Abbott Diabetes Care ART06986 Manuel d'utilisateur

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For in vitro diagnostic use.
Advanced Diabetes Management System
User’s Guide
Artwork File Name: ART06986-Rev-B
Orig. Creation Date: 28/Apr/05 By: Donald McAtee
Last Modified Date: 15/Aug/05 By: Donald McAtee
Software/Version: QuarkXpress 5.0, Photoshop,
Illustrator.
Fonts: Please Refer to Collection report.
Bar Code (Code 39):PRT06986 Rev B 8/05
Colors:
FILE INFORMATION — For Artwork and Packaging Department Use Only
PMS
286
CMYK
PMS
289
ART06986-Rev-B-CVR 8/15/05 2:11 PM Page 1
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Résumé du contenu

Page 1 - User’s Guide

For in vitro diagnostic use.Advanced Diabetes Management SystemUser’s GuideArtwork File Name: ART06986-Rev-BOrig. Creation Date: 28/Apr/05 By: Donald

Page 2 - Table of Contents

7Do not use the monitor if themonitor Display Check does not exactly match the picturehere (for example, if you see a "3" instead of an &quo

Page 3

8Forward ButtonBack Button Use these buttons to:•Review and select monitor settings•Review results and averagesBacklight Button Use this button to:•Tu

Page 4

CHAPTER 2Questions? CallCustomer Care:1-800-527-3339▼▼Setting Up Your MonitorSetting Up Your Precision Xtra Monitor Buttons to Use Mode ButtonForward

Page 5

10You may need to re-set thetime and date:•After you replace the battery.•When you travel betweentime zones or when the timezone you are in changes. I

Page 6 - Management System

11How to Set the Beeper,Date, Time, & ViewMeasurement Units To begin, pull the battery tabout. Your monitor should beturned OFF. Before you start,

Page 7

1To turn your monitor ON,Press and Hold the button. The beeper ON messageshows on the display window. The musical notes flash on and off, and the

Page 8

Set Time Hour:The Hour flashes on and off.1Press and Release the button to move the hour forward. 2If you go past the correcthour, Press and Release t

Page 9

Minutes: The Minutes flash on and off. 1Press and Release thebutton to move the minutes forward.2If you go past the correctminute, Press and Releaseth

Page 10 - Information

Set Date Year:The Year flashes on and off. 1Press and Release the button to move the year forward. 2If you go past the correctyear, Press and Release

Page 11

Month: The Month flashes on and off. 1Press and Release the button to move the month forward. 2If you go past the correctmonth, Press and Releasethe

Page 12 - Precision Xtra Monitor

Table of ContentsWelcome 11 Important Things to Know about Your Precision Xtra Advanced DiabetesManagement System 3Intended Use 3How Your Precision X

Page 13 - Your Monitor

Day: The Day flashes on and off. 1Press and Release the button to move theday forward. 2If you go past the correctday, Press and Release thebutton to

Page 14

Choice #1Choice #2Set Time Format You have two choices:Choice #1: For the 12-hourformat, AM or PM shows. Choice #2: For the 24-hourformat, AM or PM do

Page 15

Set Date Format You have two choices:Choice #1: For the month-day format, "-" shows withthe date.Example: "May 25" shows as "

Page 16

Blood Glucose Measurement Units Consult your healthcareprofessional if you have any questions about blood glucose measurement units.This screen shows

Page 17

Press and Hold thebutton to turn your monitor off. You have successfully setup your monitor.Setting Up Your Monitor21ART06986-Rev-B-MAN 8/22/05 11:0

Page 18

Questions? CallCustomer Care:1-800-527-3339CHAPTER 3Questions? CallCustomer Care:1-800-527-3339Calibrating YourPrecision Xtra MonitorWhy Calibrate You

Page 19

23What You Will Need • Precision Xtra monitor • For glucose calibration:Blood glucose test strip Blood glucose test strip instructions for useBlood gl

Page 20

24IMPORTANT: •Use only the calibrator that ispackaged in the box of teststrips you are using.•Do not use test strips thathave expired. Check theexpira

Page 21

3Hold the calibrator with theLOT number (glucose) orcalibration CODE (ß-Ketone) facing you.4Insert the calibrator into the strip port. Push it in unti

Page 22 - -" shows with

5Check that the LOT numberor calibration CODE on allthese items matches:✓ Display window✓ Test strip calibrator ✓ Test strip instructions for use✓ Tes

Page 23

6 Doing A Control Solution Test 55Why Do A Control Solution Test? 55When Is Doing A Control Solution Test Recommended? 55Important Information about C

Page 24 - You have successfully set

27Calibrating Your MonitorIMPORTANT: If the LOTnumber or calibration CODEstill does not match, contactCustomer Care. Do notattempt to monitor your blo

Page 25 - Calibrating Your

How to Recall the LOT Number orCalibration CODE1To recall the glucose LOTnumber, Press and Hold thebutton. While holding thebutton, Press and Holdthe

Page 26 - Calibrating

29Calibrating Your MonitorNote: If the LOT number orcalibration CODE that showson your monitor’s displaywindow is not correct:What It Means: Your moni

Page 27

CHAPTER 4Questions? CallCustomer Care:1-800-527-3339L O T 13758E X P 2006/03C5▼▼Example: Expiration dateMarch 31, 2006Monitoring Your Blood Glucose Wh

Page 28

Monitoring Blood Glucose•Do not use a wet, bent,scratched, or damaged test strip.•Do not use the test strip if itsfoil packet has a puncture ortear in

Page 29

2Wash your hands using warm soapy water and dry them completely.3Remove the test strip from itsfoil packet.Note: For pictures that showhow to open the

Page 30

33•Time, month, and day (if set) If date and time are not set, dashes will show insteadof numbers.•LOT number for the box ofblood glucose test strips

Page 31

Monitoring Blood GlucoseObtaining A Blood Drop Use your lancing device toobtain a blood drop.Recommendations forObtaining a Blood Drop•To obtain a sam

Page 32

35Monitoring Blood GlucoseLancets and Lancing Device•Lancets are for one-time useonly. Use a new lancet eachtime you monitor.•Discard your used lancet

Page 33 - Blood Glucose

Status barCountdown362Continue to touch the blooddrop to the end of the teststrip until the monitorbegins the test. The monitorbegins the test when: •

Page 34 - Monitoring

1WelcomeThank you for choosing the Precision Xtra™Advanced Diabetes Management System.Important steps for using the System are inside thisguide. Pleas

Page 35

37CorrectApply second drop✔Important: If the countdowndoes not start:What It Means: You might not have appliedenough blood to the test strip.What to D

Page 36

Monitoring Blood GlucoseShutting Off Your Monitor1Removing the test strip fromthe strip port turns off themonitor. You can use theopened foil packet t

Page 37

▼Understanding Your Result"LO" ResultWhat It Means: Your monitor has determinedthat your blood glucose result is lower than 20 mg/dL (1.1mmo

Page 38

40"HI" ResultWhat It Means: Your monitor has determinedthat your blood glucose result is higher than 500 mg/dL (27.8 mmol/L) or there may be

Page 39

Monitoring Blood Glucose"E-4" ResultWhat It Means: Your blood glucose may be toohigh to be read by the system,or there may be a problem with

Page 40

42•HI shows on the display window.•You obtain a high bloodglucose result, but you do not have symptoms of highblood glucose.•Your monitor displays a r

Page 41

CHAPTER 5Questions? CallCustomer Care:1-800-527-3339Monitoring Your Blood ß-KetoneIt is important to check yourketones when:•You have an illness.•Your

Page 42

Made in UK. P/N 120-1025Rev. 0 1/03ß-Ketone Test StripAbbott LaboratoriesAbbott Diabetes CareAlameda, CA 94502 USA 70208 2006/03/

Page 43

▼•Read the lancing deviceinstructions for use.•The blood ß-Ketone test stripfoil packet contains adesiccant tablet (Zeolite -Sodium CalciumAluminosili

Page 44

2Wash your hands usingwarm soapy water and drythem completely.3Remove the test strip fromits foil packet.4Insert the three black lines at the end of t

Page 45

In the United States, call Customer Care at 1-800-527-3339 with any questions you may haveabout the Precision Xtra Advanced DiabetesManagement System.

Page 46 - Blood ß-Ketone

•Time, month, and day (if set) If date and time are not set,dashes will show instead of numbers.•Calibration CODE for the box of blood ß-Ketone testst

Page 47

48Fingertip samplingObtaining A Blood DropUse your lancing device toobtain a blood drop. Important: Blood ß-Ketonetest strips have not beenevaluated f

Page 48

Monitoring Blood ß-KetoneLancets and Lancing Device•Lancets are for one-time useonly. Use a new lancet eachtime you monitor.•Discard your used lancetp

Page 49

Monitoring Blood ß-KetoneStatus barCountdown50•You hear the beeper, if thebeeper is ON.•The display window shows thestatus bar. •Then the display wind

Page 50

Monitoring Blood ß-Ketone3At the end of the countdown: •If the beeper is ON, listen forthe beeper.•The blood ß-Ketone resultshows on the display windo

Page 51

52▼Understanding Your ResultBlood ß-Ketone is expected tobe lower than 0.6 mmol/L.3Blood ß-Ketone may be higherwhen a person is ill, is fasting,exerci

Page 52

When:•Blood ß-Ketone result remains high or becomeshigher than 1.5 mmol/L:What It Means: You may be at risk ofdeveloping diabeticketoacidosis (DKA).3-

Page 53

Monitoring Blood ß-Ketone"E-4" ResultWhat It Means: There may be a problem withthe test strip.What to Do: Monitor your blood ß-Ketoneagain w

Page 54

CHAPTER 6Questions? CallCustomer Care:1-800-527-3339▼▼Control Solution Testing▼55Doing A ControlSolution TestWhy Do A ControlSolution Test?The contro

Page 55

solutions, read the controlsolution instructions for use.•MediSense Control Solutions may be used forglucose or ketone controlsolution testing.•Do not

Page 56

CHAPTER 1Questions? CallCustomer Care:1-800-527-3339▼Important InformationImportant Things to Know about Your Precision XtraAdvanced DiabetesManagemen

Page 57

57What You Will Need •Precision Xtra monitorcalibrated to match the LOTnumber (glucose) orcalibration CODE (ß-Ketone)of the test strip you are using•B

Page 58 - Solution Test

58Control Solution Testing2Remove the test strip fromits foil packet.Note: For pictures thatshow how to open theblood glucose test strip foilpacket, p

Page 59 - Solution Testing

4Push the test strip in until it stops.The monitor turns on automatically. These items show on the displaywindow, one after the other:•Display Check –

Page 60 - Control Solution

Control Solution TestingControl Solution Testing•LOT number (glucose) orcalibration CODE (ß-Ketone)for the box of test strips youare using. •Apply Blo

Page 61

Applying Control Solution tothe Test Strip1Turn the control solutionbottle upside down three to four times to mix the solution.2Remove the cap. 3Apply

Page 62

62Glucoseß-KetoneNote: Do not remove the test strip from the monitor or disturb it during the countdown.Important: If the countdowndoes not start:What

Page 63

Control Solution Testing63Note: If you are doing a ß-Ketone control solution test,KETONE will also show withthe result.•The result is stored in yourmo

Page 64

▼Understanding Your ResultCompare the control result tothe "Expected Results for Usewith MediSense ControlSolutions" range printed on: •The

Page 65

CHAPTER 7Reviewing & UsingYour ResultsWhat Can Your MonitorShow You?MemoryYour Precision Xtra monitor has a memory that stores up to 450 events. T

Page 66

66▼Important:•To review blood glucoseaverages, you must set the date and time before monitoring.•If you do not mark controlsolution tests, this may af

Page 67

4• Precision Xtra™and Precision™POC Blood Glucose Test Stripsare different. Please refer toyour test strip instructions foruse for important informati

Page 68 - Your Results

672Press and Release the button. •The Display Check shows onthe display window. •Then your most recent resultshows with its units on themonitor’s disp

Page 69 - Reviewing Results

68A control solution result inMemory shows with acontrol bottle, as long asyou marked the test as acontrol solution test. 3To review previous results,

Page 70

Reviewing Results4When you reach the last result in Memory, the display window shows three dashes. 5To return to a result youpreviously reviewed, Pres

Page 71

70Reviewing Results1While in Memory, Press andRelease the button at anytime to see the 7-Dayaverage of your bloodglucose results. Note: n means ho

Page 72

71Reviewing Results5Press and Hold thebutton to turn off yourmonitor. Otherwise, themonitor turns off after 30 seconds. Transferring Your Resultsto a

Page 73

CHAPTER 8Temperature istoo hot or toocold for thesystem to workproperly. • Move yourmonitor and teststrips to a locationwhere thetemperature isappropr

Page 74

What It What You MessageMeans Need to DoMonitor error.There may be a problem withthe test strip.• Turn themonitor off,then repeatpreviousmonitorings

Page 75 - Error Messages

Message What It What YouMeans Need to DoBlood glucoseresult may betoo high to beread by thesystem.ORThere may be aproblem withthe bloodglucose orbloo

Page 76

What It What You MessageMeans Need to DoCalibration/Teststrip error.Test strip error.Test strip isdamaged, used,or the monitordoes notrecognize it.•

Page 77

Monitor error.Monitor error.• Remove teststrip, turnmonitor off, and try tomonitor again.• If the errormessageappears again,contactCustomer Care.• Rem

Page 78

Precision Xtra Kit Contents Precision Xtra Monitor Precision Xtra User’s Guide– Contains system information and directions.Carrying Case– Use this to

Page 79 - Means Need to Do

CHAPTER 9Your Monitor’sSpecifications & LimitationsSize Length 2.94" (7.47 cm)Width Top 2.10" (5.33 cm)Bottom 1.70" (4.32 c

Page 80 - & Limitations

Specifications & LimitationsStorage Temperature Monitor: –13° to 131ºF (–25º to 55ºC)Test Strips: See test strip instructions for use.Control So

Page 81

Specifications & LimitationsData port YesMonitor Operating RangeTemperature: 50º to 122ºF (10º to 50ºC)Relative Humidity: 10% to 90%, non-condens

Page 82

80▼Important Informationabout Using BloodSamples from the Forearm, Upper Arm, orBase of the Thumb:•Contact your healthcare professional before you beg

Page 83

81•Do not use blood samplesfrom alternative sites when:1.You think your blood glucose is low or ischanging rapidly,2.You have been diagnosed with hypo

Page 84

Questions? CallCustomer Care:1-800-527-3339CHAPTER 10▼82Caring For Your MonitorCleaning Your MonitorStore your monitor in its carrying case. If the su

Page 85 - Caring For

▼Caring for Your MonitorReplacing Your Monitor’s BatteryWhen your monitor needs itsbatteries replaced, the displaywindow shows one of two things:This

Page 86 - Caring for Your

How to Replace Your Monitor’s Battery 1Gently push the batterycover in and up with your thumb. 2Lift the battery cover out ofthe monitor.3Pull on the

Page 87 - Caring for

4Insert a new CR 2032Lithium (coin cell) batterywith the plus sign (+) facing up. 5Place the notches on the battery cover into the appropriate molded

Page 88

7Press and Hold the buttonto turn your monitor on. Ifyour monitor does not turnon, review the batteryinstallation steps and reinstallthe battery.8

Page 89

Important InformationDisplay CheckBack ButtonBacklightButtonStripPortModeButtonForward ButtonDisplayWindow▼Items not included:MediSense Control Soluti

Page 90 - Limited Warranty

Questions? CallCustomer Care:1-800-527-3339Support, Guarantee &Limited WarrantySupportAbbott Laboratories, AbbottDiabetes Care, is committed topro

Page 91 - Repair, & Guarantee

88Guarantee & Limited WarrantyPrecision Xtra Advanced Diabetes Management System:Abbott Laboratories Inc., Abbott Diabetes Care (“Abbott”) offers

Page 92 - References

ReferencesReferences1. Directive 1999/45/EC of the European Parliamentand of the Council of 31 May 1999 concerning theapproximation of the laws, regul

Page 93 - PRT06986 Rev. B 8/05

Distributed by:Abbott LaboratoriesAbbott Diabetes CareAlameda, CA 94502USACustomer Care available 24 hours a day, 7 days a week at 1-800-527-3339 or v

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