Patient monitor and support system

A system for monitoring the health and medical requirements of a plurality of patients located at remote sites and providing these requirements to a care center. At the patient site, there is a base unit, which can be connected to a number of sensors and/or recorders with sensors. The sensors are for monitoring the patient's medical state and the recorders are for recording the medical data. The base unit stores the data and transfers the data to a care center, where the data is stored and analyzed. The care center may likewise communicate with the base unit and may reconfigure the base unit based on the data analyzed. The data retrieved from the base units is accessible on a local area network and care providers of the patients may monitor their patients by accessing the local area network.

MICROFICHE APPENDIX 
A microfiche appendix containing computer source code is attached. The 
microfiche appendix comprises 13 sheets of microfiche having 684 frames, 
including one title frame. This microfiche appendix contains material 
which is subject to copyright protection. The copyright owner has no 
objection to the reproduction of such material, as it appears in the files 
of the Patent and Trademark Office, but otherwise reserves all copyright 
rights whatsoever. 
BACKGROUND OF THE INVENTION 
1. Field of the Invention 
The present invention relates generally to medical electronics and, more 
specifically, to a system for monitoring the medical status of patients at 
home from a care center. 
2. Description of the Related Technology 
Modern medical technology is used to monitor a variety of medical 
conditions, medical risks and disease states such as high blood pressure 
(hypertension), at-risk pregnancies, AIDS, cancer and kidney failure. 
Patients having such medical conditions are often required to make 
frequent visits to physicians' offices or medical institutions. Moreover, 
patients having chronic conditions often are institutionalized in a 
hospital, convalescent home or the like. The cost of providing medical 
care to patients using conventional methods can be unimaginably expensive. 
This has been due largely to the low ratio of patient to medical care 
personnel required under the existing medical care infrastructure. 
Patients who are unable to gain access to hospitals or are not inclined to 
be treated in medical institutions are generally unable to effectively and 
adequately monitor their own medical condition or treatment. Field nurses 
assigned to monitor these patients may spend many hours traveling from 
each patient site, significantly reducing their productivity. Moreover, 
patients may not be able to gain access to trained medical staff who can 
continuously monitor their treatment or medical conditions either due to 
distance, lack of available funds or lack of trained personnel. 
Furthermore, patients who attempt to monitor their own medical conditions 
may actually complicate their conditions through lack of training or the 
absence of proper medical equipment programmed to assist them in 
monitoring and supporting their conditions and medical treatment. For 
instance, the monitoring of certain medical conditions, like blood 
pressure, may be required of a patient who has selected home care. 
In the past, such information would either be recorded manually by the 
patient, or stored in a device. However, such information may not be 
conveyed in a timely manner to a health care provider such as a doctor or 
nurse. Alternative, such information may not be conveyed to a health care 
provider at all, due to negligence or miscommunications. Patients who have 
difficulty in using the equipment may require the attention of a field 
nurse. Monitoring patients from home to home drastically decreases the 
productivity of such medical personnel. 
At present, there are few provisions for a centrally stored medical data. 
There is also no easy access to such medical information. The lack of such 
pooled medical data is a significant loss to researchers, and the 
gathering of such medical data is both time consuming and expensive. Since 
it may take a significant amount of time to gather information, it will 
take an even longer period of time to develop treatment of medical 
conditions. 
Consequently, a need arises for providing quality medical care to a 
plurality of patients through more cost effective means. There also exists 
a need to increase the productivity of medical and paramedical personnel 
such that more patients per medical care infrastructure unit can be 
treated without jeopardy or degradation of the quality of care. There is 
the additional need of providing a central source of medical data, 
including patient information, so as to facilitate medical research. 
Finally, there is the need to provide quality medical care to patients 
who, due to the remote sites they are located in or, physical disabilities 
or inconveniences, are unable to make the required and/or frequent visits 
to their physicians or health care institutions to monitor their medical 
conditions or disease states. 
SUMMARY OF THE INVENTION 
The present invention satisfies these needs by providing adequate care in 
the home while maintaining low cost through use of a patient monitor and 
support system. It also provides increased productivity of medical and 
paramedical personnel by providing monitoring of a plurality of patients 
by a care center without jeopardy or degradation of the quality of care. 
The present invention also provides a central source of medical data, 
including patient information, so as to facilitate medical research. 
Finally, the present invention provides quality medical care to patients 
who, due to the remote sites they are located in or, physical disabilities 
or inconveniences, are unable to make the required and/or frequent visits 
to their physicians or health care institutions to monitor their medical 
conditions or disease states. 
The present invention is a system for monitoring the health and medical 
requirements of a plurality of patients suffering from a variety of 
medical conditions, risks or disease states from a remote location. 
The system comprises a sensor for monitoring the patient's medical state, 
the sensor generating a parameter indicative of the patient's medical 
state; a data base located at a remote location from the sensor for 
storing the patient's medical state; a means for communicating the 
parameter to the data base; a means for retrieving the parameter from the 
data base; and a means for providing medical procedure to the patient in 
response to the retrieved parameter.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS 
The description of the presently preferred patient monitor and support 
system is presented in the following sections: I. System Overview; II. 
Structure and Operation of the Remote Base Units; III. Functional Modules 
Used in Monitoring of At-Risk Pregnancy; IV. Functional Modules Used in 
Monitoring of Other Disease States; V. System Process Flow; VI. Process 
Flow for Monitoring At-Risk Pregnancy; VII. Data Flow between the Remote 
Base Unit and the Care Center; VIII. Data Flow between the Remote Base 
Unit and the Recorders; IX. Human Interface Process Flow; and X. Exemplary 
Demonstration Sequence. 
I. System Overview 
FIG. 1 depicts a site block diagram wherein a patient monitor and support 
system 50 of the present invention is configured. The patient monitor and 
support system 50 includes a number of patient sites 100 a, 100 b, 100c 
the total number indicated by L), which are individually connected via a 
set of communications links 500a, 500b, 500c to a care center 600. 
A subsystem at each of the patient sites 100 has control and data 
acquisition capabilities and may be configured to automatically transfer 
patient communications and data to the care center 600 and to receive 
nursing communications, instructions and prompts from the care center 600. 
The care center 600 comprises a plurality of support workstations 650a, 
650b and 650c (the total number indicated by M) and a Central Database on 
a database computer 660. In the present preferred embodiment, the 
workstations 650 is an IBM compatible personal computer using one of the 
80.times.86 family of microprocessors. 
In the present embodiment, each patient site 100 communicates with one of 
the workstations 650 over a communications link 500. The communications 
link 500 may be any communications system such as a radio communications 
link, a modem/telephone line link, a fiber optic link or any other 
communications link. In the present embodiment, a dial-up or leased 
telephone line switched across the public telephone network is used and 
communications is established via a modem at the patient site 100 and the 
care center 600. The patients at sites 100 may also communicate by voice 
with the workstation 650. 
The data received by the workstation 650 is ultimately stored in the 
patient database computer 660. The care center 600 is typically connected 
to the facility's existing Local Area Network ("LAN") 700. Thus, the 
information collected by the care center 600 is accessible from any 
computer on the LAN 700 and may be assimilated by existing database 
management software. In this configuration, the primary care physician 
sites 710a, 710b, 710c (the total number indicated by N) can access 
information collected on each patient monitored by the care center 600 via 
communications link 525. In addition, the primary care physicians at sites 
710 may communicate by voice with the staff monitoring the care center 600 
and with the patients at the sites 100. 
The care center 600 is staffed by a medical team comprising a case nurse, a 
field nurse, a pharmacist, a therapist and a nutritionist. Additional 
medical personnel is added as required. The care center 600 also has the 
ability to download settings and instructions to the subsystem located at 
each patient site 100. The subsystem may also be configured to alert the 
patient when it is time to take measurements and/or medication. It will 
also prompt the patient and guide them through the procedure through 
visual displays. 
II. Structure and Operation of the Remote Base Units 
The subsystem located at each patient site 100 is controlled by a base unit 
150 as shown in FIG. 2. The base unit 150 is a self-contained system 
configured to monitor and support a specific disease state or medical 
condition. 
FIG. 2 is a block diagram of a preferred embodiment of the patient 
monitoring and support system 50 of FIG. 1 configured to monitor at-risk 
pregnancy. As illustrated in FIG. 2, the base unit 150 is connected to a 
set of modules 110 which provide measurements of a patient's medical 
status. The base unit 150 is also connected via the communications link 
500 to the care center 600. As previously described, the communications 
link 500 may comprise any communications system such as a radio 
communications link, a modem/telephone line link, a fiber optic link or 
any other communications link. In the present embodiment, a dial-up or 
leased telephone line is used and communications is established via a 
modem 670 at the care center 600. 
Two types of functional modules 110 may be connected to the base unit 150: 
sensors 120, which are directly connected to the base unit 150, and 
recorders 160, which receive inputs from sensors 120, record the sensor 
information, and transmit the recorded data to the base unit 150. The 
recorders 160 are completely portable and may be used remotely by the 
patient. The recorders 160 must, however, be periodically docked in the 
base unit 150 so as to upload or download data or instructions and to 
charge its batteries. 
In one of the presently preferred embodiments, the base unit 150 may be 
provided with three recorders 160 for monitoring and supporting the 
treatment of at-risk pregnancy. A combined fetal heart rate/uterine 
activity recorder 210, a blood pressure recorder 220 and a urinalysis 
recorder 230 provide measurements of fetal heart rate and uterine 
activity, blood pressure and urinalysis test data respectively to the base 
unit 150. 
The sensors associated with the recorders 160 are as follows. An ultrasound 
transducer 212 provides the means for monitoring the fetal heart rate and 
provides signals indicative of the fetal heart rate, to the fetal heart 
rate/uterine activity recorder 210. Likewise, a tokodynamometer 214 
provides the means for monitoring uterine activity and provides signals 
indicative of uterine activity to the fetal heart rate/uterine activity 
recorder 210. Similarly, a blood pressure cuff 222 provides the means for 
monitoring blood pressure and provides signals indicative of the blood 
pressure of a patient to the blood pressure recorder 220. Reagent strips 
232 provided to the urinalysis recorder 230 provide the required 
urinalysis test data. 
In the illustrated embodiment, five types of sensors 120 may be directly 
connected to the base unit 150. These sensors 120 are: weight scale 122, a 
temperature probe 124, an event switch 126, an infusion pump 128 and a 
glucometer 130. The weight scale 122 provides a signal indicative of the 
patient's weight to the base unit 150; the temperature probe 124 provides 
a signal indicate of the patient's temperature; the event switch 126 is a 
manual switch provided to the patient to monitor contractions; the 
infusion pump 128 infuses medicine into the patient's bloodstream and 
provides signals of the quality and quantity of medicine infused into the 
patient's system; and the glucometer provides signals indicative of the 
glucose levels in a patient's system. The base unit 150 may also provide 
signals to the infusion pump 128 to reconfigure the amount and frequency 
of medicine which is supplied to a patient's system. The sensors 120 and 
recorders 160 will be described in greater detail in the following 
sections. 
FIG. 3A is a perspective view of a preferred embodiment of the base unit 
150. FIG. 3B illustrates the rear panel of the remote base unit of FIG. 
3A. The unit is small and portable such that it may be placed on a table 
next to the patient's bed. 
As illustrated in FIG. 3A, the base unit 150 comprises a lid assembly 300 
and a base assembly 400. The lid assembly 300 comprises a display assembly 
310, a lid assembly board 340 (shown in FIG. 4) and two recorder docking 
ports 350a, 350b. The base assembly 400 comprises a system board 410 
(shown in FIG. 4), a third recorder docking port 350c, a storage bay 440 
and a rear panel 460. The lid assembly board 340 and the system board 410 
provide the circuitry for the base unit 150 and will be described below. 
As depicted in FIG. 3C, the display assembly 310 comprises a Liquid Crystal 
Display ("LCD") 312 with backlight 313 capability, a touch-sensitive 
screen 314, a control panel 316 and three indicator lights 324, 326, 328. 
In the present embodiment, the LCD display 312 is a graphics display with 
a CGA resolution of 320.times.200 pixels and a viewing area of 5.04 
inches.times.4.33 inches. The touch sensitive screen 314 is capable of 
displaying a set of function keys (not shown), generated through software, 
for user selection. The function keys are generic and reconfigurable in 
software, may be selected by touching the screen 314. Up to 24 keys may be 
generated by software. 
The control panel 316 comprises four buttons. The leftmost button 317 
controls power from the fluorescent backlight. The next button 318 
controls the up contrast voltage to the LCD display 312. The third button 
320 from the left controls the down contrast voltage to the LCD display 
312. This second and third buttons 318, 320 are used to provide 
compensation for different light levels and angles. The rightmost button 
322 is the Enter key. It is used for returning to a previous screen. The 
three indicator lights indicate the status of system. The leftmost 
indicator light 324 indicates the start of a session, the middle indicator 
light 326 indicates if the power is on, and the rightmost indicator light 
328 is a low battery warning indicator alarm. 
The lid assembly board 340 comprises integrated circuits for the control of 
the LCD 312 and touchscreen 314 of the display assembly 310. The 
components of the board will be discussed in greater detail in the 
following sections. 
The docking ports 350a, 350b, 350c on the lid assembly 300 and the base 
assembly 400 provide for mechanical docking of the recorders 160. The 
docking reports 350a, 350b and 350c are identical and can receive any one 
of the recorders 160. Data transfer to and from the recorders 160 and 
battery charging of the recorders 160 are provided through electrical and 
optical interfaces with the base unit 150. 
In the present embodiment and as shown in FIGS. 3B and 3C, the docking port 
350 is molded to accept the shape of the recorder 160, illustrated in 
FIGS. 3D and 3E, which is similar to that of a cordless phone cradle. The 
narrow end 162 of the recorder 160 fits into the cradle 164 of the docking 
port 350 and a magnet 166 in the base will contact a metal plate 168 in 
the middle of the recorder 160 to retain it during charging and data 
exchange. Three spring-loaded contacts 370a, 370b, 370c, at the bottom of 
the cradle 164 in the docking ports 350 provide the electrical and optical 
interface with the base unit 150. The contacts 370 connect to 
corresponding contacts 372 on the end of the recorder 160 for charging of 
the battery and powering the recorder 160 while the recorder 160 is 
docked. A molded projection 170 on the narrow end 162 of the recorder 160 
presses against an interlock switch 178 in the base of the docking port 
350 to indicate that a recorder 160 is docked. 
Four infrared components 174 at the top end of the recorder 160 allow the 
transmitting and receiving of data, and two of the infrared components 174 
are flag channels for indicating the recorder is busy and the battery 
charging state. Four infrared components 176 in the docking port 350 
correspond to and communicate with the four infrared components 174 in the 
recorder 160 via the infrared and power link 415 (shown in FIG. 4). When 
the recorder 160 is removed from the docking port 350, all power is 
removed from the accessible metal contacts 370, 372. 
The storage bay 440 is a cavity located in the right side of the base 
assembly 400. It provides storage space for sensors 120 and associated 
accessories required for measuring a variety of parameters. Two 
communications ports 443, 444 for receiving the temperature probe 124 and 
the event switch 126 are located in the storage bay 440. 
As shown in FIG. 3B, the rear panel 460 is an input/output interface which 
provides further monitoring and control capabilities for the base unit 
150. In the preferred embodiment, the rear panel 460 comprises a power 
switch 462 and a plurality of connectors. The power switch 462 permits the 
powering on and off of the base unit 150. The first connector 466 provides 
for connection from an external 16 volt DC supply. The second connector 
468 provides connection to a sensor. Preferably, a DB-9 connector is used, 
which accepts bi-directional data from the infusion pump 128. The third 
connector 466 provides connection to a second sensor. The connector is 
preferably a DB-9 connector which accepts data from a glucometer 130. The 
fourth connector 470 accepts an analog signal from the weight scale sensor 
122 and provides power to the load cells in the scale 122. The fifth 
connector 472 is provided for connection to a printer 136 which prints 
fetal heart rate/uterine activity charts. The sixth connector 474 is a 
direct connect port 474. The port is preferably a conventional RS-232 type 
port, provided to permit the base unit 150 to be connected directly to 
another personal computer 138 for testing and data retrieval. The seventh 
connector 476 provides for connection to a telephone line 134. Preferably, 
the connector is an RJ-11 jack, which provides for direction connection to 
the public switched telephone network. The eighth connector 478 provides 
for connection to a telephone line 134. Preferably, a RJ-11 connector is 
used, which accepts a standard telephone and provides a connection to the 
telephone line 134 when the modem 670 is not on-line. 
FIG. 4 is a functional block diagram of an exemplary base unit 150 and the 
modules 110 (sensors 120 and recorders 160) and care center 600 with which 
it interfaces. As depicted in FIG. 4, the base unit 150 communicates with 
the care center 600 from remote sites 100. As illustrated, the sensors 120 
are connected to the remote base unit (RBU) 150 via connectors 464, 466, 
468, 470, 472, 474, 476 and 478 on the rear panel 460 of the RBU 150 and 
via connectors 443 and 444 located within the storage bay 440 of the RBU 
150. The recorders 160 communicate with the RBU 150 via infrared and power 
links 415. These connectors 443, 444, 464, 466, 468, 470, 472,474,476 and 
478 and infrared links 415 provide the signals from the sensors 120 and 
recorders 160 to the electronics circuitry in the RBU 150. 
As previously discussed, the RBU 150 comprises a lid assembly 300 (shown in 
FIG. 3) and a base assembly 400 (shown in FIG. 3). The lid assembly 300 
comprises a display assembly 310, a lid assembly board 340 and two 
recorder docking ports 350a, 350b. The base assembly 400 comprises a 
system board 410, a third recorder docking port 350c, a storage bay 440 
and a rear panel 460. 
As shown in FIG. 4, the lid assembly board 340 comprises integrated 
circuits for the control of the LCD 312 and touchscreen 314 and two 
recorder interface boards 416a, 416b. 
The system board 410 comprises a recorder interface board 416c, a 
microprocessor-based central processing unit (CPU) 412, a memory module 
418, a temperature/scale board 420, a memory interface circuit 430, a 
communications interface circuit 440, a modem board 450, a microprocessor 
decode buffer circuit 461, three power supplies 471a, 471b, 471c and a 
power interface and control circuit 480. 
The memory module 418, connected to the CPU 412 via a conventional data 
bus, comprises 64 Kbytes of Read Only Memory (ROM) used for the Basic I/O 
System (BIOS), 1 Megabyte of ROM used for the operating system and 
applications software and up to 32 Megabytes of Random Access Memory 
(RAM). 
As illustrated in FIG. 4, the fetal heart rate/uterine activity recorder 
210, the blood pressure recorder 220 and the urinalysis recorder 230 are 
each connected using infrared and power links 415a, 415b, 415c via the 
docking interface boards 414a, 414b, 414c in each recorder 210, 220, 230 
to one of two recorder interface boards (RIBs) 416 on the Lid Assembly 300 
or to the recorder interface board 416 on the base assembly 400. 
Information previously recorded by the recorders 210, 220, 230 are then 
transferred to the CPU 412. Alternatively, when a session is scheduled, 
the patient takes the required measurements and the recorders 210, 220, 
230 store the information, which is transferred to the CPU 412. 
The five directly connected sensors are connected to the RBU as follows. 
The weight scale sensor 122 is plugged into connector 470 in the rear 
panel 460 of the RBU 150. Likewise, the infusion pump 128 and the 
glucometer 130 are plugged into either connector 466 or connector 468 on 
the rear panel 460 of the RBU 150. The temperature probe 124 and the event 
switch 126 are plugged into the receptacles 443 and 444 located within the 
storage bay 440 of the base assembly 400. 
The measurements monitored by the temperature probe 124 and weight scales 
122 are provided to the temperature/scale board 420, which processes the 
signals provided by the temperature probe 124 and weight scales 122. The 
resultant signals are provided via the communications interface circuit 
440 to the CPU 412. 
Signals provided by the event switch 126 via event receptacle 444 are 
provided to an I/O port decode circuit 820, in the communications 
interface circuit 440 which provides proper selection of the I/O ports to 
be read. Similarly, signals provided by the glucometer 130 and infusion 
pump 128 via connectors 466, 468 are first provided to electromagnetic 
interference/electromagnetic static discharge (EMI/ESD) circuits 832, 834 
which filter the signals from extraneous electromagnetic radiation. The 
signals from the I/O port decode circuit 820 and the EMI/ESD circuits 832, 
834 are provided to the interface circuit 445, which permits the CPU 412 
to select the device it communicates with. Here, the device is either the 
event switch 126, glucometer 130 or infusion pump 128. The resultant 
signals are provided to the microprocessor decode buffer circuit 461, 
which then provides the signals to the CPU 412. 
The external power supply 132 is provided to the power supply interface and 
control circuitry 480 via power connector 464. The power is provided via 
the microprocessor decode buffer circuitry 461 to the other elements in 
the RBU 150. 
The telephone line 134 is provided via an RJ-11 connector 478 to the 
internal modem circuitry 450 of the RBU 150. A portable printer 136 for 
printing fetal heart rate/uterine activity charts, is connected via 
connector 472 to the CPU 412 and then to the modem 450. A computer 138 for 
testing and data retrieval may be connected via a direct connector 474 to 
the CPU 412 and then to the modem 450. 
FIG. 5 is a schematic diagram of an exemplary docking interface board (DIB) 
414 in each of the recorders 160. The DIB 414 comprises four infrared 
circuits 702, 704, 706, 708, a battery charge control circuit 712, and a 
battery charge ESD protection circuit 714. Of the four infrared circuits, 
two circuits 702, 704 are dedicated for receiving and transmitting data, 
respectively. The other two circuits provide two flag channels 706, 708 
used for indicating that the recorder 160 is busy and for indicating the 
battery charging state of the recorder 160 and docking port 350, 
respectively. 
As discussed earlier, three spring-loaded contacts at the bottom of the 
cradle in the docking ports 416 provide the electrical and optical 
interface with the RBU 150. The contacts connect to corresponding contacts 
on the end of the recorder case for charging of the battery and powering 
the recorder 160 while the recorder 160 is docked. A molded projection 178 
(FIGS. 3D and 3E) on the narrow end 164 of the recorder 160 presses 
against an interlock switch 176 (FIG. 3C) in the docking port 350 to 
indicate that a recorder 160 is docked. The battery charge controller 706 
coordinates the charging of the battery in the recorder 160. The battery 
charge ESD protection circuit 722 isolates the board from extraneous ESD. 
The battery cells in the DIB 414 are charged by a battery pack in the RBU 
150 via connector 716. The battery cells permit the recorder to record 
measurements remote from the RBU 150. Connector 718 provides for 
connection to the LCD 312. A second connector 720 provides a means for 
supplying power to the components on the DIB 414. Preferably, these 
connectors are Molex connectors. An ambient light chopper and controller 
722 ensures that ambient light does not interfere with the functioning of 
the infrared sensors. 
FIG. 6 is a schematic diagram of an exemplary recorder interface board 
("RIB") 416 of the RBU 150 diagrammed in FIG. 4. The RIB 416 comprises 
four infrared circuits 732, 734, 736, 738, a light beam interrupt sensor 
740 and an LED power charge indicator 326. Two of the circuits 732, 734 
provide channels for transmitting and receiving data, respectively, from 
the recorders 160 and two flag channels 736, 738, for indicating the RBU 
160 is busy and in a battery charging state, respectively. These four 
channels correspond to the four infrared channels on the DIB 414 (FIG. 5). 
The LED 326 on the RIB 416 provides indication of the power charging state 
of the RBU 150 and a light beam interrupt sensor 740 indicates the 
presence of a docked recorder 160. 
FIG. 7 is a schematic diagram of an exemplary Lid Assembly Board 340 of RBU 
150 diagrammed in FIG. 4. The LCD Assembly Board 340 comprises an EPSON E 
1330DA LCD display controller chip 750 which controls the LCD display 312 
and touch screen 314 decoding functions, as well known in the art. The LCD 
controller 750 is provided with volatile Random Access Memory ("RAM") 750 
for screen bit mapping and a Read Only Memory ("ROM") 750 for character 
generation. A Peripheral Interface Adapter (PIA) 752, connected to the 
controller chip 750, is used to provide the interface with the touch 
sensitive screen 314. These components are well known in the art. 
In the present embodiment, the LCD screen brightness and contrast control 
voltages are provided by a digital rheostat 754 which is controlled by a 
pair of switches 318, 320 mounted on the front control panel 316 of the 
lid assembly 300. Preferably, the rheostat 754 is a DS 1669-50 digital 
rheostat. The lid assembly board 340 also has an LED power supply 756 
which supplies power for the up/down contrast voltage controlled by 
buttons 318, 320 on the control panel 316 and a backlight power supply 758 
controlled by the button 317. The lid assembly board 340 also provides 
connectors 760 for the system board's input/output (I/O) bus and 
annunciator signals (power on, low battery and Scheduled Appointment 
Reminder Indicator (SARI)). Electrical signals from the lid assembly board 
are routed to and from the base assembly flex cables (not shown). The 
matrix pullups circuit 762 and the matrix drivers circuit 764 identify the 
area of the touch screen 314 the area has selected, as known in the art. A 
decode latches circuit 768 enables data to be saved, as known in the art. 
FIG. 8 is a schematic of the temperature and scale board 420. It comprises 
an analog-to-digital converter (ADC) 770, temperature signal procession 
772 and a weight scale signal processor 774. As shown in FIG. 8, the ADC 
770 accepts analog inputs from multiple channels. In the present 
embodiment, the ADC 770 accepts inputs from 3 channels. The low voltage 
sense signals from the RBU 150 enter the ADC 770 which converts the sense 
signals to digital form upon request by the CPU 412. The digitized values 
are read by the CPU 412 via a conventional data bus connecting the ADC 770 
to the CPU 412. 
As shown in FIG. 8, the temperature scale signal processor 772 is connected 
to an external temperature probe 124 (FIG. 4) via a connector 443 in the 
storage bay 440, and comprises a temperature probe presence detect signal 
line 776, an autocalibration circuit 778, a gain and offset circuit 780 
and a filter 782. When the temperature probe 124 is plugged into the 
connector 443, the temperature presence detect signal line 776, which is 
read by the CPU 412 (FIG. 4), is grounded by the temperature probe 124, 
thereby indicating that the probe 124 is plugged in. A second signal is 
concurrently provided by the probe 124 to an autocalibration circuit 778, 
which calibrates the scale to be used in measuring the incoming signal. 
Calibration is performed by the software. The gain and offset circuit 780 
then amplifies the signal from the temperature probe 124 so as to 
correspond to the range of the ADC 770, and offsets the signal to take 
full advantage of the ADC's range. The signal is then filtered through 
filter 782 to eliminate random noise and then provided to the ADC. The CPU 
412 will then read the output of the ADC 770. 
The weight scale signal processor 774 is also connected to an external 
weight scale 122 (FIG. 4), via connector 470. The processor 774 comprises 
a scale presence detect signal line 784, a scale gain potentiometer 786, a 
gain and offset circuit 788 and a filter 790. The scale presence detect 
signal line 784 detects the presence of an external scale 122 in the same 
manner as the temperature probe 124 presence detect signal line 776. A 
second signal provided by the scale 122 is concurrently provided to the 
scale gain potentiometer 786, which sets the signal range for proper 
digitization for the ADC 770. The signal is then provided to a gain and 
offset circuit 788. The gain and offset circuit 788 then amplifies the 
signal so as to correspond to the range of the ADC 770, and offsets the 
signal to take full advantage of the ADC's range. The signal is then 
filtered via filter 790 to eliminate random noise and then provided to the 
ADC 770. The CPU 412 will then read the output of the ADC 770. 
FIG. 9 illustrates the Memory Interface Circuit 430 of the RBU 150 
diagrammed in FIG. 4. The Memory Interface Circuit 430 comprises an 
address bus buffer 792, a boot microprocessor decoder 794, a ROM BIOS Hook 
796, a data decoder 798, a run decoder 799, a data bus buffer 800, a 
memory module with 4 sets of memory 418a, 418b, 418c, 418d and a 
programmable configuration change circuit 810. 
The memory module 418, connected to the CPU 412 (FIG. 4) via a conventional 
data bus, comprises 64 Kbytes of Read Only Memory (ROM) used for the Basic 
I/O System (BIOS), 1 Megabyte of ROM used for the operating system and 
applications software and up to 32 Megabytes of Random Access Memory 
(RAM). 
Signals from the CPU 412 are provided to the address bus buffer 792 which 
provides a boost to signal strength along the address bus. The address bus 
buffer 792 then provides the signals to the boot microprocessor decoder 
794 which decodes ROM addresses and enables the ROM BIOS hook 796. The ROM 
BIOS hook 796 provides a mechanism for allowing the software to be 
executed during the boot-up process. The signals are then provided to the 
data bus buffer 800 which ensures that the memory circuits are adequately 
driven and the programmable configuration change circuit 810 permits 
changes in configuration to be implemented. These signals are then 
provided to the memory modules 418 which reside on the same circuit board 
as the memory interface circuit 430. 
Signals from the CPU 412 are also provided to the data decoder 798 which 
provides selection of the correct channels. These signals are then 
provided to the run decoder 799 which coordinates signal flow. Signals 
from the run decoder are then provided to the data bus buffer 800, which 
functions as described above and which provides the signals to the memory 
modules 418. Signal flow between the CPU 412 and the memory modules 418 
via the memory interface board 430 is bi-directional. The components 
described above are well understood in the art. 
As shown in FIG. 10, the Communications Interface Board 440 comprises an 
I/O Port Decode Circuit 820 implemented by two Universal Asynchronous 
Receiver/Transmitters 822, 824 (UART) as known in the technology. The UART 
provides clear-to-send and request-to-send processing used for data flow 
control. Multiplexers 826, 828 connected to each of the UARTs 822, 824 
select microprocessor communication with communications ports 446, 448 and 
the event switch receptacle 444. The multiplexer 828 is connected via 
RS232 converter 830 which converts RS 232 voltages to 
transistor-to-transistor (TTL) voltage levels, as known in the art. The RS 
232 converter 830 is connected to two EMI/ESD circuits 832, 834. The 
EMI/ESD circuits 832, 834 filter extraneous electromagnetic signals from 
the circuits and are connected to communications ports 446, 448. 
Also illustrated in FIG. 10, the Hardware Watchdog Alarm 836 connected to 
the CPU 412 forces a system reset if the system is not triggered at a 
predetermined interval, as known in the technology. In the present 
embodiment, the predetermined interval is 30 seconds and serves to 
conserve power. The system reset is also announced by a 200 millisecond 
beep from a small piezoelectric speaker. 
FIG. 11 depicts the Internal Modem Circuit 450 of the RBU 150. One serial 
interface of the communications interface circuit 440 is used to 
communicate to an internal modem 450, which in turn connects to a 
telephone line 134 (FIG. 4) via phone jack 478 to communicate with the 
care center 600. In the present embodiment, the internal modem 450 is a 
Hayes-compatible integrated circuit 840 which provides 2400 baud 
modulation and demodulation for direct telephone line connection. 
Alternatively, the serial interface is used to communicate to a radio 
interface (not shown) which in turn connects to a radio (not shown) to 
communicate with the care center 600. Those skilled in the relevant 
technology will appreciate that other communications links may also be 
used. The internal modem circuit 450 also has a ring detect circuit 842 
which indicates when a message is received. Finally, the circuit 450 has a 
line interface circuit 844 which provides the necessary interface from the 
modem circuit 840 to the connector 478 and the ring detect circuit 842. 
FIG. 12 is a schematic diagram of the Microprocessor Buffer Decode Circuit 
461 of the RBU 150 diagrammed in FIG. 4. This circuit provides a buffer 
for the CPU 412 and permits the CPU 412 to select the device it is reading 
from or to. The microprocessor of the CPU 412 fits into the connector 850 
on the microprocessor buffer decode circuit 461. The connector connects to 
a microprocessor buffer decode circuit 852 which provides a buffer for the 
CPU 412 as known in the art. The buffer decode circuit 852 is connected to 
flex cables 854 which connect the base assembly board 410 to the lid 
assembly board 340. The communications interface circuit 858 connects the 
direct connector 474 to the CPU 412 and the ESD/EMI circuit 860 connects 
the printer connector 472 to the CPU 412. 
As illustrated in FIG. 13, three identical power supplies each provide 
+8.75 volts DC to power each of the recorders 210, 220, 230 for data 
communications and operation. An additional lead 862a, 862b, 862c in each 
of the power supplies 471a, 471b, 471c provide a 600 mA constant current 
source to charge the battery pack. The power supplies 471a, 471b, 471c 
additionally controls the shutdown interlock via connections 864a, 864b, 
864c. 
As shown in FIG. 14, the Power Interface and Control Circuitry 480 provides 
an interface to external power and circuitry for control and monitoring of 
power. An external source 132 provides the +16 volts DC to the RBU's I/O 
bus via power connection 462. From the external power source 132, the 
control circuitry 870 derive +5 volts DC power necessary for other 
elements in the RBU 150. The control circuit 872 derives power for the LCD 
backlight 313 and the indicator lights 324, 326, 328. A separate 
battery-backed RAM 874 is provided to retain memory during power loss. 
Presently, nickel-cadmium batteries are used. The power interface and 
control circuit 480 also has a shutdown circuit 876 which shuts down the 
system in the event of a catastrophic circuit failure and a low power 
shutdown circuit 878 which provides for power shutdown when the battery 
voltage falls below the limit required for normal operations. 
III. Functional Modules for Monitoring At-Risk Pregnancy 
As shown in FIGS. 2 and 4, two types of modules 110 may be connected into 
the RBU 150: sensors 120 which may be plugged directly into the RBU 150, 
and recorders 160, which receive inputs from sensors 120, record the 
sensor information, and transmit the inputs to the RBU 150. The recorders 
160 are completely portable and may be used remotely by the patient. The 
recorders 160 must however, be periodically placed into a docking port 350 
in the RBU 150 so as to upload or download data or instructions and to 
charge its batteries. 
In the present embodiment, the RBU 150 is configured to receive three 
recorders 210, 220, 230 for monitoring a the medical status or condition 
of a patient. In one embodiment, the medical condition monitored is an 
at-risk pregnancy. Advantageously, the recorders utilized to monitor this 
condition are: a combined fetal heart rate/uterine activity recorder 210, 
a blood pressure recorder 220 and a urinalysis recorder 230. 
The fetal heart rate/uterine activity recorder 210 is a hand-held, 
completely self-contained ultrasound fetal heart rate monitor with uterine 
activity and event channels. The fetal heart rate/uterine activity 
recorder comprises a docking interface board (DIB) 414 and a fetal heart 
rate/uterine activity circuit board (not shown). 
The DIB 414 comprises four infrared channels which provide logic levels to 
indicate that the recorder is busy with a measurement, to indicate that 
the battery pack is 10 degrees C above ambient (indicating full battery 
charge) and the third and fourth channels are used to transmit and receive 
data as discussed above. 
An intrauterine sensor 214 is connected to the fetal heart rate/uterine 
activity board via a connector. A tokodynamometer as claimed in pending 
U.S. patent application Ser. No. 07/754,960 and assigned to the assignees 
of the present invention is preferably used as the intrauterine sensor 214 
and is connected to the uterine activity recorder via a connector. 
In the presently preferred embodiment, the fetal heart rate/uterine 
activity circuit board is model number 4220 provided by Seward Medical 
Ltd. in Newport, Wales. An ultrasound transducer 212, model 4220 provided 
by Seward Medical Ltd. is also connected to the fetal heart rate/uterine 
activity circuit board via a connector. The ultrasound transducer 212 
monitors the fetal heart rate and provides the fetal heart rate to the 
fetal heart rate/uterine activity circuit board. The fetal heart 
rate/uterine activity circuit board utilizes continuous doppler shift 
ultrasound technology, as known in the relevant technology, to provide the 
fetal heart rate signals on the LCD 312 of the RBU 150. The fetal heart 
rate may be detected via headphones connected to the fetal heart rate 
circuit board. A programmable timer in the fetal heart rate/uterine 
activity circuit board controls the monitoring session length and overall 
exposure time to ultrasound energy. 
The fetal heart rate/uterine activity recorder 210 is docked in the RBU 150 
and the LCD 310 in the RBU 150 prompts the patient through the set-up 
procedure and monitoring session. Various warning prompts and an audible 
beeper alerts the patient to any problems during the session. 
The blood pressure recorder 220 comprises an DIB 414 and a blood pressure 
circuit board. The DIB is substantially similar to the DIB described 
above. The blood pressure circuit board is model number 90207 provided by 
Spacelabs Medical Inc. from Redmond, Wash. A blood pressure cuff 222 with 
a pressure transducer is connected to the blood pressure recorder 220 and 
used to monitor blood pressure. One of four blood pressure cuff sizes may 
be selected, and these are model numbers SAD 4211, AD 4212, LAU 4213 and 
EXL 4214 provided by Spacelabs Medical Inc. The blood pressure recorder 
220 is a battery-operated microprocessor-controlled non-invasive pressure 
monitor. The blood pressure recorder 220 automatically inflates and 
deflates a range of pressure cuffs described above. The blood pressure 
recorder 220 has two modes of operation: an ambulatory mode, where the 
patient wears the cuff 222 for an extended period and the RBU 150 
automatically takes readings and a reminder mode where the unit alerts the 
patient that it is time for a reading. The blood pressure recorder 220 is 
placed in one of the RBU's docking ports 350 to charge its batteries and 
transfer its data. The RBU 150 may also reset the controls in the blood 
pressure recorder 220. 
The urinalysis recorder 230 used in the present embodiment is disclosed in 
U.S. Pat. No. 5,182,707 assigned to the assignee of the present invention 
and is hereby incorporated by reference. The urinalysis recorder 230 
additionally comprises an DIB 414 which is substantially identical to DIB 
414 described above. The urinalysis recorder 230 is a battery-operated 
microprocessor-controlled device that permits a patient to visually match 
the results of a urine reagent strip 232 with color blocks printed on the 
top of the recorder 230. Each record is time and date stamped and stored 
in memory. When the urinalysis recorder is returned to the RBU 150, the 
data will be transferred to the RBU memory 418 via the infrared link 415. 
The LCD display 312 is employed to prompt the patient through the 
measurements. Additionally, the front panel overlay on the urinalysis 
recorder 230 can be changed to accommodate different combinations of 
reagent test pads. 
The sensors 110 which are directly plugged into the RBU 150 to monitor 
at-risk pregnancy are: a temperature probe 124, a weight scale 122, an 
infusion pump 128, an event switch 126 and a glucometer 130. 
In the present embodiment, the temperature probe 124 is of the thermistor 
variety. The thermistor is located at the end of a four-inch long shaft 
encased in an aluminum tube. The tip is isolated from the rest of the 
shaft via a plastic separator section with the rest of the shaft made of 
stainless steel. The opposite end of the shaft has a molded plastic grip 
that will also provide a cable strain relief. The cable connected to the 
probe is a three feet long coiled cord terminated at a connector that 
mates with the connector in the storage bay. 
The weight scale 122 used in the present embodiment is a platform which 
connects via cable to the rear panel 460 of the RBU 150. The presently 
preferred scale utilizes a four load cell configuration for a measuring a 
maximum weight of 440 pounds, .+-.0.5 pounds. The platform is preferably 
covered with a molded plastic housing and provided with a bottom plate to 
protect the load cells. In the present embodiment, the platform is 
11".times.13".times.2". 
The infusion pump 128 used in the present embodiment is model 508 
manufactured by Mini-Med Inc. of Sylmar, Calif. The infusion pump 128 
contains a data interface and may be connected to serial ports 466 or 468 
on the rear panel 460. The infusion pump 128 may be reprogrammed from the 
care center 600 and medical information stored in the pump's internal 
memory may be uploaded from the pump 128 to the care center 600. In the 
at-risk pregnancy configuration, the patient may, for example, be infused 
with trebutaline under certain conditions. 
The event switch 126 used in the present embodiment is model 4201 
manufactured by Switchcraft Co. The event switch 126 is mounted in a 
hand-grip housing with a thumb button at one end and six feet of cable at 
the other end. The event switch 126 provides a means of counting the kicks 
of the fetus when the fetal recorder 210 is not included with the system. 
Alternatively, the event switch 126 may be reconfigured to monitor the 
occurrence of any event. 
The glucometer 130 utilized in the present embodiment is model PVD 
manufactured by Miles Diagnostic Inc. of Illinois. The glucometer 130 
contains a data interface and is connected to either serial ports 466 or 
468 on the rear panel 460 of the RBU 150. The results of the glucose 
measurements stored in the glucometer's internal memory is transferred 
into the memory of the RBU 150 and subsequently transmitted to the care 
center 600. 
IV. Functional Modules Used in Monitoring of Other Disease States 
The RBU 150 may also be reconfigured to monitor a variety of other medical 
conditions or therapies. These conditions may be monitored in conjunction 
with at-risk pregnancy to provide a more complete treatment tailored to a 
patient's particular needs. Alternatively, the RBU 150 may be configured 
to monitor other specific medical therapies for the treatment of specific 
medical conditions. The following sections will continue to refer to FIGS. 
2 and 4 in discussing: A. Monitoring of Human Organ Flow; B. Monitoring of 
In Vivo Plasma Separation; C. Monitoring of Blood Cholesterol Exchange; 
and D. Monitoring of Gas Exchange. It should be noted that the RBU 150 may 
be similarly reconfigured to monitor other disease states. 
A. Monitoring of Human Organ Flow 
The RBU 150 may be reconfigured to monitor human organ flow. Treatment of 
various disease states, such as kidney failure or liver failure, requires 
therapy involving the monitoring of fluid flow. 
1. Monitoring of Kidney Dialysis 
The RBU 150 may be reconfigured to monitor kidney dialysis. A kidney 
dialysis recorder may be used in place of one of the recorders 160 
described above for a patient with an at-risk pregnancy condition, or used 
in conjunction with fetal heart rate/uterine activity recorder 210, the 
blood pressure recorder 220, and urinalysis recorder 230. 
The kidney dialysis apparatus disclosed in U.S. Pat. No. 5,151,082 and 
assigned to the assignee of the present invention, which is hereby 
incorporated by reference, may be used in place of one of the recorders 
160. In the presently preferred embodiment, this kidney dialysis recorder 
additionally comprises an DIB 414, which is substantially identical to the 
DIB 414 described above, and which is used to facilitate data 
communications with the RBU 150. 
2. Monitoring of Liver Support Therapy 
The RBU 150 may also be reconfigured to monitor liver support. A liver 
support recorder may be used in place of one of the recorders 160 
described above or used in conjunction with the blood pressure recorder 
220, and urinalysis recorder 230 or any other recorder 160. 
The apparatus for monitoring human organ flow disclosed in U.S. Pat. No. 
5,151,082 and assigned to the assignee of the present invention, which is 
hereby incorporated by reference, is preferably used to monitor liver 
support. In the presently preferred embodiment, this liver support 
recorder additionally comprises an DIB 414, which is substantially 
identical to the DIB 414 described above, and which is used to facilitate 
data communications with the RBU 150. 
Just as the infusion pump 128 may be reprogrammed from the care center 600, 
the kidney dialysis recorder and the liver support recorder may also be 
reprogrammed from the care center 600. Such reprogramming includes updated 
treatment schedules and updated medical procedures which reflect changes 
in the treatment of kidney dialysis. Medical information stored in the 
kidney dialysis recorder's memory and that stored in the liver support 
recorder's memory may be uploaded from the respective recorders 160 to the 
care center 600. 
B. Monitoring of In Vivo Plasma Separation 
The recorder 160 for monitoring in vivo plasma separation is disclosed in 
U.S. Pat. No. 4,950,224, assigned to the assignees of the present 
invention and hereby incorporated by reference. The recorder additionally 
comprises an DIB 414 as described above and is docked in the recorder 
docking port 350 in the same manner as the recorders 160 described above. 
A catheter, as claimed and described in pending U.S. application Ser. No. 
07/229,138, assigned to the assignees of the present invention, and hereby 
incorporated by reference, is used to connect the recorder to the 
patient's vein. The RBU 150 may also reconfigure the settings of the in 
vivo plasma separation recorder. 
C. Monitoring of Blood Cholesterol Exchange 
The recorder 160 for monitoring blood cholesterol exchange is disclosed in 
U.S. Pat. No. 5,152,743, assigned to the assignees of the present 
invention and is hereby incorporated by reference. In the present 
preferred embodiment, this recorder additionally comprises an DIB 414 as 
described above, to facilitate data transmission with the RBU 150. A 
catheter, as claimed and described in pending U.S. application Ser. No. 
07/229,138, assigned to the assignees of the present invention and hereby 
incorporated by reference, is used to connect the recorder to the 
patient's vein. The recorder is docked, and information between the 
recorder and the RBU 150 is transmitted and received in the same manner as 
for the recorders described above. The RBU 150 may also reconfigure the 
settings of the in blood cholesterol exchange recorder. 
D. Monitoring of Gas Exchange 
The recorder 160 for monitoring gas exchange is disclosed in pending U.S. 
patent application Ser. No. 07/745,912, assigned to the assignees of the 
present invention and hereby incorporated by reference. In the present 
preferred embodiment, this recorder additionally comprises a DIB 414 as 
described above. A catheter, as claimed and described in pending U.S. 
application Ser. No. 07/229,138, assigned to the assignees of the present 
invention and hereby incorporated by reference, is used to connect the 
recorder to the patient's vein. The recorder is docked, and information 
between the recorder and the RBU 150 is transmitted and received in the 
same manner as for the recorders described above. The RBU 150 may also 
reconfigure the settings of the in gas exchange recorder. 
V. System Process Flow 
FIG. 15 is an operational flowchart of the patient monitoring and support 
system 50 of the present invention. In general, the RBUs 150-150C acquire 
data representing the medical status and requirements of a patient and 
transmits the data to the care center. The care center 600 performs 
primarily the functions of obtaining data from the RBUs 150-150C and for 
communicating with the RBUs 150-150C. The care center 600 also accepts 
inputs from medical personnel monitoring the status of the patients at the 
care center 600 or from primary care physicians 710 on the LAN 700 and 
transfers the data to the RBU 150. It can also reconfigure the RBUs 150 
based on the input provided at the care center 600. 
With reference to state 880 in FIG. 15A, the primary care physician 710 or 
medical personnel from a clinic or hospital initially supplies individual 
patient history including surgery and/or therapy, the patient's medical 
status and symptoms to the care center 700 staff. Based on the patient's 
history and medical status, the doctor prescribes home care. The patient's 
personal data is entered into the database at the care center 600. 
Next, as illustrated by state 882, the doctor and staff consults with each 
other and the doctor provides a prescription of the required therapy or 
treatment as shown in block 884. Based on the prescription, the care 
center staff constructs a regimen initially tailored for the patient. 
These include system configuration, the definition of protocols, 
developing a report of the structure, configuring the system and 
validating the system. The care center staff comprises a field nurse, a 
case nurse, a nutritionist, a therapist and other medical support 
personnel. 
When the regimen is properly constructed, the system is delivered and 
installed in the patient's home as shown in state 886. Upon installation, 
a member of the care center staff trains the patient monitoring and status 
system 50 of the present invention, as shown in state 888. 
When training is completed, the patient is ready to operate the system as 
shown in state 890. When a test or scheduled session has been completed, 
the medical data obtained is sent as depicted in state 892, to the care 
center staff who enters the data into the database, as shown in state 894. 
The staff then prepares the necessary physician reports and transmits them 
to the physician as shown in state 896. 
Upon receipt of the data, the physician interprets and analyzes the data as 
shown in state 900. Based on the physician's analysis, the care center 
staff calculates, orders, delivers drugs or supplies and schedule nurse 
visits as required, as shown in state 902. These instructions are sent to 
the patient. 
Based on the physician's analysis, the patient's prescription, visits and 
schedules are changed as shown in state 904. The care center staff 
accordingly changes the configuration, protocols, etc., according to the 
new prescription via modem. The patient receives the changes and 
implements the changes via modem or manually. 
If configuration is required, the process in state 904 is repeated. If no 
configuration is necessary, operation of the system (state 890) is 
reinitiated and further therapy is obtained (state 908), otherwise, the 
session is terminated at state 910. 
VI. Process Flow for Monitoring At-Risk Pregnancy 
FIG. 16 is a flow diagram of the at-risk pregnancy monitoring and support 
software of the present invention, which is located in the remote base 
unit 150. Software for the base unit 150 function is, in a presently 
preferred embodiment, written in the "C++" language. The software 
described herein, which is listed in the attached Microfiche Appendix, was 
translated from the source code into object code using a Borland "C++" 
compiler. Nonetheless, one skilled in the technology will recognize that 
the steps in the accompanying flowcharts can be implemented by using a 
number of different languages, language translators, computers and 
circuitries. 
The RBU 150 comprises a microprocessor such as the AMPRO XT (CPU 412, FIG. 
4) which executes a computer program. The computer program controls the 
operation of the system. At the start of the program, (state 912) 
initialization of variables, program data and device registers occurs. 
Global variables which are common variables used by more than one function 
and/or object in the program are first initialized, as shown in state 914. 
The state machine is then initialized, as shown in state 916. This is a 
definition of process structure and starting point. Next, vendor 
communication is initiated at state 918. This is an initialization of the 
routines in communications software obtained from a third party; which 
make use of the modem and serial ports for data communications with the 
care center 600, the recorders 160 and other peripherals. 
The Read Configuration file used to configure registers for the session 
program input/output, is then initialized (state 920). Next, hardware 
objects such as LCD control are initialized (state 922), followed by 
Interface objects (state 924) and Test Configuration (state 926) such as 
calibration settings. These are the software routines which control the 
hardware, interface data and test data. 
Next, initialization of patient data configuration occurs (state 928). 
Patient Data includes the name, Patient identification, phone number of 
primary physician and care center and a list of their scheduled sessions. 
The Event Schedule which handles the multitasking of the software objects 
is next initialized (state 930). Initialization of the User Interface Data 
follows (state 932). This includes initialization of Error Handling 
format, the Icon Manager and the System Input and Output. 
The Hardware Input/Output registers are next initialized (state 934). These 
include initialization of the port and docking detects, the light 
indicators, the battery check register, the recorder charging register and 
the watchdog register. 
Initialization of the Session Manager follows, as shown in state 936. The 
Session Manager schedules the sessions and updates all sessions displayed 
on the machine. Sessions here refer to the scheduled periods during which 
the patient monitors his medical condition. Variables in the Home Display 
are then initialized (state 938). 
Upon completion of initialization, the program queries if the QUIT flag, a 
variable stored in RAM, is set as shown in state 940. If the flag is set, 
the program proceeds to delete the previously initialized values as shown 
in states 955-976. If the QUIT flag is not set, the program proceeds to 
the next state, state 942, which retriggers the hardware watchdog alarm. 
This process prevents the computer from being reset, and permits the 
program from continuing without interruption. The program then proceeds to 
examine if the program state is idle as shown in state 946. This state 
examines the reasons for inactivity. 
If the program state is found to be idle, i.e., there is no activity in the 
base unit 150 indicated by the program, the program proceeds to state 948, 
which checks if there has been a system input by examining if a 
touchscreen 314 function key on the LCD 312 has been selected. The program 
also checks with the scheduler to examine if a session is scheduled. If 
either a key has been selected or a session has been scheduled, the 
program requests performance of the specified task as shown in state 954. 
For example, a session may be initiated, measurements such as blood 
pressure are taken and the data is transmitted from the base unit 150 to 
the care center 600. The human interface portion of the base unit 150 
software will be described in some detail below with respect to FIGS. 18 
to 22. If neither of these activities occurred, the program proceeds to 
examine if the program state is still idle as shown in state 950. 
If the base unit 150 is idle, the program checks the test battery, the 
session controller and the recorder docking bays to see if a recorder is 
docked, it then updates the time clock, coordinates the charging of the 
recorder. If all these activities are not in error, the program returns to 
state 950 and checks if the base unit 150 is still idle. When the base 
unit 150 is no longer idle or if an error has been corrected, it proceeds 
to perform the task as specified by the patient or as scheduled (state 
954).Upon completion of the task, the program checks the QUIT flag (state 
940) and continues examination of the program state and performance of the 
specified tasks until request for termination is made. When termination of 
the program is requested, deletion of previously initialized values are 
deleted (states 955-976). Finally, the program examines if the restart 
flag is set as shown in state 980. If so, the program starts up again 
(state 982). If not, the program is terminated (state 984). 
VII. Data Flow between the Remote Base Unit and the Care Center 600 
A. Data Flow 
As shown in FIG. 17, the care center 600 functions as the system controller 
in the present embodiment and performs the following primary functions: 
poll the remote base units ("RBUs") 150 (FIG. 2) for data, provides the 
data received to a member of the medical staff, stores information 
obtained from the RBUs 150 in a central database managed by or maintained 
on the facility's patient database computer 660 (FIG. 1), transmits 
information such as instructions, medical procedures and scheduling of 
appointments to the RBUs 150. In the present embodiment, a South Mountain 
Communication Board with 8 channels is used. The patient database computer 
is preferably a VAX with 10 Gigabytes of memory. 
The care center 600 is typically connected to the facility's existing Local 
Area Network ("LAN") 700. This facility may be a hospital, a service 
center or a clinic. One example of the LAN system is the Novell Operating 
System. Thus, the information collected by the care center 600 is 
accessible from any workstation 650 on the LAN 700. In this configuration, 
the primary care physician located at the remote site 710 can access 
information collected on each patient monitored by the care center 600. 
Data transmission from the RBU 150 to the care center 600 is initiated in 
one of three ways. First, the user may request transmission. Second, 
transmission may be initiated at the end of a scheduled session. Third, 
transmission may be initiated by the care center 600 at a specified time. 
The second technique is represented by state 992 in FIG. 17. 
When data transmission is initiated, the RBU 150 constructs a temporary 
output file or output files for transmission on the RAM drive, as shown in 
state 994. The RBU 150 then calls the care center 600 via the 
communications link 500 previously described and connects with the care 
center 600 as depicted in state 996. All available data is then 
transmitted by the RBU 150, as shown in state 998. This includes all 
concatenated physiological data files (state 998), for example, weight and 
temperature measurements, and the waveform data files (state 1000), for 
instance, contractions. Each session will be sent as a separate file with 
specific names. Examples of files that are sent are patient 
identification, data identification # where "TP" represents tocolytic 
data, "FH" represents fetal heart rate and "FA" represents fetal 
assessment. The "#" sign represents the characters 0 through 9 or A 
through F, which represent the hexadecimal value of the session number. 
Next, a "trigger" file is sent, as depicted in state 1002. This file 
triggers the care center 600 to take an action. Specifically, the RBU 150 
transmits a dummy file to the care center 600 to indicate that it is ready 
to receive files from the care center 600. The RBU 150 then indicates the 
end of its transmit phase, as illustrated in state 1004. The RAM drive 
files such as session data, are then temporarily deleted. 
Upon receipt of the "trigger" file, the care center 600 prepares to 
transmit data to the RBU 150. The care center 600 first interrogates its 
data base (state 1006) to determine if there has been any change in 
patient configuration requiring an update of the RBU 150, as shown in 
state 1008. If no change is required, the care center 600 proceeds to 
transmit the time and date, as shown in state 1014. If there is a change 
in patient configuration, updated files are transmitted, as indicated in 
state 1010. Basically, the care center 600 transmits all pertinent files 
to update the RBU's configuration. The RBU 150 receives these files as 
temporary files and stores them on the RAM drive (state 1012). 
The care center 600 then proceeds to send its current time and date, as 
indicated in state 1016. The end of the care center 600 transmit phase is 
then indicated (state 1016) and the call is terminated through issuing of 
hangup commands by both the RBU 150 and the care center 600, as depicted 
in state 1018. 
Upon termination of the call, the RBU 150 updates its time clock from data 
received from the care center 600 (state 1020). File management in the RBU 
150 then takes place at state 1024. If data transmission was successful, 
all measurement data files are deleted. If file reception was successful, 
the received files are distributed to the addressed locations. The 
remaining received files are then deleted. The RBU 150 then tests if any 
patient configuration, such as test schedules, medical procedures,etc., 
has changed (state 1026). If not, the present sequence ends and normal 
patient monitoring resumes (state 1030). If patient configuration has 
changed, the RBU 150 reboots itself, as indicated in state 1028. Upon 
rebooting, the present sequence ends and normal patient monitoring resumes 
(state 1030). 
B. Remote Base Unit File Structures 
The design of the files structures for the RBU is based on C++ computer 
language. The source code is used by both receiving and transmitting 
programs. All data is stored in separate files on the RBU. Each 
measurement taken is appended to a file named for the measurement, for 
instance, weight data, temperature date, etc. All data storage files 
consists of the data records only, without file headers or data header 
lines. 
1. Physiological Data 
Prior to transmission, all data contained in these files are concatenated 
into a single file for transmittal, with a File Header at the beginning of 
the file and a Data Header preceding each set of data. The filename of the 
concatenated files are derived from the patient identification with a 
"PHY" extension. Individual data structures or records have comma 
delimited fields and carriage return delimited records, with all data 
initially being in ASCII for development purposes. 
2. Waveform Data 
Each session of waveform data collection is stored in separate files on the 
RBU with a daily session number as part of the extension. All data storage 
files consists of the Data Headers and Data Records only. At the time for 
transfer of data, this data is prefixed with the File Header data and 
transmitted as separate files. Individual data structures or records have 
comma delimited fields, except for the waveform data itself, and carriage 
return delimited records, with all data initially in ASCII for development 
purposes. 
VIII. Data Flow Between the Remote Base Unit and the Recorders 
The recorders have certain parameters that can be configured by the nursing 
personnel at the care center 600, which may be transferred to the recorder 
via the RBU. In the present embodiment, the RBU is programmed to prompt 
the patient to collect data at predetermined intervals, as described 
below. 
A. Infrared and Power Link 
A serial data link via infrared (IR) transmitters and receivers permits 
data transfer from the recorder to the RBU after the recorder is placed in 
the RBU 150 docking port. The RBU 150 detects when the recorder has been 
placed in the docking port and queries the recorder for status. When 
communications is established, the RBU 150 accepts recorded data or 
transfers new programming information to the recorder. A data format of 
9600 bits per second, with 8 data bits and one stop bit is preferably 
used. The first of four IR channels per docking port provides logic levels 
to indicate that the recorder is Busy with a measurement. The second IR 
channel indicates that the battery pack has a full charge, and the third 
and fourth IR channels are for transmit and receive data connections. 
B. Recorder to Remote Base Unit Operation 
The flow diagram of FIG. 18 is a description of the communication process 
1040 between the remote base unit (RBU) 150 and a recorder 160 (FIG. 2). 
Beginning at a start state 1042 of FIG. 18a, the process 1040 moves to a 
state 1044 wherein the recorder 160 is placed into one of the docking 
ports on the RBU 150, thereby activating the interlock switch 178 (FIG. 
3C), which indicates that a recorder 160 is docked. Moving to state 1046, 
when the recorder 160 is docked, the RBU 150 provides a +8.75 Volt DC 
source via a power lead to power the recorder 160 for data communications 
and operation. The recorder 160 is in a reduced power mode. An additional 
power lead provides a 600 mA constant current source to charge the battery 
pack of the recorder. A third lead provides a ground return path. The four 
Infrared (IR) channels are for receiving data, transmitting data, 
indicating that the RBU 150 is busy processing a request or previously 
sent data, and indicating full battery charge. When the recorder 160 is 
placed in the docking port 350, the presence of the +8.75 Volts from the 
base unit alerts the recorder 160 that it is docked. The RBU 150 then 
checks to determine if the Full Charge line is low and attempts to charge 
the battery if it is low. The RBU 150 charges the battery until the Full 
Charge line is true. 
The process 1040 moves on to state 1048 wherein the RBU 150 polls the 
recorder 160 to obtain status available by use of an Enquiry command. At 
state 1050, the recorder 160 responds with a Status Response message. The 
format of the Status Response is as follows: 
&lt;Recorder ID&gt;&lt;Serial Number&gt;&lt;Hardware Revision&gt;&lt;Software 
Revision&gt;&lt;BatteryType&gt;&lt;BatteryStatus&gt;&lt;DataStatus&gt;&lt;Recorder 
Status&gt;&lt;Date&gt;&lt;Time&gt;. 
The Data Status field in the Status Response indicates a number of readings 
value stored in the recorder. Moving to state 1052, the RBU 150 sends an 
Acknowledge signal to the recorder 160 to indicate reception of the status 
response. At state 1054, the process 1040 assigns a recorder object to the 
docking port 350 of the recorder 160. The recorder object includes a 
collection of functions specific to the type of recorder 160 and causes an 
icon, corresponding to the specific recorder type, to be displayed on the 
LCD screen 314 of the RBU 150. Moving to state 1056, the RBU 150 sends a 
Set Time message to the recorder 160 to synchronize the internal clock to 
the RBU 150. At state 1058, the recorder 160 sends an Acknowledge signal 
back to the RBU 150 to indicate reception of the message. 
The process 1040 moves to a decision state 1060 to determine if the number 
of readings value from the Status Report message is greater than zero, 
i.e., the recorder has data available. If so, the following sequence of 
states describes the transfer of data to the RBU 150. However, if the 
decision state 1060 proves to be false, the process continues at a 
decision state 1086. Moving from decision state 1060 to state 1062, the 
RBU 150 issues a Transmit Data Request message to the recorder 160 to 
initiate the data transfer. At state 1064, the recorder 160 sends an 
Acknowledge signal back to the RBU 150 to indicate reception of the 
message. Then at state 1066, the recorder 160 sends a Data Block message 
to the RBU 150. With the exception of Waveform data, each reading stored 
in the recorder is sent to the RBU 150 in a separate Data Block message 
having incrementing block numbers. A format is defined for data messages 
exchanged between the RBU 150 and the recorder 160. This format includes a 
message identification, message content and a cyclic redundancy checksum 
(CRC) for detecting error. Moving to state 1068, the RBU 150 stores the 
incoming Data Block message in volatile storage, such as a Ram disk file. 
The RBU 150 responds to the recorder 160 at state 1070 with an Acknowledge 
signal to indicate reception of the data. Moving to a decision state 1072, 
a determination is made whether the number of readings value equals the 
Data Block number, i.e., whether all Data Blocks have been sent by the 
recorder. If not, the process 1040 loops back to state 1066 to retrieve 
the next Data Block. 
When the last Data Block is sent to the RBU 150, as determined by decision 
state 1072, the recorder 160 sends an End of Transmission (EOT) message to 
the RBU 150. Moving to a decision state 1076, the process 1040 determines 
whether the maximum Data Block number equals the number of readings value. 
If not, the process 1040 moves to a decision state 1110 for error handling 
that will be described hereinbelow. If the decision state 1076 proves 
true, the process 1040 moves to a decision state 1078 to determine if any 
errors occurred during transmission or transferal of data. The CRC is 
utilized at state 1078. If an error is detected, the process 1040 moves to 
the decision state 1110 for error handling. If no errors are detected at 
decision state 1078, the process 1040 continues at state 1080 wherein the 
data temporarily stored in the volatile storage, e.g., Ram disk file, is 
transferred to non-volatile storage, and the file is deleted. Moving to 
state 1082, the RBU 150 issues a Clear Data Request message to command the 
recorder 160 to delete all its stored data. At state 1084, the recorder 
160 sends an Acknowledge signal back to the RBU 150 to indicate reception 
of the message. The data transfer sequence of states is now completed. 
Moving to a decision state 1086, the process 1040 determines if an update 
of the recorder configuration is required. The recorder configuration may 
be changed, for example, to modify the frequency that a measurement is 
performed. A nurse or doctor transmits information necessary for states 
1086 and 1088 to the RBU 150. Based on this information, if an update is 
required, the process 1040 moves to state 1088 wherein the RBU 150 issues 
a Recorder Configuration message to the recorder 160. At state 1090, the 
recorder sends an Acknowledge signal back to the RBU 150 to indicate 
reception of the message. 
At the completion of state 1090 or if decision state 1086 proves to be 
false, the process 1040 moves to state 1092 to begin an idle loop, through 
state 1100, that polls to see if new data has been collected. At state 
1092, the RBU 150 issues a Status Request message to the recorder 160. 
This request is made periodically at predetermined time intervals, as 
dictated by the session protocol. Moving to state 1094, the recorder 160 
sends an Acknowledge signal back to the RBU 150 to indicate reception of 
the message. Continuing at state 1096, the recorder 160 sends the Status 
Report message back to the RBU 150 to which the RBU 150 responds at state 
1098 with an Acknowledge signal back to the recorder to indicate reception 
of the message. Moving to a decision state 1100, the process 1040 
determines if the Status Report indicates new status, such as the 
collection of new data. If not, the process 1040 loops back to state 1092 
to repeat the idle loop. However, if the decision state 1100 determines 
that a change in status has occurred, the process 1040 moves to state 1056 
to repeat part of the previously described sequence of states. 
If an error is detected by either of the decision states 1076 or 1078, the 
process 1040 moves to decision state 1110 to determine if the maximum 
number of transmission retries has been reached. The maximum number of 
retries is a predetermined number, typically three, that indicates the 
number of times the process 1040 directs the RBU 150 to attempt the data 
transfer from the recorder 160. If the maximum number is not reached, the 
process 1040 moves to state 1112 and increments the retry count by one, 
and then loops back to state 1062 wherein another Data Request message is 
sent to the recorder 160. If the maximum number of retries is reached, as 
determined at decision state 1110, the RBU 150 issues a Cancel command to 
the recorder 160 at state 1114. Further data transmission attempts from 
the recorder 160 are canceled at this time. Moving to state 1116, the 
process 1040 waits for an asynchronous interrupt to indicate that the 
recorder 160 is removed from the docking port 350 of the RBU 150, or that 
the start button of the recorder 160 is pressed while the recorder 160 is 
in the docking port 350. Because these two activities occur 
asynchronously, the process 1040 periodically checks for the corresponding 
interrupt and initiates an appropriate task as will be shown in FIGS. 18b 
and 18d. 
Referring to FIG. 18b, the asynchronous task 1128 that is performed in 
response to the interrupt for when a user presses the start button while 
the recorder 160 is in the docking port 350 will be described. Beginning 
at a start state 1130, the task 1128 moves to state 1132 wherein the user 
initiates a measurement cycle by pressing the start button on the recorder 
160. Alternatively, the recorder 160 begins a scheduled session. Moving to 
state 1134, the recorder asserts a Busy signal during the measurement. The 
Busy signal alerts the RBU 150 that the recorder is busy. Proceeding to 
state 1136, the RBU 150 charge current to the recorder 160 is removed, if 
previously applied. Charging is suspended during the time of measurement. 
Continuing at state 1138, periodic communication between the RBU 150 and 
the recorder 160 is suspended until the Busy signal is deasserted. Because 
of the Busy signal, the RBU 150 does not post an error message when the 
Status Response is not received from this docking port 350 during an idle 
loop poll (state 1092). The measurement is now taken by the recorder 160. 
Moving to state 1140, when the measurement is complete, the recorder 160 
deasserts the Busy signal. At state 1142, the RBU 150 reestablishes the 
charging and polling operations with the recorder 160. The task 1128 ends 
at state 1144. The recorder 160 waits for the next poll from the RBU 150. 
The RBU 150 will then extract the data from the recorder 160. The data 
from the recorder 160 is then stored in RBU 150 memory and may be 
transmitted at the end of a scheduled session or when the patient 
indicates transmission to the care center 600. 
Referring to FIG. 18d, the asynchronous task 1168 that is performed in 
response to the interrupt for when the recorder 160 is removed from the 
docking port 350 will be described. Beginning at a start state 1170, the 
task 1168 moves to state 1172 wherein the port detect is deactivated by 
the removal of the recorder 160 from the docking port 350, as previously 
described. Proceeding at state 1174, all communication between the 
recorder 160 and the RBU 150 is halted. Continuing at state 1176, the RBU 
150 charge current, if applied, is removed from the recorder 160 along 
with the operational supply voltage. The task 1168 ends at state 1178. 
Referring to FIG. 18c, a background task 1148 for the charge current will 
be described. Task 1148 utilizes the temperature of the recorder battery 
pack and the ambient temperature to determine when the battery pack is 
fully charged. Task 1148 is repeated every 24 hours, although other time 
intervals may be used in other embodiments. Beginning at a start state 
1150, task 1148 moves to state 1152 wherein the recorder deactivates the 
Charge Enable signal when, in the preferred embodiment, the temperature of 
the recorder battery pack is ten degrees Celsius above the ambient 
temperature. Proceeding to state 1154, the RBU 150 responds by removing 
the charge current to the recorder 160 and then waiting 24 hours at state 
1156. After the 24 hour interval, the task 1148 continues at state 1158 
wherein the RBU 150 reapplies the charge current to the recorder battery 
pack and repeats the charging cycle. The task 1148 continues by looping 
back to state 1152 wherein the Charge Enable signal is deactivated at the 
appropriate time. 
IX. Human Interface Process Flow 
A. Session Procedure Flow 
FIG. 19 is a state diagram of the Session Procedure Flow of the Perform 
Specified Task Function shown in FIG. 16. A session is initiated when the 
patient presses the SESSION icon on the touch screen 314 of the RBU 150 
and runs a session through selection of an item on the session screen in 
state 1200. 
When the session screen in state 1200 is selected, a number of icons are 
illustrated on the screen. Each of the states 1212, 1214, 1202, 1204, 1206 
and 1208 represents an icon. As shown in FIG. 19, state 1212 represents 
the Help icon, state 1214 represents the Message Display icon, state 1202 
represents the Home icon, state 1204 represents the Error icon, state 1206 
represents the Emergency icon and state 1208 represents the Activity icon. 
The CANCEL key represented in state 1210 may also be selected to return to 
the previous screen as shown in state 1232. 
By selecting one of the icons, an associated session is stared. The session 
will end or be ended if any of the following occurs: the patient completes 
all activities; the CANCEL key in state 1212 is pressed while in the 
session screen 1200; the HOME icon in state 1202 is pressed; the EMERGENCY 
icon is pressed; or a timeout occurs due to patient inactivity. 
The Activity icon in state 1208 is the mechanism by which all tests within 
a session are invoked. Each of the icons displayed must be pressed and the 
subsequent test performed, as shown in state 1226, before remaining 
activities are checked (state 1228). Upon checking the remaining 
activities (state 1228), the user may return to the session screen 1200, 
or declare a session completed (state 1230) and return to a previous 
screen (state 1232). As each scheduled test is performed, the associated 
activity icon will be removed. 
The Error icon shown in state 1204 is active only when a system error has 
occurred within the RBU 150, such as a recorder 160 communication failure. 
Pressing this icon will invoke a text display to prevent the error message 
(state 1220) and, where possible, a solution to the problem. 
The Home icon shown in state 1202 is always active. Pressing this while a 
session is in progress will cancel the session (state 1216) and return the 
user to the HOME screen (state 1218). 
The Emergency icon shown in state 1206 is always active. Pressing this icon 
while a session is in progress will cancel the session (as shown in state 
1222), and then invoke the Nurse Emergency Routine shown in state 1224. 
The Message icon shown in state 1214 is active only when there is an unread 
message from the care center 600. Pressing this icon will invoke a text 
display to present the message, as shown in state 1240. After displaying 
the message, the user may return to the Session Screen 1200. 
The Help icon in state 1212, when selected, will present a listing of the 
type of help required, as shown in state 1234. The user may select from 
the following types of assistance: 
Should I call my Doctor? 
Activity Help 
Base Unit Tutorial 
Information Library 
Upon selecting one of the above, information will be provided to the user. 
For example, when the Activity Help icon is pressed as shown in state 
1236, the Activity Help Menu is presented (stated 1238). This menu is 
illustrated in FIG. 20 and discussed in the following text section. At any 
given time, the user may return to the Session Screen 1200. 
B. Activity Help Function & Flow 
FIG. 20 is a state diagram of the Activity Help Menu Flow of the Perform 
Human Interface Function shown in FIG. 6. As illustrated, the Activity 
Help Menu 1250 provides a listing of the instructions available for each 
of the tests to be conducted in monitoring and support treatment of 
at-risk pregnancy. In the present embodiment, the patient may select 
instructions for performing the tests required to monitor fetal heart rate 
1252, uterine activity 1254, blood pressure 1260, urinalysis 1258, body 
temperature 1266, body weight 1262, kicks and contractions 1256 and blood 
glucose 1268. The patient may also obtain instructions regarding the use 
of the infusion pump 1270, his sleep or rest schedule 1264 and answering 
of the questionnaires 1272. Option tests may be listed on the Activity 
Menu 1250, as indicated by Circle 1274. 
By selecting one of the listed items on the Activity Help Menu 1250, they 
user will access test instructions corresponding to the listed 
tests/questionnaire/schedules 1252-1274. 
For instance, when the user selects the fetal heart rate test instructions 
1252 from the Activity Help Menu 1250, a display of the fetal heart rate 
help instructions 1276 will be illustrated on the LCD screen of the RBU 
150. Likewise, instructions 1278-1298 corresponding to the other tasks 
1254-1274 may be obtained. 
Examples of the test instructions are listed below. 
1. Fetal Monitor (both UA and FHR) 1252 
I will record your uterine activity and your baby's heart rate for 60 
minutes. You will be letting me know when your baby moves by pressing KICK 
and when you feel a contraction by pressing CONTRACTION. If you need to 
interrupt me, please press PAUSE. Be sure to start again within 15 minutes 
or I will need to restart my clock at 60 minutes. 
Let's start by plugging the uterine activity and fetal heart rate sensors 
into my fetal monitor recorder. Now you can get into a comfortable 
reclining position, tilted to one side. A pillow under your hip can make 
it easy! Your baby would like you to stay tilted when you are lying 
down--not flat on your back. 
Watch the displays on my recorder's screen. I will help you with every step 
! 
2. Fetal Monitor Recorder (UA only) 1254 
I will record your uterine activity for 60 minutes. You will be letting me 
know when you feel a contraction by pressing CONTRACTION. If you need to 
interrupt me, please press PAUSE. Be sure to start again within 15 minutes 
or I will need to restart my clock at 60 minutes. 
Let's start by plugging the uterine activity sensor into my fetal monitor 
recorder. Now you can get into a comfortable reclining position, tilted to 
one side. A pillow under your hip can make it easy! Your baby would like 
you to stay tilted when you are lying down--not flat on your back. 
Watch the displays on my recorder's screen. I will help you with every step 
3. Fetal Kick Count 1256 
I will record your baby's movements. You will let me know when your baby 
moves by press the event switch each time. I will let you know when I am 
finished. If your baby does not move at all during the next hour please 
call your HPS nurse. 
4. Blood Pressure Recorder 1260 
I will be recording your blood pressure and pulse rate. Be sure that you 
refrain from extreme exertion, eating, smoking, and extreme heat and cold 
for 15 minutes prior to each recording. 
Let's start by plugging the cuff into my blood pressure recorder. Now you 
can get into a comfortable position, tilted to your left side. A pillow 
under your hip can make it easy! Use the arm that is on top of your body. 
All tight clothing should be removed from that arm. Slide your arm into 
the cuff so that the bottom of the cuff is 1-2 inches above your elbow at 
about the level of your heart. 
Tighten the cuff securely. Support your arm on your lap, table, or chair 
armrest. Be as still as possible during the recording! 
Watch the displays on my recorder's screen. I will help you with every step 
5. Urinalysis Recorder 1258 
I will be analyzing your urine for the presence of several substances. It 
is best to use the first urine of the morning for this test. To obtain a 
midstream urine sample, begin to urinate, stop the flow for a second, then 
begin the collection. 
Make sure to have your bottle of urine strips handy. Watch the displays on 
my recorder's screen. I will help you with every step 
6. Temperature 1266 
I will be recording your body's temperature. Be sure that you do not eat, 
drink or smoke for 15 minutes prior to taking your temperature. 
Let's start by putting a sheath on the temperature probe. Then place the 
probe in your mouth under your tongue. I will let you know when I have 
finished by displaying your temperature. 
7. Weight/Scales 1262 
I will be recording your body weight. Be sure that you weigh yourself at 
the same time each day wearing the same amount of clothing. 
Step up onto the scale pad. I will let you know when I have finished by 
displaying your weight. 
C. User Initiated Testing Flow 
FIG. 21 is a state diagram of User Initiated Testing Method of the Perform 
Human Interface Function shown in FIG. 16. As illustrated, the user may 
initiate the performance of a range of tests. 
User Initiated Testing (state 1310) is the mechanism by which a patient can 
perform any test function manually. It is similar in look and feel to the 
Session Screen (FIG. 19) in that the Activity Icons displayed across the 
top of the screen are used to initiate the tests. User initiated testing 
does not operate as a menu. General Icon functions are limited or modified 
in order to control system access. The Activities themselves are shown in 
FIG. 20 and the corresponding text sections. 
When User Initiated Testing is selected (state 1310), the user may access 
the Activity Icon (except the Questionnaire) (state 1328), the Help Icon 
(state 1312), the Message Icon (state 1314), the Home Icon (state 1316), 
the Error Icon (state 1318), the Main Menu Icon (state 1320), the Cancel 
Key (state 1324), and the Questionnaire Icon (state 1326). 
The Help Icon (state 1312), Message Icon (state 1314), Home Icon (state 
1316), Error Icon (state 1318), Cancel Key (state 1324) are similar to 
those available in the Session Screen feature discussed above. 
The Activity Icon (state 1328) invokes all tests (state 1352), except for 
the Questionnaire, which is accessed by pressing the Questionnaire Icon 
(state 1326). Pressing the Questionnaire Icon as shown in state 1326 
invokes the Questionnaire Menu (state 1346). Once in the Questionnaire 
Menu, the user first selects the type of Questionnaire he wants to respond 
to, as indicated by state 1348. He then answers each question (state 1350) 
and may return to the Questionnaire Menu (state 1346) to answer more 
questions by touching the touch screen 314 (state 1348). 
X. Exemplary Demonstration Sequence 
FIG. 22 is a flow diagram of an exemplary demonstration sequence of the 
patient monitor and support system of the present invention, configured 
for monitoring at-risk pregnancies. The sequence 1358 is used to 
illustrate typical steps of interaction between a user and the remote base 
unit (RBU) 150, but is not intended to show an actual set of steps. The 
sequence 1358 is also an example of the manual user initiated testing 
described above. 
Beginning at a start state 1360, the sequence 1358 moves to state 1362 
wherein an introduction screen is presented to the user of the system on 
the LCD 312 of the RBU 150 (FIG. 4.) This screen has instructions to the 
user of the system. The actual system software produces a set of 
introductory screens. For example, in the demonstration of the system 50 
being used to monitor high risk pregnancy, the following text may be 
provided: 
______________________________________ 
ANTENATAL (OB1) TUTORIAL 
______________________________________ 
I am your OB1 system. 
You can interact with me by pressing 
or touching the screen lightly. 
When you plug the system into the 
outlet (110 Volts) you have given 
power to my system. 
Please place all of the Recorder 
units into the base. 
Once the system has power, the 
system will display your name and 
the time. 
You will have a HOME screen which 
will be the starting point for all 
functions I need to perform with 
you. 
You will always be able to return to 
the Home screen. The Home screen 
will display your next Scheduled 
Session time. 
A "Session" is the activities and 
monitoring tests which have been 
prescribed by your doctor. 
Your doctor has set up a schedule of 
monitoring tests for you and your 
baby. 
When it is time for your session, I 
will alert you with an alarm. The 
alarm will give you a warning period 
to begin your session. 
After pressing the Session button, 
the activity test buttons will be 
displayed. You will need to press 
the button which is blinking. 
To complete your session you must 
push the test buttons until they 
have all disappeared. 
Once you finish your session's 
activities, you will return to the 
HOME screen. 
The HOME screen will now show the 
next scheduled session time. 
If you have any questions please 
press the Main Menu button. The 
Main Menu provides access to all of 
the system help. 
The Main Menu provides access to: 
Schedules Sessions 
User Initiated Testing 
Help Menu 
System Menu 
Please refer to the Main Menu to 
access these programs to assist you. 
You will always have the Emergency 
button on the lower right corner of 
the screen. If you press this 
button, you will get phone numbers 
to: 
Your doctor, 
Your Healthdyne Center, and 
Your local Hospital. 
If you have any questions. Please 
press the Main Menu button. The 
Main Menu provides access to all of 
the system help. 
______________________________________ 
After the introductory screen has been displayed, the sequence 1358 moves 
to state 1364 wherein the user lightly presses the next screen icon on the 
LCD display to advance to the next screen of information. At state 1366, a 
list of antenatal capabilities, such as oral maternal temperature, uterine 
contractions, maternal weight, maternal blood pressure, fetal heart rate, 
and other capabilities, are displayed for the user. Moving to state 1368, 
the user presses the next screen icon to advance to a screen wherein a 
choice of care plans is presented to the user. Decision state 1370 
determines whether the user selects the preeclampsia care plan at state 
1372 or the preterm labor plan at state 1374. States 1372 and 1374 display 
screens corresponding to the selected care plan with the associated 
activity test buttons. The user presses the test button that is blinking 
to perform the monitoring test or activity corresponding to the test 
button. When a test is completed, the next test button blinks. The user 
then presses the next blinking test button to perform the next test and so 
forth until all test buttons have been pressed. 
When the sample session activities have been completed at either state 1372 
or 1374, the sequence 1358 continues at state 1376 wherein the user 
presses the weight icon. Moving to state 1378, the maternal weight 
measurement is performed by use of a load cell scale connected to the RBU 
150. Proceeding to state 1380, the user presses the questionnaire icon. 
Depending on the selection determined at decision state 1370, the sequence 
1358 determines the corresponding care plan questionnaire at state 1382. 
If preterm labor is selected, the sequence 1358 moves to state 1384 
wherein a PO Tocolytics questionnaire is displayed for the user to answer. 
The questionnaire is similar to the following: 
______________________________________ 
PO TOCOLYTIC PATIENTS 
______________________________________ 
Cramping? Pelvic Pressure. 
1 Yes 2 No 1 Yes 2 No 
Backache? Discharge? 
1 Yes 2 No 1 Yes 2 No 
Is uterine irritability present? 
Shortness of breath? 
1 Yes 2 No 1 Yes 2 No 
Jitters? 
1 Yes 2 No 
______________________________________ 
If preeclampsia is selected, the sequence 1358 moves to state 1386 wherein 
a hypertension (or preeclampsia) questionnaire is displayed for the user 
to answer. The hypertension questionnaire is similar to the following: 
______________________________________ 
HYPERTENSION PATIENTS 
______________________________________ 
Edema? 
1 Yes 2 No 
Headache? 
1 Yes 2 No 
Epigastric pain? 
1 Yes 2 No 
Visual disturbances? 
1 Yes 2 No 
______________________________________ 
When either of the questionnaires at state 1384 or 1386 is completed, the 
sequence 1358 moves to state 1388 wherein a session complete screen is 
displayed, including a blinking telephone icon to simulate data 
transmission to the care center. Moving to state 1390, the user presses 
the next screen icon to advance to the next screen. At state 1392, the 
Home screen is displayed which has the capabilities listed. The sequence 
1358 ends at state 1394. 
The unique features and functions of the patient monitor and support system 
50 provide quality medical care to a plurality of patients with improved 
cost effectivity and outcomes. This is accomplished through comprehensive 
managed care, tailored to the patients' specific and individual medical 
history, and acute clinical needs. The present system 50 enables more 
patients to be treated per medical case infrastructure unit and thereby 
provides an increase in the productivity of medical and paramedical 
personnel. 
In addition, the system 50 can be configured to monitor a variety of 
medical conditions and treatments, including hypertension, at-risk 
pregnancies, human organ flow such as kidney dialysis and liver support, 
cardiovascular diseases and immune system diseases. It can also monitor 
specific disease states, including parameters, subsystem component 
hardware, software, instructions, schedules, communication protocols, 
medication protocols, therapeutic devices, etc. 
Moreover, the system 50 provides improved patient care and outcomes because 
of the same specific assigned team of physicians, nurses, and paramedical 
personnel to the individual throughout the course of care which reduces 
the learning factor involved with new or changing personnel., i.e., 
hospital shifts. 
In summary, the patient monitor and support system 50 includes a number of 
patient sites 100 which are individually connected via a set of 
communications links 500 to a care center 600. A subsystem at each of the 
patient sites 100 has control and data acquisition capabilities and may be 
configured to automatically transfer patient communications and data to 
the care center 600. The subsystem is controlled by a remote base unit 150 
which can down load from the care center 600 computer Patient 
Identification and Operating files to the base unit 150 in the home 
initialization and operating protocol files specific to that particular 
patient. Examples of these files include: medication schedules, blood 
pressure protocols, patient identification data, patient logistical data, 
parameter thresholds, auto dial phone numbers and schedules, call-in 
schedule, infusion pump settings and patient specific qualitative data 
questionnaires (relating to her present progress). 
The base unit 150 at the patient sites 100 auto-dials the care center 600 
on scheduled intervals and sends data to auto-receiving units which 
operate unattended. This ability provides for substantial savings in phone 
costs as well as human labor costs. The auto receiving units make the 
latest data available to the computer at the work station 650 which, among 
other capabilities: 
a. Provides for qualified clinical reading and interpretation of data; 
b. Provides for LAN 700 (local area network) communication with the center 
computer 660 for the purpose of updating the patients file and permanent 
record with both qualitative and quantitative data; 
c. Provides for compilation, printing, and/or transmission of the patients 
record to the physician at appropriate intervals; 
d. Provides the mechanism for special patient communications and 
instructions as well as instrumentation settings via the modem down link 
to the home base unit 150; 
e. Provides the vehicle for recording and implementing physician 
instructions and changes in protocol. 
The patient monitor and support system 50 is human engineered to make all 
operations as simple and user friendly as possible. The LCD display 312 on 
the home base unit 150 provides a communicative means to insure patient 
compliance with nor only the measurement regimes but other physician 
directed activities and therapy such as medication, diet and nutrition, 
exercise, sleep and rest periods, etc. 
Finally, the care center database 600 provides information for medical 
research, supportive records for medico-legal purposes, and most 
importantly a tool for comparative analysis of patient progress against 
peer cases. 
Although the preferred embodiment of the present invention has been 
described and illustrated above, those skilled in the art will appreciate 
that various changes and modifications to the present invention do not 
depart from the spirit of the invention. Accordingly, the scope of the 
present invention is limited only by the scope of the following appended 
claims.