Insulet INT2-D001-MM-OUS2, Руководство пользователя

Страница: 201 / 222

Appendix
184
Appendix
Frequency: 2,400-2,480 GHz, digitally modulated, with an effective radiated
power of 1.14 mW
The Omnipod DASH™ System complies with the immunity requirements of the
general standard for electromagnetic compatibility, IEC 60601-1-2.
The Omnipod DASH™ System has demonstrated immunity to both radio-
frequency identification (RFID) systems and Electronic Article Surveillance
(EAS) systems. Testing has been performed in accordance with AIM 7351731 to
demonstrate this immunity.
Caution:
Portable RF communications equipment (including peripherals, such
as antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the Omnipod DASH™ System. Otherwise, degradation
of the performance of this equipment could result.
Electromagnetic Emissions
This equipment is intended for use in the electromagnetic environment specified below. The
user of this equipment should assure that it is used in such an environment.
Emissions Compliance
according to
Electromagnetic environment
RF Emissions
(CISPR 11)
Group 2 The Pod and the PDM emit low-level
electromagnetic energy (RF) in order to
communicate. Although unlikely, nearby
electronic equipment may be affected.
CISPR B
Emissions
Classification
Class B The System is suitable for use in all establishments
including domestic establishments.
Electromagnetic Immunity
The System is intended for use in the electromagnetic environment specified
below. You should observe these requirements when using the System.
Immunity
against
IEC 60601-1-2
test level
Compliance
level (of this
device) Electromagnetic environment
ElectroStatic
Discharge, ESD
(IEC 61000-4-2)
contact
discharge:
± 8 kV
air discharge:
± 15 kV
± 8 kV
± 15 kV
If floors are covered with synthetic material,
try to avoid electrostatic discharges.
Power
frequency
magnetic fields
50/60 Hz (IEC
61000-4-8)
30 A/m 400 A/m Suitable for most environments. Magnetic
field strengths in excess of 400 A/m would
be unlikely except in close proximity to
industrial magnetic devices.
Effective Date: 27SEP2019, ECO-000240