RELATED APPLICATIONS 
       [0001]    This is a continuation-in-part application filed under 35 U.S.C. §111(a) of U.S. application Ser. No. 14/882,715, filed under 35 U.S.C. §111(a) on Oct. 14, 2015, published; which claims priority to U.S. Provisional Application No. 62/064,503, filed under 35 U.S.C. §111(b) on Oct. 16, 2014, and is a continuation-in-part application of international application PCT/US14/36777, filed under the authority of the Patent Cooperation Treaty on May 5, 2014; published; which claims priority to U.S. Provisional Application No. 61/819,747, filed under 35 U.S.C. §111(b) on May 6, 2013. The entire disclosures of all the aforementioned applications are incorporated herein by reference for all purposes. 
     
    
     TECHNICAL FIELD 
       [0002]    The invention relates generally to medical devices. More specifically, the invention is a radial check device. 
       BACKGROUND OF THE INVENTION 
       [0003]    Radial artery access is being increasingly used by physicians for diagnostic and coronary procedures. In preparation for such procedures, the Allen&#39;s test (or modified plethysmography) has been used to determine the patency of the radial and ulnar arteries. This is a manual test in which a healthcare professional, usually a nurse, places his or her thumbs over the radial arteries of a patient while the patient is clenching his or her fists. This compresses the radial arteries. The patient is then asked to open his or her hands into a relaxed position. The healthcare professional then observes the color of the palms, which should normally turn pink promptly. An abnormal test occurs when the color of the palm does not return within eight seconds. This procedure is then repeated by occluding the ulnar arteries. In another form of this test, the fingers of the healthcare professional are used to occlude both the radial and ulnar arteries of the patient. Pressure on the ulnar artery is then removed while maintaining pressure on the radial site. The color of the palm is then observed. This procedure is then performed on the other arm. 
         [0004]    In those patients that require a second procedure through the same radial site, it is often useful to perform a reverse Allen&#39;s test. In this procedure, the healthcare professional releases pressure over the radial artery rather than the ulnar artery. This may detect proximal radial artery disease/occlusion that may be asymptomatic. 
         [0005]    Barbeau&#39;s test is another preparation procedure. This test includes the steps as follows: placing a pulse oximeter (plethysmography) on an index finger or a thumb to demonstrate a normal waveform/tracing and releasing pressure over the ulnar artery and watching the pulse oximetry tracing. The immediate return of normal waveform suggests a normal (positive) test, which is indicative of good ulnar flow and a lower risk of hand ischemia with radial catheterization. If the waveform does not immediately return, one can wait two minutes to evaluate the waveform. If the waveform returns within two minutes, then one can still consider radial catheterization. 

 
         [0006]    It has been found that these tests are deficient for a variety of reasons. For example, they are done in a subjective fashion in which the healthcare professional uses his or her observation of palm color to determine the patency of the arteries. Further, they require extensive expertise and training on the part of the healthcare professional performing the tests. Finally, they do not provide a permanent record of the tests for future use. 
       BRIEF SUMMARY OF THE INVENTION 
       [0007]    The invention provides a medical device that overcomes the deficiencies of the current manual tests as described above. In this regard, the radial check device according to the invention establishes a new standard of pre-procedural care for patients undergoing any type of radial artery canalization. Further, the invention provides a relatively simple automated test that generates documentation of ulnar and radial flow. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0008]      FIG. 1  is a perspective view of an embodiment of the radial check device according to the invention positioned on a patient. 
           [0009]      FIG. 2  is a perspective view of an embodiment of the cuff according to the invention. 
           [0010]      FIG. 3  is a perspective view of an alternative embodiment of the radial check device according to the invention positioned on a patient. 
           [0011]      FIG. 4  is an exploded view of the radial check device shown in  FIG. 3 . 
           [0012]      FIG. 5  is an exploded view of the radial check device shown in  FIG. 3 . 
           [0013]      FIG. 6  is an exploded view of the radial check device shown in  FIG. 3 . 
           [0014]      FIG. 7  is a schematic view of an embodiment of the control system for the radial check device shown in  FIG. 3 . 
           [0015]      FIG. 8A  is a schematic view of an embodiment of the control system for the radial check device shown in  FIG. 3 . 
           [0016]      FIG. 8B  is a schematic view of an embodiment of the control system for the radial check device shown in  FIG. 3 . 
           [0017]      FIG. 9  is a perspective view of an alternative embodiment of the radial check device according to the invention positioned on a patient. 
           [0018]      FIG. 10  is a detailed perspective view of the occlusion cuff and the first and second inflatable portions of the radial check device shown in  FIG. 9 . 
           [0019]      FIG. 11  is a cross-sectional view taken along line  11 - 11  of  FIG. 10 . 
           [0020]      FIG. 12  is a perspective view of an embodiment of the radial check device. 
           [0021]      FIGS. 13A-13B  are side elevational views of the readout device of an embodiment of the radial check device. 
           [0022]      FIG. 14  is a perspective view of a rechargeable battery for the readout device. 
           [0023]      FIG. 15  is view of the graphic user interface (GUI) displayed on the readout device of an embodiment of the radial check device. 
           [0024]      FIG. 16  is an elevational view of the display screen on the readout device. 
           [0025]      FIGS. 17A-17J  are non-limiting schematics of circuit board layouts for use in the readout device of an embodiment of the radial check device. 
           [0026]      FIGS. 18A-18B  are views of a circuit board of the readout device. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0027]    The invention will now be described in detail with reference being made to the drawings. In the drawings, an embodiment of the radial check device according to the invention is indicated generally by the reference number “10.” Referring to  FIG. 1 , the radial check device  10  has an occlusion cuff  12  configured for positioning on a patient&#39;s arm and a pulse oximeter  14  configured for positioning on a patient&#39;s finger, such as an index finger, or thumb. 
         [0028]    As shown in  FIGS. 1-2 , the occlusion cuff  12  has an interior surface  16  and an exterior surface  18 . A first fastener  20  is positioned on the interior surface  16  and a second fastener  22  is positioned on the exterior surface  18 . For example, the first and second fasteners  20  and  22  can be hook and loop-type fasteners that adhere to each other when pressed together. The engagement of the first and second fasteners  20  and  22  position the occlusion cuff  12  on a patient&#39;s arm. 
         [0029]    Still referring to  FIGS. 1-2 , the interior surface  16  of the occlusion cuff  12  includes a first inflatable portion  24  and a second inflatable portion  26 . The first and second inflatable portions  24  and  26  are configured to expand and contract in order to occlude or release one or both of the radial and ulnar arteries when the occlusion cuff  12  is positioned on a patient&#39;s arm as shown in  FIG. 1 . 
         [0030]    As shown in  FIG. 1 , the occlusion cuff  12  has a control member  28  positioned on the exterior surface  18 . In an embodiment, the control member  28  includes an energy source such as a battery to actuate the first and second inflatable portions  24  and  26 , a cuff display screen  30  powered by the battery, and a cuff on/off button  32 . The control member  28  includes hardware, software and/or firmware configured to control the operation of the radial check device  10 . 
         [0031]    Still referring to  FIG. 1 , the pulse oximeter  14  includes first and second finger members  34  and  36  that are connected by a hinge or other device to allow for clamping on a patient&#39;s finger. In an embodiment, the pulse oximeter  14  includes an energy source such as a battery, a pulse oximeter display screen  38  powered by the battery, and a pulse oximeter on/off button  40 . The pulse oximeter  14  includes hardware, software and/or firmware configured to control the operation of the radial check device  10 . 
         [0032]    As shown in  FIG. 1 , the pulse oximeter  14  is operatively connected to the control member  28  as indicated by the line  42 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the pulse oximeter  14  and the control member  28 . 
         [0033]    Still referring to  FIG. 1 , the radial check device  10  includes a recording device  44  that is operatively connected to the control member  28  as indicated by the line  46 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the control member  28  and the recording device  44 . The recording device  44  is used to produce a record of the data being generated by the radial check device  10 . For example, the recording device  44  can be a printing device that produces a paper record of the data. In another example, the recording device  44  can be an electronic device such as a computer that produces an electronic record of the data. In another example, the recording device  44  is integral with the control member  28 . The record can then be entered in a patient&#39;s paper and/or electronic chart to document a test. 
         [0034]    In use, the radial check device  10  is positioned on a patient as shown in  FIG. 1 . In an embodiment, the first and second inflatable portions  24  and  26  are inflated to occlude the radial and ulnar arteries, respectively. The pulse oximeter  14  provides an automated oximetry tracing to the control member  28 . In an embodiment, such tracing is shown on the cuff display screen  30 . The second inflatable portion  26  is then released and the oximetry tracing is transmitted to the recording device  44 . The record produced by the recording device  44  is then entered in the patient&#39;s chart. In an embodiment, the radial check device  10  can perform a reverse Barbeau test to check for radial flow for patients with repeat radial procedures. 
         [0035]    Referring to  FIGS. 3-8B , an alternative embodiment radial check device  50  is shown and described. As shown in  FIG. 3 , the radial check device  50  has an occlusion cuff  52  configured for positioning on a patient&#39;s arm and a pulse oximeter  54  configured for positioning on a patient&#39;s finger, such as an index finger, or thumb. The occlusion cuff  52  has a bottom housing  56 , a top housing  58 , a first end  60 , a second end  62 , a first side  64  and a second side  66 . A first strap  68  is positioned adjacent to the first end  60  and a second strap  70  is positioned adjacent to the second end  62 . For example, the first and second straps  68  and  70  can include hook and loop-type fasteners that adhere to each other when pressed together. The first and second straps  68  and  70  position the occlusion cuff  52  on a patient&#39;s arm. The pulse oximeter  54  can be of the type described above with respect to pulse oximeter  14 . In an embodiment, the pulse oximeter can be of a conventional type. 
         [0036]    Referring to  FIGS. 3-6 , the occlusion cuff  52  includes a first actuator  72  having a first actuator tip  74  and a second actuator  76  having a second actuator tip  78 . For example, as shown in this embodiment, the first and second actuators  72  and  76  can be pneumatic cylinder actuators. However, it should be understood that the first and second actuators  72  and  76  can be any suitable type of actuator that can move the first and second actuator tips  74  and  78 . 
         [0037]    As shown in  FIGS. 4-6 , the first and second actuators  72  and  76  are movably mounted in the bottom housing  56  of the occlusion cuff  52 . In this regard, the first and second actuators  72  and  76  are mounted on an actuator plate  80  that is pivotally positioned on a mounting frame  82  by first and second shafts  84  and  86 . The actuator plate  80  includes a rod  88  that includes first and second rod ends  90  and  92  for mounting first and second knobs  94  and  96 , which are positioned on the first and second sides  64  and  66 , respectively, of the occlusion cuff  52 . The turning of the first and second knobs  94  and  96  causes the first and second actuators  72  and  76  to be moved in order to adjust the first and second actuator tips  74  and  78  with respect to the patient&#39;s arm. As shown in  FIG. 6 , the first and second actuator tips  74  and  78  are positioned on first and second tip housings  98  and  100 , respectively. As shown in  FIG. 6 , the first actuator  72  is in communication with first actuator tubes  102  and  104 , and the second actuator  76  is in communication with second actuator tubes  106  and  108 . 
         [0038]    Referring to  FIGS. 3, 7, 8A, and 8B , the radial check device  50  has a control system  110 . As shown and described in the drawings, the control system  110  generally includes a power supply  112 , a controller  114 , a controller interface  116 , and an actuator control system  118 . The control system  110  includes hardware, software and/or firmware configured to control the operation of the radial check device  50 . 
         [0039]    As shown in  FIGS. 6, 7, 8A and 8B , the actuator control system  118  includes a pump  120  in communication with first, second, third and fourth valves  122 ,  124 ,  126  and  128  that are in communication with the first and second actuator tubes  102 ,  104 ,  106  and  108 . The actuation of the pump  120  controls the actuation of the first and second actuators  72  and  76 . It should be understood that any suitable control system  110  can be used to control the actuation of the first and second actuators  72  and  76 . 
         [0040]    Referring to  FIG. 3 , the radial check device  50  can include a recording device  130  that is operatively connected to the control system  110  as indicated by the line  132 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the control system  110  and the recording device  130 . The recording device  130  is used to produce a record of the data being generated by the radial check device  50 . For example, the recording device  130  can be a printing device that produces a paper record of the data. In another example, the recording device  130  can be an electronic device such as a computer that produces an electronic record of the data. In another example, the recording device  130  is integral with the control system  110 . Further, the pulse oximeter  54  can be operatively connected to the control system  110 , as indicated by the line  134 , for recording data. The recorded data can then be entered in a patient&#39;s paper and/or electronic chart. As shown in  FIG. 3 , the occlusion cuff  52  can include a cuff display screen  136  to allow for the viewing of, for example, generated data and user interface symbols. 
         [0041]    In use, the radial check device  50  is positioned on a patient as shown in  FIG. 3 . In this regard, the first and second actuators  72  and  76  are positioned over, for example, the radial and ulnar arteries of the patient. The positioning of the first and second actuators  72  and  76  can be adjusted by turning the first and second knobs  94  and  96 . Once the radial check device  50  is in position, first and second actuators  72  and  76  are actuated or inflated by the control system  110  to cause the first and second actuator tips  74  and  78 , respectively, to occlude the radial and ulnar arteries. The pulse oximeter  54  provides an oximetry tracing. The second actuator  76  is then released and the pulse oximeter  54  provides another oximetry tracing. The oximetry tracings are read by the healthcare professional performing the test. In an embodiment, the oximetry tracings are shown on the cuff display screen  136 . In an embodiment, the oximetry tracings are transmitted to the recording device  130 . In an embodiment, the record produced by the recording device  130  is entered in the patient&#39;s chart. In an embodiment, the radial check device  50  can perform a reverse Barbeau test to check for radial flow for patients with repeat radial procedures. 
         [0042]    Referring to  FIGS. 9-11 , an alternative embodiment radial check device  150  is shown and described. As shown in  FIG. 9 , the radial check device  150  has an occlusion cuff  152  configured for positioning on a patient&#39;s arm and a pulse oximeter  154  configured for positioning on a patient&#39;s finger, such as an index finger, or thumb. 
         [0043]    As shown in  FIGS. 9-10 , the occlusion cuff  152  has an interior surface  156  and an exterior surface  158 . A first fastener  160  is positioned on the interior surface  156  and a second fastener  162  is positioned on the exterior surface  158 . For example, the first and second fasteners  160  and  162  can be hook and loop-type fasteners that adhere to each other when pressed together. The engagement of the first and second fasteners  160  and  162  position the occlusion cuff  152  on a patient&#39;s arm. 
         [0044]    Referring to  FIGS. 9-11 , the interior surface  156  of the occlusion cuff  152  includes a first inflatable portion  164  and a second inflatable portion  166 . The first and second inflatable portions  164  and  166  are configured to expand and contract in order to occlude or release one or both of the radial and ulnar arteries when the occlusion cuff  152  is positioned on a patient&#39;s arm as shown in  FIG. 9 . In an embodiment, the first and second inflatable portions  164  and  166  are adjustable with respect to the occlusion cuff  152  to allow such inflatable portions to be properly positioned with respect to the radial and ulnar arteries. For example, the first inflatable portion  164  can include a first portion mounting member  168  and the second inflatable portion  166  can include a second portion mounting member  170  in which such mounting members are sized and adapted for sliding engagement in a slot  172  of a mounting bracket  174  that is positioned on the interior surface  156  of the occlusion cuff  152  as shown in  FIGS. 10-11 . In addition to this example, it should be understood that the first and second inflatable portions  164  and  166  can be adjustably positioned with respect to the occlusion cuff  152  in a variety of ways. In an embodiment, the occlusion cuff  152  and the first and second inflatable portions  164  and  166  are constructed of plastic. In an embodiment, the occlusion cuff  152  and the first and second inflatable portions  164  and  166  are disposable after use. 
         [0045]    As shown in  FIG. 9 , the radial check device  150  has a control member  176  that is separate from the occlusion cuff  152 . In an embodiment, the control member  176  is operatively connected to the first and second inflatable portions  164  and  166  by first and second lines or tubes  178  and  180 . In an embodiment, the control member  176  includes an energy source such as a battery  182  to actuate the first and second inflatable portions  164  and  166 , a cuff display screen  184  powered by the battery  182 , and a cuff on/off button  186 . In an embodiment, the control member  176  includes an actuation device such as a pump system  188  to provide a fluid such as air through the first and second tubes  178  and  180  to inflate or deflate the first and second inflatable portions  164  and  166 . In an embodiment, each of the first and second inflatable portions  164  and  166  includes an expandable and contractible bladder  190  that is in fluid communication with the first and second tubes  178  and  180  and thus the pump system  188  as shown in  FIGS. 9 and 11 . The control member  176  includes hardware, software and/or firmware configured to control the operation of the radial check device  150 . 
         [0046]    Referring to  FIG. 9 , the pulse oximeter  154  includes first and second finger members  192  and  194  that are connected by a hinge or other device to allow for clamping on a patient&#39;s finger. In an embodiment, the pulse oximeter  154  includes an energy source such as a battery  196 , a pulse oximeter display screen  198  powered by the battery  196 , and a pulse oximeter on/off button  200 . The pulse oximeter  154  includes hardware, software and/or firmware configured to control the operation of the radial check device  150 . 
         [0047]    As shown in  FIG. 9 , the pulse oximeter  154  is operatively connected to the control member  176  as indicated by the line  202 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the pulse oximeter  154  and the control member  176 . 
         [0048]    Still referring to  FIG. 9 , the radial check device  150  includes a recording device  204  that is operatively connected to the control member  176  as indicated by the line  206 . For example, such connection can be wired or wireless. This allows for the transmission of signals between the control member  176  and the recording device  204 . The recording device  204  is used to produce a record of the data being generated by the radial check device  150 . For example, the recording device  204  can be a printing device that produces a paper record of the data. In another embodiment, the recording device  204  can be an electronic device such as a computer that produces an electronic record of the data. In another example, the recording device  204  is integral with the control member  176 . The record can then be entered in a patient&#39;s paper and/or electronic chart to document the test. 
         [0049]    In use, the radial check device  150  is positioned on a patient as shown in  FIG. 9 . In an embodiment, the first and second inflatable portions  164  and  166  are inflated to occlude the radial and ulnar arteries, respectively. The pulse oximeter  154  provides an automated oximetry tracing to the control member  176 . In an embodiment, such tracing is shown on the cuff display screen  184 . The second inflatable portion  166  is then released and the oximetry tracing is transmitted to the recording device  204 . The record produced by the recording device  204  is then entered in the patient&#39;s chart. In an embodiment, the radial check device  150  can perform a reverse Barbeau test to check for radial flow for patients with repeat radial procedures. 
         [0050]    Referring now to  FIGS. 12-18 , an alternative embodiment of a radial check device  250  is shown and described. As shown in  FIG. 12 , the radial check device  250  includes a readout device  252  and a pulse oximeter  254  configured for positioning on a patient&#39;s finger, such as an index finger or thumb, where the pulse oximeter  254  is operatively connected to a readout device  252 . As shown in  FIG. 12 , the pulse oximeter  254  is connected to the readout device  252  by cable  256 . The readout device  252  includes hardware, software, and/or firmware configured to control operation of the pulse oximeter  254 , and receive, display, and store pulse readings from the pulse oximeter  254 . Measurements from the pulse oximeter  254  can be displayed through a graphical user interface  258  on a display screen  260  of the readout device  252 . Further, the readout device  252  produces an electronic record of the data, and can enter the data in a patient&#39;s electronic chart. 
         [0051]    The readout device  252 , depicted in  FIGS. 13A-13B , is generally composed of a housing  262  having a top cover  264  and a bottom cover  266 , a display screen  260 , a circuit board  268 , and a battery  270 . The top cover  264  and the bottom cover  266  are connected and together house the display screen  260 , circuit board  268 , and battery  270 , which are operatively connected to produce a graphical user interface  258  displayable on the display screen  260 , and read and store readings from the pulse oximeter  254 . The top cover  264  includes an opening through which the display screen  260  is accessible to the user. The readout device  252  as illustrated can be powered by a rechargeable battery, such as the battery  270  depicted in  FIG. 14 , or by disposable batteries. The rechargeable battery  270  can be charged while the device  250  is connected to a computer via a suitable connection, such as a USB connection. Alternatively, the readout device  252  can be powered by an external power source, in which case there is no need for a battery  270  within the housing  262 . The readout device  252  can be connected to the pulse oximeter  254  via any suitable connection, including hardwired or wireless (e.g., Bluetooth) connections. The non-limiting example radial check device  250  depicted in  FIGS. 12-18  is shown with a hardwired connection between the readout device  252  and the pulse oximeter  254 . 
         [0052]    The readout device  252  generally includes a number of ports  274  for connection to extraneous devices. In addition to a suitable port  274  for connecting via wire to the pulse oximeter  254 , the readout device  252  may include one or more additional ports  274  for connection to other devices or systems such as, but not limited to, monitors, tablets, computers, and phones, as well as internet connections. The readout device  252  may further include a headphone jack, and in such embodiments may be configured to play audible sounds that convey information about the measured pulse oximetry data. As shown in  FIGS. 13A-13B , the readout device  252  may include a USB port  274   a,  for receiving a removable storage device such as a flash drive, a nine-pin serial port  274   b,  for connecting the readout device  252  to the pulse oximeter  254 , and an HDMI port  274   c,  for connecting the readout device  252  to an external monitor or the like. However, the number and identity of ports  274  on the readout device  252  are customizable based on the desired use environment. For example, the readout device  252  may include one or more additional ports  274  for firewire connections, Ethernet connections, audio connections, and the like. Furthermore, the readout device  252  may include a power connector configured to power the readout device  252  through a normal power outlet instead of, or as a backup to, the battery  270 . 
         [0053]    As seen in  FIG. 15 , the graphical user interface  258  on the readout device  252  can display information such as the name of the patient, the patient&#39;s date of birth, an identification number for the patient, and any other patient-specific information desired. Further, the graphical user interface  258  can display real-time data gathered from the pulse oximeter  254 , such as in three rectangular boxes  290   a,    290   b,    290   c,  as depicted in  FIG. 15 . The rectangular boxes  290   a,    290   b,    290   c  can be highlighted when displaying real-time pulse readings for the user&#39;s convenience. For example, in  FIG. 15 , the top rectangular box  290   a  is shown highlighted with an oximetry trace displayed therein. 
         [0054]    The display screen  260  is generally a touchscreen, such that the graphical user interface  258  is displayed on a touchscreen where a user may enter commands and control the pulse oximeter  254  or data recording functions of the readout device  252  by selecting the appropriate options on a touchscreen menu. The display screen  260 , depicted in  FIG. 16 , can be fabricated from any suitable touchscreen monitor material, and may be, for example, a thin-film-transistor liquid-crystal display. The touchscreen  260  can be secured by screws  276  between the top cover  264  and bottom cover  266  of the housing  262 . As shown in  FIG. 16 , the display screen  260  has two side flanges  292   a ,  292   b  which include screw holes  278   a,    278   b,    278   c,    278   d  that align with screw holes  280   a ,  280   b  in the top cover  264  of the housing  262  and screw holes  282   a,    282   b  in the bottom cover  266  of the housing  262 . The side flanges  292   a,    292   b  may further include additional screw holes  294 , as depicted in  FIG. 16 , for alternative or additional connections between the display screen  260  and the housing  262 . 
         [0055]    The touchscreen display  260  may be configured to allow use of a special stylus or one or more fingers. Though a touchscreen-type of display is described for exemplary purposes, and a touchscreen-type of display is generally more convenient for the user, it is understood that the display screen  260  need not be a touchscreen. Rather, the device  252  may be configured to be controlled through a mouse, external touchpad, voice commands, or the like, instead of touchscreen menu options. 
         [0056]      FIGS. 17A-17J  depict non-limiting schematics of example layouts for the circuit board  268  in the readout device  252 .  FIGS. 18A-18B  show views of an example circuit board  268  incorporating the schematic designs shown in  FIGS. 17A-17J . Though these schematics are shown for illustrative purposes, it is understood that other circuit board layouts, including layouts that utilize multiple circuit boards, are possible and entirely encompassed within the present disclosure. The example circuit board  268  depicted in  FIGS. 18A-18B  includes conventional circuit board components, such as a central processing unit  284 , and a memory component  286 , such as a ferroelectric RAM. The readout device  252  is capable of storing pulse measurements in the memory  286 . These stored measurements can be accessed by a user along with the patient information, date, time, and status of each test performed. Similarly, the memory  286  can be cleared so as to remove stored records from the radial check device  250 . 
         [0057]    The circuit board  268  includes screw holes  288   a,    288   b,    288   c,    288   d  that align with the screw holes  280   a,    280   b  of the top cover  264  and screw holes  282   a,    282   b  of the bottom cover  266 , as well as with the screw holes  278   a,    278   b,    278   c,    278   d  of the display screen  260 . Thus, the circuit board  268  is physically secured to the display screen  260  and the top cover  264  and the bottom cover  266  of the housing  262  with screws  276  or the like. The circuit board  268  and the display screen  260  are operatively connected through suitable electronic connections. 
         [0058]    The radial check device  250  depicted in  FIGS. 12-18  does not include an occlusion cuff in operative connection with the oximeter  254  or readout device  252 . Instead, this embodiment of the radial check device  250  is intended for use with any means of occluding the radial and/or ulnar arteries. This can include manual occlusion with the practitioner&#39;s hands, the use of a conventional blood pressure cuff, or the use of an occlusion cuff such as an occlusion cuff similar to the occlusion cuff  12  depicted in  FIGS. 1-2 , the occlusion cuff  52  depicted in  FIGS. 3-6 , or the occlusion cuff  152  depicted in  FIGS. 9-11 , though without operative connections to the readout device  252  or the pulse oximeter  254 . In each case, the practitioner will be responsible for properly occluding the radial and/or ulnar arteries. However, the absence of an occlusion cuff in operative connection with the oximeter  254  or the readout device  252  renders this embodiment of the radial check device  250  more versatile because it provides the user with the freedom to implement their preferred method of artery occlusion. 
         [0059]    The graphical user interface  258  displayed in the embodiment of the radial check device  250  depicted in  FIGS. 12-18  can be programmed and customized in a variety of manners to produce an operational system. The system includes the pulse oximeter  254 , the readout device  252 , and the graphical user interface  258 , where the system is configured to (i) prompt a user, through the graphical user interface  258 , to attach the pulse oximeter  254  to the patient; (ii) detect from the pulse oximeter  254 , display on the graphical user interface  258 , and record in memory  286 , a baseline pulse of the patient over a first period of time; (iii) prompt the user, through the graphical user interface  258 , to occlude radial and ulnar arteries of the patient; (iv) detect from the pulse oximeter  254 , display on the graphical user interface  258 , and record in memory  286 , an absent pulse of the patient over a second period of time following occlusion of the radial and ulnar arteries of the patient; (v) prompt the user, through the graphical user interface  258 , to release the radial and ulnar arteries of the patient; (vi) detect from the pulse oximeter  254 , display on the graphical user interface  258 , and record in memory  286 , a restored pulse of the patient over a third period of time; and (vii) display on the graphical user interface  258  each of the baseline pulse, the absent pulse, and the restored pulse so as to allow the user to compare the baseline pulse, the absent pulse, and the restored pulse. For ease of use, the first, second, and third periods of time are typically equal, though they need not be. The graphical user interface  258  can display all three measured pulses on the same screen for easy comparison. 
         [0060]    A non-limiting example operation of the system, described through device operation, GUI displays, and methods of using the device, will now be described with reference to various operational modes of the device referred to as introductory mode, idle mode, sleep mode, detecting baseline pulse mode, recording baseline pulse mode, detecting absent pulse mode, recording absent pulse mode, release ulnar artery mode, detecting restored pulse mode, and test complete mode. However, it is understood that the system may be programmed to omit or alter one or more of these operational modes, or to include other operational modes. For example, the system may further include a historical data mode, where the system displays pulse measurements recorded from a particular patient in the past. 
         [0061]    In the non-limiting example operation of the system, when the readout device  252  is first powered on, the readout device  252  proceeds to introductory mode, where the graphical user interface  258  displays an introduction screen which may include hospital logos, legal disclaimers, copyright notices, simple instructions for users, and the like. The user can turn the readout device  252  to idle mode by touching the appropriate touchscreen menu item. 
         [0062]    In idle mode, the readout device  252  displays patient information, three blank pulse waveforms in rectangular boxes  290   a,    290   b,    290   c,  and instructions to begin, such as, “Attach sensor to patient and touch screen to begin.” Upon a user touching the appropriate touch screen menu item, a serial receive interrupt is enabled and a five-minute countdown begins, after which time the system proceeds to sleep mode if the screen is not touched. However, if the screen is touched during the five-minute countdown, the system proceeds to detecting baseline pulse mode and detects the baseline pulse through the pulse oximeter  254 . 
         [0063]    In sleep mode, the readout device  252  can be powered off by toggling an on/off switch or selecting the appropriate touch screen menu item. Alternatively, touching the screen  260  or connecting a USB to the readout device  252  transitions the system from sleep mode back to the introduction screen. 
         [0064]    In detecting baseline pulse mode, the graphical user interface  258  highlights the top pulse waveform box  290   a,  with a trace drawing of the measured pulse appearing from left to right on the screen in the highlighted box  290   a.  In this mode, the middle waveform box  290   b  and the bottom waveform box  290   c  are displayed as blank. During this time, the graphical user interface  258  displays an informative status message such as, “Detecting baseline pulse, please wait.” The user can stop the measurement by disabling the serial receive interrupt through the appropriate touch screen menu item. Otherwise, the system reads the pulse from the oximeter  254  measurements, draws the pulse in the top waveform box  290   a  from left to right on the screen, wrapping, and adjusts the amplifier gain and LED brightness to maximize pulse amplitude without clipping. The pulse is displayed as a function of time. If a pulse is detected with stable amplitude and frequency for five seconds, the system proceeds to recording baseline pulse mode. If  30  seconds elapse without detecting a pulse, the graphical user interface  258  displays a message such as, “Test failed, baseline pulse not detected.” If no pulse is detected, the system records an incomplete test result to memory  286  (such as the ferroelectric RAM inside the readout device  252 , or a removable flash drive inserted in the readout device  252  during operation), and proceeds to idle mode. Alternatively, instead of recording the incomplete test result to memory, the system may transmit the incomplete test result to an external server. 
         [0065]    In recording baseline pulse mode, the graphical user interface  258  highlights the top pulse waveform box  290   a  with a trace drawing from left to right in the box, and with a status message such as, “Recording baseline pulse, please wait.” During this time, the graphical user interface  258  displays a countdown for five seconds. The system reads the pulse from the oximeter  254  measurements, draws the pulse waveform in the top waveform box  290   a  from left to right, wrapping, and records the pulse waveform to memory. The pulse is displayed as a function of time. If the pulse is lost, the system proceeds to detecting baseline pulse mode. If five seconds elapse with a pulse present, the system proceeds to detecting absent pulse mode. 
         [0066]    In detecting absent pulse mode, the graphical user interface  258  highlights a middle pulse waveform box  290   b,  with a trace drawing from left to right in the middle pulse waveform box  290   b.  The top pulse waveform box  290   a  retains the measured baseline pulse waveform, but is no longer highlighted. The bottom pulse waveform box  290   c  is blank. The graphical user interface  258  displays a message prompting the user to occlude the radial and ulnar arteries, such as, “Occlude radial and ulnar arteries.” The system reads the pulse from the pulse oximeter measurements, and draws the measured pulse in the middle waveform box  290   b  from left to right, wrapping. The pulse is displayed as a function of time. If a pulse is absent for five seconds, the system proceeds to recording absent pulse mode. If  30  seconds elapse with the pulse still present, the system records an incomplete test to memory, displays a status message such as, “Test failed, arteries not occluded”, and proceeds to idle mode. 
         [0067]    In recording absent pulse mode, the graphical user interface  258  highlights the middle pulse waveform box  290   b,  with a trace drawing from left to right in the middle pulse waveform box  290   b.  The graphical user interface  258  displays an informative status message such as, “Recording absent pulse, please wait”, and displays a five-second countdown. The system reads the pulse from the pulse oximeter  254  measurements, draws the measured pulse in the middle waveform box  290   b  from left to right, wrapping, and records the pulse waveform to memory. The pulse is displayed as a function of time. If the pulse returns, the system proceeds to detecting absent pulse mode. If five seconds elapse with a pulse still absent, the system proceeds to release ulnar artery mode. 
         [0068]    In release ulnar artery mode, the graphical user interface  258  highlights a bottom pulse waveform box  290   c,  with a trace drawing from left to right in the bottom pulse waveform box  290   c.  The top pulse waveform and the middle pulse waveform remain in respective top and middle pulse waveform boxes  290   a,    290   b,  though the top and middle pulse waveform boxes  290   a,    290   b  are no longer highlighted. The graphical user interface  258  displays a message such as, “Release ulnar artery in 5 . . . 4 . . . 3 . . . 2 . . . 1 . . . ” while conducting a five-second countdown. During this five-second time period, the system reads the pulse from the pulse oximeter  254  measurements, and draws the measured pulse in the bottom waveform box  290   c  from left to right, wrapping. The pulse is displayed as a function of time. When the countdown reaches zero, the readout device  252  audibly beeps and the system proceeds to recording restored pulse mode. If a pulse returns before the countdown reaches zero, the system proceeds to detecting absent pulse mode. 
         [0069]    In detecting restored pulse mode, the graphical user interface  258  highlights the bottom pulse waveform box  290   c,  with a trace drawing from left to right in the bottom pulse waveform box  290   c.  The graphical user interface  258  also displays a status message such as, “Detecting pulse restoration.” The system reads the pulse from the pulse oximeter  254  measurements, and draws the measured pulse in the bottom waveform box  290   c  from left to right, wrapping. The pulse is displayed as a function of time. The system records the pulse waveform to memory  286 , and begins a 20-second countdown which is displayed on the graphical user interface  258 . If a pulse is detected, the system begins a five-second countdown. If the 20 seconds elapse without a pulse detected continuously for five seconds, the graphical user interface  258  displays a failure message such as, “Pulse not detected”, the system records a negative test complete to memory  286 , and the system proceeds to test complete mode. If, on the other hand, a pulse is detected and five seconds elapse with the pulse present, the graphical user interface  258  displays a success message such as, “Pulse restoration detected”, the system records a positive test complete to memory, and the system proceeds to test complete mode. 
         [0070]    In test complete mode, the graphical user interface  258  retains all three pulse waveforms on display in the respective boxes  290   a,    290   b,    290   c,  and retains the test result message (i.e., either the failure message or the success message). The graphical user interface  258  also displays completion messages such as, “Touch screen to finish/save”, and “Long press to cancel/restart”. Once in test complete mode, the system enables a serial receive interrupt and begins a five-minute timer. If five minutes elapses without the screen being touched, or upon the screen being touched during the five minutes, the system proceeds to idle mode. Alternatively, if the screen is long-pressed as prompted, the system restarts by returning to introduction mode. 
         [0071]    Other possible functions of the system include reporting battery conditions, receiving and implementing firmware updates from an external source, and communicating with the patient&#39;s electronic medical records. The particular functions of the system are not intended to be limiting. Rather, the system is versatile and can be customized for desired uses. 
         [0072]    By way of non-limiting examples, the radial check device  10 ,  50 ,  150 , or  250  can be used in all places of a hospital or other healthcare facility (e.g., cardiac catheterization lab, vascular interventions lab, pediatric and/or adult intensive care unit, or pre-operative anesthesia unit) in which the radial artery of a patient is used for cannulation. The present disclosure provides embodiments of a relatively simple medical device that a healthcare professional can utilize to access the ulnar and/or radial flow of a patient, and then place the documentation generated by the device in the paper and/or electronic chart of the patient. As will be appreciated by those skilled in the art, the present disclosure establishes a new standard of pre-procedural care for patients undergoing any type of radial artery canalization. 
         [0073]    Certain embodiments of the systems, devices, and methods disclosed herein are defined in various examples. It should be understood that these examples, while indicating particular embodiments of the invention, are given by way of illustration only. From the above discussion and these examples, one skilled in the art can ascertain the essential characteristics of this disclosure, and without departing from the spirit and scope thereof, can make various changes and modifications to adapt the compositions and methods described herein to various usages and conditions. Various changes may be made and equivalents may be substituted for elements thereof without departing from the essential scope of the disclosure. In addition, many modifications may be made to adapt a particular situation or material to the teachings of the disclosure without departing from the essential scope thereof.
A radial check device, system, and related methods are provided for accessing ulnar and/or radial flow and producing documentation or electronic records of such assessment.