WO1997046878A1

WO1997046878A1 - Device for measuring the properties of an endogenous fluid

Info

Publication number: WO1997046878A1
Application number: PCT/EP1997/002747
Authority: WO
Inventors: Emmanuel Anapliotis
Original assignee: Selfcare International Gmbh
Priority date: 1996-05-30
Filing date: 1997-05-27
Publication date: 1997-12-11
Also published as: EP0912894A1; AU3092797A; CA2255711A1; DE19780517D2; AU718050B2

Abstract

The invention concerns a device for measuring the properties of an endogenous fluid, in particular for measuring the pH of vaginal fluid, in a manual medical examination. The device comprises an elastic protective clothing article which can be slipped on and used for the examination, a test strip (2) comprising a coating with an indicator agent (2.2) for measuring the pH of the vaginal fluid during the examination, and a double-sided adhesive tape (2.3) for securing the test strip to a section (1.1) of the protective clothing article.

Description

DEVICE FOR MEASURING THE PROPERTIES OF A BODY'S LIQUID

description

The invention relates to a device for measuring the properties of an endogenous fluid of the type specified in the preamble of claim 1.

It is known to use the change in the properties of the body's own fluids for diagnostic purposes and thus to improve the early detection of organ diseases or the restriction of organ functions.

One of the most common causes of vaginal infections and durcn these participants drawn in many cases premature births is rien the colonization of the vagina with infection-causing Bakte ^¬. Such changes in the vaginal milieu often go unnoticed by women and by the expectant mother. The foreign bacteria displace the na ^¬ türlicherweise present in the vagina Milchsaure- bacteria which produce lactic acid by the formation of an acidic vaginal environment. The acidic environment of the vagina provides an naturl.cnen Scnutz against the entry of foreign Bak ^¬ αar criteria.

A change in the natural equilibrium to the detriment of the miic acid content leads to a measurable change in the pH.

The earlier a pathological change in the vaginal milieu is recognized due to the penetration of foreign, infection-causing bacteria, the sooner successful countermeasures can be initiated by the treating doctor.

From the rus _t rule utility model DE-GM 94 074% ₁₅ t em Untersuchuncsnandschuh to Emnalgebraucn to gleicnzeiti- ger Messur - ce. pH i :. αci Scheice a: woman loading knows. Then an examination glove is proposed, from the fingers of which the finger, the so-called examination finger, has a test strip firmly attached to it to determine the pH.

In the test strip proposed in this form and provided on the examination glove for the examination of the vaginal milieu, disadvantageous evaluations often result in evaluations by the patient, or at least difficulties in the qualitative evaluation of the test strip used.

Furthermore, it is disadvantageously difficult with the proposed examination glove to securely attach the test strip required for the examination of the vaginal milieu to the examination glove with little effort in the form of an assembly.

Starting from the shortcomings of the prior art, the invention is therefore based on the object of specifying a device which is suitable for examining the body's own fluids, in particular vaginal fluid, and which can be evaluated without particular effort and with relatively great accuracy and with simple means is inexpensive to manufacture.

This object is achieved by a device described in claim 1.

The invention includes the observation that, in a packaging of best of an elastic material ^¬ Henden protective clothing manufacturing technical means Vor¬ parts are accessible when the additional elements by gluing are connected to the protective clothing agent. The invention further includes the knowledge that the more qualitatively the test strip is attached to a color support with the color values to be compared, the more convenient and the more precisely it can be carried out based on a color change is. If, in addition, the background color is adapted to the starting or normal color of the indicator and the area of the indicator that is not covered by the cover bearing the background color has the form of an attention symbol in a positive or negative representation, a color change represents a hazard or warning , which can even be grasped by one of the addressees who are unfamiliar with reading and writing without further thought. This also applies to inscriptions such as "Caution" and "Warning" because these inscriptions have the same effect.

According to a preferred embodiment of the invention, the slip-on, elastic protective clothing for carrying out pH measurements of the vaginal fluid in gynecological examinations of the vagina has a test strip to be used for the pH measurement, which is attached to the surface with a double-sided adhesive tape Protective clothing is attached. The test strip has a carrier provided with an indicator, which in turn is connected to one of the two adhesive layers of the double-sided adhesive tape. The finger section of the protective clothing designed as a glove, preferably the index finger (hereinafter referred to as the examination finger) intended for examination, is connected to the second adhesive layer of the double-sided adhesive tape.

The use of a double-sided adhesive tape has the particular advantage that on the one hand the separate application wearing an adhesive is avoided and on the other hand the amount of adhesive and the position of the adhesive are fixed. As a result, the surface to be glued on the protective clothing means, in particular on the examination finger, is prevented from becoming dirty by excess adhesive. Such contamination would render the protective clothing useless for the intended examination.

It is particularly advantageous in the invention that test strips made of the most varied of materials can be attached quickly and securely. Also, the protective clothing used does not have to be prepared in any special way beforehand in the areas intended for gluing. The protective clothing according to the invention has two variants, one of which is intended for the doctor and the other for the patient herself. The differences and advantages of the two solutions are described in more detail below.

The double-sided adhesive tape is advantageously suitable for positioning the test strip on a slip-on, elastic protective clothing which is used when examining a body's own fluid, for example for measuring the pH of the vaginal fluid during gynecological examinations of the vagina.

For a qualitative evaluation of the medical examination on the inner side of the protective clothing agent before ^¬ Trains t in the region of the hand area, a labeled color gamut provided fens to determine the current pH value by comparison with the color of Teststrei-. The border area for em is advantageously m on the color scale of the vaginal milieu so that even a layperson can qualitatively recognize a disease.

According to another advantageous embodiment of the invention, the test strip on its side facing the body area to be examined has a cover which partially covers the layer of the indicator agent which reacts to a pathological change in the body area to be examined with a color change. As a result, neutral surface sections are advantageously located in the immediate vicinity of the partial surfaces of the indicator medium layer reacting with color change, which by special design, in particular coloring, for analysis of the color change or corresponding partial surfaces of the indicator surface ^* '. 'can be used. In another variant sine I ^r . : ι tutor and comparison area in the immediate vicinity on the carrier to be inserted into the vagina, in particular the finger of a glove.

According to a favorable further development of the invention, the cover located on the indicator medium layer of the test strip is designed as a template in the form of a monochrome, opaque film, in which, for example, circular or rectangular recesses are provided. With the body fluid, these recesses give chemically reacting surfaces of the Layer of the test strip free and are completely enclosed by color-neutral film sections. The film-shaped cover is attached to the indication medium layer in a simple manner by gluing.

According to another advantageous development of the invention, the cover has an em coloration which preferably corresponds to the color shade that the indicator medium layer assumes when the vaginal fluid has a pH value which can be assigned to the healthy vaginal milieu. This advantageously results in a uniform color over the entire surface for the test strip if the vaginal milieu shows no pathological changes. In the case of a pathological vaginal milieu, only the sections of the indicator medium layer accessible through the recesses change color due to the cover, so that the color change can be perceived by the direct comparison of the discolored area of the indicator medium layer and the cover adjacent to this area.

According to a variant of the invention, the cover has a labeled color scale, which extends parallel to the longitudinal axis of the test strip and is arranged next to the recesses. The color comparison between the coloring in the recesses and the color scale leads in a simple manner to the current pH value of the vaginal milieu.

In the same way, the color assignment can be selected for an examination of other body fluids or secretions.

This type of evaluation of the test strip according to the invention is particularly suitable for medical laypersons, since even a slight scar change in the areas of the indicator medium layer that are located can be easily recognized by direct comparison with the color of the cover. The exact quantitative evaluation of the color change can be carried out after the above-described early detection of the medical examination.

According to a further embodiment of the invention, the recesses provided in the cover form an icon. This symbol is designed, for example, as a warning or exclamation mark or as a lettering for a warning. As a result, in addition to the color change in the event of a pathological change in the examined fluid of a specific body area, for example the vaginal fluid, an advantageous physiological effect is simultaneously generated and an optical warning is triggered.

According to another advantageous development of the invention, a plurality of test strips of the same design are detachably fastened in a serial arrangement on a carrier strip. The carrier strip is wound up into a tear-off roll and each has a predetermined separation point between two successively arranged test strips. This form of storage of the test strips enables the test strips to be handled comfortably when the protective clothing used for a medical examination is to be assembled as required with a test strip according to the invention.

According to an advantageous further development of the invention, at one end of the double-sided adhesive tape carrying the test strip, there is a section on both sides that is adhesive-free and designed as a grip tab. This enables the test strip to be handled comfortably when assembling the protective clothing means with the for the test strips required for the examination. It is equally advantageous that the indication medium layer of the test strip does not have to be touched by hand in order to be able to position it at the selected location. This avoids influencing the indication medium layer, which could possibly lead to a falsification of the examination result and would make a new examination necessary.

According to another embodiment of the invention, the protective clothing is designed as a finger cot.

The use of a fingerstick glued to a test strip of the type described above advantageously allows the gynecologist or the patient to individually select which finger is used for the examination and on which side of the finger the test strip is to be positioned .

The material advantageously provided for the glove and the fingerling is polyethylene, with this material a particularly secure bond between the test strip and the selected examination finger of the glove or fingerling can be achieved in a simple manner by means of a double-sided adhesive tape.

Depending on the size of the test strip, the test strip attached to the examination finger inevitably leads to a certain disability in the vaginal penetration of the examination finger. In order to prevent the patient from developing a mental aversion to such an examination, according to another embodiment of the invention, the ratio of the physical size of the test strip to the surface of the inside of the index finger of the hand is advantageously selected shoe that has a value small to 1, preferably in the range of 5 ". Such a test strip size is sufficient for the visual perception of a color change and is hardly perceived by the patients as disturbing.

To carry out a gynecological examination, it is advantageous for the attending doctor if the test strip is arranged off-center and in the middle area of the examination finger of the glove, since the doctor has to penetrate the vagina relatively far anyway in the course of other tactile examinations. The investigation described here thus represents a quasi-automatically obtainable side effect.

For an informative self-test by the patient, on the other hand, it is sufficient if the test strip is arranged in the center and in the area of the fingertip of the index finger. The patient needs to insert the examination finger only slightly into the vagina, so that the self-test can also be carried out by a medical layperson without any particular problems.

According to a favorable further development of the invention, the test strip has a carrier with an indicator medium layer applied by printing.

For the protective clothing that can be used to determine the pH of the vaginal fluid by means of a test strip, a packaging is provided according to the invention in which one or more gloves or finger cots are individually packaged. This results in particular advantages in terms of storage, for quick and easy access or when transporting devices for examining body fluids. The packaging according to the invention preferably has a substantially rectangular base plate, on the side edges of which hinged flaps are provided. The tabs arranged opposite one another are opened in pairs, the tabs covering the entire base plate and a pair of tabs being pressed against the base plate by reaching over the other pair of tabs. The free ends of the overlapping tabs can be connected to one another, for example by an adhesive overlap provided on the tab edges. A tear-open tongue is provided on one of the overlapping tabs for simplified loosening of the adhesive bonding of the overlapping sections.

To connect the two overlapping tabs, according to an advantageous further development, a slot-shaped recess on the edge of the other tab is provided on one tab edge.

In accordance with the preferred embodiment of the invention, the base plate has shapes in which the protective clothing means can be arranged in a secure position. In order to perfect the securing of the position, each recess equipped with protective clothing is closed with a thin cover film. The cover film consists of a plastic and has a grip tab in order to be able to remove the cover film from the opened packaging in order to remove the protective clothing means.

In order to ensure proper application of the protective clothing according to the invention when vaginal examinations are carried out, the packaging, which preferably consists of cardboard or a material similar to cardboard, has a print which indicates the contents of the package and its use. According to an additional development of the invention, a base plate made of plastic is provided in order to prevent an undesirable influence of moisture, in particular of atmospheric moisture, on the packaging content.

According to a variant of the invention, it is advantageous to transport or store a plurality of individual packagings in a storage box. The storage box has on the front side a hinged removal opening or a slide opening, through which sequential access to the individual packaging is possible. A color scale attached to the front of the storage box with a separately marked color area assigned to a healthy vaginal milieu facilitates the evaluation of the test strip used, so that even a medical layperson can make a preliminary rough diagnosis in a simple manner

Other advantageous developments of the invention are characterized in the subclaims or are shown in more detail below together with the description of the preferred embodiment of the invention. It shows:

Figure 1 em * i '. Good embodiment of the invention on top; m ^* ,

FIG. 2 shows another advantageous embodiment of the invention,

FIGS. 3a and 3b advantageous developments of the embodiment of the invention shown in FIG. 1,

FIG. 4 shows a detail of ^{the embodiment of} the invention shown in FIG. 1, viewed from the side, FIG. 5 shows an application possibility of the embodiment of the invention shown in FIG. 1,

FIG. 6 shows another advantageous embodiment of the invention in a view from above,

FIG. 6a shows a detail of the embodiment of the invention shown in FIG. 6,

FIG. 7 shows a favorable further development of the embodiment of the invention shown in FIG. 6,

FIGS. 8a and 8b further variants of the embodiment of the invention shown in FIG. 6,

FIG. 9 shows an additional development of the embodiment of the invention shown in FIG. 6,

10 shows the view of a section along the line A ... A according to FIG. 9,

FIG. 1] an additional variant of the invention in perspective view,

FIG. 12a shows a packaging for the embodiment of the invention shown in FIG. 1 in plan view,

FIG. 12b shows the packaging shown in FIG. 12a in a side view,

FIG. 12c shows a sectional illustration along the line A ... A according to FIG. 12a,

FIG. 13a shows a packaging for the embodiment of the invention shown in FIG. 2 in a top view,

FIG. 13b the packaging shown in FIG. 13a in a side view, and FIG. 14 shows a further packaging variant in a perspective view.

The protective clothing means shown schematically in FIGS. 1 and 2 are designed as elastic gloves 1 or as finger cots 1 ', which carry a test strip 2 or 2' which, in relation to the size of the examination finger 1 'or 1.1. covers a relatively large area of the examination finger.

FIGS. 3a and 3b show protective clothing 1 in plan view, in each of which a test strip 2 "or 2" 'is provided, which only covers a relatively small area of the examination finger 1.1 "or 1.1"'. The ratio of the surface of the test strip 2 "or 2" 'to the total surface of the inside of the examiner has a value "1, preferably a value of 0.05.

According to FIG. 3a, the test strip 2 "is arranged on the center line 15 of the examination finger 1.1" in the region of the finger tip. This form of protective clothing 1 "is particularly intended for patients who carry out a self-test to determine the condition of the vaginal milieu and only have to insert the examination finger into the front vaginal area with a shallow depth of penetration. The one attached to the inside of the glove 1" Color scale 19 has two color values 19.1, 19.2, which color-code the range limits within which the pH lies in the normal range indicating a healthy vaginal milieu. A protective clothing means 1 "'for use by the doctor is shown in Figure 3b. The test strip 2"' is positioned off-center and is located in the middle area of the examination finger 1.1 "'. The arrangement of the test strip is therefore provided at this point because during the examination the attending physician also detects vaginal sections lying further inwards and a falsification-free measurement of the pH value of the vaginal milieu is also possible there.

FIG. 4 shows part of the examination finger 1.1 corresponding to FIG. 1 in a view from the side.

The test strip 2, which is attached to the examination finger 1.1 of the protective clothing 1 by means of a double-sided adhesive tape 2.3, has an indicator layer 2.2 arranged on a carrier 2.1, which indicates the current pH value of the vaginal fluid through a color reaction. The type of color reaction enables the examiner to make a statement about a possibly pathological change in the vaginal milieu.

By using the handle piece 2.5, the test strip 2 connected to the side 2.4 of the double-sided adhesive tape 2.3 via its carrier 2.1 can be comfortably attached manually to the use finger 1.1 of the protective clothing 1 without touching the indication layer 2.2. The adhesive layer connected to the use finger 1.1 after the protective clothing 1 has been assembled is designated 2.6.

FIG. 5 shows a typical application example for protective clothing 1 stripped over the right hand with a test strip arranged on the index finger 1.1 2 to determine the pH of the vaginal milieu. The area of the female pelvis shown in partial section is designated by 3. The index finger 1.1 is pushed toward the vagina 4 with a slight rotation in order to achieve better wetting with the vaginal fluid. The indicator layer (compare position 2.2 according to FIG. 4) of the test strip 2 reaches up to 3 αx deep in the vagina 4 and changes color according to the pH value of the vaginal milieu.

The elastic protective clothing shown in FIGS. 6 and 7 carry test strips 12 and 22 for examining the vaginal milieu, in particular for determining the pH of the vaginal fluid, which carry a template-like cover 13, 23. The protective clothing means smd formed as a glove 10 or as a finger cot 20 and shown in a schematic form.

The test strips 12, 22 fastened to the examination finger 10.1 of the glove 10 or to the finger 20 by means of a double-sided adhesive tape 11, 21 each have an indicator agent layer 16 which is at least partially covered by a cover 13 or 23 and which is caused by a color reaction A statement about the pH of the vaginal environment is possible.

When examining the pH of the vaginal milieu, the indicator layer 16 does not come into contact with the vaginal fluid in the covered areas.

Recesses 17, 27, 27.1 are provided in the cover, which partially release the indicator medium layer 16 and which make contact with the indicator medium layer with the vaginal fluid associated with a color reaction possible. lent. Only in these areas can the color of the indicator layer 16 change.

Instead of a cover, a separate area can be provided, which does not cover the indication means, which is arranged in the immediate vicinity of the indicator area and is colored in accordance with a predetermined indicator state. Direct comparison can then quickly and reliably determine whether there is a pathological change in the vaginal environment and thus a risk to the patient. With this version, too, it is no longer necessary to bring the indicator and comparative color carrier together.

The cover 13, 23 consists of a plastic film and is glued to the indicator layer 16. The cover is colored and has a color which corresponds to the color of the indicator layer 16 when the vaginal fluid has a pH value corresponding to a healthy vaginal milieu. As a result, the entire test strip 12, 22 shows a uniform, uniform color, preferably a sunflower-yellow color, if there is a healthy vaginal milieu. The direct comparison between the color of the exposed surface areas 17, 27, 27.1 of the indica ^¬ tion middle layer 16 and the hue of the directly sur- rounding cover 13, 23 are also genngfugige Farbanderun- _pen also by medical laypersons detected, so that a quantitatively accurate gynecological examination can be conducted.

The cover 33 of the test strip 12 of the glove 10 shown in FIG. 6 has rectangular recesses 17 which are only visible when the color of the flat sections of the indicator medium layer 16 accessible to the vaginal fluid is visible.

FIG. 6a shows the examination finger 10.1 shown in FIG. 6 in a view from the side. The cover 13 is glued to the indicator medium layer 16 arranged on a carrier 18. The elements 13, 16, 18 form a test strip 12, which in turn is attached to the index finger 10.1 of the glove by the double-sided adhesive tape 11 with the adhesive surfaces 11.1, 11.2. The grip tab 11.3 of the adhesive tape 11 is itself adhesive-free and allows the test strip 12 to be handled comfortably when attached to the selected examination finger.

The recesses 27, 27.1 of the cover 23 of the test strip 22 form a sign which, due to its generally valid meaning, additionally triggers a psychological effect when the exclamation mark 27, 27.1 appears optically in the case of a color change caused by pathological changes in the vaginal milieu.

The test strips 12 and 22 can be manually used by using a glue-free grip tab (compare position 2.5 in FIG. 4) of the double-sided adhesive tape 11 or 21 without touching the indication layer 16 on a carrier (compare position 28 in FIG. 10) can be conveniently attached to the use finger 10.1 of the glove 10 or to the finger cot 20.

- The protective clothing 10, 20 designed as a glove or as a finger cot is made of polyethylene, since the double-sided adhesive tape can be attached to this material in a particularly simple and secure manner. FIGS. 8a and 8b show film-like, opaque covers 23 "and 23"'m in plan view, which recesses 27' and 27 "have the shape of a lettering. The recesses form in a simple manner an attention symbol, which is from the The patient is recognized without further thought as a hazard warning if a color reaction occurs when the vaginal environment changes pathologically and the lettering stands out in color from the cover.

FIGS. 9 and 10 show a test strip 22 ′ in a top view and as a cross-sectional view, the cutting being carried out along the line A ... A according to FIG. 9. In addition to the recesses 27 and 27 'forming an exclamation mark, the template-like cover 23' has a color scale 25 which is arranged on the outside of the test strip 22 'and extends parallel to the longitudinal axis thereof. The color scale 25 has a plurality of evaluating color gradations 25.1, with which the color tone of the uncovered flat areas of the indicator medium layer 16 which arises after a color change can be conveniently compared by direct comparison for a preliminary diagnosis.

The double-sided adhesive tape for attaching the adhesive strip 22 'is designated 21, the carrier of the indicator medium layer 28.

FIG. 11 shows a tear-off roll 40 on which there are a plurality of test strips 12 for examining a certain body fluid, for example the vaginal fluid. The individual test strips 12 are detachably fastened in a serial arrangement on a rolled-up support strip 29 and can, if necessary, be of a roll 40 are removed. In order to facilitate separation, the carrier strip has a predetermined separation point 30 between each two adjacent test strips. After detaching the carrier strip located on the double adhesive strip (compare positions 2.3, 21 in FIGS. 4 and 10), the corresponding test strip 12 can be attached to an elastic glove 10 or to a finger cot by gluing.

The packaging 5 shown in a plan view in FIG.

Foldable tabs 7.1, 7.2 or 8.1 and 8.2 are hinged to the side edges of the essentially rectangular base plate 6. The oppositely arranged lugs 7.1, 7.2, 8.1 and 8.2 are in pairs unfolded, said tabs cover the entire bottom plate be¬ and em pair of tabs 7.1, is 7.2 prints by overlapping the other flap pair 8.1, 8.2 ge against the bottom plate 6 ^¬. The free ends of the overlapping tabs 8.1 and 8.2 are connected to one another by an adhesive overlap 8.3 provided on the tab edges, as shown in FIG. 12b as a side view of the packaging 5. By connecting the tab edges the United ^¬ can pack 5 is not open unexpectedly.

By pulling on the tear-open tongue 9, the adhesive connection 8.3 can be released at the overlap> and the protective clothing 1 can be removed from the opened packaging.

The sectional view according to FIG. 12c shows the position of a glove located in the packaging. th protective clothing 1. The glove 1 is folded across the longitudinal direction of the fingers and lies in the formation 6.1, which is hygienically closed by a thin protective film 6.2. The tear-open tab 6.3 arranged on one side allows the protective film to be pulled off easily when the glove 1 is to be removed from the opened package. To open the packaging, the two overlapping tabs 8.1 and 8.2 must be unfolded, the adhesive connection 8.3 being loosened mechanically.

FIGS. 13a and 13b show a packaging 50 for protective clothing designed as finger cot 1 'in the closed state as a top view or as a side view.

The finger cots 1 'are ready for use in an elongated form, in each case individually with the test strips 2' glued upwards in a configuration 51.1, 51.2 provided in the base plate 51. The formations 51.1, 51.2 smd in accordance with the explanations for FIG. 12c are hygienically closed by a cover film (not shown).

The overlapping tabs 53.1 and 53.2 have as connection means on their free edges a slot-shaped recess (not shown) and a tongue 54 which is inserted into the recess in order to close the packaging 50.

FIG. 14 shows a storage box 60 in which a plurality of individual packs 5 with a protective glove 1 are kept. The storage box can be opened from the front by a slide 62 which can be moved in the direction of the arrow, as a result of which the individual packs 5 are accessible and can be removed sequentially. The frontseitiq auige- The printed color scale 61 allows a convenient qualitative evaluation of the medical examination by comparing the colors with a test strip used. The particularly marked color range 61.1 is assigned to the healthy vaginal milieu.

The embodiment of the invention is not limited to the preferred exemplary embodiments specified above. Rather, a number of variants are conceivable which make use of the solution shown even in the case of fundamentally different designs.

Claims

claims

1. Device for measuring the properties of a body's own fluid, in particular measuring the pH of the vaginal fluid, during a manual medical examination, which is an elastic protective garment (1, 1 ', 1 "to be used for the examination) , 1 "', 10, 20), a test strip (2, 2', 2", 2 "', 12, 22, 22') having a coating with an indicator (2.2, 2.2 ', 16) for measuring the pH Has values of the vaginal fluid, characterized by

A double-sided adhesive tape (2.3, 11) for attaching the test strip to a section (1.1, 1.1 ", 1.1" ', 10.1) of the protective clothing.

2. Device according to claim 1 or its preamble, in which the

Indication middle layer (2.2, 2.2 ', 16) has a cover (13, 23, 23', 23 ", 23"') by which it is partially covered in such a way that the covered areas are deprived of the effect of the body's own fluid, wherein the color of the cover onsmittels substantially corresponds to the color of the indication-and in the initial state within a specified ^differently surrounded therapeutic area or in which the cation Indi¬ middle layer in the immediate vicinity of a region is disposed, which is substantially of the color of the indication means in the initial state and within a given indication range.

3. Device according to claim 2, in which the cover (13, 23, 23 ', 23 ", 23 *") is designed in the form of a template and has recesses (17, 27, 27.1, 27', 27 ") through which the indicator medium layer (2.2, 2.2 ', 16) comes into active contact with the body's own fluid, for example the vaginal fluid.

4 • Device according to claim 2 or 3, wherein the recess or the area has the shape of a circle or a rectangle (17) and / or form an attention symbol (27, 27.1, 27 ', 27 "), which of the Addressees are recognized as a hazard warning without further thought.

5. The device according to claim 4, in which the symbol em attention or exclamation mark (27, 27.1) and / or em generally understood! icncε warning sign {21 ') or a generally understandable

(27 ") is provided.

6. device; r: a:! ι one of claims 2 to 5, wherein the cover (] 3, 13, 23 ', 23 ", 23"') or the area is designed as an opaque film.

7. The device according to claim 6, wherein the cover ^" (13, -23, 23 ', 23", 23 "') or the area is fixed by gluing on the indicator medium layer (2.2, 2.2 ', 16) and consists of a colored, preferably sunflower-colored, plastic.

8. The device according to claim 7, wherein the color corresponds to the hue that the indicator layer (2.2, 2.2 ', 16) assumes when the vaginal fluid has a pH value corresponding to a healthy vaginal milieu.

9. Device according to one of claims 2 to 8, wherein the cover (23 ') or the area has a color gamut (25) with graded from sunflower yellow to ocher colored hues which are in the direction of the longitudinal axis (22.1') of the test strip (22 ') and which essentially contains all shades of color which the indicator middle layer (2.2, 2.2', 16) can assume when examining the vaginal fluid.

10. Device according to one of the preceding claims, in which a test strip is provided with a support (2.1, 18, 28) printed with the middle layer of indicators (2.2, 2.2 ', 16) and / or the region.

11. Device according to one of the preceding claims, in which the double-sided adhesive tape (2.3, 21) of one side (2.4) is connected to the carrier (2.1, 28) of the indicator medium layer (2.2) and to the other side (2.6 ) can be attached to a part (1.1, 1.1 ", 1.1"'10.1) of the protective clothing (1, 1', 1 ", 1"', 10, 20) to be used for the examination.

12. The device according to claim 11, wherein an adhesive-free grip tab (2.5, 2.5 ', 21.1) is provided at one end of the double-sided adhesive tape (2.3, 21) used to fasten the test strip (2, 2').

13. Device according to one of the preceding claims, in which a removal device is provided for the test strip in the form of a carrying strip (29) wound into a tear-off roll (40), on which a plurality of similar test strips (12) are arranged in a serial arrangement. are located, the longitudinal axis of which extends parallel to the longitudinal axis of the supporting strip (29).

14. Device according to one of the preceding claims, in which an embodiment of the protective clothing is provided as a glove (1, 1 ", 1" ', 10) or as a finger cot (1', 20), with at least two on the inside of the glove Comparative colors 19.1, 19.2 having a scale (19) is arranged, which limit the color range for the pH value in a healthy vaginal milieu.

15. The apparatus of claim 14, wherein the protective clothing (1, 1 ', 1 ", 1'", 10, 20) is made of polyethylene.

16. The apparatus of claim 14, wherein the test strip (2, 2 ", 2"') on an examination finger, in particular ^{¬ in} particular the index finger (1.3, 1.1 ", 1.1"', 10.1) of the glove (1, 1 " , 1 "', 10) is attached.

17. Device according to one of claims 14 to 16, in which the ratio of the flat size of the test strip (2 ", 2" ') to the surface of the inside of the ühterκx ± rurιgs £ ιn- gers (1.1 ", 1.1"') des Glove (1 ", 1 '") or the finger has a value small to 1, preferably in the range of 5'ό.

18. Device according to one of claims 16 or 17, in which the test strip (2 ", 2"') in an examination provided for self-examination of a patient in the middle ° and in the region of the tip of the examination finger (1.1 ") or in one provided for the examination by the doctor Aus¬ leadership eccentrically and (1.1 "') or of the fingerstall is arranged in the central region of the examination ^¬ fingers.

19. Device according to one of the preceding claims 5, wherein a package (5, 50) for a plurality of

Protective clothing means with a plate-shaped bottom (6, 51) is vorgeselK ", which has at least one shape (6.1, 51.1, 31 .. ') for receiving a protective clothing means (1, 1', 1", ^' . "', 10, 20) and which has at its boundary edges 0, preferably Lascnei i ^' .l, 7.2, 8.1, 8.2, 52.1, 52.2, 53.1, 53.2) articulated in pairs foldable, which in the unfolded state has the bottom (6, 51) cover completely, with an overlap of part of the tabs (7.1, 7.2, 52.1, 52.2) by the remaining 5 tabs (8.1, 8.2, 53.1, 53.2).

20. Device according to claim 19, in which the preferably overlapping bottom, preferably rectangular pulls in pairs foldable tabs (8.1, 8.2, 53.1, 53.2) formed at their free ends connectable smd.

21. The apparatus according to claim 19, wherein the flaps (8.1, 8.2) spanning the floor have at their free ends an adhesive overlap (8.3) or, alternatively, a slit and a tongue (54) that can be inserted in this slit.

22. The apparatus of claim 21, in which a tear-open tongue (9) is provided at the overlap-free end of the tab (8.1).

23. The apparatus of claim 19, wherein the Ausformun¬ gene (6.1, 51.1, 51.2) are each provided with a detachably attached, a tear tab (6.3) having cover sheet (6.2) ver¬.

24. The apparatus of claim 19, wherein the bottom (6, 51) made of plastic, cardboard or of a substantially cardboard-like material and the foldable tabs (7.1, 7.2, 8.1, 8.2, 52.1, 52.2, 53.1, 53.2) made of cardboard or consist of a substantially cardboard-like material and have a print that indicates the contents of the package and its application.

25. The device according to any one of claims 19 to 24, wherein the packaging is designed as a reusable packaging (5, 50).