Insulet Corporation 019 Manuale Utente
157
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Medical Device Directive
This device complies with Medical Device Directive 93/42/EEC.
Contact Person: The Complaints Officer
Address: HealthLink Europe BV, Centaurusweg 123
NL-5015 TC TILBURG, The Netherlands
Address: HealthLink Europe BV, Centaurusweg 123
NL-5015 TC TILBURG, The Netherlands
TEL: +31.13.5479300
FAX: +31.13.5479302
E-mail: complaints@HealthlinkEurope.com
Insulet Corporation complies with EU Directive, HIPAA, and rele-
vant provisions of PIPEDA.
E-mail: complaints@HealthlinkEurope.com
Insulet Corporation complies with EU Directive, HIPAA, and rele-
vant provisions of PIPEDA.
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mylife OmniPod System Notice
Concerning Interference
The mylife OmniPod Insulin Management System (both the Pod
and the Personal Diabetes Manager or PDM) complies with Part
15 of the 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, includ-
15 of the 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, includ-
ing interference that may cause undesirable operation.
Changes or modifications not expressly approved by Insulet
could void the user’s authority to operate the equipment.
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 radio
communications. There are no guarantees that interference will
not occur in a particular installation. If the mylife OmniPod Sys-
tem does cause harmful interference to radio and television
reception, the interference may be corrected by one of the fol-
lowing measures:
•
frequency energy, and may cause harmful interference to radio
communications. There are no guarantees that interference will
not occur in a particular installation. If the mylife OmniPod Sys-
tem does cause harmful interference to radio and television
reception, the interference may be corrected by one of the fol-
lowing measures:
•
Move or reposition the mylife OmniPod System.
•
Increase the distance between the System and the other
device that is emitting or receiving interference.
device that is emitting or receiving interference.
Insulet Corporation declares that the mylife OmniPod System is
in compliance with the essential requirements and other rele-
vant provisions of Directive 1999/5/EC. This ISM device complies
with Canadian ICES-003 and IC-RSS-210.
in compliance with the essential requirements and other rele-
vant provisions of Directive 1999/5/EC. This ISM device complies
with Canadian ICES-003 and IC-RSS-210.
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Electromagnetic Compatibility
The information contained in this section (such as separation
distances) is, in general, specifically written with regard to the
mylife OmniPod System. The numbers provided will not guaran-
tee faultless operation but should provide reasonable assurance
of such. This information may not be applicable to other medical
electrical equipment; older equipment may be particularly sus-
ceptible to interference.
mylife OmniPod System. The numbers provided will not guaran-
tee faultless operation but should provide reasonable assurance
of such. This information may not be applicable to other medical
electrical equipment; older equipment may be particularly sus-
ceptible to interference.