A:
Height | 580 mm (22.8 in) |
Width | 890 mm (35 in) |
Depth | 390 mm (15.4 in) |
Weight | 45 Kg (99.2 lbs) |
A:
A: Yes. The machine’s design and operation was built around the EQ CSTD capabilities and features.
Using the EQ CSTD can offer many additional advantages such as:
All efficient automation will need some consumable that is uniform, because otherwise constant calibration and adjustments are needed. Might as well use a consumable that is also offering you protection against hazardous drugs.
A:
Syringe Unit Sizes 1 ml to 60 ml*
Vials Heights 20 mm to 95 mm (0.8 in to 3.7 in)
Vials Cap Diameters 13 mm and 20 mm (0.51 in and 0.79 in)
IV Bags Different types, up to 1000 ml
* Excluding EQUASHIELD® SU-EZ60/2.
A: IV bags and syringe preparations only. Will perform testing to see if we can incorporate elastomeric pumps and semi-rigid bottles in the future.
A: We should be compatible with most common consumables on the market since we interface with the CSTD mostly. However, some general ‘rules’:
Vials:
IV Bags:
A: In general, it should be able to compound any drug that can be compounded manually with EQ. However, we will have more information once we have tested real drugs in beta sites.
Some guidelines of which drug to use in Mundus Mini:
A: Yes. Note, reconstitution is a separate function from the compounding. It will not reconstitute and then compound using the same vial. It requires the operator to perform a visual inspection on the reconstituted vial prior to using in compounding.
A: Only one preparation at a time.
A: No. It can prepare individualized preparations, one at a time.
A: If there is not enough drug, the machine will recognize a huge air bubble that it can’t resolve (while attempting to withdraw drug from the vial). The air bubble that can’t be resolved is the trigger to tell the machine that the vial is empty. The machine will prompt the user to load another vial of the same drug. Once another vial is loaded, the compounding will continue and finish compounding the prescription.
A: Yes – Only from the same drug and strength. During initial loading, you can load 2 vials. The machine will prompt you to load subsequent vials during the compounding process if more vials are needed (until the prescription is complete).
A: The 3 stations allow for flexibility in different circumstances. Some options:
A: All the data relevant to the compounding. It will also include high-resolution photos of drug vial / IV bag labels and filled syringe unit that were taken as part of compounding process.
A: There is no printer in the Mundus Mini. The prescription labels will be supplied by the facility. The only requirement from the Mundus Mini is that it has the prescription info embedded within a QR code. Many EMR systems have this already. If this is not available at your facility, we will assist with getting this.
A: No (or minimally). We designed the machine to fit into your existing workflow. You will continue with your same workflow as prior, with the added benefits of what the Mundus Mini has to offer (dose accuracy, vial and iv bag verification, reduced stress injuries, documentation etc.).
A: Yes. (The training should have documentation that is maintained by the facility.) However, training requires minimal time and resources. Since the machine is so intuitive and user friendly, the training process will be relatively simplified.
The user interface was designed to be used with people of all ages and comfort levels with technology. Most new users feel comfortable with the machine in a matter of minutes/hours (compared to days/weeks).
Equashield will have a lot of training resources available such as the user manual, ‘how to’ videos, placards, and more.
A: 1 year warrantee, will have multiple tiered service plans ranging from basic coverage to more extensive service.
Note that the service should be minimal, with easy to replace parts.
Also, hope to implement machine health monitoring in the future that will essentially monitor the machine and identify any potential for malfunction before it happens.
A: No calibration needed. An automatic self-calibration will happen after each login and/or restart.
A: Relatively simple compared to standard automation.
A: We don’t connect to the hospital EMR, we connect to a third-party called Intersystems. Intersystems works with 80% of the EMRs in Europe.
A: We provide the relevant data to Intersystems. It depends on the hospital’s EMR on what data they are able to receive in return.
A: The supervisor or anyone who is not the operator can see the compounding report after the compounding is completed. The decision was made not to require external verification as it delays the throughput.
A: The software complies with all regulatory requirements regarding protection of sensitive data (such as: HIPPA, GDPR)
Also, no data is stored on the Mundus Mini. All data will be sent to the hospital server to be managed by the facility.
The Mundus Mini HD complies with the following standards:
· ISO 13485 Medical Devices – Quality management systems – Requirements for regulatory purposes.
· US FDA 21 CFR Part 820 Quality System Regulation.
· EU Machinery Directive 2006/42/EC.
· EU Low Voltage Directive (LVD) 2014/35/EU.
· EU Electromagnetic Compatibility (EMC) Directive 2014/30/EU.
· EN ISO 14971 Medical devices – Application of risk management to medical devices.
· EN 62304 Medical device software – Software life-cycle processes.
· EN 60601-1 Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.
· EN 60601-1-2 Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and tests.
· EN IEC 61326-1 Electrical equipment for measurement, control and laboratory use – EMC requirements – Part 1: General requirements.
· CE mark meeting the applicable European Community EC directives.
A: Mundus Mini meet ISO:13485 guidelines.
A: The Mundus mini’s accuracy verification process relies mainly on image processing, which is done by capturing key stages in the drug preparation process and identifying them with image recognition algorithms, as part of the devices’ software.
All the processes executed in the device are controlled by cameras that are installed in the device combined with unique, custom-made, image processing algorithms. The image processing functions allow rapid feedback control over delicate and critical processes during the drug preparation process.
In addition, the accuracy of the device is being validated. The volumetric accuracy is compared to gravimetric accuracy by weighing filled / empty syringe units. The validation is performed with different types and shades of liquids (clear, dark, aqueous, and viscous).
A: No. Mundus mini operates on different technologies that use cameras and image processing algorithms.
Gravimetric validation is a slow process and can be easily influenced by external factors such as air flow, electrical pulses, etc. It also requires frequent calibration from the user which can be time consuming.
Our process is using image process algorithms that confirm dose accuracy from a pixelation standpoint. In other words, it is not reading the syringe gradients to ensure the correct dose was withdrawn. Rather, it is ensuring the amount of drug (determined by pixelation) that was captured in the image processing matches that the expected drug amount withdrawn.
Note that the methods used for dose accuracy in the Mundus Mini will be validated and compared to gravimetric accuracy.
A: ISO class 7 (Grade B/C)
A: The Mundus Mini is designed to work inside a PEC and in a cleanroom environment to maintain the sterility of the compounding process. Installing the Mundus Mini outside of the cleanroom will compromise the sterility of the preparation.
A: Currently, 0.3ml is the smallest dose.
A: Yes. Safety is the highest consideration. We comply with all the regulations regarding machinery, safety, electricity, etc.
There is also an ‘emergency stop’ button that stops all movement if needed.
