Patent Description:
External infusion devices (e.g., infusion pumps) may be used for delivering medication to users, such as insulin to diabetics. Portable external infusion devices may be attached to a user's belt, for example, or placed in a user's pocket. In external infusion devices delivering insulin, for example, the insulin may be delivered via a cannula, inserted in subcutaneous tissue of the user.

Some conventional external infusion pumps may communicate remotely with another controlling device, such as a remote controller that is physically separated from the external infusion pump, for altering one or more functional settings of the external infusion pump. One example of such device is shown and described in <CIT>. Another example is shown and described in <CIT> and <CIT>. Other conventional infusion pumps may include a remote controller with a blood glucose measurement device. One example of such device is shown and described in <CIT>. <CIT> describes a medical system comprising first means of secure communication (e.g. pairing) and second means of less-controlled communication. <CIT> describes a physiological monitoring system that is to be placed in proximity to exchange a secret key using a near field wireless link.

Since most remote controllers and infusion pumps are designed to communicate via radio frequency (RF) communications, there is a growing concern among device manufacturers, users, and government regulators that RF transmissions are susceptible to interception and/or manipulation. Under certain circumstances, it has been suggested that a corrupted or malicious signal might be sent to an infusion device. Although no such instances outside of a laboratory are known to applicants, such an inaccurate or deliberately false signal to the infusion device might cause or be intended to cause a change in the delivery of medication that is harmful to the patient.

By utilization of various technical features described herein, the coupling or pairing of a plurality of medical devices to respective remote controllers is convenient and potentially safer for the user, and instances of incorrect device pairing are believed to be reduced. These technical features are believed to be heretofore unrecognized in the conventional system. Specifically, in one embodiment, a disease management system is provided that includes a medical device and a remote controller. The medical device includes a display for the device and having medical device identification information. The remote controller includes a controller display and remote controller identification information, in which the medical device display is configured to display the controller identification information and the controller display is configured to display the medical device's identification information when the controller and medical device are linked to each other.

In a further embodiment, a method to verify a wireless connection between a medical device and a remote controller is provided. The method can be achieved by: connecting a remote controller with a medical device via a wireless link; providing identification information specific to the medical device to the remote controller; providing identification information specific to the remote controller on the medical device; and confirming that the medical device identification is with the remote controller and that remote controller identification information is on the medical device.

In yet a further embodiment, a method of operating a diabetes management system is provided in which the system includes a medical device and at least a remote controller. The method can be achieved by: exchanging identification information of the remote controller to the medical device and identification information of the medical device to the remote controller; and permitting control of the medical device by the remote controller upon acceptance of the remote controller's identification information in the medical device and acceptance of the medical device's identification information in the remote controller.

In another embodiment of the invention the remote controller and infusion pump each employ radio frequency identification (RFID) tags with a unique code. The use of RFID tags may permit a faster, simpler method of pairing by placing the remote controller and infusion pump in close proximity to one another, allowing for the information stored on the RFID tags to complete the pairing process.

In yet another embodiment of the invention, potentially corrupted or inaccurate signals that instruct the pump to deliver medication outside of a normal usage pattern, that might be harmful to the patient, or is otherwise outside of parameters pre-set into the infusion device's microcontroller and associated memory can be "confirmed" by requiring the user to place the remote in close proximity to the infusion device. The exchange of information on the RFID tags can allow for verification that the dosing information received via RF communication from the remote controller is accurate and intended, or may allow the user to cancel and unintended or inaccurately programmed delivery.

The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, serve to explain features of the invention, in which:.

The drawings, which are not necessarily to scale, depict selected exemplary embodiments and are not intended to limit the scope of the invention.

Preferred embodiments described and illustrated herein are directed generally to a system having a remote controller, which may wirelessly communicate with a medical device that dispenses a fluid or medication and various methods of operation. We will describe, via the use of examples, how the remote controller and the medical device wirelessly communicate identification information with each other, how icons are used to notify a user that a wireless link that has been established between the remote controller and medical device, how similar user interfaces are used on both the remote controller and medical device, who multiple remote controllers can be paired with a medical device, how time windows are established for measured blood glucose values, and how device identification can be used with command histories.

In addition, as used herein, the terms "patient", "host" and "subject" refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.

Referring to <FIG>, an operational configuration of a remote controller <NUM> and a medical device <NUM> is shown in which the device <NUM> is physically connected to a user to provide monitoring of physiological parameters (e.g., heart or brain activities, body temperature, glucose level), active intervention (e.g., brain or cardiac management), or infusing of medication or bioactive agents. In the exemplary embodiments, the medical device <NUM> is configured as an insulin infusion pump <NUM>, which, when placed in a wireless link with a specified remote controller <NUM>, can indicate identification information specific to the remote controller (as "Controller 1AB3DE" which is printed or affixed to the remote controller <NUM>). Conversely, the remote controller <NUM>, when placed in the wireless link with the infusion pump <NUM>, can indicate identification information specific to the infusion pump (as "Pump <NUM>" which is printed or affixed to the pump <NUM>).

Thus, as configured and to be described in additional detail below, a disease management system can be configured for a chronic disease such as diabetes where the system includes a medical device, which has a display for the device and a remote controller. The remote controller has a controller display with the controller having controller identification information. In this system, the medical device display is configured to display the controller identification information, and the controller display is configured to display the medical device's identification information when the controller and medical device are linked to each other via a wireless link. As used herein, a "link" is a bidirectional communication connection using radio waves, microwave, ultraviolet, infrared or combinations thereof. In this system, the controller display includes a first screen representative of analyte measurement information and a second screen representative of an infusion pump operational information. Of note is the use of a generally common or identical user indicia and user interface for both the medical device and the remote controller. As used herein, the term "user indicia" indicates the graphical text, symbols, light or sounds and the particular arrangement of the text, symbols, light or sounds to define various functional screens (e.g., menus) to allow for programming and controlling of the controller <NUM> and pump <NUM> whereas the term "user interface" indicates the components such as buttons, switches or even a voice response interface in combination with the user indicia to allow for inputs or commands by the user. With the use of a display on the remote programmer, instructional graphics can be used to walk the user through various modes of the system, thereby making the system even more user friendly. By virtue of the system, a method is obtained in which the infusion pump and the remote controller are paired by exchanging identification information, which may include a serial number of the device; names; icons; avatars, speech identification, sounds, or combinations thereof. Also, where appropriate, the method allows for the pairing of additional remote controllers while unlinking or decoupling with any other previously paired remote controller.

<FIG> is a perspective view of a remote controller <NUM> for use in the exemplary embodiments. Remote controller <NUM> includes a first housing <NUM>, a first display <NUM>, a first OK button <NUM>, a first down button <NUM>, back button <NUM>, a first up button <NUM>, light emitting diode (LED) <NUM>, and strip port connector (SPC) <NUM>. Remote controller <NUM> is schematically shown in <FIG> to further include the following functional components such as a first display (DIS) <NUM>, a first navigational buttons (NAV) <NUM>, a first radio frequency module (RF) <NUM>, a blood glucose measurement (BGM) module <NUM>, a first battery (BAT) <NUM>, a wired communication port (COM) <NUM>, a first alarm (AL) <NUM>, a first microprocessor (MP) <NUM>, a memory portion (MEM) <NUM>, and a memory chip port (MCP) <NUM> as shown in <FIG>. In one exemplary embodiment, shown here in <FIG>, a first housing <NUM> is ergonomically designed to be handheld and to incorporate the functional circuitry required for measuring glucose episodically and adapted to allow wireless communication with infusion pump <NUM>.

Referring back to <FIG>, the remote controller <NUM> includes a port cover <NUM>. In one exemplary embodiment, port cover <NUM> is an elastomeric material that covers over a wired connection port <NUM> (not shown) and a memory chip port <NUM> (not shown). Examples of a wired connection port may be a universal serial bus (USB) or IEEE RS <NUM>. Examples of memory suitable for insertion into memory receiving port may be a flash memory such as a SIMM card, a SmartCard, Smart Media, or any devices capable of storing data.

Referring to <FIG> and <FIG>, first display <NUM> may be a liquid crystal display (LCD) to show both textual and graphical information to a user. A user interface (VI) may be software driven menu that is shown on first display <NUM> that enables the user to operate remote controller <NUM>. A user can navigate through the UI using first navigation buttons <NUM> which include first up button <NUM>, first down button <NUM>, first OK button <NUM>, and back button <NUM>. In one exemplary embodiment, the UI allows a user to operate infusion pump <NUM>, query the status of infusion pump <NUM>, measure glucose episodically, and to display data on first display <NUM> from remote controller <NUM> and/or infusion pump <NUM> (e.g. glucose concentration versus time).

First microprocessor <NUM> may control first display <NUM>, first navigational buttons <NUM>, first RF module <NUM>, blood glucose measurement module <NUM>, wired communication port <NUM>, first alarm <NUM>, and memory chip port <NUM>. First microprocessor <NUM> further provides the capability to perform various algorithms for the management of a medical treatment. Examples of such algorithms may include a predictive algorithm for a user's glucose concentrations (e.g. an algorithm that predicts a user's glucose concentration in the future) and a bolus calculator. A bolus is a pre-determined amount of a medication that is dispensed over a relatively short time period. In the case of a bolus calculator, first microprocessor <NUM> may process inputs such as food data (e.g. carbohydrates), which may be entered manually using first navigation buttons <NUM>, or via wired communication port <NUM> from a personal computer or like device. Additionally, blood glucose data may be provided to first microprocessor <NUM> directly from the blood glucose measurement module <NUM>. Using the inputted food data and glucose measurement data, a bolus of insulin can be determined, and shown on first display <NUM>, and transmit the bolus amount wirelessly from remote controller <NUM> to infusion pump <NUM>. This enables infusion pump <NUM> to dose an appropriate amount of insulin to a user while at the same time reducing the amount of user interactions with infusion pump <NUM>.

First RF module <NUM> on remote controller <NUM> provides for bi-directional communication to infusion pump <NUM> and potentially other devices such as a continuous glucose monitor, a personal computer, a personal digital assistant, a cell phone, or a second infusion pump, which may dispense glucose. Exemplary frequencies that may be suitable for use with first RF module <NUM> are about <NUM>, about <NUM>, about <NUM>, and about <NUM>. In one exemplary embodiment, first RF module <NUM> may include a commercially available component such as a Chipcon CC <NUM>, an antenna, and a RF impedance matching network. First RF module <NUM> may send commands to infusion pump <NUM> such as a basal pump rate, duration of pump, and bolus amounts. In addition, first RF module <NUM> may receive data from infusion pump <NUM> which includes an alarm indicating an occlusion or low insulin in reservoir, battery lifetime status, a continuous or semi-continuous glucose reading, and amount of remaining insulin in reservoir.

Wired communication port <NUM> provides the option of transferring data to or from an external device such as a personal computer. Wired communication port <NUM> may also be used to upgrade the software memory portion <NUM> of remote controller <NUM>. Memory portion <NUM> may be a volatile memory type such as for example flash memory. Memory portion <NUM> may contain the application and system software for operating remote controller <NUM>. Wired communication port <NUM> may then re-write memory portion <NUM> such that the entire application and system software is upgraded. This allows potential bugs in the software to be fixed and may be used to create added functionality in remote controller <NUM>. In addition, a flash memory card may be inserted into memory chip port <NUM> for upgrading remote controller <NUM> without connecting it to a personal computer. Alternatively, the flash memory card may also be used for adding language support, or supplying calibration information (e.g., for a CGMS device to be paired with the controller).

Remote controller includes first alarm <NUM> which may be in a variety of forms to warn a user of various statuses that might need an actionable response. For example, first alarm <NUM> may include an audio alarm (monophonic beeps or polyphonic tones), a vibratory alarm, or a LED <NUM> which may be a multi-colored LED that can illuminate red, yellow, and green light. In one exemplary embodiment, an alarm signal my be used to warn a user that there is a low glucose reading, a partially filled glucose test strip, a low reservoir of insulin, an occlusion in infusion pump <NUM>, a low battery status for infusion pump <NUM>, a low battery status for remote controller <NUM>, and an improperly filled test strip. For the previously mentioned situations in which a user may need to intervene because of a potentially dangerous situation, the alarm may be a vibration, audio signal, and/or LED <NUM> switching from green to red or from green to yellow.

<FIG> is a perspective view of an infusion pump <NUM> for use in the exemplary embodiments. Infusion pump <NUM> includes a second housing <NUM>, a backlight button <NUM>, a second up button <NUM>, a cartridge cap <NUM>, a bolus button <NUM>, a second down button <NUM>, a battery cap <NUM>, a second OK button <NUM>, and a second display <NUM>. Infusion pump <NUM> may be suitable for use in dispensing medication such as insulin for improved diabetic therapies. Similar to remote controller <NUM>, second housing <NUM> may include RF transparent material and may be painted with RF transparent paint. Referring to <FIG> and <FIG>, infusion pump <NUM> may further include second display (DIS) <NUM>, second navigational buttons (NAV) <NUM>, a reservoir (RES) <NUM>, an infrared communication port (IR) <NUM>, a second radio frequency module (RF) <NUM>, a second battery (BAT) <NUM>, a second alarm (AL) <NUM>, and a second microprocessor (MP) <NUM>. In one exemplary embodiment, infusion pump <NUM> and remote controller <NUM> may bi-directionally communicate using a wireless signal <NUM> via first RF module <NUM> and second RF module <NUM>. Reservoir <NUM> typically contains insulin that can be dispensed from infusion pump <NUM> via tubing and a needle attached to a user. The tubing and needle may be attached to cartridge cap <NUM>.

Referring to <FIG> and <FIG>, in one exemplary embodiment, the antenna portion of first RF module <NUM> may be located within first housing <NUM>. Similarly, second RF module <NUM> may be located within second housing <NUM>. In such a case, the material used for first housing <NUM> and second housing <NUM> may be RF transparent (i.e. does not absorb or interfere with RF signals). Further, if first housing <NUM> or second housing <NUM> require that it be painted, the paint used may be RF transparent as well.

First RF module <NUM> and second RF module <NUM> further include a communication protocol that enables remote controller <NUM> to communicate with only a particular infusion pump <NUM>. Both remote controller <NUM> and infusion pump <NUM> have a unique identification code embedded in their respective first RF module <NUM> and second RF module <NUM>. This is desirable because under certain conditions, a second user with a second infusion pump <NUM> may be in close proximity to the first user. It would be undesirable for the first user's remote controller <NUM> to communicate with the second user's infusion pump <NUM>. In order to avoid such a scenario, a user must initiate a pairing protocol before using infusion pump <NUM> for the first time. When initiating the pairing protocol, remote controller <NUM> and infusion pump <NUM> exchange their unique identification code (e.g. serial number). In all subsequent wireless communications, the correct unique identification code must be established before exchanging data.

In one exemplary embodiment, remote controller <NUM> may have an integrated blood glucose meter that can measure glucose episodically using disposable test strips. A test strip, which may be suitable for use in the exemplary embodiments, is the commercially available OneTouch Ultra™ test strip from LifeScan™, Inc. in Milpitas, California, U. A test strip <NUM> suitable for use in remote controller <NUM> is shown in <FIG>.

In addition to measuring glucose episodically, remote controller <NUM> can also wirelessly communicate with infusion pump <NUM> to provide information on the analyte measurements to the pump <NUM>. Remote controller <NUM> can send commands to infusion pump <NUM> to dispense a fluid or medication for a pre-determined time period, rate, and/or volume. In one exemplary embodiment, a user may select from a menu of basal programs that have been programmed on infusion pump <NUM>. In another embodiment, the user may more specifically set a basal rate, a bolus dose, and a combination thereof may be programmed as commands to infusion pump <NUM> from remote controller <NUM>. Remote controller <NUM> can receive data from infusion pump <NUM> such as the status of the dispensing of medication (e.g. the dispense rate, amount of medication remaining in infusion pump <NUM>, or the proportion of medication delivered based on the amount programmed).

<FIG> is a flow chart illustrating screens for pairing a remote controller and infusion pump that may be displayed on the remote controller, as used in the exemplary embodiments. When pairing controller <NUM> and infusion pump <NUM>, the first screen is splash screen <NUM>. Splash screen <NUM> is displayed when <NUM> is turned on. If controller <NUM> has not been paired to infusion pump <NUM>, or if RF communication between <NUM> and infusion pump <NUM> is turned off, the first screen displayed after splash screen <NUM> is meter home screen <NUM>. Meter home screen <NUM> typically includes last reading <NUM>, average reading <NUM>, time <NUM>, and battery icon <NUM>. Battery icon <NUM> indicates the charge in first battery <NUM>. Pressing first OK button <NUM> while meter home screen <NUM> is displayed accesses main menu screen <NUM>. Meter settings <NUM> can be highlighted by pressing first down button <NUM>. Pressing first OK button <NUM> results in meter settings screen <NUM>. RF <NUM> can be highlighted by pressing first down button <NUM>, then selected by pressing first OK button <NUM>. RF setup screen <NUM> is then displayed, and pairing <NUM> can be highlighted by pressing first down button <NUM> followed by first OK button <NUM>, resulting in the display of pairing screen <NUM>. Pairing screen <NUM> instructs the user to activate the pairing mode on infusion pump <NUM> then to highlight and select start pairing command <NUM>. Once this is done, pairing status screen <NUM> is displayed, indicating pairing status <NUM>. In the process of pairing, units criteria <NUM> is checked. If the blood glucose units of measure are not the same in remote controller <NUM> and infusion pump <NUM> the pairing procedure is aborted. If the blood glucose units of measure are the same in remote controller <NUM> and infusion pump <NUM>, pairing result screen <NUM> is then displayed. Paired infusion pump <NUM> includes the serial number of the paired infusion pump. After verifying that paired infusion pump <NUM> is correct, accept command <NUM> is highlighted and selected. Remote infusion pump home screen <NUM> is then displayed, and can be toggled with meter home screen <NUM> by pressing first down button <NUM> and first up button <NUM>. Remote infusion pump home screen <NUM> includes infusion pump icon <NUM>, toggle icon <NUM>, signal strength icon <NUM>, battery icon <NUM>, time <NUM>, and delivery status <NUM>. Infusion pump icon <NUM> indicates that remote infusion pump home screen <NUM> is a display screen that is associated with infusion pump <NUM>. Remote infusion pump home screen <NUM> includes the serial number of the paired infusion pump, or alternatively can include a familiar name, assigned by the user to identify infusion pump <NUM>, instead of the infusion pump serial number. Toggle icon <NUM> indicates that additional screens can be viewed by pressing first down button <NUM> or first up button <NUM>. Time <NUM> displays the current time (a remote controller <NUM> setting). Signal strength icon <NUM> indicates RF signal strength between remote controller <NUM> and infusion pump <NUM>. Battery icon <NUM> indicates that infusion pump <NUM> has a full battery charge. Delivery status <NUM> is an infusion pump status indicating active basal dosing and that infusion pump <NUM> contains <NUM> units of insulin. Remote infusion pump home screen <NUM> can be toggled with meter home screen <NUM> using first down button <NUM> and first up button <NUM>. Meter home screen <NUM> includes meter icon <NUM>, indicating that meter home screen <NUM> is a display screen related to remote controller <NUM>. Meter home screen <NUM> includes toggle icon <NUM>, signal strength icon <NUM>, and battery icon <NUM>. Toggle icon <NUM> indicates that additional screens can be viewed by pressing first down button <NUM> and first up button <NUM>. Signal strength icon <NUM> indicates RF signal strength between remote controller <NUM> and infusion pump <NUM>. Battery icon <NUM> indicates the battery charge in remote controller <NUM>.

<FIG> is a flow chart illustrating screens for pairing a remote controller and infusion pump that may be displayed on the infusion pump, as used in the exemplary embodiments. When infusion pump <NUM> is turned on, local infusion pump home screen <NUM> is displayed. Local infusion pump home screen <NUM> includes time <NUM>, battery icon <NUM>, delivery status <NUM>, status command <NUM>, and <NUM>. Time <NUM> is the time set in infusion pump <NUM>. This time must match the time set in remote controller <NUM>, and displayed as time <NUM> in <FIG>. Battery icon <NUM> indicates the battery charge in infusion pump <NUM>. Delivery status <NUM> indicates the current delivery status of infusion pump <NUM>, while status command <NUM> and <NUM> are sub-menu items related to infusion pump status and the main menu of infusion pump <NUM>. After highlighting <NUM> using second up button <NUM> and second down button <NUM>, second OK button <NUM> is pressed and main menu screen <NUM> is displayed. Second down button <NUM> can be used to highlight setup <NUM>, and second OK button <NUM> is pressed to display setup screen <NUM>. After highlighting and selecting advanced <NUM>, remote setup screen <NUM> is displayed. RF <NUM> can be switched to on using second up button <NUM>, second down button <NUM>, and second OK button <NUM>. When RF <NUM> is on, channel <NUM> is set to AUTO mode. In AUTO mode the channel for RF communication is selected automatically. In remote setup screen <NUM>, search <NUM> is toggled to ON, and then remote setup screen <NUM> is displayed. Remote setup screen <NUM> includes search status <NUM>. Search status <NUM> indicates that second RF module <NUM> is searching for compatible RF signal from other devices, such as first RF module <NUM>. Once a device is found, remote setup screen <NUM> is displayed, the channel over which RF communication occurs is displayed in channel <NUM>, and the user is prompted to confirm paired remote <NUM> using confirm <NUM>. Once paired remote <NUM> is confirmed using confirm <NUM>, remote setup screen <NUM> is displayed. Remote setup screen <NUM> includes paired remote <NUM> and next <NUM>. By highlighting next <NUM> and pressing second OK button <NUM>, display <NUM> displays local infusion pump home screen <NUM>. Since infusion pump <NUM> is now paired with remote controller <NUM>, remote control icon <NUM> is displayed. When remote control icon <NUM> is displayed, it indicates that RF is enabled, infusion pump <NUM> is paired with remote controller <NUM>, and that infusion pump <NUM> is ready to receive commands from remote controller <NUM>. Remote control icon <NUM> does not indicate RF traffic/activity, signal strength, or health of communications. It simply means that infusion pump <NUM> is enabled to receive RF commands from remote controller <NUM>. If remote control icon <NUM> is not displayed on local infusion pump home screen <NUM> it means that RF communication between remote controller <NUM> and infusion pump <NUM> is disabled, and that infusion pump <NUM> will not receive commands from remote controller <NUM>.

<FIG> illustrates notifications that may be displayed on remote controller <NUM> during the pairing process of remote controller <NUM> and infusion pump <NUM>, as used in the exemplary embodiments. Since it is important that the units of measure are the same in both bolus calculations and in historical data logs, the pairing feature will fail if the units are not identical. In some embodiments, the units can be changed by the user in both remote controller <NUM> and infusion pump <NUM>. In other embodiments the units are fixed at the factory and can't be changed, in which case either remote controller <NUM> or infusion pump <NUM> are exchanged for models with compatible units of measure. In addition to units of measure, it is also important that remote controller <NUM> and infusion pump <NUM> are set to the same time. This is important in establishing when blood glucose tests were performed, and in logging events such as bolus and basal delivery. Accurate time settings are also important in monitoring averages at different times of the day.

In the exemplary embodiments, the remote controller <NUM> and the infusion pump <NUM> may incorporate a suitable radio frequency communication system, such as, for example, a far-field radio frequency communication element ("RF") for bi-directional communication. The center frequencies can be any suitable frequencies. In the preferred embodiments, the center frequencies are approximately <NUM> MegaHertz ("MHz") and approximately <NUM>. The system preferably uses the Chipcon™ Product CC1100 RF Transceiver supporting frequency modulated and Frequency Shifting Keying for data transfer. Manchester encoding can be utilized to allow for self-clocking as the clock is embedded in the signal. Alternatively, Non-Return-to-Zero or NRZ encoding can also be utilized. As described above, the RF element utilizes a communication protocol that has a learn mode or "pairing" mode which pairs the two devices (remote controller <NUM> and infusion pump <NUM>), in which the unique identification code of each communicating device is exchanged. Device "pairing" is a process in which a master (remote controller <NUM>) learns who its slave is (an infusion pump) and in which the slave (infusion pump) learns who its master (remote controller) is. All devices utilize suitable information identification, such as, for example, a fixed device-type serial number address, sound, or optical identifier. Preferably, the remote controller <NUM> holds one serial number of the infusion pump <NUM> that is paired with the controller <NUM>; the infusion pump <NUM> stores one single master remote controller's serial number from which it will accept commands; and only one remote controller <NUM> and one infusion pump <NUM> may be paired at a time. If a new remote controller <NUM> is to be "paired" to an infusion pump <NUM>, the other remote controller <NUM> is "un-paired" or whose communication is ignored. During the pairing process, a communications "channel" is established for the system. The "channel" is preferably a frequency offset from the center frequency. The use of channels is believed to provide for communication that is more robust. The RF communication can be initiated by either the infusion pump <NUM> or the controller <NUM>. In the preferred embodiments, the communication is initiated by the remote controller <NUM> (master). There is a predefined wait-listen period after the remote controller <NUM> transmits to the infusion pump <NUM>, where the remote controller <NUM> listens for a response from the infusion pump <NUM>. The infusion pump <NUM> indicates its state, if it is busy or can communicate with the remote controller <NUM>. The remote controller <NUM> will then communicate with the infusion pump <NUM> to ask for the status (alarm, alerts, insulin units delivered, etc.) of the infusion pump, and the infusion pump will send and receive data upon request to and from the remote controller <NUM>. The RF transmission can utilize a single frame of transmission. A frame can include a plurality of preamble or synchronization information, header and data.

In the preferred embodiments, the frame includes preamble and synchronization information, a frame header and an optional data packet with cyclic-redundancy-checksum ("CRC"). To conserve battery power, three preamble lengths may be utilized: (<NUM>) a long; (<NUM>) medium; and (<NUM>) short preambles. The long preamble is used for initiating communication, the medium preamble is used for automatic session initiation and a short preamble is used once communication is established. The predetermined number of preamble bytes to be transmitted will vary within a certain range instead of a fixed number of preamble bytes. The preamble bytes are sent before the frame to allow the RF receiver to lock and receive the frame. The variation is caused by the clock jitter of the timer, which may cause the preamble periods to be decreased or increased by about <NUM> milliseconds. The short and long preamble periods may be configured to account for the shortest possible variations in preamble period that could occur because of clock jitter. The buffer time period may be configured to have about the same magnitude as the clock jitter in the transmitting device. As a result, the preamble period may be about greater than or equal to the time periods for the high frequency power saving mode or the low frequency power saving mode of the receiving device. Consequently, a transmitting device may reliably and robustly send a sufficiently long preamble that will be properly received by the receiving device even if the transmitting device sends the lowest possible preamble length due to clock jitter.

The listening window scheme uses a two-stage sniff interval to optimize communication on-times. The frame header includes a command, frame number, size of the optional data packet and a CRC for the frame header. The communication protocol also incorporates a mechanism to insure that the data has been transmitted correctly by validating and verifying the transmission, this includes a use of a cyclical redundancy check and acknowledgment in the communication. For some RF commands with data packets, the associated data packet may contain the <NUM>'s complement of another data field as an added safety check for the receiver. Further, the receiver may respond to the command by repeating data fields of the initial data packet as a safety check for the originating transmitter. After the initial "pairing" has been completed, the specific address of the remote controller <NUM> and the infusion pump <NUM> are no longer transmitted as part of the data transmitted, but are contained in the CRC checksum. One example of a communication protocol and methodology that can be utilized is shown and described in International Application <CIT>.

<FIG> and <FIG> illustrate meter home screens that may be displayed on remote controller <NUM>, as used in the exemplary embodiments. <FIG> illustrates meter home screen <NUM>, a typical display before pairing, and <FIG> illustrates meter home screen <NUM>, a typical display after pairing. Before pairing, meter home screen <NUM> includes meter icon <NUM>, time <NUM>, battery icon <NUM>, last reading <NUM>, and meter home screen <NUM>. Meter icon <NUM> indicates that the screen is related to remote controller activities. Time <NUM> is the current time, as set in remote controller <NUM>. Battery icon <NUM> indicates remaining power in remote controller <NUM>, and can vary between empty, low, medium, and full. If battery icon <NUM> is empty, no functions are available in remote controller <NUM>, and an alarm screen appears. After pairing, meter home screen <NUM> includes toggle icon <NUM>, signal strength icon <NUM>, and keys locked icon <NUM>. Toggle icon <NUM> indicates that the user can switch between meter home screen <NUM> and remote infusion pump home screen <NUM> (described in reference to <FIG>), by toggling first down button <NUM> and first up button <NUM>. Signal strength icon <NUM> indicates the status of RF communication between remote controller <NUM> and infusion pump <NUM>, and varies between RF off icon <NUM>, RF down icon <NUM>, low RF strength icon <NUM>, medium RF strength icon <NUM>, and full RF strength icon <NUM>. If no infusion pump is paired, signal strength icon <NUM> is not shown. Keys locked icon <NUM> indicates that the user interface has been locked, and only limited functionality is available, preventing inadvertent activation of controller and infusion pump functions.

<FIG> illustrates an infusion pump home screen that may be displayed on remote controller <NUM>, as used in the exemplary embodiments. Remote infusion pump home screen <NUM> is only displayed on remote controller <NUM> if remote controller <NUM> is paired to infusion pump <NUM>. When remote controller <NUM> is paired to infusion pump <NUM>, the user can toggle between remote infusion pump home screen <NUM> and meter home screen <NUM> (illustrated in <FIG>) by pressing first down button <NUM> or first up button <NUM> on remote controller <NUM>. Remote infusion pump home screen <NUM> includes remote infusion pump home screen <NUM>, indicating the serial number or friendly name of infusion pump <NUM> with which remote controller <NUM> is paired. By default, remote infusion pump home screen <NUM> includes the serial number of infusion pump <NUM> with which remote controller <NUM> is paired. The serial number displayed on remote infusion pump home screen <NUM> can be checked against the serial number printed on the back of infusion pump <NUM>. To make remote infusion pump home screen <NUM> more recognizable to the user, the identifying information in infusion pump <NUM> can be programmed to display a more common name in remote infusion pump home screen <NUM> such as "Harold's infusion pump. " The common name displayed on remote infusion pump home screen <NUM> can include a common name only, a common name along with a serial number, or only the serial number, as in the preferred embodiments. This makes it easier for a user to confirm correct pairing between remote controller <NUM> and infusion pump <NUM>. In alternative embodiments, other identifiers can be used to help the user in confirmation of correct pairing. Those embodiments can included user programmed computer icons, computer avatars, names, sounds, or pictures. Whenever a user displays remote infusion pump home screen <NUM>, user programmed computer icons, computer avatars, names, sounds, or pictures can be displayed, indicating to the user correct pairing between remote controller <NUM> and infusion pump <NUM>. The identifying information in infusion pump <NUM> can be entered directly into infusion pump <NUM> by way of its keyboard, or it can be downloaded from a personal computer. Identifying information can also be added to remote controller <NUM>, and can be displayed whenever remote controller <NUM> is turned on and remote controller related screens are displayed, such as meter home screen <NUM>. Remote infusion pump home screen <NUM> also includes infusion pump icon <NUM>, toggle icon <NUM>, signal strength icon <NUM>, battery icon <NUM>, time <NUM>, and delivery status <NUM>. Infusion pump icon <NUM> is an icon that indicates to the user that they are viewing an infusion pump related screen. Toggle icon <NUM> indicates to the user that they can switch between remote infusion pump home screen <NUM> and meter home screen <NUM> (illustrated in <FIG>) by pressing first down button <NUM> or first up button <NUM>. Signal strength icon <NUM> indicates the status of RF communication between remote controller <NUM> and infusion pump <NUM>, as described previously in respect to signal strength icon <NUM> (in <FIG>). Battery icon <NUM> indicates remaining power in infusion pump <NUM>, and can vary between empty, low, medium, and full. If battery icon <NUM> indicates no remaining power in infusion pump <NUM>, no functions are available in infusion pump <NUM>, and an alarm screen appears. Time <NUM> is the current time, as entered in remote controller <NUM> and infusion pump <NUM>. Delivery status <NUM> indicates the delivery status of infusion pump <NUM>, and the remaining insulin in infusion pump <NUM>.

<FIG> illustrates an infusion pump home screen that may be displayed on the infusion pump <NUM>, as used in the exemplary embodiments. Local infusion pump home screen <NUM> differs from remote infusion pump home screen <NUM> (illustrated in <FIG>) in that local infusion pump home screen <NUM> is displayed on infusion pump <NUM>, while remote infusion pump home screen <NUM> is displayed on remote controller <NUM>. In systems that include both remote controller <NUM> and infusion pump <NUM>, and where commands entered on remote controller <NUM> can control infusion pump <NUM>, it is desirable to have user interface screens on both remote controller <NUM> and infusion pump <NUM> which allow manipulation and control of features on infusion pump <NUM>, such as basal delivery, bolus delivery, infusion pump status, and infusion pump history. In systems that use infusion pump home screens on both remote controller <NUM> and infusion pump <NUM>, it is desirable to use user interface elements that are common on both screens, as can be seen in local infusion pump home screen <NUM> and remote infusion pump home screen <NUM>. Using common user interface elements makes it intuitive for a user to control infusion pump <NUM> locally, by using local infusion pump home screen <NUM>, or remotely, by using remote infusion pump home screen <NUM>. In alternative embodiments, local infusion pump home screen <NUM> can include identifying information, such as the serial number of infusion pump <NUM>, or a friendly name or recognizable name, such as "Harold's infusion pump. " Identifying information can help in assuring to a user that they are using the correct infusion pump <NUM>. Returning to <FIG>, local infusion pump home screen <NUM> includes time <NUM>, battery icon <NUM>, delivery status <NUM>, status command <NUM>, <NUM>, and remote control icon <NUM>. Battery icon <NUM> indicates remaining power in infusion pump <NUM>, and can vary between empty, low, medium, and full. If battery icon <NUM> is empty, no functions are available on infusion pump <NUM>, and an alarm screen appears. Battery icon <NUM> on local infusion pump home screen <NUM> is similar in function and appearance to battery icon <NUM> on remote infusion pump home screen <NUM>, maintaining consistency in the user interface of remote controller <NUM> and infusion pump <NUM>. Time <NUM> displays the current time, as entered in the setup of infusion pump <NUM>. It is similar in appearance and function to time <NUM> on remote infusion pump home screen <NUM>. Delivery status <NUM> indicates the current delivery mode and remaining insulin in infusion pump <NUM>. Delivery status <NUM> is similar in appearance and function to delivery status <NUM> on remote infusion pump home screen <NUM>. Status command <NUM> is a submenu, and allows access to a series of infusion pump status screens. <NUM> is a submenu that allows access to the infusion pump main menu. Remote control icon <NUM> is an icon that indicates the infusion pump is under remote control. When remote control icon <NUM> is displayed, RF communication between remote controller <NUM> and infusion pump <NUM> is enabled, remote controller <NUM> and infusion pump <NUM> have been paired, and infusion pump <NUM> is ready to receive remotely entered commands from remote controller <NUM>. In some embodiments, this icon does not indicate RF traffic/activity, signal strength, or health of communications, as other icons do (such as signal strength icon <NUM> in <FIG>, signal strength icon <NUM> in <FIG>, which have been described previously). In other embodiments, remote control icon <NUM> can include indication as to RF traffic/activity, signal strength, or health of communications, or one can also include an icon such as signal strength icon <NUM> or signal strength icon <NUM> near remote control icon <NUM>. Alternatively, one can also include an icon that looks like an infusion pump, indicating to the user that local infusion pump home screen <NUM> is related to infusion pump functions. This can be particularly useful in systems that include remote controller <NUM> and infusion pump <NUM>, in that a user can get confused as to the function of various screens.

<FIG> illustrates an infusion pump setup screen that may be displayed on infusion pump <NUM>, as used in the exemplary embodiments. Remote setup screen <NUM> includes RF <NUM>, search <NUM>, channel <NUM>, paired remote <NUM>, confirm <NUM>, next <NUM>, and home <NUM>. RF <NUM> allows a user to enable or disable RF communication between infusion pump <NUM> and remote controller <NUM>. When RF <NUM> is toggled to on, RF communication between infusion pump <NUM> and remote controller <NUM> is enabled. When RF <NUM> is toggled to off, RF communication between infusion pump <NUM> and remote controller <NUM> is disabled. If infusion pump <NUM> is currently paired with remote controller <NUM> when RF <NUM> is toggled to off, pairing data is preserved so it can be restored when RF is re-enabled. If remote controller <NUM> is currently attempting to pair when RF <NUM> is toggled to off, the pairing attempt is aborted, and previous pairing data is restored, if available. When RF <NUM> is toggled to "ON" and infusion pump <NUM> was previously paired to remote controller <NUM>, infusion pump <NUM> automatically begins pairing to the previously paired remote controller <NUM>. If infusion pump <NUM> was not previously paired to remote controller <NUM>, infusion pump <NUM> prepares itself to be paired for the first time. Search <NUM> is used to initiate pairing between infusion pump <NUM> and remote controller <NUM>. When search <NUM> is blank, infusion pump <NUM> is not paired with remote controller <NUM>, and it does not contain pairing data. This is the state of infusion pump <NUM> when it is turned on for the first time. Unlike remote controller <NUM>, once infusion pump <NUM> is paired, there is no means to un-pair it. When search <NUM> is "ON", pairing between infusion pump <NUM> and remote controller <NUM> has begun, and is in process. When search <NUM> is "DONE", the pairing search between infusion pump <NUM> and remote controller <NUM> has ended, as a result of successful pairing, or as a result of aborted pairing. Channel <NUM> indicates the method for selecting the channel over which RF communication between infusion pump <NUM> and remote controller <NUM> will occur. When set to "AUTO", the software in infusion pump <NUM> determines the RF channel. Alternatively, the user can select a channel over which RF communication occurs, such as <NUM>-<NUM>. Paired remote <NUM> displays the pairing status between infusion pump <NUM> and remote controller <NUM>. When paired remote <NUM> is blank, infusion pump <NUM> is not paired with remote controller <NUM>. When paired remote <NUM> displays "searching", infusion pump <NUM> is attempting to pair with remote controller <NUM>. When infusion pump <NUM> has paired with a device, the device provides confirmation such as, for example, a series of tone, a display or other visual indicators. In the preferred embodiments, the paired remote <NUM> displays the serial number or other identifying information (such as a name, computer icon, sounds or series of tones/vibrations, etc.) of the device, this allows the user to easily check that they have paired with the appropriate device, particularly if the identifying information is familiar, such as "Bob's remote Controller". If paired remote <NUM> displays the serial number of the paired device, such as remote controller <NUM>, it can be checked against the serial number printed on the back of the paired device. Confirm <NUM> is a command that allows the user to confirm RF connection between infusion pump <NUM> and a paired device, such as remote controller <NUM>. If a pairing search is under way, confirm <NUM> displays a cancel command, in case the user wants to cancel the pairing search. If confirm <NUM> displays a confirm command, and it is not executed by the user, the pairing between infusion pump <NUM> and remote controller <NUM> is rejected. This allows a user to reject pairing with the wrong device, such as someone else's infusion pump.

<FIG> illustrates RF communication setup and test screens that may be displayed on the remote controller <NUM>, as used in the exemplary embodiments. RF set up screen <NUM> is displayed on remote controller <NUM>, and is a remote controller related screen, as indicated by meter icon <NUM>. By highlighting and selecting RF test <NUM>, RF test screen <NUM> is displayed. RF test screen <NUM> includes identification <NUM>, RF channel <NUM>, and start <NUM>. Identification <NUM> identifies the infusion pump <NUM> with which remote controller <NUM> is paired, and can be in the form of a serial number, a name, or other identifying feature, as mentioned previously. RF channel <NUM> identifies the RF channel over which remote controller <NUM> communicates with infusion pump <NUM>, and was selected either automatically by remote controller <NUM> and infusion pump <NUM> during pairing, or was selected for optimum signal and reception by the user. Start <NUM> is a command that initiates the start of an RF test. RF test screen <NUM> displays the result of the test, and includes RF channel <NUM>, RF signal <NUM>, and RF quality <NUM>. RF channel <NUM> identifies the channel over which RF communication occurs between remote controller <NUM> and infusion pump <NUM>, RF signal <NUM> identifies the strength of the RF signal, and RF quality <NUM> identifies the quality of the RF signal. An RF test is useful in identifying paired infusion pumps infusion pump <NUM>, and in troubleshooting the RF communication between remote controller <NUM> and infusion pump <NUM>. When using more than one remote controller <NUM> with a single infusion pump <NUM>, the RF test can also be helpful in displaying pairing specifics to the user.

<FIG> and <FIG> illustrate RF communication setup screens that may be displayed on remote controller <NUM> and infusion pump <NUM>, as used in the exemplary embodiments. <FIG> illustrates RF setup screen <NUM>, which is displayed on remote controller <NUM>. When RF channel <NUM> is highlighted and selected, RF channel selection screens are displayed. In notification <NUM>, the user is notified that the same RF channel should be used on both remote controller <NUM> and infusion pump <NUM>, and must confirm the notification using confirm <NUM>. Depending on RF channel settings, either RF channel screen <NUM> or RF channel screen <NUM> is displayed, with toggle icon <NUM> indicating that RF channel screen <NUM> can be toggled through several channels, or can be toggled to RF channel screen <NUM> for automatic RF channel selection. Screen <NUM>, with manual selection of the appropriate channels is utilized in the preferred embodiments. <FIG> illustrates a series of user interface screens that are displayed on infusion pump <NUM> and allow a user to either automatically select an RF channel, or to specify an RF channel manually. In remote setup screen <NUM>, the current RF channel is highlighted, as illustrated by channel <NUM>. Using second up button <NUM> and/or second down button <NUM>, a different channel number can be selected, as illustrated by channel <NUM> in remote setup screen <NUM>, or the channel selection can be set to automatic. Once the desired channel has been highlighted, second OK button <NUM> is pressed to program infusion pump <NUM> to that channel, and remote setup screen <NUM> is displayed.

<FIG> illustrate bolus calculator setup screens that may be displayed on the remote controller, as used in the exemplary embodiments. The screens illustrated in <FIG> are used when remote controller <NUM> is not paired with infusion pump <NUM>. When remote controller <NUM> is paired with infusion pump <NUM>, calculator settings are automatically copied from infusion pump <NUM> to remote controller <NUM>. As illustrated in <FIG>, when pairing remote controller <NUM> to infusion pump <NUM>, notification <NUM> is displayed to the user on remote controller <NUM>, reminding the user that values stored in remote controller <NUM> will be overwritten with those stored in infusion pump <NUM> when pairing between remote controller <NUM> and infusion pump <NUM> is confirmed by the user. When remote controller <NUM> is used only and only as a stand-alone device without being paired with infusion pump <NUM>, bolus calculations can be performed by remote controller <NUM> using calculator settings entered by the screens illustrated in <FIG>. In main menu screen <NUM>, bolus <NUM> is highlighted and selected, leading to customize screen <NUM>. In customize screen <NUM>, calculator setup <NUM> is highlighted and selected, leading to calculator setup screen <NUM>. In calculator setup screen <NUM>, various bolus calculator settings can be made, including I:C Ratio <NUM>, , BG Target <NUM>, BG Delta xxx and IS Factor <NUM>. I:C Ratio <NUM>, , BG Target <NUM>, BG Delta xxx and IS Factor <NUM> are used in calculating various types of bolus delivery, including those that will compensate for carbohydrate intake and those that will return blood glucose values to desired levels. I:C Ratio <NUM> is used to set an insulin to carbohydrate ratio, and is used in calculating a bolus that will compensate for ingestion of carbohydrates from a meal or snack. It is defined as the approximate number of grams of carbohydrates that can be compensated with one unit of insulin. BG Target <NUM> allows the user to enter a target blood glucose value. Target blood glucose values are used when maintaining good glycemic control. Although not specifically illustrated, BG Delta xxx allows the user to enter a value that is added to and subtracted from the BG Target <NUM> in order to define an acceptable range of blood glucose values for the user. If the user's current blood glucose reading is within the range then the meter will not adjust its insulin recommendation to compensate for the blood glucose reading being above or below BG Target <NUM>.

Among computations made by the remote controller <NUM> and the infusion pump <NUM> are, for example, suitable bolus delivery recommendations. In a normal delivery, the entire insulin bolus is delivered all at once. With a combo bolus delivery, the user can select a percentage of the infusion to deliver at once, termed the "normal" portion, with the remaining percentage, termed the "extended" portion, delivered over an extended period of time as set by the user. The user can select the initial delivery amount from <NUM>% to <NUM>% thereby allowing an all extended delivery and all normal delivery respectively. A BG combo delivery works like the combo bolus delivery except that the insulin needed for BG correction is added to the normal portion of the delivery.

Each of the devices preferably uses two calculations to provide for the recommended bolus delivery: "ezBG" and "CarbSmart. " The ezBG computation does not account for carbohydrates while the CarbSmart calculation includes carbohydrates. The microprocessor of either the remote controller or the infusion pump can perform the ezBG bolus computation. The preferred equation for ezBG Bolus Total is:
<MAT> and ezBG Bolus Total is not negative.

The preferred equations for CarbSmart Bolus Total can be determined depending on several factors relating to blood glucose measurements:.

Users have the option of delivering the recommended CarbSmart Bolus Total as a normal, combo or BG combo delivery. Combo deliveries allow the user to specify a percentage of the bolus for immediate delivery with the remainder delivered within the user specified duration. It should be noted that the BG can be calculated by the remote controller <NUM> using blood glucose measurement data stored or obtained in the remote controller <NUM> and transmitted to the device <NUM>.

<FIG> illustrate screens for turning RF communications on and off, and may be displayed on remote controller <NUM>, as used in the exemplary embodiments. In <FIG>, RF setup screen RF setup screen <NUM> allows the user to select from among several RF setup options. By highlighting and selecting RF on/off <NUM> a user can toggle RF communication on and off. In RF on/off screen <NUM>, the user is warned that communication between remote controller <NUM> and infusion pump <NUM> will stop when RF is turned off, and is prompted to continue turning RF off, or to cancel the command. If the RF is already turned off, the user will be warned that communication between paired devices will be reestablished if RF is turned on, as illustrated in RF on/off screen <NUM> and RF on <NUM> of <FIG>. Once RF on <NUM> has been selected, RF on/off screen <NUM> is displayed, indicating that RF communication is being reestablished with the previously paired device connection status <NUM>. Once RF has been reestablished, it's indicated to the user by RF on/off screen <NUM> and connection status <NUM>.

<FIG> is a flow chart illustrating screens for unpairing a remote controller and infusion pump that may be displayed on the remote controller, as used in the exemplary embodiments. When remote controller <NUM> is turned on, it displays splash screen <NUM>, followed by remote infusion pump home screen <NUM>. Remote infusion pump home screen <NUM> is displayed because remote controller <NUM> is paired with infusion pump <NUM>. Remote infusion pump home screen <NUM> includes infusion pump icon <NUM>, toggle icon <NUM>, signal strength icon <NUM>, and battery icon <NUM>, as described previously. Infusion pump icon <NUM> indicates that remote infusion pump home screen <NUM> is related to infusion pump <NUM> functions, and toggle icon <NUM> indicates that remote infusion pump home screen <NUM> can be toggled with meter home screen <NUM> by pressing first down button <NUM> and first up button <NUM>. Meter home screen <NUM> includes meter icon <NUM>, toggle icon <NUM>, and signal strength icon <NUM>. Meter icon <NUM> indicates that meter home screen <NUM> is related to remote controller <NUM> functions, while toggle icon <NUM> and signal strength icon <NUM> function as described previously. By pressing first OK button <NUM> while remote infusion pump home screen <NUM> or meter home screen <NUM> is displayed, main menu screen <NUM> will be displayed. Highlighting and selecting meter settings <NUM> causes meter settings screen <NUM> to be displayed. Highlighting and selecting RF <NUM> causes RF setup screen <NUM> to be displayed, while highlighting and selecting pairing <NUM> leads to pairing screen <NUM>. Pairing screen <NUM> notifies the user that remote controller <NUM> is paired with infusion pump <NUM> (identified by serial number, or other identifying information as described previously), and allows the user to confirm unpairing by selecting unpairing <NUM>. After selecting unpairing <NUM>, meter home screen <NUM> is displayed, without toggle icon <NUM> and signal strength icon <NUM>, as were seen in meter home screen <NUM>. Toggle icon <NUM> and signal strength icon <NUM> are not displayed in meter home screen <NUM> because remote controller <NUM> is no longer paired with infusion pump <NUM>, remote infusion pump home screen <NUM> is no longer an option for display, and RF is deactivated. When remote controller <NUM> and infusion pump <NUM> have been unpaired, various warning and notification screens can be displayed, such as notification <NUM> and notification <NUM>, illustrated in <FIG>.

<FIG> is a flow chart illustrating screens for a new pairing of remote controller <NUM> and infusion pump <NUM> that may be displayed on remote controller <NUM>, as used in the exemplary embodiments. When remote controller <NUM> is turned on, it displays splash screen <NUM>, followed by remote infusion pump home screen <NUM>. Remote infusion pump home screen <NUM> is displayed because remote controller <NUM> is paired with infusion pump <NUM>. Remote infusion pump home screen <NUM> includes infusion pump icon <NUM>, toggle icon <NUM>, signal strength icon <NUM>, and battery icon <NUM>, as described previously. Infusion pump icon <NUM> indicates that remote infusion pump home screen <NUM> is related to infusion pump <NUM> functions, and toggle icon <NUM> indicates that remote infusion pump home screen <NUM> can be toggled with meter home screen <NUM> by pressing first down button <NUM> and first up button <NUM>. Meter home screen <NUM> includes meter icon <NUM>, toggle icon <NUM>, and signal strength icon <NUM>. Meter icon <NUM> indicates that meter home screen <NUM> is related to remote controller <NUM> functions, while toggle icon <NUM> and signal strength icon <NUM> function as described previously. By pressing first OK button <NUM> while remote infusion pump home screen <NUM> or meter home screen <NUM> is displayed, main menu screen <NUM> will be displayed. Highlighting and selecting meter settings <NUM> causes meter settings screen <NUM> to be displayed. Highlighting and selecting RF <NUM> causes RF setup screen <NUM> to be displayed, while highlighting and selecting pairing <NUM> leads to pairing screen <NUM>. Pairing screen <NUM> notifies the user that remote controller <NUM> is paired with infusion pump <NUM> (identified by serial number, or other identifying information as described previously), and allows the user to confirm new pairing by selecting new pairing <NUM>. After selecting new pairing <NUM>, pairing screen <NUM> is displayed, instructing the user to activate pairing mode on infusion pump <NUM>, and to select start pairing <NUM>. Pairing screen <NUM> is then displayed, indicating that remote controller <NUM> is searching for a new infusion pump <NUM>. One parameter that is checked during the pairing search is that remote controller <NUM> and infusion pump <NUM> have the same glucose units of measure, as mentioned previously. If remote controller <NUM> and infusion pump <NUM> do not have the same glucose units of measure, the new pairing process is aborted. Assuming that the same units of measure are found, pairing screen <NUM> is then displayed, indicating that a new infusion pump <NUM> has been found, and including identification <NUM> and any other identifying information, as described previously. After accepting the pairing, remote infusion pump home screen <NUM> is displayed. Remote infusion pump home screen <NUM> includes identifying information for new infusion pump <NUM>, and can be toggled with meter home screen <NUM> using first down button <NUM> and first up button <NUM>.

<FIG> is a flow chart illustrating screens for a new pairing of remote controller <NUM> and infusion pump <NUM> that may be displayed on the infusion pump, as used in the exemplary embodiments. When infusion pump <NUM> is turned on, local infusion pump home screen <NUM> is displayed. Local infusion pump home screen <NUM> includes time <NUM>, battery icon <NUM>, delivery status <NUM>, status command <NUM>, and menu command <NUM>, described previously in reference to <FIG>. After highlighting menu command <NUM> using second up button <NUM> and second down button <NUM>, second OK button <NUM> is pressed and main menu screen <NUM> is displayed. Second up button <NUM> and second down button <NUM> can be used to highlight setup <NUM> and second OK button <NUM> is pressed to display setup screen <NUM>. After highlighting and selecting advanced <NUM>, remote setup screen <NUM> is displayed. Remote setup screen <NUM> includes RF <NUM>, search <NUM>, channel <NUM>, and identification <NUM>. Since infusion pump <NUM> is already paired to a remote controller <NUM>, RF <NUM> is ON, search <NUM> indicates DONE, and channel <NUM> is set to a channel over which RF communication between remote controller <NUM> and infusion pump <NUM> occurs. Identification <NUM> displays identifying information as to the paired remote controller <NUM>. In remote setup screen <NUM>, search <NUM> has been switched to ON, initiating a new pairing search. Remote setup screen <NUM> displays the ongoing search status, where channel <NUM> has automatically been set to AUTO since a new search is under way, and search status <NUM> indicates that infusion pump <NUM> is searching for a new remote controller <NUM>. Once a new remote controller <NUM> has been found, remote setup screen <NUM> is displayed. Channel <NUM> is set to the new channel for RF communication that was automatically set by <NUM>, and identification <NUM> displays new identifying information for remote controller <NUM>. Confirm <NUM> prompts the user to confirm pairing with new remote controller <NUM>. Once new pairing is confirmed, remote setup screen <NUM> is displayed. Selecting next <NUM> completes the new pairing process, and returns the display to local infusion pump home screen <NUM>.

In alternative embodiments, multiple remote controllers <NUM> can be paired with a single infusion pump <NUM>. This allows a user to have backup remote controllers <NUM>, or allows them to keep remote controllers <NUM> in multiple locations, such as at home and at the office. Each remote controller <NUM> must initially be paired with infusion pump <NUM> to exchange identifying information. An RF detection algorithm in infusion pump <NUM> determines if it is possible to transfer remote control from one remote controller <NUM> to another. In addition, an acknowledgment from the user is required when switching remote control from one remote controller to another. As mentioned previously, each remote controller <NUM> must be initially paired with infusion pump <NUM>. Pairing information for each remote controller <NUM> is stored in non-volatile memory within infusion pump <NUM>. Pairing information can be stored for several remote controllers <NUM>. Pairing information may include an RF address which is unique and assigned by the device manufacturer, an RF type which identifies the type of device being paired, a default channel which specifies the channel over which communication will occur the next time communications are established, flags that include additional information such as hardware/software revision levels and units of measure, and serial numbers that uniquely identify each remote controller <NUM>. An algorithm in infusion pump <NUM> determines when remote controller <NUM> may be changed. While <NUM> and <NUM> are paired, and are in RF communication with each other, they routinely communicate. For instance, on a regular interval, remote controller <NUM> requests the status of <NUM> by way of RF communication. If infusion pump <NUM> does not communicate with the currently paired remote controller <NUM> within a fixed time, it will start to search for previously paired, and memorized, remote controllers <NUM>. For efficiency, the search starts with the most recently paired remote controller <NUM>. The dwell time spent searching for each previously paired controller is based on the minimum system RF sniff time. Once a previously paired remote controller <NUM> is found, the user is prompted to acknowledge transfer of remote control to the previously paired remote controller <NUM>. An advantage of this embodiment is that it is easier for the user to switch between previously paired devices.

<FIG> is a schematic flow chart that illustrates a method of establishing an acceptable time window for blood glucose results measured by a remote controller and relied upon in bolus calculations, as used in the exemplary embodiments. The method illustrated in <FIG> can be used in remote controller <NUM> or in infusion pump <NUM>. The process begins by in initiating step <NUM>. Step <NUM> can be initiated immediately after measuring blood glucose with remote controller <NUM>, or can be initiated after measuring blood glucose with a separate blood glucose meter. Step <NUM> can be initiated whenever the user would like to deliver a bolus. Once step <NUM> is initiated, memory in remote controller <NUM> or infusion pump <NUM> is checked for recent blood glucose measurements. In a particularly preferred embodiment, recent blood glucose measurements are those taken within the last <NUM> minutes. If a blood glucose measurement was taken within the last <NUM> minutes, it is automatically entered into the bolus calculator, as illustrated in step <NUM>. Using the recent blood glucose measurement and the calculator settings (discussed previously), a recommended bolus is calculated, as illustrated in step <NUM>. Once a bolus amount has been recommended, the bolus calculation is done, as illustrated by step <NUM>, and the user has the choice of making adjustments to or delivering the recommended bolus.

In the preferred embodiments, BG results are only entered on the pump <NUM> when a bolus calculation is done on the pump <NUM>. That result must be manually entered by the user into the pump <NUM>. Such result stored in pump <NUM> is then transferred to the memory of controller <NUM> during the next communication interval.

In situations where a recent blood glucose value is not available, the user is prompted to retest their blood glucose, as illustrated in step <NUM>. If they choose to retest using remote controller <NUM>, they return to step <NUM> of the process, and the result is automatically transferred to the bolus calculator as in step <NUM>. If they choose not to retest, or if they retest using a separate blood glucose meter, the user can manually enter a blood glucose result, as illustrated in step <NUM>. As soon as the user manually enters a blood glucose value, the blood glucose calculator determines a recommended bolus, as in step <NUM>, and the user has the choice to adjust or deliver the recommended bolus. In situations where the blood glucose value is measured with remote controller <NUM> and sent to infusion pump <NUM> for use in bolus calculations, it is particularly important that the time setting of both remote controller <NUM> and infusion pump <NUM> are the same. If the time setting of remote controller <NUM> and infusion pump <NUM> are not the same, it is impossible to accurately determine the age of a blood glucose reading.

<FIG> is a flow chart illustrating screens for calculating and delivering a bolus that may be displayed on remote controller <NUM>, as used in the exemplary embodiments. Upon inserting a test strip into remote controller <NUM>, splash screen <NUM> is displayed, followed by test screen <NUM>. Test screen <NUM> includes meter icon <NUM>, indicating that it is a display screen related to remote controller functions. Test screen <NUM> indicates to the user that they should check that the lot code on their test strips matches the lot code entered in remote controller <NUM>. The user is then prompted to apply blood to the test strip, after which test screen <NUM> appears, counting down to a result. Upon completion of the blood glucose test, the blood glucose concentration is displayed using result screen <NUM>. Included in result screen <NUM> is bolus <NUM>, which leads to bolus menu screen <NUM> when selected. Bolus menu screen <NUM> includes infusion pump icon <NUM>, identification <NUM>, and ezBG <NUM>. Infusion pump icon <NUM> indicates that bolus menu screen <NUM> is related to infusion pump functions, identification <NUM> includes identifying information (such as infusion pump serial number or a familiar name), and ezBG <NUM> accesses a bolus calculator that allows correction for high blood glucose concentrations. Upon selecting ezBG <NUM>, ezBG calculator screen <NUM> is displayed. As long as a blood glucose reading has been made with remote controller <NUM> within the last <NUM> minutes, actual BG <NUM> includes a value for actual blood glucose. If a reading has not been made by remote controller <NUM> within the last <NUM> minutes, the field contains a default value (obtained from the infusion pump <NUM>), which can be changed by the user. Once an actual blood glucose value has been set (either automatically, or by the user), ezBG calculator screen <NUM> is displayed. After selecting show result <NUM>, ezBG total screen <NUM> is displayed. ezBG total screen <NUM> includes recommended bolus <NUM>, a recommended bolus amount that is based upon the data entered in ezBG calculator screen <NUM>. In screen ezBG total screen <NUM>, the user has an option to enter the recommended bolus amount <NUM>, or they can alter the user-entered bolus <NUM>. Once user entered bolus <NUM> has been entered, ezBG total screen <NUM> is displayed. By entering go command <NUM>, bolus delivery begins, as indicated in bolus screen <NUM>. Initiation of bolus delivery can be accompanied by visual or audio clues, such as beeps, tunes, or flashing lights. Upon completion of bolus delivery, result screen <NUM> is displayed, where users can enter comments or return to home screens, as desired. Although <FIG> illustrates the use of a bolus calculator in respect to blood glucose correction boluses, a similar approach can be used when using bolus calculators to determine a bolus amount to compensate for carbohydrate intake. In cases where the bolus is used to compensate for carbohydrate intake, additional parameters are entered by the user, such as recent carbohydrate intake.

<FIG>, <FIG>, and <FIG> illustrate a series of screens displayed on remote controller <NUM> that relate to the status of infusion pump <NUM>, the status of remote controller <NUM>, the logbook of remote controller <NUM>, and the history of infusion pump <NUM>, as used in the exemplary embodiments. In <FIG>, main menu screen <NUM> includes submenu item system status <NUM>. When system status <NUM> is selected, system status screen <NUM> is displayed. Selecting infusion pump status <NUM> results in display of active basal screen <NUM>, last bolus screen <NUM>, daily delivery screen <NUM>, combo bolus screen <NUM>, temporary basal screen <NUM>, and infusion pump codes screen <NUM>. Active basal screen <NUM> displays basal delivery by infusion pump <NUM>, last bolus screen <NUM> displays bolus delivery by infusion pump <NUM>, daily delivery screen <NUM> displays total delivery by infusion pump <NUM> for the day, combo bolus screen <NUM> displays the status of combination bolus delivery by infusion pump <NUM>, temporary basal screen <NUM> displays temporary basal delivery by infusion pump <NUM>, and infusion pump codes screen <NUM> displays identifying information related to infusion pump <NUM> such as software revision numbers and serial numbers. When system status screen <NUM> is displayed, meter status <NUM> can be selected, resulting in display of meter status screen <NUM>. Meter status screen <NUM> includes identifying information related to remote controller <NUM>, such as the serial number of remote controller <NUM> and its software revision number. If fast facts/history <NUM> is selected while main menu screen <NUM> is displayed, fast facts/history screen <NUM> is displayed, as illustrated in <FIG>. Highlighting and selecting logbook <NUM> results in the display of logbook entries such as logbook screen <NUM> and logbook screen <NUM>. In logbook screen <NUM>, a record related to basal delivery by infusion pump <NUM> is displayed. Logbook screen <NUM> includes an identifier (M), indicating that this particular basal delivery by infusion pump <NUM> was initiated by a command from remote controller <NUM>. Scroll <NUM> indicates that other logbook records can be accessed by pressing first down button <NUM> and first up button <NUM>. By pressing first down button <NUM> or first up button <NUM>, logbook screen <NUM> is displayed. Logbook screen <NUM> is a record of suspended delivery by infusion pump <NUM>. Suspend record <NUM> includes identifier (P) indicating that the command to suspend delivery by infusion pump <NUM> was initiated on infusion pump <NUM>. Identifiers (M) and (P) illustrate a way to keep track of whether commands to infusion pump <NUM> were initiated by the user by way of remote controller <NUM> or if commands to infusion pump <NUM> were initiated by the user by way of infusion pump <NUM>. This can help in diagnosing problems associated with use of remote controller <NUM> and infusion pump <NUM>, and can not only be kept in user accessible areas such as a logbook, but can also be written into memory only accessible by the manufacturer of remote controller <NUM> and infusion pump <NUM>. This type of memory is often referred to as a "black box", and can be used in diagnosing problems associated with operation of remote controller <NUM> or infusion pump <NUM>. Although <FIG> illustrates record retention on remote controller <NUM>, similar approaches can be used to store records directly on infusion pump <NUM>. In fact, it is often beneficial to keep a copy of all records associated with operation of remote controller <NUM> and infusion pump <NUM> on both remote controller <NUM> and infusion pump <NUM>. Hence, there can be an all-inclusive "black box" in both remote controller <NUM> and infusion pump <NUM>. If RF communication between remote controller <NUM> and infusion pump <NUM> are not enabled when the logbook on remote controller <NUM> is accessed, the user is warned with notification <NUM>. Notification <NUM> indicates that delivery data from infusion pump <NUM> may be out of date, and that the user should check logs in infusion pump <NUM> for up-to-date logbook records. Returning to fast facts/history screen <NUM>, if infusion pump history <NUM> is selected, infusion pump history screen <NUM> is displayed, as illustrated in Figure <NUM>. Infusion pump history screen <NUM> includes bolus <NUM>, total daily dose <NUM>, alarm <NUM>, and graph daily infusion pump totals <NUM>. When bolus <NUM> is selected, screens such as bolus screen <NUM> and bolus screen <NUM> are displayed. Bolus screen <NUM> and bolus screen <NUM> are examples of bolus delivery records, and may include information regarding command origination (M) or (P), time of bolus, type of bolus, amount of bolus, and degree of completion of bolus. When total daily dose <NUM> is selected on infusion pump history screen <NUM>, records such as total daily dose screen <NUM> are displayed. Total daily dose screen <NUM> summarizes total daily delivery by infusion pump <NUM>, and can include information regarding the date, the amount of temporary delivery, the number of suspended deliveries, the amount of bolus delivery, the amount of basal delivery, and the total delivery for that day. When alarm <NUM> is selected on infusion pump history screen <NUM>, records such as alarm screen <NUM> are displayed. Alarm screen <NUM> includes alarm records for infusion pump <NUM>, such as the time and date of the alarm, codes for the alarm, and a description of the alarm. Alarm records can also include identifying information to indicate if the alarm is a result of commands entered by the user using remote controller <NUM> or infusion pump <NUM>. When graph daily infusion pump totals <NUM> is selected when infusion pump history screen <NUM> is displayed, screens such as graph <NUM> are displayed, graphically illustrating daily delivery totals for infusion pump <NUM>.

Referring to <FIG>, at least one of display of the remote controller <NUM> or infusion pump <NUM> can be utilized to display information relating to blood glucose measurements in a graphical format on a display screen, shown here in screens GA1-GA6. Under the "Fast Facts/History" screen of <FIG>, the Glucose Analysis screen can be selected to provide for menu screen GAl. Under GA1, analytical information are provided such as, for example, under screen GA1, a graph of all glucose measurement results stored in at least one of the remote controller and pump; under screen GA2, the information relating to blood glucose measurements include a graph of blood glucose measurement results as indexed by time of day; under screen GA7, the information include a graph of blood glucose measurements and insulin doses stored on at least one of the remote controller and infusion pump; under screen GA3, the information include an average of at least one of blood glucose measurements and insulin doses; under screen GA4 the information relating to blood glucose measurements comprise an average of at least one of blood glucose measurements and insulin doses indexed by time of day; under screen GAS, the information include an average of at least one of blood glucose measurements and insulin doses indexed by exercise events.

To illustrate the unrecognized advantage of the utilization of the preferred remote controller, two examples are set forth herein. Under screen GA7, the user or clinician can select the graphical patterns of blood glucose measurements and insulin as indexed against time in Call screen, which becomes graphical screen GGI1. Under GGI1 screen, the display provides two graphs indexed against time. A top graph in the GGI1 screen displays blood glucose measurement over time in units of mg/dL while a bottom graph displays insulin doses in Units over time. Various trends, patterns, and messages can be determined and provided to the user or health care provider using at least the blood glucose measurements and insulin doses as further described in <CIT>. Under screen GA3, the average of all blood glucose results can be displayed in a columnar format on screen FF33.

<FIG> and <FIG> illustrate a series of warnings and notifications that are displayed on remote controller <NUM> and infusion pump <NUM>. The warnings and notifications apply to operation of remote controller <NUM> and infusion pump <NUM>, and to RF communication between remote controller <NUM> and infusion pump <NUM>. <FIG> illustrates warnings and notifications that are displayed on remote controller <NUM>, while <FIG> illustrates warnings that are displayed on both remote controller <NUM> and infusion pump <NUM>. In respect to <FIG>, warning screen <NUM> is displayed when remote controller <NUM> was able to locate infusion pump <NUM>, but the pairing procedure was canceled before it was completed. Warning screen <NUM> is displayed if remote controller <NUM> is unable to locate infusion pump <NUM> during the pairing procedure. Remote controller <NUM> and infusion pump <NUM> may not be within RF range (about ~<NUM> feet or about <NUM> meters), or pairing mode may not be activated on infusion pump <NUM>. Warning screen <NUM> is displayed when a bolus was canceled because remote controller <NUM> and infusion pump <NUM> are unable to communicate (RF is down or deactivated, remote controller <NUM> and infusion pump <NUM> are not paired, etc.). Notification screen <NUM> is displayed if the last blood glucose reading was taken more than <NUM> minutes ago and is not current enough for use in the bolus calculator. Notification screen <NUM> is displayed if communication between remote controller <NUM> and infusion pump <NUM> is suspended because infusion pump <NUM> is in the middle of a procedure. Notification screen <NUM> is displayed if remote controller <NUM> and infusion pump <NUM> are no longer paired, and are therefore not able to communicate or share data. Notification screen <NUM> is displayed if remote controller <NUM> and infusion pump <NUM> are unable to communicate. Possible causes are that remote controller <NUM> and infusion pump <NUM> are not within RF range or there is RF interference. Notification screen <NUM> is displayed when remote controller <NUM> and infusion pump <NUM> are unable to communicate. A possible cause is that RF communication has been deactivated. Notification screen <NUM> is displayed when delivery data on remote controller <NUM> may not be current because remote controller <NUM> and infusion pump <NUM> are unable to communicate. Delivery data from infusion pump <NUM> cannot be viewed on remote controller <NUM> when remote controller <NUM> and infusion pump <NUM> are unable to communicate. Notification screen <NUM> is displayed when a bolus calculator has been accessed, but remote controller <NUM> and infusion pump <NUM> are unable to communicate. The bolus calculator will use values that were last set and saved on infusion pump <NUM>. Notification screen <NUM> is displayed when remote controller <NUM> and infusion pump <NUM> are paired, and bolus calculator values on remote controller <NUM> are replaced by those that were last saved on infusion pump <NUM>. Notification screen <NUM> is displayed when a user has chosen to unpair remote controller <NUM> and infusion pump <NUM>. Notification screen <NUM> warns the user that current calculator settings may not be appropriate for a bolus delivered by devices other than infusion pump <NUM>, such as a pen or syringe. Notification screen <NUM> is displayed when an attempt has been made to initiate an infusion pump function from remote controller <NUM> when remote controller <NUM> and infusion pump <NUM> are not currently paired. Notification screen <NUM> is displayed when the glucose unit of measure on remote controller <NUM> and infusion pump <NUM> do not match. They must match for the pairing procedure to be successful. Notification screen <NUM> is displayed when the RF Channel on remote controller <NUM> and infusion pump <NUM> do not match.

In <FIG>, various infusion pump warnings are illustrated. The first column of <FIG> illustrates infusion pump warnings as they are displayed on remote controller <NUM>. The second column of <FIG> illustrates the same warnings as they are displayed on infusion pump <NUM>. Efforts are made to make the infusion pump warnings that appear on remote controller <NUM> and infusion pump <NUM> as similar as possible.

In one embodiment, the User Interfaces are identical for both the infusion pump <NUM> and remote controller <NUM>. Applicants have recognized that this feature results in a user interface that is more intuitive and less confusing for the diabetes user who may be suffering from the effects of diabetes on their visions. In particular, warning screen <NUM>, warning screen <NUM>, warning screen <NUM>, warning screen <NUM>, warning screen <NUM>, and warning screen <NUM> are displayed on remote controller <NUM>, while infusion pump warning screen <NUM>, infusion pump warning screen <NUM>, infusion pump warning screen <NUM>, infusion pump warning screen <NUM>, infusion pump warning screen <NUM>, and infusion pump warning screen <NUM> are displayed on infusion pump <NUM>. Warning screen <NUM> and infusion pump warning screen <NUM> are displayed when a basal program edit has not been saved on infusion pump <NUM>. As a result, basal delivery by infusion pump <NUM> stops. Warning screen <NUM> and infusion pump warning screen <NUM> are displayed when delivery by infusion pump <NUM> has been suspended. Warning screen <NUM> and infusion pump warning screen <NUM> are displayed when the battery in infusion pump <NUM> is very low, and only has about another hour of use. Warning screen <NUM> and infusion pump warning screen <NUM> are displayed when a new bolus command exceeds the maximum bolus limits set in infusion pump <NUM>. In this case, the new bolus command is stopped. Warning screen <NUM> and infusion pump warning screen <NUM> are displayed when a new bolus command exceeds the <NUM>-hour delivery limit that is saved in infusion pump <NUM>. In this case, the new bolus command is stopped. Warning screen <NUM> and infusion pump warning screen <NUM> are displayed when a new bolus command exceeds the maximum total daily delivery limit that is saved in infusion pump <NUM>. In this case, the new bolus command is stopped.

Although the remote controller <NUM> has been described in relation to a handheld unit sized for a user's hands, the remote controller <NUM>, in an alternative embodiment, can be integrated with or implemented as part of other remote wireless device, such as, for example, a mobile phone, PDA, pager, as long as such device includes an alphanumeric display and sufficient processing power to conduct the pairing process along with the aforementioned pump controlling functions. It is believed that implementation of the mobile phone network in conjunction with the short range wireless network between the infusion pump and the remote controller allows for monitoring of therapy compliance, performance, and real-time intervention in the event that the user is undergoing a glycemic event or other issues with the pump.

<FIG> illustrate aspects of embodiments of the invention that address the security, accuracy, and authenticity of wireless transmissions between the remote controller and the infusion pump. The aspects shown also related to another embodiment of the pairing process of the invention.

<FIG> shows an exemplary radio-frequency identification (RFID) tag <NUM>. RFID is commonly used in identification badges, passkeys, etc. that can communication with an RFID reader over a very short distance without requiring a power supply on the badge, card, etc. The primary elements of an RFID tag <NUM> comprise a near-field antenna and a near-field integrated circuit. The near field integrated circuit may typically include small, discrete pieces of information, such as a serial number, name, etc. The data stored in the near-field integrated circuit may be coded or encrypted to avoid being readable or obtained by an incorrect or unauthorized RFID reader device.

When a near-field transmission system, such as an RFID tag, is placed in proximity to a near-field receiver, the power necessary to operate a near field integrated circuit within the RFID tag is supplied by the receiver via inductive coupling between the receiver and the near-field antenna. While not wishing to be bound by theory, the receiver generates a magnetic field, and when the near field antenna within the RFID tag is placed within the magnetic field, the magnetic field around the receiver creates a current within the near-field antenna. According to the principle of induction, the magnetic field induces a current within the near field antenna and supplies the electrical current needed in the near-field transmitter system (RFID tag) to power the near-field integrated circuit. This obviates the need for a power supply to be placed within the RFID tag or, for example, to draw power from the device upon which the RFID tag is placed.

While RFID tags may be placed on the remote controller and infusion pump for purposes of inventory control, the data stored in the RFID tag may comprise information that specifically identifies the device upon which it is placed, such as the serial number of a remote control unit for an infusion pump. In this embodiment, the pairing process of the present invention is accomplished using an RFID tag on one or both of the remote controller and infusion device and placing an RFID receiver capable of reading the data on the RFID tag in one or both of the devices to allow a transfer of identification information between the devices when placed in close proximity to one another.

Illustratively, a remote control unit for an infusion device <NUM> may be equipped with an RFID reader <NUM> (shown schematically in <FIG>) and an RFID tag <NUM> placed on or within an infusion device <NUM>. Any indicia shown in <FIG> is exemplary, as those skilled in the art will recognize that RFID receiving devices are commonly available and may vary in their operating voltages, the type of crystal oscillator used, and exact schematic.

When the pairing process for the devices is initiated, a screen display <NUM> on the remote control device <NUM> may display that it is searching for an infusion device <NUM>, as illustrated by screen display <NUM> in <FIG>. When the remote control device <NUM> is placed in close proximity to or placed in contact with the infusion device <NUM>, the RFID tag <NUM> is energized by the RFID receiver <NUM> and a unique identifier encoded into the RFID tag <NUM> is transmitted to the RFID receiver <NUM>. A microcontroller within the RFID receiver may then process the unique identifier and display a message on the screen display <NUM> of the remote controller <NUM> such as the screen display <NUM> illustratively shown in <FIG>. The user of the remote control device may then accept the identifier of the infusion device <NUM>, which is indicated in <FIG> to be serial number, to complete the pairing process.

In another embodiment of the invention, illustrated in an exemplary manner in <FIG>, an RFID tag <NUM> is affixed to the outside of an infusion device <NUM>. A remote control device <NUM> that includes an RFID receiver (not shown) is placed in contact or close proximity with the infusion device <NUM> generating a wireless communication <NUM> between the devices. In this example, a command to deliver a bolus of medication was sent wirelessly from the remote controller <NUM> to the infusion device <NUM>. In order to confirm that the instruction received by the infusion device <NUM> was authentic and accurate, the infusion device <NUM> and remote controller <NUM> are placed in close proximity, energizing the RFID tag <NUM>, thereby initiating wireless communication <NUM> confirming that the bolus instruction was indeed authentic, accurate, and intended by the user.

In yet another alternative embodiment, both the remote controller <NUM> and the infusion device <NUM> are equipped with RFID transceivers (<NUM>, <NUM>) that can send and receive RFID information from one another. In this embodiment, the wireless communication <NUM> may comprise, but not limited to, one or more of authenticating a command from the remote controller <NUM> to the pump <NUM>, confirming a command from the remote controller <NUM> to the infusion device <NUM>, pairing the remote controller <NUM> to the infusion device <NUM>, issuing a command from the remote controller <NUM> to the infusion device <NUM>, or providing information from the infusion device <NUM> to the remote controller <NUM>.

It must be recognized that equivalent structures may be substituted for the structures illustrated and described herein and that the described embodiment of the invention is not the only structure that may be employed to implement the claimed invention. In addition, it should be understood that every structure described above has a function and such structure can be referred to as a means for performing that function.

Claim 1:
A method for communication between a medical infusion device (<NUM>) and a remote controller (<NUM>), the method comprising:
placing a medical infusion device (<NUM>) comprising a radio-frequency identification receiver in close proximity to or in physical contact with a remote controller (<NUM>) comprising a radio-frequency identification transmitter;
generating a first near-field communication between the remote controller and the medical infusion device; and
providing identification information specific to the remote controller (<NUM>) to the medical infusion device (<NUM>) via the first near-field communication,
wherein the first near-field communication is established between the radio-frequency identification transmitter and the radio-frequency identification receiver, and
wherein the radio-frequency identification transmitter is powered, at least partially, by an electromagnetic field generated by the radio-frequency identification receiver.