Users Manual Part 1
11
Introduction 11 Introduction
Warning: SmartAdjust technology should NOT be used by anyone under the
age of 6 years old. SmartAdjust technology should also NOT be used in people
who require less than 6 units of insulin per day as the safety of the technology has
not been evaluated in this population.
Warning: DO NOT use the Omnipod 5 System at low atmospheric pressure
(below 700hPA). You could encounter such low atmospheric pressures at high
elevations, such as when mountain climbing or living at elevations above 10,000
feet (3,000 meters). Change in atmospheric pressure can also occur during take-
o with air travel. Unintended insulin delivery can occur if there is expansion of
tiny air bubbles that may exist inside the Pod. is can result in hypoglycemia.
It is important to check your glucose frequently when ying to avoid prolonged
hypoglycemia.
Warning: DO NOT use the Omnipod 5 System in oxygen rich environments
(greater than 25% oxygen), which include home or surgical areas that use
supplementary oxygen and hyperbaric chambers. Hyperbaric, or high pressure,
chambers are sometimes used to promote healing of diabetic ulcers, or to
treat carbon monoxide poisoning, certain bone and tissue infections, and
decompression sickness. Exposure to oxygen rich environments could result in
combustion of the Pod or Omnipod 5 Controller, which can cause severe burns to
the body.
Warning: DO NOT use the Omnipod 5 System in high atmospheric pressure
environments (above 1060 hPA), which can be found in a hyperbaric chamber.
Hyperbaric, or high pressure, chambers, are sometimes used to promote healing
of diabetic ulcers, or to treat carbon monoxide poisoning, certain bone and tissue
infections, and decompression sickness. Exposure to high atmospheric pressure
environments can damage your Pod and Omnipod 5 Controller which could
result in under-delivery of insulin which can lead to hyperglycemia.
1.6. General Precautions
Caution: Federal (US) law restricts this device to sale by or on the order of a
physician.
Caution: DO NOT use any component of the Omnipod 5 System (smartphone,
Controller, Pod) if you suspect damage aer an unexpected event such as
dropping or hitting on a hard surface. Using damaged components may put
your health at risk as the system may not be working properly. If you are unsure
if one or more of your components are damaged, stop using the system and call
Customer Care for support.
Caution: ONLY use the Omnipod 5 System with authorized devices (Omnipod
5 App, Controller and Pod and Dexcom G6 CGM). DO NOT attempt to use the
Omnipod 5 System with unauthorized devices. Attempting to use the Omnipod