Medtronic CGMS iPro User Manual
CGMS® iProTM Continuous Glucose Recorder
User Guide
©2007, Medtronic MiniMed, Inc. All rights reserved.
CGMS®, Paradigm®, Paradigm Link® and Sen-serter® are registered trademarks of Medtronic MiniMed, Inc.
iPro™ is a trademark of Medtronic MiniMed, Inc.
Cavicide® is a registered trademark of Metrex.
Detachol® is a registered trademark of Ferndale Laboratories, Inc.
®
UltraLink™ is a trademark and OneTouch
FreeStyle Flash
®
is a registered trademark of Abbott Laboratories.
and Ultra® are registered trademarks of LifeScan, Inc.
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.
6025286-0U1 061608
REF MMT 7708
Contents
Using the system . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
CGMS iPro Continuous Glucose Recorder components . . . . . . . . . . . . . 3
Optional components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Indications for use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Sensor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5
CGMS iPro Magnetic Wand interference . . . . . . . . . . . . . . . . . . . . 6
CGMS iPro Magnetic Wand interference with insulin pumps . . . . . . . 6
CGMS iPro Magnetic Wand interference with PC hard drives . . . . . . . 6
Other electromagnetic interference . . . . . . . . . . . . . . . . . . . . . . 6
Precautions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
FCC notice . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7
RF interference from other wireless devices . . . . . . . . . . . . . . . . . 7
Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Other countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8
Charger . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Installing a new charger battery . . . . . . . . . . . . . . . . . . . . . . . . . 9
Charging the digital recorder . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Hardware setup . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
Supported meters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Serial switch box . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
Using the CGMS iPro digital recorder and CGMS iPro Wand . . . . . . . . 13
Communicating with Solutions CGMS iPro . . . . . . . . . . . . . . . . . . . . 14
Setting up the digital recorder . . . . . . . . . . . . . . . . . . . . . . . . . 14
Connecting the glucose sensor . . . . . . . . . . . . . . . . . . . . . . . . . 14
Downloading data from the digital recorder . . . . . . . . . . . . . . . . 16
Calibrating Solutions CGMS iPro . . . . . . . . . . . . . . . . . . . . . . . . 16
Bathing and swimming . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
CGMS® iProTM Continuous Glucose Recorder User Guide 1
Disconnecting from the glucose sensor . . . . . . . . . . . . . . . . . . . . 17
Tester . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Connecting the tester . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
Disconnecting the tester . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
Cleaning the CGMS iPro Digital Recorder . . . . . . . . . . . . . . . . . . . . 20
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
Guidance and manufacturer’s declaration . . . . . . . . . . . . . . . . . . . 22
Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26
Warranty, United States . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
Warranty, Other countries . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
Icon table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
Index . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
2 CGMS® iProTM Continuous Glucose Recorder User Guide
Using the system
The CGMS® iProTM Continuous Glucose Recorder continuously collects and records
®
patient glucose data. This data is then downloaded to the Solutions
®
CGMS
iProTM Continuous Glucose Recorder where it can be used to create clinical
reports. Performance data for this device can be found in the Solutions Software user
guide.
Software for
Digital Recorder Tester Charger CGMS iPro Wand
CGMS iPro Continuous Glucose Recorder components
A complete CGMS iPro Continuous Glucose Recorder kit includes:
•CGMS iPro Digital Recorder (MMT-7709) • Charger (MMT-7705)
• Sen-serter® device (MMT-7500)
(not shown)
• Blue Tester (MMT-7706) • Occlusive dressing (not shown)
• AAA alkaline battery(ies), size E92,
type LR03 (not shown)
You will also need the following components:
•COMLINKTM CGMS iProTM (MMT-7304NPRO/MMT-7304WPRO)
•CGMS iPro Magnetic Wand
(MMT-7712)
CGMS® iProTM Continuous Glucose Recorder User Guide 3
• Solutions® Software for CGMS® iProTM Continuous Glucose Recorder (MMT-7319)
Optional components
The following optional components allow you to connect up to four serial devices to
your PC at once. For example, you can connect a meter and a COMLINK iPro to your PC
at the same time.
• Manual serial data switch box (Part number: 1112058-003)
• Serial interface cable for the manual serial data switch box (MMT-7324)
Indications for use
The CGMS iPro Digital Recorder is intended to continuously record interstitial glucose
levels in persons with diabetes mellitus. This information is intended to supplement,
not replace, blood glucose information obtained using standard home glucosemonitoring devices. The information collected by the digital recorder may be
downloaded and displayed on a computer and reviewed by healthcare professionals.
This information may allow identification of patterns of glucose-level excursions above
or below the desired range, facilitating therapy adjustments which may minimize these
excursions.
The CGMS iPro Digital Recorder:
• Is intended for prescription use only.
• Will not allow readings to be made available directly to patients in real time.
• Provides readings that will be available for review by physicians after the recording
interval (72 hours).
• Is currently intended for occasional rather than everyday use.
• Is to be used only as a supplement to, and not a replacement for, standard invasive
measurement.
• Is not intended to change patient management based on the numbers generated, but
to guide future management of the patient based on response to trends noticed.
That is, these trends or patterns may be used to suggest when to take fingerstick
glucose measurements to better manage the patient.
The glucose sensor, tester, charger, and CGMS iPro Wand are intended for use with the
®
CGMS iPro Digital Recorder. The Sen-serter
device is indicated only for insertion of the
Medtronic MiniMed glucose sensor.
4 CGMS® iProTM Continuous Glucose Recorder User Guide
Contraindications
Do not use magnetic mattress pads while wearing the CGMS iPro Digital Recorder. The
magnetic mattress pad will cause the digital recorder to frequently enter a
transmission mode that will quickly drain the rechargeable battery and will temporarily
disable data collection. Therefore, there will be sensor data gaps and the digital
recorder is likely to not function for the entire 3-day duration. The magnetic mattress
pad will not, however, affect the accuracy of the sensor readings that are collected,
nor will it lead to any unsafe conditions.
Do not expose your digital recorder to MRI equipment or other devices that generate
strong magnetic fields. If your digital recorder is inadvertently exposed to a strong
magnetic field, discontinue use and contact your physician.
Warnings
Product contains small parts and may pose a choking hazard for young children.
Sensor
The glucose sensor should be removed if redness, bleeding, pain, tenderness, irritation,
or inflammation develops at the insertion site, or if you experience unexplained fever.
An optional occlusive dressing should be removed if irritation or reaction to the tape
develops.
The glucose sensor may create special needs regarding your patients’ medical
conditions or medications. Healthcare professionals should discuss this with their
patients before they use the glucose sensor.
Wait five minutes after glucose sensor insertion before setting up the CGMS iPro Digital
Recorder with the Solutions CGMS iPro.
• Make sure that the site is not bleeding before connection. If any blood gets inside
the digital recorder connector, the digital recorder must be discarded.
• If bleeding occurs, apply steady pressure with a sterile gauze or clean cloth at the
insertion site until bleeding stops. After bleeding stops, attach the digital recorder
to the glucose sensor.
• If bleeding persists after three minutes, remove the glucose sensor and discard.
Insert a new glucose sensor in a different location.
Contact your local country representative or the 24 Hour HelpLine (US) if you
experience any adverse reactions associated with the digital recorder or glucose sensor.
CGMS® iProTM Continuous Glucose Recorder User Guide 5
CGMS iPro Magnetic Wand interference
Do not store the CGMS iPro Magnetic Wand or any other magnet within 1.5 inches (3.8
cm) of the CGMS iPro Digital Recorder. Premature battery discharge may occur.
Do not place the CGMS iPro Magnetic Wand or any other magnet within 1.5 inches (3.8
cm) of the CGMS iPro Digital Recorder except while performing patient set-up and data
download procedures. Premature battery discharge may occur.
CGMS iPro Magnetic Wand interference with insulin pumps
Do not place the CGMS iPro Magnetic Wand directly on any insulin pump. Incorrect
pump operation may occur.
Do not insert the glucose sensor with attached CGMS iPro Digital Recorder closer than
two to three inches (5.08 - 7.62 cm) from the insulin pump. The use of the CGMS iPro
Magnetic Wand may inadvertently cause incorrect operation of the pump.
CGMS iPro Magnetic Wand interference with PC hard drives
Do not place the CGMS iPro Magnetic Wand on your PC or external hard drives, as the
magnetic field may impact the integrity of the data files stored there.
Other electromagnetic interference
The CGMS iPro Digital Recorder is designed to withstand common electromagnetic
interference, including airport security systems.
Precautions
If performing multiple CGMS iPro Digital Recorder studies on the same patient, establish
a rotation schedule for choosing new glucose sensor sites. Avoid sites that are
constrained by clothing, have scar tissue, or are subject to rigorous movement during
exercise.
If any blood gets inside the digital recorder connector, the digital recorder must be
discarded.
If you do not plan to use the digital recorder for at least 30 days, connect it to the
charger for storage. The charger will not keep the digital recorder charged, but it will
slow the digital recorder’s battery discharge. Remove the digital recorder from the
charger at least once every 60 days, wait at least one minute, then reconnect the
digital recorder to the charger. To use the digital recorder after it has been stored,
disconnect it from the charger, wait at least one minute, then reconnect it again to
start the charging process. It may take up to eight hours to fully charge a digital
recorder that has been stored for more than 30 days.
6 CGMS® iProTM Continuous Glucose Recorder User Guide
FCC notice
This device complies with the United States Federal Communications Commission (FCC)
and international standards for electromagnetic compatibility.
This device complies with Part 15 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.
The CGMS iPro Digital Recorder 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.
Important: Changes or modifications not expressly approved by the party
responsible for compliance could void the user’s authority to operate the
equipment.
RF interference from other wireless devices
Common consumer wireless devices that transmit in the same 916.5MHz/868.35MHz
frequency band used by the MMT-7709 CGMS iPro Digital Recorder (DR) transmitter may
prevent the DR transmitter from downloading appropriately to Solutions CGMS iPro
through the MMT-7304NPRO/MMT-7304WPRO COMLINK iPro receiver. Most cellular
(mobile) phones and 900 MHz cordless phones, when transmitting or receiving, may
cause significant disruption to communication between the DR transmitter and the
COMLINK iPro receiver. It is likely that other wireless devices co-existing in similar
frequency ranges will have a similar effect. This interference, however, will not cause
any incorrect data to be sent and will not cause any harm to your digital recorder.
Communication problems between the iPro DR transmitter and COMLINK iPro receiver
can usually be resolved or corrected by:
• making sure that the transmitter and receiver are as close to each other as possible,
and no further apart than six feet (1.8 meters),
• turning off, or moving away from, other RF wireless transmitting devices,
• reorienting or relocating the DR transmitter and/or COMLINK iPro receiver.
Testing conducted with several different cellular phones suggests that interference will
not be a problem if the phone is at least 12 inches (31 cm) from the DR transmitter or
CGMS® iProTM Continuous Glucose Recorder User Guide 7
COMLINK iPro receiver when used (greater separation distance may be required for
certain devices).
Assistance
United States
Medtronic provides a 24 Hour HelpLine for product assistance for U.S. users. The 24
Hour HelpLine is staffed with technicians who are trained in the setup and use of the
CGMS iPro Continuous Glucose Recorder and are able to answer your questions.
Department Telephone number
24 Hour HelpLine, if calling from within the
United States
24 Hour HelpLine if calling from outside the
United States
MiniMed Web site www.medtronicdiabetes.com
(800) 646-4633
818-576-5555
Other countries
For product assistance outside the U.S., please contact your local country
representative. Refer to the enclosed Medtronic Diabetes International Contact Card
for the Help Line in your area.
8 CGMS® iProTM Continuous Glucose Recorder User Guide
Charger
WARNING: Always clean the digital recorder after removing it from the patient
and before attaching it to the charger. See the cleaning instructions on page 20.
The digital recorder 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 indicates any problems during charging. If you see a
red light, see the Troubleshooting section on page 18. The charger needs one AAA
battery, size E92, type LR03, to operate. A new AAA battery contains enough power to
recharge the digital recorder more than 40 times.
Installing a new charger battery
1. Remove the charger battery cap by turning it
counter-clockwise 1/4 turn using a coin in the
groove of the cap.
2. Insert a new AAA battery with the flat (-) end
first. Make sure that you align the small bumps
on the battery cap with the small notches in the
charger’s battery opening. Push in the cap all
the way using a coin. Turn the cap clockwise 1/4
turn to close.
3. If the battery is installed incorrectly or is low, the charger will not work. Repeat the
steps above using a new battery.
Charging the digital recorder
Before using the digital recorder for the first time, you must fully charge the digital
recorder battery which may take up to eight hours. It is recommended to recharge the
digital recorder after each glucose sensor use. If you choose to recharge the digital
recorder after a 3-day glucose sensor use, the charging time will be less than 20
minutes.
CGMS® iProTM Continuous Glucose Recorder User Guide 9
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