Medtronic MiniMed 7703 Glucose Sensor Transmitter (GST1) User Manual Mp6025200 011 3e
Medtronic MiniMed, Inc. Glucose Sensor Transmitter (GST1) Mp6025200 011 3e
manual
1
The Medtronic MiniMed MiniLink™ transmitter (MiniLink) is a component of
continuous glucose sensing systems and sensor-enabled pump systems. The
MiniLink powers the glucose sensor, collects glucose data, and wirelessly sends
the data to a monitor. The monitor is part of a Medtronic MiniMed continuous
glucose sensing system or Medtronic MiniMed sensor-enabled pump system.
Package contents
Indications for use
The MiniLink is indicated for use as a component of select Medtronic continuous
glucose sensing systems and sensor-enabled pump systems.
Contraindications
None known.
• MiniLink transmitter • MiniLink tester
• MiniLink charger • Occlusive dressing (10 pack)
• AAA alkaline battery
0LQL/LQNFKDUJHU
0LQL/LQNWHVWHU
0LQL/LQNWUDQVPLWWHU
2
Warnings
Do not use the MiniLink to send glucose readings to the monitor while onboard an
aircraft. Disconnect the MiniLink from the sensor while travelling on an aircraft or if
interference with other transmitting devices occurs.
The sensor should be removed if redness, bleeding, pain, tenderness, irritation, or
inflammation develops at insertion site, or if user experiences unexplained fever.
Occlusive dressing should be removed if irritation or reaction to the tape develops.
The sensor may create special needs regarding your medical conditions or
medications. Discuss with your doctor before using the sensor.
Wait 5 minutes after sensor insertion to see if bleeding occurs at the insertion site:
• The MiniLink should not be attached to the sensor until after the bleeding has
stopped.
• If bleeding persists, apply steady pressure using a sterile gauze or clean cloth
at the insertion site until bleeding stops. After bleeding stops, attach the
MiniLink to the sensor.
• If bleeding persists after 3 minutes, remove the sensor and discard. Insert a
new sensor in a different location.
Contact the Medtronic Diabetes 24 Hour HelpLine if you experience any adverse
reactions associated with the MiniLink or sensor.
Note: The MiniLink is designed to withstand common electromagnetic
interference, including airport security systems.
Precautions
Establish a rotation schedule for choosing new sensor sites. Avoid sites that are
constrained by clothing, have scar tissue, or are subject to rigorous movement
during exercise.
3
Telecommunications notice
This device complies with the United States Federal Communications
Commission and international standards for electromagnetic compatibility. For the
specific regulations and test results in your area, please contact the Medtronic 24
Hour HelpLine listed on the International Contact Card.
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 undesirable operation. Changes or modifications not expressly
approved by the party responsible for compliance could void the user's authority
to operate the equipment.
The MiniLink does not interfere with any radio frequency signals transmitted from
outside sources.These FCC standards are designed to provide reasonable
protection against excessive radio frequency interference and prevent
undesirable operation of the device from unwanted electromagnetic interference.
This device receives and radiates radio frequency energy and, if installed and
used in accordance with the instruction, may experience interference in its
communications. In such an event, you are encouraged to try to correct the
interference by one or more of the following measures:
• Reorient or relocate the MiniLink and/or receiving pump or monitor
• Increase the distance between the MiniLink and the device that is
emitting interference
• Turn off or move other RF devices, such as the following: cell phones,
cordless phones, and wireless networks.
This interference will not cause any incorrect data to be sent and will not cause
any harm to your pump, monitor, or MiniLink.
4
MiniLink charger
The MiniLink transmitter contains a non-replaceable, rechargable battery so you
can recharge your MiniLink as needed. Before using your MiniLink for the first
time, you should charge the battery fully. To maintain a short re-charging period,
charge the MiniLink after each sensor use. While the MiniLink will work more than
14 days without recharging, an empty battery can take up to 2 hours to recharge.
Installing a new charger battery
1Unscrew charger battery cap.
2Insert an AAA battery with flat (-) end first and screw on charger cap.
3If battery is installed incorrectly or is bad, the charger will not work when the
MiniLink is attached. Repeat steps above using a new battery.
5
Note: A new AAA battery in the charger may charge the MiniLink over 40 times
before it needs to be replaced.
Charging the MiniLink
1Insert the MiniLink into the charger. Line
up the MiniLink connector (flat side down)
with the charger and push the two
components together fully.
Note: The charger contains green and red
LEDs (lights).
2When the MiniLink is first connected, the
charger’s green LED will blink rapidly for
1-2 seconds as charger powers on.
3As the MiniLink charges, the charger’s green LED will flash occassionally.
4When charging is complete, the charger’s green LED will turn on for 15 to 20
seconds and then turn off. Once the LED is off, disconnect the MiniLink from
$JUHHQ/('VKRZV
FKDUJHULVZRUNLQJ
$UHG/('DSSHDUVLI
FKDUJHUEDWWHU\QHHGV
UHSODFHPHQW25
WKHUHLV
DSUREOHP
ZLWKWKH
0LQL/LQN
EDWWHU\
DERXW
VHF
DERXW
VHF
6
the charger. A green LED inside the MiniLink will blink for about 5 seconds and
then turn off. This confirms that the MiniLink is ready to use.
Note: If the green LED inside the MiniLink does not blink, re-connect the
MiniLink to the charger for at least one minute. After one minute, remove
the MiniLink from the charger and watch for the MiniLink to flash green.
Connect to the sensor.
Caution: If the MiniLink LED is still lit or flashing, do not connect
the MiniLink to the charger.
Checking battery status
The charger’s red LED will flash if the charger’s internal battery is low or if the
MiniLink battery is bad.
If the charger AAA battery is low, the red LED will flash once about every 2
seconds. Replace with new AAA battery.
If the MiniLink’s battery is bad, the red LED on the charger will blink fast for about
2 seconds, turn off for about 2 seconds, and then repeat the cycle. Call the
Medtronic Diabetes 24 Hour HelpLine.
DERXWVHFV DERXWVHFV
DERXWVHFV DERXWVHFV
DERXWVHFV
7
If the charger AAA battery is low AND the MiniLink battery is bad, the red LED will
blink rapidly for 1 second, pause for 1 second, then blink once. After a 2 second
pause, the cycle repeats. Call the Medtronic Diabetes 24 Hour HelpLine.
Setting up the MiniLink transmitter
1Find the MiniLink 7-digit serial number on the flat
side of the device as shown at right. The serial
number starts with “2”.
2Enter the serial number into your continuous
glucose sensing system monitor or sensor-
enabled pump. See your monitor or pump user
guide for using a sensor transmitter with your
system.
Connecting to sensor
1Follow the instructions provided with your sensor
and insert the sensor before connecting the MiniLink.
2Once the sensor is inserted and adhered to your body, wait 5 minutes to check
for bleeding. Make sure that any bleeding has stopped (see Warnings page for
details), then connect the MiniLink to the sensor.
DERXW
VHF
DERXW
VHF
DERXWVHFV DERXW
VHF
DERXW
VHF
MEDTRONIC MINIMED
MiniLink Transmitter
REF MMT-7703XX
SN GT2XXXXXXM
FCC D: OH27703
IC: 3458-7703
1234
TM
IPX8
SN GT2XXXXXXM
8
3Hold the MiniLink as shown at right.
Touch the inserted sensor at back of
assembly to prevent movement..
4Align the MiniLink connector with the
sensor connector. The MiniLink flat
underside (with the label) should face
the skin.
5Slide the MiniLink onto the sensor.
Make sure it is pushed in firmly.The
flexible side arms of the sensor will “click”
into notches on the underside of the
MiniLink. The MiniLink will flash green for
about 10 seconds with a proper
connection.
6The MiniLink will begin to send signals to
the monitor or the pump (see your pump
or monitor user guide for instructions).
Note: If you connect the MiniLink to a sensor that has not been inserted into
your body, it will NOT flash and will NOT transmit to a monitoring device.
9
7After the MiniLink successfully
transmits signals to a monitor or pump,
you may choose to put an occlusive
dressing over the MiniLink and the
sensor.
Bathing and swimming
Once the MiniLink and sensor are
connected, they form a water-tight seal to
a depth of 8 feet for up to 30 minutes. You
can shower and swim without removing
them. No occlusive dressing is needed.
Disconnecting from sensor
1Hold the MiniLink as shown, and pinch the flexible side arms of the sensor
between thumb and forefinger.
2Gently pull the MiniLink away from the sensor assembly.
10
MiniLink tester
The tester is used to test the MiniLink and to make sure it is working.
Connecting the tester
1Grasp the MiniLink between the thumb and forefinger. Hold the tester body
with the thumb and forefinger of the other hand. Align flat side of the tester with
flat side of the MiniLink.
2Plug the tester into the MiniLink. The flexible side arms of the tester will click
into notches on the MiniLink underside. The MiniLink will flash green for about
10 seconds when properly connected.
'LGWKH0LQL/LQNIODVK"
<HV0LQL/LQNLVZRUNLQJ
1R&KHFNFRQQHFWLRQ
,IVWLOOQRIODVK0LQL/LQN
EDWWHU\QHHGVFKDUJLQJ25
WKH0LQL/LQNLVQRWZRUNLQJ
5HFKDUJHEDWWHU\
VHH&KDUJHUVHFWLRQ
11
3Use the pump or glucose sensing monitor to check that the MiniLink is sending
a signal (see the pump or monitor user guide).
Disconnecting the tester
1Hold the MiniLink body as shown and pinch the side arms of the tester.
2With the tester arms pinched, gently pull the MiniLink away from the tester.
&$87,217RVDYH
0LQL/LQNEDWWHU\OLIH
GR127OHDYHVHQVRU
RUWHVWHUFRQQHFWHG
RQFH\RXNQRZWKH
0LQL/LQNLVZRUNLQJ
12
Cleaning the MiniLink
Caution: The charger and tester units are NOT water-tight. Do
NOT immerse either in water.
For single-patient use
1Wash your hands thoroughly.
2Dampen a clean cloth with mild liquid soap and warm water. Wipe the outside
of the MiniLink.
3Rinse the MiniLink under warm tap water but do NOT get water inside the
connector.
4Using an antibacterial hand-sanitizer (available at a local drugstore) on a clean,
dry cloth, wipe down the MiniLink. Make sure to dry the inside of the connector.
5Place the MiniLink on a clean, dry cloth and air dry for 2-3 minutes.
Caution: DO NOT discard the MiniLink transmitter in a medical
waste container or otherwise subject it to incineration.
MiniLink contains a battery which may explode upon
incineration.
For multiple-patient use
1Wash your hands thoroughly.
2Dampen a clean cloth with a mild liquid soap solution. Wipe the outside of the
MiniLink.
3Rinse the MiniLink under warm tap water but do NOT get water inside the
connector.
4Apply 3-4 drops of a quaternary ammonium compound disinfectant (for
example, Cavicide®) on a clean, dry cloth and wipe the MiniLink.
5Hold the MiniLink and rinse with 70% Isopropyl alcohol.
6Place the MiniLink on a clean, dry, non-shedding cloth and air dry.
7Once the MiniLink is completely dry, place it in a sealed bag labeled with the
cleaning date (see label example below).
13
8If there is any blood inside the connector, the MiniLink must be discarded.
Dispose of the MiniLink according to the local regulations for battery disposal
(non-incineration).
([DPSOH0XOWLSOHXVHFOHDQLQJODEHO
'HYLFH
'DWH
0HWKRGRI'HFRQWDPLQDWLRQ
:DVK
'LVLQIHFWDQW
14
Specifications
Biocompatibility Transmitter: Complies with ISO 10993-1 for
long-term body contact
Operating Conditions
Transmitter Temperature: +32° to +122° F (0°
to 50° C)
Transmitter Relative Humidity: 10% to 95%
with no condensation
Charger Temperature: +50° to +104° F (10° to
40° C)
Charger Relative Humidity: 30% to 75% with
no condensation
Storage Conditions
Transmitter Temperature: -4° to +131° F (-20°
to +55° C)
Transmitter Relative Humidity: 10% to 100%
with condensation
Charger Temperature: +14° to +122° F (-10°
to +50° C)
Charger Relative Humidity: 10% to 95% with
no condensation
Battery Life
Transmitter: 14 days of continuous sensor use
immediately following a full charge
Charger: Completes 40 typical charging
operations using a new AAA battery
Transmitter Frequency 868.5 megahertz or 916.35 megahertz
15
Icon table
SN Serial Number
REF Catalogue Number
(1x) One per container/package
Date of Manufacture
Manufacturer
Fragile Product
Attention: See Instructions for use
Temperature Range
CE mark by notified body as a medical device
CE mark as a radio transmitter under the R & TTE
95/5/EC directives
Radio communications
Configuration
Type BF Equipment (Protection from electrical shock)
0459
0976
16
Warranty
Medtronic MiniMed warrants the Medtronic MiniMed MiniLink to the purchaser of
the product against defects in material and workmanship for a period of six (6)
months and the MiniLink charger for up to six (6) months from the date of
purchase.
During the warranty period, Medtronic MiniMed will repair or , at its discretion, any
defective MiniLink or MiniLink charger, subject to the conditions and exclusions
stated herein. This warranty applies only to new devices. In the event a MiniLink
or charger is repaired or replaced, the warranty period will not be extended past its
original expiration date.
This warranty is valid only if the Medtronic MiniMed MiniLink or charger is used in
accordance with the manufacturer's instructions. Without limitation, this warranty
will not apply:
• If damage results from changes or modifications made to the MiniLink or
charger by the user, or third parties, after the date of sale;
• If service or repairs are performed by any person or entity other than the
manufacturer;
• If damage results from a Force Majeure or other event beyond the control of
the manufacturer;
• If damage results from negligence or improper use, including but not limited
to: improper storage, submersion in fluid, physical abuse (such as dropping),
or otherwise; or
• If blood or water has entered the inside of the MiniLink connector.
IPX8 MiniLink: Protected Against the Effects of Continuous
Immersion in Water (8 feet immersion for 30 minutes)
Icon table
17
This warranty shall be personal to the original user. Any sale, rental or other
transfer or use of the product covered by this warranty to or by a user other than
the original user shall cause this warranty to immediately terminate. This warranty
does not apply to Glucose Sensors and other accessories.
The remedies provided for in this warranty are the exclusive remedies available
for any defects in material or workmanship in the product. Neither Medtronic
MiniMed nor its suppliers or distributors shall be liable for any incidental,
consequential, punitive or special damages of any nature or kind caused by or
arising out of a defect in the product.
All other warranties, expressed or implied, are excluded and specifically
disclaimed, including, but not limited to, any warranty of merchantability or fitness
for a particular purpose.
© 2006, Medtronic MiniMed. All rights reserved.
MiniMed® is a registered trademark of Medtronic MiniMed.
MiniLink™ is a trademark of Medtronic MiniMed.
This product is covered by at least the following U.S. Patent Nos: 5,586,533;
5,954,643; 6,248,067; 6,368,141; 6,418,332; 6,809,653.
U.S., International and/or foreign patents are pending.
18