1. Introduction
14
Hospira GemStar Manual 430-10984-001 (Rev. 03/06)
vapors.
Non-hazardous, low-level electrical potentials are commonly observed when
fluids are administered using infusion devices. These potentials are well within
accepted safety standards, but may create artifacts on voltage-sensing equipment,
such as ECG, EMG, and EEG machines. These artifacts vary at a rate that is
associated with the infusion rate. If the monitoring machine is not operating
correctly or has loose or defective connections to its sensing electrodes, these
artifacts may be accentuated so as to simulate actual physiological signals. To
determine if the abnormality in the monitoring equipment is caused by the
infusion device instead of some other source in the environment, set the infusion
device so that it is temporarily not delivering fluid (if clinically acceptable).
Disappearance of the abnormality indicates that it was probably caused by
electronic noise generated by the infusion device. Proper setup and maintenance
of the monitoring equipment should eliminate the artifact. Refer to the appropriate
monitoring system documentation for setup and maintenance instructions.
The GemStar® Pump has been tested and found to comply with EMC/EMI limits
in accordance with:
IEC/EN 60601-1-2 (2001) when using two AA disposable batteries or when
connected to the GemStar® AC Adaptor
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® system
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:
Reorient or relocate the receiving device
Increase the separation between the equipment
Connect the equipment to an outlet on a circuit different from that to which
the other device is connected
Consult the manufacturer or field service technician for help
430-10984-001.book Page 14 Friday, March 31, 2006 4:49 PM
