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Apparatus for providing power management in data communication

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1. 2004 0186362 Al 9 2004 Brauker et al 2008 0296155 Al 12 2008 Shults et al 2004 0186365 Al 9 2004 Yin et al 2008 0306368 Al 12 2008 Goode et al 2004 0199059 A1 10 2004 Brauker et al 2008 0306434 Al 12 2008 Dobbles et al 2005 0031689 Al 2 2005 Shults et al 2008 0306435 Al 12 2008 Kamath et al 2005 0038680 Al 2 2005 McMahon 2008 0306444 Al 12 2008 Brister et al 2005 0043598 Al 2 2005 Goode Jr et al 2009 0012379 A1 1 2009 Goode et al 2005 0053365 Al 3 2005 Adams et al 2009 0018424 Al 1 2009 Kamath et al 2005 0065464 Al 3 2005 Talbot et al 2009 0030294 Al 1 2009 Petisce et al 2005 0090607 Al 4 2005 Tapsak et al 2009 0036758 Al 2 2009 Brauker et al 2005 0112169 Al 5 2005 Brauker et al 2009 0036763 Al 2 2009 Brauker et al 2005 0143635 Al 6 2005 Kamath et al 2009 0043181 Al 2 2009 Brauker et al 2005 0176136 Al 8 2005 Burd et al 2009 0043182 Al 2 2009 Brauker et al 2005 0182306 Al 8 2005 Sloan 2009 0043525 Al 2 2009 Brauker et al 2005 0187720 Al 8 2005 Goode Jr et al 2009 0043541 Al 2 2009 Brauker et al 2005 0192557 Al 9 2005 Brauker et al 2009 0043542 Al 2 2009 Brauker et al 2005 0235732 Al 10 2005 Rush 2009 0045055 Al 2 2009 Rhodes et al 2005 0245795 Al 11 2005 Goode Jr et al 2009 0062633 Al 3 2009 Brauker et al 2005 0245799 A1 11 2005 Brauker et al 2009 0062635 Al 3 2009 Brauker et al 2005 0249606 A1 11 2005 Rush 2009 0076356 A1 3 2009 Simpson et al 2006 0001551 Al 1 2006 Kraft et al 2009 0076360 Al 3 2009 Brister et al
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3. This application claims priority under 35 USC 119 to Provisional Patent Application No 60 478 436 filed on Jun 12 2003 entitled Method and Apparatus for Providing Power Management in Data Communication Systems the disclosure of which is incorporated herein by reference for all purposes BACKGROUND The present invention relates to data monitoring systems More specifically the present invention relates to portable analyte monitoring systems More specifically the present invention relates to a compact blood glucose meter for use in a glucose monitoring system to self monitor glucose level in whole blood as an aid to disease management and also by healthcare professionals as an aid to monitor the effectiveness of diabetes treatment SUMMARY OF THE INVENTION The market for glucose monitoring systems in the United States as well as globally is rapidly increasing as better health education and early detection of diabetic conditions through regular check ups have increased the percentage of the dia betic population who undertake the task of monitoring their diet and daily activities based on the detected level of blood glucose using glucose monitoring systems One group of such rapidly increasing segment of the population is children with diabetic conditions who are advised to monitor their blood glucose levels While miniaturization has been a factor of recent designs in the glucose monitoring systems and the glucose meters
4. the physical constraints of the components of such systems have established a certain size limitation As such the larger and bulkier the device the less desirable and convenient for the device to be carried around or used and operated by the patients especially children In view of the foregoing in accordance with the various embodiments of the present invention there is provided a blood glucose meter which is designed to be substantially more compact than presently available commercial blood glucose meters which configuration that is much more ame nable to usage and portage by younger diabetic patients such as children More specifically in one aspect of the invention the blood glucose meter is configured to include a LCD backlight and a flashlight features which will assist the patient in reading the metered glucose level in low light testing areas such as in theaters low ambient light restaurants areas outdoors during non daylight times and so on as well as a light source to guide the insertion and removal of the test strip which may include the usage of a light emitting diode Indeed as the light source e g the LED may be pulsed and still display substantially the same light output as one which is turned on in steady state the battery life ofthe glucose meter device may be prolonged since the pulsed LED light source requires significantly less power and thus draining the battery at a much slower rate than when the LED l
5. 2 of 6 Dec 9 2014 U S Patent z IYNDIY TYNINYIL SNISS32O3d VLVO TYNYALXA OL soz UNN 329V3NH3ANI UISN LUNN 9NISS32O3d viva wusa LINN SNISS35O3d VIVG SOTYNY LINN 39vuHO1S toz LINN DNISSIIJOYUd TVYLNID 90Z LINN YOLIINNOS dRILS 1531 diMIS 1531 wous U S Patent 301 307 302 303 305 Dec 9 2014 Sheet 3 of 6 US 8 906 307 B2 a mem 09 Ie 5 J lp 304 306 309 308 310 FIGURE 3 U S Patent Dec 9 2014 Sheet 4 of 6 US 8 906 307 B2 414 413 410 411 FIGURE 4B 408 409 405 404 Dg E cos FIGURE 4A 402 U S Patent Dec 9 2014 Sheet 5 of 6 US 8 906 307 B2 501 VERIFY INSERTED TEST STRIP AND PERFORM SELF TEST TURN ON DISPLAY AND PROMPT USER TO ENTER OR CONFIRM TEST STRIP CALIBRATION CODE PROMPT USER TO APPLY BLOOD SAMPLE TO TEST STRIP AMPLE DETECTION COMPLETE YES SIGNAL TO USER THAT SAMPLE FILL IS COMPLETE AND GLUCOSE LEVEL IS NOW BEING ANALYZED DETERMINE GLUCOSE VALUE CORRESPONDING TO DETECTED BLOOD SAMPLE DISPLAY DETERMINED GLUCOSE VALUE AND STORE IN MEMORY 02 503 04 505 506 507 508 FIGURE 5 U S Patent Dec 9 2014 Sheet 6 of 6 US 8 906 307 B2 Duty Cycle FIGURE 6 50 0 o ax Do DO mdyo US 8 906 307 B2 1 APPARATUS FOR PROVIDING POWER MANAGEMENT IN DATA COMMUNICATION SYSTEMS RELATED APPLICATION
6. 302 to alert the user to check and set the test strip code while the thermometer symbol 409 is displayed on the display screen 302 when the meter is operating in a temperature range that is beyond that which will permit an accurate reading A set of sound level symbols 410 are provided in one embodiment to indicate whether the glucose meter device audible output alert mode is at a predetermined setting for example high low or off while the time set symbol 411 appears on the display screen 302inthe default clock mode when the user is setting the time information on the glucose meter device Finally the data average symbol 412 is configured to appear on the display screen 302 with a glucose reading that is the average value of the readings from the past 14 days for example or any other predetermined time period as may be established by the meter device as a default mode or by the user during calibration stage of the glucose meter device Inthe preferred embodiment ofthe present invention when the meter 103 is not otherwise in use the current date is continuously displayed on the upper line top row of five 7 segment digits of message area 403 and the current time is continuously displayed on the lower line bottom row of five 0 jak 5 20 30 40 45 60 65 10 7 segment digits of message area 403 As previously men tioned immediately after a blood glucose test is completed the numerical result is shown in
7. 6 723 072 6 730 200 6 733 446 6 740 075 6 741 877 6 752 787 6 758 810 6 764 581 6 810 290 6 811 533 6 811 534 6 813 519 6 833 540 6 835 553 6 837 858 6 840 912 6 859 831 6 862 465 6 873 268 6 931 327 6 950 708 6 958 129 6 958 705 6 974 437 6 990 372 7 003 340 7 020 508 7 024 245 7 024 249 7 041 468 7 043 287 7 067 498 7 074 307 7 081 195 7 098 803 7 108 778 7 110 803 7 123 206 7 134 999 7 136 689 7 136 704 7 153 212 7 2002 8 2002 8 2002 10 2002 10 2002 12 2002 1 2003 2 2003 2 2003 2 2003 4 2003 4 2003 5 2003 5 2003 5 2003 5 2003 5 2003 5 2003 5 2003 5 2003 5 2003 6 2003 6 2003 7 2003 7 2003 7 2003 9 2003 9 2003 11 2003 11 2003 12 2003 12 2003 1 2004 2 2004 2 2004 2 2004 3 2004 4 2004 5 2004 5 2004 5 2004 5 2004 6 2004 7 2004 7 2004 10 2004 11 2004 11 2004 11 2004 12 2004 12 2004 1 2005 1 2005 2 2005 3 2005 3 2005 8 2005 9 2005 10 2005 10 2005 12 2005 1 2006 2 2006 3 2006 4 2006 4 2006 5 2006 5 2006 6 2006 7 2006 7 2006 8 2006 9 2006 9 2006 10 2006 11 2006 11 2006 11 2006 12 2006 Bowman IV et al Kopley et al Heinonen et al Dobson et al Sirhan et al Brown et al Fathallah et al Fendrock Bang Khalil et al Stewart et al Mann et al Causey III et al Bird et al Heller et al Lebel et al Starkweather et al Say et al Henning et al Shain et al Lebel et al Lebel et al Sage Jr Lebel et al Naffziger et al Deweese
8. 709 5 661 643 5 695 949 5 699 243 5 703 928 5 822 715 5 848 990 5 899 855 5 913 833 6 027 459 6 027 496 6 027 692 6 059 546 6 063 039 6 067 463 6 071 249 6 071 251 6 073 031 6 077 660 6 081 104 6 085 871 6 093 156 6 129 823 6 132 371 6 144 303 6 144 922 6 155 992 6 160 449 6 162 202 6 173 160 6 175 752 6 185 452 6 206 841 6 208 894 6 242 961 6 245 060 6 248 067 6 262 708 6 283 926 6 295 506 6 298 255 6 306 104 6 312 888 6 315 721 6 368 274 6 375 638 6 377 894 6 403 944 6 417 074 6 425 829 References Cited U S PATENT DOCUMENTS gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt gt 10 1978 3 1984 7 1985 9 1989 1 1991 4 1991 5 1991 9 1991 1 1992 1 1992 6 1992 5 1993 5 1993 5 1993 1 1994 6 1994 11 1994 2 1995 4 1995 4 1996 10 1996 11 1996 2 1997 4 1997 4 1997 7 1997 8 1997 12 1997 12 1997 12 1997 10 1998 12 1998 5 1999 6 1999 2 2000 2 2000 2 2000 5 2000 5 2000 5 2000 6 2000 6 2000 6 2000 6 2000 6 2000 7 2000 7 2000 10 2000 10 2000 11 2000 11 2000 12 2000 12 2000 12 2000 1 2001 1 2001 2 2001 3 2001 3 2001 6 2001 6 2001 6 2001 7 2001 9 2001 9 2001 10 2001 10 2001 11 2001 11 2001 4 2002 4 2002 4 2002 6 2002 7 2002 7 20
9. Al 11 2006 Fennell 1 258 666 B2 8 2007 Brown 2007 0016381 Al 1 2007 Kamath et al 7266400 B2 9 2007 Fine et al 2007 0163880 Al 7 2007 Woo et al 7 276 029 B2 10 2007 Goode Jr et al 2007 0203966 Al 8 2007 Brauker et al 7 310 544 B2 12 2007 Brister et al 2007 0235331 Al 10 2007 Simpson et al 7 344 507 B2 3 2008 Briggs etal ccc 600 583 2008 0021666 Al 1 2008 Goode Jr et al 7 364 592 B2 4 2008 Carr Brendel et al 2008 0033254 Al 2 2008 Kamath et al 7366556 B2 4 2008 Brister et al 2008 0045824 Al 2 2008 Tapsak et al 7379765 B2 5 2008 Petisce et al 2008 0064941 Al 3 2008 Funderburk et al 7424318 B2 9 2008 Brister et al 2008 0071156 Al 3 2008 Brister et al 7 460 808 B2 12 2008 Brister et al 2008 0083617 Al 4 2008 Simpson et al 7467003 B2 12 2008 Brister et al 2008 0086042 Al 4 2008 Brister et al 7 471 972 B2 12 2008 Rhodes et al 2008 0086044 Al 4 2008 Brister et al 7 494 465 B2 2 2009 Brister et al 2008 0086273 Al 4 2008 Shults et al 7 497 827 B2 3 2009 Brister et al 2008 0108942 AI 5 2008 Brister et al 7 519 408 B2 4 2009 Rasdal et al 2008 0146900 Al 6 2008 Andrews et al 7 583 990 B2 9 2009 Goode Jr et al 2008 0183061 Al 7 2008 Goode et al 7 591 801 B2 9 2009 Brauker et al 2008 0183399 AI 7 2008 Goode et al 7 599 726 B2 10 2009 Goode Jr et al 2008 0188731 Al 8 2008 Brister et al 7 613 491 B2 11 2009 Boock et al 2008 0189051 Al 8 2008 Goode et al 7 615 007 B2 11 2009 Shults et al 2008 0194935 AI 8 2008 Brister et al
10. one ofa liquid crystal display LCD a touch sensitive screen and a plasma display unit The display unit may also include a light source to illumi nate the display unit where the light source may be config ured to provide a backlight function and a flashlight function ofthe display unit The light source in one embodiment may be configured to be pulsed at a frequency greater than 60 100 Hertz Moreover the light source may further configured to have a peak wave length of approximately 570 nanometers In one embodiment the light source may include a light emitting diode LED and more specifically a yellow green LED In a further embodiment the housing may include a port integrated on the housing configured to receive a blood glu cose test strip The port may include a light source that may be configured to substantially illuminate the port to assist in the insertion and or removal of the blood glucose test strip In yet another embodiment the display unit may be con figured to illuminate upon detection of a blood glucose test strip insertion into the port Further the display unit may be configured to remain illuminated until the test strip is removed from the port The input unit in one embodiment may include an on off switch A blood glucose meter in accordance with another embodi ment includes a compact housing for a blood glucose meter a display unit disposed on the housing the display unit including a display light
11. source at the test strip port 306 e g the LED light source is illuminated so that the user may light up the test strip 102 and the sample acquisition site on the user 101 if desired Thereafter when the meter device detects a sufficient level of blood sample on the test strip 102 5 20 25 30 35 40 45 50 55 60 65 12 i e step 505 FIG 5 is successfully performed the light source at the test strip port 306 is disabled and the backlight on the display screen 302 is once again illuminated so that the user may view the corresponding glucose level generated from the collected blood sample In a slightly different embodiment pressing the light but ton 305 powers on either the display backlight or the test strip light depending on what mode the meter is in Pressing the light button 305 in non test modes powers on the display backlight The display backlight goes out when light button 305 is pressed again or when the meter is inactive for 5 seconds Pressing the light button when the blood drop and test strip symbols appear on the display screen powers on the test strip light The test strip light goes out when the light button 305 is pressed again or the meter receives the correct amount of blood for the test 1 e the test strip is filled or after 60 seconds of meter inactivity or when the test strip is removed from the meter Thus in this embodiment the test strip light cannot be activated unless t
12. source to illuminate the display unit an input unit disposed on the housing the input unit config ured to provide input functions for the blood glucose meter anda power source provided within the housing for providing power to the blood glucose meter where the housing includes a port integrated on said housing configured to receive a blood glucose test strip The port in one embodiment may include a port light source the port light source configured to substantially illu minate the port to assist in the insertion and or removal ofthe blood glucose test strip Additionally in an alternate embodiment the port light source may be integrated with the display light source A method of measuring blood glucose level in accordance with yet another embodiment of the present invention includes the steps of providing a compact housing disposing US 8 906 307 B2 3 a display unit on the housing the display unit including a display light source to illuminate the display unit disposing an input unit on the housing the input unit configured to provide input functions for the blood glucose meter provid ing a power source within the housing for providing power to the blood glucose meter where the housing includes a port integrated on said housing configured to receive a blood glu cose test strip These and other features and advantages of the present invention will be understood upon consideration of the fol lowing detailed description of
13. the invention and the accom panying drawings INCORPORATION BY REFERENCE Applicants herein incorporate by reference application Ser No 09 434 026 filed Nov 4 1999 entitled Small Volume In Vitro Analyte Sensor and Methods application Ser No 09 753 746 filed on Jan 2 2001 entitled Analyte Monitoring Device and Methods of Use and Application Nos 60 437 374 filed Dec 31 2002 and application Ser No 10 745 878 filed Dec 26 2003 both entitled Continuous Glucose Moni toring System and Methods of Use each assigned to the Assignee of the present application for all purposes BRIEF DESCRIPTION OF THE DRAWINGS FIG 1 is a block diagram illustrating an overall glucose monitoring system in accordance with one embodiment of the present invention FIG 2 is a block diagram illustrating a glucose meter device shown in FIG 1 in accordance with one embodiment of the present invention FIG 3 illustrates the glucose meter device of FIG 2 in accordance with one embodiment of the present invention FIGS 4A and 4B illustrate the display screen of the glu cose meter device in accordance with one embodiment of the present invention FIG 5 is a flowchart illustrating the procedure for perform ing a blood glucose test using the glucose meter device in accordance with one embodiment of the present invention and FIG 6 illustrates the output LED power level as a function of the power state in accordance with one embo
14. the user 101 More specifically in accordance with one embodiment of the present invention the user interface unit 203 may include a display unit an input device such as an input keypad or any other equivalent device which may provide substantially the same functionality as the input device such as an input key pad Additionally the display unit of the user interface unit 203 may include an LCD display unit which is also capable of providing backlighting so as to permit the user to view the displayed information on the backlit display unit of the user interface unit 203 in dark ambient settings Moreover in an alternate embodiment of the present invention the user inter face unit 203 may also include a flashlight feature which upon activation by the user is configured to emit a consistent light beam to assist the user in the operation of the glucose meter device 103 and or the lancing device 104 in dark sur roundings Further the flashlight feature may also be config ured to include a timer function such that the flashlight is configured in one embodiment to automatically turn off after a predetermined period of time has elapsed In this manner the power source for the glucose meter device 103 FIG 1 may be conserved in the cases where the user 101 leaves the flashlight feature on the glucose meter device 103 on Referring yet again to FIG 2 the user interface unit 203 in accordance with a further embodiment of the present inv
15. to store the generated glucose value in the storage unit 207 FIG 2 In one embodiment the glucose meter device may be con figured to output a single audible alert notification when the collected blood sample is sufficient to generate the corre sponding glucose level information and to output a double audible alert notification when the glucose level information has been determined and displayed on display screen 302 Additionally in one embodiment the time and date informa tion may also be displayed on the display screen 302 in connection with the generated glucose level information Inaccordance with another embodiment the glucose meter device may be configured such that upon power on procedure the light source e g an LED at the test strip port 306 FIG US 8 906 307 B2 11 3 is configured to illuminate at substantially 50 of the full intensity to permit the introduction of the test strip 102 into the test strip port 306 Thereafter when the test strip 102 is fully inserted into the test strip port 306 of the glucose meter device the light source at the test strip port 306 and alterna tively in addition to the backlight of the display screen 302 is illuminated at the full intensity level to indicate blood sample collection operation When the collection of the blood sample is concluded the intensity of the light source at the test strip port 306 and alternatively as well as the backlight of the display screen 30
16. 02 Ohsawa Honda et al Brusen Tamura Stice Hale Beckers Harm et al Whitehead et al Miller et al Zelin et al Idriss et al Coffee Frank et al Martin Tortola et al Voss Cheney II et al Vimpari et al Bocker et al Stark et al Melsky et al Sahara Kim et al Lee Birch et al Blakely et al Galen et al Eckel et al Galloway et al Worthington et al Cirelli et al Brown Elstrom et al Shain et al Loomis et al Galen et al Brenan et al Cunningham et al Jeng et al Cunningham et al Cunningham et al Helstab et al Wong et al Kern Karamata Cunningham et al Hughes et al Dempsey et al Federman Douglas et al Henning et al Klomsdorf et al Sicurelli et al Liimatainen Say et al Schulman et al Cunningham et al Schulman et al Liu et al Loomis et al Causey III et al Chu Cunningham et al Heinonen et al Cordero et al Cunningham et al Wong et al Schulman et al Van Antwerp et al Nason et al Deweese et al MacKenzie et al Kopley et al Julien 6 427 088 6 437 379 6 438 385 6 466 807 6 471 980 6 492 180 6 506 168 6 514 460 6 522 530 6 526 298 6 540 891 6 551 276 6 558 320 6 558 321 6 560 471 6 562 001 6 564 105 6 565 509 6 565 738 6 569 157 6 571 128 6 577 899 6 582 393 6 585 644 6 586 971 6 600 997 6 615 061 6 615 074 6 641 533 6 648 821 6 659 948 6 669 669 6 679 841 6 687 546 6 692 457 6 694 191 6 702 857
17. 2 are reduced substantially to the 50 level again and when the test strip is removed from the test strip port 306 the light source is configured to shut off completely Indeed as the light source e g the LED may be pulsed and still display substantially the same light output as one which is turned on in steady state the battery life of the glucose meter device may be prolonged since the pulsed LED light source requires significantly less power and thus draining the battery at a much slower rate than when the LED light source is main tained at the on position Indeed in one embodiment the central processing unit 206 of the glucose meter device 103 may be configured to control the switching on and off of the light source as well as the level of light intensity by for example adjusting the duty cycle and the period during which the light source is configured to be turned on For example FIG 6 illustrates the output LED power level as a function of the power state in accordance with one embodi ment of the present invention As can be seen from the Figure 50 duty cycle as shown on the X axis corresponds to approximately 80 of the output power level for the LED light source Ina preferred embodiment a yellow green LED is used for the test strip light such as part number LT19209 40 manu factured by Ledtech Electronics Corporation located in Hsin Tien Taiwan or part number ZSG56W manufactured by SunLED Co located in Kowloon Hon
18. 7 632 228 B2 12 2009 Brauker et al 2008 0194936 AI 8 2008 Goode et al 2001 0023095 A1 9 2001 Kopley et al 2008 0194937 Al 8 2008 Goode et al 2001 0024864 Al 9 2001 Kopley et al 2008 0194938 Al 8 2008 Brister et al 2002 0118090 Al 8 2002 Park et al 2008 0195232 Al 8 2008 Carr Brendel et al 2002 0193679 Al 12 2002 Malave et al 2008 0195967 Al 8 2008 Goode et al 2003 0023317 Al 1 2003 Brauker et al 2008 0197024 A1 8 2008 Simpson et al 2003 0032874 Al 2 2003 Rhodes et al 2008 0200788 Al 8 2008 Brister et al 2003 0060765 Al 3 2003 Campbell et al 2008 0200789 Al 8 2008 Brister et al 2003 0078560 Al 4 2003 Miller et al 2008 0200791 Al 8 2008 Simpson et al 2003 0107487 Al 6 2003 Korman et al 2008 0208025 Al 8 2008 Shults et al 2003 0198558 Al 10 2003 Nason et al 2008 0214915 Al 9 2008 Brister et al 2003 0212346 Al 11 2003 Yuzhakov et al 2008 0214918 Al 9 2008 Brister et al 2003 0217966 Al 11 2003 Tapsak et al 2008 0228051 Al 9 2008 Shults et al 2004 0011671 Al 1 2004 Shults et al 2008 0228054 A1 9 2008 Shults et al 2004 0019321 Al 1 2004 Sage et al 2008 0242961 Al 10 2008 Brister et al 2004 0045879 Al 3 2004 Shults et al 2008 0262469 Al 10 2008 Brister et al 2004 0064133 Al 4 2004 Miller et al 2008 0275313 Al 11 2008 Brister et al 2004 0132220 Al 7 2004 Fish 2008 0287764 Al 11 2008 Rasdal et al 2004 0133092 Al 7 2004 Kain 2008 0287765 Al 11 2008 Rasdal et al 2004 0152622 Al 8 2004 Keith et al 2008 0287766 Al 11 2008 Rasdal et al
19. az United States Patent Andrews et al US008906307B2 US 8 906 307 B2 Dec 9 2014 10 Patent No 45 Date of Patent 54 75 73 21 22 65 63 60 51 52 APPARATUS FOR PROVIDING POWER MANAGEMENT IN DATA COMMUNICATION SYSTEMS Inventors Tae Wan Andrews San Diego CA US Stephen C Bubrick Orinda CA US Sheilah S Estoesta Mountain View CA US Brad D Etter Alameda CA US Hyoung Yoon Park Duluth GA US Gene Ming Pon San Jose CA US Christopher V Reggiardo Castro Valley CA US Heber Saravia Daly City CA US Abbott Diabetes Care Inc Alameda CA US Assignee Notice Subject to any disclaimer the term of this patent is extended or adjusted under 35 U S C 154 b by 117 days Appl No 12 859 081 Filed Aug 18 2010 Prior Publication Data US 2010 0312085 A1 Dec 9 2010 Related U S Application Data Continuation of application No 10 861 626 filed on Jun 4 2004 now Pat No 8 071 028 Provisional application No 60 478 436 filed on Jun 12 2003 Int Cl GOIN 33 00 2006 01 C120 1 54 2006 01 A61B 5 145 2006 01 US Cl CPC ies C12Q 1 54 2013 01 A61B 5 14532 2013 01 461B 2560 0209 2013 01 TEST STRIP 102 105 GLUCOSE METER DEVICE EXTERNAL COMPUTER USP iata EE 422 68 1 58 Field of Classification Search USPG eta et RR ERO 422 68 1 See application file for complete search hist
20. dependently Referring back yet again to FIG 2 in one embodiment of the present invention the central processing unit 206 is con figured to perform a plurality of functions to maintain cali 20 25 30 35 40 45 50 55 60 65 6 brate and operate the glucose meter device 103 More spe cifically upon power up of the glucose meter device 103 when the power source such as the batteries are placed in the respective section of the device housing under the control of the central processing unit 206 the glucose meter device 103 is configured to perform a power on reset sequence to initial ize the various aforementioned components of the glucose meter device 103 to the necessary configuration settings Upon successful completion of the power on reset sequence the central processing unit 206 is then configured to enter the glucose meter device 103 into a default operation mode for example the clock mode as discussed in further detail below More specifically in one embodiment the central processing unit 206 is configured to access the storage unit 207 to retrieve the corresponding power on reset sequence instruction set from the storage unit 207 for example in the ROM portion and or the RAM portion thereof Moreover in one embodi ment the central processing unit 206 is configured to perform and complete the aforementioned power on reset sequence within approximately 500 mseconds In one aspect the central p
21. diment is configured to interface with the external computer 105 FIG 1 Moreover in the glucose meter device 103 there is pro vided an analog data processing unit 201 which is configured to detect and process analog signals and which is further operatively coupled to the digital data processing unit 204 for digital data processing of the detected and processed analog signals received from the analog data processing unit 201 in one embodiment of the present invention Referring back to FIG 2 the analog data processing unit 201 of the glucose meter device 103 is further configured to operatively couple to a test strip connector unit 202 which is configured to engage with a test strip 102 FIG 1 when inserted into the US 8 906 307 B2 5 glucose meter device 103 Thereafter the analog data pro cessing unit 201 as mentioned above is configured to detect the signal level from the collected blood sample received from the test strip 102 FIG 1 via the test strip connector unit 202 and to transmit that detected and analog processed data to the digital data processing unit 204 for further data pro cessing Referring yet again to FIG 2 there is also shown a user interface unit 203 provided to the glucose meter device 103 As can be seen the user interface unit 203 is operatively coupled to the user 101 FIG 1 to receive input data or instructions therefrom or alternatively to output the pro cessed and or generated information to
22. diment of the present invention DETAILED DESCRIPTION FIG 1 is a block diagram illustrating an overall glucose monitoring system in accordance with one embodiment of the present invention Referring to the Figure the glucose moni toring system 100 in accordance with one embodiment includes a glucose meter device 103 configured to receive a test strip 102 which is used to collect the blood sample for determining the blood glucose level of the user 101 The lancing device 104 is used to draw the blood sample from the user 101 to be collected onto the test strip 102 In one embodi ment the lancing device 104 may be used on the user s fingers forearm upper arm hand thigh or calf for example Moreover the glucose meter device 103 and the system 100 is configured such that a very small blood sample size such as for example approximately 0 3 microliter of sample blood is necessary to determine a corresponding blood glucose level As can be further seen from FIG 1 the glucose meter device 103 may be operatively coupled to an external com puter 105 which may include in one embodiment a server terminal connected to a data network a stand along desktop 20 25 30 35 40 45 50 55 60 65 4 or laptop computer for use by the user s physician or care provider or the user herself a personal digital assistant PDA which is operatively configured to store and or further to communicate with a data network to
23. emoval the internal date is set to the last recorded date and in the case where there is no valid recorded dates the central processing unit 206 is configured to set the internal date to a predeter mined date such as Jan 1 2002 for example Likewise upon detection of the loss of power the internal time in one embodiment is reset to 12 00 am until a further time when the user resets the internal time Moreover the blood sample test data collected during the period of power loss is configured to be flagged with a lost time flag and the corresponding lost power internal date and time discussed above Upon re appli cation of power to the glucose meter device 103 in one embodiment the user may be prompted e g blinking signals displayed on the user interface unit 203 to reset the time and date information in the default clock mode Referring still again to FIG 2 in the test mode of operation of the glucose meter device 103 in one embodiment the correct insertion of the test strip 102 FIG 1 engaged into the test strip connector unit 202 of the meter device 103 is detected and upon removal of the test strip 102 the meter device 103 is configured to enter the default operation mode US 8 906 307 B2 7 In this manner the glucose meter device 103 may be config ured to automatically enter into the test mode of operation upon the correct insertion of the test strip 102 Alternatively the glucose meter device 103 may be con
24. en tion may include a speaker unit configured to output audio signals More specifically in one aspect of the present inven tion the user 101 may be alerted or reminded of one or more time specific events or reminder such as the next time the user 101 needs to take a blood glucose level measurement Rather than relying solely upon the user s memory the glucose meter device 103 may be configured with an alarm feature opera tively engaged with a timer function such that in addition to displaying the current time information on the display unit the glucose meter device 103 may be configured to generate and output an audible sound for each specific event or reminder which the user 101 has pre programmed into the glucose meter device 103 Moreover in a further embodi ment the audible alarm output ora series or audible tones as may be selected by the user may be simultaneously gener ated with the backlight feature of the glucose meter device 103 such that for each of use the user is able to view infor mation displayed on the display unit of the user interface unit 203 substantially immediately without the need to perform extra steps such as turning on the backlight function of the glucose meter device 103 In the preferred embodiment the meter allows the user to set up to four separate alarms to go off every 24 hours at a particular time to remind the user to test her blood glucose level Preferably the volume of each alarm may be set in
25. ent the test strip 308 is a Freestyle Test Strip currently available from the assignee of the present applica tion TheraSense Inc of Alameda Calif FIGS 4A and 4B illustrate the display screen of the glu cose meter device in accordance with one embodiment of the US 8 906 307 B2 9 present invention Referring to the Figures the display screen 302 of the glucose meter device shown in FIG 3 includes a plurality of visual representation of display information For example as shown in FIG 4A the check owner s manual symbol 401 is displayed to alert the user 101 FIG 1 to refer to the manual of the glucose meter device and may be dis played on the display screen 302 when for example the meter device detects LO or HI blood glucose level out of temperature range results and low power state The control solution test result symbol 302 is displayed to alert the user that the user has marked a test result as a control solution test Referring back to FIG 4A the message area 403 of the display screen 302 may be configured to display information such as the date information the time information the num ber of tests performed and other information related to the operation and function of the glucose meter device There is also provided in the display screen 302 a test result area 406 which is configured to display the resulting glucose level determined from the corresponding blood sample Also shown in FIG 4A are a battery s
26. es and a measurement log review mode that enables reviewing of stored analyte measure ments and configure the analyte meter to automatically exit the clock mode and enter the test mode upon receiving the analyte test strip in the strip port 2 The analyte meter of claim 1 wherein the analyte meter further comprises a mode switch to toggle between different modes of operation 3 The analyte meter of claim 1 wherein the analyte meter exits all modes of operation after exceeding a predetermined period of non activity 4 The analyte meter of claim 1 wherein the analyte meter further comprises a speaker unit to output audio signals 5 The analyte meter of claim 1 wherein the LCD displays a memory mode symbol to indicate that data has been stored in a memory unit of the analyte meter 6 The analyte meter of claim 1 further comprising alight source coupled to the housing to illuminate the strip port and a power source to provide power to the light source 7 The analyte meter of claim 6 wherein the light source is one or more LEDs 8 The analyte meter of claim 6 wherein the analyte meter pulses the light source at a predetermined frequency and predetermined duty cycle wherein the predetermined fre quency is greaterthan 100 Hz and wherein the predetermined duty cycle is approximately 1096 9 The analyte meter of claim 6 wherein the light source illuminates the LCD 20 25 30 35 14 10 The analyte meter
27. et al Khalil et al Mickle et al Causey III et al Lebel et al Lebel et al Flaherty et al Bojan et al Lebel et al Flaherty Lebel et al Brauker et al Flaherty et al Stewart et al Lebel et al Lebel et al Shults et al Causey III et al Lebel et al Forrow et al Lebel et al Lebel et al Bowman IV et al Lebel et al MacKenzie et al Han et al Cunningham et al Kloepfer et al Gelvin et al Shults et al Lebel et al Goode Jr et al Bowman IV et al Galen et al Lebel et al Lebel et al Perron et al Say et al Stirovic et al Lebel et al Weisner et al Drucker et al Khalil et al Wolf et al Simpson et al Simpson et al Mann et al Simpson et al Shults et al Hess et al Brauker et al Shults et al Schulman Karten et al US 8 906 307 B2 Page 3 56 References Cited 2006 0020191 Al 1 2006 Brister et al 2006 0020192 Al 1 2006 Brister et al U S PATENT DOCUMENTS 2006 0036139 Al 2 2006 Brister et al 2006 0036140 Al 2 2006 Brister et al 7 154 398 B2 12 2006 Chen et al 2006 0036141 AI 2 2006 Kamath et al 7 186 566 B2 3 2007 Qian 2006 0036142 Al 2 2006 Brister et al 7 192 450 B2 3 2007 Brauker et al 2006 0036143 Al 2 2006 Brister et al 7202734 Bl 4 2007 Raab 2006 0036144 Al 2 2006 Brister et al 7205409 B2 4 2007 Pei etal 2006 0036145 Al 2 2006 Brister et al 7225 535 B2 6 2007 Feldman et al 2006 0222566 Al 10 2006 Brauker et al 7 226 978 B2 6 2007 Tapsak et al 2006 0247508
28. figurable to enable manual initiation of the test mode of operation such as for example by the user s manual operation of the test mode switch not shown of the meter device 103 During the test mode of operation if a faulty operation is detected the glucose meter device 103 is configured to gen erate and output a corresponding respective message as such Examples of such faulty operation includes but not limited to the detection of a used test strip insufficient blood sample on the test strip incorrect insertion of the test strip into the test strip connector unit 202 of the meter device 103 or when the coulometer circuits are not ready for sample processing The outputted message to the user alerting of the faulty operation may include an audible sound a visual display or a combi nation of both Upon successfully collecting sufficient blood sample for processing from the user 101 FIG 1 the glucose meter device 103 is configured to process the collected sample and to generate a corresponding blood glucose data for output display to the user 101 on the user interface unit 203 The blood glucose data may be for example displayed in units of mg dL or in units of mmol Moreover in one embodiment the meter device 103 may also be configured to display the time and date information corresponding to the blood glucose level test Moreover the central processing unit 206 is further configured to store the processed and displayed bl
29. g Kong These LEDs provide a light having a peak wavelength of about 575 nanometers which has been found to provide optimal con trast between various colors of blood against various skin pigments in low light conditions More specifically using a yellow green LED with peak wavelength of 570 nanometers in one embodiment provided optional contrast between the various colors of blood against the skin pigments in low light conditions Also preferably the test light LED is pulsed faster than 60 100 hertz so that it appears to the human eye that it is continuously on without flickering most preferably 3 or 7 khz It has been discovered that a 1096 duty cycle with the LEDs specified above provides the most desired balance between light intensity and battery power savings A brighter light output than this can be disruptive in certain low light settings such as a movie theater and can inhibit inconspicu ous blood glucose testing In an alternate embodiment of the present invention the glucose meter device may be configured such that the back light on the display screen 302 is turned on when the test strip 102 is inserted into the test strip port 306 ofthe meter device Thereafter the backlight is configured to turn off when the blood drop and test strip symbols 414 are displayed in tandem to alert the user that the meter device is ready to apply the bloodsample or the control solution At the same timethat the backlight is turned off the light
30. here is a test strip inserted in the test strip port If either the test strip light or the display backlight is used during the test mode the backlight preferably powers on to show the test results after the mea surement is complete Preferably the glucose meter is powered by two coin cell batteries of a common size such as CR2032 It is also pref erable that one of the batteries is dedicated to powering the test strip light and display backlight and the other is dedi cated to powering the meter s processor and other functions It may also be desirable to allow the meter to be placed in a shelf mode after final testing at the factory such that even with batteries inserted nothing is shown on the display and the processor is in an energy saving sleep mode until one of the buttons is pressed or a test strip is inserted in the meter to resume normal operation In the manner described above in accordance with the various embodiments of the present invention the glucose meter device 103 is configured such that it is simple intuitive and easy to use permitting the user to perform the tests relatively discreetly and is also easily used by third parties such as the user s physician nurse care giver or family mem ber Moreover given the compact physical configuration the glucose meter device 103 is substantially small compact sleek and readily portable by the user Various other modifications and alterations in the structure and meth
31. ight source is maintained at the on position Indeed in one embodiment the central processing unit ofthe glucose meter device may be configured to control the switching on and offofthe light source as well as the level 20 25 30 35 40 45 50 55 60 65 2 of light intensity by for example adjusting the duty cycle and the period during which the light source is configured to be turned on Additionally in accordance with a further aspect of the invention the blood glucose meter may include a numerically displayed clock with a date display which may be visible when the meter is not in use Moreover the clock feature in yet a further embodiment of the present invention may include an alarm which would allow the users to set alarm reminder for performing blood glucose level testing where the alarm feature may include one or a combination of an auditory alarm a visual alarm alert and a vibration alert mode Indeed a blood glucose meter in accordance with one embodiment of the present invention includes a compact housing for a blood glucose meter a display unit disposed on the housing the display unit configured to display informa tion related to the blood glucose meter an input unit disposed on the housing the input unit configured to provide input functions for the blood glucose meter and a power source provided within the housing for providing power to the blood glucose meter The display unit may include
32. l WO WO 2006110913 10 2006 2009 0192366 Al 7 2009 Mensinger et al WO WO 2006113408 10 2006 2009 0192380 Al 7 2009 Shariati et al WO WO 2006113521 10 2006 2009 0192722 Al 7 2009 Shariati et al 2009 0192745 Al 7 2009 Kamath et al 2009 0192751 Al 7 2009 Kamath et al 2009 0203981 Al 8 2009 Brauker et al Barbosa R M 1996 Electrochemical Studies of Zinc in Zinc 2009 0204341 Al 8 2009 Brauker et al Insulin Solution Journal of the Royal Society of Chemistry 2009 0216103 AI 8 2009 Brister et al CAPLUS Abstract Analyst 121 12 1789 1793 2009 0240120 Al 9 2009 Mensinger et al Bard A J et al 2001 Methods Involving Forced Convection aed 0540133 m 4 anos Mesinge Hydrodynamic Methods Electrochemical Methods Fundamen enstnger eva tals and Applications 331 367 2009 0242399 Al 10 2009 Kamath et al LUE quieti EM er 2009 0242425 Al 10 2009 Kamath et al Kissinger P T 1996 Introduction to Analog Instrumentation 2009 0247855 Al 10 2009 Boock et al Laboratory Techniques in Electroanalytical Chemistry Second Edi 2009 0247856 Al 10 2009 Boock et al tion Revised and Expanded Jan 165 194 2009 0287073 Al 11 2009 Boock et al 2009 0287074 Al 11 2009 Shults et al cited by examiner US 8 906 307 B2 Sheet 1 of 6 Dec 9 2014 U S Patent V IYNDIH 0L SOL YILNANOI TYNHILX3 coL 331430 AILIN 3soon1s 391430 SNIONY 1 diMIS 1S31 toL US 8 906 307 B2 Sheet
33. od of operation of this invention will be apparent to those skilled in the art without departing from the scope and spirit of the invention Although the invention has been described in connection with specific preferred embodi ments it should be understood that the invention as claimed should not be unduly limited to such specific embodiments It is intended that the following claims define the scope of the present invention and that structures and methods within the scope of these claims and their equivalents be covered thereby What is claimed is 1 An analyte meter comprising a housing a strip port disposed in the housing and sized to receive an analyte test strip a processing unit for measuring an analyte level detected from the analyte test strip an interface unit that operatively couples the analyte meter to an external computer to transmit data related to the analyte level detected from the analyte test strip wherein the interface unit operatively couples the ana lyte meter to an external computer via a wireless con nection US 8 906 307 B2 13 a liquid crystal display LCD screen a non transitory memory comprising stored instructions that cause the processing unit to operate the analyte meter in a clock mode that displays current time and or date information on the LCD screen a test mode for performance of analyte measurements a configuration mode that enables user selection of con figuration preferenc
34. of claim 6 wherein the light source provides backlighting to the L CD 11 The analyte meter of claim 6 wherein the light source is coupled to the housing on the same end as the strip port 12 The analyte meter of claim 1 wherein the analyte meter is a glucose meter 13 The analyte meter of claim 1 measurement log review mode allows reviewing of glucose measurements stored in the meter 14 The analyte meter of claim 1 wherein when the meter is in the measurement log review mode the meter displays a glucose summary of stored results average glucose level information a number of measurements incorporated into the displayed average level or a visual indication to the user that the displayed data is average glucose level information 15 The analyte meter of claim 1 wherein the meter is configured to enter the measurement log review mode upon operation of a mode switch in a user interface unit while the meter is in the default clock mode 16 The analyte meter of claim 1 wherein the clock mode is a default mode of operation for the analyte meter 17 The analyte meter of claim 1 wherein the analyte meter comprises a self test screen that is displayed upon entry into the test mode the configuration mode or the measurement log review mode and wherein the self test screen illuminates all segments of the LCD screen prior to operation in the test mode the configuration mode or the measurement log review mode 18 The analyte mete
35. ood glucose data in the storage unit 207 Referring still to FIG 2 in the configuration mode of operation in one embodiment of the present invention the user 101 may select and input certain predetermined param eters into the glucose meter device 103 to configure the meter device 103 for subsequent use thereafter For example such configurable parameters include the displayed date and time information the alarm settings on the glucose meter device 103 the preferred display format for data display on the display unit of the user interface unit 203 in the meter device 103 the concentration unit of the generated glucose level and an average glucose level information based on a user selected number of days such as 14 day or 30 day average of stored results In the measurement log review mode of operation dis cussed above the glucose meter device 103 is configured to display a glucose summary that is the average glucose level information of stored results as well as other parameters such as the number of measurements incorporated into the displayed average level and a visual indication to the user that the displayed data is the average glucose level information and not a specific sampled glucose level data As will be discussed in further detail below the glucose meter device 103 may be configured to enter the measurement log review mode of operation upon the operation of the mode switch in the user interface unit 203 while the mete
36. orresponds to the calibration code number preassigned to the test strip inserted into the meter device After verifying the code number for the test strip at step 504 the blood drop and test strip symbols 414 FIG 4B are displayed on the display screen 302 to prompt the user to apply the blood sample to the test strip When the blood sample is in contact with the test strip the test strip acts like a sponge and pulls the blood into the strip through its edges Thereafter at step 505 it is determined whether the collected blood sample amount is sufficient to generate a corresponding blood glucose level If it is determined at step 505 that the collected blood sample amount is not sufficient to generate the corresponding blood glucose level then the procedure returns to step 504 to prompt the user to further apply the blood sample to the test strip On the other hand if it is determined at step 505 that the collected level of blood sample is sufficient to generate the corresponding blood glucose level the user 101 FIG 1 is notified as such in step 506 by an audible alert sound output via the user interface 203 e g through an output speaker and or by visual display on the display screen 302 FIG 3 The glucose meter device is then configured at step 507 to determine the glucose value corresponding to the detected blood sample and thereafter at step 508 to display the result ing glucose value on the display screen 302 FIG 3 and
37. ory 56 References Cited U S PATENT DOCUMENTS 3 930 493 A 4 018 547 A 1 1976 Williamson 4 1977 Rogen Continued FOREIGN PATENT DOCUMENTS EP 0455455 EP 0878707 11 1991 11 1998 Continued OTHER PUBLICATIONS An Electrochemical Slow Flow Meter http gore ocean washington edu researchjslow flow meter html Feb 10 2005 3 Continued Primary Examiner Sam P Siefke 74 Attorney Agent or Firm Edward J Baba Shweta Chandra Bozicevic Field amp Francis LLP 57 ABSTRACT A blood glucose meter having a compact housing a display unit disposed on the housing the display unit including a display light source to illuminate the display unit an input unit disposed on the housing the input unit configured to provide input functions for the blood glucose meter and a power source provided within the housing for providing power to the blood glucose meter where the housing includes a port integrated on said housing configured to receive a blood glucose test strip and corresponding methods of measuring blood glucose meter is provided 19 Claims 6 Drawing Sheets 104 LANCING DEVICE US 8 906 307 B2 Page 2 56 4 121 282 4 439 197 4 531 235 4 866 396 4 984 581 5 004 532 5 019 974 5 051 880 5 079 920 5 081 421 5 124 661 5 207 666 5 211 371 5 211 626 5 278 997 5 325 280 5 366 292 5 391 250 5 404 585 5 507 288 5 568 400 5 575 770 5 604 404 5 622 413 5 622 482 5 645
38. ouple to an external computer or data processing device to transfer data collected and processed by the glucose meter device 103 The data port 301 in one embodiment may include one of a Universal Serial Bus USB port an infrared data communication port a Bluetooth communication port and a Wi Fi wireless data communication port for example IEEE 802 11 or its equivalents Referring back to FIG 3 provided on the housing 307 is a display screen 302 which may be configured to display the test results and other parameters and information such as time and data information and the like The display screen 302 in one embodiment may include a built in display backlight for use in low light conditions and may be configured to auto matically switch on in low light settings for a predetermined period of time such as 1 minute for example or may be configured for manual user operation Also shown in FIG 3 are three input switches a mode switch 303 the configuration switch 304 and the light switch 305 In one embodiment the mode switch 303 may be oper ated by the user to toggle between different operation modes such as the test mode and the clock mode default configu ration mode and the measurement log review mode each discussed above The configuration switch 304 may be con figured to for example mark a test result as control solution change the test strip code time and alarm settings the output sound options date information
39. prompt for data input or alternatively to provide information to the user 101 corresponding to the user s operation of one or more functions of the glucose meter device 103 In one embodi ment the display unit of the glucose meter device 103 may include a LCD display screen which may further be config ured in an alternate embodiment to include a touch sensitive pad so as to allow the user 101 to input data therethrough Moreover in a further embodiment of the present invention the display unit of the glucose meter device 103 may be configured to include a backlight feature which would permit the user 101 to operate the glucose meter device 103 in a dark ambient setting such as in a theater outdoor at night and the like FIG 2 is a block diagram illustrating a glucose meter device shown in FIG 1 in accordance with one embodiment of the present invention Referring to FIG 2 the glucose meter device 103 in accordance with one embodiment of the present invention includes a central processing unit 206 operatively coupled to a digital data processing unit 204 The central processing unit 206 is further operatively coupled to a storage unit 207 which in one embodiment may include one or more of a data storage unit a random access memory unit and a read only memory unit As can be further seen from the Figure the digital data processing unit 204 is further opera tively coupled to an input output I O interface unit 205 which in one embo
40. r device 103 is in the default clock mode In one embodiment the glucose meter device 103 may be configured so that a LO is displayed for measured glucose values which are below 20 mg dL and in contrast a HI is displayed when the measured glucose value exceeds 500 mg dL Furthermore the meter device 103 may be configured to display the processed glucose level within approximately 15 seconds from the sampling of the corresponding blood for samples below 200 mg dL when measured at room tempera ture and humidity FIG 3 illustrates the glucose meter device of FIG 2 in accordance with one embodiment ofthe present invention As 20 25 30 35 40 45 50 55 60 65 8 shown the glucose meter device 103 includes a housing 307 which substantially encases the meter device 103 In one embodiment the glucose meter device 103 may be physically configured such that it is 3 12 inches in length 2 25 inches in width and 0 85 inches in height with no more that 1 4 ounces in weight with the batteries installed Moreover the material used for the housing 307 may comprise plastic metal poly mer ora combination ofany suitable material which provides substantial physical integrity when subject to normal usage of the meter device 103 including occasional dropping and other physical impacts Also shown in FIG 3 is a data port 301 which corresponds to the I O interface unit 205 FIG 2 and is configured to operatively c
41. r of claim 1 wherein the analyte meter is configured to exit the test mode the configuration mode or the measurement log review mode after a predetermined period of non activity or idle time and to enter the clock mode following the exiting ofthe test mode the configuration mode or the measurement log review mode 19 The analyte meter of claim 1 wherein the test mode is automatically exited and the clock mode entered upon removal of the analyte test strip from the strip port kok k k
42. rocessing unit 206 of the glucose meter device 103 may be configured for operating the meter device 103 in one of the following modes of operation the clock mode the default mode discussed above the test mode the configuration mode and the measurement log review mode The default clock mode is configured in one embodiment to display the time date information as config ured by the user 101 The test mode includes operations for the user to perform blood glucose measurements the configu ration mode includes functions for the user to select user preferences for configurable parameters of the glucose meter device 103 and the measurement log review mode allows reviewing of the glucose measurements stored in the meter device 103 In one embodiment when the glucose meter device 103 enters a non clock mode of operation the meter device 103 may be configured to display a self test screen that illumi nates all segments of the display unit in the user interface unit 203 prior to operating in the selected mode of operation Moreover the glucose meter device 103 may be configured to exit all operation modes after exceeding a predetermined period of non activity idle time for example 2 minutes such as no switch activity test strip activity or display activity for example Additionally the central processing unit 206 of the glucose meter device 103 is configured such that upon detection that there was a loss of power for example battery r
43. the measurement unit infor mation and for review of the stored sample results Also the configuration switch 304 may also be depressed to silence the output of an alarm Finally the light switch 305 is configured to control the operation of the backlight of the display screen 302 as well as the flashlight function ofthe meter device 103 Referring yet again to FIG 3 a test strip port 306 is addi tionally provided on the housing 307 of the glucose meter device 103 and is configured to receive the insertion of a test strip 308 In one embodiment the test strip port 306 substan tially corresponds to the test strip connector unit 202 shown in FIG 2 Also provided on the test strip port 306 is a light source such as a light emitting diode LED and the like which is configured to switch on and off under the operation of for example the light switch 305 or alternatively in accordance witha certain operations of the glucose meter device 103 such as for example the detection of the test strip 308 at the opening of the test strip port 306 As can be further seen the test strip 308 may include a top portion 309 and a bottom portion 310 such that the top portion 309 is configured to be inserted into the test strip port 306 of the glucose meter device 103 while the bottom portion 310 of the test strip 308 sub stantially comprises the blood sample target areas for the user to apply the blood sample or a control solution thereto In one embodim
44. the test result area 406 In this preferred embodiment the date and time information are displayed in a different area of display screen 302 from the glucose test results and with different sized digits preferably smaller as shown Also it is preferable that the test result area 406 be offset from the center of display screen 302 even more preferably located in a corner of the display screen 302 as shown In the manner described above the display screen 302 of the glucose meter device in accordance with one embodiment of the present invention may be configured to display infor mation corresponding to the glucose tests and the processed results in a easy and intuitive manner FIG 5 is a flowchart illustrating the procedure for perform ing a blood glucose test using the glucose meter device in accordance with one embodiment of the present invention Referring to FIGS 2 and 5 at step 501 the glucose meter device detects the insertion of a test strip 102 in the test strip connector unit 202 FIG 2 In response to the detection ofthe test strip 102 insertion the meter device 103 is powered on and at step 502 the inserted test strip is verified and a self test of the meter device is performed More specifically at step 502 a system check illumination briefly lights up the entire display screen 302 and the various data symbols and areas included therein and thereafter in step 503 the user 101 is prompted to input a code number which c
45. transmit and receive patient data related to the glucose level detected from the collected blood sample for further diagnosis analysis and the like In one embodiment the user 101 may provide the configu ration parameters as well as calibration code to the glucose meter device 103 while the glucose meter device 103 may be configured to output signal prompts to the user 101 such as to indicate a sample fill signal and a sample result signal and further to output display the resulting measured blood glu cose level from the sampled blood from the user 101 Fur thermore after the user 101 is lanced with the lancing device 104 to generate sufficient amount of sample blood the test strip 102 is provided in contact thereto i e to the sample blood while the test strip 102 is operatively coupled to the glucose meter device 103 In this manner the glucose meter device 103 may in one embodiment be configured to alert the user that the amount of blood sample on the test strip 102 is sufficient to determine the corresponding blood glucose level In one aspect of the present invention the glucose meter device 103 may be configured to make clinical measurements of glucose in whole blood in the range for approximately 20 to 500 mg dL Furthermore as discussed in further detail below the glucose meter device 103 may be configured to include a display unit which is configured to operate as a user interface to visually interact with the user 101 to
46. ymbol 405 and a memory mode symbol 404 where the battery symbol 405 is config ured to be illuminated when the power supply level e g the battery level is detected to be lower than the optimum oper ating level and to alert the user 101 FIG 1 to replace the same The memory mode symbol 404 on the other hand is configured to display to the user 101 FIG 1 that the test result displayed in the rest result area 406 has been stored in the memory the storage unit 207 FIG 2 of the glucose meter device In one embodiment the memory capacity of the meter device may store up to approximately 250 blood glu cose test results Referring now to FIG 4B the display screen 302 may further be configured to display a blood drop symbol and a test strip symbol 414 which are configured to operate in tandem to alert the user that the meter device is ready to apply the blood sample or the control solution Moreover the unit symbol 413 is configured to appear with the test result data displayed in the test result area 406 of the display screen 302 when the blood sample has been successfully collected and a corresponding glucose level has been determined based on the collected blood sample The date setup symbol 407 on the display screen 302 may be displayed in the configuration mode when the user is setting the date information of the glucose meter device As further shown a check and set test strip code symbol 408 is provided on the display screen

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