Intended Use

The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used for the controlled administration of fluids. These may include pharmaceutical drugs, blood, blood products and mixtures of required patient therapy. The intended routes of administration consist of the following clinically accepted routes: intravenous, arterial, subcutaneous, epidural or irrigation of fluid space. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used in conjunction with legally marketed and compatible intravenous administration sets and medications provided by the user.

The SIGMA Spectrum Infusion Pump with Master Drug Library is suitable for a variety of patient care environments such as, but not limited to, hospitals and outpatient care areas.

The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to reduce operator interaction through guided programming, thereby helping to reduce errors. The SIGMA Spectrum Infusion Pump with Master Drug Library is intended to be used by trained healthcare professionals.

WARNINGS:

The SIGMA Spectrum Infusion Pump with Master Drug Library has not been tested or evaluated for use in motor vehicles or aircraft (for example, ambulance or MedFlight helicopter).

The SIGMA Spectrum Infusion System has not been tested or evaluated for use in a hyperbaric chamber.

The SIGMA Spectrum Infusion System is not designed to be MRI compatible nor is it intended to be used in this manner. Strong magnetic fields (those beyond the level tested) may cause the device to operate improperly.

Sigma Spectrum Infusion Pump is Rx Only

For the safe and proper use of the devices referenced within, refer to the complete Instructions for Use or the appropriate manual.
Please refer to manufacturer’s Package Insert for drug products mentioned herein for Full Prescribing Information.