Medtronic iPro 2 User Manual

User Guide

6025901-022_a
REF MMT-7745

© 2016 Medtronic MiniMed, Inc. All rights reserved.

Enlite™, Sen-serter™, Sof-sensor™ are trademarks of Medtronic MiniMed, Inc.
CareLink® and iPro® are registered trademarks of Medtronic MiniMed, Inc.

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Contents

Chapter 1 1 Introduction

2 iPro2 system
3 User safety
4 Indications for use
4Contraindications
4Warnings
4Precautions
5 Meters supported by CareLink iPro for uploading
5 Compliance information
6 Interference from wireless devices
6Assistance

Chapter 2 7 One-time device setup

8 One-time iPro2 activation
10 Key notes about iPro2

Chapter 3 11 Patient setup

12 Preparing for study
13 Wiping the iPro2 with alcohol before a patient study
14 Tips for a successful patient study
15 Preparation for sensor insertion
15 Inserting the sensor
16 Briefing the patient
17 Meter use
17 First day
17 Remaining days
17 Care and wearing instructions
18 Preparing to connect the iPro2 (after briefing the patient)
18 Connecting the iPro2 to the sensor

Chapter 4 21 Uploading data to CareLink iPro

22 Before you begin
22 Disconnecting the iPro2 and removing the sensor

iPro2 CGM User Guide Contents v

22 Disconnecting the iPro2 from the sensor
22 Removing the sensor from the patient
23 Cleaning and disinfecting the iPro2
24 One-time CareLink iPro software and computer setup
24 Uploading iPro2 data

Chapter 5 28 System maintenance

29 Cleaning the iPro2
29 Cleaning the Dock
29 Components that cannot be cleaned
30 Charging the iPro2 between studies
31 Storage and organization tips

Appendix A 33 Troubleshooting

33 Troubleshooting reference
36 Checking the iPro2 connector pins
37 Dock lights quick reference
38 Resetting the iPro2

Appendix B 39 Enlite sensor performance

39 In Vivo performance
39 Results
39 Site comparison
40 Mean and Median Absolute Relative Difference
40 Clarke error grid analysis
42 Percent agreement
43 Sensor Life
43 Interference
43 Limitations

Appendix C 44 Specifications and notices

44 iPro2 system specifications
46 Guidance and manufacturer's declaration
50 Warranty
51 Icon table

Glossary 53

Index 55

iPro2 CGM User Guide Contents vi

Introduction

1

iPro2 system

user safety

1

Welcome to iPro2 Continuous Glucose Monitoring (CGM)

Thank you for your trust in Medtronic products and services. We hope you will find iPro2 to be
the simplest and most convenient CGM product that you have ever used.

• This User Guide provides the information that you need for setting up and using the iPro2
CGM system.

• You will find a page like this at the beginning of each chapter. This page gives you a basic
overview of that chapter, and the steps you will take to complete each task.

assistance

32

• You will also see a “Key Notes” area on each chapter overview page. These are the important
points for you to remember from that chapter.

iPro2 CGM User Guide Introduction 1

iPro2 system

iPro2 DockiPro2 cleaning

Dock USB

Cable

wall-powered

adapter

These are the components of the iPro2 CGM system:

• iPro®2 digital recorder, MMT-7741 (iPro2)

The iPro2 collects and stores data from a glucose sensor. The data can be uploaded into
CareLink iPro® Therapy Management Software for Diabetes (CareLink iPro, MMT-7340), to
generate reports and store the data. The iPro2 can collect up to seven 24-hour periods of
data, after which it shuts off automatically.

The iPro2 has an internal green light.

This light flashes when you connect the iPro2

to an inserted glucose sensor. It will only flash if the iPro2 detects an adequately hydrated
sensor, is fully charged, and does not already contain any data.

• iPro®2 Docking Station, MMT-7742 (Dock)

The Dock has two main functions: charging the iPro2 and uploading data from the iPro2 to
CareLink iPro. The Dock has three lights to provide status information. The white Dock power

plug

light indicates whether power is supplied to the Dock. When you connect the iPro2 to the
Dock, the green charging light and the red warning light indicate the status of the iPro2. If
the green charging light is on, the iPro2 is 100% ready to use.

In this User Guide, you will see the three Dock lights described using the following
conventions. Each light is always either off, on, or flashing.

!

!

Red Warning Light

Green Charging Light

White Dock Power Light

On

Off

Flashing

• iPro®2 Dock USB cable (refer to MMT-7747 if re-ordering)

The small end of the Universal Serial Bus (USB) cable connects to the Dock. The other end
of the cable connects to a USB port on a computer, so that you can upload data into CareLink
iPro® and charge the iPro2. You can also connect the USB cable to a wall-powered adapter.

• Wall-powered adapter (refer to MMT-7747 if re-ordering)

iPro2 CGM User Guide Introduction 2

The wall-powered adapter lets you charge the iPro2 by connecting the Dock to a regular
electrical socket, instead of a computer.

The wall-powered adapter comes with four (4) interchangeable power plugs. Connect the
appropriate power plug to the wall-powered adapter.

• Three (3) iPro®2 Cleaning Plugs, MMT-7744 (cleaning plug)

The cleaning plugs provide a watertight seal to protect the connector pins on the iPro2.
Always use a cleaning plug when cleaning and disinfecting the iPro2.

Do not clean the o-rings on the cleaning plug, as this can damage the o-rings.

The cleaning plug can be used to clean the iPro2 30 times. Keep track of cleaning plug uses
and discard the cleaning plug after 30 uses. If you continue to use the cleaning plug beyond
30 times, the iPro2 connector pins could be damaged, because the cleaning plug cannot
continue to provide a watertight seal.

Contact your local representative when you need to order more cleaning plugs.

You will also need the following:

• Serter, MMT-7500 or MMT-7510

• Sof-sensor™, MMT-7003A or Enlite™ sensor, MMT-7008A (Glucose sensor)

• A computer with Internet access to CareLink iPro, MMT-7340 (http://ipro.medtronic.com)

• Patient Log Sheet

•Patient Consent Form

• Patient Instructions Sheet

• Clinic Equipment Log Sheet

• Clinic Checklist (for patient setup and for uploading iPro2 data and printing reports)

• Occlusive adhesive dressing

User safety

This section includes important safety information such as indications, contraindications,
warnings, and precautions.

iPro2 CGM User Guide Introduction 3

Indications for use

This iPro2 digital recorder is intended to continuously record interstitial glucose levels in persons
with diabetes mellitus. This information is intended to supplement, not replace, blood glucose
information obtained using standard home glucose monitoring devices. The information
collected by the iPro2 digital recorder may be uploaded to a computer (with Internet access)
and reviewed by healthcare professionals. The information may allow identification of patterns
of glucose-level excursions above and below a desired range, facilitating therapy adjustments,
which may minimize these excursions.

This iPro2 system:

• is intended for prescription use only.

• does not allow data to be made available directly to patients in real time.

• provides data that will be available for review by physicians after the recording interval.

• is intended for occasional rather than everyday use.

• is to be used only as a supplement to, and not a replacement for, standard invasive
measurement.

Contraindications

None known.

Warnings

• This product contains small parts and may pose a choking hazard for young children.

• The glucose sensor should be removed if redness, bleeding, pain, tenderness, irritation, or
inflammation develops at the sensor insertion site, or if the patient experiences unexplained
fever.

• An optional occlusive adhesive dressing should be removed if irritation or reaction to the
tape develops.

• The glucose sensor may create special needs regarding your patients' medical conditions or
medications. Healthcare professionals should discuss this with their patients before they use
the glucose sensor.

• Do not modify this product, as modification could result in a safety hazard.

Precautions

• Do not expose the iPro2 to Magnetic Resonance Imaging (MRI) equipment, x-ray
equipment, Computed Tomography (CT) scanners, Intensity-Modulated Radiation Therapy
(IMRT), or other devices that generate strong magnetic fields or ionizing radiation. If the
iPro2 is inadvertently exposed to a strong magnetic field, discontinue use and contact your
local country representative.

• If performing multiple iPro2 studies on the same patient, establish a rotation schedule for
choosing new sensor sites.

iPro2 CGM User Guide Introduction 4

• Avoid inserting a sensor in areas on the body that are constrained by clothing, have scar
tissue, or are subject to rigorous movement during exercise.

• If the Enlite sensor (MMT-7008A) was inserted, wait five minutes before connecting the
iPro2. If a Sof-sensor (MMT-7003A) was inserted, wait 15 minutes before connecting the iPro2.

- Make sure that the sensor insertion site is not bleeding before connection. If you find

blood on top of the sensor adhesive, do not connect the iPro2. This is to prevent body
fluids from getting into the connector of the iPro2. If blood gets inside the iPro2's
connector, it may not be properly cleaned out without damaging the connector, so the
iPro2 will have to be discarded.

- If bleeding occurs, apply steady pressure with a sterile gauze or cloth at the insertion

site until bleeding stops. After bleeding stops, attach the iPro2 to the sensor.

- If bleeding persists after three minutes, remove the sensor and discard. Insert a new

sensor in a different location.

• If body fluid comes into contact with the cleaning plug's connector or the Dock's
connector, the contaminated device must be discarded to prevent contamination of the
iPro2.

• Do not allow fluids (including water, cleaning fluids, and disinfectants) on the iPro2's
connector opening or connector pins. Fluids can cause the connector pins to corrode and
may affect the iPro2's performance.

Meters supported by CareLink iPro for uploading

For a list of supported meters, see your CareLink iPro Software User Guide.

Compliance information

The iPro2 and Dock comply with the United States Federal Communications Commission (FCC)
and international standards for Electromagnetic Compatibility. For the specific regulations and
test results for your area, please contact your local representative.

These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:

1 These devices may not cause harmful interference.

2 These devices must accept any interference received, including interference that may cause

undesirable operation.

These standards are designed to provide reasonable protection against excessive radio frequency
interference and prevent undesirable operation of the device from unwanted electromagnetic
interference.

iPro2 CGM User Guide Introduction 5

Interference from wireless devices

Common wireless consumer devices, such as cellular (mobile) phones or cordless phones, may
disrupt communication during iPro2 uploads to the computer. It is likely that other wireless
devices using similar frequency ranges will have a similar effect. This interference, however, will
not cause any incorrect data to be sent, and will not cause any harm to your iPro2 system.

To reduce the likelihood of data communication errors, you should relocate either the wireless
device or the iPro2 system devices. Testing conducted with several different cellular phones
suggests that interference will not be a problem if the phone is at least 30 centimeters (12 inches)
from the iPro2 system devices.

Assistance

Please contact your Medtronic representative.

iPro2 CGM User Guide Introduction 6

One-time device setup

activate iPro2

1

2

!

!

Key Notes:

• The reset button on the Dock is used to wake up (or activate) the iPro2 because it is shipped
in a special sleep mode. This is a one-time task. In the future, doing this will erase all sensor
data that is on the iPro2.

• Never connect an iPro2 to any device other than the Dock, sensor, or cleaning plug.

• For cleaning, use only the cleaning plug.

!!

!!

iPro2 CGM User Guide One-time device setup 7

One-time iPro2 activation

!

!

The iPro2 is shipped in a special sleep mode to protect its battery. You need to wake it up by
following this one-time procedure. This should be done a minimum of eight hours before your
first iPro2 patient setup.

CAUTION: Do not perform this procedure if you already have sensor data on the iPro2. If

you press the reset button while the iPro2 is connected to the Dock, all sensor data on the

iPro2 will be erased. This procedure is only for activating the iPro2 for the first time.

1 Connect the small end of the USB cable to the Dock.

2 Connect the other end of the USB cable to the wall-powered adapter.

!

!

3 Connect the wall-powered adapter into an electrical socket. The three lights on the Dock

will flash once, and then the white Dock power light will remain on, indicating that the Dock
is plugged in.

!

!

!

iPro2 CGM User Guide One-time device setup 8

4 Place 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 complete the next

steps. This is normal because the iPro2 has not been activated. You can continue to

follow these instructions even if you see the red warning light.

5 Find the small hole on the back of the Dock, next to the USB cable. This is the reset button.

6 Insert the end of a small paper clip into the hole about 0.30 cm (1/8 inch). Push the reset

button once and release. The white Dock power light will flash

. After a few seconds,

the green light on the iPro2 will flash.

The iPro2 is now activated. It will never return to sleep mode.

7 Leave the iPro2 on the Dock to continue charging. During charging, the white Dock power

light will be on, and the green charging light will flash.

!

iPro2 CGM User Guide One-time device setup 9

8 Allow up to eight (8) hours for the iPro2 to fully charge. Once the iPro2 is charged, the green

!

!

charging light on the Dock will stop flashing and will remain on. This means that the iPro2
is fully charged.

!

When charged regularly after each sensor use, the iPro2 will become fully charged in only
about 30 minutes.

Key notes about iPro2

• The reset button on the Dock is used to wake up (or activate) the iPro2 because it is shipped
in a special sleep mode. This is a one-time task. In the future, doing this will erase all sensor
data that is on the iPro2.

• Never connect an iPro2 to any device other than the Dock, sensor, or cleaning plug.

!

!

• For cleaning, use only the cleaning plug.

iPro2 CGM User Guide One-time device setup 10

Patient setup

3

prepare for patient

1

!

Key Notes:

insert sensor

connect iPro2

32

• Use universal precautions when handling the sensor and iPro2.

• Do not use sticky skin preparation prior to sensor insertion. It can damage the sensor. Sticky
skin preparation solutions may not be available in Japan.

• If the Enlite sensor (MMT-7008A) was inserted, wait five minutes before connecting the
iPro2. If a Sof-sensor (MMT-7003A)was inserted, wait 15 minutes before connecting the
iPro2. Use this time to give instructions to the patient.

• Before setting up any patients on iPro2, make sure that your clinic has completed the one­time CareLink software and computer setup instructions in the previous chapter.

iPro2 CGM User Guide Patient setup 11

Preparing for study

Before the patient arrives in your office, make sure that all the necessary equipment and supplies
are available and ready.

!

Materials needed for patient setup:

•Cleaning plug

•Alcohol swabs

•Gloves

•Serter

• Glucose sensor

• Sharps container

• iPro2, charged and disinfected. The green charging light on the Dock must be on

flashing) before you remove the iPro2 from the Dock.

• Patient Log Sheets

•Patient Consent Form

•Patient Instructions

• Clinic Equipment Log

• Occlusive adhesive dressing

• Optional: Clinic Checklist

NOTE: Use universal precautions when handling the sensor and iPro2.

(not

iPro2 CGM User Guide Patient setup 12

Wiping the iPro2 with alcohol before a patient study

The iPro2 is intended for multiple patient use. Follow this procedure before each patient use.

WARNING: If there is any body fluid inside the connector, the iPro2 must be discarded. Do

not discard the iPro2 in a medical waste container. The iPro2 contains a battery which may

explode upon incineration. Dispose of the iPro2 according to the local regulations for

battery disposal (non-incineration). See Precautions for additional information.

1 While wearing gloves, attach the cleaning plug to the iPro2 to make sure that fluids do not

contact the iPro2's connector opening. Fluids can cause the connector pins to corrode and
affect the iPro2's performance.

CAUTION: Do not twist the cleaning plug while it is attached to the iPro2. This will

damage the iPro2.

2 Wipe the iPro2 with an alcohol swab or rinse with alcohol.

3 Disconnect the cleaning plug from the iPro2 by gently squeezing the arms of the cleaning

plug.

iPro2 CGM User Guide Patient setup 13