Document Outline

• Body -
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• Body - Bedside Unit Operator’s Guide
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  • Body - The SureStep®Pro Bedside Unit is for in vitro diagnostic use for the quantitative measurem...
    • Caution* - CAUTION
  • Body - This product contains a barcode scanner. It is a class II laser which operates at 680 nm a...
  • Body - Do not stare into the laser beam. Refer to page 8 of this guide for information and instru...
  • Body - * A Food and Drug Administration (FDA) regulation established for any product that contain...
• TOC Head - Table of Contents
• Chapter Head - Preface
  • Body - SureStepPro is LifeScan’s integrated blood glucose management system for testing, tracking...
  • Body - The SureStepPro System offers diabetes caregivers and patients off-meter blood dosing of t...
  • Body - The SureStepPro Bedside Unit Operator’s Guide provides detailed instructions on using and ...
    • Head 2 - What You’ll Find in This Guide
  • Body - Chapter 1, Introduction, provides you with an overview of the system and outlines basic op...
  • Body - Chapter 2, Quality Control Test, guides you through the steps of performing a quality cont...
  • Body - Chapter 3, Patient Test, guides you through the steps of performing a patient blood test.
  • Body - Chapter 4, Data Management, covers the bedside unit/workstation data transfer session. Det...
  • Body - Chapter 5, Care and Maintenance, instructs you on how to clean the bedside unit and test s...
  • Body - Chapter 6, Special Tests, provides instructions for performing a linearity test and an unk...
  • Body - Chapter 7, Troubleshooting, lists error conditions that may occur or messages that may app...
  • Body - Appendix A, Bedside Unit Configuration Options, includes a list of all bedside unit option...
    • Notes* - NOTE
  • Body - Points out additional information that may be helpful.
    • Important* - IMPORTANT
  • Body - Contains information necessary to successfully perform the test.
    • Caution* - CAUTION
  • Body - Alerts you to situations that could result in instrument damage, failure in a procedure, o...
  • Body - Text within shaded boxes appears throughout this guide. This information describes a speci...
  • Body - For example:
  • Body - Enter your operator ID.
  • Body - Depending on the configuration option setting, you may or may not be required to enter you...
  • Body - For a list of workstation options that are reflected in the bedside unit, refer to Appendi...
• Chapter Head - Introduction
  • Body - The SureStepPro Bedside Unit is one component of LifeScan’s professional blood glucose mon...
  • Body - The unit is equipped with a barcode scanner and a large touch-sensitive display, both of w...
  • Body - Before use, each bedside unit must be configured by your institution’s system administrato...
  • Body - The bedside unit stores patient and quality control data in internal memory. A bi-directio...
  • Body - LifeScan’s DataLink System for modems or network provides you with choices for connec- tiv...
  • Body - The complete SureStepPro Professional Care Blood Glucose Management System includes a comp...
  • Body - For important information on any of these LifeScan products, refer to the appropriate oper...
    • Caution* - CAUTION
  • Body - Do not stare into the barcode scanner or point it towards anyone’s eyes while the laser li...
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  • Body - LifeScan recommends that only certified operators in the hospital or clinic perform blood ...
  • Body - Before you can operate the bedside unit, it must be configured. Your system administrator ...
  • Body - The configuration of a bedside unit and how it operates is determined by choices the syste...
  • Body - A Main Menu lets you select from six different functions.
    • Head 2 - Entering Information
  • Body - Select an item from a list by touching the appropriate area of the screen. If a list is to...
  • Body - Manually enter IDs or lot numbers by pressing the appropriate characters on the screen. Bo...
  • Body - To delete the last character or characters entered, press Del.
    • Notes* - NOTE
  • Body - If left inactive, the bedside unit will automatically shut off. Press the power button to ...
  • Body - A configuration option may be set to maintain your ID for up to 1 hour after the bedside u...
    • Head 2 - Scanning a Barcode
  • Body - The bedside unit’s barcode scanner must be enabled at the workstation. If the scanner is e...
  • Body - To scan a barcode, hold the barcode label parallel to and approximately 6 to 10 inches fro...
    • Caution* - CAUTION
  • Body - This product contains a laser. Do not stare into the laser light or point it towards anyon...
    • Head 2 - System Beep Signals
  • Body - The SureStepPro Bedside Unit uses beeping signals to indicate various stages in the testin...
  • Body - A configuration option may be set to turn Off most beeps except error beeps and the touch ...
  • Body - SureStepPro Test Strips are the only test strips specifically designed, developed, and tes...
  • Body - When blood is applied to the pink test square, a chemical reaction takes place. A blue col...
  • Body - White Tip faces up as the test strip is inserted into the test strip holder.
  • Body - Pink Test Square is the area where the blood must be applied. For detailed information, re...
  • Body - White Pad absorbs excess blood that may extend beyond the pink test square. Do not apply b...
  • Body - Black Tip faces down and helps the unit determine when the strip has been inserted.
  • Body - Confirmation Dot is read by the bedside unit to determine the sample’s glucose concentrati...
    • Important* - IMPORTANT Test Strip Information
  • Body - For detailed information regarding SureStepPro Test Strips, read the package insert.
    • Head 2 - Infection Control
  • Body - Use universal blood precautions.* All patient samples and materials with which they come i...
  • Body - * Centers for Disease Control Report. Guideline for Infection Control in Health Care Perso...
• Chapter Head - Quality Control Test
  • Body - Three levels of SureStepPro Glucose Control Solution are available to check that the SureS...
  • Body - The SureStepPro bedside units are calibrated at the factory. Although an internal verifica...
  • Body - If you are training a new operator on how to use the bedside unit, use the glucose control...
  • Body - The number of control levels and frequency of running a QC test have been programmed by yo...
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  • Body - To ensure that a required QC test is performed at the designated time, a warning or lockou...
  • Body - A second lockout mode prevents the operator who has not performed QC testing within the de...
  • Body - If a lockout mode was selected and QC is due, a message appears when you start the bedside...
  • Body - Use SureStepPro Glucose Control Solutions with the SureStepPro Bedside Unit and SureStepPr...
    • Important* - IMPORTANT Control Solution Information
  • Body - Read the SureStepPro Control Solutions package insert for more information.
  • Body - A start-up screen appears...
  • Body - ...followed by the Status screen.
  • Body -
  • Body - Depending on the configuration option setting, you may or may not be required to enter you...
  • Body - If your operator ID is required, a configuration option may be set to remember your ID for...
  • Body -
  • Body - The control level(s) you are required to run have been selected by your system administrat...
  • Body - Depending on the configuration option setting, you may or may not be required to enter the...
  • Body -
  • Body - If you are required to enter the control lot number, a configuration option may have been ...
  • Body - Alternatively, scan the barcode on the test strip bottle label.
  • Body - A configuration option may have been selected which would allow you to enter a new test st...
    • Caution* - CAUTION
  • Body - To obtain accurate results, you must enter the correct test strip lot number (and code) fo...
  • Body - The QC Test screen appears with messages prompting you to apply the control to the test st...
    • Head 2 - Applying Control Solution to Test Strip
    • Caution* - CAUTION
  • Body - Applying too much or too little control solution may cause out-of-range results.
    • Important* - IMPORTANT
  • Body - If you fail to completely insert the test strip, the test may start; however, you may rece...
    • Important* - IMPORTANT
  • Body - You have up to 2 minutes to insert the test strip after the control solution is applied. I...
    • Important* - IMPORTANT
  • Body - Do not remove the test strip until the countdown is complete.
  • Body - Depending on the configuration option setting, the QC result will be displayed as either a...
    • Caution* - CAUTION
  • Body - If the control solution result fails, repeat the test. The system may not be functioning p...
  • Body - A configuration option was selected which may require you to select comments when a QC tes...
  • Body - The comments that appear at the Select Comment screen have been selected by your system ad...
    • Notes* - NOTE
  • Body - Results tagged with the comment “Procedure Err” are not included in the statistical calcul...
  • Body - If you have problems using the bedside unit to test the control solutions, or if the bedsi...
• Chapter Head - Patient Test
  • Body - LifeScan recommends that only certified operators perform patient blood glucose testing us...
  • Body - Follow your institution’s policies for in-service training to become a certified operator.
  • Body - A start-up screen appears...
  • Body - ...followed by the Status screen.
  • Body -
  • Body - Depending on the configuration option setting, you may or may not be required to enter you...
  • Body -
  • Body - If your operator ID is required, a configuration option may be set to remember your ID for...
    • Notes* - NOTE
  • Body - Carefully enter the ID. An accurate patient ID is imperative for transferring the correct ...
  • Body - Depending on the configuration option setting, you may or may not be required to enter the...
  • Body - Alternatively, scan the barcode on the test strip bottle label.
  • Body - A configuration option may have been selected which would allow you to enter a new test st...
    • Caution* - CAUTION
  • Body - To obtain accurate results, you must enter the correct test strip lot number (and code) fo...
  • Body - The Patient Test screen appears with messages prompting you to apply blood to the strip an...
    • Head 2 - Applying Blood Sample to Test Strip
  • Body - Obtain a drop of blood. Capillary blood can be obtained from puncturing the finger or heel...
    • Head 3 - Finger Stick
  • Body - Carefully touch the center of the pink test square to the drop of blood on the patient’s f...
    • Head 3 - Heel Stick
  • Body - Carefully touch the center of the pink test square to the drop of blood on the heel.
    • Head 3 - Syringe
  • Body - Touch the tip of the syringe to the center of the pink test square. Gently apply pressure ...
    • Caution* - CAUTION
  • Body - Avoid applying too much blood when using a syringe or you may get an inaccurate, high result.
  • Body - Alternatively, dispense the blood from the syringe into a test tube, then apply blood to t...
    • Head 3 - Pipette
  • Body - Touch the drop of blood emerging from the tip of a narrow-bore pipette to the center of th...
    • Caution* - CAUTION
  • Body - Do not apply additional blood to the test strip or you may get an inaccurate result.
  • Body - If white patches or streaks continue to appear after you have repeated the test with a new...
    • Caution* - CAUTION
  • Body - If you fail to completely insert the test strip, the test may start; however, you may rece...
    • Caution* - CAUTION
  • Body - You have up to 2 minutes to insert the test strip after the blood is applied. If you inser...
  • Body - The test result appears in approximately 30 seconds.
    • Important* - IMPORTANT
  • Body - Do not remove the test strip until the countdown is complete.
  • Body - If an error message appears, refer to Chapter 7, Troubleshooting, for information.
  • Body - A glucose range may have been defined by your system administrator. Results that fall abov...
    • Important* - IMPORTANT
  • Body - When the result is greater than 500 mg/dL and proper procedures are followed, the bedside ...
  • Body -
  • Body - Depending on the configuration option setting, you may be required to select comments when...
  • Body - The comments that appear at the Select Comment screen have been selected by your system ad...
    • Notes* - NOTE
  • Body - Results tagged with the comment “Procedure Err” are not included in any patient reports ge...
  • Body - If you have problems using the bedside unit to test patient samples, or if the bedside uni...
• Chapter Head - Data Management
  • Body - Data transfer is required periodically to exchange information between the workstation and...
  • Body - Your institution will establish a regular schedule for performing data transfer sessions.
  • Body - Depending on the configuration option setting, the bedside unit may be disabled from testi...
  • Body - You may transfer data using:
    • Head 2 - Using a Direct Infrared Port Connection
  • Body - To perform data transfer using a direct link with the workstation’s infrared port, the bed...
  • Body - Data transfer begins immediately. The time to transfer data depends on the amount of infor...
  • Body - A series of messages are displayed on the bedside unit screen indicating the status of the...
    • Head 2 - Using the Connection Module
  • Body - The connection module, used with a modem, provides a remote communication link between the...
    • Notes* - NOTE
  • Body - If a fax machine is sharing the same analog line as the connection module modem, do not tr...
    • Notes* - NOTE
  • Body - SureStepPro 2.0 users – If you are transferring data over an Ethernet network, MeterLink s...
    • Head 3 - SureStepPro 1.2 Users
  • Body - Enter the workstation modem phone number, then press Dial. (Once the phone number is enter...
  • Body - The modem begins dialing. If the line is busy, the connection module will retry up to 20 t...
  • Body - Messages appear on the screen indicating the status of the connection. The indicator light...
    • Head 3 - SureStepPro 2.0 Users
  • Body - Refer to instructions in the following Ethernet and Modem sections for details.
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  • Body - Ethernet
  • Body - If you are transferring data over an Ethernet network using a serial server, the transfer ...
  • Body - Modem
  • Body - If a modem is detected, the connection module automatically dials the receiving modem. If ...
  • Body - A series of messages are displayed on the screen indicating the status of the transfer. Wh...
  • Body - If the bedside unit is off when you remove it from the connection module, you can check to...
  • Body - The bedside unit stores up to 2500 QC and patient test results in its memory. Additionally...
  • Body - When bedside unit memory is low (less than 100 tests available), the message Data Memory L...
  • Body - When the bedside unit memory is full, a message appears informing you that there is no roo...
    • Head 2 - Accessing Memory to Review Data
  • Body - You may review patient, QC, linearity, and unknown solution test results. In-Service test ...
    • Notes* - NOTE
  • Body - Test results appearing as HIGH indicate patient, QC, and unknown solution results greater ...
• Chapter Head - Care and Maintenance
  • Body - To keep the bedside unit in good operating condition, you must keep it clean and handle it...
  • Body - Follow these simple rules:
    • Head 2 - When to Clean the Unit
  • Body - Clean the outside of the unit with a cloth moistened with a 10% bleach solution. Follow wi...
    • Caution* - CAUTION
  • Body - Do not get water inside the unit. Never im- merse the unit or hold it under running water ...
  • Body - Clean the test strip holder (cover and base), lens area, and contact points. Use a 10% ble...
    • Caution* - CAUTION
  • Body - Do not use alcohol, glass cleaners, or any cleansers containing abrasives, phenol, or ammo...
    • Caution* - CAUTION
  • Body - Bleach residue left on the test strip holder may lead to an error message or an inaccurate...
  • Body - The SureStepPro Bedside Unit is powered by two size C alkaline batteries. Change the batte...
    • Caution* - CAUTION
  • Body - Do not use rechargeable batteries.
    • Notes* - NOTE
  • Body - Neither the LOW BATTERY message nor the removal of batteries affects the test results stor...
    • Notes* - NOTE
  • Body - The battery life depends on how quickly the bedside unit is powered off after each test. U...
  • Body - You can increase or decrease the LCD screen contrast.
• Chapter Head - Special Tests
  • Body - The Special Tests function allows you to perform tests that are not routinely performed, s...
  • Body - A Linearity Solution kit is available from LifeScan. The kit contains five levels of gluco...
  • Body - Refer to your institution’s policy for establishing the linearity of a test method.
  • Body -
  • Body -
  • Body -
  • Body -
    • Caution* - CAUTION
    • Caution* - CAUTION
  • Body - Applying too much or too little linearity solution may cause out-of-range results.
    • Important* - IMPORTANT
  • Body - If you fail to completely insert the test strip, the test may start; however, you may rece...
    • Important* - IMPORTANT
  • Body - You have up to 2 minutes to insert the test strip after the linearity solution is applied....
    • Important* - IMPORTANT
  • Body - Do not remove the test strip until the countdown is complete.
    • Notes* - NOTE
  • Body - The bedside unit can display linearity results up to 766 mg/dL.
  • Body - If you wish to record additional information with the test result, press Enter Notes and c...
  • Body - When the testing of all five levels is complete, perform a data transfer to upload the lin...
  • Body - Periodically, you may be asked to perform a proficiency test on a solution for which you d...
  • Body -
  • Body -
    • Caution* - CAUTION
    • Important* - IMPORTANT
  • Body - If you fail to completely insert the test strip, the test may start; however, you may rece...
    • Important* - IMPORTANT
  • Body - You have up to 2 minutes to insert the test strip after the solution is applied. If you in...
    • Important* - IMPORTANT
  • Body - Do not remove the test strip until the countdown is complete.
  • Body - Use the In-Service mode to train and certify operators. This mode is identical to the QC T...
  • Body - The QC warning or lockout mode does not affect tests performed in the In-Service mode.
• Chapter Head - Troubleshooting
  • Body - The SureStepPro Bedside Unit displays prompts and error messages to indicate the system ha...
    • Caution* - CAUTION
  • Body - While trying to resolve an error message using the Troubleshooting section, keep in mind t...
  • Body - If you need help resolving an error or you encounter any other problem with the system, co...
  • Body -
  • Body -
• Chapter Head - Bedside Unit Configuration Options
  • Body - Following is a list of workstation options configured by your System Administrator. These ...
  • Body -
• Chapter Head - Specifications
  • Body - The performance of the system has been evaluated under the conditions listed below. Refer ...
  • Body - power supply: two size C, 1.5-V alkaline batteries
  • Body - result range: 0–500 mg/dL
  • Body - display: liquid crystal
  • Body - sample type: whole blood
  • Body - calibration: plasma equivalent
  • Body - hematocrit range: 25–60% (neonatal 25–65%)
  • Body - meter size: height 18.9 cm (7.4 in) width 8.8 cm (3.5 in) depth 6.5 cm (2.6 in)
  • Body - meter weight: 1.2 lb
  • Body - operating temperature: 18˚–30˚C (64˚–86˚F)
  • Body - operating humidity: 30%–70% relative humidity (noncondensing)
  • Body - altitude: up to 10,000 ft (3048 m) [For more information, read the SureStepPro Test Strip ...
  • Body - class II laser: 680 nm
  • Body - barcodes: Barcode 39
  • Body - Barcode 128
  • Body -
  • Body - The SureStepPro Blood Glucose Bedside Unit complies with the following standards:
  • Body - Type BF Equipment
  • Body - • Internally powered equipment
  • Body - • No patient-applied parts
  • Body - • This unit is not suitable for use in the presence of a flammable anaesthetic mixture wit...
  • Body - The following compounds can be used to clean the exterior only of the bedside unit. Follow...
  • Body - Refer to Chapter 5, Care and Maintenance, for cleaning precautions and detailed informatio...
  • Body -
  • Body - Product names may be trademarks of their respective owners.
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• Chapter Head - Index
  • Body -