Image Management System for Colposcopy Users Guide

Table of Contents Section 2-1 OPERATOR NAMES AND PASSWORDS ...1 Supervisor Access Code ...1 System Setup Information Screen ...2 User List and Password Screen ...3 Operator Access Code ...4 To Add a New User...4 To Delete a User...4 To Edit/Change a User...4 To Add/Delete Other Colposcopists ...5 To Delete Other Colposcopist(s)...5

SYSTEM BACKUP...6 To Change the time or days schedule: ...7 To Change the time or days schedule ...8

Section 2-2 Starting the system for daily operations ...1 Select Patient screen...2 To Add a New Patient ...3 To Find and Select an Existing Patient - Using a Patient MR Number ...4 To Find and Select an Existing Patient - Searching - By Complete List ...4 To Find and Select an Existing Patient - Using the Patient Last Name ...4 To Find and Select An Existing Patient - Searching - By First and/or Middle Name: ...5 Delete a Patient...5

Edit the Patient Information Screen (access from the Select Patient screen)...5 NEW VISIT (Patient with No Prior Exams)...6 NEW VISIT (Patient With Prior Exams)...8 TO PROCEED WITH CURRENT VISIT ... 14

Patient History screen...15 Laboratory and Treatment Information ...23 Examination Results... 23 PATHOLOGY RESULTS -... 24 LABORATORY TESTS - ... 24 TREATMENTS... 25 FOLLOW-UP VISITS... 25 To Update Laboratory and Treatment Information ... 32

Review Previous Visit(s)...33 Delete Visit(s)...34 VISIT DATA SCREEN...35 To enter visit data prior to an exam, following an exam and to edit data of stored visits ... 35 Pre Visit Data Entry... 35 To proceed with open visit ... 35 To enter new or edit existing data to the Visit Data screen of a stored visit: ... 35

Section 2-3 Acquire Images ... 1 Colposcopy Assessment Form (Cervix) ... 4 Selection, Display and Marking of Images ...5 Selection, Display and Marking of Images ...6 Data Entry ...7

Colposcopy Assessment Form - Vagina (Fig. 3.14)... 9 Data Entry ...9

Colposcopy Assessment Form - Vulva (Fig. 3.23) ... 11 Data Entry ...11

Colposcopy Graphic Annotation screen - Cervix... 13 Selection, Display and Marking of Images ...13 Annotations ...13

Colposcopy Image Annotation screen - Cervix ... 14 Selection, Display and Marking of Images ...14

Colposcopy Image Annotation screen - Vulva and Vagina... 15 Selection, Display and Marking of Images ...15

Review Images... 16 Split Screen ... 17 Quarter Split Screen Display... 20 Text and Graphics (Annotations)... 21 To apply Text and Graphics to visit files retrieved from storage...21 To Apply Alpha/Numeric Text ...24 To Paint Lines and Areas ...24 To Erase Annotations from the displayed image: ...25

To Close the System ... 26

Section 2-4 Save to Disk ... 1 Save to Disk (Without Compression) ...3 Save to Disk (With Compression) ...4

Print ... 5 Reports & Forms... 7 Colposcopy Procedure Form...9 To Print ...10

Visits to Arrange Reports ... 12

Section 2-5 Camera/Image Adjustments... 1 System Date and Time Maintenance... 3 Changing the Time...4 Changing the Year ...4 Changing the Month...4 Changing the Day/Date...4 Changing the Time Zone ...5 Install Settings ...6 Displaying the Clock...6

SECTION 1 SYSTEM SECURITY, ACCESS AND BACKUP For multi user locations it is recommended that only limited Supervisors on site have access to the system operating features (system setup). The Supervisors at each venue should generally be responsible for the system activities, including access to the system by the individual operators (colposcopists) and the use of established system standards.

OPERATOR NAMES AND PASSWORDS Supervisor Access Code Before routine clinic operations are begun, a Unique System Password must be installed in each individual unit. Following initial boot-up, the opening screen will appear (Fig. 1.1).

Fig. 1.1 •

Click on File (immediately at the top left corner of the screen). A sic-line menu will appear. Click on System Setup. The System Setup information screen will appear (Fig. 1.2). A prompt will appear in the System Password box. Click here to return to the Table of Contents 4 1-1

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System Setup Information Screen NOTE: Each system has been factory preset with WELCH ALLYN as the System Password. This must be replaced by the site system Supervisor with the site Unique Password

Type WELCHALLYN in the System Password Box. OK will be activated to allow access to the System Setup feature. •

Click on the Clinic Name Box and type full Clinic Name (30 characters max).

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Review the settings below and change as required.

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Click on Add/Edit Users . The User List and Passwords screen will appear (Fig. 1.3).

Fig. 1.2

Max Position Error is preset to 0. Save files as JPG is on ✔ Verify above - correct if necessary. NOTE: The image acquisition “snapping” feature has been factory preset to be mouse activated. To activate for manual or foot switch use, • Click on Foot Switch | On. Click here to return to the Table of Contents 4

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User List and Password Screen

NOTE: System must have a minimum of one installed operator at all times. Demo operator (User) Factory (Password) is factory installed. This should be deleted when site operators are entered.

Fig. 1.3

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Click on Edit Sysop PW . The Sysop Password box will be activated including prompt followed by WELCHALLYN. Double click on WELCHALLYN to highlight. Enter Supervisor Unique Password (20 characters max). Click on Change .

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Click on OK . The System Setup Information screen will appear including the following box (Fig. 1.4).

Fig. 1.4 Click on OK . A prompt will appear in the System Password box. Enter Supervisor unique Password. All feature switches will activate confirming system setup. Supervisor unique Password only can now be used to gain access to the system. •

Click OK to return to the System Setup Information screen.

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Operator Access Code Before individual operators (Colposcopists) can utilize the system, his/her name and unique password must be installed. These entries must be executed by the site supervisor will maintain a secure record of all user names and passwords.

Click Add/Edit Users . User List and Passwords screen will appear (Fig. 1. 3).

To Add a New User •

Click on Add New User . A prompt will appear in the User Name box.

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Enter user name (20 characters max).

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Press Tab key. A prompt will appear in the Password box.

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Enter Password (20 characters max).

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Click on Add . User name and password will be displayed on the User List.

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Click on OK to save New User. The System Setup Information screen will return. or

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Click on Cancel to cancel Add New User entry. The System Setup Information screen will return.

To Delete a User •

Click on designated User line to highlight.

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Click on Delete User . The selected user will disappear.

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Click on OK to Delete User. The System Setup Information screen will return. or

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Click on Cancel to cancel delete command. The System Setup Information screen will return.

To Edit/Change a User •

Click on designated User Line to highlight.

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Click on Edit User . A prompt will appear in the User Name box followed by designated user name. Change name as required. Press Tab key. Prompt will appear in Password box followed by designated user password. Change as required.

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Click on Change . Revised name and/or password will replace designated name and/or password on User List.

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Click on OK to change name and/or password. The System Setup Information screen will return. or

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Click on Cancel to cancel change command. The System Setup Information screen will return.

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Click OK to enter operating system. 1-4

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To Add/Delete Other Colposcopists Enter the System Set up Information screen ( Fig. 1.2, Page 1-2). •

Enter System Password.

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Click Add/Delete Other Colposcopists . The Add or Delete Other Colposcopists screen will appear (Fig. 1.5).

Fig. 1.5 An active cursor will appear in the New Colposcopist box. •

Type Colposcopist’s name. • Click >. . The Colposcopist’s name will appear at the top of the OTHER COLPOSCOPIST LIST.

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Click on OK .

To Delete Other Colposcopist(s) Click on the Colposcopist’s name to highlight. • Click <. The Colposcopist name will be removed from the list. Click on OK .

NOTE: Other Colposcopists are not primary users. The use of their names will not gain access to the system. When selected for a visit (See New Visit section), the other colposcopist(s) name will be permanently included in the visit file (Visit Data) and also be included in all visit printed reports. Click here to return to the Table of Contents 4 1-6

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SYSTEM BACKUP The Welch Allyn Image Management System includes an installed and pre-programmed Colorado Tape Drive. Properly used, this feature provides Full System Backup of all programs and data stored in the system. Two formatted tapes are included. Each has storage capacity equal to 50% more than the system resident hard drive. The System Backup program has been preset to execute a Full System Backup beginning at 11:59 p.m. each day of the week. Immediately following the backup procedure, the Backup program will automatically perform a Compare run to verify that the files on tape match those on the system hard drive. Depending on the amount of stored data, the Full System Backup routine will take from several minutes to as long as three hours. An equal amount of time is required to perform the Compare routine for a total of up to six hours. Up to six hours would be required to perform the Full System Backup/Compare routine for 22,500 patient visits which is the approximate capacity of the Welch Allyn Imagement Management System (before expansion). Fewer than 22,500 visits will require proportionally less time (i.e., 1,000 visits will require 18 minutes, etc.). To initiate the Backup feature, insert a tape into the tape drive. (It will not enter completely.) A green indicator light will illuminate verifying proper insertion. The drive will emit sounds for approximately one minute indicating that the tape is being properly set. The Backup feature will automatically begin to execute a Full System Backup/Compare routine at 11:59 p.m. each day. •

Remove the tape every morning before starting the Welch Allyn Image Management System and store it in a secure place (preferably a fireproof vault on or off premises).

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Insert the other tape. This tape will be used to execute the Full System Backup/Compare routine at 11:59 p.m. that evening.

The Full System Backup will overwrite all data on the tape. •

Continue to repeat the tape replacement procedure every morning alternating between the two tapes.

NOTE: The Welch Allyn Image Management System must be left ON for the backup feature to operate. At the end of daily use, Enter the Welch Allyn Imagement Management System opening screen and leave the system in this mode. Automatic Power saver features have been installed to minimize power usage during idle periods. The screen saver feature will automatically activate after a few minutes of monitor non-use -- or the monitor can be turned off. Closing the monitor will not affect the backup feature. Click here to return to the Table of Contents 4 1-7

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To Change the time or days schedule: •

Click Exit System on the Welch Allyn Image Management System opening screen.

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Click on the Scheduler icon at the bottom right hand side of the screen -- next to the clock (Fig. 1.6).

Fig. 1.6 The Colorado Scheduler window will appear (Fig. 1.7).

Fig. 1.7 The Automated Daily Backup page should indicate that the Automated Daily Backup is currently ~ On. The When to backup time should show 11:59 , ~ PM. •

Click OK to return to the Operating System. or

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To Change the time or days schedule •

Click What’s Scheduled . The What’s Scheduled page will appear (Fig. 1.8).

Fig. 1.8

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Click Modify a Schedule. An information box will appear. • Click Yes . The Schedule Item window will appear (Fig. 1.9).

Fig. 1.9 •

Click on a Day of Week tile to deactivate that day and remove from schedule. (• Click again to reactivate).

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Click on Time of Day buttons ▲ or ▼ to advance or retract the hour or minutes to set new daily start time schedule.

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Click on PM ~ or AM ~ to change.

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Click OK . The Colorado Scheduler will reappear displaying the revised day and time schedules. (If incorrect, • Click Modify a Schedule to return to the Schedule Item window.)

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Click OK if correct. The revised schedule will be set.

REFER TO THE ENCLOSED COLORADO MANUAL FOR OTHER OPERATING TIPS AND INSTRUCTIONS FOR EXPANDED PROTECTION OF SYSTEM DATA.

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SECTION 2 OPERATOR INSTRUCTIONS Patient Management and Data Entry

STARTING THE SYSTEM FOR DAILY OPERATIONS To start The Welch Allyn Image Management System turn the power on the components in the following sequence: 1. Printer 2. Monitor 3. Computer 4. Other peripherals (in any order) Following the power-up sequence, the opening screen will appear (Fig. 2.1).

Fig. 2.1 NOTE: Access to the system is prevented pending the entry of an authorized Colposcopist name and Password. • • • • •

Click on the ▼ in the colposcopist name box. A list of pre-authorized colposcopist names will appear. Click on the desired name to place in the name box. For a name that is stored after the displayed group, click and hold on the ▼ at the bottom right of the list until the desired name appears. Click in the Password box. A blinking cursor will appear. Type the selected Colposcopist’s unique password. Click on OK or press Enter. Click on Select Patient The Select Patient Screen will appear with a blinking cursor at the beginning of the MR Number box (Fig. 2.2).

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SECTION 2 OPERATOR INSTRUCTIONS Patient Management and Data Entry Select Patient Screen

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Fig. 2.2 This screen allows you to add a new patient, find and select an existing patient, and edit existing patient information.

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SECTION 2 OPERATOR INSTRUCTIONS Patient Management and Data Entry To Add a New Patient • •

Click on Add New Patient. The Patient Information screen will appear (Fig. 2.3). Enter Date Of Birth information as XX/XX/XX

Patient Information Screen

Fig. 2.3 The Race box has a multiple choice pull-down menu (Fig. 2.4). • Click on ▼ to display the first seven selections. For a selection that is stored below the displayed list, click and hold on the ▼ at the bottom right of the display until the desired selection appears. Click on choice to enter.

Fig. 2.4

NOTE: The Patient First and Last name, Date of Birth and Medical Record Number must be completed to enter Patient file into system data base. Click here to return to the Table of Contents 4

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SECTION 2 OPERATOR INSTRUCTIONS Patient Management and Data Entry Following entry to each box, press the Enter or Tab key on the keyboard to progress in sequence. •

Click on OK following completion of New Patient Information entry. All data will be entered to the patient file and system data base.

The Select Patient Screen will appear. The patient just added will be highlighted at the top of the Select Patient List and the Patient Name, Date of Birth, MR Number and SSN (if in file) will be displayed. •

Click Select Patient to continue with patient file and current visit. The Patient Visit Control screen will appear, Page 2-7. or

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Click on Add New Patient to add new patients. Repeat process.

To Find and Select an Existing Patient - Using a Patient MR Number •

Enter the patient MR Number into the MR number box. As the Alpha Numberic characters are entered, the system will automatically begin to display all the patients with an MR number beginning with the same sequence of characters.

NOTE: The MR number is exclusively unique to an individual patient. Different patients can have the same last, middle and/or first names. When the complete number is entered, the desired patient will appear highlighted at the head of the Select Patient List. The patient name, date of birth, MR number and Social Security Number (if available) will be displayed. •

Click on Select Patient to proceed with patient file and current visit. The Patient Visit Control screen will appear, Page 2-7.

To Find and Select an Existing Patient - Using the Patient Last Name •

Click in the Last Name box. Type the Patient Last Name. As the letters are entered the system will automatically begin to display patients with last names beginning with that letter sequence. When the complete last name is entered, all patients with this name will be displayed by alphabetical order, of first name.

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Click on the desired name to highlight and to display Patient Name, Date of Birth, MR Number, and Social Security Number (if available).

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Click on Select Patient to proceed with patient file and current visit. The Patient Visit Control screen will appear, Page 2-7, Fig. 2.5.

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SECTION 2 OPERATOR INSTRUCTIONS Patient Management and Data Entry To Find and Select An Existing Patient - Searching - By First and/or Middle Name: •

Click to place cursor in First name box.

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Type all or part of the Patient first name.

OR •

Click to place cursor in Middle name box.

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Type all or part of the Patient Middle Name.

The patient names beginning with that Alpha character sequence will be displayed in the Select Patient List in alphabetical order. •

Click on the desired name to highlight and to display full Patient Name, Date of Birth, MR Number and Social Security Number if on file.

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Click on Select Patient to proceed with patient file and current visit. The Patient Visit Control screen will appear.

Delete a Patient Enter the Select Patient Screen. Find and highlight the desired Patient name. •

Click Delete Patient located at top left of screen. A question box will appear requesting confirmation to proceed with patient deletion.

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Click Yes to proceed. A message box will appear confirming deletion. • Click OK.

The Patient file including all visits and other data will be permanently deleted from the data base.

Edit the Patient Information Screen (access from the Select Patient screen) Enter the Select Patient Screen Find and highlight the desired Patient name. The Edit Patient Info button will activate. •

Click Edit Patient Info. The Patient Information screen for the selected patient will appear. All data entry sections will be active.

Edit as required. •

Click OK to save. All data will be permanently entered to the Patient File and system data base.

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