Medical Device Directive; Eu General Data Protection Regulation (Gdpr); Eu Authorised Representative Details; Omnipod Dash™ System Notice Concerning Interference - Insulet Omnipod Dash User Manual

Appendix

Medical Device Directive

This device complies with Medical Device Directive 93/42/EEC.

EU General Data Protection Regulation (GDPR)

Insulet complies with the EU 2016/679 General Data Protection Regulation.

EU Authorised Representative details

Contact Person: The Complaints Officer
Address: HealthLink Europe BV, De Tweeling 20-225215 MC' s -Hertogenbosch,
The Netherlands
TEL: +31 13 547 9300
FAX: +31 13 547 9302
Email: complaints@HealthlinkEurope.com
Omnipod DASH™ System Notice Concerning
Interference
The Omnipod DASH™ Insulin Management System (both the Pod and the PDM)
complies with Part 15 of the Federal Communications Commission (FCC) Rules.
Operation is subject to the following two conditions:
1. These devices may not cause harmful interference.
2. These devices must accept any interference received, including interference
that may cause undesirable operation.
Caution: Changes or modifications not expressly approved by Insulet
Corporation could void the user' s authority to operate the equipment.
Both the Pod and the PDM generate, use and can radiate radio frequency energy,
and may cause harmful interference to the radio communications of other
devices. There are no guarantees that interference will not occur in a particular
installation.
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Effective Date: 27SEP2019, ECO-000240