Sigma Spectrum Infusion Pump User Manual

WARNINGS AND CAUTIONSWARNING Operation is Limited to Trained and Tested OperatorsSIGMA Spectrum operation is strictly limited to trained operators whose competencyin safe Spectrum operation and in safe IV therapy practices has been tested andproven. Pump owners have sole responsibility for operator training and testing evenwhen SIGMA personnel assist in training processes.WARNING Confirm Safe Operation at Start and ThereafterConfirm safe, accurate pump operation at start and periodically thereafter by:- Confirming there is no drip chamber flow when the pump is stopped.- Confirming the drop rate approximates the pump’s flow rate during RUN operation.- Confirming pump settings are as intended.- Confirming correct: patient, route, dose, time and drug/concentration.- Regularly observing that the patient’s vital signs and IV site are in good condition.Note that infiltrations can not be detected by IV pumps. They must be detected byclinicians and minimized. The Spectrum is not a substitute for regular patientobservation.Never operate the Spectrum unless all of the above safe operations are beingpracticed.WARNING Prevent InaccuracyThe following can cause flow rate inaccuracies and must be avoided:- Incompatible brand IV sets and compatible brand IV sets with unusually large orsmall diameters or unusually stiff materials.- Operating temperatures outside of 60-90°F for Standard Battery and 60-80°F forWireless Battery Module.- Using IV sets longer than 72 hours for Hospira or 96 hours for Baxter.- Using dropped, damaged, dirty or wet pump.- Pressurizing IV bags.- Positioning IV containers more than 3 feet above or 1 foot below the pump.Note: Upstream occlusion detection is only effective for occlusions present immediatelyafter the start of the pump’s run operation. Upstream occlusions caused by nonventedIV sets used with non-vented glass bottles or closed burette air ventscannot be detected because of the very slow building vacuums resulting fromthese situations.WARNING This equipment is not suitable for use in the presence of a Flammable AnestheticMixture with Air or with Oxygen or Nitrous Oxide. (This statement is a requirementof the IEC—60601-2-24 standard. It applies to oxygen enriched environments, suchas oxygen tents. It is not meant to apply to patients on breathing tubes.)- 24 -