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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
- 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
© 2006 Health Robotics. All rights reserved.
