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Table of Contents
Summary of Contents for Medingo Solo MicroPump
- Page 1 Draft 01xx-001 Rev01...
- Page 2 Healthcare Provider. We at Medingo have taken every reasonable precaution while preparing this user guide; yet no author, editor, or publisher shall have any responsibility for errors or omissions, nor for the uses made of the materials herein and the decisions based on such use.
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Page 3: Table Of Contents
Table of Contents Table of Contents Glossary ........xv Chapter 1 - Introduction and User Safety Introduction . - Page 4 Table of Contents Cradle ..........25 Cannula .
- Page 5 Table of Contents Delivery & BG Settings Overview ......87 ITC, ISF and BG Settings Overview ....91 Editing Delivery &...
- Page 6 Table of Contents Delivering a Correction Bolus ......151 Delivering a Duo Bolus ....... 153 Delivering a Long Bolus .
- Page 7 Table of Contents Chapter 9 - Help and Troubleshooting Assistance & Help Line (24 hours) ......228 Errors .
- Page 8 Table of Contents Sick-Day Recommendations ......267 General Guidelines ........267 Exercise, Sports and Water Activities .
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Page 9: Glossary
Glossary Word/Phrase Explanation There are 7 different basal profiles the user can set for different days Basal Profile or even different times of the day. i.e. on a weekend, during sport activities, etc. (see Understanding Basal Profiles on page 126). A steady trickle of low levels of insulin (see Understanding Basal Basal Rate... - Page 10 Word/Phrase Explanation This is delivered in the same way as a Normal bolus (immediately). A correction bolus is chosen when you wish to lower an elevated blood Correction Bolus glucose reading, not relating to current food consumption (see Delivering a Correction Bolus on page 149).
- Page 11 Word/Phrase Explanation A steady amount of insulin delivered over an extended period of time so that it is slowly absorbed into your body. It is normally delivered to Long Bolus cover complex high protein/fat meals (see Delivering a Long Bolus on page 156).
- Page 12 Word/Phrase Explanation Includes Reservoir, Filling Device and Handle. For additional Reservoir Assembly information see Filling Device and Handle on page Total Daily Dose – The maximum number of units of insulin you are permitted per day (Bolus and Basal together) The total dose of insulin delivered throughout the day is called TDD.
- Page 13 Introduction and User Safety Chapter 1 – Introduction and User Safety In this section: Reminders, Alerts, Alarms and Errors Introduction on page 2 Overview on page 11 Safety Definitions on page 3 System Labels on page 14 Practices Used in this User Guide on Symbols and Descriptions on page 15 page 4 Terms and Abbreviations on page 5...
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Page 14: Introduction
Introduction Introduction and User Safety Introduction Congratulations on your choice of the Solo™ MicroPump Insulin Delivery System for management of your diabetes. You are about to discover the ease with which the Solo™ System will assist you in managing your diabetes discreetly and conveniently. If you are a first-time Solo™... -
Page 15: Safety Definitions
Introduction and User Safety Introduction Safety Definitions Safety instructions are provided for the protection of Solo™ System users. The following safety conventions are used to classify and identify hazards that can occur if instructions are ignored. Warnings WARNING A warning alerts you to a situation which, if not avoided, could result in death or serious injury. -
Page 16: Practices Used In This User Guide
Introduction Introduction and User Safety Practices Used in this User Guide Procedure Instructions When appropriate, procedures start with a “ ” symbol, followed by a short description of the procedure to be performed. Procedure instructions are clearly identified and presented as numbered procedure steps. -
Page 17: Terms And Abbreviations
Introduction and User Safety Introduction The table below describes some of the styles used in this User Guide to assist you in understanding procedures and explanations. Words in: Description Bold Names of menus and screens System response that occurs as a result of button Italics pressed Bold Italics... -
Page 18: Indications For Use
Indications for Use Introduction and User Safety Indications for Use The Solo™ System is intended for the continuous delivery of insulin, at set and variable rates, for the management of Diabetes Mellitus in persons requiring insulin. The Solo™ MicroPump Insulin Delivery System is for prescription use only. -
Page 19: Solo™ Education
User Guide or improper/inadequate self-care may lead to serious injury or death. CAUTION Changes or modifications to the Solo™ System not expressly approved by Medingo Ltd. will void your authority to operate this Caution equipment. The Help & Troubleshooting section (see Chapter 9 –... -
Page 20: Proper Use Of The Solo™ System
Proper Use of the Solo™ System Insulin Types The following insulins were tested by Medingo Ltd. and were found to be safe for use in the Solo™ MicroPump Insulin Delivery System: Humalog® (do not use in the Reservoir beyond 48 hours) NovoLog®... -
Page 21: General Precautions
If the display has missing or incomplete characters, or if the Remote does not seem to be working correctly, contact Medingo Customer Care (1-877-Solo-4-you) immediately. The Solo™ Remote is not water-resistant. Do not get it wet. The MicroPump is water-resistant but should not be immersed in water. - Page 22 Proper Use of the Solo™ System Introduction and User Safety Do not attempt to insert sharp objects into the hole (#1 in Figure 1-1) in the Pump Base’s protective shield. Inserting objects into this hole can adversely affect its water-resistance. Make sure that dust/dirt do not accumulate in the hole (#1 in Figure...
- Page 23 Introduction and User Safety Proper Use of the Solo™ System Reminders, Alerts, Alarms and Errors Overview The Solo™ System is equipped with sound signals to notify you of alarms, alerts, reminders and errors that may occur. Alarms indicate a serious issue, alerts are a pre-warning of a serious issue and reminders are set by you to remind you to do certain activities such check blood glucose.
- Page 24 Examples of these errors include: Remote software errors MicroPump Error If you cannot clear an error message, please call Medingo Customer Care (1-877-Solo-4-you). Alarms Overview Once an alarm is sounded, you cannot enter new commands until you take care of the problem.
- Page 25 Introduction and User Safety Proper Use of the Solo™ System Maximum bolus limit Communication failure between Remote and MicroPump Unexpected reset alarm Remote battery status related alarms Total Daily Dose limit exceeded MicroPump Bolus related alarms Bolus Guide related alarms For a full list of alarms, please see Alarms and Alerts on page 229.
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Page 26: System Labels
System Labels Introduction and User Safety System Labels The following label appears on the rear of the Pump Base. Figure 1-2 Solo™ Pump Base Label For information on the symbols on this label, see Symbols and Descriptions on page Solo™ User Guide... -
Page 27: Symbols And Descriptions
Introduction and User Safety Symbols and Descriptions Symbols and Descriptions The table below shows a list of symbols which may appear throughout the Solo™ User Guide, on packaging or on the actual system parts. An explanation is provided next to each symbol. You should pay attention to these symbols. -
Page 28: Caring For The Environment
Caring for the Environment Introduction and User Safety Caring for the Environment The system was designed and built with an environmentally friendly approach. Discard all disposable parts according to national and local waste disposal regulation. The Solo™ System and Radio Frequency Radiation This device complies with Part 15 of the FCC Rules. -
Page 29: Chapter 2 - Solo™ System Overview And Features
Solo™ System Overview and Features Chapter 2 – Solo™ System Overview and Features In this section: Solo™ System Description on page 18 Accessories on page 27 Components on page 19 Filling Device and Handle on page 27 Solo™Remote on page 19 Inserter on page 28 Solo™... -
Page 30: Solo™ System Description
Solo™ System Description Solo™ System Overview and Features Solo™ System Description The Solo™ MicroPump is a miniature, tubeless, insulin pump that is attached to your body at a desired location. A Remote controls MicroPump programming and enables data collection and transmission from and to the MicroPump, using wireless technology. -
Page 31: Components
Solo™ System Overview and Features Components Components Solo™Remote Your Solo™ System is operated via a Remote which communicates with the MicroPump. The Remote is a reusable hand-held device with a color LCD backlight display. It is suitable for indoor/outdoor use. The Remote is used to program Basal and Bolus insulin deliveries and includes the Bolus Guide. -
Page 32: Remote Usage Guidelines
Remote to verify proper system operation. If there are other Solo™ System users in your close surroundings, you should color code or label your Remote to avoid mix-ups. If the Remote stops working, please contact Medingo Customer Care (1-877-Solo-4-you) for assistance. Solo™ User Guide... -
Page 33: Remote Batteries
Solo™ System Overview and Features Components Remote Batteries The Remote is powered by 2 AA alkaline batteries. On average, a pair of batteries powers the Remote for 17 days. An alert will sound when the Remote batteries are low. You can also see the battery status in the Status Bar of the Home screen (see Remote Status Bar on page... -
Page 34: Solo™ Micropump
Components Solo™ System Overview and Features Solo™ MicroPump The Solo™ MicroPump consists of the following two components: Pump Base – Pumping mechanism that communicates with the Remote. Reservoir – Disposable component that contains up to 200 units of insulin. Once the Reservoir is filled with insulin, it is joined with the Pump Base to create what is called the MicroPump. -
Page 35: Solo™ Pump Base
Solo™ System Overview and Features Components Solo™ Pump Base The Solo™ Pump Base receives insulin delivery instructions from the Remote and delivers insulin to your body. It also communicates delivery and status information back to the Remote. Together with the Reservoir, it forms the MicroPump. The Pump Base is reusable and has a life of 3 months. -
Page 36: Solo™ Reservoir
Components Solo™ System Overview and Features Solo™ Reservoir The Solo™ Reservoir is a sterile single-use component that is discarded after use. It holds up to 200 units (2.0 mL) of insulin and is marked with numbers in mL. The Reservoir must be filled just before use. - Page 37 Solo™ System Overview and Features Components Once the Reservoir is filled, it can be joined with the Pump Base, as shown in Figure 2-5 below. Figure 2-5 Reservoir Connected to Pump Base Cradle The Cradle is a sterile single-use component affixed to your skin with an adhesive tape.
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Page 38: Cannula
Components Solo™ System Overview and Features Description Well™ of Cradle – holds the Cannula assembly and prevents its movement during use Cradle latch – disconnects MicroPump from Cradle Cradle hook – used to attach MicroPump to Cradle MicroPump being connected to Cradle Cannula Cradle with MicroPump ready to be connected You should dispose of the Cradle as a biohazard according to national... -
Page 39: Chapter 3 - Solo™Remote Overview
Solo™Remote Overview Chapter 3 – Solo™Remote Overview This section discusses the Remote Home Screen, including messages, icons, understanding the Home Screen and navigation on the Remote. In this section: Remote Home Screen Overview on Remote Status Bar on page 40 page 34 Remote Functions and Keys on page Insulin Delivery Icons on page 43... -
Page 40: Remote Home Screen Overview
Remote Home Screen Overview Solo™Remote Overview Remote Home Screen Overview Your Solo™ System is operated using a Remote which communicates with the MicroPump. When any button on the Remote is pressed (see Figure 3-1), the Solo™ Home screen appears. This screen provides important information on the current status of the Solo™... -
Page 41: Remote Functions And Keys
Solo™Remote Overview Remote Functions and Keys Remote Functions and Keys The Home Screen is your starting point to access the programming on the Remote. The buttons and controls on the Remote are very similar to those of a cellular phone. Navigation on the Solo™... - Page 42 Remote Functions and Keys Solo™Remote Overview Table 3-1 Remote Soft Keys and Navigation Keys Item, Figure 3-2 Description When you press the Left Soft Key, you are selecting the text option that appears on the bottom left corner of the current screen. Left Soft Key and Corresponding Text On the Home screen, if you press <T.
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Page 43: Long Press Of Keys
Solo™Remote Overview Remote Functions and Keys Long Press of Keys In many fields you may continuously press (long press) the Up navigation key or the Down navigation key for faster scrolling of continuous values. This will result in the values changing in larger increments. - Page 44 Remote Functions and Keys Solo™Remote Overview In the Remote shown in Figure 3-3, the Menu option is highlighted (default setting). The instructions below explain how to access the options. Figure 3-3 Remote Menus Table 3-2 Remote Menus Item, Figure 3-3 Description Allows you to enter the Bolus menu.
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Page 45: Navigating Using A Soft Key
Solo™Remote Overview Remote Functions and Keys To access the Menu screen: 1. If: the Menu option is highlighted (orange), press <Select>. the Menu option is not highlighted (orange), use the Down navigation key so that the Menu option is highlighted in orange and press <Select>. -
Page 46: Remote Status Bar
Remote Status Bar Solo™Remote Overview Remote Status Bar The Status Bar, located at the top of the Home screen, shows the current status of the Solo™ System. This is the status screen that will be shown once you set up your MicroPump for the first time. Status Bar Figure 3-4 Status Bar The table below describes the icons that appear in the Status Bar... - Page 47 Solo™Remote Overview Remote Status Bar Table 3-3 Status Bar Item, Figure 3-4 Description Insulin Reservoir Status Icon Visual representation of units remaining in Reservoir Insulin Reservoir Status Number of units remaining in Reservoir Current time set on the Solo™ System. If time shown is Time incorrect, refer to Setting the Time and Date on page...
- Page 48 Remote Status Bar Solo™Remote Overview Table 3-4 Status Bar Icons Battery Full Battery 75% full Battery Status Battery 50% full Battery 25% full Battery Empty Communicating with MicroPump Communication Status Not communicating with MicroPump System Sound System is in Mute mode Solo™...
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Page 49: Insulin Delivery Icons
Solo™Remote Overview Insulin Delivery Icons Insulin Delivery Icons The following icons appear during insulin delivery. Appears on the Home screen when a Bolus is currently being delivered (in progress). The number next to the Bolus in Progress icon indicates the total amount of insulin that will be delivered via all active Boluses. -
Page 50: Notification Icons And Screens
Insulin Delivery Icons Solo™Remote Overview Notification Icons and Screens Notification icons notify you of a situation that needs to be addressed. If the Remote volume is turned On, you will hear a beeping sound and a message will appear next to the Notification Icon. Table 3-5 Notification Icons Alarm Alert... - Page 51 Solo™Remote Overview Insulin Delivery Icons An information icon appears when a command is disabled. If an (Information) icon appears, select <Info> to display information about the disabled button. Figure 3-6 Menu Option Dimmed with i Icon Other Icons Appears in Detailed Delivery Report Time Change when time is changed.
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Page 52: Data Screen Overview
Data Screen Overview Solo™Remote Overview Data Screen Overview Once you leave the Home Screen and enter a Data Screen, you will see orange arrows above and below a value (see Figure 3-7). The arrows indicate that you are now located on this field but are in Review mode.
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