Users Manual Part 8
362
Appendix
is table lists the immunity levels at specic test frequencies for Proximity
Magnetic Fields Range of 9 kHz to 13.56 MHz
Test Frequency Modulation Immunity Test Level (A/m)
30kHz a) CW 8
134.2 kHz Pulse modulation b) 2.1 kHz 65 c)
13.56 MHz Pulse modulation b) 7.5 c)
a) is test is applicable only to ME equipment and ME systems intended in a HOME
HEALTHCARE ENVIRONMENT.
b) e carrier shall be modulated using a 50% duty cycle square wave signal.
c) RMS before modulation is applied
Note: ese guidelines may not apply in all situations. Electromagnetic propagation is aected
by absorption and reections from structures, objects, and people.
Field strengths from xed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and
TV broadcast, cannot be predicted theoretically with accuracy. In order to assess the
electromagnetic environment due to xed RF transmitters, an electromagnetic site
survey should be considered. If the measured eld 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 reorienting or relocating the equipment.
Customer's Bill of Rights
Mission Statement
Insulet Corporation is dedicated to designing, developing, and distributing
products that provide superior treatment options and lifelong health benets for
people with diabetes.
Scope of Services
Insulet Corporation’s scope of services is limited to providing the
Omnipod 5 Automated Insulin Delivery System.
e Omnipod 5 System consists of the Pod and the handheld, wireless Controller
or compatible smartphone running the Omnipod 5 App, which programs the
Pod with insulin delivery instructions.
Compliance
e Omnipod 5 Automated Insulin Delivery System is manufactured and
distributed by Insulet Corporation. e company is committed to complying with
all federal and state regulations. If you have any questions or concerns regarding
any of our activities, please contact us at 1-800-591-3455 (from outside the United
States, 1-978-600-7850).
Inquiries
Representatives are available to answer product-related inquiries 24 hours per
day at our toll-free number, 1-800-591-3455 (from outside the United States,