Medtronic MiniMed 7811 Glucose Sensor Transmitter User Manual
Medtronic MiniMed, Inc. Glucose Sensor Transmitter Users Manual
Users Manual
Transmitter
CAUTION: Investigational Device.
Limited by Federal Law to Investigational Use.
GST3C
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Contacts:
Africa: Medtronic Africa (Pty) Ltd.
Tel: +27 (0) 11 677 4800
Australia: Medtronic Australasia Pty. Ltd.
Tel: 1800 668 670 (product orders)
Tel: 1800 777 808 (customer help)
Azerbaijan: Albatros Health Care
Tel: +994 12 498 9537
Bangladesh Sonargaon Healthcare Pvt Ltd.
Mobile: (+91)-9903995417
or (+880)-1714217131
Belarus: Badgin Ltd
Tel: +375 (172) 665128
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Tel: 0800-90805
Bosnia and Herzegovina Intermedical
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Fax: +387 33 202 183
Brasil: Medtronic Comercial Ltda.
Tel: +(11) 3707-3707
Bulgaria Interagro-90 Ltd
Tel: +359 888 636 033
Canada: Medtronic of Canada Ltd.
Tel: 1-800-284-4416 (toll free/sans-frais)
China: Medtronic (Shanghai) Ltd.
24 Hour Help (Cell): +86 400-820-1981
24 Hour Help (Landline): +86 800-820-1981
Croatia Oktal Pharma
Tel: +385 1 659 57 77
Fax: +385 1 659 57 01
Croatia Medtronic B.V.
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
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Fax: +34 91 625 03 90
24 horas: +34 901 120 335
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
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Tel: (+91)-80-22112245 / 32972359
Mobile: (+91)-9611633007
Indonesia: Medtronic International Ltd.
Tel: +65 6436 5090
or +65 6436 5000
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
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Kazakhstan: Medtronic Kazakhstan B.V.
Tel: +77273110580
Latin America: Medtronic, Inc.
Tel: 1(305) 500-9328
Fax: 1(786) 709-4244
Latvija: Ravemma Ltd.
Tel: +371 7273780
Macedonia: Kemofarm
Tel: +389 2 260 36 03
Fax: +389 2 260 36 49
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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
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Tel: +382 20 642 495
Fax: +382 20 642 540
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
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Fax: +47 67 10 32 10
POCCИЯ: Medtronic B. V.
Tel: +7 495 580 73 77
24h: 8-800-200-76-36
Philippines: Medtronic International Ltd.
Tel: +65 6436 5090
or +65 6436 5000
Polska: Medtronic Poland Sp. Z.o.o.
Tel: +48 22 465 6934
Portugal: Medtronic Portugal Lda
Tel: +351 21 7245100
Fax: +351 21 7245199
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Tel: 787-753-5270
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Tel: +82.2.3404.3600
Romania: Trustmed SRL
Tel: +40 (0) 21 220 6477
Schweiz: Medtronic (Schweiz) AG
Tel: +41 (0)31 868 0160
24-Stunden-Hotline: 0800 633333
Fax Allgemein: +41 (0)318680199
Serbia Epsilon
Tel: +381 11 311 5554
Fax: +381 11 311 5554
Singapore: Medtronic International Ltd.
Tel: +65 6436 5090
or +65 6436 5000
Slovenija: Zaloker & Zaloker d.o.o.
Tel: +386 1 542 51 11
24-h pomoč: 386 51 316 560
Slovenská republika: Medtronic Slovakia o.z.
Tel: +421 26820 6986
Fax: +421 268 206 999
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: +886.2.2183.6068
Toll Free: +886.0800.005.285
Thailand: Medtronic (Thailand) Ltd.
Tel: +662 232 7400
Turkiye: Medtronic Medikal Teknoloji
Ticaret Ltd. Sirketi.
Tel: +90 216 4694330
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USA: Medtronic Diabetes Global Headquarters
Tel: +1-800-646-4633
24 Hour HelpLine: +1-800-826-2099
To order supplies: +1-800-843-6687
Ukraine: Med EK Service Ltd.
Tel: +380445457705
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 help line:
+420 233 059 059
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The GST3C 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.
Transmitter kit components
A complete GST3C transmitter kit includes the following components:
• GST3C transmitter (MMT-7811)
• Watertight Tester (MMT-7726)
• Charger (MMT-7715)
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 for further assistance.
Warnings
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 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 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 pump when you are traveling.
Precautions
Refer to the sensor user guide for all precautions, warnings, and instructions relating to
the sensor.
Always use the Watertight 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 6 feet
(1.8 meters) 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 the 24 Hour HelpLine.
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'utilisateur de
l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est
susceptible d'en compromettre le fonctionnement.
Assistance
Medtronic MiniMed provides a 24 Hour HelpLine for assistance. The HelpLine is staffed
with representatives who are trained in the set-up and operation of your CGM system.
When calling the HelpLine, please have your pump serial number available. Your pump
serial number and the 24 Hour HelpLine phone number are listed on the back of your
device.
Department Telephone number
24 Hour HelpLine (calls within the United States) 800 826 2099
24 Hour HelpLine (calls outside the United States) +1 818 576 5555
Web site www.medtronicdiabetes.com
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, size E92,
type LR03 to operate.
Note: A new AAA or LR-03 battery contains enough power to recharge the transmitter at
least 40 times. 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:
1 Push the battery cover in and slide it off (as shown in the following illustration).
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2 Insert a new alkaline AAA or LR-03 battery. Make sure the + and - symbols on
the battery align with these same symbols shown on the charger.
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 seven days without recharging. A
depleted transmitter can take up to one hour to recharge.
To charge the transmitter:
1 Connect the transmitter to the charger by lining it up, flat
side down, with the charger. Push the two components
together fully.
2 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.
3 When charging is complete, the green light on the charger
will stay on, without flashing, for 15 to 20 seconds and then
turn off.
4 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 available your pump user guide.
To connect the transmitter to the sensor:
1 After the sensor is inserted, consult your serter user guide for details on applying the
required overtape.
2 Hold the rounded end of the inserted sensor to prevent it from moving during
connection.
3 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.
4 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.
5 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.
6 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.
7 After the transmitter successfully sends sensor data to the pump, attach the sensor's
adhesive tab to the transmitter.
8 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 available your pump user guide.
To disconnect the transmitter from the sensor:
1 Carefully remove any occlusive dressing from the
transmitter and sensor.
2 For the Enlite sensor, remove the adhesive tab from the top
of the transmitter.
3 Hold the transmitter as shown, and pinch the flexible side
arms of the sensor between your thumb and forefinger.
4 Gently pull the transmitter away from the sensor.
5 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 8 feet (2.4 meters) for up to 30 minutes. You can shower and swim without
removing them. No occlusive dressing 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 Watertight Tester with the transmitter. Do not use any
other test plug.
i✓
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. 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:
1 Hold the transmitter and the tester as shown. Line up the
flat side of the tester with the flat side of the transmitter.
2 Push the tester into the transmitter until the flexible side
arms of the tester click into the notches on both sides of the
transmitter.
3 Within five seconds, when properly connected, the green
light on the transmitter flashes for about 10 seconds.
4 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).
5 To clean the transmitter, see Cleaning the transmitter, on page 9.
6 After testing or cleaning, disconnect the tester from the transmitter.
Disconnecting the tester
To disconnect the tester:
1 Hold the transmitter body as shown and pinch the side
arms of the tester.
2 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.
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.
The device must be discarded according to local regulations for battery
disposal (non-incineration).
To clean the transmitter:
1 Wash your hands thoroughly.
2 Attach the tester to the transmitter.
3 If optional occlusive dressing was used and there is adhesive residue on the
transmitter, see Removing adhesive residue, on page 12.
4 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.
5 Prepare a cleaning solution using one teaspoon (five milliliters) of mild liquid soap per
one gallon (3.8 liters) of room temperature tap water. Never use organic solvents,
such as paint thinner or acetone, to clean the transmitter.
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6 With tester still attached, submerge the transmitter in the cleaning solution and
soak for one minute.
7 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.
8 Rinse the transmitter under running room temperature tap water for at least one
minute, and until all visible liquid soap is gone.
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9 Dry the transmitter and tester with a clean, dry cloth.
10 Holding the tester, wipe the transmitter with 70% isopropyl alcohol.
11 Place the transmitter and tester on a clean, dry cloth and air dry them completely.
12 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.
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To remove adhesive residue, you will need the following materials: Detachol®
medical adhesive remover and cotton swabs.
To remove adhesive residue:
1 Make sure the tester is attached to the transmitter.
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.
3 Continue with the cleaning procedure above.
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:
1 Wash your hands thoroughly.
2 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.
3 Place the charger on a clean, dry cloth and air dry for 2–3 minutes.
Troubleshooting
The following table contains troubleshooting information for the transmitter, charger,
and tester. For more information about troubleshooting, see your pump user guide.
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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 moisture. 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.
2 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.
During charging, the
flashing green light on
the charger turns off
and you see a flashing
red light on the
charger.
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.
1 Charge the transmitter continuously for
one hour. If flashing does not stop, pro-
ceed to step 2.
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.
1 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.
2 Charge the transmitter continuously for
one hour. If flashing does not stop, pro-
ceed to step 3.
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.
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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 sensor.
Your transmitter is not
fully connected.
Your transmitter is low
on power.
Your sensor is not prop-
erly inserted into your
body.
1 Disconnect the transmitter from the
sensor.
2 Wait for five seconds and reconnect them.
If the green light still does not flash, pro-
ceed to step 3.
3 Fully charge the transmitter. If the green
light still does not flash, proceed to step 4.
4 The sensor may not be properly inserted
into your body. Insert a new sensor.
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.
2 Fully charge the transmitter.
3 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
seven days.
Your transmitter is not
fully charged when you
connect it to the sensor.
The transmitter and
pump frequently lose
wireless connection.
1 Fully charge the transmitter before con-
necting it to the sensor. If the transmitter
battery still does not last for seven days,
proceed to step 2.
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.
3 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 seven days,
call the 24 Hour HelpLine or your local
representative. It may be time to replace
your transmitter.
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Problem Likely Cause(s) Resolution
Your transmitter has
lost connection with
your pump.
Your pump is out of
range.
There is RF interference
from other devices.
1 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.
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.
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
Because the transmitter contains a battery, do not discard in a bio-waste container.
Instead, continue to clean the transmitter, and then discard according to local regulations
for battery disposal.
Specifications
Biocompatibility Transmitter: Complies with EN ISO 10993-1
Applied parts Transmitter
Sensor
Operating conditions Transmitter temperature: 23°F to 113°F (-5°C to 45°C)
Caution: When operating the transmitter on a tester in air temperatures
greater than 106°F (41°C), the temperature of the transmitter may ex-
ceed 109°F (43°C)
Transmitter relative humidity: 5% to 95% with no condensation
Transmitter pressure: 8.9 to 15.4 psi (61.36 to 106.17 kPa)
Charger temperature: 50°F to 104°F (10°C to 40°C)
Charger relative humidity: 30% to 75% with no condensation
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Storage conditions Transmitter temperature: -13°F to 131°F (-25°C to 55°C)
Transmitter relative humidity: 10% to 100% with condensation
Transmitter pressure: 8.9 to 15.4 psi (61.36 to 106.17 kPa)
Charger temperature: 14°F to 122°F (-10°C to 50°C)
Charger relative humidity: 10% to 95% with no condensation
Battery life Transmitter: Seven days of continuous glucose monitoring immediately
following a full charge
Charger: Completes 40 typical charging operations using a new AAA
alkaline battery
Transmitter frequen-
cy
2.4 GHz, 2M65G1D modulation, less than 1mW ERP
Radio Frequency (RF)
communications
Pump to transmitter frequency: 2.4 GHz; proprietary Medtronic proto-
col; range up to 6 feet (1.8 meters).
Utilizes the IEEE 802.15.4 protocol with proprietary data format.
Transmitter expected
service life
The transmitter expected service life is 1 year depending on patient
usage.
GST3C wireless communication
Quality of service
The 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 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).
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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.
Guidance and manufacturer's declaration
Guidance and Manufacturer's Declaration - Electromagnetic Emissions
The GST3C transmitter is intended for use in the electromagnetic environment speci-
fied below. The customer or the user of the GST3C transmitter should make sure that
it is used in such an environment.
Emissions Test Compliance Electromagnetic Environment - Guidance
RF emissions
CISPR 11
Group 1 The GST3C transmitter must emit electromagnetic energy in order
to perform its intended function. Nearby electronic equipment may
be affected.
RF emissions
CISPR 11
Class B The GST3C transmitter 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 GST3C transmitter is intended for use in the electromagnetic environment speci-
fied below. The customer or the user of the GST3C transmitter should assure that it is
used in such an environment.
Immunity Test IEC 60601 Test Level Compliance
Level
Electromagnetic Envi-
ronment - Guidance
Electrostatic dis-
charge (ESD)
IEC 61000-4-2
±2 kV, ±4 kV, ±8 kV Air
±2 kV, ±4 kV, ±6 kV Indi-
rect
±8 kV Air
±6 kV Indirect
±22 kV Air,
<5% RH
For use in a typical domes-
tic, commercial, or hospital
environment.
Electrical fast transi-
ent/burst
±2 kV for power supply
lines
Not applicable Requirement does not ap-
ply to this battery powered
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 powered
device.
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Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The GST3C transmitter is intended for use in the electromagnetic environment speci-
fied below. The customer or the user of the GST3C transmitter should assure that it is
used in such an environment.
Immunity Test IEC 60601 Test Level Compliance
Level
Electromagnetic Envi-
ronment - Guidance
Voltage dips, short in-
terruptions and volt-
age variations on
power supply lines
IEC 61000-4-11
<5% UT (>95% dip in UT)
for 0.5 cycle
Not applicable Requirement does not ap-
ply to this battery powered
device.
Power frequency
(50/60 Hz) magnetic
field
IEC 61000-4-8
3 A/m 400 A/m
4000 A/m
Power frequency magnetic
fields should be at levels
characteristic of a typical lo-
cation in a typical domestic,
commercial, or hospital
environment.
Note: UT is the a.c. mains voltage prior to application of the test level.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity
The GST3C transmitter is intended for use in the electromagnetic environment speci-
fied below. The customer or user of the GST3C transmitter should assure that it is
used in such an electromagnetic environment.
Immunity Test IEC 60601 Level Compliance Lev-
el
Electromagnetic Environ-
ment Guidance
Portable and mobile RF commu-
nications equipment should be
used no closer to any part of the
GST3C transmitter, including ca-
bles, than the recommended
separation distance calculated
from the equation applicable to
the power of the transmitter.
Refer to the recommended sep-
aration distance table for more
information.
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 GST3C transmitter is intended for use in the electromagnetic environment speci-
fied below. The customer or user of the GST3C transmitter should assure that it is
used in such an electromagnetic environment.
Immunity Test IEC 60601 Level Compliance Lev-
el
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 P
80 MHz to 800 MHz
d = 0.70 P
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 surveya,
should be less than the compli-
ance level in each frequency
rangeb.
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.
aField 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 GST3C transmitter is used exceeds the applicable RF compliance level above,
the GST3C transmitter should be observed to verify normal operation. If abnormal performance is ob-
served, additional measures may be necessary, such as re-orienting or relocating the GST3C
transmitter.
bOver 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 GST3C transmitter 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 GST3C transmitter
The GST3C transmitter is intended for use in an electromagnetic environment in which
radiated RF disturbances are controlled. The customer or the GST3C transmitter users
can help prevent electromagnetic interference by maintaining a minimum distance be-
tween portable and mobile RF communications equipment and the GST3C transmitter
as recommended below, according to the maximum output power of the communica-
tions 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 P
800MHz to 6.0GHz
d = 0.70 P
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.
Icon Table
Serial number
Catalogue number
One per container/package
Date of manufacture (year - month)
Manufacturer
Follow instructions for use (appears blue on label)
Storage temperature range
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Radio communication
Configuration
Type BF equipment (protection from electrical shock)
IP48
Transmitter: Protected against the effects of continuous immersion in water
(8 feet (2.4 meters) immersion for 30 minutes).
Attention: Read all warnings and precautions in instructions for use.
Storage humidity range
©2014 Medtronic MiniMed, Inc. All rights reserved.
MiniMed™, Enlite™, and Guardian™ are trademarks of Medtronic MiniMed, Inc.
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MMT-7811
MMT-7726
MMT-7715
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