Medtronic iPro2 Guia do Utilizador

User Guide

iPro2 systemiPro2 DockiPro2 cleaning plugDock USB Cablewall-powered adapterThese are the components of the iPro2 CGM system:• iPro™2 digital recorder

Icon tableDescription IconFollow instructions for useAttention: Read all warnings and precautions ininstructions for use.Stand-by powerCharging/upload

GlossaryArea Under the Curve (AUC) - Indicates the amount in high and low excursions as determined by presetvalues. Excursion data indicates the frequ

Study - The period of time that a patient wears a glucose sensor and iPro2. This word also refers to anupload of glucose sensor data from an iPro2 int

IndexNumerics24 Hour HelpLine 8AaccessingLogbook screen 46accessing CareLink iPro 16accessing patient records 42accuracy, sensor 77activating iPr

uploading data 43uploading meter data 45viewing reports 50charging iPro2 63cleaningcleaning plug 63Dock 62iPro2 40, 62USB cable 63wall-powered

guidelines for successful reports 50Iicons 92indications for use 4inserting sensor 31insertion sitesabout 29preparing 30installation of software

performance, sensor 77precautions 5preparing for patient studyabout 26wiping iPro2 with alcohol 27preparing sensor insertion sites 30preparing to

connector pins 73Data Table report 55troubleshooting reference 66Uupgrading Firefox 23upgrading Internet Explorer 23uploadingiPro2 data 43meter

The small end of the Universal Serial Bus (USB) cable connects to the Dock. The other end of thecable connects to a USB port on a computer, so that yo

User safetyThis section includes important safety information such as indications, contraindications,warnings, and precautions.Indications for useThis

• An optional occlusive adhesive dressing should be removed if irritation or reaction to the tapedevelops.• The glucose sensor may create special need

Meters supported by CareLink iPro for uploadingData from the following blood glucose meters can be uploaded to CareLink iPro. You will need ameter cab

Computer system requirementsComputers running CareLink iPro must have the following software installed.• Operating system:-Microsoft® Windows® XP Prof

Interference from wireless devicesCommon wireless consumer devices, such as cellular (mobile) phones or cordless phones, maydisrupt communication duri

2One-time device setup!!!!!!activate iPro21Key Notes:• The reset button on the Dock is used to wake up (or activate) the iPro2 because it is shipped i

One-time iPro2 activationThe iPro2 is shipped in a special sleep mode to protect its battery. You need to wake it up byfollowing this one-time procedu

4Place the iPro2 into the Dock.!!The green charging light will start flashing. NOTE: The red warning light may turn on if you do not immediately compl

6025420-012_aREF MMT-7745 © 2010 Medtronic MiniMed, Inc. All rights reserved.iPro™ is a trademark of Medtronic MiniMed, Inc.Sen-serter® and CareLink

7Leave the iPro2 on the Dock to continue charging. During charging, the white Dock power lightwill be on, and the green charging light will flash.!8Al

• Never connect an iPro2 to any device other than the Dock, sensor, or cleaning plug. For example,never connect the iPro2 to the charger for the MiniL

3One-time CareLink iPro software andcomputer setupTM32145register cliniccreate Admin user create user accountsset up each computer for uploadingset cl

• Usernames must be unique among all CareLink iPro clinics in the system, not just your clinic.• Choose at least two people to be administrative users

5When prompted, enter the identifying information for your administrative user account (alsoknown as Admin), and click Continue.You will sign in with

It is a good idea to give administrative privileges to at least two users. Having two Admin usersmeans that the clinic does not have to rely on only o

If a particular patient has unique needs, you will be able to override these settings later forindividual patients as needed.1 Click the Clinic Settin

Time periods are used to identify which meal to associate with each meal marker. For example, ifthe breakfast time period is set from 6:00 a.m. to 10:

CAUTION: Do not connect the Dock to the computer until specifically told to do so in thisprocedure. If you connect the Dock before the iPro2 Dock driv

You should see a small pop-up at the bottom of your screen that says, Medtronic iPro2Dock. This means that the driver for the Dock is successfully ins

Contacts:Africa:Medtronic Africa (Pty) Ltd.Tel: +27 (0) 11 677 4800Australia:Medtronic Australasia Pty. Ltd.Tel: 1800 668 670 (product orders)Tel: 180

c. Check the box next to Enable Protected Mode.d. Click OK.e. Close Internet Explorer.Required Internet browser settingsOn all computers where you pla

Secure Sockets Layer (SSL) and encryptionSecure Sockets Layer (SSL) refers to a security protocol designed to protect your Web browsersessions. CareLi

Follow the instructions provided by Mozilla to download and install the latest version of Firefox.Download and print resourcesAfter you are finished w

4Patient setupprepare for patientinsert sensorconnect iPro2!32145° to 60°Key Notes:• Use universal precautions when handling the sensor and iPro2.• Do

Preparing for studyBefore the patient arrives in your office, make sure that all the necessary equipment and suppliesare available and ready.!Material

Wiping the iPro2 with alcohol before a patient studyThe iPro2 is intended for multiple patient use. Follow this procedure before each patient use.WARN

3Disconnect the cleaning plug from the iPro2 by gently squeezing the arms of the cleaning plug.CAUTION: The o-rings on the cleaning plug have lubrican

CareLink iPro needs at least one BG meter reading within an expected range every 12 hours.Erroneous BG meter readings may be ignored by CareLink iPro

• Areas with firm skinDo not insert the sensor in:• Frequently used injection or infusion sites.• The 2 inch (5.0 cm) area around the patient's n

NOTE: Do not use sticky skin preparation solutions before inserting the sensor. A stickyintravenous (I.V.) preparation solution may be used after the

Schweiz:Medtronic (Schweiz) AGTel: +41 (0)31 868 016024-Stunden-Hotline: 0800 633333Fax Allgemein: +41 (0)318680199Serbia & Montenegro:EpsilonTel:

10 Make sure the sensor is fully inserted. If the sensor is not fully inserted, manually push it intoplace. The plastic sensor base should lay flat on

Briefing the patientThe patient must receive detailed instructions on wearing the sensor and iPro2, studycompliance, meter use and maintaining a log s

3 Make sure that the patient's blood glucose meter has a good battery that will last for the entirelength of the study.4 Check the date and time

Make sure that the patient can return the iPro2 to the clinic well within 10 days of the end of thestudy. After 10 days, if the iPro2 is not connected

4Push the iPro2 onto the sensor until the sensor's flexible side arms snap into the notches on theiPro2. If the iPro2 is properly connected, and

Important: If the sensor is pulled out by more than a millimeter, the iPro2 will stop collectingdata until the sensor is pushed back in place. When th

5Uploading data to CareLink iPro!12remove iPro2 and sensorupload dataKey Notes:• Always clean and disinfect the iPro2 before connecting it to the Dock

• Do not connect more than one Dock or blood glucose meter to the computer at one time.Before you beginWhen the patient returns after wearing the iPro

3Hold iPro2 as shown, and pinch the flexible side arms of the sensor between your thumb andforefinger. Do not twist the iPro2 relative to the sensor.4

CAUTION: Do not twist the cleaning plug while it is attached to the iPro2. This willdamage the iPro2.CAUTION: The o-rings on the cleaning plug have lu

ContentsChapter 1 1 Introduction2iPro2 system4 User safety4 Indications for use4 Contraindications4 Warnings5 Precautions6 Meters supported by CareLin

7Disconnect the cleaning plug from the iPro2 by gently squeezing the arms of the cleaning plug.8 Place the iPro2 on a clean, dry, non-shedding cloth a

Uploading iPro2 data1Verify that the iPro2 you are about to upload is for the patient whose record you are viewing inCareLink iPro:a. Find the serial

You can also connect the Dock to the computer using a USB hub. However, if the white Dockpower light does not turn on, then try using a powered USB hu

If you see a message that instructs you to see the User Guide, please look up that message inTroubleshooting reference on page 66.7 Check the green ch

You can also choose to enter BG meter readings manually using the Logbook. For details, seeEntering Patient Log Sheet data on page 46.2 Follow the on-

Adding Logbook entriesCareLink iPro calibrates the sensor glucose data using the patient’s BG meter readings that areuploaded or entered manually. If

When you view the patient’s reports, the BG meter readings that you excluded will not beshown, and they will not affect the sensor information in the

6CareLink iPro reportsviewing and printing reports1Key Notes:• You can modify a patient's Report Settings, such as the glucose target range and m

Viewing and printing patient reportsAfter uploading and entering all of a patient’s study data into CareLink iPro, you have two optionsfor viewing the

About reportsCareLink iPro reports show up to seven calendar days of study data. The reports are created inPDF format, so they can easily be stored el

23 Secure Sockets Layer (SSL) and encryption23 Enabling SSL in Internet Explorer23 Enabling SSL in FireFox24 Download and print resourcesChapter 4 25

If the BG meter reading range is less than 100 mg/dL (or 5.6 mmol/L), then an MAD% of 18.0 orless is considered optimal.• # Valid Calibrations: 3 or m

Area under the curve (AUC)Area under the curve (AUC) information appears in the Excursion Summary on the Daily OverlayReport. AUC provides more insigh

Modifying Patient Report Settings1 Click the Edit link in the Patient Report Settings section of the patient record screen.The patient’s General Repor

Generating a Data Table reportIf necessary, you can generate a Data Table report (about 15 pages or more). This report lets youview detailed sensor gl

7CareLink iPro ongoing useuser tasksadministrator tasks21Key Notes:•Click the Resources hyperlink in CareLink iPro to print the newest log sheets and

User tasksPrinting more log sheets and other formsYour original iPro2 shipment may have included samples of Patient Log Sheets, ClinicEquipment Logs,

Moving a patient studyIf you accidentally upload an iPro2 study to the wrong patient record in CareLink iPro, you canmove the study to the correct pat

Administrator tasksIf you are administrative user, you will need to create, modify, or delete CareLink iPro useraccounts for your clinic as new employ

2 Select the user account and click the Open user button. The user account information appears.3 If you want to edit the user account information, suc

8System maintenance!!!cleaning and disinfectingstoring equipment12Key Notes:• Always connect the cleaning plug to the iPro2 before cleaning.• When not

55 Generating a Data Table report55 Exporting data to CSV fileChapter 7 56 CareLink iPro ongoing use57 User tasks57 Printing more log sheets and other

Cleaning the iPro2The iPro2 is intended for multiple patient use. Always clean and disinfect the iPro2 after removingit from a patient. Make sure to c

Components that cannot be cleanedYou cannot clean the following components of the iPro2 system:• Cleaning plugs (discard each cleaning plug after 30 u

If your clinic has only one iPro2, you can leave the Dock connected to the computer and connectthe iPro2 to the Dock when not in use. The computer sup

You can organize your other iPro2 supplies in a small drawer organizer, such as the one shownhere. These are some of the items that you will want to k

ATroubleshootingThis appendix contains troubleshooting information for the iPro2 CGM System. Please refer tothese instructions before contacting the 2

Troubleshooting referenceProblem Possible causes What to doThe iPro2 has beenconnected to the Dockwith adequate power fortwo to three hours, but thegr

Troubleshooting referenceProblem Possible causes What to doThere are gaps in thesensor data in the reports.A common cause of datagaps is partial senso

Troubleshooting referenceProblem Possible causes What to doI connected the iPro2 tothe Dock and all threelights are flashing on andoff repeatedly.!!!!

CareLink iPro messagesCareLink iPro error messagesProblem Possible causes What to doCareLink iPro displayedthis message during theupload process:iPro2

CareLink iPro error messagesProblem Possible causes What to doCareLink iPro displayedthis message during theupload process:The iPro2 Recorderbattery i

Glossary 93Index 95iPro2 CGM User Guide Contents viii

CareLink iPro error messagesProblem Possible causes What to doCareLink iPro displayedthis message during theupload process:Transfer failed: Anunrecove

Checking the iPro2 connector pinsIf the troubleshooting reference advises you to check the connector pins of the iPro2, use thefollowing image to assi

Dock lights quick referenceDock lights Description What it means!All of the lights are off.The Dock is not plugged into an electrical outlet orcompute

Resetting the iPro2CAUTION: This procedure erases all patient data from the iPro2. Do not perform these stepsunless you have already uploaded the last

5 Wait for the Dock to show a solid green charging light . This indicates that the data has beencleared, and the iPro2 is fully charged and ready for

BSensor performanceOverviewThe performance of the glucose sensor was assessed using post-hoc analysis1 of a 10-monthrandomized multicenter study2. Sen

Mean absolute relative difference (MARD or MAD%)Adult SubjectsUsing the iPro2 algorithm, the MARD for adult subjects was 10.8% with a standard deviati

MARD (%) by day, pediatric subjects40-400 mg/dL(2.22-22.20mmol/L)40-80 mg/dL(2.22-4.44mmol/L)81-120 mg/dL(4.50-6.66mmol/L)121-240 mg/dL(6.72-13.32mmol

Zone40-400 mg/dL(2.22-22.20mmol/L)40-80 mg/dL(2.22-4.44mmol/L)81-120 mg/dL(4.50-6.66mmol/L)121-240 mg/dL(6.72-13.32mmol/L)241-400 mg/dL(13.38-22.20mmo

Zone40-400 mg/dL(2.22-22.20mmol/L)40-80 mg/dL(2.22-4.44mmol/L)81-120 mg/dL(4.50-6.66mmol/L)121-240 mg/dL(6.72-13.32mmol/L)241-400 mg/dL(13.38-22.20mmo

1IntroductioniPro2 systemuser safetyassistance321Welcome to iPro2 Continuous Glucose Monitoring (CGM)Thank you for your trust in Medtronic products an

Glucose Levels, mg/dL (mmol/L) Performance, mg/dL (mmol/L)121-240 (6.72-13.32)15.6 (0.87)241-400 (13.38-22.20)21.5 (1.20)Pediatric subjectsUsing the i

Sensor Ranges 20% Agreement 30% Agreement 40% Agreement% (n) % (n) % (n)301-350 mg/dL(16.71-19.43 mmol/L)94.9 (187/197) 98.5 (194/197) 99.5 (196/197)3

Precision of the iPro2 system was evaluated in vitro by calibrating sensors in solutions with knownglucose concentrations (measured using a YSI Glucos

CSpecifications and noticesiPro2 system specificationsAtmospheric pressure rangeiPro2: 57.6kPa - 106kPa (16,000 to -1,300 feet [4,880 to -400meters] e

The iPro2 is an internally powered device. The mode of operation is continuous. The iPro2 is notsuitable for use in the presence of a flammable anaest

Guidance and manufacturer's declarationGuidance and Manufacturer's Declaration - Electromagnetic EmissionsThe iPro2 CGM system is intended f

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe iPro2 CGM system is intended for use in the electromagnetic environment spe

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe iPro2 CGM system is intended for use in the electromagnetic environment spe

Recommended separation distances between portable and mobile RF communications equipment andthe iPro2 CGM systemThis section provides information on t

WarrantyMedtronic Diabetes warrants the iPro2 and Dock to the purchaser of the product against defectsin material and workmanship for a period of one