Medtronic Guardian User Manual

User Guide

Guardian Sensor (3)

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English

Introduction

The Guardian™ Sensor (3) glucose
sensor is part of your Continuous
Glucose Monitoring (CGM) system.
The sensor continuously converts tiny
amounts of glucose from the interstitial
fluid under your skin into an electronic
signal. Your system then uses these
signals to provide sensor glucose
values.

C

D

A

B

A. pedestal
B. needle

housing
C. sensor
D. clear liner

Potential risks related to sensor use

General risks with sensor use include:

• Skin irritation or other reactions

• Bruising

• Discomfort

• Redness

• Bleeding

• Pain

• Rash

• Infection

• Raised bump

• Appearance of a small “freckle-like” dot where needle was
inserted

• Allergic reaction

• Fainting secondary to anxiety or fear of needle insertion

• Soreness or tenderness

• Swelling at insertion site

• Sensor fracture, breakage or damage

• Minimal blood splatter associated with sensor needle removal

• Residual redness associated with adhesive or tapes or both

• Scarring

Indications for use

The Guardian Sensor (3) is intended for use with the Medtronic
MiniMed® 670G system to continuously monitor glucose levels
in persons with diabetes. It is intended to be used for detecting
trends and tracking patterns in persons aged fourteen years
and older, and to be used by the MiniMed 670G system to
automatically adjust basal insulin levels. It is indicated for use
as an adjunctive device to complement, not replace, information

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obtained from standard blood glucose monitoring devices. The
sensor is intended for single use and requires a prescription. The
Guardian Sensor (3) is indicated for 7 days of continuous use.

Contraindications

None known.

Assistance

Department Telephone Number

24 Hour HelpLine (calls
within the United States)

800 646 4633

24 Hour HelpLine (calls
outside the United States)

[phone]

Website www.medtronicdiabetes.com

General warnings

Read this entire user guide before attempting to insert the sensor.
The one-press serter (MMT-7512) does not work the same as
other Medtronic insertion devices. Failure to follow directions or
using a different serter may result in improper insertion, pain, or
injury.

The Guardian Sensor (3) was developed for use with and the
performance evaluated with the approved system only. The sensor
should not be used as part of unapproved systems, as it may
provide inaccurate sensor glucose readings.

The sensor is designed to work with approved transmitters only.
It is not interchangeable with transmitters and recorders that
are not compatible with the sensor. Connecting your sensor to a
transmitter or recorder that is not approved for use with the sensor
may cause damage to the components or inaccurate sensor
glucose values.

Do not make therapy decisions based on sensor glucose values
because sensor glucose and blood glucose (BG) values may
differ. If your sensor glucose reading is low or high, or if you feel
symptoms of low or high glucose, do the following prior to making
therapy decisions. Confirm your blood glucose with your meter
using a fingerstick blood sample.

Taking medications with acetaminophen, such as Tylenol®, fever
reducers, or cold medicine, while wearing the sensor may falsely
raise your sensor glucose readings. The level of inaccuracy
depends on the amount of acetaminophen active in your body
and may be different for each person. Always check the label of

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any medications to confirm whether acetaminophen is an active
ingredient.

Do not expose your sensor to MRI equipment, diathermy devices,
or other devices that generate strong magnetic fields as the
performance of the sensor has not been evaluated under those
conditions and may be unsafe. If your sensor is inadvertently
exposed to a strong magnetic field, discontinue use and contact
the 24 Hour HelpLine for further assistance.

A retractable needle is attached to the sensor and minimal
blood splatter may occur. If you are a healthcare professional
or caregiver, wrap sterile gauze around the sensor to minimize
contact with blood. Keep as much distance as possible between
you and the patient when removing the needle.

Keep the needle housing within sight at all times to avoid an
accidental needlestick or puncture.

Always inspect the packaging for damage prior to use. Sensors
are sterile and non-pyrogenic, unless the package has been
opened or damaged. Do not use the sensor if the sterile package
has been opened or damaged. Use of an unsterile sensor can
cause site infection.

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

Watch for bleeding at the insertion site (under, around, or on top of
the sensor).

If bleeding occurs, do the following:

1. Apply steady pressure, using sterile gauze or a clean cloth
placed on top of the sensor, for up to three minutes. The use of
unsterile gauze can cause site infection.

2. If bleeding stops, connect the transmitter (or recorder) to the
sensor.

If bleeding does not stop, do not connect the transmitter to the
sensor because blood can get into the transmitter connector,
and could damage the device.

If bleeding continues, causes excessive
pain or discomfort, or is significantly visible
in the plastic base of the sensor, do the
following:

plastic base

1. Remove the sensor and continue to apply
steady pressure until the bleeding stops.
Discard the sensor in a sharps container.

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2. Check the site for redness, bleeding, irritation, pain,
tenderness, or inflammation. Treat based on instructions from
your healthcare professional.

3. Insert a new sensor in a different location.

General precautions

Wash your hands with soap and water before inserting the sensor
to help prevent site infection.

Wear gloves when inserting the sensor into someone other than
yourself to avoid contact with patient blood.

Do not insert the sensor through tape. Inserting the sensor through
tape may cause improper sensor insertion and function.

Only use alcohol to prepare the insertion site, to ensure that
residue is not left on the skin.

Rotate the sensor insertion site so that sites do not become
overused.

Discard used sensors and needle housings in a sharps container
after each use to avoid accidental needlestick or puncture.

Do not clean, resterilize, or try to extract the needle from the
needle housing. An accidental needlestick or puncture may occur.

Do not reuse sensors. Reuse of a sensor may cause damage to
the sensor surface and lead to inaccurate glucose values, site
irritation, or infection.

Where to insert the sensor

CAUTION: Avoid the 2 inch (5.0 cm) area around the navel
to help ensure a comfortable insertion site and to help with
sensor adhesion.

Choose an insertion site that has an adequate
amount of subcutaneous fat. Shown here
are the best body areas (shaded) for sensor
insertion.