Gebruiksaanwijzing /service van het product Blood Glucose Monitor van de fabrikant Lifescan
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® company a Hospital Meter Operator’ s Guide SSHosp.book Page 1 Thursd ay, November 14, 2002 3:44 PM.
SSHosp.book Page 2 Thursd ay, November 14, 2002 3:44 PM.
The SureStep Meter is for in vitro diagnostic use for the quantitative measurement of glucose in whole blood samples. It should not be used for the diagnosis of diabetes.
©2002, 1997 LifeScan, Inc. All rights reserved. T he system described herein is covered by one or more of the following US patents: D371,198, D367,109, 5,418,142, 5,515,170, 5,526,120, 5,563,031, 5,605,837, 5,780,304, 5,789,255, 5,922,530, 5,968,836, and 6,335,203.
iii T able of Contents Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v About this Guide . . . . . . . . . . . . . . . . . . . . . . . . . vi Here’s What You’ll Find in this Guide . . . . . . .vi Conventions Used in this Guide .
iv Performing a Quality Contr ol Test . . . . . . . . . 23 Control Solution Results . . . . . . . . . . . . . . . . 28 Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Patient Blood Test . . . . . . . . . . . . . . . . . . . . . .
v Preface The SureStep Meter is a simple, easy-to-use meter for monitoring blood glucose levels. The SureStep Hospital Blood Glucose Monitoring System offers diabetes caregivers and patients off-meter blood dosing of the test strip.
vi About th is Guide The SureStep Hospital Meter Operator’ s Guide provides detailed instru ctions on using and maintaining the SureSt ep Meter . Although operating the meter is straightforward, it is important that you read the information presented in this manual, as well as the SureStepPro T est Strip package insert.
vii Chapt er 4, Care and Maintenance, instructs you on how to clean the meter and change the batteries. Chapter 5, T roubleshooting, lists the error codes that may appear during operation and offers possible solutions to correct a problem. Conventions Used in this Guide ■ NO TE Points out additional information that may be helpful.
viii Help 1 Read through the section of the guide specific to the operation you are performing. Refer to the table of contents or index to locate information. 2 See Chapter 5 for troubleshooting information. 3 Call LifeScan Customer Service toll fr ee at: 1 800 524-7226 (USA) or 1 888 353-0800 (Canada).
Introduction 1 CHAPTER 1 Introduction The SureStep ® Hospital Blood Glucose Meter is one component of LifeScan’ s professional blood glucose monitoring system. Wh en used with SureStepPro T est Strips, the meter measures a patient’ s blood glucose level from a whole blood sample taken at the bedside.
Introduction 2 Chapter 1 Control Solutions are available to check tha t the meter and test strips are working together properly . Read the appropriate package insert for information regarding SureStepPro T est Strips and SureStepPro Glucose Control Solutions.
Introduction 3 BACK OPENED Blood Glucose Meter 1 800 524-7226 1 888 353-0800 Milpitas, California 95035 C22.2 No. 125; Risk Class 2 © LifeScan Inc. 1999 B1 R Toll-free customer service: UNITED STATES: CANADA: Insertion Poi nt T est Strip Holder Protects the lens an d holds the test strip .
Introduction 4 Chapter 1 Display Symbols The SureStep Meter uses symbols to guide you through a test and inform you if it detects a problem with the test strip or meter . A display of all symbols appears briefly each time you turn on the meter . T o check that all display symbols are working, press and hold down the blue power button.
Introduction 5 Meter Memory Result The meter stores up to 10 blood glucose and control solution test results in memory . When you turn on the meter , the last (most recent) result is automatically displ ayed (if this option is selected). Code Number The number on the meter display must match the code number on the SureStepPro T est Strip bottle.
Introduction 6 Chapter 1 Apply Blood Sample to the T est Strip This symbol prompts you to apply sample to the center of the pink test square. Insert T est Strip All the W ay In to the Meter This symbol prompts you to firmly insert the test strip all the way into the test strip holder .
Introduction 7 Meter is Reading the Result The test result appears in approximately 30 seconds. The time may vary depending on temperature and glucose level. T est Result The meter displays results between 0–500 mg/dL (0–27.8 mmol /L). (Example) SSHosp.
Introduction 8 Chapter 1 HI Result The meter reads HI in virtually all cases when a result is greater than 500 mg/dL (27.8 mmol/L). ◆ IMPORT ANT When the result is greater than 500 mg/dL and proper procedures are followed, the meter will display HI in virtually all cases.
Introduction 9 Error Messages When the mete r detects a problem it di splays a specific error mess age (Er1 through Er6). Refer to Chapter 5 for more information on error messages. Remove the T est Strip This symbol indicates that the test stri p may have been inserted incorrectly or too quickly .
Introduction 10 Chapter 1 Replace the T wo AAA Alkaline Batteries When this symbol appe ars, the batteries are low and should be replaced as soon as possible. When the symb ol is flashing, the batteries are dead and should be replaced immediately . SureStepPro T est Stri ps SureStepPro T est Strips should be used with the SureStep Hospital System.
Introduction 11 intensity of th e blue is read by the meter —the darker the blue, the higher the blood glucose level. White T ip faces up as the test strip is inserted into the test strip holder . Pink T e st Square is where you apply the blood. For detailed information, refer to step 4 on page 32.
Introduction 12 Chapter 1 Confirmation Dot is read by the meter to determine the sample’ s glucose concentration. If it turns completely blue, t his indicates an adequate volume of blood was applied. ◆ IMPORT ANT T est Strip Information For detailed information regarding SureStepPro T est Stri ps, read the package insert.
Introduction 13 • Replace the test strip bottle cap immediately after removing a test strip and close the cap tightly . • Do not use test strips that are bent, torn, cut, or damaged in any way . • Use each test strip immediately after removing it from the bottle.
Introduction 14 Chapter 1 Precauti ons • Unexpected results should be confirmed by a laboratory test. • V arious conditions ma y 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 low blood glucose, follow your institution’ s policy for treatment.
Introduction 15 perform a quality control test. A passing control result indicates the system is working properly . A control result that is out of range indicates that the system may not be working properly . Do not use the system to test patient blo od glucose unless the control solution result falls within the expected range.
Introduction 16 Chapter 1 • Never make significant changes to a medication program or ignore signs and symptoms without consulting a physician. • Failure to follow the instructions for use may result in inaccurate results. Infection Control Use universal blood precautions.
Operation 17 CHAPTER 2 Operation Coding the M eter The SureStep Meter is calibrated at the factory . Although an inte rnal verification is performed each time the met er is turned on, a system calibrati on (meter and test st rip) is necessary .
Operation 18 Chapter 2 ▲ CAUTION Match the code numb er on the meter display to the code number on the test strip bottle. If the code numbers do not match, the test results may be inaccurate.
Operation 19 2 Match the code numbers. The code number on the test strip bottle will range from 1 to 21. If the number on the display matches the code number on the test strip bottle, begin testing. If the two code numbers do not match, follow step 3 to code the meter .
Operation 20 Chapter 2 the code number on the display matches the code number on the test strip bottle. The code is now set for the package of test strips you are using.
Operation 21 • When you open a new bottle of test strips. • If a patient test has been repeated and the blood glucose results are still lower or higher than expected. • After cleaning the meter . • If there are other indications that the system is not working properly .
Operation 22 Chapter 2 • Discard any unused portion 3 mon ths after opening.W rite the opened date on the vial when you first open it. • The control ranges pr inted on the test strip bottle are for SureStepPro Glucose Control Solutions only . • Store the control solution at room temperatures below 30 ° C (86°F).
Operation 23 P erforming a Quality Con trol T est 1 T urn on the meter . Check the display and make sure that all symbol segments appear (see “Display Symbols” on page 4). 2 Check the Code . When you turn on the me ter , the last result appears (if this option is selected), followed by the code number .
Operation 24 Chapter 2 ▲ CAUTION For accurate results, th e code number on the meter must match the code number on the test strip bottle. 3 Apply a drop of control solution to the test strip as follows: ▲ CAUTION Applying too much or too little control solution may cause out-of-range results.
Operation 25 • W ipe the control solution vial tip with a lint-free cloth or tissue before replacing the cap. 4 Check the confirmation dot on the back of the test strip to verify it has turned completely blue, indicating an adequate amount of control solution was applied.
Operation 26 Chapter 2 ◆ IMPORT ANT If you fail to completely insert the test strip, the test may start; however , you may receive an out-of-range result. ◆ IMPORT ANT Y ou have up to 2 mi nute s to insert the test strip after applying con trol solution.
Operation 27 The control solution result appears in approximately 30 seconds. ◆ IMPORT ANT Do not remove the test strip until the countdown is complete. 6 Compare the control result with the control range printed on the SureStepPro T est Strip bottle, or with your institution’ s established range.
Operation 28 Chapter 2 Control Solutio n Results When the control test result falls within the control range, the meter has passed the QC check and can be used to test patient blood.
Operation 29 • testing control solutions at hi gh altitude without applying correction factors (read the SureStepPro Gl ucose Control Solution package insert for more information) ▲ CAUTION If the control result fa lls ou tside the expect ed range, repeat the test.
Operation 30 Chapter 2 Run a linearity solution test as you would a control solution test. Follow the instructions under “Performing a Quality Control T est” on page 23, testing the linearity levels in replicates as specified by your institut ion’ s policy .
Operation 31 P erforming a P atient Blood T est 1 T urn on the meter by p ressing the blue power button. Check the display and make sure that all symbol segments appear (see “Display Symbols” on page 4). 2 Check the Code . When you turn on the meter , the last result ap pea rs (if this option is selected), f oll owe d by the code number .
Operation 32 Chapter 2 ▲ CAUTION For accurate results, th e code number on the meter must match the code number on the test strip bottle. 3 Obtain a drop of blood. Obtain capillary blood by puncturing the finger using a lancing device. The puncture site should be cleaned and thoroughly dried before obtaining the sample.
Operation 33 Syringe T ouch the tip of the syringe to the center of the pink test square. As the blood emer ges from the tip of the syringe, it is absorbed by the test square. ▲ CAUTION A void applying too much blood when using a syringe, or you may get an inaccurate, high result.
Operation 34 Chapter 2 Pipette T ouch the blood em erging from the tip of a narrow-bore pipette to the center of the pink test square. 5 Check the white pad on the front of the test strip and the confirmation dot on the back of the test stri p. If the white pad becomes completely saturated, you have applied too much blood for an accurate result.
Operation 35 The confirmation dot should be completely blue. I f w h i t e patches or streaks are visible, you have not applied en ough blood for an accurate result. R ep ea t th e application with a new test strip. ▲ CAUTION Do not apply additional blood to the test strip or you may get an inaccurate result.
Operation 36 Chapter 2 ▲ CAUTION If you fail to completely insert the test strip, the test may start; however , you may receive an inaccurate, low result. ▲ CAUTION Y ou have up to 2 minutes to insert the test strip after applying blood. If you insert the test strip after 2 minutes, you may get an inaccurate result or an error message.
Operation 37 The test result appears in approximately 30 seconds. ◆ IMPORT ANT Do not remove the test strip until the countdown is complete. 7 Remove the strip and dispose of it according to your institution’ s policies and procedures. 8 Record the result.
Operation 38 Chapter 2 P atient Results The meter displays resul ts between 0 and 500 mg/dL (27.8 mmol/L). The meter displays HI for results greater than 500 mg/dL.
Settings and Memory 39 CHAPTER 3 Settings and Memory Me ter Settings The SureStep Meter has three features which are pre-set but may be modified in set-up mode. Featur e Pre-set Alternative Display of last result On Off Glucose units mg/dL mmol/L Beep signals On Off SSHosp.
Settings and Memory 40 Chapter 3 Entering Set-up Mode 1 T urn off the meter by pressing the blue power button. 2 Press and hold down the gree n C button. 3 Press and release the blue power button while continuing to hold the C button. 4 Release the C button.
Settings and Memory 41 quickly through the features, press the blue power button repeatedly or press and hold it to scroll through the settings. The meter will continue to use these settings until they are manually changed. Display of Last Result The meter is pre-set to automatically display the last test result when you turn on the meter .
Settings and Memory 42 Chapter 3 Glucose Units The meter is pre-set to display test results in milligrams per deciliter (mg/dL). Y ou may select to display results in millimoles per liter (mmol/L). The mmol/L results are displayed with a decimal point; the mg/dL results are not.
Settings and Memory 43 performed correctly . The meter can detect some, but not all errors in the test procedure. • A single short beep confirms each step in the testing procedure. • A single long beep accompanies error messages, errors detected during the test procedur e, and a HI result.
Settings and Memory 44 Chapter 3 A three-tone beep sounds when OFF is first displayed. Then it will flash silently until the meter turns off. Exiting Set-up Mode Y ou may exit set-up mode at any time by pressing the blue power bu tton and holding it down to turn off the meter .
Settings and Memory 45 symbol appears briefly , showing that there is no test result in the memory . This symbol will also appear after turning on the meter when the previous test ended in an error and the meter did not display a result.
Settings and Memory 46 Chapter 3 button. The most recent test number appears (1) followed by the result. Each time the C button is pressed, the next most recent test number will appear (2–10), followed by the result.
Settings and Memory 47 If a previous test resulted in an error condition, the error will be stored in memory . Recalling Most Recent Result After T esting Immediately after completing a test, the result you obtained from the previous test can be reviewed.
Settings and Memory 48 Chapter 3 W ith the current test result displayed, press and hold the green C button. The previous result will appear . SSHosp.book Page 48 Thurs day, November 14, 2002 3:4 4 PM.
Cleaning and Maintenance 49 CHAPTER 4 Cleaning and Maintenance Gen eral C are T o keep the meter 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.
Cleaning and Maintenance 50 Chapter 4 symbol segments appear (see “Display Symbols” on page 4). Perform a control solution test prior to running a patient blood test. Cleaning Proper cleaning is important to k eep the meter in good condition and is essential for accurate results as well as for infection control measures.
Cleaning and Maintenance 51 Cleaning the Outside of the Meter Clean the outside of the meter with a cloth moistened with a 10% bleach solution. Follow with a cloth moistened with water to remove residual bleach. Dry the meter thoroughly . ▲ CAUTION Do not get water insi de the meter .
Cleaning and Maintenance 52 Chapter 4 ammonia to clean the test strip holder or lens area because it will damage the parts. 1 Remove the test strip holder . Press down on the top of the test strip holder and slide it away from the meter . Clean the test strip holder .
Cleaning and Maintenance 53 Be sure to thoroughly wipe the gray area on the inside cover . Clean bo th sides of the base. Follow with a cotton swab or cloth moistened with water to remove residual bleach. Thoroughly dry the test strip holder with a soft cloth or lint-free tissue.
Cleaning and Maintenance 54 Chapter 4 2 Clean the lens area and contact points. Using a cotton swab or a cloth moistened with a 10% bleach solution, wipe the lens area and contact points. W ipe this area even if it doesn’ t appear to be dirty . Use a swab or cloth moistened with water to remove any residual bleach.
Cleaning and Maintenance 55 firmly in place and does not extend beyond the meter . 4 T urn on the meter . If the following symbol appears after cleaning, check to see if the test strip holder SSHosp.
Cleaning and Maintenance 56 Chapter 4 was inserted correctly . The test strip holder may be blocking the meter optics. ■ NO TE This message may also indicate tha t there is bleach residue on the inside of the test strip holder cover . If necess ary , wipe with a cloth moistened with water to remove any residue, then dry completely .
Cleaning and Maintenance 57 Replacing th e Batteries The SureStep Meter comes with two AAA alkaline batteries installed. When this symbol appears the batteries are low and should be replaced as soon as possible. If the symbol is flashing, the batteries ar e dead and should be replaced immediately .
Cleaning and Maintenance 58 Chapter 4 2 Remove the battery door . Squeeze the tab and lift up. 3 Remove the old batteries. Gently tap the meter on the palm of your hand. Never tap the meter against a hard surface. Blood Glucose Meter 1 800 524-7226 1 888 535-0800 Milpitas, California 95035 C22.
Cleaning and Maintenance 59 4 Insert new batteries. Insert two new AAA alkaline batteri es, matching the + end of each battery with the + signs inside the meter . ■ NO TE The battery life depends on how quickly the meter is powered off after each test.
Cleaning and Maintenance 60 Chapter 4 SSHosp.book Page 60 Thurs day, November 14, 2002 3:4 4 PM.
Troubleshooting 61 CHAPTER 5 T roubleshooting The SureStep Meter 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.
Troubleshooting 62 Chapter 5 LifeScan Healthcar e Profes sional Line: 1 800 524-7226 ▲ CAUTION While resolving an error message using the T roubleshooting section, keep in mind the following: • If patient symptoms indicate the need for treatment, provide appropriate medical care before you continue with troubleshooting.
Troubleshooting 63 LifeScan Healthcare Profes sional Line: 1 800 524-7226 • Do not use the Color Chart as a replacement for a meter result. If you need help resolving an error or you encounter any other problem with the system, contact the LifeScan Healthcare Professional Line at 1 800 524-72 26 (USA) or 1 888 353-0800 (Canada).
Troubleshooting 64 Chapter 5 LifeScan Healthcar e Profes sional Line: 1 800 524-7226 (continued) T he meter detected a problem with the color of the test strip .
Troubleshooting 65 LifeScan Healthcare Profes sional Line: 1 800 524-7226 T he meter detected a problem with the test strip . 1. Repeat test with new test strip, and • Check test strip expiration date . Do not use expired test strips or test strips beyond discard date .
Troubleshooting 66 Chapter 5 LifeScan Healthcar e Profes sional Line: 1 800 524-7226 (continued) T he meter detected a problem with the test strip . 2.
Troubleshooting 67 LifeScan Healthcare Profes sional Line: 1 800 524-7226 T he meter detected a problem with the position of the test strip . 1. Clean mete r , especially contact points in lens area, but NO TE: Before cleaning, compare color of test strip confirmation dot to Color Chart on test strip bottle .
Troubleshooting 68 Chapter 5 LifeScan Healthcar e Profes sional Line: 1 800 524-7226 T he meter detected a temperature problem. 1. Repeat test with new test strip. Mak e sure meter and test strip are at room temperature . • Do not apply heat or cold to meter .
Troubleshooting 69 LifeScan Healthcare Profes sional Line: 1 800 524-7226 T he meter detected a problem with the optical system. 1. Clean meter , especially gray area inside test strip holder , but NO TE: Before cleaning, compare color of test strip confirmation dot to Color Chart on test strip bottle .
Troubleshooting 70 Chapter 5 LifeScan Healthcar e Profes sional Line: 1 800 524-7226 T he meter detected a problem with the electronics. 1. Wipe contact points in lens area with cloth moistened with water to remove residual bleach.
Troubleshooting 71 LifeScan Healthcare Profes sional Line: 1 800 524-7226 He lpful M essa ge s Symbol Meaning What T o Do T est strip was not fully inserted into test strip holder . Remove test st rip . When “Insert test strip” symbol appears, firmly insert test strip into test strip holder until it stops.
Troubleshooting 72 Chapter 5 LifeScan Healthcar e Profes sional Line: 1 800 524-7226 If symbol is constant, batterie s are lo w . If sym bol is flashing, batteries are d ead. Replace batteries (see page 57). Result is greate r than 500 mg/dL. See “HI Result” on page 8 for more information.
73 Specifications The performance of the system has been evaluated under the conditions listed be low . See the SureStepPro T est Strip package insert for accuracy and precision data. power supply: two AAA alkaline batteries result range: 0–500 mg/dL (0–27.
74 hematocrit range: 25–60% dimensions: lengt h 3. 5 in (8.9 cm) width 2.4 in ( 6.1 cm) height 0.8 in (2.0 cm) weight: 3.8 oz with batteries operating temperature: 18 °–3 0°C (64°–86°F) oper.
75 A applying blood 32 – 34 blood, symbol 6 control solution 24 B battery compartment 3 replacing 57 – 59 symbol 10 beep signals 42 – 44 blood application 32 – 34 test, performing 31 – 37 C .
76 D display of last result 41 display symbols 4 – 10 E error messages 9 , 63 – 70 G glucose control solution See control solution glucose uni ts 42 H high result 38 I infection control 16 L lens .
77 symbols, meter 4 – 10 T test results 7 control solution 27 , 28 high 8 , 38 linearity 30 patient 37 , 38 test strip holder 3 cleaning 51 – 53 test strip symbol insert 6 remove 9 test strips 10 – 13 Color Chart 13 , 15 , 38 , 62 U units, glucose 42 SSHosp.
SSHosp.book Page 78 Thurs day, November 14, 2002 3:4 4 PM.
AW 0 50-097-03A ©2002 LifeScan, Inc. 11/02 SSHosp.book Page 1 Thursd ay, November 14, 2002 3:44 PM.
Een belangrijk punt na aankoop van elk apparaat Lifescan Blood Glucose Monitor (of zelfs voordat je het koopt) is om de handleiding te lezen. Dit moeten wij doen vanwege een paar simpele redenen:
Als u nog geen Lifescan Blood Glucose Monitor heb gekocht dan nu is een goed moment om kennis te maken met de basisgegevens van het product. Eerst kijk dan naar de eerste pagina\'s van de handleiding, die je hierboven vindt. Je moet daar de belangrijkste technische gegevens Lifescan Blood Glucose Monitor vinden. Op dit manier kan je controleren of het apparaat aan jouw behoeften voldoet. Op de volgende pagina's van de handleiding Lifescan Blood Glucose Monitor leer je over alle kenmerken van het product en krijg je informatie over de werking. De informatie die je over Lifescan Blood Glucose Monitor krijgt, zal je zeker helpen om een besluit over de aankoop te nemen.
In een situatie waarin je al een beziter van Lifescan Blood Glucose Monitor bent, maar toch heb je de instructies niet gelezen, moet je het doen voor de hierboven beschreven redenen. Je zult dan weten of je goed de alle beschikbare functies heb gebruikt, en of je fouten heb gemaakt die het leven van de Lifescan Blood Glucose Monitor kunnen verkorten.
Maar de belangrijkste taak van de handleiding is om de gebruiker bij het oplossen van problemen te helpen met Lifescan Blood Glucose Monitor . Bijna altijd, zal je daar het vinden Troubleshooting met de meest voorkomende storingen en defecten #MANUAl# samen met de instructies over hun opplosinge. Zelfs als je zelf niet kan om het probleem op te lossen, zal de instructie je de weg wijzen naar verdere andere procedure, bijv. door contact met de klantenservice of het dichtstbijzijnde servicecentrum.
