CytoCare Specifications

Dimensions:
CytoCare™ ships from our factory fully assembled with dimensions that are approximately 7 feet of width, 6 feet of height, and 3 feet of depth.

Weight:
CytoCare™ consists of two units: a main Unit (MU) and a pipe unit (PU).
The MU weight is is approximately 3,300 lbs. The shipping weight of the MU is about 4,000 lbs with the packaging and pallet included. The PU weight is approximately 44 lbs.

Floor Load:
Given the unit’s weight, distance between its wheels and estimating the weight of the loaded materials, the floor load is approcimately 120 lbs/sq ft.

Acoustic Noise Output:
The acoustic noise output is < 65 dB when measured at 1.6 ft from the operator panel at a height of 5 ft.

Modes of Operation:
- Data entry mode– CytoCare provides a data entry user interface for inputting order/job details.
- Start-up mode – A self-checking initialization routine is performed when the system is switched on to ensure that all operational modes of the system are fully functional.
- Batch Mode – The system is capable of preparing preprogrammed batches of IV bags or syringes.
- Single Dose Mode – The system is capable of preparing urgent individual patient specific doses.
- Shut-down Mode - The system closes down all operational modules before entry is allowed inside the preparation enclosure. The preparation of units shall be completed before shutdown.
- Test/service mode – The user/technician is able to individually test each operational system module.

Performance and Timing:
- The maximum time permitted from piercing the first vial used to compound a unit and placing that unit into a refrigerator shall be 4 Hours. (Not applicable to products requiring room temperature storage)
- Average batch size (after patient-specific prescription) is typically 10 units.
- The system is capable of preparing 20 – 30 patient-specific unit doses per hour, depending on the complexity and number of preparation steps required.
- The system design shall enable a continuous flow of product throughput.
- The number of vial punctures with the same needle shall be controlled.
- The system uses the entire contents of a source container before the next one is used.
- The system shall differentiate between single use and multi-use source containers.

Safety and Security:
- It contains appropriate hardware interlocks to maintain the integrity of the preparation enclosure.
- The system does not allow access to the preparation enclosure while the hardware is operational.
- An emergency stop capability is provided.
- The system software is password protected.
- Access to various functions within the software is controlled by user-level profiles.

Failure and Constraints:
- The system allows the operator to safely unload the machine in case of hardware or software failure.
- If volumetric limits are exceeded the system shall alert the operator