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Section 12: Appendices Appendix G: Accuracy of Flow Rate E. FCC Compliance Information Model Number: PRT12354-xxx and PRT15751-xxx. FCC Rules: Tested to comply with FCC Part 15, Class B, Security/Remote control Transmitter. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or locate the receiving antenna. Increase the separation between the equipment and transmitter. Consult the dealer or an experienced radio/TV technician for help. The user is cautioned that changes or modifications not expressly approved by Abbott Diabetes Care may void the users authority to operate this device. F. Electromagnetic Information Electromagnetic Interference (EMI) from Radio Wave Sources Section 12: Appendices Appendix G: Accuracy of Flow Rate Battery powered insulin delivery devices such as the Abbott Diabetes Care Inc. FreeStyle Aviator System may be susceptible to electromagnetic interference (EMC) such as Radio and TV station towers, amateur radio (HAM) transmitters, two way radios, cell phones, Electronic Article Surveillance (EAS) systems and Radio Frequency Identification (RFID) systems. The interference from these electromagnetic field sources may cause the insulin pump to STOP delivery of the insulin or degrade the image on the companion and pump screens. It can also permanently damage the control system of the insulin delivery pump and companion. Immunity Level The intensity of the EMI can be measured in volts per meter (V/m). The immunity level of the FreeStyle Aviator System is 10 V/m as mandated by the standard, IEC 60601-2-24. Some cellular telephones and similar products transmit signals while they are turned on, even when NOT being used. EMC/EMI Declaration:
Reference Document Performance Criteria Required Performance Criteria Met CISPR 11 IEC 61000-4-2 IEC 61000-4-8
(Radiated Emissions) Group 1 Class B Pass N/A IEC 60601-2-24 IEC 60601-2-24
(Electro Static Discharge)
+/-8kV Direct, HCP and VCP Discharges +/-15KV Air Discharges Pass
(Magnetic Immunity) 400 A/m Pass DOC15736_Rev-A-Man.indd 257-258 2/9/09 11:29:56 AM 257 258
1 | User manual 1 of 2 | Users Manual | 5.19 MiB |
Insulin Delivery and Glucose Monitoring System System Kit Users Guide DOC15736_Rev-A-Cvr.indd 1 2/9/09 11:37:42 AM DOC15736_Rev-A-Cvr.indd 2 2/9/09 11:32:16 AM Table of Contents Welcome ................................................................................................................................................................................................................ I Symbols and Important Safety Information ............................................................................................................................................... II 1 Getting Acquainted ................................................................................................................................................................................1 1.1 How to Use this Guide ...........................................................................................................................................................................1 1.2 Identify Parts of the System .................................................................................................................................................................3 Charge Companion Battery .............................................................................................................................................................. 11 1.3 Install Pump Battery ............................................................................................................................................................................ 12 1.4 Using the System for the First Time Quick Setup .................................................................................................................. 16 2 2.1 Set Up Your System .............................................................................................................................................................................. 16 Create Your Daily Basal Program for the First Time .................................................................................................................. 28 2.2 Fill Reservoir ........................................................................................................................................................................................... 33 2.3 2.4 Prime Pump and Infusion Set .......................................................................................................................................................... 44 3 Using Your System The Basics....................................................................................................................................................... 51 3.1.1 Start Basal Delivery .............................................................................................................................................................................. 51 3.1.2 View Basal Program ............................................................................................................................................................................. 54 3.1.3 Stop Basal Delivery .............................................................................................................................................................................. 56 3.2.1 Deliver a Manual, Normal Bolus ...................................................................................................................................................... 58 3.2.2 Stop Bolus Delivery ............................................................................................................................................................................. 62 3.2.3 View Bolus History ............................................................................................................................................................................... 63 4 Integrating the System into Everyday Life .................................................................................................................................. 65 4.1 Daily Living ............................................................................................................................................................................................. 65 4.2 Perform Daily Checks .......................................................................................................................................................................... 71 Carry a Daily Kit ..................................................................................................................................................................................... 73 4.3 Testing Your Blood Glucose .............................................................................................................................................................. 74 5 5.1 Perform a Control Solution Test ...................................................................................................................................................... 74 Check Your Blood Glucose ................................................................................................................................................................ 78 5.2 When Youre Ready Optional Settings ....................................................................................................................................... 90 6 Set Up Additional Options SETUP WIZARD ............................................................................................................................. 90 6.1 6.2 Edit Additional Options ...................................................................................................................................................................109 Set Reminders and Care Comments ...........................................................................................................................................124 6.3 6.4 Enter Event Data .................................................................................................................................................................................131 6.5 Review History, Status, and Reports ............................................................................................................................................137 6.6 Upload Data .........................................................................................................................................................................................149 Companion Self Test .........................................................................................................................................................................151 6.7 6.8 Pair Companion and Pump ............................................................................................................................................................154 Turn RADIO Off/On ............................................................................................................................................................................159 6.9 DOC15736_Rev-A-Man.indd 1 2/9/09 11:29:29 AM 6.10 Therapy Lockout .................................................................................................................................................................................162 Creating and Editing Specialized Basal Programs to Meet Your Needs ..........................................................................166 7 7.1 Edit a Basal Program ..........................................................................................................................................................................166 Create a New Basal Program ..........................................................................................................................................................172 7.2 Select a Basal Program .....................................................................................................................................................................176 7.3 7.4 Rename a Basal Program ................................................................................................................................................................179 7.5 Delete a Basal Program ....................................................................................................................................................................182 Set a Temporary Basal Program ....................................................................................................................................................185 7.6 8 Creating and Editing Specialized Bolus Programs to Meet Your Needs .........................................................................188 8.1 Deliver an Extended Bolus ..............................................................................................................................................................188 8.2 Deliver a Dual Bolus ..........................................................................................................................................................................193 Calculate and Deliver a Food Bolus .............................................................................................................................................199 8.3 8.4 Calculate and Deliver a Correction Bolus ..................................................................................................................................203 8.5 Calculate and Deliver a Food & Correction Bolus ...................................................................................................................207 8.6 Deliver a Quick Bolus from QBolus Menu .................................................................................................................................213 8.7 Deliver a Quick Bolus from QBolus Soft Key .............................................................................................................................215 9 Respond to Alarms, Alerts, Errors, and Other Problems .......................................................................................................218 10 System Maintenance .........................................................................................................................................................................229 10.1. Replace Pump Battery ......................................................................................................................................................................229 10.2. Clean Your Companion and Pump ...............................................................................................................................................230 10.3. Store Your Aviator Companion and Aviator Pump .................................................................................................................231 10.4. Handle a Damaged or Wet Companion or Pump ...................................................................................................................231 10.5. Conditions for Transport, Storage, and Use ..............................................................................................................................232 11 Manage Your Diabetes Safely ........................................................................................................................................................233 Appendices...........................................................................................................................................................................................242 12 A. Table of Settings .........................................................................................................................................................................242 B. SETUP WIZARD Default Configuration and Settings .....................................................................................................251 C. Device Specifications Companion ...................................................................................................................................254 D. Device Specifications Pump ...............................................................................................................................................255 E. FCC Compliance Information ................................................................................................................................................257 F. Electromagnetic Information ................................................................................................................................................258 G. Accuracy of Flow Rate ..............................................................................................................................................................259 H. Alarm Priority ..............................................................................................................................................................................261 I. FreeStyle Aviator Menus Companion .............................................................................................................................262 J. FreeStyle Aviator Menus Pump .........................................................................................................................................265 Glossary
..........................................................................................................................................................................................................268 Resources ..........................................................................................................................................................................................................275 Welcome Thank you for selecting the FreeStyle Aviator Insulin Delivery and Glucose Monitoring System to help you manage your diabetes. FreeStyle Aviator is a state-of-the-art continuous insulin delivery and glucose monitoring system designed to make pump therapy easy and safe. This Users Guide has been developed to ensure the ease-of-use, with explanations and guidance that are simple to understand and follow. Welcome Customer Care Call Customer Care, 24 hours a day, 7 days a week, if you have any questions about the programming or operation of your companion and pump. Abbott Diabetes Care (ADC) Customer Care is staffed with professionals trained to answer your questions. Please have your companion and pump serial numbers available. The serial numbers and the ADC Customer Care telephone number are printed on the back of the companion and pump. For non-urgent questions, Customer Care can also be reached online at www.AbbottDiabetesCare.com. For more information about your blood glucose control or your management of diabetes, call your healthcare professional. For questions that involve the mechanics of the pump, call ADC Customer Care. Learn about the FreeStyle Aviator System It is very important for you to get to know your new companion and pump before you begin using it. You should:
Read through this entire Users Guide before using your Work closely with your healthcare professional until you are comfortable with all aspects of pump therapy. Devote adequate time for record keeping, reading, and meeting with your healthcare professional to ask questions and learn new tips. Aviator Companion and Aviator Pump. WARNING: The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only. DOC15736_Rev-A-Man.indd 2-1 2/9/09 11:29:29 AM I Symbols and Important Safety Information Symbols and Important Safety Information Do not use near MRI Lot number Read instructions for use Sterilized by Ethylene Oxide For sale by prescription only Storage Temperature Range Type BF Medical Equipment (patient isolated, not defibrillator protected) Water-Tight Equipment (protected against the effects of submersion;
tested to 12 feet (3.6 meters) for 24 hours) IPX8 Serial Number Expiration date Do not re-use Reorder number CE Mark Manufacturer The European Battery Directive requires separate collection of spent batteries, aiming to facilitate recycling and to protect the environment. The batteries in this product should be removed and disposed in accordance with local regulations for separate col-
lection of spent batteries. This product must not be disposed of via general household waste collection. Separate collection for electrical and electronic equipment waste per Direc-
tive 2002/96/EC in the European Union is required. Contact the manufacturer for details. Do not use if package is damaged Consult instructions for use Warnings, Cautions and Important Notes Possible hazards that, if NOT avoided, could result in serious injury or death. Hazard that can cause minor personal harm or damage your Aviator Companion and Aviator Symbols and Important Safety Information Important information you need to pay attention to. NOT hazard related. Warnings Cautions Pump. Important Notes 1. Warnings General Aviator Companion and Aviator Pump are NOT intended to be used by a person who is visually-impaired Aviator Companion and Aviator Pump are NOT intended to be used by a person who is hearing-impaired Aviator Companion and Aviator Pump. You should Read this entire Users Guide before you begin using your start pump therapy only under the supervision of your healthcare professional. Incorrect usage or failure to fol-
low the instructions provided with the Freestyle Aviator Insulin Delivery and Glucose Monitoring System may cause serious injury or death. You should always be prepared to inject insulin in case your pump fails or you need to return it for service. If your pump stops and you are NOT prepared to give yourself insulin injections, extreme hyperglycemia (high blood glucose) and Diabetic Ketoacidosis (DKA) could develop within a few hours. Before going to bed, make sure that the pump contains enough insulin to get you through the night. Failure to do so could result in no insulin delivery and life threatening hyperglycemia. The or whose hearing makes it unlikely that the person will hear the companion and pumps sounds. The or whose sight makes it unlikely that the person will see the companion and pumps screens. Ensure that your healthcare professional has oriented you to the size and brightness of the screen. The When using the USB features of the system, place the companion in its charger cradle and connect to the cradles USB port. Use The graphical output glucose range limitations are 20 to 500 mg/dL (1.1 to 27.8 mmol/L). The accuracy of graphical output and statistics are dependent on the time being accurately set. NOT expose your companion or pump to MRI, X-ray, CAT scan, or ultrasound equipment. ALWAYS discon-
Do nect your companion and pump and store it away from the machines. Do NOT bring the companion and/or pump into the procedure room at any time. You should have an alternate therapy plan for insulin delivery ready in the event that:
An unexpected interruption in insulin delivery occurs. The companion and pump do FreeStyle Aviator System must only be used with EN60950-1 rated PCs. ONLY ADC supplied cables in order to avoid the risk of electrical shock. NOT operate as described in the systems instructions and guide. DOC15736_Rev-A-Man.indd 2-3 2/9/09 11:29:31 AM II III Symbols and Important Safety Information one or both of The companion and/or pumps screen are missing segments or some of the screen is blank. Discontinue use immediately. Use of the system may result in incorrectly displayed information and may cause you to mis-
use the companion or pump, resulting in possible adverse medical events or serious injury. Call Customer Care and/or your healthcare professional. Aviator Companion and Aviator Pump are intended only for continuous subcutaneous (under the skin) The infusion of insulin and should NOT be used for any other type of therapy. Discontinue use of the pump and switch to an alternate insulin therapy method in the event that the pumps speakers fail to sound as part of the change from idle mode to basal delivery mode, or following the replacement of a battery. It is very important that the time and date are correctly set. Your pump will be programmed to deliver specific basal rates of insulin at specific times of the day. If you set the incorrect time, you may get incorrect insulin amounts, resulting in high or low glucose, and possible adverse medical events including serious injury due to delivery errors. If your companion or pump is cracked or a button is torn, this may result in water getting into the internal parts of the pump causing malfunction. Discontinue use and switch to an alternate insulin therapy method immedi-
ately AND contact your healthcare professional and/or Customer Care. ONLY Abbott Diabetes Care should take care of a damaged companion or pump. Using your pump and/or companion inappropriately will void the warranty. If the pumps status cannot be obtained using the companion, use the pumps screen. If you still cannot obtain the pump status, reposition the companion closer to the pump. Do disposable supplies. Be sure to follow your healthcare professionals instructions for the specific settings described in Additional Options. Do Do Parts of the pump and infusion sets may be a choking hazard. Keep the pump and all accessories out of the reach of small children. Section 6.9). Discontinue use of the companions radio link to the pump when on board a commercial aircraft (
The trainer Mode feature on your pump should only be used for training and should never be used when deliv-
ering actual therapy. User notification of alarms may be delayed when using Trainer Mode on the pump because notification of Pump alarms is held off whenever the Pump screen is on and displaying a screen other than the Home screen and the Trainer Mode prevents the Pump screen from timing out. Although the pump is water resistant, avoid getting it wet because it is submerged under water or other fluids as this may damage the battery or internal components. NOT attempt to sterilize your pump. NOT use the pump near flammable or explosive materials. NOT use the sterile supplies (reservoir, infusion set, insulin, etc.) after their expiration date. Do NOT reuse any not waterproof. The pump should not be Section 6.1 Set If your pump has been dropped, the water resistance capability of your pump may be compromised. If you sus-
pect that your pump is damaged, contact your healthcare professional and/or Customer Care. Symbols and Important Safety Information Insulin Delivery and Calculations NOT infuse MUST disconnect from the pump using the quick disconnect feature of If you receive an occlusion alarm, you the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the occlusion is removed. When an occlusion alarm sounds, it is recommended to change the infusion set, tubing, and reservoir. Rapid or short-acting U-100 Insulin is the only substance that should be delivered via your pump. Do blood, cellular blood products or other medications. Use of any other product may result in adverse medical events or serious injury. Ask your healthcare professional which type of insulin you will be using and what action time should be set. If you do NOT set these values correctly, you may receive the wrong amount of insulin, which may result in ad-
verse medical events like extreme hyperglycemia and DKA. Insulin that has been degraded by environmental conditions (extreme heat over 104F (40 C), extreme cold below 30F (-1 C), has clots, etc.) may cause adverse medical events or serious injury. Discard any insulin that has been exposed to extreme temperatures. Accurate determination and programming of the insulin to blood glucose ratios (insulin sensitivity) are neces-
sary to avoid possible delivery errors that may result in adverse medical events or serious injury. Accurate determination and programming of the insulin to carbohydrate ratios are necessary to avoid possible delivery errors that may result in adverse medical events or serious injury. Accurate calculation and programming of blood glucose targets and insulin sensitivity are necessary to avoid possible delivery errors that may result in adverse medical events or serious injury. The stability of insulin following six days of storage in a pump Reservoir has been verified. Storage of insulin in the Reservoir beyond six days might result in adverse medical events (including serious injury). Blood Glucose Testing NOT insert any foreign materials in the test strip port. ONLY on your fingers if you are testing for hypoglycemia (low blood glucose) or if you have hypoglycemia Test unawareness. Do FreeStyle Lite Test Strips insert for further information. Peritoneal dialysis solutions containing icodextrin or compounds of Galactose 13 mg/dL ( 0.7 mmol/L), Malt-
ose 20 mg/dL (0.6 mmol/L) or Lactose 10 mg/dL ( 0.3 mmol/L) cause the integrated FreeStyle Lite Blood Glucose Meter to overestimate blood glucose test results. If you are receiving such treatment, do NOT use the blood glucose meter and discuss this issue with your healthcare professional to ensure proper treatment. Blood glucose levels MUST be tested when the pumps operation is stopped. When the pump is stopped, and and lancets are small parts that may be dangerous if swallowed. Refer to package DOC15736_Rev-A-Man.indd 4-5 2/9/09 11:29:31 AM IV V Symbols and Important Safety Information there is NO insulin delivered, blood glucose levels will rise resulting in hyperglycemia. Check with your health care professional about instructions for your care when you are disconnected from your pump. Always check your blood glucose 1 to 3 hours or as your healthcare professional directs after inserting a new in-
fusion set, refilling the insulin reservoir, or if your pump has stopped operating for any duration. It is imperative that you confirm that insulin is flowing through the pump prior to sleep. Do NOT change your infusion set less than 3 hours before bedtime as you need to be awake to notice any problems that may arise with a new site. Blood glucose measurements taken outside the companions operating temperature range may be less accurate. Reconnecting NO air in the tubing. If there is air in the tubing, you will NOT When reconnecting, be sure to check that there is get the correct insulin dose. Follow the User Guides recommendations on priming to replace any air in the tub-
ing before reconnecting, by using the pumps PRIME TUBING feature (Section 2.4). Infusion Sets and Reservoirs single use only. Do NOT reuse. Use only the Aviator-supplied Your pumps reservoir and infusion sets are for reservoir intended for your pump. Do NOT substitute with any other reservoir. While the pump and infusion set are disconnected from your body, you can practice filling your insulin reservoir with saline until you are comfortable with the procedure. You MUST dispose of the used practice infusion set and reservoir after practicing. Do NOT refill the reservoir. Before filling the reservoir, make sure your insulin is at room temperature to limit the amount of bubbles. If you have questions about the correct temperature, consult your insulin manufacturers product insert or your healthcare professional. Filling the reservoir with cold insulin may result in delivery errors. Do NOT pre-fill and store insulin in the reservoir prior to use in your pump. The reservoir protective cover is for temporary use while preparing the reservoir and infusion set for use. You must pump. ALWAYS the pump There is a possibility of occurrence of adverse medical events or serious injury if the reservoir is NOT installed in the pump and the reservoir is accidentally pressed or hit. NEVER in accidental delivery of insulin and possible adverse medical events or serious injury. Your pumps reservoir is for NOT substitute any other reservoir. Install the reservoir protective cap to maintain the integrity of the reservoir contents after filling if there is a delay in attaching the reservoir to the infusion set. NOT put the reservoir into the pump without first putting on the reservoir cap. Do prime infusion set while attached to your body. If infusion set is attached when priming, this may result NOT have the infusion set tubing connected to your body when removing the reservoir from the disconnect your pump and infusion set from your body before removing the insulin reservoir from single use only. Use only the Aviator-supplied reservoir intended for your pump. Do Symbols and Important Safety Information NOT twist the reservoir cap onto the reservoir. Just snap it on and make sure the alignment guides match up. NOT allow any insulin or fluid to get into the reservoir compartment. Use a Q-tip to wipe up the moisture. MUST remove all air bubbles, larger than champagne-sized, from your tubing and reservoir. Delivery of air NOT hold the plunger while placing the reservoir into the pump. NOT force the reservoir into the pump. Make sure the reservoir alignment mark is lined up with the pump Do Push the reservoir into the reservoir cap until the two are tightly mated to avoid possible delivery errors that may result in adverse medical events (including serious injury). Rotate the reservoir cap fully closed when installing the reservoir and infusion set assembly into the Pump to avoid causing delivery errors that might result in adverse medical events (including serious injury). Check for any damage to the catch feature before mating the infusion set reservoir cap to the reservoir barrel. Do Do alignment mark and gently wiggle into place. Do You bubbles can result in unexpected hyperglycemia. Do Use adverse medical events or serious injury. You need to install the reservoir in the pump and prime tubing before attaching the infusion set to your body. If the infusion set is attached to your body when priming, this may result in accidental delivery of insulin and possible adverse medical events (including serious injury). If reservoir, infusion set tubing or cannula is improperly primed, this may result in delivery errors and adverse medical events or serious injury. Prime infusion set cannula after every infusion set change. NOT use an infusion set if the sterile packaging has been damaged. ONLY the Aviator infusion sets intended for your pump. NOT using the correct infusion set may result in Basal Rates NOT stop your daily basal delivery program without consulting your healthcare professional. When You should NO basal insulin is being delivered, this can lead to hyperglycemia and DKA. Insulin MUST BE delivered by an-
other means. Discuss with your healthcare professional regarding how long you can safely stop your basal rate. STOP Accurate basal rate programming and appropriate selection of the active Basal Program are necessary to avoid adverse medical events or serious injury. STOP basal delivery before removing the battery (Section 3.1.3). basal delivery before removing the reservoir. When changing batteries, leaving them out for more than 15 minutes may delete your time and date settings and IOB (Insulin on Board) calculations. Your pump may also lose the history of any recent boluses. Ensure that your pump settings are current after replacing the batteries as described in Section 6.1. Bolus and IOB DOC15736_Rev-A-Man.indd 6-7 2/9/09 11:29:31 AM VI VII Symbols and Important Safety Information Appropriate and accurate bolus amounts are necessary to avoid delivery errors that may result in adverse medi-
cal events or serious injury. Delivering a meal bolus but then NOT eating a meal may result in low blood glu-
cose values. Eating a meal and NOT delivering a meal bolus to cover the meal may result in high blood glucose values. Batteries Make sure the fresh battery is at room temperature to avoid false alarms. ONLY Duracell MN2400 or Energizer E92 AAA alkaline primary battery (non-rechargeable) in your pump. Use NOT use lithium, nickel cadmium (NiCad), nickel metal hydride (NiHM), carbon zinc (heavy duty), or recharge-
Do able batteries in your pump. Using other types of batteries may shorten the life of the battery, cause inappropri-
ate low battery alert warnings, or fail to give low battery alert warnings. The At the end of their useful life dispose of local environment and other rules and regulations that may apply. FreeStyle Aviator System components and accessories according to Aviator Companion contains lithium internal batteries. Alarms MUST disconnect from the pump using the quick disconnect feature of If you receive an occlusion alarm, you the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the occlusion is removed. Continued use of a pump with malfunctioning sounds may result in the user being unaware of an alarm or alert condition or that delivery has stopped, resulting in possible adverse medical events or serious injury. When your insulin supply is low, there will be a Low Insulin Alert or No Insulin alarm. Also, the insulin icon in the Levels panel on the Home screen will show the level of insulin in the reservoir. VIII Symbols and Important Safety Information 2. Cautions General Section 10), there is a possibility the insulin in your Aviator Pump is carried at a vertically higher position than the infusion site, a very small amount of ad-
Remove your pump before prolonged exposure to water, and follow your healthcare professionals recommen-
dations on insulin dosing when you are disconnected from the pump. You should avoid exposing your pump to temperatures above 104 F (40 C), common in hot tubs, whirlpools, and saunas. If your pump is exposed to extreme temperature ranges (see pump will be damaged or destroyed. The insulin in the reservoir and tubing needs to be replaced (see Section 2.4), and the infusion set changed. If the ditional insulin infusion or interruption delivery may take place. To minimize this condition and maintain pump delivery accuracy, the pump should be carried no higher than 12 inches (30 cm) above the insertion site. For those using basal rates of less than 1.0 units per hour, this may be especially important. When using very low basal rates of less than 1.0 units per hour, position the pump vertically below the level of the infusion site to eliminate this condition. This behavior is common to most traditional insulin pumps. If Aviator Pump is exposed to large changes in vertical height, a small amount of additional insulin infusion or interruption of delivery may take place. To minimize this condition and maintain pump delivery accuracy, avoid sudden large changes in height between the pump and infusion site, when using basal rates less than 1.0 unit per hour. This behavior is common to most traditional insulin pumps. If the pump malfunctions or a problem is detected, the pump will alarm. If you the issue continues, contact Customer Care. Aviator Pump is exposed to large temperature changes, a small amount of additional insulin infusion or inter-
If ruption of delivery may take place due to thermal expansion or contraction of the insulin volume. This behavior is common to most traditional insulin pumps. To minimize this condition and maintain pump delivery accuracy, avoid large temperature changes The resulting insulin delivery or interruption in delivery more greatly affects people who use basal rates less than 1.0 units per hour. Aviator Pump is exposed to a high G force, such as might occur on an amusement park ride, it might cause a If small volume of insulin to be either unintentionally delivered to your body, or unintentionally be siphoned from your body. Be careful breaking of the metal prongs. The Make sure the hub connections are properly tightened. If any are loose, insulin may accidentally leak out of the system, reducing insulin delivery, and your blood glucose levels could rise rapidly to dangerous levels. Hyperbaric chambers will affect pump operation and may damage the pump. Avoid high humidity (greater than 90 percent) and high or low (10,000 feet [3048 meters] or more above sea NOT to use too much force to place the battery cap on the pump. Excess force can lead to bending or Aviator Pump is intended for your own personal use only. Do NOT share your pump with others. CANNOT resolve the alarm and IX DOC15736_Rev-A-Man.indd 8-9 2/9/09 11:29:31 AM Symbols and Important Safety Information NOT use abrasive cleaners or sharp instruments while cleaning your pump, as they may damage the case NOT use steam or hot water to clean your pump. NOT put your pump in the dishwasher or microwave. NOT use a hairdryer to dry your pump. level) atmospheric pressure, as the system may not operate properly under those conditions. NOT use household or jewelry cleaners, petroleum-based products, or products containing high levels of Do N, N-diethyl-m-toluamide (DEET) near the pump as they may damage the pumps case. Also be sure that your hands are free of these products before touching the pump. Do or screen, a damaged case or screen will NOT be water-resistant, and will require service. Small cracks resulting from sharp objects can allow water from the atmosphere to damage pump internal parts. Do Do Do Be sure to review with your healthcare professional any changes in your daily routine as well as strategies for daylight savings time and travel across time zones. The with other manufacturers parts and accessories may result in inaccuracies or damage the pump. If your companion or pump is damaged, it will need to be serviced or replaced. Call Customer Care to obtain detailed instructions regarding servicing or replacement procedures. The pumps sounds can be heard. Do the system will log Carbs entered through a Food Bolus event. To reduce the possibility of spreading an infectious disease, caregivers should take proper cautions, such as wearing gloves, when handling components of the FreeStyle Aviator System that is used by another person. Results from Aviator Pump should be visually checked often when surrounding noise levels make it unlikely that the Aviator Pump is designed for use with the parts and accessories recommended in the Users Guide. Use FreeStyle Control Solution tests do NOT reflect your blood glucose level. NOT create a Food Event entry on the companion to cover food for which you created a Food Bolus event, as Insulin Delivery and Calculations WHILE AN ALARM IS ACTIVE an alarm as soon as possible. Insulin delivery does because you have NOT begun insulin delivery yet.
, INSULIN DELIVERY IS STOPPED. Therefore, it is important for you to respond to NOT stop with ALERT. However, delivery is NOT occurring when you get a Pump Idle Alert, Blood Glucose Testing Follow your healthcare professionals recommendations for checking your blood sugar when you have been off the pump. To prevent high glucose, follow your healthcare professionals recommendations for replacing missed basal and bolus insulin when you are disconnected from the pump. Infusion Sets and Reservoirs You MUST replace the pumps reservoir and infusion set each time you replenish your insulin supply. X MUST change your infusion set every three days or sooner according to your healthcare professionals ad-
You vice. You may need to change your infusion set more frequently if it becomes dislodged, if skin irritation or signs of infection develop, signs of poor control appear, or at the advice of your healthcare professional. You must replace your infusion set every time you change your pumps reservoir and vice versa. Use aseptic techniques when filling the reservoir and connecting the infusion set. Make sure everything is clean and sterile to prevent infection. Symbols and Important Safety Information Basal Rates/Bolus When setting a temporary basal percent, make sure that you are setting the percent of your basal that will be delivered and NOT the percentage reduction in your basal rate. Refer to Section 6.1. 3. Important Notes General FreeStyle Aviator System. Consult your health-
NO specific recommendations regarding the treatment of your diabetes. You should Follow all instructions provided with your pumps accessories (infusion sets, etc.). The Users Guide contains work with your healthcare professional to design the best treatment program for your specific needs. Regular medical checkups are an important part of pump therapy. Your healthcare professional plays a key role in your diabetes management. Work with your healthcare professional to learn how to use the care professional when any problems or questions arise. Work with your healthcare professional to obtain proper instruction on how to program and deliver boluses, and how to use basal programs to enhance your use of the Aviator Pump. Talk with your healthcare professional about your individual insulin needs. Ask your healthcare professional to help you complete the Table of Settings in meet your personal needs. You should consult your healthcare professional before making any major edits or changes to your basal program(s). You will hear a number of clicks depending on your movements on the scroll pad. Be sure to always check that you have scrolled to the correct menu or option as desired. Before you go to sleep, be sure the tubing is close so it will NOT dislodge the infusion set. Protection against delivery errors is provided by two microprocessors, which continuously check each other. In addition, two position sensors in the pumps drive mechanism are regularly cross checked to protect against er-
rors caused by sensor or drive mechanism malfunction. XI NOT where pets or children might pull or chew on it. Keep tubing Section 11 Appendix A, to DOC15736_Rev-A-Man.indd 10-11 2/9/09 11:29:31 AM Symbols and Important Safety Information Electromagnetic interference (EMI) sources, such as radio and TV station transmitters, amateur radio (HAM) transmitters, two way radios and cellular phones can affect the delivery of insulin in battery powered insulin delivery devices. Follow the warnings listed below to reduce the chance of user interface distortion or the stop-
page of an insulin delivery of your FreeStyle Aviator System, which could result in adverse events or serious injury:
Do MRI procedure room. Be aware of nearby transmitters, such as radio and TV towers, and avoid going close to them. Do Be aware that adding accessories or modifying the tible to interference from EMI (Refer to Section 12D for more information). NOT place your FreeStyle Aviator System next to another electronic device such as a cellular phone. FreeStyle Aviator System may make it MORE suscep-
NOT use your FreeStyle Aviator System during MRI; leave your FreeStyle Aviator System outside the Symbols and Important Safety Information is good for three months after opening the bottle or until the expiry date printed Your community requires safe disposal of sharps. FreeStyle Control Solution on the label, whichever comes first. Count forward three months from the date you open a new bottle of control solution. This is your discard date. Write this date on the side of the control solution bottle. The control solution range is a target range for control solution only. It is glucose level. NOT a target range for your blood Blood Glucose Testing FreeStyle ONLY the FreeStyle Lite Test Strips with the companion. Using other test strips will produce inaccurate NOT reuse lancets. Use a new sterile lancet for each test. NEVER use a lancet or lancing device for more than Check your blood glucose level frequently as recommended by your healthcare professional and follow recom-
mendations from your healthcare professional when your blood glucose is too high or too low. To ensure accurate results, wash your hands and test site (for example, your forearm) with soap and water. Make sure there is NO cream or lotion on the test site. Thoroughly dry your hands and test site. Use results. For important test strip information, including detailed storage and usage information, refer to the Lite Test Strip package insert. Do one person. It is possible you may experience bruising at the test site. If bruising does occur, you may choose to lance an-
other site or adjust lancing depth. Do Do Do Do Do Do Do Low or high glucose readings can indicate a potentially serious medical condition. LO readings display as less than 20 mg/dL (1.1 mmol/L), and HI readings display as over 500 mg/dL (27.8 mmol/L). Use a sealed container such as a Sharps container to avoid exposure to the sharps by yourself or someone else. NOT use test strips more than once. Discard used test strips in accordance with local disposal regulations. NOT press the test strip against the test site. NOT scrape the blood onto the test strip. NOT apply blood to the flat side of the test strip. NOT apply blood to the test strip when the test strip is out of the companion. NOT apply blood to both edges of the test strip. NOT put blood or foreign objects into the companions test strip port. DOC15736_Rev-A-Man.indd 12-13 2/9/09 11:29:32 AM XII XIII Section 1: Getting Acquainted 1.1 How to Use this Guide 1 Getting Acquainted 1.1 How to Use this Guide Purpose When To learn to use this Users Guide so you can find the information you need to use your Aviator Companion and Aviator Pump correctly and safely. Do this task:
Before you use your Aviator Companion and Aviator Pump for the first time. When you are ready to begin reading the Users Guide. FreeStyle Aviator System Users Guide. The Materials Helpful Information It is very important for you to get to know your new companion and pump before you begin using it. You should:
Read through this entire Users Guide before using the companion and pump. Work closely with your healthcare professional until you are comfortable with all aspects of pump therapy. Devote adequate time for record keeping, reading, and meeting with your healthcare professional to ask questions and learn new tips. Dont be afraid to ask questions. Keep a list of the questions you have as you progress through the Users Guide and as you begin wearing your pump. The list will help you remember to ask questions at your follow-up visit with your healthcare professional. How to Use this Guide This Users Guide provides the information you need to use your new companion and pump. Information is divided into sections. Most tasks can be performed using the companion or the pump, or either one. This Users Guide provides instructions for using the Aviator Companion to operate the system, call Customer Care if you need instructions on operating the pump only. Each section contains useful information about:
Purpose of the task. When to do the task. Materials you will need to perform the task. Helpful information such as important notes or tips. Steps you need to follow to complete the task. Section 1: Getting Acquainted 1.1 How to Use this Guide FreeStyle Aviators menus and screens. As you complete each section of the Users Guide:
Read through the section and complete each task, following the outlined steps. Be sure to check your work. Explore and move around in Pay particular attention to the information that will help you use the Aviator Companion and Aviator Pump safely. Complete each task and check your work at the end as appropriate. Refer to the Refer to the Glossary if you need the definition and information about a specific term. Key terms will be in blue. Table of Contents if you need information about a specific topic. Warnings, Cautions, and Notes highlighted in the boxes. They provide key safety What to Ask Your Healthcare Professional About Using the Companion and Pump What should I do if I have problems operating the companion and/or pump as described in the Users Guide?
What back-up insulin therapy method should I use if the pump fails to operate as described in the Users Guide?
What are my personal settings for the Table of Settings in Section 12 - Appendix A?
When should I contact my healthcare professional with questions?
What other resources does my healthcare professional recommend?
Other Questions to Consider Key Terms Key terms in each section will be in blue. Refer to the Glossary (in the back of the User Guide) for definitions and information about any specific term. DOC15736_Rev-A-Man.indd 1-2 2/9/09 11:29:32 AM 1 2 Section 1: Getting Acquainted 1.2 Identify Parts of the System 1.2 Identify Parts of the System Purpose When Materials To identify and locate parts of the system and get familiar with the system so you can use your Aviator Companion and Aviator Pump safely and correctly. Do this task:
Before you use your Aviator Companion and Aviator Pump for the first time. Before you program your pump for use. The Your FreeStyle Aviator System Users Guide (This document). Aviator Companion (The remote handheld used to operate pump). Aviator Pump (The insulin delivery pump). Your Helpful Information FreeStyle Aviator Insulin Delivery and Glucose Monitoring System continuously delivers insulin to your body in a way that closely matches how the body delivers insulin throughout the day. By using information you and your healthcare professional develop together and programming your doses accurately into your Aviator Pump, your pump is able to do two important things:
1. 2. basal insulin. Basal insulin is the continuous trickle of Every few minutes, it will provide your body with insulin necessary to suppress glucose production by your body in between meals and overnight. Basal insulin is personalized to your specific needs and then spread out over a 24-hour period. At specific times, you will program the pump to deliver a of insulin taken either to cover the rise in blood glucose that occurs after eating, or to correct high blood glucose. bolus of insulin. Bolus insulin is an extra burst Caution: To reduce the possibility of spreading an infectious disease, caregivers should take proper cautions, such as wearing gloves, when handling components of the FreeStyle Aviator System that is used by another person. Identify Parts of the Aviator Companion This section introduces you to the parts of your new Aviator Companion. Place your companion next to the picture below and locate the parts of the companion. Section 1: Getting Acquainted 1.2 Identify Parts of the System Pump Screen Blood Glucose Meter Test Strip Port USB Port Backlight/
QBolus Soft Key Jogwheel/
Enter Button Back Button Wake Up Soft Key to MAIN Menu Note: Your Aviator Companion is designed to always be ON when the batteries are charged. Companion Parts The oval shaped lower button on the right side of the companion screen below the jogwheel. It is QBolus Soft Key To turn on/off the backlight, press the bottom left soft key on the companion Back Button used to cancel a change made to a value, and to move back to the previous screen. Backlight/
with the light bulb icon for 2 seconds when you are NOT at the Home screen. To deliver a quick bolus, press the QBolus soft key from the Home screen. Using the jogwheel, select amount of bolus to deliver and press Enter button. Blood Glucose Meter Test Strip Port cose. Companion Screen Jogwheel/Enter Button The top jogwheel button on the right side of the companion. It scrolls to allow you to move up and down through the companion options. You can also use this button to select an item and to move forward to the next screen. You can also stop a bolus in progress. Wake Up Soft Key to icon for 2 seconds to access the MAIN MENU. USB Port MAIN MENU To wake up the companion, press the bottom right soft key with the Power The port where you insert a test strip when checking your blood glu-
The USB port to connect to the charger of your companions battery. The part of the companion where the information is displayed. DOC15736_Rev-A-Man.indd 3-4 2/9/09 11:29:32 AM 3 4 Section 1: Getting Acquainted 1.2 Identify Parts of the System Identify Parts of the Aviator Pump This section introduces you to the parts of your Aviator Pump. Place your pump next to the picture below and identify the parts of the pump. Back Button The picture below identifies the parts of the Insulin Reservoir. Section 1: Getting Acquainted 1.2 Identify Parts of the System Reservoir Cap Insulin Reservoir Reservoir Plunger Reservoir Compartment Reservoir Cap Battery Cap Bolus/
Wake Up Button Infusion Set Tubing Battery Cap l m 1 l m 2 t t o b b A Cap Pump Reservoir Plunger Handle Pump Screen Scroll Pad Backlight/Enter Button Note: Your Aviator Pump does NOT have an on/off button. Your pump is designed to always be on when the batteries are in. The screen may go blank when it times out. The bottom button on the right side of the pump screen with an indented triangle The top button on the right side of the pump screen with an indented triangle pointing to the Pump Parts Back Button left. It is used to cancel a change made to a value, or to move back to the previous screen. Backlight/Enter Button pointing to the right .To turn on/off the backlight, press this button for 2 seconds. It is also used to select an item and to move forward to the next screen. Display Right or Left the right side of the pump for right-handers or on the left side of the pump for left-handers. Battery Cap Battery Compartment Bolus Button/Wake up Button The button on the side of the pump. Press it the number of times needed to deliver a quick bolus using the One-Button Bolus function. You can also press it once to stop a bolus in progress. Press and hold the button to wake up the pump from sleep mode, and see the Home screen. Pump Screen Scroll Pad down through the pump options. It is like the scroll pad on a computer. The indented, oval area on the right side of the pump screen. It scrolls to allow you to move up and A setting that allows you to switch the screen orientation such that the buttons are on The part of the pump where the information is displayed. Cap cover for the battery compartment. Where the pump battery is stored. Cannula Housing AAAAAA Battery Battery Compartment Pump Connector Needle Insulin Reservoir Parts The cover that comes with your pump used to protect the reservoir compartment (NOT pictured). Insulin Reservoir Located on the upper-left side of your pump. The reservoir holds the insulin your pump will deliver to your body. The reservoir holds 250 units of insulin. Your healthcare professional will tell you how much insulin to use when you fill the reservoir. The reservoir is a single-use only item. Discard it after a single use. Mul-
tiple uses of the reservoir may result in problems with insulin delivery. Dust Cover Reservoir Cap placed in the pump. This connects the Reservoir to the infusion set. Reservoir Compartment Reservoir Plunger Reservoir Plunger Handle draw insulin into the reservoir, and is discarded after the reservoir is filled. The clear plastic cap and handle that is on the outside of your pump when the reservoir is The handle attached to the end of the plunger that is removable. Used only to The hollow area in the pump that houses the insulin reservoir. The gray plunger of the insulin reservoir. l m 1 l m 2 t t o b b A Cap Pump Reservoir Plunger Handle DOC15736_Rev-A-Man.indd 5-6 2/9/09 11:29:32 AM 5 6 Section 1: Getting Acquainted 1.2 Identify Parts of the System The picture below identifies parts of the infusion set. Reservoir Cap Infusion Set Tubing Cannula Housing Adhesive Backing Paper Introducer Needle Connector Needle Cannula Adhesive Infusion Set Parts A slender plastic tube that is under the skin and delivers the insulin in your body. During the insertion Needle The part of the infusion set that contains a needle to connect to the cannula. Cannula of the infusion set, the center of the cannula contains a fine gauge introducer needle to help the cannula pen-
etrate the skin. The introducer needle is then removed after insertion, leaving the plastic cannula in your skin. Cannula Housing The part of the infusion set where the tubing connects to the infusion set on your body. Connector Infusion Set reservoir into your body. It is used one time only, and is discarded after each use. Infusion Set Tubing Introducer Needle and only the cannula is left in your body. Reservoir Cap placed properly in the pump. This connects the Reservoir to the infusion set. Part of the infusion set that carries insulin from the pump to the cannula. The needle inside the cannula that helps insert it under your skin. The needle is removed The combination of the reservoir cap, tubing, and cannula that delivers insulin from the pumps The clear plastic cap and handle that is on the outside of your pump when the reservoir is Getting Familiar with the System You will be using the jogwheel, buttons, and soft keys to move around the menus and screens of your Aviator Companion after it is charged and set up. Review how you will be navigating the system:
Section 1: Getting Acquainted 1.2 Identify Parts of the System Jogwheel
/ Button /
Soft Keys Jogwheel Enter button Back button Backlight/QBolus soft key Use this to Activate this by Scroll through and highlight panels, menus, or screen options that you want to select. Clear, Select and highlight actions such as OK, Done, Skip, Edit, Yes, or No, to advance to the next screen. Confirm the panel, menu, screen options, and actions that you have highlighted and selected. Move forward to the next screen. Stop a normal bolus in progress. Go back to the previous menu or screen. Cancel a value that was changed. Turn on/off the backlight. Deliver a quick bolus. Scrolling the jogwheel using either your thumb or index finger in an upward or downward direction. Important Note: Be sure to always check that you have scrolled to the correct menu or option as desired. Pressing the jogwheel on the right side of the companion. Pressing the oval shaped Back button on the right side of the companion screen below the jogwheel. Pressing the bottom left soft key on the companion that has a light bulb icon for 2 seconds, when you are NOT at the Home screen. Pressing the QBolus soft key from the Home screen. Using the jogwheel, select amount of bolus to deliver and press Enter button. DOC15736_Rev-A-Man.indd 7-8 2/9/09 11:29:33 AM 7 8 Section 1: Getting Acquainted 1.2 Identify Parts of the System Jogwheel
/ Button /
Soft Keys Wake Up soft key Use this to Wake up the companion from sleep state. low power Note: The Home screen appears with Main highlighted whenever you wake up the companion. Access the screen. MAIN MENU from the Home Activate this by Pressing the bottom right soft key with the Power icon for 2 seconds until Main is highlighted. Note: You can activate the Sleep mode to quiet an alert for as little as 15 minutes or as long as 12 hours. It is like hitting a snooze button on an alarm clock. For example, if Sleep is highlighted and you want to change it to 1 hour, then press Enter, scroll to 1 hour, and press Enter again. Note: You may also want to set your timeout to longer than 15 or 30 seconds initially as you practice using your companion and setting up all your basic options. Refer to Section 6.1 and ask your healthcare professional for help as needed. The Home screen will appear after initial set-up is complete, and when you wake up your companion from low power sleep state. There are two options for setting up the Home screen:
based (displays basal and bolus insulin delivery status information) Information Activity based (displays a list of menu items such as Alarms, Status, Reports, Setup, etc.) Other Tips Section 1: Getting Acquainted 1.2 Identify Parts of the System You will go to the Home screen when you need to:
View basal and bolus insulin delivery status information (Information-based View insulin reservoir level (The syringe icon in the insulin level. View battery level (The battery icon in the Levels panel on the bottom left indicates the pumps battery level. View RF signal (Radio Frequency signal On/Off indicates whether the companion and pump are connected or not) Access all other companion functions, menus, and screen options. Levels panel on the bottom left indicates the reservoirs Home screen only). CONFIRMATION screens and messages that require your decision on specific actions. Always check Clear alerts/alarms or Skip certain options/actions. Make sure you select the correct actions to You may get that you are selecting the correct actions to take as you perform tasks on your pump. You may have to take. Pump Idle alert, you can select Clear the alert to return to the Home screen. You will also When you receive a have the option to put your pump to sleep for 15 minutes (default), or program your pump to Sleep for longer than 15 minutes to quiet an alert, until you are ready to prime your pump later. You must highlight and select You can press WARNING screen with Dashed items must be set. message displays if you try to press the Enter button The in a screen where Next, Done, or Accept is selected, when you have NOT completed all required information. You will notice that OK is highlighted and you will need to press the Enter button. Complete all information as required. Done and press Enter button for all setting changes to be saved to your system. Enter on items that are set to dashes, e.g., time. You may see dashes displayed for status information on the companions lished and status information is obtained from the pump. You will see a When accessing a longer period. SYNCING screen when you access pump menus (BASAL/BOLUS/SETUP) from your companion. PUMP DIARY or BOLUS HISTORY from your companion, you may see the SYNCING screen for Home screen until connection is estab-
DOC15736_Rev-A-Man.indd 9-10 2/9/09 11:29:33 AM 9 10 Section 1: Getting Acquainted 1.3 Charge Companion Battery 1.3 Charge Companion Battery Purpose When Do this procedure:
To fully charge the companions battery so that you can use it to operate the pump. Materials Before you set up your companion and pump for the first time. Anytime you see the Aviator Companion. Your Companion charger cradle. Low Battery Alert screen. Your companion will also be charged if connected to a powered USB cable. Helpful Information WARNING: Use ONLY the USB cable provided. Use of an unapproved cable may lead to loss of electromagnetic compatibility, and make the system more susceptible to electronic interference. Procedure:
Steps 1. Connect companion to charger. 2. Allow your companion to fully charge. Do This a. b. c. Notice battery is charging. Connect your charger cradle to an electrical outlet. Place your companion into the cradle. Charge your companions battery for at least 6 hours. 3. Check your work. Notice that your battery is fully charged. Section 1: Getting Acquainted 1.4 Install Pump Battery 1.4 Install Pump Battery Purpose When To install or replace your pump battery. Do this procedure:
Before you set up your pump for the first time. Anytime you see the Low Battery Alert screen. One Materials Duracell MN2400 or Energizer E92 AAA alkaline primary battery (non-rechargeable). Warning: Do NOT use any other battery including lithium, nickel cadmium (NiCad), nickel metal hydride (NiHM), carbon zinc (heavy duty), or rechargeable batteries. Using other types of batteries may shorten the life of the battery, cause inappropriate low battery alert warnings, or fail to give low battery alert warnings. Helpful Information carry a spare battery with your pump supplies. Once the battery is installed correctly, you will hear a series of beeps and vibrations confirming that the pumps speakers and vibrating device are working properly. Your battery will typically last at least four weeks. Battery life may be shortened if you select the vibrate setting instead of the audio setting, or use the backlight frequently. The number of alarms/alerts you receive will also impact battery life. Always Remove the battery if you are storing your pump for prolonged periods of time. Do battery for a long period of time could result in losing some settings and then having to reset them. Do battery is cold, the pump may display a battery-related alarm as the pump may NOT be receiving full power. The battery level display may be inaccurate. Expended batteries should be disposed of in accordance with local regulations. NOT use a cold battery (e.g., one that has just been in your refrigerator or in your car in cold weather). If the NOT remove an existing battery unless you are storing your pump for a long period of time. Removing the DOC15736_Rev-A-Man.indd 11-12 2/9/09 11:29:33 AM 11 12 Section 1: Getting Acquainted 1.4 Install Pump Battery Procedure:
Steps 1. Prepare to install a new battery into your pump. Do This If you are Already wearing the pump Then do this 1. 2. delivery. See Section 3.1.1 for Stop basal procedure. Disconnect your pump and infusion set from your body. Follow the procedure described in your infusion sets instructions to disconnect the infusion set. Note: You may only need to detach the cannula from the cannula housing. Setting up the pump for the first time Go to Step 2. 3. Go to Step 2. 2. Obtain a fresh AAA alkaline battery. Be ready to install a fresh battery within 15 minutes of removing the old battery. 3. Remove the battery compartment cap. Warning: A 15 minute delay may delete your time and date settings and Insulin on Board (IOB) calculations. Your pump may also lose the history of any recent boluses. Make sure the fresh battery is at room temperature to avoid false alarms. a. b. c. d. Find the battery compartment on the side of your pump. With the pump screen facing you, as shown in the picture, place your thumb on the groove and turn the cap counter-clockwise until the cap pops out. If necessary, gently pull the battery cap off. Decide what to do next. If you are Removing an old battery Installing a fresh battery Then do this Go to Step 4. Go to Step 5. Steps 4. Remove the battery. Do This If necessary, tap the pump against your hand or gently pull to remove the battery. Section 1: Getting Acquainted 1.4 Install Pump Battery The European Battery Directive requires separate collection of spent batteries, aiming to facilitate recycling and to protect the environment. The batteries in this product should be removed and disposed in accordance with local regulations for separate collection of spent batteries. 5. Insert a fresh battery. Insert the battery negative end (-) first. AAA 6. Replace the battery component cap. a. Carefully place the metal prongs of the battery cap into the space between the battery and the inside of the pump compartment at a 90 degree angle. b. c. Push down and use your thumb to press the cap in place. Twist cap clockwise to close it securely. Caution: Be careful NOT to use too much force to place the battery cap on the pump. Excess force can lead to bending or breaking of the metal prongs. DOC15736_Rev-A-Man.indd 13-14 2/9/09 11:29:33 AM 13 14 Section 1: Getting Acquainted 1.4 Install Pump Battery Steps 7. Check your work. Do This Caution:
All the signals below must be presented. If any signals below do reinsert the battery again or try inserting another fresh battery. If the problem happens again, do insulin delivery method and call your healthcare professional or Customer Care. NOT use the pump. Switch to an alternate NOT occur, a. b. c. d. Power up screen will appear. Notice the Listen for one long beep and four quick beeps. Feel two short vibrations. Look for the next screen. If you are Setting up the pump for the first time Then do this You will see the Set Date/Time screen. Go to Section 2.2 to Set Up Your System. 1. You will see the TIME/DATE screen. Replacing the battery within 15 minutes after the pump has already been initialized 2. 3. 4. Next is highlighted. Notice Enter button to return to Home screen. Press Reconnect cannula to cannula housing and then RESTART your basal delivery from your companion. Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System 2 Using the System for the First Time Quick Setup 2.1 Set Up Your System Purpose When Materials To program basic information into your Aviator Pump including time and date, insulin profile, and inactivity alarm, using your Aviator Companion. Do this procedure:
After you have charged the companions battery, and installed the pumps battery. Before you use your companion and pump as a system for the first time. Your companion fully charged and powered on. Your pump with battery installed. Your companion and pump already paired. This means that your pump is associated with your companion and your pump and companion can only communicate with each other. Information from your healthcare professional about the type of insulin you will use with your pump and other setting information that you will need as recorded in your Table of Settings in Section 12 Appendix A. Helpful Information You will perform this task using your companion, and the settings will automatically be set up on your pump as well. Before entering your settings, be sure to ask your healthcare professional which type of insulin you will be using and what is the length of its action time. Record your personalized settings in the Table of Settings in Section 12 Appendix A. When you have more experience with pumping, you can set up your companion with more optional settings in Section 6. If you are interrupted while doing this setup, the pump will beep to let you know it is waiting for you to finish these steps. For a detailed list of the screen settings and the order in which they appear, refer to the Menus in Section 12 Appendix G. Freestyle Aviator DOC15736_Rev-A-Man.indd 15-16 2/9/09 11:29:34 AM 15 16 Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Procedure (First Time Initial Setup):
Steps 1. Do This WARNING:
Set time and date using your FreeStyle Companion. It is very important that the time and date are correctly set. Your pump will be programmed to deliver specific basal rates of insulin at specific times of the day. If you set the incorrect time, you may get incorrect insulin amounts, resulting in high or low glucose, and possible adverse medical events including serious injury due to delivery errors. Caution:
Be sure to review with your healthcare professional any changes in your daily routine as well as strategies for daylight savings time and travel across time zones. a. b. Notice Press Time line with dashes is highlighted. Enter button. 2. Set current hour. a. b. Notice Press Hour is highlighted. Enter button. c. d. Scroll to the current hour. Press Enter button. Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 3. Set current minutes. Do This a. b. Notice Press Minute is highlighted. Enter button. c. d. Scroll to the current minutes. Press Enter button. 4. Set AM or PM. a. b. Notice Press AM/PM is highlighted. Enter button. c. d. Scroll to select Press Enter button. AM or PM. DOC15736_Rev-A-Man.indd 17-18 2/9/09 11:29:34 AM 17 18 Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 5. Do This Check that you have set the correct time. Check your time settings. If settings are Correct Incorrect Then do this Notice Accept is highlighted. Press Enter button. 1. 2. 3. 4. 5. 6. Scroll up to highlight the item you want to change. Press Scroll to the correct setting. Enter button. Press Scroll to highlight Enter button. Press Accept, if not already highlighted. Enter button. 6. Set date. 7. Set current month. a. b. Notice the date line with dashes is highlighted. Press Enter button. a. b. Notice Press Month is highlighted. Enter button. c. d. Scroll to the current month. Press Enter button. Steps 8. Set current day. Do This Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System a. b. Notice Press Day is highlighted. Enter button. c. d. Scroll to the current day. Press Enter button. a. b. Notice Press Year is highlighted. Enter button. c. d. Scroll to the current year. Press Enter button. 9. Set current year. DOC15736_Rev-A-Man.indd 19-20 2/9/09 11:29:34 AM 19 20 Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 10. Do This Check that you have set the correct date. Check your date settings. 11. Verify your Time and Date settings. If settings are Correct Then do this Notice Accept is highlighted. Press Enter button. Incorrect 1. 2. 3. 4. 5. 6. Enter button. Scroll up to highlight the item you want to change. Press Scroll to the correct setting. Enter button. Press Scroll to highlight Enter button. Press Accept, if not already highlighted. Check that you have set the correct time and date. If settings are Correct Incorrect Enter button. Then do this Scroll to Accept and press Enter button. 1. 2. 3. 4. 5. 6. Scroll to highlight the item you want to change. Press Scroll to the correct setting. Enter button. Press Scroll to highlight Enter button. Press Accept, if not already highlighted. Procedure (First Time Setup Wizard):
Steps 1. Go to the SETUP menu. Do This Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System a. b. Notice Press Main is highlighted on the Home screen. Enter button. 2. Access SETUP WIZARD. a. b. Scroll to highlight Enter button. Press SETUP. c. d. Scroll to Highlight Enter button Press WIZARD. 3. The STEP 1 screen a. b. STEP 1 screen, notice OK is highlighted. On the Press Enter button. 12. Check your work. Review that the correct time is displayed on the Home screen. Go to the next page to continue setting up your FreeStyle Aviator System using the SETUP WIZARD. 4. Select language. a. b. Notice Notice Language = English. (This CANNOT be changed.) Next is highlighted. c. Press Enter button. DOC15736_Rev-A-Man.indd 21-22 2/9/09 11:29:34 AM 21 22 Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 5. Select time format as needed. Do This Note: To keep the default time and date settings, press the Enter button on Next and go to Step 8. a. b. c. Scroll to highlight Enter button. Press Format. Decide how you want your companion and pump to display the time. If you want this format Time = 12 Hour (default) Time = 24 Hour Then do this Notice Accept is highlighted. Press Enter button. OR 1. 2. 3. 4. Scroll to highlight Enter button. Press Time. Scroll to Press 24 Hour. Enter button. Steps 6. Select date format. Do This Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System a. b. c. Date is highlighted. Enter button. Notice Press Decide how you want your companion and pump to display the date. If you want this format Month Day Year (default) Example: Dec 12, 2007 Day Month Year Example: 12 Dec 2007 Then do this Notice Mmm dd, yyyy is displayed. Press Enter button. Scroll to dd Mmm yyyy. Press Enter button. OR d. e. Notice Press Accept is highlighted. Enter button. 7. Confirm time and date format. a. b. Verify that the time and date are correct on the Scroll to highlight Next. TIME/DATE screen. c. Press Enter button. 8. Set Insulin Profile. Look at the INSULIN PROFILE settings on the display. Go to step 9 to make changes. To keep the default insulin profile settings, press the Enter button on Next and go to Step 12. WARNING: Ask your healthcare professional which type of insulin you will be using and what action time should be set. If you do NOT have these settings correct, you may receive the wrong amount of insulin, which may result in adverse medical events or serious injury. DOC15736_Rev-A-Man.indd 23-24 2/9/09 11:29:34 AM 23 24 Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 9. Select type of insulin. Do This If you use this type of insulin Rapid Acting Insulin Lispro
(Humalog) Insulin Glulisine (Apidra) Insulin Aspart (Novolog) Short acting (Humulin R, Novolin R) Then do this Go to Step 10. 1. 2. 3. 4. 5. Scroll to highlight Enter button. Press Type. Short. Scroll to Press Go to next step. Enter button. 10. Select action time. a. Scroll to highlight Action Time, if it is not already highlighted. Note: There is a different duration for different types of insulin. The default for Rapid is 5h 00m and the default for Short is 8h 00m. The action time will be per default if not changed. b. Press Enter button. c. d. Scroll to desired action time, which ranges between 2h 00m 8h 00m. Press Enter button. Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 11. Confirm insulin type and action time is correct. Do This a. b. c. Check your settings displayed on the screen. Notice Press Next is highlighted. Enter button. 12. Set Inactivity Alarm. a. b. Notice Press Time is highlighted. Enter button. c. d. Scroll to the amount of time when you want the pump to alert you that you have had NO interaction with the pump. The time ranges between 1h 24h. Press Enter button. 13. Confirm the time for inactivity alarm is correct. a. b. c. Check the time setting on the Notice Press Next is highlighted. Enter button. INACTIVITY ALARM screen. DOC15736_Rev-A-Man.indd 25-26 2/9/09 11:29:34 AM 25 26 Section 2: Using the System for the First Time Quick Setup 2.1 Set Up Your System Steps 14. Skip optional settings. Do This a. b. c. d. e. Skip. Edit is highlighted. Notice Scroll to highlight Enter button. Press If you are setting up your pump for the first time you will not see the Setup Wizard is complete screen. Skip to the next task in Section 2.2. Decide what to do next. If you want to Create your daily basal program now (using default settings) Set up or edit bolus calculator options, bolus and basal limits, audio/
vibe, low insulin, alarms, display preferences, locked items, and one-
button bolus for first time use Then do this You will skip to the next task 2.2 Create Your Daily Basal Program for the First Time. Go to Section 6: When Youre Ready Optional Settings for instructions on editing optional settings. Ask healthcare professional for assistance as needed. The table in Section 12 Appendix B shows the default settings for all options. 15. Check your work. You have done this procedure correctly when the time and date are correct, and you have selected all your basic settings correctly. Section 2: Using the System for the First Time Quick Setup 2.2 Create Your Daily Basal Program for the First Time 2.2 Create Your Daily Basal Program for the First Time Purpose When Do this procedure:
To program your daily basal delivery information into your pump using the Aviator Companion. Materials Before you use your system for the first time. After you have set up basic settings for your pump in Section 2.1. Your companion fully charged and paired with your pump. Your companion and pump with initial settings programmed. Healthcare professionals recommendations for your starting basal pump settings in 12 Appendix A. Section Helpful Information FreeStyle Aviator System, you are able to program a specific basal rate for each segment of time in With the your day. These segments are referred to as blocks. Each block of time can be programmed for a specific period of time at a specific rate. There are a maximum of 48 blocks one block for each hour of the day. Your daily basal program must include will prevail for 24 hours. Your goal is to work with your healthcare professional to find the check with your healthcare professional regularly until you find the basal rates that work for you. To edit your daily basal rate, follow the procedures in Section 7.1. You can also create other basal programs, such as weekend, exercise, or a at least ONE block or time range. If you only enter one block, the rate basal rates that work for you. Be prepared to temporary basal in Section 7. Procedure:
Steps 1. Create your Daily basal program. Do This a. b. Notice Press OK is highlighted. Enter button. DOC15736_Rev-A-Man.indd 27-28 2/9/09 11:29:35 AM 27 28 Section 2: Using the System for the First Time Quick Setup 2.2 Create Your Daily Basal Program for the First Time Steps 2. Do This basal block. Create a 3. Set the Start Time for Basal Block 1. a. b. Notice that the first blocks time line with dashes is highlighted. Press Enter button. a. b. c. d. Notice Press Time is highlighted. Enter button. Scroll to select desired start time for basal block 1. Press Enter button. Note: The range is 12AM 11:30 PM with 30 minute increments. Your first basal time block will start after midnight at the time you choose. You CANNOT set your last time block later than 11:30PM. Look at the following examples:
Example 1:
If doctor advises One basal rate of 0.5 units/hour Create Block Set Time 1 Any time you choose the basal rate will be the same for 24 hours. Example 2:
If doctor advises 0.8 units/hour from 3 am to 7 am 0.5 units/hour from 7 am to 10 pm 0.3 units/hour from 10 pm to 3 am Create Blocks Set Time 1 2 3 3 am 7 am 10 pm Section 2: Using the System for the First Time Quick Setup 2.2 Create Your Daily Basal Program for the First Time Steps 4. Set the Rate for Block 1. Do This a. b. Notice Press Rate is highlighted. Enter button. Scroll to select Basal Block 1 desired rate of insulin per hour. c. Note: The default basal rate is 0.0 to 2.0 Units/hour. If your basal rate needs to be more than 2.0 Units per hour, you can change it in the SETUP menu. Refer to Section 6.2. d. Press Enter button. 5. Confirm Block 1 values are correct. Verify Time and U/h values. If Correct Incorrect and you want to edit them Then do this Notice Next is highlighted. Press Enter button. 1. Scroll to highlight the item you want to change (
or Rate). Press Scroll to select desired setting. Press Enter button. Enter button. 2. 3. 4. Time DOC15736_Rev-A-Man.indd 29-30 2/9/09 11:29:35 AM 29 30 Section 2: Using the System for the First Time Quick Setup 2.2 Create Your Daily Basal Program for the First Time Steps 6. Do This If you want to Add another time block and basal rate Decide if you want to add another block or delete the block you just created. Then do this 1. 2. 3. Add Block is highlighted. Enter button. Notice Press Repeat Steps 2 to 5 to add additional time blocks and basal rates. Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Steps 7. Check your work. Do This Go to Section 3.1.2 View Basal Program and follow the procedure to review the daily basal program that you just created. Delete the time block and basal rate you just created Be finished with creating time blocks and basal rates for your daily program Note: You can add up to 48 blocks. Daily is the default, and the * identifies the block associated with the current basal rate. 1. Notice Next is highlighted. 2. 3. 4. Scroll to highlight Enter button. Press Delete. Notice the message displays. CONFIRM screen and Delete block?
5. 6. Scroll to highlight Enter button. Press Yes. Note: If you only enter ONE block, it will continue for 24 hours. 1. 2. 3. Scroll to highlight Enter button. Press Done. Notice the screen shows the message is complete. and Done is highlighted. Setup Wizard 4. Press Enter button to return to the Home screen. DOC15736_Rev-A-Man.indd 31-32 2/9/09 11:29:35 AM 31 32 Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir 2.3 Fill Reservoir Purpose When To fill the pumps reservoir with insulin for delivery. Need to fill your Do this procedure when you:
Caution: When your insulin supply is low, there will be a Low Insulin Alert or Insulin Empty alarm. Also, the insulin icon in the Levels panel on the Home screen will show the level of insulin in the reservoir. insulin reservoir. Want to practice filling the insulin reservoir. WARNING: While the pump and infusion set are disconnected from your body, you can practice filling your insulin reservoir with saline until you are comfortable with the procedure. You must dispose of the used infusion set and reservoir after practicing. Do NOT refill the reservoir. WARNING: Insulin that has been degraded by environmental conditions [extreme heat over 104F (40 C), extreme cold below 30F (-1 C), has clots, etc.] may cause adverse medical events or serious injury. Discard any insulin that has been exposed to extreme temperatures. WARNING: ALWAYS disconnect your pump and infusion set from your body before removing the insulin reservoir from the pump. There is a possibility of occurrence of adverse medical events or serious injury if the reservoir is NOT installed in the pump and the reservoir is accidentally pressed or hit. Materials Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Gather these materials before you begin:
Package containing the reservoir with the removable plunger handle attached to the reservoir plunger and a reservoir protective cap (female luer cap). WARNING: Your pumps reservoir is for single use only. Use only the Aviator-
compatible reservoir intended for your pump. Do NOT substitute with any other reservoir. Do NOT reuse the plastic reservoir. It is intended to work best when replaced after one use. Insulin (or water or saline, if you are practicing). WARNING: Do NOT allow any insulin or fluid to get into the reservoir compartment. WARNING: Before filling the reservoir, make sure your insulin is at room temperature to limit the amount of bubbles. If you have questions about the correct temperature, consult your insulin manufacturers product insert or your healthcare professional. WARNING: Use only rapid-acting or short-acting U-100 insulin with the Aviator Pump. Use of another type of insulin may result in adverse medical events or serious injury. Package for the The following insulins have been tested by Abbott Diabetes Care, Inc. and found to be safe for use in the Aviator Pump: Humalog , Apidra, Novolog, and regular insulin. Before using a different insulin with this pump, check the insulin label to make sure the insulin can be used with the pump. filling needle. Use in conjunction with one of the following:
Tyco Healthcare Kendall Monoject 22 GA (0.7mm) x 1 (25.4mm) -
Part Number 8881 250222 Tyco Healthcare Kendall Monoject 23 GA (0.6mm) x 1/2 (12.7mm) -
Part Number 8881 250263 - (Available in USA only) infusion set containing the infusion set with an attached reser-
Package for the voir cap. Soap and water Alcohol swab DOC15736_Rev-A-Man.indd 33-34 2/9/09 11:29:35 AM 33 34 Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Helpful Information Caution: You MUST replace the pumps reservoir and infusion set each time you replenish your insulin supply. Caution: You MUST change your infusion set every three days or sooner according to your healthcare professionals advice. You may need to change your infusion set more frequently if it becomes dislodged, if skin irritation or signs of infection develop, signs of poor control appear, or at the advice of your healthcare professional. Tip:
The insulin reservoir is packaged with the reservoir plunger handle attached to the plunger tail. l m 1 l m 2 t t o b b A Cap Pump Reservoir Plunger Handle If it is necessary to reattach a plunger handle that has become disconnected, follow these steps:
1. 2. Hold the plunger handle so the 3 prongs resemble 2 eyes and a nose. reservoir plunger in the space between the nose and the eye to the viewers Place the serrated side of the right. Make sure the plunger makes contact with the surface of the plunger handle in between the eyes and the noses. l m 1 l m 2 t t o b b A Cap Pump 3. 4. Holding the plunger handle stationary, twist the reservoir counter-clockwise towards you. If done correctly, the groove on the back of the plunger should be positioned between the two eyes. Procedure:
Steps 1. Decide if you are filling a reservoir for the first time. Do This If you are Filling the reservoir for the first time Removing a used reservoir to fill a new reservoir Then do this Go to Step 4. Go to Step 2. Steps 2. Remove your pump and infusion set. Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Do This WARNING:
You must STOP your basal delivery before removing the reservoir. Always disconnect your pump and infusion set from your body before removing the insulin reservoir from the pump. Follow the procedure described in your infusion sets instructions, or your healthcare professional. WARNING:
Do Check the sterile supplies for the expiration date. Do expired components. NOT use an infusion set if the sterile packaging has been damaged. NOT use any 3. Remove the insulin reservoir from the pump. a. Locate the insulin reservoir cap on the upper left side of your pump. b. c. Place your thumb in the groove on the face of the reservoir cap. Gently rotate the handle counter-clockwise 90 degrees, or until you cannot turn it any further. d. Gently pull out on the handle to remove the insulin reservoir. Note: Do NOT force. You may have to wiggle the insulin reservoir to loosen it enough for you to remove it. Dispose of the empty reservoir and connected infusion set. DOC15736_Rev-A-Man.indd 35-36 2/9/09 11:29:35 AM 35 36 Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Steps 4. Do This Wash your hands and gather materials. Wash your hands vigorously with soap and warm water. a. Caution: Use aseptic techniques when filling the reservoir and connecting the infusion set. Ensure everything is clean and sterile to prevent infection. b. 1ml 2ml C a p P u m p Abbott Place the following items in front of you:
Insulin vial (or water or saline, if you are practicing) NOT pictured) Alcohol swab (
New filling needle package (
New New infusion set package Aviator Reservoir package (NOT pictured) NOT pictured) Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Steps 7. Insert the filling needle with its protective cover attached into the tip of the reservoir so that it is secure. Do This l m 1 l m 2 t t o b b A Cap Pump 8. 9. Clean the top of the insulin vial with an alcohol swab. Open the sterile packaging for a new infusion set. a. b. Open the packaging. Leave the infusion set inside the packaging until later. 5. Open the sterile packaging for a new filling needle a. DO NOT USE IF CAP SEAL IS BROKEN. 10. Remove the protective cap from the needle and discard Align cap seal downward away from face (eyes), body and patient. Caution:
Break tamper-evident cap seal by twisting the cap or by applying a downward snap. 6. Open the sterile packaging for a new reservoir a. b. Open the packaging (NOT pictured). Take out the reservoir and leave the protective cover inside the package for later. 37 38 DOC15736_Rev-A-Man.indd 37-38 2/9/09 11:29:36 AM Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Steps 11. With your clean reservoir in hand, pull back on the plunger to draw air into the reservoir. Do This Note: The amount of air drawn into the reservoir should be equal to the amount of insulin you intend to draw into the reservoir. Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir 12. Pierce the needle through the top of the insulin vial While holding the insulin vial and reservoir upright, gently push down on the reservoir so that the needle pierces through the top of the insulin vial. 13. Push the plunger handle downward to expel the air into the insulin vial. While keeping the insulin vial, filling needle, and attached reservoir on a flat surface, push the plunger handle downward so that the air you drew into the reservoir is expelled into the insulin vial. 14. Fill the insulin reservoir. a. b. c. While keeping pressure on the end of the removable handle, turn the insulin vial upside down. Next, release the pressure on the end of the plunger handle and allow insulin to flow into the reservoir. Gently pull down on the plunger handle until enough insulin is in the reservoir. DOC15736_Rev-A-Man.indd 39-40 2/9/09 11:29:36 AM 39 40 Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir 15. a. Remove air bubbles in the reservoir. Look for any large air bubbles in the reservoir and remove them before use. You can do this by gently tapping on the side of the reservoir with your fingernail to loosen any air bubbles b. WARNING:
You must remove all air bubbles in the reservoir before proceeding. Champagne-sized bubbles may remain. Delivery of air bubbles can result in unexpected hyperglycemia. c. Remove the collected air bubbles by pushing up on the plunger handle. Pull reservoir and attached filling 16. needle out of the insulin vial. l m 1 l m 2 t t o b b A Cap Pump a. b. c. d. Once the reservoir is filled with the proper amount of insulin, turn the set of items in your hands so that it is parallel to the flat surface. While keeping your finger and thumb on the insulin vial, gently pull the reservoir and attached filling needle out of the insulin vial. Put the insulin vial on the flat surface. Hold the reservoir so that the reservoir tip points up. Note: To ensure sterility, do NOT touch the tip of the insulin reservoir. C a p P u m p 17. Remove the needle from the reservoir by gently twisting it off. Dispose of the needle in a sharps container. 18. Disconnect plunger handle. Section 2: Using the System for the First Time Quick Setup 2.3 Fill Reservoir Caution: RISK OF NEEDLESTICK INJURY. Used needles may be contaminated and should be disposed of in puncture-resistant (sharps) containers. Do not resheath used needles. Handle per national/
institutional guidelines and policies. Follow local waste disposal regulations when disposing of sharps containers. a. Twist the plunger handle clockwise to disconnect it from the reservoir plunger. Note: Check to make sure you still have your desired amount of insulin, and that the reservoir is free of air bubbles. l m 1 l m 2 t t o b b A Cap Pump b. Dispose of the plunger handle. 19. Attach reservoir cap of infusion set to the new reservoir. a. b. Carefully take the infusion set out of the infusion set packaging. Ensure that the black mark on the side of the reservoir cap aligns with the black line on the side of the reservoir. Cap Pump WARNING:
NOT put the reservoir into the pump without first putting on the NOT twist the reservoir cap onto the reservoir. Just snap it on Do and make sure the alignment guides match up. Do reservoir cap. Check for any damage to the catch feature before mating the infu-
sion set reservoir cap to the reservoir barrel. c. Attach the infusion sets reservoir cap to the tip of the new reservoir. Ensure that the infusion set reservoir cap snaps onto the reservoir barrel. DOC15736_Rev-A-Man.indd 41-42 2/9/09 11:29:37 AM 41 42 Section 2: Using the System for the First Time Quick Setup 2.4 Fill Reservoir 20. Insert the insulin reservoir into the pump. a. Line up Line up the reservoir with the the black dotted line with the arrow on the reservoir in line with the white line on the pump. reservoir compartment by placing WARNING:
NOT hold the plunger while placing the reservoir into the pump, Do or you may accidentally deposit insulin into the tubing and cause problems with insulin delivery and possible adverse events or seri-
ous injury. WARNING:
NOT force the reservoir into the pump. Make sure the black res-
Do ervoir alignment mark is lined up with the pump alignment mark and gently wiggle into place. WARNING:
Do NOT allow any insulin or fluid into the reservoir compartment. b. c. Slide the reservoir back into the reservoir compartment. Gently wiggle it if necessary until it drops fully into place. Tip: If you hold the reservoir compartment vertically, the reservoir will slide into the pump once you have turned it into the correct position. There is NO need to push the reservoir into the pump. d. Use your thumb or finger to rotate the cap handle 90 degrees clockwise, or until it aligns with the side of the pump. 21. Return the insulin vial to its storage location. Section 2: Prime Pump and Infusion Set 2.4 Fill Reservoir 2.4 Prime Pump and Infusion Set Purpose When To prime the pump, infusion set tubing and cannula using the Aviator Companion, so that the pump is ready to deliver insulin. Do this procedure when you:
Change your infusion set o o Before connecting the infusion set to your body to remove the air from the tubing. Just after connecting the infusion set to your body to replace the small amount of air that was in the cannula (soft tubing that remains in your body to deliver insulin). Notice air in your tubing and have disconnected the infusion set from your body to remove the air from the tubing. WARNING: Use ONLY the Aviator infusion sets intended for your pump. NOT using the correct infusion set may result in adverse medical events or serious injury. WARNING: You need to install the reservoir in the pump and prime tubing before attaching infusion set to body. WARNING: If infusion set is attached to your body when priming, this may result in accidental delivery of insulin and possible adverse medical events or serious injury. WARNING: If reservoir, infusion set tubing or cannula is improperly primed, this may result in delivery errors and adverse medical events or serious injury. WARNING: Prime infusion set cannula after every infusion set change. Materials Your companion with battery charged and initial settings programmed. Your pump with the battery installed and reservoir filled. Your companion and pump already paired. A Unomedical comfort, comfort short or inset II infusion set DOC15736_Rev-A-Man.indd 43-44 2/9/09 11:29:37 AM 43 44 Section 2: Prime Pump and Infusion Set 2.4 Fill Reservoir Helpful Information Aviator Insulin Delivery System, When priming your pump, you are actually priming the different parts of the which is the infusion set tubing and the cannula. Priming ensures that there is insulin in the infusion set tubing and cannula. Note: It is critical that all priming is complete before beginning basal delivery. Priming ensures that all the parts of the insulin pump system are ready to deliver insulin when you attach it to your body. If any air remains in the tubing when you begin your basal delivery or deliver a bolus, you will NOT receive insulin, and you will receive air. This could result in possible adverse medical events or serious injury. Steps in this procedure MUST be completed; otherwise you will NOT be delivering insulin to your body, resulting in high blood glucose. Make sure you see a small amount of insulin (one or two drops) appearing at the end of the infusion set needle to confirm that the infusion set is primed. You may need to increase the amount of the prime to at least 4 6 units. Caution: You MUST change your infusion set every three days or sooner according to your healthcare professionals advice. You may need to change your infusion set more frequently if it becomes dislodged or if skin irritation or signs of infection develop, or blood appears in your tubing. Procedure:
Steps 1. PRIME MENU Access from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press PRIME. Steps 2. Select TUBING. Section 2: Prime Pump and Infusion Set 2.4 Fill Reservoir Do This a. Notice b. Press Tubing is highlighted. Enter button. WARNING: If infusion set is attached to your body when priming, this may result in accidental delivery of insulin and possible adverse medical events or serious injury. WARNING screen and Detach infusion set from body. message c. d. e. f. Notice displays. Notice Confirm that the infusion set is Press OK is highlighted. Enter button. NOT attached to your body. 3. Prime Tubing. Scroll to select desired units of insulin to prime tubing. a. Note: Check that you are delivering a large enough volume of insulin for priming to be completed in both the tubing and cannula. If a tiny amount of insulin has NOT come out of the end of the tubing, you may need to increase the amount of the prime to at least 4 6 Units. You will need to prime approximately 20 Units if you use the LONGER tubing. The amount of insulin required to prime will vary depending on the type of infusion set you use. The default is 0.0 U to a maximum of 30.0 U. Press Enter button. b. Note: You will hear two beeps (from the pump). Verify that the pump is delivering insulin to prime tubing. c. Note: As the prime is delivered, the Units will be counted off. As your pump is priming, you should be watching for a small amount (one or two drops) of insulin to emerge from the end of the connector needle. When this occurs, priming your tubing is complete. Tip: You may find it easier to see the insulin flowing through the tubing if you hold the tubing against a dark background, such as a dark table or towel. DOC15736_Rev-A-Man.indd 45-46 2/9/09 11:29:37 AM 45 46 Section 2: Prime Pump and Infusion Set 2.4 Fill Reservoir Steps 4. Decide what to do next. Do This If you want to Finish priming the tubing STOP priming the tubing Then do this Allow pump to complete priming and automatically return to PRIME MENU screen. Note: You will hear two more beeps when prime is finished. If the amount primed was NOT sufficient, you will return to the Home screen. Go back to Step 3. Notice Press Continue to Step 5. Stop is highlighted 1. Enter button to return to the PRIME MENU screen. 2. Note: If the amount primed was NOT sufficient before stopping the prime, you will automatically return to the Home screen. Go back to Step 3. Done. Scroll to highlight Enter button. Press 3. 4. You have NOT primed the tubing; go back to Step 1 if you want to prime the tubing and infusion set. Note: It is important that you prime the tubing sufficiently to engage the reservoir. Ensure insulin is flowing through the tubing and emerging from the end of the connector needle or inserter needle, depending upon the set you are using. 5. Attach and prepare infusion set for priming. If you are using Then do this Inset II Comfort or comfort short Attach the inset II infusion set to your infusion site, following the infusion sets instructions. Attach cannula housing to your body, following the infusion sets instructions. Connect the tubing to the cannula housing, following the infusion sets instructions. Steps 6. CANNULA from Select the PRIME MENU. Section 2: Prime Pump and Infusion Set 2.4 Fill Reservoir Cannula is highlighted. Do This a. Notice Note: If Cannula is NOT already highlighted, scroll to highlight Cannula from the PRIME MENU. b. Enter button. Press 7. Prime Cannula. Scroll to select desired units of insulin to prime the cannula. a. Note: The range is between 0.00 U and 1.00 U. The specific units to prime the cannula will be listed in the package insert of your infusion set (e.g. for the comfort and comfort short, it is 0.5 to 1.0 units). The default for the amount will appear on the screen for the last amount used to prime the cannula. If you are using a different set this time, you will need to verify that the amount listed is correct. Ask your healthcare provider. Press Enter button. b. Note: You will hear two beeps (from the pump) when priming starts. c. Hear the pump delivering insulin to prime the cannula and see insulin emerging from the end of the connector needle. Note: Select infusion sites away from scarred or infected areas, and rotate infusion site locations regularly. DOC15736_Rev-A-Man.indd 47-48 2/9/09 11:29:38 AM 47 48 Section 2: Prime Pump and Infusion Set 2.4 Fill Reservoir Steps 8. Decide what to do next. Do This If you want to Finish priming the cannula Then do this 1. Allow pump to complete delivering prime. Note: You will hear two more beeps when prime is finished. STOP priming the cannula 2. 1. 2. 3. Go to the next step. Stop is highlighted Notice Enter button. Press Go to the next step. 9. Decide whether to start daily basal now, or wait till later. Note: If you inserted a new reservoir and went directly to prime cannula, make sure the amount is enough to engage the reservoir and insulin emerges from the end of the connector needle, or else the pump will return to the Home screen instead of prompting you to start basal delivery. Also make sure there are NO bubbles in the tubing. Notice the CONFIRM screen and Start Daily Basal? message displays immediately after cannula priming is complete. Steps 10. Check your work. Section 3: Using Your System The Basics 3.1.1 Start Basal Delivery Do This Check that your Daily basal is started in the Basal panel on the Home screen. The name of the active basal program and the units will display in the Basal panel. Note: If you started your daily basal here from your pump, there is NO need to also start basal delivery from the companion. WARNING: Check blood glucose 2-3 hours after inserting a new infusion set to make sure your blood glucose level is normal. If you want to Start your daily basal NOW Then do this 1. 2. Scroll to highlight Press Yes. Enter button to return to the Home screen. Note: You will hear 4 beeps and the pump will vibrate twice. Start your daily basal LATER 3. 1. 2. Go to Step 10 to check your work. Notice Press No is highlighted. Enter button. Note: The pump screen will return to the Home screen. 3. 4. Basal panel on the Home screen showing Review the that Daily basal has NOT started. Check with your healthcare professional to decide when you should start your daily basal. 49 50 DOC15736_Rev-A-Man.indd 49-50 2/9/09 11:29:38 AM Section 3: Using Your System The Basics 3.1.1 Start Basal Delivery 3 Using Your System The Basics 3.1.1 Purpose Start Basal Delivery When Materials NOT done so after To start or restart your basal delivery using your Aviator Companion from the Main menu. SKIP this task if basal delivery is already started. Do this procedure:
Whenever you need to start your basal delivery program, if you have priming your pump and infusion set. Whenever you need to restart your basal delivery after setting additional options. WARNING: Accurate basal rate programming and appropriate selection of the active Basal Program are necessary to avoid adverse medical events or serious injury. Your companion with battery charged and initial setup and Your pump with the battery installed and initial setup and basal settings programmed. Your companion and pump already paired. Your reservoir filled and inserted into pump. Your infusion set and cannula primed. Healthcare professionals assistance and recommendations for your basal settings. basal settings programmed. Section 3: Using Your System The Basics 3.1.1 Start Basal Delivery Note: If you need to change your basal options such as basal insulin increment and basal insulin maximum, refer to Section 6.2, and obtain assistance from your healthcare professional. Procedure:
Steps 1. Access MAIN MENU from Home screen. Do This a. Notice b. Press Main is highlighted. Enter button. 2. Start Basal. a. b. Notice Press Start Basal is automatically highlighted. Enter button. 3. Confirm Start Basal. Helpful Information Basal rates are programmed to deliver insulin continuously over 24 hours. The rate programmed is intended to keep the blood glucose within your target range between meals and overnight. The basal rate is measured in units per hour (U/hr). Basal rates can vary throughout the day (e.g. your basal rate while sleeping may be different than when you are awake), and may be different on different days (e.g. weekdays versus weekends). The Aviator Pump can accom-
modate up to 4 different 24-hour basal rate patterns (e.g. one for weekdays, one for workout days, and one for weekends). With the These segments are referred to as blocks. Each block of time can be programmed for a specific period of time at a specific rate. There are a maximum of 48 blocks one block for each hour of the day. Your pump should always be delivering basal insulin. Aviator Pump, you are able to program a specific basal rate for each segment of time in your day. Before you start your basal insulin delivery for the first time, make sure you have completed the following tasks:
Set up your pump using the Section 2.3) Fill your insulin reservoir (
Prime your infusion set and cannula (
SETUP WIZARD (Section 2.1). Section 2.4). CONFIRM screen and Start Daily Basal? message displays. a. b. If you want to Start your basal delivery now Notice the Determine what to do next. Then do this 1. 2. 3. Yes. Scroll to highlight Enter button. Press Notice the pump automatically returns to the screen. Home Note: You will hear 4 quick beeps and feel 2 short vibrations from the pump. Cancel starting your basal delivery 1. 2. 3. 4. No is already highlighted. Enter button. Notice Press Review the basal is NOT started. Check with your healthcare professional to decide when you should start your daily basal. Basal panel on the Home screen showing that DOC15736_Rev-A-Man.indd 51-52 2/9/09 11:29:38 AM 51 52 Section 3: Using Your System The Basics 3.1.2 View Basal Program Steps 4. Check your work. Do This If you started your basal delivery, review the name of the current basal program and the insulin rate displayed in the Basal panel on the Home screen. If you did NOT start your daily basal, review the Basal panel on the Home screen showing that the basal has NOT started. 3.1.2 Purpose When View Basal Program Section 3: Using Your System The Basics 3.1.2 View Basal Program To view your existing basal program(s) and specific time blocks and basal rates using your Aviator Companion. Do this procedure:
Whenever you need to view your basal program settings after creating or editing them. Your companion and pump with basal delivery started. Healthcare professionals recommendations for your basal settings for the pump. Your personalized Table of Settings in Appendix A. Materials Helpful Information You nor edit any basal rates or times. CANNOT select a different basal program to be the active basal program from the VIEW program option Procedure:
Steps 1. Access BASAL MENU from Home screen. Do This a. Notice b. Press Main is highlighted. Enter button. 2. Select BASAL. a. b. Scroll to highlight Enter button. Press BASAL. 3. Select VIEW option. a. b. Scroll to highlight Enter button. Press VIEW. DOC15736_Rev-A-Man.indd 53-54 2/9/09 11:29:38 AM 53 54 Section 3: Using Your System The Basics 3.1.3 Stop Basal Delivery Steps 4. Do This a. Notice Select basal program to view.
*Daily is highlighted. Note: Daily is the default, and the * identifies the current active basal program. Scroll to view another program as appropriate, if you have created other basal programs. b. Press Enter button. 5. Review basal program time blocks and basal rates. a. Scroll to highlight and select a time block to view. Note: The * represents the block/rate that is associated with the current time. b. c. Enter button. Press View the time and rate for the block. d. e. Notice Press Next is highlighted. Enter button. f. g. h. Scroll to select and review other basal time blocks and basal rates that were created as needed. Scroll to highlight Press Enter button to return to Home screen. Done when you are done reviewing. 6. Check your work. i. You have verified that the basal program has the correct basal time blocks and basal rates. 2. Stop Basal. 3.1.3 Purpose When Stop Basal Delivery Section 3: Using Your System The Basics 3.1.3 Stop Basal Delivery To stop your basal delivery using your Aviator Companion. Do this procedure:
Materials Whenever you need to stop your basal delivery to replace a battery, refill an insulin reser-
voir, or change your infusion set. Your companion and pump with basal delivery started. Healthcare professionals recommendations for your basal settings. Helpful Information WARNING: You should NOT stop your daily basal delivery program without consulting your healthcare professional. If NO basal insulin is being delivered, this can lead to hyperglycemia and DKA unless insulin is delivered by another means. Be sure to discuss with your healthcare professional regarding how long you can stop your basal rate. If you are stopping a temporary basal program, basal delivery for your active basal program will resume. Refer to Section 7.6 for more information on temporary basal programs. You will perform this task using the companion. Refer to Section 12 to stop basal delivery using your pump. Procedure:
Steps 1. Access BASAL MENU from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. a. b. Notice Press Stop Delivery is highlighted. Enter button. DOC15736_Rev-A-Man.indd 55-56 2/9/09 11:29:38 AM 55 56 Section 3: Using Your System The Basics 3.2.1 Deliver a Manual, Normal Bolus Steps 3. Confirm Stop Basal. Do This Note: If an extended bolus is in progress, you must stop the bolus first. Refer to Section 3.2.3 to stop bolus delivery. Note: If a temporary basal is in progress, you must stop the temporary basal first before stopping the active basal. Notice the Determine what to do next. CONFIRM screen and Stop Daily Basal? message displays. 3.2.1 Purpose When If you want to STOP your basal delivery Then do this 1. 2. Scroll to highlight Press Enter button to return to the Home screen. Yes. Materials Note: You will hear 2 quick beeps from the pump when basal stops. Cancel stopping your basal delivery 3. 1. 2. 3. 4. Check your work. No is highlighted. Enter button. Go to Step 4. Notice Press Review the NOT stopped and is still delivering. Home screen and see that basal delivery has If you STOPPED your basal delivery Then you will see this Basal Stopped displays on the Home screen. RESTART basal. Refer to Section 3.1.1 as needed. Cancelled stopping your basal delivery The current basal delivery program and insulin rate still displays in the Basal panel on the Home screen. Deliver a Manual, Normal Bolus Section 3: Using Your System The Basics 3.2.1 Deliver a Manual, Normal Bolus To deliver a normal bolus from your Aviator Companion to cover a meal or lower a high glucose reading. Do this procedure:
Whenever you need to deliver a normal bolus for food or to correct a high glucose level and you do NOT want to use the bolus calculator. WARNING: Appropriate and accurate bolus dosing is necessary to avoid possible delivery errors that may result in adverse medical events or serious injury. Your companion completely set up. Your pump completely set up and delivering basal insulin. Healthcare professionals recommendation for your bolus settings for the pump and as-
sistance from Diabetes Educator or pump trainer as needed. Your personalized Table of Settings in Section 12 - Appendix A. START basal delivery before you deliver any boluses. Helpful Information Note: In order to follow the directions and use the functions described in this section, you should have already set up your companion using the SETUP WIZARD. Detailed instructions for setting up your companion can be found in Section 2.1 and Section 6.1. You MUST Bolus insulin is an amount of insulin your body needs at any specific time in order to deal with food intake and/
or blood glucose levels that are elevated above your personal safety threshold. You can record your personal-
ized bolus recommendations in the Table of Settings in Appendix A. The companion looks at the amount of insulin that is still active from earlier boluses. This amount is displayed as insulin on board (IOB). As the insulin gets used in the body, the amount of IOB goes down. Your IOB will be displayed in the panel on the Home screen. There may be times when there is not enough information to calculate an accurate IOB level. In those instances, a question mark will appear next to the insulin on board reading indicating that the IOB calculation may NOT have sufficient information to accurately calculate IOB. The companion offers several other options for administering a bolus. Additional bolus features include Ex-
tended and Dual Bolus types, and Bolus Calculators. Additional bolus features include Extended and Dual Bolus types, and Bolus Calculators. You may choose to use these options or simply use the Manual Bolus feature. bolus options should already have been set up via the SETUP WIZARD. You should record your per-
Personal sonal list of bolus options in the Table of Settings in Appendix A. These options can be modified in the SETUP WIZARD. DOC15736_Rev-A-Man.indd 57-58 2/9/09 11:29:38 AM 57 58 Section 3: Using Your System The Basics 3.2.1 Deliver a Manual, Normal Bolus Procedure:
Steps 1. BOLUS MENU Do This Access from MAIN MENU. a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. Note: You can also scroll to the Bolus panel on the Home screen and press Enter to access the BOLUS MENU. 2. Select MANUAL bolus. 3. Select Normal Bolus Type. a. b. a. b. c. d. Scroll to highlight Enter button. Press MANUAL. Notice Press Notice Press Bolus Type is highlighted. Enter button. Normal is highlighted. Enter button. Note: It is possible to access other types of bolus delivery. If you accidentally scroll to another bolus type, make sure you scroll back to Normal. Steps 4. Set Normal Bolus. Do This Section 3: Using Your System The Basics 3.2.1 Deliver a Manual, Normal Bolus a. b. c. Bolus is highlighted. Enter button. Notice Press Scroll until the desired bolus number of units display. Note: You CANNOT deliver a bolus greater than the maximum bolus amount you have set in your pump. Refer to Section 6.1 for setting maximum bolus options. d. Press Enter button. 5. Confirm Bolus Type is Normal and Bolus units are correct. a. b. c. d. 6. Deliver Normal bolus. Bolus Type and Bolus units on the screen. Review the Scroll up to select and make edits if needed. Notice Press Deliver is highlighted. Enter button. Note: You will hear 2 quick beeps or feel 2 short vibrations from the pump. Notice that the bolus starts to deliver. DOC15736_Rev-A-Man.indd 59-60 2/9/09 11:29:39 AM 59 60 Section 3: Using Your System The Basics 3.2.2 Stop Bolus Delivery Steps 7. Decide what to do next. Do This If you want to Finish delivering the normal bolus STOP the normal bolus delivery immediately Then do this Allow the normal bolus to deliver to the amount that was set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps or feel 2 more short vibrations and then you will return to the Home screen. Go to Step 8 to check the bolus delivery. 1. 2. 3. Stop is highlighted. Enter button. STOPPED ALERT screen appears and Normal Notice Press Notice bolus stopped. message displays. Notice Press the Home screen. Notice that the last bolus that you stopped is displayed in the Bolus panel. Clear is highlighted. Enter button to clear the message and return to 4. 5. 6. 8. Check your work. Review the amount and time of the Last Bolus that was delivered, on the Bolus panel of the Home screen. 3.2.2 Purpose When Stop Bolus Delivery Section 3: Using Your System The Basics 3.2.3 View Bolus History To stop a normal bolus delivery using the Enter (Jogwheel) button on your Aviator Companion or Aviator Pump. Do this procedure:
Whenever you want to stop a normal bolus in progress quickly and discreetly. Your pump in the process of delivering a normal bolus. Stop item that displays on the MAIN MENU, BOLUS MENU, and SELECT PROGRAM screens stop ONLY an Do This Materials Helpful Information The extended bolus (Section 8.1). Procedure:
Steps 1. Notice Normal bolus is in progress. 2. Stop the normal bolus delivery. 3. Check your work. a. b. a. b. c. Notice on the screen that the bolus delivery is in progress, and highlighted. Press the Enter (Jogwheel) button to immediately stop the delivery. Stop is STOPPED ALERT screen pops up and Normal bolus stopped. Notice the message displays. Notice Press Clear is highlighted. Enter button to clear the message and return to Home screen. DOC15736_Rev-A-Man.indd 61-62 2/9/09 11:29:39 AM 61 62 Review the Last Bolus amount and time that you just stopped, on the Bolus panel of the Home screen. View Bolus History Section 3: Using Your System The Basics 3.2.3 View Bolus History 3.2.3 Purpose When Do this procedure:
To view your last 10 boluses delivered by your pump, using the Aviator Companion. Materials Whenever you need to review a previous bolus that was delivered by your pump, using the companion. Your companion fully operating. Your pump fully operating. Helpful Information Note: In order to follow the directions and use the functions described in this section, you should have already set up your pump using the SETUP WIZARD. Detailed instructions for setting up your pump can be found in Section 6.1. Bolus History option gives a listing of your last 10 boluses. The Procedure:
Steps 1. BOLUS MENU Access from MAIN MENU. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. Note: You can also scroll to the Bolus panel on the Home screen and press Enter to access the BOLUS MENU. Steps 3. Review the last bolus. Do This Section 4: Integrating the System into Everyday Life 4.1 Daily Living a. b. Review the last bolus that the pump administered. Decide what to do next. If you Want to review another bolus Have finished reviewing your bolus history Next is highlighted. Enter button. Then do this 1. Notice Press 2. 3. Repeat Step 3 to review up to 10 previous boluses. Note: When you are reviewing BOLUS HISTORY 2 through 10, you can press the Back button to go back to the previous history screen. Scroll to highlight Done. Press Enter button to return to the Home screen. 4. Check your work. Verify that you have obtained the information about your bolus history as needed. You will see the amount and time of your Last Bolus on the Home screen. Note: If you have Magnify display option turned on (in Section 6.1), you will only see the time of the last bolus. 2. Access Bolus History. a. b. Scroll to highlight Enter button. Press HISTORY. DOC15736_Rev-A-Man.indd 63-64 2/9/09 11:29:39 AM 63 64 Section 4: Integrating the System into Everyday Life 4.1 Daily Living 4 Integrating the System into Everyday Life 4.1 Daily Living Purpose When To decide if, where, when, and how to wear your Aviator Pump during daily activities, and how to carry and use your Aviator Companion. When you start to carry and use your companion every day. Read all the information in this section before you begin using your system. When you are getting ready to wear your pump while:
Doing normal daytime activity Sleeping Bathing or showering Exercising or playing sports Swimming Engaging in sexual intimacy Traveling Receiving medical treatment or care, including X-ray or MRI Materials Helpful Information Section 6.7 for instructions on performing a self test on your companion. NOT drop your companion or pump, or hit it against hard surfaces. If this occurs, see Section 9 to trouble-
Refer to Do shoot system error or problems with your system. If your companion or pump is damaged, it will need to be serviced or replaced. Call Customer Care to obtain detailed instructions regarding servicing or replacement procedures. If your pump is accidentally submerged in water and the battery cap and infusion set hub are in place, you can towel dry the outside of the pump. Inspect the reservoir compartment and battery compartment and dry any water you find with a Q-tip. Do NOT use a hair dryer to dry your pump. If your pump was submerged in salt wa-
ter, thoroughly clean with a damp cloth before drying. If your pump is accidentally submerged in water and the battery cap or the infusion set is stalled, submersion will likely damage internal pump components. If your companion is accidentally submerged in water, you can towel dry the outside of the companion. Do recharge or reuse the companion. Contact Customer Care. NOT properly in-
NOT Daily Living:
In the left column of the following table, find the activity you are going to do. Then look in the right column for information and instructions about wearing your pump during that activity. Section 4: Integrating the System into Everyday Life 4.1 Daily Living If the activity is Normal Daytime Activity Do This Choose a convenient way to wear your pump. You can place the pump:
In the belt clip that came with the pump and clip the device onto your belt or waistband. In a pocket. Inside a bra or other item of clothing. In a cloth pouch you can fasten around your waist, thigh, ankle, or other area. Caution: If the pump is carried at a vertically higher position than the infusion site, a very small amount of additional insulin infusion may take place. To minimize this condition and maintain pump delivery accuracy, the pump should be carried no higher than 12 inches (30 cm) above the insertion site. For those using basal rates of less than 1.0 units per hour, this may be especially important. When using very low basal rates, position the pump vertically below the level of the infusion site to eliminate this condition. Sleeping Choose where to place the pump according to your sleeping habits. If you Do NOT want pump attached to your sleepwear Then Place the pump next to you on your mattress. Note: If you use tubing 42 inches or longer, you can put the pump on your nightstand. Want pump attached to your sleepwear Attach the pump to your sleepwear as you would for normal daytime activity (as above). Important Note: Before you go to sleep, be sure the tubing is NOT where pets or children might pull or chew on it. DOC15736_Rev-A-Man.indd 65-66 2/9/09 11:29:39 AM 65 66 Section 4: Integrating the System into Everyday Life 4.1 Daily Living If the activity is Bathing or Showering Do This Caution:
You should remove your pump before prolonged exposure to water, or tempera-
tures above 104F (40 C) such as might occur with the use of a hot tub, sauna, or whirlpool. If your pump is damaged, it will need to be serviced or replaced. Call Customer Care to obtain detailed instructions regarding servicing or replacement proce-
dures. a. b. c. Disconnect your pump tubing from the infusion site and remove it before bathing or showering. Keep your basal running; you do not need to stop your pump. Take your bath or shower. Reconnect to the pump. WARNING:
When reconnecting, be sure to check that there is air in the tubing, you will NOT get the correct insulin dose. Follow your health-
care professionals recommendations on priming to replace any air in the tubing before reconnecting, by using the pumps PRIME TUBING feature. NO air in the tubing. If there is Caution:
Follow your healthcare professionals recommendations for checking your blood sugar when you have been off the pump. To prevent high glucose, follow your healthcare professionals recommendations for replacing missed basal and bolus insulin when you are disconnected from the pump. You should NOT have to prime again after the disconnection at the infusion site. 67 If the activity is Exercising or Playing Sports Do This Determine if the activity or sport is too rough or prolonged to wear your pump, for example, football or soccer games. Section 4: Integrating the System into Everyday Life 4.1 Daily Living If activity is Too rough or prolonged to wear the pump OK for wearing the pump Then do this 1. 2. Disconnect and remove the pump. While off the pump, follow recommendations from your healthcare professional. When you are ready to reattach the pump, follow your healthcare professionals recommendations for replacing the insulin you missed. 3. Decide if you need to select a different basal program for exercising according to your healthcare professionals recommendations. If And You have You need NOT to select a set up a different Temporary basal or Exercise program program Then do this 1. Follow the steps in Section 7.6 to create a temporary basal rate, OR follow the steps in Section 7.2 to Create a New Basal Program. Follow the steps in Section 7.3 Select a Basal Program to select the Exercise program you just created. 2. Follow the steps in Section 7.3 Select a Basal Program. You have already set up the program Do nothing. Do NOT need a different basal program 68 DOC15736_Rev-A-Man.indd 67-68 2/9/09 11:29:39 AM Section 4: Integrating the System into Everyday Life 4.1 Daily Living If the activity is Swimming Do This a. b. Disconnect the pump and remove it from your body. Decide how long you will be off the pump. If off the pump for 1 hour or less More than 1 hour Then Follow the directions for Bathing or Showering. While off the pump, you may need to take injections of insulin with a syringe or reconnect to bolus during your time away. It is important to get specific instructions from your healthcare professional. Use an alternate insulin therapy method according to recommendations from your healthcare professional. Engaging in Sexual Activity Note: Removing your pump is optional. If you decide to remove your pump, follow these directions:
Disconnect and remove the pump from the infusion site. a. Reminder: Follow your healthcare professionals instructions for how long you can be off the pump without any insulin replacement. b. Keep your pump running and remember to reconnect your pump when you finish the activity, before you fall asleep. Note: Stopping the pump could cause insulin to retract into the tubing, and problems with delivery. Receiving Medical Treatment or Care Talk with your healthcare professional about whether or NOT you should use your pump during outpatient procedures, hospitalizations, surgeries, or emergency room visits. WARNING: Do NOT take your pump into a MRI, X-ray, CAT scan or ultrasound equipment procedure room. You MUST disconnect your pump and store it away from the machines. Do NOT bring the companion or pump into the procedure room at anytime. 69 If the activity is Traveling Do This Remember these key points when traveling with your companion and pump:
Section 4: Integrating the System into Everyday Life 4.2 Perform Daily Checks Topic Different Time Zone Manually change your pump time and date to match Key Points the time zone you are in so your basal doses are delivered at the correct time. Note: Time zone changes also affect your meal, snack schedule, and actual amount of insulin delivered in a day. When planning a trip that involves time zone changes you should talk with your healthcare professional about how to best handle this issue. Changes in Daily Routine and Sleep Patterns and/or Shift Work Travel by Air Other Important Considerations Talk with your healthcare professional about how to best handle these changes. Turn RF Off/On (refer to Before and after flights:
During flights:
Section 6.9). Prevent dehydration by keeping bottled water with you and drinking frequently. Carry snacks and treatment for a low blood glucose in case of delays. Check your blood glucose level frequently accord-
ing to your healthcare professionals instructions. Have your healthcare professional supply you with a prescription for insulin and the name of a doctor in the area of your travels. Always carry your daily kit of supplies that will help you prevent emergencies, and keep with you at all times. (see Section 4.3 Carry a Daily Kit). Be sure to bring extra pump-related supplies with you, NOT in checked luggage. 70 DOC15736_Rev-A-Man.indd 69-70 2/9/09 11:29:39 AM Section 4: Integrating the System into Everyday Life 4.2 Perform Daily Checks 4.2 Perform Daily Checks Purpose Your infusion site is clean and secure. Your reservoir insulin level is adequate for the day. Your companion is fully operating without defects. To make sure:
Perform this procedure at the beginning of each day, with your pump already started delivering insulin based on your basal and bolus programs. The pump and diabetes-care supplies needed for this procedure depend on what you discover as you perform your checks. See the instructions within each step for specific information. Your companion with battery charged and settings programmed. When Materials Helpful Information Procedure:
These steps should become part of your daily routine to prevent problems. Refer to Section 6.7 for instructions on performing a self test on your companion. Steps 1. Examine your infusion site. See that your infusion site is clean of any visible dirt. See that there are NO signs of infection or irritation. Do This a. b. If you notice Discomfort or tenderness Redness or inflammation Warmth, discharge or drainage You have a temperature A firm lump under your skin at the catheter site Then do this Change the infusion site and follow the instructions of your healthcare professional for treating the infection. Change your infusion set and contact your healthcare professional. Change infusion set and contact your healthcare professional immediately. Steps 2. Check your reservoir insulin level. 3. Look at all the tubing. 4. Check your work. Section 4: Integrating the System into Everyday Life 4.3 Carry a Daily Kit Do This When considering how much insulin remains in your reservoir, be sure to think about whats going on in your life today that may affect how much insulin you may need:
If you do NOT have adequate insulin in your reservoir, follow the procedure in Section 2.3 Fill Reservoir. Make sure there are NO air bubbles in the tubing. What were the results from your blood glucose tests?
Are you planning on exercising?
What are you planning to eat?
Are you menstruating?
Are you sick?
Follow your healthcare professionals instructions if you see air bubbles. You will begin your day having confirmed:
Your infusion site is clean and healthy. Your tubing is free of air bubbles. Your insulin reservoir has an ample supply of insulin to meet the demands of your day. Important Note: Check your blood glucose level as frequently as recommended by your healthcare professional and follow recommendations from your healthcare professional when your blood glucose is too high or too low. WARNING: Always check your blood glucose 1 to 3 hours after inserting a new infusion set or according to recommendations from your healthcare professional. 71 72 DOC15736_Rev-A-Man.indd 71-72 2/9/09 11:29:39 AM Section 5: Testing Your Blood Glucose 5.1 Perform a Control Solution Test 4.3 Carry a Daily Kit Purpose When Materials To take care of your daily pump needs. Do this procedure every day. Keep a daily kit with you at ALL times. This kit should include:
Blood glucose monitoring supplies Ketone monitoring supplies Glucose tablets/gel or liquid or other source of carbohydrate to treat a low glucose condi-
tion. A Glucagon Emergency Kit (Glucagon Emergency Kits have an expiration date). Important Reminder: Check frequently to make sure your Glucagon Emergency Kit has NOT expired. Extra infusion sets Insulin Extra unopened pump reservoirs An extra AAA alkaline battery Dressings and adhesives Spare battery cap Insulin syringe and short or rapid-acting insulin vial or insulin pen. Important Reminder: Insulin is sensitive to temperature extremes. Replace your spare insulin monthly. Section 5: Testing Your Blood Glucose 5.1 Perform a Control Solution Test 5 Testing Your Blood Glucose 5.1 Perform a Control Solution Test Purpose When To check that the integrated FreeStyle Lite Blood Glucose Meter and FreeStyle Lite Test Strips are working properly without using any blood. Do this procedure:
Aviator Companion, before doing a blood glucose test with the Materials When you first get your integrated FreeStyle Lite Blood Glucose Meter. Whenever you need to practice testing without having to use your own blood. You want to confirm that your companion and test strips are working properly. FreeStyle Lite Test Strips FreeStyle Control Solution Your Helpful Information The FreeStyle Control Solution is a red liquid that contains a fixed amount of glucose. Aviator Companion fully operating For information on how to obtain control solution, call Customer Care. Important: FreeStyle Control Solution is good for three months after opening the bottle or until the expiration date printed on the label, whichever comes first. Important: Count forward three months from the date you open a new bottle of control solution. This is your discard date. Write this date on the side of the control solution bottle. Example: You open the control solution on January 15th. Count forward three months to April 15th. This is the discard date that you record on the bottle. DOC15736_Rev-A-Man.indd 73-74 2/9/09 11:29:39 AM 73 74 Section 5: Testing Your Blood Glucose 5.1 Perform a Control Solution Test Ensure accurate control solution results by doing the following:
ONLY FreeStyle Control Solution and FreeStyle Lite Test Strips. Use Replace the cap on the control solution bottle immediately after using. NOT use control solution after the expiration date. Do NOT add water or any liquid to control solution. Do Control solution tests are specified to be accurate Control solution test results should fall within the appropriate range printed on the test strip vial label. ONLY when used between 59 to 104 F (15 to 40C). Important: The control solution range is a target range for control solution only. It is NOT a target range for your blood glucose level. If control solution results are out of this range, repeat the test. If your control solution test results continue to fall outside of the appropriate range printed on the test strip vial, do NOT use the integrated FreeStyle Lite Blood Glucose Meter to test your blood glucose. Contact Customer Care. Caution: Results from FreeStyle Control Solution tests do NOT reflect your blood glucose level. Important Note: For important test strip information, including detailed storage and usage information, refer to the FreeStyle Lite Test Strip package insert. Display Screen Displays your test results and other important information. FreeStyle Lite test strip Sample Area Top Bottom Test Strip Port Insert the Top end of a new FreeStyle Lite test strip here. The companion display powers on when you insert the test strip. Sample Areas (dark-colored half-circles on test strip) Apply blood or control solution to one Sample area only. Insert strip into the system printed side up (see image above.) 75 FPO screenshot Blood Drop and Test Strip Symbols These symbols work together an animation to tell you when the companion is ready for you to apply blood or control solution. Procedure:
Steps 1. Insert test strip into the companion. Section 5: Testing Your Blood Glucose 5.1 Perform a Control Solution Test Do This WARNING: Do NOT insert any foreign materials in the meters test strip port. WARNING: Remove USB cable before testing. If you insert a test strip into the strip port when the companion is plugged in, you will get the following warning: BG Check not available. Insert the top of a FreeStyle Lite Test Strip into the test strip port until it stops, and the display switches on. Note: If you do NOT start the test within 2 minutes, the meter will turn off. To restart your meter, take out the unused FreeStyle Lite Test Strip and reinsert it into the meter. Wait for the screen to display the Blood Drop and Test Strip symbols. 2. Apply control solution to test strip. Gently squeeze the control solution vial so that a drop of control solution touches only ONE side of the sample area of the test strip to the control solution. Important: Do NOT apply control solution to both test strip sample areas. Note: If the sound prompt is on, your companion will beep when the test strip is full. An image of a moving clock will appear while the sample is processing. 3. Observe the results. a. b. c. Look at the results appearing on the display screen, and listen for 2 beeps if the sound is on. To mark the result as a control solution result, scroll to Enter. Change to Yes and press Enter. Control and press Note: Result is marked as control solution when advanced to next screen. 76 DOC15736_Rev-A-Man.indd 75-76 2/9/09 11:29:40 AM Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 4. Do This a. Compare Solution Range. Compare your control solution test result to the appropriate range printed on your test strip vial label. Check that your control solution results are within the appropriate range printed on your test strip vial. b. Note: Out of range test results may be caused by:
Expired or bad control solution. Expired or bad test strip. Error in performing test, such as applying blood sample incorrectly, or using control solution that has expired. Watered-down control solution. Device malfunctions. Control solution test done outside 59 to 104 F (15 to 40 C). c. Remove the test strip. 5. Remove and discard the test strip. 6. Check your work. Discard all used test strips as they are for single use only. Follow local regulations on safe disposal of used test strips. You have obtained control solution results that fall within the appropriate range, as printed on your test strip vial. Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose 5.2 Check Your Blood Glucose Purpose When Materials To obtain an accurate blood glucose reading using the integrated FreeStyle Lite Blood Glucose Meter on your Aviator Companion. Do this procedure:
Whenever you need to check your blood glucose manually using the integrated FreeStyle Lite Blood Glucose Meter on your companion. Soap, water, and a clean towel FreeStyle Lite Test Strips A lancing device (
Sterile lancets A Sharps container Your companion FreeStyle Lancing Device or another brand) Helpful Information How the integrated FreeStyle Lite Blood Glucose Meter should be used:
The integrated vitro diagnostic use only). The integrated sugar) from samples taken from the fore arm, upper arm, hand, thigh, calf, or fingers. FreeStyle Lite Blood Glucose Meter is intended for use outside the body (in other words, in FreeStyle Lite Blood Glucose Meter is used for measuring blood glucose (also known as blood Testing blood glucose. Testing only with fresh capillary whole blood samples (in vitro). USE the integrated FreeStyle Lite Blood Glucose Meter for:
Do NOT use the integrated FreeStyle Lite Blood Glucose Meter for:
WARNING:
The diagnosis of diabetes. Testing of newborns. Testing of arterial blood. FreeStyle Lite test strips and lancets are small parts that may be dangerous if swallowed. The Peritoneal dialysis solutions containing icodextrin or compounds of Galactose 13 mg/dL ( 0.7 mmol/L), Maltose 20 mg/dL (0.6 mmol/L) or Lactose 10 mg/dL ( 0.3 mmol/L) cause the integrated FreeStyle Lite Blood Glucose Meter to overestimate blood glucose test results. If you are receiving such treatment, do NOT use the integrated FreeStyle Lite Blood Glucose Meter and discuss this issue with your healthcare professional to ensure proper alternative treatment. DOC15736_Rev-A-Man.indd 77-78 2/9/09 11:29:40 AM 77 78 Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Caution: Please read all the instructions provided in this section and practice the testing procedures before using the integrated FreeStyle Lite Blood Glucose Meter. Blood glucose monitoring should be done with the guidance of a healthcare professional. Important health-related information:
hypoglycemia). Severe dehydration and excessive water loss may cause false low results. If you believe you are suffering from severe dehydration, consult your physician immediately. Test results below 60 mg/dL (3.3 mmol/L) mean low blood glucose (
Test results greater than 240 mg/dL (13.3 mmol/L) mean high blood glucose (hyperglycemia). NOT have symptoms If you get results below 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L) and do of hypoglycemia or hyperglycemia, repeat the test. If you have symptoms or continue to get results that fall be-
low 60 mg/dL (3.3 mmol/L) or above 240 mg/dL (13.3 mmol/L), follow the treatment of your healthcare profes-
sional. If you are experiencing symptoms that are all instructions described in this section, call your healthcare professional. Important: To ensure accurate results, wash your hands and test site (for example, your forearm) with soap and water. Make sure there is NO cream or lotion on the test site. Thoroughly dry your hands and test site. NOT consistent with your blood glucose test and you have followed r s c e FPO O n h o P e F s t With the or calf. Testing with the integrated of blood. This is about the size of a pinhead (example: ). Aviator Companion, you can test your blood glucose on your forearm, fingers, upper arm, hand, thigh, FreeStyle Lite Blood Glucose Meter requires a very small sample size, 0.3 microliter WARNING: Test ONLY on fingers if you think blood glucose may be low, you have hypoglycemic unawareness, or your glucose is changing rapidly. When you are feeling symptoms such as weakness, sweating, nervousness, headache or confusion. When you have delayed a meal after taking insulin. When your healthcare professional advises you to do so. Times when you may consider checking for low blood glucose include:
Important: Use ONLY the FreeStyle Lite Test Strips with the Aviator Companion. Using other test strips will produce inaccurate results. Procedure:
Steps 1. Prepare your companion. Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Do This Insert a FreeStyle Lite Test Strip into the strip port until it stops, and the display switches on. WARNING: Remove USB cable before checking your BG. If you insert a test strip into the strip port when the companion is plugged in, you will get the following warning:
BG Check not available. Note: If you do NOT start the test within 2 minutes, the display will turn off. To start the display, take out the unused FreeStyle Lite Test Strip and reinsert it into the strip port. Check the screen to ensure that the blood drop and test strip symbols appear on the display screen. Note: When you insert a test strip and the Apply Sample screen appears, you can turn on or off the display backlight and test light. 2. Select a test site. Most Test Sites Available Select from among the test sites shown including the boxed areas. WARNING: Test only on your fingers if you are testing for hypoglycemia (low blood glucose) or if you have hypoglycemia unawareness. Note: The areas shown can be tested with the integrated FreeStyle Lite Blood Glucose Meter. Avoid moles, veins, bones, and tendons. Suggested Test Areas for the Hand Upper arm Forearm Hand Fingertips Thigh Calf DOC15736_Rev-A-Man.indd 79-80 2/9/09 11:29:41 AM 79 80 Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 3. Do This a. Obtain a blood sample using your lancing device. Wash your hands and the selected site with soap and water. Make sure there is no lotion or cream on the test site. Thoroughly dry your hands and the test site. b. Steps 4. Fill test strip with blood sample. Do This a. Make sure the FreeStyle Lite Test Strip is in the strip port and the display is switched on. Take out the test strip and reinsert it into the strip port if the display is off. Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Note: Refer to the FreeStyle Lancing Device insert for detailed instruction. If you are using another lancing device brand, follow the instructions that came with it. Important: Do NOT reuse lancets. Use a new sterile lancet for each test. NEVER use a lancet for more than one person. c. Prepare the test site for lancing. If you are using A finger Your forearm Then do this Gently massage the finger to bring blood to the surface. Rub the test site vigorously until you feel it getting warm
(three to five seconds). d. Use your lancing device to obtain the blood sample. Note: It is possible you may experience bruising at the test site. If bruising does occur, you may choose to lance another test site and/or change the depth setting. Note: The Blood Drop and Test Strip symbols should appear on the display screen. b. Bring the test strip to the blood sample at a slight angle, and gently touch the half-circle on the test strip to the sample. Note: The FreeStyle Lite Test Strip acts like a sponge and pulls the blood into the strip through the sample area. Important:
Do Do Do Do Do the strip port. Do Do NOT use FreeStyle Lite Test Strips more than once. Discard used test strips. NOT press the FreeStyle Lite Test Strip against the test site. NOT scrape the blood onto the FreeStyle Lite Test Strip. NOT apply blood to the flat side of the FreeStyle Lite Test Strip. NOT apply blood to the FreeStyle Lite Test Strip when the test strip is out of NOT apply blood to both edges of the FreeStyle Lite Test Strip. NOT put blood or foreign objects into the FreeStyle Lite Test Strip port. s c r e e n F s P h O o t Test Strip Sample Area DOC15736_Rev-A-Man.indd 81-82 2/9/09 11:29:41 AM 81 82 Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 5. Wait for result. Do This a. Observe the companion screen. Note: Do NOT pull the FreeStyle Lite Test Strip away until you hear ONE beep or see the image of the clock moving on your companion screen. This means you have enough blood and the companion is reading your glucose. Note: If after 5 seconds your companion screen does NOT show the image of a moving clock, the sample may be too small. You may add blood to the same sample area of the test strip with which you started for up to 60 seconds from the time of the first application. If The image of the clock moving does NOT appear after 5 seconds The companion beeps once Your blood glucose test results appear in the display (usually takes 5-7 seconds), and you hear two beeps The companion beeps three times Then Continue adding blood sample to the SAME half-circle. Enough blood was applied. The test is complete, go to the next step. The test has failed. Repeat the test. Go to Step 12 to troubleshoot error messages. b. The test result is complete when your blood glucose result is shown on the display screen and you hear two beeps. Note: On average, your results will display in 5 seconds. The time that the companion takes depends on your blood glucose level. The higher your glucose level, the longer it takes to get a result. Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 6. Decide if the blood glucose reading is control solution. Do This If reading is Control Not control Control. Use the scroll to select Press Scroll to select Press Then do this 1. 2. 3. 4. Notice Control = No Go on to the next step. Enter button. Yes. Enter button. 7. Decide if a Bolus needs to be delivered. a. b. c. Bolus is highlighted. Notice Press the Notice the refer to Section 8 of this Users Guide to administer the bolus. Enter button. Bolus menu is displayed. Decide what type of bolus to deliver and Note: If a bolus is NOT needed, and you want to return to the Home screen, scroll to highlight Home and press Enter button. d. Go to the next step. DOC15736_Rev-A-Man.indd 83-84 2/9/09 11:29:41 AM 83 84 Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 10. Discard the lancet. Do This Important: Use a sealed container such as a sharps container to avoid exposure to the sharps by yourself or someone else. Your community may requires safe disposal of sharps. Follow local regulations. 11. Check your work. You have obtained accurate blood glucose readings. Ensure you have followed all the steps and obtained an accurate BG reading. Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 8. Interpret the blood glucose results. Do This Important: Low or high glucose readings can indicate a potentially serious medical condition. The Aviator Companion can display results from 20 to 500 mg/dL
(1.1 to 27.8 mmol/L). If Lo appears in the display -- test result is lower than 20 mg/dL
(1.1 mmol/L) Hi appears in the display test result is above 500 mg/dL
(27.8 mmol/L) And You do NOT have low blood glucose symptoms You have symptoms such as weakness, sweating, nervousness, headache or confusion This is your second test You do NOT have high blood glucose symptoms You have symptoms such as fatigue, thirst, excess urination or blurry vision This is your second test The companion displays results from 20 to 500 mg/dL
(1.1 mmol/L to 27.8 mmol/L) Then Repeat the test with a new test strip. Test on your finger. Follow your healthcare professionals recommendations for treating severe hypoglycemia (low blood glucose). Repeat the test (rewashing your hands) using a new test strip. Follow your healthcare professionals recommendations for treating hyperglycemia
(high blood glucose). Continue to the next step. 9. Remove and discard the test strip. Discard all used test strips as they are for single use only DOC15736_Rev-A-Man.indd 85-86 2/9/09 11:29:41 AM 85 86 Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Steps 12. Troubleshooting Error Messages. Do This Error 1 (Er 1) Possible Causes:
What You Should Do:
1. Sample is too small. Problem with the Problem with the companion. Very low blood glucose (less then 20 mg/dL [1.1 mmol/L]). FreeStyle Lite Test Strip. If you have symptoms such as weakness, sweating, nervousness, headache or confusion, follow your healthcare professionals recommendation for treating hypoglycemia. Conduct a control solution test using a new results of the control solution test are within the appropriate range printed on the side of your test strip vial, retest using blood and a new FreeStyle Lite Test Strip. If the retest using control solution does NOT work or the error persists, call Customer Care. FreeStyle Lite Test Strip. If the 2. 3. FreeStyle Lite Test Strip. Error 2 (Er 2) Possible Causes:
Problem with the Problem with the companion. Very high blood glucose (above 500 mg/dL [27.8 mmol/L]). HIGH control solution applied when temperature is too cold. (This applies only to control solution that is labeled as HIGH). What You Should Do:
1. If you have symptoms such as thirst, fatigue, excess urination or blurry vision, follow your healthcare professionals recommendation for treating hyperglycemia. Conduct a control solution test using a new results of the control solution test are within the appropriate range printed on your test strip vial, retest using blood and a new FreeStyle Lite Test Strip. NOT work or the error persists, call If the retest using control solution does Customer Care. FreeStyle Lite Test Strip. If the 2. 3. Steps Troubleshooting Error Messages (continued).
(Error 4 screenshot) FPO Section 5: Testing Your Blood Glucose 5.2 Check Your Blood Glucose Do This Error 3 (Er 3) Possible Causes:
What You Should Do:
1. Incorrect test procedure. For example, putting blood on the test strip before inserting the test strip into the strip port or applying blood before the blood drop and test strip symbols display. Problem with the Problem with the companion. FreeStyle Lite Test Strip. Be sure you see the blood drop and test strip symbols on the display screen before you apply blood or control solution. Conduct a control solution test using a new FreeStyle Lite Test Strip. If the results of the control solution test are within the appropriate range printed on your test strip vial, retest using blood and a new FreeStyle Lite Test Strip. If the retest using control solution does NOT work or the error persists, call Customer Care. 2. 3. FreeStyle Lite Test Strip. Problem with the Problem with the companion. Error 4 (Er 4) Possible Causes:
What You Should Do:
1. FreeStyle Lite Test Strip. If the Conduct a control solution test using a new results of the control solution test are within the appropriate range printed on the side of your test strip vial, retest using blood and a new FreeStyle Lite Test Strip. If the retest using control solution does Customer Care. NOT work or the error persists, call 2. DOC15736_Rev-A-Man.indd 87-88 2/9/09 11:29:41 AM 87 88 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps Troubleshooting Other Problems (continued). 1. Do This Probable Cause The battery is depleted Companion does NOT enter the test mode after inserting a test strip. Test strip inserted upside down, wrong-end in, or incompletely inserted into the companion Defective companion or test strips Blood or foreign objects inserted into the test strip port. 2. Test does NOT start after applying the blood sample. Probable Cause Blood sample too small Defective test strip Sample applied after companion times out
(two minutes) and turns off Defective companion or test strips What to Do Recharge the battery (and reset the date and time, if necessary.) Insert the FreeStyle Lite Test Strip with the printed side up and the top of the strip in the strip port. Call Customer Care. Call Customer Care. What to Do You may add blood to the same sample area of the FreeStyle Lite Test Strip from which you started for up to 60 seconds from the time of the first application. If necessary, repeat the test using a new FreeStyle Lite Test Strip and a larger blood sample. Repeat the test with a new FreeStyle Lite Test Strip. Repeat the test using a new test strip. Wait until you see the blood and test strip symbols on the display screen before you apply the blood sample. Call Customer Care. 6 When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Purpose Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Display preferences Bolus calculator options Bolus and basal limits Audio/vibrate Low insulin alert and alarms Locked items One-button bolus To program additional settings using your Aviator Companion following a step-by-step process in SETUP WIZARD, including:
Do this procedure:
After you have set up basic settings for your pump. After you have created a daily basal program. Whenever you are ready or need to set optional settings using Your companion with the battery charged and initial settings programmed Your pump with the battery installed and initial settings programmed. Your personalized Table of Settings recommended by your healthcare professional in Section 12 - Appendix A. SETUP WIZARD. When Materials Helpful Information Section 12 for Your healthcare professional will need to help you determine your individual settings. Refer to more information on why and how you would use these optional settings. Locking the basal, bolus, and prime options should be considered if a caregiver is responsible for operating the pump when the user is a child, elderly, or other person with a limited understanding of the pump use and func-
tions. On, then in some cases, the full text does NOT fit on the screen, so it If you choose to turn the Magnify option to will require more scrolling to view the entire message. The behavior of each screen will vary, for example, when you are programming, only the option name will appear, and you will need to scroll further to view the option choices; in the basal or bolus calculator screens, you may see only the time block, and you will need to scroll further to get to the next programming choice. It is recommended that you practice using the Magnify can become familiar with how the screen will appear using either option. On vs. Magnify Off, and scroll through the screens so you DOC15736_Rev-A-Man.indd 89-90 2/9/09 11:29:41 AM 89 90 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Helpful Information (continued) occlusion alarm is set to high sensitivity, it will detect an occlusion and sound an alarm within the When the time it would take to deliver 3 Units of insulin at your programmed basal delivery rate, or within 1 minute, whichever is longer. When the occlusion alarm is set to low sensitivity, it will detect an occlusion and sound an alarm within the time it would take to deliver 6 Units of insulin at your programmed basal delivery rate, or within 2 minutes, whichever is longer. For a detailed list of the screen settings and the order in which they appear, refer to the Menus in Section 12 Appendix E. FreeStyle Aviator Procedure:
Steps 1. Go to the SETUP menu. basal delivery before you go to the SETUP menu. Do This STOP a. See Section 3.1.3 for procedure as needed. Notice Press Main is highlighted. Enter button. b. c. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 3. Go to the STEP 2 screen Do This a. On the STEP 1 screen, notice OK is highlighted. Note: You may have to scroll through several screens to get to the options that you want. b. c. d. e. f. g. Scroll to highlight Enter button. Press Skip. Edit is highlighted on the CONFIRM screen with Skip or edit optional Notice settings? message. Enter button. Press STEP 2 screen, notice OK is highlighted. On Press Enter button. d. e. Scroll to highlight Enter button. Press SETUP. 4. Set Display Preferences. a. Review the default settings and change as needed. Note: Buttons on Right will allow controls to be on the right side of pump face. These do NOT affect button settings on the Companion. 2. Access SETUP WIZARD. a. b. Scroll to highlight Enter button. Press WIZARD. b. c. d. e. f. g. h. Buttons. Enter button. on Right or on Left of the screen. Scroll to highlight Enter button. Press Scroll to select display Press If the settings are changed, press Enter, change the value(s), and press Enter again. Review the changes. Scroll to highlight Enter button. Press NOT correct, scroll up to the setting that needs to be Next, if it is not already highlighted. DOC15736_Rev-A-Man.indd 91-92 2/9/09 11:29:42 AM 91 92 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 5. Set Timeout. Do This Note: The timeout is the number of seconds before the pump display goes blank. The timeout can be set from 15 to 120 seconds. You may want to set it at 30-60 seconds if you are frequently timing out while performing tasks. a. b. c. d. Timeout is highlighted. Enter button. Notice Press Scroll to select timeout seconds ranging from 15 sec to 120 sec. Press Enter button. 6. Set Home screen display. Home is highlighted. Enter button. Information (default) or Activity display for Home screen. Enter button. a. Notice b. Press c. Select d. Press Example:
Information based (displays basal and bolus insulin delivery status information) Activity based (displays a list of menu items such as Alarms, Status, Reports, Setup, etc 7. Verify Display Preferences are correct. a. b. c. Scroll up to select and change any setting as needed. Notice Press Next is highlighted. Enter button. Note: The Home screen examples in this Users Guide are set to Information. Steps 8. Select Edit Mode. Do This Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD a. b. Review the default settings for how the screen shows your options or selections. Change as needed. Note: The screenshot examples in this Users Guide are set to Highlight and Magnify by default. Example of Cursor set to Outline:
9. Verify Edit Mode is correct. c. d. e. f. g. h. i. j. a. b. c. Cursor for the option to highlight or outline text on the Scroll to highlight screen. Press Scroll to select Press Enter button. Enter button. Highlight or Outline. Magnify is highlighted. This option allows text to be a larger font on Notice the pump for easier reading. Press Scroll to select Press Enter button. Enter button. On or Off. Scroll up to select and change any setting as needed. Notice Press Next is highlighted. Enter button. DOC15736_Rev-A-Man.indd 93-94 2/9/09 11:29:42 AM 93 94 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 10. Set Bolus Calculator Options. Do This Note: The Bolus Calculator is a tool to allow you to easily determine how many units are needed for your bolus. It also shows you the numbers used to calculate that volume. a. b. Notice Press OK is highlighted. Enter button. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 11. Set
(correction factor) for Block 1. 1U DROP Do This WARNING: Accurate determination and programming of the insulin to blood glucose ratios are necessary to avoid possible delivery errors that may result in adverse medical events or serious injury. Note: 1U DROP sets how much 1 unit of insulin will lower your blood glucose level.(
Insulin Sensitivity Factor) Note: The 1U Drop can be changed to different values throughout a 24 hour period. The range is 12 AM to 11 PM in 1 hour increments. Create your earliest block first. Once you add a block at 11 PM (the last time slot), you will NO longer see the Add Block option on the 1U Drop screen and you CANNOT add any additional blocks. If you ONLY set ONE block, it will prevail for 24 hours. a. b. c. d. e. f. g. h. i. j. Enter button. Time is highlighted. Enter button. Notice Time line and dashes are highlighted. Press Notice Press Scroll to the desired time. Press Notice Press Scroll to the correction factor (insulin sensitivity factor) recommended by your healthcare professional and recorded in your Table of Settings in Appendix A. Press Enter button. 1U Drop is highlighted. Enter button. Enter button. Note: The default is 50 mg/dL (2.8 mmol/L), and the range is 5 mg/dL to 500 mg/dL ( 0. 28 mmol/L - 27.8 mmol/L). DOC15736_Rev-A-Man.indd 95-96 2/9/09 11:29:42 AM 95 96 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 12. Check that the time and 1U Drop for the block are correct. Do This a. b. c. d. Time and 1 U Drop settings on the screen. Review the Scroll up to select and change any setting as needed. Notice Press Next is highlighted. Enter button. 13. Decide whether to add another block, delete the block, or continue to set carb ratios. If you want to Add another block Delete the block Then do this 1. 2. 3. Add block is highlighted. Enter button Notice Press Repeat Steps 11 to 13 to add additional blocks per your healthcare professionals recommendations. Scroll to highlight Enter button. Press Scroll to Press Yes to confirm block deletion. Enter button. Delete. 1. 2. 3. 4. Continue to set carb ratios Note: You must add at least 1 block before continuing or you will get a warning. Clear the warning by pressing Enter button. Scroll to highlight Next if not already highlighted. Press Enter button. Steps 14. Set CARB RATIOS. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Do This WARNING: Accurate determination and programming of the insulin to carbohydrate ratios are necessary to avoid possible delivery errors that may result in adverse medical events or serious injury. Time line and dashes are highlighted. Enter button. Time is highlighted. Enter button. Notice Press Notice Press Scroll to the desired time. Press Notice Press Scroll to select desired a. b. c. d. e. f. g. h. i. Note: This sets the amount of insulin for a certain number of carbohydrates. The default setting is 1U/15g and the range is 1U/1g to 1U/150g. Enter button. I:CHO is highlighted. Enter button. I:CHO. 15. Check that the time and I:CHO for the block are correct. Press Enter button. a. b. c. d. Time and I:CHO settings on the screen. Review the Scroll up to select and change any setting as needed. Notice Press Next is highlighted. Enter button. DOC15736_Rev-A-Man.indd 97-98 2/9/09 11:29:42 AM 97 98 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 16. Do This Decide whether to add another block, delete the block or continue to set BG targets. If you want to Add another block Delete the block Then do this 1. 2. 3. Add block is highlighted. Enter button. Notice Press Repeat Steps 14 to 16 to add additional blocks. 1. 2. 3. 4. Scroll to highlight Enter button. Press Delete. Yes to confirm block deletion. Scroll to Press Enter button. Steps 17. Set BG TARGETS. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Do This WARNING: Accurate determination and programming of blood glucose targets is necessary to avoid possible delivery errors that may result in adverse medical events or serious injury. a. b. c. d. e. f. g. h. i. Time line and dashes are highlighted. Enter button. Time is highlighted. Enter button. Notice Press Notice Press Scroll to the desired time. Press Notice Press Scroll to the desired blood glucose target. Enter button. BG Target is highlighted. Enter button. Note: The default setting is 110 mg/dL (6.1 mmol/L), and the range is 50 mg/dL to 300 mg/dL (2.8 mmol/L to 16.7 mmol/L). Continue to set BG targets Note: You must add at least 1 block before continuing. Scroll to highlight Next if not already highlighted. Press Enter button. 18. Check that the time and BG Target settings are correct. j. a. b. c. d. Enter button. Time and BG Target settings on the screen. Press Review the Scroll up to select and change any setting as needed. Notice Press Next is highlighted. Enter button DOC15736_Rev-A-Man.indd 99-100 2/9/09 11:29:43 AM 99 100 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 19. Decide whether to add another block, delete the block or continue. Do This If you want to Add another block Then do this 1. 2. 3. Add block is highlighted. Enter button. Notice Press Repeat Steps 17 to 19 to add additional blocks. Steps 21. Set BOLUS LIMITS. Delete the block 1. 2. 3. 4. Scroll to highlight Enter button. Press Delete. Yes to confirm block deletion. Scroll to Press Enter button. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Increment. Do This a. b. Scroll to highlight bolus Press Enter button. Note: Increment values are 0.05, 0.10, 0.50, or 1.00 Units. The default setting is 0.10U. c. d. Scroll to the desired increment. Press Enter button. Note: If you changed the increment in step c, you MUST also reset the Maximum bolus. e. f. Notice Press Maximum is highlighted. Enter button. Note: The scrolling range depends on the increment you selected above. See the following table:
Continue to set bolus and basal limits Note: You must add at least 1 block before continuing. Scroll to highlight Next if not already highlighted. Press Enter button to go to STEP 4 screen, Set bolus and basal limits. 20. Set bolus and basal limits. a. b. Notice Press OK is highlighted. Enter button to reach BOLUS LIMITS screen. 22. Check that the Increment and Maximum values are correct. g. h. a. b. c. d. If increment is 0.05 U 0.10 U 0.50 U 1.00 U Then range is 0.05 to 9.95 U 0.10 to 50.0 U 0.50 to 50.0 U 1.00 to 50.0 U Scroll to select desired maximum units of insulin. Press Enter button. Increment and Maximum settings on the screen. Review the Scroll up to select and change any settings as needed. Notice Press Next is highlighted. Enter button. DOC15736_Rev-A-Man.indd 101-102 2/9/09 11:29:43 AM 101 102 Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 23. Set ONE-BUTTON BOLUS. Do This a. b. c. d. Scroll to highlight Enter button. Press Scroll to select Press Enter button. On or Off. On/Off. The default is On. If On Off Then do this 1. 2. 3. Increment is highlighted. Enter button. Notice Press Scroll to select desired increment.
(0.5U or 1.0U). Press Notice Press Enter button. Next is highlighted. Enter button. 4. 5. 6. Notice Next is highlighted and Increment is gone from the screen. Press Enter button. 24. Set BASAL LIMITS. a. b. Scroll to highlight Enter button. Press Increment. Note: Increment values are 0.05, 0.10, 0.50, and 1.00 U/h. The default setting is 0.05 U/h. c. d. e. f. Scroll to select desired increment. Press Notice Press Enter button. Maximum is highlighted. Enter button. Note: This sets the maximum limit for basal rates when you edit your basal programs. The default is 2.00 U/h, and the range is 0.05-30.00 U/h. g. h. Scroll to select desired maximum U/h. Press Enter button. 103 Steps 25. Check that the basal limit increments and maximums are correct. 26. Set Temporary Basal setting. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Increment and Maximum settings on the screen. Do This a. Review b. Scroll up to select and change any setting as needed. c. Notice d. Press Next is highlighted. Enter button. Temp is highlighted. Enter button. Notice Press Scroll to select a. b. c. Example: If your active basal rate is 0.35 U/h, then selecting 75% will set the temporary basal at 0.26 U/h, which is 75% of the current basal. d. Percent or Units. Enter button. Press 27. Check that the Temp Basal setting is correct. a. b. c. d. Temp setting on the screen. Review your Scroll up to select and change any setting as needed. Notice Press Next is highlighted. Enter button. 28. Set audio/vibe, low insulin, and alarms. If you want to Set audio or vibe, low insulin, and alarms Skip this set up Then do this 1. 2. 3. 1. 2. 3. OK is highlighted. Enter button. Notice Press Go to Step 29. Scroll to highlight Enter button. Press Go to Step 35 to set locked items. Skip. 104 DOC15736_Rev-A-Man.indd 103-104 2/9/09 11:29:43 AM Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 29. Set AUDIO/VIBRATE. Do This Note: The Audio/Vibrate setting establishes whether your pump will notify you with audible sounds or vibrations. a. Notice Next is highlighted. Pump. b. c. d. e. Scroll to highlight Enter button. Press Scroll to select Press Enter button. Audio (default) or Vibrate. If you select Audio Then do this Notice Audio is highlighted. Press Enter button. Scroll to select Low, Medium, or High. Press Enter button. 30. Verify AUDIO/VIBE setting. Review your Pump setting on the screen. If setting is Correct Incorrect Then do this Notice Next is highlighted. Press Enter button. Repeat Step 29. Section 6: When Youre Ready Optional Settings 6.1 Set Up Additional Options SETUP WIZARD Steps 31. Set OCCLUSION ALARM. Do This Note: The Occlusion Alarm alerts you that there is pressure in your pump or tubing sensed the pump. This can result in insulin NOT being delivered to your infusion site as programmed. The Occlusion Alarm Sensitivity is set to High by default. Next is highlighted. Sensitivity. a. b. c. d. e. Notice Scroll to highlight Enter button. Press Scroll to select Press Enter button. High or Low. 32. OCCLUSION Check that ALARM sensitivity is correct. Notice your Sensitivity setting on the screen. If setting is Correct Incorrect Then do this Notice Next is highlighted. Press Enter button. Repeat Step 31. 33. Set LOW INSULIN ALERT. a. b. c. d. e. Next is highlighted. Notice Scroll to highlight alarms). Press Scroll to set low insulin Press Enter button. Enter button. alert level. Low Alert (Number of units left in reservoir when pump DOC15736_Rev-A-Man.indd 105-106 2/9/09 11:29:43 AM 105 106 Note: The default is 20U. The range is 5U to 50U. Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps Verify 34. ALERT level is correct LOW INSULIN Do This a. b. c. d. Low Alert setting on the screen. Review your Scroll up to select and change the level as needed. Notice Press Next is highlighted. Enter button. 35. Set LOCKED ITEMS. a. b. OK is highlighted on the screen STEP 6 Set locked items (Used in the Notice case that the patient needs to be prevented from changing settings or giving insulin). Press Enter button. 36. Set Basal to Locked or Unlocked. a. Review locked items settings, and change as needed. Basal. b. c. d. e. Scroll to highlight Enter button. Press Scroll to select Press Enter button. Locked or Unlocked. Steps 37. Set Bolus to Locked or Unlocked. 38. Set Prime to Locked or Unlocked. 39. Verify your ITEMS settings. LOCKED Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Do This a. Notice b. Press c. Scroll to select d. Press Enter button. Bolus is highlighted or scroll to highlight Bolus as needed. Enter button. Locked or Unlocked. a. b. c. d. a. b. c. d. Prime is highlighted or scroll to highlight Prime as needed. Enter button. Locked or Unlocked. Notice Press Scroll to select Press Enter button. Basal, Bolus, and Prime settings on the screen. Review the Locked Scroll up to select and change any settings as needed. Notice Press Next is highlighted. Enter button 40. Check your work. a. You will see the message screen. Setup Wizard is complete. on the SETUP WIZARD Note: The screen will automatically go to the Home screen after 5 seconds. b. c. To check your settings, follow the sequence in this task to proceed through each screen. RESTART YOUR BASAL DELIVERY. DOC15736_Rev-A-Man.indd 107-108 2/9/09 11:29:43 AM 107 108 Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options 6.2 Edit Additional Options Purpose To edit additional options using your Aviator Companion following direct menu options or the SETUP WIZARD including:
Note: Refer to the Glossary for explanation of the above terms. audio/vibe settings inactivity or occlusion alarms low insulin alert time/date format basal and bolus limits one-button bolus setting display settings blood glucose target range system name locked items insulin profile bolus calculator options When Materials Do this procedure:
current pump settings. Whenever you want to make changes to your Your companion fully operating with initial and optional settings programmed. Your pump fully operating with initial and optional settings programmed. Your healthcare professionals recommendations for the settings of your pump. Your personalized Table of Settings in Appendix A. Procedure:
Steps 1. Determine what settings you want to edit. Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Then do this Make your edits from the ALARMS menu. Go to Step 2. Make your edits from the SETUP menu Go to Step 7. You CANNOT change the default insulin type and unit values. Note: Aviator Pump uses U100 insulin only. Make your edits from the SETUP WIZARD menu. Refer to Section 6.1: Set Additional Options for the procedure to change all the desired settings. Do This If you are editing Audio or vibrate settings Inactivity alarm Occlusion alarm Low Insulin alert Time or date format Basal limits Basal Setup (Temporary basal setup) Bolus limits/One-button bolus setting Insulin Profile Preferences/
Display settings Name of system BG Target Range Values More than 3 SETUP WIZARD settings
(including bolus calculator options, locked items, etc.) DOC15736_Rev-A-Man.indd 109-110 2/9/09 11:29:44 AM 109 110 Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps 2. Access the ALARMS menu. Home screen, notice Main is highlighted. Do This a. From the b. Enter button. Press c. Scroll to highlight d. Press e. Decide which alarm you want to edit. ALARMS. Enter button to display the ALARMS menu. If you are editing Audio or vibrate settings Inactivity alarm Occlusion alarm Low Insulin alert Then do this Go to Step 3. Go to Step 4. Go to Step 5. Go to Step 6. 3. Edit AUDIO/VIBRATE. a. b. Notice Press Audio/Vibrate is highlighted. Enter button. c. d. Audio, Vibrate, or Progress Tones to change as needed for Scroll to highlight the companion. Press Enter button. Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options g. h. Notice Press Next is highlighted. Enter button. i. Decide to select Audio or Vibrate for the Aviator Pump. If you want your pump to be on Audio and at a different level Vibrate Then do this 1. 2. 3. 4. 5. 6. 1. 2. 3. 4. 5. 6. Scroll to highlight Enter button. Press Audio. Scroll to select Press Enter button. Low, Medium, or High. Done is highlighted. Notice Enter button. Press Scroll to highlight Enter button. Press Pump. Scroll to select Press Enter button. Vibrate. Notice Press Done is highlighted. Enter button. e. f. Scroll to select values as recommended by your healthcare professional. Press Enter button. You have completed editing the Audio/Vibrate setting. Continued on next page. 111 112 DOC15736_Rev-A-Man.indd 111-112 2/9/09 11:29:44 AM Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps 4. Edit INACTIVITY ALARM. Do This a. b. c. d. e. Scroll to highlight Press Enter button. INACTIVITY. Time. Scroll to highlight Enter button. Press Scroll to set the time for the inactivity alarm to sound. Note: Scrolling range is 1 - 24 hours. f. g. h. Press Notice Press Enter button. Done is highlighted. Enter button. You have completed editing the Inactivity Alarm setting. 5. Edit OCCLUSION ALARM. OCCLUSION. Sensitivity. a. b. c. d. e. Scroll to highlight Enter button. Press Scroll to highlight Enter button. Press Scroll to select High or Low. Steps 6. Edit LOW INSULIN ALERT. Do This Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options a. b. c. d. Scroll to highlight Enter button. Press LOW INSULIN. Scroll to highlight Enter button. Press Low Alert. e. Scroll to set low insulin level alert. Note: Scrolling range is 5 - 50 U. f. Press Enter button. g. h. Notice Press DONE is highlighted. Enter button to return to Home screen. You have completed editing the Low Insulin Alarm setting. Note: Occlusion Alarm Sensitivity is set to High by default. f. g. h. Press Notice Press Enter button. Done is highlighted. Enter button. You have completed editing the Occlusion Alarm setting. DOC15736_Rev-A-Man.indd 113-114 2/9/09 11:29:44 AM 113 114 Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps 7. Go to the SETUP menu. Do This Steps Do This Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options a. b. From the Home screen, Notice Press Enter button. Main is highlighted. c. d. e. SETUP. Scroll to highlight Press Decide which setting you want to edit. Enter button to go to SETUP menu. If you are editing Preferences/
Display Settings Name of system BG Target Range Then do this 1. 2. 3. 1. 2. 3. 1. 2. 3. Scroll to highlight Enter button. Press Go to Step 14. Scroll to highlight Enter button. Press Go to Step 15. Scroll to highlight Enter button. Press Go to Step 16 PREFERENCES. NAME. TARGET RANGE. TIME/DATE is highlighted. Enter button. If you are editing Time and date format Basal limits Basal setup
(Temporary basal setup) Bolus limits /
One-Button Bolus Insulin Profile Then do this 1. 2. 3. 1. 2. 3. 1. 2. 3. 1. 2. 3. 1. 2. 3. Notice Press Go to Step 8 & 9. Scroll to highlight Enter button. Press Go to Step 10. Scroll to highlight Enter button. Press Go to Step 11. Scroll to highlight Enter button. Press Go to Step 12. Scroll to highlight Enter button. Press Go to Step 13. BASAL LIMITS. BASAL SETUP. BOLUS LIMITS. INSULIN. 8. Edit Time. a. b. c. d. e. f. g. h. i. j. Scroll up to select the time. Press Enter button. Hour. Scroll up to select Enter button. Press Scroll to set the current hour. Press Enter button. Minute is highlighted. Enter button. Notice Press Scroll to select the current minute. Press Enter button. Continued on next page. 115 Continued on next page. 116 DOC15736_Rev-A-Man.indd 115-116 2/9/09 11:29:44 AM Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps Do This k. Notice l. Press m. Scroll to select n. Press o. Notice p. Press Am/Pm is highlighted. Enter button. AM or PM. Enter button. Accept is highlighted. Enter button. If you are changing Only the time and NOT the date Then do this 1. 2. Scroll to highlight Press screen. Done. Enter button to return to HOME The date You have completed editing the time. Go to Step 8. 9. Edit Date. a. b. Notice the date is highlighted. Press Enter button. c. d. e. f. Month. Enter button. Scroll up to highlight Press Scroll to change month. Press Enter button. Steps Do This Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options k. l. m. n. o. p. q. r. s. Year is highlighted. Enter button. Notice Press Scroll to change to current year as needed. Press Enter button. Accept is highlighted. Enter button. Notice Press Review date and time, and make changes as needed. Notice Press DONE is highlighted. Enter button to return to the HOME screen. You have completed editing the date. Day is highlighted. Enter button. Notice Press Scroll to change the day. Press g. h. i. j. Continued on next page. Enter button. DOC15736_Rev-A-Man.indd 117-118 2/9/09 11:29:44 AM 117 118 Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps 10. Edit Basal Limits. Do This Steps 12. Edit Bolus Limits. Do This Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options a. b. c. d. e. f. g. h. i. j. k. l. m. to edit basal limits. See Section 3.1.3 for procedure Increment. Enter button. STOP BASAL DELIVERY as needed. Scroll up to highlight Press Scroll to select desired increment. Press Notice Press Scroll to select desired maximum. Press Enter button. Maximum is highlighted. Enter button. Enter button. Review settings, and make changes as needed. Notice Press RESTART BASAL DELIVERY Done is highlighted Enter to return to the Home screen. if you have no other edits. 11. Edit Temp Basal Setup. You have completed editing the basal limits. Temp. a. b. c. d. Scroll to highlight Enter button. Press Scroll to select Press Enter button. Percent or Units. e. f. Notice Press Done is highlighted. Enter button to return to the Home screen. You have completed editing the temp basal setup. 119 a. b. c. d. e. f. g. h. i. j. k. l. m. n. o. Increment. Enter button. Enter button. Maximum is highlighted. Enter button. Scroll up to highlight Press Scroll to select desired increment. Press Notice Press Scroll to select desired maximum. Press Review settings. Notice Press Notice Scroll up to highlight Press Scroll to select Press Enter button. Enter button. Enter button. On or Off. On/Off. Next is highlighted. Enter button. ONE-BUTTON BOLUS screen displays. If you selected On Off Then do this 1. 2. 3. Enter button. Increment is highlighted. Enter button. Notice Press Scroll to select desired increment.
(0.5 u or 1.0 u). Press Review settings, and make changes as needed. Notice Press 4. 5. 6. 7. Notice Done is highlighted and Increment is gone from the screen. Press Enter button to return to the Home screen. Done is highlighted. Enter button to return to the Home screen. You have completed editing the bolus limits. 120 DOC15736_Rev-A-Man.indd 119-120 2/9/09 11:29:45 AM Section 6: When Youre Ready Optional Settings 6.2 Edit Additional Options Steps 13. Edit Insulin Profile. Type. Do This a. b. c. d. e. f. g. h. i. Scroll to highlight Enter button. Press Scroll to select Enter button. Press Scroll to highlight Scroll to select action time. Press Notice Press Rapid or Short. Action Time. Enter button. Next is highlighted. Enter button to return to Home screen. Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments Steps Contrast. 0, 1, or 2 (Low, Medium, or High). Do This m. n. o. p. q. r. s. You have completed editing the display preferences. Scroll to highlight Enter button. Press Scroll to select Press Review settings. Scroll to highlight Press Enter button to return to Home screen. Enter button. Done. You have completed editing the insulin profile. 15. Create/Edit Name to personalize your system. Note: The name will display when you wake up the pump. 14. Edit Display Preferences. a. b. c. Timeout is highlighted. Enter button. Notice Press Scroll to select screen timeout ranging from 15 to 120 seconds. Note: You may want to change your timeout to 30 or 60 seconds if you frequently timeout. Highlight or Outline (see examples on next page). Cursor. Enter button. Press Scroll to highlight Enter button. Press Scroll to select Enter button. Press Scroll to highlight Enter button. Press Information or Activity display for Home screen. Select Enter button. Press d. e. f. g. h. i. j. k. l. Continued on the next page. Home. Reminder: To get here from Home screen, go to Main menu, Setup menu and select Name. a. highlight and select each letter by pressing the Enter button to Scroll to spell out the name you want for your system, for example, Amy. b. c. Scroll to highlight Done when you have finished spelling the name. Press Enter button to return to the Home screen. You have completed creating/editing the name. DOC15736_Rev-A-Man.indd 121-122 2/9/09 11:29:45 AM 121 122 Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments Steps 16. Edit BG Target Range. Do This Low Target is highlighted. Enter button. Notice Press Scroll to select desired low target value. Press Enter button. When Materials a. b. c. d. e. f. g. h. High Target. Scroll to highlight Enter button. Press Scroll to select desired high target value. Press Enter button. i. j. Done Press is highlighted. Enter button to return to the Home screen. 17. Check your work. You have completed editing the BG target range. Repeat from Step 1 to review the different settings in the various menus. RESTART YOUR BASAL DELIVERY as needed. Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments 6.3 Set Reminders and Care Comments Purpose To set reminders to alert you to a diabetes care task or to turn on certain care comments noted in your Aviator Companion. Do this procedure:
When you need to set up a task reminder. When you wish to set up care comments in your companion/pump. Your companion operating with all settings programmed. Your pump operating with all settings programmed and delivering basal. Assistance from healthcare professional as needed. Helpful Information Off by default, and are a choice to discuss with your healthcare profes-
Reminders and Care Comments are set to sional. Reminders prompt you to perform certain tasks by making your pump beep or vibrate. They also display a screen message on the time or day that you specify. Up to six separate reminders can be programmed on your companion in any way or combination you choose from the list below (i.e., set six Check BG reminders, or two Check BG reminders and one Exercise reminder, or one snack reminder only if thats all you want. Time to Test your blood glucose Take your medications Eat a snack Do a pickup Attend a meeting Go for your exercise Deliver a bolus Start or stop basal Wake up from naps/sleep Reminder Message Check BG Meds Snack Pickup Meeting Exercise Bolus Basal Wakeup DOC15736_Rev-A-Man.indd 123-124 2/9/09 11:29:45 AM 123 124 All reminders prompt you by making your pump beep or vibrate and display a screen message at the time youve specified, except for the Bolus reminder. If you deliver a bolus within 2 hours before the pump is sched-
uled to give you a reminder, it will self-cancel and you will NOT get that particular bolus reminder until the next day. These are non-recurring reminders. Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments Procedure:
Steps 1. Do This Go to the ALARMS menu. a. b. c. d. e. Home screen, notice Main is highlighted. From the Press Enter button. ALARMS. Scroll to highlight Press Decide which alarm you want to edit. Enter button to go to ALARMS menu. If you are setting Reminders Care Comments Then do this Go to Step 2. Go to Step 5. 2. Set REMINDERS. a. b. Scroll to highlight Enter button. Press REMINDERS. c. d. Notice Press 1. Check Bg (Off) is highlighted. Enter button. 3. Set time for REMINDERS. a. b. c. d. Time. Scroll to highlight Enter button. Press Scroll to set time for the first reminder. Press Enter button. Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments Steps 4. Set REMINDER Options. Do This a. b. Notice Press Message is highlighted. Enter button. c. d. e. f. g. h. i. Check BG, Wakeup, Basal, Bolus, Exercise, Meeting, Pickup, Scroll to select Snack, or Meds. Press Notice Press Enter button. On/Off is highlighted. Enter button. On or Off. Scroll to select Press Decide what to do next. Enter button. If you want to Add reminders Finish setting up reminders Next is highlighted. Enter button to return to REMINDERS screen. Notice Press Scroll to highlight Enter button. Press Repeat Steps 3 and 4 to add more reminders (up to six). Then do this 1. 2. 3. 4. 5. Scroll to highlight Done. Press Enter button to return to the Home screen. 2. Check BG (Off). You have completed setting up a reminder(s). DOC15736_Rev-A-Man.indd 125-126 2/9/09 11:29:45 AM 125 126 Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments Steps Set 5. CARE COMMENTS. Do This a. b. Scroll to highlight Enter button. Press CARE COMMENTS. c. Notice Disable All is highlighted. Note: Disable All is set to Yes by default; all other options are initially off. The asterisk next to an item indicates the option is enabled. Disable All with Yes selected overrides settings for other care comments. d. e. f. g. h. Disable All. Enter button. Press Scroll to highlight Enter button. Press No. Scroll to select Enter button. Press i. j. Notice Press Next is highlighted. Enter button to return to CARE COMMENTS screen. Steps 6. Set INSULIN TEMP, SITE CHANGE and/or CHECK BG. Section 6: When Youre Ready Optional Settings 6.3 Set Reminders and Care Comments Do This Decide what care comments you want to set. If you selected Insulin Temperature Then do this 1. Scroll to highlight INSULIN TEMP. Note: The alarm will sound if the pump senses a temperature above or below the recommended insulin temperatures. 2. 3. 4. 5. 6. 7. 8. Alert. Enter button. Next is highlighted. Press Notice Scroll to highlight Enter button. Press On. Scroll to select Enter button. Press Next is highlighted (to set another care comment) Notice OR scroll to highlight Done. Press Enter button to return to CARE COMMENTS screen. 9. You have completed setting care comments for Insulin Temperature. Continued on next page. DOC15736_Rev-A-Man.indd 127-128 2/9/09 11:29:45 AM 127 128 Section 6: When Youre Ready Optional Settings 6.4 Enter Event Data Steps Do This Steps Do This Section 6: When Youre Ready Optional Settings 6.4 Enter Event Data If you selected Site Change
(to remind you to change your infusion set and site) Then do this 1. 2. Scroll to highlight Press Enter button. SITE CHANGE. 3. Notice Next is highlighted. 4. 5. 6. 7. Scroll to highlight Alert. Press Enter button. Scroll to select On. Press Enter button. 8. 9. 10. 11. Notice Frequency is highlighted (default 2.0 days). Press Enter button. Scroll to set frequency. Press Enter button. 12. 13. Notice Next is highlighted (to set another care comment) OR scroll to highlight Done. Press Enter button to return to the Home screen. You have completed setting care comments for Site Change. If you selected Check BG
(to remind you to test your blood glucose) Alert. CHECK BG. Then do this 14. 15. 16. 17. 18. 19. 20. 21. Scroll to highlight Enter button. Press Next is highlighted. Notice Scroll to highlight Enter button. Press On. Scroll to select Enter button. Press Next is highlighted (to set another care Notice comment) OR scroll to highlight Done. Press screen. Notice Press 22. Enter button to return to CARE COMMENTS Done is highlighted. Enter button to return to the Home screen. 23. 24. You have completed setting care comments for Checking BG. 7. Check your work. To check your settings, follow the steps in this task from the beginning again to review each menu and screen. Continued on next page. DOC15736_Rev-A-Man.indd 129-130 2/9/09 11:29:46 AM 129 130
1 | User manual 2 of 2 | Users Manual | 2.65 MiB |
Section 6: When Youre Ready Optional Settings 6.4 Enter Event Data 6.4 Enter Event Data Purpose When Do this procedure:
To enter event data into your Aviator Companion for a record of event history. Materials When you wish to enter insulin, meals, exercise, state of health, or generic event data into your companion. Your companion operating with all settings programmed. Your pump operating with all settings programmed. Assistance from healthcare professional as needed. Helpful Information Procedure:
You can ONLY perform this task using your companion. You CANNOT enter event data using your pump. Steps 1. Access the EVENT menu. SELECT Do This a. b. c. d. e. From the Home screen, notice Enter button. Press Scroll to highlight Press Decide what event you want to add. ADD EVENT. Enter button to go to SELECT EVENT menu. Main is highlighted. If you are adding an event for Insulin Food Exercise State of Health Generic Then do this Go to Step 2. Go to Step 3. Go to Step 4. Go to Step 5. Go to Step 6. Steps 2. Go to the menu. INSULIN Section 6: When Youre Ready Optional Settings 6.4 Enter Event Data Do This a. b. c. d. e. f. g. h. i. Notice Press INSULIN is highlighted. Enter button. Type is highlighted. Enter button. Notice Press Scroll to select insulin type (Rapid, Intermediate, Pre-Mix, Long Acting, Short-
Acting, Inhaled) Press Enter button. Units. Scroll to highlight Enter button. Press Scroll to select the units of insulin. Note: The range is 0.00 to 99.50. j. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. k. l. Scroll to highlight Press Done. Enter button to return to the Home screen. You have completed adding an insulin event. DOC15736_Rev-A-Man.indd 131-132 2/9/09 11:29:46 AM 131 132 Section 6: When Youre Ready Optional Settings 6.4 Enter Event Data Steps 3. Do This FOOD menu. Go to the a. b. c. d. e. f. g. h. i. Scroll to highlight Enter button. Press FOOD. Type is highlighted. Enter button. Notice Press Scroll to select meal type (Breakfast, Lunch, Dinner, and Snack). Press Enter button. Carbs (CARBOHYDRATE) is highlighted. Enter button. Notice Press Scroll to select the amount of Carbs. Note: The range is 0 to 350 grams. j. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. k. l. Scroll to highlight Press Done. Enter button to return to the Home screen. You have completed adding a meal event. Steps 4. Go to the menu. EXERCISE Section 6: When Youre Ready Optional Settings 6.4 Enter Event Data Do This a. b. Scroll to highlight Enter button. Press EXERCISE. Note: You can just enter the exercise type and NOT the duration or intensity. c. d. e. f. g. h. i. Type is highlighted. Enter button. Notice Press Scroll to select exercise type (Aerobics, Walking, Jogging, Running, Swimming, Biking, Weights, or Other). Enter button. Press Scroll to highlight Enter button. Press Scroll to select the exercise duration. Duration. Note: The range is 0:00 to 5:00 hours. j. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. k. l. m. n. o. p. Intensity. Scroll to highlight Enter button. Press Scroll to select exercise intensity (Low, Medium, High, None). Enter button. Press Scroll to highlight Press Enter button to return to the Home screen. Done. DOC15736_Rev-A-Man.indd 133-134 2/9/09 11:29:46 AM 133 134 You have completed adding an exercise event. Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Steps 5. Do This STATE OF Go to the HEALTH menu. a. b. c. d. e. f. Scroll to highlight Enter button. Press STATE OF HEALTH. State is highlighted. Enter button. Notice Press Scroll to select state of health (Normal, Cold, Sore Throat, Infection, Tired, Stress, Fever, Flu, Allergy, Period, Dizzy, Alcohol, Low Symptoms, or High Symptoms). Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. g. h. Scroll to highlight Press Done. Enter button to return to the Home screen. You have completed adding a state of health event. Steps 6. Go to the menu. GENERIC Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Do This a. b. Scroll to highlight Enter button. Press GENERIC. Note: You can enter up to eight generic events. c. d. e. Event is highlighted. Enter button. Notice Press Scroll to select event number. Note: The range is 1 to 8. You need to define what the generic events 1 to 8 means and record in your Table of Settings in Section 12-Appendix A. f. Press Enter button. Note: You can scroll to highlight Cancel and press Enter to cancel any entries at anytime. g. h. Scroll to highlight Press Done. Enter button to return to the Home screen. You have completed adding a generic event. 7. Check your work. Go back to each event menu to see if you have the correct information added. DOC15736_Rev-A-Man.indd 135-136 2/9/09 11:29:46 AM 135 136 Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports 6.5 Review History, Status, and Reports Purpose When To review important system and diabetes care information using your Aviator Companion. Do this procedure when you need detailed information about:
Bolus status (up to 30 days) Basal status (up to 30 days) System status Pump levels Companion levels Pump version Companion version Bolus History BG History Line Graph BG Statistics Event History (up to 150 most recent events) Pump Diary Your companion and pump fully operating. Assistance from healthcare professional as needed.
(Therapy, Events, Alarms) Materials Procedure:
Steps 1. Decide if you need to review system status or reports. Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Do This If you are reviewing Last Bolus Status Basal Status System Status (Battery/Insulin levels) Pump Levels Companion Levels Pump Version Companion Version Bolus History BG History Line Graph BG Statistics Event History Pump Diary (Therapy, Events, Alarms) Then do this Go to Step 2 - STATUS menu. Go to Step 3 - REPORTS menu. Helpful Information If you need to call Customer Care, you may be asked to provide information from your companion or pump screens. If you have unexplained high or low blood glucose, review your recent bolus history to see if you missed deliv-
ering a bolus or if you delivered an incorrect dose (see Section 11), as well as review your basal rates and daily totals to assist you or your healthcare professional to resolve the cause of the observation. DOC15736_Rev-A-Man.indd 137-138 2/9/09 11:29:46 AM 137 138 Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Steps 2. STATUS menu. Go to the Do This Note: The following screens will appear when the system is paired, Radio is ON, and pump communication is available. a. b. From the Press Enter button. Home screen, Notice Main is highlighted. Note: You can also access System Status screens from the System Status panel. c. d. e. f. Scroll to highlight Enter button. Press STATUS. Review the bolus status. Notice Next is highlighted. Note: You can scroll to highlight Done and Press Enter button to return to the MAIN MENU screen at any time. g. h. i. j. Enter button. Press Review the basal status. Notice Press Next is highlighted. Enter button. Steps Do This Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports q. Review the pumps version. Note: The version numbers displayed on your system may be different. r. s. t. u. Next is highlighted. Enter button. Notice Press Review the companions version. Decide whether to return to MAIN MENU or Home screen. If MAIN MENU Home screen Then do this Notice Next is highlighted. Press Enter button. Scroll to highlight Done. Press Enter button.. You have completed reviewing status information about your pump. k. l. m. Review the pumps battery and insulin levels. Notice Press Next is highlighted. Enter button. n. o. p. Review the companions battery level. Notice Press Next is highlighted. Enter button. Continued on next page. DOC15736_Rev-A-Man.indd 139-140 2/9/09 11:29:46 AM 139 140 Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Steps 3. Do This REPORTS Go to the menu. a. b. c. d. Home screen, Notice Main is highlighted. From the Press Enter button. Scroll to highlight Enter button. Press REPORTS. Note: The pump screen will only display Bolus History, Pump Diary, and Send Diary. e. Decide what to review. If you are reviewing Bolus History BG History Line Graph BG Statistics Event History Pump diary including therapy, events, and alarms Then do this Go to step 4. Go to Step 5. Go to Step 6. Go to Step 7. Go to Step 8. Go to Step 9. 141 Steps 4. View Bolus History. Do This a. b. Scroll to highlight Enter button. Press BOLUS HISTORY. Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports c. d. e. Review your bolus history starting from the most recent bolus. Notice Press Next is highlighted. Enter button to review another bolus. f. Press Enter button on Next to review as many bolus records as needed. g. h. Highlight Press Done when you have reviewed enough bolus history records. Enter button to return to the Home screen. You have completed reviewing your Bolus history. 5. View BG History. a. b. Scroll to highlight Enter button. Press BG HISTORY. c. d. Scroll to review your blood glucose readings. Press Enter button when you are done reviewing. e. f. Notice Press Done is highlighted. Enter button to return to the Home screen. You have completed reviewing your BG history. 142 DOC15736_Rev-A-Man.indd 141-142 2/9/09 11:29:47 AM Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Steps 6. View BG Line Graph. Do This Steps 7. View BG Statistics. Do This Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports a. b. Scroll to highlight Press Enter button. LINE GRAPH. a. b. Scroll to highlight Press Enter button. BG STATISTICS. c. Review your blood glucose line graph. d. Press Enter button. e. f. Scroll to select the time period to display on the line graph. (If a 4 hour time range is selected, then the bottom scroll displays data in 4 hour time periods from 12am to 11pm), and press Enter button. Notice the time period highlighted at the bottom of the line graph. Press Enter button again to use the scroll to select a specific time period to view, for example, 5pm to 6pm. g. Press Back button to return to the REPORTS menu. You have completed reviewing your BG line graph. c. Scroll to review your blood glucose information for 7, 14, or 21 days as needed. d. Press Enter button when you are done reviewing. e. f. Notice Press Done is highlighted. Enter button to return to the Home screen. You have completed reviewing your BG statistics. 8. View Event History. a. b. Scroll to highlight Press Enter button. EVENT HISTORY. DOC15736_Rev-A-Man.indd 143-144 2/9/09 11:29:47 AM 143 144 Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Steps Do This c. Scroll to select (View All, Insulin, Food, Exercise, State of Health, or Generic) event history to review. Note: You can review up to the last 150 events, starting from the most recent events. d. Press Enter button. Note: Press the Back button to go backwards to a previous screen. Section 6: When Youre Ready Optional Settings 6.5 Review History, Status, and Reports Steps 9. View Pump Diary. Do This a. Notice b. Press c. Decide whether to view therapy, events, or alarms. PUMP DIARY is highlighted. Enter button. If you want to review Insulin therapy amounts Pump events Alarm history Then do this Go to Step 10. Go to Step 11. Go to Step 12. 10. Review Therapy amounts. a. b. c. d. e. Therapy is highlighted. Enter button. Notice Press Review the bolus and basal insulin units, and basal percentage. Notice Press Next is highlighted. Enter button. Note: You can scroll to highlight Done and Press Enter button to return to the Home screen at any time. Note: If you want to go back to previous therapy screens, press the Back button. You can press Enter button on Next to go through all the therapy screens logged on the pump. When you press Enter button for the Next action on the last therapy screen, you will return to the PUMP DIARY screen. You have completed reviewing your insulin therapy amounts. e. f. g. Press Notice Press Enter button when you reach the end of data. Done is highlighted. Enter to return to the Home screen. You have completed reviewing your Event history. DOC15736_Rev-A-Man.indd 145-146 2/9/09 11:29:47 AM 145 146 Section 6: When Youre Ready Optional Settings 6.6 Upload Data Steps 11. Review Events. Do This Note: Pump diary events provide information about your basal delivery programs and basal rates. a. b. c. d. Events. Scroll to highlight Enter button. Press Review the basal delivery events that have occurred on your pump. Notice Next is highlighted. Note: You can scroll to highlight Done and Press Enter button to return to the Home screen e. Press Enter button on Next to review as many events as you need. Note: If you want to go back to previous event screens, press the Back button. f. g. When you are done reviewing, scroll to highlight Enter button to return to the Home screen. Press Done. You have completed reviewing your pump events. Section 6: When Youre Ready Optional Settings 6.6 Upload Data Steps 12. View Alarms history. Do This a. b. Scroll to highlight Enter button. Press Alarms. c. d. e. Review the alarm history of your pump. Notice Press Next is highlighted. Enter button on Next to review your last 10 alarms as needed. f. g. When you are done reviewing, scroll to highlight Enter button to return to the Home screen. Press Done. You have completed reviewing the alarm history of your pump. 13. Check your work. You are able to obtain all information related to your companion and pump status and reports following the steps above. DOC15736_Rev-A-Man.indd 147-148 2/9/09 11:29:47 AM 147 148 Section 6: When Youre Ready Optional Settings 6.7 Companion Self Test 6.6 Upload Data Purpose When To upload event data from your companion to your computer. Do this procedure:
When you wish to upload data from your companion to your computer. Your companion and pump fully operating. Assistance from healthcare professional as needed. Materials Steps 3. Check your work. Do This a. Check that uploaded data is displayed on the screen. CoPilot for FreeStyle Aviator Section 6: When Youre Ready Optional Settings 6.7 Companion Self Test You will perform this task using the companion. Make sure the USB cable is connected and the battery is charging. Helpful Information WARNING: Use ONLY the USB cable provided. Use of an unapproved cable may lead to loss of electromagnetic compatibility, and make the system more susceptible to electronic interference. Procedure:
Steps 1. Go to the Home screen. Do This a. Follow instructions detailed in the perform the data upload CoPilot for FreeStyle Aviator users guide to 2. Upload data. a. The Aviator Companion will display the data transfer screen during the data transfer process. DOC15736_Rev-A-Man.indd 149-150 2/9/09 11:29:47 AM 149 150 Steps 2. Observe Self Test. Do This a. Check the display (the display will highlight). Section 6: When Youre Ready Optional Settings 6.8 Pair Companion and Pump Note: The display automatically advances through the sequence of screens at a rate of 0.5 seconds per screen. Section 6: When Youre Ready Optional Settings 6.7 Companion Self Test 6.7 Companion Self Test Purpose To perform a self test for the Aviator Companion to ensure that the display, audio, vibrator, backlight, test light, and memory functions are working. Do this procedure:
Before you set up and use your companion and pump for the first time. When you wish to self test the companion because you are functions are working properly. Anytime you see the Low Battery Alert screen. NOT sure if all the When Materials Procedure:
Steps 1. Go to the SETUP menu. Do This From the Press Enter button. a. b. c. d. e. f. Your companion operating with all settings programmed. Assistance from healthcare professional as needed. b. Confirm audio sounds (you will hear beeps). Home screen, notice Main is highlighted. c. Confirm vibrator (you will feel short vibes). Scroll to highlight Enter button. Press SETUP. Scroll to highlight Enter button. Press SELF TEST. d. Confirm backlight (the backlight turns on). e. Confirm test light (the test light turns on). f. Check memory. Note: You will automatically return to the SETUP menu, and Home screen if no other actions are taken. DOC15736_Rev-A-Man.indd 151-152 2/9/09 11:29:48 AM 151 152 Section 6: When Youre Ready Optional Settings 6.8 Pair Companion and Pump Steps 3. Check your work. Do This Confirm that ALL functions are working properly when you performed the companion self-test. Call Customer Care, if any of the functions are NOT working, or you get a Companion Memory Error warning. Caution:
If your pump audio or vibratory annunciators are not functioning, switch to insulin injections immediately AND contact your healthcare professional and/or Customer Care. Materials Section 6: When Youre Ready Optional Settings 6.8 Pair Companion and Pump 6.8 Pair Companion and Pump Purpose When To pair your Aviator Companion and Aviator Pump to operate as a system. Do this procedure:
When you receive a new companion or pump thats a replacement for your system. Your companion fully charged. Your pump with battery installed and initialized. Assistance from healthcare professional as needed. Pairing establishes an association of your pump with your companion so that the two will only communicate with each other. Your companion and pump should already be paired when you receive your FreeStyle Aviator System package. The RF will automatically turn ON when pairing, if it is NOT already on. Helpful Information Procedure:
Steps 1. Go to the Companions SETUP menu. Do This Note: The following steps are performed using your companion. a. b. Main is highlighted. Enter button. Notice Press c. d. Scroll to highlight Enter button. Press SETUP. DOC15736_Rev-A-Man.indd 153-154 2/9/09 11:29:48 AM 153 154 Section 6: When Youre Ready Optional Settings 6.8 Pair Companion and Pump Steps 2. Do This Go to the Companions PAIR PUMP menu to prepare the Companion. a. b. Scroll to highlight Enter button. Press PAIR PUMP. c. d. Notice Notice CONFIRM screen with Is Pump ready? message displays. No is highlighted. Steps 4. Go to the Pumps DEVICE menu to prepare the Pump. PAIR Section 6: When Youre Ready Optional Settings 6.8 Pair Companion and Pump Do This a. b. Scroll to highlight Enter button. Press PAIR DEVICE. c. Notice PUMP screen is searching for companions. 3. Go to the Pumps menu. SETUP Note: The following steps are performed using your pump. a. b. Notice Press Main is highlighted. Enter button. FPO
<insert screen with SETUP highlighted>
c. d. Scroll to highlight Enter button. Press SETUP. 5. Go to the Companions CONFIRM screen to pair pump. Note: The following steps are performed using your companion. a. b. Scroll to highlight Enter button. Press Yes. c. Notice COMPANION screen is searching for pumps. DOC15736_Rev-A-Man.indd 155-156 2/9/09 11:29:48 AM 155 156 Section 6: When Youre Ready Optional Settings 6.9 Turn RADIO Off/On Steps 6. Confirm pairing of pump with Companion Do This Note: The following steps are performed using your companion. a. b. Notice Notice CONFIRM screen with Pair with Pump S/NPPPPP. No is highlighted. c. d. Scroll to highlight Enter button. Press Yes if pump is correct. 7. Verify paired pump and Companion Verify that the companion and pump are paired by the Radio On signal in both devices displayed on the Home screens. Section 6: When Youre Ready Optional Settings 6.9 Turn RADIO Off/On Do This Verify that the companion and pump are paired by the serial numbers displayed on the Status screens. Check your work. Steps 8.
<insert companion Status screen with paired pump information>
FPO FPO
<insert pump Status screen with paired companion information>
DOC15736_Rev-A-Man.indd 157-158 2/9/09 11:29:48 AM 157 158 Section 6: When Youre Ready Optional Settings 6.9 Turn RADIO Off/On 6.9 Turn RADIO Off/On Purpose When Materials To turn off the radio frequency signal between your Aviator Companion and Aviator Pump before you get on an airplane. Do this procedure:
Before you take off in an airplane or as directed by any other official. Your companion and pump fully operating. Your companion and pump already paired. Assistance from healthcare professional as needed. Steps 2. Go to the on your Companion. RADIO menu Section 6: When Youre Ready Optional Settings 6.10 Therapy Lockout Do This a. b. Scroll to highlight Enter button. Press RADIO. c. Notice Done is highlighted. If your companion and pump are NOT paired, radio setting will be Off. Helpful Information Procedure:
Steps 1. SETUP menu Go to the on the Companion. Do This a. b. From the Press Enter button. Home screen, notice Main is highlighted. c. d. Scroll to highlight Enter button. Press SETUP. 3. Go to the SETUP menu on the pump. d. e. f. g. h. i. a. b. Radio. Scroll to highlight Enter button. Press Scroll to Press Enter button. Off. Notice Press Done is highlighted. Enter button. Home screen, notice Main is highlighted. From the Press Enter button. DOC15736_Rev-A-Man.indd 159-160 2/9/09 11:29:48 AM 159 160 c. d. Scroll to highlight Enter button. Press SETUP. Section 6: When Youre Ready Optional Settings 6.10 Therapy Lockout Steps 4. RADIO menu Go to the on your Pump. Do This a. b. c. RADIO. Scroll to highlight Enter button. Press Done is highlighted. Notice 6.10 Purpose When d. e. f. g. Radio. Scroll to highlight Enter button. Press Scroll to Press Enter button. Off. Done is highlighted. Notice h. Press Enter button. 5. Check your work. Look at the system status panel on the Home screen to verify that the radio signal is off. To turn the radio signal back on, repeat all the steps above and scroll to select Radio to On. Therapy Lockout Section 6: When Youre Ready Optional Settings 6.10 Therapy Lockout To lock and unlock the Aviator Pumps basal and bolus features from your Aviator Companion. Do this procedure when you wish to prevent access to the following pump options:
MAIN MENU screen. Home screen. Selecting either the basal or bolus panels on the QBolus soft key on the Home screen. Using the Selecting any of the following on the Your companion fully operating. START/STOP BOLUS BASAL PRIME The Materials Helpful Information Procedure:
Steps 1. SETUP menu. Go to the Lockout setting is Off by default. Do This a. b. From the Press Enter button. Home screen, notice Main is highlighted. c. d. Scroll to highlight Enter button. Press SETUP. DOC15736_Rev-A-Man.indd 161-162 2/9/09 11:29:48 AM 161 162 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 2. Do This THERAPY Go to the LOCKOUT screen. a. b. Scroll to highlight Enter button. Press THERAPY LOCKOUT. c. Notice Lockout is Off. d. e. f. g. Scroll to highlight Enter button. Press Lockout. On. Scroll to Press Enter button. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 3. Set Duration for lockout. Do This Note: The duration is set to Always by default when lockout is On. a. b. Notice Decide what to do next. Duration is highlighted. If you want duration to be Once Then do this 1. 2. 3. Press Scroll to select Press Enter button. Enter button. Once. Always Done. 4. Scroll to highlight Enter button. 5. Press Scroll to highlight Done. Press Enter button. 4. Check your work. Go back to the THERAPY LOCKOUT screen and verify that the settings are correct. To unlock your pump therapy features, go to Step 5. DOC15736_Rev-A-Man.indd 163-164 2/9/09 11:29:48 AM 163 164 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 5. Do This Note: If you attempt to access any basal or bolus features when Lockout is On, you will see a Confirmation screen. Unlock pump therapy features. CONFIRM screen with Insulin delivery changes are locked out. a. b. Notice the message displays. Notice Cancel is highlighted. Note: If you select Cancel, you will return to the Home screen and pump therapy features remain locked out. c. d. e. Scroll to highlight Enter button. Press Unlock. Administer your basal or bolus insulin delivery as recommended by your healthcare professional. 165 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program 7 Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Purpose When Do this procedure:
To edit an existing basal program in your pump using your Aviator Companion. Materials Whenever you need to edit an existing basal program, including adding or deleting basal time blocks and basal rates. Your companion with battery charged and basal settings programmed. basal settings programmed. Your pump with the battery installed and Healthcare professionals recommendations for your personalized basal settings for the pump in Section 12 Appendix A. Important Note: It is strongly recommended that you and your healthcare professional work on fine tuning your basal rates. Always notify your healthcare professional if you make changes to prescribed plans of care. Helpful Information Edit program is one of the MODIFY program options from the BASAL MENU. The other Modify program The options are Create program, Rename program and Delete program. Your currently running active program will have an asterisk (
*) to the left of the name. Procedure:
Steps 1. Access BASAL MENU from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BASAL. 166 DOC15736_Rev-A-Man.indd 165-166 2/9/09 11:29:48 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 2. Do This MODIFY Select program. a. b. Scroll to highlight Enter button. Press MODIFY. c. d. Notice Press Edit is highlighted. Enter button. 3. Select the existing program to edit. Notice *Daily is highlighted. Note: The * represents the active program, and Daily is the default program. If you want to Edit your Daily program Edit a different program Then do this Press Enter button. Scroll to highlight the program you want to edit, for example, Travel. Press Enter button. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.1 Edit a Basal Program Steps 4. Decide what edits you want to make. Do This If you want to Edit an existing time block and basal rate Add a time block and basal rate Delete a time block and basal rate 2. 3. 1. 2. 3. 1. Return to the Home screen without editing a basal program Then do this 1. 5. Enter button. Add Block is highlighted. Enter button. Scroll to the desired time block and basal rate to edit. Press Go to Step Notice Press Go to Step Scroll to the desired time block and basal rate to delete. Enter button. Press Go to Step 8. 2. 3. Scroll to highlight Done. Press Enter button. 11. Note: You MUST have at least ONE block and You MUST select Done to complete and save all the changes you have made. 5. Edit Time block. a. b. c. d. Scroll to highlight Enter button. Press Time. Scroll to select the desired time for the block. Press Enter button. DOC15736_Rev-A-Man.indd 167-168 2/9/09 11:29:49 AM 167 168 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program Steps 6. Do This Edit Basal Rate. a. b. Notice Press Rate is highlighted. Enter button. Note: If you are keeping the same basal rate, leave the basal rate as shown. c. d. Scroll to select desired basal rate. Press Enter button. e. f. Notice Press Next is highlighted. Enter button. 7. Decide what to do next. If you want to Edit another time block and basal rate Then do this 1. Add a time block and basal rate 2. 3. 1. 2. 3. Enter button. Scroll to another time block and basal rate that you want to edit. Press Repeat Steps 5 and 6 to edit additional time blocks and basal rates. Notice Press Go to Step Add Block is highlighted. Enter button. 8. Note: If the last time block begins at 11:30 pm, the Add block option is removed from the screen and you CANNOT add another block. Delete a time block and basal rate Be finished with all your edits and return to the Home screen 1. 2. 3. 1. 2. 3. 169 11. Enter button. Scroll to desired time block and basal rate to delete. Press Go to Step Scroll to highlight Enter button. Press Go to Step task. 13 to confirm you have completed this Done. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program Steps 8. Set Time for new block. Do This a. b. Notice Press Time is highlighted. Enter button. c. d. Scroll to select desired time for the block. Press Enter button. Note: The starting time for the new block will be hour after the block you just created. 9. Set Rate for new block. a. b. c. d. e. f. Notice Press Rate is highlighted. Enter button. Scroll to select desired basal rate for the block. Press Enter button. Notice Press Next is highlighted. Enter button. 10. Decide what to do next. If you want to Add another time block and basal rate Then do this 1. 2. 3. Add Block. Scroll to highlight Enter button. Press Repeat Steps 8 and 9 to add additional time blocks and basal rates. Scroll to desired time block and basal rate to delete. Press Go to Step 11. Enter button. 2. 3. Scroll to highlight Done. Press Enter button. Delete a time block and basal rate 1. Be finished with all your edits and return to the Home screen 170 DOC15736_Rev-A-Man.indd 169-170 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program Steps 11. Delete block(s). Do This a. Notice b. Scroll to highlight Enter button. c. Press Next is highlighted. Delete. d. e. CONFIRM screen and Delete block? message displays. Notice Decide what to do. If you want to Delete the time block and basal rate Cancel deleting the time block Then do this 1. 2. Scroll to highlight Enter button. Press Yes. Note: Notice that the time block has been deleted from the list. 3. 1. 2. 3. 4. Repeat Steps 10 and 11 to delete other blocks and basal rates. No is highlighted. Notice Enter button. Press Scroll to highlight Enter button. Press Next. Note: You will return to the list of time blocks and basal rates. Check the settings. 12. Decide what to do next. If you want to Make any additional changes to the basal program Be finished with all your edits and return to the Home screen Then do this Go back to Step 4. Scroll to highlight Done. Press Enter button. 13. Check your work. View the program you have just edited, and verify the settings that you have changed. Refer to Section 3.1.2 View Basal Program for the procedure as needed. Note: The Daily basal rate is now reflecting the edits made above. 171 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.2 Create a New Basal Program 7.2 Create a New Basal Program Purpose When Do this procedure:
To create up to four basal programs that suit your lifestyle, using the Aviator Companion. Whenever you need to create a weekend, exercise, sick day, or custom-named basal pro-
gram, in addition to your daily basal program. Your companion with battery charged and initial basal settings programmed. Your pump with the battery installed and initial basal settings programmed. Healthcare professionals recommendations for your basal settings for the pump in tion 12 - Appendix A. Sec-
Create program is one of the Modify program options from the BASAL MENU. The other Modify program The options are Edit program, Rename program and Delete program. You should consult your healthcare professional before creating any new basal programs. Materials Helpful Information Procedure:
Steps 1. Access BASAL MENU from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BASAL. 2. Access MODIFY PROGRAM menu. a. b. Scroll to highlight Enter button. Press MODIFY. 172 DOC15736_Rev-A-Man.indd 171-172 2/9/09 11:29:49 AM Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.3 Select a Basal Program Steps 3. Do This Access CREATE PROGRAM menu. a. b. Scroll to highlight Enter button. Press CREATE. 4. Decide the type of program to create. If you want to create Weekend basal program Exercise basal program Sick day basal program Custom-named basal program Then do this Notice Weekend is highlighted. Press Enter button. Scroll to highlight Exercise. Press Enter button. Scroll to highlight Sick. Press Enter button. 1. 2. 3. Custom. Scroll to highlight Enter button. Press Scroll to highlight each letter and press the button each time, as you spell out the name for your customized program, for example, Travel. Enter Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.3 Select a Basal Program Steps 5. Set Time for BLOCK 1. Do This a. b. Notice Press Time dashed line is highlighted. Enter button. c. d. e. f. 6. Set Rate for BLOCK 1. Time is highlighted. Enter button. Notice Press Scroll to select desired start time for the block. Press Enter button. a. b. Notice Press Rate is highlighted. Enter button. c. d. Scroll to select desired rate of insulin per hour. Press Enter button. Note: At least ONE block must be added. If NO additional blocks are added, the first block will prevail for 24 hours. Note: The first letter and a letter following a space is automatically capitalized. Note: To clear an entry if you make a mistake, highlight Erase and press the Enter button to erase the last letter entered as needed. 4. 5. Scroll to highlight Enter button. Press Next when you are done. Note: If you try to create more than 4 programs, the WARNING screen and the Max number of programs already exist. message displays. Notice that OK is highlighted, press Enter button to continue. DOC15736_Rev-A-Man.indd 173-174 2/9/09 11:29:49 AM 173 174 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.4 Rename a Basal Program 7.3 Select a Basal Program Purpose When Materials To activate the different basal programs by selecting and choosing between them using your Aviator Companion. Do this procedure:
Whenever you need to change your active basal program. Your companion and pump fully operating with daily basal already started. Your companion and pump with additional programs created, such as Weekend, Exercise, Sick day, or your custom-named program. Instructions or assistance from your healthcare professional. Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information The system allows you to program multiple basal profiles. The one you select is called the active program. When viewing your basal programs, the currently running active program will have an asterisk (*) to the left of the name. Important Note: It is strongly recommended that you and your healthcare professional work on fine tuning your basal rates. Always notify your healthcare professional if you make changes to prescribed plans of care. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.3 Select a Basal Program Steps 7. Decide whether to add or delete new blocks. Do This If you want to Add another time block and basal rate Then do this 1. 2. 3. 4. 5. Next is highlighted Enter button. Add block is highlighted. Enter button. Notice Press Notice Press Repeat Steps 5 and 6 to add additional time blocks and basal rates. Scroll to highlight Enter button. Press Delete. Notice the message displays. CONFIRM screen and Delete block?
Delete the time block and basal rate you just created 1. 2. 3. 4. 5. Scroll to highlight Enter button. Press Yes. Add only ONE block and/or be finished with all your edits Scroll to highlight Done if not already highlighted. Press Enter button and return to the Home screen. 8. Check your work. Review the program you have just created. Refer to Section 3.1.2 View Basal Program for the procedure as needed. Record your personalized basal rate information for the new basal program(s) in the Table of Settings in Section 12 - Appendix A DOC15736_Rev-A-Man.indd 175-176 2/9/09 11:29:49 AM 175 176 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.4 Rename a Basal Program Procedure:
Steps 1. Do This Access BASAL MENU from Home screen. a. b. Main Press is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BASAL. OR Note: This is a short cut to get to the SELECT PROGRAM screen when basal is delivering. OR a. b. c. Basal panel on the Home screen. Scroll to select the Enter button. Press Go to Step 3 2. SELECT PROGRAM Access menu. a. b. Scroll to highlight Enter button. Press SELECT. Steps 3. Select the program that you want to be active. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.4 Rename a Basal Program Do This Note: In this example, the Daily program is the currently active program running, because it has an * beside Daily. a. b. Scroll to highlight the desired program, for example, Weekend. Press Enter button. CONFIRM screen and Start (your selected) program? message c. d. e. Notice the displays. Scroll to highlight Enter button. Press Yes. Note: You will hear four short confirmation beeps from your pump. 4. Check your work. Verify that the Home screen displays the active basal program you have just selected. DOC15736_Rev-A-Man.indd 177-178 2/9/09 11:29:50 AM 177 178 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.5 Delete a Basal Program 7.4 Rename a Basal Program Purpose When To rename an existing basal program of your pump using your Aviator Companion. Do this procedure:
When you CHOOSE to rename a previously created existing basal program. Your companion with battery charged and basal settings programmed. Your pump with the battery installed and basal settings programmed. Your pump with basal programs that have already been created and named. Your personalized Table of Settings in Section 12 - Appendix A. Materials Helpful Information Rename program is one of the Modify program options in the Basal menu. The other Modify program op-
The tions are Edit program, Create program and Delete program. Procedure:
Steps 1. Access BASAL Menu from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BASAL. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.5 Delete a Basal Program Steps 2. Access MODIFY PROGRAM menu. Do This a. b. Scroll to highlight Enter button. Press MODIFY. 3. RENAME Access PROGRAM screen. a. b. Scroll to highlight Enter button. Press RENAME. 4. Select program to rename. a. b. Scroll to highlight the program you want to rename. Press Enter button. 5. Delete existing program name. a. b. Scroll to highlight Keep pressing the Erase. Enter button to erase each letter of the old program name. DOC15736_Rev-A-Man.indd 179-180 2/9/09 11:29:50 AM 179 180 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.5 Delete a Basal Program Steps 6. Do This Create new program name. a. Scroll to highlight each letter and press the out the new program name. Enter button each time to spell Note: To clear an entry if you make a mistake, highlight Erase and press the Enter button to erase the last letter entered as needed. 7. Complete the name change. b. c. a. b. Scroll to highlight Enter button. Press Next. Scroll to highlight Press Done. Enter button to return to the Home screen. 8. Check your work. Review the program you have just renamed. Go to Section 3.1.2 View Basal Program for the procedure. Record the names and what they mean in your Table of Settings in Appendix A. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.6 Set a Temporary Basal Program 7.5 Delete a Basal Program Purpose When Materials To remove (delete) a basal program already programmed into your pump using your Aviator Companion. Do this procedure:
Whenever you need to delete an existing basal program. Your companion with battery charged and basal settings programmed. Your pump with the battery installed and basal settings programmed. Instruction or assistance from your healthcare professional. Delete program is one of the Modify program options. The other Modify program options are Edit pro-
The gram, Create program, and Rename program. You Consult your healthcare professional before deleting any of your basal programs. CANNOT delete a basal program that is active. Helpful Information Procedure:
Steps 1. Access BASAL menu from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BASAL. DOC15736_Rev-A-Man.indd 181-182 2/9/09 11:29:50 AM 181 182 Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.6 Set a Temporary Basal Program Steps 2. Do This Access MODIFY PROGRAM menu. a. b. Scroll to highlight Enter button. Press MODIFY. Steps 5. Decide what to do next. Section 7: Creating and Editing Specialized Basal Programs to Meet Your Needs 7.6 Set a Temporary Basal Program Do This Notice the CONFIRM screen with Delete program? message displays. If you want to Delete the program Then do this 1. 2. Scroll to highlight Enter button. Press Yes. 3. Select DELETE program. a. b. Scroll to highlight Enter button. Press Delete. 4. Select program to delete. a. Scroll to highlight the program you wish to delete. For example, Trip. Note: You CANNOT delete an active program, indicated with an asterisk *. b. Press Enter button. Note: If you get this warning screen with OK highlighted, press Enter to clear the warning and return to the Home screen. Start over at Step 1 to delete a program that is NOT active. Note: The program is deleted from the pumps memory and you will return to the Home screen. Cancel deleting the program 3. 1. 2. 3. 4. Go to Step 6 to check your work. No is highlighted. Notice Enter button. Press Scroll to Highlight Enter button. Press Done. Note: You will return to the Home screen. Your deletion is cancelled and the program is still an option 6. Check your work. Verify that you have deleted the program. The program you deleted should NOT be listed when you review basal programs. Refer to Section 3.1.2 View Basal Program for the procedure as needed. DOC15736_Rev-A-Man.indd 183-184 2/9/09 11:29:50 AM 183 184 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus 7.6 Set a Temporary Basal Program Purpose When Materials To program a temporary basal rate and the length of time you want the temporary basal rate to last, using your Aviator Companion. Do this procedure:
When you want to make a one time, temporary change to the currently delivered basal rate, for example, when you exercise or when you are sick. Your companion and pump fully operating and delivering basal insulin. Healthcare professionals instructions for your temporary basal pump settings. Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information A temporary basal rate is in effect from 30 minutes to 72 hours in increments of 30 minutes. This temporary rate is limited by the set up of your pumps maximum basal rate setting (Refer to Section 6). You set your basal rate increment to 0.1 units/hour. You modified your maximum basal rate to 5.0 units/hour. Your regular daily basal rate is set at 0.5 units/hour. If you have NOT modified your maximum basal delivery rate, you will be allowed to increase your basal rate to a value up to 30 units per hour (default). If you set up a different maximum basal delivery rate, you can only set the temporary rate to that number of units/hour maximum limit. Example A:
1. 2. 3. Setting a temporary basal rate of 10% for a duration of 3 hours would result in a temporary basal rate of 0.05 units/hour. If the desired temporary basal delivery rate is higher than the maximum basal rate of your pump settings, your pump will NOT deliver the requested temporary rate. Example B:
1. 2. You set your basal rate increment to 3.0 units/hour. You modified your maximum basal rate to 5.0 units/hour, telling the pump that you never want to have a basal rate to exceed 5.0 units/hour. If you set a 200% temporary basal, this will result in a basal rate of 6.0 units/hour. This is more than the basal maximum, so it would NOT be allowed by the pump. Your pump will beep and display a Warning: invalid %
Maximum rate exceeded screen. You will have to increase the basal maximum and reset a temporary basal rate within the range for it to take effect. You may choose either specific units/hour OR a percentage of your current active basal rate. The active basal program will resume when the temporary basal delivery is either manually stopped or reaches completion of duration. Refer to Section 11 for more information on how to set temporary basal to manage exercise or illness. 185 Procedure:
Steps 1. Access BASAL MENU from Home screen. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BASAL. 2. Choose SELECT program. a. b. Scroll to highlight Enter button. Press SELECT. 3. Select TEMP BASAL. a. b. Scroll to highlight Enter button. Press TEMP BASAL. 4. Set Duration. a. b. c. Duration is highlighted. Enter button. Notice Press Scroll to select the amount of time you want your temporary basal to be in effect. Note: The range is 30 minutes to 72 hours. d. Press Enter button. 186 DOC15736_Rev-A-Man.indd 185-186 2/9/09 11:29:50 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Steps 5. Do This Caution: When setting a temporary basal percent, make sure that you are setting the percentage of your basal that will be delivered, and NOT the percentage reduction in your basal rate. Decide to set Percent or Rate. Example: If your active basal rate is 0.35 U/h, then selecting 75% will set the temporary basal at 0.26 U/h, which is 75% of the current basal. If you want to set the temporary basal At a percentage of the current rate Then do this 1. 2. 3. Percent is highlighted. Enter button. Notice Press Scroll to select the desired percentage of the active basal rate. Enter button. Press Percent is highlighted. Notice Enter button. Press Scroll to highlight Enter button. Press Scroll to select the desired units per hour for the temporary basal delivery. Press Enter button. Rate. As a set rate 4. 1. 2. 3. 4. 5. 6. 6. Confirm and activate Temp Basal. 7. Check your work. a. b. c. d. Verify the duration and percentage/rate is correct. Scroll up to make any changes as needed. Notice Press Activate is highlighted. Enter button. Notice that the Temp Basal is activated and displayed in the Basal panel on the Home screen. Note: When the duration for the temporary basal is over, it will automatically revert back to your Daily basal program. Record your personalized temporary basal values in the Table of Settings in Section 12 - Appendix A. 187 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus 8 Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Purpose When Materials Do this procedure:
Helpful Information To administer an extended bolus from your pump using your Aviator Companion. Whenever you need to deliver an extended bolus over a period of time. Your companion set up with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional. Your personalized Table of Settings in Section 12 - Appendix A. You will perform this task using the companion. To administer an extended bolus using your pump, refer to tion 12. Bolus insulin is the insulin you program whenever you need insulin other than your basal needs. For example you would bolus for a meal or bolus to correct for blood glucose levels that are higher than your target glucose range. You can record your personalized bolus recommendations in the Table of Settings in Section 12 - Appen-
dix A. You should have set up your bolus options using the SETUP WIZARD in Section 6.1. Sec-
Procedure:
Steps 1. Access Bolus Menu from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. 188 DOC15736_Rev-A-Man.indd 187-188 2/9/09 11:29:50 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.1 Deliver an Extended Bolus Steps 2. Do This MANUAL Bolus. Select 3. Set Extended Bolus Type. 4. Set Extended Bolus amount. 5. Set Duration for the Extended Bolus. a. b. a. b. c. d. a. b. c. d. Scroll to highlight Enter button. Press MANUAL. Bolus Type is highlighted. Enter button. Notice Press Scroll to display Press Enter button. Extended. Bolus is highlighted. Enter button. Notice Press Scroll to select the extended bolus amount you want to deliver. Press Enter button. Duration is highlighted. Enter button. Notice Press Scroll to select the duration for extended bolus delivery. a. b. c. Note: The range depends on the amount of the bolus. When divided across the full duration, the rate is NOT less than 0.05 U/h. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Steps 6. Check that Extended Bolus Type, Bolus amount and Duration time is correct. Do This a. b. If you want to Change a setting Bolus Type, Bolus amount, and Duration settings on the BOLUS screen. View Decide if you need to change a setting. Then do this 1. 2. 3. 4. Go to the next step. Enter button. Scroll up to highlight the setting you want to change. Press Scroll to desired setting. Press Enter button. Keep the settings 7. Deliver Extended bolus. a. b. c. d. Deliver is highlighted. Enter button. Notice Press Notice that the extended bolus is delivering. Allow the extended bolus to deliver the amount that was set for the specified time duration. Go to Step 10 to check your extended bolus delivery. e. You have completed delivering an Extended Bolus. Note: Go to Step 8 only if you want to STOP the Extended Bolus. d. Press Enter button. DOC15736_Rev-A-Man.indd 189-190 2/9/09 11:29:51 AM 189 190 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Steps 8. Do This Decide whether to STOP extended bolus. a. b. Go to the Press Enter button. MAIN MENU. c. d. Notice Press STOP is highlighted. Enter button. e. Decide what to do next. If you want to STOP the extended bolus delivery immediately Then do this 1. 2. 3. Scroll to highlight Enter button. Press Continue to Step 9. Yes. Allow extended bolus to finish delivering 1. 2. 3. No is highlighted. Enter button to return to the Home screen. Notice Press Go to Step 10 to check your extended bolus delivery. Steps 9. Decide whether to STOP basal delivery. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Do This Note: Unless you had to change the battery, you will normally NOT stop basal delivery even though the CONFIRM screen and Stop (your active basal program)? message displays. a. b. CONFIRM screen and Stop (your active basal program)?
Notice the message displays. Decide what to do next. If you want to STOP the basal delivery now
(e.g. to change batteries) Continue the basal delivery Then do this 1. 2. 3. Yes. Scroll to highlight Enter button. Press Notice that the basal program has stopped on the screen. Home You have STOPPED the Extended bolus and also the Basal delivery. Check with your healthcare professional for recommendations. 1. 2. No is highlighted. Enter button. Notice Press 3. Review the basal is still delivering on the Home screen. Last Bolus (Ext.) that was administered and You have STOPPED the Extended bolus but your basal program is still delivering insulin. 10. Check your work. Check that the extended bolus amount, and time duration is displayed in the Bolus box on Home screen. Review the extended bolus amount and time that is being administered. If you want to STOP the Extended Bolus, go to Step 8. DOC15736_Rev-A-Man.indd 191-192 2/9/09 11:29:51 AM 191 192 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus 8.2 Deliver a Dual Bolus Purpose When Materials To administer a dual bolus using your Aviator Companion so that you can deliver a bolus immediately and also trickle out insulin as the food you eat is converted into glucose over time. The pump has the option to deliver two waves of insulin over a period of time. This option is helpful if there are foods in your meal plan that have a long duration and require longer periods of digestion. These foods will affect your glucose both immediately and over a number of hours later. Do this procedure:
Whenever you need to deliver a dual bolus, which includes a normal bolus and an extended bolus. Your companion set up with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional. Refer to your personalized Table of Settings in needed. Section 12 - Appendix A as Helpful Information SETUP WIZARD. You should record your personalized You should have already set up your bolus options via the list of your bolus options in the Table of Settings in Appendix A. These options can be changed via the SETUP WIZARD. Discuss with your healthcare professional what types of foods would require a dual bolus. For example, you may want to consider a dual bolus for eating: pizza (due to the carbohydrate content of the dough plus the high fat content of the cheese, sausage, pepperoni, etc.); appetizers at a party (such as nibbling chips or other carbohy-
drate foods for an extended period of time); Mexican food (the carbohydrates from chips, beans and rice plus the protein and fat from the meat and cheese). Procedure:
Steps 1. Access BOLUS MENU from Home screen. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. 2. Select MANUAL bolus. a. b. Scroll to highlight Enter button. Press MANUAL. 3. Set Dual Bolus Type. a. b. Notice Press Bolus Type is highlighted. Enter button. c. d. Scroll to display Press Enter button. Dual. DOC15736_Rev-A-Man.indd 193-194 2/9/09 11:29:51 AM 193 194 4. Set Normal Bolus amount. a. b. Notice Press Normal is highlighted. Enter button. c. d. Scroll to select the normal bolus amount you want to deliver. Press Enter button. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.2 Deliver a Dual Bolus Steps 5. Do This Set Extended Bolus amount. a. b. Notice Press Extended is highlighted. Enter button. c. d. Scroll to select the extended bolus amount you want to deliver. Press Enter button. 6. Set Duration for the Extended Bolus. a. b. Notice Press Duration is highlighted. Enter button. 7. Check that the Normal bolus, Extended bolus, and duration settings are correct. c. d. a. b. Scroll to select the duration for the extended bolus delivery. Press Enter button. Bolus Type, Bolus amount, and Duration settings on the BOLUS screen. View Decide if you need to change a setting. If you want to Change a setting Keep the settings Then do this 1. Scroll up to highlight the setting you want to change. Press Scroll to desired setting. Press Enter button. Enter button. 2. 3. 4. Go to the next step. Steps 8. Deliver the Dual bolus. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus Do This Note: If you changed only the Normal or Extended Bolus settings in Step 7, and did NOT change the Duration, scroll to highlight Deliver. The Dual bolus is now set to deliver. a. b. c. Notice Press Deliver is highlighted. Enter button. Notice that the normal bolus is delivering. 9. Decide whether to stop the Dual bolus. If you want to Then do this Finish delivering the normal bolus Allow the normal bolus to deliver the amount that was set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps or feel 2 more short vibrations on your pump and you will return to the Home screen. STOP the dual bolus immediately Go to Step 10. 1. 2. 3. Stop is highlighted. Enter button. Notice Press Notice the stopped. message displays. Notice stopped). Press 4. STOPPED ALERT screen and Dual bolus Clear is highlighted (to confirm that the bolus is Enter button to return to the Home screen. 5. You have STOPPED the dual bolus. DOC15736_Rev-A-Man.indd 195-196 2/9/09 11:29:51 AM 195 196 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus Steps 10. Decide whether to finish delivering the Extended Bolus. Do This If you want to Finish delivering the extended bolus Then do this Allow the extended bolus to deliver the amount that was set for the specified time duration. Note: Once the Normal bolus is completely delivered, you will automatically return to the Home screen where you will see the extended bolus, bolus amount, and time duration displayed in the Bolus panel. You will also see the IOB value, which reflects the Normal bolus that was delivered. Another possible reason to stop basal here is when you realize there is too much IOB and need some time to recover. STOP the extended bolus MAIN MENU. Go to Step 13 to check your extended bolus delivery. 1. 2. 3. 4. Go to the STOP is highlighted. Notice Enter button. Press Continue to Step 11. a. b. CONFIRM screen and Stop Extended Bolus? message displays. Notice the Decide what to do next. 11. Decide whether to STOP the extended bolus. Then do this 1. 2. 3. Scroll to highlight Enter button. Press Continue to Step 12. Yes. If you want to STOP the extended bolus delivery immediately Allow extended bolus to finish delivering Steps 12. Decide whether to STOP basal delivery. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus Do This Note: Unless you wanted to change the battery you will normally NOT stop basal delivery even though the CONFIRM screen and Stop (your active basal program)? message displays. Another possible reason to stop basal here is when you realize there is too much IOB and need some time to recover a. b. CONFIRM screen and Stop (your active basal program)? message Notice the displays. Decide what to do next. If you want to STOP the basal delivery now
(e.g. to change batteries) Continue the basal delivery Then do this 1. 2. 3. Yes. Scroll to highlight Enter button. Press Notice that the basal program has STOPPED on the Home screen. You have STOPPED the Extended bolus and also STOPPED the Basal delivery. No is highlighted. 1. Enter button. 2. Notice Press Note: You will automatically return to the Home screen. Review the Last Bolus that was administered. 3. You have STOPPED the Extended bolus but your basal program is still delivering insulin. 1. 2. 3. No is highlighted. Enter button to return to the Home screen. Notice Press Go to Step 13 to check your extended bolus delivery. 13. Check your work. Check that the extended bolus amount, and time duration is displayed in the Bolus panel on Home screen. Review the extended bolus amount and the time that it is being administered. Review the IOB value, which reflects the normal bolus that was delivered. DOC15736_Rev-A-Man.indd 197-198 2/9/09 11:29:51 AM 197 198 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.3 Calculate and Deliver a Food Bolus 8.3 Calculate and Deliver a Food Bolus Purpose When To calculate and deliver a food bolus using your Aviator Companion. Do this procedure:
Materials Whenever you want to calculate carbohydrates and administer a bolus to cover a meal or snack. Your companion set up with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional and assistance from Diabetes Educator as needed. Your personalized Table of Settings in Section 12 - Appendix A. Helpful Information To be able to use this option, you must first have an understanding of carbohydrate counting, and have refer-
ences for the carbohydrate content of foods. Consult your Diabetes Educator and/or Registered Dietitian before using this feature. You can set up bolus calculator options and bolus limits in Section 6.1 before performing this task. It would be easier to program a food bolus and use the bolus calculator if you have established settings. Procedure:
Steps 1. Access BOLUS MENU from Home screen. 2. Select FOOD bolus. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. a. b. Scroll to highlight Press Enter button. FOOD. 199 Steps 3. Set Carbs. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus Do This a. Notice b. Press c. Scroll to select the number of grams of carbohydrates you are planning to eat. Carbs is highlighted. Enter button. Note: The range is 0-200 g. d. Press Enter button. 4. Decide what to do next. Note: The I:CHO ratio is established when setting up your pump using the SETUP WIZARD in Section 6.1. Unless instructed otherwise by your healthcare professional, do NOT change this value. If you want to Continue to select bolus type View Food Calculation Details Change I:CHO ratio Details. Then do this Notice Next is highlighted. Press Enter button. 1. 2. 3. 4. 5. 1. 2. 3. Note: The range is 1U/1g to1U/150g. Scroll to highlight Enter button. Press Review the insulin-to-carbohydrate ratio. Notice Press Scroll to highlight Press Scroll to change Accept is highlighted. Enter button. I:CHO as needed. Enter button. I:CHO. 4. 5. 6. Press Notice Press Enter button. Accept is highlighted. Enter button. 200 DOC15736_Rev-A-Man.indd 199-200 2/9/09 11:29:51 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus Do This Steps a. 5. Notice b. Press Bolus Type is highlighted. Normal is the default. Enter button. Set Bolus Type. Note: The recommended calculated bolus amount is displayed. Pay careful consideration before changing the recommended amount, depending on situations such as exercise, stress, sickness, etc. that may influence more or less insulin delivery at this time. Scroll to select the bolus type you want to deliver. c. Note: Remember to also set the duration for Extended or Dual bolus types if you are delivering either type of bolus. Refer to Section 8.1 or 8.2 as needed. 6. Review Bolus amount. Decide what to do next. d. Press Enter button. If you want to Accept the calculated bolus amount and continue to bolus Change the bolus amount Then do this 1. Notice Scroll to highlight 2. Bolus is highlighted. Deliver. 1. 2. 3. 4. Bolus is highlighted. Enter button. Notice Press Scroll to select the bolus amount to deliver. Press Enter button. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus Steps 8. Deliver Food bolus. Deliver is highlighted. Enter button. Do This a. Notice b. Press Note: You will hear 2 quick beeps from your pump. c. d. Notice that the bolus is delivering. Decide what to do next. If you want to Finish delivering food bolus Then do this Allow the food bolus to deliver the amount that was set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then return to the Home screen. STOP the food bolus delivery immediately STOPPED ALERT screen and Normal Stop is highlighted. Enter button. Go to Step 9 to check your bolus delivery. 1. 2. 3. Notice Press Notice the bolus stopped. message displays. Notice Press Clear is highlighted. Enter button to return to the Home screen. 4. 5. You have STOPPED the food bolus and it is reflected in the Bolus panel. 7. Confirm that bolus type, bolus amount
(and duration) are correct. Check your Bolus Type and Bolus settings on the BOLUS screen. 9. Check your work. Note: The value displayed is from the bolus calculator. Scroll up to select and make edits as needed. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. DOC15736_Rev-A-Man.indd 201-202 2/9/09 11:29:52 AM 201 202 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.4 Calculate and Deliver a Correction Bolus 8.4 Calculate and Deliver a Correction Bolus Purpose When To calculate and deliver a correction bolus using your Aviator Companion. Do this procedure:
Materials Whenever you want to calculate and administer a correction bolus because your blood glucose levels are higher than your target glucose. Your companion set up with basal delivery started. Your pump and pump set up with basal delivery started. Bolus recommendations from your healthcare professional and assistance from your Dia-
betes Educator as needed. Your personalized Table of Settings in Section 12 - Appendix A Helpful Information Establish setting for programming a correction bolus and use of the bolus calculator with the instructions listed in Section 6.1 before performing this task. Using this feature requires that you have a working understanding and knowledge of your insulin sensitivity, or correction factor, and know your BG targets obtained from your healthcare team. Refer to Section 12 Appendix A for calculation sheet. While the pump will provide a suggested dose based on the settings you have established, there may be other factors that may affect the dosage decision (such as anticipated increased physical activity), so be sure to discuss this feature with your healthcare team. Procedure:
Steps 1. Access BOLUS MENU from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. 203 Steps 2. Select bolus. CORRECTION Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Do This a. b. Scroll to highlight Enter button. Press CORRECTION. 3. Set Current BG. 4. Determine what to do next. Note: You may get a WARNING screen and message Less than 2 hours since last bolus. with OK highlighted. Consider the possible safety issues if another bolus is delivered at this time, prior to pressing the Enter button. Note: If there is NO bolus history, and the pump has NOT been powered on for the duration of the action time, you may get a CONFIRMATION screen and message Last bolus time unknown. Continue? displayed. Press Enter to continue. a. b. c. d. Current Bg. Scroll to highlight Enter button. Press Scroll to select your current blood glucose level. Press Enter button. If you want to Continue to select bolus type Then do this Notice Next is highlighted. Press Enter button. View BG Calculation Details Scroll to highlight Enter button. Press Details. Review the Target BG, 1U Drop and, IOB. Notice Press Accept is highlighted. Enter button. Scroll to highlight Enter button. Press Next. 1. 2. 3. 4. 5. 6. 7. 204 DOC15736_Rev-A-Man.indd 203-204 2/9/09 11:29:52 AM Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps 5. Set Bolus Type. Do This a. Notice b. Press Bolus Type is highlighted. Enter button. Note: The recommended calculated bolus amount is displayed. Pay careful consideration before changing the recommended amount, depending on situations such as exercise, stress, sickness, etc. that may influence more or less insulin delivery at this time. c. Scroll to select the bolus type you want to deliver. Note: Remember to also set the duration for Extended or Dual bolus types if you are delivering either type of bolus. Refer to Section 8.1 or 8.2 as needed. 6. Review Bolus amount. Press d. Enter button. Decide what to do next. If you want to Accept the calculated bolus amount and continue to bolus Change the bolus amount Then do this 1. 2. Notice Scroll to highlight Bolus is highlighted. Deliver. 1. 2. 3. 4. Bolus is highlighted. Enter button. Notice Press Scroll to select the bolus amount to deliver. Press Enter button. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps 8. Deliver Correction bolus. Do This a. Notice b. Press Deliver is highlighted. Enter button. Note: You will hear 2 quick beeps from your pump. c. d. Notice that the bolus is delivering on the screen. Decide what to do next. If you want to Finish delivering correction bolus Then do this Allow the correction bolus to deliver the calculated amount Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and return to the Home screen. STOP the correction bolus delivery immediately STOPPED ALERT screen and Normal bolus Stop is highlighted. Enter button. Go to Step 9 to check your bolus delivery. 1. 2. 3. Notice Press Notice the stopped. message displays. Clear is highlighted. Notice Enter button to return to the Home screen. Press 4. 5. You have STOPPED the correction bolus and it is reflected in the Bolus panel. 7. Confirm that bolus type, bolus amount
(and duration) is correct. Check your Bolus Type and Bolus amount settings on the BOLUS screen. Scroll up to select and make edits as needed. 9. Check your work. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. DOC15736_Rev-A-Man.indd 205-206 2/9/09 11:29:52 AM 205 206 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus 8.5 Calculate and Deliver a Food & Correction Bolus Purpose To calculate and deliver a bolus when you are about to eat and your blood glucose levels are above or below your pre-meal target goals. Do this procedure:
Whenever you want to administer a bolus because you are about to eat a meal, and your blood glucose is above or below your target range. Your companion with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional and assistance from your Diabetes Educator as needed. Your personalized Table of Settings in Section 12 - Appendix A. When Materials Helpful Information food and correction bolus, you must first have an understanding and knowledge of your insu-
To administer a lin sensitivity, or correction factor and your I:CHO ratio, which you will have obtained from your healthcare team
(see Section 6.1 for additional settings). Procedure:
Steps 1. Access BOLUS MENU from Home screen. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. Steps 2. FOOD &
Select CORRECTION Bolus. 3. Set Carbs. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Do This a. b. a. b. c. Scroll to highlight Enter button. Press FOOD & CORRECT. Notice Press Carbs is highlighted. Enter button. Scroll to select the number of grams of carbohydrates you are planning to eat. Note: The range is 1-200 grams. d. Press Enter button. Note: The I:CHO ratio is established when setting up your pump using the SETUP WIZARD in Section 6.1. Unless instructed otherwise by your healthcare professional, do NOT change this value. DOC15736_Rev-A-Man.indd 207-208 2/9/09 11:29:52 AM 207 208 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.5 Calculate and Deliver a Food & Correction Bolus Steps 4. Decide what to do about I:CHO ratio. Do This If you want to Continue to select bolus type Then do this Notice Next is highlighted. Press Enter button. View Food Calculation Details Change I:CHO ratio 1. 2. 3. 4. 5. 1. 2. 3. Details. Scroll to highlight Enter button. Press Review the insulin-to-carbohydrate ratio. Accept is highlighted. Notice Enter button. Press Scroll to highlight Enter button. Press Scroll to change I:CHO as needed. I:CHO. Note: The range is 1U/1g to1U/150g. 4. 5. 6. 7. 8. Press Notice Press Enter button. Accept is highlighted. Enter button. Notice Press Next is highlighted. Enter button. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.6 Deliver a Quick Bolus from QBolus Menu Steps 5. Set CURRENT BG. Do This a. Notice b. Press c. Scroll to select your current blood glucose level. Current Bg is highlighted. Enter button. Note: The default value is whatever your current Target BG is. When Target BG is NOT defined in WIZARD, both Current BG and Target BG defaults to 110 mg/dL (6.1 mmol/L). d. Press Enter button. 6. Decide what to do next. If you want to Continue to select bolus type View BG Calculation Details Then do this Notice Next is highlighted. Press Enter button. 1. 2. 3. Scroll to highlight Enter button. Press Review the make changes as needed. Details. IOB on the BG CALC DETAILS screen, and Note: You CANNOT change the IOB on this screen. When IOB is questionable, a question mark appears next to it on the BG CALC DETAILS screen. For example, IOB may be questionable when you initially turn on the pump within the first insulin action time, based on initial setup. 4. 5. 6. 7. 8. Accept is highlighted. Enter button. Details is highlighted. Notice Press Notice Scroll to highlight Enter button. Press Next. DOC15736_Rev-A-Man.indd 209-210 2/9/09 11:29:52 AM 209 210 Note: The recommended calculated bolus amount is displayed. You should change this only if you purposely want to give a different amount than what is recommended by the pump. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.6 Deliver a Quick Bolus from QBolus Menu Do This Steps a. 7. Notice b. Press Bolus Type is highlighted on the BOLUS screen. Enter button. Set Bolus Type. Note: The recommended calculated bolus amount is displayed. You should change this only if you purposely want to give a different amount than what is recommended by the pump. c. Scroll to select the bolus type you want to deliver. Note: Remember to also set the duration for Extended and Dual bolus types if you are delivering either type of bolus. d. Press Enter button. 8. Set Bolus. Decide what to do next. If you want to Accept the calculated bolus amount and continue to bolus Change the bolus amount Then do this 1. Notice Scroll to highlight 2. Bolus is highlighted. Deliver. 1. 2. 3. 4. Bolus is highlighted. Enter button. Notice Press Scroll to adjust the amount that was calculated. Press Enter button. 9. Check that bolus type and bolus amount is correct. Check your Bolus Type and Bolus amount settings on the screen. Scroll up to select and make edits as needed. Steps 10. Food &
Deliver Correction bolus. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.7 Deliver a Quick Bolus from QBolus Soft Key Do This a. b. Notice Press Deliver is highlighted. Enter button. Note: You will hear 2 quick beeps from your pump. c. d. Notice that the bolus is delivering on the screen. Decide what to do next. If you want to Finish delivering food and correction bolus Then do this Allow the food and correction bolus to deliver the amount that was set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then you will return to the Home screen. STOP the food and correction bolus delivery immediately Stop is highlighted. Enter button. Go to Step 11 to check your bolus delivery. 1. 2. 3. Notice Press Notice the stopped. message displays. Clear is highlighted. Notice Enter button to clear message and return to the Press Home screen. STOPPED ALERT screen and Normal bolus 4. 5. You have STOPPED the food and correction bolus, and it is reflected on the Bolus panel. 11. Check your work. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. DOC15736_Rev-A-Man.indd 211-212 2/9/09 11:29:53 AM 211 212 Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.7 Deliver a Quick Bolus from QBolus Soft Key 8.6 Deliver a Quick Bolus from QBolus Menu Purpose When Do this procedure:
Whenever you need to deliver a normal bolus from the Qbolus menu. To administer a normal bolus using the QBOLUS menu of your Aviator Companion. Materials Procedure:
Steps 1. Access BOLUS MENU from Home screen. Note: The increments are either 0.5 or 1.0 Units. Your companion set up with basal delivery started. Your pump set up with basal delivery started. Bolus recommendations from your healthcare professional. Do This a. b. Notice Press Main is highlighted. Enter button. c. d. Scroll to highlight Enter button. Press BOLUS. 2. Set QBOLUS. a. b. c. QBOLUS is highlighted. Enter button. Notice Press Scroll to select the desired quick bolus amount to administer. Note: The increments are either 0.5 or 1.0 Units. d. Press Enter button. Section 8: Creating and Editing Specialized Bolus Programs to Meet Your Needs 8.7 Deliver a Quick Bolus from QBolus Soft Key Steps 3. Deliver Quick bolus. Do This a. Notice that the bolus is delivering on the screen. Note: You will hear 2 quick beeps from your pump. b. Decide what to do next. If you want to Finish delivering the quick bolus Then do this Allow the quick bolus to deliver the amount that you set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps from your pump and return to the Home screen. STOP the quick bolus delivery immediately Stop is highlighted. Enter button. Go to Step 4 to check your bolus delivery. 1. 2. 3. Notice Press Notice the bolus stopped. message displays. Notice Press Home screen. 4. 5. Clear is highlighted. Enter button to clear message and return to the STOPPED ALERT screen and Normal You have STOPPED the quick bolus and it is reflected on the Bolus panel. 4. Check your work. Review the Last Bolus amount and time displayed in the Bolus panel on the Home screen. DOC15736_Rev-A-Man.indd 213-214 2/9/09 11:29:53 AM 213 214 Section 9: Respond to Alarms, Alerts, Errors, and Other Problem 8.7 Deliver a Quick Bolus from QBolus Soft Key Purpose When To administer a normal bolus using the QBolus soft key from your companions Home screen. Do this procedure:
Whenever you need to administer a normal bolus quickly, conveniently, and discreetly, using the fewest steps possible. Your companion and pump set up with basal delivery started. Bolus recommendations from your healthcare professional. Materials Helpful Information Normal bolus may be delivered using the QBolus soft key from your companions Home screen. You should A have already set up the bolus increments using the procedure in Section 6.1. Do This Locate the QBolus soft key (also called the Backlight soft key) on the bottom left of your companion. Procedure:
Steps 1. Locate the QBolus soft key on your companion. FPO Screen shot QBolus Soft Key Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps 2. Initiate the number of bolus increments to deliver. 1 button push displays:
Do This a. Press the increments to deliver, companion sounds a beep with each press. QBolus soft key the same number of times as the number of Note: You may have to press the soft key once to wake companion up. Note: The increments for the one-button bolus are either 0.5 or 1.0 Units. b. c. Notice that after a few seconds, the companion will of times that you pressed the QBolus soft key to verify your instructions. After the beeps, press the to CONFIRM the correct number of increments for bolus delivery. QBolus soft key ONE MORE TIME within 2 seconds beep the same number 2 button pushes displays:
Note: You MUST press the Bolus button after the complete feedback beeps within 2 seconds, or the bolus is cancelled. Note: The bolus will also be cancelled if you press the Bolus button before the feedback completes. 3 button pushes displays:
DOC15736_Rev-A-Man.indd 215-216 2/9/09 11:29:53 AM 215 216 Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps 3. Deliver the bolus. Do This a. b. Notice that the bolus is delivering on the screen. Decide what to do next. If you want to Finish delivering the quick bolus Then do this Allow the bolus to deliver the amount that you set. Note: Once the bolus has finished delivering, you will hear 2 more quick beeps and then you will return to the Home screen. STOP the quick bolus immediately Stop is highlighted. Enter button. Go to Step 4 to check your bolus delivery. 1. 2. 3. Notice Press Notice the bolus stopped. message displays. Notice Press Home screen. 4. 5. Clear is highlighted. Enter button to clear message and return to the STOPPED ALERT screen and Normal You have STOPPED the quick bolus and it is reflected in the Bolus panel. 4. Check your work. Look at the Bolus box on the Home screen to review the amount and time of the last bolus. Section 9: Respond to Alarms, Alerts, Errors, and Other Problem 9 Respond to Alarms, Alerts, Errors, and Other Problems Purpose To resolve alarm and alert messages, error codes, or problems related to your Aviator Companion and Aviator Pump. Do this procedure:
When you receive an alarm, alert, or error code on your companion or pump. Your companion or pump is dropping your companion or pump, or other problems, etc. NOT turning on, you CANNOT start basal delivery, When Materials Your companion and pump may either be operating normally or in an alarm failsafe battery state (non-rechargeable). Your personalized Table of Settings in Section 12- Appendix A. Helpful Information This section offers suggestions for addressing problems or difficulties that you may experience with your com-
panion and pump. Call your healthcare professional for questions about your blood glucose control or diabetes management. Call Customer Care, 24 hours a day, 7 days a week, for questions involving the mechanics of your companion or pump, or regarding any alarms and errors not covered in this section. You may also check the Table of Contents and Index for sections that may be helpful. Refer to the Glossary for the definitions of different Alarms and Alerts. ALARM is active, insulin delivery IS stopped. Therefore, it is important for you to respond to an alarm as WARNING:
While an soon as possible to prevent medically adverse events or serious injury. Insulin delivery does because you have NOT begun insulin delivery yet. NOT stop with an ALERT. However, delivery is NOT occurring when you get a pump idle alert, All alarms and alerts appear as text on the screen of your companion or pump. For example, DOC15736_Rev-A-Man.indd 217-218 2/9/09 11:29:53 AM 217 218 Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other Problem If your pump is in AUDIO mode You are also alerted to an insulin delivery (pump) alarm or alert either by sound or vibration (on the pump). A beep will sound. This beep will gradually change to continuous tones of increasing frequency and higher pitch until the alarm/alert is addressed or, in the case of alerts, if the SLEEP mode is activated. Your pump will vibrate initially, but eventually the vibrations will change to beeps, which will gradually change to continuous tones of increasing frequency unless the alarm/alert is addressed or, in the case of alerts, if the SLEEP mode is activated. If your pump is in VIBRATE mode Sleep mode is like hitting a snooze button on an alarm clock. Sleep mode gives you the option of postponing your response to an ALERT or reminder for a specific, limited amount of time. You CANNOT use sleep mode with alarms. Sleep mode can be used to quiet an alert for as little as 15 minutes or as long as 12 hours. Pump Idle Alert which is 15 minutes to a maximum of 1 hour. An exception is the WARNING: If you receive an occlusion alarm, you MUST disconnect from the pump using the quick disconnect feature of the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the occlusion is removed. Discuss the occlusion alarm setting with your healthcare professional to help you determine which setting is best for you. All Companion related alerts appear as text on the screen of your Companion. For example, a low battery alert on your Companion battery. You are also alerted to a companion alert either by sound or vibration on the Companion. Companion related alerts will not gradually escalate in the way a pump alarm or alert does. Procedure:
Steps 1. Determine what you need to resolve. Do This If you are resolving An alarm or alert A companion alert System errors Other problems or difficulties with your pump. Then do this Go to Step 2. Go to Step 3. Go to Step 4. Go to Step 5. 219 Steps 2. Identify the type of pump alarm or alert and respond as appropriate. Do This Look at the screen of your pump. If the alarm/
alert is a Bad battery alarm Then do this 1. 2. 3. 4. 5. Clear is highlighted. Enter button to clear the alarm. Notice Press Change the battery information (see Section 1.4) and resume basal delivery. Confirm or reset RESTART within 15 minutes to avoid losing basal delivery (see Section 3.1.1). Time and Date. Note: Refer to your Table of Settings in Section 12
-Appendix A to determine the method of insulin replacement as recommended by your healthcare professional, if NOT able to replace battery right away until the issue is resolved. Stopped bolus alert Inactivity alert OR Inactivity alarm 1. 2. 3. 1. 2. 3. Clear is highlighted. Enter button to clear the alert. Notice Press Review the amount of the last bolus that was delivered and accommodate for undelivered insulin, if you accidentally stopped your bolus. Notice Press pump and return to the Home screen. RESTART Clear is highlighted. Enter button to clear the alert, reactivate your basal delivery if delivery has stopped. Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. Change the length of the inactivity time as needed. Continued on next page. 220 DOC15736_Rev-A-Man.indd 219-220 2/9/09 11:29:53 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/
alert is an Occlusion alarm WARNING: If you receive an occlusion alarm, you MUST Then do this disconnect from the pump using the quick disconnect feature of the Infusion Set before investigating the cause of the occlusion. Bolus delivery may occur when the cause of the occlusion is removed. 1. 2. 3. 4. 5. Clear is highlighted. Enter button to clear the alarm and return to the Notice Press Home screen. Check your blood glucose level. Disconnect the pump. Administer an insulin injection if necessary as it is possible that your pump has NOT been delivering insulin for some time. Change your infusion set and reservoir immediately. 6. Note: Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. 7. Prime the pump (see being pumped. Section 2.4) to see if insulin is If insulin IS being pumped, finish priming, reconnect pump and start basal delivery again. If insulin is NOT being pumped, change infusion site and tubing, then change the reservoir, before calling Customer Care or your healthcare professional for further assistance. Note: If you get frequent occlusion alarms, talk to your healthcare professional about setting high or low sensitivity for alarm, as well as best sites for infusion set and tubing. Steps Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/alert is a No insulin alarm Then do this 1. 2. 3. 4. Clear is highlighted. Enter button to clear the alarm and return to the Notice Press Home screen. Disconnect tubing from cannula and remove cannula from infusion site. Replace reservoir with a new reservoir filled with insulin (see Section 2.3). Prime pump (see Insert new infusion set. Prime cannula. RESTART 5. 6. 7. 8. Note: Refer to your Table of Settings in Section 12
-Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. basal delivery. Section 2.4). Reservoir alarm 1. 2. 3. Clear is highlighted. Enter button to clear the alarm and return to the Notice Press Home screen. Disconnect tubing from cannula and remove cannula from infusion site. Remove reservoir and replace it (see Prime Pump (see Insert new infusion set. Prime cannula. RESTART Contact Customer Care if problem persists. 4. 5. 6. 7. 8. 9. Note: Refer to your Table of Settings in Section 12
-Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. basal delivery. Section 2.3). Section 2.4). Continued on next page. 221 Continued on next page. 222 DOC15736_Rev-A-Man.indd 221-222 2/9/09 11:29:54 AM Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/alert is a Low battery alert Then do this Note: The Aviator Pump will notify the user when the battery is nearing depletion NOT less than 24 hours before the pump stops delivery due to a depleted battery. Steps Identify the type of pump alarm or alert and respond as appropriate (continued). Do This If the alarm/alert is a Pump idle alert/
pump NOT started
<Insert screen shots>
FPO Cancellation alert 1. 2. 3. 4. 1. 2. 3. Clear. Sleep is highlighted. Enter button to clear the alert and return to Notice Scroll to highlight Press Home screen. Replace the battery as soon as possible (see 1.4). Notice Press Reenter your changes/edits ONLY if necessary so that they are saved. Clear is highlighted. Enter button to clear the alert. Section Note: Change the idle screen time to a longer period if this occurs frequently. Low insulin alert 1. 2. 3. 4. Continued on next page.
<insert screenshots>
FPO Clear. Sleep is highlighted. Enter button to clear the alert and return to Notice Scroll to highlight Press Home screen. Replace and refill the reservoir as soon as possible
(see Section 2.3). Then do this Sleep is highlighted. Notice Decide what to do next. 1. 2. If you want to Clear the alert Then Scroll to highlight Clear and press Enter button to return to Home screen. Press Enter button to put pump back to sleep again. Scroll to highlight Sleep Time. Press Enter button. Scroll to change the sleep time. Press Enter button. Put pump back to sleep again Put pump back to sleep for a longer time 3. Identify the type of Companion alert and respond as appropriate. If the alarm/alert is a Low battery alert Note: Change the length of Sleep Time as needed. 3. basal delivery (see Section 3.1.1) per healthcare START professional recommendations. Then do this 1. 2. 3. OK is highlighted. Enter button to clear the alert and return to Notice Press Home screen. Recharge the battery as soon as possible. The alert indicates that you have 30% of battery charge remaining. (see Section 1.3). DOC15736_Rev-A-Man.indd 223-224 2/9/09 11:29:54 AM 223 224 Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Section 9: Respond to Alarms, Alerts, Errors, and Other Problem Steps 4. Resolve System Errors. 5. Troubleshoot pump problems or issues. Steps Do This Very Low battery alert Depleted battery alert BG check not available alert 1. 2. 3. 1. 2. 3. OK is highlighted. Enter button to clear the alert and return to Home Notice Press screen. Recharge the battery as soon as possible. The alert indicates that you have 15% of battery charge remaining.
(see Section 1.3). OK is highlighted. Enter button to clear the alert and return to Home Notice Press screen. The companion may shut down at any time. Recharge the battery immediately to continue using the Companion (see Section 1.3). 1. 2. 3. Remove the test strip from the strip port. Remove the USB cable from the USB port on the Companion. Insert a perform a blood glucose test (see Section 5.2). FreeStyle Lite Test Strip into the strip port to WARNING: Use ONLY the USB cable provided. Use of an unapproved cable may lead to loss of electromagnetic compatibility, and make the system more susceptible to electronic interference. Do This a. b. all system errors will indicate a failure in the pump system. However, if Contact Customer Care. NOT the pump fails, you MUST DISCONTINUE use of the pump. Refer to your Table of Settings in Section 12 -Appendix A to determine the method of insulin replacement as recommended by your healthcare professional until the issue is resolved. Identify what the problem may be. If Your pump wont turn on Your pumps batteries are NOT lasting very long (occurs when backlight is used frequently or pump is allowed to alarm for long periods of time) Your pumps screen is hard to read or is distorted Then 1. 2. ONLY Energizer or Duracell alkaline batteries. Section 1.4) Remove and reinsert battery. (see Energizer and Insert a new AAA alkaline battery (
Duracell brands are recommended) if the issue is NOT resolved. Contact Customer Care or your healthcare professional if the issue is still NOT resolved. Use audio instead of vibrate. Set your pump to Reduce the use of the backlight if possible. Respond to alarms as quickly as possible, as batteries will run down quicker if the pump is allowed to alarm for long periods of time. Contact Customer Care if the issue is still resolved. Turn on the backlight if you are in a dark room. Remove your sunglasses if applicable. Move indoors or into the shade if applicable. Keep your pump out of direct heat (e.g., away from heaters) or cold (e.g., by placing under your clothing on a cold day). Contact Customer Care if the issue is still resolved. NOT NOT 3. 1. 2. 3. 4. 5. 1. 2. 3. 4. 5. 225 Continued on next page. 226 DOC15736_Rev-A-Man.indd 225-226 2/9/09 11:29:54 AM Section 10: System Maintenance Steps Troubleshoot pump problems or issues
(continued). Do This If Basal delivery wont start Your pump got wet Then do this 1. 2. Check that the devices are paired properly. Check that you are delivering a large enough volume of insulin for priming to be completed in both the tubing and cannula. If a tiny amount of insulin has NOT come out of the end of the tubing, you may need to increase the amount of the prime to at least 4 6 units (see Section 2.4). Note: If you attempt to start basal delivery and the pump needs to be primed, the pump will display a warning to prime pump first. 3. Check that the insulin reservoir is filled. If empty, fill the reservoir. Note: The pump will display a NO INSULIN ALARM. Refer to Step 2 for more information. 4. 1. 2. Contact Customer Care or your health care professional if you are still unable to start basal delivery. Towel dry the outside of the pump. Inspect the reservoir and battery compartments and dry any water you find. Caution: Do NOT use a hair dryer to dry your pump. 3. 4. 5. If your pump was submerged in salt water, thoroughly clean with a damp cloth before drying with towel. Section 4.1 for additional details on what to do. Refer to Contact Customer Care or your healthcare professional if you are unable to use your pump. Steps Troubleshoot pump problems or issues
(continued). Do This If You dropped your pump You suspect pump alarm(s) may not be functioning correctly
(check for operational safety). Section 10: System Maintenance Then do this 1. Examine the screen and buttons for chips, cracks, or other damage. Caution:
If your pump is cracked or a button is torn, switch to insulin injections immediately AND contact your healthcare professional and/or Customer Care. 2. 3. Carefully examine the pump, making sure the battery cap and reservoir cap are secure. Examine the infusion set for damage, making sure the tubing, tubing connector, and soft cannula are intact. Caution:
If your pump has been dropped, the waterproof capability of your pump may be compromised. 4. 1. 2. 3. 4. If you suspect that your pump has been damaged, and are concerned that its waterproof capability has been compromised, please contact Customer Care. Stop basal delivery. Set it aside for 5 minutes without starting basal delivery. Let the alarm escalate and check that it cycles through both audio and vibratory annunciation. Check that the pumps audio speakers sound as part of the transition from idle mode to basal delivery mode, or following insertion of a battery. Caution:
If your pump audio or vibratory annunciators are not functioning, switch to insulin injections immediately AND contact your healthcare professional and/ or Customer Care. 6. Check your work. Make sure your pump is operating fully and normally again after responding to the alarm, alert, system error, or other problem(s). DOC15736_Rev-A-Man.indd 227-228 2/9/09 11:29:54 AM 227 228 Section 10: System Maintenance 10 System Maintenance Purpose When Materials To keep your companion and pump in good working order. To assist you with battery-related issues, cleaning, storage and what to do if companion or pump is damaged or gets wet. Do this procedure when:
You need to replace your pump battery. You need to clean your companion and pump. You need to transport or store your companion and pump. Your companion or pump is damaged or gets wet. One rechargeable). One cloth dampened with mild soapy water. One damp cloth. One dry cloth. Duracell MN2400 or Energizer E92 AAA alkaline primary battery (non-
WARNING: Do NOT use lithium, nickel cadmium (NiCad), nickel metal hydride (NiHM), carbon zinc (heavy duty), or rechargeable batteries. These types of batteries will NOT power Aviator Pump properly, and/or the battery level indicator may not display accurately. Basal delivery MUST be stopped before removing the battery (Section 3.1.3). Replace Pump Battery 10.1. Helpful Information ALL delivery prior to removing the battery. Stop Always carry a spare battery with your pump supplies. NOT use a cold battery (e.g., one that has just been in your refrigerator or in cold weather). If the battery is Do cold, the pump may display a battery-related alarm: the pump may NOT be receiving full power. The battery level display may be inaccurate. Your battery is expected to last at least 30 days. Battery life may be shortened if you select the vibrate mode, or use the backlight frequently. The battery life will also vary based on the number of alarms or alerts you receive. Do time. NOT remove the battery unless you are installing a new battery or are storing your pump for a long period of Section 10: System Maintenance NOT install a new battery within 15 minutes of taking out the old one, you will need to reset the time If you do and date, you will lose your bolus history and Insulin-on-Board (IOB) calculation. You will NOT be able to receive IOB information until the next bolus is delivered and a calculation can be established. Batteries should be disposed of in accordance with local regulations. For detailed instructions on battery insertion, see RESTART Note: The Aviator Pump will notify the user with a low battery alert when the battery is nearing depletion NOT less than 24 hours before the pump stops delivery due to a depleted battery. basal delivery as recommended by your healthcare professional. Section 1.4. Note: The Aviator Companion contains lithium batteries. At the end of their useful life, dispose system components and accessories according to local environment and other rules and regulations that may apply. Contact Customer Care for replacements. Clean Your Companion and Pump 10.2. Helpful Information NOT use household cleaners (e.g., petroleum-based products, bleach, and jewelry cleaner) or products NOT use organic solvents (e.g., lighter fluid, paint thinner, nail polish remover) and be sure that your hands Do are free of these products before touching the companion or pump. Do containing high levels of N, N-diethyl-m-toluamide (DEET) near the companion or pump and be sure that your hands are free of these products before touching the companion or pump. Do Do Do Do NOT use abrasive cleaners, scouring pads, or sharp instruments. NOT use lubricants with your companion or pump. NOT steam or sterilize your companion or pump. NOT put your companion or pump in the dishwasher or microwave. Wipe your companion or pump. 2. Dry your companion or pump. Do This Caution: Do NOT place Aviator Companion or Aviator Pump under water. Wipe the outside with a cloth dampened with mild soapy water. Wipe clean with a damp cloth, then wipe dry with a dry cloth. Procedure:
Steps 1. DOC15736_Rev-A-Man.indd 229-230 2/9/09 11:29:54 AM 229 230 Store Your Aviator Companion and Aviator Pump Conditions for Transport, Storage, and Use Section 11: Manage Your Diabetes Safely 10.3. Helpful Information Stop all delivery prior to removing the pump battery. Remove the battery before storing your pump. Store your pump with the battery cap and dust cap in place to protect the inside of your pump. Store your Aviator Companion and pump in a clean, dry place where there are humidity, or extreme atmospheric pressures. NOT extreme temperatures, high 10.4. Handle a Damaged or Wet Companion or Pump Caution: If your companion or pump is cracked or a button is torn, discontinue use and switch to an alternate insulin therapy method immediately. Follow your healthcare professionals recommendations for alternate insulin delivery method in Section 12-Appendix A and/or call Customer Care. ONLY the personnel at Abbott Diabetes Care should take care of a damaged pump. Helpful Information NOT to drop your companion or pump, or hit it against hard surfaces. NOT submerge the companion in water. If it is accidentally dropped in water, towel dry the outside of the Be careful Check for missing segments and that the screens display correctly and audio / vibration occurs after installing a pump battery. Also verify the audio / vibration test when starting basal delivery. Do companion. Do NOT use a hair dryer to dry your companion. If your pump is accidentally submerged in water and the battery cap and infusion set hub are in place, you can towel dry the outside of the pump. Inspect the reservoir compartment and battery compartment and dry any water you find with a Q-tip. Do NOT use a hair dryer to dry your pump. If your pump was submerged in salt wa-
ter, thoroughly clean with a damp cloth before drying. If your pump is accidentally submerged in water and the battery cap or the infusion set is stalled, submersion will likely damage internal pump components. Call Customer Care. If your companion is accidentally submerged in water, you can towel dry the outside of the companion. Do recharge or reuse the Companion. Contact Customer Care. You should remove your pump before every prolonged exposure to water, including bathing, showering, and swimming. Because of the If your pump is damaged, it will need to be serviced or replaced. Call Customer Care for information about ser-
vicing or replacing your pump. Aviator Pumps unique hub connection, use ONLY Aviator-compatible sets with the pump. NOT properly in-
NOT Section 11: Manage Your Diabetes Safely 10.5. Helpful Information Do sible adverse events or serious injury. NOT to subject your companion or pump to extreme conditions, which may cause malfunctions and pos-
Try to AVOID:
Exposing your companion or pump to temperatures above 104F (40C), as might happen in a sauna or on a very hot day. Allowing your companion or pump to absorb radiant heat (e.g., sunlight) that would increase its temperatures to above 104 F (40C). This can also damage your insulin in the tubing exposed to the radiant heat. Using a dark colored pump case, which would increase the intensity of radiant heat. Lowering the temperature of your companion or pump below 41F (1C). Storing your pump below or above the recommended temperature when you are not using the pump. Note that storage temperature should be between -4F to 104F (-20C to 43C). Exposing your companion or pump to very high humidity (over 100 percent) for prolonged periods of time. Your system may NOT operate properly. Low atmospheric pressures (Elevation 10,000 feet [3048 meters] and above. Commercial airliners are OK because of the pressurized cabins.) Your system may NOT operate properly. The and accessories according to local environment and other rules and regulations that may apply. Avoid getting dirt, dust, blood, control solution, water or any other liquid in the and data port. When traveling by air, pack your extra lithium batteries in checked baggage. Aviator Companion contains lithium batteries. At the end of their useful life, dispose system components Aviator Companions test strip Caution: If your pump is exposed to these extreme ranges, there is a possibility the insulin in your pump will be damaged or destroyed. The insulin in the insulin reservoir may need to be replaced (see Section 2.3), and the infusion set changed. Please check with your healthcare professional. DOC15736_Rev-A-Man.indd 231-232 2/9/09 11:29:54 AM 231 232 Section 11: Manage Your Diabetes Safely 11 Manage Your Diabetes Safely This section provides detailed information related to the safe use of your companion and pump. It describes what the companion and pump are used for and what it must NEVER be used for. Review this section carefully. If you have any questions or concerns after reviewing this section, contact Customer Care or your healthcare professional for assistance. Indication The FreeStyle Aviator Insulin Delivery and Blood Glucose Monitoring System is intended for continuous delivery of insulin at set and variable rates and as an aid in the management of diabetes mellitus in persons requiring insulin. The FreeStyle Aviator System is also intended for the quantitative measurement of glucose in fresh whole capillary blood (in vitro). The system is available by prescription only. Contraindications The Aviator System is NOT intended for:
Blood Glucose Testing Your blood glucose levels should stay within the range determined by you and your healthcare professional. It is extremely important that you check your blood glucose levels regularly and often while using your insulin pump. In addition to this ongoing testing, your blood glucose level must also be tested:
People who are unwilling to consistently test their blood glucose levels at least 4 times a day. People who are unwilling to self-insert an infusion set every 2-3 days. People who dont want to work closely with their healthcare professional. People whose vision is impaired to the point where they People whose hearing is impaired to the point where they Whenever you stop your pumps operation for any length of time, as the insulin level in your blood will be de-
pleted quickly and blood glucose levels will rise rapidly when the pump is stopped. Within 1-3 hours of replacing the insulin reservoir and/or inserting/attaching a new infusion set. More frequently during times of illness, injury or stress. When you first start pump therapy and are adjusting your basal rates. When changing insulin dosages. Refer to Section 5 for more information about testing your blood glucose using your integrated Aviator Companion Blood Glucose Meter. Two Consecutive High Blood Glucose Readings despite the CANNOT hear the companion or pumps alarms. CANNOT read the companion or pumps screen. Administration of a Correction Bolus If you get two consecutive unexplainable high blood glucose readings while on pump therapy, do the following:
Section 11: Manage Your Diabetes Safely 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. If your healthcare professional plan calls for a correction bolus, follow the recommendations for administering the correction bolus. Check for ketones, if your healthcare professional instructed you to do so. Evaluate your pump and infusion set for loose connections or insulin leakage. Check your pump programming to confirm you are receiving your expected basal rate dose. Check bolus history to ensure you have received your last several boluses. Check your daily total insulin amount to make sure that you are on track with the amount of insulin you have been using. Inspect your tubing for air bubbles. Check to see if it is connected to your site correctly and that your site has NOT accidentally become dislodged. Evaluate other causes of unexpected high blood sugars:
Are you sick?
Have you had a change in your physical condition (pain, menses, surgery, illness)?
Has your insulin been exposed to higher temperatures in the day or hours leading up to these higher levels?
Have you recently started taking a medication that could be causing your blood sugar to be high?
Have you encountered additional personal or physical stress in the hours leading up to this episode?
NO clear reason for the high blood sugars, then it is recommended that you disconnect your If there is infusion set from your body, throw away the set, tubing, and reservoir of insulin. Fill a new reservoir with fresh insulin, prime your system, and reinsert a new set into a different area of your body. Continue to measure your blood glucose levels every 1 to 3 hours after the new insertion to insure your blood glucose levels return to your normal levels. If in doubt with any step, contact your healthcare professional for guidance. DOC15736_Rev-A-Man.indd 233-234 2/9/09 11:29:54 AM 233 234 Section 11: Manage Your Diabetes Safely Section 11: Manage Your Diabetes Safely FreeStyle Aviator Safety Features A number of advanced safety features are incorporated into the Aviator Pump. Some of the more important features are listed in the table below. Safety Feature What It Does To Set the Safety Feature or for More Information See Section 6 Maximum Bolus Maximum Basal Rate Bolus Calculator Speaker Backups Limits the size of your bolus, so you dont accidentally give yourself too much insulin in a single bolus (protects from over-infusion). Limits your basal insulin delivery, so you dont accidentally set a basal rate that is too high
(protects from over-infusion). Allows you to easily calculate an insulin bolus. Clearly shows you the data used to determine units to deliver (protects from over- or under-
infusion). Also allows you to adjust a bolus. The Aviator Pump has a set of backup speakers to make sure the audio tones are heard. See Section 6 See Section 6 N/A Essentials for Safe and Effective Use In order to use your FreeStyle Aviator System safely and effectively, you will need:
Support from and close contact with your healthcare professional trained in the use of insulin pumps. A commitment to follow-up appointments for continuing care. An understanding of the basic principles of diabetes care. An understanding of basal and bolus insulin use. Dedication to frequent blood glucose testing: 4 or more times per day and appropriate actions based on testing results. A backup plan of insulin administration, in case of interruption of pump usage. Potential Risks Connected with Pump Therapy Complications can arise as a result of pump therapy if you are NOT attentive to routine glucose testing and evaluation. These risks include:
The best way to avoid any risk while using the pump is to be prepared with a written plan from your healthcare professional to deal with each risk. Each risk has specific ways your healthcare professional can instruct you to lessen the risk. Frequent glucose monitoring and taking action with the results will also protect you from undetected high or low blood glucose. Frequent or severe hypoglycemia. Diabetic Ketoacidosis (DKA)
. Infections where you insert your cannula for insulin delivery. 235 Infections Ways to avoid the potential for infection:
NOT blow on your site to help it dry after you clean it. You may transfer germs from your mouth and/or lungs Always clean the intended insertion site with soap and warm water or a solution suggested by your healthcare professional. Do onto your skin. These germs then enter your skin when you insert the cannula. Be diligent in changing your infusion set time. This will increase your chance for infection and may potentially eliminate the site from future use. at least every 3 days. Do NOT use your infusion set for long periods of Other points about your infusion site:
Select infusion sites away from scarred or infected areas, and rotate infusion site locations regularly. When you remove your infusion set, there may be some clear drainage or a small bump under the surface of the skin where the cannula is inserted. The bump should heal and go away over a few days. If it becomes worse, check with your healthcare professional for any infection. Your infusion site should never have any type of cloudy, smelly, or colored drainage. There may be slight redness around the site from your adhesive tape but there should dened skin around the infusion site. Your site should lumps at the infusion site, you need to contact your healthcare professional immediately. They will help you ad-
dress the problem quickly so you avoid additional problems of infection moving to another area of tissue. Most commonly, a mild antibiotic is prescribed to help cure the infection. When inserting a new infusion set, avoid inserting within 2 inches of a site that had been infected. Failure to do so could result in further infection, DKA and/or high blood glucose due to absorption issues. If you have ques-
tions, contact your healthcare professional. NOT be tender or hurt. If you notice any drainage, redness, hot to the touch, tenderness or NOT be a ring of red-
Hypoglycemia Hypoglycemia, or low blood sugar, occurs when your blood glucose level falls below the lower limit of your established safe blood glucose range. Symptoms of hypoglycemia include:
Feeling light-headed, dizzy, confused, sleepy, weak, nervous, and/or hungry. Shakiness. Excessive perspiration. Common causes of hypoglycemia include:
Too much insulin. Skipping a meal (or eating a meal that is smaller than you anticipated). Heavy exercise or a higher-than-normal activity level. Excessive consumption of alcohol. 236 DOC15736_Rev-A-Man.indd 235-236 2/9/09 11:29:54 AM Section 11: Manage Your Diabetes Safely Section 11: Manage Your Diabetes Safely If you are experiencing any of the symptoms of hypoglycemia, you should test your blood glucose level. If it is below your lower blood glucose target, follow the Rule of 15. 1. 2. 3. 4. 15 grams of simple carbohydrate (1/2 cup fruit juice or sweetened soda, 3-4 glucose Eat approximately tablets or glucose gel). NO fat should be in the foods used to treat hypoglycemia to make them fast to absorb. Wait 15 minutes and then check your blood glucose level again. If your blood glucose level is still too low, repeat steps 1 and 2 until your blood glucose level measures within your acceptable range. Once your blood glucose level is normalized, resume your usual meal and snack schedule. If you will eating a meal within an hour, you should consider having a snack. NOT be Severe hypoglycemia may require an injection of the hormone glucagon. You should have a Glucagon Emergency Kit as part of your emergency kit. Your entire emergency kit should be kept with you at all times. You should let family members, co-workers, and close friends know where it is and how to use it. Ask your healthcare professional how to use glucagon. Note: You should talk with your healthcare professional if you are experiencing hypoglycemia frequently. 1. An increased hunger or thirst. A need to urinate frequently. Blurred vision. Hyperglycemia Hyperglycemia, or high blood sugar, occurs when your blood glucose level is higher than the upper limit of the blood glucose range set by you and your healthcare professional. Possible symptoms of hyperglycemia are:
Possible reasons for hyperglycemia are:
Interrupted insulin delivery due to:
Under delivery of insulin. Eating more carbohydrates than you anticipated or was aware of. Illness, infection, stress, menses, less activity or exercise. Check to see if you are receiving your expected basal rate dose. Check your bolus history. Check your total daily insulin delivered. Your basal or bolus doses may need to be adjusted. Occlusion in the tubing or infusion set. The tubing has tangles or kinks. The insulin reservoir is empty. The infusion set or cannula is dislodged. 3. 4. 2. 237 5. 6. Insulin has gone bad (e.g. exposed to high temperature, expired.) Taking a medication that raises blood glucose. (Check with your healthcare professional or pharmacist). Possible interventions:
Section 8). Test your blood glucose level again after an NOT functioning properly, you need to disconnect from the pump and Use your pump to administer a correction bolus (see hour. If you think the companion or pump is administer insulin using an alternate delivery method. Call Customer Care to report the problem with your pump. If you think there is a problem with the tubing or infusion set, remove the old infusion set from the pump and replace with a new infusion set. Follow the instructions for priming and reinsertion (See Section 2.4 and your infusion sets Instructions for Use). If you are unable to determine the reason for your hyperglycemia and are unable to correct it, call your health-
care professional. If your blood glucose level is very high, you should check your urine or blood for ketones and follow the advice of your healthcare professional. Diabetic Ketoacidosis Diabetic Ketoacidosis (DKA) can develop if your blood glucose levels have been too high for a period of time. DKA is different from hyperglycemia in that in addition to an elevated blood glucose level, your body is producing ketones, which change the pH (acidity) of your blood. DKA is extremely serious, and requires immediate treatment by your healthcare professional. Contact your healthcare professional immediately if you suspect DKA. DKA can be life threatening. How long it takes to develop DKA is based on the individual. No matter what your particular situation, once insulin delivery stops (from a clog, dislocation of your infusion set, disconnecting and forgetting to reconnect), within 3-5 hours (the duration of action of the insulin used in your pump) you will be insulin deficient. If you do NOT restore insulin delivery, you are at risk of even higher blood glucose levels and the development of ketones, which, if left untreated, can lead to the life-threatening consequences of DKA. It is VERY IMPORTANT that any time you discover insulin delivery has been disrupted, you should immediately test your urine or blood for ketones. Follow the plan you and your healthcare provider have designed. Symptoms of DKA, which can be mistaken for flu-like symptoms, include:
Headache. Stomach ache. Fruity odor on breath. Very dry mouth. Shortness of breath. Nausea/vomiting. 238 DOC15736_Rev-A-Man.indd 237-238 2/9/09 11:29:55 AM Section 11: Manage Your Diabetes Safely Improper use of insulin. Infection or illness. Stress. Possible causes of DKA include:
Your risk of DKA is lessened if you follow these guidelines:
Work with your healthcare professional to make sure your pump is programmed properly, that you know how to use your pump, and that your selected bolus and basal insulin doses are appropriate. Always have insulin and reservoirs available. Keep your emergency kit with backup insulin supplies with you at all times. Monitor your blood glucose level closely when you are ill or during periods of high activity or stress. Talk with your healthcare professional if you have any questions about DKA or what you can do to prevent it. How Illness Affects Blood Glucose Levels Infection or illness is usually accompanied by higher than normal blood glucose levels (hyperglycemia). Your insulin needs will most likely increase when you are ill. Follow these guidelines:
Insulin must be taken when you are ill; contact your healthcare professional for specific advice, but do taking basal insulin, even if you feel too sick to eat. Check your blood glucose level every 2-4 hours. Check your blood or urine for ketones;
Your insulin pump can be programmed with a basal insulin pattern that can be used when you are ill (see Section 7); you may want to talk with your healthcare professional about this option. Sick Day Management When you are sick, your bodys stress level increases. The body produces hormones to help fight off the sickness. However, there are side effects: blood glucose levels increase and insulins ability to lower blood glucose levels decrease. In this situation, blood glucose levels are much more difficult to keep in your target range, which could lead to DKA. You need to plan ahead, work with your healthcare professional, and prepare a sick day plan in advance. The plan should include:
When to call your healthcare team. How often to test blood glucose. When and how often to test for ketones. What medicines to take. A plan for eating. Contact numbers for your healthcare team. NOT stop Section 12: Appendices Appendix A: Table of Settings How Exercise Affects Blood Glucose Levels Exercise can help lower blood glucose levels. The more active you are, the more dramatic this lowering will be. When starting or stopping an exercise program (or increasing or decreasing your level of activity), you may have to adjust your basal rates. Your food intake may also need to be adjusted. Your insulin pump can be programmed with a basal insulin pattern or a temporary basal rate that can be used on days you are exercising (see Section 7.6). You may want to talk with your healthcare professional about this option or any other questions you may have about how exercise affects your blood glucose levels and insulin needs. In addition, there are other resources that may be helpful to understand the impact of exercise on your diabetes. See the Resources section of this User Guide for additional resources on exercise and diabetes. Your Daily Kit You must have a backup plan in case something goes wrong with your pump or you have a medical emergency. Keep a daily kit with you at all times. Let family members, co-workers, and close friends know where it is and how to use it. Your kit should include:
Blood glucose monitoring supplies. Ketone monitoring supplies. Glucose tablets/gel or liquid or other sources of carbohydrate to treat a low glucose. A Glucagon Emergency Kit (Glucagon Emergency Kits have an expiration date; check frequently to make sure your kit has NOT expired). An extra insulin infusion set. An extra unopened pump reservoir. An extra AAA alkaline battery. Dressings and adhesives. Spare battery cap. Insulin syringe and short or rapid-acting insulin vial or insulin pen. Remember, insulin is sensitive to temperature extremes. Replace your spare insulin monthly. Discontinuing Pump Use If you and your healthcare professional determine that stopping pump therapy makes sense, you must be prepared to switch to an alternate insulin therapy method. Medical Procedures You may need to suspend pump use for/during certain medical procedures. Keep these points in mind:
NOT expose your companion or pump to MRI, X-ray, CAT scan, or ultrasound equipment. ALWAYS discon-
Do nect your companion and pump and store it away from the machines. Do NOT bring the companion and/or pump into the procedure room at any time. Talk with your healthcare professional about whether or cedures, hospitalizations, surgeries, or ER visits. NOT you should use your pump during outpatient pro-
DOC15736_Rev-A-Man.indd 239-240 2/9/09 11:29:55 AM 239 240 Section 12: Appendices Appendix A: Table of Settings Frequently Asked Questions Q. How do I obtain supplies for my pump?
A. Supplies for the Aviator Pump can be obtained by calling Customer Care. Q. When a question or problem arises, should I call Customer Care or my healthcare provider?
A. In general, if you have a question about the programming or operation of your pump, you should call Customer Care. If you have a question about your personal insulin therapy, treatment plan, or diabetes management, you should contact your healthcare professional. Q. Should I insure my pump?
A. Contact your insurance provider to see if they offer coverage. Q. Is it okay to take a break from pump therapy?
A. Consult your healthcare professional before changing or stopping pump therapy. If you take a break from pump therapy, you must switch back to injecting insulin. Be sure to administer insulin for meals and to cover basal insulin requirements. Q. Is a pump support group worthwhile?
A. Many people find a pump support group helpful. It can be a place to go where you can discuss pump therapy with and be supported by your peers. If you are interested in a pump support group, ask your healthcare professional. 241 12 Appendices A. Table of Settings Everyone has different insulin requirements and pump preferences. Before you begin using your pump, you will need to work with your healthcare professional to determine the correct pump settings to meet your individual needs. Section 12: Appendices Appendix A: Table of Settings It is important to keep your personal settings charts updated. Remember to record any changes recommended by your healthcare professional. The table below provides the options available as well as the factory default setting. 1. Pump Settings Record your pump settings here for future reference:
SETUP WIZARD: Language, Time/Date, and Insulin Settings Setting Language What it Allows You to Do Set the language your pump will use for its text instructions. Options Available English Factory Default English Your Setting English Time/Date Format Time Select the time format. Date Select the date format. Current Time Set the time. Current Date Set the date. Insulin Concentration The insulin concentration on your pump is fixed at U100. 12 hour Mmm dd, yyyy
N/A N/A U100 12-hour (e.g., 1 PM will appear as 1:00 PM) or 24-hour (e.g., 1 PM will appear as 13:00). Month/day/year or day/month/year N/A N/A U100 242 DOC15736_Rev-A-Man.indd 241-242 2/9/09 11:29:55 AM Section 12: Appendices Appendix A: Table of Settings Setting Type Action Time What it Allows You to Do Select the type of insulin you will be using in your pump. Set the action time of the insulin you will be using in your pump. Your Setting Options Available Rapid or short 2 to 8 hours Factory Default Rapid 5 hours 00 minutes SETUP WIZARD: Bolus and Basal Settings Bolus Limits Increment Maximum One-Button Bolus On/Off Increment Bolus Calculator Carb Ratios Set the increments (in Units) of insulin that may be programmed for a bolus. Set the maximum programmable amount of insulin for a single bolus. Turn the one-button bolus function on or off. Set the One-Button bolus increment (how much each button press increases the bolus amount). Select the amount of bolus insulin needed to handle each gram of carbohydrate you plan to eat, for up to 24 different time blocks. 0.05U, 0.1U, 0.5U, or 1.0U 0.1U 10.0U 0.1 - 50.0 when increment =>0.1 units 0.05 9.95 when increment = 0.05 units On/Off Off 0.5U or 1.0U If One-Button is off, there is no option. If set to on, 0.5U 1-150 (1U/1g-
1U/150g)
Section 12: Appendices Appendix A: Table of Settings Your Setting Setting 1 U Drop What it Allows You to Do Set how much 1U of insulin will lower your blood glucose level, for up to 24 different time blocks. Blood Glucose Range Blood Glucose Targets Set the values for your blood glucose targets for up to 24 different time blocks. Basal Settings Increment Maximum Temporary Select the increment for changes in basal insulin delivery rates Select the maximum amount of insulin to be used for hourly basal insulin delivery rates. Set the format used to program a temporary basal rate in either absolute Units or as a percentage of the programmed basal rate. Options Available 5 - 500 mg/dL
(0.28 27.8 mmol/L) Factory Default
50-300 mg/dL
(2.8 16.7 mmol/L) 110 mg/dL
(6.1 mmol/L) 0.05 U/h, 0.10 U/h, 0.50 U/h, or 1.00 U/h 0.05 U/h 0.05 U/h to 30.00 U/h 2.00 U/h Units or Percent Percent SETUP WIZARD: Feedback and Alerts/Alarms Pump Feedback Options Feedback Set your pump to give either audio (beeps) or vibratory signals. Audio or Vibrate Audio DOC15736_Rev-A-Man.indd 243-244 2/9/09 11:29:55 AM 243 244 Section 12: Appendices Appendix A: Table of Settings Setting Audio What it Allows You to Do Set the volume of auditory alerts. Note: All vibrations are at the same intensity. Companion Feedback Options Feedback Audio Set your Companion to give audio (beeps) and/
or vibratory signals and progress tones. Set the volume of auditory alerts. Options Available Low, Medium, or High Factory Default If audio is selected, High Audio and/or Vibrate Audio Low, Medium, or High If audio is selected, Low Vibrate Set the length of vibratory alerts. Long, Medium, or Short If audio is selected, Long Progress Tones Set the volume of progress tones. Low, Medium, or High If audio is selected, Low Occlusion Alarm Sensitivity Set the level of sensitivity of the Occlusion Alarm. Low or High High Your Setting Setting What it Allows You to Do Options Available Factory Default Section 12: Appendices Appendix A: Table of Settings Your Setting Low Insulin Alert Low Alert Inactivity Alarm Inactivity Select the insulin level that will trigger the Low Insulin Alert. 5 50U Set the time of the Inactivity Alarm. 1 24 hr SETUP WIZARD: Display and Locked Items Settings Display Settings 20U 1 hr Buttons Timeout Home Cursor Contrast Magnify On Right/On Left Right 15 - 120 seconds 15 seconds Information or Activity Information Highlight or Outline Highlight 0 - 2 On or Off 2 On Invert the screen to suit your hand preference
(right or left handed). Set the amount of time the display may remain idle before reverting to the idle screen. Select the Home screen display format. Select how highlighted options will appear. Select the contrast of the companion display. (this setting is only available on the Companion) Select whether highlighted options will be magnified in larger font size. (This setting is only available on the pump) DOC15736_Rev-A-Man.indd 245-246 2/9/09 11:29:55 AM 245 246 Section 12: Appendices Appendix A: Table of Settings Setting What it Allows You to Do Options Available Locked Items Note: Locked items can only be accessed through the SETUP WIZARD. Basal Unlocked or Locked Your Setting Factory Default Unlocked 2. Personal Settings Record your personal settings here for future reference:
Standard Daily Basal Rates Basal Rate Start Time Basal Rate (Units/h) Section 12: Appendices Appendix A: Table of Settings Lock or unlock basal functions on the pump (select, edit, create, delete, rename program). Lock or unlock bolus functions on the pump
(One-Button Bolus, Food and Correction Bolus, Correction Bolus, Food Bolus, Manual Bolus). Lock or unlock prime functions on the pump
(tubing, cannula). Bolus Prime Unlocked or Locked Unlocked Unlocked or Locked Unlocked Therapy Lockout Note: Therapy Lockout is only available on the Companion. Therapy Lockout On or Off Disable access to start/
stop delivery features on the Companion including Basal and Bolus. Set the lockout duration. Once or Always Duration Off If On is selected duration is Once Basal Rates: Alternate Pattern 1 (for example workout days) Use these basal rates when Basal Rate Start Time Basal Rate (Units/h) DOC15736_Rev-A-Man.indd 247-248 2/9/09 11:29:55 AM 247 248 Section 12: Appendices Appendix B: SETUP WIZARD Default Configuration and Settings Basal Rates: Alternate Pattern 2 Use these basal rates when Basal Rate Start Time Basal Rate (Units/h) Section 12: Appendices Appendix B: SETUP WIZARD Default Configuration and Settings Temporary Basal Settings For detailed information about setting a Temporary Basal, see Section 7.6. When to use Temporary Basal:
What to set Temporary Basal at (indicate if this is a percentage of your standard basal pattern or a specific Unit rate):
Bolus Settings For detailed information about Bolus programming, see Section 8. When to use a Normal bolus:
When to use an Extended bolus:
When to use a Dual bolus:
When to use the One-Button Bolus function:
Basal Rate (Units/h) 3. Other Information Record any additional instructions from your healthcare professional below. Basal Rates: Alternate Pattern 3 Use these basal rates when Basal Rate Start Time DOC15736_Rev-A-Man.indd 249-250 2/9/09 11:29:55 AM 249 250 Section 12: Appendices Appendix B: SETUP WIZARD Default Configuration and Settings B. SETUP WIZARD Default Configuration and Settings Valid Values Increment Item Language Time Date Hour Minute AM/ PM Month Day Year Type Action Time Time Buttons Timeout Home Cursor Magnify Time, 1U Drop Screen SELECT LANGUAGE TIME/DATE FORMAT TIME/DATE FORMAT SET TIME SET TIME SET TIME SET DATE SET DATE SET DATE INSULIN PROFILE INSULIN PROFILE INACTIVITY ALARM DISPLAY DISPLAY DISPLAY EDIT MODE EDIT MODE 1U DROP Time, I:CHO CARB RATIOS Time, mg/dL BG TARGETS Default Config English 12 Hour Mmm dd, yyyy
AM
Rapid 5h 00m
-- h on Right 15 Sec Information Highlight VALUE CANNOT BE CHANGED 12 Hour, 24 Hour Mmm dd, yyyy, dd Mmm yyyy 01 12 (12hr); 00 23 (24hr) 00 59 AM, PM Jan, Feb, Mar, Apr, May, Jun, Jul, Aug, Sep, Oct, Nov, Dec 01 31 2007 2049 Rapid, Short 2h 00m 8h 00m 1 24 (always On) on Right, on Left 15 120 Information, Activity Highlight, Outline On On, Off
24 blocks of time allowed 5 500 mg/dL (0.28 27.8 mmol/L) Programming starting value: 50 in one unit increments 24 blocks of time allowed 1 150 (1U/1g 1U/150g) Programming starting value: 1U/15g Carbs 1 200 grams 24 blocks of time allowed 50 300 mg/dL (2.8 16.7 mmol/L) Default value is 110 mg/dL (6.1 mmol/L) Increment BOLUS LIMITS 0.1 U 0.5 U, 1.0 U N/A N/A N/A 1 1 N/A N/A 1 1 N/A 15 (min) 1 N/A 15 N/A N/A N/A 1 hour 1 1 hour 1 1 1 hour 2 N/A Wizard Step 1 1 1 1 1 1 1 1 1 1 1 1 2 2 2 2 2 3 3 3 4 4 Wizard Step Item Screen Default Config Valid Values Increment Section 12: Appendices Appendix C: Device Specifications Companion 4 4 4 4 4 5 5 5 5 6 6 6 7 7 7 7 On/Off ONE-BUTTON BOLUS On Off, On Increment ONE-BUTTON BOLUS Enabled 0.5 U 0.5 or 1.0 (0.5 or 1.0) Increment BASAL LIMITS 0.05 U/h 0.05 U/h, 0.10 U/h, 0.50 U/h, 1.00 U/h Maximum BASAL LIMITS 2.00 U/h 0.05 30.00 BASAL SETUP Percent Units, Percent Temp Pump Audio AUDIO/VIBE AUDIO/VIBE Sensitivity OCCLUSION ALARM Low Alert LOW INSULIN ALERT Audio Audio, Vibrate High High 20 U Medium, High, Low High, Low 5 50 Basal Bolus Prime Time Rate Time Rate LOCKED ITEMS Unlocked Unlocked, Locked LOCKED ITEMS Unlocked Unlocked, Locked LOCKED ITEMS Unlocked Unlocked, Locked Add Block 1 12:00 a.m. 12:00 a.m. 11:30 p.m. Add Block 1 Add Block n+1 Add Block n+1
0.00 Max Limit
(user programmable) Time of Block n +:30 11:30 p.m.
(or 23:30 for 24 hour) 0.00 Max Limit
(user programmable) N/A 0.5 N/A
.05 N/A N/A N/A N/A 5 N/A N/A N/A 30 (min) user programmable 30 (min) user programmable Maximum BOLUS LIMITS 10.0 U 0.1 50.0 when increment => 0.1 units 0.05 9.95 when increment = 0.05
= Increment 251 252 DOC15736_Rev-A-Man.indd 251-252 2/9/09 11:29:55 AM Section 12: Appendices Appendix D: Device Specifications Pump Other Preferences That are Not Part of the Wizard C. Device Specifications Companion Section 12: Appendices Appendix D: Device Specifications Pump Menu REMINDERS Item Reminders 1 6 On/Off REMINDERS Reminders 1 6 Message REMINDERS Disable All Care Comments REMINDERS On/Off REMINDERS On/Off REMINDERS Frequency REMINDERS On/Off Insulin Temp Care Comments Site Change Care Comments Site Change Care Comments Check BG Care Comment Screen Default Config Off On, Off Valid Values Increment N/A N/A N/A N/A N/A N/A N/A Test On Off Off Test, Wakeup, Basal, Bolus, Exercise, Meeting, Pickup, Snack, Meds On, Off Off, On Off, On 2.0 days 2.0, 2.5, 3.0 Off Off, On 253 Assay Method (FreeStyle Lite Blood Glucose meter):
Automatic shutoff:
Calibration (FreeStyle Lite Blood Glucose meter):
Hematocrit (FreeStyle Lite Blood Glucose meter):
Measurement Units:
Result Range (FreeStyle Lite Blood Glucose meter):
Sample (FreeStyle Lite Blood Glucose meter):
Sample size (FreeStyle Lite Blood Glucose meter):
Test time (FreeStyle Lite Blood Glucose meter):
Dimensions:
Display Type:
Display Viewable Dimensions:
Display Backlight:
Audio/Vibe Alert:
Weight:
Companion Battery:
Battery Life:
Memory:
Water Resistance:
Operational Conditions (Temperature, Humidity and Pressure):
Storage Range Data Storage Time:
Coulometric electrochemical sensor User settable up to two minutes after last user action Plasma equivalent 15% to 65%
Either mg/dL or mmol/L 20 to 500 mg/dL (1.1 to 27.8 mmol/L) Whole blood, capillary 0.3 microlitre (300 nanolitres) Dot graphic Average of 5 seconds 3.89 X 2.44 x 0.63 (99 X 62 X 16 mm ) 1.77 x 1.28 (45 X 32.5 mm) Yes Yes 2.6 oz (75 grams) Lithium polymer, 3.7V 690mAh 3 days The expected life of the battery is dependant upon the following usage:
- 5 boluses per day with total daily bolus delivery of 24 Units (U100)
- Basal delivery of 1U/h (U100) 24 hr/day, 7 days/week
- Prime of 20 Units (U100) occurs 3 times per week.
- 5 blood glucose readings per day
- Enter and log 8 events per day
- Data transfer to CoPilot three times per month 90 days worth of events. All events can be seen if downloaded to a PC. None 41F 104F (5C to 40C) with 10% to 90% relative humidity 14.7 psia - 10.2 psia (equivalent to an altitude of sea level to 10,000 feet [3048 meters] under standard atmospheric conditions) Shipping container for 1 year at -4 113F, average temperature at 72.5F
(-20C to 45C, average temperature at 22.5C) with 10% to 90% relative humidity, non-condensing. The Companion has the ability to store a minimum of 90 days of events in non-volatile memory for the expected life of the companion. 254 DOC15736_Rev-A-Man.indd 253-254 2/9/09 11:29:56 AM Section 12: Appendices Appendix E: FCC Compliance Information D. Device Specifications Pump Dimensions:
Display Type:
Display Viewable Dimensions:
Display Backlight:
Audio/Vibe Alert:
Weight:
Reservoir:
Reservoir Connection:
Basal Increment:
Total Basal Rates:
Basal Profile Configuration:
Basal Profiles:
Basal Interval:
Basal Frequency:
Basal Rate Range:
Temporary Basal:
Bolus Dose Range:
Bolus Increments:
Normal Bolus Delivery Rate:
Prime Deliver Rate:
Extended Bolus:
1 U Bolus Duration:
Inactivity Alarm:
DOC15736_Rev-A-Man.indd 255-256 Dot graphic 3.3 X 1.8 X 0.75 (84 X 46 X 19 mm) 0.97 X 0.76 (24.7 X 19.4 mm ) Yes Yes Without battery and reservoir/hub, weight is approximately 2.7 oz (76.5 g). Add battery and empty reservoir, weight is approximately 3.3 oz (93.6 g). Single use plastic reservoir Proprietary secure connector 0.05 units 48/day Numerical display 4 30 minutes Every 3 minutes 0.05 to 30U/h
+/- 10% increment between 0-200% for 0.05 to 30U/h* OR +/- 0.05 unit increment, single rate for 0.05 to 30U/h.
You may set a temporary basal for up to 72 hours. The minimum allowable percentage is equal to the minimum basal rate (0.05) divided by the lowest basal rate over the specified duration of the temporary basal that is greater than 0. (e.g. if the lowest basal rate greater than 0.0U over the duration is 0.20U, the minimum percentage is 25% 0.05/0.2 = 0.25) The maximum allowable percentage is equal to the maximum basal limit (Setup: Basal Limits: Maximum) divided by the highest basal rate over the specified duration of the temporary basal, truncated to the nearest 10%. (e.g. if the highest basal rate over the duration is 1.35 U/h, and the maximum basal limit is 2.00 U/h, the maximum percentage is 140% 2.00/1.35 = 1.48) 0.05 to 50U 0.05U, 0.1, 0.5 or 1.0 using One-Button Bolus (audio/vibrate) At least 0.1U per second At least 0.1U per second Yes 10 seconds typical Always on, 1 24 hours. 255 Maximum Time to Assert Occlusion Alarm:
Occlusion Alarm set to High Sensitivity 1 U/hr 0.05U/hr Approximately 3 hrs Approximately 60 hrs Approximately 6 hrs Approximately 120 hrs Section 12: Appendices Appendix F: Electromagnetic Information Occlusion Alarm Threshold/Pressure
(Maximum Infusion Pressure) Bolus Volume upon Release of an Occlusion Pump Battery:
Battery Life:
Memory:
Water Resistance:
Moisture Protection:
IEC Classification:
Reservoir Volume:
Operational Conditions (Temperature and Humidity):
Storage Range:
Accuracy:
Data Storage:
25 psig (pounds per square inch gauge) Approximately 2.0 units One AAA battery (Energizer E92 or Duracell MN2400 recommended). Other models from these companies have not been tested. 30 days (in typical use cases) The expected life of the battery is dependent upon the following usage:
Basal: 1 U/h (U100) 24 hr/day, 7 days/week Bolus: 5 boluses per day with a total daily bolus delivery of 24 Units (U100) Prime: 20 Units (U100) occurs three times a week 90 days worth of events; display shows last 30, remainder can be seen if downloaded to a PC Water resistant to IPX8 IPX8 (Water resistant to 8 feet [2.4 meters] for 30 minutes and 12 feet [3.6 meters] for 3 minutes) Internally powered equipment, Type BF applied part (protection against electric shock) 250U or 2.5 mL 41F 104F (5C to 40C) with 10% to 90% relative humidity Shipping container for 1 year at -4F 113F, average temperature at 72.5F (-20C to 45C, average temperature at 22.5C) with 10% to 90% relative humidity. Bolus Accuracy : +0.1U / -0.2U (or +0.001ml/-0.002ml); for doses from 0.05U to 2U inclusive
+5% / -10%; for doses greater than 2U up to and including 6U
+5% / -5% for doses greater than 6U Basal Accuracy: +/-5%
The Pump has the ability to store a minimum of 2700 patient events in non-volatile memory for the expected life of the pump. 256 2/9/09 11:29:56 AM Section 12: Appendices Appendix G: Accuracy of Flow Rate E. FCC Compliance Information Model Number: PRT12354-xxx and PRT15751-xxx. FCC Rules: Tested to comply with FCC Part 15, Class B, Security/Remote control Transmitter. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions:
1. This device may not cause harmful interference. 2. This device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
Reorient or locate the receiving antenna. Increase the separation between the equipment and transmitter. Consult the dealer or an experienced radio/TV technician for help. The user is cautioned that changes or modifications not expressly approved by Abbott Diabetes Care may void the users authority to operate this device. F. Electromagnetic Information Electromagnetic Interference (EMI) from Radio Wave Sources Section 12: Appendices Appendix G: Accuracy of Flow Rate Battery powered insulin delivery devices such as the Abbott Diabetes Care Inc. FreeStyle Aviator System may be susceptible to electromagnetic interference (EMC) such as Radio and TV station towers, amateur radio (HAM) transmitters, two way radios, cell phones, Electronic Article Surveillance (EAS) systems and Radio Frequency Identification (RFID) systems. The interference from these electromagnetic field sources may cause the insulin pump to STOP delivery of the insulin or degrade the image on the companion and pump screens. It can also permanently damage the control system of the insulin delivery pump and companion. Immunity Level The intensity of the EMI can be measured in volts per meter (V/m). The immunity level of the FreeStyle Aviator System is 10 V/m as mandated by the standard, IEC 60601-2-24. Some cellular telephones and similar products transmit signals while they are turned on, even when NOT being used. EMC/EMI Declaration:
Reference Document Performance Criteria Required Performance Criteria Met CISPR 11 IEC 61000-4-2 IEC 61000-4-8
(Radiated Emissions) Group 1 Class B Pass N/A IEC 60601-2-24 IEC 60601-2-24
(Electro Static Discharge)
+/-8kV Direct, HCP and VCP Discharges +/-15KV Air Discharges Pass
(Magnetic Immunity) 400 A/m Pass DOC15736_Rev-A-Man.indd 257-258 2/9/09 11:29:56 AM 257 258 Section 12: Appendices Appendix H: Alarm Priority G. Accuracy of Flow Rate This graph shows the flow rate during the stabilization period. Measurements were made at a basal rate of 1U/h, in accordance to IEC 60601-2-24:1998 using an Aviator Insulin Reservoir and a Unomedical Comfort infusion set. 0.020 0.015
) h
L m
w o l F 0.010 0.005 0.000 100 200 300 400 500 600 800 700 900 Time (minutes) 1000 1100 1200 1300 1400 This graph show the maximum errors observed for specific observation intervals. Measurements were made at a basal rate of 1U/h, in accordance to IEC 60601-2-24:1998 using an Aviator Insulin Reservoir and a Unomedical Comfort infusion set.
w o l F f o r o r r E e g a t n e c r e P 20 15 10 5 0
-5
-10
-15
-20 Overall percentage error: -1.1%
15 60 150 330 570 930 Observation Interval (minutes) 259 At the minimum rate of 0.05 U/h (0.0005 mL/h), setup errors associated with the IEC 60602-2-24 test are too large to accurately determine the flow rate of the pump. An alternate test method was used which determines delivery accuracy by analyzing the movement of drive motor, as reported by an encoder on the motor shaft. Actual insulin flow rate may be less accurate. This graph shows the calculated flow rate during the stabilization period. Encoder data was collected at a basal rate of 0.05U/h. Section 12: Appendices Appendix I: Aviator Menus - Companion
) h
L m
w o l F 0.010 0.009 0.008 0.007 0.006 0.005 0.004 0.003 0.002 0.001 0.000 0 100 200 300 400 500 700 600 800 Time (minutes) 900 1000 1100 1200 1300 1400 This graph show the maximum errors calculated for specific observation intervals. Encoder data was collected at a basal rate of 0.05U/h.
e t a R w o l F f o r o r r E e g a t n e c r e P 20 15 10 5 0
-5
-10
-15
-20 Overall percentage error: -0.01%
15 60 150 330 Observation Interval (minutes) 570 930 260 DOC15736_Rev-A-Man.indd 259-260 2/9/09 11:29:56 AM Section 12: Appendices Appendix I: Aviator Menus - Companion H. Alarm Priority This section documents the Aviator Pumps alarm priorities in accordance with the 60601-1-8:2006 - `Medical electrical equipment - General requirements for basic safety and essential performance - Collateral Standard:
General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. All of the Aviator Pump alarms are classified as MEDIUM PRIORITY per the 60601-1-8:2006 collateral safety standard. Failure to respond to the cause of an Aviator alarm condition may potentially result in adverse medical conditions
(including death or irreversible injury) over an extended time period. While an alarm is active, insulin delivery is stopped. Therefore, it is important that you to respond to all alarms without delay. Possible Aviator alarms are:
Inactivity Alarm Reservoir Alarm No insulin alarm Occlusion alarm Section 12: Appendices Appendix I: Aviator Menus - Companion Normal Extended Dual QBolus Manual Food Correction Food & Correction History I. FreeStyle Aviator Menus Companion HOME START BASAL/STOP DELIVERY BOLUS MENU BASAL MENU ALARMS STATUS MAIN MENU Start/Stop Basal Select View Modify System Status (Bolus & Basal) Pump Levels Controller Levels Pump Version Controller Version Audio/Vibrate Inactivity Occlusion Reminders Care Comments Low Insulin Edit Create Rename Delete Daily Temp Basal Daily DOC15736_Rev-A-Man.indd 261-262 2/9/09 11:29:56 AM 261 262 7 Day Average 14 Day Average 21 Day Average Insulin Food Exercise State of Health Generic Therapy Events Alarms Pump Diary BG History Line Graph BG Statistics Section 12: Appendices Appendix J: Aviator Menus - Pump PRIME MENU Tubing Cannula REPORTS MENU ADD EVENT SETUP Buttons Timeout Home Cursor Magnify Contrast Time/Date Basal Limits Basal Setup Bolus Limits Insulin Preferences Therapy Lockout Target Range Wizard Select Language Time/Date Time/Date Format Insulin Profile Insulin Type Section 12: Appendices Appendix J: Aviator Menus - Pump Timeout Home Cursor Type Magnify Insulin Action Time Inactivity Alarm Set Display Preferences Edit Mode Bolus Calculator Options Bolus Limits One-Button Bolus Basal Limits Basal Setup (Temp) Audio/Vibe Occlusion Alarm Low Insulin Alert Locked items 1U Drop Carb Ratios BG Targets Name Values Self Test Pair Pump Radio DOC15736_Rev-A-Man.indd 263-264 2/9/09 11:29:56 AM 263 264 Glossary Normal Extended Dual QBolus Manual Food Correction Food & Correction History Section 12: Appendices Appendix J: Aviator Menus - Pump J. FreeStyle Aviator Menus Pump HOME START BASAL/STOP DELIVERY BOLUS MENU BASAL MENU ALARMS STATUS PRIME MENU MAIN MENU Start/Stop Basal Select View Modify Audio/Vibrate Inactivity Occlusion Reminders Care Comments Bolus Status Basal Status Pump Levels Pump Version Edit Create Rename Delete Daily Temp Basal Tubing Cannula Daily Bolus History Pump Diary Therapy Events Alarms REPORTS MENU SETUP Time/Date Basal Limits Basal Setup Bolus Limits Insulin Preferences Display Edit Mode Model Wizard Buttons Timeout Home Select Language Time/Date Time/Date Format Insulin Profile Insulin Type Insulin Action Time Inactivity Alarm Set Display Preferences Edit Mode Bolus Calculator Options Bolus Limits One-Button Bolus Basal Limits Basal Setup (Temp) Audio/Vibe 1U Drop Carb Ratios BG Targets Cursor Magnify DOC15736_Rev-A-Man.indd 265-266 2/9/09 11:29:56 AM 265 266 Glossary Occlusion Alarm Low Insulin Alert Locked items Name Values Pair Device Radio RF Stats Glossary Glossary
(Key terms are in Blue the first time it is used in the User Guide Sections)
- Menu driven Home screen. Settings that allow you to customize how your pump communicates alerts to you. Settings that allow you to customize how your pump communicates alarms to you.
- The oval shaped lower button on the right side of the companion screen below the Settings that allow you to decide whether your pump uses audio (beeps) or vibrations The way your pump tells you an event has occurred that requires your immediate attention. Delivery of The way your pump tells you an event has occurred that requires your attention in the near future. Deliv-
Activity Display Alarm insulin IS stopped. Alarm Settings Alert ery of insulin is NOT stopped. Alert Settings Audio/Vibe Settings when there is an alarm. Back Button (companion) jogwheel. It is used to cancel a change made to a value, and to move back to the previous screen. Back Button (pump) The top button on the right side of the pump screen with an indented triangle pointing to the left when in the right-hand mode. It is used to cancel a change made to a value, and to move back to the previous screen. Backlight/QBolus Soft Key (companion)
- To turn on/off the backlight, press the bottom left soft key on the companion with the light bulb icon for 2 seconds, when you are NOT at the Home screen. To deliver a quick bolus, press the QBolus soft key from the Home screen. Using the jogwheel, select amount of bolus to deliver and press Enter button. Backlight/Enter Button (pump) triangle pointing to the right. To turn on/off the backlight, press this button for 2 seconds. It is also used to select an item, or to move forward to the next screen. Basal Basal Block Basal Insulin Basal Menu pump. Basal Panel ing the basal. When highlighted and selected, allows you to access basal options. Basal Program Basal Rates throughout the day. The small, frequent pulses of background insulin that your body continuously needs. Allows you to get to the basal-related functions to make changes in the basal settings on your Displays the status of whether basal has started or stopped, and which active program is deliver-
The rates of insulin delivery you set when you are creating basal programs. Basal rates can vary The baseline or background level of insulin that you need delivered throughout the day. The bottom button on the right side of the pump screen with an indented A programmed basal rate for a period of time during the day. A sequence of up to 48 basal blocks for a 24-hour period. DOC15736_Rev-A-Man.indd 267-268 2/9/09 11:29:56 AM 267 268 Glossary Glossary Where the pump battery is stored. Cap cover for the battery compartment. The amount of glucose in a sample of blood. The port where you insert a FreeStyle Lite Test Strip when checking The main sugar found in the blood and the bodys main source of energy. This is also An extra burst of insulin taken either to cover the rise in blood glucose that occurs after eating, or to cor-
Settings that allow you to define the basal amount, basal maximum limit, and the temporary The blood glucose you wish your pump to correct to. It is used in the correction bolus calculator, Basal Settings basal format. Battery Cap Battery Compartment BG Target --
and abbreviated as Target BG. This target value is developed with the guidance of your health care professional and varies from person to person Note that it may be different than your desired blood glucose range. Blood Glucose (BG) called blood sugar. Blood Glucose Level Blood Glucose Meter Test Strip Port your blood glucose. Bolus rect high blood glucose.
(pump) The button on the side of the pump. Press it the number of times needed to Bolus/Wake Up Button deliver a quick bolus using the One-Button Bolus function. You can also press it once to stop a normal bolus in progress. The pump will timeout in 15-120 seconds. Press and hold the button to wake up the pump from sleep mode to display the Home screen. Bolus Calculator Settings for calculating a bolus based on food intake, and/or a correction to a desired blood glucose level. It helps you calculate the correct dose of insulin based on carbohydrates, current blood glucose, and how much insulin from earlier boluses remains active in the body. It does NOT take other factors into ac-
count, such as exercise, illness, and food other than carbohydrate. Bolus History Bolus Options as well as your bolus calculator options. Bolus Panel Cancellation Alert Occurs when the screen timed out when there are pending changes on a screen, or if you pressed and held the Back button to return to the Home screen when there are pending changes on a screen, intentionally canceling the change. Cannula A slender plastic tube that is under the skin that is used to deliver insulin in your body. During the in-
sertion of the infusion set, the center of the cannula contains a fine gauge needle to help the cannula penetrate the skin. The needle is then removed after insertion, leaving the plastic cannula in your skin. Cannula Housing Carbohydrates (CHO) mary energy source from food. The part of the infusion set where the tubing connects to the infusion set on your body. The component of food that most directly affects your blood glucose levels. The pri-
Settings to customize your bolus insulin settings, including bolus increments and maximums, Displays the status of the most recent or last bolus given including bolus volume and time. A list of your last 10 boluses. Descriptions of what the pump is NOT intended for. The part of the companion where the information is displayed. A period of time occurring in the middle of the sleep cycle where the body releases extra Needle The part of the infusion set that contains a needle to connect to the cannula. An alert to remind you to check your blood glucose levels 2 hours following a site change. Alerts for specific activities, i.e. such as to remind you to change your infusion set. You can Allows you to create up to four basal programs and assign each a specific name, i.e., on week-
A setting that allows you to change the appearance of the selection cursor from a dark highlight cursor A bolus given to lower blood glucose level elevated above the target blood glucose level. Also known as sensitivity factor and 1 U Drop. This amount is how much blood glucose Care Comments turn these on or off. Check BG Companion Screen Connector Contraindications Correction Bolus Correction Factor drops with delivery of 1 units of short or rapid-acting insulin. The number is unique to each user and is pro-
grammed into the pump for use in the bolus calculator. When glucose is high or low the calculator will use this information to estimate your insulin dose. Create Program ends, during exercise, or when you are ill. Cursor
(reverse video) to an outline cursor. Dawn Phenomenon amounts of glucose into the blood stream, requiring a temporary increase in your basal insulin needs. Delete Program Diabetic Ketoacidosis blood glucose levels from a severe lack of insulin, result in the breakdown of body fat for energy and an accumu-
lation of ketones in the blood and urine. Display Preferences viewing the cursor in highlight or outline mode, and whether or not you want to magnify the text. Display Right or Left the right side of the pump or on the left side of the pump. Dual Bolus is consumed that may have both an early effect on your glucose as well as a longer effect, such as pizza. Dust Cover Edit Program time blocks and basal rates. Enter/Backlight Button (pump)
- The bottom button on the right side of the pump screen with an indented triangle pointing to the right. It is used to select an item, or to move forward to the next screen. To turn on/off the backlight, press this button for 2 seconds. Enter Button/Jogwheel (companion) -
jogwheel scrolls to allow you to move up and down through the companion. You can also depress this button to A bolus that combines a NORMAL bolus with an EXTENDED bolus. It is sometimes used when food Allows you to make changes to an existing basal program, including adding or deleting basal Settings that allow you to choose right or left display, timeout, home screen appearance,
(DKA) A potentially life threatening emergency condition in which extremely high A setting that allows you to switch the screen orientation such that the buttons are on The cover that comes with your pump used to protect the reservoir compartment. The top jogwheel button on the right side of the companion. The Function that allows you to delete a basal program. DOC15736_Rev-A-Man.indd 269-270 2/9/09 11:29:56 AM 269 270 Glossary Glossary A Bolus Calculator option that allows administration of a bolus to correct blood A bolus delivered over a determined period of time that is sometimes used to better match a A bolus calculator option that allows administration of a bolus to account for food about to be select an item and to move forward to the next screen. You can also stop a normal bolus in progress. Extended Bolus food that is absorbed slowly. Food Bolus eaten. Food and Correction Bolus glucose levels that are higher than the desired blood glucose level and takes into account food about to be eaten. Highlight Home Screen:
Setting the Cursor to highlight gives the text a highlighted display as you scroll and select options. Information-based home screen provides details about current basal and bolus status, including the The time and amount of your last bolus and whether basal delivery is running or stopped. When basal delivery is running, the name of the active basal profile and delivery rate is displayed. The and last bolus status is accessible through the STATUS option. Activity-based home screen provides direct access to the pump options. Information about the basal Blood glucose levels that are higher than target level. Blood glucose levels that are lower than target level. Home Screen Appearance -
The Information-based home screen provides details about current basal and bo-
lus status, including the time and amount of your last bolus, and whether basal delivery is running or stopped. When basal delivery is running, the name of the active basal profile and delivery rate is displayed. Hyperglycemia Hypoglycemia
(or Carb Ratio) Insulin-to-carbohydrate ratio that defines how many grams of carbohydrates 1 unit of I:CHO insulin covers. CHO is an abbreviation for carbohydrate. This number is programmed into the pump for use by the bolus calculator. When you program in your number of carbohydrates you are about to eat, the bolus calcu-
lator helps you decide how much insulin may be needed for that food. It does NOT take into account food other than carbohydrates. Inactivity Alarm selected. If you do NOT respond to an inactivity alert within 15 minutes, the INACTIVITY ALARM will sound and basal insulin delivery is stopped. Inactivity Alert displays the INACTIVITY ALERT screen to keep delivery going. Indication Information Display and bolus delivery. Also offers short cuts to get to lower level menus. Infusion Set reservoir into the body. It is used one time only, and is discarded after each use. The combination of the reservoir cap, tubing, and cannula that delivers insulin from the pumps A safety alarm that sound when you have NOT touched any buttons within the time period When the inactivity time has elapsed without any interaction on the pump, the pump first Home screen configuration that provides important status information concerning basal A description of what the pump should be used for. Part of the infusion set that carries insulin from the pump to the cannula. Attaches to the top of the insulin vial and is used in place of a filling needle to An alert that lets you know if the temperature of the pump is too hot or too cold. The amount of insulin units that remain active in your body. The IOB is calculated us-
The needle that guides the insertion of the cannula in your body. The needle is removed The reservoir holds the insulin that the pump will deliver to your body. The reservoir holds Provides an indication of the amount of insulin that is still active in your body from past boluses. A hormone that helps the body use glucose for energy. When the body cannot make enough insulin, it Infusion Set Tubing Insulin is taken in by injection or through use of a pump. Insulin On Board (IOB) ing the insulin action time setting chosen in your insulin profile (see Section 2.1), along with looking at ear-
lier boluses delivered. In addition, if a correction dose has recently been given, (for information on correction boluses, refer to Section 8.4.) the IOB feature may help you prevent giving too much insulin to correct your high glucose. Insulin Reservoir 250 units of insulin. Your healthcare professional will tell you how much insulin to use to fill the reservoir. The reservoir is a single-use only item. Insulin Reservoir Vial Adapter transfer liquid into the insulin reservoir. Insulin Temp Introducer Needle and only the cannula is left in your body. IOB Panel Jogwheel/Enter Button (companion) -
The top jogwheel button on the right side of the companion. It scrolls to allow you to move up and down through the companion. You can also use this button to select an item and to move forward to the next screen. You can also stop a normal bolus in progress. Levels Panel Locked Item Setting Setting that allows change of whether Bolus and Basal Menu options are locked (inac-
cessible) or unlocked (accessible). This is a safety feature to prevent unwanted changes in insulin, by a child for example. Low Insulin Alert Low Power ately puts the pump to sleep by pressing and holding the back button on the Home screen. Magnify Main Menu prime menu, reports menu, and setup menu. Manual Bolus Modify Program Normal Bolus be delivered immediately. Occlusion Alarm Sleep State This means the display is blank when the display timed out or when the user deliber-
A one time quick dose of insulin that is programmed when you eat or need a dose of insulin to Lists the options to start/stop basal, go to bolus menu, basal menu, Alarm Setup, bolus status, Alarm that alerts you to an obstruction of fluid. The alarm occurs when pressure is detected Turning the Magnify option to On makes the text larger and easier to view on the screen. An alert, based on programmed settings telling when insulin is getting low. A bolus that is delivered without using the bolus calculator. Displays the battery and insulin reservoir levels by icons. Allows edit, create, rename, or delete basal programs. DOC15736_Rev-A-Man.indd 271-272 2/9/09 11:29:56 AM 271 272 Resources This means the basal delivery is stopped for 5 minutes. A function that allows you to deliver a Normal Bolus with fewer steps using the pump, An option that allows you to review your insulin therapy amounts, pump-related events, and Sets how much 1 unit of insulin will lower blood glucose level. Setting the Cursor to Outline gives the text an outline around it as you scroll and select options. A procedure to make sure that air is removed from the entire infusion set before you attach the pumps as the pump tries to deliver insulin. It tells you there may be a problem with your infusion site and that insulin may NOT be delivered. An Occlusion Alarm STOPS insulin delivery. The sensitivity setting of the alarm is adjust-
able and may be changed. One-Button Bolus simply by pressing the One-Button Bolus button without looking at the display. The pump makes special sounds or vibration patterns that guide you through the procedure. This same function is performed using the QBolus soft key on the companion. 1U Drop Outline Prime tubing to your body. This important procedure is done to make sure you receive the correct amount of insulin. Pump Diary alarm history. Pump Idle Pump Idle Alert Occurs when the basal has been stopped for 5 minutes. This alert can be put to sleep for up to one hour. A pump idle alert would NOT occur until you have completed the SETUP WIZARD. After that, if for any reason the basal is stopped for 5 minutes, the pump idle alert will sound. Pump Screen QBolus Reminders Rename Program Reports events and information. Reservoir Alarm Reservoir Cap properly in the pump. This connects the Reservoir to the infusion set Reservoir Compartment Reservoir Plunger Reservoir Plunger Handle insulin into the reservoir. Scroll Pad you to move up and down through the pump options. It is like the scroll pad on a computer. Select Program SETUP WIZARD The menu that allows you to review bolus history and the pump diary that logs various pump-related A manual option to deliver a Normal bolus of insulin, using fewer steps than the Normal Bolus option. The indented, oval area on the right side of the pump when in right-hand mode. It scrolls to allow An easy way to set up your pump. Individual SETUP WIZARD options are also accessible via The clear plastic cap and handle that is on the outside of the pump when the reservoir is placed Alerts reminding you to do certain things, such as eat a snack or test blood glucose levels. The white removable handle attached to the end of the plunger. Used to draw Occurs when the reservoir is removed while the pump is still delivering insulin. The hollow area in the pump that encloses the insulin reservoir. The part of the pump where the information is displayed. Allows you to choose and start a different basal program. Allows changing the name of a basal program. The gray plunger of the insulin reservoir. The blood glucose value to correct to. It is used in the correction bolus calculator, and An error that must be addressed immediately by calling Customer Care. It sometimes may indi-
A programmable alert that reminds you to change your site 2, 2.5, or 3 days following a cannula A way to silence alerts for a specified period of time. Allows you to start an existing basal program. Allows you to stop the actively running basal program. A function that allows you to stop any type of bolus delivery of insulin as it is occurring. the SETUP Menu. This feature is typically used the first time you set up all the features of your pump. Site Change prime, after you inserted your infusion set. Sleep Mode Start Basal Stop Basal Stop Bolus System Error cate a pump failure. Target blood glucose abbreviated as Target BG. Note that it may be different than desired blood glucose range. Temporary Basal A way to deliver basal insulin at a different rate for a temporary period of time, such as for exercise or illness. You may choose either specific units/hour or percentage, of your currently active basal rate. Timeout USB Port Vial Adaptor Cap View Program Wake Up/Soft Key to MAIN MENU (companion) with the Power icon for 2 seconds to access the MAIN MENU. Wake Up/Bolus Button (pump) the pump from sleep mode to display the Home screen. Press it the number of times needed to deliver a quick bolus using the One-Button Bolus function. You can also press it once to stop a normal bolus in progress. The pump will timeout in 15-120 seconds. The time before the pump display goes blank. The timeout can be set from 15 to 120 seconds. The USB port to connect to the charger for your companions battery. The button on the side of the pump. Press and hold the button to wake up The cap that covers the top of the vial adaptor to store unused insulin. To wake up the companion, press the bottom right button Allows you to view all existing basal programs. DOC15736_Rev-A-Man.indd 273-274 2/9/09 11:29:57 AM 273 274 Resources Resources The following books and web sites may be of help as you begin pump therapy:
Books:
Smart Pumping: A Practical Approach to Insulin Pumping by Howard Wolpert, MD Insulin Pump Therapy Demystified: An Essential Guide for Everyone Pumping Insulin by Gabrielle Kaplan-Mayer Pumping Insulin: Everything You Need for Success with an Insulin Pump by John Walsh, PA, CDE and Ruth Roberts, MA Web Sites:
Abbott Diabetes Care www.AbbottDiabetesCare.com American Diabetes Association www.diabetes.org Centers for Disease Control Diabetes Public Health Resource www.cdc.gov/diabetes Diabetes Exercise and Sports Association www.diabetes-exercise.org US Food and Drug Administration Diabetes Information www.fda.gov/diabetes Insulin Pump Online Support www.insulin-pumpers.org Pump Supplies:
Unique Accessories Inc. www.uniaccs.com Diabetes Mall www.Diabetesnet.com/diabetes_technology Pump Wear Inc. www.pumpwearinc.com 275 DOC15736_Rev-A-Man.indd 275 2/9/09 11:29:57 AM DOC15736_Rev-A-Cvr.indd 3 2/9/09 11:32:16 AM Distributed by:
(Place distribution addresses here.) Caution: Federal Law restricts this device to sale by or on the order of a physician.
(Patent information to be placed here.) 2008 Abbott DOC15736 Rev. A 12/08 DOC15736_Rev-A-Cvr.indd 4 Humalog, Apidra, Novolog, and Kendall Monoject are not trademarks of the Abbott Group of Companies. 2/9/09 11:32:19 AM
frequency | equipment class | purpose | ||
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1 | 2009-02-23 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
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1 | Effective |
2009-02-23
|
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1 | Applicant's complete, legal business name |
Abbott Diabetes Care
|
||||
1 | FCC Registration Number (FRN) |
0008524399
|
||||
1 | Physical Address |
1360 South Loop Road
|
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1 |
Alameda, California 94502
|
|||||
1 |
United States
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
m******@ccsemc.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
QXS
|
||||
1 | Equipment Product Code |
AV2-C
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
J******** J****** S****
|
||||
1 | Title |
Regulatory Affairs
|
||||
1 | Telephone Number |
510-8********
|
||||
1 | Fax Number |
510-8********
|
||||
1 |
j******@abbott.com
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 08/22/2009 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Insulin Pump/Glucose Meter Transmitter | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
Elliott Laboratories LLC
|
||||
1 | Name |
D**** B********
|
||||
1 | Telephone Number |
408-2******** Extension:
|
||||
1 | Fax Number |
408-2********
|
||||
1 |
d******@elliottlabs.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
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Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC