Chapter 1. Introduction
16
Hospira GemStar System Operating Manual
6
IEC/EN 60601-1-2 (2001) when using two AA disposable batteries or when
connected to the GemStar AC Adaptor
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IEC/EN 60601-1-2 (2001) (ESD exemption) when using Li-Ion Docking
Station or Li-Ion Battery Pack
When connected to other power sources or optional system components in
commercial distribution before November 30, 2004, the GemStar Pump complies
with EMC/EMI limits in accordance with IEC/EN 60601-1-2 (1993). These limits
are designed to provide reasonable protection against harmful interference in a
typical medical installation. The equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in the vicinity.
However, there is no guarantee that interference will not occur in a particular
installation. If this equipment does cause harmful interference with other devices,
which can be determined by turning the equipment off and on, the user is
encouraged to try to correct the interference by one or more of the following
measures:
6
Reorient or relocate the receiving device
6
Increase the separation between the equipment
6
Connect the equipment to an outlet on a circuit different from that to which
the other device is connected
6
Consult the manufacturer or field service technician for help
6
The use of portable and mobile RF equipment may have an impact on this and
other pieces of medical equipment
6
Prior to using the GemStar Pump and optional system components, refer to
Appendix A for additional information and precautionary procedures regarding
electrical potentials (electromagnetic compatibility and electrostatic discharge).
Regarding Handling and Maintenance
6
Use proper care during unpacking, installation, and operation of the pump. If the
pump is inadvertently mishandled, check connections and programmed data to
ensure there is no damage. Refer to Chapter 14 Operation Test for further
information.
6
Accessory equipment connected to the analog and digital interfaces must be
certified according to the respective IEC standards, (e.g., IEC 60950 for data
processing equipment, and ICE 60601-1 for medical equipment). Furthermore, all
configurations shall comply with the system standard IEC 60601-1-1. Any person
who connects additional equipment to the signal input or output part configures a
medical system, and is therefore responsible for ensuring that the system complies
with the requirements of IEC 60601-1-1. If in doubt, contact Hospira Technical
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