mylife V01 Orbit Inserter User Manual

June 5, 2024
mylife

MyLife V01 Orbit Inserter

mylife-V01-Orbit-Inserter-product

Intended purpose

The mylife™ Orbit®Inserter is a manually operated insertion device for the application of compatible Infusion Sets. It helps to introduce the infusion set cannula into the subcutaneous fatty tissue. The device is for single patient use only.

Warnings

Keep the inserter pointed towards the infusion site and away from eyes and any body part where insertion is not desired. Activating the inserter pointed away from the injection site during readying and in its loaded state, may result in pain or injury. For further advice, please consult your doctor or diabetes advisor.  Follow the pictures on the box for the usage of the mylife™ Orbit®Inserter. Consult the Instructions for Use for the mylife™ Orbit® infusion set or the mylife™ YpsoPump® Orbit® infusion set.
Notes: The mylife™ Orbit®Inserter is solely intended to be used with the following infusion sets:

  • mylife™ Orbit®micro
  • mylife™ Orbit®soft
  • mylife™ YpsoPump® Orbit®micro mylife™ YpsoPump Orbit soft

Do not use the mylife™ Orbit®Inserter with any other infusion sets except the ones listed here. The mylife™ Orbit®Inserter must be discarded or replaced if it becomes too soiled. Clean by wiping with a damp cloth. Reporting of serious incidents: Inform Ypsomed and your local health authority in case of serious health effects (such as serious injury or hospitalization) and/or serious malfunction of the device.

  • Manufacturer
  • Date of manufacture
  • Keep dry
  • Consult instructions for use
  • EU-Authorized Representative
  • Medical device
  • Keep away from sunlight
  • Importer
  • Lot number
  • Reference / model number
  • Single patient – multiple uses

References

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