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4. General information
The CE mark on a medical device states that the product meets the provisions
of the EU Directive on Medical Products 93/42/EEC. The ESYSTA
®
BT Pen
insulin injection device meets the requirements of dosing accuracy under ISO
11608-1: Pen injectors for medical use – Part 1: Pen injectors – Requirements
and test procedures. As part of the tele-medical ESYSTA
®
product system, the
ESYSTA
®
BT Pen is equipped with a wireless interface for data. The ESYSTA
®
BT Pen meets the fundamental requirements of Directive 1999/5/EC for wireless
installations and telecommunication transmission facilities.
The ESYSTA
®
BT Pen has been tested for electromagnetic compatibility in
accordance with EN 60601-1-2 Medical electrical equipment Part 1-2: General
requirements for basic safety and essential performance - Collateral standard:
Electromagnetic compatibility - Requirements and tests.
You can set your insulin dose in whole units. The ESYSTA
®
BT Pen has a
memory that saves all your doses, along with the date and time. The memory
capacity is approx. 1,000 data records.
In combination with the ESYSTA
®
App, the data is transferred to a Bluetooth
®
-
enabled smartphone.
