WO2008026004A2

WO2008026004A2 - A medical device

Info

Publication number: WO2008026004A2
Application number: PCT/GB2007/050505
Authority: WO
Inventors: Elizabeth Paul
Original assignee: Medaro Medical Limited
Priority date: 2006-08-31
Filing date: 2007-08-23
Publication date: 2008-03-06
Also published as: WO2008026004A3

Abstract

The invention relates to a medical device (2) for indicating the presence of a septicaemic rash, the medical device (2) comprising a first section (4) and a second section (6), the first section (4) being substantially transparent and adapted to be placed against a body, the second section (6) being substantially opaque and located on a periphery of the first section (4).

Description

A Medical Device

The invention relates to a medical device. Particularly, but not exclusively, the invention relates to a medical device for indicating the presence of a septicaemic rash.

The invention further relates to a medical device incorporating audible communication means. In particular, the invention relates to a medical device for indicating the presence of a septicaemic rash, the device incorporating audible communication means.

The accurate use of a medical device is dependent on the capability of the person using the device. In a hospital environment, or similar, the user is often trained to operate the device and to interpret the results generated therefrom. However, outside of the hospital environment, such training is generally not given and the user must first read a set of instructions, in order to understand how to operate the device, prior to use.

There are a number of different medical devices, and procedures, for diagnosis and treatment of various conditions. When and how to use these devices or procedures, and how to interpret the results, is generally not obvious to the layman, for example, a member of the public. Failure to use said devices properly can, at the very least, render the device useless and, in many cases, can be dangerous to either the operator and/or the patient .

Disadvantageously, when such devices are for use by a member of the public, it is common for a person to only look at the instructions at the time when the device is urgently needed. Consequently, there may be a delay in using the device while the person reads the instructions. Such a delay may have serious consequences to the patient.

Furthermore, there is an associated risk that the person will not be able to read the instructions, for example, due to physical impairment (e.g. blindness), lack of light, or that it may be essential to maintain immediate visual contact with the patient.

Many devices require a person to use both hands to operate the device. Commonly, such devices comprise a separate housing and body; the housing for storing at least the body and other component parts. Disadvantageously, the instructions are either fixed to the housing of the device, which is generally away from the body in use, or the instructions are in booklet form, and the person is unable to turn pages or to hold the instructions. Further, it may be difficult to position the instructions where they can be easily read.

An example of a medical condition which the general public are advised to be aware of and to be able to self-diagnose is septicaemia, often associated with meningitis. Septicaemia is the term given to blood poisoning. Septicaemia can be caused by many types of bacteria but is most commonly associated with meningococcal bacteria which multiply in the blood stream to release toxins which damage blood vessels, tissues and organs. Meningococcal septicaemia can present alone, or in combination with meningitis, which is the inflammation of the lining around the brain and spinal cord. Symptoms of septicaemia include a rash which may occur locally on any part of the body. The rash comprises red or purple spots that do not fade when pressure is applied to them. This type of rash is often referred to as a non- blanching rash.

Early detection of septicaemia is crucial because the disease is life threatening. It is therefore important that a person is able to readily recognise the symptoms of the disease. A commonly used test for detecting the presence of a septicaemic rash is known as the "Tumbler Test". The general public are advised to carry out this test and reach a diagnosis. The test consists of pressing a glass tumbler firmly against the rash. If the spots can be seen through the glass and do not fade, it is likely the patient has septicaemia.

A particular problem with the "Tumbler Test" is that the user is often a medically unqualified person. Therefore, there is a risk that the test is not being carried out correctly and/or the result of the test is not being correctly interpreted.

Further disadvantageously, the "Tumbler Test" is dependent upon a person having access to a glass tumbler. This is likely to be problematic if away from the home. Further, the test relies on the person being able to hold the tumbler on the skin and apply a downwards force. This is particularly difficult for elderly people who may not have the required strength or dexterity to carry out the test. It is an object of the invention to provide a medical device which is simple to use with minimal user intervention. It is a further object of the present invention to provide a medical device for testing the presence of a septicaemic rash.

According to an aspect of the present invention there is provided a medical device for indicating the presence of a septicaemic rash, the medical device comprising a first section and a second section, the first section being substantially transparent and adapted to be placed against a body, the second section being substantially opaque and located on a periphery of the first section.

Preferably, the second section is located along a first edge of the first section. Preferably, the first edge is perpendicular to a longitudinal axis of the device. Preferably, an edge portion of the second section is fixedly attached to the first edge of the first section, preferably along substantially the entire length of the first edge. Preferably, the first section and the second section form a one piece unit.

The second section may surround the first section. The second section may substantially surround the perimeter of the first section.

Advantageously, the configuration of the medical device enables a wide range of people with varying abilities to test for a septicaemic rash. Particularly, the device can be readily handled by the elderly whom might otherwise not be able to pick up a tumbler, which is a prior art device used for testing. Preferably, the medical device is substantially lozenge shaped. Preferably, the medical device comprises parallel sides. Preferably, the medical device comprises curved edges. Preferably, the first section curves upwardly, preferably the second section curves upwardly.

Preferably, the first section and the second section curve upwardly in the same direction. Preferably, the first section and the second section are substantially concave in shape.

Preferably, substantially half of the medical device comprises the first section and substantially half of said device comprises the second section. Preferably, substantially half of said device is opaque and substantially half of said device is transparent. Preferably, the first section has substantially the same peripheral shape as the second section.

The first section and the second section may be substantially convex in shape. The first section and/or the second section comprises a concave face and convex face, and may be square in plan view. The first and/or second section may be substantially rectangular in shape, or may be square in shape.

Preferably, the medical device comprises a cap, preferably comprising at least one curved end. Preferably, the cap is dimensioned to be received by the first section or the second section. Preferably, the cap is located on the first section when the medical device is not in use. Preferably, the cap is located on the second section when the medical device is in use. The cap may cover both the first section and the second section simultaneously.

Preferably, the cap comprises at least one cut-out. Preferably, said cut-out is located on an upper face of the cap. Two cut-outs mat be provided, preferably being opposite to each other, preferably one cut-one is located on an upper face of the cap and the other cut-out is located on a lower face of the cap.

Preferably, the or each cut-out is adapted to receive a gripping portion located on the medical device. Preferably, the gripping portion is located on the body of the medical device. Preferably, the gripping portion is located on both the first and the second sections, preferably being located centrally of said first and second sections. Preferably, the gripping portion is substantially oval in shape. Preferably, the gripping portion comprises a plurality of upstanding members. Preferably, at least a part of the gripping portion is received in the cut-out on the cap. Preferably, said part comprises substantially half of the total surface area of the gripping portion.

Provision of the cap ensures that the first section remains covered when the device is not in use. Advantageously, the cap provides protection against the first section, which is preferably transparent, becoming scratched or damaged.

Advantageously, the gripping portion allows a user to grip on the upstanding members in order to gain leverage on said portion, to push the cap and the body of the medical device apart.

Preferably, the cut-out is dimensioned to receive the gripping portion from either the direction of the first section or the second section. In so doing, the cap may be removed from the first section and placed onto the second section. When the cap is placed on the second section, the cap provides additional support to the second section, thereby minimising the risk of the second section being moving away, or breaking apart from the first section .

In an aspect of the invention, the first section is located centrally of the second section. The first section may be substantially rectangular in shape and may comprise a first pair of sides of equal length, and a second pair of sides of equal length. The first pair of sides may be substantially between 2cm and 20cm in length, preferably substantially between 3cm and 10cm, most preferably substantially 6cm in length. The second pair of sides may be substantially between 2cm and 10cm in length, preferably substantially between 2cm and 5cm, most preferably substantially 4cm in length. The first section may have a cross sectional area of substantially 24cm².

The medical device may be substantially square in shape wherein the first section has sides of equal length, preferably each side being substantially between 2cm and 10cm, preferably substantially between 2cm and 5cm, most preferably 3cm. Preferably, the first section has a cross sectional area of substantially 9cm². Preferably, the second section is adapted to be placed against the body. Preferably, the second section is substantially partially elliptical in shape. The second section may be substantially rectangular in shape. Preferably, the second section comprises a first pair of side of equal length, and a second pair of sides of equal length. Preferably, the first pair of sides are substantially between 5cm and 25cm in length, preferably substantially between 12cm and 16cm in length. Preferably, the second pair of sides is substantially between 3cm and 14cm in length, preferably substantially between 3cm and 7cm, most preferably substantially 4cm in length .

The medical device may be substantially square in shape having sides of equal length. Preferably, each side is substantially between 4cm and 20cm. Preferably, when each side of the first section is substantially 3cm in length, each side of the second section is substantially between 5cm and 9cm, preferably substantially 7cm.

Preferably, the first section has a thickness of substantially less than 0.5cm, preferably substantially less than 0.3cm. Preferably the first section has a thickness of 0.2cm.

Preferably, the first section comprises a polymeric material. Preferably, the polymeric material is Perspex®. Alternatively, the first section may comprise glass.

Preferably, the second section has a thickness of less than substantially 2cm, preferably less than substantially lcm, preferably less than substantially 0.5cm. Preferably, the second section has a thickness of substantially 0.3cm. Preferably, the second section comprises a plurality of side portions, preferably four side portions. Preferably, at least two of the side portions are of equal thickness, preferably each of the four side portions are of equal thickness.

Preferably, the second section comprises a plastics material. Alternatively, the second section comprises a paper-based material.

Preferably, the first section is of substantially the same thickness as the second section.

The second section may be adapted to form a border or surround about the first section. The border may be substantially between lcm and 5cm in depth, preferably substantially between lcm and 3cm, most preferably substantially 1.5cm.

Preferably, an information area is provided on the device, preferably on the second section. The information area is adapted to provide information to a user. Preferably, in an aspect of the invention wherein the medical device is rectangular in shape, four of said areas may be provided, one each of the four side portions of the second section. Preferably, the or each information area comprises a plurality of indicia.

Preferably, a pressure sensing means is provided on the device, preferably on the second section. Preferably, the pressure sensing means is adapted to detect a change in pressure on the device. Preferably, the pressure sensing means is operable to trigger an illumination means upon detection of the change in pressure. Preferably, the illumination means is operable to cause illumination of at least a portion of the device, preferably the information area, preferably substantially all of the information area .

Advantageously, when a tester places the medical device onto an area of skin to be tested, when sufficient pressure is applied, the pressure sensing means operate to trigger the illumination means to illuminate the information area/s on the device. The information area preferably indicates a message to guide the tester whether to seek medical attention.

Preferably, a microprocessor is provided in the device. Preferably, the microprocessor is operable as a language translator, preferably to translate the information provided on the information area into tester's preferred language.

The first section may be removable from the second section. An opening may be provided in the second section through which the first section may be removed from the medical device.

In a further aspect the invention provides a method of testing for a septicaemic rash, the method comprising: a) Placing a medical device against an area of a body, the medical device comprising a first section and a second section, the first section being substantially transparent, the second section located on a periphery of the first section and being substantially opaque; b) Applying a pressure to the medical device; and c) Determining the result of the test with respect to information provided in an information area.

Preferably, the second section substantially surrounds said first section.

In a further aspect, the invention provides the medical device comprising a first section, a second section and a cap, the cap adapted to be located on the first section or the second section, wherein, in a first position, the cap is located on the first section, and in a second position the cap is located on the second section.

Preferably, in the second position, the medical device is in a testing configuration, or "in use" configuration.

Advantageously, the cap serves a dual purpose, firstly to provide a cover over either the first or second section, and secondly to provide reinforcement to the second section when the device is in the second position.

Preferably, the medical device is adapted for indicating the presence of a septicaemic rash. Preferably, the first section is substantially transparent, preferably being adapted to be placed against the body. Preferably, the second section is substantially opaque. Preferably, the second section is located on the periphery of the first section . In a further aspect, the invention provides a handheld medical device incorporating means for producing an audible instruction to the user.

Preferably, the medical device is adapted to indicate the presence of a septicaemic rash. Preferably, electronic means are provided for producing the audible instruction to the user.

Preferably, the medical device further comprises means for producing a visual instruction to the user. Preferably, the visual instruction may be written text or images.

Preferably, the audible instruction is configured to inform the user of when to use the device. Preferably, the audible instruction further informs the user of how to use the device.

Preferably, the medical device comprises a memory device adapted for storing spoken instructions. Preferably, the medical device further comprises an audio output device, preferably a loudspeaker; preferably a control mechanism; preferably, a micro-controller adapted for controlling the apparatus; preferably means of converting a stored representation of audio wave-form into a signal needed to drive the audio output device. Preferably, one or more sensors are provided on the medical device and are adapted to determine when a or which specific type of message is produced. The audio content may be stored as a digitised, or preferably compressed signal. Alternatively, analogue means of storing the representation of the audio signal may be used. Preferably, the medical device is powered by a battery source. Preferably, the battery source is electrically isolated from the circuitry of the device when the device is not in use. Preferably, the battery source is adapted to operate when the medical device is in contact with the body of the patient.

Alternatively, the medical device is operable to produce the audible instruction substantially immediately when the circuitry of the medical device is complete, preferably when the device is operated for the first time.

Advantageously, when a user first operates the device, the user may, for example, pull a safety tag out of the device. The tag acts as an insulator to isolate the circuitry prior to purchase. On pulling the tag, the circuitry is complete and the medical device is operable. Simultaneously, when pulling the tag, the medical device produces sound which alerts the user to the fact that the medical device uses audible instructions.

Provision of a medical device which can be held and operated wholly from a user's hand, advantageously allows the user to operate the device on the patient whilst at the same time being given audible instructions from said device. The configuration negates the need for the user to turn away from his patient in order to seek instruction on how to operate the device. The operation of the device and diagnosis can be performed in the direct line of vision.

Preferably, the medical device comprises two parts, a medical component part and an instruction component part. Preferably, the instruction component part is a printed circuit board, preferably containing the means for producing audio, preferably at least one switch adapted for user input, preferably a battery power source connector, and preferably an audio output device. The medical component part may preferably be a part configured to test the condition, for example, in a meningitis test, said component part is a transparent portion which is placed against the body.

Preferably, the device comprises at least one switch, which is adapted to configure the control circuitry of the medical device, preferably depending on the type of medical device to be used. Preferably, a plurality of switches are provided and are adapted to change the circuitry according to the requirements of the user. In so doing, the medical device can be adapted and configured to diagnosis and test for a number of different conditions, for example, childhood diseases including whooping cough, meals, chicken pox and mumps.

In a further aspect the invention provides a medical device for indicating the presence of a septicaemic rash comprising electronic means for producing an audible instruction to a user.

Preferably, at least one operating button is provided on the medical device being adapted to trigger the audible instruction. Preferably, four operating buttons are provided, preferably on the second section. Preferably, said operating buttons are connected to illumination means. In this manner, one or each operating button may be illuminated when in operation. This provides an additional signal or indication to the user of which stage they have reached in the operating procedure of the medical device.

Preferably, the audible instruction comprises at least one instruction section, preferably a plurality of instruction sections. Preferably, the audible instruction is configured to enable a user to switch between a first instruction section and any one of said plurality of instruction sections. In this manner, a user is able to skip between the audible instruction sections without the need to listen to the whole audible instruction provided in the device. The user can preferably choose a sequence of sections to listen to.

The audible instruction may have a time delay between the next instruction. For example, four audible instructions may be given, each having a two minute delay.

Preferably, the audible instruction comprises substantially between 5 and 600 seconds of total audio, preferably substantially between 60 and 480 seconds of total audio, most preferably substantially 320 seconds of total audio.

In a further aspect the invention provides a method of testing and diagnosis of a medical condition, the method comprising : a) Placing a medical device against an area of a body; b) Receiving audible instruction from the medical device; c) Operating the medical device in accordance with a series of audible instructions given by the medical device; d) Determining the result of the test with respect to information provided by the audible instructions.

All of the features described herein may be combined with any of the above aspects, in any combination.

An embodiment of the invention will now be described, by way of example only, with reference to the accompanying drawings, wherein:

Figures Ia and Ib show a schematic plan view and a schematic sectional side view respectively of a medical device according to the invention;

Figures 2a and 2b show a schematic perspective view and a schematic side view respectively of a medical device according to the invention;

Figure 3 shows a schematic plan view of a medical device according to the invention;

Figure 4 shows a schematic perspective view of a medical device according to the invention;

Figures 5a and 5b show a schematic side view and a schematic plan view respectively of a medical device according to the invention; Figures 6a and 6b show a schematic perspective front view and a schematic perspective rear view respectively of a medical device according to the invention;

Figure 7 shows a schematic perspective view of a medical device according to the invention in a first configuration;

Figure 8 shows a schematic perspective view of a medical device according to the invention in a second configuration;

Figure 9 shows a schematic perspective view of a medical device according to the invention in a third configuration;

Figure 10 shows a schematic perspective view of a medical device according to the invention in a fourth configuration;

Figure 11 shows a schematic perspective view of a medical device according to the invention in a fifth configuration;

Figure 12 shows a schematic perspective view of a medical device according to the invention;

Figure 13 shows a schematic perspective view of a medical device according to the invention;

Figures 14a and 14b show a schematic side view and a plan view respectively of a medical device according to the invention; Figure 15 shows a schematic plan view of a medical device according to the invention;

Figure 16 shows a schematic perspective view of a medical device according to the invention, in a first arrangement;

Figure 17 shows a schematic perspective view of a medical device according to the invention, in a second arrangement;

Figure 18 shows a schematic perspective view of a medical device according to the invention, in a third arrangement;

Figure 19 shows a schematic perspective view of a medical device according to the invention; and

Figures 20a and 20b show a schematic side view and a schematic plan view of a medical device according to the invention.

Figure Ia shows a medical device 2 according to the invention. The medical device 2 is generally rectangular in plan view and comprises a first section 4 and a second section 6. The second section 6 surrounds the first section 4 to create a frame or border 8. The border 8 is approximately 1.9cm in depth.

The first section 4 has a cross sectional area of approximately 24cm . Said section 4 is rectangular in plan view and is manufactured from a suitable transparent material. Such material may be glass but a polymeric material is preferred, for example, Perspex®. This is because such material is transparent and is readily pliable, being easy to bend and shape to match the contour a person's body.

The first section 4 is fixed in a substantially rigid position within the second section 6. In this manner, the first section 4 remains in position when a test is being carried out. The second section 6 is manufactured from opaque material. Such material may be card or plastics.

A sensing means 10 is located on the second section 6 as shown in Figure Ib. The sensing means 10 comprises a pressure sensor which operates to detect a pressure applied to the medical device 2. Although the sensing means 10 is shown located towards an upper end 12 of the device 2, it will be understood by the reader, that the sensing means may be located at any suitable position on the device 2. The sensing means 10 may be operable to trigger a signal, for example, an audible alarm, or visual signal, when sufficient pressure has been applied. The operation of the sensing means 10 is described in more detail below with reference to Figure 3.

In use, the tester holds the second section 8, so as not to obstruct the transparent viewing window or first section 4, and places the device 2 onto the rash on a body. The tester then applies a downwards force and looks through the first section 4 to inspect the rash. If the rash remains visible, this is an indication of septicaemia.

Figures 2a and 2b show an alternative embodiment of a medical device 50. The device 50 comprises a first section 52 and a second section 54. The second section 54 comprises a concave face 56 and a convex face 58. The first section 52 is fixed into the second section 54 and bends to follow the contour of said second section 54. It will be understood by the reader that the first section 52 may be removable and replaceable from the second section 54. Sensing means 60 are provided on the second section 54.

Figure 3 shows a device 70 having an information area 72. The information area 72 is provided on and around the surface of a second section 74, which surrounds a first section 75. The information area 72 may comprise indicia 76. The information area 72 provides the tester with details of what to expect if a septicaemic rash is present, or whether to seek medical help. The information area 72 may also provide pictures of a typical septicaemic rash .

The information area 72 is linked to illumination means, for example a LED located within the second section 74. The illumination means is triggered by a sensing means 78 so that when a pressure is applied to the device 70, the illumination means operate to light up the information area 72.

It will be appreciated that the information area 72 and illumination means are equally suitable to be incorporated into the devices show in Figures 1 and 2.

Figure 4 shows a further alternative embodiment of a medical device 100 according to the invention. The device 100 is generally lozenge shaped and comprises a body 102 and a cap 104. Both the body 102 and the cap 104 are concave in shape. The body 102 comprises a first section 106 and a second section 108, as will be described in more detail below. When the device is not in use, the cap 104 covers the first section 106.

A gripping portion 110 is provided on the body 102. The gripping portion 110 is generally oval in shape and comprises a plurality of upstanding members 112. The upstanding members 112 provide leverage for a person to push against when removing the cap 104. An abutment ledge 114 projects upwardly from the gripping portion 110 and encircles the body 102 around the front fact 116 thereof, and a rear face 118 of the body 102. The abutment ledge 114 projects upwardly from the body 102 to a distance which is equal to the depth of the cap 104. In so doing, when the cap 104 is placed on the body 102, the cap abuts against the abutment ledge 114 to provide a smooth profile to the device 100.

The cap 104 comprises a cut-out 120 which is dimensioned to receive the gripping portion 110 as shown in Figure 5b. An arc 122 is provided on the cap 104. The arc 122 is raised from the surface of the cap 104 to provide additional leverage for the user to push against when removing the cap 104 from the body 102.

Figures 7 to 12 show the first section 106 and the second section 108 in greater detail. The first section 106 is fixedly attached to the second section 108 along a first edge 109 of the first section 106. The edge 109 is perpendicular to the longitudinal axis of the device 100. The figures show a sequence whereby the cap 104 is removed from the first section 106, as shown in Figures 7 and 8, and placed on to the second section 108 as shown in Figures 9 to 12.

To prepare the medical device 100 for use, the cap 104 is pushed away from the body 102 by the user pressing against the gripping portion 110. The cap 104 slides off the first section 106, as shown in Figure 8. It can be seen in Figure 8 that the body 102 comprises the first section 106 which is substantially transparent, and the second section 108 which is substantially opaque. The cap 104 is placed over the second section 108 as shown most clearly in Figure 10. In this configuration, the gripping portion 110 is received by the cut-out 120 on the cap 104 and is slid into place over the second section 108 until the cap 104 abuts against the abutment ledge 114.

Figure 12 shows the medical device in a configuration ready for use. Advantageously, the cap provides additional support to the second section 108 during use. The second section 108 is, therefore, reinforced by the cap 104 and, in so doing, is less prone to being broken when the user applies a force down on the device 100 during testing on the patient. Further, the upstanding members 112 and the arc 122 provide a raised surface against which the user can further grip the device 100 when applying the downward force.

During use, the person operating the device presses the device against a patient's body, so that the first section

106 pushes downwards on the body. In so doing, when the device 100 is being used to test for a septicaemic rash, the user is given an indication of whether said rash is present .

The device 100 further comprises an information area 124. The information area 124 comprises indicia 126 directing the user on how to operate the device 100. The information area 124 is shown provided on a cap 104 but it will be appreciated by the reader that the information area 124 may be incorporated on any part of the device which is visible to the user.

A further alternative embodiment of the invention is shown in Figures 13 to 20. The medical device 200 comprises a body 202 and a cap 204. In this embodiment, the cap 204 is dimensioned to fit over a first section 206, as shown in Figure 16. The body 202 comprises the first section 206 and a second section 208.

A gripping portion 210 is provided on the body 202. The gripping portion 210 comprises a pair of gripping members

219, one of each being provided on a front face 216 and a rear face 218 of the device 200, as shown in Figure 20a. The or each gripping member 219 comprises upstanding members 212, as previously described in relation to the embodiment of Figures 4 to 12. An abutment area 214 is located on the gripping portion 210, against which the cap 204 abuts when the device is not in use. A curved portion 217 extends downwardly from the gripping portion 210.

The cap 204 comprises a cut-out 220. The cut-out 220 of this embodiment comprises a pair of symmetrical cut-outs

220, each of which is dimensioned to receive one of the gripping members 219 located on the front face 216 and the rear face 218.

The second section 208 comprises an information area 224. The information area 224 comprises indicia 226 and a plurality of buttons 228. A speaker 230 is located towards an end of the second section 208. The speaker 230 comprises a series of arches 232 but it will be appreciated that any suitable configuration of speaker may be incorporated into the device 200.

Four buttons 228 are shown on the device 200 in Figures 13 to 20. Alongside each button 228 is corresponding indicia 226 which provides information to the user. The information relates to audible instruction given in relation to the corresponding button 228. Each of the four buttons 228 on the body 102 provide a different function for the device 200. The first button 234, when pressed, relays audible information on the symptoms of the disease being tested for. For example, on the device shown in Figures 13 to 20, the first button 234 relays audible information on the symptoms of meningitis. The second button 236 relays audible information to the user on how to use the device 200. The third button 238 relays audible information on interpreting the results. Similarly, the fourth button 240 relays audible information on interpreting the results. Depending on the results of the test, the user can optionally press either the third button 238 or the fourth button 240.

LEDs may be provided behind each button 228 to illuminate said button 228 when in use. Figures 16 to 20 show a sequence of how a user operates the device 200. In particular, Figure 16 shows that the cap 204 is removed from device 200 to reveal the transparent first section 206. Although the cap 204 is not shown to be placed on the second section 208, it will be appreciated by those skilled in the art that the cap 204 may be configured to fit over the second section 208 and said cap 204 may incorporate a grid or grill, through which sound from the speaker 230 may pass so as not to impede the audible instruction.

The device 200 is pressed against a patient's body. The operator of the device 200 may be given immediate audible instruction from the device 200 due to the pressure exerted on the device. Alternatively, the audible instruction may be given when the cap 204 is removed from the device 200. Alternatively, the user may press a button, preferably the first button 234, to begin the sequence of operation of the device 200 to produce audible instructions. The audible instructions may relay symptoms of the condition for the person to be aware to look for on the patient; instruction on how to use the device, including error signals to watch for during operation; and audible diagnosis of the condition depending on the symptoms presented.

The means of producing the audible instructions includes a memory device for storage of spoken instructions, audio output device, for example, the speaker 230, a control mechanism such as a micro-controller for controlling electronic means, and a means of converting stored representation of audio waveforms into a signal needed to drive the audio output device 230. Additionally, one or more sensors may be provided to determine when and which message is produced.

It would be obvious to those skilled in the art that any one of a wide range of technologies may be used for the instruction component, for example, MP3 players, audio cassette tape players, or CD players. Further, whilst most electronic devices store the audio content as a digitised, and optionally compressed, signal, it would be appreciated that analogue means of storing the facilitation of the audio signal may also be incorporated into the device 200.

The device 200 may comprise a separate body 102 and electronic means for producing the audible instruction. In this manner, the electronic component may be incorporated into any device, particularly a medical device, in order for the device to produce audible instructions to the user.

Advantageously, the instruction component is a single printed circuit board containing the means for producing audio, switches to allow user input, battery connections, and the audio output device. The instruction component may alternatively be an integral part of the medical device .

Alternatively, the device may take the form of a hinge, with one leaf of the hinge holding the means for producing spoken instructions. This, again, allows for common instruction holders to be used in a variety of different medical device. A user is thus able to interchange the audible instruction component depending on the condition to be tested.

Alternatively, the instruction component may be embedded into a range of different devices, and hence not necessarily separately identifiable or removable.

Examples of medical devices which may incorporate the audible instruction means include the meningitis device of the present invention, a medical case containing local anaesthetic, suture material and dressings; or a medical case containing a set of clearly numbered syringes preloaded with a course of injections.

Advantageously, a given instruction component may be used for a variety of different medical devices. Each instruction component may be programmed with the appropriate set of instructions for said device.

Advantageously, the instructions may also be provided in written form. This may take the form of printing directly onto the surface of the device, for example, on a display screen, and/or a printed card, booklet or leaflet.

Advantageously, the printed instructions may be in multiple languages, which may include those of the spoken mechanism. In so doing, a fail-safe mechanism is in place in the event of malfunction or the power source being drained.

Advantageously, the instructions are split into multiple steps, each of which may be triggered by one or more of the following mechanisms: • Opening the medical device, for example, removing the cap .

• A pre-determined time having elapsed (for example, if a test requires that the user wait two minutes before examining the results of a test, this time may be automatically determined by the instruction component .

• Completion of the preceding instruction.

• The user pressing one or more buttons or switches on the device.

• The user replacing the cap.

• The device being lifted, tilted or turned.

• One or more sensors on the device, e.g. pressure, temperature, light sensor etc. • Means for sensing audio signals (e.g. microphone) may allow the user to issue spoken commands. When combined with speech recognition software, such as that used in mobile phones for voice-activated dialling, this permits the user to 'ask' the device to play specific instructions.

Advantageously, the device includes a display mechanism that provides user feedback to the user. This typically shows which step of the process is being described by the written instructions. In the device shown in Figure 13, LEDs are arranged next to printed text. Alternatively, a text or graphics display showing the title of the step or displaying the full text of the instructions as they are spoken may be provided. Advantageously, the device provides spoken instructions in more than one language. The language used may be selected by a variety of mechanisms including but not limited to:

• a switch having two or more positions

• a combination of one or more switches being pressed as the device is powered up

• a sequence of one or more switch presses.

Advantageously, the device may be programmed with a range of different instruction sets with the active set being selected using the above mechanisms. This allows a single container to be produced and its instructions set according to the contents of the container.

And this may be done by any or a combination of the following methods:

• set during production

• set by a party in the distribution chain • set by the retailer before or at the time of purchase

• selected by the user at the time of purchase or at the time of use.

Advantageously, the device includes a mechanism by which the battery or other power source is electrically isolated from the circuit until the device is activated. This may be done by means of an insulator that is normally separating the battery from one of its contacts but is removed as the device is opened for use thus completing the circuit. This mechanism thereby extends the shelf- life of the device by eliminating any leakage current that would otherwise gradually discharge the battery when the device is not in use.

Advantageously, the device provides for the battery power source to be isolated when the device is not in use. For example, closing the device or replacing the cap may force said insulator back between the battery and contact, again isolating the battery source.

Advantageously, the device includes text to speech components allowing the instructions to include synthesized speech which may, therefore, include the outputs of sensors.

Alternatively, a simple power switch may be provided to isolate the battery from the rest of the circuit.

Advantageously, the instructions follow a simple format that helps users become familiar with a range of devices. These typically include:

• when to use and when not to use the device

• how to use the device

• next steps to take having used it.

The configuration of a medical device which is easy to operate but is also readily available to a user is highly beneficial both for use by the public or a medical professional. The device is compact and can be easily stored, unlike the traditional "Tumbler Test" which requires the user to have access to a glass. Further, the device of the present invention can be used by a wide range of people and is particularly suited to people who have reduced dexterity.

Advantageously, the invention provides a medical device which prompts or instructs a user, preferably by using audible means. Preferably, the instructions include when and preferably how to use said device. Preferably when the medical device is a diagnostic device, the diagnostic device comprises instructions on how to interpret results obtain therefrom. Preferably when the medical device is used for treatments, said device comprises advice to the user on follow-up and subsequent procedures.

The reader's attention is directed to all papers and documents which are filed concurrently with or previous to this specification in connection with this application and which are open to public inspection with this specification, and the contents of all such papers and documents are incorporated herein by reference.

All of the features disclosed in this specification (including any accompanying claims, abstract and drawings), and/or all of the steps of any method or process so disclosed, may be combined in any combination, except combinations where at least some of such features and/or steps are mutually exclusive.

Each feature disclosed in this specification (including any accompanying claims, abstract and drawings) may be replaced by alternative features serving the same, equivalent or similar purpose, unless expressly stated otherwise. Thus, unless expressly stated otherwise, each feature disclosed is one example only of a generic series of equivalent or similar features.

The invention is not restricted to the details of the foregoing embodiment (s) . The invention extends to any novel one, or any novel combination, of the features disclosed in this specification (including any accompanying claims, abstract and drawings), or to any novel one, or any novel combination, of the steps of any method or process so disclosed.

Claims

1. A medical device for indicating the presence of a septicaemic rash, the medical device comprising a first section and a second section, the first section being substantially transparent and adapted to be placed against a body, the second section being substantially opaque and located on a periphery of the first section.

2. A medical device as claimed in claim 1, wherein the second section is located along a first edge of the first section .

3. A medical device as claimed in claim 2, wherein the first edge is perpendicular to a longitudinal axis of the device .

4. A medical device as claimed in claims 2 or 3, wherein an edge portion of the second section is fixedly attached to the first edge of the first section, along substantially the entire length of the first edge.

5. A medical device as claimed in any one of the preceding claims, wherein the first section and the second section form a one piece unit.

6. A medical device as claimed in any one of the preceding claims, wherein the medical device is substantially lozenge shaped and comprises parallel sides and curved edges.

7. A medical device as claimed in any one of the preceding claims, wherein the first section and the second section are substantially concave in shape.

8. A medical device as claimed in any one of the preceding claims wherein substantially half of the medical device comprises the first section and substantially half of said device comprises the second section.

9. A medical device as claimed in any one of the preceding claims wherein substantially half of said device is opaque and substantially half of said device is transparent .

10. A medical device as claimed in any one of the preceding claims wherein said device comprises a cap.

11. A medical device as claimed in claim 10, wherein the cap comprises at least one curved end, and is dimensioned to be received by the first section or the second section.

12. A medical device as claimed in claims 10 or 11, wherein the cap is located on the first section when the medical device is not in use and the cap is located on the second section when the medical device is in use.

13. A medical device as claimed in any one of the claims 10 to 12 wherein the cap comprises at least one cut-out.

14. A medical device as claimed in any one of the preceding claims, wherein at least one gripping portion is located on the body of the medical device.

15. A medical device as claimed in any one of the preceding claims wherein the first section is substantially transparent, being adapted to be placed against the body, and the second section is substantially opaque .

16. A medical device as claimed in any one of the preceding claims wherein an information area is provided on the device.

17. A medical device as claimed in any one of the preceding claims wherein a pressure sensing means is provided on the device.

18. A medical device as claimed in claim 17, wherein the pressure sensing means is adapted to detect a change in pressure on the device.

19. A medical device as claimed in any one of the preceding claims wherein a microprocessor is provided in the device.

20. A method of testing for a septicaemic rash, the method comprising: a) Placing a medical device against an area of a body, the medical device comprising a first section and a second section, the first section being substantially transparent, the second section located on a periphery of the first section and being substantially opaque; b) Applying a pressure to the medical device; and c) Determining the result of the test with respect to information provided in an information area.

21. A medical device comprising a first section, a second section and a cap, the cap adapted to be located on the first section or the second section, wherein, in a first position, the cap is located on the first section, and in a second position the cap is located on the second section .

22. A handheld medical device incorporating means for producing an audible instruction to the user.

23. A handheld medical device as claimed in claim 22, wherein electronic means are provided for producing the audible instruction to the user.

24. A handheld medical device as claimed in claims 22 or 23, wherein the medical device comprises a memory device adapted for storing spoken instructions.

25. A handheld medical device as claimed in any one of claims 22 to 24, wherein an audio output device is provided on said device.

26. A medical device as claimed in any one of the preceding claims comprising a battery source.

27. A medical device as claimed in claim 26, wherein Preferably, the battery source is electrically isolated from the circuitry of the device when the device is not in use.

28. A medical device for indicating the presence of a septicaemic rash comprising electronic means for producing an audible instruction to a user.

29. A medical device as claimed in any one of claims 22 to

28, wherein at least one operating button is provided on said device being adapted to trigger the audible instruction .

30. A medical device as claimed in any one of claims 22 to

29, wherein the audible instruction comprises at least one instruction section, the audible instruction being configured to enable a user to switch between a first instruction section and any one of a plurality of instruction sections.

31. A medical device as claimed in any one of the preceding claims wherein the medical device is adapted for indicating the presence of a septicaemic rash.

32. A medical device substantially as hereinbefore described with reference to any one of the accompanying drawings .