Insulet INT2-D001-MM-OUS2, User Manual

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Appendix Appendix
Electromagnetic Immunity
Radiated RF
(IEC 61000-4-3)
10 V/m at
80 MHz–
2.7 GHz
10 V/m Suitable for most environments. Keep
portable RF communications equipment
at least 30 cm (12 inches) away from the
Omnipod DASH™ System.
Note: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflections from structures, objects and people.
a
Field strengths from fixed transmitters, such as base stations for radio (mobile/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV
broadcast, cannot be predicted theoretically with accuracy. To assess the electromagnetic
environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the equipment is used
exceeds the applicable RF compliance level above, the equipment should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be
necessary, such as re-orientating or relocating the equipment.
Warranty for the Omnipod DASH™ Insulin Management
System Personal Diabetes Manager and Pods (Europe)
WARRANTY COVERAGE
Warranty Coverage for the Omnipod DASH™ System Personal Diabetes Manager
Subject to the terms and conditions below, Insulet Netherlands BV (“Insulet”) warrants to
you, the original recipient of the Omnipod DASH™ Insulin Management System for use in
Europe, that, if Insulet determines that your Personal Diabetes Manager (“PDM”) has a defect
in material or workmanship while utilised under normal use and conditions during the period
of four (4) years from the date of purchase (or receipt where purchased on your behalf), Insulet
will either repair or replace, at its sole discretion, the PDM.
This four-year (4) warranty period applies only to new PDMs and, in the event that the PDM is
repaired or replaced, the warranty period shall not be extended or reset.
Warranty Coverage for the Omnipod® System Pods
Subject to the terms and conditions below, Insulet warrants to you, the original recipient of
the Omnipod® System, that if Insulet determines that an Omnipod® System Pod (“Pod”)
you have received has a defect in material or workmanship while utilised under normal use
and conditions during the period of eighteen (18) months from the date of manufacture and
seventy-two (72) hours from the time of activation, Insulet will either repair or replace, at its
sole discretion, that Pod. To be eligible for replacement, the activation of the Pod must fall
within both time periods (i. e. occur on or before the expiry date printed on the label with a
manufacture date no more than eighteen (18) months before and on or before a time no more
than seventy-two (72) hours before you notify Insulet of the claim).
This eighteen (18) month and seventy-two (72) hour warranty period only applies to new Pods
and, in the event that a Pod is repaired or replaced, the warranty period shall not be extended or
reset.
Effective Date: 27SEP2019, ECO-000240