Intended use
The Diabecare DANA-i is intended for the subcutaneous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. The pump is intended to be used both alone and in conjunction with digitally connected medical devices for the purpose of drug delivery, such as receiving, executing and verifying commands from digital connections, including automated insulin injection software. Also, the device is not intended for use with blood or blood products.
Contraindication
Patients whose vision or hearing is impaired to recognize the signs on the screen of the insulin pump or the alarms from the insulin pump. Patients who are not able to operate the insulin pump or to change DANA Infusion Sets and DANA 3cc Syringe regularly as the instruction manual guides for avoiding contamination, if a helper is not provided.
General Precautions
- 1. Pump users need more than 4 blood glucose measurements per day,
and vision and hearing to receive any pump alarm.
- 2. Confirm regularly that the screen display turns on, you can hear
audible beeps, and feel the vibrate. If these features are not working,
discontinue use of the pump and contact a healthcare professional or
technical support from the local Insulin Pump distributor.
- 3. Patients must not open the Pump housing or handle any internal
components.
- 4. The Diabecare DANA-i Insulin Pump is intended for use with a
proprietary Infusion Set, reservoir and other accessories specified. DO
NOT use the Pump with any other infusion system or accessories.
- 5. Press buttons with the pad of the finger. DO NOT use fingernails or
any sharp objects.
- 6. The Insulin Pump comes with factory default settings and alarms,
maximum daily totals, basal and bolus doses. These settings can be
adjusted by a healthcare professional.
- 7. The pump is indicated for use with U-100 insulin. The other insulins
have not been tested and may not be compatible for use with the Diabecare DANA-i insulin pump.
- 8. Change the reservoir and the Infusion Set regularly, as recommended
by healthcare professionals. DO NOT use for longer than the intended
period.
- 9. Check the expiration dates and dispose of any expired accessories.
- 10. Avoid impact damage such as dropping. If there is any known
damage of pump and accessory, contact a healthcare professional or
technical support from the local Insulin Pump distributor.
- 11. For any trouble with any of the system components, turn off the
Insulin Pump by removing the battery and contact a healthcare
professional or Insulin Pump trainer.
- 12. Remove the battery for long-term storage.
- 13. If remote control is not intended to be used, it is suggested to turn
the BLE off by activating ‘Airplane Mode’ to prevent unintentional
delivery.
- 14. If you forgot pump password, contact technical support from the local
Insulin Pump distributor.
- 15. Check your infusion site daily for proper placement and leaks. If you
notice leaks around the site replace infusion set.
- 16. When the memory is full, the oldest data is deleted in order and the latest data is saved.
- 17. If a cybersecurity-related threat is detected, please contact the manufacturer.
- updated on 2026-06-15