Medtronic MINIMED 630G User Manual

MINIMEDTM 630G

SYSTEM USER
GUIDE

MiniMed™ 630G

SYSTEM USER GUIDE

Copyright & trademarks

© 2017 Medtronic MiniMed, Inc. All rights reserved. Medtronic, Medtronic logo and Further, Together are
trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other
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CareLink™, Guardian™, Bolus Wizard™, MiniLink™, Dual Wave™, Square Wave™, MiniMed™, SmartGuard™,

Paradigm™

and

are trademarks of Medtronic MiniMed, Inc.

Ascensia, the Ascensia Diabetes Care logo, and CONTOUR

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WARNING: The SmartGuard Suspend on low feature will cause the
pump to temporarily suspend insulin delivery for two hours when the
sensor glucose reaches a set threshold. Under some conditions of use
the pump can suspend again resulting in very limited insulin delivery.
Prolonged suspension can increase the risk of serious hyperglycemia,
ketosis, and ketoacidosis. Before using the SmartGuard Suspend on
low feature, it is important to read the SmartGuard Suspend on low
information in the Getting Started Guide and the MiniMed 630G
System User Guide and discuss proper use of the SmartGuard Suspend
on low feature with your healthcare provider.

Warranty

The expected life of the MiniMed insulin pump is a maximum of 4 years.
Medtronic Diabetes warrants the MiniMed insulin pump against defects in
materials and workmanship for a period of 4 years from the date of purchase.

During the warranty period, Medtronic Diabetes will, at its discretion, replace (with
a new or recertified pump, at Medtronic Diabetes’ discretion) any defective pump
or motor, subject to the conditions and exclusions stated herein. In the event that
a pump replaced, the warranty period will not be extended.

This warranty is valid only if the MiniMed insulin pump is used in accordance with
the manufacturer’s instructions. This warranty will not apply:

• If damage results from changes or modifications made to the pump by the
user or third persons after the date of manufacture.

• If damage results from use of non-Medtronic reservoirs and/or infusion sets.

• If damage results from service or repairs 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 or physical abuse, such as dropping or otherwise.

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 batteries, infusion sets, reservoirs, and other accessories.

The remedies provided for in this warranty are the exclusive remedies available

for any breach hereof. Neither Medtronic Diabetes nor its suppliers or

distributors shall be liable for any incidental, consequential, or special damage

of any nature or kind caused by or arising out of a defect in the product.

All other warranties, expressed or implied, are excluded, including the

warranties of merchantability and fitness for a particular purpose.

Contents

 ■   Before you begin

3Using this user guide

4Assistance

4Emergency kit

5 Medical emergency card and travel information

6User safety

6 Indications

7 Contraindications

7Potential risks

10 Benefits

11 General warnings

14 General precautions

17 Adverse reactions

■

Contents

17 Notice

19 Keeping track of your system information

19 Insulin guidelines

20 Consumables

21 Additional 630G system devices

21 Accessories

22 Ordering supplies and accessories

 ■   First steps

25 Your pump

Contents vii

26 Using the buttons

27 About batteries

28 Inserting the battery

29 Removing the battery

30 Getting to know your pump

30 Entering your startup settings

32 Unlocking your pump

33 Home screen

34 Status bar

37 Status screens

38 Using the Menu screen

40 Scroll bar

40 Power modes

41 If you remove your pump

 ■   Basal

45 Basal rate

46 Basal insulin settings

47 Max Basal Rate

47 Example 1: Max basal

47 Example 2: Max basal

48 Basal patterns

48 Adding a new basal pattern

52 Editing, copying, or deleting a basal pattern

52 Changing from one basal pattern to another

53 Example 1: Basal patterns

53 Example 2: Basal patterns

54 Temporary basal rates

54 About Temp Basal rates

55 Starting a Temp Basal rate

56 Preset Temp basal rates

59 Canceling a Temp Basal or Preset Temp basal rate

viii Contents

59 Viewing your basal information

61 Stopping and resuming your insulin delivery

 ■   Bolus

65 About bolus deliveries

65 Bolus types

66 Bolus type example

67 Bolus delivery options

68 Bolus settings

69 Max Bolus

70 Example 1: Max bolus

70 Example 2: Max bolus

70 Bolus Increment

71 Bolus Speed

71 Bolus Wizard feature

71 Understanding your Bolus Wizard settings

72 Setting up the Bolus Wizard feature

■

Contents

75 Changing your Bolus Wizard settings

77 Turning off the Bolus Wizard feature

78 About active insulin

78 Bolus Wizard warnings

79 Normal bolus

79 Delivering a Normal bolus with the Bolus Wizard feature

81 Delivering a Normal bolus using Manual Bolus

82 Square Wave bolus

83 Turning on or off the Square Wave bolus

83 Delivering a Square Wave bolus with the Bolus Wizard feature

84 Delivering a Square Wave bolus using Manual Bolus

85 Dual Wave bolus

85 Turning on or off the Dual Wave bolus

86 Delivering a Dual Wave bolus with the Bolus Wizard feature

87 Delivering a Dual Wave Bolus using Manual Bolus

Contents ix

88 Easy Bolus feature

89 Understanding Easy Bolus step sizes

89 Setting up the Easy Bolus feature

89 Delivering a bolus using the Easy Bolus feature

91 Preset Bolus

91 Setting up and managing Preset Bolus deliveries

93 Delivering a Preset Bolus

93 Stopping a bolus delivery

 ■   Reservoir and infusion set

97 Setting up the reservoir and infusion set

110 Disconnecting your infusion set

111 Reconnecting your infusion set

 ■   Meter

115 About your CONTOUR NEXT LINK 2.4 meter

116 Wirelessly connecting your pump and meter

116 Setting up Remote Bolus

116 Deleting a meter from your pump

 ■   History and events

121 History

121 Summary screen

122 Understanding the Summary screen

125 Daily History

125 Alarm History

126 Using Sensor Glucose Review

128 ISIG History

128 Event Markers

 ■   Reminders

133 Personal reminders

x Contents

134 Bolus BG Check reminder

135 Missed Meal Bolus reminder

136 Low Reservoir reminder

137 Set Change reminder

137 Calibration reminders

 ■   General settings

141 Airplane Mode

142 Audio Options

143 Auto Suspend

143 Block Mode

145 Carb Unit

145 Display Options

146 Language

146 Managing your pump settings

150 Self Test

151 Sensor Demo

152 Time and date

 ■   Setting up continuous glucose monitoring

155 Understanding continuous glucose monitoring (CGM)

156 Home screen with CGM

■

Contents

159 Understanding glucose settings

159 High settings

160 Low settings

168 Turning on the Sensor feature

168 Setting up the High Settings

171 Setting up the Low Settings

174 Manually resuming basal delivery during a SmartGuard Suspend on low

event

175 Wirelessly connecting your pump and transmitter using Auto Connect

178 Wirelessly connecting your pump and transmitter using Manual Connect

Contents xi

181 Deleting the transmitter from your pump

181 Inserting the sensor

181 Connecting the transmitter to the sensor

181 Starting the sensor

183 Calibrating your sensor

184 Where to enter your calibration BG meter reading

185 When to calibrate

186 Guidelines for calibrating

187 Disconnecting the transmitter from the sensor

187 Removing the sensor

187 Turning off Sensor Settings

 ■   Using continuous glucose monitoring

191 The sensor graph

192 Identifying rapid changes in sensor glucose

193 Silencing Glucose Alerts

 ■   Alarms, alerts, and messages

199 About alarms, alerts, and messages

200 Alarms

201 Alerts

202 Messages

202 Pump alarms, alerts, and messages

215 CGM (sensor) alarms, alerts, and messages

223 CareLink software alert and message

 ■   Troubleshooting

227 Troubleshooting pump issues

228 My pump buttons are stuck

228 What is a Check Settings alarm?

228 My pump is asking me to rewind

229 I dropped my pump

xii Contents

229 I cannot get to the Manage Settings screen

229 My pump display times out too quickly

230 Where is my pump status screen?

230 My pump is asking me to enter my settings

233 Troubleshooting sensor issues

233 My pump cannot find the sensor signal

234 Calibration not accepted

235 Why does the SmartGuard suspend icon on my Home screen appear

gray?

 ■   Maintenance

239 Cleaning your pump

240 Cleaning your transmitter

240 Storing your pump

241 Storing your transmitter

 ■   Product specifications and safety information

■

Contents

245 Product specifications

245 Alarm and alert escalation

246 Altitude range

246 Audio frequency

247 Backlight

247 Basal delivery

248 BG Target

248 BG meter value

248 Bolus delivery

249 Bolus Wizard feature default settings

249 Bolus Wizard feature specifications

252 Carb ratios

252 Delivery accuracy

253 Easy Bolus feature

254 Environmental conditions

Contents xiii

254 Essential performance

254 Filling the infusion set and cannula

254 Infusion pressure

255 Insulin delivery default settings

256 Insulin sensitivity factor

256 Low Reservoir reminder

256 Max Bolus

257 Normal bolus

257 Occlusion detection

257 Percent temp basal

257 Program safety checks

257 Pump dimensions

258 Pump memory

258 Pump weight

258 Sensor default settings

259 Alert performance

267 Guidance and manufacturer's declaration

272 Wireless communication

272 Quality of service

273 Radio frequency (RF) communications specifications

273 FCC notice

274 Data security

275 Icon glossary

 ■   Appendix A: End user software license agreement

279 End user software license agreement

 ■   Glossary

 ■   Index

xiv Contents

Before you begin

Before you begin

This user guide is designed to help you understand the operation of the

MiniMed 630G system with SmartGuard technology. The SmartGuard technology

can temporarily suspend insulin delivery based on your sensor glucose values.
Work closely with your healthcare professional when starting insulin pump therapy.

Using this user guide

This user guide contains valuable information about using your new insulin pump.
To help you find the information you need, you can use the table of contents at
the beginning of the user guide and the index at the end of the user guide. There
is also a glossary of terms, which starts on page 283.

The following table describes certain terms, conventions, and concepts used in this
user guide.

■

Before you begin

Convention What it means

Select To activate a screen item, accept a value, or initiate an action.

Select and
hold

Press To push and then release a button.

Press and
hold

Bold text To indicate screen items and buttons. For example, "Select Next to

To perform an action using your pump screen, press the Select
button and hold until the action is complete.

To push and keep pressure on a button.

continue."

Before you begin 3

Convention What it means

Note

Note: A note provides helpful information.

Caution

Caution: A caution notifies you of a potential
hazard, which, if not avoided, may result in minor
or moderate injury or damage to the equipment.

WARNING

WARNING: A warning notifies you of a
potential hazard, which, if not avoided, could
result in death or serious injury. It may also
describe potential serious adverse reactions and
safety hazards.

Assistance

Department Telephone number

24 Hour HelpLine (calls within the United States) 800 646 4633

24 Hour HelpLine (calls outside the United States) [phone]

Web site www.medtronicdiabetes.com

Emergency kit

Keep an emergency kit with you at all times to make sure that you always have
necessary supplies. Tell a family member, co-worker, or friend where you keep your
emergency kit.

It is important that you test your blood glucose (BG) more frequently while you are
traveling. The routine hassle of travel, including stress, changes in time zones,
schedules and activity levels, meal times and types of food, can all affect your
diabetes control. Be extra attentive to monitoring your BG frequently, and be
prepared to respond if needed.

Your emergency kit should include these items:

4 Chapter 1

• Fast-acting glucose tablets.

• Blood glucose monitoring supplies.

• Urine or blood ketone monitoring supplies.

• Extra MiniMed infusion set and MiniMed reservoir.

• Extra new AA lithium or alkaline batteries, or fully charged NiMH batteries.

• Insulin syringe and fast-acting insulin (with dosage instructions from your
healthcare professional).

• Adhesive dressing.

• Glucagon emergency kit.

WARNING: Do not use the Bolus Wizard feature to calculate a bolus
for a period of time after giving a manual injection of insulin by
syringe or pen. Manual injections are not accounted for in the
active insulin amount. Therefore, the Bolus Wizard feature could
prompt you to deliver more insulin than needed. Too much insulin
can cause hypoglycemia. Consult with your healthcare professional
for how long you need to wait after a manual injection of insulin
before you can rely on the active insulin calculation of the Bolus
Wizard feature.

WARNING: Do not insert the reservoir into your pump until you
have been instructed to do so by your healthcare professional, and
have received formal training with a certified product trainer.
Attempting to use insulin in your pump before you have received
training may result in the delivery of too little or too much insulin,
which can cause hyperglycemia or hypoglycemia.

■

Before you begin

For details on pump safety, see User safety, on page 6.

Medical emergency card and travel information

Your pump accessories are packaged with a Medical emergency card that you
should complete and carry with you at all times, especially when traveling.

Before you begin 5

It is important that you test your blood glucose (BG) more frequently while you are
traveling. The routine hassle of travel, including stress, changes in time zones,
schedules and activity levels, meal times and types of food, can all affect your
diabetes control. Be extra attentive to monitoring your BG frequently, and be
prepared to respond if needed.

User safety

Indications

MiniMed 630G system with SmartGuard technology

The MiniMed 630G system with SmartGuard technology is intended for continuous
delivery of basal insulin (at user selectable rates) and administration of insulin
boluses (in user selectable amounts) for the management of diabetes mellitus in
persons, fourteen years of age and older, requiring insulin as well as for the
continuous monitoring and trending of glucose levels in the fluid under the skin.
The MiniMed 630G system includes SmartGuard technology, which can be
programmed to temporarily suspend delivery of insulin for up to two hours when
the sensor glucose value falls below a predefined threshold value.

The MiniMed 630G system consists of the following devices: MiniMed 630G Insulin
Pump, Guardian Sensor (3), one-press serter, the Guardian Link (3) transmitter
system, CareLink USB, CONTOUR®NEXT LINK 2.4 Wireless Meter, and CONTOUR
NEXT Test Strips. The system requires a prescription.

The MiniMed 630G system is not intended to be used directly for making therapy
adjustments, but rather to provide an indication of when a finger stick may be
required. All therapy adjustments should be based on measurements obtained
using a home glucose monitor and not on values provided by the MiniMed 630G
system.

The MiniMed 630G system is not intended to be used directly for preventing or
treating hypoglycemia but to suspend insulin delivery when the user is unable to
respond to the SmartGuard Suspend on low alarm to take measures to prevent or
treat hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should
be administered according to the recommendations of the user’s healthcare
professional.

6 Chapter 1

WARNING: Do not use the Suspend on low feature to prevent or
treat low glucose. The Suspend on low feature is designed to
suspend insulin delivery when you are unable to respond to the
Suspend on low alarm. Always confirm your sensor glucose reading
using your BG meter, and follow the instructions of your healthcare
professional. Using Suspend on low to prevent or treat low glucose
may result in prolonged hypoglycemia.

Contraindications

Pump therapy is not recommended for people who are unwilling or unable to
perform a minimum of four blood glucose tests per day.

Pump therapy is not recommended for people who are unwilling or unable to
maintain contact with their healthcare professional.

Pump therapy is not recommended for people whose vision or hearing does not
allow recognition of pump signals and alarms.

Potential risks

Risks related to insulin pump infusion

■

Before you begin

General risks related to insulin pump infusion set may include:

• Localized infection

• Skin irritation or redness

• Bruising

• Discomfort or pain

• Bleeding

• Irritation

•Rash

Patients should be instructed to follow the provided user guides for insertions and
care of infusion sets. If an infusion site becomes irritated or inflamed, the infusion
set should be removed and another placed in a new location.

Risks related to insulin administration and pump use

Due to the use of insulin, there is risk related to the infusion of insulin and the
potential interruptions of insulin delivery. These general risks may include:

Before you begin 7

•Hypoglycemia

• Hyperglycemia

Risks related to sensor use

General risks related to sensor use may include:

• Skin irritation or reaction to adhesives

• Bruising

•Discomfort

•Redness

• Bleeding

•Pain

•Rash

•Infection

• Irritation from tapes used with glucose-sensing products

•Raised bump

• Appearance of a small "freckle-like" dot where needle was inserted

• Allergic reaction

• Fainting secondary to needle insertion

• Soreness or tenderness

• Swelling at insertion site

• Sensor fracture, breakage or damage

• Minimal blood splatter associated with sensor needle removal

• Residual redness associated with adhesive and or tapes

• Scarring

Specific risks related to sensor use

Taking medications with acetaminophen, including, but not limited to Tylenol,
fever reducers, or cold medicine, while wearing the sensor may falsely raise your
sensor glucose readings. The level of inaccuracy depends on the amount of
acetaminophen active in your body and may be different for each person. Always
use BG meter readings to verify your glucose level before making therapy

8 Chapter 1

decisions, including when you could have acetaminophen active in your body.
Always check the label of any medications to confirm whether acetaminophen is
an active ingredient.

Sensor placement and insertion has been studied in the belly (abdomen) and back
of upper arm only and is not approved for other sites.

Risks related to serter use

General risks with serter use may include skin infection around the area where the
serter is used.

Risks related to the MiniMed 630G insulin pump system

General risks related to the MiniMed 630G insulin pump system may include:

•Hypoglycemia

• Hyperglycemia

Specific risks related to the MiniMed 630G insulin pump system

During the conduct of the In-Clinic, Randomized, Cross-Over Study to Assess the
Efficacy of the Low Glucose Suspend (LGS) Feature in the MiniMed Paradigm X54

System with Hypoglycemic Induction from Exercise

1

, the following specific system

risks were identified:

• Bruising at sensor site (1 incident reported)

• Bleeding at sensor site (1 incident reported)

• Urine ketones resulting from improper connection of the tubing to the insulin
pump (1 incident reported)

■

Before you begin

1 Medtronic Inc., An In-Clinic, Randomized, Cross-Over Study to Assess the Efficacy of the Low Glucose

Suspend (LGS) Feature in the MiniMed Paradigm X54 System with Hypoglycemic Induction from
Exercise, CER235/Z25/A, November 2011.

Before you begin 9

Benefits

The MiniMed 630G system provides advanced protection
glucose levels through an integrated insulin pump and continuous glucose
monitoring (CGM). Clinical studies show that integrated insulin pump and CGM
systems are proven to provide better diabetes management, compared with
multiple daily injections or with the pump alone. When you pair pump therapy
with the information provided by the sensor, it can significantly improve HbA1C

levels without increasing the risk of hypoglycemia.

3, 4

The MiniMed 630G system also features SmartGuard technology, which
automatically suspends insulin when the sensor reaches a preset low limit, referred
to as Suspend on low. When a Suspend on low event occurs, you can choose to
continue to keep insulin suspended, or you can choose to resume insulin delivery.
You can also personalize your low settings with up to eight different segments to
fit your schedule and diabetes management needs.

Patients using Suspend on low experienced 35% less low sensor glucose exposure
(<70 mg/dL), both day and night combined, as compared to patients without
Suspend on low. While using Suspend on low at night, patients had a 37.5%
reduction in the magnitude and duration of nocturnal low sensor glucose values

compared to the control group.

5

2, 3, 4

from dangerous low

In addition to the clinical benefits of the system, the new design lets you
personalize your diabetes management with customizable options and user­friendly menus. You can now easily deliver a remote manual bolus using your
CONTOUR NEXT LINK 2.4 meter and have the convenience of an informative Bolus
Wizard feature, a color screen, customizable alerts, and up to eight basal patterns.

2 Bergenstal RM, Tamborlane WV, Ahmann A, et al. Effectiveness of sensor-augmented insulin-pump

therapy in type 1 diabetes [STAR 3 study]. N Engl J Med. 2010;363:311–320.

3 Battelino T, Conget I, Olsen B, et al. The use and efficacy of continuous glucose monitoring in type 1

diabetes treated with insulin pump therapy [SWITCH study]. Diabetologia. 2012 Dec;55(12):3155-62. doi:

10.1007/s00125-012‐2708‐9. Epub 2012 Sept 11.

4 Bergenstal RM, Klonoff DC, Bode BW, et al. Threshold-based insulin-pump interruption for reduction of

hypoglycemia [ASPIRE in-home study]. N Engl J Med. 2013;369(3):224-232.

5 Bergenstal RM, Klonoff DC, Bode BW, et al. Threshold-based insulin-pump interruption for reduction of

hypoglycemia [ASPIRE in-home study]. N Engl J Med. 2013;369(3):224-232.

10 Chapter 1

General warnings

Pump

• Do not use the pump when a flammable anesthetic mixture with air, oxygen,
or nitrous oxide is present. These environmental conditions can damage your
pump and result in serious injury.

• Never rely on the pump beeps or vibrations alone to navigate through the
pump screens or menus. Always check your pump screen as you navigate.
The pump beeps and vibrations are intended to notify you of a condition that
may require attention. Relying on the pump beeps or vibrations alone to
navigate can result in incorrect menu selection or settings.

• Do not rely on preset pump alarms or reminders alone to prompt you to
check your blood glucose. This can cause you to forget to check your blood
glucose. Set additional reminders on other devices, such as your cell phone.

• Do not use standard Luer sets with the MiniMed 630G insulin pump. Luer sets
are not compatible with the pump. MiniMed reservoirs and MiniMed infusion
sets are specifically designed for use with the MiniMed 630G insulin pump.

• Do not change or modify your MiniMed reservoir or MiniMed infusion set
unless expressly approved by Medtronic Diabetes. Modifying the devices can
cause serious injury, interfere with your ability to operate the device, and void
your warranty.

■

Before you begin

• Only use U-100 insulin that has been prescribed by your healthcare
professional for use with an infusion pump. Do not put any other drugs or
medications inside your reservoir for use with this pump. Other drugs or
medications are not intended for use with this pump. Use of other drugs or
medications can cause serious injury.

• Always make sure the infusion set is disconnected from your body before you
rewind your pump or fill the infusion set tubing. Never insert the reservoir into
the pump while the tubing is connected to your body. Doing so could result
in an accidental infusion of insulin.

• Do not insert the reservoir in the pump if you did not rewind your pump.
Doing so could result in an accidental infusion of insulin.

Before you begin 11

• Do not use the MiniMed 630G insulin pump or additional system devices
adjacent to other electrical equipment which may cause interference with the
normal system operation. This includes mobile communication devices such
as cell phones, GPS navigation systems, anti-theft systems, and any electrical
equipment that has an output transmitter power greater than 1W. For more
information about recommended separation distance guidelines between the
insulin pump and common RF emitters, see Guidance and manufacturer's
declaration, on page 267. The recommended separation distance between the
insulin pump and common RF emitters is 12 inches. Other electrical
equipment that may compromise normal system operation has been
contraindicated. For more information, see Exposure to magnetic fields and
radiation, on page 13.

• Do not unscrew or retighten the tubing connector on the reservoir while the
infusion set is connected to your body. Doing so could result in an accidental
infusion of insulin.

•

Do not use the MiniLink transmitter, MMT-7703, with the MiniMed 630G

insulin pump. This device does not communicate with this insulin pump. Use
of this transmitter with this insulin pump can result in serious injury.

• Do not use the Guardian Link transmitter, MMT-7763, with the Guardian
Sensor (3), MMT-7020. They do not work together. Use of this transmitter with
this sensor, causes damage.to these devices and can result in serious injury.

• Do not use your pump if the screen appears broken or unreadable. In some
instances, impact to the pump can damage the screen while the buttons
continue to function. If the screen is broken or unreadable, do not press any
buttons. Remove the pump and begin using your backup insulin plan per the
direction of your healthcare professional. If the pump is accidentally
programmed while the screen is broken or unreadable, this could result in
high or low blood glucose levels. If your screen is damaged, contact the 24
Hour HelpLine to arrange for shipment of a replacement pump.

Pursuant to IEC60601-1-2:2007; subclause 5.2.2:

The MiniMed 630G insulin pump should not be used adjacent to other electrical
equipment. If adjacent use becomes necessary, the MiniMed 630G insulin pump
should be observed to verify normal system operation.

12 Chapter 1

Exposure to magnetic fields and radiation

• Do not expose your pump to MRI equipment, diathermy devices, or other
devices that generate strong magnetic fields (for example, x-ray, CT scan, or
other types of radiation). The strong magnetic fields can cause the devices to
malfunction, and result in serious injury. If your transmitter is exposed to a
strong magnetic field, discontinue use and contact the 24 Hour HelpLine for
further assistance.

■

• Always remove your pump, sensor, transmitter, and meter before entering a
room that has x-ray, MRI, diathermy, or CT scan equipment. The magnetic
fields and radiation in the immediate vicinity of this equipment can make your
devices nonfunctional or damage the part of the pump that regulates insulin
delivery, possibly resulting in over delivery and severe hypoglycemia.

• Always carry the Medical emergency card provided with your device when
you are traveling. The Medical emergency card provides critical information
about airport security systems, and using your pump on an airplane, that can
help you and others. Not carrying the Medical emergency card could result in
serious injury.

• Do not expose your pump to a magnet, such as pump cases that have a
magnetic clasp. Exposure to a magnet may interfere with the motor inside the
pump. Damage to the motor can cause the device to malfunction, and result
in serious injury.

Reservoir and infusion sets

• Only use reservoir and infusion sets manufactured by Medtronic Diabetes. The
pump has undergone extensive testing to confirm appropriate operation
when used with compatible reservoirs and infusion sets manufactured or
distributed by Medtronic Diabetes. We cannot guarantee appropriate
operation if the pump is used with reservoirs or infusion sets offered by third
parties. We are not responsible for any injury or malfunctioning of the pump
that may occur in association with such use.

Before you begin

• Only use U-100 insulin that has been prescribed by your healthcare
professional for use with an infusion pump. Do not put any other drugs or
medications inside your reservoir for use with this pump. Other drugs or
medications are not intended for use with this pump. Use of other drugs or
medications can cause serious injury.

Before you begin 13

• Always refer to the reservoir and infusion set user guides for all precautions,
warnings, and instructions relating to the reservoir and infusion set. Not
referring to the reservoir and infusion set user guides can result in serious
injury or damage to the sensor.

Sensor

• Do not attempt to remove the sensor yourself if you suspect that the sensor is
broken. While there is no evidence of a Guardian Sensor (3) breaking in a
patient’s body, sensor breakage can result in serious injury. Contact your
healthcare professional for assistance in removing the sensor.

• Always refer to the sensor user guide for all precautions, warnings, and
instructions relating to the sensor. Not referring to the sensor user guide can
result in serious injury or damage to the sensor.

Transmitter

• Do not allow children to put small parts in their mouth. This product poses a
choking hazard for young children.

• Always refer to the transmitter user guide for all precautions, warnings, and
instructions relating to the transmitter. Not referring to the transmitter user
guide can result in serious injury or damage to the transmitter.

Meter

• Always refer to the meter user guide for all precautions, warnings, and
instructions relating to the CONTOUR NEXT LINK 2.4 meter. Not referring to
the meter user guide can result in serious injury or damage to the meter.

General precautions

• Always test your blood glucose levels at least four times per day. Although the
pump has multiple safety alarms, it cannot notify you if the infusion set is
leaking, or the insulin has lost its potency. If your blood glucose is out of
range, check the pump and the infusion set to ensure that the necessary
amount of insulin is being delivered.

14 Chapter 1