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SIGMA Manual Number 41018
Revision AR
INTRODUCTION AND SAFETY
Intended Device Use
The SIGMA Spectrum and SIGMA Spectrum with Master Drug Library are intended to be used for
the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs,
blood, blood products, antibiotics, nutritional fluids and mixtures of required patient therapy. The
intended routes of administration consist of the following clinically acceptable routes: intravenous,
arterial, subcutaneous, intrathecal, epidural or irrigation of fluid space. The SIGMA Spectrum is
intended to be used in conjunction with legally marked intravenous administration sets and medica-
tions provided by the user.
The SIGMA Spectrum and SIGMA Spectrum with Master Drug Library is suitable for many user
facility applications such as, but not limited to, hospitals, outpatient care areas, homecare and
ambulatory care services. The SIGMA Spectrum and SIGMA Spectrum with Master Drug Library
has not been tested or approved for use in motor vehicles or aircraft.
The SIGMA Spectrum and SIGMA Spectrum with Master Drug Library are intended to reduce oper-
ator interaction through automated programming, thereby helping to reduce errors associated with
complex device programming. Parameter programming requires a trained healthcare professional to
confirm the limits and drug therapy parameters in accordance with a physician's instructions.
Related Documents
The following documents also pertain to the Spectrum and Spectrum with Master Drug Library:
■
Service Manual P/N 41019
■
MDL User Manual P/N 41020
Regulatory Information
Conforms to UL STD 60601-1
Certified to CAN/CSA STD C22.2 NO 601.1-M90
Contacting SIGMA Technical Support
Contact SIGMA LLC for all service information at:
Telephone:1-800-356-3454
Email: [email protected]