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BU.book Page i Monday, October 28, 2002 11:14 PM 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.
BU.book Page ii Monday, October 28, 2002 11:14 PM ▲ 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. ©2002, 1996 LifeScan, Inc. All rights reserved.
BU.book Page iii Monday, October 28, 2002 11:14 PM Table of Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . v About This Guide . . . . . . . . . . . . . . . . . . . vi What You’ll Find in This Guide. . . . . . . vi Conventions Used in This Guide . . . . . . . viii Help . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ix CHAPTER 1–Introduction . . . . . . . . . . . . . 1 The Bedside Unit . . . . . . . . . . . . . . . . . . . . . 3 General Operating Information . . . . . .
BU.book Page iv Monday, October 28, 2002 11:14 PM Table of Contents CHAPTER 4–Data Management . . . . . . . Transferring Data to the Workstation . . . . Using a Direct Infrared Port Connection Using the Connection Module. . . . . . . . Bedside Unit Memory . . . . . . . . . . . . . . . . Accessing Memory to Review Data . . . . 41 41 42 44 49 49 CHAPTER 5–Care and Maintenance . . . . General Care . . . . . . . . . . . . . . . . . . . . . . . When to Clean the Unit . . . . . . . . . . . .
BU.book Page v Monday, October 28, 2002 11:14 PM 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.
BU.book Page vi Monday, October 28, 2002 11:14 PM 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.
BU.book Page vii Monday, October 28, 2002 11:14 PM 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.
BU.book Page viii Monday, October 28, 2002 11:14 PM 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. Text within shaded boxes appears throughout this guide.
BU.book Page ix Monday, October 28, 2002 11:14 PM 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.
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BU.book Page 1 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 2 Monday, October 28, 2002 11:14 PM 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 information from the workstation to the bedside unit. LifeScan’s DataLink System for modems or network provides you with choices for connectivity solutions.
BU.book Page 3 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 4 Monday, October 28, 2002 11:14 PM Introduction 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 The base holds the test strip in place. The cover protects the lens. BACK Battery Compartment holds two size C alkaline batteries.
BU.book Page 5 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 6 Monday, October 28, 2002 11:14 PM Introduction A Main Menu lets you select from six different functions. Patient Test allows you to run a patient test. QC Test allows you to run a quality control test. Transfer Data transfers data between bedside unit and workstation. Review Data displays stored test results and reagent lot numbers. Special Tests allows you to run linearity and unknown test solutions and perform in-service testing. Setup allows you to adjust the bedside unit’s LCD contrast.
BU.book Page 7 Monday, October 28, 2002 11:14 PM 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. ■ NOTE If left inactive, the bedside unit will automatically shut off. Press the power button to turn it back on.
BU.book Page 8 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 9 Monday, October 28, 2002 11:14 PM 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. • A single short beep sounds each time a selection is made or a button is pressed on the screen. • Three short beeps sound when a test result is displayed.
BU.book Page 10 Monday, October 28, 2002 11:14 PM 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 white tip white pad pink test square black tip confirmation dot White Tip faces up as the test strip is inserted into the test strip 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.
BU.book Page 11 Monday, October 28, 2002 11:14 PM ◆ IMPORTANT Test Strip Information For detailed information regarding SureStepPro Test Strips, read the package insert. • Use only SureStepProTest 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). Do not refrigerate, freeze, or place in direct heat or sunlight.
BU.book Page 12 Monday, October 28, 2002 11:14 PM 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. If the color of the test strip confirmation dot is darker than that shown on the Color Chart, do not use the test strip.
BU.book Page 13 Monday, October 28, 2002 11:14 PM – 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. 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.
BU.book Page 14 Monday, October 28, 2002 11:14 PM 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. * Centers for Disease Control Report. Guideline for Infection Control in Health Care Personnel. Am J Infect Control. 1998;26:289–354.
BU.book Page 15 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 16 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 17 Monday, October 28, 2002 11:14 PM 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. • Do not use a control solution after the expiration date printed on the vial label. • Discard any unused portion 3 months after opening.
BU.book Page 18 Monday, October 28, 2002 11:14 PM Quality Control Test Performing a Quality Control Test 1 Press the power button to turn on the unit. A start-up screen appears... ...followed by the Status screen. 2 18 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.
BU.book Page 19 Monday, October 28, 2002 11:14 PM 3 Select QC Test from the Main Menu. 4 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. 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.
BU.book Page 20 Monday, October 28, 2002 11:14 PM Quality Control Test 5 Select the control level you wish to run; for example, High. Select QC Test High (req.d) Low (req.d) Normal (req.d) Menu 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. 6 Select the control lot number from the list displayed. The last control lot selected appears at the top of the list.
BU.book Page 21 Monday, October 28, 2002 11:14 PM 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. 7 Select the test strip lot number (and code) from the list displayed.
BU.book Page 22 Monday, October 28, 2002 11:14 PM 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. 8 Apply the control solution as follows: • Gently shake the control solution vial. • Touch a drop of control solution to the center of the pink test square.
BU.book Page 23 Monday, October 28, 2002 11:14 PM 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 with a new test strip.
BU.book Page 24 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 25 Monday, October 28, 2002 11:14 PM ◆ 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. Or, if you wish to record additional information with the test result, press Enter Notes and choose 1 to 3 comments from the list.
BU.book Page 26 Monday, October 28, 2002 11:14 PM 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 comments with the test result. Read the SureStepPro Test Strip package insert for information on troubleshooting a failed QC test.
BU.book Page 27 Monday, October 28, 2002 11:14 PM ■ 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.
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BU.book Page 29 Monday, October 28, 2002 11:14 PM 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 1 Press the power button to turn on the unit.
BU.book Page 30 Monday, October 28, 2002 11:14 PM Patient Test A start-up screen appears... ...followed by the Status screen. 2 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. 3 Select Patient Test from the Main Menu.
BU.book Page 31 Monday, October 28, 2002 11:14 PM 4 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. 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.
BU.book Page 32 Monday, October 28, 2002 11:14 PM Patient Test Depending on the configuration option setting, you may or may not be required to enter the patient’s ID. 6 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. Alternatively, scan the barcode on the test strip bottle label.
BU.book Page 33 Monday, October 28, 2002 11:14 PM 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. The puncture site should be cleaned and thoroughly dried before obtaining the sample. Follow your institution’s policy and procedure guidelines for blood collection.
BU.book Page 34 Monday, October 28, 2002 11:14 PM Patient Test 7 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.
BU.book Page 35 Monday, October 28, 2002 11:14 PM 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. Alternatively, dispense the blood from the syringe into a test tube, then apply blood to the test square using a narrow-bore pipette.
BU.book Page 36 Monday, October 28, 2002 11:14 PM Patient Test 8 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. FRONT • The confirmation dot on the back of the test strip should be completely blue.
BU.book Page 37 Monday, October 28, 2002 11:14 PM ▲ 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. 9 Firmly insert the test strip all the way into the test strip holder until it stops (the confirmation dot should be facing down).
BU.book Page 38 Monday, October 28, 2002 11:14 PM 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. Results that fall above or below the limits of this range appear as follows: • CRITICAL HIGH indicates a result above the range.
BU.book Page 39 Monday, October 28, 2002 11:14 PM • 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. This indicates hyperglycemia. Follow your institution’s policies for treatment.
BU.book Page 40 Monday, October 28, 2002 11:14 PM Patient Test 11 Press Enter Notes and choose 1 to 3 comments that correspond to the patient’s current situation. Press Ok. Or press Menu and continue testing. Ok 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.
BU.book Page 41 Monday, October 28, 2002 11:14 PM 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 schedule for performing data transfer sessions.
BU.book Page 42 Monday, October 28, 2002 11:14 PM 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 bedside unit must be situated next to the workstation.
BU.book Page 43 Monday, October 28, 2002 11:14 PM 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. 2 Place the bedside unit’s infrared communication port approximately 6 to 10 inches (15 to 25 centimeters) from the workstation’s infrared port. Data transfer begins immediately.
BU.book Page 44 Monday, October 28, 2002 11:14 PM Data Management 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. Data Transfer Data Transfer Complete Cont. Using the Connection Module The connection module, used with a modem, provides a remote communication link between the bedside units and the workstation.
BU.book Page 45 Monday, October 28, 2002 11:14 PM 1 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. Data Transfer Awaiting Link Dock the Bedside Unit Menu 2 Place the bedside unit in the connection module. SureStepPro 1.2 Users Enter the workstation modem phone number, then press Dial. (Once the phone number is entered, it will remain in the bedside unit memory.
BU.book Page 46 Monday, October 28, 2002 11:14 PM 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. 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.
BU.book Page 47 Monday, October 28, 2002 11:14 PM 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. Modem If a modem is detected, the connection module automatically dials the receiving modem.
BU.book Page 48 Monday, October 28, 2002 11:14 PM Data Management If the workstation modem phone number was not preprogrammed, enter the phone number, then press Dial. If the phone number appears on the screen, simply press Dial. Enter Phone # 9236699 1 2 3 4 5 6 7 8 9 Clear 0 Del Menu Wait Dial A series of messages are displayed on the screen indicating the status of the transfer. When the transfer is complete, the bedside unit beeps and a message appears.
BU.book Page 49 Monday, October 28, 2002 11:14 PM 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. When bedside unit memory is low (less than 100 tests available), the message Data Memory Low appears.
BU.book Page 50 Monday, October 28, 2002 11:14 PM Data Management 1 Press Review Data from the Main Menu. 2 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.
BU.book Page 51 Monday, October 28, 2002 11:14 PM 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 unknown tests for the last 30 days, beginning with the most recently performed test. The control solution level (L, N, H) is listed next to the QC result.
BU.book Page 52 Monday, October 28, 2002 11:14 PM 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 dates currently entered in the system. The last lot number used appears at the top of the list. The solution type abbreviation is listed next to the lot number.
BU.book Page 53 Monday, October 28, 2002 11:14 PM 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: • Keep the test strip holder and lens area clean. • Keep the unit dry and avoid exposing it to extremes in temperature and humidity. • Do not take apart the unit. • If you drop the unit, inspect it for obvious damage.
BU.book Page 54 Monday, October 28, 2002 11:14 PM 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. Never immerse the unit or hold it under running water because it will damage the unit.
BU.book Page 55 Monday, October 28, 2002 11:14 PM 2 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. ▲ 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.
BU.book Page 56 Monday, October 28, 2002 11:14 PM Care and Maintenance 5 Dry the lens area gently with a clean, soft, lintfree cloth or tissue. Remove any lint. 6 Slide the closed test strip holder into the unit. Push the holder until it clicks into place. 7 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.
BU.book Page 57 Monday, October 28, 2002 11:14 PM 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. ▲ CAUTION Do not use rechargeable batteries.
BU.book Page 58 Monday, October 28, 2002 11:14 PM Care and Maintenance 1 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. 3 Remove both batteries from the battery compartment and dispose of them according to your institution’s guidelines.
BU.book Page 59 Monday, October 28, 2002 11:14 PM 4 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 approximately 1000 tests.
BU.book Page 60 Monday, October 28, 2002 11:14 PM Care and Maintenance Adjusting the Screen Contrast You can increase or decrease the LCD screen contrast. 1 Select Setup from the Main Menu. 2 Press the arrows to increase or decrease the LCD contrast. A change occurs each time you press the arrow. The gauge in the Low/High bar gives you an approximate indication of the current setting. 3 When you are satisfied with the setting, press Ok to save the setting and proceed to the Main Menu.
BU.book Page 61 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 62 Monday, October 28, 2002 11:14 PM Special Tests 1 Select Special Tests from the Main Menu. 2 Select Lin/Unkn Test from the Special Tests menu. 3 Enter your operator ID.
BU.book Page 63 Monday, October 28, 2002 11:14 PM 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. 4 Start by selecting Lin 1.
BU.book Page 64 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 65 Monday, October 28, 2002 11:14 PM 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. ▲ CAUTION To obtain accurate results, you must enter the correct test strip lot number (and code) for each new test. 7 SureStepPro 2.
BU.book Page 66 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 67 Monday, October 28, 2002 11:14 PM ◆ 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.
BU.book Page 68 Monday, October 28, 2002 11:14 PM 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. 10 SureStepPro 2.0 – Press Ok at the Linearity Level Result screen to display the Lin Level screen. Press Ok to proceed with the remaining replicates of level 1. SureStepPro 1.2 – Press Ok to display the Lin/Unkn Test screen. Proceed with the remaining replicates of level 1. 11 SureStepPro 2.
BU.book Page 69 Monday, October 28, 2002 11:14 PM 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. 1 Select Special Tests from the Main Menu. 2 Select Lin/Unkn Test from the Special Tests menu.
BU.book Page 70 Monday, October 28, 2002 11:14 PM Special Tests 3 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. 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.
BU.book Page 71 Monday, October 28, 2002 11:14 PM 4 Select an option to identify your unknown solution, for example Unkn A. 5 Select the solution lot (or identification) number from the list displayed. HIGH003 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.
BU.book Page 72 Monday, October 28, 2002 11:14 PM 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 number and expiration date.
BU.book Page 73 Monday, October 28, 2002 11:14 PM ▲ CAUTION To obtain accurate results, you must enter the correct test strip lot number (and code) for each new test. 7 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. Repeat the application with a new test strip.
BU.book Page 74 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 75 Monday, October 28, 2002 11:14 PM 9 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.
BU.book Page 76 Monday, October 28, 2002 11:14 PM Special Tests 2 Select In-Service Mode from the Special Tests menu. Menu 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.
BU.book Page 77 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 78 Monday, October 28, 2002 11:14 PM Troubleshooting ▲ CAUTION While trying to resolve an error message using the Troubleshooting section, keep in mind the following: • If patient symptoms indicate the need for treatment, provide 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.
BU.book Page 79 Monday, October 28, 2002 11:14 PM Error Messages ERROR Error 1 Sample Application POSSIBLE CAUSE SOLUTION The bedside unit 1.Repeat test with new test detected a problem strip and: with the color of • Apply blood to pink test the test strip. square only. • Make sure confirmation dot turns completely blue. • Insert test strip within 2 min of applying blood. 2. Check that sample hematocrit is within range: adult 25–60%, neonatal 25–65%. 3.
BU.book Page 80 Monday, October 28, 2002 11:14 PM Troubleshooting ERROR Error 2 Test Strip POSSIBLE CAUSE SOLUTION The bedside unit 1.Repeat test with new test detected a problem strip and: with the test strip. • Check test strip expiration date. Do not use expired test strips or test strips beyond discard date. • Apply sample to pink test square only. • Make sure confirmation dot turns completely blue.
BU.book Page 81 Monday, October 28, 2002 11:14 PM ERROR Error 3 Test Strip POSSIBLE CAUSE SOLUTION The bedside unit 1.Clean bedside unit, 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 appropriate steps to monitor patient and provide medical care. • Repeat test with new test strip.
BU.book Page 82 Monday, October 28, 2002 11:14 PM Troubleshooting ERROR POSSIBLE CAUSE Error 4 The bedside unit Temperature detected a Range temperature problem. SOLUTION 1.Repeat test with new test strip. Make sure bedside unit and test strip are at room temperature. • Do not apply heat or cold to unit (operating temperature is 18°–30°C). 2.
BU.book Page 83 Monday, October 28, 2002 11:14 PM ERROR POSSIBLE CAUSE SOLUTION Error 5 The bedside unit 1.Clean bedside unit, Meter Optics detected a problem 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 appropriate steps to monitor patient and provide medical care. • Repeat test with new test strip.
BU.book Page 84 Monday, October 28, 2002 11:14 PM Troubleshooting ERROR POSSIBLE CAUSE SOLUTION Error 6 The bedside unit 1.Wipe contact points in lens System Error detected a problem area with cloth moistened with the electronics. with water to remove residual bleach. Dry thoroughly, but NOTE: Before cleaning contact points, compare color of test strip confirmation dot to Color Chart on test strip bottle.
BU.book Page 85 Monday, October 28, 2002 11:14 PM Unexpected Messages and Observations MESSAGE POSSIBLE CAUSE SOLUTION Apply Blood Bedside unit is ready for blood application. Obtain a drop of capillary blood and apply it to center of pink test square. • If white pad becomes saturated, you have applied too much blood. Repeat application with new test strip. • If white patches or streaks appear on confirmation dot, you have not applied enough blood. Repeat application with new test strip.
BU.book Page 86 Monday, October 28, 2002 11:14 PM Troubleshooting MESSAGE POSSIBLE CAUSE SOLUTION Check 1. Bedside unit was 1.Do not remove bedside Connections removed from unit from connection at Bedside connection module until link is Unit module before established and data are connection was transferred. established. 2. Bad connection 2.Check connection between between modem connection module and and connection modem. module. 3. Connection module or modem error. 3.Contact LifeScan. Check 1.
BU.book Page 87 Monday, October 28, 2002 11:14 PM MESSAGE POSSIBLE CAUSE SOLUTION Data Less than 100 test Transfer data to free memory Memory Low records can be space. generated. Data Transfer Bedside unit/ Error workstation communication error. Retry data transfer. Enter Narrower Range(s) or MinMax. Insert Strip Test strip not fully Remove test strip.
BU.book Page 88 Monday, October 28, 2002 11:14 PM Troubleshooting MESSAGE POSSIBLE CAUSE SOLUTION Invalid Operator ID Operator ID format Re-enter your ID using not correct. barcode scanner or alphanumeric touch screen. Invalid Patient ID Patient ID format not correct. Invalid Phone Number Phone number not Re-enter phone number. entered or more than four pause characters entered. Re-enter patient ID using barcode scanner or alphanumeric touch screen.
BU.book Page 89 Monday, October 28, 2002 11:14 PM MESSAGE POSSIBLE CAUSE No Room for Bedside unit New Test memory full. Data SOLUTION Transfer data to free memory space. 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 Busy at modem phone Workstation line being used by fax machine. 1.Workstation modem’s phone line must be a dedicated line.
BU.book Page 90 Monday, October 28, 2002 11:14 PM 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. • If white pad becomes saturated, you have applied too much solution. Repeat application with new strip. • If white patches or streaks appear on confirmation dot, you have not applied enough solution.
BU.book Page 91 Monday, October 28, 2002 11:14 PM APPENDIX A 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 Meaning Glucose units ❍ mg/dL ❍ mmol/L The units selected for displaying and reporting control and blood glucose results.
BU.book Page 92 Monday, October 28, 2002 11:14 PM Bedside Unit Configuration Options 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.
BU.book Page 93 Monday, October 28, 2002 11:14 PM Configuration Option Nursing unit to which bedside unit is assigned Meaning Each bedside unit is assigned to a particular nursing unit. Do not use the bedside unit outside the designated nursing unit. ❑ Reagent Entry at If selected, you must Workstation Only 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.
BU.book Page 94 Monday, October 28, 2002 11:14 PM Bedside Unit Configuration Options Operator and IDs Configuration Option Meaning ❑ ID required for all tests ❑ Maintain ID for ____ 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.
BU.book Page 95 Monday, October 28, 2002 11:14 PM Quality Control Configuration Option Meaning Glucose units ❍ mg/dL ❍ mmol/L The units selected for displaying and reporting control and blood glucose results. Required QC tests ❑ High ❑ Low ❑ Normal Three glucose controls are available. Any combination may be selected. Control solution ranges (high, low, normal) for specified test strip The passing range for each control solution level has been defined.
BU.book Page 96 Monday, October 28, 2002 11:14 PM Bedside Unit Configuration Options Configuration Option Meaning QC Test Period ❍ Time of day____ ❍ 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.
BU.book Page 97 Monday, October 28, 2002 11:14 PM 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: two size C, 1.5-V alkaline batteries result range: 0–500 mg/dL display: liquid crystal sample type: whole blood calibration: plasma equivalent hematocrit range: 25–60% (neonatal 25–65%) meter size: height 18.
BU.book Page 98 Monday, October 28, 2002 11:14 PM 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 • Black and white only; no color background. • 1/4-in border surrounding barcode symbol (optimal).
BU.book Page 99 Monday, October 28, 2002 11:14 PM 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.
BU.book Page 100 Monday, October 28, 2002 11:14 PM 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. • water • 10%bleach • 70% isopropyl alcohol • 12.
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BU.book Page 105 Monday, October 28, 2002 11:14 PM For use with bedside units, versions 1.2 and 2.0. AW 061-296-01A ©2002 LifeScan, Inc.
