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21. Supplemental Information
Essential Performance
Essential Performance, as defined by IEC 60601-1, is not
applicable to the InPen™ system.
Dose Accuracy
InPen™ fulfils the functional requirements and
specification limits for dose accuracy according to ISO
11608-1.
Applied Parts
The InPen™ is a hand held device and is considered the
applied part as defined by IEC 60601-1.
Declaration of Conformity
Companion Medical declares that this product is in
conformity with the essential requirements of Directive
1995/5/EC on Radio and Telecommunications Terminal
Equipment and Council Directive 93/42/EEC of 14 June
1993 concerning medical devices (M5).
FCC Compliance
This device complies with FCC Part 15 license exempt
RSS standard(s). Operation is subject to the following
two conditions: (1) this device may not cause
interference, and (2) this device must accept any
interference, including interference that may cause
undesired operation of the device.
22. Warranty
Companion Medical warrants the InPen™ System
against defects in materials and workmanship for a
period of 1 year from the date of purchase.
During the warranty period, Companion Medical will,
at its discretion, replace any defective device, subject
to the conditions and exclusions stated herein. In the
event that a device is replaced, the warranty period will
not be extended.
