1 Introduction
1.1 Definitions
Device InsulCheck DOSE
User Insulin pen user, Patient or Operator
1.2 General description
InsulCheck DOSE helps you track your insulin injections. It can streamline your
diabetes management by automatically logging injections events into a paired
diabetes management app. You can easily identify the previous dosage amount
dialled and the time since last injection on the display, helping you to stay on top of
your injection routine. InsulCheck DOSE is clipped-on to your insulin injection pen.
InsulCheck DOSE must not be used as the only indicator to decide when or how much
insulin to inject. You must rely on your own memory and knowledge, your blood
glucose level and your healthcare provider’s advice when deciding to inject.
1.3 Intended Use
InsulCheck DOSE is an add-on device for insulin injection pens to support users by
automatically capturing and displaying injection event data, such as time of injection
and the dialled dosage.
InsulCheck DOSE does not change or modify the function of the injection pen, nor
does it make any decisions or recommendation as to the timing or dosage to be
administered.
The Device is intended to be used in common environments such as your home,
office, or school.
The Device is intended for users who see a benefit in logging their injection event
data. This data can be logged either manually by the user or automatically by wireless
transmission.
InsulCheck DOSE should not be used as the sole or primary source for informing
injection decisions.
1.4 Intended Users
InsulCheck DOSE is intended for people living with diabetes who are able to manage
their treatment without the use of the device, and their care givers.
The intended users are expected to be familiar with the normal aspects of insulin
usage and the operation of injection pens.
