Patent Publication Number: US-2020278338-A1

Title: Diagnostic medical device and methods of use thereof

Description:
RELATED APPLICATIONS 
     This application is a divisional of pending U.S. Non-Provisional patent application Ser. No. 15/009,979, filed Jan. 29, 2016, the entire contents of which is incorporated by reference herein by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to handheld electronic devices, and more particularly to diagnostic (fluid testing) medical devices. 
     BACKGROUND INFORMATION 
     Medical devices include diagnostic devices to determine a medical condition of a patient or other person. Diagnostic medical devices include fluid testing medical devices, which may be used to test bodily fluids of a person. One such diagnostic medical device is a blood glucose meter, which is used as a diagnostic device to determine blood glucose levels of a person having diabetes mellitus. 
     Blood glucose meters use a test strip that receives a blood sample from a person when placed thereon. The blood glucose meter includes a test strip port to receive the test strip. The test strip includes electrical contacts that are electrically coupled to the meter when the test strip is inserted into the meter. The meter may then determine a blood glucose level by measuring electrical current passed through the electrical contacts of the strip, and provide a determination of the glucose concentration level in the person&#39;s blood with an algorithm. 
     As may be appreciated, a person may have to measure their blood glucose level at various times during a day. As such, the blood glucose meter typically remains with the person. Unfortunately, the meter may be stored or otherwise placed in environments where solid (e.g. dirt) and liquid (e.g. water) debris may enter the test strip port, which may damage the blood glucose meter from proper operation. 
     It also may be appreciated that a person may have to measure their blood glucose level at night. As such, if surrounding artificial light is not present, it may become difficult to properly place the test strip in the test strip port. 
     SUMMARY 
     The present disclosure provides medical devices, particularly diagnostic (fluid testing) medical devices which make use of a test strip to test bodily fluid of a body, particularly that of a person or animal. More particularly, the diagnostic medical devices may be blood glucose meters, which are used as diagnostic devices to a determine blood glucose level of a person or animal having diabetes mellitus. 
     The diagnostic (fluid testing) medical devices disclosed herein include a test strip port having a test strip port receptacle to receive the test strip. The test strip port may be lighted to assist in proper placement of a test strip in the test strip port at night or otherwise low light conditions. The test strip port may also be protected from egress of solid particulate as well as liquid. 
     In certain embodiments, a medical device to test bodily fluid may comprise a light emitting source, the light emitting source arranged to emit light inside the medical device; a test strip port, the test strip port having a test strip port receptacle to receive a test strip; and the light emitting source and the test strip port arranged such that, when the light emitting source emits light, at least a portion of the light emitted from the light emitting source is redirected inside the medical device to provide redirected light inside the medical device, and at least a portion of the redirected light lights the test strip port from inside the medical device in a manner than the redirected light is visible outside the test strip port. 
     In certain embodiments, the test strip port may include a light guide comprising a light guide annular ring defining a light guide annular ring opening, the light guide annular ring arranged such that, when a test strip is received into the test strip port receptacle, the test strip extends through the light guide annular ring opening; and the light guide is arranged to receive light emitted from the light emitting source and redirect at least a portion of the light from the light emitting source towards the light guide annular ring to light the light guide annular ring from inside the medical device. In certain embodiments, the light guide is translucent or transparent. 
     In certain embodiments, the light guide may be formed from a thermoplastic polymer composition. In certain embodiments, the thermoplastic polymer composition may include at least one translucent polymer and/or at least one transparent polymer. In certain embodiments, the thermoplastic polymer composition may include at least one of polycarbonate, polyurethane, polystyrene and polymethyl methacrylate. 
     In certain embodiments, the medical device to test bodily fluid may further comprise an outer cover which is detachable from the medical device and reattachable to the medical device, and the test strip port may be fastened to the outer cover. In certain embodiments, the light guide of the test strip port may be fastened to the outer cover. 
     In certain embodiments, the test strip port may include a test strip connector, the test strip connector including electrical contacts which electrically couple with the test strip, and the light guide may form a pocket with the outer cover which receives a portion of the test strip connector. 
     In certain embodiments, the light emitting source may be arranged such that, when a test strip is received into the test strip port receptacle, the light from the light emitting source is aimed substantially transverse to a longitudinal axis of the test strip and towards the test strip. 
     In certain embodiments, the light guide may be arranged to redirect at least a portion of the light from the light emitting source approximately ninety degrees towards the light guide annular ring such that the redirected light travels substantially parallel to the longitudinal axis of the test strip. 
     In certain embodiments, the test strip port may further comprise a seal which inhibits ingress of at least one of solid particulate and water into the test strip port receptacle. 
     In certain embodiments, the seal may provide an ingress protection rating of IP22 when tested in accordance with International Standard IEC 60529:1989+A1:1999(E) of the International Electrotechnical Commission. 
     In certain embodiments, the seal may include a closure flap which extends over at least a portion of the test strip port receptacle. 
     In certain embodiments, the test strip port may include a light guide comprising a light guide annular ring defining a light guide annular ring opening, the light guide annular ring arranged such that, when a test strip is received into the test strip port receptacle, the test strip extends through the light guide annular ring opening, and the light guide may be arranged to receive light emitted from the light emitting source and redirect at least a portion of the light from the light emitting source towards the light guide annular ring to light the light guide annular ring from inside the medical device, the seal closure flap may extend over at least a portion of the light guide annular ring opening to inhibit the ingress of at least one of the solid particulate and the water into the test strip port receptacle. 
     In certain embodiments, the seal may comprise a seal annular ring defining a seal annular ring opening, the seal annular ring arranged such that, when a test strip is received into the test strip port receptacle, the test strip extends through the seal annular ring opening. 
     In certain embodiments, the seal may be formed from an elastomeric polymer composition. The elastomeric polymer composition may include at least one translucent polymer and/or at least one transparent polymer, and the elastomeric polymer composition may include at least one elastomer. The at least one elastomer may be a (silicone) rubber. In certain embodiments, the seal may be translucent or transparent. 
     The present disclosure also provides a handheld electronic device comprising a main body, a cover engageable to the main body by engagement of a snap-fit connection and disengageable from the main body by disengagement of the snap-fit connection, the snap-fit connection engageable by translational motion of the cover relative to the main body, and the snap-fit connection disengageable by rotational motion of the cover relative to the main body, while the snap-fit connection is not disengageable by translational motion of the cover relative to the main body. 
     In certain embodiments, the main body comprises a center axis and at least two resilient cantilevered arms, and the at least two resilient cantilevered arms are arranged to move towards and away from the center axis. 
     In certain embodiments, the at least two resilient cantilevered arms are arranged to move towards each other during engagement of the snap-fit connection. 
     In certain embodiments, the at least two resilient cantilevered arms each include at least one engagement tab, the cover includes at least two engagement tab receptacles, and each of the at least two engagement tab receptacles is configured to receive one of the engagement tabs. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
       The above-mentioned and other features of this disclosure, and the manner of attaining them, will become more apparent and better understood by reference to the following description of embodiments described herein taken in conjunction with the accompanying drawings, wherein: 
         FIG. 1  is a front (plan) view of a medical device according to the present disclosure; 
         FIG. 2  is a top end view of the medical device of  FIG. 1 ; 
         FIG. 3  is a partial perspective view of the medical device of  FIG. 1 ; 
         FIG. 4A  is a rear (plan) view of the medical device of  FIG. 1  with a test module; 
         FIG. 4B  is a rear (plan) view of the medical device of  FIG. 1  without the test module; 
         FIG. 5  is an inner perspective view of the test module; 
         FIG. 6A  is a side view of the medical device of  FIG. 1  before the test module is attached to the main body of the medical device; 
         FIG. 6B  is cross-sectional end view of the medical device of  FIG. 6A  taken along line  6 B- 6 B of  FIG. 6A ; 
         FIG. 6C  is an enlarged cross-sectional end view of the portion of the medical device within circle  6 C of  FIG. 6B ; 
         FIG. 7A  is a side view of the medical device of  FIG. 1  while the test module is being attached to the main body of the medical device; 
         FIG. 7B  is cross-sectional end view of the medical device of  FIG. 7A  taken along line  7 B- 7 B of  FIG. 7A ; 
         FIG. 7C  is an enlarged cross-sectional view of the portion of the medical device within circle  7 C of  FIG. 7B ; 
         FIG. 7D  is partial cross-sectional plan view of the medical device of  FIG. 7A  taken along line  7 D- 7 D of  FIG. 7A ; 
         FIG. 8A  is a side view of the medical device of  FIG. 1  after the test module is attached to the main body of the medical device; 
         FIG. 8B  is cross-sectional end view of the medical device of  FIG. 8A  taken along line  8 B- 8 B of  FIG. 8A ; 
         FIG. 8C  is an enlarged cross-sectional view of the portion of the medical device within circle  8 C of  FIG. 8B ; 
         FIG. 8D  is partial cross-sectional plan view of the medical device of  FIG. 8A  taken along line  8 D- 8 D of  FIG. 8A ; 
         FIG. 9A  is a side view of the medical device of  FIG. 1  during removal of the test module where the test module is rotated at an angle A of 5 degrees relative to the x-y plane and longitudinal axis LA; 
         FIG. 9B  is a side view of the medical device of  FIG. 1  during removal of the test module where the test module is rotated at an angle A of 15 degrees relative to the x-y plane and longitudinal axis LA; 
         FIG. 10  is an inner view of a cover of the test module of the medical device of  FIG. 1  before assembly of the electronic components with the cover; 
         FIG. 11  an inner view of the test module of the medical device of  FIG. 1  after assembly of the electronic components with the cover; 
         FIG. 12  is a close-up inner view of the test module of  FIG. 11  without the electronic components; 
         FIG. 13  is close-up inner view of the test module of  FIG. 11 ; 
         FIG. 14  a perspective view of a light guide of the test module of the medical device of  FIG. 1 ; 
         FIG. 15  is a perspective view of the light guide and a seal of the test module of the medical device of  FIG. 1 ; 
         FIG. 16  is a cross-sectional side view of the test module of the medical device of  FIG. 5  taken along line  16 - 16  of  FIG. 13  without the cover; and 
         FIG. 17  is a cross-sectional side view of the medical device of  FIG. 1  taken along line  17 - 17  of  FIG. 1  with a test strip inserted in the test strip port. 
     
    
    
     DETAILED DESCRIPTION 
     It may be appreciated that the present disclosure is not limited in its application to the details of construction and the arrangement of components set forth in the following description or illustrated in the drawings. The invention(s) herein may be capable of other embodiments and of being practiced or being carried out in various ways. Also, it may be appreciated that the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting as such may be understood by one of skill in the art. 
     By way of brief introduction, the present disclosure discloses medical devices, particularly diagnostic (fluid testing) medical devices which make use of a test strip to test bodily fluid of a person or animal. More particularly, the diagnostic medical devices may be blood glucose meters, which are used as diagnostic devices to a determine blood glucose level of a person or animal having diabetes mellitus. 
     Referring now to the drawings, particularly  FIGS. 1-5 , there is shown a handheld, electronic, diagnostic (fluid testing) medical device  10 , and more particularly a blood glucose meter. As shown, device  10  includes a test strip port  32 . As best shown in  FIGS. 2-3 , test strip port  32  comprises a test strip receptacle  34  to receive a disposable test strip  2  therein (see e.g.  FIG. 17 ). More particularly test strip  2  may be a blood glucose test strip. While medical device  10  may be referred to in particular embodiments herein as a blood glucose meter, the disclosure should not be understood as being limited to blood glucose meters. 
     Blood glucose meter  10  includes comprises a main body  12 . Among other features, main body  12  includes a visual output display panel  14  to display test results. 
     Main body  12  also includes an enclosure  16  which contains the visual display  14 . Enclosure  16  comprises a front housing  18  and a rear housing  20  which provide a housing to protect at least a portion of the main body electronic components contained in the blood glucose meter  10 . 
     Blood glucose meter  10  also includes a removable/detachable and replaceable/reattachable test module  30  which includes the test strip port  32 . However, the configuration of the test module  30  and main body  12 , and more particularly the following assembly/latching mechanism, may inhibit disassembly/unlatching of the test module  30  by a patient, or other individual/person unauthorized for such removal. 
     As shown, test module  30  may be mechanically fastened to the main body, particularly by two mechanical fasteners  22 , which may particularly comprise threaded fasteners such as screws. 
     Test module  30  comprises a test module cover  36  to which electronic components  40  of the test module  30  are fastened, which includes at least one printed circuit board. 
     Referring now to  FIGS. 6A-8D , the test module  30  may be assembled to the main body  12  with a snap-fit connection by being pressed onto the main body  12 , particularly with an assembly force F being applied to the test module  30  transverse to a Cartesian plane CP (parallel with the z-axis) of the main body  12 , which may be understood as the x-y reference plane of the Cartesian x, y, z coordinate system (shown in  FIGS. 1 and 2 ). 
     More particularly, in addition to the use of separate mechanical fasteners  22 , test module  30  may also be detachably fastened to main body  12  by a positive mechanical engagement which provides the snap-fit connection. As shown in  FIGS. 6A-6C , the positive mechanical engagement may be created by two opposing engagement tabs  44  provided on the lateral outer sides of resilient cantilevered arms  46  of the main body  12 , which enter two opposing mating engagement tab receptacles  48 , respectively, formed in the cover  36 . 
     During assembly, as shown in  FIGS. 7A-7D , and more particularly  FIG. 7C , each engagement tab  44  of resilient cantilevered arms  46  bears against an inwardly directed opposing engagement tab  49  of test module cover  36 , respectively forcing each cantilevered arm  46  to move inwards from an initial first position (as shown in  FIG. 6C ) and deflect with elastic deformation towards one another, which inward deflection is biased by the resiliency thereof. More particularly, each cantilevered arm  46  may rotate about the z-axis in the x-y (Cartesian) plane, with each arm moving predominately in the x direction towards the center of the main body  12 . 
     As shown in  FIG. 7C , once each cantilevered arm  46  moves to a second position at which the arm  46  deflects inwards a sufficient distance to enable the engagement tabs  44  of each arm  46  to clear the opposing engagement tab  49  of test module cover  36 , and enter engagement tab receptacles  48  provided by the test module cover  36 , the resiliency of each cantilevered arms  46  may then return each cantilevered arm  46  to its first position as shown in  FIGS. 8A-8D , and more particularly  FIG. 8C . More particularly, as each engagement tab  44  enters the engagement tab receptacle  48  formed in the test module cover  36 , the cantilevered arms  46  rotate outwards to form the positive mechanical engagement and complete assembly of the overlap snap fit connection. 
     Once assembled, transversely extending peripheral lip  43  and ribs  37  ( FIG. 5 ) of the test module  30  may positively mechanically engage within a mating transverse peripheral groove  45  and rib receptacles  39  (transverse to the x-y plane) of the main body  12 , respectively, to inhibit the test module  30  from sliding off the main body  12  along the x-y plane. 
     As set forth above, the test module  30  may be initially secured by mechanical fasteners  22 . However, the mechanical fasteners  22  may be removed in the field. To thwart disassembly of test module  30  in the absence of mechanical fasteners  22 , as also explained above, the test module  30  is first configured to inhibit being slid off the main body  12  along the x-y plane. Furthermore, the positive mechanical engagement formed between the main body  12  and test module  30  inhibits the test module  30  from being separated transverse to the x-y plane. 
     Referring now to  FIGS. 9A-9B , in order to disassemble test module  30  from the main body  12  after the removal of mechanical fasteners  22 , the test module  30  may be rotated relative to the main body  12 . More particularly, the test module  30  may be rotated about an axis transverse to the longitudinal axis LA (e.g. x-axis), which is shown further as a center axis, particularly by lifting laterally extending medial edge  47  of test module cover  36 . In such manner, a medial region  41  of the test module  30  may be lifted relative to a peripheral region  42  of the test module  30 . As the medial region  41  of the test module  30  is raised, such may cause each engagement tabs  44  on the lateral outer sides of resilient cantilevered arms  46  of the main body  12  to once again bear against inwardly directed opposing engagement tab  49  of test module cover  36 , respectively forcing each cantilevered arm  46  to cantilever inwards, forcing each cantilevered arm  46  to deflect inwards with elastic deformation towards one another, which is biased by the resiliency thereof. Once each cantilevered arm  46  deflects inwards a sufficient distance to enable the engagement tabs  44  to clear engagement tabs  49  and exit engagement tab receptacles  48  formed in cover  36 , the test module  30  is passively released and the resiliency of each cantilevered arms  46  may then return each cantilevered arm  46  to its first position. 
     The configuration of the test module  30  and main body  12 , and more particularly the foregoing disassembly mechanism, is configured to passively release the test module  30  when the test module  30  is rotated at an angle A of 5-30 degrees relative to the longitudinal axis LA, and more particularly 10-20 degrees relative to the longitudinal axis LA. 
     Now, to further thwart undesirable disassembly of the test module  30 , as the medial region  41  of the test module  30  is lifted relative to a peripheral region  42  of the test module  30 , the force required to lift the medial region increases (due to increasing resistance of the positive mechanical engagement) as the angle A increases, until the test module  30  is passively released. In light of such, to a person untrained in disassembly of the test module  30 , the increase in force to lift the medial region  41  may give an impression that the test module  30  may break if lifted in a manner as set forth above, causing attempted disassembly to be abandoned. However, no portion of the main body  12  or test module  30  is intended to break. 
     From the foregoing description, a medical device  10  is provided in which the test module cover  36  is engageable to the main body  12  by engagement of a snap-fit connection and disengageable from the main body  12  by disengagement of the snap-fit connection. More particularly, the snap-fit connection is engageable by translational motion of the test module cover  36  relative to the main body  12 , and disengageable by rotational motion of the test module cover  36  relative to the main body  12 , while not being disengageable by translational motion of the test module cover  36  relative to the main body  12 . It should be understood that medical device  10  may be any electronic device, and not be limited to a medical device. 
     Furthermore, it should be understood that the main body  12  comprises a center axis, such as the longitudinal axis LA, and the cantilevered arms  46  are arranged to move towards and away from the center axis, particularly during engagement/disengagement of the snap-fit connection. More particularly, the cantilevered arms  46  are arranged to move towards each other, as well as away from each other during engagement/disengagement of the snap-fit connection. 
     Turning to operation of the test module  30 , and  FIGS. 10-17 , the entrance to the test strip receptacle  34  is provided by a narrow slot (through hole)  38  formed in the test module cover  36 . Referring particularly to  FIG. 16 , the test strip receptacle  34  thereafter extends through seal  50 , light guide  52  and into a test strip connector  54 , which electrically couples test strip  2  to the electronic components  40  of the test module  30 . Once a test strip  2  is inserted within test strip receptacle  34  and properly seated therein, and blood is placed thereon, the blood glucose meter  10  may then determine a blood glucose level by measuring electrical current passed through the electrical contacts of the test strip  2  in a known manner, and provide a determination of the glucose concentration level in the blood. 
     In order to light the test strip port  32  to assist in proper placement of a test strip  2  in the test strip port  32  at night or otherwise low light conditions, light guide  52  receives light from a light emitting source  24  of the blood glucose meter  10  which may be located in the main body  12  (see  FIG. 17 ). Light emitting source  24  may comprise at least one light emitting diode (InGaN, water clear lens, viewing angle 120°/20.5) which emits white (visible) light in a wavelength of 390-700 nm (or frequency range of 430-770 THz) and a luminous intensity in a range of 200-900 millicandela, and more particularly 400-700 millicandela, when tested in accordance with CIE127-2007 (I F =5 mA) standards. 
     As best shown by  FIGS. 14-15 , light guide  52  includes a U-shaped section  60  and an oblong annular ring section  62  defining a slot (through hole)  64 . As shown, U-shaped section  60  includes a horizontal center span  66  disposed between two spaced apart vertical stanchions  72  which are transverse to the center span  66 . Center span  66  includes a centrally disposed cylindrical light receiving post  68  having a planar, circular light receiving surface  70  arranged to receive light from the light emitting source  24  of the main body  12 . 
     As shown by  FIG. 12-13 , the vertical stanchions  72  of the U-shaped section  60  are fastened to the inner surface of test module cover  36 , particularly by adhesive. The center span  66  and the stanchions  72  form a recess pocket  74  which contains an end lip portion  56  of test strip connector  54 . Together, the center span  66  of the U-shaped section  60  of the light guide  52  and the end lip portion  56  of test strip connector  54  define a portion of the test strip receptacle  34 , including a slot  76  therebetween to accommodate test strip  2  as it extends through slot  38  in the test module cover  36 , slot  64  in the oblong annular ring section  62  of the light guide  52  and completely into test strip connector  54 . 
     In order to transmit light, light guide  52  is formed of a light transmissive polymer composition. As used herein, a light transmissive polymer composition may be characterized as providing integral transmission of at least 60% of incident light in the visible spectrum (about 400-700 nm wavelength), and more preferably at least 70% of incident light in the visible spectrum, and even more preferably, at least 80% or 90% of incident light in the visible spectrum. A light transmissive polymer composition may be optically translucent and, more preferably, an optically transparent. The light transmissive polymer composition may be a thermoplastic polymer composition which is suitable for injection molding. The thermoplastic light transmissive polymer composition may comprise at least one transparent polymer such as polycarbonate, polyurethane, polystyrene and polymethyl methacrylate. 
     With the foregoing arrangement, the light emitting source  24  is arranged to emit light inside the medical device  10 . In addition, the light emitting source  24  and the test strip port  32  are arranged such that, when the light emitting source  24  emits light, at least a portion of the light emitted from the light emitting source  24  is redirected inside the medical device  10  to provide redirected light inside the medical device  10 , and at least a portion of the redirected light lights the test strip port  32  from inside the medical device  10 . 
     More particularly, the light guide  52  is arranged to receive light emitted from the light emitting source  24  and redirect at least a portion of the light from the light emitting source  24  towards the light guide annular ring  62  to light the light guide annular ring  62  from inside the medical device  10 . 
     More particularly, the light emitting source  24  is arranged such that, when a test strip  2  is received into the test strip port receptacle  34 , the light from the light emitting source  24  is aimed substantially transverse to a longitudinal axis of the test strip  2  and towards the test strip  2 . The light guide  52  is arranged to redirect at least a portion of the light from the light emitting source  24  approximately ninety degrees towards the light guide annular ring  62  such that the redirected light travels substantially parallel to the longitudinal axis of the test strip  2 . 
     When light is emitted from light emitting source  24  into light receiving post  68  of light guide  52 , light guide  52  is configured such that the light from the oblong annular ring section  62  of the light guide  52  will be emitted in the form of annular ring around the test strip  2 , which may be oriented substantially parallel with the longitudinal axis of the test strip  2  upon insertion of the test strip  2  into the test strip port  32 . 
     While blood glucose meter  10  may be configured to automatically light the test strip port  32  in response to receiving a test strip  2  therein, blood glucose meter  10  may also be configured to light test strip port  32  in response to manual push button activation, such as by pushing activation (on/off) button  26  as shown in  FIGS. 2 and 3 . To save power, the blood glucose meter  10  may include an ambient light sensor  28  to disable such functionally when ambient light is above a predetermined level. 
     While visible (white) light may be preferred to light the test strip  2 , light emitting source  24  may be configured to emit various individual colors of the electromagnetic spectrum. For example, the light emitting source  24  may emit red (620-700 nm), yellow (570-590 nm) or green (495-565 nm) light as an indicator of port status (e.g. green is ready for use, yellow is not ready for use and red is to report an error), or the light may blink to remind the patient to test their blood glucose level. 
     Test strip port  32  may also be protected from egress of solid particulate as well as liquid by seal  50 . Similar to light guide  52 , seal  50  includes an oblong annular ring section  92  defining a slot (through hole)  94 . Oblong annular ring section  92  is disposed on an intermediate section  80  of the light guide  52  disposed between a shoulder  82  of the U-shaped section  60 , and the oblong annular ring section  62 . Oblong annular ring section  92  forms a seal against the shoulder  82  of the U-shaped section  60  and the inner surface of test module cover  36  surrounding slot  38  formed in the test module cover  36 . In this manner, external debris is inhibited from entering test strip port  32  between seal  50  and test module cover  36 . 
     Oblong annular ring section  92  further includes an elastically deformable U-shaped entrance door flap  96  which is in a closed position when test strip  2  is not within the test strip port  32 , and which may rest against (i.e. be in connect with the inner side of oblong annular ring section  62  of light guide  52 . At this time, the entrance door flap  96  is in a closed position which substantially closes slot  64  of the light guide  52  to inhibit external debris from entering test strip port  32 , and more particularly inhibits debris from entering the test strip receptacle  34  beyond slot  64  in the oblong annular ring section  62  of the light guide  52 . 
     When test strip  2  is inserted within test strip port  32 , elastically deformable entrance door flap  96  deforms elastically inward, particularly along a hinge portion  98 , upon being contacted by test strip  2  to open slot  64  in the oblong annular ring section  62  of the light guide  52  and correspondingly open slot  94  in the oblong annular ring section  92  of seal  50 . Entrance door flap  96  may rotate at an angle θ in a range of, for example of 60 to 90 degrees. 
     Seal  50  may be particularly formed of an elastomeric polymer composition. As used herein, an elastomeric polymer composition may be characterized as a composition that has an elongation at 23° C. of at least 100%, and which, after being stretched to twice its original length and being held at such for one minute, may recover in a range of 50% to 100% within one minute after release from the stress. More particularly, the elastomeric polymer composition may recover in a range of 75% to 100% within one minute after release from the stress, and even more particularly recover in a range of 90% to 100% within one minute after release from the stress. The elastomeric polymer composition may be a composition with a Tg below room temperature and which is at most, 50% crystalline (i.e., the material contains an amorphous phase of 50% or greater, up to 100% amorphous phase). The elastomeric polymer composition may comprise a thermoplastic polymer composition which is suitable for injection molding. The elastomeric polymer composition may comprise at least one thermoplastic elastomer, such as styrene block polymers, such as styrene block copolymers (e.g. styrene-butadiene copolymer) and styrene block terpolymers (e.g. styrene-butadiene-styrene terpolymer, styrene-ethylene/butylene-styrene terpolymer, styrene-ethylene/propylene-styrene terpolymer); polyolefin blends (e.g. polypropylene and ethylene-propylene-diene monomer rubber, polypropylene and nitrile rubber, ethylene-propylene rubber); elastomeric alloys such as melt-processable rubbers and thermoplastic vulcanizates; polyolefins; polyurethanes; polyesters; and rubbers such as natural rubber, neoprene rubber, acrylic rubber, butadiene rubber, butyl rubber, ethylene-propylene rubber, ethylene propylene diene monomer rubber, fluorocarbon rubber, isoprene rubber, nitrile rubber, polyurethane rubber and silicone rubber. 
     The seal  50  may also be formed of a rigid polymer composition, particularly where the hinge portion  98  may be configured as a living hinge. Example materials include polypropylene or acrylonitrile-butadiene-styrene. 
     Furthermore, the elastomeric polymer composition of seal  50  may also be a light transmissive polymer composition. As used herein, a light transmissive polymer composition may be characterized as providing integral transmission of at least 60% of incident light in the visible spectrum (about 400-700 nm wavelength), and more preferably at least 70% of incident light in the visible spectrum, and even more preferably, at least 80% or 90% of incident light in the visible spectrum. A light transmissive polymer composition may be optically translucent and, more preferably, an optically transparent. 
     With the foregoing constriction, seal  50  of the test strip port  32  of blood glucose meter  10  may passively seal to inhibit external debris, liquid (e.g. water) and solid (e.g. dirt), from entering the test strip port. More particularly, test strip port  32  may be sealed to meet IP22 fluid and particulate ingress requirements for home use medical products per International Electrotechnical Commission International Standard IEC 60529:1989+A1:1999(E), which is incorporated herein by reference. 
     The IP Code, International Protection Marking or IEC standard 60529, sometimes interpreted as Ingress Protection Marking or IP Rating, classifies and rates the degree of protection provided against intrusion (body parts such as hands and fingers), dust, accidental contact, and water by mechanical casings and electrical enclosures. It is published by the International Electrotechnical Commission (IEC) as noted above. 
     For example, an electrical socket rated IP22 is protected against insertion of fingers and will not be damaged or become unsafe during a specified test in which it is exposed to vertically or nearly vertically dripping water. The first digit indicates the level of protection that the enclosure provides against ingress of solid foreign objects. A level of 2 corresponds to the enclosure providing protection against ingress of objects greater than 12.5 mm, which is effective against fingers or similar objects. The second digit indicates the level of protection that the enclosure provides against harmful ingress of water. A level of 2 corresponds to the enclosure providing protection against ingress of dripping water when tilted up to 15 degrees (i.e. vertically dripping water shall have no harmful effect when the enclosure is tilted at an angle up to 15° from its normal position). The enclosure is tested for 10 minutes, with a water equivalent to 3 mm rainfall per minute. 
     Furthermore, when light is emitted from light emitting source  24  into light receiving post  68  of light guide  52 , light guide  52  is configured such that light will be transmitted and directed into the oblong annular ring section  92  of seal  50  such that light from the oblong annular ring section  92  of the seal  50  will be emitted in the form of annular ring around the test strip  2 . 
     Moreover, when light is emitted from light emitting source  24  into light receiving post  68  of light guide  52 , light guide  52  is configured such that light will be transmitted and directed into the door flap  96  of seal  50  such that light will be emitted from the door flap  96  of the seal  50 . 
     In addition to the foregoing, medical device  10  may also provide protection against electrostatic discharge (ESD). For example, medical device  10  may comply with International Standard IEC 60601-2-24:2012, as tested per IEC 61000-4-2: 2008, incorporated by reference, (Electromagnetic compatibility (EMC)—Part 4: Testing and measurement techniques—Section 2: Electrostatic Discharge Immunity Test) at a level of +/−8 kV contact discharge and +/−15 Kv air discharge. 
     While the principles of the invention have been described herein, it is to be understood by those skilled in the art that this description is made only by way of example and not as a limitation as to the scope of the invention. Other embodiments are contemplated within the scope of the present invention in addition to the exemplary embodiments shown and described herein. Modifications and substitutions by one of ordinary skill in the art are considered to be within the scope of the present invention, which is not to be limited except by the following claims. 
     LIST OF REFERENCE CHARACTERS 
     
         
         
           
               2  test strip 
               10  medical device 
               12  main body 
               14  visual display 
               16  main body enclosure 
               18  front housing 
               20  rear housing 
               22  mechanical fasteners 
               24  light emitting source 
               26  light emitting source activation (on/off) push button 
               28  ambient light sensor 
               30  test module 
               32  test strip port 
               34  test strip receptacle 
               36  test module cover 
               37  ribs 
               38  test module cover slot 
               39  rib receptacles 
               40  test module electronic components 
               41  medial region 
               42  peripheral region 
               43  transverse lip 
               44  engagement tab 
               45  transverse groove 
               46  cantilevered arm 
               47  medial edge 
               48  engagement tab receptacle 
               49  engagement tab 
               50  seal 
               52  light guide 
               54  test strip connector 
               56  test strip connector end portion 
               60  U-shaped section 
               62  oblong annular ring section 
               64  oblong annular ring section slot 
               66  center span 
               68  light receiving post 
               70  light receiving surface 
               72  stanchion 
               74  recess pocket 
               76  slot 
               80  intermediate section 
               82  shoulder 
               92  oblong annular ring section 
               94  oblong annular ring section slot 
               96  entrance door flap 
               98  hinge portion 
             A angle