Manuel d'utilisation / d'entretien du produit SureStep Blood Glucose Monitor du fabricant Lifescan
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® company a Hospital Meter Operator’ s Guide SSHosp.book Page 1 Thursday, November 14, 2002 3 :44 PM.
SSHosp.book Page 2 Thursday, 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 o r 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 W hat You’ll Find in this Guide . . . . . . . vi Conventions Used in this Guide .
iv Performing a Quality Control Tes t . . . . . . . . . 23 Control Solution Results . . . . . . . . . . . . . . . . 28 Linearity Test . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Patient Blood Tes t . . . . . . . . . . . . . . . . . . . . . .
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 Ab out this Gu ide 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 Cha pt 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 Hel p 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 LifeSca n Customer Service toll fr ee at: 1 800 524-7226 (USA) or 1 888 353-0800 (Canada).
Introduction 1 CHAP TER 1 Introduction The SureStep ® Hospital Blood Glucose Meter is one component of LifeScan’ s professional blood glucose monitoring system. When 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 that the meter and test strips are working together properly . Read the appropriate package inse rt for information regarding SureStepPro T est Strips and SureStepPro G lucose Control Solutions.
Introduction 3 BAC K 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 Po i n t T est Strip Holde r Protects the lens and 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 p o wer button.
Introduction 5 Meter Memory Re sult The meter stores up to 10 blood glucose and control solu tion tes t results i n memory . Wh en you turn on the meter , the last (most recent) result is automati cally displayed (i f this option is selected).
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 Into 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 depen d ing on temperature and glucose level. T est R esult The meter displays results between 0–500 mg/dL (0 –27.8 mmo l/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). ◆ IMPOR T 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 meter detec ts a problem it dis plays 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 strip may have bee n 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.
Introduction 11 intensity of the blue i s 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 est Square is where you apply the blood. For detailed information, refer to step 4 on page 32.
Introduction 12 Chapter 1 Confir mation Dot is read by the meter t o determine the sample’ s glucose concentration. If it turn s completely blue, this indicates an adequate volume of blood was applied. ◆ IMPOR T ANT T est Strip Information For detailed information regarding SureStepPro T es t Stri ps, read the pa ckage 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 Precaut ions • Unexpected results should be confirmed by a laboratory test. • V arious co nditions may ca use the me ter 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 contr ol 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 pat ient blood glucose unless the control solution result falls within the expected range.
Introduction 16 Chapter 1 • Never make signifi cant change s 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 Co ntrol Use universal blood precautions.
Operation 17 CHAP TER 2 Operation Co ding the M eter The SureStep Meter is calibrated at the factory . Although an inte rnal verification is performed each time the mete r is turned on, a system cal ibration (meter and t est strip) is necessary .
Operation 18 Chapter 2 ▲ CA UTION 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 str ip 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 po rtion 3 months after opening.W rite the opened date on the vial when you fi rst open it. • The control ranges pr inted on the test strip bottle are f or SureStepPro Glucose Control Solutions only . • Store the control solution at room temperatures below 30 °C (86°F).
Operation 23 P e rforming a Quality C ontro l 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 th e 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 ▲ CA UTION 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: ▲ CA UTION Applying too much or too little control solution may cause out-of-range results.
Operation 25 • W ipe the control solution vial tip wit h a lint-free cloth or tissue before replaci ng the cap . 4 Check the confirmation dot on the back of the test strip to verify i t has turned completely blue, indicating an adequate amount of control solution was ap plied.
Operation 26 Chapter 2 ◆ IMPOR T ANT If you fai l to completely insert the test strip, the test may start; however , you may receive an out-of-range result. ◆ IMPOR T ANT Y ou have up to 2 minute s to insert the test strip after applying con trol solution.
Operation 27 The control solution result appears in approximately 30 seconds. ◆ IMPOR T 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 So lution Result s 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 solut ions at high altitude without applying correction factors (read the Sure StepPro Gl ucose Control Solution package insert for more information) ▲ CA UTION If the control resul t fa lls outside the exp ected range, repeat the test .
Operation 30 Chapter 2 Run a linear ity solution test as you would a control solution t e st. Follow the instructions under “Performing a Quality Control T est” on page 23, testing the linearity level s in replicates as specified by your institution’ s policy .
Operation 31 P e rformi ng a P atient Blood T est 1 T urn on the meter by pressing the blue power button. Check the display and make sure that all symbol segments appear (see “Display Symbols” on page 4). 2 Check th e Code. When you turn on the meter , the last result a pp ea r s (if this option is selected), f o ll o we d by the code number .
Operation 32 Chapter 2 ▲ CA UTION 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 clean e d 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 emerges from the tip of the s y ringe, it is absorbed by the test square. ▲ CA UTION 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 blo od emer gin g 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 confirmati on dot on the back of the t est strip. If the white pad becomes completely saturated, you have applied too much blood for an accurate result.
Operation 35 The confirmation dot should be comp letel y blue. I f w h i t e patches or streaks are visible, you have not app lied enough blood for an accurate result. R e p e a t t h e application with a new test strip. ▲ CA UTION Do not apply additional blood to the test strip or you may get an inaccurate result.
Operation 36 Chapter 2 ▲ CA UTION If you fai l to completely insert the test strip, the test may start; however , you may receive an inaccurate, low result. ▲ CA UTION 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. ◆ IMPOR T 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 Resu lts The meter dis plays results between 0 and 500 mg/dL (27.8 mmol/L). Th e meter displays HI for results greater than 500 mg/dL.
Settings and Memory 39 CHAP TER 3 Settings and Memory M eter Settings The SureStep Meter has three features which are pre-set but may be modified in set-up mode. F eature Pre-set Altern ative 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 green C bu tton. 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 tes t results in milligrams per deci liter (mg/dL). Y ou may select to display res ults 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 mete r can detect some, but not all error s in the test procedure. • A single short beep confirms each step in the testing proced ure. • A single long beep acc ompanies error messages, errors detected during the test proc edure, an d a HI resul t.
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 th e blue power button 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 previ o us 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 th e green C button. The prev ious result will appear . SSHosp.
Cleaning and Maintenance 49 CHAPTER 4 Cleaning and Maintenance Ge ne ra l C are T o keep the meter in good operating condition, you must keep it clean and handle it with care. Foll ow 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 co ntrol solution test prior to running a patient blood test. Cleani ng Proper cleani ng is important to keep the meter in good condition and is essential for accurate results as well as for infection control measures.
Cleaning and Main tenance 51 Cleaning the Outside of the Meter Clean the outside of the meter wi th a cloth moistened with a 10% bleach solution. Follow wit h a cloth moistened with water to remove residual bleach. Dry the meter thoroughl y . ▲ CA UTION 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 wi pe 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 poin ts. 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 u rn 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 als o indicate that 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 the 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 flashi ng, the batteri es are 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 Main tenance 59 4 Insert new batterie s. Insert two new AAA alkaline batteries, 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 Thursday , November 14, 2002 3:44 PM.
Troubleshooting 61 CHAP TER 5 T roubleshooting The SureStep Meter displays prompts and error messages to indi cate the system has detected a problem with its internal function, the test strip, or the testi ng procedure. These messages help in resolving some common problems that may occur during testing.
Troubleshooting 62 Chapter 5 LifeSca n Healthcar e Profes sional Line: 1 800 524-7 226 ▲ CA UTION While resolving an error message usi ng the T roublesh ooting section, keep in mind the following: • If patient symptoms indicate the need for treatment, provide appropriate medical care before you continue with troubleshooting.
Troubleshootin g 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 hel p resolving an error or you encounter any other problem with the system, contact the LifeScan Healthcare Professional Line at 1 800 524-7226 (USA) or 1 888 353 -0800 (Canada).
Troubleshooting 64 Chapter 5 LifeSca n Healthcar e Profes sional Line: 1 800 524-7 226 (continued) T he meter detected a problem with the color of the tes t strip .
Troubleshootin g 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 expira tion date . Do not use expired test strips or test strips beyond discard date .
Troubleshooting 66 Chapter 5 LifeSca n Healthcar e Profes sional Line: 1 800 524-7 226 (continued) T he meter detected a problem with the test strip . 2.
Troubleshootin g 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 meter , especially contact points in l ens area, bu t NO T E: Before cleaning, compare color of test strip confirmation dot to Color Chart on test strip bottle .
Troubleshooting 68 Chapter 5 LifeSca n Healthcar e Profes sional Line: 1 800 524-7 226 T he meter detected a temper ature proble m. 1. Repeat test with new test strip . Mak e sure meter and test strip a re at room temperature . • Do not ap ply 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 T E: Before cleaning, compare color of test strip confirmation dot to Color Chart on test strip bottle .
Troubleshooting 70 Chapter 5 LifeSca n Healthcar e Profes sional Line: 1 800 524-7 226 T he meter detected a problem with the electronics . 1. Wipe contact points in lens area with cloth moistened wi th w ater to remove residual bleach.
Troubleshooting 71 LifeScan Healthcare Profes sional Line: 1 800 524 -7226 H elp fu l M es sag e s Symb ol Meani ng What T o Do T est st rip w as not fully inserted into test strip holder . Remove te st stri p . When “Insert test strip” symbol appe ars , firm ly inser t test strip i n to test strip holder until it stops .
Troubleshooting 72 Chapter 5 LifeSca n Healthcar e Profes sional Line: 1 800 524-7 226 If symbol is constan t, batteries are l ow . I f sy mbo l is flashing, batterie s are dead. Replace batterie s (see page 57). Result is greater than 50 0 mg/dL. See “HI Result” on page 8 for more information.
73 Specifications The performance of the system has been evaluated under th e conditions listed below . See the SureStepPro T est Strip package insert for accuracy and precision data. power su pply: two AAA alkaline batteries result range: 0–500 mg/dL (0–27.
74 hematocrit range: 25–60% dimensions: le ngth 3.5 in (8 .9 cm) width 2.4 i n (6.1 cm) height 0.8 in ( 2.0 cm) weight: 3.8 oz wi th batteries operating temperature: 18 °–30°C (6 4°–86 °F) o.
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 applicat ion 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 sol ution gluc ose units 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 strip s 10 – 13 Color Chart 13 , 15 , 38 , 62 U units, gl ucose 42 SSHosp.
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A W 0 50-097-03A ©2002 LifeScan, Inc. 11/02 SSHosp.book Page 1 Thursday, November 14, 2002 3 :44 PM.
Un point important après l'achat de l'appareil (ou même avant l'achat) est de lire le manuel d'utilisation. Nous devons le faire pour quelques raisons simples:
Si vous n'avez pas encore acheté Lifescan SureStep Blood Glucose Monitor c'est un bon moment pour vous familiariser avec les données de base sur le produit. Consulter d'abord les pages initiales du manuel d'utilisation, que vous trouverez ci-dessus. Vous devriez y trouver les données techniques les plus importants du Lifescan SureStep Blood Glucose Monitor - de cette manière, vous pouvez vérifier si l'équipement répond à vos besoins. Explorant les pages suivantes du manuel d'utilisation Lifescan SureStep Blood Glucose Monitor, vous apprendrez toutes les caractéristiques du produit et des informations sur son fonctionnement. Les informations sur le Lifescan SureStep Blood Glucose Monitor va certainement vous aider à prendre une décision concernant l'achat.
Dans une situation où vous avez déjà le Lifescan SureStep Blood Glucose Monitor, mais vous avez pas encore lu le manuel d'utilisation, vous devez le faire pour les raisons décrites ci-dessus,. Vous saurez alors si vous avez correctement utilisé les fonctions disponibles, et si vous avez commis des erreurs qui peuvent réduire la durée de vie du Lifescan SureStep Blood Glucose Monitor.
Cependant, l'un des rôles les plus importants pour l'utilisateur joués par les manuels d'utilisateur est d'aider à résoudre les problèmes concernant le Lifescan SureStep Blood Glucose Monitor. Presque toujours, vous y trouverez Troubleshooting, soit les pannes et les défaillances les plus fréquentes de l'apparei Lifescan SureStep Blood Glucose Monitor ainsi que les instructions sur la façon de les résoudre. Même si vous ne parvenez pas à résoudre le problème, le manuel d‘utilisation va vous montrer le chemin d'une nouvelle procédure – le contact avec le centre de service à la clientèle ou le service le plus proche.
