Personal Protection #
When operating the compounder, wear personal protection gear according to the facility’s
regulations. Protective gear can include: gloves, facemask, gown, or any other required gear.
Make sure the EQUASHIELD® Pro is cleaned and cleared; that no vials, Syringe units, IV bags, or any other equipment is left in the compounder.
The facility and operator are required to follow all instructions for use, maintenance, and calibration
requirements as per the EQUASHIELD® Pro User Manual and Service Manual. Responsibility falls on
the facility if the manufacturer’s recommendations and requirements are not met.
Shock Hazard #
- Residual voltage exists when power is removed.
- Do not remove from plug for one minute after removing power.
EQUASHIELD® CSTD #
Load the EQUASHIELD® CSTD into the EQUASHIELD® Pro according to the recommended process.
- The EQUASHIELD® CSTD should be taken out of its sterile blister only inside the compounder’s cabinet, to ensure an ISO 5 clean environment and to maintain its state of cleanliness. Make sure to work above the table, do not work above open areas like the air grills.
- Before loading the CSTD, make sure it is not damaged. Do not use the CSTD if the package is damaged.
- Before loading an EQUASHIELD® syringe unit, make sure its piston is closed and that the blister was initially intact.
- Ensure the EQUASHIELD® vial adaptor is pressed all the way onto the drug vial, ensuring a tight, sealed connection with the vial.
- Ensure that the entire length of the spike of the EQUASHIELD® spike adaptor is inserted into the IV bag spike port.
Note that syringe units should be removed from the EQUASHIELD® Pro at the end of the shift or day. User should check the entire compounder for syringes, including the syringe unit conveyor, robot pumps, preparation stations, and reconstitution robot.
Drug Vial Handling #
- It is the operator’s responsibility to load the system with drugs that are valid (not expired). The system records the vial’s expiration date, but it does not control it.
- Make sure the vial label is clean and complete.
- Re-using drug vials: The system can receive drug vials that are partially used.
- When re-using a vial, wipe the Vial Adaptor’s rubber septum with sterile 70% isopropyl alcohol Prep pad, upon loading it into the system.
- Do not load drug vials that were reconstituted outside the system.
- Do not load vials that contain less than 2ml of drug.
Safety Systems and Emergency Stops #
The compounder is equipped with a safety system, to protect the operator from mechanical harm. However, the system’s safety (emergency) stops are abrupt, and can cause a waste of drug and a waste of time in the recovery process.
Therefore, it is advisable to avoid safety stops, except in emergency situations.
- Emergency Stop Button: The Emergency Stop Button stops all the system’s mechanical actuators. After pressing the Emergency Stop Button, the system needs to be shut down and cleared of all its content (vials, syringe units, IV bags etc.). All prescriptions that were being processed in the compounder will receive a ‘Failed’ sticker and should not be used.
- Protection (glass) wall and Upper Light Sensor: these protect the operator from the moving parts in the upper (open) compartment of the system. Removing a safety wall or interfering with the Upper Light Sensor during operation will have the same results as pressing the Emergency Stop Button.
- Vial Insertion Light Sensor: during operation, the Vial Insertion Light Sensor will stop the Vial Robot upon interference. Do not place your hands or any other object to the vial insertion area unless you have permission from the system given through a message on the Touchscreen.
- Syringe Insertion Light Sensor: during operation, the Syringe Insertion Light Sensor will stop the
Syringe Magazine upon interference. Do not open the Syringe Insertion Door unless you have permission from the system given through a message on the Touchscreen.
Cabinet Front Window #
The cabinet is designed to operate with the front window opened to a maximum of 250mm.
- Do not open the window above this height during the compounder’s operation.
- The window may be opened above the 250mm height for cleaning or maintenance purposes.
Lower the glass window to the correct position as soon as the cleaning/maintenance procedure is completed.
Cabinets Doors #
The cabinet doors are the stainless steel doors located below the working area.
The doors are protected by a safety interlock. If the doors are open, the compounding process cannot be performed. Opening the doors interferes with the air flow regime of the cabinet.
Open the doors only when necessary, for maintenance, cleaning, or waste bin replacement.
Close the doors as soon as the procedure is done.