MP6025958-022 / A MiniMed™ 640G System User Guide D E S E R A E L
MP6025958-022 / A D E S E R A E L
MP6025958-022 / A MiniMed™ 640G System User Guide D E S E R A E L
MP6025958-022 / A Copyright & trademarks ©2014 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.
MP6025958-022 / A Contacts: Africa: Medtronic Africa (Pty) Ltd. Tel: +27 (0) 11 677 4800 Eire: Accu-Science LTD. Tel: +353 45 433000 Macedonia: Alkaloid Kons Dooel Tel: +389 2 3204 430 Australia: Medtronic Australasia Pty. Ltd. Tel: 1800 668 670 (product orders) Tel: 1800 777 808 (customer help) España: Medtronic Ibérica S.A. Tel: +34 91 625 05 42 Fax: +34 91 625 03 90 24 horas: +34 901 120 335 Magyarország: Medtronic Hungária Kft.
MP6025958-022 / A Serbia: Epsilon Tel: +381 11 311 5554 Fax: +381 11 311 5554 Österreich: Medtronic Österreich GmbH Tel: +43 (0) 1 240 44-0 24 – Stunden – Hotline: 0820 820 190 Serbia: Medtronic B.V. Serbia Tel: +381 11 2095 900 Fax: +381 11 2095 985 Česká republika: Medtronic Czechia s.r.o. Tel: +420 233 059 401 Non-stop help line: +420 233 059 059 Singapore: Medtronic International Ltd. Tel: +65 6436 5090 or +65 6436 5000 Slovenija: Zaloker & Zaloker d.o.o.
MP6025958-022 / A ■ contents ■ ■ Contents Before you begin 3 Using this user guide 4 Emergency kit 5 User safety 5 Indications 6 Contraindications 6 General warnings 8 General precautions D E S A E L 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 E R First steps 19 Your pump 20 Using the buttons 21 About batteries 22 Inserting t
MP6025958-022 / A ■ ■ 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 A
MP6025958-022 / A 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 71 About active insulin 72 Bolus Wizard warnings 73 Normal bolus 73 Delivering a Normal bolus with the Bolus Wizard 75 Delivering a Normal bolus using Manual Bolus 76 Square Wave bolus 76 Turning on or off Square Wave bolus 77 Delivering
MP6025958-022 / A ■ Reservoir and infusion set 93 107 ■ ■ ■ ■ Setting up the reservoir and infusion set 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
MP6025958-022 / A 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 ■ contents ■ 139 Setting up Continuous Glucose Monitoring 151 Understanding Continuous Glucose Monitoring (CGM) 152 SmartGuard 152 Home screen with CGM 155 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
MP6025958-022 / A ■ ■ ■ 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 216 CGM (sensor) alarms, alerts, and messages 225 CareLink alert and message A E L Troubleshooting x D E S E R 229 Troubles
MP6025958-022 / A ■ 241 Cleaning your pump 242 Cleaning your transmitter 242 Storing your pump 243 Storing your transmitter ■ ■ Maintenance Product specifications and safety information contents 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
MP6025958-022 / A ■ 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 D E S A E L E R xii Contents
MP6025958-022 / A before you begin D E S E R A E L
MP6025958-022 / A D E S E R A E L
MP6025958-022 / A ■ before you begin 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 D E S 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.
MP6025958-022 / A Convention Note What it means 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.
MP6025958-022 / A • 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. ■ before you begin 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.
MP6025958-022 / A 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.
MP6025958-022 / A 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. WARNING: Keep the pump away from magnetic fields and avoid direct contact with any magnets.
MP6025958-022 / A 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.
MP6025958-022 / A 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.
MP6025958-022 / A 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.
MP6025958-022 / A 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. D E S A E L • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and the receiver.
MP6025958-022 / A 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.
MP6025958-022 / A Pump serial number and purchase date Serial Number: Purchase Date: Insulin guidelines ■ 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™ D E S A E L Before using different insulin with this pump, check the insulin label to make sure the insulin can be used with the pump.
MP6025958-022 / A • Reservoirs – Use only Medtronic reservoirs. For the MMT-1512 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-1712 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.
MP6025958-022 / A Accessories The following accessories may be used with your MiniMed 640G system. • 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.
MP6025958-022 / A D E S A E L E R 16 Chapter 1
MP6025958-022 / A first steps D E S E R A E L
MP6025958-022 / A D E S E R A E L
MP6025958-022 / A ■ This chapter gives you an overview of your pump so you can become familiar with the buttons and screens. Read this entire chapter to understand the basic features and initial setup before using your pump to deliver insulin. Your pump D E S The following illustration shows the different parts of your pump. The reservoir, with the tubing connector attached, is inserted into the reservoir compartment.
MP6025958-022 / A Using the buttons Caution: Do not use sharp objects to press the buttons on your pump. Using sharp objects can damage your pump. The following picture shows the buttons, the notification light, and the light sensor on your pump. The notification light flashes when your pump has an alarm or alert. The notification light is not visible unless flashing. The keypad has a backlight that lights up the buttons when in use.
MP6025958-022 / A The following table describes how to use the buttons. To do this: Follow these steps: Scroll up or down a menu or list, or increase or decrease the value of a setting. Press the Select an item on a screen or menu. Press the , , , or buttons to select the desired item, and then press the button. Enter a value into a field. Press the , , , or buttons to select the desired field, and then press the button. The field or buttons to you select flashes.
MP6025958-022 / A Inserting the battery Your pump does not ship with the battery cap on. The battery cap is located in the pump box, separate from the pump. To insert the battery: 1. Insert the new or fully charged AA battery, making sure to insert the negative end (−) first. After you insert the battery, the positive end (+) is visible. 2. Use the belt clip to tighten the battery cap. D E S Caution: Do not overtighten or undertighten the battery cap.
MP6025958-022 / A 3. If this is the first time you have inserted a battery in your pump, the Startup Wizard begins. For more information about the Startup Wizard, see Entering your startup settings, on page 24. If this is not the first time you have inserted a battery into your pump, the Home screen appears and the pump resumes your basal delivery. Removing the battery ■ To remove the battery: D E S 1. Before removing a battery from your pump, clear any active alarms or alerts. 2.
MP6025958-022 / A If you are removing the battery to place your pump in storage, see Storing your pump, on page 242 for more information. Getting to know your pump This section shows you how to navigate through the screens and menus on your pump. It also helps you learn how to enter information and view the status of your pump. Entering your startup settings Your pump has a Startup Wizard that begins when you insert your battery for the first time.
MP6025958-022 / A 4. When the Enter Date screen appears, adjust the Year, Month and Day to the current date. Select Next. D E S A E L E R A message confirms that your initial setup is complete, and then the Home screen appears. After you enter your initial settings, see the following sections in this chapter to become familiar with the buttons and screens on your pump. First steps 25 first steps When the Enter Time screen appears, adjust the setting to the current time.
MP6025958-022 / A Unlocking your pump Your pump automatically locks when entering sleep mode. When you wake up your pump from sleep mode, you must unlock your pump before navigating away from the Home screen. When you press menu or select , you will be shown a screen asking you to unlock your pump. Press the highlighted button to unlock your pump. The pump will take you to your selected screen after you press the correct button.
MP6025958-022 / A To see what your Home screen looks like if you use a sensor, see Home screen with CGM, on page 152. 17:00 status bar current time BG BG meter readings mg/dL Active Insulin Basal bolus delivery options active insulin amount first steps Bolus 1.0 U ■ 110 basal delivery options The following items appear on your Home screen: Item Description Status bar Displays icons that show a quick status of your pump system. For more information, see Status bar, on page 28.
MP6025958-022 / A Item Description Bolus Allows you to access your bolus delivery options, and provides access to all of your insulin settings. For details about entering your bolus settings and delivering bolus insulin, see the Bolus chapter on page 59. If you have not set up the Bolus Wizard and Preset Bolus features, you only have access to Manual Bolus from this screen. For details about setting up the Bolus Wizard feature, see Bolus Wizard, on page 65.