Draft SRS - FGCU



Final SDD

For 80047 ISM 4331

H.I.S. Patient Monitor System

Software Design Description

PMS SDD Final Ver. 4.4

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Group 5: H.I.S. Patient Monitor System

Individual SDD work estimations and signature:

Pascal Benoit: 5 % _________________________

Mike Cormier: 55 % _________________________

Barry Hom: 40 % _________________________

For FGCU assignment due 11-18-03

Table of Contents

1. Introduction…………………………………………..……………..….……….….4

1.1 Purpose……………………………….………..………….……………….…..4

1.2 Scope………………………………….……..…………….……………….….4

1.3 Definitions…………………………………..………….………….……….….5

1.4 References…………………………………..…………………….……….…..6

2. Decomposition Description……………………..…..…………..…….………..…..7

2.1 Module Decomposition…………….……………….…………………………7

Figure 2.1.1 Architectural Diagram…..…………………………….……………..7

Figure 2.1.2 Module Diagram……………………………………………………..8

Figure 2.1.3 Class Diagram………………………………………………………..9

2.1.1 Communication Module description….….…..….………………………….9

2.1.2 Display Module description……………..…...…………………..…….10

2.1.3 Options Module description………….….…….……...………….…….10

2.1.4 Main Control Module description………..…….…….…………….…..10

2.2 Concurrent Process Decomposition………….………….…….…….……..……11

Figure 2.2 Module Concurrent Processes…………….………………….…...12

2.2.1 Main Control Module Process description……….………………….…13

2.2.2 Communication Module Process description……..……………….…...13

2.2.3 Alarm Module Process description……………….………….……...….13

2.2.4 Option Module Process description……………….………….…….…..13

Figure 2.3 Data Diagram..………………….….….…………………….…….14

3. Dependency Description..…………………………………..………...…….........14

3.1 Intermodule Dependencies…..…………………….…..…….….....................14

3.2 Interprocess Dependencies…………………………….….…..……….…......15

Figure 3.3 Data Dependency Diagram……………………………………….15

3.3 Data Dependencies…………………………………….……………..………14

4. Interface Description………………………………..…………….…….....……..15

4.1 Module Interface…….……………………..…………….….………..……...15

4.1.1 Communication Module description…….……..………………..……..15

Figure 4.1.1 Communication Module……………………………….…16

4.1.2 Display Module description……………….………………..………….16

Figure 4.1.2 Main Control Module…………………………………….17

4.1.3 Options Module description………………….….…...…………..……18

Figure 4.1.3 Options Module…………………………………………..19

Figure 4.1.5 Display Module…………………………………………...19

4.2 Process Interface……………………………………………………….…….19

Figure 4.2 Process Interface Diagram………………………………………..20

5 Detailed design………………………..…..……………………………………....20

5.1 Module Detailed Design………..……………………………………………20

5.1.1 Communication Module detail………….………………………………20

5.1.2 Display Module detail…..………………………….….….…….………20

5.1.3 Alarm Module design……………………….…….….…………………21

5.1.4 Main Control Module design..….…………….…………….……….......21

5.2 Data detailed design……………………………………………………….…..21

5.2.1 Patient Data detail.……………….………………………...……………21

5.2.2 EKG Data detail…………………..……………………………………..21

5.2.3 Pulse Data detail…………………..………………………..………..….21

5.2.4 Body Temperature Data detail……………………..…………….……...21

6 Pseudocode………………………………………………………………………...23

7 Appendices………………………………………………………………………...26

7.1 Appendix #1: Minutes of Meeting #1………………………………………….27

7.2 Appendix #2: Minutes of Meeting #2…………………………………………28

7.3 Appendix #3: SDD Verification and Evaluation……………………………….29

Anomaly List…………………………………………………………………..30

Inspection Anomaly Summary…………………………………………………31

7.4 Appendix #4: SRS Traceability Matrix……………………………………...…32

7.5 Appendix #5: ADC Technical Data……………………………………………34

7.6 Appendix #6: ADC Tester Data………………………………………………..35

1. Introduction

1.1 Purpose

This Software Design Description (SDD) [4] represents the software needed for

the Patient Monitoring System [2]. This SDD gives software design information

for use by the software development team, as well as project managers, system

designers, programmers, testers, and maintainers.

The Patient Monitoring System (PMS) accepts analog measurements converted

to digital signals by a SuperLogics ADC-1 [9] and sent to a Windows 98

computer Com port as specified [10]. The PMS software displays graphical and

numeric representations of the original analog patient sensor outputs.

This SDD shows four G.U.I. designs implemented in Visual Basic 6. However,

the final coding is specified as a Java applet able to run in a browser [2]. The

pseudo code provided in this SDD is done in Java.

This SDD provides entity attribute information from four specified [4] design

views: a decomposition description, a dependency description, an interface

description, and a detail description. These views conform to specifications [4].

1.2 Scope

The Patient Monitor System (PMS) [2] conforms to the specific requirements of

the Digital Hospital and Medical Information System (HIS) [3] for its Real-Time

Patient Monitoring System (PMS) [3]. This software SDD follows international

specifications set by the IEEE standards for SDDs [4].

The PMS [3] accepts existing analog patient monitoring inputs and will output

a graphic display for EKG and six numeric displays for EKG, Oximeter, systolic

blood pressure, diastolic blood pressure, mean blood pressure, and for body

temperature. The PMS will also display text for Patient ID and time of day [3].

The values must be within 3% of actual value and display remotely within 5

seconds. This PMS also provides a standard pulse oximeter graphical display.

1.3 Definitions, acronyms, and abbreviations [1].

1.3.1 AES. Advanced Encryption Standard.

1.3.2 ASP. Application Service Provider.

1.3.3 Diastolic Blood Pressure. The diastolic pressure represents the pressure at which a heart’s aortic valve closes.

1.3.4 DOB. Date of Birth

1.3.5 DSP. Distributed Services Provider.

1.3.6 EKG. An EKG (or ECG) graphically and numerically represents the

difference in signals between two to six heart sensors placed on a patient’s chest. These representations conform to universal standards.

1.3.7 EKG Oscilloscope Monitor. An EKG monitor displays a heart rate

represented by a graphical waveform interpreted from the sensor outputs. The sensor outputs and monitors are usually proprietary and

brand specific, although their displays conform to universal standards.

1.3.8 FAT32. File Allocation Table 32 Bit, a digital encoding standard.

1.3.9 Fps. Frames per second, a reference to video speed.

1.3.10 HIPAA. This is an acronym for the Health Insurance Portability and

Accountability Act of 1996.

1.3.11 H.I.S. Health Information System. This Patient Monitor System

(PMS) is part of the overall Health Information System (HIS). Refer

to 1.4 References [1], page 6.

1.3.12 ISO 8601. A standard format for representing date and time

recommended by the International Organization for Standardization.

1.3.13 JPEG. Joint Photographic Experts Group. This is another digital

image standard.

1.3.14 Non-Digitized Professionals. The H.I.S. SRS [1] specifies NDRs as

health-care providers who have no access to digital records through

lack of hardware, software, or preference to legacy flat file charting

methods.

1.3.15 PMS. The Patient Monitoring System. A “real-time” software

program which displays a digital graphic representation of up to 8

analog patient sensor outputs sent to a computer’s serial COM port

from a SuperLogics ADC-1 analog to digital serial capture device

[3], as specified in the H.I.S. S.R.S. [1]. This SDD describes that

software program (HIS/PMS or PMS).

1.3.16 Pulse Oximeter. An oximeter device represents the percentages of

oxygenated hemoglobin in a bloodstream; a pulse representation.

1.3.17 SDD. Software Design Description. [4].

1.3.18 SDLC. This is an acronym for a Systems Development Life Cycle.

1.3.19 SRS. Software Requirements Specification [5].

1.3.20 Systolic Blood Pressure. The systolic pressure represents the peak pressure in an arterial system.

1.4 References

[1] Alhir, Sinan Si, Learning UML, O’Reilly & Associates, Sebastopol,

California, 2003.

[2] Benoit P., Cormier M., Hom B., Patient Monitor System SRS, Florida

Gulfcoast University, Fort Myers, Fl., October, 2003

[3] Ciliberti J., Hoyt E., Mack B.,and Lewis J., Digital Hospital and Medical

Information System SRS, Florida Gulf Coast University, Fort Myers,

Fl., September, 2002.

[4] IEEE Recommended Practice for Software Design Descriptions,

IEEEE Std. 1016-1998, New York, New York, September 23, 1998.

[5] IEEE Recommended Practice for Software Requirements Specifications,

IEEEE Std. 830-1998, New York, New York, June, 1998.

. [6] Hewlett-Packard, HP Viridia Component Monitoring System User’s

Guide, Hewlett-Packard GmbH, U.S.A., 1998.

[7] Masimo Corporation, Radical Signal Extraction Pulse Oximeter

Operator’s Manual, Irvine, California, 2002.

[8] Quatrani, Terry, Visual Modeling With Rational Rose 2002 And UML,

Addison-Wesley, Pearson Education, Inc., Boston, Maryland, 2003.

[9] SuperLogics, ,

September, 2003.

[10] SuperLogics, ADC/DIG User’s Manual, SuperLogics, Newton, MD,

May, 2001.

2. Decomposition Description

2.1 Module Decomposition

The PMS software will be composed of the I/O information shown below in the

PMS Architecture Diagram, figure 2.1.1; the Module Diagram, figure 2.1.2; and

the Class Diagram, figure 2.1.3.

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Figure 2.1.1 Architectural Diagram

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Figure 2.1.2 Module Diagram

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Figure 2.1.3 Class Diagram

2.1.1 Communication Module description

The Communication Module will be a user interface that saves default

settings to communicate with the ADC-1 data capture device through a

chosen Com port and port speed, using digital commands.

This module will receive digital inputs from the ADC for up to eight

analog devices which are hooked to the ADC data capture device.

This module uses its default timing settings to poll all eight devices in turn.

This module will output data for the eight devices and any error messages

to the Main Control Module.

2.1.2 Display Module description

The Display Module will be an interface used by the Main Control Module.

This module will display the moving graphic diagrams, the numeric values,

and the alarm values for eight possible devices hooked to the ADC device.

The module will flash the display when an Alarm value is reached.

This module receives input from the Main Control Module.

2.1.3 Options Module description

The Options Module will be a possible user interface to implemented at a

later time when the HIS [?] interface requires these capabilities.

Saving and Printing will effectively terminate the data inputs from the ADC

unit and the reliability and need for streaming video is currently being

studied. Use of the Internet for vital patient monitoring is being studied.

2.1.4 Main Control Module description

The Main Control Module is the primary User Interface. This module will

receive inputs from the Communication, Alarm, and Options Modules.

This module outputs to the display module. User selections made to the

Main Control Module will control the functions of the overall PMS [?]

software. The Main Control Module also displays any Error Messages

from the Communication Module or the future Options Module.

2.2 Concurrent Process Decomposition

The PMS software will include the concurrent processes shown on the next page

in the Module Concurrent Processes diagram, Figure 2.2.

Each Module’s Concurrent Processes will be detailed in following sections.

Most user actions are handled by the Main Control Module which outputs to the

Display Module. These two modules are displayed together whenever the PMS

is running. The other Modules are also active, but only displayed when selected.

Status of the Communication Module is displayed in the Main Control Module.

The Communication Module inputs and outputs via the selected COM port to the

ADC device. The ADC device is hooked to the analog patient sensors.

The Communication Module retains the communication settings. This module

passes the ADC sensors’ data and any error messages to the Main Control Module.

Starting and stopping of the Communication Module is done by User Input to

the Main Control Module. The Main Control Module also displays any error

messages from the Communication Module.

The Alarm and Options Modules store their respective settings and output any

User Inputs to the Main Control Module. The Main Control Module flashes

a warning when any Alarm Setting is reached and also resets the alarms from

User Input. The Alarm and Options Module are User Interfaces and Processes.

The Options Module is not active in this iteration of the PMS. The Options

Module will later store settings and the Main Control Module will display separate

forms when the User selects one of the Options.

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Figure 2.2 Module Concurrent Processes

2.2.1 Start PMS

The user starts the PMS and adjusts the settings through the Main Control Module on the display. The user can make different selections among communications, alarms, options, starts and stops, and to exit the PMS.

2.2.2 Communications

The Communications Module is adjusted by the user through the Main Control Module. The Communications Module passes the user adjustments to the ADC. The data and error message from the ADC sensors are passed back to the Main Control Module.

2.2.3 Alarms

The Alarms can be adjusted by the user. The alarms are monitored by the Main Control Module. The displays flash a warning when data is passed from the alarms.

2.3 Data Decomposition

The data will be grouped together in the manner in which it is collected or inputted.

A Data diagram, Figure 2.3, is provided on the next page.

2.3.1 Patient Data

Patient Data has the Patient ID (first name and last name), the current date, and the current time. Patient Information is user adjustable.

2.3.2 EKG Data

EKG Data will be collected from disposable electrode sensors.

2.3.3 Pulse Data

Masimo finger sensors will collect pulse information. Pulse data will include pulse oximeter outputs, systolic pressure, diastolic pressure, and mean pressure.

2.3.4 Body Temperature Data

Body Temperature Data will be collected through an alternative sensor. Figure 2.3

Below shows a Data Diagram.

Figure 2.3 Data Diagram

3. Dependency Description

3.1 Intermodule Dependencies

The two modules are the inputs coming from the patient into the H.I.S. and the outputs from the H.I.S. to the display. From the finger sensors, chest sensors, and other alternate sensors, data on the EKG, pulse, and body temperature are sent to the H.I.S. The H.I.S. processes this information and outputs it to a display. The display shows the data in an

understandable and useable form so the user can interpret and understand the data properly.

3.2 Interprocess Dependencies

The main data process occurs in the ADC-1 device in the H.I.S. The Communications Module passes data from the ADC sensors to the Main Control Module, where the data is displayed.

3.3 Data Dependencies

The ADC-1 device depends on data from the patient so it can pass it along to the user.

A Data Dependency diagram, Figure 3.3, is provided below.

Figure 3.3 Data Dependency Diagram

4. Interface Description

4.1 Module Interfaces

4.1.1 Communication Module

The Communication Module will receive digital inputs from the ADC for up to eight analog devices, which are hooked to the ADC data capture device. Figure 4.1.1 shows the Communication Module.

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Figure 4.1.1 Communications Module

4.1.2 Main Control Module

The Main Control Module has the main controls and does the main data processing. Figure 4.1.2 below shows the Main Control Module.

The Main Control Module is a user interface that will receive inputs from the Communications and Options Modules.

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Figure 4.1.2 Main Control Module

4.1.3 Options Module

Options Module will be implemented at a later time. A proposed interface is shown

below in Figure 4.1.3.

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Figure 4.1.3 Options Module

4.1.4 Display Module

The Display Module is the graphical screen that is at the center of Main Control Module. Figure 4.1.4 shows the Display Module.

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Figure 4.1.4 Display Module

4.2 Process Interface

A Process Interface Diagram, Figure 4.2, is provided below.

Figure 4.2 Process Interface Diagram

5. Detailed Design

5.1 Module Detailed Design

5.1.1 Communication Module

The Communication Module will receive all the Patient Sensors data (EKG Graphical, EKG Numeric, Systolic BP Numeric, Diastolic BP Numeric, Mean BP Numeric, Body Temp Numeric, and Oximeter Numeric) through the ADC.

5.1.2 Display Module

The Display Module receives input from the Main Control Module displaying data like EKG Graphical, EKG Numeric, Systolic BP Numeric, Diastolic BP Numeric, Mean BP Numeric, Body Temp Numeric, and Oximeter Numeric.

5.1.3 Alarm Module

The user must set the alarm settings, depending on the person, to best aid the person during their stay. These settings will be displayed in the Main Control Module.

5.1.4 Main Control Module

The Main Control Module (considered to be the primary module) retrieves all the Patient Sensors data from the Communication, Alarm, and Option Module and displays them in the Display Module. This information will be saved for future examination for future visits.

5.1.5 Options Module

Options Module will be having the option to print and save information

5.2 Data Detailed Design

5.2.1 Patient Data

Contains information of all patients, mainly being their name.

5.2.2 EKG Data

EKG Data will be retrieved from the ADC-1, using disposable sensors.

5.2.3 Pulse Data

Pulse data will include pulse oximeter outputs, systolic pressure, diastolic pressure, and mean pressure, which are all retrieved from the ADC-1.

5.2.4 Body Temperature Data

Body Temperature Data will let us know how the patient reacts to certain activities, letting doctors know if it’s harmful.

6. Pseudocode

Process Overview

User turns on system

Main Control Module activates Communication Module

Communication Module activates ADC-1

ADC-1 activates sensors

ADC-1 collects data from sensors

Sensors send data to the ADC-1

ADC-1 sends data to the Main Control Module

Main Control Module builds graph and other GUI images

Graph and GUI images are displayed for the user

User has option to continue using the system or turning it off

Communication Module scans for new data from the ADC-1 every 3 seconds

Detailed Process

1. Power On Process

Boolean: User presses On button, turns on system

If On Button Pressed Boolean = true, then send message to Main Control Module (Main Control Module = pmMain) to begin process

Else exit

If Main Control Module Begin Process Boolean = True, then pmMain activates Communication Module, pmMain On Boolean = true

Else exit

Communication Module Activation (Communication Module = pmCommo)

If pmMain On Boolean = true, then continue

Else exit

Set COM port speed = 9600

Send COM port speed to ADC-1

Turn on ADC-1

If COM Port Speed Received Boolean = true, then turn on ADC-1 input module

Else exit

If ADC-1 Input Module Boolean = true, then turn on patient sensors

Else exit

2. System Process

ADC-1 receive analog inputs from patient

ADC-1 scan sensors for analog inputs

If Systolic Pressure Boolean = true, then send Systolic Pressure integer to ADC-1

Else continue

If Diastolic Pressure Boolean = true, then send Diastolic Pressure int to ADC-1

Else continue

If Mean Pressure Boolean = true, then send Mean Pressure integer to ADC-1

Else continue

If EKG Boolean = true, then send EKG integer to ADC-1

Else continue

If Body Temperature Boolean = true, then send Body Temperature double to

ADC-1

ADC-1 sends Systolic Pressure integer, Diastolic Pressure integer, Mean Pressure integer, EKG integer, and Body Temperature double to Communication Module (pmCommo)

If pmCommo Received Boolean = true, then ADC-1 continue to receive digital inputs from patient

Else continue

If ADC-1 Error Message Boolean = true, then send Error Message to pmCommo

If pmCommo Error Message Received Boolean = true, then send ADC-1 Error Message to pmMain

Else continue

If pmCommo Received Boolean = true, then send Systolic Pressure integer, Diastolic Pressure integer, Mean Pressure integer, EKG integer, and Body Temperature double to Graph (pmGraph)

Else continue

If pmCommo Received Boolean = true, then send Systolic Pressure integer, Diastolic Pressure integer, Mean Pressure integer, EKG integer, and Body Temperature double to pmMain

Process pmGraph

pmGraph: Three Graph boxes, two text boxes

pmGraph Systolic Pressure: Create Graph box for Systolic Pressure, create Text Label for Systolic Pressure pmGraph

pmGraph Diastolic Pressure: Create Graph box for Diastolic Pressure, create Text Label for Diastolic Pressure pmGraph

pmGraph Mean Pressure: Create Graph box for Mean Pressure, create Text Label for Mean Pressure pmGraph

EKG pmGraph Text Box: Create Text Box for EKG, create Text Label for EKG

Body Temperature pmGraph Text Box: Create Text Box for Body Temperature, create Text Label for Body Temperature pmGraph Text Box

Process patient data for pmGraph

Convert Systolic Pressure integer to X-Y coordinates for Graph, new data type Systolic Pressure pmGraph double

Hold Systolic Pressure pmGraph double in pmGraph Systolic Pressure

Convert Diastolic Pressure integer to X-Y coordinates for Graph, new data type Diastolic Pressure pmGraph double

Hold Diastolic Pressure pmGraph double in pmGraph Diastolic Pressure

Convert Mean Pressure integer to X-Y coordinates for Graph, new data type Mean Pressure pmGraph double

Hold Mean Pressure pmGraph double in pmGraph Mean Pressure

Convert EKG integer for EKG Text Box, new data type EKG pmGraph Text Box Data integer

Hold EKG pmGraph Text Box Data integer in EKG pmGraph Text Box

Convert Body Temperature integer for Body Temperature Text Box, new data type Body Temperature pmGraph Text Box Data integer

Hold Body Temperature pmGraph Text Box integer in Body Temperature pmGraph Text Box

When all data is processed, pmGraph Complete Boolean = true

If pmGraph Boolean = true, store pmGraph for output, pmGraph Finished Boolean = true

Else continue

If pmMain Error Message Received = true, then process error message

Else continue

pmMain: Process error message

Retrieve ADC-1 Error Message from pmCommo

Link with H.I.S. Error Message database

Obtain Error Message Alert Code integer, Error Message Alert Code from 1 to 10

If Error Message Alert Code > 5, then exit

Else continue

Output pmGraph

If pmGraph Finished Boolean = true, then output pmGraph to display

User sees pmGraph on display

pmMain waiting for response

Scan Off button every 3 seconds

If Off Button Pressed Boolean = true, then exit system

Else continue

pmCommo scans ADC-1 for new data

Scan for new data every 3 seconds

If ADC-1 New Data = true, then start at “2. System Process”

Else continue

Appendix 1

Minutes from Tu/Th ISM 4331 Team 5 (ADC) SDD Meeting of October 21, 2003

- Call to order at 5:10 pm. Present are Benoit P, Cormier M., and Hom B.

- Meeting delayed because classroom was locked

- Examined the box that will be used to represent the patient in the H.I.S. system

- Examined sample SDD drafts from previous semester classes

- Discussed what method to code the project: Visual Basic, Java, or HTML?

- Discussed what language to use for GUIs

- Examined properties of the H.I.S. system

- Explored unknown traits of the project: printing, Internet connection

- Examined the ADC manual

- Examined a sample GUI of an EKG output

- Determined that answering the question “What is a module?” is the key to understanding the project

- Gave assignments, split the SDD draft into three equal parts

- Closed meeting at 6:15 pm

Appendix 2

Minutes of November 4, 2003 meeting

- Called to order at 5:00 pm

- Meeting place moved to common area in Academic 3 Building because the classroom was too noisy.

- Examined Mike’s work with the ADC input box.

- Reviewed draft: Divided SDD draft into three equal parts, reviewed and corrected mistakes and omissions.

- Changes were made to comply with the HIS requirements.

- Examined Mike’s sample GUIs and sample programs on Mike’s computer.

- Determined that 2-3 state charts were needed

- Discussed what state charts were the most crucial to put into the SDD

- Need GUI interfaces – decided to build forms in Visual Basic

- Need Pseudocode

- Divided work up: Mike will write up the Software Review, improve his GUIs and assist Pascal with the Pseudo code. Pascal will handle the State Charts, and Barry will do the presentation.

- Ended meeting at 6:15 pm

Appendix 3

H.I.S. Patient Monitoring System Draft SDD Review

Date of Review:

November 04, 2003

Time of Review:

5:00 P.M. to 06:15 P.M.

Draft SDD Reviewed:

H.I.S. Patient Monitoring System (HIS/PMS) ver. 2.1 (10/28/03)

Document size: 16 pages.

Draft SDD authors:

Benoit P., Cormier M., and Hom B.

Team Inspection Leader:

Cormier, Michael

Team Recorder:

Cormier, Michael

Team Readers:

Benoit P., Cormier, M., and Hom, B.

Team Authors:

Benoit, P., Cormier, M., and Hom, B.

Team Inspectors:

Benoit P., Cormier M., and Hom B.

Review Inputs:

Objective:

The objective of this review is to establish conformance of the Draft SDD to the requirements specified by the H.I.S. SRS, document and plan any changes, anomalies or exceptions, and to review hardware and software planning.

Specific inputs:

The required inspection inputs were available.

These included the Draft SDD, the Final PMS SRS, the HIS SRS, and hardware specifications for the ADC-1 unit. Also available were Draft G.U.I.s, sample ADC programs and a draft PMS program sample.

Entry Criteria:

The minimum entry criteria were satisfied and approved by the project management, Professor Zalewski, including meeting time, place, and training.

The team had four days to prepare for the inspection.

Specific inspection planning and objectives:

The inspection team members were assigned to read and inspect a third of the Draft SDD that they had not authored.

Draft SDD sections 1 through 2.2 by Cormier, M.:

inspected by Hom, B., read by Benoit, P.

Draft SDD sections 2.2.1 through 4.2 by Hom, B.:

inspected by Benoit, P., read by Cormier, M.

Draft SDD sections 5.2.1 through 5.2.4 by Benoit, P.:

inspected by Cormier, M., read by Hom, B.

Alternatives were discussed and decided upon before the inspection was closed.

The anomaly list was reviewed for clarity, completeness and accuracy.

The inspection objectives were met during the inspection.

Exit criteria:

The exit decision was decided to be acceptance with minor rework.

________________________________________________________________________

Anomaly list:

Location: Description: Classification:

Section 1.2 Scope Masimo graphical display (b) superfluous

Section 1.4 [7] References Textbook not listed. (a) missing

Fig. 2.1 Architectural Diagram modules not connected. (a) missing

Fig. 2.2 Concurrent Processes inputs/outputs not separated (f) non-conformance

Section 2 Class diagram needed (a) missing

Section 4 GUI diagrams needed (a) missing

Section 5 psuedo code needed (a) missing

Section 5 State Charts needed (a) missing

Appendix 1 Meeting minutes needed (a) missing

Appendix 3 Traceability Matrix needed (a) missing

Appendix 4 ADC-1 data needed (a) missing

Appendix 5 ADC Tester data needed (a) missing

Inspection Anomaly Summary

Category Number of Anomalies Ranking

(b) superfluous 1 Minor

(a) missing 10 Major

(f) non-conformance 1 Major

Disposition of the Software Review

As planned, the team member agreed to improve or fix all anomalies that were discovered and listed during this software review.

** End of Software Review **

Appendix 4

HIS SRS Traceability Matrix for the HIS/PMS draft SDD

HIS Requirement List

Number H.I.S. SRS Section Requirement Description

1) 1.2 PMS will be a Java applet

2) 2.1 PMS must run in a browser

3) 2.1 PMS may implement MPEG video

4) 2.1 PMS has a Java bean graph plotter

5) 2.1 PMS may implement still images

6) 2.2.1 PMS must work in Windows or Linux

7) 5.1.1 PMS shall accept existing equipment

8) 5.1.2 PMS shall display real-time, remote data

9) 5.1.3 PMS displays graphical EKG data

10) 5.1.4 PMS displays numeric EKG data

11) 5.1.5 PMS displays numeric oximeter data

12) 5.1.6 PMS displays numeric systolic B.P.

13) 5.1.7 PMS displays numeric diastolic B.P.

14) 5.1.8 PMS displays mean B.P. data

15) 5.1.9 PMS displays body temperature

16) 5.1.10 PMS displays patient I.D. text

17) 5.1.11 PMS displays time and date data

18) 5.2.1 PMS data displays within 5 seconds

19) 5.2.1 PMS data displays within 3% of actual value

20) 5.2.8 PMS must operate 24 hours per day

HIS SRS Traceability Matrix for the PMS SDD

Class/Objects▼ Req #► |1 |2 |3 |4 |5 |6 |7 |8 |9 |10 |11 |12 |13 |14 |15 |16 |17 |18 |19 |20 | |Comm/Port Capture | | | | | | |X |X | | | | | | | | | | | |X | |Comm/Digital In | | | | | | |X |X | | | | | | | | | | | |X | |Comm/Digital Output | | | | | | |X |X | | | | | | | | | | | |X | |Comm/Timing | | | | | | |X |X | | | | | | | | | | | |X | |Comm/Set Defaults | | | | | | | |X | | | | | | | | | | | |X | |Display/ ID / Time | | | | | | | |X | | | | | | | |x |x | | |X | |Display/ EKG # | | | | | | |X |X | |x | | | | | | | | | |X | |Display/ oximeter # | | | | | | |X |X | | |X | | | | | | | | |X | |Display/ syst # | | | | | | |X |X | | | |X | | | | | | | |X | |Display/ diast # | | | | | | |X |X | | | | |X | | | | | | |X | |Display/ mean # | | | | | | |X |X | | | | | |X | | | | | |X | |Display/ temp # | | | | | | |X |X | | | | | | |x | | | | |X | |Display/ EKG graph | | | | | | |X |X |X | | | | | | | | | | |X | |Alarm/ EKG # | | | | | | |X |X | |X | | | | | | | | | |X | |Alarm/ oximeter # | | | | | | |X |X | | |X | | | | | | | | |X | |Alarm/ syst # | | | | | | |X |X | | | |X | | | | | | | |X | |Alarm/ diast # | | | | | | |X |X | | | | |X | | | | | | |X | |Alarm/ mean # | | | | | | |X |X | | | | | |X | | | | | |X | |Alarm/ temp # | | | | | | |X |X | | | | | | |X | | | | |X | |Alarm/ EKG graphical | | | | | | |X |X |X | | | | | | | | | | |X | |Options/ Save | | | | | | | |X | | | | | | | | | | | |X | |Options/ Print | | | | | | | |X | | | | | | | | | | | |X | |Options/ video | | |x | |x | |X |X | | | | | | | | | | | |X | |Main/ Start | | | | | | | | | | | | | | | | | | | |X | |Main/ Stop | | | | | | | | | | | | | | | | | | | |X | |Main/ Update Display | | | | | | | | | | | | | | | | | | | |X | |Main/ Start Alarm | | | | | | | | | | | | | | | | | | | |X | |Main/ Cancel Alarm | | | | | | | | | | | | | | | | | | | |X | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | |

Appendix 5

ADC-1 Specifications

SuperLogics ADC-1:

The SuperLogics ADC-1 is an RS-232 Data Acquisition Device. It accepts up to 8 single-ended or 4 differential Volt or mA inputs. It has an external power supply, a 9-pin Analog input, a DB-25 multi I/O RS-232 output, a 3-wire Serial output, and a Serial Timing I/O. All I/Os are buffered and protected within values stated below.

Analog Inputs

Channels: 8 single-ended or 4 differential (software selectable per channel)

Input Type: V, mA. Input Range: ±5V, ±20mA or 0-5V, 0-20mA (software selectable)

Sampling Rate: Over 1000 Samples/second achievable at 115.2 KBps; With WINview CP Plus: 5 Samples/second (Computer Dependent). Linearity: ±0.012% (± .5 LSB)

Span Drift: ±100ppm/°C (max.). CMR @50/60 Hz:92 dB min

Over Voltage Protection:±15V

Digital Inputs/Outputs:

Number: 16 lines, each line direction software selectable.

Input Level: TTL with 4.7 K ohm pull-up resistor. Two 8-bit Ports.

Maximum Output Current per line: Low: 25 mA (sinking), High: 25mA (sourcing).

Total current PORT1 = 200 ma. Total current PORT2 = 200 ma.

Digital I/O Voltage Levels:

Input Off (0) = 0V - 0.8V, Input On (1) = 2.0V - 5.0V

Output Off (0) = 0.6V max., Output On (1) = 4.3V min.

Counter/Timer

PWM (Pulse width modulation). Output number = 1 Channel.

PWM Freq.: 1.8KHz - 430KHz PWM duty: 0%-100%

Counter input number = 1 Channel. 1 MHz max. input rate.

16 bit counter capture. Counter increments on high-low transition.

-- All specifications subject to change, © SuperLogics 1990-2003 --

Appendix 6

ADC-Tester Specifications

[pic]

ADC-1 TESTER USER’S MANUAL

11-02-03 BY Mike Cormier

--Charge the tester for 12 to 14 hours.

--The charger will not work unless the Main switch is “OFF” (handle towards the point

of the lid’s heart shape). No lights will work.

--Before using please read the ADC Manual, available on CD from Prof. Zalewski.

--Hook up DB9 cables from the ADC unit to the computer serial port and to the tester.

--Flip the single bottom switch to “ON”.

--The green power light will glow and the blue light will send steady battery volts to pins 6, 7, 8, and 9.

--The four top switches will turn on the four lights above them. From left to right, they are pins # 1, 2, 3, and 4. Pin 5 is always ground.

--After about 4 to 6 hours, the first light will fade out (the blue LED) as the battery voltage drops. The blue LED (channels 6,7,8,9) sends about 3 VDC and others send lesser voltages.

--When the LEDs begin fading out, it is time to turn off the main switch, so that the charger will work.

** End Of SDD **

[pic]

-----------------------

add customer [set data=0] / CustInfo.create

Initialization

do / Initialize ADC-1 connection

Inactive

entry / Register customer

exit / close data

cancel

Canceled

Communications

Main Control

Alarm

Display

User

Display

ADC-1

Patient Data

EKG Outputs

Pulse Oximeter Outputs

Systolic Pressure

Diastolic Pressure

Mean Pressure

Body Temperature

Patient Data

Patient ID

Date

Time

H.I.S.

Pulse

Pulse Oximeter outputs

Systolic Pressure

Diastolic Pressure

Mean Pressure

EKG Outputs

Body Temperature

Patient

Active

do / Suspend data

Shutdown [enough data] / CustInfo.closed

startup [more data required] / CustInfo.retreived

cancel

CustInfo.delete

Figure 5.3 State Diagram

ADC-1

COM port

Digital inputs

Eight analog devices

Receives patient data

pmCommo

Set COM port speed

Receives patient data

Timing settings

Receive errors

pmGraph

Patient data

pmMain

Process patient data

On/Off functions

Process errors

Display

Display graph

Display errors

User

Reads data

Controls On/Off function

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