Customer Care: 1.888.BDCARES BD Strive ™ Insulin Management System (IMS) User Guide IMPORTANT: It is important to receive training prior to using the BD Strive™ Insulin Management System. If you have not received training, call Customer Care at 1.888.BDCARES. 92038.01_IFUCanada.
Contents 1 Before you start 8 1.1 About this guide..............................................................................9 1.2 Symbols and terms........................................................................11 1.3 Important safety information...................................................24 1.4 Indications for use.........................................................................28 1.5 Contraindications...........................................................................
.4 Understanding Food Doses........................................................52 4 Getting started 54 4.1 Read before you begin.................................................................55 4.2 Set up Remote.................................................................................57 4.3 About Remote’s screen.................................................................69 5 Using BD Strive™ 81 5.1 Prepare BD Strive™.........................................................................
6.3 Hyperglycemia (high blood sugar)..........................................201 6.4 Diabetic Ketoacidosis (DKA)......................................................204 6.5 Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHS) .......................................................................................................................208 6.6 Preparing for Emergencies..........................................................211 6.7 Exercise / Sports.................................................
1. Before you start 1.1 About this guide Customer care information: Make sure you read and understand this User Guide, and be sure to retain this User Guide for future reference. Speak to your healthcare team if you have questions or concerns about using your BD Strive™ Insulin Management System (BD Strive™) correctly. If you need assistance in setting up, using or maintaining the BD Strive™, or to report a malfunction or an unexpected event, call Customer Care at 1-888-BDCARES.
1.1 About this guide (continued) 1.1 Symbols and terms 1.2 Healthcare Team: Working with HCP to train patients Your Healthcare Team will include: •• Your doctor or Healthcare Provider (HCP) •• Certified Diabetes Educator (CDE) Your team will help you learn how to use the BD Strive™ system. They will teach you how to set your: In this section: This section provides information about the symbols you will find on the device or instructions (such as this User Guide and the Quick Start Guide).
Symbols and terms Safety-related symbols: Term Explanation WARNING Indicates a hazardous situation that, if not avoided, could result in death or serious injury. CAUTION Indicates a hazardous situation that, if not avoided, could result in minor or moderate injury. IMPORTANT Indicates instructions that are important to follow to ensure proper use of the system.
Symbols and terms Symbol What it means Symbol What it means MR Serial Number. Device Indicates the device’s serial number soMR that the medical device can be identified. MR Use-by date. MR Indicates the device’s use-by date so that the medical device will not be used after the date accompanying the symbol. Manufacturer. % Indicates the manufacturer of the device. % Storage Temperature Limits. Indicates the temperature limits to%which the medical device can be safely exposed.
Symbols and terms Symbol What it means CE Mark. Indicates the mandatory conformity markMR for products sold within the European Economic Area. CAUTION: Federal law (United States) restricts this device to sale by or on the order of a physician. Refer to Manual. MR Indicates that the user needs to refer and follow the instructions in the manual/booklet. 16 92038.01_IFUCanada.indd 16-17 Symbol What it means Do Not Reuse.
Symbols and terms Symbol What it means MRType BF Medical Device. Indicates that the device is protected against electric shock. Sterilized Using Ethylene Oxide. MR Indicates that the device is provided sterile and has been sterilized using ethylene oxide. Symbol What it means IP Code (on Remote). Level of ingress protection. IP22 The Remote is protected against solid foreign objects of 12.5 % mm diameter and greater and protected against vertically falling water drops when tilted up to 15 degrees.
Symbols and terms Symbol What it means Symbol Non-Pyrogenic. MR Authorized European Representative. Indicates the Authorized representative in the European Community. Do Not Use if Package Is Damaged. MR MR that should not be used if the MR Indicates a medical device package has been damaged or opened. 20 92038.01_IFUCanada.indd 20-21 Storage Humidity Limits. % Indicates a medical device that is non-pyrogenic..
Symbols and terms Terminology and abbreviations: The following are terms and abbreviations used in this User Guide along with their explanations. Term Explanation Icon A picture on your touchscreen, back of Remote, IDD, or package that points to a choice or information. IDD Insulin Delivery Device. The component of the BD Strive™ System that delivers insulin and attaches to your body. HCP Healthcare Provider. Menu A list of choices on your touchscreen. 22 92038.01_IFUCanada.
1.1 Important safety information 1.3 Important safety information In this section: This section provides general safety information about using BD Strive™. Follow all instructions in this section and throughout this User Guide to ensure proper use and avoid injury. CAUTION: Federal law (United States) restricts this device to sale by or on the order of a physician. 24 92038.01_IFUCanada.indd 24-25 WARNING: You must be trained before using BD Strive™.
Important safety information WARNING: The BD Strive™ System is not recommended for patients with type 1 Diabetes Mellitus. WARNING: If the device stops working it will not deliver insulin. You should carry an WARNING: If you have a medical emergency, call 911 (US only) or call 112 (EU only). You may also call your HCP or go directly to the hospital. For non-medical emergencies or for technical questions about your BD Strive™ setup or operation, you can call Customer Care at 1.888.
1.1 Indications for use 1.4 1.1 Contraindications 1.5 The BD Strive™ Insulin Management System (BD Strive™) is intended for the continuous subcutaneous delivery of insulin, at set and adjustable rates, for the management of type 2 diabetes mellitus in adult patients requiring insulin. Contraindications: 28 92038.01_IFUCanada.
2. BD Strive™ System Overview 2.1 1.1 Introduction Welcome to BD Strive™! The BD Strive™ Insulin Management System (BD Strive™) provides you with a new way to deliver insulin. If you have any questions about BD Strive™, you can call Customer Care at: 1.888.BDCARES. 30 92038.01_IFUCanada.indd 30-31 Customer Care: 1.888.
Introduction Before BD Strive™, you may have been giving your insulin with different types of insulins in separate pens or vials. What to expect from BD Strive™: Previous insulin injection schedule using pens or syringes Once you program your preset basal insulin during setup, BD Strive™ will automatically give you small amounts of insulin throughout the day to replace your basal (i.e. long-acting) insulin needs.
1.1 Introduction Introduction New insulin infusion using BD Strive™ (U-100 Humalog® ONLY) Basal INFUSION with Swatch Food doses with Swatch BD Strive™ has 2 main components: •• The Insulin Delivery Device (IDD), which delivers insulin. •• The wireless Remote, which can program and control the IDD Insulin Delivery Device (IDD) Wireless Remote IMPORTANT: 34 You will work with your Healthcare Provider (HCP) to adjust the insulin doses to meet your specific needs. 92038.01_IFUCanada.
2.2 1.1 About the IDD About the IDD Overview of Insulin Delivery Device (IDD): The IDD can be worn on the body for up to three days. It is designed to be worn during all your activities (see exceptions on page 188 and page 222). The IDD precisely delivers insulin from its internal reservoir once filled. IDD package: IDDs are provided in individual sterile packages which include the Filling syringe and Filling needle. You will use this each time you fill the IDD with your prescribed insulin amount.
About the IDD IDD details: Description of details: Safety cap (tab) Fill port Catheter hole PULL Light Adhesive patch 38 Side buttons (for Food Dose) 92038.01_IFUCanada.indd 38-39 Vent The following table lists each detail on the IDD and package alphabetically, and describes its function.
About the IDD Detail Description Filling syringe Used to fill the IDD with insulin. Filling needle Used to fill the IDD with insulin. Light Safety cap (tab) 40 92038.01_IFUCanada.indd 41 Detail Description Side buttons Used when pairing device during IDD setup, and for delivering a food dose when your controller is not available. Green light will blink during IDD setup. Tray Package also used to help you hold the IDD stable during filling.
1.1 2.3 About the Remote Safety tips for the IDD: • Keep the system and accessories away from young children, as they contain small parts that might be dangerous if swallowed. • Change IDD every 3 days, or when insulin runs out. • One-time use only (cannot be reused). IDDs are designed for one-time use. DO NOT attempt to refill or reapply a used IDD. • DO NOT use if the package has been opened or damaged. This device is sterile, non-toxic, and non-pyrogenic unless the package has been opened or damaged.
About the Remote Remote details: Power button Touch screen display Safety tips for the Remote: • DO NOT use someone else’s Remote. Remember to check your Remote name when unlocking the screen before initiating pairing, changing basal setting, changing IDD button amount setting, or starting a Food Dose. This ensures that you are using your personal Remote. • Remote Life. Use life for the Remote is 2 years. Low battery light • Disposal. When disposing of any waste (IDDs, Remote, battery, etc.
3. Insulin therapy 1.1 Target blood glucose value 3.1 The target blood glucose value is a single number that falls within your blood glucose goals. The target blood glucose value is used to adjust your insulin dose. Your target blood glucose value should be determined by your Healthcare Provider. 46 92038.01_IFUCanada.indd 46-47 Customer Care: 1.888.
1.1 Using insulin with BD Strive™ 3.2 Using insulin with BD Strive™ Insulin action: Insulin types you can use with BD Strive™: The duration of insulin action is the amount of time that insulin remains active and available for use in your body. Different types of insulin will have different durations of action. Rapid acting insulins typically have a duration of action from 3 to 5 hours. Only use the U-100 rapid-acting insulins with BD Strive™ listed below.
1.1 Understanding basal rate 3.3 Handling insulin: What is a basal rate? Follow the warnings below when using BD Strive™ and handling insulin. The BD Strive™ Insulin Management System releases a small amount of insulin every few minutes. This is called basal or background insulin. The dose or amount of insulin delivered is called the basal rate. You need basal insulin, between meals and at night, to cover glucose being released by your liver.
1.1 Understanding Food Doses 3.4 What is a Food Dose? When you eat or drink, the body breaks down the food into glucose and releases it into the blood. The pancreas releases a burst of insulin to match the rapid rise in blood glucose that occurs after a meal. Before each meal, you will deliver a Food Dose to match the glucose from your meal. Guidelines from Healthcare Provider (HCP): Your HCP will tell you the correct basal rate and Food Dose for each meal.
4. Getting started 1.1 Read before you begin 4.1 Your healthcare provider will teach you how to: •• Fill the IDD with insulin. •• Place IDD on your body correctly. •• Use the Remote to tell the IDD how much insulin to give yourself during the day and night. •• Use the Remote or the IDD to give you mealtime insulin. 54 92038.01_IFUCanada.indd 54-55 Customer Care: 1.888.
4.2 1.1 Set up Remote IMPORTANT: You should have received training and your basal and Food Dose insulin settings from your Healthcare Provider (HCP). If you have NOT received training or your settings, contact your HCP before you proceed. 56 92038.01_IFUCanada.indd 56-57 In this section: The steps in this section provide instructions for entering your insulin delivery settings and setting options such as language, date, and time.
Step 1. Power on Remote Set up Remote IMPORTANT: After 1 minute of inactivity the screen will automatically go to sleep. To unlock again, power on Remote, swipe your finger across arrows on screen, then tap Confirm Unlock . For more information see Section 4.3 on page 69. a. Slide battery door off Remote. 58 92038.01_IFUCanada.indd 58-59 b. Align + and - on batteries and compartment and install batteries. c. Slide battery door on until it snaps into place. d. The Remote automatically turns on.
Step 2. Set language Step 3. Set Remote name The Remote name you set appears on screen each time you turn on the Remote so that you can make sure you have the correct Remote. Write the name here, as a reminder: a. Tap blue arrows to set your language. Tap OK . 60 92038.01_IFUCanada.indd 60-61 b. Tap Set up Remote to begin entering Remote settings. c. Tap blue arrows to set a 3-letter Remote name. Tap Next .
Step 4. Set time Step 5. Set date d. Tap blue arrows to set the current time e. Tap blue arrows to set the current date (hour, minute, and AM/PM). Tap Next . 62 92038.01_IFUCanada.indd 62-63 (year, YYYY; month, MM; and day, DD). Tap Next .
Step 6. Set basal delivery About basal insulin: Basal insulin is the background insulin you receive in small doses throughout the day. Set up Remote My prescribed basal insulin: units per day WARNING: Entering incorrect insulin delivery settings could lead to low blood sugar (Hypoglycemia) or high blood sugar (Hyperglycemia). Make sure you set the basal insulin rate that your Healthcare Provider prescribed. a. Write the number of insulin units you were prescribed for your basal insulin here.
Step 7. Set IDD Food Dose Set up Remote (Amount per squeeze of IDD side buttons) About delivering Food Doses with the IDD: If you do not have the Remote at meal times, you can still give insulin using your IDD. Each squeeze of the IDD side buttons will deliver a preset number of units. Note: You might need to squeeze the IDD side buttons more than once to get your full Food Dose insulin. The maximum units per dose is 30 units.
Step 7. Set IDD Food Dose (continued) 1.1 About Remote’s screen 4.3 In this section: This section describes how to interact with the Remote’s touchscreen, the information included on the Remote’s Home screen, and an explanation of icons and buttons that appear on screen. c. Setup is complete and Remote is ready. Tap OK . 68 92038.01_IFUCanada.indd 68-69 d. The Remote Home screen is displayed. See Section 5.1 on page 82 when ready to set up an IDD.
About Remote’s screen Remote’s Sleep Mode: After installing the batteries, the screen will automatically go to sleep after 45 seconds of inactivity. To unlock again, follow these instructions. a. If Remote is off, press 70 92038.01_IFUCanada.indd 71 (squeeze) and hold button on top of Remote until screen turns on. b. Always confirm that your Remote’s name appears on the screen. Swipe your finger across arrows to unlock. c. Tap Confirm Unlock to unlock screen.
About Remote’s screen Screen areas: Top Information and controls for each screen appear in three basic areas on the Remote screen: •• Top: Includes navigation icons and time •• Middle: Includes primary information and/or functions for that screen Middle •• Bottom: Includes more information, or a button that will send you to the next screen Bottom (example values) 72 92038.01_IFUCanada.
About Remote’s screen Home screen: 1. After you have setup the Remote and IDD, the Home screen displays: 2. 3. 1. System’s status 2. Time 4. 3. Menu 4. Main button 5. Food Dose information 6. Total units of insulin delivered with current IDD 5. 6. (example values) 74 92038.01_IFUCanada.
About Remote’s screen Screen icons and buttons: Icon What it means Main button: This button provides different functions based on the button label: “Give Food Dose” to deliver insulin at meal times. “Press to Cancel” to cancel a Food Dose. “Setup IDD” to set up a new IDD. “Deactivate IDD” to deactivate your current IDD before setting up a new one. 76 92038.01_IFUCanada.indd 76-77 Icon What it means Check mark status icon: The check mark icon means the IDD is operating normally.
About Remote’s screen Icon What it means Menu icon: Tapping this icon will display the menu of all the system options. Home icon: Tapping this icon displays the Home screen. Back arrow: Tapping this icon displays the previous screen. Icon What it means Up/Down arrows: Tap these buttons to adjust a setting, such as date or Food Dose amount. Note: To make the counter advance faster, tap and hold the arrow.
5. Using BD Strive™ This page intentionally left blank 80 92038.01_IFUCanada.indd 80-81 Customer Care: 1.888.
5.1 1.1 Prepare BD Strive™ Prepare BD Strive™ In this section: Before you start: The steps in this section provide instructions for connecting the IDD and filling the IDD with insulin. If you are currently wearing an IDD, you must deactivate and remove it before preparing a new IDD. CAUTION: Make sure your Remote is properly set up, as described in Section 4.2 on page 57. 82 92038.01_IFUCanada.indd 82-83 CAUTION: Before applying a new IDD, you must deactivate and remove the old IDD. See Section 5.
Step 1. Gather supplies Prepare BD Strive™ Swatch U-100 0086 1 Insulin Delivery Device Remote Your insulin 84 92038.01_IFUCanada.indd 84-85 Alcohol wipe Sharps container (Rapid acting Humalog®) a. Wash your hands with soap b. Gather supplies shown and water, then dry them. New IDD package above and on next page onto a clean, flat surface. WARNINGS: •• DO NOT use IDD if the package is damaged, if the IDD or insulin is past the expiration date. •• IDDs are designed for one-time use.
Step 2. Connect to IDD a. Press and hold button on top of Remote until screen turns on. 86 92038.01_IFUCanada.indd 86-87 Prepare BD Strive™ b. Always confirm that your Remote’s name appears on the screen. Swipe your finger across arrows to unlock. c. Tap Confirm Unlock to unlock Remote. d. Tap Set up IDD circle to start setting up the IDD.
Step 2. Connect to IDD (continued) Prepare BD Strive™ Green light IDD PULL No Yes Cover e. Peel IDD package cover from corner to open package. Remove IDD. 88 92038.01_IFUCanada.indd 88-89 f. Squeeze both IDD side buttons at the same time to wake up IDD. Look for the green light. g. Once green light is on, the IDD is ready to pair. Place IDD back in the tray and place Remote on top of IDD.
Step 2. Connect to IDD (continued) Prepare BD Strive™ IMPORTANT: For successful pairing, keep IDD and Remote in close range to each other (Remote above the IDD). Ensure you are at least 6 feet (2m) away from other Remotes, IDD’s, or other equipment that might interfere with the pairing communication. Once IDD is connected, you will have 60 minutes to complete setup step. h. Tap Yes on Remote to connect to IDD.
Step 3. Prepare Fill syringe Prepare BD Strive™ My prescribed 3-day insulin name and amount: U-100 insulin units a. Write the insulin name 92 and number of units your Healthcare Provider prescribed for 3 days here. 92038.01_IFUCanada.indd 92-93 b. Clean insulin vial top with alcohol swab. Filling needle Filling syringe c. Remove Filling syringe and Filling needle from IDD package. d. Screw Filling needle onto Filling syringe until it stops.
Step 3. Prepare Fill syringe (continued) Prepare BD Strive™ e. Remove needle guard. IMPORTANT: Use care after removing the needle guard and exposing the needle. 94 92038.01_IFUCanada.indd 94-95 f. Pull plunger out until it aligns with the 3-day insulin amount you were prescribed. g. Place vial on table and insert h. Press plunger all the way to needle into vial. push all air out of syringe and into vial.
Step 3. Prepare Fill syringe (continued) Prepare BD Strive™ WARNING: If you see air bubbles (larger than a grain of rice): a) Tap syringe with your finger to move bubbles to the top. b) Push plunger to push air back into vial. c) Pull plunger out again to withdraw insulin. i. Turn vial and syringe upside j. Slowly pull plunger out down together. 96 92038.01_IFUCanada.indd 96-97 until top ring of plunger aligns with the 3-day insulin amount you were prescribed. k.
Step 4. Fill IDD with insulin Prepare BD Strive™ CAUTION: To avoid damaging the IDD when filling it, insert needle straight into IDD. IDD in tray a. Once Startup is complete, the Remote will prompt you to fill the IDD with insulin. 98 92038.01_IFUCanada.indd 98-99 b. Insert needle straight into IDD fill port (marked with syringe icon ) until it stops.
Step 4. Fill IDD with insulin (continued) c. Press plunger down all the way to inject entire syringe contents. Continue to hold plunger down and pull 100needle out of IDD. 92038.01_IFUCanada.indd 100-101 d. Fill syringe and needle are for single use only. Immediately dispose of the fill syringe and needle in the sharps container after use. Prepare BD Strive™ e. Tap OK on Remote after filling the IDD.
Step 5. Prepare IDD Prepare BD Strive™ (example value) a. Tap blue arrows to enter the number of insulin units you put into the IDD, then Tap OK . 102 92038.01_IFUCanada.indd 102-103 (example value) b. Tap Confirm on Remote. (example values) c. Wait while IDD prepares itself. d. Wait until Remote prompts It is normal to hear sounds coming from the IDD. you to apply IDD, then proceed to step 6.
Step 6. Select and prepare site Prepare BD Strive™ IMPORTANT: Rotate to a different site each time you apply a new IDD a. Before applying the IDD, you must first choose a site on your body. The graphic indicates in green the places on your body that you should use. 104 92038.01_IFUCanada.indd 104-105 •• Although the abdomen might be easier to see and use, it is important to rotate the sites you use to place the IDD. Rotate to a different site each time you apply a new IDD.
Step 6. Select and prepare site (continued) IMPORTANT: • Cleaning the site will help prevent skin infection or irritation, and keep your skin healthy. • Changing your IDD after a shower is a good practice. b. Clean site with an alcohol wipe and let it air-dry. 106 92038.01_IFUCanada.indd 106-107 Step 7. Apply IDD and insert catheter IMPORTANT: • DO NOT remove safety cap and do not press insertion button until instructed on the Remote’s screen.
Step 7.Apply ApplyIDD IDD and insert catheter Step 7. and insert catheter (continued) (continued) Prepare BD Strive™ PULL PULL a. Remove paper pieces to expose adhesive on back of IDD. 108 92038.01_IFUCanada.indd 108-109 b. Place IDD on insertion site and apply firm pressure for 10 to 15 seconds. c. Press edges of adhesive pad d. Tap OK on Remote. down with your finger.
Step 7.Apply ApplyIDD IDD and insert catheter Step 7. and insert catheter (continued) (continued) Click PULL e. Remove orange IDD safety cap (tab) by pulling it straight out from IDD. 110 92038.01_IFUCanada.indd 110-111 Prepare BD Strive™ f. Tap OK on Remote. g. Press the button on top of IDD all the way down until it locks in place. This inserts the catheter into your skin. h. Tap OK on Remote.
Step 8. Complete IDD setup a. After you insert the catheter b. A green check mark should and tap OK , Remote will connect to IDD. 112 92038.01_IFUCanada.indd 112-113 appear to show your IDD is working. Prepare BD Strive™ (example values) (example values) c. Tap DONE on Remote. IDD d. The Remote’s Home screen Setup is complete. Your IDD is now delivering basal insulin. appears with “Give Food Dose” circle. See Section 5.3 or Section 5.4 if you need to 113 deliver a Food Dose.
Step 8. Complete IDD setup (continued) IMPORTANT: Once Remote name e. After set up, each time you use the Remote, confirm your Remote name appears on the unlock screen. 114 92038.01_IFUCanada.indd 114-115 paired, your Remote is only communicating to your IDD. Be careful not to use another person’s Remote. When unlocking the Remote screen, confirm your Remote name is correct prior to completing any action, such as delivering a dose or changing device settings. Safety tips when your wearing your IDD 5.
Safety tips when wearing your IDD WARNING: If your device is damaged or dropped, it might not deliver insulin properly. Ensure that it is still working properly. If you are unsure as to potential damage, call Customer Care at 1.888.BDCARES. Safety tips for the IDD: • Check to see that IDD is secure throughout the day. • DO NOT loosen patch during use. During use, do not loosen the IDD adhesive patch or dislodge the catheter.
1.1 5.3 Delivering DeliveringaFood FoodDose Doseusing usingRemote Remote Delivering a Food Dose using Remote In this section: Follow the instructions in this section to set and start a Food Dose using the Remote. Before you start: Before giving yourself a Food Dose, check the Food Dose information (time and amount of your last dose) on the Home screen. (example values) Food Dose information 118 92038.01_IFUCanada.
Delivering a Food Dose using Remote IMPORTANT: If it has been less than 1 hour since your last food dose, the following screen will appear to alert you that you have recently received a dose. If you still want to give an additional dose, then tap Yes to proceed. (example values) a. Tap Give Food Dose circle on Remote’s Home screen. 120 92038.01_IFUCanada.indd 120-121 (example value) b.
Delivering a Food Dose using Remote IMPORTANT: Once the Food Dose has started, you can cancel the dose if needed by tapping Press to Cancel circle on the Remote’s screen. See Section 5.5 on page 128 for more information on how to cancel your Food Dose. (example value) (example value) c. Swipe your finger across arrows, then tap to start dose. 122 92038.01_IFUCanada.indd 122-123 Confirm Start (example value) d. Once started, the screen displays the Food Dose’s progress.
5.4 Food Dose Dose using usingIDD IDD 1.1 Delivering a Food a. Make sure you know how much In this section: insulin is delivered each time you squeeze the side buttons. Follow the instructions in this section to set, confirm, and start a Food Dose using the IDD. Before you start: Before giving yourself a Food Dose, consider when you delivered your last dose. If you have your Remote, check the Food Dose information (time and amount of your last dose) on the Home screen.
Delivering a Food Dose using IDD b. To deliver your dose, squeeze and release firmly and quickly both IDD buttons at the same time. Each squeeze of the IDD buttons equals a preset number of units. For example, if your preset units is set at 5 units per press (squeeze) and you need 20 units, you would squeeze the side buttons 4 times. You can feel each squeeze, and may hear a click with each press.
5.5 1.1 Canceling a Food Dose Canceling a Food Dose In this section: This section explains how to cancel your Food Dose delivery if needed. (example value) a. Tap 128 92038.01_IFUCanada.indd 128-129 Press to Cancel circle on Remote’s Home screen if you want to stop the Food Dose. (example value) b. Tap Yes to confirm. Tap No to continue Food Dose. c. After you confirmed, Remote will cancel the Food Dose.
1.1 Checking 5.6 Checkingyour yourinsertion insertion siteregularly regularly In this section: This section explains the issues to look for when checking your insertion site. Checking your insertion site regularly In addition, check for signs of insulin leakage by looking for wetness around the insertion site. As part of your daily routine, check the insertion site area around the IDD at least once per day. Each time you change the IDD, check the actual insertion site after removing the empty IDD.
5.7 1.1 Checking IDD Status Checking IDD Status In this section: This section explains how to check your IDD Status from the Remote’s home screen. For more information on different IDD Status notifications and errors, see Section 7.3 on page 240. IDD Status and Food Dose information: The Remote Home screen displays two types of information about the IDD at the bottom of the screen: •• IDD Status. The IDD Status displays the total units of insulin delivered since you set up your IDD. 132 92038.
Checking IDD Status Food Dose state What it means Last Food Dose Provides the units and time of the last Food Dose delivered. Partial Food Dose A Food Dose started, but only part of the dose finished delivering. The units and time of the last Food Dose that were successfully delivered are provided. No Recent Dose No recent Food Dose has been delivered over the last 24 hours.
Checking IDD Status IDD Status screen: The IDD Status screen displays two types of information: •• IDD Status. The IDD Status provides information on the status of your IDD, the amount of insulin used, and what action to take. For more information on different IDD Status notifications and errors, see Section 7.3 on page 240. The IDD Status screen will be displayed. IDD Status •• Food Dose information.
Checking IDD Status Home •• Action button at the bottom of the screen enables you to deactivate your IDD or set up a new IDD. •• Home icon at the top of the screen enables you to return to the Home screen (e.g., if you do not want to take action from the IDD Status screen). (example values) 138 92038.01_IFUCanada.
5.8 1.1 Replacing an IDD In this section: When “IDD Status Empty,” “IDD Status Expired,” or “Deactivate IDD” appears on Remote (typically after 3 days), you must deactivate and replace the IDD. Follow the instructions in this section to deactivate and remove your IDD. Replacing an IDD CAUTION: When changing IDD, and before bedtime: •• Avoid changing your IDD before bedtime or if you will not be able to test your BG at least 1–2 hours after a new IDD is placed.
Step 1. Deactivate current IDD a. Wash your hands with soap b. Tap and water, then dry them. 142 92038.01_IFUCanada.indd 142-143 Deactivate IDD circle. Replacing an IDD c. Tap Yes to confirm you want to remove the old IDD. d. Wait while Remote deactivates IDD.
Step 1. Deactivate current IDD (continued) Step 2. Safely dispose of IDD WARNING: Please follow your local laws when disposing of the BD Strive™. After use, parts of the BD Strive™ are considered biohazardous and can potentially transmit disease. e. When Remote prompts you f. Tap to, gently peel adhesive edges and remove IDD from your skin. 144 92038.01_IFUCanada.indd 144-145 OK on Remote. a. Discard IDD in sharps container.
Step 3. Prepare and apply new IDD 1.1 Viewing dose history 5.9 In this section: This section provides instructions for viewing your dose history. Your dose history helps you to keep track of your daily doses, as well as your Food Dose averages over the last 7, 14, and 30 days. It also helps you and your Healthcare Provider keep better track of your overall insulin and diabetes management. a. After tapping OK on the previous step, the Remote will display “Set up . IDD.” Refer to Section 5.
Viewing today’s doses Viewing dose history (example values) (example values) a. On the Home screen, tap the Menu icon top right corner. 148 92038.01_IFUCanada.indd 148-149 in the b. Tap on History c. To view your doses from today, tap Today’s Doses . d. Your Food Dose volumes and delivery times are displayed here. To exit the screen, tap OK .
Viewing today’s doses Viewing dose history (example values) (example values) a. On the Home screen, tap the Menu icon top right corner. 150 92038.01_IFUCanada.indd 150-151 in the b. Tap on History c. To view summaries of your average dose over 7, 14, and 30 days, tap on Dose Summary . d. Your basal insulin rate and Food Dose insulin averaged over the last 7 days is displayed. Tap Next 151 .
Viewing today’s doses 1.1 Changing 5.10 Changingbasal basalinsulin insulinrate rate In this section: This section provides instructions on how to change the basal insulin rate. Basal insulin is the constant flow of insulin you receive each day. WARNING: Incorrect insulin delivery settings could lead to low blood sugar (Hypoglycemia) or high blood sugar (Hyperglycemia). (example values) e. Your Food Dose insulin averaged over the last 14 and 30 days is displayed. Tap OK to exit. 152 92038.01_IFUCanada.
Changing basal insulin rate (example values) a. On the Home Screen, tap the Menu icon top right corner. 154 92038.01_IFUCanada.indd 154-155 in the b. Tap Settings c. Tap Insulin Settings . d. To change the basal insulin settings, tap Basal Insulin .
Changing basal insulin rate (example value) e. Screen displays current basal insulin rate. To change the rate, tap on Change . Note: if you do not want to change the current setting, tap the Home icon to return to the Home screen. 156 92038.01_IFUCanada.indd 156-157 (example value) f. Tap blue arrows to change the basal insulin rate (units delivered per day). Tap Save . (example value) g. You have now changed the basal insulin rate.
1.1 Changing 5.11 ChangingIDD IDDbutton buttoninsulin insulinsettings settings Changing IDD button insulin settings In this section: This section provides instructions on how to change the amount of insulin delivered with each squeeze of the IDD buttons when you give yourself a Food Dose (extra insulin at meal times). WARNING: Incorrect insulin delivery settings could lead to low blood sugar (Hypoglycemia) or high blood sugar (Hyperglycemia).
Changing IDD button insulin settings c. Tap on Insulin Settings . 160 92038.01_IFUCanada.indd 160-161 d. To change the IDD button insulin settings, tap IDD Button . (example value) e. Screen displays current preset units for the IDD button dose. To change the preset units, tap Change . Note: if you do not want to change the current setting, tap the Home icon to return to the Home screen.
1.1 Changing 5.12 Changingdate date In this section: This section provides instructions on how to change the date setting (year, month, and day) on your Remote. (example value) f. Tap blue arrows to change the number of units for each press (squeeze) of IDD side buttons. Tap Save . 162 92038.01_IFUCanada.indd 162-163 (example value) g. You have now changed the IDD button preset. (example values) a. On the Home screen, tap the Menu icon top right corner.
Changing date b. Tap on Settings 164 92038.01_IFUCanada.indd 164-165 c. Tap on Date . d. Tap blue arrows to change the date (year, YYYY; month, MM; and day, DD). e. Tap Save . You have now set the date.
5.13 1.1 Changing Changingtime time Changing time In this section: This section provides instructions on how to change the time format (12-Hour or 24-Hour) and time (hour, minute, and AM/PM) settings on your Remote. (example values) a. On the Home screen, tap the 166 92038.01_IFUCanada.indd 166-167 Menu icon right corner. in the top b. Tap on Settings c. Tap on Time .
1.1 Changing 5.14 Changinglanguage language In this section: This section provides instructions on how to change the language setting on your Remote. (example values) d. Tap blue arrows to change the time format (12-Hour or 24-Hour). Tap Save . 168 92038.01_IFUCanada.indd 168-169 e. Tap blue arrows to change the time (hour, minute, and AM/PM). Tap Save . You have now set the time. a. On the Home screen, tap the Menu icon top right corner.
Changing language b. Tap on Settings 170 92038.01_IFUCanada.indd 170-171 c. Tap on More Settings . d. Tap on Language . e. Tap blue arrows to change the language. Tap Save . You have now changed the language.
5.15 ChangingRemote Remotename name 1.1 Changing Changing Remote name In this section: This section provides instructions to help you change the name of your Remote so you can recognize your own Remote. (example values) a. On the Home screen, tap the 172 92038.01_IFUCanada.indd 172-173 Menu icon right corner. in the top b. Tap on Settings c. Tap on More Settings .
Changing Remote name d. Tap on Name Remote . 174 92038.01_IFUCanada.indd 174-175 e. Tap blue arrows to set a 3-letter Remote name (three letters (A-Z) or numbers (0-9)). f. Tap Save . You have now set the Remote name.
5.16 About Remote Viewing today’s doses About Remote In this section: This section provides instructions on identifying the serial number and software version of your Remote. (example values) a. On the Home Screen, tap 176 92038.01_IFUCanada.indd 176-177 the menu icon top right corner. in the b. Tap on Help c. Tap on About Remote .
About Remote (example values) d. The serial number of the Remote and software versions are displayed. If an IDD is not currently paired, no software version will be listed for the IDD. 178 92038.01_IFUCanada.
1.1 Pairing 5.17 PairingRemote Remotewith withSmartphone Smartphone Pairing Remote with Smartphone In this section: Follow the instructions in this section to pair your Remote to your smartphone and view your dose history on your smartphone. Before you start: Make sure the Bluetooth is turned on in your smartphone settings 180 92038.01_IFUCanada.indd 180-181 a. Download the mobile app from your App Store, and launch the application on your phone. b.
Unpair 1.1 Unpair youryour Remote Remote a. On your Remote home screen, tap the menu icon in the top. 182 92038.01_IFUCanada.indd 182-183 b. Tap on Unpair your Remote Unpair Phone c. Tap on Yes . d. Your Remote is now or disconnected. Tap to return to the home screen.
1.1 Get 5.18 Getthe themost mostfrom fromBD BDStrive™ Strive™ In this section: This section provides information about how to get the most from BD Strive™ by keeping the Remote accessible, communication with the IDD, and data security. This section also provides information on the temperature ranges in which you should use BD Strive™. Remote should be accessible: Since the IDD and Remote communicate wirelessly, you do not need to keep the Remote right next to the IDD for it to work.
Get the most from BD Strive™ Communicating with your IDD: Data security: When you use your Remote to communicate with the IDD, hold the Remote at least 6 feet (2m) away from other Radio Frequency (RF) devices (other Remotes and IDDs, cell phones, etc). Your IDD is programmed to only accept RF communications from the recognized Remote. This is programmed during the pairing step during “IDD Setup.” The BD Strive™ ensures data security using encryption algorithms and data integrity checking.
Get the most from BD Strive™ •• DO NOT expose insulin to extremes of hot and cold. Store insulin at room temperature. •• Avoid using the IDD in temperatures below 5°C (41°F) or above 37°C (98.6°F). •• DO NOT store or leave your Remote in extreme temperature conditions, such as inside a car. •• DO NOT use IDD at extreme temperature and humidity (IP27), exposure to water at depths greater than 1m (3.28 feet) or longer than 30 minutes. •• Avoid exposing the IDD to direct sunlight.
6 Living with Diabetes 1.1 Diabetes management 6.1 Check your blood glucose: •• Your Healthcare Provider (HCP) will help you set blood glucose goals or targets. These are the ranges of numbers that your blood glucose should fall within most of the time. When you self-monitor your blood glucose, you are checking to see if you are staying within your targets. If you are outside your targets you might need to take action. 190 92038.01_IFUCanada.indd 190-191 Customer Care: 1.888.
1.1 Hypoglycemia (low blood sugar) 6.2 Strive™ is not working properly. This will give you and your HCP the necessary information needed to make changes to your treatment plan. Avoiding highs and lows: When you have diabetes, it is important to avoid high and low blood sugar. Out-of-control blood sugar can lead to short-term and long-term complications. The following chapters will provide you with more details regarding causes, detection and prevention, signs and symptoms, and treatment options.
Hypoglycemia (low blood sugar) This might happen if you took your insulin and: •• Did not eat enough food at a meal/snack or skipped/delayed a meal •• Took more insulin than needed for the meal that you ate •• Exercised or were more active than usual •• Drank alcohol prior to eating food The signs and symptoms of Hypoglycemia are mild, moderate, or severe. See the charts on the following pages for the symptoms of mild, moderate, and severe Hypoglycemia. Never ignore the signs of low blood sugar.
Hypoglycemia (low blood sugar) Mild Hypoglycemia Moderate Hypoglycemia In the early stages of Hypoglycemia you might feel all, some, or in some cases, none of these signs and symptoms. If this reaction is not treated, the symptoms will progress to: .. Sudden hunger .. Headache .. Shaking .. Fast or pounding heartbeat .. Sweating .. Tiredness .. Dizziness .. Blurred vision .. Nervousness or excitement .. Drowsiness .. Numbness or tingling around mouth and lips .. Personality change .. Irritability ..
Hypoglycemia (low blood sugar) How do I detect and prevent Hypoglycemia? Hypoglycemia causes high insulin levels that may cause the body to react poorly. Remember food raises blood glucose and insulin and exercise lowers blood glucose. If you think you are having a low blood glucose reaction you should: 1. If possible, check your blood glucose level. 2. If your blood glucose is less than 70mg/dl (3.
6.3 1.1 Hyperglycemia Hyperglycemia(high (highblood bloodsugar) sugar) If you are unable to check your blood glucose, treat as described and wait 15 minutes. If you do not feel better, repeat the treatment. All treatment for Hypoglycemia should be followed by one of the following meals or snacks: •• If a meal is scheduled for 30–60 minutes, eat a snack that includes about 15 grams of carbohydrates (5 crackers, a piece of fruit, or a slice of bread).
Hyperglycemia (high blood sugar) Signs and symptoms of Hyperglycemia: •• Increased thirst •• Weakness, stomach pains, general aches •• Heavy, labored breathing •• Fatigue •• Loss of appetite, nausea, and vomiting How do I detect and prevent Hyperglycemia? 1. Check blood glucose levels often •• Large amounts of sugar in the blood 2. Notify your Healthcare Provider when your blood glucose is above the targeted range for more than 2-3 readings in a row •• Frequent urination 3.
Viewing today’sKetoacidosis doses 6.4 Diabetic (DKA) Diabetic Ketoacidosis (DKA) About DKA: What causes DKA? Diabetic Ketoacidosis is a condition that is rarely seen in people with type 2 diabetes. It happens in people whose pancreas no longer makes insulin. people with T1DM are at greater risk for DKA DKA is a condition that happens when a severe lack of insulin causes the body to break down fat to use as energy.
Diabetic Ketoacidosis (DKA) Signs and symptoms of DKA: •• Extreme thirst •• Fruity odor on breath •• Frequent urination •• Confusion •• Feeling tired •• High blood glucose levels •• Nausea, vomiting, or abdominal pain •• High ketone levels in the urine •• Difficulty breathing 206 92038.01_IFUCanada.indd 206-207 How do I detect and prevent DKA? DKA is a condition that happens when a severe lack of insulin causes the body to break down fat to use as energy.
6.5 Hyperosmolar Hyperglycemic 1.1 HyperosmolaSyndrome rHyperglycemicNonk etoticSyndrome(HHS) Nonketotic (HHS) About HHS: Hyperosmolar Hyperglycemic Nonketotic Syndrome (HHS) is rarely seen in type 2 diabetes but might be serious if not discovered early. In HHS, there are very high blood glucose levels and severe dehydration. The body tries to rid itself of the large amounts of glucose by passing it into the urine. This might lead to severe dehydration.
1.1 6.6 Preparing for Emergencies How do I detect and prevent HHS? HHS occurs when your diabetes is uncontrolled. The best way to avoid HHS is to check blood glucose levels frequently, especially when ill. You should also check the IDD Status on your Remote often to ensure it is delivering insulin. HHS might be avoided by checking blood glucose often (2-4 times a day) and reporting high readings to your HCP. Keep an emergency kit with you at all times in the event that BD Strive™ is not working properly.
6.7 1.1 Exercise / Sports 6. Blood glucose testing supplies Before you exercise: 7. Glucose tablets, another fast acting carbohydrate, or if necessary, a glucagon emergency kit. 8. Alcohol prep swabs 9. HCP contact information Exercise is part of your treatment plan. It has the potential to lower blood glucose. Speak to your Healthcare Provider about your exercise goals and blood glucose targets before and after exercise in order to avoid Hypoglycemia. 10.
1.1 Travel 6.8 In this section: This section provides information and tips about traveling with BD Strive™. Time zones: Traveling with BD Strive™ is easy! Your basal rate will stay the same, simply adjust your meal doses to the time zone you are now in. To adjust the time on your Remote, see Section 5.13 on page 166. IMPORTANT: Remember to reset the time on your Remote to the local area when you get to your destination.
1.1 Sick days 6.9 Airport security: In this section: In the United States: Make TSA workers aware that you have diabetes and are carrying medical supplies. Unused syringes and insulin IDD supplies are permitted when accompanied by insulin or other injectable medication. Medication and related supplies are normally X-rayed. When you are sick, your body releases stress hormones that help your body fight against your illness, but they will also raise your blood glucose.
Sick days Sick Day Rules: Drink fluids even if you are able to eat food. Every hour, sip 8 ounces (240 ml) of sugar-free, caffeine-free drinks such as water, green tea, or black tea without milk or sugar free soft drinks. Every third hour, sip 8 ounces (240 ml) of broth, bouillon (clear, thin soup), or canned clear soup to provide sodium and other minerals your body needs. Check your blood glucose every 2-4 hours when you are sick, especially if you are vomiting.
6.10 Hospitalizationand andsurgeries surgeries 1.1 Hospitalization If you cannot eat or keep food down, you will need to alternate fluids that have calories with no-calorie/no carbohydrate drinks all day as follows: Your insulin regimen: 1. First hour – drink 4-8 oz. (120-240ml) of regular soda Discuss with your Healthcare Provider (HCP) regarding adjustments to your insulin regimen. They will vary depending upon the medical procedure. 2. Next hour or two – drink 4-8 oz.
7. Notifications and Troubleshooting WARNING: DO NOT use BD Strive™ in these environments: •• Electromagnetic radiation. During procedures involving strong electromagnetic radiation, such as CT, X-ray, MRI or similar scans, remove BD Strive™ and keep the system outside of the area of strong radiation. Strong electromagnetic radiation might damage BD Strive™ and cause it to malfunction. •• Hyperbaric chamber. BD Strive™ should NOT be used in a hyperbaric chamber, as there is a potential for explosion.
1.1 Remote Screen Notifications 7.1 Delivering FoodScreen Dose 1.1 Remote Notifications In this section: What it means: This section provides instructions for Remote screen notifications. The instructions explain what the notification means and what actions you should take to solve the notification. • The delivering Food Dose screen will appear after you confirm a Food Dose from your Remote or after administering a manual Food Dose through the IDD buttons.
Syncing Connecting 226 92038.01_IFUCanada.indd 226-227 What it means: What it means: • Remote and IDD are within range and are attempting to communicate with each other. • Remote and IDD are within range and are attempting to communicate with each other. • Appears automatically after you wake up the display on your Remote or when you complete a screen prompt that attempts to establish communication between your Remote and IDD.
1.1 IDD Status Notifications 7.2 IDD not connected In this section: What it means: This section provides instructions for IDD Status notifications. The instructions explain what the notification means and what actions you should take to solve the notification. • The “IDD Status Not Connected” message at the bottom of the screen means the Remote and IDD are not paired and connected. What to do: • Tap the orange Setup IDD circle and proceed with screen prompts to set up your new IDD, see Section 5.
IDD not connected (continued) • For more information on your most recent Food Dose and current IDD Status, tap the orange Alert icon to view the IDD Status screen. Note: there might not be Food Dose information from the IDD. • To set up a new IDD, tap Setup IDD at the bottom of the screen and proceed with the screen prompts to set up your IDD. See Section 5.1 on page 82 for more instructions. 230 92038.01_IFUCanada.
IDD near empty IDD near empty (continued) What it means: • The screen also displays the amount of units that were used out of the total amount in the IDD. For example, if 270 of 300 units have been used, there are only 30 units left (i.e., 300 minus 270) to use in the IDD before the IDD is empty. • The “IDD Status Near empty” message at the bottom of the screen means your IDD is currently delivering insulin but will soon be empty. What to do: (example values) 232 92038.01_IFUCanada.
IDD near expiry IDD near expiry (continued) What it means: • The screen will also display the amount of unit that were used out of the total amount in the IDD. • The “IDD Status Change IDD” message at the bottom of the screen means your IDD is currently delivering insulin but is nearing the end of the 3-day IDD life period. Note: the 3-day IDD life period might expire before all the IDD insulin is used. What to do: (example values) 234 92038.01_IFUCanada.
IDD empty IDD empty (continued) What it means: • For more information on your most recent Food Dose and the time your IDD went empty, tap the orange Alert icon to view the IDD Status screen. • The “IDD Status Empty” message at the bottom of the screen means the IDD is empty and is no longer delivering insulin to you. The IDD must be deactivated. What to do: (example values) 236 92038.01_IFUCanada.
IDD expired IDD expired (continued) What it means: • For more information on your most recent Food Dose and the time your IDD expired, tap the orange Alert icon to view the IDD Status screen. • The “IDD Status Expired” message at the bottom of the screen means the IDD has reached its 3-day expiry and is no longer delivering insulin. The IDD must be deactivated. What to do: (example values) 238 92038.01_IFUCanada.
7.3 1.1 IDD Status Errors IDD Status Error 1 In this section: What it means: This section provides instructions for IDD Status errors. The instructions explain what the status error means and what to do to solve the status error. • The “IDD Status Not Connected” message at the bottom of the screen means the Remote and IDD are not connected. This message appears once you have deactivated your old IDD and can set up your new IDD. (example values) 240 92038.01_IFUCanada.
IDD Status Error 1 (continued) IDD Status Error 2 What it means: • For more information on your most recent Food Dose and current IDD Status, tap the orange Alert icon to view the IDD Status screen. (example values) • To deactivate your IDD, tap Deactivate IDD at the bottom of the screen and proceed with the screen prompts to deactivate your IDD. See Section 5.8 on page 138 for more instructions. IMPORTANT: You cannot restart or reuse your IDD once you have deactivated the device. 242 92038.
IDD Status Error 2 (continued) •• To deactivate your IDD, tap Deactivate IDD at the bottom of the screen and proceed with the screen prompts to deactivate your IDD. •• Check your blood glucose and treat as instructed by your healthcare provider. 7.4 1.1 Communication and System Errors In this section: This section provides instructions for system and communication errors. The instructions explain what the error is and what the required actions are to solve the error.
Communication error 246 92038.01_IFUCanada.indd 246-247 Communication error (continued) What it means: What to do: • Remote and IDD are not close enough to communicate. • Move Remote closer to IDD or move to a different room and tap Yes . • Remote and IDD are experiencing interference. • Keep the IDD and Remote close to each other and away from other IDDs. • Remote and/or IDD antenna are not working.
Communication error remains What it means: What to do: • Remote and IDD are not close enough. • Tap No to continue trying to establish communication between Remote and IDD. • Remote and IDD are experiencing interference. • Remote and/or IDD antenna are not working. • Other system-related malfunction. 248 92038.01_IFUCanada.
IDD/Remote Compatibility Error What it means: What it means: • Remote and IDD software versions are incompatible. • Remote has a software, hardware, or other issue that is causing it to malfunction. • Your Remote and IDD will not work. What to do: Call the customer service number at 1.888. BDCARES. 250 92038.01_IFUCanada.indd 250-251 Customer Service Display What to do: • Call the customer service number at 1.888.BDCARES.
Customer Service Display (continued) No Display What it means: What it means: • Remote has a software, hardware, or other issue that is causing it to malfunction. • Remote and IDD software versions are incompatible. • Your Remote and IDD will not work What to do: IMPORTANT: Remind to press and hold power button as described on page 70. • Call the customer service number at 1.888.BDCARES What to do: Display will not turn on 252 92038.01_IFUCanada.
1.1 Smartphone Pairing Errors 7.5 Battery issue What it means: In this section: • Remote has a battery-related issue. This section provides instructions for smartphone pairing errors. The instructions explain what the error means and what actions you should take to solve the error. • Remote has software, hardware, or other issue that is causing it to malfunction. What to do: • Remove the battery cover and replace the old batteries with a fresh set.
Pairing to Smartphone Error 256 92038.01_IFUCanada.indd 257 Syncing Data to Smartphone Issue Issue: Issue: • Remote is unable to pair and connect with Smartphone. • Recent dose data is not displayed on your mobile app What to do: What to do: • Tap Yes and follow instructions on Remote. • Turn your Remote on by pressing and holding the button on top of the Remote until the screen turns on.
Syncing Data to Smartphone Issue • Swipe and tap to unlock. Once the home screen is displayed, press the button • Press button again • Press again to turn the Remote off 258 92038.01_IFUCanada.indd 259 7.6 Troubleshooting Troubleshooting Issue Instructions Cannot see Remote screen when outside If you are having trouble reading the display on the Remote, avoid intense sunlight and relocate.
Troubleshooting Issue Instructions Issue Instructions Wrong language is displayed If the wrong language is displayed, refer to Section 5.14 on page 169 to change the language. Signs of infection Change IDD if there are signs of infection or irritation. Wrong time is displayed When traveling to different time zones or to account for daylight savings time, refer to Section 5.13 on page 166 on how to change the time.
8. Appendix 1.1 Care and maintenance 8.1 In this section: This section provides information on caring and maintaining your Remote, such as replacing the batteries and cleaning. 262 92038.01_IFUCanada.indd 262-263 Customer Care: 1.888.
Care and maintenance Replacing Remote batteries: The Remote requires two (2) AAA Alkaline Batteries. Batteries should be replaced approximately every 3 weeks. CAUTION: Use only new AAA alkaline batteries to power the wireless Remote. Never use rechargeable, old, or used batteries; Remote might not work properly. IMPORTANT: Use proper technique and avoid excessive force when handling the device. 264 92038.01_IFUCanada.
Care and maintenance To replace the batteries: 1. Remove the battery cover on the back of the Remote. 2. Remove the old batteries. 3. Replace the batteries using the diagram inside showing the proper direction of the batteries. 4. Replace the battery door. Your Remote is now ready to use. 5. Dispose of the old batteries in accordance with your local waste disposal regulations. If your Remote settings were lost, see Section 4.2 on page 57 to set up your Remote settings. 266 92038.01_IFUCanada.
Care and maintenance If your Remote becomes submerged or wet, dry the Remote with a clean lint-free cloth, open the battery compartment, and immediately discard the batteries, then dry the compartment with the cloth. Leave the compartment open until the Remote is dry. DO NOT replace the batteries until the Remote is completely air-dried. WARNING: Never use a blow dryer to dry the If you drop your Remote: If you drop your Remote, inspect it for any visible signs of damage.
1.1 Ordering supplies 8.2 For product ordering information, please contact 1.888.BDCARES. 270 92038.01_IFUCanada.indd 270-271 1.1 BD Strive™ options and settings 8.3 Languages English (US/UK), Spanish, Canadian French, Dutch, Danish, Finnish, Norwegian, Swedish, German, French Remote name 3 alphanumeric characters (A-Z and 0-9) Time 12-hr or 24-hr - Default: 12:00 AM. Date yyyy/mm/dd - Default: 2018/01/01. Basal Rates 10-70 units/day Default: 10 units/day. Default: AAA.
1.1 Technical Specifications 8.4 Food Dose Volumes Up to 30 units in less than 10 minutes. Food Dose Button Amount Reservoir Fill Amount Dose History Averages Duration of Use 272 IDD specifications Size 5.2 cm long x 4.1 cm wide x 1.5 cm high. 0, 1, 2, or 5 units per button press. Default 2 units per press. Weight (without insulin) 23 grams. 100, 150, 200, 250, or 300 units. Operating Temperature Range 5 – 37°C. Storage Temperature Range 5 – 30°C.
Technical Specifications Storage Relative Humidity Range 20 – 90% relative humidity noncondensing. Compatible Insulin Type Humalog®. Operating Atmospheric Pressure Range 700 mbar to 1060 mbar. Compatible Insulin Concentration U-100 insulin (1 unit= 0.01mL) Storage Atmospheric Pressure Range 700 mbar to 1060 mbar. Cannula Insertion Depth 4.5 mm-8.0 mm. Residual Volume ≤ 300 ul (30 units) Waterproof Rating 1m (3.28 ft.) of water for 30 minutes (IPX7). Occlusion Detection within 5 units.
Technical Specifications Remote specifications Flow capability Basal: 0.5U pulses up to 70 units per day. Food Dose: 4 units per minute. Size 10.3 cm x 6.1 cm x 1.7 cm. Weight (without batteries) 71 grams. Delivery Accuracy (tested per IEC60601-2-24) Basal: +/- 10%. Food Dose: +/- 10%. Screen Non-pyrogenic Fluid Pathway Only. Battery 2 AAA alkaline batteries. Protection from electrical shock Type BF Medical Device. Battery Life Approximately 3 weeks. 276 92038.01_IFUCanada.indd 276-277 4.
Technical Specifications Operating Temperature Range 5-37°C Storage Temperature Range 5-30°C Operating Relative Humidity Range 20 – 90% relative humidity non-condensing. Storage Relative Humidity Range 20 – 90% relative humidity non-condensing. 278 92038.01_IFUCanada.indd 278-279 Operating Atmospheric Pressure Range 700 mbar to 1060 mbar. Storage Atmospheric Pressure Range 700 mbar to 1060 mbar. Communication Distance within a distance of up to 10 feet (~ 3 meters) utilizing the BLE Standard.
Technical Specifications BD Strive™ system notice concerning interference This device complies with part 15 of the FCC Rules (US Only). Operation is subject to the following two conditions: 1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by BD could void the user’s authority to operate the equipment.
Technical Specifications BD declares that the BD Strive™ System is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU. This ISM device complies with FCC Part 15, Canadian ICES-003, RSS-Gen, RSS-247, and RSS-102. and put into service according to the EMC information provided in this document and the User Guide. Portable and mobile RF communications equipment can affect the function of medical electrical equipment.
Technical Specifications The BD Strive™ System communicates with the following characteristics: Frequency of 2.402-2.480 GHz using GFSK modulation with an effective isotropic radiated power of -10.6 dBm for Insulin Delivery Device and -7.0 dBm for Wireless Controller. The data rate is 1Mbps, and general data transmission throughput is 1mb/sec with very low duty cycle. Using BLE 4.1, the RF quality out-of-band pairing and AES128 encryption algorithm ensures data integrity.
Technical Specifications Guidance and Manufacturer’s Declaration Electromagnetic Emissions Guidance and Manufacturer’s Declaration Electromagnetic Emissions (Continued) The BD Strive™ system is intended for use in the electromagnetic environment specified below. The customer or user of the system should assure that it is used in such an environment.
Technical Specifications Guidance and Manufacturer’s Declaration Electromagnetic Immunity The BD Strive™ system is intended for use in the electromagnetic environment specified below. The customer or the user of the system should assure that it is used in such an environment.
Technical Specifications Guidance and Manufacturer’s Declaration Electromagnetic Immunity Immunity Test IEC 60601 level Voltage Dips, Short Interruptions, and Voltage Variations IEC 61000-4-11 <5% Ut (>95% dip in Ut) for 0.5 cycle (Ut is ac mains voltage prior to application of the test level) 290 92038.01_IFUCanada.indd 290-291 Compliance level Not Applicable Electromagnetic Environment Guidance Requirements do not apply to BD Strive™ system because it is a battery powered device.
Technical Specifications Guidance and Manufacturer’s Declaration Electromagnetic Immunity (Continued) Immunity Test IEC 60601 level Compliance level Radiated RF IEC 61000-4-3 10V/m for 80~2700 MHz, 10V/m 80% AM at 1 kHZ 10V/m for 80~2700 MHz, 10V/m 80% AM at 1 kHZ Refer to table on page 284 for details Refer to table on page 284 for details IEC 60601-1-2 ed 4.0 Clause 8.10 292 92038.01_IFUCanada.
Technical Specifications Guidance and Manufacturer’s Declaration Electromagnetic Immunity (Continued) NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies. NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people.
Technical Specifications Radiated RF Test specifications including separation distances for BD Strive™ system and common radio transmitters Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment Maximum Power (W) Distance (m) Immunity Test Level (V/m) Pulse modulation(b) 18 Hz 1,8 0,3 27 430 – 470 GMRS 460, FRS 460 FM (c) ± 5 kHz deviation 1 kHz sine 2 0,3 28 704 – 787 LTE Band 13, 17 Pulse modulation (b) 217 Hz 0,2 0,3 28 Test Frequency (MHz) Band(a) (
Technical Specifications Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment (Continued) Test Frequency (MHz) Band(a) (MHz) Distance (m) Immunity Test Level (V/m) Pulse modulation(b)18 Hz 2 0,3 28 Pulse modulation (b) 217 Hz 2 0,3 28 Modulation (b) 800 – 960 GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 1 700 – 1 990 GSM 1800; CDMA 1900; GSM 1900; DECT; LTE Band 1, 3, 4, 25; UMTS 870 930 1 720 1 845 Maximum Power (W) Service (b) 810 1 970 2
Technical Specifications Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment (Continued) Test Frequency (MHz) 2 450 Band(a) (MHz) 5 500 Maximum Power (W) Distance (m) Immunity Test Level (V/m) Pulse modulation (b) 217 Hz 2 0,3 28 Pulse modulation (b) 217 Hz 0,2 0,3 9 Service (b) Modulation (b) 2 400 – 2 570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 5 100 – 5 800 WLAN 802.11 a/n 5 240 5 785 300 92038.01_IFUCanada.
Technical Specifications Test specifications for ENCLOSURE PORT IMMUNITY to RF wireless communications equipment (Continued) NOTE: If necessary to achieve the IMMUNITY TEST LEVEL, the distance between the transmitting antenna and the ME EQUIPMENT or ME SYSTEM may be reduced to 1 m. The 1 m test distance is permitted by IEC 61000-4-3. For some services, only the uplink frequencies are included. The carrier shall be modulated using a 50% duty cycle square wave signal.
Technical Specifications Recommended separation distances between portable and mobile RF communications equipment and the BD Strive™ System (Continued) Rated maximum output power of transmitter, in watts Separation distance according to frequency of transmitter, in meters Recommended separation distances between portable and mobile RF communications equipment and the BD Strive™ System (Continued) For transmitters rated at a maximum output power not listed above, the recommended separation distance d in m
8.5 1.1 Dose accuracy IDD flow rate upon initial startup (per IEC 60601-2-24) Average flow rate during 24 hours period. Stabilization Period Flow Rate 50 40 Flow Rate (ul/h) The basal dose accuracy was evaluated for three samples. The following graphs show the typical basal flow rate accuracy of the system against given time periods. The measurements were taken at an intermediate basal rate of 40U/day in accordance with 60601-2-24 at controlled room temperature.
Dose accuracy IDD flow accuracy after initial stabilization period (per IEC 60601-2-24) The Trumpet curve shows the accuracy of the flow rate as a function of an averaging window. The reported percent deviation is calculated from the overall weight increase across the full T2 time period. Trumpet Curve of analysis Period 15 Percentage error (%) 10 5 0 Average Error = 4.7% -5 0 308 100 200 300 Observation Window (min) 92038.01_IFUCanada.
8.6 1.1 Glossary Glossary The table in this section defines terms used in this User Guide. Term Definition Adhesive patch Medical adhesive that keeps your device attached to your body for up to 3 days. Adverse reaction An unwanted effect caused by a drug or medical device. Alert status icon The “!” icon means the IDD Status has changed and needs attention, Tapping the icon will provide more information about the alert. 310 92038.01_IFUCanada.
Glossary Another term for blood sugar. Catheter hole The site where the catheter comes out of the IDD when inserted on your body. Blood glucose (BG) level The amount of glucose, sugar, in the bloodstream. Carbohydrate (carb) Come from plants (fruits, vegetables, grains, cereal products, and desserts). Carbs convert 100 percent into glucose, 1 to 2 hours after eating. Calorie A unit of measurement used to express the energy value of food. Calories come from carbohydrate, protein, fat, and alcohol.
Glossary Checkmark status icon The checkmark icon means the IDD is operating normally. Tapping the icon displays information about the insulin delivered from the current IDD. Communication error An error which occurs when the Remote and IDD are not close enough, interference between Remote and IDD, and/or Remote or IDD antenna not working. Contraindications Situation(s) in which an individual should not use a product.
Glossary Dose summary Tap Dose Summary, to view your average dose over 7, 14, and 30 days. Duration of insulin action The length of time that certain types of insulin remain active and available in your body after an insulin dose is given. This duration can vary greatly depending on the type of insulin you take. Emergency kit 316 92038.01_IFUCanada.
Glossary Glucose tablets A sugar tablet that is most commonly used to increase blood glucose in episodes of low blood sugar (hypoglycemia) Health Care Provider (HCP) An individual who practices medicine and is authorized by the state to perform duties within the scope of their practice. This may include, a Nurse Practitioner, Physician’s Assistant or CDE This may include but is not limited to a Nurse Practitioner, Physician’s Assistant, CDE, or MD. Hyperglycemia 318 92038.01_IFUCanada.
Glossary Introducing a liquid substance to the body over a period of time at a specific rate. IDD light Green light will blink during IDD setup. Insertion site The location on the body where the catheter is inserted under the skin for insulin delivery. IDD replacement kit IDDs are provided in individually-packaged replacement “kits” that include the Filling syringe and needle you will use each time you fill the IDD with your prescribed insulin amount.
Glossary Ketones Weak acids produced when the body begins to break down fat for energy instead of glucose. Lancet A device used to puncture the tip of your finger to expel blood. Leakage An accidental escape of a fluid (insulin) from the IDD. Lotion A thick, smooth aqueous preparation with insoluble materials intended to be applied to the skin for medical or cosmetic purpose. Menu A list of choices on your touchscreen. 322 92038.01_IFUCanada.
Glossary Pancreas Organ in the body consisting of beta cells that make and release insulin in response to blood glucose. Protein One of the three main nutrients in food. Foods that provide protein include meat, poultry, fish, cheese, milk, dairy products, eggs, and dried beans. Pattern management/ Pattern Control Adjusting insulin doses based on a pattern of blood glucose readings over three days or more.
Glossary Rotate Infusion sites should be changed each time the IDD is changed. A new infusion site should be at least 1 inch (2.5 cm) away from the last site. You should not use the same insertion site again for 7 – 10 days. Self blood glucose monitoring Regular blood checks to detect blood glucose levels. Blood glucose checks are used to make changes to one’s treatment plan. Rx Only For sale by or on the order of a physician only (US).
Glossary Subcutaneous Under the skin. Sick Day Rules Advice to follow when you are sick. Your body releases stress hormones that help your body fight against your illness, but will also raise your blood glucose. Sick day rules will help you avoid diabetes complications from high blood glucose. Submerged Completely under water or any type of liquid. Sleep Mode After installing the batteries, the screen will automatically go to sleep after 1 minute of inactivity.
Glossary Type 1 diabetes The type of diabetes occurs primarily in children and young adults. The pancreas produces little to no insulin. Type 2 Diabetes Mellitus A metabolic disorder that is characterized by decreased insulin production, insulin resistance, and high blood sugars. Rapid U-100 insulins Humalog® (insulin lispro). Warning Indicated a hazardous situation that, is not avoided, could result in death or serious injury. 330 92038.01_IFUCanada.
1.1 Recycling information for Remote 8.7 9. Index BD encourages recycling of its products. Since disposal facilities, environmental conditions, and regulations vary across states and countries, please consult qualified professionals and applicable regulations or authorities within your region to ensure proper disposal of your wireless Remote. 332 92038.01_IFUCanada.indd 332-333 Customer Care: 1.888.
Index A adhesive...........................38, 39, 108, 109, 116, 117, 144, 213, 310 airport security............................................................................................216 alert icon..................................77, 135, 230, 237, 239, 242, 243, 310 alerts...................................................................................................................77 current IDD Status.................................................... 74, 230, 242, 243 empty..............
Index level....................................193, 195, 199, 201, 203, 206, 208, 210, ...................................................................217, 260, 311, 312, 315, 319 monitoring................................................................... 53, 191, 198, 327 readings.............................................................................................. 53, 324 bolus..........................................................................................
Index preset insulin units..................................................... 45, 125, 158-162 Remote name................................................................................ 172-175 time..........................................................................................166-168, 260 check blood glucose....................................... 117, 126, 131, 141, 185, ...................191, 199, 200, 203, 210, 212, 218, 221, 231, 224, 244 cleaning..........................................
Index changing..........................................79, 163-165, 166-168, 214, 260 deactivate Insulin Delivery Device (IDD)..... 42, 76, 83, 138, 140-144, 229, ..................233, 235, 236-237, 238-239, 241-242, 243-244, 249 device expiration........................................85, 140, 234-235, 238-239 diabetes..................................................................10, 210, 215, 216, 315 management............................................. 53, 147, 190-192, 321, 313 type 1..........
Index fill needle........................................................ 37, 40, 93, 94, 99, 317, 321 syringe..................................................... 37, 40, 91-97, 100, 318, 321 Insulin Delivery Device (IDD)......................................................36, 37, ......................................38, 41, 42, 54, 82, 85, 91, 98-101, 272, 321 food dose....32, 34, 38, 45, 53, 56, 225, 230, 237, 239, 242, 318 cancel...............................................
Index warning..........................................................................12, 20, 25, 26, 27, .............................................48, 49, 50, 64, 66, 85, 97, 115,116, 131, .....................................145, 153, 158, 205, 211, 222,267, 268, 330 healthcare provider (HCP).......... 99, 10, 22, 34, 47, 49, 52, 53, 55, .56, 64, 66, 92, 117, 125, 126, 131, 47, 153, 158, 191, 192, 203, 205,209, 210, 211, 212, 213, 218, 221, 244, 311,317, 318, 331 high blood glucose...................
Index menu......................................................................22, 78, 148, 150, 154, ........................................................ 159, 163, 166, 169, 172, 176, 182 illness................................................................................201, 207, 217, 328 infection......................................... .105, 106, 116, 130, 131, 201, 261 infusion set...................................................................................................
Index lows, highs, and DKA, avoid...................................................................207 M malfunction.........................................9, 222, 229, 248, 251, 252, 254 meal bolus............................................................................. see Food Dose MRIs (Medical Resonance Imaging)..........17, 221, 222, 285, 323 O operating temperatures...........................................187, 273, 306, 324 options and settings................................................
Index S safety alerts and alarms........................................................................see alerts cap...........................................................................38, 40, 107, 110, 326 information...................................................24-27, 35, 145, 285, 283 symbols................................................................................................12, 17 tips......................................................................................
Index storage temperature...................................................................................15 Insulin Delivery Device (IDD).............................................................273 Remote........................................................................................................278 supplies ............................................................................... 26, 84, 212, 317 ordering..............................................................................
Index extreme.................................................................................187, 188, 268 operating....................................................................187, 273, 306, 324 storage........................................................................... 15, 273, 278, 328 time zones.......................................................................................... 214, 260 training........................................................................................
Support If you have any questions about using the BD Strive™ type 2 Insulin Management System, call Customer Care at 1.888.BDCARES. If you have any health questions or concerns about your diabetes treatment, contact your Healthcare Provider. If you have a medical emergency, call 911(US only) or 112 (EU only), your doctor, or go directly to the hospital. MR BD Switzerland Sàrl Terre Bonne Park A4, Route de Crassier 17 1262 Eysins, Switzerland 92038.01_IFUCanada.
