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The Spectrum and Spectrum with Master Drug Library is intended to be used for the controlled administration of intravenous fluids. These fluids may include pharmaceutical drugs, blood, blood products 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 spectrum is intended to be used in conjunction with legally marketed intravenous administration sets and medications provided by the user. The Spectrum and 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 Spectrum and Spectrum with Master Drug Library is intended to reduce operator interaction through automated programming thereby helping to reduce errors associated with complex device programming. Parameter programming requires trained healthcare professional confirmation of limits and drug therapy to physician's directive.

The Spectrum with Master Drug Library (device) is an infusion pump having a basic The Spectrum with Master Brag Libra, P(2018) Section 5725. The Spectrum infusion desomplon as loonimou nicuitry and mechanical mechanisms that are integrated into pump consists of clouronio sirounly and mechanical operations are software a lightweight plastic ontroller and processor technology. The motor control / controlled dolly disorte merces in the linear peristaltic design using inlet and exit recoback partiping moontrol. Infusion therapy fluids and selected intravenous (IV) sets The Spectrum infusion pump is specifically are supplied by the device user. are Supplied by the cated for the application of standard gravity infusion sets of a manufacturer's brand, as indicated by the Spectrum's labeling. The IV set is loaded into the Spectrum infusion pump. After acceptance of program parameters, the pump is the Upontain 'infactor' palled by the rhythmic action of the pumping mechanism against started and is properies a fine in tubing. The pump is controlled to create smooth fluid the outbide carace on volumetric accuracy, and uniformity of flow rate profile. The Spectrum infusion pump is small in comparison to the traditional "Large Volume" infusions pumps currently on the market. However, it is designed to be used in a infosions pampe carren IV pole mounted configuration or carried by the user in an ambulatory manner. The Master Drug Library (MDL) capability is a software package that allows the rno nation and management of a patented downloadable drug library into to a target infusion pump. The library may be loaded directly into the infusion pump or uploaded into another computer, Personal Assistants (PDA's), or other transfer apparatus (I.e. "smart" C-pen) for wired or wireless communication to the infusion pump. The MDL software reduces the risk of medication errors by providing programmed delivery profiles and limits for a corresponding drug that is intend for a specific use classification. The MDL software will operate on a popular software systems platform (I.e. Windows) and have the capability (using external peripherals) of printing text / barcode labels that may be used to label and identify drug therapy bags and or patient identification labels. Through the application of the C-pen equipment, scanned patient and IV prescription information can be downloaded into the Spectrum infusion pump. The Spectrum infusion pump has the capability of communicating with a hospital information management system. The Spectrum infusion pump uses coded passwords and redundancy checks to mitigate the acceptance of improper information.

The "Sigma Syringe Delivery System" is designed for the controlled intermittent administration of small volume intravenous fluid medications for the treatment of human or animal subjects. Its specific design characteristics limit the device's use to slow, non-rate critical, small volume parenteral applications, identical to the predicate devices.

The SIGMA Syringe Deliver Systems are syringe infusion pumps that operate using two principles for delivery - a spring and resistive tubing. The mechanical principle is produced by relaxing spring force. The devices are strictly mechanical in operation and do not require the execution of software. This type of infusion pump is used to pump fluids into a patient in a controlled manner. The models are designed specifically for the controlled, parenteral infusion of non-rate critical drugs and medications. The SIGMA infusers are best identified and described in Title 21, Part 880.5725, of the Code of Federal Regulations, as classification Class II, Infusion Pump. The "SIGMA Syringe Infusion System" is a combination of three components : 1) an Infuser, 2) Rate-Control Extension Set and 3) syringes(supplied by the user). All three components act together as a system. The infuser acts as the energy force that pushes fluid from the syringe, the fluid reservoir, through a Rate-Control IV Extension Administration Set, that controls the rate of the fluid delivery to the patient.