MiniMed 640G User Manual

MiniMed™ 640G
System User Guide
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MP6025957-024 / A
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MiniMed™ 640G
System User Guide
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Copyright & trademarks
©2015 Medtronic MiniMed, Inc. All rights reserved.
CareLink™, Guardian™, Bolus Wizard™, Enlite™, MiniLink™, Dual Wave™, Square Wave™, MiniMed™, and SmartGuard™ are trademarks of Medtronic MiniMed, Inc.
Bayer™ is a trademark of Bayer.
Humalog™ is a trademark of Eli Lilly and Company.
NovoLog™ and NovoRapid™ are trademarks of Novo Nordisk A/S.
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s.r.o. Tel: +420 233 059 401 Non-stop help line: +420 233 059 059
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Contents
 ■   Before you begin
3Using this user guide
4Emergency kit
5User safety
5 Indications
6 Contraindications
6General warnings
8 General precautions
10 Adverse reactions
10 Notice
12 Keeping track of your system information
13 Insulin guidelines
13 Consumables
14 Optional devices
15 Accessories
15 Ordering supplies and accessories
 ■   First steps
19 Your pump
20 Using the buttons
21 About batteries
22 Inserting the battery
23 Removing the battery
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24 Getting to know your pump
24 Entering your startup settings
26 Unlocking your pump
26 Home screen
28 Status bar
31 Status screens
32 Using the Menu screen
34 Scroll bar
34 Power modes
35 If you remove your pump
 ■   Basal
39 Basal rate
40 Basal insulin settings
41 Max Basal Rate
41 Basal patterns
42 Adding a new basal pattern
46 Editing, copying, or deleting a basal pattern
46 Changing from one basal pattern to another
47 Temporary basal rates
47 About Temp Basal rates
48 Starting a Temp Basal rate
49 Preset Temp basal rates
52 Canceling a Temp Basal or Preset Temp basal rate
52 Viewing your basal information
54 Stopping and resuming your insulin delivery
 ■   Bolus
59 About bolus deliveries
59 Bolus types
60 Bolus type example
61 Bolus delivery options
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62 Bolus settings
63 Max Bolus
64 Bolus Increment
64 Bolus Speed
65 Bolus Wizard
65 Understanding your Bolus Wizard settings
66 Setting up the Bolus Wizard feature
69 Changing your Bolus Wizard settings
71 Turning off the Bolus Wizard feature
72 About active insulin
72 Bolus Wizard warnings
73 Normal bolus
74 Delivering a Normal bolus with the Bolus Wizard
75 Delivering a Normal bolus using Manual Bolus
76 Square Wave bolus
77 Turning on or off Square Wave bolus
77 Delivering a Square Wave bolus with the Bolus Wizard
79 Delivering a Square Wave bolus using Manual Bolus
79 Dual Wave bolus
80 Turning on or off Dual Wave bolus
80 Delivering a Dual Wave bolus with the Bolus Wizard
82 Delivering a Dual Wave Bolus using Manual Bolus
83 Easy Bolus
83 Understanding Easy Bolus step sizes
84 Setting up Easy Bolus
84 Delivering a bolus using Easy Bolus
86 Preset Bolus
86 Setting up and managing Preset Bolus deliveries
88 Delivering a Preset Bolus
88 Stopping a bolus delivery
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 ■   Reservoir and infusion set
93 Setting up the reservoir and infusion set
107 Disconnecting and reconnecting your infusion set
 ■   Meter
111 About your compatible Bayer meter
112 Wirelessly connecting your pump and meter
112 Setting up Remote Bolus
112 Deleting a meter from your pump
 ■   History and events
117 History
117 Summary screen
118 Understanding the Summary screen
121 Daily History
122 Alarm History
122 Using Sensor Glucose Review
124 ISIG History
124 Event Markers
 ■   Reminders
129 Personal reminders
130 Bolus BG Check reminder
131 Missed Meal Bolus reminder
132 Low Reservoir reminder
133 Set Change reminder
133 Calibration reminders
 ■   General settings
137 Airplane Mode
138 Audio Options
139 Auto Suspend
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139 Block Mode
140 Carb Unit
141 Display Options
141 Language
142 Managing your pump settings
145 Self Test
146 Sensor Demo
148 Time and date
 ■   Setting up Continuous Glucose Monitoring
151 Understanding Continuous Glucose Monitoring (CGM)
152 SmartGuard
153 Home screen with CGM
156 Understanding glucose settings
156 High settings
157 Low settings
167 Turning on the Sensor feature
167 Setting up the High Settings
171 Setting up the Low Settings
174 Manually resuming basal delivery during a suspend by sensor event
175 Wirelessly connecting your pump and transmitter using Auto Connect
179 Wirelessly connecting your pump and transmitter using Manual Connect
181 Deleting the transmitter from your pump
182 Inserting the sensor
182 Connecting the transmitter to the sensor
182 Starting the sensor
184 Calibrating your sensor
185 Setting up Auto Calibration
185 Where to enter your calibration BG meter reading
186 When to calibrate
187 Guidelines for calibrating
188 Disconnecting the transmitter from the sensor
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188 Removing the sensor
188 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
216 CGM (sensor) alarms, alerts, and messages
226 CareLink alert and message
 ■   Troubleshooting
229 Troubleshooting pump issues
230 What is a Check Settings alarm?
230 My pump is asking me to rewind
230 I dropped my pump
231 I cannot get to the Manage Settings screen
231 My pump display times out too quickly
231 Where is my pump status screen?
232 My pump is asking me to enter my settings
234 Troubleshooting sensor issues
234 My pump cannot find the sensor signal
236 Calibration not accepted
236 Why does the SmartGuard suspend by sensor icon on my Home screen
appear gray?
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 ■   Maintenance
241 Cleaning your pump
242 Cleaning your transmitter
242 Storing your pump
243 Storing your transmitter
 ■   Product specifications and safety information
247 Product specifications
247 Alarm and alert escalation
248 Altitude range
248 Audio frequency
249 Backlight
249 Basal delivery
250 BG Target
250 BG meter value
250 Bolus delivery
251 Bolus Wizard feature default settings
251 Bolus Wizard feature specifications
254 Carb ratios
254 Delivery accuracy
255 Easy Bolus
255 Environmental conditions
256 Filling the infusion set and cannula
256 Infusion pressure
256 Insulin delivery default settings
257 Insulin sensitivity factor
257 Low Reservoir reminder
258 Max Bolus
258 Normal bolus
258 Occlusion detection
259 Percent temp basal
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259 Program safety checks
259 Pump dimensions
259 Pump memory
259 Pump weight
260 Sensor default settings
262 Guidance and manufacturer's declaration
268 Wireless communication
268 Quality of service
269 Radio frequency (RF) communications specifications
269 Data security
270 Icon table
 ■   Appendix A: End user software license agreement
273 End user software license agreement
 ■   Glossary
 ■   Index
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before you begin
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Before you begin
This user guide is designed to help you understand the operation of your MiniMed™ 640G system. 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 277.
The following table describes certain terms, conventions, and concepts used in this user guide.
Convention What it means
Select To activate a screen item, accept a value, or initiate an action.
Select and hold
To perform an action using your pump screen, press the Select button and hold until the action is complete.
Press To push and then release a button.
Press and hold
To push and keep pressure on a button.
Bold text To indicate screen items and buttons. For example, "Select Next to
continue."
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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.
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:
Fast-acting glucose tablets.
Blood glucose monitoring supplies.
Urine or blood ketone monitoring supplies.
Extra MiniMed-compatible infusion set and MiniMed reservoir.
Extra new AA lithium or alkaline batteries, or fully charged NiMH batteries.
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Insulin syringe and fast-acting insulin (with dosage instructions from your healthcare professional).
Wallet card (packaged with your pump accessories).
Adhesive dressing.
Glucagon emergency kit.
WARNING: Do not use the Bolus Wizard™ 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 could prompt you to deliver more insulin than needed. Too much insulin may 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 your Bolus Wizard.
For details on pump safety, see User safety, on page 5.
User safety
Indications
MiniMed 640G system
The MiniMed 640G system is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. In addition, the system is indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and detecting possible low and high glucose episodes. When using a sensor and transmitter, the pump displays continuous sensor glucose values and stores this data so that it can be analyzed to track patterns and improve diabetes management. This data can be uploaded to a computer for analysis of historical glucose values.
The continuous sensor glucose values provided by the MiniMed 640G system are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that a confirmation fingerstick measurement may be required. All therapy adjustments should be based on measurements obtained using a home blood glucose monitor and not based on the value displayed by the pump.
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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.
General warnings
Pump
The pump is not suitable for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Never rely on the pump beeps or vibrations alone to navigate through the pump screens or menus because this may result in incorrect menu selection or setting.
Do not rely on preset pump alarms or reminders alone to prompt you to check your blood glucose. Set additional reminders on other devices, such as your cell phone, to avoid forgetting to check your blood glucose.
Standard Luer sets are not compatible with the MiniMed 640G insulin pump. MiniMed reservoirs and MiniMed-compatible infusion sets are specifically designed for use with the MiniMed 640G insulin pump. Do not modify your MiniMed reservoir or MiniMed-compatible infusion set.
Only use U100 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.
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.
While the infusion set is connected to your body, do not unscrew or retighten the tubing connector on the reservoir.
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Do not use the MiniLink™ transmitter (MMT-7703) with the MiniMed 640G insulin pump as this device does not communicate with this insulin pump.
Do not modify this product, as modification could result in a safety hazard.
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 or your local representative to arrange for shipment of a replacement pump.
Exposure to magnetic fields and radiation
WARNING: Keep the pump away from magnetic fields and avoid direct contact with any magnets.
If you are going to have an X-ray, MRI, diathermy treatment, CT scan, or other type of exposure to radiation, take off your pump, sensor, transmitter, and meter before entering a room containing any equipment of this kind. 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.
Do not expose your pump to a permanent magnet, such as pump cases that have a magnetic clasp. Exposure to a permanent magnet may interfere with the motor inside the pump.
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.
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Only use U100 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.
For additional warnings related to the reservoir and infusion set, refer to the user guides provided with those devices.
Sensor
While there is no evidence of an Enlite™ sensor breaking in a patient’s body, if you suspect that sensor breakage has occurred, do not attempt to remove the sensor yourself. Contact your healthcare professional for assistance in removing the sensor.
For warnings related to the sensor, refer to the user guide provided with that device.
Transmitter
Keep the transmitter away from children. This product contains small parts and may pose a choking hazard.
For warnings related to the transmitter, refer to the user guide provided with that device.
Meter
For warnings related to compatible Bayer™ meters, refer to the user guide provided with that device.
General precautions
Although the pump has multiple safety alarms, it cannot notify you if the infusion set is leaking or the insulin has lost its potency. It is essential, that you test your blood glucose levels at least four times per day. 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.
Waterproof capabilities
At the time of manufacture and when the reservoir and tubing are properly inserted, your pump is waterproof. It is protected against the effects of being underwater to a depth of up to 3.6 meters (12 feet) for up to 24 hours.
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If the pump is dropped, hit against a hard object, or otherwise damaged, the waterproof characteristics of the outer casing of the pump may be compromised. If your pump has been dropped or you suspect your pump is damaged, carefully inspect your pump to ensure there are no cracks before exposing your pump to water.
If you believe that water has entered your pump or you observe any other possible pump malfunction, check your blood glucose, and treat high blood glucose as necessary, using an alternative source of insulin. Contact your local representative for further assistance. Always contact your healthcare professional if you experience excessively high or low blood glucose levels or if you have any questions about your care.
Electrostatic discharge
Although your MiniMed 640G insulin pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump's software and a pump error alarm. After clearing the alarm, verify that your pump is set to the correct date and time and that all other settings are programmed to the desired values because the software reset could erase your previously programmed settings.
For more information on pump alarms, see Pump alarms, alerts, and messages, on
page 202. For more information on re-entering your pump settings, see My pump is asking me to enter my settings, on page 232. If you are unable to re-enter your
pump settings, or otherwise believe there is a problem with your pump, contact your local representative.
Avoid extreme temperatures
Exposure to extreme temperatures can damage your device, which can adversely affect safety and effectiveness of your device. Avoid the following conditions:
1. Avoid exposing your pump to temperatures above 40 °C (104 °F) or below
5 °C (41 °F) because this may damage your device.
2. Insulin solutions freeze near 0 °C (32 °F) and degrade at high temperatures. If
you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool.
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3. Do not steam, heat, sterilize, or autoclave your pump. Exposure to high
temperatures may damage your device.
Lotion, sunscreen, and insect repellent
Some skin care products, such as lotion, sunscreen, and insect repellents, can cause damage to plastics, which is a material used in your pump case. After using such products, be sure to wash your hands prior to handling your pump. If you get any skin care products or insect repellents on your pump, wipe them off as soon as possible with a damp cloth and mild soap. For instructions on cleaning your pump, see Cleaning your pump, on page 241.
Infusion sets and sites
For precautions related to the infusion sets and sites, refer to the user guides provided with those devices.
Sensor
For precautions related to the sensor, refer to the user guide provided with that device.
Transmitter
For precautions related to the transmitter, refer to the user guide provided with that device.
Meter
For precautions related to compatible Bayer™ meters, refer to the user guide provided with that device.
Adverse reactions
For adverse reactions related to the sensor, refer to the user guide provided with that device.
Notice
Radio Frequency (RF) communication
This device complies with the United States Federal Communications Commission (FCC) and international standards for electromagnetic compatibility.
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This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.
These standards are designed to provide reasonable protection against excessive radio frequency interference, and prevent undesirable operation of the devices from unwanted electromagnetic interference.
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or relocate the receiving antenna.
Increase the separation between the equipment and the receiver.
This device can generate, use, and radiate radio frequency energy and, if installed and used in accordance with the instructions, may cause harmful interference to radio communications. If the device does cause interference to radio or television reception, you are encouraged to try to correct the interference by one or more of the following measures:
Decrease the distance between the transmitter and the insulin pump to 1.8 meters (6 feet) or less.
Decrease the distance between the meter and the insulin pump to 1.8 meters (6 feet) or less.
Increase the separation between the transmitter and the device that is receiving/emitting interference.
If other devices that employ radio frequencies are in use, such as cell phones, cordless phones, and wireless networks, they may prevent communication between the transmitter and the insulin pump. This interference does not cause
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any incorrect data to be sent and does not cause any harm to your devices. Moving away from, or turning off, these other devices may enable communication. If you continue to experience RF interference, please contact your local representative.
Caution: Changes or modifications to the internal RF transmitter or antenna not expressly approved by Medtronic could void the user's authority to operate this insulin delivery system.
Directive 1999/5/EC
Medtronic declares that this product is in conformity with the essential requirements of Directive 1999/5/EC on Radio and Telecommunications Terminal Equipment.
For additional information, contact Medtronic MiniMed at the address or phone number provided on the back cover.
For Canada only
This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device.
Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.
Keeping track of your system information
The serial number (SN) is located on the back of your pump. If you are using the belt clip, you need to remove the belt clip to view the serial number. It also displays in your Pump status screen. For more details on the status screens, see Status screens, on page 31. For future reference, enter the serial number of your pump and the purchase date in the following table:
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Pump serial number and purchase date
Serial Number:
Purchase Date:
Insulin guidelines
WARNING: Never start on insulin until directed by your healthcare professional. Doing so could result in an unintended delivery of insulin, which may cause hypoglycemia.
The pump is intended for use with U100 insulin. The following insulins have been tested by Medtronic Diabetes and found to be safe for use with the MiniMed 640G insulin pump:
•Humalog
NovoLog™
NovoRapid™
Before using different insulin with this pump, check the insulin label to make sure the insulin can be used with the pump.
Consumables
The pump uses disposable (single-use) MiniMed reservoirs and infusion sets for insulin delivery.
WARNING: 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 and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.
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Reservoirs – Use only Medtronic reservoirs. For the MMT-1511 pump model, use the MMT-326A, 1.8 ml (180-unit) reservoir.
Look on the back of your pump for your model number.
For the MMT-1711 pump model, use either the MMT-332A, 3.0 ml (300-unit) reservoir or the MMT-326A, 1.8 ml (180-unit) reservoir, depending on your insulin needs.
Infusion sets – Medtronic Diabetes provides a variety of infusion sets to fit your needs. Contact your healthcare professional for help in choosing an infusion set. Change your infusion set every two to three days per your infusion set manufacturer's instructions.
Optional devices
Compatible Bayer blood glucose meter – The 640G system comes with a compatible Bayer blood glucose meter. It wirelessly connects to your pump, allowing you to send BG meter readings to your pump. The Remote Bolus feature allows you to use your meter to start a bolus on your pump. You can also use this meter to upload system data to your diabetes management software using the USB port on your computer. For more details, see your meter user guide.
Note: The compatible Bayer meter may not be available in all countries.
Guardian™ 2 Link transmitter (MMT-7731) – used with your pump for Continuous Glucose Monitoring (CGM). A device that connects to a glucose sensor. The transmitter collects data measured by the sensor and wirelessly sends this data to monitoring devices.
Enlite glucose sensor (MMT-7008) – used with your pump for CGM. The small part of the continuous glucose monitoring system that you insert just below your skin to measure glucose levels in your interstitial fluid. The sensor is a single-use device.
CareLink
USB (MMT-7306) – used to upload system data to the diabetes
management software using a USB port on your computer.
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Accessories
The following accessories may be used with your MiniMed 640G system.
Belt clip (ACC-1599) – used to wear the pump on your belt. Also, you can use the tip of the belt clip to open the battery compartment on your pump.
Activity guard (ACC-1520) – used if you are active in sports, or if a child is wearing the pump. Using the activity guard prevents the reservoir from being rotated or removed from the pump.
Skins – used to personalize the look of your pump. Skins are decorative overlays. Your pump is designed to have skins attached to the back of the pump and the front of the belt clip. Skins also provide additional protection against surface scratches.
Ordering supplies and accessories
To order supplies or accessories, contact your local representative.
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