Medtronic guardian 2 link Manual de usuario

Marca: Medtronic

Modelo: guardian 2 link

Tipo: Manual de usuario

Transmitter

Transmetteur

Transmitter

Transmisor

Zender

Trasmettitore

Sender

Lähetin

Sändare

Sender

Transmissor

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Contacts:

Africa: Medtronic Africa (Pty) Ltd.

Tel: +27 (0) 11 677 4800

Argentina: Corpomedica S.A.

Tel: +(11) 4 814 1333

Medtronic Directo 24/7: +0800 333 0752

Australia: Medtronic Australasia Pty. Ltd.

Tel: 1800 668 670 (product orders)

Tel: 1800 777 808 (customer help)

Azerbaijan: Isomed

Tel: +994 (12) 464 11 30

Bangladesh: Sonargaon Healthcare Pvt Ltd.

Mobile: (+91)-9903995417

or (+880)-1714217131

Belarus: ОДО “Баджин”

Tel: +375 17 313 0990

België/Belgique: N.V. Medtronic Belgium S.A.

Tel: 0800-90805

Bosnia and Herzegovina: Medimpex d.o.o.

Tel: +387 33 476 444

or +387 33 476 400

Fax: +387 33 476 401

or +387 33 432 241

Brasil: Medtronic Comercial Ltda.

Tel: +(11) 2182-9200

Medtronic Directo 24/7: +0800 773 9200

Bulgaria: RSR Ltd.

Tel: +359 885 428 900

Canada: Medtronic of Canada Ltd.

Tel: 1-800-284-4416 (toll free/sans-frais)

Chile: Medtronic Chile

Tel: +(9) 66 29 7126

Medtronic Directo 24/7: +1 230 020 9750

Medtronic Directo 24/7 (From Santiago): +(2)

595 2942

China: Medtronic (Shanghai) Ltd.

24 Hour Help (Cell): +86 400-820-1981

24 Hour Help (Landline): +86 800-820-1981

Colombia: Medtronic Latin America Inc. Sucursal

Colombia

Tel: +(1) 742 7300

Medtronic Directo 24/7 (Landline): +01 800 710

2170

Medtronic Directo 24/7 (Cellular): +1 381 4902

Croatia: Medtronic Adriatic d.o.o.

Tel: +385 1 488 11 20

Fax: +385 1 484 40 60

Danmark: Medtronic Danmark A/S

Tel: +45 32 48 18 00

Deutschland: Medtronic GmbH

Geschäftsbereich Diabetes

Telefon: +49 2159 8149-370

Telefax: +49 2159 8149-110

24-Stdn-Hotline: 0800 6464633

Eire: Accu-Science LTD.

Tel: +353 45 433000

España: Medtronic Ibérica S.A.

Tel: +34 91 625 05 42

Fax: +34 91 625 03 90

24 horas: +34 900 120 330

Europe: Medtronic Europe S.A. Europe, Middle

East and Africa Headquarters

Tel: +41 (0) 21-802-7000

France: Medtronic France S.A.S.

Tel: +33 (0) 1 55 38 17 00

Hellas: Medtronic Hellas S.A.

Tel: +30 210677-9099

Hong Kong: Medtronic International Ltd.

Tel: +852 2919-1300

To order supplies: +852 2919-1322

24-hour helpline: +852 2919-6441

India: I

ndia Medtronic Pvt. Ltd

Tel: (+91)-

80-22112245 / 32972359

Mobile: (+91)-9611633007

Indonesia: Medtronic International Ltd.

Tel: +65 6436 5090

or +65 6436 5000

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Israel: Agentek

Tel: +972 3649 3111

Italia: Medtronic Italia S.p.A.

Tel: +39 02 24137 261

Fax: +39 02 24138 210

Servizio assistenza tecnica:

Nº verde 24h: 800 20 90 20

Japan: Medtronic Japan Co. Ltd.

Tel: +81-3-6430-2019

24 Hr. Support Line: 0120-56-32-56

Kazakhstan: Medtronic BV in Kazakhstan

Tel: +7 727 311 05 80 (Almaty)

Tel: +7 717 224 48 11 (Astana)

Круглосуточная линия поддержки: 8 800 080

5001

Latin America: Medtronic, Inc.

Tel: 1(305) 500-9328

Fax: 1(786) 709-4244

Latvija: Ravemma Ltd.

Tel: +371 7273780

Macedonia: Alkaloid Kons Dooel

Tel: +389 2 3204 430

Magyarország: Medtronic Hungária Kft.

Tel: +36 1 889 0688

Malaysia: Medtronic International Ltd.

Tel: +603 7946 9000

Middle East and North Africa: Regional Office

Tel: +961-1-370 670

Montenegro: Glosarij

Tel: +382 20 642 495

Fax: +382 20 642 540

México: Medtronic Servicios S. de R. L. de C.V.

Tel (México DF): +(11) 029 058

Tel (Interior): +01 800 000 7867

Medtronic Directo 24/7 (from México DF):

+(55) 36 869 787

Medtronic Directo 24/7: +01 800 681 1845

Nederland, Luxembourg: Medtronic B.V.

Tel: +31 (0) 45-566-8291

Gratis: 0800-3422338

New Zealand: Medica Pacifica

Phone: 64 9 414 0318

Free Phone: 0800 106 100

Norge: Medtronic Norge A/S

Tel: +47 67 10 32 00

Fax: +47 67 10 32 10

Philippines: Medtronic International Ltd.

Tel: +65 6436 5090

or +65 6436 5000

Poccия: ООО «Медтроник»

Tel: +7 495 580 73 77

Круглосуточная линия поддержки: 8 800 200 76

Polska: Medtronic Poland Sp. Z.o.o.

Tel: +48 22 465 6934

Portugal: Medtronic Portugal Lda

Tel: +351 21 7245100

Fax: +351 21 7245199

Puerto Rico: Medtronic Puerto Rico

Tel: 787-753-5270

Republic of Korea: Medtronic Korea, Co., Ltd.

Tel: +82.2.3404.3600

man

ia: Medtronic BV Reprezentanta

Tel: +40 372 188 000

Schweiz: Medtronic (Schweiz) AG

Tel: +41 (0)31 868 0160

24-Stunden-Hotline: 0800 633333

Fax Allgemein: +41 (0)318680199

Serbia: Medtronic B.V. Serbia

Tel: +381 11 2095 900

Singapore: Medtronic International Ltd.

Tel: +65 6436 5090

or +65 6436 5000

Slovenija: Zaloker & Zaloker d.o.o.

brezplačna številka: 080 1880

Tel: +386 1 542 51 11

Slovenská republika: Medtronic Slovakia, s.r.o.

Tel: +421 26820 6942

HelpLine: +421 26820 6986

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Sri Lanka: Swiss Biogenics Ltd.

Mobile: (+91)-9003077499

or (+94)-777256760

Suomi: Medtronic Finland Oy

Tel: +358 20 7281 200

Help line: +358 400 100 313

Sverige: Medtronic AB

Tel: +46 8 568 585 20

Fax: +46 8 568 585 11

Taiwan: Medtronic (Taiwan) Ltd.

Tel: 02-21836000

Toll free: +886-800-005285

Thailand: Medtronic (Thailand) Ltd.

Tel: +662 232 7400

Türkiye: Medtronic Medikal Teknoloji

Ticaret Ltd. Sirketi.

Tel: +90 216 4694330

USA: Medtronic Diabetes Global Headquarters

24 Hour HelpLine: +1-800-646-4633

To order supplies: +1-800-843-6687

Ukraine: Medtronic B.V. Representative office in

Ukraine

Tel: +38 044 392 04 01

Лінія цілодобової підтримки:

0 800 508 300

United Kingdom: Medtronic Ltd.

Tel: +44 1923-205167

Österreich: Medtronic Österreich GmbH

Tel: +43 (0) 1 240 44-0

24 – Stunden – Hotline: 0820 820 190

Česká republika: Medtronic Czechia s.r.o.

Tel: +420 233 059 401

Non-stop helpLine:

+420 233 059 059

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The Guardian™ 2 Link transmitter is a component of the continuous glucose

monitoring system for the MiniMed

™

640G insulin pump. The transmitter collects data

from the Enlite™ glucose sensor. The transmitter then wirelessly sends the data to

the insulin pump.

Guardian 2 Link transmitter kit components

A complete Guardian 2 Link transmitter kit includes the following components:

• Guardian 2 Link transmitter (MMT-7731)

•

Watertight Tester (MMT-7726)

•

Charger (MMT-7715)

•

One-press serter (MMT-7512)

Indications for use

The transmitter is indicated for single-patient use as a component of select Medtronic

continuous glucose sensing systems and MiniMed sensor-enabled pump systems.

Contraindications

Do not expose your transmitter to MRI equipment, diathermy devices, or other

devices that generate strong magnetic fields. If your transmitter is inadvertently

exposed to a strong magnetic field, discontinue use and contact the 24 Hour

HelpLine or your local representative for further assistance.

Warnings

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

If the tester comes in contact with blood, the tester must be discarded. Dispose of the

tester according to the local regulations for medical waste disposal.

Bleeding may occur after inserting the sensor. Make sure that the site is not bleeding

before connecting the transmitter to the sensor. If bleeding occurs, apply steady

pressure with a sterile gauze or clean cloth at the insertion site until bleeding stops.

After bleeding stops, connect the transmitter to the sensor.

Contact the 24 Hour HelpLine or your local representative if you experience any

adverse reactions associated with the transmitter or sensor.

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Magnetic fields

Do not expose your transmitter to MRI equipment, diathermy devices, or other devices

that generate strong magnetic fields. If your transmitter is inadvertently exposed to a

strong magnetic field, discontinue use and contact the 24 Hour HelpLine or your local

representative for further assistance.

X-rays, MRIs, diathermy devices, and CT scans

If you are going to have an x-ray, diathermy treatment, CT scan, MRI or other type of

exposure to radiation, remove your sensor and transmitter before entering a room

containing any of these equipment.

Important information about airport security systems, and using your transmitter on an

airplane, can be found on the Emergency Card. Be sure to carry the Emergency Card

provided with your device when you are traveling.

Precautions

Refer to the Enlite Sensor User Guide for all precautions, warnings, and instructions

relating to the sensor.

Always use the tester when cleaning the transmitter. Do not use any other test plug with

the transmitter.

Do not twist the tester or sensor while attached to the transmitter. This will damage the

transmitter.

Do not allow water, or any other liquid, to come in contact with the tester when it is not

connected to the transmitter. A wet tester can cause damage to the transmitter.

Do not allow the transmitter to come in contact with any liquid when not connected to a

sensor or to the tester.

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

Notice

Caution: Any changes or modifications to the devices not expressly approved by

Medtronic Diabetes could interfere with your ability to operate the

equipment, cause injury, and void your warranty.

Radio Frequency (RF) communication

This device complies with the United States Federal Communications Commission (FCC)

and international standards for electromagnetic compatibility.

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This device complies with Part 15 of the FCC Rules. Operation is subject to the

following two conditions: (1) This device may not cause harmful interference, and (2)

this device must accept any interference received, including interference that may

cause undesired operation.

These standards are designed to provide reasonable protection against excessive

radio frequency interference, and prevent undesirable operation of the devices from

unwanted electromagnetic interference.

This equipment has been tested and found to comply with the limits for a Class B

digital device, pursuant to Part 15 of the FCC rules. These limits are designed to

provide reasonable protection against harmful interference in a residential

installation. This equipment generates, uses, and can radiate radio frequency energy

and, if not installed and used in accordance with the instructions, may cause harmful

interference to radio communications. However, there is no guarantee that

interference will not occur in a particular installation. If this equipment does cause

harmful interference to radio or television reception, which can be determined by

turning the equipment off and on, the user is encouraged to try to correct the

interference by one or more of the following measures:

• Reorient or relocate the receiving antenna.

• Increase the separation between the equipment and the receiver.

This device can generate, use, and radiate radio frequency energy and, if installed

and used in accordance with the instructions, may cause harmful interference to

radio communications. If the device does cause interference to radio or television

reception, you are encouraged to try to correct the interference by one or more of the

following measures:

• Decrease the distance between the transmitter and the insulin pump to 1.8

meters (6 feet) or less.

• Increase the separation between the transmitter and the device that is receiving/

emitting interference.

If other devices that employ radio frequencies are in use, such as cell phones,

cordless phones, and wireless networks, they may prevent communication between

the transmitter and the insulin pump. This interference does not cause any incorrect

data to be sent and does not cause any harm to your devices. Moving away from, or

turning off, these other devices may enable communication. If you continue to

experience RF interference, please contact your local representative.

Caution: Changes or modifications to the internal RF transmitter or antenna

not expressly approved by Medtronic could void the user's

authority to operate this insulin delivery system.

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For Canada only

This device complies with Industry Canada licence-exempt RSS standard(s).

Operation is subject to the following two conditions: (1) this device may not cause

interference, and (2) this device must accept any interference, including

interference that may cause undesired operation of the device.

Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux

appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions

suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'appareil doit

accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible

d'en compromettre le fonctionnement.

Directive 1999/5/EC

Medtronic declares that this product is in conformity with the essential requirements of

Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment.

For additional information, contact Medtronic MiniMed at the address or phone number

provided on the back cover.

Assistance

Please contact your local representative for assistance. Refer to the Medtronic Diabetes

International Contacts list at the beginning of this user guide for contact information.

Charger

The transmitter contains a non-replaceable, rechargeable battery that you can recharge

as needed with the charger. The charger has a green light that shows the charging status

and a red light that communicates any problems during charging. If you see a red light,

see the Troubleshooting section. The charger needs one AAA alkaline battery.

Note: If the battery is installed incorrectly or is low, the charger will not work. Repeat the

battery installation steps using a new battery.

Installing a battery in the charger

To install a battery in the charger:

Push the battery cover in and slide it off (as shown in the following illustration).

Insert a new alkaline AAA battery. Make sure the + and - symbols on the battery align

with these same symbols shown on the charger.

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3 Slide the cover back on the charger until it clicks into place.

Charging the transmitter

Caution: Charge the transmitter after each sensor use. A fully charged

transmitter works at least six days without recharging. A depleted

transmitter can take up to one hour to recharge.

To charge the transmitter:

Connect the transmitter to the charger by lining it up, flat

side down, with the charger. Push the two components

together fully.

Within 10 seconds after the transmitter is connected, a

green light on the charger will flash for one to two seconds

as the charger powers on. For the rest of the charging time,

the charger’s green light will continue to flash in a pattern of

four flashes with a pause between the four flashes.

When charging is complete, the green light on the charger

will stay on, without flashing, for 15 to 20 seconds and then

turn off.

After the green charger light turns off, disconnect the

transmitter from the charger. The green light on the

transmitter will flash for about five seconds and then turn

off.

Inserting the sensor

Always refer to the serter user guide for instructions on how to insert the sensor.

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Connecting the transmitter to the sensor

Before proceeding, have your pump user guide available.

To connect the transmitter to the sensor:

After the sensor is inserted, consult your serter user guide for details on applying the

required overtape.

Hold the rounded end of the inserted sensor to prevent it from moving during

connection.

Hold the transmitter as shown. Line up the two notches on the

transmitter with the side arms of the sensor. The flat side of the

transmitter should face the skin.

Slide the transmitter onto the sensor until the sensor’s flexible

arms snap into the notches on the transmitter. If the transmitter

is properly connected, and if the sensor has had enough time to

become hydrated, the green light on the transmitter will flash

within 10 seconds.

If the transmitter light does not flash, disconnect the transmitter from the sensor, wait

for several seconds and then reconnect. If the transmitter light still does not flash,

charge the transmitter.

When the transmitter light flashes green when connected to the sensor, use your

pump to start the sensor. For more instructions, see your pump user guide.

After the transmitter successfully sends sensor data to the pump, attach the sensor's

adhesive tab to the transmitter.

Follow the instructions that appear on the pump screen or follow the instructions in

your pump user guide.

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Disconnecting the transmitter from the sensor

Before proceeding, have your pump user guide available.

To disconnect the transmitter from the sensor:

Carefully remove any occlusive dressing from the

transmitter and sensor.

For the Enlite sensor, remove the adhesive tab from the top

of the transmitter.

Hold the transmitter as shown, and pinch the flexible side

arms of the sensor between your thumb and forefinger.

Gently pull the transmitter away from the sensor.

Follow the instructions that appear on the pump or follow

the instructions in your pump user guide.

Removing the sensor

Always refer to the sensor user guide for instructions on how to remove the sensor.

Bathing and swimming

After the transmitter and sensor are connected, they form a waterproof seal to a

depth of 2.4 meters (eight feet) for up to 30 minutes. You can shower and swim

without removing them. No occlusive dressing or overtape is needed.

Watertight Tester

The tester is used to test the transmitter to make sure it is working. It is also used as

a required component for cleaning the transmitter. Properly connecting the tester to

the transmitter will ensure that fluids do not come in contact with the transmitter’s

connector pins. Fluids can cause connector pins to corrode and affect the

transmitter’s performance.

Do not twist the tester while attached to the transmitter. This will damage the

transmitter.

The tester can be used for one year. If you continue to use the tester for more than

one year, the transmitter's connector pins could be damaged, because the tester

cannot continue to provide a waterproof seal. For instructions on how to check the

connector pins, see Inspecting the transmitter connector pins, on page 8.

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Caution: Only use the tester with the transmitter. Do not use any other test plug.

✓

Inspecting the transmitter connector pins

This image is an example of how the connector pins should look.

connector opening

connector pins

housing

Look inside the transmitter’s connector opening to make sure that the connector pins are

not damaged or corroded. If the connector pins are damaged or corroded, the transmitter

cannot communicate with the charger or pump. Contact the 24 Hour HelpLine or your

local representative. It may be time to replace your transmitter.

Also look for moisture inside the connector opening. If you see any moisture, allow the

transmitter to dry for at least one hour. Moisture inside the connector opening could

cause the transmitter to not work properly, and could cause corrosion and damage over

time.

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Connecting the tester for testing or cleaning

Before proceeding, have available your pump user guide.

To connect the tester:

Hold the transmitter and the tester as shown. Line up the

flat side of the tester with the flat side of the transmitter.

Push the tester into the transmitter until the flexible side

arms of the tester click into the notches on both sides of the

transmitter.

Within five seconds, when properly connected, the green

light on the transmitter flashes for about 10 seconds.

To test the transmitter, check the sensor icon on the pump

to ensure that the transmitter is sending a signal (see your pump user guide).

To clean the transmitter, see Cleaning the transmitter, on page 9.

After testing or cleaning, disconnect the tester from the transmitter.

Disconnecting the tester

To disconnect the tester:

Hold the transmitter body as shown and pinch the side

arms of the tester.

With the tester arms pinched, gently pull the transmitter

away from the tester.

Note: To save transmitter battery life, do NOT leave the

tester connected after cleaning or testing.

Cleaning the transmitter

The transmitter is a single-patient use device and not intended for multi-patient use.

Caution: Do not discard the transmitter in a medical waste container or

otherwise subject it to incineration. The transmitter contains a

battery that may explode upon incineration.

Note: The tester is a required component for cleaning the transmitter. For details,

see Watertight Tester, on page 7.

Always clean the transmitter after each use.

To clean the transmitter, you will need the following materials: mild liquid soap, a soft-

bristled toddler toothbrush, a container, 70% isopropyl alcohol, and a few clean, dry

cloths.

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Warning: Cracking, flaking, or damage of the housing are signs of deterioration

and the performance of the device may be compromised. This may

affect the ability to properly clean and disinfect the transmitter. If these

signs are noted, stop using the device and call the 24 Hour HelpLine or

your local representative. The device must be discarded according to

local regulations for battery disposal (non-incineration).

To clean the transmitter:

Attach the tester to the transmitter.

If optional occlusive dressing or overtape was used and there is adhesive residue on

the transmitter, see Removing adhesive residue, on page 10.

Rinse the transmitter under room temperature tap water for at least one minute, and

until visibly clean. Make sure all hard-to-reach areas are rinsed completely.

Prepare a mild liquid soap solution using 5 milliliters (1 teaspoon) of liquid soap per

3.8 liters (1 gallon) of room temperature tap water.

With tester still attached, submerge the transmitter in the cleaning solution and soak

for one minute.

Holding the tester, brush the entire surface of the transmitter using a soft-bristled

toddler toothbrush. Make sure to brush all hard-to-reach areas until visibly clean.

Rinse the transmitter under running room temperature tap water for at least one

minute, and until all visible liquid soap is gone.

Dry the transmitter and tester with a clean, dry cloth.

Place the transmitter and tester on a clean, dry cloth and air dry them completely.

Disconnect the tester from the transmitter.

Removing adhesive residue

You may need to perform this procedure only if you have used optional occlusive

dressing, which may leave adhesive residue on the transmitter. If you visually inspect the

transmitter and see adhesive residue on it, follow the instructions below.

To remove adhesive residue, you will need the following materials: medical adhesive

remover (such as Detachol

- which is a mineral spirit) and cotton swabs.

Note: During testing, Medtronic MiniMed used Detachol to remove the adhesive residue

from the transmitter. Detachol is recommended for use but may not be available in

all countries.

To remove adhesive residue:

Make sure the tester is attached to the transmitter.

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2 Holding the tester, saturate a cotton swab in the Detachol solution and gently rub

the adhesive residue on the transmitter until it is fully removed.

Continue with the cleaning procedure. See Cleaning the transmitter, on page 9

for details.

Cleaning the charger

This procedure is for general cleaning as required, based on physical appearance.

Caution: The charger is NOT waterproof. Do NOT immerse in water or any

other cleaning agent.

Caution: Dispose the charger according to the local regulations for battery

disposal (non-incineration).

To clean the charger:

Wash your hands thoroughly.

Use a damp cloth with mild cleaning solution, such as a dishwashing detergent,

to clean any dirt or foreign material from the outside of the charger. Never use

organic solvents, such as paint thinner or acetone, to clean the charger.

Place the charger on a clean, dry cloth and air dry for two to three minutes.

Troubleshooting

The following table contains troubleshooting information for the transmitter, charger,

and tester. For more information about troubleshooting, see your pump user guide.

Problem Likely Cause(s) Resolution

You connected the

transmitter to the

charger and no lights

came on.

The transmitter connec-

tor pins are damaged or

corroded.

Your charger battery has

no power.

1 Check the transmitter connector pins for

damage or corrosion. For more informa-

tion about your connector pins, see In-

specting the transmitter connector pins,

on page 8. If the pins are damaged or cor-

roded, contact the 24 Hour HelpLine or

your local representative. It may be time

to replace your transmitter.

If there is no damage to the connector

pins, replace the battery in the charger.

For instructions on replacing your charger

battery, see Installing a battery in the

charger, on page 4.

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Problem Likely Cause(s) Resolution

During charging, the

flashing green light on

the charger turns off

and you see a flashing

red light on the charg-

er.

Your charger battery is

low on power.

Replace the battery in the charger. For instruc-

tions on replacing your charger battery, see In-

stalling a battery in the charger, on page 4.

During charging, the

flashing green light on

the charger turns off

and you see a series of

quick flashing red lights

on the charger.

Your transmitter is low

on power.

Charge the transmitter continuously for

one hour. If flashing does not stop, pro-

ceed to step 2.

Charge the transmitter continuously for

eight hours. If flashing does not stop, call

the 24 Hour HelpLine or your local repre-

sentative. It may be time to replace your

transmitter.

During charging, a mix

of quick and long flash-

ing red lights appear

on the charger.

Your charger and your

transmitter are low on

power.

Replace the battery in the charger. For in-

structions on replacing your charger bat-

tery, see Installing a battery in the

charger, on page 4.

Charge the transmitter continuously for

one hour. If flashing does not stop, pro-

ceed to step 3.

Charge the transmitter continuously for

eight hours. If flashing does not stop, call

the 24 Hour HelpLine or your local repre-

sentative. It may be time to replace your

transmitter.

The green light on the

transmitter does not

flash when you con-

nect it to the sensor.

Your transmitter is not

fully connected.

Your transmitter is low

on power.

Your sensor is not prop-

erly inserted into your

body.

Disconnect the transmitter from the sen-

sor.

Wait for five seconds and reconnect them.

If the green light still does not flash, pro-

ceed to step 3.

Fully charge the transmitter. If the green

light still does not flash, proceed to step 4.

The sensor may not be properly inserted

into your body. Insert a new sensor.

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Problem Likely Cause(s) Resolution

The green light on the

transmitter does not

flash when you con-

nect it to the tester.

Your transmitter is low

on power.

Your transmitter is not

fully connected.

1 Check the connection between the trans-

mitter and the tester. If the green light still

does not flash, proceed to step 2.

Fully charge the transmitter.

Test the transmitter with the tester again.

If you still do not see the green light flash,

call the 24 Hour HelpLine or your local

representative. It may be time to replace

your transmitter.

Your transmitter bat-

tery does not last for

six days.

Your transmitter is not

fully charged when you

connect it to the sensor.

The transmitter and

pump frequently lose

wireless connection.

Fully charge the transmitter before con-

necting it to the sensor. If the transmitter

battery still does not last for six days, pro-

ceed to step 2.

Move away from any device that can

cause RF interference. For more informa-

tion on RF interference, see Radio Fre-

quency (RF) communication, on page 2.

Make sure your pump and your transmitter

are located on the same side of your body

to minimize any RF interference. If your

fully charged transmitter battery continues

to lose power before a full six days, call

the 24 Hour HelpLine or your local repre-

sentative. It may be time to replace your

transmitter.

Your transmitter has

lost connection with

your pump.

Your pump is out of

range.

There is RF interference

from other devices.

Move away from any device that can

cause RF interference. For more informa-

tion on RF interference, see Radio Fre-

quency (RF) communication, on page 2. If

your transmitter is still not communicating

with your pump, proceed to step 2.

Make sure your pump and your transmitter

are located on the same side of your body

to minimize any RF interference. If your

transmitter is still not communicating with

your pump, call the 24 Hour HelpLine or

your local representative for assistance.

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Storing the devices

Store the transmitter, charger, and tester in a clean, dry location at room temperature. If

the transmitter is not in use, you must charge the transmitter at least once every 60 days.

Although not required, you may store the transmitter on the charger. If you are storing the

transmitter on the charger, you must disconnect and reconnect the charger and the

transmitter at least once every 60 days.

Disposal

Discard the transmitter according to local regulations for battery disposal.

Specifications

Biocompatibility Transmitter: Complies with EN ISO 10993-1

Applied parts Transmitter

Sensor

Operating conditions Transmitter temperature: -5 °C to 45 °C (23 °F to 113 °F)

Caution: When operating the transmitter on a tester in air temperatures

greater than 41 °C (106 °F), the temperature of the transmitter may exceed

43 °C (109 °F)

Transmitter relative humidity: 5% to 95% with no condensation

Transmitter pressure: 61.36 kPa to 106.17 kPa (8.9 psi to 15.4 psi)

Charger temperature: 10 °C to 40 °C (50 °F to 104 °F)

Charger relative humidity: 30% to 75% with no condensation

Storage conditions Transmitter temperature: -25 °C to 55 °C (-13 °F to 131 °F)

Transmitter relative humidity: 10% to 100% with condensation

Transmitter pressure: 61.36 kPa to 106.17 kPa (8.9 psi to 15.4 psi)

Charger temperature: -10 °C to 50 °C (14 °F to 122 °F)

Charger relative humidity: 10% to 95% with no condensation

Battery life Uses one new AAA battery to charge the transmitter.

Transmitter frequen-

2.4 GHz, 2M65G1D modulation, less than 1mW ERP

Maximum output

power (EIRP)

-0.63 dBm

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Radio Frequency (RF)

communications

Pump to transmitter frequency: 2.4 Ghz; proprietary Medtronic protocol;

range up to 1.8 meters (6 feet)

Utilizes the IEEE 802.15.4 protocol with proprietary data format

Operating frequency: 5 frequencies are used: 2420, 2435, 2450, 2465, and

2480 MHz

Bandwidth: 5 MHz, which is allocated channel bandwidth per IEEE protocol

Transmitter expected

service life

The transmitter expected service life is 1 year depending on patient usage

Guardian 2 Link wireless communication

Quality of service

The Guardian 2 Link transmitter and the MiniMed 640G insulin pump are associated

as part of an 802.15.4 network for which the pump functions as the coordinator and

the transmitter as an end node. In an adverse RF environment the pump will assess

channel changing needs based on "noise" levels detected during an energy scan.

The pump will perform the energy scan if after 10 minutes no CGM transmitter signal

has been received. If the channel change occurs the pump will send beacons on the

new channel.

The Guardian 2 Link transmitter will initiate a channel search when beacon detection

fails on the associated channel. The search will be conducted across all five

channels. When the beacon is located the transmitter will rejoin on the identified

channel. Upon re-association any missed packets (up to 10 hours) will be transmitted

from the transmitter to the pump.

In normal operation the transmitter will transmit a packet every 5 minutes and

retransmit the packet if the data is corrupted or missed.

Data security

The MiniMed 640G insulin pump is designed to only accept radio frequency (RF)

communications from recognized and linked devices (you must program your pump

to accept information from a specific device).

The MiniMed 640G insulin pump and system components (meters and transmitters)

ensure data security via proprietary means and ensures data integrity using error

checking processes, such as cyclic redundancy checks.

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Guidance and manufacturer's declaration

Guidance and Manufacturer's Declaration - Electromagnetic Emissions

The Guardian 2 Link is intended for use in the electromagnetic environment specified

below. The customer or the user of the Guardian 2 Link should make sure that it is

used in such an environment.

Emissions Test Compliance Electromagnetic Environment - Guidance

RF emissions

CISPR 11

Group 1 The Guardian 2 Link must emit electromagnetic energy in order to

perform its intended function. Nearby electronic equipment may

be affected.

RF emissions

CISPR 11

Class B The Guardian 2 Link is suitable for use in all establishments, in-

cluding domestic and those directly connected to the public low-

voltage power supply network that supplies buildings used for

domestic purposes.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Guardian 2 Link is intended for use in the electromagnetic environment specified

below. The customer or the user of the Guardian 2 Link should assure that it is used in

such an environment.

Immunity Test IEC 60601 Test Level Compliance

Level

Electromagnetic Envi-

ronment - Guidance

Electrostatic discharge

(ESD)

IEC 61000-4-2

±2 kV, ±4 kV, ±8 kV Air

±2 kV, ±4 kV, ±6 kV Indirect

±8 kV Air

±6 kV Indirect

±22 kV Air,

<5% RH

For use in a typical do-

mestic, commercial, or

hospital environment.

Electrical fast transient/

burst

±2 kV for power supply

lines

Not applicable Requirement does not ap-

ply to this battery pow-

ered device.

IEC 61000-4-4 ±1 kV for input/output lines

Surge

IEC 61000-4-5

±1 kV line(s) to line(s)

±2 kV line(s) to earth

Not applicable Requirement does not ap-

ply to this battery pow-

ered device.

Voltage dips, short in-

terruptions and voltage

variations on power

supply lines

IEC 61000-4-11

<5% U

(>95% dip in U

)

for 0.5 cycle

Not applicable Requirement does not ap-

ply to this battery pow-

ered device.

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Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Guardian 2 Link is intended for use in the electromagnetic environment specified

below. The customer or the user of the Guardian 2 Link should assure that it is used in

such an environment.

Immunity Test IEC 60601 Test Level Compliance

Level

Electromagnetic Envi-

ronment - Guidance

Power frequency

(50/60 Hz) magnetic

field

IEC 61000-4-8

3 A/m 400 A/m

4000 A/m

Power frequency magnet-

ic fields should be at lev-

els characteristic of a

typical location in a typical

domestic, commercial, or

hospital environment.

Note:

is the a.c. mains voltage prior to application of the test level.

Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Guardian 2 Link is intended for use in the electromagnetic environment specified

below. The customer or user of the Guardian 2 Link should assure that it is used in

such an electromagnetic environment.

Immunity Test IEC 60601 Level Compliance Lev-

Electromagnetic Environ-

ment Guidance

Portable and mobile RF commu-

nications equipment should be

used no closer to any part of the

Guardian 2 Link, including ca-

bles, than the recommended

separation distance calculated

from the equation applicable to

the power of the transmitter.

Refer to the recommended sepa-

ration distance table for more in-

formation.

Conducted RF

IEC 61000-4-6

3 V/m

150 kHz to

80 MHz

Not applicable Not applicable

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Guidance and Manufacturer's Declaration - Electromagnetic Immunity

The Guardian 2 Link is intended for use in the electromagnetic environment specified

below. The customer or user of the Guardian 2 Link should assure that it is used in

such an electromagnetic environment.

Immunity Test IEC 60601 Level Compliance Lev-

Electromagnetic Environ-

ment Guidance

Radiated RF

IEC 61000-4-3

3 V/m

80 MHz to

6 GHz

10 V/m

80 MHz to

6 GHz

d = 0.35

80 MHz to 800 MHz

d = 0.70

800 MHz to 6 GHz

Where P is the maximum output

power rating of the transmitter in

watts (W) according to the trans-

mitter manufacturer and d is the

recommended separation dis-

tance in meters (m).

Field strengths from fixed RF

transmitters, as determined by

an electromagnetic site survey

should be less than the compli-

ance level in each frequency

range

Interference may occur in the vi-

cinity of equipment marked with

the following symbol:

Note:

At 80 MHz and 800 MHz, the higher frequency range applies.

Note:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption, and reflection from structures, objects and people.

Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones

and land mobile radios, amateur radio, AM and FM radio broadcasts and TV broadcast cannot be pre-

dicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF trans-

mitters, an electromagnetic site survey should be considered. If the measured field strength in the

location in which the Guardian 2 Link is used exceeds the applicable RF compliance level above, the

Guardian 2 Link should be observed to verify normal operation. If abnormal performance is observed,

additional measures may be necessary, such as re-orienting or relocating the Guardian 2 Link.

Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

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Recommended separation distances between the Guardian 2 Link and common

household radio transmitters

Household RF Transmitter Frequency Recommended Sepa-

ration Distance (me-

ter)

Recommended Sepa-

ration Distance (inch)

Telephones

Cordless Household 2.4 GHz 0.3 12

Cordless Household 5.8 GHz 0.3 12

TDMA-50 Hz (cell phone) 1.9 GHz 0.3 12

TDMA-50 Hz (cell phone) 800 MHz 0.3 12

PCS (cell phone) 1.9 MHz 0.3 12

DCS (cell phone) 1.8 MHz 0.3 12

GSM (cell phone) 900 MHz 0.3 12

GSM (cell phone) 850 MHz 0.3 12

CDMA (cell phone) 800 MHz 0.3 12

Analog (cell phone) 824 MHz 0.3 12

CDMA (cell phone) 1.9 MHz 0.3 12

WiFi Networks

802.11b; 11Mbps maximum 2.4 GHz 1 39.5

802.11g; 54 Mbps maximum 2.4 GHz 1 39.5

802.11n; 11Mbps maximum 2.4 GHz 1 39.5

Bluetooth 500 kb/s 2.4 GHz 0.1 3.93

ZigBee 250 kb/s 2.4 GHz 0.1 3.93

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Recommended separation distances between portable and mobile RF

communications equipment and the Guardian 2 Link

The Guardian 2 Link is intended for use in an electromagnetic environment in which

radiated RF disturbances are controlled. The customer or the Guardian 2 Link users

can help prevent electromagnetic interference by maintaining a minimum distance be-

tween portable and mobile RF communications equipment and the Guardian 2 Link as

recommended below, according to the maximum output power of the communications

equipment.

Rated maximum

output power of

transmitter (W)

Separation distance according to the frequency of transmitter (m)

150 kHz to 80

MHz

Not applicable

80MHz to 800MHz

d = 0.35

800MHz to 6.0GHz

d = 0.70

0.01 Not applicable 0.035 0.07

0.1 Not applicable 0.11 0.11

1 Not applicable 0.35 0.7

10 Not applicable 1.1 2.2

100 Not applicable 3.5 7

For transmitters rated at a maximum output power not listed above, the recommended separation dis-

tance d in meters (m) can be estimated using the equation applicable to the frequency of the transmit-

ter, where p is the maximum output power rating of the transmitter in watts (W) according to the

transmitter manufacturer.

Note:

At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note:

These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects, and people.

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Icon Table

Serial number

Catalogue or model number

One per container/package

Date of manufacture

Manufacturer

Follow instructions for use (appears blue on label)

Consult instructions for use

Storage temperature range

Radio communication

CONF

Configuration or unique version identifier

Degree of protection against electric shock: Type BF applied part

IP48

Transmitter: Protected against the effects of continuous immersion in water

(2.4 meters (8 feet) immersion for 30 minutes).

Storage humidity range

RF device distributed in Australia

Marking of Conformity: This symbol means the device fully complies with

MDD 93/42/EEC (NB 0459).

RF device distributed in Canada

Authorized representative in the European community

MiniMed

™

, Enlite

™

, and Guardian

™

are trademarks of Medtronic MiniMed, Inc.

Detachol

is a registered trademark of Ferndale Laboratories Inc.

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Le transmetteur Guardian™ 2 Link est un composant du système de mesure du

glucose en continu pour la pompe à insuline MiniMed

™

640G. Le transmetteur reçoit

les données provenant d'un capteur de glucose Enlite™. Le transmetteur les

transmet ensuite à la pompe à insuline via une connexion sans fil.

Composants du kit de transmetteur Guardian 2 Link

Un kit complet de transmetteur Guardian 2 Link comprend les éléments suivants :

• Transmetteur Guardian 2 Link (MMT-7731)

•

Testeur étanche (MMT-7726)

•

Chargeur (MMT-7715)

•

Serteur One-Press (MMT-7512)

Indications

Le transmetteur est destiné à un usage pour un seul patient, comme composant de

certains systèmes de mesure du glucose en continu de Medtronic et des systèmes

intégrés capteur/pompe de MiniMed.

Contre-indications

N'exposez pas un transmetteur à un équipement IRM, des appareils de diathermie

ou d'autres appareils pouvant générer des champs magnétiques de forte intensité.

En cas d'exposition involontaire du transmetteur à un champ magnétique de forte

intensité, arrêtez-en l'utilisation et contactez l'assistance 24 h/24 ou un représentant

local.

Avertissements

Le produit comporte des pièces de petite taille qui peuvent présenter un risque

d'étouffement pour les enfants en bas âge.

Si le testeur entre en contact avec du sang, le testeur doit être jeté. Éliminez le

testeur conformément à la réglementation locale applicable à l'élimination des

déchets médicaux.

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L'insertion du capteur est susceptible de produire des saignements. Avant la connexion

du transmetteur au capteur, assurez-vous de l'absence de saignement au niveau du site

d'insertion. En cas de saignement, appliquez une pression constante avec une gaze

stérile ou un tissu propre sur le site d'insertion jusqu'à l'arrêt du saignement. Lorsque le

saignement s'arrête, connectez le transmetteur au capteur.

Contactez l'aide en ligne 24 h/24 ou un représentant local en cas de réactions

indésirables liées au transmetteur ou au capteur.

Champs magnétiques

N'exposez pas un transmetteur à un équipement IRM, des appareils de diathermie ou

d'autres appareils pouvant générer des champs magnétiques de forte intensité. En cas

d’exposition involontaire du transmetteur à un champ magnétique de forte intensité,

arrêtez-en l’utilisation et contactez l'aide en ligne 24 h/24 ou un représentant local.

Radiographie, IRM, diathermie et tomodensitométrie

Avant une radiographie, un traitement par diathermie, un tomodensitogramme, une IRM

ou un autre examen utilisant des radiations, retirez le capteur et le transmetteur avant

d'entrer dans une pièce contenant ces appareils.

Vous trouverez sur votre carte d'urgence des informations importantes sur les systèmes

de sécurité des aéroports et sur l'utilisation de votre transmetteur dans les avions. En cas

de déplacements, veillez à toujours porter sur vous la carte d'urgence fournie avec

l'appareil.

Précautions

Reportez-vous systématiquement au manuel d'utilisation du capteur Enlite pour

l'ensemble des précautions, avertissements et instructions relatifs au capteur.

Utilisez systématiquement le testeur lorsque vous nettoyez le transmetteur. N'utilisez

aucun autre testeur avec le transmetteur.

Ne tournez pas le testeur ou le capteur quand celui-ci est connecté au transmetteur sous

peine d'endommager le transmetteur.

Ne laissez pas de l'eau ou tout autre liquide entrer en contact avec le testeur lorsque

celui-ci n'est pas connecté au transmetteur. Un testeur mouillé peut endommager le

transmetteur.

Évitez que le transmetteur entre en contact avec du liquide lorsque celui-ci n'est pas

connecté à un capteur ou au testeur.

Ne nettoyez pas les joints toriques du testeur, sous peine de les endommager.

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Remarque

Attention : Tout changement ou modification apporté aux appareils sans

l’autorisation expresse de Medtronic Diabetes pourrait interférer

avec votre capacité à faire fonctionner l’appareil, entraîner des

blessures corporelles ou annuler la garantie.

Communication radiofréquence (RF)

L'appareil est conforme à la réglementation de la FCC (Federal Communications

Commission, Commission fédérale américaine pour les communications) et aux

normes internationales de compatibilité électromagnétique.

Cet appareil est conforme aux exigences de la section 15 de la réglementation FCC.

Son fonctionnement est soumis aux deux conditions suivantes : (1) l'appareil ne doit

pas provoquer de brouillage nuisible et (2) il doit accepter les brouillages reçus, y

compris ceux pouvant entraîner un fonctionnement indésirable.

Ces normes ont pour but d'assurer une protection raisonnable contre les

interférences de radiofréquence excessives et d'éviter un fonctionnement indésirable

des appareils causé par des interférences électromagnétiques.

Les tests réalisés ont démontré la conformité de l'appareil aux limites applicables aux

appareils numériques de classe B telles que définies dans la section 15 de la

réglementation FCC. Ces limites ont été fixées afin d'assurer une protection

raisonnable contre les interférences nuisibles en milieu résidentiel. Cet appareil

produit, utilise et peut émettre des signaux de radiofréquence susceptibles de créer

des interférences nuisibles aux communications radio ou télévisuelles. Cependant, il

est impossible de garantir qu'aucune interférence ne se produira dans une

installation particulière. Si cet appareil provoque des brouillages nuisibles à la

réception radio ou télévision, ce qui peut être déterminé en mettant l'appareil hors

tension puis sous tension, l’utilisateur peut essayer de corriger les brouillages en

prenant une ou plusieurs des mesures suivantes :

• Réorientez ou déplacez l'antenne de réception.

• Augmentez la distance entre l'appareil et le récepteur.

Cet appareil peut produire, utiliser et émettre des signaux de radiofréquence et s'il

est installé et utilisé dans le respect du mode d'emploi, est susceptible de créer des

interférences nuisibles aux radiocommunications. Si l'appareil provoque des

interférences de réception radiophonique ou télévisuelle, il est conseillé de tenter de

corriger ces interférences en appliquant une ou plusieurs des mesures qui suivent :

• Réduisez la distance entre le transmetteur et la pompe à insuline à 1,8 mètre

(6 pieds) maximum.

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• Augmentez la distance entre le transmetteur et l’appareil recevant ou émettant le

brouillage.

Lorsque d'autres appareils à radiofréquence sont utilisés, tels que des téléphones

portables ou sans fil, des réseaux sans fil, la communication entre le transmetteur et la

pompe à insuline peut être perturbée. L'interférence ne provoque aucun envoi de

données incorrectes et ne cause aucun dommage aux appareils. Il suffit parfois de se

déplacer ou d'éteindre ces autres appareils pour rétablir la communication. Si les

interférences RF persistent, contactez votre représentant local.

Attention : Tout changement ou modification apporté au transmetteur RF interne

ou à l'antenne non explicitement approuvé par Medtronic peut annuler

le droit de l’utilisateur à faire fonctionner ce système d'administration

d'insuline.

Uniquement pour le Canada