Haldor ORLocate User manual

© 2010 Haldor Advanced Technologies Ltd.P0037 Rev.0 Page 1 out of 28
RFID-BASED SYSTEM TO HELP ASSEMBLE SURGICAL SETS
ACCURATELY AND EASILY
USER MANUAL
REVISION 0
Packing System

User Manual ORLocate™ Packing System
© 2010 Haldor Advanced Technologies Ltd.P0037 Rev.0 Page 2 out of 28
Copyright
©
2011 Haldor Advanced Technologies Ltd. All rights reserved.
All rights reserved. No part of this publication may be reproduced, stored in a retrieval system or
transmitted in any form by any means, electronic, mechanical, photo reproductive, recording or
otherwise without the express prior written permission of Haldor Advanced Technologies Ltd.
Haldor Advanced Technologies Ltd. reserves the right to change or improve its products and
accompanying technical literature without specific notice to changes or improvements.
Text revised January 2011.
2 Habanai Street, Hod Hasharon 45319, Israel
Tel: [phone] , Fax: [phone], Email: suppo[email protected]
TABLE OF CONTENTS
1. INTRODUCTION..........................................................................................................................3
2. SAFETY.......................................................................................................................................5
3. INTRODUCTION TO THE HALDOR ORLOCATE™ PACKING SYSTEM.................................................7
4. STERILE AND CLEANING CONSIDERATIONS..................................................................................8
5. SETTING ORLOCATE™ PACKING SYSTEM COMPONENTS...............................................................9
6. USING THE SYSTEM ..................................................................................................................10
7. THE ORLOCATE™ FUNCTIONALITY.............................................................................................21
8. SHUTTING DOWN THE SYSTEM .................................................................................................22
9. MAINTENANCE AND SERVICE....................................................................................................22
10. TROUBLE SHOOTING ................................................................................................................23
11. OPERATING SPECIFICATIONS ....................................................................................................25
12. SYSTEM SPECIFICATIONS ..........................................................................................................26
13. EMC CONSIDERATIONS.............................................................................................................27

User Manual ORLocate™ Packing System
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1. INTRODUCTION
1.1 THE HALDOR ORLOCATE™ PACKING SYSTEM
Haldor ORLocate™ Packing system is a supplementary system for the Operating Room ORLocate™
system and to the ORLocate™ Management system, which is described in a different User Manuals.
Generally, Haldor ORLocate™ system is an RFID system that provides a solution enabling the
enumeration of RFID tagged sponges and surgical instruments to keep track of the items during surgery,
by utilizing passive RFID tags (battery-less transponder that does not radiate any electromagnetic field
when not activated).
Haldor ORLocate™ Packing system is an RFID system that provides a solution enabling the enumeration
of RFID tagged surgical instruments to keep track of the items during their usage (OR-SPD cycle), by
utilizing passive RFID tags (battery-less transponder that do not radiate any electromagnetic field when
not activated).
The ORLocate Packing system provides a method for packing RFID-tagged surgical items within a surgical
set, and is to be used during sterilization and while packing units in hospitals.
1.2 ABOUT THIS MANUAL
This manual provides the information necessary to operate the Haldor ORLocate™ Packing system in a
safe and efficient manner. Please read this manual before operating the system. If any part of this
manual is not clear, contact Haldor Customer Support for clarification.
1.2.1 WARNINGS, CAUTIONS AND NOTES
Three types of special messages appear in this User Guide:
-Awarning indicates the possibility of injury to the patient or operator.
-Acaution indicates a condition that may lead to an equipment malfunction.
- Anote provides other important information.
1.3 GLOSSARY
ANTENNA:
A powered device that is capable of sending and receiving signals from the RFID tags. There is one
antenna in the ORLocate™ Packing system called Tool Pack.

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ITEMS MISSING:
Items that are listed in the inventory list but were not scanned in the Tool Pack antenna during
assembly.
INVENTORY LIST:
The list of items that create a surgical set. This list is uploaded to the system by a system
administrator at the ORLocate management system.
INSTRUMENT:
A specific tool that can be used on surgeries performed at a hospital. An instrument in the system will
usually be part of a set and will be tracked and managed by ORLocate™ Management system.
INSTRUMENT TYPE:
a template of instrument that defines its expected use, the set in which it may belong to and its exact
shape. Each instrument in the system is characterized by a single instrument type.
INSTRUMENT SET/ TRAY:
A box that contains a set of sterile surgical instruments. The Set includes a non-sterile external
container, and a sterile inner “net” that contains the instruments. The instruments are arranged in a
predefined layout within the set (in a Tray). A set in the system will be tracked and managed by
ORLocate™ Management system.
SET TYPE:
A template of a set that defines its expected use, the procedures it might be used in, its specific
packaging instructions, the type and quantity of required instruments and the layout of instruments
in it.
SET TYPE CODE:
An alphanumeric code uniquely attached to a specific set type. The code serves as an internal
convention in the hospital.
LAYER:
A segment within the set that refers to either a physical layer or to an area within the set layout. Each
layer may include several instruments arranged in a specific layout. The layer may or may not include
a physical container. The content of each layer is defined in the Set Type.
RFID:
Radio Frequency Identification –a technology that enables communication with items that have
RFID-tags attached to them.
An RFID system includes a small radio transmitter that is activated by an antenna and in response
sends its ID back to the antenna. Passive RFID tags, like those used in ORLocate™, do not contain a
battery.
RFID TAG:
A small, self-enclosed device that contains an RFID and is attached to a surgical instrument or is
attached to an instrument set/tray.
PACKING PERSONNEL/TECHNICIAN:

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A trained team member whose job is to assemble surgical sets at the packing unit
PACKING INSTRUCTIONS:
Instructions written by a system administrator that guides how to pack or place a certain item.
SET TAG
An RFID tag that is attached to a specific instrument set/tray. The tag is attached with a metal ring
and is removable.
UNTAGGED ITEMS:
Instruments that do not have an RFID tag attached, for example due to the small size of the
instrument.
2. SAFETY
2.1 GENERAL SAFETY INSTRUCTIONS.
Do not use before reading this manual.
Plug the Tool Pack Antenna into a properly installed power outlet of the appropriate voltage.
Caution: Do not use the system if the power supply is faulty or unreliable.
Changes or modifications not expressly approved by Haldor Advanced Technologies Ltd. can affect
the safety and effectiveness of the system and will void the system's warranty.
Do not operate with damaged cords or plugs. If damaged, have the cord or plug replaced
immediately by a qualified service technician.
The system contains no user-serviceable components. Do not open the system covers.
2.2 WARNINGS
FCC Warning: Changes or modifications not expressly approved by the party responsible
for compliance could void the user's authority to operate the equipment.
1
For the ORLocate Packing system to operate use only Haldor's RFID tags.
2
Dispose RFID tags according to standard environmental regulations.
3
Do not use the system in the presence of a flammable gas.
4
Continuous stay next to the Tool Pack Antenna should be limited for up to 3 minutes
within a distance of 10 cm (4") or less.
5

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2.3 INDICATIONS
The ORLocate™ Packing system is indicated for use in detecting RFID-tagged surgical instruments and set
tags. The product is indicated for providing a method of packing surgical items to create surgical sets.
2.4 SYSTEM LABELS
SPD –Tool Pack Antenna
Tool Pack
Model No. ILS100 S/N: ILS-11-0501
Not user-serviceable. Service by trained personnel only.
Consult accompanying documents.
Haldor Advanced Technologies, Ltd.
2nd Habanai st. Hod Hasharon 45319, Israel
Tel: [phone] , Fax: [phone],
Email: supp[email protected]om
FCC ID: X4V-SPD
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
conditions:
1. This device may not cause harmful interference and
2. This device must accept any interference received, including interference that may cause
undesired operation.
Warning Label on Tool Pack Antenna:
The FCC Wants You to Know
This equipment has been tested and found to comply with the limits for a Class A digital
device, pursuant to part 15 of the FCC Rules. These limits are designed to provide
reasonable protection against harmful interference when the equipment is operated in a
commercial environment.
This equipment generates, uses, and can radiate radio frequency energy and, if not
installed and used in accordance with the instruction manual, may cause harmful
interference to radio communications.
Operation of this equipment in a residential area is likely to cause harmful interference, in
which case the user will be required to correct the interference at his own expense.
6
Continuous stay next to the Tool Add should be limited for
up to 3 minutes within a distance of 10 cm (4") or less.
Discard properly

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Package Labeling for the ORLocate™ Packing System:
Model No. ___
S/N____
ORLocate™ Packing System:
Fragile: Handle with care
This Side Up
Keep Dry
Haldor Advanced Technologies, Ltd.
2 Habanai st, Hod Hasharon Israel 45319
Outside Package Template
70°C
-40°C
Transport
& Storage
3. INTRODUCTION TO THE HALDOR ORLOCATE™ PACKING SYSTEM
For general introduction - see chapter 1.1. The Haldor ORLocate™ Packing System.
3.1 DESCRIPTION OF SYSTEM COMPONENTS
The system includes three main components:
(1) User interface component.
(2) Tool Pack Antenna.
(3) Tagged items.
3.1.1 USER INTERFACE COMPONENTS
The interface hardware consists of two modules:
1. PC –Intel Core 2 Duo, 1.8MHz, 2G memory, 160G disk, Serial,
USB and LAN ports.
2. Touch screen –15” or 17” touch screen
The modules can be provided as one component combining both
(Panel PC) or two separate components.

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3.1.2 TOOL-PACK ANTENNA
The Tool Pack Antenna is used to scan RFID tagged surgical instruments and set tags
before placing them inside the set. RFID tagged instruments and set tags should be
held near the antenna as shown by the figure on the right. There are three types of
feedback:
(1) Beep, indicating that the instrument is detected by the Tool Pack.
(2) An indication on the currently opened screen, specifying which instrument was detected.
Note: Move the RFID tagged item close to the Tool Pack Antenna and keep it steady for two
seconds in front of the antenna until all RFID tagged items are registered in the system (i.e.
information appears on screen).
Note: Maximum 5 instruments should be scanned at one time.
Warning Label on Tool Pack Antenna:
3.1.3 TAGGED AND UNTAGGED ITEMS
Tagged items are RFID-tagged surgical instruments and trays. The system is designed to detect tagged
items.
Untagged items do not have RFID tags. Examples of untagged items are screws, blades and needles.
The system allows for manual recording of untagged items.
4. STERILE AND CLEANING CONSIDERATIONS
4.1 SURGICAL INSTRUMENTS THAT HAVE RFID TAGS
Unless specifically noted, surgical instruments and tools with RFID tags may be sterilized according to
the standard protocol.
4.2 CLEANING TOOL PACK ANTENNA
The Tool Pack Antenna can be cleaned with any conventional material that is used to clean the packing
station (see section 10.1 for detailed cleaning instructions).
Continuous stay next to the Tool Add should be limited for
up to 3 minutes within a distance of 10 cm (4") or less.

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5. SETTING ORLOCATE™ PACKING SYSTEM COMPONENTS
This section describes the setup procedures required, prior to using the ORLocate™ Packing System.
5.1 SETTING THE PANEL PC (TOUCH SCREEN)
The touch screen should be located close to where the packing personnel/technician is located during
assembly to enable easy viewing of the screen, and close enough to the Tool Pack Antenna to enable an
ergonomic operation, as shown in figure 1 below:
Figure 1
The panel pc should be connected to AC power and to the network as shown in figure 1 above.
5.2 SETTING THE TOOL PACK ANTENNA
The Tool Pack Antenna should be located on top of a table where the instrument sets/trays are located,
and close to where the packing personnel/technician is located during assembly.
The Tool Pack Antenna should be connected to an AC power supply and to the panel PC/ touch screen,
as shown in figure 2 below:
Figure 2
Tool Pack
AC power
Panel PC AC
power supplier
Network
Tool Pack
Com. to
Panel PC

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6. USING THE SYSTEM
6.1 GENERAL PRINCIPLES OF USE
(1) Each set tray has an RFID tag that indicates which type of set it is (e.g., "General Basic"). The tag is
attached to the set tray with a metal ring and can easily be replaced with a different tag. The tag is
able to withstand hundreds of sterilization cycles, after which the system notifies the user to replace
the tag.
(2) Before the packing personnel/technician starts packing, the set tag should be scanned in the Tool
Pack Antenna, to specify to the system which type of set is going to be assembled. Set inventory list
will appear on the screen with two values for each item –1) the quantity that is defined for that
item (standard quantity), and 2) the actual number that was inserted into the set.
(3) Any RFID tagged item that is added to the set tray during packing must be scanned before inserting
it into the set. The system will display the details of the scanned items on the screen. The inventory
list will be updated automatically according to the progress of packing.
(4) Items that were already scanned (i.e., registered as part of the set) will not be displayed again on
the screen when scanned again. The system ignores re-scanning.
(5) Untagged items should be registered manually.
(6) The system has two main views: the full inventory list or a list of only the missing items (items
needed minus items scanned).
(7) Set may be sealed with missing items
6.2 SYSTEM WORKFLOW –USER INTERFACE
1. Welcome screen
Touch the “Start Packing” button on the welcome screen (Figure 3).
Figure 3

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2. Set details screen
Scan the Set Tag in the Tool Pack Antenna Set type and set ID will appear on screen (Figure
4). Ensure set details are correct and select the “Start” button.
Figure 4
3. Packing main screen
Once the main screen appears (Figure 5) start packing by scanning items according to the
inventory list. The main screen includes 4 areas: On the right side of the screen is the set
inventory list. The inventory list includes all items that comprise the set divided to different
areas or levels of packing (as seen in figure 5 “left side, right side”).
The second area of the main screen is the Set Details area (top left) in which the set type is
indicated and there is a bar that represents graphically the progress of the assembly.
In the third area of the main screen (middle left) appears the most recently scanned items,
and in the forth area of the screen (bottom left) the function buttons are located.

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Figure 5
The four areas of the main screen will now be described in detail.
3.1. Main screen : Set Inventory list
Figure 6
The inventory list displays a table listing all items that need to be packed in the set. Touching
any row of the list will display details of the item in that row: a photo of that item and its
packing instructions, if specified.
(1)
(2)
(3)

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Figure 7
A yellow bar (1) next to the serial number represents an item that has no RFID tag attached, i.e.:
untagged item. These items should be manually registered into the system. Touch the row of
that item to open a pop-up in which the number of items can be specified, as shown in figure 8
below:
Figure 8
Items that have a triangle on the upper right corner of their row (2) are items for which packing
instruction exist. Touching the row will open a pop-up with packing instructions for that item (as
can be seen in Figure 7).
The inventory list has two different views that are controlled by two buttons titled “Show all”
and “Show missing”(3). The default view is “show all” in which all items are listed. The “Show
Missing” view will filter the list so that only types of items that are still not packed (either not
packed at all or have not been fully packed) will appear on the list.

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Once all items of a certain type are packed the row changes the color to green, as shown in
figure 9 below:
Figure 9
3.2. Main screen : Set details area
Figure 10
In the set details area appears the set type and ID and a progress bar that represents the
progress of the set assembly (approximation) (1). Also in this area is a “Preview” button (2) –
pressing the button will display a photo of a packed set, as shown in figure 11 below:
(1)
(2)

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Figure 11
3.3. Main screen: last scanned items
In this area all items that are scanned at a given time (maximum 5 items at once) will
appear. Each item type appears in a separate row with two values: the quantity of the
items that were scanned (1), and the still required number of items (2).
Figure 12
(1)
(2)
(3)
TEST SET Preview
X

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After scanning items ensure that the information that appears is correct and that every item
that is scanned actually appears on the screen. Match between the number of items that are
scanned to the value that appears at the bottom of this area (3)
3.4. Main screen: Function buttons
Three function buttons exist on the main screen (figure 13):
3.4.1. Maintenance button: if a defected tool is detected before inserting into the set during the
routine examination of items, then the item should be registered as defected. This is done
by touching the “maintenance button” and scanning the item again in the Tool Pack
Antenna. See figure 14 to view the maintenance pop up.
Figure 13
Screen 3.4.1: maintenance pop up
Figure 14

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After scanning the item, the item’s details appear on screen and the nature of the malfunction
should be specified by selecting a reason in the dropdown list (figure 15).
Figure 15
3.4.2.“Scan for info” button
This button enables the scanning of items for the purpose of viewing their information
(figure 16). The items scanned will not be registered as packed in the set.
Screen 3.4.2 : scan for information pop up
Figure 16
3.4.3. Exclude button
If items were scanned by mistake or for any other reason, they can be removed from the set
inventory by touching the “Exclude” button (figure 17 shows the exclude pop-up).
Screen 3.4.3: exclude

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Figure 17
4. System alerts
4.1. If an RFID tagged item was registered in the ORLocate operating room system as defected, it
will appear as defected in the ORLocate Packing system once it is scanned (figure 18). This item
can’t be packed and should be sent to maintenance using the “maintenance" button as
described in section 3.4.1.
If there were several items scanned and only few of them are registered as defected, all items
should be scanned again one by one. When the item/s that is defected is scanned, the message
will appear again.
System message: Defected item scanned
Figure 18
4.2. If items that were previously registered as going to maintenance are scanned again in the
system, the system will show the following alert:

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Figure 19
Items that were registered as defected (i.e. were scanned in the maintenance pop-up) cannot be
packed until a system administrator scans the item as repaired in the ORLocate Management
system.
4.3. Replace set tag: when the set tag has exceeded its usage period (defined by the number of
times the set was packed with that tag), the tag should be replaced. The system will show an
alert (see figure 20 below) right after the set tag is scanned.
Take the current set tag and discard. Take a new set tag and attach to the metal ring and to the
set tray. Scan it in the Tool Pack Antenna and continue packing.
Figure 20
5. Register untagged item
Items that have no RFID tag should be registered manually in the system. These items are marked
with a yellow line in the inventory list as shown in figure 21 below:
Figure 21
To register these items, touch the name of the item (anywhere on that row) and a pop-up will
appear as shown in figure 22 below.
Insert the number of items that are being packed into the set by using the numeric keypad

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Figure 22
6. Finish packing
Once packing is finished touch the “Continue” button as shown in figure 23 below:
Figure 23
If there are items not packed, the system will show on the left side of the screen the missing
items, as shown in figure 24 (1). To continue packing the missing items, touch the “Back” button
(2). To finish the packing procedure for this set, touch the “Done” button (3).