Patent Description:
Reference to background art herein is not to be construed as an admission that such art constitutes common general knowledge in Australia or elsewhere.

Medical devices are associated with a definitive risk of bacterial and fungal infections. To reduce the risk of infections, some medical devices are extensively cleaned after each use. For example, medical scopes such as endoscopes are normally washed and reused after each use as they are expensive to manufacture and hence to purchase.

Whilst cleaning medical scopes assist in reducing the risk of infection, determining whether the medical device has been adequately cleaned is difficult. A visual inspection gives a general indication that the medical device has been cleaned. However, internal components of the medical device may still be soiled.

Furthermore, ensuring that the internals of the medical device are dried within a predetermined time is a difficult task. As would be appreciated, failing to dry the medical device within a predetermined time may increase the risk of infection.

<CIT>) discloses a cleansing device and method for tubular-shaft and hollow surgical instruments. The device has a holder (<NUM>) for cleaning liquid and instruments (<NUM>), first and second pressure connections (<NUM>,<NUM>) for connection to instruments, a channel selector (<NUM>) and manifold, a flowmeter (<NUM>), a pressure device (<NUM>) and a main channel (<NUM>) from the manifold to the pressure device. The channel selector opens one channel while closing the others and pressure can be passed through one instrument under pressure while the flow through it is measured by the flowmeter.

<CIT>) discloses a sterilizing unit for a medical appliance. The sterilizing unit includes a sterilizing substance generator and a mechanism part. The mechanism part includes an air flow forming device. When a suction tube connected to the air flow forming device is connected to the tip of the tubular part of the endoscope and the sterilizing unit is driven, air including negative ions generated by the sterilizing substance generator is made to pass through the tubular part to sterilize and dry the inside of the tubular part.

It is an aim of this invention to provide a sanitary monitoring system and method of use which overcomes or ameliorates one or more of the disadvantages or problems described above, or which at least provides a useful alternative.

Other preferred objects of the present invention will become apparent from the following description.

The present invention provides a sanitary monitoring system in accordance with claim <NUM>.

Preferably, the medical device is in the form of a scope. Typically, the medical device is in the form of a flexible scope or a rigid scope. Normally, the medical device is an endoscope, gastroscope, bronchoscope, duodenoscope, enterscope, ultrasound scope, toe probe, truss probe, Brachy probe and/or ENT flexible or rigid scope.

Normally, the medical device includes one or more ports to be respectively connected to the one or more conduits. Preferably, the one or more conduits include a releasable coupling to connect to the one or more ports. Typically, the one or more conduits include a valve that allows fluid flow when the one or more ports are connected thereto. Preferably, the one or more conduits are approximately <NUM> in diameter. Preferably, the diameter of the one or more conduits is used to restrict flow therethrough.

Preferably, the hollow member includes an inner hollow member and an outer hollow member.

Preferably, the hollow member is configured to support the medical device in a storage position. Normally, the hollow member includes at least one hanger thereon to support the medical device. Preferably, the at least one hanger is configured to rotate about the hollow member.

Typically, the one or more conduits are connected to an upper portion of the hollow member and/or a lower portion of the hollow member.

According to the present invention, the one or more measurement devices are connected to the one or more conduits. Typically, the one or more measurement devices are connected downstream of the one or more ports. According to the present invention, one of the one or more measurement devices are connected to the hollow member.

According to the present invention, the one or more measurement devices are in communication with the status device.

Normally, the one or more measurement devices are in the form of pressure sensors.

The one or more measurement devices assist in determining the one or more flow rates associated with the medical device by communicating one or more pressures to the status device.

The one or more measurement devices assist in determining the one or more flow rates associated with the medical device by:.

Preferably, the status device is configured to receive information associated with the medical device. Normally, the status device is configured to receive information associated with the medical device from a tag. Normally, the tag is a radio frequency identification (RFID) tag. Preferably, the RFID is active and includes its own power source. Alternatively, the RFID tag is passive and requires a power signal to operate.

Typically, the information associated with the medical device includes information relating to the one or more ports. Preferably, the information relating to the one or more ports includes a total number of ports. Normally, the information relating to the one or more ports includes a number of upper ports and a number of lower ports. Preferably, the upper ports are associated with a top handpiece of the medical device and the lower ports are associated with an umbilical cable.

Typically, the information associated with the medical device includes one or more aperture sizes. Preferably, the one or more aperture sizes relate to the one or more ports of the medical device. That is, preferably the information from the tag contains information relating to the size of each port in the medical device. Normally, the aperture size corresponds to an aperture size of the one or more conduits.

Preferably, the status device is configured to determine the one or more flow rates associated with the medical device based on the aperture size and a pressure difference. Normally, the pressure difference is between the one or more pressures from the one or more conduits and the one or more pressures from the hollow member.

Typically, the status device is configured to retrieve a minimum flow rate. Preferably, the minimum flow rate is associated with the medical device and/or the one or more conduits. Normally, the status device retrieves the minimum flow rate from the tag.

Preferably, the status device is configured to determine the sanitary condition of the medical device by comparing the minimum flow rate with the one or more flow rates. For example, in response to a flow rate within the one or more conduits being determined as lower than the minimum flow rate associated therewith, the status device determines that the medical device is soiled or alike (e.g. partially connected).

Typically, the status device is configured to determine the sanitary condition of the medical device by establishing whether the minimum flow rate associated with the medical device has been reached over a period of time. Reaching a minimum flow rate over a period of time accounts for a predetermined drying time.

Normally, the status device is configured to determine the sanitary condition of the medical device by establishing whether a port of the medical device is not connected to the one or more conduits. Typically, the status device determines when a port of the medical device is not connected to the one or more conduits by comparing the total number of ports to the one or more flow rates associated with the medical device.

For example, in response to receiving three flow rates associated with the medical device that has a total number of four ports, the status device is configured to determine that one port of the medical device is not connected.

Preferably, the status device is configured to determine the location of the port not connected to the one or more conduits. Typically, the status device determines the location of the port not connected to the one or more conduits by comparing the number of upper and lower ports with the one or more flow rates associated therewith. For example, if the medical device has three upper connections and two lower connections but there is only one flow rate from a lower connection, it can be substantially determine that a lower port is not connected to the one or more conduits.

Preferably, the status device is configured to determine the sanitary condition of the medical device by establishing whether a port of the medical device has been connected to a wrong conduit of the one or more conduits. Normally, the status device determines when the port of the medical device has been connected to wrong conduit of the one or more conduits based on the number of the ports, the location of the ports and/or the one or more flow rates.

Typically, the status device is configured to assist in alerting an operator that that sanitary condition of the medical device is unsatisfactory (i.e. in an unsanitary condition). Preferably, the status device is configured to assist in alerting an operator that the one or more conduits is not connected to the one or more ports and/or is connected to the wrong port. Normally, the status device is configured to indicate the location of the unconnected port(s) and/or wrongly connected port(s).

In another form the invention resides in a method for sanitary monitoring in accordance with claim <NUM>.

Preferably, the step of connecting the medical device to the one or more conduits includes connecting one or more ports of the medical device to the one or more conduits.

Normally, the step of connecting the one or more ports of the medical device to the one or more conduits includes:.

Preferably, the step of determining the one or more flow rates associated with the medical device from a fluid flow provided through the one or more conduits includes measuring one or more pressures along the one or more conduits.

Typically, the step of determining the one or more flow rates associated with the medical device from a fluid flow provided through the one or more conduits includes measuring one or more pressures along the hollow member.

Preferably, the step of determining the one or more flow rates associated with the medical device includes defining a pressure difference. Normally, the pressure difference is between the one or more pressures along the one or more conduits and the one or more pressures along the hollow member.

Typically, the step of determining the one or more flow rates associated with the medical device includes retrieving one or more aperture sizes. Preferably, the one or more apertures sizes are related to the one or more ports.

Preferably, the step of determining the one or more flow rates associated with the medical device includes calculating the one or more flow rates based on the aperture size and the pressure difference.

Normally, the step of determining the sanitary condition from the one or more flow rates includes comparing the one or more flow rates with an associated minimum flow rate. Typically, the minimum flow rate is related to aperture size of the one or more ports. Preferably, the minimum flow rate allows a channel within the medical device to dry within a predetermined amount of time. Preferably, the minimum flow rate indicates that a channel within the medical device is clean.

Preferably, the step of determining the sanitary condition includes detecting whether one or more of the conduits are not connected to the one or more ports.

Normally, the step of detecting whether one or more of the conduits are not connected to the one or more ports includes:.

Preferably, in response to detecting an unconnected port, the method further includes determining the location of the unconnected port. Typically, the step of determining the location of the unconnected port includes:.

Preferably, the step of determining whether the sanitary condition of the medical device from the one or more flow rates includes determining when the port of the medical device has been connected to wrong conduit of the one or more conduits based on the number of the ports, the location of the ports and/or the one or more flow rates.

Normally, the method further includes indicating that the medical device is unsanitary. Preferably, the method further includes indicating that a port is unconnected, partially connected and/or not connected to the correct conduit. Typically, the method further includes indicating the location of the unconnected port and/or wrongly connected port.

Further features and advantages of the present invention will become apparent from the following detailed description.

By way of example only, preferred embodiments of the invention will be described more fully hereinafter with reference to the accompanying figures, wherein:.

<FIG> illustrates a sanitary monitoring system 1a according to an embodiment of the invention. The sanitary monitoring system 1a includes a medical device in the form of a scope <NUM>, a tag <NUM>, conduits <NUM> located in a medical container 100a, measurement devices <NUM> and a status device <NUM>.

At the outset, it is noted that in this disclosure the use of a reference numeral followed by a lower case letter indicates alternative embodiments of a general element identified by the reference numeral. Thus for example an upper conduit 110a is similar to but not identical to a lower conduit 110c. Further, references to an element identified only by the numeral refer to all embodiments of that element. Thus for example a reference to conduits <NUM> is intended to include both the upper conduit 110a and the lower conduit 110c.

The scope <NUM> includes an upper portion in the form of handpiece <NUM> and a lower portion in the form of umbilical cable <NUM>. The handpiece <NUM> includes two upper ports <NUM> and the umbilical cable <NUM> includes a lower port <NUM>. As would be appreciated, the upper and lower ports <NUM>, <NUM> are connected to channels that extend along the internals of the scope <NUM>.

The tag <NUM> is attached to the scope <NUM>. The tag <NUM> is in the form of an active radio frequency identification (RFID) tag in this embodiment. However, it would be appreciated that the tag <NUM> may be passive and require a power signal from a reader device to operate. The tag <NUM> is configured to store and process information along with transferring and receiving information. In this embodiment, the tag <NUM> stores and transfers information relating to the aperture size of the ports <NUM>,<NUM>, the number of ports <NUM>, <NUM>, the location of the ports <NUM>, <NUM> and minimum flow rates associated with the scope <NUM>. The minimum flow rates associated with the scope <NUM> relate to minimum air flow rates required through the channels within the scope <NUM> to ensure that the channels are not soiled (i.e. blocked) and can dry within a predetermined time.

The conduits <NUM> in this embodiment include upper conduits 110a, 110b and lower conduit 110c. The upper conduits 110a, 110b are configured to be connected to the upper ports <NUM>. The lower conduit 110c is configured to be connected to the lower port <NUM>. The conduits <NUM> are connected to a hollow member 120a inside the medical container 100a. The hollow member 120a also provides storage support for the scope <NUM>. In particular, connected to the hollow member 120a is a rotatable hanger 130a that provides storage support to the scope <NUM>.

The medical container 100a also includes pumps 140a. The pumps 140a work in conjunction such that a vacuum is created in the medical container 100a whereby air is i) drawn into the channels of the scope <NUM>; ii) flows through the ports <NUM>, <NUM>; iii) flows through the conduits <NUM>; and iv) then flows through the hollow member 120a.

The measurement devices <NUM> in this embodiment are in the form of pressure sensors. Measurement devices 200a, 200b are connected to upper conduits 110a, 110b, respectively. Measurement device 200c is connected to lower conduit 110c. Further measurement device 110d is connected downstream of the measurement devices 110a, 110b, 110c to the hollow member 120a.

The status device <NUM> is located on the hanger 130a in the medical container 100a such that when the scope <NUM> is connected to the hanger 130a, the status device <NUM> is in communication with the tag <NUM>. Further to the above, the status device <NUM> is configured to retrieve information from the tag <NUM> relating to the aperture size of the ports <NUM>,<NUM>, the number of ports <NUM>, <NUM>, the location of the ports <NUM>, <NUM> and the minimum flow rates associated with the scope <NUM> (i.e. minimum flow rates through the channels, ports <NUM>, <NUM> and/or conduits <NUM>).

The status device <NUM> is also in communication with the measurement devices <NUM>. That is, pressures measured by the measurement devices <NUM> are communicated to the status device <NUM>. Furthermore, the status device <NUM> is configured to allocate the measurement devices <NUM> to a location. For example, the status device <NUM> may allocate the measurement devices 200a, 200b at an upper location and the measurement device 200c as a lower location.

The status device <NUM> is configured to determine flow rates associated with the scope <NUM> in this embodiment. That is, from pressures received from the measurement devices <NUM>, the status device <NUM> is configured to calculate flow rates associated with the conduits <NUM> using the aperture sizes of each related port <NUM>,<NUM>.

In particular, the status device <NUM> is configured to define respective pressure differences between each measurement device 200a, 200b, 200c, connected to the conduits <NUM>, and the measurement device 200d, connected to the hollow member <NUM>. From these respective pressure differences, the status device <NUM> is configured to calculate the flow rates in each conduit <NUM> using the respective aperture sizes of the ports <NUM>, <NUM> retrieved from the tag <NUM>. As would be appreciated, the flow rates in each conduit <NUM> have an association with the flow rates through each related port <NUM>, <NUM> and channels connected thereto.

From the flow rates associated with the scope <NUM> (i.e. the flow rates through the conduits <NUM>), the status device <NUM> is configured to determine whether the channels within the scope <NUM> are soiled, whether a conduit <NUM> is not connected or is partially connected to one of the ports <NUM>, <NUM> and/or whether one of the conduits <NUM> have been connected to an incorrect port <NUM>, <NUM>. As would be appreciated, all of the above situations are indications that the scope <NUM> is in a sanitary condition that is unsatisfactory (i.e. an unsanitary condition).

In order to determine whether a conduit <NUM> is not connected to the ports <NUM>, <NUM>, the status device <NUM> is configured to compare the information relating to the number of ports <NUM>, <NUM> and the measurements of the measurement devices <NUM>. This is outlined further below. In addition, the status device <NUM> is configured to determine a location of the unconnected port <NUM>,<NUM> from the measurements of the measurement devices <NUM>. This again is outlined further below.

With regards to determining whether the scope <NUM> is soiled or unsoiled (i.e. the sanitary condition), the status device <NUM> is configured to compare the flow rates associated with scope <NUM> and the minimum flow rates associated therewith from the tag <NUM>. If the flow rates associated with the scope <NUM> are below the minimum flow rates associated therewith, this is an indication that the internal channels or ports <NUM>,<NUM> of the scope <NUM> are soiled. Alternatively, it may indicate that a further problem in the system <NUM> (e.g. there is a loose connection between the conduit 110a and port <NUM> and/or conduit 110a is connected to the wrong port <NUM>).

In the event that the status device <NUM> determines that the scope <NUM> is soiled, not connected to conduits <NUM> or incorrectly connected to the conduits <NUM>, the status device <NUM> is configured to provide an indication to a user of the associated problem (i.e. scope <NUM> is soiled, not connected, partially connected and/or incorrectly connected). Furthermore, the status device <NUM> may also give an indication of the location where the scope <NUM> is not connected to the conduits <NUM> (i.e. an upper conduit 110a, 110b or a lower conduit 110c).

In addition, the status device <NUM> may be configured to record the associated problem (i.e. scope <NUM> is soiled, not connected, partially connected and/or incorrectly connected) on the tag <NUM> such that auditing or future processes can be decided having this information. Alternatively, or additionally, data from the status device <NUM> relating to the scope <NUM> may be directed to a monitoring network. It would be appreciated that the status device <NUM> may only report associated problems to the network to minimising data packet traffic on the network.

<FIG> illustrates a section schematic view of a sanitary monitoring system 1b. The scope <NUM> is not shown in the sanitary monitoring system 1b but the sanitary monitoring system 1b is substantially similar to the sanitary monitoring system 1a. Like numbering has therefore been used between <FIG> and <FIG>. However, a notable difference between the sanitary monitoring systems 1a, 1b is the hollow member 120b.

The hollow member 120b includes an outer hollow member 122b and an inner hollow member 124b. The outer hollow member 122b is sealed at either end with the assistance of the inner hollow member 124b. The inner hollow member 124b is open to the cabinet 100b at one end.

Airflow is provided into the cabinet 100b through the inner hollow member 124b. The inner hollow member 124b is connected an outlet of a pump 140b via connector 128b. The airflow through the inner hollow member 124b is delivered to a lower portion of the cabinet 100b.

Air is withdrawn from the cabinet 100b via the outer hollow member 122b. The outer hollow member 122b is connected to an inlet of the pump 140b via connector 126b. The outer hollow member 122b is also in fluid communication with the conduits <NUM> to draw air through the scope <NUM> from the cabinet 100b.

Airflow through the inner and outer hollow members 122b, 124b is shown further in <FIG> illustrates a close up view of section E shown in <FIG>.

<FIG> outlines a method for sanitary monitoring <NUM> with reference to <FIG> and <FIG>.

At step <NUM>, an operator washes the scope <NUM>. Normally, manual washing of the scope <NUM> takes place in a number of stages and, thereafter, an automatic washing unit is used to complete cleaning of the scope <NUM>.

At step <NUM>, the operator visually inspects the scope <NUM> to determine whether any contaminants remain on the outside of the washed scope <NUM>.

At step <NUM>, after passing visual inspection, the operator loads the scope <NUM> into the medical container <NUM>. Loading the scope <NUM> into the medical container <NUM> is outlined further in <FIG>.

At step <NUM>, the operator opens a door of the medical container <NUM>. The operator may be required to swipe an identification tag to open the door of the medical container <NUM>.

Following this, at step <NUM>, the operator places the scope <NUM> on the hanger <NUM>. This supports the scope <NUM> above a floor of the medical container <NUM> such that the scope <NUM> hangs substantially in a vertical direction.

At step <NUM>, the operator connects the conduits <NUM> to the ports <NUM>, <NUM> of the scope <NUM>. That is, the operator connects the upper conduits 110a, 110b to the upper ports <NUM> and the lower conduit 110c to the lower port <NUM>.

At step <NUM>, the status device <NUM> retrieves information from the tag <NUM>. The status device <NUM> is triggered to obtain information from the tag <NUM> when they come into proximity with each other. Communication may be slightly delayed to allow adequate time for the operator to connect the conduits <NUM> to the ports <NUM>, <NUM>. The status device <NUM> obtains information from the tag <NUM> in the form of the aperture sizes of the ports <NUM>, <NUM>, the number of ports <NUM>, <NUM>, the location of the ports <NUM>, <NUM> and the minimum flow rates associated with the scope <NUM> (i.e. minimum flow through the channels,, ports <NUM>, <NUM> and/or conduits <NUM>).

At step <NUM>, the status device <NUM> calculates associated flow rates through the scope <NUM>. The associated flow rates through the scope <NUM> in this embodiment are calculated through each of the conduits <NUM>. As would be appreciated, the flow through the conduits <NUM> is substantially the same as through the respective channels and ports <NUM>, <NUM> of the scope <NUM>.

With the above in mind, to calculate the flow rate through each conduit 110a, 110b, 110c the status device <NUM> defines a pressure difference between each of the measurement devices 200a, 200b, 200c and the measurement device 200d connected to the hollow member <NUM>. As would be appreciated by a person skilled in the art, the pressure difference between each measurement devices 200a, 200b, 200c and the measurement device 200d is indicative of the dynamic pressure in each conduit 110a, 110b, 110c.

In this regard, as the aperture size (i.e. diameter) of the conduits <NUM> is substantially the same as the aperture size (i.e. diameter) of each port <NUM>, <NUM>, retrieved from the tag <NUM>, the status device <NUM> is then configured to calculate the flow rate through each conduit 110a, 110b, 110c based on the pressure differences above and the aperture size of each port <NUM>, <NUM>.

At step <NUM>, the status device <NUM> compares the flow rate through each conduit 110a, 110b, 110c with the minimum flow rates retrieved from the tag <NUM>. The minimum flow rates are specific to each conduit 110a, 110b, 110c.

At step 1700a, in response to the status device <NUM> determining that the flow rate through each conduit 110a, 110b, 110c is higher than the minimum flow rate associated therewith, the status device <NUM> is configured to indicate that the flow through each conduit 110a, 110b, 110c (or each channel in the scope <NUM>) is adequate. Having an adequate flow through each conduit 110a, 110b, 110c is indicative of the internals of the scope <NUM> being adequately sanitised. Furthermore, having an adequate flow through each conduit 110a, 110b, 110c substantially ensures that the internals of the scope <NUM> are dried within a predetermined time.

At step 1700b, in response to the status device <NUM> determining that the flow rate through one or more of the conduits 110a, 110b, 110c is lower than the minimum flow rate associated therewith, the status device <NUM> is configured to indicate that the flow through the specific conduit(s) 110a, 110b, 110c (or their related channel in the scope <NUM>) is inadequate. Having an inadequate flow through one or more conduits 110a, 110b, 110c is indicative of the internals of the scope <NUM> being inadequately sanitised, one or more of the ports <NUM>, <NUM> of the scope <NUM> not being adequately connected to the conduits <NUM> and/or one or more of the ports <NUM>, <NUM> being connected to the wrong conduit <NUM>.

At step 1700c, in response to the status device <NUM> receiving one or more measurements from the flow devices <NUM> that is less than the total number of ports <NUM>, <NUM>, the status device <NUM> is configured to indicate that one or more of the conduits <NUM> are not connected to the ports <NUM>, <NUM>. Furthermore, by comparing the location of the ports <NUM>, <NUM> with the location of flow devices <NUM> not receiving a change in measurement, the status device <NUM> may also determine and indicate the location of the unconnected port <NUM>, <NUM>,.

Moreover, in view of the above, it would be appreciated that there may be alternation between the steps 1700a, 1700b and 1700c. For example, upon detecting that the one or more of the conduits <NUM> are not connected to the ports <NUM>, <NUM> at step 1700c, the operator may connect the conduit <NUM> to one of the ports <NUM>, <NUM>. Upon connecting the port <NUM>, <NUM>, the status device <NUM> may then indicate that the scope <NUM> is unsanitary at step 1700b, after proceeding through steps <NUM>, <NUM> again, and provide an indication that the scope <NUM> needs to be re-cleaned.

Furthermore, it would be appreciated that the status device <NUM> may indicate steps 1700a, 1700b and/or 1700c through a network to a user. It may also record information relating to steps 1700a, 1700b and/or 1700c on the tag <NUM> for auditing and/or determining whether the scope <NUM> is fit for use in a further process.

The sanitary monitoring system <NUM> and method <NUM> monitor that each conduit <NUM> is correctly connected, is connected in the correct location and has correct airflow. This is achieved by, for example, the programming of the tag <NUM> to include characteristics of each scope <NUM> and the flow devices <NUM> providing indications of flow (i.e. pressure) to the status device <NUM>.

The sanitary monitoring system <NUM> and method <NUM> therefore substantially ensure that i) the flow rate of air through each channel in the scope <NUM> is such that a drying cycle within a designated time is achieved; and ii) the channels within the scope <NUM> are substantially clean. A flow rate failure or failure to connect, for example, creates an alert to the operator that the scope <NUM> may not be fit for use. This assists in reducing the risk of infection.

Moreover, the sanitary monitoring system <NUM> and method <NUM> allow processes related to the scope <NUM> to be recorded for later auditing and/or risk management assessments.

The sanitary monitoring system <NUM> and method <NUM> also reduces the amount of processing and reprocessing required for the scope <NUM>. Furthermore, the sanitary monitoring system <NUM> and method <NUM> can work with either pressure or a vacuum.

In this specification, adjectives such as first and second, left and right, top and bottom, and the like may be used solely to distinguish one element or action from another element or action without necessarily requiring or implying any actual such relationship or order. Where the context permits, reference to an integer or a component or step (or the like) is not to be interpreted as being limited to only one of that integer, component, or step, but rather could be one or more of that integer, component, or step etc..

The above description of various embodiments of the present invention is provided for purposes of description to one of ordinary skill in the related art. It is not intended to be exhaustive or to limit the invention to a single disclosed embodiment. As mentioned above, numerous alternatives and variations to the present invention will be apparent to those skilled in the art of the above teaching. Accordingly, while some alternative embodiments have been discussed specifically, other embodiments will be apparent or relatively easily developed by those of ordinary skill in the art. The invention is intended to embrace all alternatives, modifications, and variations of the present invention that have been discussed herein, and other embodiments that fall within the scope of the above described invention.

Claim 1:
A sanitary monitoring system for a medical device (<NUM>) having a plurality of ports (<NUM>, <NUM>) connected to channels that extend along the internals of the medical device, the system comprising:
a medical container (100a) having a first fluid pump (140a) configured to pump fluid into the container and a second fluid pump (140a) configured to draw air from the container into the channels of the medical device (<NUM>) via a hollow member (120a);
one or more conduits (<NUM>) configured to be connected to the medical device, said one or more conduits being connected to the hollow member (120a), said hollow member is configured to be in fluid communication with the second fluid pump;
one or more measurement devices (<NUM>) configured to assist in determining one or more flow rates of fluid drawn through the one or more conduits (<NUM>); and
a status device (<NUM>) configured to determine a sanitary condition of the medical device (<NUM>) from the one or more flow rates,
wherein in use, fluid is drawn through the medical device (<NUM>) and the one or more conduits (<NUM>) and then through the hollow member with the first and second fluid pumps working in conjunction to create a vacuum in the container, and in that
in the event that the status device (<NUM>) determines that the medical device (<NUM>) is soiled, not connected to the conduits (<NUM>), partially connected to the conduits (<NUM>) or incorrectly connected to the conduits (<NUM>), the status device is configured to provide an indication to a user of the associated problem;
characterized in that the one or more measurement devices (<NUM>) assist in determining the one or more flow rates associated with the medical device by:
communicating one or more pressures from the one or more conduits (<NUM>) to the status device; and
communicating one or more pressures from the hollow member (120a) to the status device.