TouchCare® Insulin Management System Important Safety Information
Check with your healthcare provider (diabetes team) regarding your individual training needs. Do NOT attempt to use the TouchCare® System before you have been properly trained.
As part of your training, your healthcare provider will work with you to establish diabetes management guidelines and settings that best fit your needs. Your healthcare provider can provide you with the initial settings of your Insulin Pump and CGM system. After adequate training and practice, you will find it easy to enter and change the system’s settings.
The TouchCare® Pump is designed to use U-100 insulin. The following insulin analogs have been tested and found to be safe for use in with the TouchCare® Pump: Humalog®, NovoRapid®, Apidra®, Fiasp® and Lyumjev® and Insulin lispro Sanofi. Before you use different insulin with this Pump, check the insulin label to make sure that it can be used with your Pump. Use of any insulin with lesser or greater concentration can result in serious injury or even death. Your Pump is not intended to deliver any other substance.
The TouchCare® Continuous Glucose Monitoring (CGM) System incorporates a Glucose Sensor and a Transmitter. The Glucose Sensor measures the glucose level of interstitial fluid. The Transmitter wirelessly transmits your real-time Sensor glucose information to your Personal Diabetes Manager (PDM).
Indications for use
The Insulin Management System is indicated for use in people (ages 2 -75 years) with Type 1 diabetes. The system is intended for single patient use and should be used under the guidance of a healthcare provider. Insulin Management System includes APGO technology, which can automatically adjust the insulin delivery based on recent insulin delivery, the glucose trends and several sequential readings.
The Insulin Pump is indicated for the continuous subcutaneous delivery of insulin. The Insulin Pump is indicated for use in people (ages 2 to 75 years) with diabetes. The Insulin Pump is intended for single patient use and should be used under the guidance of a healthcare provider.
The Continuous Glucose Monitoring System is indicated for continuous monitoring of interstitial fluid glucose levels. The Continuous Glucose Monitoring System is indicated for use in people (ages 2 to 75 years) with diabetes. The Continuous Glucose Monitoring system is intended for single patient use.
Contraindications
The TouchCare® System is not recommended for people who are unwilling or unable to:
• Maintain contact with their healthcare provider.
• Monitor glucose as recommended by their healthcare provider.
• Maintain sufficient diabetes self-care skills.
• Use the pump, CGM, and all other system functions in accordance with their respective instructions for use. Recognize and respond to alerts and alarms. (Sufficient vision and/or hearing are required.)
General Statements
Make sure that you have read and are familiar with the User Guide before using the TouchCare® System. Failure to follow the instructions may result in pain or injury and may also affect the system’s performance. If you do not understand something or have questions, ask your healthcare provider, call customer support, or contact your local Medtrum distributor.
The TouchCare® System has many different settings and features. It is best to talk with your healthcare provider to determine which settings and features are right for you. Some features require great knowledge of insulin pumping and advanced self-care skills. Do NOT use the TouchCare® System until you have specific information for your treatment plan and have had specific training on each feature from your healthcare provider or local Medtrum distributor.
Report any serious incident with your TouchCare® System and the competent authority of the Member State in which you are established.
General Precautions
Do NOT use skin care products, protector solar or insect repellent around the products. The use of such items may cause the products to not stick well or could damage the plastic of the product. If you find a crack in any part of the TouchCare® System, contact customer support.
The TouchCare® System includes active medical devices. When you dispose of any device in the TouchCare® System, follow the local waste disposal regulations.
We recommend that you have someone around you (family, friends, etc.) who understands diabetes and the TouchCare® System, so that in case of an emergency, they can help you. Make sure that they are familiar with any information given by your healthcare provider.
General Warnings
No modification of this system is allowed.
Do NOT use the TouchCare® System if you have delicate skin or if you are allergic to acrylic adhesives.
Do NOT use anything other than the accessories specified in this User Guide, which could permanently damage your system and void its warranty.
Do NOT allow young children to hold the Reservoir Patch, Pump Base, Transmitter, or Sensor without adult supervision. The Reservoir Patch, Pump Base, Transmitter, and Sensor contain small parts and could pose a choking hazard.
Do NOT operate your TouchCare® System in the presence of flammable anesthetics or explosive gases.
Do NOT use the TouchCare® System in oxygen rich environments.
Patch Pump Precautions
Contact your healthcare provider about lifestyle changes such as starting/stopping your exercise program or significant weight loss/gain because this can affect the way that your body uses insulin.
Patch Pump Warnings
In case the TouchCare® System is unable to properly deliver insulin you must be prepared to give yourself an injection of insulin. Knowing how to do this will help to avoid the risk of diabetic ketoacidosis (DKA) or very high blood glucose (BG).
Do NOT stop using your Pump if you are ill unless instructed to do so by your healthcare provider. Even when you are ill, your body still needs insulin.
If failure or damage of your Pump Base is found during usage, please contact customer support or your local Medtrum distributor for a replacement.
CGM System Precautions
The Sensor may create special needs regarding your medical conditions or medications. Please discuss these conditions and medications with your healthcare provider before using the Sensor.
If failure or damage of your Transmitter is found during usage, please contact customer support or your local Medtrum distributor for a replacement.
CGM System Warnings
Do NOT ignore symptoms of high or low glucose. If you believe your Sensor glucose readings are inconsistent with how you feel, manually measure your blood glucose with a blood glucose meter. If the problem continues, discard the old Sensor and insert a new one.
If you suspect your Sensor is broken during usage, do NOT attempt to remove it yourself. Contact your healthcare provider for assistance in removing the Sensor.
Auto Mode Warnings and Precautions
Do Not use Auto Mode before you are authorized by your Healthcare Provider.
Do Not use Auto Mode unless you are trained on the whole system.
When you think the sensor reading is not accurate, or your symptoms don’t match the sensor readings or glucose trend, check BG, and calibrate the sensor, if necessary, before making therapy decisions.
Do not give a manual injection of insulin by syringe or pen if you are using Auto Mode. The manual injection will not be counted by Auto Mode which might cause over delivery.
Check the delivery history before you manually deliver a bolus. Failing to do so may result in over delivery and cause hypoglycemia.
Turn on the Audio and Vibrate before you activate Auto Mode, this will help you be alarmed if abnormal conditions occur.
Personal Diabetes Manager (PDM) Precautions
Your PDM is featured by its color touchscreen. Please operate with dry fingers.
Before you put your PDM in your pocket or purse, remember to press the power button to put the PDM on sleep mode, so that you can avoid mis operation resulting from accidental bumps and movements. Press the power button again to wake the screen.
Check your PDM occasionally to make sure that it emits audible beeps that are easily detectable and that the vibrate feature is working properly.
If you return your PDM for service, a replacement PDM will be sent. Do NOT use the replacement PDM until it has been programmed to fit your specific needs.
If you drop your PDM or if it has been hit against something hard, check whether the display screen and the touch screen are working properly, and whether the PDM can be charged normally. Call customer support or your local Medtrum distributor if you identify or suspect your PDM has been damaged. Your PDM is designed to be charged by a matching charger. Use of anything other than a charger that does not match could permanently damage your PDM and void its warranty.
Operating Temperature Range
Your TouchCare® System is designed to operate between 5°C (41°F) and 40°C (104°F). Do NOT expose the system to temperatures outside that range. Do NOT expose the system to direct sunlight for a long period of time.
Cleaning
Cleaning your Pump BasePump Base is waterproof. If you need to clean a pump base, gently wipe it with a clean, damp cloth or you can use an alcohol wipe to clean the surface and let it air dry.
Cleaning your TransmitterTransmitter is waterproof. If you need to clean a transmitter, gently wipe it with a clean, dap cloth or you can use an alcohol wipe to clean the surface and let it air dry.
Cleaning your PDMPress the Power button briefly to put your PDM to sleep.
Wipe the outer surface of the PDM with a lint-free cloth, or an alcohol wipe and let it air dry.
Do NOT use household cleaners, chemicals, solvents, bleach, scouring pads or sharp instruments to clean your device. Never put your PDM, Pump Base or transmitter in the dishwasher or use very hot water to clean it.
Do NOT use a hair dryer, microwave oven, or conventional oven to dry your PDM, Pump Base or transmitter. Use a soft towel.
X-rays, MRIs and CT Scans
The TouchCare® System may be affected by strong radiation or magnetic fields. If you are going to have an X-ray, MRI, CT scan or other type of exposure to radiation, remove your Patch Pump and CGM System, and put them outside the treatment area with your PDM. Change the Reservoir Patch and Sensor after the test or procedure is completed.
The TouchCare® System is designed to tolerate common electromagnetic and electrostatic fields, including airport security systems and mobile phones.
Consumables
Reservoir PatchThe Pump Base (MD8201) is only used with the 200-unit Medtrum Reservoir Patch (MD8200). The Pump Base (MD8301) is only used with the 300-unit Medtrum Reservoir Patch (MD8300). The Reservoir Patch is disposable (single-use only) and the Pump Base is a reusable device. Change your Reservoir Patch every 2-3 days or as directed by your healthcare provider.
Glucose SensorThe Transmitter (MD1158) is used with the Medtrum Glucose Sensor (MD3658). Glucose sensor is disposable (single-use only) and transmitter is a reusable device. Change your MD3658 Glucose Sensor every fourteen days.
Warning: For your protection the Pump Base and Transmitter have undergone extensive testing to confirm appropriate operation when used with consumables manufactured or distributed by Medtrum. We recommend using Medtrum Reservoir Patches and Glucose Sensors as we cannot guarantee appropriate operation if the system is used with consumables offered by third parties and therefore we are not responsible for any injury or malfunctioning of the system that may occur in association with such use.
Radio Frequency (RF) Communication
Note: The TouchCare® System can generate, use and radiate radio frequency energy, and may cause harmful interference to radio communications. There are no guarantees that interference will not occur in a particular installation. If the TouchCare® System does cause harmful interference to radio or television reception, you are encouraged to try to correct the interference by one of the following measures:
• Move or relocate the TouchCare® System.
• Increase the distance between the TouchCare® System and the other device that is emitting/receiving interference.
Common consumer electronic devices that transmit in the same frequency band used by the TouchCare® System may prevent communication between the PDM and your Patch Pump or Transmitter. This interference, however, does not cause any incorrect data to be sent and does not cause any harm to your device.
Based on GFSK modulation, the system communicates at frequencies between 2402 and 2480 MHz with power level 0 dBm. RF communication between your Patch Pump and PDM works up to a distance of 4 meters (13 feet). RF communication between your Transmitter and PDM works up to a distance of 10 meters (33 feet).
Emergency Kit
Keep an emergency kit with you at all times to make sure you have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept.
Dustproof and Waterproof Capabilities
Both your Patch Pump and Sensor (including the installed Transmitter) are waterproof to a depth of 2.5 meters (8 feet) for up to 60 minutes (IP28). After exposure to water, rinse the devices with clean water and dry them with a towel. Both your Patch Pump and Sensor (including the installed Transmitter) also provides protection against insertion of large objects.
Warning: Do NOT expose your Patch Pump or Sensor (including the installed Transmitter) to water at depths greater than 2.5 meters (8 feet) or for more than 60 minutes. Check often to make sure that the devices are securely attached and in place.
Warning: The PDM is protected against insertion of fingers and will not be damaged or become unsafe during a specified test in which it is exposed to vertically dripping water (IP22).
Warning: The Patch Pump may not be able to deliver normally in water. The Transmitter may not be able to send data normally in water. Note: Hot water may decrease Sensor life.
Storage
Store the Pump Base and Reservoir Patch at temperatures between -10°C (14°F) and 55°C (131°F), and at humidity levels between 20% and 90% relative humidity. Do NOT store the Pump Base and Reservoir Patch in direct sunlight, extreme temperatures, or in very humid areas.
Store the Sensor at temperatures between 2°C (36°F) and 30°C (86°F), and at humidity levels between 20% and 90% relative humidity for the length of the Sensor’s shelf life. For temperatures greater than 30°C (86°F), the Sensor will require cooled storage at temperatures no lower than 2°C (36°F). You may store the Sensor in the refrigerator if it is within this temperature range. The Sensor should not be stored in the freezer. Wait for the Sensor to warm to room temperature before usage to prevent condensation. Storing the Sensor improperly may cause the Sensor glucose readings to be inaccurate, and you might miss a low or high blood glucose value.
Store the Transmitter at temperatures between -10°C (14°F) and 55°C (131°F), and at humidity levels between 20% and 90% relative humidity. Keep the USB charging cable and the Transmitter separate when in storage.
Store the Personal Diabetes Manager (PDM) at temperatures between -10°C (14°F) and 55°C (131°F), and at humidity levels between 20% and 90% relative humidity.
Risks and Side Effects
Risks Related to Insulin Administration and Pump UseRisks related to insulin infusion and potential interruptions of insulin delivery include:
• Hypoglycemia
• Hyperglycemia
• Diabetic ketoacidosis
• Death
• Localized infection
• Skin irritation or redness
• Bruising
• Discomfort or pain
• Bleeding
• Irritation
• Rash
Follow the instructions in the provided user guides for the insertion and care of infusion sets. If an infusion site becomes irritated or inflamed, dispose of the infusion set in a sharps container, and select a different location to insert a new infusion set.
Risks Related to Sensor UseRisks related to sensor use include:
• Skin irritation
• Allergic reaction
• Bruising
• Discomfort
• Redness
• Bleeding
• Pain
• Rash
• Infection
• Swelling at insertion site
• Residual redness associated with adhesive, tape, or both
• Scarring
• Side effects include discomfort and skin irritation at the insertion site.
• Not getting your alerts
• Using sensor glucose to make treatment decisions when you shouldn't
• Using the inaccurate sensor readings to deliver an inaccurate dose of insulin which can lead to hypoglycemia or hyperglycemia.
The algorithm using the incorrect information, including inaccurate sensor readings, incorrect product settings, and incorrect delivery history to decide the insulin delivery which can lead to hypoglycemia or hyperglycemia.
Risks Related to the TouchCare® Insulin Management System
• Hypoglycemia
• Hyperglycemia
• Diabetic ketoacidosis
• Death