YPSOMED V01 Orbit Inserter User Manual

June 3, 2024
YPSOMED

YPSOMED V01 Orbit Inserter

Intended purpose

The Orbit®Inserter is a manually operated insertion device for 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 inserter pointed towards the infusion site and away from eyes and any body part where insertion is not desired. Activating inserter pointed away from
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 Orbit®Inserter.
Consult the Instructions for Use for the Orbit® infusion set or the YpsoPump® Orbit® infusion set.
Notes: The Orbit®Inserter is solely intended to be used with the following infusion sets:

  • Orbit®micro
  • Orbit®soft
  • YpsoPump® Orbit®micro
  • YpsoPump® Orbit®soft

Do not use the Orbit®Inserter with any other infusion sets except the ones listed here.
The 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 hospitalisation) and/or serious
malfunction of the device

DISPOSAL

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

Ypsomed AG Brunnmattstrasse 6 3401 Burgdorf Switzerland +41 34 424 41 11 www.ypsomed.com

References

Read User Manual Online (PDF format)

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Download This Manual (PDF format)

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