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T-DOC v12 What's New

Getinge IT Solutions ApS

Project No.: - Type: USR Document No.: 476 Revision No.: 02 Language: US Status: Released Date: 2015-03-16

T-DOC v12

USR476_02_US - What's New in T-DOC v12.docx 2 / 41

Table of contents

1 Legal Statement ..................................................................................................................................................... 4

1.1 Copyright ............................................................................................................................................... 4

1.2 Trademarks ............................................................................................................................................ 4

1.3 No warranty ........................................................................................................................................... 4

1.4 Limitation of liability ............................................................................................................................. 4

2 Feedback and comments ...................................................................................................................................... 4

3 New in this version ................................................................................................................................................ 5

4 Introduction ............................................................................................................................................................ 6

4.1 Purpose of this document .................................................................................................................... 6

4.2 Audience ................................................................................................................................................ 6

4.3 Before reading further… ....................................................................................................................... 6

5 Exporting the system log ...................................................................................................................................... 6

6 Accessing operation lists and operation details ................................................................................................. 7

6.1 Configuration ........................................................................................................................................ 7

6.2 Viewing a list of scheduled operations ............................................................................................... 7

6.3 Viewing operation details ..................................................................................................................... 8

6.4 Starting and stopping an operation ..................................................................................................... 9

6.5 Adding and removing units from an operation .................................................................................. 9

6.5.1 Adding units 9 6.5.2 Removing units 9

7 Automatic login after location change ............................................................................................................... 10

7.1 New scanner option ............................................................................................................................ 10

7.2 Compatibility with scanner macros ................................................................................................... 10

7.3 Compatibility with default macros ..................................................................................................... 10

8 Applying Standard comments ............................................................................................................................ 11

8.1 Defining standard comments ............................................................................................................. 11

8.2 Understanding standard comment visibility .................................................................................... 12

8.3 Associating standard comments with units ..................................................................................... 12

8.3.1 Using the T-DOC Admin Client 12 8.3.2 Using the T-DOC Scanner Client 12 8.3.3 Using the T-DOC Web Client 13

8.4 Viewing standard comments ............................................................................................................. 13

8.4.1 Using the T-DOC Admin Client 13 8.4.2 Using the T-DOC Scanner Client 15 8.4.3 Using the T-DOC Web Client 15

8.5 Hiding comments ................................................................................................................................ 15

9 Using easy picture importing and live camera .................................................................................................. 16

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9.1 File explorer ......................................................................................................................................... 16

9.1.1 Locating media files 16 9.1.2 Viewing media files 17 9.1.3 Associating media files 17 9.1.4 Removing media files 17

9.2 Monitoring folders ............................................................................................................................... 17

9.2.1 Specifying the folders to be monitored 17 9.2.2 Specifying the types of media to be included 18 9.2.3 Removing a folder from monitoring 18

9.3 Using live capture ............................................................................................................................... 19

9.3.1 Adding a picture or video from a live camera 19 9.3.2 Replacing a picture or video with another from a live camera 20

10 Using indicators and incubators ........................................................................................................................ 21

10.1 Changes to types of indicators .......................................................................................................... 21

10.2 Using Biological indicator types........................................................................................................ 22

10.3 Defining indicator types ..................................................................................................................... 23

10.4 Implications of indicator types associated with products and/or programs ................................. 23

10.5 Defining incubators ............................................................................................................................ 24

10.5.1 Defining incubator machine models 24 10.5.2 Defining incubator machines 24

10.6 Locations ............................................................................................................................................. 24

10.6.1 Indicator incubation location 24 10.6.2 Pre-batch and Post-batch locations 24

10.7 Viewing indicators and incubators .................................................................................................... 25

10.7.1 T-DOC Scanner Client 25 10.7.2 T-DOC Admin Client 28 10.7.3 T-DOC Machine Viewer 28 10.7.4 Understanding the overviews 29 10.7.5 Understanding a basic incubation procedure 32

11 Processing and using endoscopes .................................................................................................................... 36

11.1 Managing time intervals ..................................................................................................................... 36

11.2 Managing endoscope handling.......................................................................................................... 36

11.3 Allowing endoscope sterilization ...................................................................................................... 36

11.4 Using placements in drying cabinets ................................................................................................ 37

11.5 Using endoscope groups ................................................................................................................... 37

11.6 Monitoring endoscopes ...................................................................................................................... 37

11.6.1 Understanding drying cabinet details 38 11.6.2 Understanding placement details 38 11.6.3 Filtering placement details 39 11.6.4 Understanding endoscope details 39

Appendix A - Document History .................................................................................................................. 40

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1 Legal Statement Information in this document is subject to change without notice.

1.1 Copyright Copyright © 1986 - 2015 Getinge IT Solutions ApS Amaliegade 4, DK-1256 Copenhagen K, Denmark, All Rights

Reserved.

Copyright in this document (hereafter referred to as the "Contents") is owned by Getinge IT Solutions ApS, unless

otherwise indicated. Getinge IT Solutions ApS hereby authorizes permission to copy this document for non-commercial

uses within your organization. In consideration of this authorization, you agree that any copy of these documents which

you make shall retain all copyright and other proprietary notices contained herein.

Note that any product, process or technology described may be the subject of other Intellectual Property rights reserved

by Getinge IT Solutions ApS, and are not licensed hereunder.

1.2 Trademarks Getinge IT Solutions, T-DOC and LinkStation are registered trademarks and/or Copyrights governed by Getinge IT

Solutions ApS. All other trademarks and registered trademarks are owned by their respective companies.

Use, duplication, or disclosure by the United States Government is subject to the restrictions set forth in DFARS

252.227-7013 (c)(1)(ii) and FAR 52.227-19.

1.3 No warranty The software, documents, information, and materials in this publication are provided "as is" without warranty of any kind,

either express or implied, including, but not limited to, the implied warranties of merchantabilities, fitness for a particular

purpose, or non-infringement.

The contents of this publication could include technical inaccuracies or typographical errors. Changes are periodically

added to the information herein; these changes will be incorporated in new editions of the publication. Getinge IT

Solutions ApS may make improvements and/or changes to the product(s) and/or program(s) described in this publication

at any time without notice.

1.4 Limitation of liability In no event will Getinge IT Solutions ApS be liable for direct, indirect, special, incidental, economic, cover, or

consequential damages arising out of the use of or inability to use the Contents even if advised of the possibility of such

damages, Some areas do not allow the exclusion of limitation of implied warranties or limitation of liability for incidental or

consequential damages, so the above limitation or exclusion may not apply to you.

2 Feedback and comments Questions regarding this document and/or suggestions for changes to the contents herein must be directed to the R&D

Manager at Getinge IT Solutions ApS. Emails can be sent to [email protected]

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3 New in this version

Date Rev. # Revised by Name Description/Changes

2015-03-16 02 Robin Kiszka-Kanowitz Added endoscopes section.

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4 Introduction

4.1 Purpose of this document This document describes new features and functionality in T-DOC v12.

4.2 Audience This document is intended for Getinge Sales and Support staff, which require a basic understanding of the new features

and functionality in T-DOC v12.

4.3 Before reading further… Please be aware that:

This document is not a comprehensive description of the new features and functionality in T-

DOC v12.

Some of the functionality mentioned herein may not yet be available.

Some of the referenced documents and help file sections may not yet be available.

Availability of some features and functionality requires the appropriate T-DOC licenses.

For complete and comprehensive descriptions refer to the T-DOC Online Help file and/or the other documents as and

when made available by Getinge IT Solutions.

5 Exporting the system log The System event viewer accessible from System > Tools > System event viewer now includes an Action > Export

to Excel function in the menu. This is for the event log and the audit log, and allows for exporting the events to an MS

Excel file format for further analysis in third-party applications. This is possible even if MS Excel is not installed on the

computer from which the export is being performed.

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6 Accessing operation lists and operation details A list of Scheduled operations is now accessible in the T-DOC Web Client. Users can see the processing status of

operations for their customer and identify operations that may be problematic. Note that the list only displays operations

associated with the customer that user logged in with.

It is also possible to view the details of an operation. Units (articles) can be added or removed from the operation and

patient concerned.

6.1 Configuration The T-DOC system must be configured to allow the T-DOC Web Client to function as an Operation Area workstation in

order to view operation lists and related operation data. This is specified in Factories in T-DOC Admin, namely by

selecting the location type to be used by the T-DOC Web Client in the Web client operation location data field of the

factory concerned.

6.2 Viewing a list of scheduled operations The list of Scheduled operations is available from the Scheduled operations link in the main menu of the T-DOC Web

Client.

As in the previous image, the list displays each operation's Start time and End time (date and time), the Operation (its

identifier as defined in Operation data), Code (the Operation type identifier), Name (the Operation type name), Doctor,

Room, Status, Patient (patient ID) and patient Name are also displayed. The list of operations is automatically

refreshed every 60 seconds. For users with the T-DOC Stock Module each operation in the list has a color code that

indicates its order processing status. This is identical to that seen in T-DOC Admin.

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6.3 Viewing operation details The details of an operation can be viewed from the T-DOC Web Client, for example:

Click on the Operation ID link in the Scheduled operations list to view the details of a specific operation.

Scanning an operation ID barcode with a wedge scanner will filter the list to a specific operation allowing for easier

selection.

The operation details include its:

Orders accessed via the Order no. link. This displays the orders details.

Articles (products, items, endoscopes etc.) with links to the article details. For items that are

serialized the serial numbers are also listed. For products the units are also listed and

linked.

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6.4 Starting and stopping an operation The and buttons in the operation details can be used to start and stop the operation respectively. When starting an

operation its:

Articles are bound to the operation in accordance with Order scanning mode option.

Units receive status in accordance with the Unit status to set option.

6.5 Adding and removing units from an operation As standard, an operation must have Status Started for units to be added or removed. This follows the same approach

as seen in T-DOC Admin in earlier T-DOC versions.

6.5.1 Adding units Units that have been dispatched to the respective customer and are not already included in the operation can be added

to the operation. To add a unit:

Perform a search in the Add unit field to locate the unit and then press the Add button.

- or -

Manually enter the unit number in the Add unit field .

- or -

Scan the unit barcode by using a wedge scanner.

- or -

Scan the product serial number by using a wedge scanner.

If the product is not already in the operation then a new row with Ordered 0 is applied. If the product is in the operation

then Delivered is increased by 1, but ordered remains unchanged. Status of the unit is determined by the Unit

status to set option.

6.5.2 Removing units A unit must have Status Used or Opened to be able to be removed from an operation.

To remove a unit, press the Remove button alongside the product concerned. A Remove unit dialog opens in which

the unit(s) can be selected and removed. The removed units receive a Status in accordance with Unit status to

set for unused option setting. The Delivered count is decreased accordingly. If Delivered is 0 then the row will be

removed from the operation, unless the units were delivered as an order.

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7 Automatic login after location change A user can now switch locations on the same T-DOC Scanner Client without having to login when changing to another

location. Note that the user is logged out of the location that they are leaving.

7.1 New scanner option A new Automatic login location option is available for all locations. This has values:

Specified default user

If a default user is specified for a location, and a barcode is scanned when no user is

logged, then the default user will automatically be logged in. This is the default setting (for

new and existing installations).

Current user

If a user is logged in to T-DOC and changes to a new location, then the same user is

automatically logged in to the new location. If a user changes location when no user is

logged in, then the Specified default user behavior is applicable.

Not used

A user is not automatically logged in when changing locations. The specified default user

setting will also be ignored.

The following image depicts a simple example where Specified default user is applied. Here the user switches

between the Pack and Dispatch Areas, but no user barcode is scanned after the initial login at the Pack Area. The

scanner log records the user login as if a user barcode had been scanned. Note that the user is logged out of the old

locations when switching to the new location.

7.2 Compatibility with scanner macros Specified default user is the default setting and it retains current functionality, therefore all macros will continue

to function as before. Modifying this setting can imply that macros using location changes may need to be modified.

7.3 Compatibility with default macros Automatic user login occurs prior to execution of default location macros. This is consistent with earlier behavior.

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8 Applying Standard comments Comments are used to record and display information regarding units. They are created during the T-DOC Production

Cycle and can later be displayed at various locations.

Standard comments are a v12 enhancement of the comment functionality seen in earlier T-DOC versions. A Standard

comment has a standard text (standard comment) and an optional user text (free text).

Various settings determine whether comments can be added to units during production and whether the user can include

a user text.

8.1 Defining standard comments Standard comments are defined and managed in T-DOC Admin in Standard comments. This is seen in System >

Administration > Standard comments in the Main menu. Each standard comment has a unique ID.

Various settings determine whether:

The user can enter a free text to accompany the standard comment (Free text comment).

The comment will display, for example when scanning the unit's barcode (Show in

production).

The standard comment is available at all or specific production locations (Allowed location

processes).

The standard comment is available at all or specific factories (Factories).

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8.2 Understanding standard comment visibility Comments associated with units can be seen as follows:

Comments associated at Pack locations

Can be printed on labels for the unit, but are not shown anywhere in the T-DOC Production

Cycle.

Comments associated at Operation locations

Can be added by using the T-DOC Web Client and/or the T-DOC Scanner Client in the

Operation area. These comments will be shown in Return and Pack locations, if allowed by

the location's Show Comment option setting.

Comments associated at Return locations

Shown in Pack locations, if allowed by the location’s Show Comment option setting.

All comments associated with units

Always shown in the event log on the Events tab in Units in T-DOC Admin. They can also

be seen when viewing units in the T-DOC Web Client on the Events tab.

Furthermore, a location's Show Comment option determines whether all comments are displayed or not at the location,

and whether hiding of specific displayed comments is possible.

8.3 Associating standard comments with units

8.3.1 Using the T-DOC Admin Client It is not possible to apply comments to units when manually producing goods with T-DOC Admin, for example when

using Pack unit in Products or the various Action > Daily functions in Units.

8.3.2 Using the T-DOC Scanner Client Adding comments is performed in the T-DOC Scanner Client by using an Add comment… barcode. Applying a standard

comment to a unit, for example in the Pack Area, is performed by scanning Add comment, other unit (1563)

followed by the unit barcode. An Input dialog appears in which the Standard comment to be used can be selected (in

accordance with the location and factory selections). Alternatively the Add comment (1559) barcode can be used when

the respective unit is already under focus.

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Another approach is to scan the barcode of the Standard comment, followed by the unit barcode. This automatically sets

the Standard comment in the Input dialog to match that scanned.

Earlier T-DOC versions allowed for user comments without any standard comment being selected. This is still possible

by using the Add comment dialog without any Standard comment selection.

8.3.3 Using the T-DOC Web Client When using the T-DOC Web Client, unit details are typically viewed in an Operation area location. To add a comment,

perform a query to locate the unit of interest and then press the Add comment button. The Add comments dialog

appears.

8.4 Viewing standard comments

8.4.1 Using the T-DOC Admin Client All comments associated with a unit are stored and visible as events in the unit’s event log. In T-DOC Admin these can

be seen in Units on the Events tab.

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The Event and Info fields display the standard comment and user comment respectively.

These can also be seen in a Unit events list by pressing the Open all events button.

Comments are not displayed in T-DOC Admin when manually processing goods. However, all comments associated with

a unit (from the Pack, Prepare, Wrap and Endo clean & test areas) can be printed as labels from Units by pressing the

button and selecting Comment label or by selecting Action > Comment label in the menu.

Comment labels can also be printed when manually producing goods in T-DOC Admin by setting the Print Unit

Comment Label location option to Yes in the Admin (System) location. Each label includes the Standard comment

and User comment texts. The labels can then be affixed to the unit as necessary.

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8.4.2 Using the T-DOC Scanner Client Depending on the location and factory where a unit is being managed, where the comment was associated and if the

comment is visible, an Information dialog automatically appears when the unit barcode is scanned. This displays the

first comment associated with the unit.

Pressing or scanning Continue or OK closes the dialog and continues with the next production step. If there are

multiple comments then these are displayed consecutively and production can continue only when the last comment has

been viewed.

Comments associated with a unit can be printed as comment labels. A comment label includes the Standard comment

and User comment texts. This can be printed from the T-DOC Scanner Client by setting the Print Unit Comment

Label location option to Yes in for the respective location - Prepare, Wrap, Pack and Endo clean & test areas.

8.4.3 Using the T-DOC Web Client Comments associated with a unit can be seen as events on the Events tab of the unit.

8.5 Hiding comments There are various alternatives to hiding comments.

Hiding specific comments

As standard, comments associated with a unit appear in the Information dialog at the

appropriate production locations. Selecting Do not show again at any location in the

Information dialog for a specific comment, hides the specific comment from all applicable

production locations. This selection is only available in the Information dialog where the

location has its Show Comment option set to Yes, allow to permanently hide.

Hiding all comments based on a specific Standard comment

As standard, all comments associated with a Standard comment appear as appropriate in

production. However, if the user actively sets Show in production to Disabled in the

specific Standard comment, then all comments based upon the Standard comment are

hidden.

Hiding all comments at a location

All comments for all units can be hidden at a specific location. This is by setting the Show

Comment location option to No at the location concerned.

Note that an event is always logged when a comment is created, even if the comments are not visible in production.

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9 Using easy picture importing and live camera New multimedia functionality has been provided to quickly locate, import, and where appropriate, capture multimedia

content. The functionality is available in the T-DOC Admin Client and the T-DOC Scanner Client.

9.1 File explorer A new File explorer lists the computer's folders, attached storage devices and monitored folders (T-DOC media) that can

contain media files. These files can be associated with data in the T-DOC database.

The File explorer only lists files that match the type of media being added. For example, when associating a picture, the

File explorer dialog is titled Add picture and only picture files are listed. When associating a video, only videos file types

are listed in an Add video dialog. Likewise the dialog appears as Replace video, Replace picture, Replace sound and

Insert text as appropriate.

9.1.1 Locating media files The File explorer includes a left-hand pane. This displays:

T-DOC media

A logical representation in the T-DOC database of the folders specified in the Media import

folders dialog (see Monitoring folders). This category only displays the folder(s) that are

monitored (no subfolders are shown). A specific folder can be selected, following which the

center pane lists the relevant media therein. Selecting the top level T-DOC media category

lists all the relevant media files in the watched folders, these also displaying their Folder

location.

Computer

A list of storage devices on the computer or connected thereto, each with their folder

hierarchy.

Libraries

Music, Video, Documents and Pictures categories that represent the user’s My Music,

My Videos, My Documents and My Pictures folders.

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9.1.2 Viewing media files Each media file is displayed in a file list with a thumbnail, the physical file name and date and time of creation. Selecting

a file’s checkbox or simply highlighting a file in the list displays a preview thereof in the right-hand panel. It is always the

highlighted file that appears in the preview.

The listed files can be sorted by pressing the button, this by date of creation or physical file name. As standard, the

files are sorted by date of creation with the most recent file first.

9.1.3 Associating media files Single and multiple files can be associated by selecting their checkbox and pressing the Add button. Selecting the

checkbox at the top of the list selects all files in the list. Likewise clearing the selection clears all selections in the list.

Single files can be quickly associated by double clicking on the file in the list.

9.1.4 Removing media files

Pressing the button or DELETE key deletes selected files. If the files are deleted from the T-DOC media group, then

the files are deleted from the T-DOC database only, the physical files are not removed from their file directory. If the files

are deleted from a specific folder, then the physical file is deleted from the folder concerned.

9.2 Monitoring folders The T-DOC system can be configured to monitor specific folders for relevant media files. These folders could be

accessed by various media capture devices, for example multiple cameras, sound recorders and scanners in a

production facility. This allows for a repository from which relevant media can be selected and associated with T-DOC

data such as products, items etc.

The list of folders to be monitored must be specified using the T-DOC Spool Server. The T-DOC Database

Maintenance Job must be running on T-DOC Job Server, this provides access to the media server in T-DOC. The

Job specific tab specifies the number of days to retain unused imported files.

9.2.1 Specifying the folders to be monitored

The folders containing media are applied by using the T-DOC Spool Server. Right-clicking on the T-DOC Spool

Server icon displays a pop-up menu. Selecting Media import folders in the pop-up menu opens a Media import

folders dialog in which folders can be added.

Files in the monitored folders are automatically imported into the T-DOC database at regular intervals. A physical file is

deleted from the watched folder if its folder has Clear after import selected in the Media import folders dialog.

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Imported files in the database that have not been used are removed by T-DOC Database Maintenance Job, this if

they have been in the database for a number of days exceeding the job’s Days to keep unused imported data setting

(as standard set to 60 days).

9.2.2 Specifying the types of media to be included The types of media to be monitored for inclusion can be specified in a File types column of the folder concerned. As

standard all the following files types are applicable:

BMP Bitmap image

GIF Graphic Interchange Format

JPG JPEG image

JPEG JPEG image

ICO Icon image

EMF Windows Metafile

WMF Windows Metafile

PNG Portable Network Graphic

AVI Audio Video Interleave

WMV Windows Media Video

TXT Text file

WAV Wave Audio Format

Note that changes to the selections for included file types only applies to files applied after the change was made, unless

the change was made when adding the folder to the T-DOC media group.

9.2.3 Removing a folder from monitoring Monitoring can easily be stopped on a folder by opening the Media import folders dialog, selecting the folder to be

removed and pressing Delete button.

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9.3 Using live capture Pictures and video can now be added as media directly from live cameras.

9.3.1 Adding a picture or video from a live camera

The Media window includes a Take picture or video button. This opens a Camera dialog.

If more than one camera is attached then a Select camera dialog appears in which the appropriate camera can be

selected. Pressing the and buttons respectively selects whether a picture or a video is to be taken with the

camera.

If picture is selected then pressing the button captures the picture. If video is selected then pressing the button

starts recording and the button stops recording. A Retake button allows the picture or video is to be recaptured.

When completed, focus is returned to the window and the picture or video appears in the left hand pane.

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9.3.2 Replacing a picture or video with another from a

live camera

A picture or video can be replaced by selecting it in the Media window and pressing the button. The Camera dialog

opens and the procedure described previously can be used.

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10 Using indicators and incubators

10.1 Changes to types of indicators Previous T-DOC versions used immediate and delayed indicators. This has been enhanced to include:

Immediate indicators

As before, primarily Chemical indicators that can be analyzed upon completion of a machine

process. These can be associated with products and/or programs.

Delayed indicators

As before, a Delayed indicator may include several approval steps. There may be intervals

of several hours or days between each step. In T-DOC v12 a delayed indicator can be

based upon a Biological indicator type and can be:

Control indicators

These delayed indicators are Biological indicators that cannot be placed in a batch and

are not subject to a machine process. Control indicators cannot be associated with

products and/or programs as they are not placed in batches. A Control indicator must

be based on a single item that is traceable by LOT number.

A Control indicator is used to confirm whether a LOT of Biological indicators has been

incubated correctly (regarding temperature), stored correctly and also help identify

factors that could cause spore growth. Placing a Control indicator in an incubator

should produce a positive result (contamination). This implies that then other Biological

indicators from the same LOT are usable.

Biological indicators

These delayed indicators, when not a Control indicator, can be based on a single item

traceable by LOT number or traceable by item number. They can be associated with

products and/or programs and are placed in batches.

For both the above a series of monitoring steps can be defined. These indicators must

be placed in incubators, even if it they have 0 as their Incubation time.

Combined indicators

A pack consisting of an Immediate and a Delayed indicator. These can be associated with

products and/or programs.

Note! For clarity purposes in the following sections, the term Control indicator is used to represent a Biological indicator

that cannot be placed in a batch and therefor is not subject to a machine process. A Biological indicator that has been in

a batch and subjected to a machine process is specifically termed a Processed biological indicator. The term Biological

indicator used to collectively refer to all Biological indicators.

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10.2 Using Biological indicator types T-DOC is delivered with a default set of Biological indicator types:

Getinge Assure AccuFast

1291 3M™ Attest™ Rapid Readout



1491 3M™ Attest™ Super Rapid Readout

1492V 3M™ Attest™ Super Rapid Readout

Other Biological indicators can be created as necessary. Biological indicator types are accessed from System >

Configuration > Indicators > Biological indicators in the Main menu in T-DOC Admin. Each has a unique identifier,

which is used when basing an indicator type upon a Biological indicator type and when defining well placement details in

incubators (machines).

A Biological indicator type also has an Incubation time. This is applied as the Incubation time in the first BI result

step – one or more steps ensure the correct approval/disapproval of the indicator and thereby correct handling of the

good in the batch.

A Min. cooling time defines the time required for the indicator to cool down after having been in a process (measured

from process completion). Only after this time has elapsed can the indicator be placed in an incubator well. Attempting to

scan an indicator from a completed process before this time has elapsed will prompt the user with the remaining time.

Each Biological indicator type is identifiable by a set of colors that can be seen in the incubator overview and reflect the:

Cap color

Processed color – if it has been in a batch and

Unprocessed color – if it has not been in a batch.

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10.3 Defining indicator types Indicator types has been repositioned to the System > Configuration > Indicators > Indicator types menu. This must

not be confused with Biological indicator types that has its own data type.

It is here that the three types of indicators can be created:

Immediate

Delayed (in T-DOC this nearly always implies Biological indicators).

Combined

The General tab in Indicator types includes a Control Indicator field. This identifies whether Indicator type is a Control

indicator and this requires the Result type to be Delayed and traceability of the Item to be LOT.

10.4 Implications of indicator types associated with

products and/or programs This has been simplified in comparison with previous T-DOC versions.

Immediate indicator

An On disapprove immediate indicator selection appears on the Associations tab.

Error mark all units in batch or Only error mark associated products

can be selected.

Delayed indicator

An On disapprove delayed indicator selection appears on the Associations tab, with the

same selections described above.

Combined indicator

An On disapprove immediate indicator selection and an On disapprove delayed

indicator selection appears on the Associations tab, with the same selections described

above.

In all cases the Only error mark associated products selection is only available if products have been

associated in the lists on the Associations tab.

Note! Associations are not possible if the indicator type is a Control indicator,

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10.5 Defining incubators Incubators are machines that are used to store, incubate and analyze Delayed indicators until they have been approved

or disapproved. This is by using a set of placements, or wells, into which the indicators can be inserted.

10.5.1 Defining incubator machine models T-DOC allows for defining machine models where their Type is Incubator. Here it is possible to specify:

The frequency for Control indicators usage:

Daily (once every 24 hours and for all machines combined)

Daily per machine (once every 24 hours and for each machine individually) or

None (Control indicator usage is permitted but not required)

Each placement, or well, into which indicators are inserted. Each well has a number, for

example from 1 to 10.

Four predefined incubator Machine models will be available in T-DOC – three from 3M and one from Getinge. Other

incubator machine models can be created as necessary.

10.5.2 Defining incubator machines Specific incubator machines can be based upon the incubator machine models. A Placements tab displays a row for

each placement in the incubator as specified in Placement count in the Machine model. Biological indicator types can

be applied to the placement(s). Note that depending on the Placement configuration in Machine models - Single or

Dual - one or two Biological indicator types can be applied.

10.6 Locations

10.6.1 Indicator incubation location A new Incubation process location is available. This is used to display a graphic representation of the incubator and

indicator status (see the following sections).

10.6.2 Pre-batch and Post-batch locations Triggers are used in the Pre-batch area when scanning indicators. For example, a Control indicator cannot be placed in a

batch and a warning appears when attempting this. Also the location’s LOT info mode option determines whether a

prompt appears for a Biological indicator’s LOT number when the indicator is scanned for inclusion in a batch and when

it has no LOT number.

Immediate indicators and Immediate indicator steps in Combined indicators can be approved/disapproved in the Pre-

batch and Post-batch areas, and no dialog is displayed.

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10.7 Viewing indicators and incubators A graphic representation of the incubators is available. For example in the T-DOC Scanner Client:

The incubators (machines in T-DOC) are presented by name in alphabetic order. An Offline icon clearly identifies

whether the incubator is online or offline.

The T-DOC Admin Client and the T-DOC Machine Viewer provide a more simple single machine overview without the

indicator lists – they are simply a quick status of the incubator without functionality seen in the T-DOC Scanner Client.

10.7.1 T-DOC Scanner Client The overview in the T-DOC Scanner provides more functionality than that seen in the T-DOC Admin Client and the T-

DOC Machine Viewer.

An Incubators tab includes:

An Awaiting incubation panel that lists Delayed Indicators and Combined Indicators from

completed batches that have not yet been placed in wells.

o If the indicator is cooling down then this is displayed by an icon and time in the Awaiting

incubation list. The indicator cannot be placed in a well until this time has elapsed.

o The Batch value links to a List of units dialog showing details such as Batch,

Sterilizer, Indicator ID, Unit number, Product Name and Customer.

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o Pressing the LOT button opens a LOT information dialog. This allows for viewing, and

if necessary, modifying LOT information of the indicator.

Note! The LOT button and the need to specify a LOT number for an indicator are

relevant when the incubator is of a machine model where Control indicator required is

Daily or Daily per machine. Placement of Biological indicators without LOT

numbers in an incubator is only possible if the incubator’s machine model has Control

indicator required set to None.

A Control Indicators panel that:

o Lists all Created Control indicators (not yet placed in wells).

o Allows for registering a Control indicator in a well.

o Allows for creating new Control indicators (if needed).

o Provides a LOT button to open the LOT information dialog as described earlier.

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An Indicator queue tab provides a summarized listing of indicators awaiting incubation as well as those subjected to

incubation.

Indicators that require user action are displayed at the top of the list.

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10.7.2 T-DOC Admin Client As in the T-DOC Scanner Client, a graphic representation of the incubators is provided. This is accessible from View >

Machines in the Main menu where the Incubators appear as part of the machine overview. This follows the standard

approach seen with sterilizers, washer-disinfectors etc. in earlier T-DOC versions.

Note that this view differs from that in the T-DOC Scanner client as it is without the lists, Indicator queue tab and

functionality associated with the wells and their assignments.

10.7.3 T-DOC Machine Viewer As for the T-DOC Admin Client described above.

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10.7.4 Understanding the overviews

10.7.4.1 Incubator viewer

The elements and styles used in the various overviews are similar across T-DOC Admin Clients, T-DOC Scanner Clients

and the T-DOC Machine Viewer.

10.7.4.1.1 Incubators

Each indicator displays its name.

Indicator colors are according to the color settings of the Biological indicator types (on the

General tab in Biological indicator types).

Incubator colors are in accordance with the color settings of the Biological indicator types

(on the General tab in Biological indicator types) as applied to the machine (on the

Placements tab in Machines).

Data logging status is identifiable by an icon.

10.7.4.1.2 Wells

Various indicator states can be displayed.

Time remaining for the indicator in a well is displayed, typically in minutes and with a

countdown timer.

Warnings are shown.

Errors in incubator well numbers are according to its machine configuration.

Batch number of an indicator in a well is displayed unless it is a Control indicator

LOT number of Biological indicator is displayed.

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10.7.4.1.3 Indicators

Placement of Biological indicator types in an incubator is in accordance with the incubator’s

configuration.

Biological indicator colors are according to the Biological Indicator configuration.

Detailed indicator information and approval steps and step times are visible in the Indicator

information pop-up on the well.

The number of steps also appears alongside the well in the Incubators overview as a series

of green, white and grey dots. Green indicating checked and passed, white implying the next

applicable test can be performed and grey being a check that has not yet become

applicable.

Warnings and errors codes replace the remaining time in the well.

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10.7.4.2 Biological Indicator queue

The Indicator queue is only available in the T-DOC Scanner Client. It provides much of the same information see on the

Incubators tab, but here being a list of the indicators being managed.

A series of icons in the first column indicate the status of the indicator:

Red - failed result or control disapproved or missing.

Green – result ready with data logging.

Blue – result ready, but no data logging.

Yellow warning - data logging lost during incubation.

Green warning – result ready with data lost during logging.

Cooling –cooling underway.

Also listed are:

ID of the Indicator.

ID of the Incubator it is placed in.

Status of test steps.

Time until next step or approval.

Date and time the indicator was inserted into the incubator.

Indicator’s LOT number (where appropriate).

Associated Control Indicator (where relevant).

Identifier of the batch the indicator was placed in or Control if it is a Control indicator.

ID of the sterilizer the batch was in (not relevant for Control indicators).

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10.7.5 Understanding a basic incubation procedure The following describes a very simple approach to using Biological indicators in incubators. It is not a complete

procedural description.

1. Placement of an indicator in an incubator well in T-DOC occurs by:

Clicking on the well and selecting the indicator.

This can also be done by clicking on the indicator in the Awaiting incubation and Control

indicators lists and then clicking on the well.

The Biological indicator must now be physically placed in the incubator.

The incubator analyzes the indicator and displays a or result.

The interpretation of the result must take the type of indicator into consideration.

Control indicators

A result implies contamination. This is expected as it should show contamination and can be

approved. A result implies no contamination and it must be disapproved.

Processed biological indicators

A result implies contamination and it must be disapproved. A result implies no

contamination and can therefore be approved.

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2. Approval steps can be performed after the incubator provides a passed indicator result. In this

example it displays Ready as this does not use data logging, but with data logging it will be + or -.

If there are multiple approval steps then the time must elapse before the step can be performed,

unless a forced approval is applied. The Control indicator is always tested first.

This is also reflected by the green, white and grey dots alongside the occupied wells in the

Incubators overview.

If a Control indicator fails, then this can fail other Biological indicators from the same LOT that

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were in the incubator at the same time as the failed Control indicator. Another Control indicator

from the affected LOT must be incubated and passed before Biological indicators from the LOT

can be approved.

In summary:

The use of Biological indicators from a specific LOT requires that the last Control indicator from

the LOT has passed successfully. This must be in accordance with the Control indicator

required setting of the incubator’s machine model. For example, if Daily was selected for

Control indicator required, then a Control indicator must have been approved within the past 24

hours in order to approve Biological indicators from the same LOT (as the Control indicator). If the

last test of a Control indicator from the LOT failed, or was passed more than 24 hours ago, then a

new Control indicator from the LOT must be incubated and tested before Biological Indicators

from the LOT can be approved.

Note - while the incubator can report an indicator’s incubation result, it is ultimately the T-

DOC user that must approve or fail the indicator in the T-DOC system. A failed result must

be registered with an error by the T-DOC user.

3. Approval/disapproval of the Biological Indicator follows the same approach as the Control

indicator. In both cases, if there are multiple steps then the time for each step must expire before

the step concerned can be approved/disapproved.

Forced approval is only permitted if the user’s Can force indicator approval setting is

True. This disregards the time intervals and forces an immediate approval. The user’s Can

approve indicators setting must also be True.

Multiple approval steps also appear on the Incubators tab.

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4. If the incubator has data logging then an indicator is removed from T-DOC by physically removing

the indicator from the well. This is also the case in manual machines when the indicator is

approved/disapproved.

For manual machines where the indicator must be removed prior to approval/disapproval or for

logged machines when data logging has been lost, pressing the button in the Indicator

information dialog unregisters the indicator from the well. For logged machines the indicator

must also be physically removed from the well, if not then the indicator appears as unknown when

data logging is restored.

The well is cleared and ready to accept another indicator.

5. Approval steps on remaining indicators can be tested when their wait time has been exceeded.

Approval steps that are ready for approval appear in white. These change to green when

successfully approved. The Approval steps also appear in the Incubators overview.

The incubation details of the indicator can be seen on the Incubation tab of Indicators.

T-DOC v12


11 Processing and using endoscopes Various enhancements have been made in the T-DOC Endoscope Module. The enhancements are also applicable to the

the T-DOC EndoTrace product.

11.1 Managing time intervals Prior to v12, the time intervals that determined whether endoscopes were good for use were defined at factory level. For

example, Std. Endo Expire time, Cycle to cabinet time, Endo shelf delay rel. time and Endo shelf delay time.

T-DOC is now delivered with a predefined set of Time Rules, each of which has a standard time value. These rules can

be included in Expire Time Groups, and such a group can be associated at factory, endoscope product and serialized

endoscope product levels. The association at serialized product level overrides that at product level, which in turn

overrides that at factory level. A Standard expire time rule is obligatory in all Expire Time Groups.

11.2 Managing endoscope handling Prior to v12, the various handling steps to be used when processing endoscopes were assigned at factory level. T-DOC

now includes a Handling step and a Handling type concept.

A Handling step is a single task to be performed when processing an endoscope, for example checking that its

parts are clean.

A Handling type is a collection of Handling steps. It also allows for specifying the order in which the steps are to

be performed, whether a step mandatory and what should happen if the step is not completed.

As with Expire Time Groups, a Handling type can be associated at factory, endoscope product and serialized endoscope

product levels. The serialized endoscope product association overrides that at endoscope product level, while the

endoscope product level association overrides that at factory level.

11.3 Allowing endoscope sterilization Endoscope sterilization can form part of the T-DOC Endoscope Production Circle.

T-DOC v12


New in T-DOC v12, to ensure that endoscopes comply as regards their processing times, the following Time Rules are

available:

Rule 3 - End washing to sterilization start

Maximum time allowed from end of the washer process (machines with data logging) or from approval of the

washer process (machines without data logging) until start of the sterilizer process.

Rule 4 - End sterilization to usage

Maximum time allowed from end of the sterilizer process (machines with data logging) or from approval of the

sterilizer process (machines without data logging) until start of endoscope usage.

As described earlier, these Time Rules can be included in Expire Time Groups and applied as necessary.

11.4 Using placements in drying cabinets It is now possible to automatically create the placements in Endoscope drying cabinets. The number of placements in the

endoscope drying cabinet machine model can be specified at machine model level. Using this number of placements,

creating a specific machine of this type allows for automatically creating the placements therein.

11.5 Using endoscope groups In T-DOC EndoTrace systems an endoscope can now be assigned to an Endoscope group. In T-DOC 2000 systems

with the T-DOC Endoscope Module the standard Item groups concept is applicable. By assigning an endoscope to such

a group allows for filtering the endoscopes when displaying drying cabinets in the endoscope overviews (described in the

following section).

11.6 Monitoring endoscopes T-DOC v12 provides an Endoscopes in dryers overview. This allows for displaying a choice of endoscope drying

cabinets, their placements and the endoscopes therein. For example:

As standard the overview is set to refresh every 10 minutes, but this can be modified as necessary.

T-DOC v12


11.6.1 Understanding drying cabinet details Each Endoscope drying cabinet is labeled with its Name (as defined in Machines). If more Endoscope drying cabinets

are included than can be displayed, then a set of arrow buttons allows for navigating backwards and forward through the

machines. If the number of placements in an Endoscope drying cabinet exceeds the display area, then these are

viewable by using vertical scroll bar.

11.6.2 Understanding placement details Each placement is represented by its identification number. If placements have not been defined for a machine, then the

placements are not numbered and appear with a ? symbol.

A placement containing an endoscope displays the endoscope's Name. Also displayed is the endoscope's serial number

(Serial no.) or barcode (Barcode), this being configurable. Hovering the mouse cursor over the placement to display a

pop-up with these details.

The placement appears with a countdown timer indicating the time remaining until the Endoscope expiry time is

reached. If the endoscope has not been removed from the cabinet prior to this time, then the timer appears with a

negative value with increasing absolute value, indicating that time that the endoscope has exceeded its Endoscope

expiry time.

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11.6.3 Filtering placement details The placement information can be displayed according to various filters. For example, it is possible to display

endoscopes by using the group and marker buttons. The group/marker appears in blue when selected, and deselecting a

group/marker resets their color to grey

The All group button is always available and includes all the endoscopes irrespective of their group. Endoscopes that

have not been associated with an Endoscope group appear with a button labeled by their endoscope product Name.

One or more of these groups/products can be selected.

A set of standard markers are provided. Only a single marker can be selected for display. For example:

Pick

Displays in green the next endoscope to be used and this irrespective of the selected groups/products. This is

useful to ensure that the first endoscope in, and that which has typically dried first, is also the endoscope that

will be first picked for use.

Still wet

Displays endoscopes where their Drying time has not been exceeded. These endoscopes are considered as

being wet and must remain in the drying cabinet.

Ex 4 hours

Indicates the endoscopes that are due to expire within the next 4 hours.

etc.

When using a Marker, one or more Endoscope groups/products should be selected. If none have been selected then

All is activated. Only one marker can be selected at any time.

11.6.4 Understanding endoscope details The color of a drying cabinet placement in the overview reflects an endoscope’s status with respect to its Endoscope

expiry time. For example, the placement appears in yellow when a configurable number of hours and minutes is

reached before the Endoscope expiry time has been exceeded. As standard this is set to 2 hours. In brief, the

background color of a placement appears as:

White

The placement is empty or the endoscope therein has no expiry date.

Yellow

The overview’s configurable Near expire time has been reached with respect to the Endoscope expiry time.

Red

The Endoscope expiry time has been exceeded.

Green

The Pick filter has been selected to indicate the next endoscope(s) to be used.

Blue

Any of the Endoscope group/products filters are selected or where a time marker has been selected.

T-DOC v12


Appendix A - Document History

Date Rev. # Revised by Name Description/Changes

2015-03-16 02 Robin Kiszka-Kanowitz Added endoscopes section.

2014-12-23 01 Robin Kiszka-Kanowitz First version of this document.

Getinge Australia Pty. Ltd.

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Getinge Group is a leading global provider of products and systems that

contribute to quality enhancement and cost efficiency within healthcare

and life sciences. We operate under the three brands of ArjoHuntleigh,

Getinge and Maquet. ArjoHuntleigh focuses on patient mobility and wound

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