USR10044 - 01 - US - Getting Started - Single Item Tracking

Integrated Workflow Solutions
Single item tracking Project No.:

Type:
-
USR
Document No.: 10044
Getting started Revision No.:

Language:
Status:
01
US
Re<leased
Date: 2019-09-05
This document is intended to provide information to an international audience outside of the US.
USR10044_01_US - Getting started - Single item tracking.docx
Single item tracking
Table of contents
1 Legal statement...................................................................................................................................................... 3
2 Feedback and comments ...................................................................................................................................... 3
3 New in this version ................................................................................................................................................ 4
4 Introduction ............................................................................................................................................................ 5
4.1 Purpose of this document .................................................................................................................... 5
4.2 Audience ................................................................................................................................................ 5
4.3 Before reading further…....................................................................................................................... 5
5 Prerequisites .......................................................................................................................................................... 6
6 Marking single items ............................................................................................................................................. 7

6.1 RFID (Radio Frequency IDentifier) tags .............................................................................................. 7
6.2 DPM (Direct Part Marking) code........................................................................................................... 7
7 Reading instrument codes .................................................................................................................................... 8

7.1 RFID scanners ....................................................................................................................................... 8
7.2 DPM code readers ................................................................................................................................. 8
8 Defining serialized products and serialized items .............................................................................................. 9

8.1 Defining serialized single items ........................................................................................................... 9
8.2 Defining serialized products ................................................................................................................ 9
9 Scanning a code .................................................................................................................................................. 10
10 Creating serialized single items for a specific single item ............................................................................... 12
11 Associating serialized items with products....................................................................................................... 17

11.1 Using a serialized product ................................................................................................................. 17
11.2 Using a non-serialized product .......................................................................................................... 21
11.3 Workflow .............................................................................................................................................. 23
12 Using products that are not assigned a Counting group ................................................................................. 24
13 Using fixed serialized items in a product........................................................................................................... 25

13.1 Using serialized products .................................................................................................................. 25
13.2 Using non-serialized products ........................................................................................................... 26
13.3 Products with a Counting point group .............................................................................................. 26
13.4 Products without a Counting point group ........................................................................................ 26
13.5 Workflow .............................................................................................................................................. 27
14 Tracking single items in operations ................................................................................................................... 28
15 Tracking single items upon return ..................................................................................................................... 33
16 Conclusion ........................................................................................................................................................... 36
APPENDIX A - Document history ................................................................................................................. 37
USR10044_01_US - Getting started - Single item tracking.docx 2 / 38

1 Legal statement
Copyright
Copyright© 1986-2019 Getinge AB. All rights reserved. Getinge AB and all its subsidiaries and/or affiliates, hereinafter referred
as Getinge, expressly reserve and retain all right, title and interest in and to all existing intellectual property in the products of
Getinge, its subsidiaries and/or affiliates. No right, title or interest is granted by Getinge.
Trademark
GETINGE, T-DOC, Tegris, INSIGHT Surgical, INSIGHT Emergency, and myMedis are trademarks or registered trademarks of Getinge.
All other company or product names are trademarks or registered trademarks of their respective holders.
No Warranty
All products, information, software, documents or materials described herein are provided AS IS and without warranty of any kind.
Getinge do not make any representations or warranties (express or implied) as to the accuracy or completeness of the products,
information software, documents or materials described herein; nor shall Getinge be liable for damages arising from the use of any
products, information software, documents or materials described herein, whether from errors or omissions or otherwise.
GETINGE EXPRESSLY DISCLAIM ANY EXPRESS OR IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTY
OF MERCHANTABILITY OR FITNESS. Getinge do not warrant that any products, information software, documents or materials
described herein shall be free of the rightful claim of any third person by way of patent, copyright, trademark, or trade secret
infringement or the like. Further, Getinge do not warrant that the products, information software, documents or materials
described herein will be error-free or operate uninterrupted.
The contents of this publication may include technical inaccuracies and/or typographical errors. Getinge reserves the right to make
changes to products, information, software, documents or materials described herein at any time without notice.
Limitation of Liability
To the fullest extent permitted by applicable laws, in no event, shall Getinge be liable for any loss of profits or revenues, or any
direct, indirect, consequential, incidental, unforeseen, special or punitive damages including, but not limited to, loss of use of any
Products, loss of stored, transmitted or recorded data, damage to Products, cost of capital, cost of substitute products, facilities,
service or replacement service, or downtime costs, arising out of any products, information, software, documents or materials
described herein, even if advised of the possibility of such damages.
2 Feedback and comments

Questions regarding this document and/or suggestions for changes to the contents herein must be directed to Getinge IT
Solutions ApS.

3 New in this version

Date Rev. # Revised by [Name] Description/Changes
2019-09-05 01 Robin Kiszka-Kanowitz First version of this document.

4 Introduction
4.1 Purpose of this document
This document explains how single items can be tracked using T-DOC. It provides pragmatic examples of typical
workflows in a CSSD and Operating Room where the presence and use of single items must be ensured.
Single item and instrument tracking as per this document can be a key element when compliance with UDI regulations is
required.
4.2 Audience
This document is intended for Getinge Sales and Support staff, distributor staff and customer staff, which require a basic
understanding of the how single item tracking can be performed with T-DOC.
Readers of this document must have the following knowledge prior to commencing:
• Create single items

• Create serialized single items
• Create composite items
• Create products
• Create serialized products
• Use of Counting groups
• Use of a scanner in the Pack area to create units of products
• Auto-numbering on various data types such as items and item serial numbers
4.3 Before reading further…

Please be aware that certain prerequisites must be satisfied prior to commencing.
• Note that the examples provided use a Getinge-supported DPM scanner and an RFID reader. Use of standard
barcode scanners and imagers may be possible, but are not always practical. If in doubt regarding supported
scanner/reader hardware then contact your local Getinge office for details.
• This document is not a comprehensive description of the use of serial item tracking features and functionality in
T-DOC. The availability of this functionality also depends upon the system license being used.
• 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 Prerequisites
The following prerequisites must be complied with:
• Item and product definitions
o Autonumbering masks must be defined (in System data or Factories as appropriate) for single items,
serialized single items and serialized products.
o The single items to be tracked must have their Trace by value set to Serial numbers (in Single
items).
o The single items must be included in a serialised product. This is for products based upon a single item
or composite (tray that includes the serialized single item). It is possible to include serialized items in
non-serialized products, but this will not offer the traceability desired on the single item.
o The products must have their Trace type value set to Serial numbers. For optimal tracking the
product must be traced by serial numbers, and the items in the product must be set to Trace type is
Serial number.*
o The serialized product that contains serialized item(s) must be associated with a Counting group (in
Counting point group in Products) to have any real meaning when tracking the serialized single
items therein.
* It is possible to track serialized single items in non-serialized products. This has limitations and is
explained in this guide. For the purposes of this guide serialized products will be used.
• Hardware
o The physical serialized single items must have an appropriate code etched or marked onto the metal
or have an RF ID tag mounted. The type of identifier or code determines the type of scanner/reader
that must be used at the various locations in the hospital (CSSD, Operation Area etc.).
o Depending on the type of code being used – DPM or RFID – the appropriate scanners must be
installed and configured to read these codes.
• Licenses and keys
o The use of serialized single items is only possible if the T-DOC Single Instrument Tracking module is
included in the T-DOC license key.
o Counting in the Operation Area is only possible if the T-DOC Operation Count Module is module is
included in the T-DOC license key.

6 Marking single items

The physical size of a single item typically places constraints on how an item can be permanently marked. It is
impractical, if not impossible to use standard barcodes. The most common techniques are described below.
6.1 RFID (Radio Frequency IDentifier) tags

An RFID is typically a mounted metal capsule or rubber capsule that can be placed on the instrument without affecting its
functionality. Factory-mounted tags are also encountered. For example:
6.2 DPM (Direct Part Marking) code

A DPM code is a code etched into the metallic part of the single item. This is typically a 2-D data matrix code.
Instruments may be delivered from the factory with a DPM code, thus it is essential to ensure that these codes are
unique.

7 Reading instrument codes

T-DOC is compatible with scanners that can read RFID tags and scanners that can read DPM codes.
7.1 RFID scanners

T-DOC supports the RR9 series and the TSL 1128 BLUETOOTH UHF RFID scanner. The latter looks as follows:
As with all RFID scanners, this scanner can read the RFID tags of multiple serialized items in a single scan sweep.
See INS10028 - Connecting TSL 1128 scanners to T-DOC.
7.2 DPM code readers

T-DOC supports various data matrix readers, but the GLDK T-DOC 2D Tabletop Scanner Ultra is a robust reader for
serial item tracking.
This scanner requires a separate scan of each serialized single item to read the DPM code.
See INS10033 - Connecting GLDK T-DOC 2D Tabletop Scanner Ultra to T-DOC.

8 Defining serialized products and serialized

items
8.1 Defining serialized single items
When a single item definition has been created in Single items, the standard T-DOC approach is to generate a set of
serialized items that appears in Item serial numbers. This is standard T-DOC functionality and is described in other
relevant documentation.
However, it is possible to auto-generate the serialized item definitions by using a scanner or reader. This approach is
described in the following sections.
8.2 Defining serialized products

Serialized products are created using the standard T-DOC approach and have these appear in Product serial numbers.
Unlike single items, scanning or reading a code will not auto-generate product serial numbers, simply because products
require other data input to be meaningful (see Scanning a code on page 10).

9 Scanning a code
When a code (RFID or DPM) on a single item is read, and T-DOC cannot associate the read value with any existing data
in the database, then T-DOC regards this as an external barcode and following the user’s selection will place the code
value in the Barcodes field of a specific item, serialized item or serialized product concerned. Scanning such an
unknown code at a specific location in the T-DOC Scanner Client opens an Unidentified external ID dialog (if the
location options allow thgis), and it is here where it is possible to specify what needs to be created or where the code is
to be applied.
There are the following possibilities:
Create a new serialised item (for the item selected in the list). The serialised item
receives the next auto serial number and the scanned value is applied as its Barcodes
(external) value.
Create a new single item, but also create the first serialised item of this new item with
the scanned value applied as its Barcodes (external) value.
Apply the read value as the Barcodes value of the serialized single item selected in the
list.

N/A
Create a new single item with the scanned value applied as its Barcodes (external) value
of this item.
Apply the read value as the Barcodes value of the single item selected in the list.
N/A
N/A
Apply the read value as the Barcodes value of the product selected in the list.
Create a new serialised product (for the product selected in the list). The serialised
product receives the next auto serial number and the scanned value is applied as its
Barcodes (external) value.
N/A
Apply the read value as the Barcodes value of the serialised product selected in the list.
Note that the button is inactive in all cases when a selection has not been made in the list.

10 Creating serialized single items for a

specific single item
The following depicts how scanning/reading an unknown code allows for creating an association with a serialized item.
Note that the code being scanned is not yet associated with any data in the T-DOC database.
The scanner shows the scanning as follows:
The Unidentified external ID dialog opens.

The aim in this example is to use the scanned code to create a new serialized item that can be used in production. This
will allow traceability of the serialized single item.
Item serial number is selected as Data type in the dialog. As standard all item serial numbers are listed as well as
those serialized items that do not have any serialized items.
In this example new item serial numbers are to be created for a single item that already has serial numbers. Here the
filter field is used to search for the specific single item of interest.
The list shows that 5 serialized items of the single item already exist. The scanned external code will allow creating the
sixth serial item.

Select a serial number in the list. This is simply to identify the single item (in Item.Item) to be used.
Click to create a new serialized single item for the single item selected in the list.
The New item serial number dialog appears listing the planned serialized item (Serial number) and the scanned code
(External ID) that will be applied as its Barcodes value.
The Serial number value is auto-generated from the Autonumbering definition that was applied in T-DOC for serialized
single items.
The dialog also allows the scanning of multiple external codes, here two more have been scanned. If an RFID scanner is
being used then all the codes can be read in a single scan swipe of the instruments, if not then each needs to be
read/scanned individually.

When completed press . The respective serialized single items are created with the scanned code as their
Barcodes value.

The workflow where only new serialized single items need to be created for a selected single item (by pressing ) is
as follows:
When using this method with RFID it must be ensured that one RFID at a time is scanned, otherwise there is no way to
know which item the scanner considered.

If the single item also needs to be created, then pressing has the following workflow.

11 Associating serialized items with products

11.1 Using a serialized product
In this example a serialized product is scanned in the Pack Area to create a unit thereof. This product is assigned a
Counting group (in Products), and therefore the Current contents list appears.
On this example the product is based upon a composite item that includes two single items. The single items are of the
same type and this single item is set to be traceable by serial number (in Single items), meaning that specific serial
numbers of the item must be applied in the Current contents list.
The serialized items can be created by reading/scanning the external code (for example RFID or DMR), following which
the Unidentified external ID dialog appears. This requires that the scanned code is not already associated with data in
T-DOC. From this dialog the serial number can be created as described in the previous section. The scanned code is
applied as the Barcodes value of the serialized single item.
The following depicts two serialized items. Note that the Barcodes value of each has a value, this being the scanned
external barcode.

When the serial numbers have been created the codes can be rescanned and applied in the Current content list. With
an RFID scanner, multiple codes (of the serialized items) can be scanned in a single scan. The following depicts the
Current content list where the item serial numbers are applied via the Barcodes association (from the RFID or DMR
code).
Click .to create the unit when the minimum criteria of the Current content list have been satisfied
The serialized product indicates the Unit created from it.

In Units the unit displays the items (on the Items tab) that it contains as well as the product (Serial no.) upon which it is
based.
The serialized single items allow for viewing the units they have been used in. This is in the menu by selecting View
> Related data > Unit content. For example:
The scanner log for this production flow appears as follows:

The tracking of the single items can be represented as in the following image.
 The serialized items show the current serialized product they are
associated with. This is the Product serial value.
 The serialized product shows the unit it is currently used in. This is in
Unit.
 The unit lists the serialized items therein. This is on the Items tab.
 The serialized item can also show the units that it has been associated
with.
 The list of units that a serialized item is used in can be used to access the
units directly.
It is thereby possible to know exactly which units a serialized single item has been used in. By knowing the unit ID it is
possible to see what sterilization batches the item was in, the operations it was used in, the washer-disinfection batches
it was included in etc. Basically, the use of specific serialized items can be followed in the production circle.

11.2 Using a non-serialized product

Consider a product that has Product number as Trace type.
In this example it is based on a serialized single item.
Here a specific serial number of the single item has been created
This has been used in the non-serialized product. Note that the Product serial does not have a value in the previous
image as the product is not serialized.

When a unit of the product is created, the unit shows that the serialized item has been included.
The units that the serialized item has been used in can be seen in the List of unit content.
Just as with serialized products, the unit number can be used to see the serialized item was used, for example in an
operation, machine processing etc.
Although this example used a product based upon a single item, the same applies if it were based on a composite item,
only here multiple serial numbers would need to be specified when using Current contents.
The same RFID/DPM scanning techniques can be used to create serialized items as necessary.

11.3 Workflow
The workflow for the two approaches can be depicted as follows:

12 Using products that are not assigned a

Counting group
If a product does not have assigned a Counting point group value, then for example, packing the product, will without
user intervention, apply the required single items. It is not possible to specify exactly which item serial numbers are
applied and these will not be recorded on the unit (Items tab in Units). This means the used serialised items are not
recorded and cannot be traced by using Units for the resulting unit, as described in the previous sections. This applies to
both serialized products and non-serialized products.
The workflow can be depicted as follows:

13 Using fixed serialized items in a product

13.1 Using serialized products
If a serialized item is included in a serialized product (where the product is based upon a composite item or a single
item), it is possible to specify exactly which serialized items (numbers) must be used with the specific serialized product.
This is to ensure that these serialized items are always present in units of the serialized product.
This is done using the Current item serial numbers function in the Action menu.
This opens a dialog in which the serialized items can be applied or created as described in earlier sections.

The serial numbers are selected.
These appear in Current item serial numbers.
13.2 Using non-serialized products

The Current item serial numbers function in the Action menu is not available for non-serialised products.
13.3 Products with a Counting point group

If the product has a Counting point group, then packing the serialized product opens the Current contents list and the
associated single items are listed. The listed serialised items can be applied or modified as necessary and the unit can
then be packed.
Note – the Prefill mode setting on the Counting point affects the visibility of these serial items in the Current contents
list. If they do not appear then it could be that this has been set to Empty list, mandatory for user to fill
in all counts or Everything prefilled, except serialized item.
13.4 Products without a Counting point group

If the serialized product does not have a Counting point group and serialized items have been associated with it, then
the Current contents list does not appear and the associated serialized single items are not applied in the resulting unit.

13.5 Workflow
The workflows for these scenarios can be depicted as follows:

14 Tracking single items in operations

Note – the following is not a complete description of counting and tracking serialized single items in operations.
For detailed information refer to USR462 – Getting started with T-DOC Operation Count.
The T-DOC OperationCount module allows for confirming the existence and use of specific serialized items in an
operation. This is by using operation count areas such as Pre-OP, Per-OP and Post-OP in the Operation Area. For
example Pre-OP which is a Pre-Operation type location counting point is defined as follows.
The areas at which counting in the Operation Area is to be performed applied by the Counting point group value in
Operation types. For example OP, on the Operation type.

This represents a collection of Counting points (as defined in Counting points), in this case OP being the Pre-OP, Per-
OP and Post-OP in that order. The OP Counting point group is one of several delivered as standard with the T-DOC
Operation Module. It will be used in the following examples.
Starting an operation that has the OP Counting point group assigned to it will cause the counting dialog to appear. Here
a unit is packed and applied to an operation. When the operation is started or when the unit is added to the operation the
Content list appears for the Pre-OP area.
Here the included serialized items can be confirmed.
Pressing the button opens a Select serial numbers to add dialog where a serialized item can be applied. As before,
an external barcode can be scanned and a serialized item will be found if it is associated therewith. If the code is
unknown then using the Unidentified external ID dialog a serialised item can be created for the code or the code can be
associated with an existing serialised item. Again, a reason must be entered and the added serialized item appears in
green.
If serialised items are missing, then they can be removed by pressing the button and using the Select items to
remove dialog that appears. As before, an external barcode can be scanned and a serialized item will be found if it is
associated therewith. If the code is unknown then using the Unidentified external ID dialog, the code can be associated
with an existing serialised item. Creating a serialized item in this dialog has no significance when using the Content list to
removed items from a unit. A reason for the change must be specified in the Count change dialog.

The removed serial number appears in red.
The result for the items in the unit (and operation) appear as follows:
Clicking the (i) button opens a dialog displaying the serialized items and what they have been subjected to.

As before, the serialized single items allow for viewing the units they have been used in. This is by viewing the List of
Unit content that is accessible from the menu by selecting View > Related data > Unit content.
Use of the serialized single item can be seen in Units.

The Handling tab in Units shows the Operation in which the unit (and the items therein) was used.

15 Tracking single items upon return

Note – the following is not a complete description of counting and tracking serialized single items. For detailed
information refer to USR468 – Getting started with T-DOC CountAssure.
The previous section described single item tracking and counting in the Operation Area. At the outset the unit’s contents
were specified by having the Pack & OP Counting group assigned to the product. This included the Pack, Pre-Op,
Per-Op and Post-Op Counting points.
T-DOC also allows creating Wrap Area and Return Area Counting points. These can then be included in Counting
groups. For example, a Pack & Return Counting group can include the Pack Counting point and the Return
Counting point.
The Pack & Return Counting point group has been assigned to the following product (in the Counting point group
field). This means that the counting of serialized single items is performed at the Pack Area and at the Return Area.

Packing a unit of this product, which is a tray with two serialized items, opens the Current contents list. The single item
serial numbers are applied as necessary (as described in section xxxx).
The unit is created and when on stock is dispatched to the customer.
The unit shows the included serialized items.

The unit can now be returned. The unit is scanned upon return in the Return Area. The Current content list appears.
Here the serialised items can be controlled to see if they exist or not. T-DOC can be configured to force the inclusion of
another serialized item before returning the unit. Likewise, it can give a warning message or ignore the missing item.
These possibilities are managed by various option settings on the location definition (in Locations).

As seen earlier, scanning an external code allows for identifying a serialised item. If the code is unknown, then the
Unidentified external ID dialog allows for creating the association with an existing serialised single item or even creating
a new single item or a new serialised single item. Again, an RFID/DMR scanner can be used where RFID scanner allow
the scanning of multiple codes in a single sweep.
The result of the counting process can be seen in Units. By using the unit number to track the serialised single items, the
existence and use of the units in the production cycle can be evaluated.
16 Conclusion
T-DOC provides the necessary data interrelationships that allow for tracking the use of single items in a production cycle.
By using this information, the operation and patient on which items were used can be determined. This provides a history
trail of item usage and thereby enables compliance with UDI regulations.
Other T-DOC functionality such as Fast Tracking, Repairs, Weights, Multi-site etc. allow for closer monitoring of the
processing of items.

APPENDIX A - Document history

Date Rev. # Revised by [Name] Description/Changes
2019-09-05 01 Robin Kiszka-Kanowitz First version of this document.

USR10044_01_US - Getting started - Single item tracking.docx

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Integrated Workflow Solutions

Single item tracking Project No.:

Getting started Revision No.:

2 Feedback and comments ...................................................................................................................................... 3

3 New in this version ................................................................................................................................................ 4

6 Marking single items ............................................................................................................................................. 7

7 Reading instrument codes .................................................................................................................................... 8

8 Defining serialized products and serialized items .............................................................................................. 9

9 Scanning a code .................................................................................................................................................. 10

10 Creating serialized single items for a specific single item ............................................................................... 12

11 Associating serialized items with products....................................................................................................... 17

12 Using products that are not assigned a Counting group ................................................................................. 24

13 Using fixed serialized items in a product........................................................................................................... 25

14 Tracking single items in operations ................................................................................................................... 28

15 Tracking single items upon return ..................................................................................................................... 33

APPENDIX A - Document history ................................................................................................................. 37

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2 Feedback and comments

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3 New in this version

2019-09-05 01 Robin Kiszka-Kanowitz First version of this document.

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• Create single items

4.3 Before reading further…

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• Item and product definitions

• Licenses and keys

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6 Marking single items

6.1 RFID (Radio Frequency IDentifier) tags

6.2 DPM (Direct Part Marking) code

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7 Reading instrument codes

7.1 RFID scanners

7.2 DPM code readers

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8 Defining serialized products and serialized

8.2 Defining serialized products

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There are the following possibilities:

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10 Creating serialized single items for a

The Unidentified external ID dialog opens.

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11 Associating serialized items with products

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The serialized product indicates the Unit created from it.

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The scanner log for this production flow appears as follows:

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11.2 Using a non-serialized product

In this example it is based on a serialized single item.

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12 Using products that are not assigned a

The workflow can be depicted as follows: