Indications for Use 
‍twiist AID System Indications for Use 
The twiist System is intended for the subcutaneous delivery of insulin, at set and variable rates, for the  management of diabetes mellitus in persons requiring insulin, ages six and above. The pump is able to  reliably and securely communicate with compatible, digitally connected devices, including automated  insulin dosing software, to receive, execute, and confirm commands from these devices. The twiist System is intended for single patient, home use and requires a prescription. 
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Simple Bolus Calculator Indications for Use 
The twiist Automated Insulin Delivery System includes a simple bolus calculator available when Loop is off. It is indicated for use for aiding the user in determining the bolus insulin dosage for management of diabetes mellitus based on consumed carbohydrates, operator-entered blood glucose, insulin sensitivity, insulin to carbohydrate ratio, target glucose values, and current insulin on board.

twiist Loop Algorithm Indications for Use 
The twiist Loop algorithm is intended for use with compatible integrated continuous glucose monitors  (iCGMs) and the twiist alternate controller enabled (ACE) insulin infusion pump to automatically  increase, decrease, and suspend delivery of basal insulin based on iCGM readings and predicted glucose  values. It can also recommend, and with the user’s confirmation, control the delivery of correction  boluses when glucose values are predicted to exceed user configurable thresholds. The twiist Loop algorithm is intended for the management of type 1 diabetes mellitus in persons six  years of age and greater. The twiist Loop algorithm is intended for single-patient use and requires a  prescription. 

Contraindications 
The twiist Automated Insulin Delivery System is not intended for anyone unable or unwilling to:
• Test blood glucose (BG) levels as recommended by their healthcare provider.
• Maintain sufficient diabetes self-care skills.  
• See their healthcare provider regularly.  
• Demonstrate adequate carbohydrate-counting skills (preferred, not required).
The user must not: 
• Have difficulty seeing. 
• Have difficulty hearing. 
• Have deficient cognitive capabilities. 
• Have physical impairments which would make operating the pump or iPhone difficult. 

Compatibility 
Insulin Compatibility and Use 
warning Only use fast-acting U-100 Humalog (insulin lispro), or Novolog (insulin aspart). Use of other concentrations may lead to insulin delivery errors that may lead to low or high blood glucose. 
Follow the insulin manufacturer’s instructions for safe use and handling.

Checking Glucose 
warning Treat symptoms of low blood glucose immediately to prevent severe low blood glucose. If not treated it could lead to loss of consciousness, seizure or death. 
warning Do not ignore how you feel or symptoms of high and low glucose. If your CGM glucose readings  do not match how you feel, measure your blood glucose with a BG meter even if your CGM  reading is not in the high or low range. Ignoring the symptoms of high and low glucose even  when your CGM reading is not in the high or low range may lead to incorrect treatment  decisions which may lead to harm. When in doubt, get your meter out. 

Working with your Healthcare Provider 
It is the responsibility of the healthcare provider and caregiver to determine if the patient is a good candidate for treatment with the twiist Automated Insulin Delivery System. 

warning Do not set glucose safety limit, correction range, pre-meal range, workout range, carb ratios,  basal rates, delivery limits, insulin model, or insulin sensitivities without direction from your  healthcare provider. Incorrect settings may lead to low or high blood glucose. 

Pediatric Use 
Review your device settings and features like ONE-BUTTON-BOLUS to make sure they are configured  appropriately. Younger users may press the pump button leading to unintentional delivery of insulin. Children may dislodge their infusion site more frequently. Make sure infusion set tubing is secure. 

Medical Procedures 
block The twiist Automated Insulin Delivery System is Magnetic Resonance Unsafe. Disconnect your twiist pump before entering an MRI scan room. Do not bring your iPhone or twiist pump into an MRI scan room. Contact with, or being in proximity to, an MRI scanner may cause the twiist pump and iPhone to move or lead to electric shocks and may result in severe injury.
warning Always notify medical staff about your diabetes and your twiist Automated Insulin Delivery System. If you need to stop insulin delivery or remove your CGM Sensor for a medical procedure, follow guidance from your healthcare provider about insulin missed while disconnected from your pump. Check your blood glucose before disconnection and reconnection and treat your highs and lows.

warning Do not expose your system to: 
o X-ray 
o Computed Tomography (CT) scan 
o Magnetic Resonance Imaging (MRI) 
o Positron Emission Tomography (PET) scan 
o Diathermy Devices 
o Electrocautery Devices 
o Pacemaker/Automatic Implantable Cardioverter Defibrillator (AICD) placement or  reprogramming 
o Cardiac Catheterization 
o Nuclear Stress Test 
o Other exposure to radiation 

Remove your twiist system and leave it outside the room prior to these procedures. Failure  to do so may lead to harm. 

warning Do not use the twiist Automated Insulin Delivery System when using hydroxyurea, a medication  used in the treatment of diseases including cancer and sickle cell anemia. CGM readings being  used by the system may be inaccurate while taking hydroxyurea, meaning the twiist Automated  Insulin Delivery System will not have accurate information to use for dosage recommendations.  This could result in over-delivery of insulin, which can lead to low glucose. Talk to your  healthcare provider about using your BG meter for treatment decisions instead. 
warning Do not use the twiist Automated Insulin Delivery System if you are taking GLP-1 agonists or  SGLT-2 inhibitors, metformin or DPP-4. The twiist Automated Insulin Delivery System has not  been tested in populations using additional diabetes medications and the performance of the  system in conjunction with these medications is unknown. 
warning Do not take external insulin, such as manual insulin injections or inhaled insulins, while Loop is  on and the twiist pump is operational. The twiist Automated Insulin Delivery System does not  receive information about insulin taken outside the system. If you choose to take additional  insulin with another method while Loop is on and the twiist pump is working, over-delivery or  under-delivery of insulin may occur, which can lead to high and low glucose. Consult with your  healthcare provider about how long to wait after manually taking insulin before enabling  automated insulin delivery. 
warning Do not use the twiist Automated Insulin Delivery System if you have a condition which, in the  opinion of your healthcare provider, would put you at risk. Examples of individuals who should  not use the twiist Automated Insulin Delivery System include those with uncontrolled thyroid  disease, renal failure (e.g. dialysis or eGFR <30), hemophilia, or another major bleeding disorder,  or unstable cardiovascular disease. 
warning Loop is not indicated for use by anyone who is pregnant, on dialysis, or critically ill. It is not  known how different conditions or medications used in these scenarios may affect performance  of the twiist Automated Insulin Delivery System. CGM readings being used by the system may be  inaccurate in these cases, meaning the twiist Automated Insulin Delivery System will not have accurate information to use for dosage recommendations. This could result in over-delivery or  under-delivery of insulin, which can lead to low or high glucose.
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Training and Use 
warning Do not use the twiist Automated Insulin Delivery System if you have not received training on  appropriate use by a certified twiist trainer. Discuss your individual training needs with your  healthcare provider. Failure to receive the appropriate training could result in serious injury or  death. 
warning Federal law restricts this device to sale by or on the order of a licensed physician. Use of this  device without the training and supervision of a physician may lead to errors that result in harm.

Cassette Change / Infusion Site Care 
warning Always follow your infusion set manufacturer instructions for infusion site insertion and care.  Failure to do so may result in over or under delivery of insulin or infection. 
warning Complete a cassette change and change your infusion set every 48 to 72 hours, when the  cassette is empty, or as instructed by your healthcare provider. Rotate insulin infusion sites to  help prevent infusion site complications like scar tissue and infection. Rotating insulin infusion  sites reduces the risk of scarring. Using a site with scar tissue can lead to problems with insulin  absorption or blockages that may lead to high blood glucose. 
warning Do not fill a cassette before you plan to use it. Filling a cassette before you plan to use it may  result in spoilage or a change to the potency or purity of insulin, which may lead to harm.
warning Only use twiist cassettes with compatible infusion sets. Failure to do so may affect accuracy or  blockage detection which may lead to over or under delivery and cause low or high blood  glucose. 
warning Do not use cassettes, infusion sets, needles, or syringes if:
o The expiration date on the package has passed.  
o Packaging has been previously opened or damaged.  
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Use of disposable components that are expired or from previously opened or damaged  sterile packaging may lead to infection. 
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warning Do not use damaged cassettes or infusion sets. Using damaged cassettes or infusion sets may  result in start-up failures, interruptions in therapy, topical exposure to insulin or delivery errors  leading to high or low blood glucose. 
warning Wash your hands and use clean technique when filling the cassette, inserting the infusion site,  and connecting the infusion set tubing. Failure to do so may lead to infection. 
warning Check your infusion site every day for proper placement. Replace your infusion site if you notice  leaks around the site. Improper placement or leaks around the site may result in under delivery  of insulin resulting in high blood glucose. 
warning Dispose of used components such as cassettes, syringes, needles, infusion sets, and CGM  Sensors following the instructions from your local authorities. Wash your hands thoroughly after  handling used components. 

Priming / Air / Unintended Delivery 
warning Make sure to prime the infusion set tubing. Failure to prime the infusion set tubing may lead to  a delay in the delivery of insulin resulting in high blood glucose or cause a delivery error.
warning Do not fill the cassette with cold insulin. Filling the cassette with cold insulin may result in air  bubbles forming in your cassette or infusion set tubing that may result in delivery errors that  may lead to harm. Allow insulin to adjust to room temperature before filling the cassette. 
warning If air bubbles are present in the infusion set tubing, perform a cassette change. Air bubbles  present in the infusion set tubing may lead to under or over delivery of insulin, which may lead  to high or low blood glucose. 
warning Do not connect a filled cassette and infusion set tubing to your infusion site if the cassette is not  attached to the pump. Connecting the filled cassette and infusion set tubing to your infusion site  before connecting the cassette to the pump may lead to unintended insulin delivery leading to  low blood glucose. 
warning Do not connect infusion set tubing to your infusion site before the pump completes self-test.  Connecting infusion set tubing to your infusion site during self-test may lead to unintended  delivery of insulin, which may lead to low blood glucose. 
warning Disconnect the infusion set tubing from your infusion site before removing the cassette from the  pump. Leaving the infusion set tubing connected may lead to unintended delivery, which may  cause low blood glucose. 

Insulin Delivery 
warning When Loop is on, do not modify a bolus to be greater than the recommended value. Increasing  the bolus can lead to increased risk of low blood glucose. 

Important information about the use of your iPhone 
Do not quit the twiist app or remove the twiist app from your iPhone. Quitting the twiist app or  removing it from your iPhone will result in loss of communication with the pump and will prevent  modification of therapy settings. However, the pump will continue to deliver your basal insulin. 

warning Your iPhone should not be used with the twiist Automated Insulin Delivery System if your iPhone:
• battery cannot last a full day 
• shuts down unexpectedly 
• cannot be powered down or restarted 
• cannot maintain Bluetooth communication 
• screen, speaker, camera or vibration motor are broken 

Use of your iPhone under these conditions may result in harm. 
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warning Make sure the time and date is set correctly on your iPhone. If the time and date is not set  correctly, delivery errors may occur resulting in low or high blood glucose. 

Notifications and Critical Alerts 
warning Allow Notifications and Critical Alerts for the twiist app in your iPhone settings. Failure to allow  Notifications and Critical Alerts may lead to missed twiist app notifications which may lead to  high or low glucose. 
warning In order to hear or feel notifications, your iPhone volume must be louder than your  surroundings, and vibrate must be enabled. 
warning Disconnect your iPhone from audio devices such as Bluetooth headphones or speakers when  you are no longer using them. Remaining connected to audio devices when they are no longer in  use may lead to missed twiist app notifications. 

iOS Features 
warning Avoid using accessibility features on the iPhone. Using accessibility features on the iPhone may  affect the ability to view the twiist app which could lead to harm. 
warning Use of the following features may result in missed or delayed notifications, which may lead to  harm: 
o Focus features such as Do Not Disturb 
o Screen Time 
o Scheduled Summary 

If Focus features such as Do Not Disturb are used, make sure to allow notifications from the  twiist app to prevent missed or delayed notifications. If Screen Time is used, make sure the  twiist app is configured as Always Allowed. If Scheduled Summary is used, do not add the  twiist app to the Summary list.  

Unauthorized Modifications / Untrusted Applications 
warning Do not run the twiist app on an iPhone with unauthorized modifications. In order for the twiist  app to work properly, it must be used on a compatible iPhone that does not have a modified  operating system (jailbroken device). 
warning Do not install apps on your iPhone from untrusted sources. Installing apps from any source  other than the App Store on your iPhone running the twiist app may put you at risk of  unintentionally installing malware, which may impact the use of the twiist app. Only install apps  from the App Store. Malware, or malicious software from unknown sources, is designed to  damage your device and/or read your private information. The most common method for  spreading malware is the use of unknown apps and unknown downloads. Malware can prevent  the twiist app from functioning as intended, causing over-delivery or under-delivery of insulin,  which may lead to low or high glucose. 

If you believe you have malware on your iPhone, discontinue use of the twiist app and use an  alternate means of insulin delivery until you are able to resolve. If you have any apps installed  from unknown sources, delete the app, restore your iPhone to factory default settings and  contact Sequel Customer Support. 

Secure Wi-Fi 
warning Only join secure Wi-Fi networks. Unknown or public Wi-Fi networks may not provide data  security. 

Pump and CGM Placement 
warning Your CGM and pump should be kept within 33 ft (10 m) of each other without obstructions  between them or they may not be able to communicate. To help maintain communication, keep  the CGM and pump on the same side of your body. Bluetooth communication does not work  well through water. Range may be reduced while swimming or bathing.
warning Choose a CGM insertion site that is at least 1 inch (2.5 cm) away from your insulin infusion site  that is unlikely to be bumped, pushed, or slept upon, and is also away from tattoos, scarring or  irritation. 

Backup Plan / Emergency Supplies 
warning Always have a backup insulin therapy plan ready. A backup plan is needed if insulin delivery is  stopped unexpectedly or the pump fails. Failure to have a backup insulin therapy plan may lead  to delays of insulin delivery. Extended delay of insulin delivery may cause high blood glucose or  diabetic ketoacidosis (DKA). 

warning If the twiist Automated Insulin Delivery System fails to work as described within this user guide, stop using the system and switch to your backup insulin therapy. Using the system when it is not working as described within this user guide may lead to harm.

Always have emergency supplies available. Talk to your healthcare provider about what you should keep  in your emergency supplies in addition to: 
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• Blood glucose monitoring supplies 
• Fast-acting glucose tablets 
• 3 mL syringes 
• 26 gauge x ½ inch needles 
• Cassettes 
• Infusion Sets 
• Spare insulin 
• Alcohol wipes 

Location of Use 
warning The system may affect nearby electrical devices (such as antennas or radios), including medical  ones. This could cause these devices not to work properly or stop working. Keep the pump and  pump battery charger away from these devices. 
warning Retail anti-theft detectors may affect pump accuracy or trigger an alarm. Walk through retail  anti-theft detectors at a normal pace, but avoid standing in them. 
warning Portable RF communications equipment including antenna cables and external antennas may  affect the communication between the twiist pump and app, or interrupt operation of the  pump. Keep the pump at least 12 in (30 cm) away from these items. 
warning Metal detectors may affect pump accuracy or trigger an alarm. Handheld or walk through metal  detectors may be used near the system, but prolonged exposure to them should be avoided.
warning Avoid exposing your pump to temperatures below 41 °F (5 °C) or above 104 °F (40 °C). When in  cold temperatures, the pump should be worn close to the body and covered in warm clothing. If  you are in warm temperatures, take measures to keep the pump cool. 
warning Avoid using the twiist Automated Insulin Delivery System in oxygen rich environments (greater than 25% oxygen), which includes the use of supplemental oxygen and hyperbaric chambers. Exposure to oxygen rich environments could result in combustion of components of the twiist Automated Insulin Delivery System including your twiist pump and compatible CGM. This can cause severe burns on the body.
warning Prolonged noise or vibration may interfere with the ability of the pump to continue delivery and  trigger an alarm.
warning The pump, when connected to a cassette has a rating of IP28, indicating protection from  continuous immersion in water. The pump can tolerate immersion to depths of up to 12 feet  (3.7 m) for 1 hour. Prevent submerging the pump in water for extended periods of time. Keeping  the pump submerged in water can block Bluetooth communication between the twiist pump  and app, which may cause a delayed response to an alarm condition which may cause under delivery, resulting in high blood glucose. 
warning Check your glucose frequently during amusement park rides, flying, hiking, skiing, snowboarding  or other situations where sudden changes or extremes of air pressure, altitude, or gravity may  be occurring. The atmospheric pressure in an airplane cabin can change during flight, which may  affect insulin delivery. Rapid changes in altitude and gravity, such as those typically found on  amusement park rides or flight take-off and landing, can affect insulin delivery, leading to  possible hypoglycemia or injury. If needed, follow treatment instructions from your healthcare  provider. 
warning Avoid using the twiist Automated Insulin Delivery System at low atmospheric pressure (below 700hPA). Encounters with low atmospheric pressure can happen at high elevations (above 10,000 feet or 3,048 meters). Exposure to such low atmospheric pressures can damage components of the twiist Automated Insulin Delivery System, including your twiist pump and compatible CGM, which could result in over-delivery or under-delivery of insulin, which can lead to low or high blood glucose.
warning Avoid using the twiist Automated Insulin Delivery System in high atmospheric pressure environments (above 1060hPA), which can be found in hyperbaric chambers. Exposure to high atmospheric pressure environments can damage components of the twiist Automated Insulin Delivery System, including your twiist pump and compatible CGM, which could result in over delivery or under-delivery of insulin, which can lead to low or high blood glucose.
warning Do not expose your twiist pump to X-ray screening used for carry-on and checked luggage.  Newer full body scanners used in airport security screening are also a form of X-ray and your  pump should not be exposed to them. Notify the security agent that your twiist pump should  not be exposed to X-ray machines and request an alternate means of screening. Your pump has  been designed to withstand common electromagnetic interference including airport metal  detectors. 

Troubleshooting 
warning Do not perform troubleshooting steps while the pump is connected to your infusion site.  Performing troubleshooting steps while the pump is connected to your infusion site may lead to  unintended delivery of insulin, which may lead to low blood glucose. 
warning Keep the pump, cassette, and infusion set tubing away from sharp objects. Sharp objects may  damage these components which may cause delivery error and lead to harm. 
warning Pets may damage your infusion set tubing while sleeping which may lead to an interruption of  insulin delivery or infection. Do not sleep with the infusion set tubing exposed if pets are  present. 
warning Do not use batteries or battery chargers that were not supplied with the system. Use of  batteries and battery chargers that did not come with the system may lead to unsafe operation  which may lead to harm. 
warning Only use the provided wall power adapter and charging cable. Use of another wall power  adapter or cables could damage the system or result in fire or burns.
warning Do not use the wall power adapter if it is visibly damaged or malfunctioning. Using a damaged or malfunctioning wall power adapter can result in electrical shock. 
warning Contact with insect repellants that contain DEET, skin care products, or sunscreens can damage the pump or cassette, which may lead to leaks, pump malfunctions, or delivery interruption.  Avoid getting insect repellents, skin care products, or sunscreens on the pump or cassette. If  these products do get on the cassette or pump, wipe them off immediately with a clean cloth. 

Verification of Functionality 
warning Damaging the inside of the pump, which is exposed while changing the cassette or battery, may  affect pumping accuracy which may increase or decrease delivery and lead to low or high blood  glucose. 
warning Stop using the pump and switch to your backup insulin delivery method in the event the pump  housing is cracked, the pump button is damaged, or there is other evidence of damage to the  pump. Failure to do so may lead to pump malfunctions resulting in interruption of therapy. 
warning Discontinue use of the twiist Automated Insulin Delivery System and switch to an alternate insulin therapy if the pump annunciator fails to signal during the pump self-test.

Small Parts 
warning Do not ingest small parts, such as pump batteries. Small parts could pose a choking hazard. If  swallowed, these small parts may cause internal injury or infection. 
warning Exposed infusion set tubing could pose a choking hazard. Keep exposed infusion set tubing out  of the reach of unsupervised children. 

Before Going to Sleep 
warning Before going to sleep, check to make sure you have enough insulin in your cassette and  sufficient charge remaining in your pump battery to last through the night. It is possible to sleep  through, or fail to hear, a Cassette Empty alarm and miss a portion of your basal delivery. 

When Using a FreeStyle Libre 3 Plus Sensor 
warning FreeStyle Libre 3 Plus new Sensor readings and CGM alerts are not available during the 60- minute warmup period and will not be displayed. Check your blood glucose using your BG meter  to prevent severe low or high blood glucose. 
warning Use your blood glucose meter to make diabetes treatment decisions when you see the        symbol during the first 12 hours of wearing a FreeSyle Libre 3 Plus Sensor, if your sensor glucose  reading does not match how you feel, or if the reading does not include a number. 
warning The FreeStyle Libre 3 Plus Sensor contains small parts that may be choking hazards and may be  dangerous if swallowed. 
warning Only apply the FreeStyle Libre 3 Plus Sensor to the back of the upper arm. If placed in other  areas, the Sensor may not function properly and could give inaccurate readings. Select an  appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or  skin irritation. Avoid areas with scars, moles, stretch marks or lumps. Select an area of skin that  generally stays flat during normal daily activities (no bending or folding.) Choose a site that is at  least 1 inch (2.5 cm) from an insulin injection site. To prevent discomfort or skin irritation, you  should select a different site other than the one most recently used.
warning The FreeStyle Libre 3 Plus Sensor should be removed prior to exposing it to an X-ray machine.  The effects of X-rays on the performance of the Sensor has not been evaluated. The exposure  may damage the Sensor and may impact proper function of the device to detect trends and  track patterns in glucose values during the wear period. 
warning FreeStyle Libre 3 Plus Sensor performance when used with other implanted medical devices,  such as pacemakers, has not been evaluated. 
warning Physiological differences between the interstitial fluid and capillary blood may result in  differences in glucose readings between the FreeStyle Libre 3 Plus Sensor and results from a  fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial  fluid and capillary blood may be observed during times of rapid change in blood glucose, such as  after eating, dosing insulin, or exercising. 
warning Clean hands prior to handling/inserting a FreeStyle Libre 3 Plus Sensor to help prevent infection.
warning If a FreeStyle Libre 3 Plus Sensor breaks inside your body, call your healthcare provider.
warning Applying the FreeStyle Libre 3 Plus Sensor may cause bruising or bleeding. If there is bleeding  that does not stop, remove the Sensor and contact your healthcare provider. 
warning After applying the FreeStyle Libre 3 Plus Sensor, put the cap back on the Sensor Applicator.  Discard the used Sensor Applicator according to local regulations. 

Interfering Substances 
Taking more than 1000 mg of Vitamin C per day may falsely raise your FreeStyle Libre 3 Plus Sensor  readings. This could cause you to miss a severe low glucose event. Vitamin C can be found in  supplements including multivitamins and cold remedies such as Airborne® and Emergen-C®. See your  health care professional to understand how long Vitamin C is active in your body.


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