
4
Introduction and Safety
Manual 41018v0800
SIGMA Spectrum Infusion System
Revision B
Operator’s Manual
WARNING
Emissions and Immunity.
The use of accessories or cables other than those specified by Baxter
may result in increased Emissions or decreased Immunity of this
medical device.
Procedural Warnings
WARNING
Operation is Limited to Trained Operators.
SIGMA Spectrum Infusion Pump operation is strictly limited to trained
operators who are competent in safe SIGMA Spectrum Infusion
Pump operation and in safe IV therapy practices. Pump owners have
sole responsibility for operator training and testing even when Baxter
personnel assist in training processes.
WARNING
Environmental Limits
Use of the SIGMA Spectrum Infusion System outside the
environmental limits, noted in Appendix A as “Operational Conditions”
may cause performance issues with the SIGMA Spectrum Infusion
System, including but not limited to: under or over infusion, inability to
detect upstream or downstream occlusions, inability to charge
battery, and/or decreased battery life.
WARNING
Confirm Safe Operation.
Never operate the SIGMA Spectrum Infusion Pump unless all of the
following safe operations are being practiced.
Always confirm safe, accurate Pump operation by:
Ensuring that IV sets or container vents are properly functioning,
that tubing clamps are in the proper positions and that tubing is
free from kinks or signs of collapse outside the Pump to prevent
undetected upstream occlusions.
Observing the drip chamber to verify that there is no flow from the
fluid container when the Pump is stopped.
Ensuring the drip rate approximates the Pump’s flow rate during
RUN operation.
Ensuring correct patient, correct route and correct drug.
Ensuring Pump settings, for example; drug/concentration, dose
mode, dose rate and time.
Monitoring vital signs and IV access sites per facility’s standard
practice of care.
Monitoring the infusion to ensure that the infusion is delivered as
intended.
Periodically checking battery status and replace if necessary.
The SIGMA Spectrum Infusion System is not intended to replace
clinician patient observation.
Содержание 35700BAX2
Страница 152: ...146 Appendix B Flow Rate Accuracy Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual ...
Страница 154: ...148 Appendix B Flow Rate Accuracy Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual ...
Страница 176: ...170 Glossary Manual 41018v0800 SIGMA Spectrum Infusion System Revision B Operator s Manual ...