Medtronic Guardian 4 ユーザーガイド

Sensor UserGuide

Guía del usuario del sensor

探头用户指南

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English

Introduction

The Guardian 4 sensor is part of the

Continuous Glucose Monitoring (CGM)

system. The sensor converts small

amounts of glucose from the interstitial

fluid under the skin into an electronic

signal. The system then uses these

signals to provide sensor glucose

values.

Sensor assembly

Indications for use

The Guardian 4 sensor (MMT-7040) is intended to monitor glucose

levels for the management of diabetes for persons ages seven

years and older. It is indicated for use as an adjunctive device to

complement, not replace, information obtained from the standard

blood glucose monitoring devices. The sensor is intended for

single use and requires a prescription. The Guardian 4 sensor is

indicated for up to seven days of continuous use. Refer to the

system user guide for treatment decisions.

Contraindications

Refer to the system guide for contraindications associated with

Guardian 4 sensor use.

User safety

Warnings

Read this entire user guide before attempting to insert the

Guardian 4 sensor. The one-press serter (MMT-7512) is the only

serter approved for use with the sensor. Failure to follow directions,

or the use of a different insertion device, may result in improper

insertion, pain, or injury.

Do not attempt to connect a transmitter or recorder that is not

compatible with the sensor. The sensor is designed to work with

approved transmitters only. Connecting the sensor to a transmitter

or recorder that is not approved for use with the sensor may

damage the components. Refer to the system user guide for a list

of compatible products.

Do not use continuous glucose monitoring if hydroxyurea, also

known as hydroxycarbamide, is taken. Hydroxyurea is used to

treat certain diseases, such as cancer and sickle cell anemia.

Hydroxyurea use results in higher sensor glucose readings

compared to blood glucose readings. Taking hydroxyurea while

using continuous glucose monitoring can result in substantially

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higher sensor glucose readings in reports than actual blood

glucose readings. For pump users, taking hydroxyurea while using

continuous glucose monitoring can result in hypoglycemia caused

by over-delivery of insulin.

Always check the label of any medication being taken to confirm

if hydroxyurea or hydroxycarbamide is an active ingredient. If

hydroxyurea is taken, consult a healthcare professional. Use

additional blood glucose meter readings to verify glucose levels.

Taking medications that contain acetaminophen or paracetamol,

including, but not limited to fever reducers and cold medicine, while

wearing the sensor, may falsely raise sensor glucose readings.

The level of inaccuracy depends on the amount of acetaminophen

or paracetamol active in the body and may be different for each

person. Always check the label of any medications to confirm

whether acetaminophen or paracetamol is an active ingredient.

Do not expose the sensor to MRI equipment, diathermy devices,

or other devices that generate strong magnetic fields. The

performance of the sensor has not been evaluated under those

conditions and may be unsafe. If the sensor is exposed to a strong

magnetic field, discontinue use and contact 24-hour Technical

support for further assistance.

Always inspect the packaging for damage prior to use. Sensors are

sterile and non-pyrogenic, unless the package has been opened or

damaged. If the sensor packaging is open or damaged, discard the

sensor directly into a sharps container. Use of a non-sterile sensor

may result in infection at the insertion site.

Do not allow children to put small parts in their mouth. This product

poses a choking hazard for young children.

Do not use the Guardian 4 sensor if you are pregnant or critically

ill. Since the sensor has not been studied in these populations,

the impact of medications common to these conditions on sensor

performance is unknown and the sensor may be inaccurate in

these populations.

Healthcare professionals and caregivers:

• Always wear gloves to insert the sensor. A retractable needle is

attached to the sensor. Minimal bleeding may occur.

• Cover the sensor with sterile gauze to remove the needle

housing from the sensor.

Place the needle housing directly into a sharps container after

sensor insertion to prevent accidental needlestick injury.

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

the sensor).

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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 may 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 may get into the transmitter connector,

and may 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.

2. Check the site for redness, bleeding, irritation, pain,

tenderness, or inflammation. Treat based on instructions from

a healthcare professional.

3. Insert a new sensor in a different location.

For questions or concerns related to sensor use, contact

24-Hour Technical Support for assistance.

For medical questions or concerns, contact a healthcare

professional.

Precautions

Wash hands with soap and water before inserting the Guardian 4

sensor to help prevent site infection.

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. Using alcohol to

prepare the insertion site makes sure that residue is not left on the

skin.

Rotate the sensor insertion site so that sites do not become

overused.

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.

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Risks and side effects

Risks related to 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 the sensor 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

Reagents

The Guardian 4 sensor contains two biological reagents: glucose

oxidase, and human serum albumin (HSA). Glucose oxidase is

derived from Aspergillus niger and manufactured to meet industry

requirements for the extraction and purification of enzymes for use

in diagnostic, immunodiagnostic, and biotechnical applications.

The HSA used on the sensor consists of purified and dried albumin

fraction V derived from pasteurized human serum, which is cross-

linked via glutaraldehyde. Approximately 3 μg of glucose oxidase

and approximately 10 μg of HSA are used to manufacture each

sensor. HSA is approved for IV infusion in humans at quantities

much larger than in the sensor.

Removing the sensor

To change the Guardian 4 sensor, disconnect the transmitter from

the sensor as described in the Guardian 4 transmitter user guide.

Gently pull the sensor from the body to remove it. Discard the

sensor in a sharps container.

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Components

BA

One-press serter

A. bump on both buttons

B. thumbprint marking

C

D

A

B

Glucose sensor assembly

A. pedestal

B. needle housing

C. sensor

D. clear liner

A

B

Sensor base

A. sensor connector

B. sensor snaps

Transmitter

BB

A

First piece of oval tape

A. liner 1

B. liner 2

BB

A

Second piece of oval tape

A. liner 1

B. liner 2

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Where to insert the sensor

Choose an insertion site for the applicable age group and make

sure that the site has an adequate amount of subcutaneous fat.

Ages 7-17 years

Back of the upper arm

Caution: Guardian 4 sensor is indicated for arm use only.

Do not use Guardian 4 sensor in other sites, including the

abdomen or buttocks, due to a difference in performance

that could result in hypoglycemia or hyperglycemia

Ages 18 years and older

Back of the upper arm

Note:

• Assistance will likely be needed for sensor insertion into the

back of the upper arm. Some users find it difficult to insert the

sensor into their arm by themselves.

For best sensor glucose performance, and to prevent accidental

sensor removal:

• Do not insert the sensor into muscle, tough skin, or scar tissue.

• Avoid areas that are constrained by clothing or accessories.

• Avoid areas subjected to vigorous movement during exercise.

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Inserting the sensor

WARNING: Always wear gloves when inserting the sensor into

another person to avoid contact with patient blood. Minimal

bleeding may occur. Contact with patient blood may cause

infection.

11. Wash hands thoroughly with soap

and water.

22. Choose an insertion site that has

a sufficient amount of fat.

33. Clean the insertion site with

alcohol. Let the area air dry.

44. Open the sensor package.

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55. Hold the pedestal and remove the

glucose sensor assembly from the

package. Place the pedestal on a

clean, flat surface such as a table.

6

Correct

tucked tab

Incorrect

6. Confirm that the

adhesive tab of the

sensor is tucked

under the sensor

connector and

sensor snaps.

7

thumb on thumbprint marking

Correct Incorrect

7. Using either hand,

place a thumb on

the thumbprint

marking to hold the

serter. Fingers must

not touch the serter

buttons.

88. Push the serter

down onto the

pedestal until the

base of the serter

sits flat on the table

and there is a click.

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99. With either hand,

place two fingers

on the base of the

pedestal. With the

other hand, grip the

serter and pull the

serter upwards.

arrow

Note: The arrow on the side of the

serter aligns with the needle inside

the serter.

WARNING: Never point a loaded serter toward any body part

where insertion is not desired. An accidental button-push may

cause the needle to inject the sensor in an undesired location,

causing minor injury.

10 10. Place the serter on top

of the prepared insertion

site.

11 11. Press and release both

serter buttons at the

same time. Continue to

hold the serter on top

of the insertion site for

five seconds or more to

let the adhesive stick to

the skin.

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12 12. Lift the serter away

from the insertion site.

Fingers must not press

the buttons while lifting

the serter.

B

A

AC

D

E

Sensor base

A. sensor snaps

B. sensor connector

C. adhesive tab

D. adhesive liner

E. adhesive pad

If the sensor is inserted without assistance, complete step 13a. If a

healthcare professional or caregiver assisted with sensor insertion,

complete step 13b.

13a Patient:

13. a. Hold the sensor base

against the skin at the sensor

connector and at the opposite

end of the sensor base. Hold

the needle housing at the

top and pull away from the

sensor.

OR

13b

Healthcare professional or

caregiver:

13. b. Wrap sterile gauze around

the sensor. Hold the sensor

base against the skin at the

sensor connector and the

opposite end of the sensor

base. Hold the needle

housing at the top and pull

away from the sensor.

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WARNING: Always watch for bleeding at the insertion site. If

bleeding occurs under, around, or on top of the sensor, 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 may cause an infection. If bleeding does not

stop, remove the sensor and apply steady pressure until the

bleeding stops.

Note: After insertion, use of adhesive products, such as

Skin Tac™, in addition to the oval tape is optional. If optional

adhesive products are used, apply them to the skin under the

adhesive pad prior to removing the liner. Adhesive products

may also be applied to the adhesive pad or the skin around the

sensor base. Allow the product to dry before continuing.

14 14. Remove the adhesive liner from under

the adhesive pad. Pull the liner away

from the sensor, staying close to the

skin. Do not pull on the sensor when

you remove the liner.

Note: Do not remove the adhesive

liner from the rectangular adhesive

tab. This tab will be used to secure

the transmitter in a later step.

Note: If the sensor base moves,

hold the sensor base down.

15 15. Firmly press the adhesive pad against

the insertion site to confirm that the

sensor base remains on the skin.

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16 16. Untuck the adhesive tape from under

the sensor connector.

17 17. Straighten the sensor adhesive tab so

that it lies flat against the skin.

Applying oval tape

11. Remove the liner marked 1.

22. Apply the tape as shown and

press down firmly.

wide part of tape covers half

of sensor base

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33. Remove liners marked 2 from

each side.

44. Smooth the tape.

55. Connect the transmitter to the

sensor.

Note: Wait for the green light on

the transmitter to flash. If the green

light does not flash, refer to the

Troubleshooting section of the

Guardian 4 transmitter user guide.

66. Cover the transmitter with the

adhesive tab.

Note: Do not pull the tab too tightly.

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77. To apply a second tape, remove

liner marked 1.

88. Apply the second tape in

the opposite direction to the

first tape and place it on the

transmitter. Press down firmly.

99. Remove liners marked 2 from

each side.

10 10. Smooth the tape.

Note: For details on how to enter sensor settings into a

compatible display device, refer to the system user guide.

wide part of tape covers end

of transmitter and skin

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Maintenance

Storage

CAUTION: Do not freeze the sensor, or store it in direct

sunlight, extreme temperatures, or humidity. These conditions

may damage the sensor.

Only store sensors at room temperature between 36 °F to 80 °F

(2 °C to 27 °C). Discard sensor after the “Use-by date” indicated

on the label, if the package is damaged, or if the seal is broken.

Disposal

Dispose of the Guardian 4 sensor into a sharps container.

Assistance

Department Telephone Number

24-Hour Technical Support

(calls within the United States) +1 800 646 4633

24-Hour Technical Support

(calls outside the United States) +1 818 576 5555

Website www.medtronicdiabetes.com

Technical specifications

Approximate dimensions

1.50 x 2.60 x 2.00 inches (3.80 x 6.70 x 5.20 centimeters)

Approximate weight

0.09 ounces (2.80 grams)

Sensor life of use

The Guardian 4 sensor can be used one time and has a maximum

life of up to 170 hours (seven days). The 170-hour life span of the

sensor begins when the sensor is connected to the transmitter.

Icon table

Use-by date

Medical device

Do not re-use

Caution: consult instructions for use for important

warnings or precautions not found on the label.

(1x)

One sensor per container/package

(5x)

Five sensors per container/package

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(2x)

Two tapes per package

(10x)

Ten tapes per package

Consult instructions for use

Catalogue or model number

Batch code

Sterilized using irradiation

Do not use if package is damaged

Single sterile barrier system

XX°C

XX°F

XX°C

XX°F

Storage temperature limit

Open here

Manufacturer

Date of manufacture

Do not resterilize

Fragile, handle with care

Keep dry

Recyclable, contains recycled content.

Authorized representative in the European Community.

Conformité Européenne (European Conformity). This

symbol means that the device fully complies with

applicable European Union Acts.

Magnetic Resonance (MR) unsafe

Non-pyrogenic

Requires prescription in the USA

Icon glossary

For definitions of the symbols on the device and package labels,

see www.medtronicdiabetes.com/symbols-glossary.

trademarks of Medtronic. ™* Third-party brands are trademarks of their respective owners. All other

brands are trademarks of a Medtronic company.

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Español

Introducción

El sensor Guardian 4 forma parte del

sistema de monitorización continua de

glucosa (MCG). El sensor convierte

pequeñas cantidades de glucosa del

líquido intersticial que se encuentra

bajo la piel en una señal eléctrica. A

continuación, el sistema utiliza estas

señales para proporcionar valores de

glucosa del sensor. Conjunto de sensor

Indicaciones de uso

El sensor Guardian 4 (MMT-7040) está indicado para controlar los

niveles de glucosa en el tratamiento de la diabetes en personas

mayores de siete años. Está indicado para utilizarse como

dispositivo adicional para complementar la información obtenida

mediante los dispositivos de monitorización de glucosa en sangre

habituales, y no para sustituirla. El sensor está diseñado para un

solo uso y requiere prescripción facultativa. El sensor Guardian 4

está diseñado para utilizarse durante siete días como máximo de

manera continuada. Consulte la guía del usuario del sistema para

tomar decisiones acerca de la terapia.

Contraindicaciones

Consulte la guía del sistema para conocer las contraindicaciones

asociadas al uso del sensor Guardian 4.

Seguridad del usuario

Advertencias

Lea esta guía del usuario en su totalidad antes de intentar insertar

el sensor Guardian 4. El dispositivo de inserción One-press

(MMT- 7512) es el único dispositivo de inserción aprobado para

utilizar con el sensor. Si no se siguen las indicaciones o se utiliza

un dispositivo de inserción diferente, pueden producirse una

inserción incorrecta, dolor o lesiones.

No intente conectar un transmisor o registrador que no sea

compatible con el sensor. El sensor se ha diseñado para funcionar

únicamente con los transmisores aprobados. Si conecta el sensor

a un transmisor o registrador que no esté aprobado para utilizarse

con él, pueden producirse daños en los componentes. Consulte

la guía del usuario del sistema para ver una lista de productos

compatibles.

No utilice la monitorización continua de glucosa si toma

hidroxiurea, también conocida como hidroxicarbamida. La

hidroxiurea se utiliza en el tratamiento de determinadas

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enfermedades, como el cáncer y la anemia de células falciformes.

La toma de hidroxiurea da lugar a lecturas de glucosa del

sensor más altas que las lecturas de glucosa en sangre. Tomar

hidroxiurea mientras se utiliza la monitorización continua

de glucosa puede provocar lecturas de glucosa del sensor

sustancialmente más altas que las lecturas de glucosa en sangre

reales. Para los usuarios de la bomba, tomar hidroxiurea durante

el uso de la monitorización continua de glucosa puede provocar

hipoglucemia debido a una infusión excesiva de insulina.

Compruebe siempre el prospecto de los medicamentos que

toma para verificar si contienen hidroxiurea o hidroxicarbamida

como principio activo. Si está tomando hidroxiurea, consulte a un

profesional sanitario. Utilice lecturas adicionales del medidor de

glucosa en sangre para comprobar los niveles de glucosa.

Tomar medicamentos que contengan paracetamol (acetaminofén),

tales como antipiréticos y medicamentos contra el resfriado,

durante el uso del sensor puede elevar erróneamente las lecturas

de glucosa del sensor. El nivel de inexactitud depende de la

cantidad de paracetamol (acetaminofén) que esté activa en el

cuerpo y puede variar de una persona a otra. Compruebe siempre

el prospecto de los medicamentos para verificar si contienen

paracetamol (acetaminofén) como principio activo.

No exponga el sensor a equipos de RM, dispositivos de diatermia

u otros dispositivos que generen campos magnéticos potentes. No

se ha evaluado el funcionamiento del sensor en estas condiciones

y puede no ser seguro. Si el sensor se expone a un campo

magnético intenso, deje de utilizarlo y póngase en contacto con la

línea de asistencia técnica 24 horas para obtener ayuda.

Inspeccione siempre el embalaje por si tuviese daños antes de

utilizar este dispositivo. Los sensores son estériles y apirógenos,

a menos que el embalaje esté abierto o dañado. Si el embalaje

del sensor presenta daños o está abierto, deseche el sensor

directamente en un contenedor para objetos cortantes. El uso de

un sensor no estéril puede producir una infección en la zona de

inserción.

No permita que los niños se lleven a la boca piezas pequeñas. El

producto conlleva un peligro de asfixia para los niños pequeños.

No utilice el sensor Guardian 4 si tiene una enfermedad grave

o está embarazada. Puesto que el sensor no se ha estudiado

en estas poblaciones, se desconoce el efecto que pueden

tener los medicamentos habituales para estas situaciones en el

funcionamiento del sensor, que puede no ser preciso en estas

poblaciones.

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