InPenTM Basal smart cap User Guide 1
Contents Symbols in This User Guide 5 Introduction 7 Indications for Use 8 Contraindications: 8 Important Pediatric User Information 8 Supported Devices 9 Getting Started 10 Setup Wizard 10 About You 10 Therapy Setup 10 Long-acting Setup 11 Confirm Last Long-acting Dose 11 Attach Adapter 12 Connect InPen Basal Smart Cap 12 How it Works 13 Logging Doses Manually 15 Multi-part Injections 16 Changing Pens 16 2
Smart Device Notes 17 Troubleshooting 18 Notification Icons 18 Common Problems and Solutions 19 Support 21 Handling and Storage 21 Cleaning and Caring 21 Important Notes 22 Disposal 22 Legal Information 23 Apple Legal Notice 23 Android Legal Notice 23 About Bluetooth® 23 Supplemental Information 24 Essential Performance 24 Applied Parts 24 Declaration of Conformity 25 FCC Compliance 25 Warranty 25 3
Product Specifications 27 4
1. Symbols in This User Guide The following symbols are found on the Cap or the package labels. These symbols tell you about the proper and safe use of the Cap System.
Type BF Applied Part Device Meets European Council Directive 93/42/EEC Manufacturer Authorized Representative in the European Community European Union WEEE Directive 2012/19/EU Catalog number Use by date Batch code 6
2. Introduction This user guide will explain how to use your Cap and related features of the InPen Application (App) to help manage your long-acting insulin doses. Read it carefully before you use your Cap. For information about all other features of the InPen system, refer to the InPen System User Guide. Important: You should read this manual before use – even if you have used the Cap before. Failure to follow the instructions may result in too much or too little insulin being administered.
• View and share therapy reports with your healthcare provider Support: • • • Setup wizard within the App. User Guide links within the App Instructional videos within the App. 3. Indications for Use The InPen Basal smart cap is a reusable electronic cap for the tracking of long-acting insulin doses for single-patient use by people with diabetes under the supervision of an adult caregiver, or by a patient age 7 and older.
logging of insulin. It is the responsibility of the healthcare provider and the caregiver to determine if the patient is Appropriate for the Cap. Do not allow small children to chew on or ingest parts, such as the pen cap and adapter components. Small parts could pose a choking hazard. If ingested or swallowed, these component pieces may cause internal injury or infection. For patients who do not self-manage their disease, the smart device should always be under the supervision of a caregiver.
other people’s doses from being sent to the smart device, do not let anyone else use your Cap. The Cap is for single patient use only. Bluetooth® performance varies due to differences in phone hardware and operating systems. The App is not recommended on Jailbroken or Rooted devices. Your smart device must have enough memory storage or the InPen App will not be able to be installed or log doses. You may need to delete files or Apps from your smart device. 7.
Optionally you may set up an InPen for your rapid-acting insulin at this time. If you do not have an InPen, tap I do not have my InPen yet. Long-acting Setup The App will remind you to take your long-acting insulin. If you either take or manually log a long-acting dose before the reminder time, you will not receive a reminder from the App. If no long-acting dose was logged manually or from Cap then the App will remind you.
Confirm Last Long-acting Dose The App will ask you to confirm the last long-acting insulin dose that you have taken. The app will then update Cap with your long-acting insulin dose schedule. IMPORTANT: If the time of the last long-acting dose is incorrect then Cap may indicate that too little or too much time has passed since your last long-acting insulin dose which could lead to hyperglycemia, hypoglycemia, or injury.
Connect InPen Basal Smart Cap IMPORTANT: To ensure a secure connection, pair your Cap and smart device in a secure area with limited Bluetooth® devices in range. CAUTION: Make sure you know which Cap you are pairing with your smart device. IMPORTANT: Enable the security features of your smart device to prevent unauthorized access to your data and settings. a) Place the smart device and Cap within 3 feet (~1 meter) of each other before you begin. Your Cap will blink red and yellow when unpaired.
When to Dose Use the color of the blinking light to determine if it is time to dose. Think like a Stop Light. Blinking Light Red Recommended Action STOP. Do not double dose. Yellow CAUTION. Dose is early. Green GO. Okay to dose. Time Since Last Dose The color of the blinking light and recommended action is determined by the amount of time that has passed since your last long-acting insulin dose.
Note: You can use the logbook within the App to review your recent long-acting insulin doses, as needed. Automatically Logged Doses Long-acting insulin doses are automatically logged when the cap is flashing green or yellow and it has been removed for more than 8 seconds. A dose is never automatically logged when the cap is blinking red. When is a Dose Automatically Logged? Cap off for less than 8 seconds Cap off for more than 8 seconds No dose logged. Do not double dose. Red No dose logged.
long-acting insulin from a source other than your Cap, it must be logged manually. To enter a manual dose, tap Log Dose in the Logbook and select long-acting insulin. To enter the units of long-acting insulin taken, tap Dose Amount and enter the number of units taken from a source other than your Cap. To enter the time of the dose, tap Dose Time and enter the time when the dose was taken.
12. Changing Pens When your long-acting pen is empty or if it needs to be replaced for any reason you can simply replace the cap of the new pen with Cap. Remove Cap and replace on the new pen in less than 8 seconds to prevent logging a dose. Verify that your recent long-acting doses are logged correctly by tapping Logbook from the Home screen. Manually or incorrectly logged long-acting doses can be deleted from the logbook by tapping the dose.
13. Smart Device Notes IMPORTANT: Your smart device must be set up correctly to work properly and safely with the Cap. Your device’s internal settings override any App setting. If the settings on your device are incorrect your Cap System may not function properly. IMPORTANT: Enable the security features of your smart device to prevent unauthorized access to your data and settings. To ensure safety and security, utilize virus/malware scanning software on your smart device.
notification from the App or another App. The only way to know is to look at the screen of your device. The smart device checks and updates the date and time in your Cap. Check the date and time on your device often to be sure it is correct. Check the date and time on your smart device when you travel across time zones. Always let your smart device manage the date and time automatically. For instructions on setting the date and time on your device, see the user manual for your device.
Common Problems and Solutions The table below lists some potential issues that may arise during use of the Cap system and solutions to try. Problem I can’t install the App. I paired my Cap but doses are not appearing on the App. I left my Cap somewhere and I need to take insulin from another source. Solutions to Try Check that your smart device is compatible with the App. See Supported Devices above.
Manually for instructions on how to manually log a dose. I paired my Cap to a new smart device, and now it won’t connect with the original one. I can’t hear reminders on my smart device. The Missed Dose Reminder isn’t working. For safety, it is important to log all long-acting insulin taken. Doses taken from a paired Cap are logged automatically and do not need to be manually entered. Your Cap can only be paired to one smart device at a time.
or using the self-service Help Center any time through Settings > Help and Support > Support. Check Troubleshooting for explanations of App error messages and a list of other common issues and solutions. 16. Handling and Storage Be sure to store your Cap at room temperature when your Cap is installed on a long-acting insulin pen. Refer to the instructions that came with your insulin pen for information on how to long-acting insulin pens and how long to keep them. Do not store the Cap in a refrigerator.
● Do not try to repair a broken Cap When you receive a battery warning or the Cap can no longer communicate with the Application, contact your healthcare provider to obtain a prescription for a new Cap. If you suspect that your Cap has been damaged or may not be working properly, discontinue using it immediately, and contact Customer Support for assistance or to obtain a replacement.
About Bluetooth® Bluetooth is a type of wireless (RF) communication. Cell phones use Bluetooth technology as do many other devices. Your Cap uses Bluetooth to pair with your smart device and to send data to the App. Your Cap is subject to and complies with U.S. federal guidelines, Part 15 of the FCC rules for devices with RF capability. These rules state two conditions specific to the operation of the device. They are: ● ● This device may not cause harmful interference.
If you continue to experience interference, contact the Customer Support. The Bluetooth wordmark and logos are owned by the Bluetooth SIG, Inc. and any use of such marks by Companion Medical, Inc. is under license. Other trademarks and trade names are those of their respective owners. 20. Supplemental Information Essential Performance Essential Performance, as defined by IEC 60601-1, is not Applicable to the Cap system. Operating frequency 2.4 GHz ISM band, GFSK Effective radiated power (ERP) 0.16 mW (-8.
FCC Compliance This device complies with FCC Part 15 license exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. Changes or modifications to the equipment could void the user's authority to operate the equipment.
Voltage fluctuations/ flicker emissions Not applicable not likely to cause any interference in nearby equipment. Guidance and manufacturer’s declaration – Electromagnetic Immunity Immunity test IEC 60601-1-2: 2014 Complianc e Level Electromagnetic Environment Guidance Electrostatic discharge (ESD) ±8 kV contact ±2, 4, 8, 15 kV air For use in a typical domestic, commercial, or hospital environment.
Surge IEC 61000-4-5 Not applicable Requirement does not apply to this battery powered device. Voltage dips, short interruptions, and voltage variations on power supply lines IEC 61000-4-11 Not applicable Requirement does not apply to this battery powered device. Power frequency (50/60 Hz) electromagnetic field IEC 61000-4-8, IEC 60601-1-2 30 A/m For use in a typical domestic, commercial, or hospital environment.
Radiated RF IEC 61000-4-3 10 V/m 80 MHz to 2.7 GHz 80% AM at 1 kHz Portable and mobile RF communications equipment should be used no closer to any part of the Cap, including cables, than the recommended separation distance of 30 cm (12 inches). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, should be less than the compliance level in each frequency range.
Note: UT is the a.c. mains voltage prior to application of the test level. Note: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects, and people. 21. Warranty Companion Medical warrants the Cap against defects in materials and workmanship for a period of 1 year from the date of purchase.
exclusive remedies available for any breach hereof. Neither Companion Medical nor its suppliers or distributors shall be liable for any incidental, consequential, or special damage of any nature or kind caused by or arising out of a defect in the product. All other warranties, expressed or implied, are excluded, including the warranties of merchantability and fitness for a particular purpose. Use of the Cap system is subject at all times to the Companion Medical Inc. Terms of Service (https://www.
22. Product Specifications The Cap is intended for use by patients at home and in healthcare facilities. Operating Conditions 5 °C (41 °F) to 40 °C (104 °F) 15% to 90% RH (non condensing) Operating Altitude -381 m (-1253 ft) to 3010 m (9878 ft) Operating Pressure 70 kPa – 106 kPa Storage Conditions -25 °C (-13 °F) to 70 °C (158 °F) 15% to 90% RH (non condensing) Dimensions 8.9 cm (3.5”) x ø2.5 cm (1.
For information contact: Companion Medical, Inc. 12230 World Trade Drive, Suite 100 San Diego, CA 92128 USA www.companionmedical.com Cormedics Medizintechnik GmbH Bahnhofstrasse 32 82041 Deisenhofen Germany ©2020 Companion Medical, Inc.
