Contacts and Important Information Use the spaces below to record important health and product information.
Contents Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi About This User Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Conventions and terms . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vi Before You Get Started . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .vii Indication . . . . . . . . . . . . . . . . . . . . . .
Contents 4: Bolus Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 What is a Bolus? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Bolus Dose Options . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27 Deliver Bolus Doses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Deliver a normal bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 Deliver an extended bolus . . . . . . . . . . . . . . . . .
Contents 7: My Records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Record Keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Insulin Delivery History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 View insulin delivery history . . . . . . . . . . . . . . . . . . . . . . . . 61 Alarm History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 User and Product Information . . . . . . . . . . . . . .
Contents Appendices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 The iXL™ Pump Care and Maintenance . . . . . . . . . . . . . . . . 97 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 The iXL™ Remote Controller Care and Maintenance . . . . . 97 Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Introduction About This User Guide Conventions and Terms Symbols Convention/Term Meaning Symbol Meaning Bold Warning Describes potential serious adverse reactions, or indicates conditions that could cause death or serious injury. Caution Indicates conditions that could cause minor or moderate injury to you or damage to the device. Note Provides helpful information. Tip Offers a suggestion for successful pumping.
Introduction Before You Get Started US Federal law restricts this device to sale by or on the order of a physician. Indication The Insulet iXL Diabetes Management System is intended for the continuous subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin. Contraindications Insulin pump therapy is NOT recommended for people who are either: • Unable to perform at least four (4) blood glucose checks per day.
Introduction Your healthcare provider is a valuable resource. You are going to rely on him/her for a lot of critical information about your iXL System, especially during the first few weeks and months. If you have questions about diabetes management after starting on the iXL System, do not hesitate to talk with your healthcare provider. You can call us 24 hours a day, 7 days a week for emergencies or for technical questions about iXL System setup or operation.
Introduction Your Personal Diabetes Management Information Temp Basal Presets Name Adjustment ______________ _______ U/hr ______________ _______ U/hr ______________ _______ U/hr Basal Programs Name Time Segment ______________ 12:00 am to _______ _______ to _______ _______ to _______ _______ to _______ _______ to _______ Rate _______ U/hr _______ U/hr _______ U/hr _______ U/hr _______ U/hr ______________ 12:00 am to _______ _______ to _______ _______ to _______ _______ to _______ _______ to _______ ____
Introduction My Notes: iXL™ Diabetes Management System User Guide: Introduction x
Introduction My Notes: xi iXL™ Diabetes Management System User Guide: Introduction
Your New iXL™ Diabetes Management System Insulin Delivery with the iXL™ System The iXL System is more than just a pump. It is a complete diabetes management system. The long-term health benefits of better blood glucose control are well known. Maintaining near-normal blood glucose can help you live a longer, healthier life with fewer diabetes-related complications. However, good health is not the only advantage enjoyed by people who use the iXL Diabetes Management System.
1 Your New iXL™ Diabetes Management System How does the iXL™ System Work? The iXL Diabetes Management System is a two part system: a pump and a remote. The iXL Pump is small and has a low, thin profile. The pump is worn on the body and is comfortable to wear. An adhesive holds the pump against the skin. The pump can hold up to 200 units of deliverable insulin. Each time you activate a new pump, you fill it with the amount of insulin you need. The iXL System stores insulin right inside the pump.
Your New iXL™ Diabetes Management System The iXL™ Pump 1 The iXL™ Remote Controller The iXL Pump attaches to your skin with an adhesive backing, similar to a bandaid. All pump operations are programmed and controlled through the palm-sized iXL Remote Controller. The remote “talks” to the pump using wireless technology, similar to a mobile phone.
1 Your New iXL™ Diabetes Management System Buttons that program and control the iXL™ System Button Action Button Action Power Pressing turns the screen on and off. Holding activates the backlight, which lets you read the screen in the dark. To preserve battery life, use the backlight only when necessary. Brings you to the Status screen (shown later in this chapter).
Your New iXL™ Diabetes Management System 1 Entering and changing text To enter text, numbers, or characters (for example, when entering your personal contact information), use the Up/Down Controller button to scroll to the character you want, and then press Select. Repeat for each character needed to spell the word or name you want to add. To change a number, time, or date, select the number and use the Up/Down Controller button to increase or decrease it.
1 Your New iXL™ Diabetes Management System Primary Screens Messages on the screen tell you how the system is operating, list menu choices, or explain how to perform certain tasks. The system’s two primary screens are: Status Screen Action View the system’s current operating status • Date and time. • Remote battery level. • Insulin reservoir volume (how much insulin is in the pump). • When an extended bolus is being delivered, how much insulin has been delivered.
Your New iXL™ Diabetes Management System 1 My Notes: iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System 7
1 Your New iXL™ Diabetes Management System My Notes: 8 iXL™ Diabetes Management System User Guide: Your New iXL™ Diabetes Management System
Getting Started 2 The iXL™ Startup Kit Your kit contains: • This User Guide • One (1) iXL Remote Controller • Ten (10) iXL Pumps (filling syringe and needle is provided with each pump) • Two (2) AAA alkaline batteries • Registration card (postage paid) If you are a first-time iXL System user, you need to meet with your healthcare provider for training and system setup before using it. To get a head start on learning about your new iXL System, review this User Guide before your first training session.
2 Getting Started Set Up The iXL™ Remote Controller Chapter 6 describes the remote’s options in detail. The instructions in this chapter are simplified to help you get started. Turn on the remote 1. Open the battery compartment on the back of the remote by gently pressing down on the ribbed side of the compartment door until it opens (Figure 2-1). No special tools are necessary. Figure 2-1 2. Insert two (2) new AAA alkaline batteries into the compartment.
Getting Started The Wizard’s Welcome screen (Figure 2-2) gets you started. Press the Continue soft key to begin setting time and day, bolus and basal options, and indicators. Figure 2-2 1. Use the Up/Down Controller button to increase or decrease the time. (If you prefer a 24-hour clock, press the 12hr/24hr soft key.) Then press Next. 2. Enter the current year, then press Next. 3. Choose the current month, then press Next. 4. Enter the current day, then press Next. 5.
2 Getting Started 14.The remote now asks whether you want to activate a pump (Figure 2-3). You can: • Press Yes if you are ready to activate a new iXL Pump. • Press No if you do not want to activate a pump at this time. The remote displays the Main menu. Figure 2-3 You can press the Power button to turn off the remote at any time during setup. Otherwise, it turns off automatically after a screen time-out period you set (see Chapter 6, iXL Remote Controller Features).
Getting Started 2 My Notes: iXL™ Diabetes Management System User Guide: Getting Started 13
2 Getting Started My Notes: 14 iXL™ Diabetes Management System User Guide: Getting Started
Basal Rates What is a Basal Rate? A basal rate is a small base or background amount of insulin that is delivered, at a preset rate, continuously for a specified period of time. Even without eating, our bodies need a small, constant supply of insulin for normal cell activity. In people without diabetes, the pancreas continuously delivers this background supply of insulin.
3 Basal Rates In addition to normal daily changes, insulin needs can vary with different routines or days of the week. For example, regular school or workday routines may differ from weekend routines, and insulin needs may differ, too. With your healthcare provider, you will decide on the basal rates that best match your lifestyle and insulin needs. You will enter at least one basal program (your Basal 1 program) into your remote during the setup process (see Chapter 2, Getting Started).
Basal Rates 2. Choose Basal programs (Figure 3-2), then press Select. Figure 3-2 3. Choose [new program] (Figure 3-3), then press Create. Figure 3-3 3 4. To use the iXL System’s default naming system, simply press Next.The default naming system automatically assigns program names in numerical order, such as Basal 1, Basal 2, Basal 3. Or, to give a different name to the program: (a) Press the Up/Down Controller button to enter the characters that spell the name you want.
3 Basal Rates As a safety feature, the words “Invalid basal program name” (Figure 3-5) appear if the name you entered does not have at least one character or if the name is being used by another basal program. Press OK to return to the previous screen and enter a different name. Figure 3-5 5. Enter the rate, in U/hr, for the first basal segment (from Off to the maximum you entered during setup), then press Next. 18 iXL™ Diabetes Management System User Guide: Basal Rates 6.
Basal Rates 7. Review the graph of the new basal program (Figure 3-6). To see the program as a list, press List (Figure 3-7). To see the graph again, press Graph. Figure 3-6 Figure 3-7 3 Enable an existing basal program 1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select. 2. Choose Basal programs, then press Select. 3. Choose the program you want from the list (Figure 3-8), then press Enable. To see a graph of the basal program, press Graph.
3 Basal Rates 4. Press Enable to start the selected basal program. The pump beeps to indicate that the chosen basal program is running. Or press Cancel to return to the list and select a different program. A diamond icon (♦) appears next to the program that is currently running. You cannot select the current program to enable, because it is already running.
Basal Rates 5. Enter a basal rate for the new segment, then press Enter. 6. To save the newly entered segment into the basal program, press Save. If you want to make additional edits, press Edit and repeat steps 3-5. 7. If this is the currently active basal program, press Confirm (Figure 3-11) to update. (The pump beeps to indicate that the active basal program has been updated.) Press Save (Figure 3-12) for any other basal program.
3 Basal Rates Preset Temporary Basal Rates What is a temporary basal rate? A temporary basal rate lets you adjust your basal rate for a short period of time. If a temporary change later becomes permanent, you can create a new basal program for it. Some temporary changes are easy to predict and respond to; they happen routinely and you may know from experience how they affect your insulin needs.
Basal Rates 3 6. Review the temporary basal name and rate; press Save to accept it. Or press Back to return to the previous screen and enter a different rate. 4. Press Start to begin the temporary basal rate shown on the screen. Or press Back to return to the previous screen if you want to enter a different duration. Enable an existing temporary basal preset 1. In the Main menu, use the Up/Down Controller button to choose Temp basal (Figure 3-15); then press the soft key labeled Select.
3 Basal Rates To change a temporary basal preset: 1. Choose Edit rate, then press Select (Figure 3-16). Or press Done to back out of this process. Figure 3-16 To delete a temporary basal preset: 1. Choose Delete and then press Select. 2. Press Delete to permanently delete the preset. Or press Cancel to back out of this process. One-Time Temporary Basal Rates On occasion, you may need to change the current basal rate for a short time.
Basal Rates Cancel a one-time temporary basal rate 1. In the Main menu, use the Up/Down Controller button to choose Suspend/cancel; then press the soft key labeled Select. 2. Choose Cancel temp basal (Figure 3-17); then press Select. Figure 3-17 3. Press Confirm to cancel the temporary basal shown on the screen. Or press Back to back out of this process. 3 Maximum Basal Rate What is the maximum basal rate? The maximum basal rate is a safety feature.
3 Basal Rates My Notes: 26 iXL™ Diabetes Management System User Guide: Basal Rates
Bolus Doses What is a Bolus? A bolus is an extra dose of insulin, delivered when needed to match the carbohydrates (sugar content) in a meal or snack, or to lower blood glucose when it gets too high. This extra dose is in addition to the basal rate delivered throughout the day and night (see Chapter 3, Basal Rates). The size of a bolus dose depends on many variables. These variables include your blood glucose level, insulin-tocarbohydrate ratio, activity level, and the type and amount of food you eat.
4 Bolus Doses Deliver Bolus Doses Deliver a normal bolus 1. In the Main menu, use the Up/Down Controller button to choose Bolus (Figure 4-1); then press the soft key labeled Select. Figure 4-1 3. Press Enter. As a safety feature, the remote only allows you to give a bolus at or below your maximum bolus dose. If the dose you enter would put you over your maximum total daily dose, an on-screen message appears (Figure 4-2).
Bolus Doses 4. If you have set the blood glucose reminder option to Audible or Vibrate (see Chapter 6, iXL Remote Controller Features), the remote asks whether you want to schedule a reminder (Figure 4-3). Reminders that have been set previously appear at the bottom of this screen. Figure 4-3 4 5. Press Start to begin the bolus delivery. Or press Back if you decide not to deliver the bolus. Deliver an extended bolus 1.
4 Bolus Doses 6. If you have set the blood glucose reminder option to Audible or Vibrate (not Off) and you want to add a reminder: (a) Press Yes. (b) Enter the time for the reminder. (c) Press OK. If you do not want to set a reminder, press No. If you have set the blood glucose reminder to Off, the remote will not ask you to set a reminder. 7. Press Start to begin the bolus delivery. Or press Back if you decide not to deliver the bolus.
Bolus Doses Deliver an iBolus™ (audio bolus) The iXL System’s exclusive iBolus feature lets you deliver a bolus conveniently and discreetly, without having to look at the remote screen. The iBolus button is located on the right side of the remote (Figure 4-6). Figure 4-6 4 2. Press the iBolus button once for each increment of insulin to deliver. For example, if you want to deliver 3 units and your increment is set to 1 unit, press the iBolus button 3 times . 3.
4 Bolus Doses Cancel Active Boluses The iXL System is extremely flexible and can respond almost immediately to your changing insulin needs. It is easy to cancel an active bolus (one that is currently being delivered), even after insulin delivery has started. 1. Press the Power button to turn on the remote, if it is not already on. An on-screen message appears as long as a bolus is being delivered (Figure 4-8). 2. Press the soft key labeled Cancel. The pump beeps to confirm the bolus is canceled.
Bolus Doses 4 My Notes: My Notes: iXL™ Diabetes Management System User Guide: Bolus Doses 33
4 Bolus Doses My Notes: 34 iXL™ Diabetes Management System User Guide: Bolus Doses
The iXL™ Pump The Pump Change Process You should replace the pump at least once every 48-72 hours, or as instructed by your healthcare provider. (You can also choose to have the remote alert you when you need to replace the pump (see Chapter 6, iXL Remote Controller Features and Chapter 9, Hazard and Advisory Alarms). WARNINGS! • Do NOT attach or use a pump if its sterile packaging is open or damaged, as this may increase the risk of infection. Pumps are sterile unless packaging has been opened or damaged.
5 The iXL™ Pump Deactivate current pump 1. In the Main menu of the remote, select Settings (Figure 5-1). Figure 5-1 3. In the Confirm Pump change screen, press Confirm (Figure 5-3). Figure 5-3 2. In the Settings menu, select Pump change (Figure 5-2).
The iXL™ Pump 4. At the message, “Pump deactivated. Remove and discard the pump, and then press Continue” (Figure 5-4), remove the old pump. 5 (a) Lift the edges of the adhesive tape from your skin and remove the entire pump (Figure 5-5). Figure 5-5 Figure 5-4 (b) Use soap and water to remove any adhesive that remains on the skin or, if necessary, use an adhesive remover. (c) Discard used pump according to local waste disposal regulations. 5. After removing the old pump, press Continue.
5 The iXL™ Pump Activate a new pump 1. Remove the new pump from its sterile package. 2. Place the remote against the new pump (Figures 5-6A/5-6B). Figure 5-6A 3. Press Activate (Figure 5-7). Figure 5-7 Figure 5-6B After you press Activate, the pump beeps, indicating that the remote has successfully activated the pump. The iXL System safety features ensure that the remote works only with the newly activated pump.
The iXL™ Pump Fill the new pump 1. Use an alcohol prep swab to clean the top of the insulin vial; discard the prep swab. 2. Lock the filling needle onto the syringe by turning it clockwise (Figure 5-8). 5 6. Withdraw insulin from vial, expelling any air bubbles. Fill syringe with enough insulin for 72 hours, or at least to the MIN (minimum) fill line (Figure 5-9). Figure 5-9 Figure 5-8 Avoid using insulin from more than one vial, which may introduce air into the syringe. 3.
5 The iXL™ Pump 7. Remove needle from vial and insert into the insulin fill port on the underside of the pump body (Figure 5-10). Figure 5-10 11.Place capped needle in sharps container. Dispose of used needles according to local waste disposal regulations. The fill syringe is intended for single use only and should be used only with iXL Pumps. 12.After you fill the pump, press Continue (Figure 5-11). The pump’s RediSet system performs a series of safety checks and automatically primes the pump.
The iXL™ Pump Select the infusion site Before attaching a new pump, you must first select an appropriate infusion site. Due to ease of access, viewing, and reliable insulin absorption, the abdomen is often preferred. Your healthcare provider may suggest other potential sites, including the hip or upper thigh. • Avoid sites where belts, waistbands, or tight clothing may rub against, disturb, or dislodge the pump. • Rotate infusion sites with each pump change.
5 The iXL™ Pump 2. Attach pump to the prepared infusion site; press firmly to secure it to your skin. Under normal conditions, the iXL Pump’s adhesive keeps it securely in place for up to 3 days. A variety of products are available to help secure the pump to the skin. Ask your healthcare provider about these products. Avoid getting body lotion, creams, or oils near the infusion site; these products may loosen the adhesive. 3. After you securely attach the pump, press Continue (Figure 5-13).
The iXL™ Pump The remote will alert every 5 minutes until the pump change process is complete. You must complete the pump change process within one hour. Once the soft cannula is inserted and the prime bolus has filled the cannula, the pump will beep, indicating that it is active and delivering insulin at the programmed basal rate (Figure 5-16). Figure 5-16 5 Check Pump Status To check pump status: • From the Main menu, press Status. The remote automatically checks the status of the pump.
5 The iXL™ Pump 1. In the Main menu, use the Up/Down Controller button to choose Suspend (Figure 5-17); then press the soft key labeled Select. Figure 5-17 5. Press Suspend to confirm that you want to halt all insulin delivery (basal and bolus). The pump beeps and an on-screen message lets you know that insulin delivery is indeed suspended (Figure 5-18).
The iXL™ Pump At the end of the suspend period, a pump Advisory alarm will occur. To resume your programmed basal rate, press OK (Figure 5-19). Figure 5-19 5 Resume Insulin Delivery 1. In the Main menu, use the Up/Down Controller button to choose Resume (Figure 5-20); then press the soft key labeled Select. Figure 5-20 The Advisory alarm will repeat every 15 minutes until you press OK. 2. Press Resume to restart the basal program that was previously running.
5 The iXL™ Pump Avoid Infusion Site Infections • Always wash your hands and use aseptic technique to prepare the infusion site before attaching a pump. • Do not apply a pump to any area of skin with an active infection. If you are unsure whether to use a specific site, consult your healthcare provider. • At least once a day, use the pump’s infusion site viewing window to check the site for signs of infection and to confirm that the soft cannula is securely in place.
The iXL™ Pump 5 Water and your pump The iXL Pump is watertight to a depth of 8 feet for up to 30 minutes (IPX8). After exposure to water, rinse off the pump with clean water and dry it with a towel. Do NOT expose your iXL Pump to water at depths greater than 8 feet or for durations exceeding 30 minutes. Check often to make sure the pump and soft cannula are securely attached and in place. The iXL Remote Controller is not waterproof. Do NOT place it in or near water.
5 The iXL™ Pump My Notes: 48 iXL™ Diabetes Management System User Guide: The iXL™ Pump
iXL™ Remote Controller Features The Status Screen The top of the iXL Remote Controller Status screen (Figure 6-1) displays the “communicating” icon, an icon showing how full the battery is, and the current date and time. The center of the screen provides information on current insulin delivery (or suspension). The bottom of the screen shows an insulin gauge and the soft key for the Main menu.
6 iXL™ Remote Controller Features System Setup Menu The System setup menu lets you personalize the settings that control the iXL System. These include: • Date and time • Bolus doses and basal rates • Alerts and reminders • Remote options: remote lock, screen time-out, and backlight time-out • Diagnostics: check alarms and reset remote You and your healthcare provider entered initial system settings using the Setup Wizard (see Chapter 2, Getting Started).
iXL™ Remote Controller Features Reset the time 1. Enter the current time. 2. Choose either a 12-hour or 24-hour clock, then press Enter. 3. Press Confirm to accept the new time (Figure 6-3). Or press Cancel to back out of this process. Figure 6-3 6 Reset the date 1. Enter the current year, then press Enter. 2. Choose the current month, then press Enter. 3. Enter the current day, then press Enter. 4. Choose the date format to be displayed by the remote, then press Select. 5.
6 iXL™ Remote Controller Features Change Bolus and Basal Settings You can reset the bolus increment, the maximum bolus dose, the maximum basal rate, and the maximum daily dose. 1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select. 2. Choose System setup, then press Select. 3. Choose Bolus/basal setup, then press Select. 4.
iXL™ Remote Controller Features Set Alerts and Reminders In addition to automatic safety alarms (see Chapter 9, Hazard and Advisory Alarms), the iXL System offers a number of alerts and reminders that you can set to help you manage your diabetes. These features are optional. You can turn alerts and reminders on or off at any time. They include: BG (blood glucose) reminder: Reminds you to check your blood glucose. Choose from Off, Audible, or Vibrate. The default setting is Off.
6 iXL™ Remote Controller Features Choose alerts and reminders 1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select. 2. Choose System setup, then press Select. 3. Choose Alerts/reminders, then press Select. 4. Choose the reminder or alert you want to set (Figure 6-5), then press Select. Figure 6-5 5. Choose the desired option or set the desired value and press Select or Enter. Repeat steps 1-5 to set more alerts or reminders.
iXL™ Remote Controller Features Set remote options 1. In the Main menu, use the Up/Down Controller button to choose Settings; then press the soft key labeled Select. 2. Choose System setup, then press Select. 3. Choose Remote options (Figure 6-6), then press Select. Figure 6-6 4. Choose one of the following, then press Select: • Remote lock • Screen time-out • Backlight time-out 6 To set Remote lock: 1. Choose Off or On, then press Select.
6 iXL™ Remote Controller Features Set Diagnostic Functions The Diagnostics screen allows you to instantly confirm how the system is working or to completely update settings entered during setup (see Chapter 2, Getting Started). They include: Check alarms: Confirms that all alarms work properly when needed. When you select this function, the remote beeps, then vibrates, and then the pump beeps. If the remote fails to beep and/or vibrate, call Insulet immediately at (800) 591-3455.
iXL™ Remote Controller Features 6 To reset the remote: 1. Choose Reset remote. 2. If the pump is deactivated, the screen shows what information will be deleted. Press Confirm to reset the remote. If the pump is still active, you will be unable to reset the remote (Figure 6-9). Press OK to return to the diagnostics menu.
6 iXL™ Remote Controller Features Get the Most from Your Remote Keep it handy Wireless communication technology means you don’t have to keep the remote right next to the pump for the pump to work. Once you set your basal rate, the pump continues to deliver insulin at that rate until you decide to change it or until you give yourself a bolus dose.
iXL™ Remote Controller Features 6 My Notes: iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features 59
6 iXL™ Remote Controller Features My Notes: 60 iXL™ Diabetes Management System User Guide: IXL™ Remote Controller Features
My Records Record Keeping Record keeping is an important part of successful diabetes management. The iXL Remote Controller helps simplify this task. It automatically stores insulin-delivery records, alarm records, and personal information. If the remote batteries run out, data in the remote’s memory is at risk. Information will be lost if the batteries are not changed within 2 hours.
7 My Records 3. Press Basal (Figure 7-2). The display indicates the time of day and whether a basal was suspended, the pump was deactivated, or a temp basal rate was delivered. If a temp basal rate is currently running, a diamond icon (♦) appears next to it. If a temp basal rate was cancelled, the screen shows how long it ran before being cancelled. 4. Press Bolus (Figure 7-3). The display indicates whether the bolus was normal, extended (ext), or an iBolus (i).
My Records 7 Alarm History The remote lists the entire alarm history for the device, from the current date to when the remote was first activated. The remote can store up to 128 alarm records. 1. In the Main menu, use the Up/Down Controller button to choose My records; then press the soft key labeled Select. 2. Choose Alarm history, then press Select. The remote displays the type, date, and time of each alarm. 3. Press the shift key labeled More for additional screens.
7 My Records User and Product Information You or your healthcare provider may have entered your personal contact information (name, address, telephone numbers, and email address) during your pump-start visit. To view that information, press the User Info/Support button (?) in the upper right corner of the remote. You can add or change user information at any time (see below).
My Records 7 My Notes: iXL™ Diabetes Management System User Guide: My Records 65
7 My Records My Notes: 66 iXL™ Diabetes Management System User Guide: My Records
Achieve Healthy, Safe Pumping Your Role in Safe Pumping Before deciding on the iXL Diabetes Management System, you and your healthcare provider discussed the advantages and benefits of the iXL System, as well as the responsibilities that come with insulin pump therapy. Remember: Safe pumping begins and ends with you. If you have questions or doubts about being able to safely use the iXL System at any time, consult your healthcare provider immediately.
8 Achieve Healthy, Safe Pumping Rapid occlusion detection An occlusion is a blockage or interruption in insulin delivery. The iXL System can detect an occlusion as small as 2 units, which may lower your risk for hyperglycemia or DKA. An occlusion may result from a blockage, pump malfunction, or from using old or inactive insulin.
Achieve Healthy, Safe Pumping Inspect the infusion site At least once a day, use the iXL Pump’s viewing window to inspect the infusion site. Check the site for signs of infection, such as pain, swelling, redness, discharge, or heat. If an infusion site shows signs of infection: 1. Immediately remove the pump and attach a new one at a different site (see Chapter 5, The iXL Pump). 2. Contact your healthcare provider. 3. Treat the infection according to instructions from your healthcare provider.
8 Achieve Healthy, Safe Pumping Take enough supplies Keeping your emergency kit with you during trips or vacations is especially important (see “Prepare for emergencies” later in this chapter). It may be difficult or impossible to get insulin or supplies in an unfamiliar place. If traveling by air, be sure to pack your supplies in your carry-on luggage.
Achieve Healthy, Safe Pumping Keep supplies accessible On airplanes and trains, keep these items in your carry-on luggage, rather than checking them: • iXL Remote Controller • An emergency kit • Extra vials of insulin (cargo area temperatures may affect insulin) • A copy of your healthcare provider’s letter (see “Minimize airline security delays”) • Prescriptions for insulin and supplies • Snacks (in case food is not available) • Bottled water (especially on planes) to prevent dehydration • The name and pho
8 Achieve Healthy, Safe Pumping Hypoglycemia (low blood glucose) Hypoglycemia can occur even when a pump is working properly. Never ignore the signs of low blood glucose (no matter how mild). If left untreated, severe hypoglycemia can cause seizures or lead to unconsciousness. If you suspect or feel that your blood glucose level is low, check your blood glucose level to confirm.
Achieve Healthy, Safe Pumping Again, frequent blood glucose checks are the key to avoiding potential problems. Detecting low blood glucose early lets you treat it before it becomes a problem. Check with your healthcare provider for guidance in any and all areas listed above. To treat hypoglycemia (low blood glucose) Any time your blood glucose is low, treat it immediately.
8 Achieve Healthy, Safe Pumping Possible causes of hypoglycemia (low blood glucose) Possible cause of low Suggested action Possible cause of low Suggested action Incorrect basal rate program Pump time not set correctly Bolus too large Prolonged or intense exercise Wrong bolus timing Alcohol consumption Unplanned activity Check basal rate program. Reset time. Check bolus size and timing. Do NOT over-correct for post-meal glucose levels.
Achieve Healthy, Safe Pumping Hyperglycemia (high blood glucose) Insulin pumps use rapid-acting insulin; therefore, if there is an interruption in insulin delivery, pump users are at risk for developing hyperglycemia. Symptoms of hyperglycemia (high blood glucose) • Fatigue • Frequent urination, especially during the night • Unusual thirst or hunger • Unexplained weight loss • Blurred vision • Slow healing of cuts or sores Hyperglycemia symptoms can be confusing.
8 Achieve Healthy, Safe Pumping 5. If blood glucose levels have not decreased, take a second bolus by injection, using a sterile syringe. Ask your healthcare provider whether to inject the same amount of insulin as in step 3. 6. If you feel nauseated at any point, check for ketones and call your healthcare provider immediately (see “Diabetic ketoacidosis” later in this chapter). 7.
Achieve Healthy, Safe Pumping Possible cause of high Suggested action Possible cause of high Suggested action Incorrect bolus timing Time bolus with food intake. Check blood glucose before giving meal bolus; if necessary, adjust bolus. Incorrect basal rate Confirm that programmed basal rate is correct. Consult healthcare provider before making changes to your basal rate. High-protein or Calculate protein/fat intake and high-fat meal account for it in your bolus timing and bolus type.
8 Achieve Healthy, Safe Pumping Diabetic ketoacidosis (DKA) Insulin pumps use only rapid-acting insulin. Because there is no reserve of long-acting insulin in the body, any occlusion or interruption in insulin delivery can rapidly lead to diabetic ketoacidosis (DKA). DKA is a serious–but totally preventable– emergency that can occur if you ignore high blood glucose levels. If left untreated, DKA can cause breathing difficulties, shock, coma, and eventually death.
Achieve Healthy, Safe Pumping Handling Special Situations Prepare for emergencies Prepare and keep an emergency kit with you at all times to quickly respond to any diabetes emergency.
8 Achieve Healthy, Safe Pumping To handle sick days: • Treat the underlying illness to promote faster recovery. • Eat as normally as you can. • Adjust bolus doses, if necessary, to match changes in carbohydrate/calorie intake. • Always continue your basal insulin, even if you are unable to eat. Contact your healthcare provider for suggested basal rate adjustments during sick days. • Check your blood glucose every two hours and keep careful records of results.
Achieve Healthy, Safe Pumping 8 X-rays, MRIs, and CT scans The iXL Pump and Remote Controller may be affected by strong radiation or magnetic fields. Before having an X-ray, MRI, or CT scan (or any similar test or procedure), remove your pump and remote and put them outside the treatment area. Check with your healthcare provider on pump removal guidelines. The pump and remote can tolerate common electromagnetic and electrostatic fields, including airport security and cellular phones.
8 Achieve Healthy, Safe Pumping Notes: 82 iXL™ Diabetes Management System User Guide: Achieve Healthy, Safe Pumping
Be Aware: Hazard and Advisory Alarms Safety Checks 9 Hazard Alarms A very important safety feature of the iXL System is its ability to check its own functions and to let you know when something needs attention. When you turn on the remote, the system automatically performs a series of safety checks. To make you aware of a serious or potentially serious condition, the system will sound an audible alarm and display an on-screen message with instructions for resolving the alarm.
Hazard Alarms 9 Be Aware: Hazard and Advisory Alarms Alarm Type Source Action to resolve Alarm Type Source Action to resolve Empty reservoir Pump Press OK to acknowledge. Change pump. Pump expired Pump Occlusion detected Pump Press OK to acknowledge. Change pump. Auto Off Pump Press OK to and acknowledge. Remote Change pump. 84 iXL™ Diabetes Management System User Guide: Be Aware: Hazard and Advisory Alarms Press OK to acknowledge. Change pump.
Be Aware: Hazard and Advisory Alarms Source Action to resolve Alarm Type Source Action to resolve Pump change interruption Pump Press OK to acknowledge. Change pump. Stuck key detected Remote Press OK to acknowledge. Remove pump. Call Insulet. (800) 591-3455 Remote error Remote Press OK to acknowledge. Change pump. Remote error Remote Press OK to acknowledge. Remove pump. Call Insulet.
Hazard Alarms 9 Be Aware: Hazard and Advisory Alarms Alarm Type Source Action to resolve Alarm Type Source Action to resolve Pump error Pump Press OK to or acknowledge. Remote Change pump. Remote error Remote Press OK to acknowledge. System error Pump Press OK to or acknowledge. Remote Change pump. System error Press OK to acknowledge. Remove pump. Call Insulet.
Be Aware: Hazard and Advisory Alarms Hazard Alarms Respond to hazard alarms Due to the serious nature of hazard alarms, you must act promptly to resolve them. 1. Acknowledge the alarm condition by pressing OK, which silences the alarm. 2. Deactivate and remove the current pump (see Chapter 5, The iXL Pump). 3. Activate and attach a new pump (see Chapter 5, The iXL Pump).
9 Be Aware: Hazard and Advisory Alarms Advisory Alarms Advisory Alarms Advisory alarms tell you about a condition that requires your attention. When you hear an advisory alarm, turn on the remote to display the Status screen. The screen displays a message describing the alarm and how to resolve it. Some advisory alarms are controlled by levels you set in the Settings screen (for example, the insulin level at which the low-reservoir-volume alarm sounds).
Be Aware: Hazard and Advisory Alarms Source Beep pattern and escalation process Action to resolve Pump expiration advisory I Pump 3 sets of beeps every minute for 3 minutes. Repeats every 60 minutes. Escalates to “Pump expiration advisory II” after 2 hours. Press OK to acknowledge. Change pump. Pump expiration advisory II Pump 3 sets of beeps every minute for 3 minutes. Escalates to “Pump expired” hazard alarm after 60 minutes. Press OK to acknowledge. Change pump.
Advisory Alarms 9 Be Aware: Hazard and Advisory Alarms Alarm Type Source Beep pattern and escalation process End of suspend Pump 3 sets of beeps every minute for 3 minutes. Press OK to resume insulin Repeats until insulin delivery is resumed. delivery at programmed basal rate. Auto off advisory Pump and Remote 3 sets of beeps every minute for 15 minutes. Press OK to acknowledge. Escalates to “Auto off” hazard alarm if not acknowledged within 15 minutes.
Be Aware: Hazard and Advisory Alarms Source Beep pattern and escalation process Action to resolve Stuck key detected Remote 3 sets of beeps every 3 minutes for 60 minutes. Escalates to “Stuck key” hazard alarm if not resolved within 60 minutes of if you press Fail. Check key to resolve. If key remains stuck, press Fail. Respond to advisory alarms For an advisory alarm caused by a low reservoir or pump expiration: 1. Acknowledge the alarm condition by pressing OK, which silences the alarm. 2.
9 Be Aware: Hazard and Advisory Alarms My Notes: 92 iXL™ Diabetes Management System User Guide: Be Aware: Hazard and Advisory Alarms
Troubleshoot Communication Failures Every time you turn on or use the iXL Remote Controller, it establishes communication with the active pump. Usually, communication occurs quickly. However, communication can fail if the remote is: • Too far from the pump (it must be within 12 inches when entering or changing settings). • Interrupted by outside interference (see FCC Notice in the Appendices). In either case, the error is easy to resolve. The remote walks you through the steps you need to take.
10 Troubleshoot Communication Failures Failure during operation If the remote is unable to deliver your instructions (such as a bolus delivery or a change in basal program) to the pump within 6 seconds, you will see the messages in Figure 10-2, in sequence. Figure 10-2 1 3 2 1. At the first message, change remote position to improve communication. You do not need to press any soft keys. The remote will try to communicate with the pump for another 10 seconds. 2.
Troubleshoot Communication Failures 5. If you were entering a command when communication failed, when communication is reestablished, the system either: (a) Indicates the command was successful (Figure 10-4) and displays the next screen in the command sequence within 5 seconds. (b) Indicates the command was not received by the pump (Figure 10-5). Press OK. Figure 10-4 10 6. If you were deactivating a pump when communication failed, you will see the message in Figure 10-6.
10 Troubleshoot Communication Failures My Notes: 96 iXL™ Diabetes Management System User Guide: Troubleshoot Communication Failures
Appendices iXL™ Pump Care and Maintenance Storage Store unopened iXL Pumps in a cool, dry place. Extreme heat or cold can damage pumps and cause them to malfunction. If pumps are exposed to extreme temperatures, inspect them carefully before use. Do not attach or use pump if its sterile packaging is opened or damaged. Pumps are sterile unless packaging is opened or damaged. Cleaning iXL Pumps are water tight. If you need to clean the pump, you can gently wash it with a clean damp cloth.
Appendices Replacing batteries The iXL Remote Controller uses 2 AAA alkaline batteries. You can purchase them at any grocery, hardware, or convenience store, or order them from Insulet (see “Ordering supplies” later in this chapter). Use only new AAA alkaline batteries to power the remote. Never use old or used batteries; the remote may not work properly. On average, a pair of batteries powers the remote controller for 4 weeks.
Appendices 5. Press the Power button. The remote is now ready to use. If the remote becomes submerged in water The iXL Remote Controller is not waterproof. Do NOT place it in water or leave it near water where it can accidentally fall in. If it becomes submerged in water: 1. Dry the outside of the device with a clean, lint-free cloth. 2. Open the battery compartment; remove the batteries and discard them. 3. Use a clean, lint-free cloth to gently absorb any water in the battery compartment. 4.
Appendices Insulin and Supplies Storage Store all iXL System products and supplies (including unopened pumps) in a cool, dry place. Products or supplies that have been exposed to extreme temperatures may not function properly. It is especially important to store your insulin in a well-controlled environment. Inspect insulin before using it; never use insulin that looks cloudy or discolored. Insulin that is cloudy or discolored may be old, contaminated, or inactive.
Appendices Limited Warranty for the iXL™ Remote Controller Limited warranty coverage Insulet Corporation (“Insulet”) warrants to the original purchaser (“you”) that the iXL Remote Controller (the “Remote”) will be free from defects in materials and workmanship, under normal use and conditions, for a period of two (2) years from the date of purchase.
Appendices iXL™ System Options and Settings Time Date Bolus and iBolus increment Extended bolus duration Maximum bolus size Basal rate increment Basal programs Basal rate segments Maximum basal rate Temp basal presets Temp basal duration 12-hour or 24-hour clock Default is 12-hour MM/DD/YY DD/MM/YY MM.DD.YY DD.MM.YY Default is MM/DD/YY 0.1, 0.5, or 1.0 units Default is 0.1 units 30 minutes to 8 hours Up to 30 units in 0.1 unit increments Default is 10 units 0.
Appendices iXL™ Pump Specifications Size: 1.6” wide x 2.75” long x 0.6” high (4.1cm x 6.99cm x 1.5cm) Weight: 31 grams Operating temperature range: 41°F to 104°F (5°C to 40°C) Storage temperature range: 14°F to 122°F (-10°C to 50°C) Reservoir volume (deliverable): 200 units Cannula insertion depth: 6.5mm Water tight rating: IPX8 Insulin concentration: U-100 Alarm type: Audible Delivery accuracy (tested per IEC 60601-2-24): Basal: +/- 5% at rates > 0.
Appendices iXL™ System Label Symbols Symbol Meaning Do NOT reuse this device. Single-use only.
Appendices iXL™ System Federal Communications Commission (FCC) Notice Concerning Interference The iXL Remote Controller complies with Part 15 (Radio Frequency Devices) of the FCC Rules. As such, it is subject to the following two conditions: 1. It may not cause harmful interference. 2. It must be able to accept interference, including interference that may cause undesirable operation of the device.
Appendices My Notes: 106 iXL™ Diabetes Management System User Guide: Appendices
Glossary A1c (see Hemoglobin A1c) Advisory alarm Notification by the remote that a serious condition exists. Aseptic technique A method for maintaining sterilization and preventing contamination. Bolus dose A dose of insulin taken to correct an elevated blood glucose level or to cover carbohydrates in a meal or snack. Cannula A small, thin tube inserted below the skin, which serves to introduce a liquid medication into the body.
Glossary Correction factor (also known as sensitivity factor) A formula for how much one unit of insulin will lower your blood glucose. For example, if your sensitivity factor is 40, one unit of insulin will lower your blood glucose by 40mg/dl. Dawn phenomenon An early morning rise in blood glucose level caused by the normal release of hormones that block insulin’s effect.
Glossary Hypoglycemia unawareness A condition in which a person does not feel or recognize the symptoms of hypoglycemia. iBolus (Audio) A feature of the iXl System that allows a bolus dose to be given “on the go” without looking at the remote screen. Increment The act or process of increasing or decreasing a number, value, or amount. Infusion Introducing a liquid substance under the skin into the body. Infusion site Place on the body where an infusion set is inserted.
Glossary Sharps Any medical item that may cause punctures or cuts to those handling them. Sharps include needles, syringes, scalpel blades, disposable razors, and broken medical glassware. Sharps container A puncture-proof container used for storage and disposal of used sharps. Soft key A button on the iXL Remote whose label or function appears on the screen directly above the button. The label changes depending on the task you are performing.
Index A A1c (see hemoglobin A1c) activate pump . . . . . . . . . . . . . . . . . . . . 38 adverse reactions, avoiding . . . . . . . . . 71 airport security . . . . . . . . . . . . . . . . . . . 70 advisory alarms . . . . . . . . . . . . . . . . 87,107 auto off advisory . . . . . . . . . . . . . . . . 90 end of suspend . . . . . . . . . . . . . . . . . 90 low reservoir volume . . . . . . . . . . 11,88 pump expiration advisory I . . . . . . . . 89 pump expiration advisory II . . . . . . .
Index infusion (CSII) . . . . . . . . . . . . . . . . . . 107 contraindications . . . . . . . . . . . . . . . . . . vii conventions and terms . . . . . . . . . . . . . vi correction factor . . . . . . . . . . . . . vii,ix,107 CT scans . . . . . . . . . . . . . . . . . . . . . . . . . 81 F D G data storage . . . . . . . . . . . . . . . . . . . . . . . 2 date . . . . . . . . . . . . . . . . . . . . . . . . . . 11,50 dawn phenomenon . . . . . . . . . . . . . . .
Index select . . . . . . . . . . . . . . . . . . . . . . . . . 41 initial basal rate . . . . . . . . . . . . . . . . . . . 11 insulin . . . . . . . . . . . . . . . . . . . . . . . . . . 109 insulin gauge . . . . . . . . . . . . . . . . . . . . . 49 insulin delivery history . . . . . . . . . . . . . . . . . . . . . . . . . 42 history . . . . . . . . . . . . . . . . . . . . . . . . . 61 resume . . . . . . . . . . . . . . . . . . . . . . . . 45 suspend . . . . . . . . . . . . . . . . . . . . . . .
Index reservoir . . . . . . . . . . . . . . . . . . . . . . . . 102 resources . . . . . . . . . . . . . . . . . . . . . . . 105 resume insulin delivery . . . . . . . . . . . . . 45 S safety features . . . . . . . . . . . . . . . . . . . . 67 screen time-out . . . . . . . . . . . . . . . . . 54,55 sensitivity factor . . . . . . . . . . . . . vii,ix,107 setup wizard . . . . . . . . . . . . . . . . . . . . . . 10 sharps . . . . . . . . . . . . . . . . . . . . . . . . . . 110 sharps container . . . . . . . . .
iXL™ Diabetes Management System User Guide: 115