Lifescan SureStep Pro Operator's Manual
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Lifescan SureStep Pro Operator's Manual

Bedside unit professional blood glucose management system
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Bedside Unit Operator's Guide

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  • Page 1 Bedside Unit Operator’s Guide...
  • Page 3 ® 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.
  • Page 4 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 license, and LifeScan does not endorse or encourage the use of any strips manufactured by anyone other than LifeScan.

  • Page 5: Table Of Contents

    Table of Contents Preface ......v About This Guide ....vi What You’ll Find in This Guide.
  • Page 6 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 .

  • Page 7: Preface

    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...

  • Page 8: About This Guide

    Preface 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 vary depending on how the unit is configured, you will benefit by becoming familiar with the configuration options.
  • Page 9 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.

  • Page 10: Conventions Used In This Guide

    Preface Conventions Used in This Guide NOTE Points out additional information that may be helpful. IMPORTANT Contains information necessary to successfully perform the test. CAUTION Alerts you to situations that could result in instrument damage, failure in a procedure, or possible inaccurate results.

  • Page 11: Help

    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)
  • Page 12 Preface...

  • Page 13: Chapter 1-Introduction

    CHAPTER 1 Introduction The SureStepPro Bedside Unit is one component of LifeScan’s professional blood glucose monitoring system. 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.
  • Page 14 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.

  • Page 15: The Bedside Unit

    The Bedside Unit FRONT Power button turns the unit on and off. Barcode scanner enables direct data entry for operator ID, patient ID, and control solution and test strip lot numbers from their respective barcodes. Infrared communication port communicates with the workstation, via the connection module.
  • Page 16 Introduction TEST STRIP HOLDER The test strip holder is interchangeable—the same holder may be used in any SureStep brand meter. Closed Opened The cover protects the lens. BACK The insertion point is the area where the test strip is inserted. The base holds the test strip in place.

  • Page 17: General Operating Information

    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.

  • Page 18: Entering Information

    Introduction A Main Menu lets you select from six different functions. 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.
  • Page 19 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 numeric modes. Press Ok when you have completed the entry. To delete the last character or characters entered, press Del.

  • Page 20: Scanning A Barcode

    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.

  • Page 21: System Beep Signals

    System Beep Signals The SureStepPro Bedside Unit uses beeping 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.
  • Page 22 Introduction sample was applied. The intensity of the blue is read by the bedside unit—the darker the blue, the higher the glucose level. BACK FRONT black tip white tip pink test square confirmation dot white pad White Tip faces up as the test strip is inserted into the test strip holder.
  • Page 23 IMPORTANT Test Strip Information For detailed information regarding SureStepPro Test Strips, read the package insert. • Use only SureStepPro Test Strips with the SureStepPro Blood Glucose Bedside Unit. • 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).

  • Page 24: Precautions

    Introduction • Use each test strip immediately after removing it from the bottle. • Do not use test strips that are bent, torn, cut, or damaged in any way. • 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.
  • Page 25 – If the confirmation dot is completely 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.

  • Page 26: Infection Control

    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 as if capable of transmitting infection. Follow proper precautions in accordance with your institution’s policies when disposing of all materials.

  • Page 27: Chapter 2-Quality Control Test

    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.

  • Page 28: When To Perform A Quality Control Test

    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 display 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.

  • Page 29: Glucose Control Solutions

    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. • Gently shake each vial of control solution before use.

  • Page 30: Performing A Quality Control Test

    Quality Control Test Performing a Quality Control Test Press the power button to turn on the unit. A start-up screen appears..followed by the Status screen. Check the battery status to ensure adequate power. The battery and memory bars provide the approximate status of battery power and bedside unit memory.
  • Page 31 Select QC Test from the Main Menu. Enter your operator ID, either by pressing the touch screen or using the barcode scanner. Refer to page 8 for information on scanning a barcode. Depending on the configuration option setting, you may or may not be required to enter your operator ID.

  • Page 32: Quality Control Test

    Quality Control Test Select the control level you wish to run; for example, High. 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 QC Test screen. Select the control lot number from the list displayed.
  • Page 33 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.

  • Page 34: Applying Control Solution To Test Strip

    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. Applying Control Solution to Test Strip CAUTION Applying too much or too little control solution may cause out-of-range results.
  • Page 35 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.
  • Page 36 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.
  • Page 37 IMPORTANT Do not remove the test strip until the countdown is complete. Depending on the configuration option setting, the QC result will be displayed as either a numeric value or Passed/Failed. • If the result is PASSED, press Ok, remove the strip, and continue with the remaining required control levels.
  • Page 38 Quality Control Test • If the result is FAILED, press Enter Notes and choose from 1 to 3 comments. This will be recorded with the failed result. Press Ok, remove the test strip, and repeat the QC test. Or, if the Menu button is displayed at the Failed QC screen, you may press Menu to repeat the test without recording any...
  • Page 39 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.
  • Page 40 Quality Control Test...

  • Page 41: Chapter 3-Patient Test

    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 Press the power button to turn on the unit.

  • Page 42: Patient Test

    Patient Test A start-up screen appears..followed by the Status screen. 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.
  • Page 43 Enter your operator ID either by pressing the touch screen or using the barcode scanner. Refer to page 8 for information on scanning a barcode. Depending on the configuration option setting, you may or may not be required to enter your operator ID.
  • Page 44 Patient Test Depending on the configuration option setting, you may or may not be required to enter the patient’s ID. 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 through the list, if necessary.

  • Page 45: Applying Blood Sample To Test Strip

    The Patient Test screen appears with messages prompting you to apply blood to the strip and then insert the test strip. Applying Blood Sample to Test Strip Obtain a drop of blood. Capillary blood can be obtained from puncturing the finger or heel using a lancing device.
  • Page 46 Patient Test Apply the blood to the test strip as follows: 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.
  • Page 47 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. CAUTION Avoid applying too much blood when using a syringe or you may get an inaccurate, high result.
  • Page 48 Patient Test Check the white pad on the front of the test strip and the confirmation dot on the back of the test strip. • If the white pad becomes completely saturated, you have applied too much blood for an accurate result. Repeat the application with a new test strip.
  • Page 49 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).
  • Page 50 Patient Test The test result appears in approximately 30 seconds. IMPORTANT Do not remove the test strip until the countdown is complete. If an error message appears, refer to Chapter 7, Troubleshooting, for information. A glucose range may have been defined by your system administrator.
  • Page 51 • CRITICAL LOW indicates a result below the range. • HIGH indicates a result greater than 500 mg/dL. 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.
  • Page 52 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.

  • Page 53: Chapter 4-Data Management

    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.

  • Page 54: Using A Direct Infrared Port Connection

    Data Management You may transfer data using: • a direct infrared link with the workstation’s infrared port • a connection module that is directly connected to the workstation’s serial port • a connection module that is connected to a 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...
  • Page 55 The bedside unit is ready for the communication link to be established. If the bedside unit has been configured to communicate directly with the workstation infrared port, the message at the right appears. Place the bedside unit’s infrared communication port approximately 6 to 10 inches (15 to 25 centimeters) from the workstation’s infrared port.

  • Page 56: Using The Connection Module

    Data Management A series of messages are displayed on the bedside unit screen indicating the status of the transfer. When Data Transfer the transfer is complete, the 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.
  • Page 57 Select Transfer Data from the Main Menu. The bedside unit is ready for the communication link to be established. A message appears instructing you to dock the bedside unit. Place the bedside unit in the connection module. SureStepPro 1.2 Users Enter the workstation modem phone number, then press Dial.

  • Page 58: Data Management

    Data Management up to 20 times at 30-second intervals before it times out. Messages appear on the screen indicating the status of the connection. The indicator light on the connection module blinks during transfer. A message appears when data transfer is complete.
  • Page 59 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 screen indicating the status of the transfer. When the transfer is complete, the bedside unit beeps and a message appears.
  • Page 60 Data Management If the workstation modem phone number was not pre- programmed, enter the phone number, then press Dial. If the phone number appears on the screen, simply press Dial. A series of messages are displayed on the screen indicating the status of the transfer.

  • Page 61: Bedside Unit Memory

    Bedside 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.
  • Page 62 Data Management Press Review Data from the Main Menu. Select Patient Results, QC/ Lin/Unkn, Test Strip Lots, or Reagent Lots. Lin and Unkn refer to Linearity and Unknown Solutions. For more information, see Chapter 6, Special Tests. • If you select Patient Results, you may specify a particular patient ID and see only the results for that...
  • Page 63 results marked with the Procedure Err comment will appear as Proc Err. • If you select QC/Lin/Unkn, you may enter an operator ID and see the results for the QC, linearity, and unknown tests a particular operator has run, or leave the operator ID field blank and see the results for all QC, linearity, and...
  • Page 64 Data Management • Select Test Strip Lots to see all test strip lot numbers with expiration dates currently entered in the system. The last lot number used appears at the top of the list. • Select Reagent Lots to see all control, linearity, and unknown solution lot numbers with expiration...

  • Page 65: Chapter 5-Care And Maintenance

    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: • Keep the test strip holder and lens area clean. • Keep the unit dry and avoid exposing it to extremes in temperature and humidity.

  • Page 66: Cleaning The Outside Of The Unit

    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. CAUTION Do not get water inside the unit.
  • Page 67 Wipe the test strip holder cover and base with a cotton swab or soft cloth moistened with 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.

  • Page 68: Care And Maintenance

    Care and Maintenance Dry the lens area gently with a clean, soft, lint- free cloth or tissue. Remove any lint. Slide the closed test strip holder into the unit. Push the holder until it clicks into place. Turn on the bedside unit. If an error appears, check to make sure you installed the test strip holder correctly.

  • Page 69: Changing The Batteries

    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 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.
  • Page 70 Care and Maintenance Press the power button to turn off the bedside unit. 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.
  • Page 71 Insert two new size C batteries, matching the positive (+) end of each battery with the + signs inside the battery compartment. 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...

  • Page 72: Adjusting The Screen Contrast

    Care and Maintenance Adjusting the Screen Contrast You can increase or decrease the LCD screen contrast. Select Setup from the Main Menu. Press the arrows to increase or decrease the LCD contrast. A change occurs each time you press the arrow.

  • Page 73: Chapter 6-Special Tests

    Linearity Test 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.
  • Page 74 Special Tests Select Special Tests from the Main Menu. Select Lin/Unkn Test from the Special Tests menu. Enter your operator ID.
  • Page 75 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.
  • Page 76 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.
  • Page 77 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.
  • Page 78 Special Tests • 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.
  • Page 79 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.
  • Page 80 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 screen to display the Lin Level screen.

  • Page 81: Unknown Solution Test

    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 the Main Menu.
  • Page 82 Special Tests Enter your operator ID. 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.
  • Page 83 Select an option to identify your unknown solution, for example Unkn A. Select the solution lot (or identification) number from the list displayed. 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.
  • Page 84 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 and the Enter Unk Lot # button appears on the screen, press the button and manually enter the unknown solution lot...
  • Page 85 CAUTION To obtain accurate results, you must enter the correct test strip lot number (and code) for each new test. Apply the unknown solution to the test strip. • 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.
  • Page 86 Special Tests 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.

  • Page 87: In-Service Test

    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.
  • Page 88 Special Tests Select In-Service Mode from the Special Tests menu. 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.

  • Page 89: Chapter 7-Troubleshooting

    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.

  • Page 90: Troubleshooting

    LifeScan Healthcare Professional Line at: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada)

  • Page 91: Error Messages

    The bedside unit Sample detected a problem Application with the color of the test strip. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Repeat test with new test strip and: •...
  • Page 92 Error 2 The bedside unit Test Strip detected a problem with the test strip. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Repeat test with new test strip and: •...
  • Page 93 The bedside unit Test Strip detected a problem with the position of the test strip. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Clean bedside unit, especially contact points in...
  • Page 94 The bedside unit Temperature detected a Range temperature problem. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Repeat test with new test strip. Make sure bedside unit and test strip are at room temperature.
  • Page 95 Error 5 The bedside unit Meter Optics detected a problem with the optical system. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Clean bedside unit, especially gray area inside...
  • Page 96 Error 6 The bedside unit System Error detected a problem with the electronics. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Wipe contact points in lens area with cloth moistened with water to remove residual bleach.

  • Page 97: Unexpected Messages And Observations

    Initial data transfer Needs is required. Or, Configuration configuration is corrupted. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION Obtain a drop of capillary blood and apply it to center of pink test square.
  • Page 98 Unit 2. Bad connection between modem and wall jack. 3. Faulty phone line. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION 1.Do not remove bedside unit from connection...
  • Page 99 Invalid month or Expiration year. Or, date Date entered already expired. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION Transfer data to free memory space. Retry data transfer.
  • Page 100 There are five new (non-validated) Reagent Lot reagent lots in bedside unit list. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION Re-enter your ID using barcode scanner or alphanumeric touch screen.
  • Page 101 If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION Transfer data to free memory space.
  • Page 102 Reagent (solution) entered Type does not match test type. If you cannot resolve a problem, call LifeScan Healthcare Professional Line: 1 800 524-7226 (USA) 1 888 353-0800 (Canada) SOLUTION Gently shake vial. Touch a drop of solution to center of pink test square.

  • Page 103: Appendix A-Bedside Unit Configuration Options

    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 Configuration Option Glucose units mg/dL mmol/L Patient Messages...
  • Page 104 Bedside Unit Configuration Options Configuration Option Critical Warning Messages Lower Limit ____ Upper Limit ____ Patient Message Entry Required (for results outside critical limits) Bedside Unit Configuration Option BU lockout if no upload in ____ days Bedside unit beeper on Enable barcode scanner Meaning...
  • Page 105 Configuration Option Nursing unit to which bedside unit is assigned Reagent Entry at Workstation Only Require Solution Lot Number (High, Low, Normal, Unknown, Linearity) Modem Dialing Information (option available for SureStepPro 2.0 only) Meaning Each bedside unit is assigned to a particular nursing unit.
  • Page 106 Bedside Unit Configuration Options Operator and IDs Configuration Option ID required for all tests Maintain ID for ____ minutes after power off Patient ID required for all tests ID number string format (patient and operator) Operator Recertification Period, ___months and test settings (test settings available for SureStepPro 2.0 only)

  • Page 107: Quality Control

    Quality Control Configuration Option Glucose units mg/dL mmol/L Required QC tests High Normal Control solution ranges (high, low, normal) for specified test strip Result Display Numeric Value Pass/Fail Only (Pass/Fail available for SureStepPro 2.0 only) QC Enforcement Warning Only Bedside Unit lockout Operator Lockout...
  • Page 108 Bedside Unit Configuration Options Configuration Option QC Test Period Time of day____ Elapsed time ____ hours QC Action Messages Messages displayed in the Failed QC Guiding Messages Failed QC Message Entry Required Meaning Frequency of performing a QC test is defined as a set time each day or an elapsed time between 6 and 24 hours.

  • Page 109: Specifications

    Specifications The performance of the system has been evaluated under the conditions listed below. Refer to the SureStepPro 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...

  • Page 110: Barcode Specifications

    Specifications operating humidity: 30%–70% relative altitude: class II laser: barcodes: Example of Code 39 Example of Code 128 Barcode Specifications • Black and white only; no color background. • 1/4-in border surrounding barcode symbol (optimal). • Accepts the first 14 alphanumeric characters in a barcode that contains a maximum of 18 characters;...
  • Page 111 The SureStepPro Blood Glucose Bedside Unit complies with the following standards: • 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)

  • Page 112: Cleaning Agents

    Specifications Cleaning Agents The following compounds can be used to clean the exterior only of 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.

  • Page 113: Index

    Index applying blood 33–36 control solution 22–23 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...
  • Page 114 Index operator 7 patient 31 infection control 14 insert test strip 23, 37, 66, 74 in-service test 75–76 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...
  • Page 115 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, 4 cleaning 54–55 removing 54 transferring data 41–48...
  • Page 117 For use with bedside units, versions 1.2 and 2.0. AW 061-296-01A ©2002 LifeScan, Inc. 09/02...

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