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Specifications

The SureStepFlexx Meter complies with the following
standards:

• CAN/CSA - C22.2 No. 601.1-M94 Medical

Electrical Equipment - Part 1: General
Requirements for Safety (Complies with UL 2601-1
and IEC 60601-1).

• Internally powered equipment.

• This unit is not suitable for use in the presence of a

flammable anaesthetic mixture with air, oxygen, or
nitrous oxide.

• CAN/CSA - C22.2 No. 1010.1-92 Safety

Requirements for Electrical Equipment for
Measurement, Control, and Laboratory Use,
Part 1: General Requirements (Complies with
IEC 601010-1).

• CAN/CSA - C22.2 No. 601.1.2 Medical Electrical

Equipment Part 1: General Requirements for
Safety-2. Collateral Standard: Electromagnetic
Compatibility - Requirements and Tests (Complies
with IEC 60601-1-2).

Stealth.book Page 99 Monday, October 28, 2002 11:20 PM

Содержание SureStepFlexx

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Страница 3: ...eStep Flexx Meter 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 di...

Страница 4: ...nstructions on barcode scanner operation 2002 2000 LifeScan Inc All rights reserved The system described herein is covered by one or more of the following US patents D444 235 D367 109 5 418 142 5 515...

Страница 5: ...Main Menu and Quick Keys 8 Entering Information 8 Scanning a Barcode 10 System Beep Signals 11 SureStepPro Test Strips 12 Precautions 14 Infection Control 15 Chapter 2 Quality Control Test 17 When to...

Страница 6: ...ng a Receiving Modem Phone Number 44 Meter Memory 45 Reviewing Data 45 Chapter 5 Special Tests 49 Linearity Test 50 Unknown Solution Test 56 In Service Test 61 Chapter 6 Care and Maintenance 63 Genera...

Страница 7: ...Unexpected Messages and Observations 84 Appendix A Meter Configuration Options 91 Patient Results 91 Meter 92 Operator and IDs 93 Quality Control 94 Specifications 97 Meter Specifications 97 Barcode...

Страница 8: ...vi...

Страница 9: ...d managing patient and quality control data The SureStepFlexx System offers diabetes caregivers and patients off meter blood dosing of the test strip This design can help reduce the risk of transmissi...

Страница 10: ...Find in This Guide Chapter 1 Introduction provides you with an overview of the system and outlines basic meter operating instructions Chapter 2 Quality Control Test guides you through the steps to per...

Страница 11: ...on Options includes a list of all meter options and the default settings for meters in stand alone mode Conventions Used in This Guide NOTE Points out additional information that may be helpful IMPORT...

Страница 12: ...xample 1 Enter your operator ID For a list of workstation options that are reflected in the meter refer to Appendix A Meter Configuration Options Help 1 Read through the section of the guide specific...

Страница 13: ...1 Introduction...

Страница 14: ...scanner is available so that information can be quickly scanned into the meter Meter Configuration Each meter is shipped with default settings A meter that operates with the default settings is refer...

Страница 15: ...m the workstation to the meter Several communication options are available serial connection modems or a network A LifeScan representative can assist you with information on the appropriate connectivi...

Страница 16: ...rt optional enables direct data entry for operator ID patient ID and control solution and test strip lot numbers from their respective barcodes Communicates with the workstation via a DataLink connect...

Страница 17: ...hangeable the same holder may be used in any SureStep brand meter The insertion point is the area where the test strip is inserted The base holds the test strip in place The cover protects the lens Cl...

Страница 18: ...cation of your institution If your meter is configured for stand alone mode and you wish to change the settings contact your LifeScan representative Status Screen When you turn on the meter a clock br...

Страница 19: ...fth line displays a battery bar which gives the approximate status of battery power If there is insufficient power to perform a test the meter displays a warning message The current date and time are...

Страница 20: ...llows you to perform a patient test Special Tests allows you to perform linearity and unknown tests and perform in service testing Setup allows you to enter a modem phone number adjust the LCD contras...

Страница 21: ...select a letter or special character press the key in the right column For example to select W 1 Press the 9 key 9 is selected and W X Y Z appear to the right 2 Press the W key at the right W replace...

Страница 22: ...it could be disabled To see if the meter s barcode scanner is enabled access any data entry screen for example the Operator ID screen If the SCAN button appears on the screen the barcode scanner is e...

Страница 23: ...ate various stages in the testing procedure These signals do not indicate that the procedure is being performed correctly The meter can detect some but not all errors in the test procedure A single sh...

Страница 24: ...ple was applied The intensity of the blue is read by the meter the darker the blue the higher the glucose level White Tip faces up as the test strip is inserted into the test strip holder Pink Test Sq...

Страница 25: ...erate freeze or place in direct heat or sunlight A lot number and CTL control code are printed on the test strip bottle label The CTL code encodes the test strip expiration date control solution range...

Страница 26: ...cautions Unexpected results should be confirmed by a laboratory test Various conditions may cause the meter to produce a very low test result 20 mg dL 1 0 mmol L or less If the patient has symptoms of...

Страница 27: ...est strip bottle Color Chart and if necessary take appropriate precautions while awaiting the lab result Do not use the Color Chart as a replacement for a meter result Never make significant changes t...

Страница 28: ...16 SureStepFlexx Meter Operator s Guide...

Страница 29: ...2 Quality Control Test...

Страница 30: ...s turned on a system calibration meter and test strip is necessary This is achieved at the start of each test when you enter the test strip lot number and code corresponding for the current bottle of...

Страница 31: ...ly If you drop the meter QC enforcement Warning only Meter lockout To ensure that QC testing is performed on a meter as required a warning mode or lockout mode was selected Both modes display a messag...

Страница 32: ...label Discard any unused portion 3 months after opening Write the opened date on the vial when you first open it The control ranges printed on the SureStepPro Test Strip bottle label are for SureStep...

Страница 33: ...uality Control Test 21 Performing a Quality Control Test Setting Up the Meter 1 Press the power button to turn on the meter 2 The status screen appears Press Cont to continue 3 Select QC Test from the...

Страница 34: ...al barcode scanner you may scan the barcode on your ID badge 6 Select the control solution lot number from the list displayed The last control lot selected appears at the top of the list Use the arrow...

Страница 35: ...elected appears at the top of the list Use the arrow s to scroll through the list if necessary Require solution lot number The Select Control Lot screen appears only if you are required to enter the l...

Страница 36: ...QC Test screen appears with messages prompting you to apply the control to the test strip and insert the strip New reagent entry at workstation only The meter may be set to allow you to enter new reag...

Страница 37: ...t square If the white pad becomes completely saturated you have applied too much control solution Repeat the application with a new test strip Wipe the control solution vial tip with a lint free cloth...

Страница 38: ...wn 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 con...

Страница 39: ...e the test strip and continue with the remaining required control levels Or if you wish to record additional information with the test result press Entr Note and choose 1 to 3 comments from the list P...

Страница 40: ...tical calculations for any QC reports CAUTION If the control solution result fails repeat the test The system may not be functioning properly Do not use the system to test patient blood glucose levels...

Страница 41: ...3 Patient Test...

Страница 42: ...se testing using the SureStepFlexx System Follow your institution s policies for in service training to become a certified operator Performing a Patient Test Setting Up the Meter 1 Press the power but...

Страница 43: ...nt s barcode NOTE Carefully enter the ID An accurate patient ID is imperative for transferring the correct results to the medical record Operator ID required for all tests Maintain ID for ___ min afte...

Страница 44: ...accurate results you must enter the correct test strip lot number and code for each new test The Patient Test screen appears with messages prompting you to apply blood to the strip and insert the stri...

Страница 45: ...e obtaining the sample Follow your institution s policy and procedure guidelines for blood collection 7 Apply the blood to the center of the pink test square as follows Finger Stick Carefully touch th...

Страница 46: ...e 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...

Страница 47: ...firmation dot should be completely blue If white patches or streaks are visible you have not applied enough blood for an accurate result Repeat the application with a new test strip CAUTION Do not app...

Страница 48: ...have up to 2 minutes to insert the test strip after the blood is applied If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Discard the test strip and r...

Страница 49: ...W 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 meter will display HIGH i...

Страница 50: ...Or press and continue testing NOTE Results tagged with the comment Procedure Err are not included in any patient reports If you have problems using the meter to test patient samples or if the meter m...

Страница 51: ...4 Data Transfer and Management...

Страница 52: ...essary your institution may establish a regular schedule for performing data transfer sessions Several DataLink connectivity options are available for use with the SureStepFlexx Meter For more informa...

Страница 53: ...rns on the meter The module can detect the presence of a modem and will automatically dial the receiving modem phone number provided the number was downloaded to the meter from the workstation or ente...

Страница 54: ...be too low to perform a data transfer If necessary replace the meter s batteries Retry transferring data 2 Remove the meter from the cradle and press Cont if the meter is on The meter automatically tu...

Страница 55: ...sferring data from a remote location 1 Connect the serial cable to the meter The other end of the serial cable should be connected to the workstation a modem or a serial server The meter automatically...

Страница 56: ...er During a data transfer session the Enter Phone screen appears NOTE You may also access this screen by selecting Enter Phone Number from the Setup Menu 1 Enter the receiving modem phone number Once...

Страница 57: ...ll the message No Room for Test Data appears To continue using the meter for testing you must perform a data transfer session to upload the data to the workstation and free the meter s memory If your...

Страница 58: ...he results for QC linearity and unknown tests performed by all operators over the last 31 days beginning with the most recently performed test shown Or you may view the results from a specific operato...

Страница 59: ...Strip Lots to see all test strip lot numbers with expiration dates currently entered in the system The last lot number selected appears at the top of the list Select Control Lots to see all control li...

Страница 60: ...xx Meter Operator s Guide The solution type abbreviation is listed next to the lot number 3 Press to proceed Abbreviation Solution Type L Low N Normal H High UA UE Unknown A Unknown E L1 L5 Linearity...

Страница 61: ...5 Special Tests...

Страница 62: ...system administrator NOTE If the meter is set for Meter lockout see QC enforcement on page 19 and QC testing is overdue you will not be able to access Special Tests until QC testing is successfully p...

Страница 63: ...3 Start by selecting Linearity 1 4 Enter your operator ID and press Operator ID required for all tests Maintain ID for ___ min after power off If your ID appears at the operator ID screen press to co...

Страница 64: ...d code from the list displayed The last test strip lot number selected appears at the top of the list Use the arrow s to scroll through the list if necessary Require solution lot number The Select Lin...

Страница 65: ...first replicate of linearity solution level 1 8 Apply the linearity solution to the test strip Gently shake the linearity solution vial Touch a drop of linearity solution to the center of the pink te...

Страница 66: ...s are visible you have not applied enough linearity solution Repeat the application with a new test strip Wipe the linearity solution vial tip with a lint free cloth or tissue before replacing the cap...

Страница 67: ...meter can display linearity results up to 766 mg dL 10 Press to display the Linearity Level screen Press Run REP 2 to proceed with the remaining replicates of level 1 Or if you wish to record addition...

Страница 68: ...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 Unknown Te...

Страница 69: ...t displayed Operator ID required for all tests Maintain ID for ___ min after power off If your ID appears at the operator ID screen press to confirm it is correct If the ID is not correct or does not...

Страница 70: ...results you must enter the correct test strip lot number and code for each new test New reagent entry at workstation only The meter may be set to allow you to enter new reagent information If the unkn...

Страница 71: ...etely saturated you have applied too much solution Repeat the application with a new test strip Check the confirmation dot on the back of the test strip to verify it has turned completely blue indicat...

Страница 72: ...strip after the unknown solution is applied If you insert the test strip after 2 minutes you may get an inaccurate result or an error message Discard the test strip and repeat the test with a new tes...

Страница 73: ...forcement on page 19 and QC is overdue you will not be able to access Special Tests until QC testing is successfully performed 1 Select Special Tests from the Main Menu 2 Select In Service Mode from t...

Страница 74: ...62 SureStepFlexx Meter Operator s Guide...

Страница 75: ...6 Care and Maintenance...

Страница 76: ...eaning When to Clean the Meter If dirt blood or lint is present When an error message appears and the trouble shooting solution indicates cleaning the meter As defined by your institution s infection...

Страница 77: ...containing abrasives phenol or ammonia to clean the test strip holder or lens area because it will damage the meter parts 1 Press down on the left side of the test strip holder This releases the hold...

Страница 78: ...he test strip holder with a soft cloth or lint free tissue Close the holder and set it aside 4 Using a cotton swab or soft cloth dampened with a 10 bleach solution wipe the lens area and contact point...

Страница 79: ...st strip holder into the meter Push the holder until it clicks into place 7 Turn on the meter If an error appears check to make sure you installed the test strip holder correctly 8 If necessary wipe t...

Страница 80: ...o change the batteries if the battery bar on the status screen is low Although the meter will continue to accurately perform glucose tests until the LOW BATTERY message appears barcode scanning and da...

Страница 81: ...guidelines 4 Insert three new size AA batteries matching the positive end of each battery with the signs inside the battery compartment NOTE The battery life depends on how quickly the meter is power...

Страница 82: ...elect Setup from the Main Menu 2 Select LCD Contrast from the Setup Menu The options available at the Setup Menu are different for stand alone meters and meters configured by a DataLink workstation 3...

Страница 83: ...ode 1 Select Setup from the Main Menu 2 Select Date Time Entry from the Setup Menu The Date Time Entry option is available for stand alone meters only 3 Enter the time using the 24 hour format hours m...

Страница 84: ...date press or Changing the Receiving Modem Phone Number If the modem phone number was not downloaded to the meter from the workstation you may enter or change the number at the meter 1 Select Setup f...

Страница 85: ...se in the number For example if the phone number includes a 9 to access an outside line press WAIT after the 9 Press CLR to clear an existing number Press DEL to delete the last character entered Inst...

Страница 86: ...ity cover 3 Remove the scanner module and new battery door from the packaging CAUTION Handle the scanner module with care Do not remove the white protective label 4 Position the scanner module so that...

Страница 87: ...Chapter 6 Care and Maintenance 75 5 When the scanner module is securely in place pull the tab to remove the label 6 Install the new battery door with the laser warning label...

Страница 88: ...g a Barcode on page 10 for more information NOTE If the SCAN button does not appear check with your system administrator to make sure that the meter s barcode scanner is enabled in DataLink software A...

Страница 89: ...7 Troubleshooting...

Страница 90: ...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...

Страница 91: ...e sure confirmation dot turns completely blue Insert test strip within 2 minutes of applying blood 2 Check that sample hemat ocrit is within range adult 25 60 neonatal 25 65 3 If you continue to get a...

Страница 92: ...nly Make sure confirmation dot turns completely blue Wait approximately 1 minute but not more than 2 minutes after applying sample before inserting test strip Do not alter test strips 2 If you continu...

Страница 93: ...e appropri ate steps to monitor patient and provide medical care Repeat test with new test strip Do not move test strip after you insert it Remove test strip only when test is complete 2 If you contin...

Страница 94: ...te steps to monitor patient and provide medical care while awaiting labora tory result 3 Contact LifeScan for help Error 5 Meter Optics The meter detected a problem with the optical system 1 Clean met...

Страница 95: ...ectronics 1 Wipe contact points in lens area with cloth moistened with water to remove residual bleach Dry thoroughly but NOTE Before cleaning compare color of test strip confirmation dot to Color Cha...

Страница 96: ...strip If white patches or streaks appear on confirmation dot you have not applied enough blood Repeat application with new test strip Battery too low to use scanner or SIR Not enough battery power to...

Страница 97: ...ending modem wait for fax machine and retry connection 4 Check modem connection at wall jack 5 Have phone line inspected 6 Contact LifeScan Check Phone Line Connections at Meter 1 Meter modem phone li...

Страница 98: ...ure Min value is less than Max Insert Strip appears after you insert test strip Test strip not fully inserted into test strip holder Remove test strip When Insert Strip appears firmly insert test stri...

Страница 99: ...not entered or more than 4 pause characters entered Reenter phone number Invalid Strip Lot Number Strip lot number not correct Less than 10 digits were entered or code out of range Check lot number a...

Страница 100: ...Workstation Only Workstation option set to allow reagent entry at workstation only Youcannotenternewreagent atmeter Usereagentfromlist orasksystemadministratorto allow reagent entry at meter No Room...

Страница 101: ...appear on data entry screens 1 Meter s barcode scanner not enabled at workstation 2 Meter s battery power too low to operate barcode scanner 3 Meter not equip ped with barcode scanner 1 Contact system...

Страница 102: ...much solution Repeat application with new test strip If white patches or streaks appear on confirmation dot you have not applied enough solution Repeat application with new test strip Strip Lot Expire...

Страница 103: ...ssages Comments that appear at the patient result screen The comments allow you to record a particular situation with a result Patient critical warning messages Critical limits Lower 0 mg dL Upper 500...

Страница 104: ...ocation to which meter is assigned Each meter is assigned to a particular location Do not use the meter outside the designated location New reagent entry at workstation only If selected you must choos...

Страница 105: ...rs prevents operators who are not in the system from using the meter Warn or lock out non certified operators prevents operators who are not certified or whose certification has expired from using the...

Страница 106: ...found on the test strip bottle label Result Display Numeric value Pass fail only Determines how quality control test results are displayed QC Enforcement Warning only Meter lockout for operator QC loc...

Страница 107: ...en to correct the problem Require test comment message entry for failed QC tests Yes No If a QC test result fails you may be required to select a comment that corresponds to the failed test result Fai...

Страница 108: ...96 SureStepFlexx Meter Operator s Guide...

Страница 109: ...g dL display liquid crystal sample type whole blood calibration plasma equivalent hematocrit range 25 60 neonatal 25 65 meter size height 6 34 in 16 10 cm width 3 55 in 9 02 cm depth 1 63 in 4 14 cm m...

Страница 110: ...haracters special characters include space _ Medium density X dimension of 0 012 inches or high density X dimension of 0 0075 inches where density is the number of characters per inch and X dimension...

Страница 111: ...table for use in the presence of a flammable anaesthetic mixture with air oxygen or nitrous oxide CAN CSA C22 2 No 1010 1 92 Safety Requirements for Electrical Equipment for Measurement Control and La...

Страница 112: ...packaging Refer to Chapter 6 Care and Maintenance for cleaning precautions and detailed information on cleaning the meter and test strip holder water 10 bleach 70 isopropyl alcohol 12 5 ammonia 10 Ba...

Страница 113: ...r 67 contact points 66 lens area 66 67 solution 65 test strip holder 65 66 Color Chart 15 37 configuration options 91 95 confirmation dot 13 25 35 connection module 40 42 contact points 4 cleaning 66...

Страница 114: ...quality control 19 lot numbers reviewing 47 48 low battery power 10 68 M main menu 8 memory meter 45 messages error 79 83 unexpected 84 90 meter batteries 5 68 beep signals 11 configuration 2 3 7 dat...

Страница 115: ...alone meter 2 Status screen 6 7 21 30 68 system administrator 6 T test in service 61 linearity 50 56 patient 30 38 quality control 21 28 unknown solution 56 60 test strip blood application 33 34 Colo...

Страница 116: ...104 SureStepFlexx Meter Operator s Guide...

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