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Draft 01xx-001 Rev01 COPYRIGHT 2009 BY Medingo Ltd., ALL RIGHTS RESERVED Disclaimer This guide does not contain all of the necessary information for proper care and treatment of people with diabetes who use an insulin pump;
therefore, please consult your physician or diabetes Healthcare Provider before implementing any changes to your diabetes treatment plan. This guide is not intended as a substitute for informed medical advice. The user of this guide should not use the information provided in this guide to diagnose or treat a health problem or disease without consulting a qualified 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. No warranties are made, expressed or implied, with regard to the contents of this guide or to its applicability to specific patients or circumstances. No author, editor, or publisher shall be liable for direct, indirect, special, incidental or consequential damages arising out of the use or inability to use the contents of this guide. This book is NOT meant to be a substitution for professional medical care. Always consult your Healthcare Provider for treatment plans and recommendations. 01xx-001 Rev01 Table of Contents Table of Contents Glossary . xv Chapter 1 - Introduction and User Safety Introduction . 2 Safety Definitions . 3 Warnings . 3 Cautions . 3 Notes . 3 Practices Used in this User Guide . 4 Procedure Instructions . 4 Terms and Abbreviations . 5 Indications for Use . 6 Contraindications . 6 Risk and Benefits . 6 Solo Education . 7 Proper Use of the Solo System . 8 Insulin Types . 8 General Warnings . 8 General Precautions . 9 System Labels . 14 Symbols and Descriptions . 15 Caring for the Environment . 16 The Solo System and Radio Frequency Radiation . 16 Chapter 2 - Solo System Overview and Features Solo System Description . 18 Components . 19 SoloRemote . 19 Remote Usage Guidelines . 20 Remote Batteries . 21 MicroPump-Remote Communication . 21 Solo MicroPump . 22 Solo Pump Base . 23 Solo Reservoir . 24 Solo User Guide
|ix Table of Contents Cradle . 25 Cannula . 26 Accessories . 27 Filling Device and Handle . 27 Inserter . 28 Protective Caps . 29 Solo System Starter Kit Contents . 31 Insulin Type and Delivery Mode . 32 Chapter 3 - SoloRemote Overview Remote Home Screen Overview . 34 Remote Functions and Keys . 35 Soft Keys and Navigation Keys . 35 Long Press of Keys . 37 Locking and Unlocking Keys . 37 Navigating Using Menus. 37 Navigating Using a Soft Key . 39 Remote Status Bar . 40 Insulin Delivery Icons . 43 Notification Icons and Screens . 44 Data Screen Overview . 46 Entering Edit Mode . 46 Chapter 4 - Setting Up Your Solo System For the First Time Selecting the Insertion Site . 50 Using Your Inserter . 52 Reservoir Preparation . 60 Insulin Handling Guidelines . 61 Filling Your Reservoir . 62 Connecting Your Remote to Your MicroPump . 72 Chapter 5 - Solo Remote Settings Time and Date Settings . 82 Setting the Time and Date . 84 Changing The Time Format . 84 Changing the Time . 85 Changing The Date Format. 85 Changing The Date . 86 Your Delivery & BG Settings . 87 Solo User Guide
|x Table of Contents Delivery & BG Settings Overview . 87 ITC, ISF and BG Settings Overview . 91 Editing Delivery & BG Settings . 92 Setting ITC, ISF and BG Settings . 94 Setting Your Remote Modes Settings . 96 Setting Your Soft Keys . 98 Setting Your Display Units For Carbohydrates . 100 Setting Your MicroPump Settings . 102 Setting Reminders . 104 Setting Your Bolus Reminders. 105 Setting Your Blood Glucose Reminders . 107 Setting Alerts . 108 Setting Your Alerts . 109 Entering Blood Glucose Values . 111 Status Screen . 115 Accessing Status Screen Using the Right Soft Key. 117 About Screen . 118 Average Delivery Report . 120 Detailed Delivery Report . 122 Chapter 6 - Insulin Delivery Using Your Solo System Basal Profiles . 126 Understanding Basal Profiles . 126 Setting a Basal Profile . 128 Activating a Basal Profile . 132 Editing a Saved Profile . 134 Temporary Basal Profile Rates Overview . 136 Setting a Temporary Basal Rate . 138 Access using the Left Soft Key . 138 Access using the Menu Option . 139 Setting a Temporary Basal . 139 Stopping a Temporary Basal Rate . 141 Bolus Delivery . 142 Bolus Types . 142 Bolus Delivery Rules and Guidelines . 144 Delivering a Normal Bolus . 146 Delivering a Normal Bolus . 146 Delivering a Correction Bolus . 149 Solo User Guide
|xi Table of Contents Delivering a Correction Bolus . 151 Delivering a Duo Bolus . 153 Delivering a Long Bolus . 156 Bolus Guide . 158 Bolus Guide Important Information . 158 Bolus Guide Overview . 159 Bolus Guide Formula . 161 Bolus on Board Formula . 162 Using the Bolus Guide . 163 Stopping a Bolus . 168 Delivering a Pump Bolus . 170 Stopping a Pump Bolus . 172 Suspending Insulin Delivery . 173 Resuming Insulin Delivery . 176 Insulin Priming . 178 Chapter 7 - Routine Replacement Procedures Replacement Procedures Overview . 184 Replacing Your Cradle Only . 184 Replacing Your Reservoir . 192 Filling the Reservoir With Insulin . 194 Connecting the Reservoir to the Pump Base . 204 Replacing Your MicroPump . 209 Temporarily Removing Your MicroPump . 217 Reconnecting Your MicroPump to Your Cradle . 219 Chapter 8 - Maintenance and Care of Your Solo System Taking Care of Your Solo System . 222 Replacing Parts . 222 MicroPump and Remote Cleaning . 222 Important Guidelines for MicroPump and Remote Cleaning . 222 Storage and Environmental Conditions . 224 Remote Battery Replacement . 225 Battery Information & Guidelines . 226 Solo User Guide
|xii Table of Contents Chapter 9 - Help and Troubleshooting Assistance & Help Line (24 hours) . 228 Errors . 228 Error List . 228 Alarms and Alerts . 229 Alarms List . 230 Alerts List . 232 General Problem Solving Guide . 239 Chapter 10 - Technical Specifications Technical Specifications . 246 Accuracy Graphs . 248 Environment of Operation . 250 Equipment Classification . 250 Compliance with International Standards . 250 Equipment Classification . 250 Compliance with International Standards . 250 Degree of Protection Against Leakage of Water. 251 Electrical Safety . 252 Electrical Interference . 252 Electromagnetic compatibility (EMC) . 252 Appendix A - Taking Care of Your Diabetes With Solo About Diabetes . 254 Diabetes Terminology . 254 Carbohydrate Counting . 254 Important Diabetes Self Care . 255 Stand-By Emergency Kit . 258 Travel and Vacationing with Your Solo . 259 Time Zone Changes. 259 Preparation . 259 Carry Extra Supplies With You . 260 Airport Security . 261 Preparing for Emergencies and Special Situations . 262 High Blood Glucose (Hyperglycemia) . 262 Hyperglycemia - Signs/Symptoms and Treatment . 262 Ketoacidosis (Diabetic Coma) . 263 Low Blood Glucose (Hypoglycemia) . 264 Hypoglycemia - Signs/Symptoms and Treatment . 265 Solo User Guide
|xiii Table of Contents Sick-Day Recommendations . 267 General Guidelines . 267 Exercise, Sports and Water Activities . 269 Exercise Recommendations . 270 Hospital and Emergency Room Recommendations . 271 Medical Procedures . 272 X-rays, MRIs and CT Scans . 272 Outpatient and other Surgery Procedures . 273 Insulin Pump Therapy While in the Hospital . 275 Temporarily Discontinuing Pump Therapy . 276 Appendix B - HIPAA Privacy Notice & Customer Bill of Rights HIPAA Privacy Notice . 277 Uses and Disclosures of Medical Information . 277 Customer Bill of Rights . 278 Solo User Guide
|xiv Glossary No. Word/Phrase Explanation Basal Profile Basal Rate There are 7 different basal profiles the user can set for different days 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 Profiles on page 126). Blood Glucose The main sugar found in the blood and the body's main source of energy. Also called blood sugar. Blood Glucose Level The amount of glucose in a given amount of blood. It is noted in milligrams per deciliter (mg/dL). Bolus Bolus Guide A bolus is an extra amount of insulin taken to cover an expected rise in blood glucose, often related to a meal or snack. For additional information see Bolus Delivery on page 142. Bolus Guide Bolus Guide suggests the number of insulin units you need to deliver when you need to correct your blood glucose levels or are about to eat carbohydrates for any given meal. For additional information see Bolus Guide on page 158. Bolus on Board Amount of bolus dose available from previous boluses. Cannula Soft Teflon-type tube that delivers insulin from the MicroPump to your body, while inserted under the skin. See Cannula on page 26. The Cannula is encased in a plastic unit until it is inserted vertically via the Inserter. Connecting Needle Part of the MicroPump that is inserted into the Well of the Cradle. 1 2 3 4 5 6 7 8 9 Solo User Guide
|xv No. Word/Phrase Explanation 10 Correction Bolus 11 Cradle 12 DIA 13 Duo Bolus 14 Filling Device 15 Handle 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 glucose reading, not relating to current food consumption (see Delivering a Correction Bolus on page 149). The Cradle is a single-use component affixed to your skin with an adhesive tape. The Cradle holds the Cannula securely in position under your skin. The Solo MicroPump is attached to the Cradle (see Cradle on page 25). Duration of Insulin Action This is the period over which your Bolus insulin is depreciated. See DIA on page 89. Combines Normal and Long Bolus functions, delivering some insulin immediately and some over an extended period of time (see Delivering a Duo Bolus on page 153). It is normally delivered to cover mixed Carbohydrate, Protein/Fat meals. The Filling Device connects the insulin vial to the Reservoir so that you can fill the Reservoir with insulin. Part of the Reservoir Assembly. See Filling Device and Handle on page 27. The Handle connects to the Reservoir for easy withdrawal of insulin from the bottle. Part of the Reservoir Assembly. See Filling Device and Handle on page 27. 16 Hyperglycemia Hyperglycemia or high blood sugar is a condition in which an excessive amount of glucose circulates in the blood plasma. This is generally a blood glucose level of 180 mg/dl or more. 17 Hypoglycemia 18 Inserter 19 Insulin 20 ISF 21 ITC A condition that occurs when one's blood glucose is lower than normal, usually less than 70 mg/dL. Signs include hunger, nervousness, shakiness, perspiration, dizziness or light-headedness, sleepiness, and confusion. If left untreated, hypoglycemia may lead to unconsciousness. The Inserter is a device that is used to:
adhere the Cradle to the insertion site area
insert the Cannula into the subcutaneous tissue for insulin delivery See Inserter on page 28. A hormone that helps the body use glucose for energy. The beta cells of the pancreas make insulin. When the body cannot make enough insulin, insulin is taken by injection or through use of an insulin pump. Insulin Sensitivity Factor This factor indicates how much your blood glucose level will go down after delivering 1 unit of insulin. See ISF on page 89. Insulin to Carbohydrate Ratio This ratio indicates how many carbohydrates are counteracted by 1 unit of insulin. See ITC on page 89. Solo User Guide
|xvi No. Word/Phrase Explanation 22 Long Bolus 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 cover complex high protein/fat meals (see Delivering a Long Bolus on page 156). 23 MicroPump The Reservoir connects to the Pump Base to form the MicroPump. For additional information see Solo MicroPump on page 22. 24 Normal Bolus 25 Protective Caps 26 Pump Base 27 Pump Bolus 28 Priming 29 Reservoir A steady amount of insulin delivered immediately in bolus form. Can be activated either via the Remote (see Delivering a Normal Bolus on page 146) or by using the Pump Bolus buttons (see Delivering a Pump Bolus on page 170). The Protective Caps are placed over the Well of the Cradle and are used to:
prevent water ingress (seeping) into the Cannula insertion site
keep the Well and connecting needle clean during Cradle-MicroPump detachment and suspension For additional information see Protective Caps on page 29 The Solo MicroPump receives insulin delivery instructions from the Solo Remote and delivers insulin to your body. It also communicates delivery and status information back to the Remote. For additional information see Solo Pump Base on page 23 The Pump Bolus buttons on your MicroPump allow you to deliver a Normal bolus without using the Remote. For additional Delivering a Pump Bolus on page 170. Starts the flow of insulin from the Reservoir to the Reservoir Connecting Needle. For additional information see Insulin Priming on page 178. The Solo Reservoir is a disposable component that holds up to 200 units of insulin. For frequency of replacing the Reservoir, refer to the insulin labeling recommendations (every 48 or 72 hours depending on insulin type) and follow the directions of your healthcare team. For additional information see Solo Reservoir on page 24. Solo User Guide
|xvii No. Word/Phrase Explanation 30 Reservoir Assembly Includes Reservoir, Filling Device and Handle. For additional information see Filling Device and Handle on page 27. 31 TDD 32 Temporary Basal 33 Type-1 Diabetes 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. This includes bolus and basal deliveries during a 24-hour day. See TDD on page 89. A basal ratio defined by the user to cover a certain abnormal condition where the predetermined basal rate needs altering. Example: Due to a 3-hour hike, Joe needs to reduce his basal rate by 20% for 3 hours. For additional information see Setting a Temporary Basal Rate on page 138. A condition characterized by high blood glucose levels caused by insufficient insulin. Occurs when the body's immune system attacks the insulin-producing beta cells in the pancreas and destroys them. The pancreas then produces little or no insulin. Type 1 diabetes develops most often in young people but can appear in adults. 34 Type-2 Diabetes A condition in which the beta cells of the pancreas produce insulin but the body is unable to use it effectively because the cells of the body are resistant to the action of insulin. 35 Well Part of the Cradle that holds the Cannula assembly and prevents its movement during use. This part is attached to the Connecting Needle on the MicroPump. For additional information see Figure 2-6 on page 2-25. Solo User Guide
|xviii Introduction and User Safety Chapter 1 Introduction and User Safety In this section:
Introduction on page 2
Reminders, Alerts, Alarms and Errors Overview on page 11
Safety Definitions on page 3
System Labels on page 14
Practices Used in this User Guide on page 4
Symbols and Descriptions on page 15
Terms and Abbreviations on page 5
Caring for the Environment on page 16
The Solo System and Radio Frequency Radiation on page 16
Indications for Use on page 6
Contraindications on page 6
Risk and Benefits on page 6
Solo Education on page 7
Proper Use of the Solo System on page 8
General Warnings on page 8
General Precautions on page 9 Solo User Guide
|1 Introduction Introduction Introduction and User Safety 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 System user, ask your Healthcare Provider for step-by-step guidance on its use. Do not attempt to use the system until you have been trained by your Healthcare Provider. Use of the System without adequate training or improper setup could put your health and safety at risk. This Solo System User Guide will guide you through the proper setup and use of your new Solo System. We suggest that you read this guide thoroughly in order to familiarize yourself with the Solo System. We recommend that you become familiar with the system's multiple features to make the product work better for you and your lifestyle. Please keep this comprehensive guide within easy reach for quick reference at all times. Caution Rx Only Federal law only by or on the order of a licensed Healthcare Provider. The Solo System is restricted for sale under U.S. CAUTION The values and screen shots indicated in this user guide are provided as examples only (unless stated otherwise) and should not be considered a recommendation for MicroPump settings. Note Solo User Guide
|2 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 Warning A warning alerts you to a situation which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards. For example, misdosing insulin could result in life threatening hypoglycemia. Do not proceed beyond a WARNING message until you fully understand the conditions and you have taken the appropriate preventive action. Cautions Notes CAUTION Cautions are used to warn you of a potentially hazardous situation which, if not avoided, may result in minor or moderate injury. For example:
Caution
Misdosing insulin could result in hyperglycemia.
Improper hygiene may lead to insertion site infection. Do not proceed beyond a CAUTION message until you fully understand and observe the indicated conditions. Notes are used to provide additional information for the purpose of clarification. Note Solo User Guide
|3 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. If relevant, a system response is written below the procedure step and appears in italics. Example:
To change the system time:
1. Press <Edit> to change the time. The orange arrows start blinking on the field. 2. Use the Up/Down navigation keys to change the hour segment. 3. Press <Save> to save the value. 4. Next step, etc. The table below defines words that are commonly used for instructions. Word Description Highlight Select or highlight a screen item Press Hold Press and release a button or soft key Keep pressing a button until its function is completed Solo User Guide
|4 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 Italics Names of menus and screens System response that occurs as a result of button pressed Bold Italics Used to emphasize important information
<Soft Key>
Soft key names are written in angled brackets. A soft key is a button located next to the screen which performs a function based on text that appears on the screen above it at the time of display. For additional information see Soft Keys and Navigation Keys on page 35. The following terminology is used when referring to the Remote:
Word Menu Screen Description A list of options on the Remote. These options allow you to perform tasks. Displays programming, operating, and error/alarm/alert/reminder message information. Button Physical button on the Remote. Indicator An image on the Remote's Status Bar that indicates a certain status. For additional information see Remote Status Bar on page 40. Soft keys Three buttons (Left, Center and Right) which relate to changing text displayed just above the buttons (their functions change according to the task being performed). For additional information, see Soft Keys and Navigation Keys on page 35. Terms and Abbreviations For assistance with Terms used in this User Guide, please refer to the Glossary. Solo User Guide
|5 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. Contraindications Continuous subcutaneous insulin infusion therapy with the Solo System is not recommended for people who are:
unable to perform at least 4 blood glucose checks per day. unable to stay in contact with their Healthcare Provider. unable to follow the instructions provided for the system. unable to see or hear system signals or alarms. Risk and Benefits You should discuss the benefits and potential risks of using the Solo System with your healthcare team before using the Solo System. Please review this User Guide prior to use for detailed instructions and disclosure. The Solo MicroPump is a miniature, tubeless insulin pump, which enables you to conveniently control glucose levels 24 hours a day while maintaining an active lifestyle. For the safety and success of insulin pump therapy, you are required to take an active role in managing your care, perform frequent glucose monitoring, keep a close watch on your carbohydrate consumption, follow the instructions provided in this User Guide and periodically update your treatment regimen with your physician or health care team. Failure to keep your personal clinical parameters current or improper use may expose you to risk from hypoglycemia, hyperglycemia and infection at insertion sites, as well as the long-term health risks related to poor glycemic control. Responsible use of the Solo System will allow you to enjoy the benefits of convenient and safe insulin pump therapy. Solo User Guide
|6 Introduction and User Safety Solo Education Solo Education WARNING
Treatment with the Solo System should only be initiated after you are educated by a certified Medingo professional. Warning
Incorrect use of this system, failure to apply, implement or follow the instructions and important information contained in this User Guide or improper/inadequate self-care may lead to serious injury or death. CAUTION Caution Changes or modifications to the Solo System not expressly approved by Medingo Ltd. will void your authority to operate this equipment. The Help & Troubleshooting section (see Chapter 9 Help and Troubleshooting) contains information on troubleshooting system alarms & alerts. Certain alarms (such as the Blockage alarm) will cause system deactivation. Be sure to respond to all alarms &
alerts when they occur. Warnings, cautions and other important safety information can be found in this section and throughout the guide. Solo User Guide
|7 Proper Use of the Solo System Introduction and User Safety Proper Use of the Solo System Insulin Types General Warnings 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 (do not use in the Reservoir beyond 72 hours)
Apidra (do not use in the Reservoir beyond 48 hours) Before using different insulin with this MicroPump, check the insulin label to make sure the insulin can be used with the MicroPump. This section informs you of situations which, if not avoided, could result in potential serious adverse reactions and safety hazards, serious injury or death.
The Solo System is intended solely for Continuous Subcutaneous Insulin Infusion (CSII) into the body of its user, a person with diabetes, who has been prescribed this device by an authorized Healthcare Provider. Use the Solo System only after you have been educated and as instructed in this guide. Do not use Solo for any other type of therapy.
Only rapid acting insulin should be used to fill the Solo Reservoir.
Solo is not intended for use in the presence of flammable mixtures.
This device includes small components that could pose a choking hazard to small children.
Although the Solo System has many safety alarms, it cannot notify you if the MicroPump is leaking or the insulin has lost its potency. Therefore, it is important that you check your blood glucose levels at least 4 times per day.
Accurate time and date settings are essential for correct functioning of the system. Erroneous time settings may result in serious consequences. You will need to adjust the time and date for daylight savings adjustments and adaptation to different time zones (see Setting the Time and Date on page 84). Consult with your Healthcare Provider to determine what adjustments, if any, are necessary. Solo User Guide
|8 Introduction and User Safety Proper Use of the Solo System General Precautions This section informs you of potential hazards which may harm the device or accompanying equipment if not avoided.
Avoid using any system parts with broken seals or expired
"use by" dates. Do not attach or use a component if it is damaged in any way. A damaged component may not work properly.
If you drop the Remote or knock it against something, always inspect it carefully to verify that it is still working properly. 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. Remove the MicroPump before swimming and bathing and other water-related activities. If the MicroPump gets wet, wipe it with a clean dry cloth.
Avoid exposure of your MicroPump to temperatures above 99F (37C) or below 41F (5C).
Avoid exposure of your Remote to temperatures above 113F
(45C) or below 23F (-5C). If you are outside in cold weather, keep the Remote close to your body and covered with clothing.
Insulin should never be frozen or exposed to temperatures in excess of 99F (37C). Insulin degrades at high temperatures and will freeze near 32 F (0C). The MicroPump must be removed prior to Magnetic Resonance Imaging (MRI) scans, CT scans, direct x-rays, ultrasound examinations or any other potential exposure to a strong electromagnetic field, as they can affect the MicroPump's function.
Do not expose your MicroPump to strong light sources, such as a camera flash. Solo User Guide
|9 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 Bases 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 1-1) nor in the drainage areas of the pump
(#2 in Figure 1-1). This can result in decreased battery voltage. 1 2 Figure 1-1 Pump Base Protective Shield and Drainage Areas 2 Solo User Guide
|10 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.
The Remote sounds alarms, alerts and reminders. The MicroPump sounds MicroPump-related alarms and errors. All MicroPump errors, alarms and alerts are displayed on the Remote screen after establishing communication with the Remote. Sounds also provide feedback to certain actions such as bolus delivery. For a list of alarms, alerts and reminders and instructions on handling them, please turn to Chapter 9 Help and Troubleshooting. It is possible to mute some of the sound signals via the Remote. For additional information, see the Setting Your Remote Modes Settings on page 96. If you choose to do so, a mute sound indicator appears on the Status Bar (see Remote Status Bar on page 40) of the Remote. Visual signs will still appear on the Remote, even though the sound is muted. You cannot mute alarm sounds generated from the MicroPump. Note Alerts are sounded before alarms in order to provide an early warning which directs your attention to the anticipated occurrence. Both the MicroPump and the Remote sound the relevant beeps related to the current message. The table below details the types of beeps that are heard. Reminder Alert Alarm RC Error Remote 4 beeps 4 beeps 4 beeps 3 beeps repeated every 30 seconds MicroPump none 1 beep repeated every 5 minutes 4 beeps repeated every 5 minutesa none Replace Reservoir or MicroPump Every disconnection of the Pump Base from the Reservoir results in 1 short beep a. When the MicroPump battery is nearly depleted, the low battery indication alarm beeps 3 beeps every 3 minutes for a period of 30 minutes. When there are only 3 minutes of battery power left, there will be 1 beep repeatedly until the Reservoir is replaced or the battery is depleted. Solo User Guide
|11 Proper Use of the Solo System Introduction and User Safety If an alarm or error occur, you must take care of the problem before you can enter a new command. Your immediate attention is required to ensure the system can continue to function properly. Errors Overview Alarms Overview Errors are sounded on the Remote and are displayed with an error number and a code number. Appearance of error alarms result in insulin delivery suspension, meaning that your basal insulin will not be delivered. To prevent problems, you must respond to errors immediately. 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). Once an alarm is sounded, you cannot enter new commands until you take care of the problem. Your immediate attention is required. When you activate a procedure and an alarm occurs, an alarm icon will appear on the Status Bar (see Remote Status Bar on page 40) but the message will only be displayed once the active procedure is completed. Alarms are sounded on the Remote and MicroPump-related alarms are sounded on your MicroPump as well. An explanatory text alarm message (including an alarm number) is also displayed on your Remote screen. Alarms that occur as a result of a MicroPump failure:
inform you of MicroPump failure inform you that insulin delivery is suspended as a result of this failure Alarm Examples:
Empty Reservoir or limited amount of insulin left Pump Base has exceeded maximum operation time
Reservoir has exceeded maximum operation time
Reservoir or Pump Base operation errors
Insulin blockage alarm
Bolus delivery interruptions Solo User Guide
|12 Introduction and User Safety Proper Use of the Solo System Alerts Overview
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. Alerts are sounded before alarms, in order to provide advance warning of the problem that is anticipated. These alerts are sounded on your Remote and are accompanied by an explanatory alert message (including an alert number) on your Remote screen. Some alerts are a normal part of system use. There are alerts that warn of a system malfunction, such as an alert to replace the Reservoir or the Remote batteries. If you receive an alert message (beep) during an active procedure and the message is not related to the procedure, an alert icon will appear on the appear on the Status Bar (see Remote Status Bar on page 40) but the message will only be displayed once the active procedure is completed. For a list of alerts, please see Alerts List on page 232. Reminders Overview You can program Bolus and blood glucose reminders as you wish
(See Setting Your Bolus Reminders on page 105 and Setting Your Blood Glucose Reminders on page 107). These reminders (two brief beeps repeated twice) are sounded on your Remote only and are accompanied by an explanatory reminder message on your Remote screen. If you receive a reminder message (beep) during an active procedure and the message is not related to the procedure, a Reminder icon will appear on the Status Bar, (see Remote Status Bar on page 40) but the message will only be displayed once the active procedure is completed. Solo User Guide
|13 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 15. Solo User Guide
|14 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. Symbol Description Do not reuse Use by Batch Code Symbol IPX4 Description Indicates protection from splashed water only Date of Manufacture Method of sterilization using Ethylene Oxide Attention, consult accompanying documents Catalog number Manufacturer Keep Dry Rx Only Caution: Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner. Temperature Limitation Consult Instructions for use Fragile, Handle with care Latex Free Serial number Non-ionizing radiation Avoid exposure to humidity Identifies degree of protection against electric shock. Equipment Type BF - symbol indicates B Type equipment having a floating applied part Remove before MRI, CT, Ultrasound and X-ray Solo User Guide
|15 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. Operation is subject to the following two conditions:
This device may not cause harmful interference. This device must accept any interference received, including interference that may cause undesired operation. The Solo System 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 site. The Solo System generates and radiates radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. The Solo Remote is designed to withstand normal radio interference and electromagnetic fields. However, as with all wireless communication technology, certain operating conditions can interrupt communication. For example, electric appliances such as microwave ovens, RF transmitters such as WiFi, high voltage lines and electric machinery located in manufacturing environments may cause interference. In most cases, try moving the Remote and yourself to another location away from such appliance disturbances. If the Solo System does cause harmful interference to radio or television reception (which can be determined by removing the Solo System from the area), you can correct the interference by performing one or more of the following:
Move or relocate the Solo System.
Increase the distance between the Solo System and the other device that is emitting or receiving interference. Solo User Guide
|16 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
SoloRemote on page 19
Inserter on page 28
Solo MicroPump on page 22
Protective Caps on page 29
Solo Pump Base on page 23
Solo Reservoir on page 24
Cradle on page 25
Cannula on page 26
Solo System Starter Kit Contents on page 31
Insulin Type and Delivery Mode on page 32 Solo User Guide
|17 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. The Solo System is designed for Continuous Subcutaneous (under the skin) Insulin Infusion (CSII). The Solo MicroPump provides continuous 24-hour Basal (small amounts of insulin throughout the day) and Bolus (larger amounts of insulin prior to a meal or to correct a blood sugar) insulin deliveries through a short, thin teflon tube
(Cannula). The latex-free Solo MicroPump has no exposed tubes or wires and is compatible with variable meal, exercise and lifestyle routines. You may program and adjust up to 7 basal profiles, set a temporary basal rate, suspend insulin delivery and deliver and use a variety of Bolus types, including Normal, Long, Duo and Correction (please see Chapter 6 Insulin Delivery Using Your Solo System for specific instructions). The Solo System includes disposable and reusable parts. The components and subcomponents are summarized in Table 2-1. These parts are described in detail in the following sections Table 2-1 Solo System Components Component Description Remote MicroPump The Solo System Remote is a durable hand-held, battery-operated device that wirelessly controls operational information to and from the MicroPump. Includes the Pump Base and the Reservoir, which are joined together to form the MicroPump. Reservoir The Reservoir includes an Insulin Reservoir, Battery and connecting needle. Reservoir Assembly The Reservoir Assembly includes the pre-joined Reservoir, Filling Device and Handle. Pump Base The Pump Base includes the mechanical parts and the electronics for driving and monitoring MicroPump operation. Cradle Cannula Inserter The Cradle is adhered to the your skin by adhesive tape. The Cradle anchors the Cannula in position under the skin and enables connection and disconnection of the MicroPump from the Cannula. Soft Teflon-type tube that delivers insulin from the MicroPump to your body, while inserted under the skin. The Inserter inserts the Cannula into the subcutaneous tissue and retracts the guiding needle into the Cannula casing after insertion. Solo User Guide
|18 Solo System Overview and Features Components Components SoloRemote 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. It communicates with the MicroPump that is attached to your body and provides instructions. In addition, the Remote stores and displays insulin delivery data. When any button on the Remote is pressed (see Figure 2-1), the Solo Home screen appears. This screen provides important information on the current status of the Solo System via the Status Bar. If there are any errors, alarms, alerts or reminders, these will also appear. Figure 2-1 Solo Remote Solo User Guide
|19 Components Solo System Overview and Features 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. The Remote will automatically enter Time Out mode if not used for a certain time period as preset in the Remote Modes Time Out option (see Time Out on page 96). Note Remote Usage Guidelines
Always carry the Remote with you.
When you are in a loud or noisy environment you may not hear system alarms. Therefore, it is recommended to occasionally look at your 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
|20 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 40). Only new batteries should be used in the Remote. Do not insert used batteries. Note We do not recommend using NiCad, nickel metal hydride, carbon zinc (heavy duty), lithium or any rechargeable batteries in the Remote. For Battery Replacement Instructions, refer to Remote Battery Replacement on page 225. For additional information on battery life, refer to Battery Information & Guidelines on page 226. MicroPump-Remote Communication The Remote wirelessly communicates with the MicroPump every:
second if the Remote is not in Time Out mode 90 seconds if the Remote is in Time Out mode In the event of a communication problem, an alarm will sound and a message will appear. The Remote must be within 4.9 feet (1.5 meters) in order to change any of the MicroPump or insulin delivery settings. Solo User Guide
|21 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. The MicroPump is then connected to the Cradle (see Cradle on page 25), that is adhered to your skin. The Solo MicroPump delivers insulin to your body. It also communicates delivery and status information back to the Remote. The MicroPump continues to deliver insulin as programmed, regardless of the proximity of the Remote. However, you will need the Remote in order to:
set up or replace your MicroPump or Reservoir edit the Basal delivery settings or rates set your parameters, read system messages and make other programming changes You can deliver a Pump Bolus using your MicroPump only. However, Long, Duo and bolus deliveries using the Bolus Guide must be activated using the Remote. 10 l m 2 Figure 2-2 Solo MicroPump The Reservoir is joined with the Pump Base to create what is called the MicroPump. The MicroPump is then connected to the Cradle
(see Cradle on page 25), that is adhered to your skin. Solo User Guide
|22 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. Every 3 months you will be reminded to replace both the Pump Base and the Reservoir. You will receive an alert and an alarm informing you of the scheduled replacement time. You should always initiate the replacement via your Remote, so that all the necessary information and data is saved and transferred in an orderly fashion to the new Pump Base. Each time the Pump Base is replaced, it has to be recognized by the Remote. In this way the data that is stored in your Remote is transferred to the new Pump Base. Each time you match a new Pump Base with the Remote, you are required to confirm the serial number from the back of the Solo Pump Base. For additional information see Replacing Your MicroPump on page 209. Figure 2-3 Solo Pump Base Solo User Guide
|23 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. For frequency of replacing the Reservoir, refer to the insulin labeling recommendations (every 48 or 72 hours depending on insulin type) and follow the directions of your healthcare team. The Reservoir contains a Zinc-air battery, which powers the MicroPump. The battery should be activated (by removing the protective strip) only when you are ready to attach the Reservoir to the Pump. Zinc-air battery Syringe Reservoir Battery Protective Strip Figure 2-4 Solo Reservoir Solo User Guide
|24 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. The Cradle holds the Cannula securely in position under your skin. In addition, the Cradle holds the MicroPump, which is simply clicked into the Cradle, allowing easy disconnection. You can wear the Cradle for up to 72 hours before you replace it with a new one. If you participate in any activity in which you remove your MicroPump, you should cover the Well of the Cradle with the Protective Caps (see Protective Caps on page 29). 3 4 6 1 2 5 Figure 2-6 MicroPump and Cradle in Various Views Solo User Guide
|25 Components Solo System Overview and Features Description 1 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 2 3 4 5 6 Cannula You should dispose of the Cradle as a biohazard according to national and local regulations The Cannula is a soft Teflon tube that is inserted under the skin and delivers insulin from the MicroPump to your body. The Cannula remains under the skin for the entire usage period of up to 72 hours. The Cannula is available in both 6 mm and 9 mm sizes. The Cannula is encased in a plastic unit until it is inserted vertically via the Inserter (see Inserter on page 28). The Cannula is sterile. The plastic encasing should be discarded once the Cannula is inserted. You should dispose of the Cannula encasing as a biohazard according to national and local regulations. Guiding Needle Covered by the Cannula Figure 2-7 Cannula Encased in Plastic Unit Solo User Guide
|26 SoloRemote Overview Chapter 3 SoloRemote 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 page 34
Remote Functions and Keys on page 35
Remote Status Bar on page 40
Insulin Delivery Icons on page 43
Soft Keys and Navigation Keys on page 35
Notification Icons and Screens on page 44
Navigating Using Menus on page 37
Navigating Using a Soft Key on page 39
Data Screen Overview on page 46
Entering Edit Mode on page 46 Solo User Guide
|33 Remote Home Screen Overview SoloRemote 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 System using the Status Bar (see Remote Status Bar on page 40). If there are any errors, alarms, alerts or reminders, these will also appear on this screen (see Notification Icons and Screens on page 44). Figure 3-1 Remote Home Screen The Remote automatically switches OFF if not used for a certain time period as preset in the Remote Modes Time Out option (see Time Out on page 96). Turning off the Remote screen does not turn off
(or affect) your MicroPump, which will continue delivering insulin as programmed. Note Solo User Guide
|34 SoloRemote 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 System is very simple. The buttons on the Remote are referred to as keys. Each key has its own function, as described in Table 3-2 Remote Menus on page 3-38. The numbers that appear on the keys are primarily used for entering a password to the Remote. Note Keys can be grouped into 2 categories:
Soft Keys used to select a function based on the corresponding text on the screen.
Navigation Keys used to move up, down, right or left Soft Keys and Navigation Keys A Soft Key is a button located next to the screen which performs a function based on the text that appears next to it at the time of display. Figure 3-2 shows the Soft Keys and Table 3-1 describes these keys. The Navigation Keys are used to move up, down, right and left throughout menus and screens. The Navigation Keys have arrows indicating the direction you will move if the key is pressed. Select Key Left Soft Key Right Soft Key Up Navigation Left Navigation Right Navigation Down Navigation Remote Figure 3-2 SoloRemote Home Screen and Soft Keys Solo User Guide
|35 Remote Functions and Keys SoloRemote Overview Table 3-1 Remote Soft Keys and Navigation Keys Item, Figure 3-2 Description Left Soft Key and Corresponding Text Right Soft Key and Corresponding Text Select Key and Corresponding Text When you press the Left Soft Key, you are selecting the text option that appears on the bottom left corner of the current screen. On the Home screen, if you press <T. Basal>, you are opening the Temporary Basal screen (for additional information see Setting a Temporary Basal Rate on page 138). When you press the Right Soft Key, you are selecting the text option that appears on the bottom right corner of the current screen. On the Home screen, if you press the Right Soft Key, you are pressing
<Status>. When you press the Select Key (located in Center at top of keypad), you are selecting the text option that appears in the bottom center of the current screen. On the Home screen, if you press <Select>, you are selecting the currently highlighted (orange) option. Up Navigation Used to move up Left Navigation Used to move left Down Navigation Used to move down Right Navigation Used to move right On the Home Screen shown in Figure 3-2:
if you press <T. Basal> (Left Soft Key), the Temp Basal
(Temporary Basal) screen will open. if you press <Status> (Right Soft Key), the Status screen will open. if you press <Select> (Select Key), the Menu screen opens. In the instructions provided in this User Guide, the left Soft Key, right Soft Key and Select Key appear within angled brackets. The factory default keys are shown Figure 3-2. However, you can modify the setting of the Left and Right Soft Keys if you wish (see Left Key on page 98 and Right Key on page 98). Solo User Guide
|36 SoloRemote 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. Locking and Unlocking Keys The keys on your Remote automatically lock after a certain amount of time since the last key press on the Remote (from 30 seconds to 5 minutes). The length of time is set in the Remote Modes screen (see Setting Your Remote Modes Settings on page 96. You may also lock the keypad manually by pressing the Left navigation key while at the Home screen and following the instructions on the screen. To unlock the keypad, press the left navigation key followed by the Left Soft Key. Navigating Using Menus The option that is currently selected on the screen is highlighted in orange. Solo User Guide
|37 Remote Functions and Keys SoloRemote 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. 1 2 Figure 3-3 Remote Menus Table 3-2 Remote Menus Item, Figure 3-3 Description 1 Bolus Allows you to enter the Bolus menu. This option is for administering a Bolus and not setting parameters. This field changes to Replace when the MicroPump is not operative or Resume when insulin delivery is suspended. For additional information see Delivering a Normal Bolus on page 146. 2 Menu Allows you to access other Solo System menus and screens. Solo User Guide
|38 SoloRemote 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>. The Menu screen opens.
To access the Bolus screen:
1. If the Bolus option is not highlighted (orange), use the Up navigation key so that the Bolus option is highlighted in orange. 2. Press <Select>. The Bolus screen opens. If a menu option is dimmed and is currently not available on the menu, an i icon will appear on the right side of the option (see Figure 3-6). To see why this is not available, select <Info>. Note Navigating Using a Soft Key The following describes how to use the Soft Keys to access other screens.
To access the Temp Basal screen via Left Soft Key:
Press the <T. Basal> key. The Temp Basal screen opens.
To access the Status screen via Right Soft Key:
Press the <Status> key. The Status screen opens. Solo User Guide
|39 Remote Status Bar SoloRemote 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 1 2 3 4 5 6 7 Figure 3-4 Status Bar The table below describes the icons that appear in the Status Bar shown in Figure 3-4. Additional status icons that may appear on your Remote are shown in Table 3-4. Solo User Guide
|40 SoloRemote Overview Remote Status Bar Item, Figure 3-4 Insulin Reservoir Status Icon Insulin Reservoir Status Time 1 2 3 4 Communication Status Icon 5 Battery Power Status Icon 6 Active Basal Profile Name and Units/Hour or suspension 7 Mute Sound Icon Table 3-3 Status Bar Description Visual representation of units remaining in Reservoir Number of units remaining in Reservoir Current time set on the Solo System. If time shown is incorrect, refer to Setting the Time and Date on page 84. Indicates that the Remote is communicating with the MicroPump.
). For additional If no communication has occurred for a half hour, a diagonal line appears across the icon (
information see Chapter 9 Help and Troubleshooting. Visual display of approximate Remote battery life remaining. For additional information see Table 3-4 Status Bar Icons on page 3-42. Indicates the name and rate of the active Basal Profile or while in suspension mode, indicates "Suspension" (flashing on). For information on basal settings, see Setting a Basal Profile on page 128. Indicates that sound is set to Mute. There is no icon to indicate that sound is On. For sound settings see Remote Sound on page 96. Solo User Guide
|41 Remote Status Bar SoloRemote Overview Table 3-4 Status Bar Icons Battery Full Battery 75% full Battery Status Battery 50% full Battery 25% full Battery Empty Communication Status Communicating with MicroPump Not communicating with MicroPump System Sound System is in Mute mode Solo User Guide
|42 SoloRemote Overview Insulin Delivery Icons Insulin Delivery Icons The following icons appear during insulin delivery. Bolus in Progress Active Basal or Bolus Insulin Delivery Suspended Appears on the Home screen when a Bolus is currently being delivered (in progress). The number next to the icon indicates the total amount of insulin that will be delivered via all active Boluses. Appears in the Basal Profile screen next to the currently active Basal Profile to indicate the Basal Profile currently being delivered. Appears in the Basal Profiles screen when insulin delivery is suspended. For additional information see Suspending Insulin Delivery on page 173. Solo User Guide
|43 Insulin Delivery Icons SoloRemote 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 Error Reminder Figure 3-5 shows examples for Alarms, Alerts, Errors and Reminders. Figure 3-5 Notification Examples When any of these messages appear on your Remote, follow the instructions shown on your screen. Solo User Guide
|44 SoloRemote 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 Time Change Appears in Detailed Delivery Report when time is changed. Pump error Paired Pump Stop Bolus This icon appears in the list of MicroPumps when replacing MicroPump. This indicates that the pump is in an error state or is not compatible with your Remotes software version. Appears near the name of a paired Pump in the list of MicroPumps when replacing MicroPump. Appears in the Detailed Delivery Report when a Bolus is stopped. Solo User Guide
|45 Data Screen Overview SoloRemote 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. To change a value, you must be in Edit mode. The left screen in Figure 3-7 shows an example of a screen that is not in edit mode since Edit appears at the bottom of the screen
(you will see on your own screen that the orange arrows are not blinking). Static orange arrows indicate that you are highlighting a certain field but are not in edit mode. Entering Edit Mode You must be located within a data screen to enter Edit mode (almost any screen except for the Home screen).
To enter Edit mode:
Press <Edit> (via the Select key). Once you are in Edit mode (right screen in Figure 3-7), blinking orange arrows above and below the value of the current field indicate you are in edit mode and the Select key Edit has changed to Save. Review Mode Edit Mode Blinking Arrows Figure 3-7 Review Mode and Edit Mode Examples Solo User Guide
|46
frequency | equipment class | purpose | ||
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1 | 2009-12-22 | 2401.3 ~ 2481.6 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2009-12-22
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||||
1 | Applicant's complete, legal business name |
Medingo Ltd.
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1 | FCC Registration Number (FRN) |
0018070565
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1 | Physical Address |
Industrial Park, Building No.7
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1 |
261
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1 |
Yoqneam Illit, 20692
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|||||
1 |
Israel
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|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
c******@telefication.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
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app s | FCC ID | |||||
1 | Grantee Code |
WNR
|
||||
1 | Equipment Product Code |
09SOLORC5
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
A******** N******
|
||||
1 | Title |
VP Research & Development
|
||||
1 | Telephone Number |
+972 ********
|
||||
1 | Fax Number |
+972 ********
|
||||
1 |
a******@medingo.com
|
|||||
app s | Technical Contact | |||||
1 | Firm Name |
Hermon Laboratories Ltd.
|
||||
1 | Name |
M****** N******
|
||||
1 | Physical Address |
Harakevet Industrial zone
|
||||
1 |
23
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|||||
1 |
Binyamina, 30500
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|||||
1 |
Israel
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|||||
1 | Telephone Number |
+972 ********
|
||||
1 | Fax Number |
+972 ********
|
||||
1 |
n******@hermonlabs.com
|
|||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | No | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Remote control of the insulin delivery device | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | Yes | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Hermon Laboratories
|
||||
1 | Name |
G****** S********
|
||||
1 | Telephone Number |
972-4********
|
||||
1 | Fax Number |
+972 ********
|
||||
1 |
g******@hermonlabs.com
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Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2401.30000000 | 2481.60000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC