems using the bedside unit to test patient samples or if the bedside unit malfunctions call the LifeScan Healthcare Professional Line at 1 800 524 7226 40 CHAPTER 4 Data Management Transferring Data to the Workstation Data transfer is required periodically to exchange information between the workstation and the bedside unit Configuration information is transferred from the workstation to the bedside unit and QC and patient test results are transferred from the bedside unit to the workstation Your institution will establish a regular s
8. low normal for specified test strip The passing range for each control solution level has been defined This range may be the same as or different from the range found on the test strip bottle label Result Display O Numeric Value O Pass Fail Only Pass Fail available for SureStepPro 2 0 only Determines how quality control test results are displayed QC Enforcement O Warning Only O Bedside Unit lockout U Operator Lockout Time period for Operator Lockout is 24 hours for SureStepPro 1 2 An option to ensure QC is successfully completed as scheduled Warning Only displays a message but allows you to perform a patient test Bedside Unit lockout displays the same message but does not allow you to perform a patient test Operator Lockout prevents the operator who has not successfully per formed QC testing within the designated time period 1 to 365 days from performing a patient test 95 M Configuration Options 96 Bedside Unit Configuration Option Meaning QC Test Period O Time of day____ O Elapsed time ___ hours Frequency of performing a QC test is defined as a set time each day or an elapsed time between 6 and 24 hours QC Action Messages Messages displayed in the bedside unit following a failed QC test These messages allow you to record the steps taken to correct the problem You are required to select at least one message Failed QC Guiding
9. 4 cleaning 54 55 removing 54 transferring data 4148 troubleshooting error messages 79 84 unexpected messages 85 90 u unknown solution test 69 75 Ww workstation 1 2 103 LifeScan Healthcare Professional Line United States 1 800 524 7226 Canada 1 888 353 0800 Visit the LifeScan website at www LifeScan com www SureStepPro com LIFESCAN a fohmonafohmron company Milpitas California 95035 Printed in USA For use with bedside units versions 1 2 and 2 0 AW 061 296 01A 2002 LifeScan Inc 09 02
10. 5 Care and Maintenance 53 General Care 00 000 0000 53 When to Clean the Unit 53 Cleaning the Outside of the Unit 54 Cleaning the Test Strip Holder and Lens 54 Changing the Batteries 57 Adjusting the Screen Contrast 60 CHAPTER 6 Special Tests 61 Linearity Test 0 0 0 0 000s 61 Unknown Solution Test 69 In Setvice Test posne ahs lean ee 75 CHAPTER 7 Troubleshooting 77 Error Messages 00000 0000 79 Unexpected Messages and Observations 85 APPENDIX A Bedside Unit Configuration Options 91 Specifications 2020 eee 97 Bedside Unit Specifications 97 Barcode Specifications 98 Cleaning Agents 04 100 Preface SureStepPro is LifeScan s integrated blood glucose management system for testing tracking and managing patient and quality control data The SureStepPro System offers diabetes caregivers and patients off meter blood dosing of the test strip This design can help reduce the risk of transmission of blood borne pathogens between patients while providing accurate and reliable blood glucose results at the point of patient care Preface vi About This Guide The SureStepPro Bedside Unit Operator s Guide provides detailed instructions on using and maintaining the SureStepPro Bedside Unit Because bedside unit settings will var
11. E NOTE Test results appearing as HIGH indicate patient QC and unknown solution results greater than 500 mg dL or linearity solution results greater than 766 mg dL 51 Data Management e Select Test Strip Lots tose mmn all test strip lot numbers oC q with expiration dates currently entered in the neS 100894010 12 97 system The last lot Yoosss009 12 97 101210008 02 98 101211007 02 98 number used appears at Joto 12 98 101551005 12 98 100894010 04 99 the top of the list 100894010 04 99 100894010 12 99 Menu e Select Reagent Lots tose all control linearity and ef q unknown solution lot numbers with expiration Reagent Lots dates currently entered in oos1229 N 12 87 0052000 Li 02 98 the system The last lot eE ee 0119401 N 04 98 number used appears at pjeseza L oyes cap0697 UA 06 97 the top of the list Menu Wee ooa The solution type abbreviation is listed next to the lot number Abbreviation Solution Type i Low N Normal H High UA UE Unknown A Unknown E L1 L5 Linearity Solutions 1 5 Press Menu to proceed or turn off the bedside unit 52 CHAPTER 5 Care and Maintenance General Care To keep the bedside unit in good operating condition you must keep it clean and handle it with care Follow these simple rules e Keep the test strip holder and lens area clean e Keep
12. Failed e If the result is PASSED press Ok remove the strip and continue with the remaining required control levels Or if you wish to record additional information with the test result press Enter Notes and choose 1 to 3 comments from the list Press Ok and remove the test strip eS OC q Select Comment Passing QC Procedure Err New Strip Lot Used New Ctrl New Ctrl Lot Cleaned Meter Ok 25 Quality Control Test e If the result is FAILED Pa press Enter Notes and O C choose from 1 to 3 comments This will be Seige comment recorded with the failed Procedure Ew result Press Ok remove cs er the test strip and repeat rien the QC test Or if the Menu button is ok displayed at the Failed QC Ld screen you may press Menu to repeat the test without recording any comments with the test result Read the SureStepPro Test Strip package insert for information on troubleshooting a failed QC test A CAUTION If the control solution result fails repeat the test The system may not be functioning properly Do not use the system to test a patient s blood glucose level unless the control solution result falls within the expected range A configuration option was selected which may require you to select comments when a QC test fails If Enter Notes is the o
13. Refer to page 8 for information on scanning a barcode me mT OC 4 Main Menu Patient Test QC Test Transfer Data Review Data Special Tests Setup Last Upload 09 14 98 2 28PM SS ee oC q Enter Oper ID 999 E 1 4 7 az o oe a N e gt Menu Scan Ok a operator ID Depending on the configuration option setting you may or may not be required to enter your the existing ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after the bedside unit is turned off If your ID appears at the operator ID screen press Ok to confirm it is correct If the ID is not correct simply enter your ID and it will replace Quality Control Test E 5 Select the control level you wish to run for example o q High Select QC Test Low req d Normal req d Menu Pewee a E The control level s you are required to run have been selected by your system administrator They are labeled req d required at the Select QCTest screen pE O Select the control lot number from the list OC q displayed The last control _ Select Lot lot selected appears at the High Control top of the list Use the arr
14. opened date on the bottle when you first open it Replace the test strip bottle cap immediately after removing a test strip and close the cap tightly Do not transfer test strips to a new bottle or any other container e Introduction e Use each test strip immediately after removing it from the bottle e Do not use test strips that are bent torn cut or damaged in any way e Compare the color of the confirmation dot from an unused test strip to the Unused color dot shown on the Color Chart on the test strip bottle label If the color of the test strip confirmation dot is darker than that shown on the Color Chart do not use the test strip The test result may be inaccurate e You have up to 2 minutes to insert the test strip after applying blood or control solution If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Precautions e Unexpected results should be confirmed by a laboratory test e Various conditions may cause the bedside unit to produce a very low test result 20 mg dL 1 0 mmol L or less e If the patient has symptoms of low blood glucose follow your institution s policy for treatment e If the patient does not have symptoms of low blood glucose check the confirmation dot on the back of the test strip If the confirmation dot has white patches or streaks repeat the test with a new test strip 12 If the confirmation dot is co
15. problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 87 e Troubleshooting POSSIBLE MESSAGE CAUSE SOLUTION Invalid Operator ID format Re enter your ID using Operator ID not correct barcode scanner or alphanumeric touch screen Invalid Patient ID format Re enter patient ID using Patient ID not correct barcode scanner or alphanumeric touch screen Invalid Phone number not Re enter phone number Phone entered or more Number than four pause characters entered Invalid Reagent lot Check lot number and Reagent Lot number not correct re enter it Number or field left blank Invalid Strip Strip lot number Check lot number and Lot Number not correct Less re enter it than 10 digits were entered or code out of range Low Battery Battery power low Change batteries Modem Not Bedside unit Check with your LifeScan Supported by modem model not representative for modem SureStepPro supported by models supported System software New A workstation You cannot enter new Reagent option is set to reagent from bedside unit Entry at allow reagent entry Use reagent from list or ask Workstation at workstation administrator to allow Only only reagent entry at bedside unit No Room for There are five new Transfer data and validate New non validated new reagent lots Reagent Lot reagent lots in bedside unit list If you c
16. strip Slee until the countdown is complete Enter Notes Menu If an error message appears refer to Chapter 7 Mod Troubleshooting for information A glucose range may have been defined by your system administrator Results that fall above or below the limits of this range appear as follows e CRITICAL HIGH ai indicates a result above o qi the range Patient Result GE 50 maid CRITICAL HIGH Repeat Test Do Lab Draw Check Ketones Enter Menu Notes a 38 e CRITICAL LOW o indicates a result below od q the range Patient Result cN IU myat CRITICAL LOW Repeat Test Do Lab Draw Menu iones Ne a e HIGH indicates a result eS greater than 500 mg dL oC q Patient Result 8 HIGH CRITICAL HIGH Repeat Test Chk Hsp Policy Call Doctor Menu otes a te ee IMPORTANT When the result is greater than 500 mg dL and proper procedures are followed the bedside unit will display HIGH in virtually all cases Additionally the confirmation dot will be darker than the 350 mg dL sample color dot on the test strip bottle Color Chart This indicates hyperglycemia Follow your institution s policies for treatment Remove the test strip and dispose of it according to you institution s policies and procedures 39
17. the bedside upload in unit cannot be used for days testing if a data transfer session has not been performed within the specified number of days maximum of 60 days U Bedside unit If selected optional beeper on bedside unit beeps are enabled Enable barcode If selected the bedside scanner unit barcode scanner is enabled If not selected you must enter all ID and lot number information manually Configuration Option Meaning Nursing unit to which bedside unit is assigned Each bedside unit is assigned to a particular nursing unit Do not use the bedside unit outside the designated nursing unit U Reagent Entry at Workstation Only If selected you must choose an existing test strip or control lot number from the list displayed If not selected you may enter test strip and control solution lot numbers that have not yet been entered in the system U Require Solution If selected you must select Lot Number High or enter valid control and Low Normal linearity solution lot Unknown numbers when performing Linearity those tests Modem Dialing The workstation modem Information phone number can be option available for SureStepPro 2 0 only preprogrammed If preprogrammed you do not need to enter the phone number when transferring data 93 M Configuration Options 94 Bedside Unit Operator and IDs Configuration Option Mean
18. the bedside unit Follow the instructions for use on the product s packaging Refer to Chapter 5 Care and Maintenance for cleaning precautions and detailed information on cleaning the bedside unit and test strip holder e water e 10 bleach e 70 isopropyl alcohol e 12 5 ammonia e 10 Bacdown e 30 Cavicide e Cidex glutaraldehyde e Cidex Plus e Progard e Softgard e Hibiclens e 22 Lysol e Sanicloth Staphene e 5 5 WEX Cide Product names may be trademarks of their respective owners 100 Index a applying blood 33 36 control solution 22 23 b barcode scanner 3 cleaning 56 using 8 barcode specifications 98 barcode specs 98 batteries changing 57 59 status 18 30 57 bedside unit batteries 4 57 data transfer 41 48 description 1 3 4 memory 49 operation 5 9 screen contrast 60 specifications 97 99 beep signals 9 blood application 33 36 c cleaning agents 100 barcode scanner 56 contact points 55 lens area 55 56 solution 54 test strip holder 54 55 Color Chart 12 13 39 configuration options 91 96 confirmation dot 10 23 connection module 42 45 contact points 3 cleaning 55 control CTL code 11 control solution 17 applying 22 23 at high altitudes 17 out of range result 24 results 24 26 CTL code 11 21 d data reviewing 49 52 transferring 41 48 e entering information 6 8 error codes 79 84 glucose c
19. the unit dry and avoid exposing it to extremes in temperature and humidity e Do not take apart the unit e If you drop the unit inspect it for obvious damage Perform a quality control test prior to running a patient blood glucose test When to Clean the Unit e If dirt blood or lint is present e When an error message appears and the troubleshooting solution indicates cleaning the unit e As defined by your institution s infection control policies 53 Care and Maintenance Cleaning the Outside of the Unit Clean the outside of the unit with a cloth moistened with a 10 bleach solution Follow with a cloth moistened with water to remove residual bleach Dry the unit thoroughly A CAUTION Do not get water inside the unit Never im merse the unit or hold it under running water because it will damage the unit Cleaning the Test Strip Holder and Lens Clean the test strip holder cover and base lens area and contact points Use a 10 bleach solution followed by water A CAUTION Do not use alcohol glass cleaners or any cleansers containing abrasives phenol or ammonia to clean the test strip holder or lens area because it will damage the parts Q Press down on the left side of the test strip holder the end closest to the power button This releases the holder allowing you to slide it from the unit 54 2 Wipe the test strip holder cover and base with a cotton swab or soft cloth moistened wi
20. to Color Chart on test strip bottle to see if glucose level is very high or very low e Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 4 Clean bedside unit and repeat test with new test strip 5 Contact LifeScan for help If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 79 a Troubleshooting POSSIBLE ERROR CAUSE SOLUTION Error 2 The bedside unit 1 Repeat test with new test Test Strip detected a problem strip and with the test strip e Check test strip expira tion date Do not use expired test strips or test Strips beyond discard date e Apply sample to pink test square only e Make sure confirmation dot turns completely blue Wait approximately 1 min but not more than 2 min after applying sam ple before inserting test strip e Do not alter test strips 2 If you continue to get any error message obtain a laboratory result and e Compare color of test Strip confirmation dot to Color Chart on test strip bottle to see if glucose level is very high or very low e Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Clean bedside unit and repeat test with new test strip 4 Contact LifeScan for help If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800
21. 4 7226 USA 1 888 353 0800 Canada POSSIBLE communication error MESSAGE CAUSE SOLUTION Data Less than 100 test Transfer data to free memory Memory Low records can be space generated Data Transfer Bedside unit Retry data transfer Error workstation you insert test Strip strip holder Enter High low or Check ranges Make sure min Narrower normal control value is less than max Range s or range error Min lt Max Min gt Max Insert Strip Test strip not fully Remove test strip When appears after inserted into test Insert Strip appears firmly insert test strip until it stops Internal Communica tion Error Faulty internal communications Retry operation If problem persists do not use bedside unit Contact LifeScan Internal Error System Error Turn off bedside unit expired Power Down Contact LifeScan Invalid Conflicting option Contact system Configuration set or administrator to review configuration configuration settings corrupted Transfer data Invalid Value Re enter correct control Control gt 500 mg dL was value Value entered Invalid CTL Expiration date not Check CTL code on control Code correct or CTL code solution vial and re enter it format invalid Invalid Invalid month or Check expiration date and Expiration year Or date re enter it Date entered already If you cannot resolve a
22. 524 7226 USA 1 888 353 0800 Canada 80 POSSIBLE ERROR CAUSE SOLUTION Error 3 The bedside unit 1 Clean bedside unit Test Strip detected a problem especially contact points in with the position of lens area but the test strip NOTE Before cleaning compare color of test strip confirmation dot to Color Chart on test strip bottle If glucose level is very high or very low take appropri ate steps to monitor patient and provide medical care e Repeat test with new test strip e Do not move test strip after you insert it Remove test strip only when test is complete 2 If you continue to get any error message obtain a laboratory result Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 81 a Troubleshooting POSSIBLE ERROR CAUSE SOLUTION Error 4 The bedside unit 1 Repeat test with new test Temperature detected a Strip Make sure bedside Range temperature unit and test strip are at problem room temperature e Do not apply heat or cold to unit operating temperature is 18 30 C 2 If you continue to get any error message obtain a laboratory result and e Compare color of test strip confirmation dot to Color Chart on test strip bottle to see if glucose level i
23. Blood Glucose Management System includes a computer workstation and software bedside units test strips glucose control solutions glucose linearity kit and carrying case Computer products may vary from those shown For important information on any of these LifeScan products refer to the appropriate operator s guide or reagent package insert It is important that you read and understand all instructions before you operate the system The Bedside Unit FRONT Power button turns the unit on and off Test strip holder covers the lens area and holds the test strip The holder slides out of the unit for easy cleaning The lens area located under the test strip holder contains the optics that reads the glucose level on the test strip Contact points under the test strip holder sense the position and orientation of the test Strip LCD screen displays test results and prompts that guide you through QC and patient testing Barcode scanner enables The touch sensitive direct data entry for operator ID screen allows you to patient ID and control solution select options and enter and test strip lot numbers from information by simply their respective barcodes touching an area of the Infrared communication port SCEen communicates with the workstation via the connection module A CAUTION Do not stare into the barcode scanner or point it towards anyone s eyes while the laser light is on e Introductio
24. Data transfer begins immediately The time to transfer data depends on the amount of information being exchanged 43 Data Management A series of messages are e e displayed on the bedside O cqa unit screen indicating the status of the transfer When the transfer is complete the Data Transfer Data Transfer bedside unit beeps and a Complete message appears Cont Using the Connection Module The connection module used with a modem provides a remote communication link between the bedside units and the workstation By placing the bedside unit in the connection module and dialing the workstation modem data is transferred through a standard analog phone line E NOTE If a fax machine is sharing the same analog line as the connection module modem do not transfer data while a fax is being sent or received E NOTE SureStepPro 2 0 users If you are transferring data over an Ethernet network MeterLink software must be running on the workstation 44 Q Select Transfer Data from e the Main Menu Ol qd Main Menu Patient Test QC Test Review Data Special Tests Setup Last Upload 09 14 98 2 28PM n 2S eet The bedside unit is ready for mm the communication link to OC q be established A message appears instructing you to Data Transfer Awaiting Link dock the beds
25. When used with SureStepPro Test Strips the bedside unit measures a patient s blood glucose level from a whole blood sample taken at the bedside Blood is applied directly to the test strip before the strip is inserted into the bedside unit A confir mation dot on the test strip helps you check that an adequate volume of sample was applied The unit is equipped with a barcode scanner and a large touch sensitive display both of which allow you to enter operator patient and reagent information Before use each bedside unit must be configured by your institution s system administrator Your administrator has defined a set of options from a central workstation running DataLink Data Management System software or compatible data management software This configuration process provides the flexibility to customize a blood glucose testing protocol that meets the needs of your institution e Introduction The bedside unit stores patient and quality control data in internal memory A bi directional data transfer performed with the workstation sends test results from the bedside unit to the workstation and the latest configuration infor mation from the workstation to the bedside unit LifeScan s DataLink System for modems or network provides you with choices for connec tivity solutions Following a data transfer session reports can be generated and printed from the workstation The complete SureStepPro Professional Care
26. annot resolve a problem call LifeScan Healthcare Professional Li 88 1 800 524 7226 USA 1 888 353 0800 Canada POSSIBLE MESSAGE CAUSE SOLUTION No Room for Bedside unit Transfer data to free memory New Test memory full space Data No Room for There are five new Transfer data and validate New Test non validated new test strip lots Strip Lot test strip lots in bedside unit list Phone Line 1 Workstation 1 Workstation modem s Busy at modem phone phone line must be a Workstation line being used dedicated line Do not by fax machine share line with a fax machine 2 Faulty telephone 2 Have phone line inspected line QC Due for Unit will bein QC Perform required QC tests Bedside Unit lockout if required within 2 hours in Less than QC not performed Two Hours within 2 hours QC Due QC overdue or QC Successfully perform all QC Missed or test failed required QC tests Failed Reagent Lot Reagent solution Enter and use new reagent Expired lot expired lot Discard any remaining expired reagent Remove Strip Not enough Remove test strip Check appears after sample on test confirmation dot If white youinsert strip or test strip patches or streaks appear not test strip inserted too enough blood was applied for quickly an accurate result Repeat test with new test strip When Insert Strip appears firmly and more slowly insert test strip until it stops
27. as if capable of transmitting infection Follow proper precautions in accordance with your institution s policies when disposing of all materials Centers for Disease Control Report Guideline for Infection Control in Health Care Personnel Am J Infect Control 1998 26 289 354 14 CHAPTER 2 Quality Control Test Three levels of SureStepPro Glucose Control Solution are available to check that the SureStepPro Bedside Unit and SureStepPro Test Strips are functioning properly The SureStepPro bedside units are calibrated at the factory Although an internal verification is performed each time the bedside unit is turned on a system calibration bedside unit and test strip is necessary This is achieved at the start of each test when you enter the lot number and code for the current bottle of test strips If you are training a new operator on how to use the bedside unit use the glucose control solutions and perform the testing in the In Service mode Refer to In Service Test on page 75 for more information The number of control levels and frequency of running a QC test have been programmed by your system administrator High Low and Normal control levels are available any one control level or a combination of levels may have been selected Quality Control Test To ensure that a required QC test is performed at the designated time a warning or lockout mode was selected Both modes displa
28. cation with a new test strip Wipe the linearity solution vial tip with a lint free cloth or tissue before replacing the cap o Firmly insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down 66 IMPORTANT If you fail to completely insert the test strip the test may start however you may receive an out of range result IMPORTANT You have up to 2 minutes to insert the test strip after the linearity solution is applied If you insert the test strip after 2 minutes you may get an out of range result or an error message Discard the test strip and repeat the test with a new test strip The test result appears in approximately 30 seconds The time may vary depending on the temperature and glucose level IMPORTANT Do not remove the test strip until the countdown is complete E NOTE OC q Lin Level 1 Result cn IU mga er s Ok eo Menu The bedside unit can display linearity results up to 766 mg dL 67 Special Tests If you wish to record additional information with the test result press Enter Notes and choose a comment from the list Press Ok SureStepPro 2 0 Press Ok at the Linearity Level Result OC q screen to display the Lin Level Lin Level 1 screen Press Ok to proceed a un with the remaining r
29. change the batteries if the battery bar on the Status screen is low However the unit will continue to function properly until the LOW BATTERY message appears A CAUTION Do not use rechargeable batteries a Go ae oC oC q 05 00 S05 00US 05 00 S05 00US Nursing Unit Name Tag 4 North Low QC Due in 10 05 Upload Battery Due in 30 days Scanner ON E F Batt I Memory Menu 15 25 12 14 97 Seri Neither the LOW BATTERY message nor the removal of batteries affects the test results stored in the bedside unit s memory 57 Care and Maintenance Press the power button to turn off the bedside unit 2 Turn the unit over Use a coin or screwdriver to loosen the screw from the battery compartment door Lift open the door Remove both batteries from the battery compartment and dispose of them according to your institution s guidelines 58 4 Insert two new size C batteries matching the positive end of each battery with the signs inside the battery compartment E NOTE The battery life depends on how quickly the bedside unit is powered off after each test Under optimal conditions using the barcode scanner to enter information and turning off the bedside unit immediately after test results are displayed and recorded you can expect approximately 1000 tests 5 R
30. chedule for performing data transfer sessions Depending on the configuration option setting the bedside unit may be disabled from testing if a data transfer session is not performed within a designated number of days 41 Data Management You may transfer data using e a direct infrared link with the workstation s infrared port e a connection module that is directly connected to the workstation s serial port e a connection module that is connected toa serial server or modem Using a Direct Infrared Port Connection To perform data transfer using a direct link with the workstation s infrared port the bedside unit must be situated next to the workstation DataLink Data Management System software must be running on the workstation i Q Select Transfer Data from the Main Menu O q Main Menu Patient Test QC Test Review Data Special Tests Setup Last Upload 09 14 98 2 28PM Wee 42 The bedside unit is ready aa for the communication Cq link to be established If the bedside unit has been ae configured to communicate Communications directly with the workstation Data Transfer infrared port the message at the right appears Menu Wi ee Place the bedside unit s infrared communication port approximately 6 to 10 inches 15 to 25 centimeters from the workstation s infrared port
31. creen indicating the status of the transfer When the transfer is complete the bedside unit beeps and a message appears Modem ee E oC qd Data Transfer Data Transfer Complete Cont If a modem is detected the connection module automatically dials the receiving modem If the line is busy the connection module will retry up to 20 times at 30 second intervals before it times out 47 Data Management If the workstation modem m phone number was not pre oC q programmed enter the phone number then press Entet Prone Dial If the phone number ae appears on the screen simply 4 l5 press Dial z l8 l9 cear 0 f Menu wait oiai A series of messages are displayed on the screen axa indicating the status of the transfer When the transfer Data Transfer is complete the bedside unit Modem beeps and a message appears Tears o Remove the bedside unit from the connection module and press Cont to continue Cont If the bedside unit is off when you remove it from the connection module you can check to see that the transfer was successful by turning on the bedside unit If an error occurred during transfer the following message appears after the Status screen Last Data Transfer mm ddlyy hh mm Failed 48 Be
32. ctronics with water to remove residual bleach Dry thoroughly but NOTE Before cleaning contact points compare color of test strip confirma tion dot to Color Chart on test strip bottle If glucose level is very high or very low take appropriate steps to monitor patient and provide medical care e Repeat test with new test strip e Make sure test strip lot number and code entered at bedside unit matches number on test strip bottle 2 If you continue to get any error message obtain a laboratory result Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 84 Unexpected Messages and Observations POSSIBLE MESSAGE CAUSE SOLUTION Apply Blood Bedside unit is Obtain a drop of capillary corrupted ready for blood blood and apply it to center application of pink test square e If white pad becomes satu rated you have applied too much blood Repeat application with new test strip e If white patches or streaks appear on confirmation dot you have not applied enough blood Repeat application with new test strip Bedside Unit Bedside unit Contact system Disabled deleted from administrator for current system or status of bedside unit unassigned Bedside Unit Initia
33. d the Enter Unk Lot button appears on the screen press the button and manually enter the unknown solution lot number and expiration date QO Select the test strip lot number and code from the list displayed The last test strip lot number selected appears at the top of the list Use the arrows to scroll eCa Select Strip Lot Lot CODE 1012101 8 1009992 10 1012113 9 1015500 6 Enter STRIP Lot Menu through the list if necessary Scan Alternatively scan the barcode on the test strip bottle label A configuration option may have been selected which would allow you to enter a new test strip lot number at the bedside unit If you do not see the lot number in the list and the Enter Strip Lot button appears on the screen press the button and manually enter the test strip lot number and CTL code 72 A CAUTION To obtain accurate results you must enter the correct test strip lot number and code for each new test Q Apply the unknown solution to the test strip e Touch the drop of solution to the center of the pink test square If the white pad becomes completely saturated you have applied too much solution Repeat the application with a new test strip Check the confirmation dot on the back of the test strip to verify it has turned completely blue indicating an adequate amount of s
34. dside Unit Memory The bedside unit stores up to 2500 QC and patient test results in its memory Additionally the lot IDs for test strips and control linearity and unknown solutions are also stored in memory This information can be accessed by selecting Review Data from the Main Menu When bedside unit memory is low less than 100 tests available the message Data Memory Low appears When the bedside unit memory is full a message appears informing you that there is no room for test data To continue using the bedside unit for testing you must perform a data transfer session to upload the data to the workstation and free the bedside unit s memory Accessing Memory to Review Data You may review patient QC linearity and unknown solution test results In Service test results are not available for review You may also review a list of test strip lot numbers and reagent lot numbers 49 Data Management Press Review Data from the Main Menu Ol q Main Menu Patient Test QC Test Transfer Data Special Tests Setup Last Upload 09 14 98 2 28PM Se ee Select Patient Results QC D Lin Unkn Test Strip Lots or OC q Reagent Lots Review Data Lin and Unkn refer to Linearity a and Unknown Solutions For Tost Stip Lots m
35. e 31 Patient Test Depending on the configuration option setting you may or may not be required to enter the patient s ID QO Select the test strip lot pA number and code from the OC q list displayed The last test Select St Lot strip lot number selected Tot OODE appears at the top of the list 1009992 10 Use the arrows to scroll Tae 5 through the list if necessary sso stR Lot Alternatively scan the Menu Scan barcode on the test strip Ns bottle label A configuration option may have been selected which would allow you to enter a new test strip lot number at the bedside unit If you do not see the lot number in the list and the Enter Strip Lot button appears on the screen press the button and manually enter the test strip lot number and CTL code A CAUTION To obtain accurate results you must enter the correct test strip lot number and code for each new test 32 The Patient Test screen appears with messages prompting you to apply blood to the strip and then insert the test strip a Ta aaa Patient Test Patient Test Use 1012101008 Use 1012101008 CODE 8 strip CODE 8 strip Apply Blood andis Insert strip or a Menu Srp Menu Strip WN Bete Applying Blood Sample to Test Strip Obtain a d
36. eplace the battery compartment door and tighten the screw M QO Turn on the unit to verify the power 59 Care and Maintenance Adjusting the Screen Contrast You can increase or decrease the LCD screen contrast Q Select Setup from the Main Menu Main Menu Patient Test QC Test Transfer Data Review Data Special Tests Last Upload 09 14 98 2 28PM Press the arrows to increase or decrease the LCD O q contrast A change occurs LCD Contrast each time you press the arrow The gauge in the Low Hic Low High bar gives you an approximate indication of the current setting Menu Ok Miso ee 3 When you are satisfied with the setting press Ok to save the setting and proceed to the Main Menu Or press Menu to ignore any changes and proceed to the Main Menu 60 CHAPTER 6 Special Tests The Special Tests function allows you to perform tests that are not routinely performed such as a linearity test and an unknown solution test Special Tests also features an In Service mode which allows you to use the bedside unit for training new operators Test results obtained while operating in the In Service mode are uploaded to the DataLink workstation and can be viewed in the Datalog Report generated by the system administrator Linearity Tes
37. eplicates Rep 1 of level 1 SureStepPro 1 2 Press Ok to display the Lin Unkn Test screen Proceed with the e remaining replicates of level 1 11 SureStepPro 2 0 users press Next Level from the Linearity Level screen to continue with the remaining linearity solution levels 2 through 5 SureStepPro 1 2 users continue with the remaining levels When the testing of all five levels is complete perform a data transfer to upload the linearity test results to the workstation so a linearity report can be generated 68 Unknown Solution Test Periodically you may be asked to perform a proficiency test on a solution for which you do not know the glucose value This type of testing may be required by your institution s accreditation organization Select Special Tests from ee the Main Menu OC q Main Menu Patient Test QC Test Transfer Data Review Data Special Tests Setup Last Upload 09 14 98 2 28PM Nee Select Lin Unkn Test from aE the Special Tests menu o q Special Tests Lin Unkn Test In Service Mode Menu 69 Special Tests TEN oC q Enter Oper ID 999 I 1 4 o Enter your operator ID o a 7 az Q ce Menu Scan Ok
38. eport Q Select Special Tests from the Main Menu Main Menu Patient Test QC Test Transfer Data Review Data Special Tests Setup Last Upload 09 14 98 2 28PM 75 Special Tests 2 Select In Service Mode from the Special Tests menu Special Tests Lin Unkn Test 3 Follow the instructions in Chapter 2 Quality Control Test beginning with step 4 Use the SureStepPro High Low and Normal Glucose Control Solutions The QC warning or lockout mode does not affect tests performed in the In Service mode 76 CHAPTER 7 Troubleshooting The SureStepPro Bedside Unit displays prompts and error messages to indicate the system has detected a problem with its internal function the test strip or the testing procedure These messages help in resolving some common problems that may occur during testing However the bedside unit cannot detect all problems When the unit does detect a problem it may not produce an error message every time the problem occurs In some situations improper use may cause an inaccurate result without producing an error message 77 Troubleshooting A CAUTION While trying to resolve an error message using the Troubleshooting section keep in mind the following e If patient symptoms indicate the need for treatment prov
39. eric modes Press Ok when you have completed the entry To delete the last character or characters entered press Del E NOTE If left inactive the bedside unit will automatically shut off Press the power button to turn it back on If you entered your operator ID before the unit was turned off it can remain in memory for up to 1 hour A configuration option may be set to maintain your ID for up to 1 hour after the bedside unit is turned off e Introduction Scanning a Barcode The bedside unit s barcode scanner must be enabled at the workstation If the scanner is enabled the Scanner field at the Status screen reads ON when you turn on the unit and the Scan button appears on data entry screens If the scanner is not enabled the field reads OFF and the Scan button does not appear on the screens To scan a barcode hold the barcode label parallel to and approximately 6 to 10 inches from the unit s scanner Press and release the Scan button on the screen Scanning begins when your thumb is lifted from the screen After a successful scan the information appears in the display field and the bedside unit beeps Press Ok to confirm the entry Press Release A CAUTION This product contains a laser Do not stare into the laser light or point it towards anyone s eyes while scanning a barcode System Beep Signals The SureStepPro Bedside Unit uses beeping
40. form a test a warning message appears Press Cont to continue eo 3 Select Patient Test from the Main Menu Ol q Main Menu Patient Test QC Test Transfer Data Review Data Special Tests Setup Last Upload 09 14 98 2 28PM S a 30 a 4 Enter your operator ID either by pressing the touch screen OC 4 or using the barcode scanner Refer to page 8 for 21 information on scanning a 2 3 barcode 45 6 7 8 9 az O Oe Menu Scan Ok We ee Depending on the configuration option setting you may or may not be required to enter your operator ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after the bedside unit is turned off If your ID appears at the operator ID screen press Ok to confirm it is correct If the ID is not correct simply enter your ID and it will replace the existing ID Enter the patient s ID either by pressing the touch screen o q or using the barcode scanner Enter Pat ID 2057 8 E NOTE 12 Carefully enter the ID An ePi accurate patient ID is L313 i i AZ Del imperative for transferring ele Menu Scan Ok the correct results to the medical record He
41. his will prepare you for what to expect when performing QC and patient tests You may request a Location or Nursing Unit Configuration Report from your system administrator This report lists each option that was selected for all bedside units within a selected nursing unit e Introduction A Main Menu lets you select from six different functions Patient Test allows you to run a patient test Main Menu QC Test allows you to run a quality control test Patient Test E Transfer Data transfers data between bedside unit and workstation Transfer Data Review Data displays stored test Review Data results and reagent lot numbers Special Tests Special Tests allows you to run setup linearity and unknown test solutions and perform in service testing Last Upload 09 14 98 _ 2 28PM Setup allows you to adjust the bedside unit s LCD contrast Last Upload displays the date and time of the last successful data transfer session SureStepPro 2 0 only Entering Information Select an item from a list by touching the appropriate area of the screen If a list is too long to fit on one screen arrow buttons allow you to scroll through the list Manually enter IDs or lot numbers by pressing the appropriate characters on the screen Both alpha and numeric characters are available for data entry Use the A Z and 0 9 buttons to switch between alpha and num
42. icense and LifeScan does not endorse or encourage the use of any strips manufactured by anyone other than LifeScan A Food and Drug Administration FDA regulation established for any product that contains a laser Table of Contents Preface 2 0 cc ccc cc cee eee ees v About This Guide 04 vi What You ll Find in This Guide vi Conventions Used in This Guide viii Help sseitsgei eee ee daa daie EE ix CHAPTER 1 Introduction 1 The Bedside Unit 3 General Operating Information 5 Entering Information 6 Scanning a Barcode 8 System Beep Signals 9 SureStepPro Test Strips 0 9 PRECAUTIONS arasia tsiis dolce ENRE R 12 Infection Control 0 14 CHAPTER 2 Quality Control Test 15 When to Perform a Quality Control Test 16 Glucose Control Solutions 17 Performing a Quality Control Test 18 Applying Control Solution to Test Strip 22 CHAPTER 3 Patient Test 29 Performing a Patient Test 29 Applying Blood Sample to Test Strip 33 lt Table of Contents CHAPTER 4 Data Management 41 Transferring Data to the Workstation 41 Using a Direct Infrared Port Connection 42 Using the Connection Module 44 Bedside Unit Memory 49 Accessing Memory to Review Data 49 CHAPTER
43. ide appropriate medical care before you continue with troubleshooting If you repeatedly get any error message or you are otherwise unable to obtain a bedside unit result perform a laboratory test Take appropriate steps to monitor the patient and provide medical care while awaiting the laboratory result After any test you can compare the test strip confirmation dot to the Color Chart on the test strip bottle If the comparison indicates that the glucose level is very high or very low perform a laboratory test Take appropriate steps to monitor the patient and provide medical care while awaiting the laboratory result e Do not use the Color Chart as a replacement for a bedside unit result If you need help resolving an error or you encounter any other problem with the system contact the LifeScan Healthcare Professional Line at 1 800 524 7226 USA 1 888 353 0800 Canada 78 Error Messages POSSIBLE ERROR CAUSE SOLUTION Error 1 The bedside unit 1 Repeat test with new test Sample detected a problem strip and Application with the color of e Apply blood to pink test the test strip square only e Make sure confirmation dot turns completely blue e Insert test strip within 2 min of applying blood 2 Check that sample hemat ocrit is within range adult 25 60 neonatal 25 65 3 If you continue to get any error message obtain a laboratory result and e Compare color of test Strip confirmation dot
44. ide unit Dock the Bedside Unit Menu a e SEE 2 Place the bedside unit in the connection module SureStepPro 1 2 Users Enter the workstation SS modem phone number then O q press Dial Once the phone ca number is entered it will _Enter Phone i P i R 92366998 remain in the bedside unit a memory For subsequent a5 sessions simply press Dial 7lele Clear Q De The modem begins dialing If the line is busy the connection module will retry Menu Wait Dial 45 Data Management up to 20 times at 30 second intervals before it times out Messages appear on the pe screen indicating the status cqa of the connection The indicator light on the Data Transtar connection module blinks Modem during transfer A message gore appears when data transfer is complete Cont 3 Remove the bedside unit from the connection module and press Cont to continue SureStepPro 2 0 Users Refer to instructions in the following Ethernet and Modem sections for details Direct connection with workstation connection module 46 Connection module connected to serial server or modem Ethernet If you are transferring data over an Ethernet network using a serial server the transfer begins immediately A series of messages are displayed on the bedside unit s
45. ing U ID required for all tests Q Maintain ID fort minutes after power off If selected all operators are required to enter their IDs for each test If Maintain ID is selected the last ID entered remains in memory for 1 to 60 minutes from the time the unit is turned off until it is turned on again Operators need only confirm their ID if it appears at the operator ID screen U Patient ID required for all tests If selected a patient ID is required ID number string format patient and operator A string format was defined for all IDs entered at the bedside unit The string defines the number and type of characters allowed for example five alphanumeric characters Operator Recertification Period months and test settings test settings available for SureStepPro 2 0 only The period is the frequency at which each operator must be re certified Test settings define the number of patient tests as well as low normal and high QC tests an operator must run within the re certification period to be eligible for re certification Quality Control Configuration Option Meaning Glucose units O mg dL O mmol L The units selected for displaying and reporting control and blood glucose results Required QC tests Q High Q Low Q Normal Three glucose controls are available Any combination may be selected Control solution ranges high
46. l data transfer Transfer data Needs is required Or Configuration configuration is If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 85 e Troubleshooting MESSAGE POSSIBLE CAUSE SOLUTION Check Connections at Bedside Unit 1 Bedside unit was removed from connection module before connection was established 2 Bad connection between modem and connection module 3 Connection module or modem error 1 Do not remove bedside unit from connection module until link is established and data are transferred 2 Check connection between connection module and modem 3 Contact LifeScan Check Connections at Workstation 1 Workstation modem not turned on 2 Bad connection between modem and wall jack 3 Workstation modem error 1 Turn on workstation modem 2 Check modem connection at wall jack 3 Contact LifeScan Check Phone Line Connections at Bedside Unit 1 Bedside unit modem phone line being used by fax machine 2 Bad connection between modem and wall jack 3 Faulty phone line 1 If fax is being used by same phone line as connection module modem wait for fax machine and retry connection 2 Check modem connection at wall jack 3 Inspect phone line If you cannot resolve a problem call LifeScan Healthcare Professional Li 86 1 800 52
47. mpletely blue compare it to the sample color dots on the test strip bottle Color Chart If the color comparison indicates very low blood glucose repeat the test If the result is still lower than expected perform a quality control test A passing control result indicates the system is working properly A control result that is out of range indicates that the system may not be working properly Do not use the system to test patient blood glucose unless the control solution result falls within the expected range e If patient symptoms are inconsistent with monitoring results and procedural errors are ruled out follow your institution s policies for treating the symptoms and confirm the glucose measurement with a laboratory test e If you repeatedly get any error message obtain a result from a laboratory test Compare the test strip confirmation dot to the colors on the test strip bottle Color Chart and if necessary take appropriate precautions while awaiting the laboratory result Do not use the Color Chart as a replacement for a bedside unit result e Never make significant changes to a medication program or ignore signs and symptoms without consulting a physician Failure to follow the instructions for use may result in inaccurate results a Introduction Infection Control Use universal blood precautions All patient samples and materials with which they come in contact are considered biohazards and should be handled
48. n TEST STRIP HOLDER The test strip holder is interchangeable the same holder may be used in any SureStep brand meter Closed The insertion point is the area where the test strip is inserted Opened EON The base holds the test strip in place The cover protects the lens BACK Battery Compartment holds two size C alkaline batteries Manufactured uirescan Iniptas cx Re sau Milpitas California 95035 For service or assistance call 1 800 524 7226 CAUTION IFFT DO NOT STARE INTO BEAM ns MIGNE CLASS i LASER PRODUCT 680 nm LASER 0 88 MILLIWATT This product meets 21CFR 1040 10 laser light when open AW 052 387 01 CAUTION Laser light when open DO NOT STARE INTO BEAM AVOID EXPOSURE Laser light is WH emitted from this aperture W General Operating Information LifeScan recommends that only certified operators in the hospital or clinic perform blood glucose testing using the SureStepPro System Before you can operate the bedside unit it must be configured Your system administrator will perform this function after completing the initial system setup The configuration of a bedside unit and how it operates is determined by choices the system administrator makes within DataLink Data Management software running at the workstation It may be helpful for you to familiarize yourself with the exact configuration for the bedside unit you are operating T
49. nly option available at the failed QC Result screen you are required to select at least one comment The comments that appear at the Select Comment screen have been selected by your system administrator 26 E NOTE Results tagged with the comment Procedure Err are not included in the statistical calculations for any QC reports generated by the system administrator If you have problems using the bedside unit to test the control solutions or if the bedside unit malfunctions call the LifeScan Healthcare Professional Line at 1 800 524 7226 27 CHAPTER 3 Patient Test LifeScan recommends that only certified operators perform patient blood glucose testing using the SureStepPro System Follow your institution s policies for in service training to become a certified operator Performing a Patient Test Q Press the power button to turn on the unit 29 Patient Test A start up screen appears followed by the Status screen cqa an V05 00 S05 00US l Name Tag LIFESCAN prte Serial BS 0014 QC Due in 10 15 Upload Due in 60 days Scanner ON E F Bat E Memory 15 25 PM Wes oe ee 10 14 96 eee Check the battery status to ensure adequate power The battery and memory bars provide the approximate status of battery power and bedside unit memory If there is insufficient battery power or memory to per
50. not see the lot number in the list and the Enter Strip Lot button appears on the screen press the button and manually enter the test strip lot number and CTL code A CAUTION To obtain accurate results you must enter the correct test strip lot number and code for each new test 21 Quality Control Test The QC Test screen appears with messages prompting you to apply the control to the test strip and then insert the test strip A ea a xq o q High QC Test High QC Test Use 1012101008 Use 1012101008 CODE 8 strip CODE 8 strip Shake and apply High Control and Insert strip D a n i Stri Strip Menu rP Meni Lot Stic 8 ee ee Applying Control Solution to Test Strip A CAUTION Applying too much or too little control solution may cause out of range results Apply the control solution as follows e Gently shake the control solution vial e Touch a drop of control solution to the center of the pink test square 22 If the white pad becomes completely saturated you have applied too much control solution Repeat the application with a new test strip Check the confirmation dot on the back of the test strip to verify it has turned completely blue indicating an adequate amount of control was applied If white patches or streaks are visible you have not applied enough control solution Repeat the application
51. of 18 characters special characters include space ONAQG GOO e Medium density X dimension of 0 012 inches or high density X dimension of 0 0075 inches where density is the number of characters per inch and X dimension is the width of the narrowest element in the symbol 98 The SureStepPro Blood Glucose Bedside Unit complies with the following standards e CAN CSA C22 2 No 601 1 94 Medical Electrical Equipment Part 1 General Requirements for Safety Complies with UL 2601 1 and IEC 601 1 CAN CSA C108 6 M91 CISPR 11 1990 Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics in Industrial Scientific and Medical ISM Radio Frequency Equipment Complies with Canadian ICES 001 CANICSA C22 2 No 1010 1 92 Safety Requirements for Electrical Equipment for Measurement Control and Laboratory Use Part 1 General Requirements Complies with IEC 1010 1 CANICSA C22 2 No 601 1 2 94 Medical Electrical Equipment Part 1 General Requirements for Safety 2 Collateral Standard Electromagnetic Compatibility Requirements and Tests Complies with IEC 601 1 2 z Type BF Equipment e Internally powered equipment e No patient applied parts e This unit is not suitable for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide 99 Specifications Cleaning Agents The following compounds can be used to clean the exterior only of
52. olution was applied If white patches or streaks are visible you have not applied enough solution Repeat the application with a new test strip 73 Special Tests 8 Firmly insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down IMPORTANT If you fail to completely insert the test strip the test may start however you may receive an inaccurate low result IMPORTANT You have up to 2 minutes to insert the test strip after the solution is applied If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Discard the test strip and repeat the test with a new test strip The test result appears in e approximately 30 seconds oC qa IMPORTANT _ Unkn A Result Do not remove the test strip pa en until the countdown is complete Enter Notes OK Menu 74 Press Ok to display the Lin Unkn Test screen Or if you wish to record additional information with the test result press Enter Notes and choose a comment from the list Press Ok In Service Test Use the In Service mode to train and certify operators This mode is identical to the QC Test mode However In Service test results cannot be viewed in Review Data mode In Service results are uploaded to the DataLink workstation and appear in the All Datalog R
53. on 3 months after opening Write the opened date on the vial when you first open it The control ranges printed on the SureStepPro Test Strip bottle label are for SureStepPro Control Solutions only Store the control solution at room temperature below 30 C 86 F Do not refrigerate or freeze e The control solutions contain dye that stains clothing The control solutions are not for human consumption Control solution values can be affected at altitudes of 3000 feet or greater Read the SureStepPro Glucose Control Solutions package insert for specific information and correction factors Quality Control Test Performing a Quality Control Test Q Press the power button to turn on the unit A start up screen appears followed by the Status screen V05 00 S05 00US Name Tag LIFESCAN North Serial BSU0014 QC Due in 10 15 Upload Due in 60 days Scanner ON E F Bat E Memory lt lt 15 25 PM Lo 10 74 96 eae Check the battery status to ensure adequate power The battery and memory bars provide the approximate status of battery power and bedside unit memory If there is insufficient battery power or memory to perform a test a warning message appears Press Cont to continue 18 3 Select QC Test from the Main Menu 4 Enter your operator ID either by pressing the touch screen or using the barcode scanner
54. onal Line 90 1 800 524 7226 USA 1 888 353 0800 Canada Bedside Unit Configuration Options Following is a list of workstation options configured by your System Administrator These options apply to all bedside units within a nursing unit and directly affect how these bedside units function Patient Results APPENDIX A Configuration Option Meaning Glucose units O mg dL O mmol L The units selected for displaying and reporting control and blood glucose results Patient Messages Notes that appear at the patient test result screen These notes allow you to record a particular situation with a test result 91 M Configuration Options 92 Bedside Unit Configuration Option Meaning Critical Warning Messages Lower Limit _ Upper Limit ____ Notes that appear at the patient test result screen when the test result falls outside the critical limits The notes are intended to offer suggestions for abnormal results The upper and lower limits of the range for patient results as defined by your institution Patient Message Entry Required for results outside critical limits If a patient test result falls outside the critical limits you may be required to select a comment which O Yes corresponds to the patient s ONo current situation Bedside Unit Configuration Option Meaning LY BU lockout if no If selected
55. ontrol solution 17 glucose range 38 101 i ID operator 7 patient 31 infection control 14 insert test strip 23 37 66 74 in service test 75 76 l laser information ii 4 LCD screen 3 contrast 60 lens area 3 cleaning 55 56 linearity test 61 68 result 67 upper limit 67 lockout data transfer 41 operator 15 QC 15 lot numbers reviewing 52 m main menu 6 memory bedside unit 49 messages error 79 84 unexpected 85 90 o operator ID7 lockout 15 out of range result control test 24 linearity test 67 102 Index p patient ID 31 patient results critical values 38 39 displayed 38 39 reviewing 50 patient test 29 40 power button 3 precautions 12 q QC lockout 15 quality control results displayed 24 26 reviewing 51 quality control solution applying 22 23 lot number 20 quality control test 18 27 r results critical 38 39 linearity 67 patient 38 39 quality control 24 26 unknown solution 74 reviewing data 49 52 S scanning a barcode 8 screen contrast 60 special tests in service 75 76 linearity 61 68 unknown solution 69 75 Status screen 18 30 57 system administrator 1 5 system beep signals 9 t test in service 75 76 linearity 61 68 patient 29 40 quality control 18 27 unknown solution 69 75 test strip blood application 33 36 control application 22 23 general information 9 12 inserting 23 37 66 74 lot number 21 32 64 72 test strip holder 3
56. ore information see Chapter a 6 Special Tests Menu Nes e Ifyou select Patient oF Results you may specify a O Cq particular patient ID and see only the results for that MOO patient or leave the ID EIAN 8 7 field blank and see the lex a results for all patients for ee the last 30 days beginning BBM i with the most recently veu 4 performed patient test ee a Results for each day are preceded by a header which includes the date and number of test results for that day T est 50 results marked with the Procedure Err comment will appear as Proc Err e Ifyou select QC Lin Unkn _ you may enter an operator ed q ID and see the results for 1 i QC Unk the QC linearity and 2GiLinioko _ unknown tests a particular Sian a7 8 18AM 329 H operator has run or leave se BL 8 04 AM 259 HF the operator ID field blank Seay See 8 33AM 41 L and see the results for all 834 AM_351_H QC linearity and Men 4 unknown tests for the last Si eet 30 days beginning with the most recently performed test The control solution level L N H is listed next to the QC result An F following the solution type indicates the result failed UA UE is listed next to unknown solution results L1 LS is listed next to linearity solution results Results for each day are preceded by a header which includes the date and the number of test results for that day
57. ows to scroll through the HigHoo HIGHOOS Enter High Lot Menu Scan list if necessary Alternatively scan the barcode on the control vial _____ Depending on the configuration option setting you may or may not be required to enter the control lot number If you are not required to enter the control lot number the Select Lot screen will not appear 20 If you are required to enter the control lot number a configuration option may have been selected which will allow you to enter a new control solution lot number at the bedside unit If you do not see the lot number in the list and the Enter Control Lot button appears on the screen press the button and manually enter the control solution lot number and expiration date Select the test strip lot fo ee number and code from the OC q list displayed The last test Select Strip Lot strip lot number selected Lot CODE A ozon e 8 appears at the top of the list a Use the arrows to scroll wens 9 through the list if necessary m S stip Lot Menul scan 4 Alternatively scan the barcode on the test strip eer bottle label A configuration option may have been selected which would allow you to enter a new test strip lot number at the bedside unit If you do
58. roblems Appendix A Bedside Unit Configuration Options includes a list of all bedside unit options that have been configured selected by your system administrator at the workstation vii e Preface Conventions Used in This Guide E NOTE Points out additional information that may be helpful IMPORTANT Contains information necessary to successfully perform the test A CAUTION Alerts you to situations that could result in instrument damage failure in a procedure or possible inaccurate results Text within shaded boxes appears throughout this guide This information describes a specific workstation option and how it may affect bedside unit operation For example Q Enter your operator ID Depending on the configuration option setting you may or may not be required to enter your operator ID viii For a list of workstation options that are reflected in the bedside unit refer to Appendix A Bedside Unit Configuration Options Help 1 Read through the section of the guide specific to the operation you are performing Refer to the table of contents and index to locate information 2 See Chapter 7 for error messages and troubleshooting information 3 Call LifeScan Healthcare Professional Line at 1 800 524 7226 USA 1 888 353 0800 Canada CHAPTER 1 Introduction The SureStepPro Bedside Unit is one component of LifeScan s professional blood glucose monitoring system
59. rop of blood Capillary blood can be obtained from puncturing the finger or heel using a lancing device The puncture site should be cleaned and thoroughly dried before obtaining the sample Follow your institution s policy and procedure guidelines for blood collection 33 Patient Test Apply the blood to the test strip as follows 34 Finger Stick Carefully touch the center of the pink test square to the drop of blood on the patient s finger The test area will quickly absorb the blood Heel Stick Carefully touch the center of the pink test square to the drop of blood on the heel g A S N Syringe Touch the tip of the syringe to the center of the pink test square Gently apply pressure to the plunger As the blood emerges from the tip of the syringe it is absorbed by the test square A CAUTION Avoid applying too much blood when using a syringe or you may get an inaccurate high result Alternatively dispense the blood from the syringe into a test tube then apply blood to the test square using a narrow bore pipette Pipette Touch the drop of blood emerging from the tip of a narrow bore pipette to the center of the pink test square 35 Patient Test Check the white pad on the front of the test strip and the confirmation dot on the back of the test strip e If the white pad becomes completely saturated you have applied too much blood for an accurate result Repeat
60. s very high or very low e Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 82 POSSIBLE ERROR CAUSE SOLUTION Error 5 The bedside unit 1 Clean bedside unit Meter Optics detectedaproblem especially gray area inside with the optical test strip holder but system NOTE Before cleaning compare color of test strip confirmation dot to Color Chart on test strip bottle If glucose level is very high or very low take appropri ate steps to monitor patient and provide medical care e Repeat test with new test strip e Make sure test strip holder is fully inserted into bedside unit e Wait for Insert Strip to appear on display before inserting test strip 2 If you continue to get any error message obtain a laboratory result Take appropriate steps to monitor patient and provide medical care while awaiting laboratory result 3 Contact LifeScan for help If you cannot resolve a problem call LifeScan Healthcare Professional Line 1 800 524 7226 USA 1 888 353 0800 Canada 83 a Troubleshooting POSSIBLE ERROR CAUSE SOLUTION Error 6 The bedside unit 1 Wipe contact points in lens System Error detected a problem area with cloth moistened with the ele
61. signals to indicate various stages in the testing procedure These signals do not indicate that the procedure is being performed correctly The unit can detect some but not all errors in the test procedure e A single short beep sounds each time a selection is made or a button is pressed on the screen e Three short beeps sound when a test result is displayed e A single long beep accompanies error messages and errors that are detected in the test procedure as well as CRITICAL HIGH CRITICAL LOW and HIGH results This beep is also used at various times during the test strip insertion stages of the test A configuration option may be set to turn Off most beeps except error beeps and the touch screen feedback beep SureStepPro Test Strips SureStepPro Test Strips are the only test strips specifically designed developed and tested for use with the SureStepPro Bedside Unit When blood is applied to the pink test square a chemical reaction takes place A blue color forms in the confirmation dot on the back of the test strip If the confirmation dot is completely blue this indicates that an adequate volume of e Introduction sample was applied The intensity of the blue is read by the bedside unit the darker the blue the higher the glucose level FRONT BACK white tip black tip white pad pink test square 3 confirmation dot White Tip faces up as the test strip is inserted into the test s
62. t A Linearity Solution kit is available from LifeScan The kit contains five levels of glucose solution used to check the linearity of the system Linearity solution results can be affected at altitudes of 2000 feet or greater Read the SureStepPro Linearity Test Kit package insert for information Refer to your institution s policy for establishing the linearity of a test method 61 Special Tests Select Special Tests fromthe Main Menu q Main Menu Patient Test QC Test Transfer Data Review Data Special Tests Setup Last Upload 09 14 98 2 28PM Wi ee Select Lin Unkn Test from S S O the Special Tests menu o q Special Tests Lin Unkn Test In Service Mode Menu o Enter your operator ID o q Enter Oper ID 999 I 14 2 4 5 6 8 7 az O De Menu Scan Ok 62 Depending on the configuration option setting you may or may not be required to enter your operator ID If your operator ID is required a configuration option may be set to remember your ID for up to 1 hour after the bedside unit is turned off If your ID appears at the operator screen press Ok to confirm it is correct If the ID is not correct simply enter your ID and it will replace the existing ID
63. th a 10 bleach solution Be sure to thoroughly wipe the area on the inside cover Clean both sides of the base Follow with a swab moistened with water to remove residual bleach A CAUTION Bleach residue left on the test strip holder may lead to an error message or an inaccurate high result 3 Dry the test strip holder with a soft cloth or lint free tissue Close the holder and set it aside 4 Using a cotton swab or soft cloth moistened with a 10 bleach solution wipe the lens area and contact points Wipe this area even if it does not appear to be dirty Use a swab or cloth moistened with water to remove residual bleach Be careful not to scratch the lens area contact points lens area 55 Care and Maintenance 5 Dry the lens area gently with a clean soft lint free cloth or tissue Remove any lint O QO Slide the closed test strip holder into the unit Push the holder until it clicks into place Q Turn on the bedside unit If an error appears check to make sure you installed the test strip holder correctly 8 If necessary wipe the scanner with a soft cloth moistened with water AE 9 Perform a quality control test to verify that the result is within the expected range 56 Changing the Batteries The SureStepPro Bedside Unit is powered by two size C alkaline batteries Change the batteries when the LOW BATTERY message appears on the screen You may want to
64. the application with a new test strip FRONT e The confirmation dot on the back of the test strip should be completely blue J confirmation a dot BACK FRONT If white patches or streaks are visible on the blue confirmation dot you may not have applied enough blood for an accurate result Repeat the application with a new test strip 0 i BACK 36 A CAUTION Do not apply additional blood to the test strip or you may get an inaccurate result If white patches or streaks continue to appear after you have repeated the test with a new test strip and a larger sample volume call the LifeScan Healthcare Professional Line at 1 800 524 7226 Firmly insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down A CAUTION If you fail to completely insert the test strip the test may start however you may receive an inaccurate low result A CAUTION You have up to 2 minutes to insert the test strip after the blood is applied If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Discard the test strip and repeat the test with a new test strip 37 Patient Test The test result appears in approximately 30 seconds oC q IMPORTANT Patient Result Do not remove the test
65. trip holder Pink Test Square is the area where the blood must be applied For detailed information refer to Applying Blood Sample to Test Strip on page33 White Pad absorbs excess blood that may extend beyond the pink test square Do not apply blood directly to the white pad Black Tip faces down and helps the unit determine when the strip has been inserted Confirmation Dot is read by the bedside unit to determine the sample s glucose concentration If it turns completely blue this indicates that an adequate volume of blood was applied IMPORTANT Test Strip Information For detailed information regarding SureStepPro Test Strips read the package insert e Use only SureStepProTest Strips with the SureStepPro Blood Glucose Bedside Unit e SureStepPro Test Strips are sensitive to heat light and moisture Keep them tightly sealed in their original bottle and store in a cool dry place below 30 C 86 F Do not refrigerate freeze or place in direct heat or sunlight A lot number and CTL control code are printed on the test strip bottle label The CTL code encodes the test strip expiration date control solution ranges and linearity reference values When entering this information always get the lot number and CTL code from the test strips currently in use Do not use the test strips after the expiration date printed on the bottle label Discard any unused test strips 4 months after opening Write the
66. with a new test strip Wipe the control solution vial tip with a lint free cloth or tissue before replacing the cap O Firmly insert the test strip all the way into the test strip holder until it stops the confirmation dot should be facing down 23 Quality Control Test IMPORTANT If you fail to completely insert the test strip the test may start however you may receive an out of range result IMPORTANT You have up to 2 minutes to insert the test strip after the control solution is applied If you insert the test strip after 2 minutes you may get an out of range result or an error message Discard the test strip and repeat the test with a new test strip 10 The QC test result appears in approximately 30 seconds The time may vary depending on the temperature and glucose level 24 IMPORTANT Do not remove the test strip until the countdown is complete Oca High QC Result qENM JU mga PASSED Passing range 280 420 mad Enter Menu Notes Ok Ss OC q High QC Result In ILU mga FAILED Passing range 280 420 mg d Repeat Test Expired Strip Ctrl expired Shake Ctrl Cin Strip Hidr Enter Notes Re ee Depending on the configuration option setting the QC result will be displayed as either a numeric value or Passed
67. y depending on how the unit is configured you will benefit by becoming familiar with the configuration options For more detailed information on configuration options ask your system administrator or refer to Appendix A Bedside Unit Configuration Options for a list of bedside unit options configured at the workstation What You ll Find in This Guide Chapter 1 Introduction provides you with an overview of the system and outlines basic operating instructions Chapter 2 Quality Control Test guides you through the steps of performing a quality control test Chapter 3 Patient Test guides you through the steps of performing a patient blood test Chapter 4 Data Management covers the bedside unit workstation data transfer session Details for this procedure can be found in the DataLink System Administrator s Guide Chapter 4 also provides information on reviewing test results stored in bedside unit memory Chapter 5 Care and Maintenance instructs you on how to clean the bedside unit and test strip holder and change the batteries Chapter 6 Special Tests provides instructions for performing a linearity test and an unknown solution test Also included are instructions on in service training when teaching new operators how to use the bedside unit to perform a glucose test Chapter 7 Troubleshooting lists error conditions that may occur or messages that may appear during operation and offers solutions to correct the p
68. y a message informing you that QC is due The warning mode allows you to continue with a patient test the lockout mode prevents you from using the bedside unit for a patient test until QC is successfully performed A second lockout mode prevents the operator who has not performed QC testing within the designated number of days from using the bedside unit to test patient blood Ifa lockout mode was selected and QC is due a message appears when you start the bedside unit You cannot proceed with patient testing until the required QC tests have been successfully performed When to Perform a Quality Control Test e As required by your institution s quality control policy or local regulatory requirements e When you open a new bottle of test strips e Ifa patient test has been repeated and the blood glucose results are still lower or higher than expected e After cleaning the bedside unit e If there are other indications that the system is not working properly e If you drop the bedside unit Glucose Control Solutions Use SureStepPro Glucose Control Solutions with the SureStepPro Bedside Unit and SureStepPro Test Strips only IMPORTANT Control Solution Information Read the SureStepPro Control Solutions package insert for more information e Gently shake each vial of control solution before use e Do not use a control solution after the expiration date printed on the vial label Discard any unused porti

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