# Patent

## Title
External unit for implantable medical device coupled by cord

## Abstract

User interface for external power source, recharger, for an implantable medical device. At least some of patient controls and display icons of an energy transfer unit are common with at least some of the patient controls and the display icons of a patient control unit. An energy transfer unit is operable by the patient with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device. An external antenna having a primary coil can inductively transfer energy to a secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.

## Background
RELATED APPLICATIONS
This application is a division of U.S. patent application Ser. No. 10/958,191, filed Oct. 4, 2004, entitled User Interface for External Charger for Implantable Medical Device, and claims priority to U.S. Provisional Application Ser. No. 60/508,198, filed Oct. 2, 2003, entitled User Interface for External Charger for Implantable Medical Device, and from U.S. Provisional Application Ser. No. 60/513,732, filed Oct. 23, 2003, entitled User Interface for External Charger for Implantable Medical Device. The entire contents of the foregoing applications are hereby incorporated by reference.


FIELD OF THE INVENTION
This invention relates to implantable medical devices and, in particular, to energy transfer devices, systems and methods for implantable medical devices.
BACKGROUND OF THE INVENTION
Implantable medical devices for producing a therapeutic result in a patient are well known. Examples of such implantable medical devices include implantable drug infusion pumps, implantable neurostimulators, implantable cardioverters, implantable cardiac pacemakers, implantable defibrillators and cochlear implants. Of course, it is recognized that other implantable medical devices are envisioned which utilize energy delivered or transferred from an external device.
A common element in all of these implantable medical devices is the need for electrical power in the implanted medical device. The implanted medical device requires electrical power to perform its therapeutic function whether it be driving an electrical infusion pump, providing an electrical neurostimulation pulse or providing an electrical cardiac stimulation pulse. This electrical power is derived from a power source.
Typically, a power source for an implantable medical device can take one of two forms. The first form utilizes an external power source that transcutaneously delivers energy via wires or radio frequency energy. Having electrical wires which perforate the skin is disadvantageous due, in part, to the risk of infection. Further, continuously coupling patients to an external power for therapy is, at least, a large inconvenience. The second form utilizes single cell batteries as the source of energy of the implantable medical device. This can be effective for low power applications, such as pacing devices. However, such single cell batteries usually do not supply the lasting power required to perform new therapies in newer implantable medical devices. In some cases, such as an implantable artificial heart, a single cell battery might last the patient only a few hours. In other, less extreme cases, a single cell unit might expel all or nearly all of its energy in less than a year. This is not desirable due to the need to explant and re-implant the implantable medical device or a portion of the device. One solution is for electrical power to be transcutaneously transferred through the use of inductive coupling. Such electrical power or energy can optionally be stored in a rechargeable battery. In this form, an internal power source, such as a battery, can be used for direct electrical power to the implanted medical device. When the battery has expended, or nearly expended, its capacity, the battery can be recharged transcutaneously, via inductive coupling from an external power source temporarily positioned on the surface of the skin.
Transcutaneous energy transfer through the use of inductive coupling involves the placement of two coils positioned in close proximity to each other on opposite sides of the cutaneous boundary. The internal coil, or secondary coil, is part of or otherwise electrically associated with the implanted medical device. The external coil, or primary coil, is associated with the external power source or external charger, or recharger. The primary coil is driven with an alternating current. A current is induced in the secondary coil through inductive coupling. This current can then be used to power the implanted medical device or to charge, or recharge, an internal power source, or a combination of the two.
Since it may be necessary for the patient to operate the external power source and since the patient may not be medically skilled nor electronically skilled, it is desirable that the external power source have a user interface that is both intuitive and simple to use and operate.
SUMMARY OF THE INVENTION
In an embodiment, the present invention provides an implantable medical device system. An implantable medical device provides a therapeutic output to a patient. An external patient control unit can be operatively coupled via telemetry with the implantable medical device allowing the patient to control the therapeutic output of the implantable medical device. An external energy transfer unit can be operatively coupled to the implantable medical device to transcutaneously transfer energy to the implantable medical device. The external patient control unit has a user interface operable by the patient having patient controls and display icons indicative of a status of operation of the patient control unit. The energy transfer unit has a user interface operable by the patient having patient controls and display icons indicative of a status of operation of the energy transfer unit. At least some of the patient controls and the display icons of the energy transfer unit are common with at least some of the patient controls and the display icons of the patient control unit.
In another embodiment, the present invention provides an external energy transfer unit adapted to transcutaneously transfer energy to an implantable medical device for providing a therapeutic output to a patient. The implantable medical device is capable of communication with an external patient control unit allowing the patient to control the therapeutic output of the implantable medical device. The external patient control unit has a user interface operable by the patient having patient controls and display icons indicative of a status of operation of the patient control unit. A user interface operable by the patient has patient controls and display icons indicative of a status of operation of the energy transfer unit. At least some of the patient controls and the display icons of the energy transfer unit are common with at least some of the patient controls and the display icons of the patient control unit.
In another embodiment, the present invention provides a method of providing therapeutic output to a patient using an implantable medical device. An external patient control unit is operatively coupled via telemetry with the implantable medical device allowing the patient to control the therapeutic output of the implantable medical device. An external energy transfer unit is operatively coupled to the implantable medical device to transcutaneously transfer energy to the implantable medical device. The external patient control unit has a user interface operable by the patient having patient controls and display icons indicative of a status of operation of the patient control unit. The energy transfer unit has a user interface operable by the patient and has patient controls and display icons indicative of a status of operation of the energy transfer unit. At least some of the patient controls and the display icons of the energy transfer unit are common with at least some of the patient controls and the display icons of the patient control unit.
In a preferred embodiment, at least one of the display icons is an icon representative of a state of charging of an energy storage device in the implantable medical device.
In a preferred embodiment, at least one of the patient controls is a control for adjusting the therapeutic output of the implantable medical device.
In a preferred embodiment, the external energy transfer unit inductively couples energy to the implantable medical device.
In a preferred embodiment, the implantable medical device has a rechargeable energy storage device and wherein the energy transfer unit charges the rechargeable energy storage device.
In another embodiment, the present invention provides an implantable medical device system. An implantable medical device provides a therapeutic output to a patient. An external energy transfer unit can be operatively coupled to transcutaneously transfer energy to the implantable medical device. The energy transfer unit is operable by the patient with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device.
In another embodiment, the present invention provides an external energy transfer unit adapted to transcutaneously transfer energy to an implantable medical device for providing a therapeutic output to a patient. Energy transfer circuitry transcutaneously transfers energy to the implantable medical device. Less than three operative controls control energy transfer from the external energy transfer unit to the implantable medical device.
In another embodiment, the present invention provides a method providing a therapeutic output to a patient with an implantable medical device. An external energy transfer unit is operatively coupled with the implantable medical device to transcutaneously transfer energy to the implantable medical device. The energy transfer unit is controlled with less than three operative controls to control energy transfer from the external energy transfer unit to the implantable medical device.
In a preferred embodiment, the energy transfer unit is operable with two operative controls to control energy transfer from the external energy transfer unit to the implantable medical device.
In a preferred embodiment, the two operative controls comprise a start control and a stop control.
In a preferred embodiment, the start control is a start button and wherein the stop control is a stop button.
In a preferred embodiment, the energy transfer unit also has operative controls to start and stop the therapeutic output of the implantable medical device.
In a preferred embodiment, the energy transfer unit also has a control to enable and silence audio feedback from the energy transfer unit.
In a preferred embodiment, the external energy transfer unit inductively couples energy to the implantable medical device.
In a preferred embodiment, the implantable medical device has a rechargeable energy storage device and wherein the energy transfer unit charges the rechargeable energy storage device.
In another embodiment, the present invention provides an implantable medical device system. An implantable medical device provides a therapeutic output to a patient. The implantable medical device is capable of receiving inductively coupled energy with a secondary coil and is capable of being transcutaneously controlled using an internal telemetry coil. An external antenna has a primary coil adapted to inductively transfer energy to the secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An external energy transfer unit is adapted to be operatively coupled by a cord to the external antenna driving the primary coil to inductively transfer energy to the implantable medical device. The energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.
In another embodiment, the present invention provides an external energy transfer system adapted to transcutaneously transfer energy to an implantable medical device for providing a therapeutic output to a patient. The implantable medical device is capable of receiving inductively coupled energy with a secondary coil and is capable of being transcutaneously controlled using an internal telemetry coil. An external antenna has a primary coil adapted to inductively transfer energy to the secondary coil of the implantable medical device when the external antenna is externally placed in proximity of the secondary coil. An external energy transfer unit is adapted to be operatively coupled by a cord to the external antenna driving the primary coil to inductively transfer energy to the implantable medical device. The energy transfer unit has an external telemetry coil allowing the energy transfer unit to communicate with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.
In another embodiment, the present invention provides a method of controlling an implantable medical device for providing a therapeutic output. The implantable medical device is capable of receiving inductively coupled energy with a secondary coil and is capable of being transcutaneously controlled using an internal telemetry coil. Energy is inductively transferred to the secondary coil with an external antenna having a primary coil when the external antenna is externally placed in proximity of the secondary coil. The primary coil is driven with an external energy transfer unit operatively coupled by a cord to the external antenna to inductively transfer energy to the implantable medical device. An external telemetry coil in the energy transfer unit communicates with the implantable medical device through the internal telemetry coil in order to at least partially control the therapeutic output of the implantable medical device.
In a preferred embodiment, the inductively transferring step and the communicating step occur simultaneously.
In a preferred embodiment, the energy transfer unit can control the implantable medical device to turn the therapeutic output on and off.
In a preferred embodiment, the energy transfer unit can control the implantable medical device using the external telemetry coil while transferring energy to the implantable medical using the primary coil of the antenna.
In a preferred embodiment, the implantable medical device has a rechargeable energy storage device and wherein the energy transfer unit charges the rechargeable energy storage device.



BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a block diagram of an external programmer and an external charging device for an implantable medical device such as can be utilized in the present invention;
FIG. 2 is a detailed block diagram of an implantable medical device implanted subcutaneously and an associated external charging device in accordance with an embodiment of the present invention;
FIG. 3 illustrates the start-up flow of an external programmer usable in conjunction with an implantable medical device;
FIG. 4 illustrates operation flow of an external programmer usable in conjunction with an implantable medical device;
FIG. 5 illustrates a therapy status screen of an external programmer;
FIG. 6 illustrates access to menu selection of an external programmer;
FIG. 7 illustrate group selections of an external programmer;
FIG. 8 illustrate parameter selections of an external programmer;
FIG. 9A illustrate screens of an external programmer;
FIG. 9B illustrate messages of an external programmer;
FIG. 9C illustrate warnings of an external programmer;
FIG. 10 illustrate menu selections of an external programmer;
FIG. 11 illustrates audio status of an external programmer;
FIG. 12 illustrates contrast of an external programmer;
FIG. 13 illustrates INS/ENS time of an external programmer;
FIG. 14 illustrate time/number formats of an external programmer;
FIG. 15 illustrate patient programmer information;
FIG. 16 illustrates INS/ENS information;
FIG. 16A illustrates Telemetry N information;
FIG. 17 illustrates the navigation flow of an external charger for recharging the INS;
FIG. 18 illustrates the navigation flow of an external charger for recharging the external power source;
FIG. 19 illustrates screen shots of charge status of an external charger;
FIG. 20 illustrates status messages displayed during charging of the INS;
FIG. 21 illustrates external power source charge status screens;
FIG. 22 illustrates status messages displayed during recharging of the external power source; and
FIGS. 23A and 23B illustrate screens, information messages and warnings.



DETAILED DESCRIPTION OF THE INVENTION
The entire content of U.S. patent application Ser. No. 10/958,191, filed Oct. 4, 2004, U.S. Provisional Application Ser. No. 60/508,198, filed Oct. 2, 2003, and U.S. Provisional Application Ser. No. 60/513,732, filed Oct. 23, 2003, is hereby incorporated by reference.
In FIG. 1, external programming unit 2 is attachable via cord 4 to an external telemetry coil 6. External programming unit 2 can program operations implantable medical device 16 (FIG. 2) in a conventional manner using external telemetry coil 6. External antenna 52 is attachable via cord 56 to external charging device 48 is inductively transfer power to implantable medical device 16 when external antenna 52 is placed in proximity of a secondary coil 24 associated with implantable medical device 16. External charging device 48 receives AC power from cord 8 through transformer 10. External antenna 52 can be held in position on a patient with belt 12.
FIG. 2 illustrates an embodiment of implantable medical device 16 situated under cutaneous boundary 38. Charging regulation and therapy control is conventional. Implantable medical device 16 also has internal telemetry coil 44 configured in conventional manner to communicate through external telemetry coil 46 to an external programming device 2, charging unit 50 or other device in a conventional manner in order to both program and control implantable medical device and to externally obtain information from implantable medical device 16 once implantable medical device has been implanted. Internal telemetry coil 44, rectangular in shape with dimensions of 1.85 inches (4.7 centimeters) by 1.89 inches (4.8 centimeters) constructed from 150 turns of 43 AWG wire, is sized to be larger than the diameter of secondary charging coil 34. Secondary coil 34 is constructed with 182 turns of 30 AWG wire with an inside diameter of 0.72 inches (1.83 centimeters) and an outside diameter of 1.43 inches (3.63 centimeters) with a height of 0.075 inches (0.19 centimeters). Magnetic shield 36 is positioned between secondary charging coil 34 and housing 32 and sized to cover the footprint of secondary charging coil 34.
Internal telemetry coil 44, having a larger diameter than secondary coil 34, is not completely covered by magnetic shield 36 allowing implantable medical device 16 to communicate with the external programming device with internal telemetry coil 44 in spite of the presence of magnetic shield 36.
Rechargeable power source 24 can be charged while implantable medical device 16 is in place in a patient through the use of external charging device 48. In a preferred embodiment, external charging device 48 consists of charging unit 50 and external antenna 52. Charging unit 50 contains the electronics necessary to drive primary coil 54 with an oscillating current in order to induce current in secondary coil 34 when primary coil 54 is placed in the proximity of secondary coil 34. Charging unit 50 is operatively coupled to primary coil by cable 56. In an alternative embodiment, charging unit 50 and antenna 52 may be combined into a single unit. Antenna 52 also contains external telemetry coil 46 which may be operatively coupled to charging unit 50 if it is desired to communicate to or from implantable medical device 16 with external charging device 48. Alternatively, antenna 52 may contain external telemetry coil 46 which can be operatively coupled to external programming device 2, either individually or together with external charging unit 48.
The user interface of external programming unit 2 is illustrated by reference to FIG. 3 through FIG. 16. The following terms are used throughout the description of the user interface of external programming unit 2.
As noted below in the explanation of acronyms utilized in the following paragraphs and table, DTC refers to desktop charger which is used to denote the AC power supply (transformer 10) and power cord (cord 8). The DTC is “docked” when external charger 48 is connected to an source of AC power. The DTC is “undocked” when external charger 48 is disconnected from a source of AC power.

    DTC Desktop Charger
    ENS External Neurostimulator
    INS Implanted Neurostimulator
    INSR Another name for the RX1 Patient Recharger. Acronym stands for Implanted Neurostimulator Recharger
    LCD Liquid Crystal Display


Refer to FIG. 3 and FIG. 4 for start-up flow and navigation flow, respectively.
User interface components in the keypad are shown below.












Name
Label
Function







Power button
   
Turn display on and off




Turn backlight on when held down


Therapy On
   
Turn therapy on




Turn display on if pressed when programmer 




is powered down


Therapy Off
   
Turn therapy off




Turn display on if pressed when programmer 




is powered down.


Increase
   
Change values


Decrease
▬
Change values


Sync
   
Interrogate the implanted device; activate a 




group




Turn display on if pressed when programmer 




is powered down.


Scroll
▴ ▾
Select displayed items


Up/Down




Scroll
      
Access available choices for a selected item


Left/Right









The LCD is backlit and consists of 96 (Horizontal)×58 (Vertical) dots with asymmetrical dots 0.35 (H)×0.4 (V). The active area on the LCD is 33.3 mm (H)×23.2 mm (V). Four colors of display available. These are named below (from lightest to darkest):

    
    
        White
        Light Gray
        Dark Gray
        Black
    
    


Icons are shown in Tables 1-6 below.
Notes:


    
    
        Coordinates specified in the Tables 1-6 below are based on rows numbered 0-57 and columns numbered 0-95
        Effective display area: rows 1-56, columns 1-94; always leave rows 0 and 57, columns 0 and 95 blank
        With the exception of status_stim_on, status_stim_off and status_ins_battery_* in Table 1, check_off in Table 2, specified size in Tables 1-6 includes a 1-pixel wide white border around all symbols
    
    









TABLE 1







Icons for Status Line











Name
File
Icon
Size
Coordinates





Status Line 
Box_17x78
   
80 w ×
R0 C2


Box


19 h



Stim On
status_stim_on
   
16 w ×
R2 C9





15 h



Stim Off
status_stim_off
   
16 w ×
R2 C9





15 h



INS Batt1
status_ins_battery_
   
22 w ×
R2 C29



100

15 h



INS Batt2
status_ins_battery_75
   
22 w ×
R2 C29





15 h



INS Batt3
status_ins_battery_50
   
22 w ×
R2 C29





15 h



INS Batt4
status_ins_battery_25
   
22 w ×
R2 C29





15 h



INS Batt5
status_ins_battery__0
   
22 w ×
R2 C29





15 h



Programmer 
status_ppg_battery_
   
21 w ×
R2 C55


Batt1
100

15 h



Programmer 
status_ppg_battery_75
   
21 w ×
R2 C55


Batt2


15 h



Programmer 
status_ppg_battery_50
   
21 w ×
R2 C55


Batt3


15 h



Programmer 
status_ppg_battery_25
   
21 w ×
R2 C55


Batt4


15 h



Programmer 
status_ppg_battery_0
   
21 w × 
R2 C55


Batt5


15 h



ENS Batt1
status_ens_battery_
   
22 w ×
R2 C29



100

15 h



ENS Batt2
status_ens_battery_75
   
22 w ×
R2 C29





15 h



ENS Batt3
status_ens_battery_50
   
22 w ×
R2 C29





15 h



ENS Batt4
status_ens_battery_25
   
22 w ×
R2 C29





15 h



ENS Batt5
status_ens_battery_0
   
22 w × 
R2 C29





15 h



Small Arrow
small_arrow
      
10 w × 
R6 C83





 8 h
















TABLE 2







Icons for Groups Line











Name
File
Icon
Size
Coordinates





Groups Line 
box_15x78
   
80 w ×
R18 C2


Box


17 h



Check Off
check_off
   
12 w ×
R20 C9





13 h



Check On
check_on
   
12 w ×
R20 C9





13 h



Scheduled
scheduled_therapy
   
18 w ×
R20 C40


Therapy


13 h



Null Set
null_set
   
12 w × 5 h
R24 C25


Small Arrow
small_arrow
      
10 w × 8 h
R22 C83


Group Labels

—
—
R21 C26
















TABLE 3







Icons for Parameters Line











Name
File
Icon
Size
Coordinates





Parameters
box_22x78
   
80 w ×
R34 C2


Line Box


24 h



Amp1
Amplitude_1
   
21 w ×
R38 C7





18 h



Amp2
Amplitude_2
   
21 w ×
R38 C7





18 h



Amp3
Amplitude_3
   
21 w ×
R38 C7





18 h



Amp4
Amplitude_4
   
21 w ×
R38 C7





18 h



PW1
Pulsewidth_1
   
26 w ×
R37 C7





18 h



PW2
Pulsewidth_2
   
26 w × 
R37 C7





18 h



PW3
Pulsewidth_3
   
26 w ×
R37 C7





18 h



PW4
Pulsewidth_4
   
26 w × 
R37 C7





18 h



Rate
Rate
   
23 w ×
R37 C9





18 h



Decimal
decimal
   
 6 w × 6 h
R50a


Comma
Comma

 7 w × 7 h
R49a


Num0
number_0
0
13 w ×
R37b





19 h



Num1
number_1
1
 7 w × 19 h
R37b


Num2
number_2
2
13 w ×
R37b





19 h



Num3
number_3
3
14 w × 19 h
R37b


Num4
number_4
4
14 w × 19 h
R37b


Num5
number_5
5
13 w × 19 h
R37b


Num6
number_6
6
13 w × 19 h
R37b


Num7
number_7
7
13 w × 19 h
R37b


Num8
number_8
8
13 w × 19 h
R37b


Num9
number_9
9
13 w × 19 h
R37b


Null Value
Null_set_value
---
40 w × 5 h
R43 C22


Small Arrow
small_arrow
   
10 w × 8 h
R42 C83





Notes


aColumn position will vary, depending on parameter value


bAll numbers will be displayed in R37; column position will vary, depending on parameter symbol and value













TABLE 4







Icons for Information Messages and Cautions











Name
File
Icon
Size
Coordinates





Wait Signal
msg_wait_signal
   
14 w ×
R3 C5





16 h



Communicating
msg_communicate
   
59 w × 
R26 C18





23 h



Communicating-
msg_communicate_ens
   
61 w × 23 h
R26 C18


ENS






All cautions
msg_ppg_information
   
17 w ×
R3 C5





17 h



INS Battery
msg_ins_battery_low
   
36 w ×
R27 C30


Low


24 h



ENS Battery
msg_ens_battery_low
   
43 w ×
R28 C26


Low


23 h



Programmer
msg_ppg_battery_low
   
36 w ×
R26 C30


Battery Low


26 h



Amp at Upper
msg_upper_limit_amplitude
   
40 w ×
R30 C28


Limit


17 h



PW at Upper
msg_upper_limit_pulsewidth
   
44 w ×
R32 C26


Limit


14 h



Rate at Upper
msg_upper_limit_rate
   
41 w ×
R30 C27


Limit


18 h



Amp at Lower
msg_low_limit_amplitude
   
41 w ×
R30 C27


Limit


17 h



PW at Lower
msg_low_limit_pulsewidth
   
43 w ×
R32 C26


Limit


14 h



Rate at Lower
msg_low_limit_rate
   
41 w ×
R30 C27


Limit


18 h



Poor
msg_poor_communication
   
59 w ×
R26 C18


Communication


23 h



Poor
msg_poor_communication_ens
   
61 w ×
R26 C18


Communication-


23 h



ENS






Sync Up
msg_sync
   
36 w ×
R24 C30





29 h



Stim On
msg_stim_on
   
36 w ×
R24 C30





29 h



Codes for Call
Med 15 pt font
—
—
R44, C**


Your Doctor






IR
msg_ir_communication
   
22 w ×
R14, C37


Communication*


40 h



Connect ENS
msg_cable_problem
   
78 w ×
R23 C9


Cable


31 h





*Note:


display msg_wait_signal and msg_ir_communication for IR Communication Screen













TABLE 5







Icons for Warnings











Name
File
Icon
Size
Coordinates





All warnings
msg_ppg_attention
   
16 w ×
R4 C5





14 h



Recharge
msg_recharge_stim
   
82 w ×
R26 C7


Stimulator


24 h



Replace ENS
msg_ens_battery_
   
79 w ×
R24 C8


Battery
depleted

27 h



Replace
msg_ppg_battery_
   
72 w ×
R14 C12


Programmer
depleted

27 h



Battery






Sync Up-
msg_sync
   
36 w ×
R23 C30


Required


29 h



Turn 
msg_turn_stim_on
   
36 w ×
R23 C30


Stimulation On


29 h



Call Your 
msg_call_your_
   
57 w ×
R8 C19


Doctor
doctor

43 h



Codes for Call
Med 15 pt font
—
—
R44, C**


Your Doctor






Sync Up-Start
msg_sync
   
36 w ×
R15 C30





29 h



Text for 
Med 15 pt font
—
—
R14, C23


Splash*






Wait Signal-
msg_wait_signal
   
14 w ×
R28 C41


Splash*


16 h





*Note:


display Text for Splash (Med 15 pt font) and Wait Signal-Splash (msg_wait_signal) for Splash Screen


**Note:


column position will vary, depending on codes displayed













TABLE 6







Icons for Menu Selections











Name
File
Icon
Size
Coordinates





Box for Menu 
menu_box_26x78
   
80 w ×
R0 C2


Selections1


28 h



Box for Contrast,
menu_box_16x78
   
80 w ×
R29 C2


Audio and System Info


18 h



Values






Box for INS/ENS Time
menu_box_16x21
   
23 w ×
R30 C3


Values


18 h



Box for INS/ENS Time-
menu_box_16x13
   
15 w ×
R30 C47


AM/PM


18 h



Box for Time/Number
menu_box_27x78
   
80 w ×
R29 C2


Format and Telemetry


29 h



N Information Values






Small arrows
small_arrow
   
10 w × 8 h
R2, C83


Audio
menu_audio
   
15 w ×
R2 C19





24 h



Audio
menu_audio_on
   
17 w ×
R31 C19





14 h



Audio
menu_audio_off
   
17 w ×
R31 C19





14 h



Contrast
menu_contrast
   
26 w ×
R2 C15





24 h



Contrast
menu_slide
   
72 w × 9 h
R34 C6


Contrast
menu_slider
   
 6 w × 12 h
R32 C4


INS/ENS Time
menu_clock
   
24 w ×
R2 C13





24 h



Values for
Med 15 pt font
—
—
R35 C5


Hours/Minutes






Colon-INS/ENS
menu_colon
:
 4 w × 8 h
R36 C24


Time






Time/Number Format
menu_time_number
   
24 w ×
R2 C14





24 h



Number-OUS Value
number_comma
1.000,00
54 w ×
R31 C9





13 h



Number-US Value
number_decimal
1,000.00
54 w ×
R31 C9





13 h



Time-12h Value
menu_time12h_format 
10:00pm
51 w ×
R43 C9





13 h



Time-24 h Value
menu_time24h_format
22:00
36 w ×
R44 C9





11 h



System Info
menu_info6
   
19 w ×
R5 C13





19 h



System Info Values
Med15 pt font7
—
—
—





Notes


1Displayed on all menu selection screens


2Row position will vary, depending on menu box that is displayed: R10 for menu_box_26x78; R34 for menu_box_16x78; R35 for menu_box_16x21 and menu_box_16x13; R40 for menu_box_27x78


3C2 for hours; C27 for minutes


4Column position will vary, depending on contrast setting


5Column position will vary, depending on values


6Display “PI” next to menu_info for Patient Programmer Information, “NSI” next to menu_info for INS/ENS Information and “TNI” next to menu_info for Telemetry N Information (Refer to Error! Reference source not found., Error! Reference source not found. and Error! Reference source not found.)


7Med15 pt font will be used for Patient Programmer Information and INS/ENS Information.






Therapy status screen display layout is divided vertically into three lines of information: status line, groups line and parameters line as shown in FIG. 5. When a successful initial interrogation has been performed, software will display the Therapy Status Screen of the active set with the following highlighting priority: parameters line if displayed; groups line if displayed; and status line.
Scroll up and scroll down keys will be used to access the status line, groups line and parameters line on the display. A box highlights user selection. Scroll left and right will be used to cycle through available choices for a selected line. Software will display a “real-time” INS charge level on the status line. The charge level will be updated and displayed whenever a parameter adjustment is made. Software will display programmer battery status on the status line.
Access to Menu Selections is from the status line are shown in FIG. 6. Initial interrogation will include data on all groups currently available to the patient (“Baseline” setting).
Software will display labels for all groups the user can activate, including those containing no adjustable parameters. Refer to FIG. 7 for Group Selections. All unnecessary text will be removed from the display: e.g., if there is only 1 group, software will not display the groups line. Software will not display parameters that the user cannot adjust: i.e., the clinician programmer disallows access or upper and lower limits are the same. The user will access all available groups by scrolling through a linear list: A, B, C, . . . , Z. When the user scrolls to a different group, software will display the first adjustable parameter in the group. The user will scroll left/right through available groups to access an inactive group.
Software will display all adjustable parameters for inactive groups. The user will scroll down to highlight parameters and scroll left or right to view them. If a user presses Therapy Off or Therapy On when the screen displays an inactive group, software will turn the INS off, and display the Therapy Status Screen with the active group highlighted. A check in its check box will be used to indicate an active group (check_on); a check box without a check will be used to indicate inactive groups (check_off). The user will press the Sync key to activate a group at the displayed parameter value(s).
The neurostimulator does not have to be on to activate a new group. The user can activate a group when therapy is off. The user can activate a new group when the groups line is highlighted or when the parameters line is highlighted. The check box will be updated whenever a new group is activated.
Software will display labels for all parameters the user can adjust as shown in FIG. 8, Parameter Selections. Software will display the first adjustable parameter of the active group when a Sync has been performed for an initial interrogation. The user will access all adjustable parameters by scrolling through a linear list. The order of scrolling through adjustable parameters in a group is Amp1, Amp2, Amp3, Amp4, PW1, PW2, PW3, PW4, Rate, Amp1, . . . . Refer to FIG. 8, Parameter Selections. Increase/decrease keys will be inactive until a session has been initiated—i.e., the INS has been interrogated. When the user presses and holds the increase/decrease keys, software will send a change to the neurostimulator every 1⁄2 second. When the user changes a parameter, software will display the updated parameter value.
Therapy control events are described in screens, information messages and warnings that are displayed on the programmer as shown in FIGS. 9A, 9B and 9C. Operational requirements are described in tables that specify conditions for entry and expected changes in control.










Power Down Screen (blank display)


Screen Entry: User Control/System Event


System timeout or Power Button keypress








User Control/



System Event
System Response: Table 10 reference





Power button
Start Screen, 14, 15


Therapy On
1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Therapy Off
1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Sync
1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Scroll up/down/
Ignore


Scroll left/right



Increase/Decrease
Ignore


Replace programmer 
Splash Screen


batteries



















Start Screen


Screen Entry: User Control/System Event


Power button








User Control/



System Event
System Response: Table 10 reference





Therapy On
1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Therapy Off
1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Sync
1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Power button/System 
Power Down Screen


timeout



Scroll up/down/Scroll 
Ignore


left/right



Increase/Decrease
Ignore


Increase + Decrease and 
10


hold for 2-3 seconds



















Therapy Status Screen


Screen Entry: User Control/System Event


Telemetry success








User Control/System 



Event
System Response: Table 10 reference





Therapy On
1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Therapy Off
1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Sync
1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23, 24


Increase
1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 17, 18, 19,



20, 23, 24


Decrease
1, 2, 3, 4, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 16, 19, 20,



23, 24


Scroll left/right from 
Audio Screen, Time/Number Formats


status line



Power button/System
Power Down Screen


timeout









The i symbol will be displayed on all information messages as shown in FIG. 9B. The user can clear all messages by pressing the 4-way button (Scroll up/down, Scroll left/right), Therapy Off to turn stimulation off or the Power button to turn the display off. If the system times out, the display will turn off (Power Down Screen). Refer to Table 7.







TABLE 7







Processing Requirements for Information Messages








Message
User Control/System Response: Feedback/Next Screen





INS Battery Low
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 6, 11, 12, 13, 14, 15, 23, 24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


ENS Battery Low
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 8, 9, 12, 13, 14, 15, 20, 23, 24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Programmer Battery
4-way button: Previous screen


Low
Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 15, 20, 23, 24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Amp at Upper Limit
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


PW at Upper Limit
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Rate at Upper Limit
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Amp at Lower Limit
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


PW at Lower Limit
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Rate at Lower Limit
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: ignore



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Poor Communication -
Allow a repeat of the last keypress for Stim On, Sync, Increase and


INS
Decrease



4-way button: Sync Up Required



Stim Off: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15



Stim On: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15



Sync: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15



Increase/Decrease: Table 10-1, 2, 3, 5, 6, 11, 12, 13, 14, 15, 16,



17, 18, 19



System timeout or Power button: Power Down


Poor Communication -
Allow a repeat of the last keypress for Stim On, Sync, Increase and


ENS
Decrease



4-way button: Sync Up Required



Stim Off: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24



Stim On: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24



Sync: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24



Increase/Decrease: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 16, 17,



18, 19, 20, 23, 24



System timeout or Power button: Power Down


Sync Up
4-way button: Therapy Status



Stim Off: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Stim On: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Sync: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20



Increase/Decrease: ignore



System timeout or Power button: Power Down


Turn Stimulation On
4-way button: Therapy Status



Stim Off: ignore



Stim On: Table 10-1, 2, 3, 5, 6, 7, 8, 9, 11, 12, 13, 14, 15, 20, 23,



24



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down


Connect ENS Cable
4-way button: Sync Up Required



Stim Off: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24



Stim On: Table 10-2, 7, 8, 9, 12, 13, 14, 15, 20, 23, 24



Sync: ignore



Increase/Decrease: ignore



System timeout or Power button: Power Down









The exclamation mark symbol will be displayed on all warnings as shown in FIG. 9C. All warnings will remain on the display until the user takes appropriate action. Refer to Table 8.







TABLE 8







Processing Requirements for Warning Messages









User Action/System Response: Feedback/Next


Message
Screen





Recharge Stimulator
System timeout or Power button: Power Down


Replace ENS Battery
System timeout or Power button: Power Down


Replace Programmer
Replace programmer battery: Start Screen


Battery
System timeout or Power button: Power Down


Sync Up Required
Sync button or Therapy On or Therapy Off:



Therapy Status



System timeout or Power button: Power Down


Call Your Doctor
Therapy Off and telemetry success with audio



feedback: Call Your Doctor



Therapy Off and telemetry failure with audio



feedback: Call Your Doctor



System timeout or Power button: Power Down


Call Your Doctor - EOS
System timeout or Power button: Power Down


Call Your Doctor - POR
System timeout or Power button: Power Down









“In the box” messages are described in Table 9.
“In the Box” Messages

    
    
        Software will notify the user with 3 beeps when “In the Box” messages are displayed
        All “In the Box” messages will remain on the display until the system times out or the user presses the Power button to turn off the display. Refer to Table 9.
    
    









TABLE 9







Processing Requirements for “In the Box” Messages











User Action/System Response: Feedback/Next



Message
Screen






INS in the Box
System timeout or Power button: Power Down



ENS in the Box
System timeout or Power button: Power Down









Therapy control events are described in Table 10.







TABLE 10







Processing Requirements for Therapy Control Events and Device Communication










User Control/System Event
System Response












1.
Communicating with the INS
Display Communicating - INS Message


2.
Successful telemetry
Display Therapy Status Screen


3.
Telemetry failure - INS
Display Poor Communication - INS




Message


4.
Software is unable to refresh/update the
Display Sync Up Required Warning



Therapy Status Screen after a telemetry




failure



5.
INS battery low
Display INS Battery Low Message


6.
INS battery depleted
Display Recharge Stimulator Warning


7.
ENS battery low or battery
Display ENS Battery Low Message



disconnected



8.
ENS battery depleted
Display Replace ENS Battery Warning


9.
ENS screening cable disconnected
Display Connect ENS Cable Message


10.
User presses Increase + Decrease and
Display Patient Information Screen



holds for 2-3 seconds
(Error! Reference source not found.)


11.
INS error - EOS
Display Call Your Doctor - EOS




Warning


12.
INS error - battery voltage too high;/
Display Call Your Doctor Warning



ENS error - POR, battery voltage too




high



13.
System Error and Warning
Display Call Your Doctor Warning


14.
Patient programmer battery low
Display Programmer Battery Low




Message


15.
Patient programmer battery depleted
Display Replace Programmer Battery




Warning


16.
Parameter at lower limit
Display At Lower Limit Message


17.
Parameter at upper limit or out of reg
Display At Upper Limit Message


18.
Increase with therapy off
Display Turn Stimulation On Message


19.
Increase/decrease parameter of inactive
Display Sync Up Message



group



20.
ENS error - POR, battery voltage too
Display Communicating - ENS,



low
followed by INS/ENS Time with 12:00




displayed


21.
Communicating via IR
Display IR Communication Screen


22.
Replace programmer batteries
Display Splash Screen


23.
Communicating with the ENS
Display Communicating - ENS




Message


24.
Telemetry failure - ENS
Display Poor Communication - ENS




Message


25.
INS error - locked normal
Display INS in the Box Message


26.
ENS error - ENS has no programs or
Display ENS in the Box Message



groups



27.
INS error - POR
Display Call Your Doctor - POR




Warning









Access to menu selections is from the status line on the Therapy Screen as shown in FIG. 10.
The display is divided vertically into two lines of information: menu option line and value line. Scroll up and down keys will be used to access the menu option line and the value line on the display. A box highlights user selection. Scroll right and left and increase/decrease keys will be used to change values for Audio, Contrast, Time/Number Format and the Information options. In addition, Increase/decrease keys will be used to change values.
Software will display screens for the menu options in Table 11 Menu Selections.







TABLE 111







Menu Selections and Navigation Flow










Menu Item
References






Audio
FIG. 11, Table 12-1, 3, 9



Contrast
FIG. 12, Table 12-1, 3, 4, 6, 7, 9



INS/ENS Time
FIG. 13, Table 12-1, 2, 4, 7, 8, 9



Time/Number Format
FIG. 14, Table 12-1, 3, 9



Patient Programmer Information
FIG. 15, Table 12-1, 2, 9, 10



INS/ENS Information
FIG. 16, Table 12-1, 2, 9, 10



Telemetry N Information
FIG. 16A, Table 12-1, 2, 9, 10









The user interface of the external charger is described below. A description of the user interface for an external recharger for an implantable medical device is described. The appearance of the screens and how users interact with these screens are defined.
The following terms are used throughout the description of the user interface for the external charger.

    DTC Desktop Charger
    ENS External Neurostimulator
    INS Implanted Neurostimulator
    INSR Another name for the RX1 Patient Recharger. Acronym stands for Implanted Neurostimulator Recharger
    LCD Liquid Crystal Display


Refer to FIG. 17 and FIG. 18 for navigation flow.
FIG. 17 illustrates a process for charging rechargeable power source 24 in implantable medical device 16 by using external charging device 48.
In order to charge rechargeable power source 24, a patient may use belt 12 to attach external antenna 52 to the patient's body at approximately the location of implanted medical device 16. It is desirable that primary coil 54 of external antenna 52 be aligned as closely as possible with secondary coil 34 of implantable medical device 16. Techniques for attaching external antenna 52 to the patient's body and positioning primary coil 54 in close proximity to secondary coil 34 can be found in co-pending U.S. patent application Ser. No. 10/837,506, filed Apr. 30, 2004, the entire contents of which are hereby incorporated by reference. This application claims priority from U.S. Provisional Patent Application Ser. No. 60/508,174, filed Oct. 2, 2003.
After affixing external antenna 52 to the approximate location of implantable medical device 16, the patient (or other user such as a medical professional or family member assisting the patient) may then press (step 110) the “Start Charge” button 90 (FIG. 1) on charging unit 50.
Charging unit 50 then determines (step 112) if telemetry with implantable medical device 16 is successful. If telemetry is unsuccessful (step 114), an error message is generated such as a telemetry timeout (Reposition Antenna—Press Start Charge), system error (Antenna Too Hot) or external charging device 48 error due to INSR battery low or INSR battery depleted and external charging device displays the appropriate message. If telemetry is successful, then charging unit 50 waits (step 116) and the appropriate charge status may be indicated (step 118) in the display of charging unit 50.
If charging of rechargeable power source 24 is not yet complete (step 120), charging unit 50 returns through step 118. The surface temperature of antenna 52 is monitored as well as the charging current and battery voltage levels. An error message is generated and charging is suspended if measurements are not within limits.
Once charging of rechargeable power 24 is complete (step 122), charging unit 50 indicates in the display that charging is complete and the user may press the “Stop Charge” button 92 on charging unit 50 to terminate the charging process. Of course, it is to recognized and understood that the “Stop Charge” button 92 may be pressed at any time during the charging process in order to terminate the charging process, i.e., the user need not wait until the complete charging has been indicated.
Charging unit 50 may be operated to charge rechargeable power 24 in implantable medical device 16 by the use of only two buttons, namely the “Start Charge” button 90 and the “Stop Charge” button 92. These are the only two buttons which need be used. While a preferred embodiment of charging unit 50 does contain a third button, namely “Silence” button 94, this third button is not necessary. “Silence” button 94 is used only to disable, or to re-enable, audio output of charging unit 50. Since audio feedback is not required for the charging process, this button may be used or not at the convenience of the user.
In an alternative embodiment, charging unit 50 may itself be powered by a rechargeable power source, such as a battery. Since the charging process could take several hours, it would be desirable.
FIG. 18 illustrates the process used to charge the external charging unit 48. The external charging unit 48 is connected (step 124) to a suitable power source, such as a readily available AC power outlet. A check is made (step 126) to determine whether a “recharge event”, i.e., an alert or alarm condition, has occurred and, if so, issue the appropriate message (step 128). If a “recharge event” has not occurred, the process updates and displays (step 130) the charge status of external charging device 48. If recharge of external charging is not complete (step 132), the process again updates and displays the charging status in step 130. Once charging of external charging device 48 is complete (step 134), charging unit 50 displays a message indicative of a complete charging process.
The LCD is backlit and consists of 96 (Horizontal)×58 (Vertical) dots with asymmetrical dots 0.35 (H)×0.4 (V). The active area on the LCD is 23.2 mm (V)×33.3 mm (H).
Four colors of display are available. These are named below (from lightest to darkest):

    
    
        White
        Light Gray
        Dark Gray
        Black
    
    


The keypad has the following buttons.












Name
Label
Function







Start Charge
 
Start charge




Turn display on if pressed when recharger is




powered down


Stop Charge
 
Stop charge


Audio
 
Toggle audio on/off




Turn display on if pressed when recharger is




powered down


Therapy On
 
Turn therapy on




Turn display on if pressed when recharger is




powered down


Therapy Off
 
Turn therapy off




Turn display on if pressed when recharger is




powered down









See Tables 11 through 16 below for icons.







TABLE 12







Icons for Status Line















Coordi-


Name
File
Icon
Size
nates





INSR Wait
msg_insr_wait_signal
 
14 w × 16 h
R3 C5


Signal






Therapy On
status_stim_on
 
16 w × 16 h
R1 C6


Therapy Off
status_stim_off
 
16 w × 16 h
R1 C6


Audio On
status_beep_on
 
17 w × 14 h
R3 C27


Audio Off
status_beep_off
 
17 w × 14 h
R3 C27


INSR Batt1
status_hhp_battery_100
 
21 w × 15 h
R2 C49


INSR Batt2
status_hhp_battery_75
 
21 w × 15 h
R2 C49


INSR Batt3
status_hhp_battery_50
 
21 w × 15 h
R2 C49


INSR Batt4
status_hhp_battery_25
 
21 w × 15 h
R2 C49


INSR Batt5
status_hhp_battery_0
 
21 w × 15 h
R2 C49


Power
status_plug
 
16 w × 11 h
R6 C75


Source






Symbol
















TABLE 13







Icons for INS Recharge Progress Line











Name
File
Icon
Size
Coordinates





Wait Signal
Wait_signal
 
75 w × 22 h
R20 C10


Recharging
recharge_antenna
 
31 w × 20 h
R21 C7


Antenna






Recharging Sprites
energy_symbol
 
11 w × 11 h
R25 C40


INS Charging 0 to
ins_charge_0_to_25
 
36 w × 24 h
R20 C53


25%






INS Charging 25
ins_charge_25_to_50
 
36 w × 24 h
R20 C53


to 50%






INS Charging 50
ins_charge_50_to_75
 
36 w × 24 h
R20 C53


to 75%






INS Charging 75
ins_charge_75_to_100
 
36 w × 24 h
R20 C53


to 100%






INS Charging 0%
ins_charge_0
 
36 w × 24 h
R20 C53


INS Charging 25%
ins_charge_25
 
36 w × 24 h
R20 C53


INS Charging 50%
ins_charge_50
 
36 w × 24 h
R20 C53


INS Charging 75%
ins_charge_75
 
36 w × 24 h
R20 C53


INS Charging
ins_charge_100
 
36 w × 24 h
R20 C53


100%






INS Recharge
Msg_ins_charge_complete
 
36 w × 34 h
R20 C30


Complete






Antenna Too Hot
Msg_antenna_too_hot
 
56 w × 36 h
R20 C20
















TABLE 14







Icons for INS Recharge Efficiency Line











Name
File
Icon
Size
Coordinates





Recharge
recharge_efficiency_0
 
65 w × 9 h
R46 C15


Efficiency-0






Recharge
recharge_efficiency_1
 
65 w × 9 h
R46 C15


Efficiency-1






Recharge
recharge_efficiency_2
 
65 w × 9 h
R46 C15


Efficiency-2






Recharge
recharge_efficiency_3
 
65 w × 9 h
R46 C15


Efficiency-3






Recharge
recharge_efficiency_4
 
65 w × 9 h
R46 C15


Efficiency-4






Recharge
recharge_efficiency_5
 
65 w × 9 h
R46 C15


Efficiency-5






Recharge
recharge_efficiency_6
 
65 w × 9 h
R46 C15


Efficiency-6






Recharge
recharge_efficiency_7
 
65 w × 9 h
R46 C15


Efficiency-7






Recharge
recharge_efficiency_8
 
65 w × 9 h
R46 C15


Efficiency-8
















TABLE 15







Icons for INSR Charge Status Screen











Name
File
Icon
Size
Coordinates





Therapy On
status_stim_on
 
16 w × 16 h
R1 C6


Therapy Off
status_stim_off
 
16 w × 16 h
R1 C6


Audio On
status_beep_on
 
17 w × 14 h
R3 C27


Audio Off
status_beep_off
 
17 w × 14 h
R3 C27


INSR Charging 0 to 25%
Insr_charge_0_to_25
 
36 w × 26 h
R24 C10


INSR Charging 25 to
Insr_charge_25_to_50
 
36 w × 26 h
R24 C10


50%






INSR Charging 50 to
Insr_charge_50_to_75
 
36 w × 26 h
R24 C10


75%






INSR Charging 75 to
Insr_charge_75_to_100
 
36 w × 26 h
R24 C10


100%






INSR Charging 0%
Insr_charge_0
 
36 w × 26 h
R24 C10


INSR Charging 25%
Insr_charge_25
 
36 w × 26 h
R24 C10


INSR Charging 50%
Insr_charge_50
 
36 w × 26 h
R24 C10


INSR Charging 75%
Insr_charge_75
 
36 w × 26 h
R24 C10


INSR Charging 100%
Insr_charge_100
 
36 w × 26 h
R24 C10


Recharging Sprites
energy_symbol
 
11 w × 11 h
R37 C48


INSR Plug
Insr_plug
 
29 w × 23 h
R26 C57
















TABLE 16







Icons for Information Messages











Name
File
Icon
Size
Coordinates





All information
msg_insr_information
 
17 w × 17 h
R3 C5


messages






Antenna Too Hot
msg_antenna_too_hot
 
56 w × 36 h
R20 C20


INS Battery Low
msg_ins_battery_low
 
36 w × 24 h
R27 C30


INS Recharge
msg_ins_charge_interrupted
Note 1
36 w × 24 h
R27 C30


Interrupted






INS Recharge Complete
msg_ins_charge_complete
 
36 w × 34 h
R18 C30


INSR Battery Low
msg_insr_battery_low
 
36 w × 26 h
R26 C30


INSR Recharge
msg_insr_charge_interrupted
Note 2
36 w × 26 h
R26 C30


Interrupted






INSR Recharge
msg_insr_charge_complete
 
36 w × 34 h
R18 C30


Complete






Call Your Doctor - ERI
msg_call_your_doctor
 
57 w × 43 h
R8 C19


IR Communication
msg_ir_communication:
 
22 w × 43 h
R11 C37



Note 3





Text for Splash
Med 15pt font
—
—
R14, C23



Note 4





Wait Signal - Splash
msg_wait_signal
 
14 w × 16 h
R28 C41



Note 4





Connect INSR Antenna
msg_connect_insr_antenna
 
68 w × 26 h
R25 C14





Note 1: display INS battery status symbol for current charge level: ins_charge_25, ins_charge_50, ins_charge_75 (refer to Table 12), or msg_ins_charge_complete (refer to Table 15)


Note 2: display INSR battery status symbol for current charge level: insr_charge_25, insr_charge_50, insr_charge_75 (refer to Table 14)


Note 3: display msg_insr_wait_signal (refer to Table 11) and msg_ir_communication (refer to Table 5) for IR Communication Screen


Note 4: display Text for Splash (Med 15pt font) and Wait Signal—Splash (msg_wait_signal) for Splash Screen













TABLE 17







Icons for Warning Messages and Physician Recharge Mode











Name
File (*.bmp)
Icon
Size
Coordinates





All warning messages
msg_insr_attention
 
16 w × 14 h
R4 C5


Reposition Antenna
msg_reposition_antenna
 
47 w × 27 h
R25 C6


Reposition Antenna -
msg_reposition_antenna_stim
 
47 w × 27 h
R25 C6


Stim






Press Start Charge
msg_press_test
 
36 w × 29 h
R23 C54


Press Therapy Off
msg_press_stim_off
 
36 w × 29 h
R23 C54


Press Therapy On
msg_press_stim_on
 
36 w × 29 h
R23 C54


Recharge Stimulator
msg_recharge_stim
 
82 w × 24 h
R26 C7


Recharge INSR
msg_recharge_insr
 
76 w × 26 h
R25 C10


Call Your Doctor
msg_call_your_doctor
 
57 w × 43 h
R8 C19


Physician Recharge1
msg_phys_recharge
 
61 w × 26 h
R7 C17


Physician Recharge -
msg_antenna_too_hot
 
56 w × 36 h
R2 C20


Antenna Too Hot2






Values for
Med18pt font
—
—
R40 C3


Minutes/Seconds






System Info
system_info4
 
19 w × 19 h
R3 C5


System Info Values
system font5
—
—
—









The INS charge status screen display is divided vertically into three lines of information: status line, recharge progress line and recharge efficiency line. Refer to FIG. 19 and FIG. 20.
Therapy On, Therapy Off, Start Charge and Stop Charge are dedicated function keys. When the display is blank and the user presses Therapy On, Therapy Off or Start Charge, software will perform the function and turn the display on. System timeout is <30 seconds.
The INS battery status display has 5 settings: 0%, 25%, 50%, 75% and 100%. During recharge, software will display the appropriate quartiles in solid fill and the next higher quartile in a flashing on/off manner every second. The exception is 100%. Even if the INS battery voltage indicates 100%, software will flash the last quartile until the recharge session is complete.
The INSR charge status screen display is divided vertically into two lines of information: status line and recharge progress line. Refer to FIG. 21, INSR Charge Status Screen, and FIG. 22, Recharging the INSR.
The INSR battery status has 5 settings: 0%, 25%, 50%, 75% and 100%. During recharge, software will display the appropriate quartiles in solid fill and the next higher quartile in a flashing on/off manner every second. The exception is 100%. Even if the INSR battery voltage indicates 100%, software will flash the last quartile until the recharge session is complete.
Recharging events are described in screens, information messages and warnings that are displayed on the recharger as shown in FIG. 23A and FIG. 23B. Operational requirements are described in tables that specify conditions for entry and expected changes in control. Refer to the operational requirements for each screen in this section.
The i symbol will be displayed on all information messages. With the exception of INSR System Information screen, the user can exit the messages by pressing Audio or wait for the system to timeout. Therapy On and Off will always be active when the messages are displayed. When the user presses Therapy On or Off, software will turn stimulation on/off and clear the information message.
The exclamation mark symbol will be displayed on all warnings. All warnings will remain on the display until the user takes appropriate action.
1—Power Down Screen (Blank Display)
Screen Entry: User Control/System Event


    
    
        System timeout from Start Screen—Not Docked
    
    













User Control/



System Event
System Response: Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Start Screen - Not Docked with Therapy



On/Off icon on status line (Table 17-22)



Telemetry event: refer to Table 18


Start Charge
Antenna temperature OK: Wait Screen (Table 17-1)



Antenna too hot: Antenna Too Hot Message (Table 17-30)



Antenna failure: Call Your Doctor Warning (Table 17-18)



Antenna disconnected: Connect INSR Antenna Message (Table



17-14)



INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)


Stop Charge
No change


Audio
Start Screen - Not Docked (Table 17-24, 25)



INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)


Attach DTC
INSR recharge complete: INSR Recharge Complete Message



(Table 17-11)



INSR recharge incomplete: INSR Charge Status Screen (Table



17-7)


Audio + Stop Charge
INSR System Information Message (Table 17-17)


Audio + Start Charge
Antenna temperature OK: Physician Recharge Screen (Table 17-


and hold for >10
21)


seconds
Antenna too hot: Physician Recharge - Antenna Too Hot (Table



17-31)









2—Start Screen—Not Docked

Screen Entry: User Control/System Event

    
    
        Therapy On/Off keys when the recharger is powered down
        Audio key when the recharger is powered down
        Any key from Splash Screen
        Detach DTC
        System timeout or message clear when DTC is detached
        Stop Charge from Physician Recharge Screen or Physician Recharge—Antenna Too Hot Screen
        Host terminates the session, the Reset button is activated or the user presses Audio from IR Communication Screen
    
    













User Control/



System Event
System Response: Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Therapy On/Off icon on status line (Table



17-22)



Telemetry event: refer to Table 18


Start Charge
Antenna temperature OK: Wait Screen (Table 17-1)



Antenna too hot: Antenna Too Hot Message (Table 17-30)



Antenna failure: Call Your Doctor Warning (Table 17-18)



Antenna disconnected: Connect INSR Antenna Message (Table



17-14)



INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)


Stop Charge
No change


Audio
Audio icon (Table 17-24)


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


System error
Call Your Doctor Warning (Table 17-18)


Attach DTC
INSR recharge complete: INSR Recharge Complete Message



(Table 17-11)



INSR recharge incomplete: INSR Charge Status Screen (Table



17-7)


Audio + Stop Charge
INSR System Information Message (Table 17-17)


Audio + Start Charge
Antenna temperature OK: Physician Recharge Screen (Table


and hold for >10
17-21)


seconds
Antenna too hot: Physician Recharge - Antenna Too Hot



(Table 17-31)


System timeout
Power Down Screen









3—Start Screen—Docked

Screen Entry: User Control/System Event

    
    
        System timeout or message clear
        Any key from Splash Screen
        Host terminates the session, the Reset button is activated or the user presses Audio from the Splash Screen
        Stop Charge from Physician Recharge Screen or Physician Recharge—Antenna Too Hot Screen
    
    













User Control/
System Response:


System Event
Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Therapy On/Off icon on status



line (Table 17-22)



Telemetry event: refer to Table 18


Start Charge
Antenna temperature OK: Wait Screen



(Table 17-1)



Antenna too hot: Antenna Too Hot Message



(Table 17-30)



Antenna failure: Call Your Doctor Warning



(Table 17-18)



Antenna disconnected: Connect INSR Antenna



(Table 17-14)


Stop Charge
No change


Audio
Audio icon (Table 17-24)


System error
Call Your Doctor Warning (Table 17-18)


Detach DTC
Start Screen - Not Docked


Audio + Stop Charge
INSR System Information Message (Table 17-17)


Audio + Start Charge
Antenna temperature OK: Physician Recharge


and hold for >10
Screen (Table 17-21)


seconds
Antenna too hot: Physician Recharge - Antenna



Too Hot (Table 17-31)









4—Wait Screen

Screen Entry: User Control/System Event

    
    
        Start Charge
        Antenna temperature OK
        System timeout or message clear
    
    













User Control/



System Event
System Response: Feedback/Next Screen (requirement)







Therapy On/Off
No change


Telemetry success
INS Charge Status Screen or INS Charge Status - 90 to 100%



Screen (Table 17-2)


Telemetry failure or
Reposition Antenna - Press Start Charge Warning (Table 17-12)


poor charging condition


INS error: ERI
Call Your Doctor - ERI Message (Table 17-19)


INS error: POR
Call Your Doctor - POR Message (Table 17-27)


INS error: EOS, battery
Call Your Doctor Warning (Table 17-18)


voltage too high


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


Antenna too hot
INS Charge Status - Antenna Too Hot (Table 17-13)


Antenna failure
Call Your Doctor Warning (Table 17-18)


Antenna disconnected
Connect INSR Antenna Message (Table 17-14)


System error
Call Your Doctor Warning (Table 17-18)


Start Charge
No change


Stop Charge (not
Start Screen - Not Docked


docked)


Stop Charge (docked)
INSR recharge incomplete: INSR Charge Status Screen (Table



17-7)



INSR recharge complete: INSR Recharge Complete Message



(Table 17-11)


Audio
No change


Attach DTC
No change


Detach DTC
No change


Audio + Stop Charge
No change


Audio + Start Charge
No change


and hold for >10


seconds









5—INS Charge Status Screen

Screen Entry: User Control/System Event

    
    
        Telemetry success
        System timeout or message clear
        Antenna temperature OK
    
    













User Control/



System Event
System Response: Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Therapy On/Off icon on status line (Table



17-22)



Telemetry event: refer to Table 18


Start Charge
Antenna temperature OK: refresh recharge efficiency line



(Table 17-26)



Antenna too hot: INS Charge Status - Antenna Too Hot (Table



17-13)


Stop Charge
Charge complete: INS Recharge Complete Message (Table 17-



6)



Charge incomplete and not INS battery low: INS Recharge



Interrupted Message (Table 17-5)



INS battery low: INS Battery Low Message (Table 17-3)



INS battery depleted: Recharge Stimulator Warning (Table 17-



4)


Audio
Toggle Audio icon (Table 17-24)


Attach DTC
Power source symbol on status line (Table 17-23)


Detach DTC
INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)



Status line without power source symbol (Table 17-23)


INS recharge complete
INS Recharge Complete Message (Table 17-6)


INS error: ERI
Call Your Doctor ERI Message (Table 17-19)


INS error: POR
Call Your Doctor - POR Message (Table 17-27)


INS error: EOS, battery
Call Your Doctor Warning (Table 17-18)


voltage too high


Antenna too hot
INS Charge Status - Antenna Too Hot (Table 17-13)


Antenna failure
Call Your Doctor Warning (Table 17-18)


Antenna disconnected
Connect INSR Antenna Message (Table 17-14)


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


INSR recharge
INSR Batt1 on status line (Table 17-25)


complete


System error
Call Your Doctor Warning (Table 17-18)


Audio + Stop Charge
No change


Audio + Start Charge
No change


and hold for >10


seconds









6—INSR Charge Status Screen

Screen Entry: User Control/System Event

    
    
        Attach DTC from Power Down Screen, Start Screen—Not Docked or Recharge INSR Warning
        Attach DTC from INSR Battery Low Message when not charging INS
        System timeout or message clear
    
    













User Control/
System Response:


System Event
Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Therapy On/Off icon on status



line (Table 17-22)



Telemetry event: refer to Table 18


Start Charge
Antenna temperature OK: Wait Screen



(Table 17-1)



Antenna too hot: Antenna Too Hot Message



(Table 17-30)


Audio
Toggle Audio icon (Table 17-24)


Detach DTC
Charge incomplete and not INSR battery low:



INSR Recharge Interrupted Message



(Table 17-10)



INSR battery low: INSR Battery Low Message



(Table 17-8)



INSR battery depleted: Recharge INSR Warning



(Table 17-9)



INSR recharge complete: INSR Recharge



Complete Message (Table 17-11)


INSR recharge
INSR Recharge Complete Message (Table 17-11)


complete


Audio + Start Charge
Antenna temperature OK: Physician Recharge


and hold for >10
Screen (Table 17-21)


seconds
Antenna too hot: Physician Recharge - Antenna



Too Hot (Table 17-31)


System error
Call Your Doctor Warning (Table 17-18)









7—Physician Recharge Screen

Screen Entry: User Control/System Event

    
    
        Audio+Start Charge and hold for >10 seconds
        Antenna temperature OK
        System timeout or message clear
    
    













User Control/
System Response:


System Event*
Feedback/Next Screen (requirement)







Successful
INS Charge Status Screen (Table 17-2)


communication with


INS


Timer goes to zero and
Start Screen - Not Docked without Therapy


system times out (not
On/Off icon on status line (Table 17-22)


docked)


Timer goes to zero and
INSR recharge incomplete: INSR Charge Status


system times out
Screen (Table 17-7)


(docked)
INSR recharge complete: INSR Recharge



Complete Message (Table 17-11)


Stop Charge (not
Start Screen - Not Docked


docked)


Stop Charge (docked)
Start Screen - Docked


Detach DTC
INSR battery low: INSR Battery Low Message



(Table 17-8)



INSR battery depleted: Recharge INSR Warning



(Table 17-9)


Antenna too hot
Physician Recharge - Antenna Too Hot



(Table 17-31)


Antenna failure
Call Your Doctor Warning (Table 17-18)


Antenna disconnected
Connect INSR Antenna Message



(Table 17-14)


System error
Call Your Doctor Warning (Table 17-18)


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


INSR recharge
No change


complete





*Note: all keys inactive except Stop Charge






8—IR Communication Screen

Screen Entry: User Control/System Event

    
    
        Reset button from any screen when DTC is not docked and IR command is received

Processing Requirements

        All keys inactive
        Software will display the screen until the host terminates the session, the Reset button is activated or the Audio key is pressed. (Table 17-28)
        When the host terminates the session or the Reset button is activated, software will display Start Screen—Not Docked.

9—INS Battery Low Message

Screen Entry: User Control/System Event

        Therapy On/Off
    
    













Entry



Screen
User Control/System Event: Next Screen







Power
Audio key or system timeout: Start Screen - Not Docked with


Down
Therapy On/Off icon on status line (Table 17-22)


Start -
Therapy On/Off and telemetry success: Start Screen - Not


Screen
Docked with Therapy On/Off icon on status line (Table 17-


Not
22)


Docked
Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen



(Table 17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: no change


Start
Audio key or system timeout: Start Screen - Docked with


Screen -
Therapy On/Off icon on status line (Table 17-22)


Docked
Therapy On/Off and telemetry success: Start Screen - Docked



with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen



(Table 17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: no change


INSR
Audio key or system timeout: INSR Charge Status Screen


Charge
with Therapy On/Off icon on status line (Table 17-22)


Status
Therapy On/Off and telemetry success: INSR Charge Status



with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen/INS



Charge Status (Table 17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: no change









INS Battery Low Message—continued

Screen Entry: User Control/System Event

    
    
        Stop Charge
    
    













Entry



Screen
User Control/System Event: Next Screen







INS
Audio key or system timeout: Start Screen - Not Docked


Charge
Therapy On/Off and telemetry success: Start Screen - Not


Status
Docked with Therapy On/Off icon on status line (Table 17-22)


(not
Therapy On/Off and telemetry event: Refer to Table 18


docked)
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: no change


INS
Audio key and INSR recharge incomplete: INSR Charge


Charge
Status with Therapy On/Off icon on status line


Status
(Table 17-22)


(docked)
Audio key and INSR recharge complete: INSR Recharge



Complete Message (Table 17-11)



Therapy On/Off and telemetry success and INSR recharge



incomplete: INSR Charge Status with Therapy On/Off icon on



status line (Table 17-22)



Therapy On/Off and telemetry success and INSR recharge



complete: Start Screen - Docked with Therapy On/Off icon on



status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: no change









10—INS Recharge Interrupted Message

Screen Entry: User Control/System Event

    
    
        Stop Charge
    
    













Entry



Screen
User Control/System Event: Next Screen







INS
Audio key or system timeout: Start Screen - Not Docked


Charge
Therapy On/Off and telemetry success: Start Screen - Not


Status
Docked with Therapy On/Off icon on status line (Table 17-22)


(not
Therapy On/Off and telemetry event: Refer to Table 18


docked)
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: no change


INS
Audio key or system timeout and INSR recharge incomplete:


Charge
INSR Charge Status with Therapy On/Off icon on status line


Status
(Table 17-22)


(docked)
Audio key or system timeout and INSR recharge complete:



INSR Recharge Complete Message (Table 17-11)



Therapy On/Off and telemetry success and INSR recharge



incomplete: INSR Charge Status with Therapy On/Off icon on



status line (Table 17-22)



Therapy On/Off and telemetry success and INSR recharge



complete: Start Screen - Docked with Therapy On/Off icon on



status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: no change









11—INS Recharge Complete Message

Screen Entry: User Control/System Event

    
    
        Stop Charge
        INS recharge complete
    
    













Entry Screen
User Control/System Event: Next Screen







INS Charge Status
Audio key or system timeout: Start Screen - Not Docked


(not docked)
Therapy On/Off and telemetry success: Start Screen - Not


INS Charge Status -
Docked with Therapy On/Off icon on status line (Table 17-22)


90 to 100% (not docked)
Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: no change


INS Charge Status
Audio key or system timeout and INSR recharge incomplete:


(docked)
INSR Charge Status


INS Charge Status -
Audio key or system timeout and INSR recharge complete:


90 to 100% (docked)
INSR Recharge Complete Message (Table 17-11)



Therapy On/Off and telemetry success and INSR recharge



incomplete: INSR Charge Status with Therapy On/Off icon on



status line (Table 17-22)



Therapy On/Off and telemetry success and INSR recharge



complete: Start Screen - Docked with Therapy On/Off icon on



status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: no change









12—INSR Battery Low Message

Screen Entry: User Control/System Event

    
    
        Therapy On/Off
    
    













Entry



Screen
User Control/System Event: Next Screen







Power
Audio key or system timeout: Start Screen - Not Docked with


Down
Therapy On/Off icon on status line (Table 17-22)


Start
Therapy On/Off and telemetry success: Start Screen - Not


Screen -
Docked with Therapy On/Off icon on status line (Table 17-22)


Not
Therapy On/Off and telemetry event: Refer to Table 18


Docked
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: INSR Charge Status with Therapy On/Off icon on



status line (Table 17-23)


INS
Audio key or system timeout: previous screen with Therapy


Charge
On/Off icon on status line (Table 17-22)


Status
Therapy On/Off and telemetry success: Wait Screen


INS
Therapy On/Off and telemetry event: Refer to Table 18


Charge
Start Charge and antenna temperature OK: Wait Screen (Table


Status -
17-1)


90 to
Start Charge and antenna too hot: INS Charge Status - Antenna


100%
Too Hot Screen (Table 17-13)



Stop Charge: Start Screen - Not Docked



Attach DTC: previous screen with Therapy On/Off icon and



Power Source Symbol on status line (Table 17-22, 23)









Screen Entry: User Control/System Event

    
    
        Start Charge
    
    













Entry



Screen
User Control/System Event: Next Screen







Power
Audio key or system timeout: Wait Screen/INS Charge Status/


Down
INS Charge Status - 90 to 100%


Start
Therapy On/Off and telemetry success: Wait Screen/INS


Screen -
Charge/INS Charge Status - 90 to 100% Status with Therapy


Not
On/Off icon on status line (Table 17-22)


Docked
Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: Wait Screen/INS Charge Status/INS Charge



Status - 90 to 100%









INSR Battery Low Message—continued

Screen Entry: User Control/System Event

    
    
        Audio
    
    













Entry



Screen
User Control/System Event: Next Screen







Power
Audio key or system timeout: Start Screen - Not Docked


Down
Therapy On/Off and telemetry success: Start Screen - Not



Docked with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Attach DTC: INSR Charge Status









Screen Entry: User Control/System Event

    
    
        INSR battery low condition
    
    













Entry Screen
User Control/System Event: Next Screen







Wait Screen
Audio key or system timeout or Attach DTC: Wait Screen/INS



Charge Status/INS Charge Status - 90 to 100%


Physician Recharge
Audio key or system timeout or Attach DTC: Physician Recharge


Physician Recharge -
Audio key or system timeout or Attach DTC: Physician Recharge -


Antenna Too Hot
Antenna Too Hot


INS Charge Status
Audio key or system timeout or Attach DTC: INS Charge Status


INS Charge Status 90 to
Audio key or system timeout or Attach DTC: INS Charge Status - 90


100%
to 100%


INS Charge Status -
Audio key or system timeout or Attach DTC: INS Charge Status -


Antenna Too Hot
Antenna Too Hot


Start Screen - Not
Audio key or system timeout: Start Screen - Not Docked


Docked
Attach DTC: INSR Charge Status









INSR Battery Low Message—continued

Screen Entry: User Control/System Event

    
    
        Detach DTC
    
    













Entry Screen
User Control/System Event: Next Screen







INS Charge Status
Audio key or system timeout: previous screen


INS Charge Status -
Therapy On/Off and telemetry success: previous screen with


90 to 100%
Therapy On/Off icon on status line (Table 17-22)


INS Charge Status -
Therapy On/Off and telemetry event: Refer to Table 18


Antenna Too Hot
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status - Antenna



Too Hot Screen (Table 17-13)



Stop Charge: Start Screen - Not Docked



Attach DTC: previous screen with power source symbol on status



line (Table 17-23)


INSR Charge Status
Audio key or system timeout: Start Screen - Not Docked



Therapy On/Off and telemetry success: Start Screen - Not



Docked with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach DTC: INSR Charge Status


Physician Recharge
Audio key or system timeout: previous screen


Screen
Therapy On/Off: no change


Physician Recharge -
Start Charge: no change


Antenna Too Hot
Stop Charge: Start Screen - Not Docked



Attach DTC: previous screen









13—INSR Recharge Interrupted Message

Screen Entry: User Control/System Event

    
    
        Detach DTC
    
    













Entry Screen
User Control/System Event: Next Screen







INSR Charge
Audio key or system timeout: Start Screen - Not Docked


Status
Therapy On/Off and telemetry success: Start Screen -



Not Docked with Therapy On/Off icon on status line



(Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen



(Table 17-1)



Start Charge and antenna too hot: Antenna Too Hot



Message (Table 17-30)



Stop Charge: no change



Attach DTC: INSR Charge Status









14—INSR Recharge Complete Message

Screen Entry: User Control/System Event

    
    
        INSR recharge complete
    
    













Entry



Screen
User Control/System Event: Next Screen







INSR
Audio key: Start Screen - Docked


Charge
Therapy On/Off and telemetry success: Start Screen - Docked


Status
with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: Start Screen - Not Docked









Screen Entry: User Control/System Event

    
    
        Attach DTC
    
    













Entry



Screen
User Control/System Event: Next Screen







Power
Audio key: Start Screen - Docked


Down
Therapy On/Off and telemetry success: Start Screen - Docked


Start
with Therapy On/Off icon on status line (Table 17-22)


Screen -
Therapy On/Off and telemetry event: Refer to Table 18


Not
Start Charge and antenna temperature OK: Wait Screen (Table


Docked
17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Detach DTC: Start Screen - Not Docked









15—INSR System Information Message

Screen Entry: User Control/System Event

    
    
        Audio+Stop Charge
    
    













Entry



Screen
User Control/System Event: Next Screen







Power
Audio key: Cycle through information


Down
Stop Charge or System timeout and not docked: Start Screen -


Start
Not Docked


Screen -
Stop Charge or System timeout and docked: Start Screen -


Not
Docked


Docked
Therapy On/Off and telemetry success: Start Screen - Not


Start
Docked with Therapy On/Off icon on status line (Table 17-22)


Screen -
Therapy On/Off and telemetry event: Refer to Table 18


Docked
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Attach/Detach DTC: no change









16—Call Your Doctor—ERI Message

Screen Entry: User Control/System Event

    
    
        Therapy On/Off
    
    













Entry Screen
User Control/System Event: Next Screen







Power Down
Audio key or system timeout: Start Screen - Not Docked with


Start Screen - Not
Therapy On/Off icon on status line (Table 17-22)


Docked
Therapy On/Off and telemetry success: Start Screen - Not



Docked with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge/Attach DTC: no change


INS Charge Status
Audio key or system timeout: previous screen with Therapy


INS Charge Status -
On/Off icon on status line (Table 17-22)


90 to 100%
Therapy On/Off and telemetry success: previous screen with


INS Charge Status -
Therapy On/Off icon on status line (Table 17-22)


Antenna Too Hot
Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status - Antenna



Too Hot Screen (Table 17-13)



Stop Charge and not docked: Start Screen - Not Docked



Stop Charge and docked: Start Screen - Docked



Attach DTC/Detach DTC: no change


INSR Charge Status
Audio key or system timeout: INSR Charge Status Screen with



Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry success: INSR Charge Status



with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge/Detach DTC: no change


Start Screen - Docked
Audio key or system timeout: Start Screen - Docked with



Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry success: Start Screen - Docked



with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge/Detach DTC: no change









Call Your Doctor—ERI continued

Screen Entry: User Control/System Event

    
    
        INS error: ERI
    
    













Entry Screen
User Control/System Event: Next Screen







Wait Screen
Audio key or system timeout: Wait Screen



Therapy On/Off and telemetry success: Wait Screen



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status - Antenna



Too Hot Screen (Table 17-13)



Stop Charge/Attach DTC/Detach DTC: no change


INS Charge Status
Audio key or system timeout: previous screen


INS Charge Status -
Therapy On/Off and telemetry success: previous screen with


90 to 100%
Therapy On/Off icon on status line (Table 17-22)


INS Charge Status -
Therapy On/Off and telemetry event: Refer to Table 18


Antenna Too Hot
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status - Antenna



Too Hot Screen (Table 17-13)



Stop Charge and not docked: Start Screen - Not Docked



Stop Charge and docked: Start Screen - Docked



Attach DTC/Detach DTC: no change









17—Call Your Doctor—POR Message

Screen Entry: User Control/System Event

    
    
        Therapy On/Off
    
    













Entry Screen
User Control/System Event: Next Screen







Power Down
Audio key or system timeout: Start Screen - Not Docked


Start Screen - Not
with Therapy On/Off icon on status line (Table 17-22)


Docked
Therapy On/Off: no change



Start Charge/Stop Charge/Attach DTC/Detach DTC: no



change


INS Charge Status
Audio key or system timeout: previous screen with Therapy


INS Charge Status -
On/Off icon on status line (Table 17-22)


90 to 100%
Therapy On/Off: no change


INS Charge Status -
Stop Charge and not docked: Start Screen - Not Docked


Antenna Too Hot
Stop Charge and docked: Start Screen - Docked



Start Charge/Attach DTC/Detach DTC: no change


INSR Charge Status
Audio key or system timeout: INSR Charge Status Screen



with Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off: no change



Start Charge/Stop Charge/Attach DTC/Detach DTC: no



change


Start Screen - Docked
Audio key or system timeout: Start Screen - Docked with



Therapy On/Off icon on status line (Table 17-22)



Therapy On/Off: no change



Start Charge/Stop Charge/Attach DTC/Detach DTC: no



change









Screen Entry: User Control/System Event

    
    
        INS error: POR
    
    













Entry Screen
User Control/System Event: Next Screen







Wait Screen
Audio key or system timeout: Wait Screen



Therapy On/Off and telemetry success: Wait Screen



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge/Attach DTC/Detach DTC: no change


INS Charge Status
Audio key or system timeout: previous screen


INS Charge Status -
Therapy On/Off and telemetry success: previous screen with


90 to 100% INS
Therapy On/Off icon on status line (Table 17-22)


Charge Status -
Therapy On/Off and telemetry event: Refer to Table 18


Antenna Too Hot
Stop Charge and not docked: Start Screen - Not Docked



Stop Charge and docked: Start Screen - Docked



Start Charge/Attach DTC/Detach DTC: no change









18—Antenna Too Hot Message

Screen Entry: User Control/System Event

    
    
        Start Charge
    
    













Entry Screen
User Control/System Event: Next Screen







Power Down
Audio key or system timeout and not docked and antenna too


Start Screen -
hot: Start Screen - Not Docked


Docked
Audio key or system timeout and docked and antenna too hot:


Start Screen - Not
Start Screen - Docked


Docked
Audio key or system timeout and docked/not docked and


INSR Charge
antenna cools: INS Charge Status/INS Charge Status - 90 to


Status
100%


INS Battery Low
Therapy On/Off and telemetry success and not docked: Start


INS Recharge
Screen - Not Docked with Therapy On/Off icon on status line


Interrupted
(Table 17-22)


INS Recharge
Therapy On/Off and telemetry success and docked: Start


Complete
Screen - Docked with Therapy On/Off icon on status line


INSR Battery Low
(Table 17-22)


INSR Recharge
Therapy On/Off and telemetry event: Refer to Table 18


Interrupted
Start Charge: no change


INSR Recharge
Stop Charge and charge complete: INS Recharge Complete


Complete
Message (Table 17-6)


Call Your Doctor -
Stop Charge and charge incomplete and not INS battery low:


ERI
INS Recharge Interrupted Message (Table 17-5)


Call Your Doctor -
Stop Charge and INS battery low: INS Battery Low Message


POR Reposition
(Table 17-3)


Antenna - Press
Stop Charge and INS battery depleted: Recharge Stimulator


Start Charge
Warning (Table 17-4)


Warning
Attach/detach DTC: no change


Connect INSR


Antenna









19—Warning Messages












Warning
User Control/System Event: Next Screen







Recharge Stimulator
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



System timeout: Power Down


Recharge INSR
Attach DTC: INSR Charge Status Screen with Power Source



Symbol



System timeout: Power Down


Reposition Antenna -
Start Charge and antenna temperature OK: Wait Screen (Table


Press Start Charge
17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



System timeout: Power Down


Reposition Antenna -
Therapy Off and telemetry success: Start Screen - Docked or


Press Therapy Off
Start Screen - Not Docked with Therapy Off icon on status



line (Table 17-22)



Therapy Off and telemetry event: refer to Table 18



System timeout: Power Down


Reposition Antenna -
Therapy On and telemetry success: Start Screen - Docked or


Press Therapy On
Start Screen - Not Docked with Therapy On icon on status



line (Table 17-22)



Therapy On and telemetry event: refer to Table 18



System timeout: Power Down


Call Your Doctor
System timeout: Power Down


Call Your Doctor -
System timeout: Power Down


EOS









20—Splash Screen

Screen Entry: User Control/System Event

    
    
        Application is loading
        Reset button is activated and application is reloading

Processing Requirements

        All keys active
        Software will display the screen until the user presses any key or the system times out.
        When the user presses any key or the system times out, software will display the Start Screen—Docked or Start Screen—Not Docked (Table 17-29)

21—Connect INSR Antenna Message

Screen Entry: User Control/System Event

        Antenna disconnected
    
    














User Control/System Event: Next Screen (assuming antenna


Entry Screen
and recharger are making full contact)







Wait Screen
Audio key or system timeout and not docked: Start Screen -


INS Charge Status
Not Docked


Screen
Audio key or system timeout and docked: Start Screen -


INS Charge Status -
Docked


90 to 100%
Therapy On/Off and telemetry success and not docked: Start



Screen - Not Docked with Therapy On/Off icon on status line



(Table 17-22)



Therapy On/Off and telemetry success and docked: Start



Screen - Docked with Therapy On/Off icon on status line



(Table 17-22)



Therapy On/Off and telemetry event: Refer to Table 18



Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status -



Antenna Too Hot Screen (Table 17-13)



Stop Charge: no change



Attach/detach DTC: no change


Physician Recharge
Audio key or system timeout and not docked: Start Screen -


Screen
Not Docked


Physician Recharge
Audio key or system timeout and docked: Start Screen -


Screen - Antenna
Docked


Too Hot
Therapy On/Off: no change



Start Charge: no change



Stop Charge: no change



Attach/detach DTC: no change









Screen Entry: User Control/System Event

    
    
        Therapy On/Off
        Start Charge
    
    














User Control/System Event: Next Screen (assuming antenna


Entry Screen
and recharger are making full contact)







All screens and
Audio key or system timeout and not docked: Start Screen -


messages with the
Not Docked


exception of
Audio key or system timeout and docked: Start Screen -


Physician Recharge
Docked


Screen, Physician
Therapy On/Off and telemetry success and not docked: Start


Recharge -
Screen - Not Docked with Therapy On/Off icon on status line


Antenna Too Hot
(Table 17-22)


Screen, IR
Therapy On/Off and telemetry success and docked: Start


Communication
Screen - Docked with Therapy On/Off icon on status line


Screen, Splash
(Table 17-22)


Screen and all
Therapy On/Off and telemetry event: Refer to Table 18


reposition antenna
Start Charge and antenna temperature OK: Wait Screen (Table


warnings
17-1)



Start Charge and antenna too hot: Antenna Too Hot Message



(Table 17-30)



Stop Charge: no change



Attach/detach DTC: no change









22—INS Charge Status—90 to 100% Screen

Screen Entry: User Control/System Event

    
    
        System timeout or message clear
        Antenna temperature OK
        Battery voltage indicates 90%
    
    













User Control/



System Event
System Response: Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Therapy On/Off icon on status line (Table



17-22)



Telemetry event: refer to Table 18


Start Charge
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status -



Antenna Too Hot Screen (Table 17-13)


Stop Charge
INS Recharge Complete Message (Table 17-6)


Audio
Toggle Audio icon (Table 17-24)


Attach DTC
Power source symbol on status line (Table 17-23)


Detach DTC
INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)



Status line without power source symbol (Table 17-23)


INS recharge complete
INS Recharge Complete Message (Table 17-6)


INS error: ERI
Call Your Doctor ERI Message (Table 17-19)


INS error: POR
Call Your Doctor - POR Message (Table 17-27)


INS error: EOS, battery
Call Your Doctor Warning (Table 17-18)


voltage too high


Antenna too hot
INS Charge Status - Antenna Too Hot (Table 17-13)


Antenna failure
Call Your Doctor Warning (Table 17-18)


Antenna disconnected
Connect INSR Antenna Message (Table 17-14)


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


INSR recharge
INSR Batt1 on status line (Table 17-25)


complete


System error
Call Your Doctor Warning (Table 17-18)


Audio + Stop Charge
No change


Audio + Start Charge
No change


and hold for >10


seconds









23—INS Charge Status—Antenna Too Hot Screen

Screen Entry: User Control/System Event

    
    
        Antenna too hot
        System timeout or message clear
    
    













User Control/



System Event
System Response: Feedback/Next Screen (requirement)







Therapy On/Off
Telemetry success: Therapy On/Off icon on status line (Table



17-22)



Telemetry event: refer to Table 18


Start Charge
Start Charge and antenna temperature OK: Wait Screen (Table



17-1)



Start Charge and antenna too hot: INS Charge Status -



Antenna Too Hot Screen (Table 17-13)


Stop Charge
Not docked: Start Screen - Not Docked



Docked and INSR recharge complete: INSR Recharge



Complete Message (Table 17-11)



Docked and INSR recharge incomplete: INSR Charge Status



Screen (Table 17-7)


Audio
Toggle Audio icon (Table 17-24)


Attach DTC
Power source symbol on status line (Table 17-23)


Detach DTC
INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)



Status line without power source symbol (Table 17-23)


INS error: ERI
Call Your Doctor ERI Message (Table 17-19)


INS error: POR
Call Your Doctor - POR Message (Table 17-27)


INS error: EOS, battery
Call Your Doctor Warning (Table 17-18)


voltage too high


Antenna too hot
INS Charge Status - Antenna Too Hot (Table 17-13)


Antenna cooled
Wait Screen/INS Charge Status (Table 17-1)


Antenna failure
Call Your Doctor Warning (Table 17-18)


Antenna disconnected
Connect INSR Antenna Message (Table 17-14)


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


INSR recharge
INSR Batt1 on status line (Table 17-25)


complete


System error
Call Your Doctor Warning (Table 17-18)


Audio + Stop Charge
No change


Audio + Start Charge
No change


and hold for >10


seconds









24—Physician Recharge—Antenna Too Hot Screen

Screen Entry: User Control/System Event

    
    
        Antenna too hot
    
    













User Control/



System Event*
System Response: Feedback/Next Screen (requirement)







Successful
INS Charge Status Screen (Table 17-2)


communication with


INS


Timer goes to zero and
Start Screen - Not Docked without Therapy On/Off icon on


system times out (not
status line (Table 17-22)


docked)


Timer goes to zero and
INSR recharge incomplete: INSR Charge Status Screen


system times out
(Table 17-7)


(docked)
INSR recharge complete: INSR Recharge Complete Message



(Table 17-11)


Stop Charge (not
Start Screen - Not Docked


docked)


Stop Charge (docked)
Start Screen - Docked


Detach DTC
INSR battery low: INSR Battery Low Message (Table 17-8)



INSR battery depleted: Recharge INSR Warning (Table 17-9)


Antenna too hot
Physician Mode - Antenna Too Hot (Table 17-31)


Antenna failure
Call Your Doctor Warning (Table 17-18)


Antenna disconnected
Connect INSR Antenna Message (Table 17-14)


System error
Call Your Doctor Warning (Table 17-18)


INSR battery low
INSR Battery Low Message (Table 17-8)


INSR battery depleted
Recharge INSR Warning (Table 17-9)


INSR recharge
No change


complete





*Note: all keys inactive except Stop Charge














TABLE 18







1
When the user presses start charge or the antenna has cooled,



software will display the Wait Screen until successful communication



with the INS is established..


2
Software will display the INS Charge Status Screen as soon as



successful communication with the INS is established.


3
Display INS Battery Low Message


4
Display Recharge Stimulator Warning


5
Display INS Recharge Interrupted Message


6
Display INS Recharge Complete Message


7
Display INSR Charge Status Screen


8
Display INSR Battery Low Message


9
Display Recharge INSR Warning


10
Display INSR Recharge Interrupted Message


11
Display INSR Recharge Complete Message


12
Display Reposition Antenna Press Start Charge Warning


13
Display INS Charge Status - Antenna Too Hot Screen


14
Display Connect INSR Antenna Message


15
Display Reposition Antenna Press Therapy On Warning


16
Display Reposition Antenna Press Therapy Off Warning


17
Display INSR System Information Message


18
Display Call Your Doctor Warning


19
Display Call Your Doctor - ERI Message


20
Entry intentionally left blank to preserve numbering


21
Display Physician Recharge Screen


22
Software will display an indicator for stimulation status (On/Off)



on the status line.


23
Software will display the power source symbol when the desktop



charger is docked.


24
Software will display an indicator for audio control on the status line.


25
Software will display the INSR charge level on the status line.


26
Software will update the recharge efficiency line each time user



presses Start Charge.


27
Display Call Your Doctor - POR Message


28
Display IR Communication Screen


29
Display Splash Screen


30
Display Antenna Too Hot Message


31
Display Physician Recharge - Antenna Too Hot Screen
















TABLE 19







Therapy On/Off Events










System Event
Next Screen (requirement)












1.
Telemetry failure for Therapy On
Reposition Antenna - Press Therapy On




Warning (Table 17-15)


2.
Telemetry failure for Therapy Off
Reposition Antenna - Press Therapy Off




Warning (Table 17-16)


3.
INS battery low
INS Battery Low Message (Table 17-3)


4.
INS battery depleted or in sleep mode
Recharge Stimulator Warning (Table 17-4)


5.
INS error - ERI
Call Your Doctor - ERI Message (Table 17-




19)


6.
INS error - POR
Call Your Doctor - POR Message (Table




17-27)


7.
INS error - EOS or battery voltage too
Call Your Doctor Warning (Table 17-18)



high



8.
INSR battery low
INSR Battery Low Message (Table 17-8)


9.
INSR battery depleted
Recharge INSR Warning (Table 17-9)


10.
Antenna failure
Call Your Doctor Warning (Table 17-18)


11.
Antenna disconnected
Connect INSR Antenna Message (Table 17-




14)


12.
System error
Call Your Doctor Warning (Table 17-18)


13.
Antenna too hot
Display INS Charge Status - Antenna Too




Hot Screen (Table 17-13) or Antenna Too




Hot Message (Table 17-30)









User familiarity with both external programming unit 2 and charging unit 50 is enhanced through the use of common patient controls and/or display icons across both devices. The user is presented with common controls and displays across both platforms.
The primary purpose of external programming unit 2 is to manipulate therapeutic programs such as starting therapy and stopping therapy. The primary purpose of charging unit 50 is to charge or recharge rechargeable power source 24. However, patients may want to control their therapy while charging unit 50 is charging the rechargeable power source 24 of implantable medical device 16. Thus, charging unit 50 is also equipped with controls to start and stop therapy as well as controls to start and stop charging.
External programming unit 2 and charging unit 50 both have similar “Therapy On” controls as illustrated in Table 1 and Table 11, respectively. Similarly, both external programming unit 2 and charging unit 50 also have similar “Therapy Off” controls as illustrated in Table 1 and Table 11, respectively.
To aid in familiarity by the user, both external programming unit 2 and charging unit 50 also have similar or identical icons to display the same or similar messages to the user. Battery charging level icons “INSR Batt 1”, “INSR Batt 2”, “INSR Batt 3”, “INSR Batt 4” and “INSR Batt 5” icons are similar or identical between external programming unit 2 and charging unit 50 as illustrated in Table 1 and Table 11, respectively.
Similarly, the “Call Doctor” icon illustrated in Table 5 with respect to external programming unit 2 is the same as, or very nearly the same as, the “Call Doctor” icon illustrated in Table 15 with respect to charging unit 50.
The “Warnings” icon illustrated in Table 5 with respect to external programming unit 2 is the same as, or very nearly the same as, the “Warnings” icon illustrated in Table 16 with respect to charging unit 50.
“Audio On” and “Audio Off” icons illustrated in Table 6 with respect to external programming unit 2 are the same as, or very nearly the same as, the “Audio On” and “Audio Off” icons illustrated in Table 11 with respect to charging unit 50.
These are examples of controls and icons that are the same, or very similar, between both platforms, the external programming unit 2 and the charging unit 50 to aid in user familiarity.
As noted with respect to FIG. 17 describing the process of charging rechargeable power source 24 using external charging device 48, charging unit 50 receives information via telemetry from implantable medical device 16 during the charging process. External antenna 52 contains both primary coil 54 and external telemetry coil 46 and implantable medical device 16 contains both secondary coil 34 and internal telemetry coil 44. When external antenna 52 is positioned properly at or near the site of implantable medical device 16, primary coil 54 can be inductively coupled to secondary coil 34 to facilitate the charging process. Similarly, external telemetry coil 46 can be coupled with internal telemetry coil 44 to communicate information across cutaneous boundary 38 during the charging process.
Also as noted above, magnetic shield 36 prevent electromagnetic radiation stimulating secondary coil 34 from reaching the interior of housing 32 of implantable medical device. However, external telemetry coil 46 and internal telemetry coil 44 are sized to be larger than magnetic shield 36 allowing electromagnetic communication between external telemetry coil 46 and internal telemetry coil 44.
At step 112 of the charging process illustrated in FIG. 17, a check is made to determine if telemetry between charging unit 50 and implantable medical device 16. Further, the status of charging rechargeable power source 24 is communicated from implantable medical device 16 and displayed by charging unit 50 (step 118). The charging status displayed by charging unit 50 can be the actual known charging status of rechargeable power source 24 as communicated from implantable medical device 16 to charging unit 50. This prevents essentially guessing the internal charging status of rechargeable power source 24 by some external means such as simply by the passage of time. Rather, the actual charging status of rechargeable power source 24, e.g., the battery voltage, can be measured and transmitted to charging unit 50 for display to the user.
Typically, inductive charging and telemetry operations are time division multiplexed during the charging operation. That is, a portion of the time during which charging occurs is dedicated to telemetry. During this dedicated telemetry time, the inductive charging by primary coil 54 to secondary coil 34 is momentarily stopped and telemetry allowed to occur. As soon as telemetry has occurred and the required information has been communicated, inductive coupling can be resumed. Typically, only a relatively small portion of the time period during charging is required to be devoted to telemetry. Inductive charging can be stopped only for a short, e.g., a few seconds, to allow for telemetry and then inductive charging can be resumed. Although the time division multiplexing occurs over the entire charging period, only a small portion of the charging time is lost to telemetry. Time division multiplexing of inductive coupling charging and telemetry prevents the possibility of inductive charging from interfering with telemetry signals.
Thus, embodiments of the user interface for external charger for implantable medical device are disclosed. One skilled in the art will appreciate that the present invention can be practiced with embodiments other than those disclosed. The disclosed embodiments are presented for purposes of illustration and not limitation, and the present invention is limited only by the claims that follow.

## Claims

1. An implantable medical device system, comprising:
an implantable medical device for providing a therapeutic output to a patient, said implantable medical device being configured to inductively couple energy with a secondary coil and configured to be transcutaneously controlled using telemetry; and
an external antenna having a primary coil configured to inductively transfer energy to said secondary coil of said implantable medical device when said external antenna is externally placed in proximity of said secondary coil;
an external unit configured to be operatively coupled to said external antenna to inductively transfer energy to said implantable medical device;
said external unit being configured to communicate with said implantable medical device by way of telemetry in order to at least partially control said therapeutic output of said implantable medical device during the process of transferring energy to said implantable medical device using said primary coil of said antenna;
wherein said external unit is configured to time division multiplex between said telemetry and said process of transferring energy.

2. The implantable medical device system as in claim 1 wherein said external unit comprises circuitry and wherein said circuitry of said external unit drives said external antenna to inductively transfer energy to said implantable medical device.

3. The implantable medical device system as in claim 1 wherein said external unit is configured to be attachable to said external antenna.

4. The system as in claim 1 wherein said external unit can control said implantable medical device to turn said therapeutic output on and off.

5. The system as in claim 1 wherein said implantable medical device has a rechargeable energy storage device and wherein said external unit charges said rechargeable energy storage device.

6. The system as in claim 1 wherein said external antenna comprises a temperature sensor operatively coupled to said external unit and wherein said external unit is configured to monitor a surface temperature of said external antenna.

7. The system as in claim 1 wherein said external unit comprises a display configured to display information regarding said system.

8. The system as in claim 7 wherein said display comprises a color display and wherein said information is displayed in a plurality of colors.

9. The system as in claim 8 wherein said plurality of colors comprises differing shades of gray.

10. The system as in claim 1 wherein said external unit comprises a rechargeable power source operatively coupled to said circuitry of said external unit.

11. The system as in claim 1 wherein said external unit is configured to be operated with said external unit lacking a screen and input buttons.

12. The system as in claim 1 wherein said external unit is configured to be operated without an internal power source.

13. The system as in claim 1 wherein said external unit is configured to be operated with said external unit lacking a screen and input buttons and without an internal power source.

14. An external energy transfer system configured to transcutaneously transfer energy to an implantable medical device for providing a therapeutic output to a patient, said implantable medical device capable of receiving inductively coupled energy with a secondary coil and being capable of being transcutaneously controlled using telemetry, comprising:
an external antenna having a primary coil configured to inductively transfer energy to said secondary coil of said implantable medical device when said external antenna is externally placed in proximity of said secondary coil; and
an external unit configured to be operatively coupled to said external antenna driving said primary coil to inductively transfer energy to said implantable medical device;
said external unit being configured to communicate with said implantable medical device by way of telemetry in order to at least partially control said therapeutic output of said implantable medical device during the process of transferring energy to said implantable medical device using said primary coil of said antenna;
wherein said external unit is configured to time division multiplex between said telemetry and said process of transferring energy.

15. The external energy transfer system as in claim 14 wherein said external unit comprises circuitry and wherein said circuitry of said external unit drives said external antenna to inductively transfer energy to said implantable medical device.

16. The external energy transfer system as in claim 14 wherein said external unit is configured to be attachable to said external antenna.

17. The external energy transfer system as in claim 14 wherein said external unit can control said implantable medical device to turn said therapeutic output on and off.

18. The external energy transfer system as in claim 14 wherein said implantable medical device has a rechargeable energy storage device and wherein said external unit charges said rechargeable energy storage device.

19. The external energy transfer system as in claim 14 wherein said external antenna comprises a temperature sensor operatively coupled to said external unit and wherein said external unit is configured to monitor a surface temperature of said external antenna.

20. The external energy transfer system as in claim 14 wherein said external unit comprises a display configured to display information regarding said system.

21. The external energy transfer system as in claim 20 wherein said display comprises a color display and wherein said information is displayed in a plurality of colors.

22. The external energy transfer system as in claim 21 wherein said plurality of colors comprises differing shades of gray.

23. The external energy transfer system as in claim 14 wherein said external unit comprises a rechargeable power source operatively coupled to said circuitry of said external unit.

24. The external energy transfer system as in claim 14 wherein said external unit is configured to be operated with said external unit lacking a screen and input buttons.

25. The external energy transfer system as in claim 14 wherein said external unit is configured to be operated without an internal power source.

26. The external energy transfer system as in claim 14 wherein said external unit is configured to be operated with said external unit lacking a screen and input buttons and without an internal power source.

27. A method of controlling an implantable medical device for providing a therapeutic output, said implantable medical device capable of receiving inductively coupled energy with a secondary coil and being capable of being transcutaneously controlled using telemetry, comprising the steps of:
inductively transferring energy to said secondary coil with an external antenna having a primary coil when said external antenna is externally placed in proximity of said secondary coil;
driving said primary coil with an external unit operatively coupled to said external antenna to inductively transfer energy to said implantable medical device; and
communicating between said external unit and said implantable medical device through telemetry in order to at least partially control said therapeutic output of said implantable medical device;
wherein time division multiplexing occurs between said telemetry and said inductively transferring energy.

28. The method as in claim 27 wherein said driving step further comprises driving said external antenna with circuitry of said external unit to inductively transfer energy to said implantable medical device.

29. The method as in claim 27 wherein said external unit is configured to be attachable to said external antenna.

30. The method as in claim 27 wherein said communicating step is operable to turn said therapeutic output on and off.

31. The method as in claim 27 wherein said implantable medical device has a rechargeable energy storage device and wherein said external unit charges said rechargeable energy storage device.

32. The method as in claim 27 further comprising the step of monitoring a surface temperature of said external antenna with a temperature sensor.

33. The method as in claim 27 further comprising the step of displaying information regarding said system using a display.

34. The method as in claim 33 wherein said display comprises a color display and wherein said displaying step displays said information in a plurality of colors.

35. The method as in claim 34 wherein said plurality of colors comprises differing shades of gray.

36. The method as in claim 27 wherein said external unit comprises a rechargeable power source operatively coupled to said circuitry of said external unit.

37. The method as in claim 27 wherein said external unit is configured to be operated with said external unit lacking a screen and input buttons.

38. The method as in claim 27 wherein said external unit is configured to be operated without an internal power source.

39. The method as in claim 27 wherein said external unit is configured to be operated with said external unit lacking a screen and input buttons and without an internal power source.

40. The implantable medical device as in claim 3 wherein said external unit is configured to be attachable to said external antenna by a cord.

41. The implantable medical device as in claim 1 wherein said external unit further comprises a telemetry coil and wherein said external unit is configured to communicate with said implantable medical device through said telemetry coil.

42. The implantable medical device as in claim 1 wherein said external unit utilizes time division multiplexing to communicate with said implantable medical device in order to at least partially control said therapeutic output of said implantable medical device while transferring energy to said implantable medical device.

43. The energy transfer system as in claim 16 wherein said external unit is configured to be attachable to said external antenna by a cord.

44. The energy transfer system as in claim 14 wherein said external unit further comprises a telemetry coil and wherein said external unit is configured to communicate with said implantable medical device through said telemetry coil.

45. The energy transfer system as in claim 14 wherein said external unit utilizes time division multiplexing to communicate with said implantable medical device in order to at least partially control said therapeutic output of said implantable medical device while transferring energy to said implantable medical device.

46. The method as in claim 29 wherein said external unit is configured to be attachable to said external antenna by a cord.

47. The method as in claim 27 wherein said external unit further comprises a telemetry coil and wherein communicating between said external unit and said implantable medical device comprises communicating during said inductively transferring step, between said telemetry coil of said external unit and said implantable medical device.

48. The method as in claim 27 wherein said communicating step is accomplished, at least in part, utilizing time division multiplexing.