Section 12 • Electromagnetic Immunity (EMC)
65
SECTION 12 - ELECTROMAGNETIC IMMUNITY
(EMC)
Mobile RF communications equipment can affect the operation of the ambIT
®
pump.
The ambIT
®
pumps that have a remote BOLUS switch connector should only be used with
the Summit Medical remote BOLUS switch. Use of any remote BOLUS switch other than the
approved ambIT
®
PCA remote BOLUS switch manufactured by Summit Medical Products, Inc.
(product #220265) could result in an inadvertent bolus. It may also result in increased emissions
or decreased immunity of the device.
The ambIT
®
pump uses RF energy only for its internal function. Therefore, its RF emissions are
very low and are not likely to cause any interference in nearby electronic equipment.
WARNING:
The ambIT
®
pump should not be used adjacent to or stacked with other
equipment. If adjacent or stacked use is necessary, the ambIT
®
pump and other
equipment should be observed to verify normal operation in the configuration
in which it will be used.
The ambIT
®
pump is suitable for use in home healthcare and healthcare facility environments.
The purpose of the ambIT
®
pump is to infuse medication from a fluid reservoir into a patient at
a controlled rate (flow rate). The ambIT
®
pump has been tested to ensure that it is not affected
by normal electromagnetic emissions from surrounding electronic devices. However, if the
surrounding electronic devices emit excessive electromagnetic emissions, the performance
of the ambIT
®
pump may be degraded. Specifically, the pump display may cease to function
until the ambIT
®
pump is placed in pause and then powered off and back on. The pump will
continue to infuse at the correct rate and all other functions will not be compromised.
WARNING:
Use of accessories other than those provided by the manufacturer of the
ambIT
®
pump could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation.
WARNING:
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 ambIT
®
pump and remote BOLUS switch. Otherwise,
degradation of the performance of the ambIT
®
pump could result.
The ambIT
®
pump meets the immunity test levels shown in the tables below. The emissions
group and class of the ambIT
®
pump is Group 1 and Class B.