User interface and method for control of medical instruments, such as dialysis machines

• US 5,788,851 A
• Filed: 02/14/1997
• Issued: 08/04/1998
• Est. Priority Date: 02/13/1995
• Status: Expired due to Term

• Current Assignee: Baxter Healthcare SA (Baxter International Inc.), Baxter International Inc.
• Original Assignee: Aksys Ltd.
• Inventors: Treu, Dennis M., Barrett, Shawn O., Kenley, Rodney S., Brose, Tom L., Peter, Frederick H. Jr., Wiklund, Michael Edward, Dolan, William R., Gebhardt, Andrew, Plummer, Lori A., Wilkerson, Douglas L., Matthews, Dawn, Sage, Russel L., DeJesus, Joel
• Primary Examiner(s): Drodge, Joseph W.
• Application Number:
  US08/800,405
• Time in Patent Office: 536 Days
• Field of Search: 210/143, 210/321.71, 210/646, 210/647, 210/929, 210/739, 604/4-6, 248/917, 248/919-923, 345/173, 345/904, 345/905, 361/681, 361/682, 361/364, 364/188, 395/140, 395/326
• US Class Current: 210/739
• CPC Class Codes: A61M 1/14 Dialysis systems; Artificial kidneys; Blood oxygenators semi-permeable membranes characterised by the material, manufacturing processes therefor B01D71/00 ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
• CPC Class Codes: A61M 2205/17 with redundant control systems
• CPC Class Codes: A61M 2205/502 User interfaces, e.g. screens or keyboards
• CPC Class Codes: A61M 2205/505 Touch-screens; Virtual keyboard or keypads; Virtual buttons; Soft keys; Mouse touches
• CPC Class Codes: A61M 2205/52 with memories providing a history of measured variating parameters of apparatus or patient
• CPC Class Codes: G16H 20/40 relating to mechanical, radiation or invasive therapies, e.g. surgery, laser therapy, dialysis or acupuncture
• CPC Class Codes: G16H 40/63 for local operation
• CPC Class Codes: Y10S 248/919 Adjustably orientable video screen support

Abstract

A user interface for a medical instrument such as a dialysis machine is described which uses both a touch screen and at least one hard key off of the touch screen to effectuate a change in a parameter associated with the operation of the machine or the treatment session. The user interface is connected to a central computer control system having a host microprocessor and a backup safety microprocessor. The hard key is directly wired to the safety microprocessor. After the user selects a new parametric value on the touch screen, the user presses a hard key. The host and safety microprocessors implement a verification routine to insure that the entered parameter is appropriate for the patient'"'"'s treatment and the display on the touch screen. If the verification procedure ends in a positive result, the user is prompted to presses a second hard key to confirm the change, causing an additional verification check to be performed. If the additional verification check is successful, the parametric value is entered into a memory (such as a hard disk) storing instructions for operation of the medical instrument.

Claims

1. A system for controlling the operation of a dialysis machine, comprising, in combination:

a) a user interface comprising;

1) a touch screen displaying messages and information as to said machine to a user and permitting said user to touch said touch screen to select at least one parametric value pertinent to operation of said machine or pertinent to a treatment by said machine, and

2) at least one hard key off of said touch screen, said touch screen operable for prompting said user to press said hard key to signify that the selection of said at least one parametric value by said user has been completed;

b) a control system within said machine for controlling operation of said machine and responsive to said touch screen and said at least one hard key, said control system comprising a host processing unit and a safety processing unit, said host processing unit and said safety processing unit operatively connected to said hard key and to each other so as to respond to a pressing of said hard key and to enable an exchange of information related to said at least one selected parametric value,

c) wherein said pressing of said hard key causes said host and safety processing units to undergo a verification routine whereby information as to said selected parametric value is passed from said host processing unit to said safety processing unit said safety processing unit checking said selected parametric value to confirm that said parametric value meets validation or safety criteria for a patient connected to said machine so as to prevent changes to said parametric value potentially harmful to said patient.

2. The system of claim 1, wherein said hard key is directly wired to said safety microprocessor so as to permit said safety microprocessor to reliably respond to a pressing of said hard key.

3. The system of claim 1, wherein said said at least one hard key comprises first, second and third hard keys, said first hard key associated with an emergency stop function for said machine, said second hard key associated with an entry function for entering said selected at least one parametric value, and said third hard key associated with a confirmation function for confirming that the at least one entered parametric value is intended by said user of said machine, said touch screen prompting said user to touch either said second hard key or said third hard key after said user has touched said touch screen to select said at least one parametric value.

4. The system of claim 1, wherein said at least one hard key comprises first and second hard keys, said first hard key having a first color and said second hard key having a second color distinctly different from said first color, said control system performing said verification routine upon the pressing one of said first or second hard keys.

5. The system of claim 4, wherein said user interface further comprises a third hard key having a third color, wherein said first color comprises red, and said third color comprises green.

6. The system of claim 1, wherein said at least one hard key comprises first, second and third hard keys, each of said first, second and third hard keys hard wired to said safety microprocessor, said control system performing said verification routine upon the pressing one of said first, second or third hard keys.

7. The system of claim 1, wherein said at least one hard key comprises a first hard key and a second hard key, and wherein said user presses a second hard key to confirm that said selected at least one parametric value is intended by said user.

8. A method of changing a parametric value pertinent to operation of a dialysis machine, said machine having a user interface comprising a touch screen, a first hard key and a second hard key, and a control system responsive to said first and second hard keys comprising a host processing unit and a safety processing unit, said host and safety processing units each having a first memory and a second memory storing machine operation instructions, the method comprising the steps of:

a) displaying on said touch screen a display permitting a user to touch said touch screen to select a parametric value associated with a parameter pertinent to operation of said machine or pertinent to a dialysis treatment conducted by said machine;

b) pressing said first hard key to enter said selected parametric value, said control system responsively storing said selected parametric value in said first memory associated with said host processing unit;

c) in response to pressing said first hard key, transmitting data associated with said parametric value and said parameter from said host processing unit to said safety processing unit and implementing a verification routine in said safety processing unit, wherein said parametric value is checked to confirm that said parametric value meets validation or safety criteria for a patient connected to said machine so as to prevent changes to said parametric value potentially harmful to said patient;

d) if said verification routine indicates that said parametric value meets said validation or safety criteria, prompting said user to press said second hard key to confirm the change selected in step a) and responsively pressing said second hard key and storing said data associated with said parametric value in said first memory associated with said safety processing unit;

e) storing in said second memory associated with said host and safety processing units said data associated with said parametric value; and

f) checking, with said host and safety processing units, the contents of their respective first and second memories against each other to insure that said data associated with said parametric value stored in their respective first and second memories is the same.

9. The method of claim 8, wherein said second memory associated with said host processing unit comprises a hard disk storing a prescription for said patient connected to said machine.

10. The method of claim 8, wherein said first and second hard keys are directly connected to said safety processing unit.

11. A method of changing a parametric value pertinent to operation of a dialysis machine, said machine having a user interface comprising a touch screen, a first hard key and a second hard key, and a control system responsive to said first and second hard keys comprising a host processing unit and a safety processing unit, said host and safety processing units each having a first memory and a second memory storing machine operation instructions, the method comprising the steps of:

displaying on said touch screen a display permitting a user to touch said touch screen to select a parametric value associated with a parameter pertinent to operation of said machine or pertinent to a dialysis treatment conducted by said machine,

pressing said first hard key to enter said selected parametric value, said control system responsively storing said selected parametric value in said first memory associated with said host processing unit;

in response to pressing said first hard key, transmitting data associated with said parametric value and said parameter from said host processing unit to said safety processing unit and implementing a verification routine in said safety processing unit, wherein said parametric value is checked to confirm that said parametric value meets validation or safety criteria for a patient connected to said machine so as to prevent changes to said parametric value potentially harmful to said patient;

if said verification routine indicates that said parametric value meets said validation or safety criteria, prompting said user to press said second hard key to confirm the change selected in step a) and responsively pressing said second hard key and storing said data associated with said parametric value in said first memory associated with said safety processing unit;

storing in said second memory associated with said host and safety processing units said data associated with said parametric value; and

checking with said host and safety processing units, the contents of their respective first and second memories against each other to insure that said data associated with said parametric value stored in their respective first and second memories is the same,

wherein said verification routine comprises the steps of;

calculating with said host processing unit a first cyclical redundancy check value associated with said selected parametric value;

transmitting from said host processing unit to said safety processing unit, in addition to said parametric value, said first cyclical redundancy check value, a first identifier associated with a screen displayed by said touch screen during said step of selection of said parametric value, and a second identifier associated with said parameter;

calculating with said safety processing unit a second cyclical redundancy check value associated with said data;

(1) verifying with said safety processing unit from said first and second identifiers that said touch screen could display said screen given the current state of said machine and that said parameter may be changed on said screen;

(2) verifying with said safety processing unit that said parametric value associated with said data is within a predetermined range associated with said parameter, and

(3) verifying with said safety processing unit that said second cyclical redundancy check matches said first cyclical redundancy check; and

, in the event that each of said verification steps (1), (2) and (3) results in a positive result, transmitting an approval signal from said safety processing unit to said host processing unit indicating that said positive result was achieved.

12. An improved user interface and screen display apparatus for a dialysis machine that promotes ease of use of said user interface by a user operating said machine without immediate supervision by trained professional medical personnel, comprising:

a) a touch screen;

b) a screen display for said touch screen, said screen display arranged in at least two portions extending across said display, said at least two portions comprising;

1) a first portion displaying instruction and status information to a user of said machine; and

2) a second portion adjacent to said first portion on said display and displaying a plurality of icons, each of said icons associated with specific functional attributes of either said machine or a treatment session of said machine;

c) at least one hard key associated with said display, said first portion of said screen display operable for prompting said user to press said at least one hard key in a process of entering or confirming entry of information into said machine; and

d) a host processing unit and a safety processing unit, said host and safety processing units in communication with each other and both responsive to pressing of said at least one hard key, said pressing of said at least one hard key causing said host and safety processing units to perform a verification routine to confirm that changes to machine operation or treatment parameters meet safety or validation criteria for a patient connected to said machine.

13. The apparatus of claim 12, wherein at least one of said icons is selected from the group of icons consisting of a treatment icon, a schedule icon, a prescription icon, and a setup and care icon.

14. The apparatus of claim 12, wherein said machine is coupled to a transmission medium allowing said machine to receive messages from a source remotely of said machine, and wherein said first and second portions are arranged above each other and extend across the width of said display, and wherein said screen display further comprises a third portion adjacent to said first and second portions, and wherein said third portion of said screen display displays a plurality of icons, at least one of said icons associated with a message transmission or receiving function for said dialysis machine and indicating whether said machine has received a message from said remote source.

15. An ergonomically efficient and easy to use human interface for a dialysis machine, said dialysis machine having an enclosure containing hydraulic circuitry for said machine comprising:

an arm having a proximal end connected to said machine and a free distal end portion;

a display assembly connected to said free distal end portion of said arm, said display comprising a touch screen said display assembly further comprising three hard keys positioned adjacent to said touch screen each hard key having a distinctly different appearance from the other of said hard keys and each hard key associated with a different function with respect to machine operation or the entry of parametric value information into said machine, and

a control system for said instrument requiring a touching of both said touch screen and a pressing of at least one of said hard keys in order to effectuate a change in said parametric value information;

wherein said proximal end of said arm is mounted to said machine in a manner permitting said arm to rotate about a vertical axis relative to said machine to thereby position said display assembly at the distal portion thereof in a multitude or different positions relative to said machine; and

wherein said display assembly is connected to said free distal end portion of said arm by first and second hinges permitting a user of said machine to rotate said display assembly about two different axes relative to said arm.

16. The user interface of claim 15, further comprising a handle portion below said touch screen comprising a lower lip enabling a user to grasp said user interface housing and a front surface extending across a portion of the width of said housing, said lower lip and said front surface enabling a user to manually manipulate said user interface housing in a manner to cause rotation of said user interface about said at least one axis relative to said machine and said at least one axis relative to said arm.

17. An ergonomically efficient and easy to use human interface for a medical instrument especially suited for use by a user other than trained professional medical personnel, comprising:

a) a display assembly comprising a housing having a front surface;

b) a touch screen incorporated into said front surface of said display assembly said touch screen displaying information as to machine operation parameters;

c) first, second and third hard keys incorporated into said front surface of said display assembly and placed adjacent to said touch screen, said touch screen operable for displaying a message prompting said user to press both said touch screen and at least one of said first, second and third hard keys during operation of said human interface of said medical instrument to change a parameter pertinent to said instrument or pertinent to a treatment performed by said instrument on said patient;

d) wherein each of said first second and third hard keys presents a substantially different visual appearance to a user so as to readily permit said user to associate each of said plurality of hard keys with a different functional attribute associated with said operation of said human interface; and

d) a control system for said instrument requiring a touching of both said touch screen and a pressing of at least one of said hard keys in order to effectuate said change in said parameter.

18. The user interface of claim 17, wherein each of said first, second and third hard keys are provided with a distinctly different color.

19. The user interface of claim 18, wherein at least one of said hard keys has a distinctly different shape from the other two of said hard keys.

20. The user interface of claim 18, wherein said first hard key has a red color and associated with a emergency stop function, said second hard key has a blue color and is associated with an entry function, and said third hard key has a green color and is associated with a confirmation function, said first, second and third hard keys located adjacent said touch screen on said front surface of said display assembly.

21. The user interface of claim 18, wherein said display assembly is mounted to a free end of an arm connected to said medical instrument, with said arm rotatable relative to said medical instrument about a vertical axis and with said display assembly comprising first and second hinges to as to permit said display assembly to be rotatable relative to said free end of said arm about a horizontal axis and a vertical axis.