User’s Guide
SituateTM
Detection System 200X
User’s Guide
SituateTM
Detection System 200X
For use with software version 2.X
Part Number: PT00119220
Preface
Preface
This guide and the equipment it describes are for use only by qualified medical professionals
trained in the particular technique and surgical procedure to be performed. It is intended as
a guide for using the Medtronic Situate™ detection system 200X only.
Equipment covered in this manual
Situate™ Detection System 200X with software version 2.x.
Conventions Used in this Guide
Warning
Indicates a potentially hazardous situation which, if not avoided, could result in death or serious
injury.
Caution
Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.
Note: Indicates a hazard which may result in product damage, an operating tip, or a
maintenance suggestion.
ii Situate™ Detection System 200X User's Guide
Limited Warranty
Medtronic warrants each covered product listed below to be free from defects in material
and workmanship for normal use and service for the period(s) set forth below. Medtronic’s
obligation under this warranty is limited to the repair or replacement, at its sole option, of
any product, or part thereof, which has been returned to it (or its authorized distributor)
within the applicable time period shown below after delivery of the product to the original
purchaser, and which examination discloses, to Medtronic’s satisfaction, that the product is
defective. This limited warranty does not apply to any product, or part thereof, which has
been repaired or altered in a way so as, in Medtronic’s judgment, to affect its stability or
reliability, or which has been subjected to misuse, neglect, or accident.
The warranty periods for Medtronic products are as follows:
Limited Warranty
SituateTM Detection System 200X
Notwithstanding any other provision herein or in any other document or communication,
Medtronic’s liability with respect to this limited warranty and the products sold hereunder
shall be limited to the aggregate purchase price for the products sold to the customer. This
limited warranty is non-transferable and runs only to the original purchaser of the covered
product(s). There are no warranties which extend beyond the terms hereof. Medtronic
disclaims any liability hereunder or elsewhere in connection with the sale of products and
for any form of indirect, tort, or consequential damages.
This limited warranty and the rights and obligations hereunder shall be construed under and
governed by the laws of the State of Colorado, USA. The sole forum for resolving disputes
arising under or relating in any way to this limited warranty is the District Court of the County
of Boulder, State of Colorado, USA.
Medtronic reserves the right to make changes in covered products built or sold by it at any
time without incurring any obligation to make the same or similar changes to equipment
previously built or sold by it.
THE OBLIGATION TO REPAIR OR REPLACE A DEFECTIVE OR NONPERFORMING PRODUCT IS
THE SOLE REMEDY OF THE CUSTOMER UNDER THIS LIMITED WARRANTY. EXCEPT AS
EXPRESSLY PROVIDED HEREIN, Medtronic DISCLAIMS ALL OTHER WARRANTIES,
WHETHER EXPRESS OR IMPLIED, ORAL OR WRITTEN, WITH RESPECT TO PRODUCTS,
INCLUDING WITHOUT LIMITATION ALL IMPLIED WARRANTIES, WARRANTIES OF
MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE.
One year from date of shipment
Situate™ Detection System 200X User's Guide iii
Software License
Software License
Medtronic llc, (collectively called “Medtronic” herein) own the entire right, title, and interest
in and to all of the computer programs and all portions thereof, and associated
documentation (collectively, the “Software”) provided to Customer as may be installed in the
Products and equipment addressed herein or provided separately, and it has the sole right
to grant licenses hereunder.
The evaluation allowance herein and any ultimate price paid by Customer for the products
incorporating the Software include as a portion of that evaluation allowance, or price, a
license fee granting Customer only the rights set forth in this Software License. Customer
further acknowledges and agrees that the Software is owned exclusively by Medtronic. The
Software is licensed to be used on only one computing device or Product, and a valid license
must be purchased for each computing device on which the Software is installed.
Single User License Grant: Medtronic grants to Customer a limited, nonexclusive, nonsublicensable, nontransferable and revocable license to use the Software, exclusively at
Customer’s location as identified by Customer as the ship-to location of the Product, solely
in machine-readable object code form only on a single central processing unit owned or
leased by Customer or otherwise embedded in equipment provided by Medtronic, and for
the sole purpose of Customer’s internal business purpose in the operation of the Product or
equipment purchased from, other otherwise provided by, Medtronic or its affiliates.
Except to the extent expressly authorized in this Software License or by law, Customer shall
not and shall not cause any third party to: (i) decompile, disassemble, or reverse engineer the
Software; (ii) modify or create any derivative works (including, without limitation,
translations, transformations, adaptations or other recast or altered versions) based on the
Software, or alter the Software in any way; (iii) merge the Software with any other software
or product not supplied by Supplier; (iv) use, copy, sell, sublicense, lease, rent, loan, assign,
convey or otherwise transfer the Software except as expressly authorized by the Agreement;
(v) distribute, disclose or allow use of the Software, in any format, through any timesharing
service, service bureau, network or by any other means, to or by any third parties; (vi) remove
or modify any copyright, confidential and/or proprietary markings, legends or restriction
which are in the Software originally supplied to Customer; or (vii) violate any obligations
with regard to Medtronic’s Confidential Information. To the extent that Customer is expressly
permitted by applicable mandatory law to undertake any of the activities listed in the
preceding sentence, Customer will not exercise those rights until Customer has given
Medtronic thirty (30) days written notice of Customer’s intent to exercise any such rights
unless an order of a government agency of competent jurisdiction will not so allow.
Except for the limited license rights expressly granted in this Software License, Medtronic
reserves all rights in and to the Software and any modifications thereto and derivations
thereof, including, but not limited to, all title, ownership, intellectual property rights and all
other rights and interests. Customer will own only the hardware or physical media on which
the Software is stored or processed, if any.
Customer agrees that the Software, including the specific design and structure of individual
programs, constitute confidential information and trade secrets of Medtronic, whether or
not the programs may be copyrighted or copyrightable, and/or patented or patentable.
Customer agrees not to disclose, provide, or otherwise make available such confidential
information, trade secrets or copyrighted material in any form to any third party. Customer
agrees that it will make the Software available only to employees, contractors, or consultants
iv Situate™ Detection System 200X User's Guide
with a need to know, who are obligated to comply with all license restrictions contained in
this Software License Agreement and to maintain the secrecy of the Software and all other
Confidential Information. Customer is responsible for the compliance of all users with these
obligations.
Customer may, from time to time, request that Medtronic incorporate certain features,
enhancements or modifications into the Software. Medtronic may, in its sole discretion,
undertake to incorporate such changes and distribute the Software so modified to all or any
of Medtronic's customers. All such error corrections, bug fixes, patches, updates or other
modifications provided to Medtronic shall be the sole property of Medtronic.
This Software License is effective until terminated. Customer may terminate this License at
any time by destroying all copies of Software including any documentation. This License will
terminate immediately upon notice from Medtronic if Customer fails to comply with any
provision of this License or any supplier agreement. Medtronic may terminate the Software
licenses granted herein and exercise all available rights by giving written notice, effective
immediately, if within ten (10) business days of Customer’s receipt of a reasonably detailed
written request to cure, Customer has not cured all breaches of this License’s limitations or
restrictions. Upon such termination, Customer will immediately pay all undisputed fees
outstanding, cease use of all Software, return or delete, at Medtronic’s request, all copies of
the Software in Customer’s possession, and certify compliance with all of the obligations
herein to Medtronic in writing.
Software License
Limited Warranty: Medtronic represents and warrants to Customer that the Software will
perform substantially as described in Medtronic's then current documentation for such
Software for the longer of (a) the remaining warranty applicable to the product with which
such Software was delivered (not to exceed one year) or (b) ninety (90) days from the date
such Software was shipped or first made available to Customer for electronic download from
Medtronic’s service site. If you notify Medtronic of defects during the warranty period,
Medtronic will replace the Software or, at its option, refund the purchase price. Your remedy
for breach of this limited warranty shall be limited to replacement or refund and shall not
encompass any other damages. No dealer, distributor, agent or employee of Medtronic is
authorized to make any modification or addition to the warranty and remedies stated above.
Notwithstanding these warranty provisions, all of Medtronic's obligations with respect to
such warranties shall be contingent on Customer’s use of the Software in accordance with
this Agreement and in accordance with Medtronic's instructions as provided by Medtronic
in the documentation, as such instructions may be amended, supplemented, or modified by
Medtronic from time to time. Medtronic shall have no warranty obligations with respect to
any failures of the Software which are the result of accident, abuse, misapplication, extreme
power surge or extreme electromagnetic field.
This warranty does not apply to any damages, malfunctions, or non-conformities caused to
or by: (i) Customer’s use of Software in violation of the license granted under the Agreement
or in a manner inconsistent with any provided documentation; (ii) use of non-Medtronic
furnished equipment, software, or facilities with its equipment or Products; (iii) Customer’s
failure to follow Medtronic’s installation, operation, repair or maintenance instructions; (iv)
Customer’s failure to permit Medtronic timely access, remote or otherwise, to Products; (v)
failure to implement all new Updates to Software provided under the Agreement; (vi)
Products or equipment with their original manufacturer’s serial numbers altered, defaced or
deleted; (vii) Products or equipment that have been altered, serviced or modified by a party
Situate™ Detection System 200X User's Guide v
Software License
other than Medtronic; or (viii) Software that has been subjected to abnormal physical or
electrical stress, misuse, negligence or accident by Customer or a third party.
DISCLAIMER: EXCEPT AS SPECIFIED IN THIS WARRANTY, ALL EXPRESS OR IMPLIED
CONDITIONS, REPRESENTATIONS, AND WARRANTIES INCLUDING, WITHOUT LIMITATION,
ANY IMPLIED WARRANTY OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
ARISING FROM A COURSE OF DEALING, USAGE, OR TRADE PRACTICE, ARE HEREBY
EXCLUDED TO THE EXTENT ALLOWED BY APPLICABLE LAW.
IN NO EVENT WILL EITHER PARTY BE LIABLE FOR ANY LOST REVENUE, PROFIT, OR DATA, OR
FOR SPECIAL, INDIRECT, CONSEQUENTIAL, INCIDENTAL, OR PUNITIVE DAMAGES HOWEVER
CAUSED AND REGARDLESS OF THE THEORY OF LIABILITY ARISING OUT OF THIS SOFTWARE
LICENSE EVEN IF SUCH PARTY HAS BEEN ADVISED OF THE POSSIBILITY OF SUCH DAMAGES.
IN NO EVENT SHALL ONE PARTY’S LIABILITY TO THE OTHER PARTY, WHETHER IN CONTRACT,
TORT (INCLUDING NEGLIGENCE), OR OTHERWISE, EXCEED THE PRICE PAID OR TO HAVE BEEN
PAID BY CUSTOMER. THE FOREGOING LIMITATIONS SHALL APPLY EVEN IF THE ABOVESTATED WARRANTY FAILS OF ITS ESSENTIAL PURPOSE. SOME STATES DO NOT ALLOW
LIMITATION OR EXCLUSION OF LIABILITY FOR CONSEQUENTIAL OR INCIDENTAL DAMAGES.
U.S. Government Rights. The Software is a “commercial item” developed exclusively at
private expense, consisting of “commercial computer software” and “commercial computer
software documentation” as such terms are defined or used in the applicable U.S. acquisition
regulations. The Software is licensed hereunder (i) only as a commercial item and (ii) with
only those rights as are granted to all other customers pursuant to the terms and conditions
of this License. Customer shall not use, duplicate, or disclose the Software in any way not
specifically permitted by this License. Nothing in this License requires Medtronic to produce
or furnish technical data for or to Customer.
If any provision of this Agreement shall be held by a court of competent jurisdiction to be
illegal, invalid or unenforceable, the remaining provisions shall remain in full force and effect.
This License Agreement contains the entire understanding and agreement between the
parties respecting the Software. This Agreement may not be supplemented, modified,
amended, released or discharged except by an instrument in writing signed by each party's
duly authorized representative. All captions and headings in this Agreement are for
purposes of convenience only and shall not affect the construction or interpretation of any
of its provisions. Any waiver by either party of any default or breach hereunder shall not
constitute a waiver of any provision of this Agreement or of any subsequent default or
breach of the same or a different kind.
The construction and performance of this Agreement will be governed by the laws of the
State of Colorado without reference to its choice of law principles. The parties hereby submit
to the jurisdiction of the courts of the State of Colorado.
vi Situate™ Detection System 200X User's Guide
Symbol Glossary
Standards and IEC Classifications
The console meets all pertinent clauses of the IEC 60601-1.
Non-ionizing electromagnetic radiation
Classified with respect to electrical shock, fire, and mechanical hazards
only in accordance with UL standard 60601-1; certified to CSA standard
C22.2 No. 601.1.
Symbol Glossary
Symbols
This device complies with part 18 of the FCC rules
Not made with natural rubber latex
For prescription use only
Consult the instructions for use
Caution
Situate™ Detection System 200X User's Guide vii
Symbol Glossary
-40°F
-40°C
10%
500hPa
158°F
70°C
90%
1060hPa
Temperature limitations for storage
Humidity limitations for storage
Atmospheric pressure limitations for storage
Product contains waste from electrical and electronic
equipment, and should be separately collected and not
disposed of as unsorted municipal waste
Alternating current
Catalog number
Manufacturer
Serial number
Date of manufacture
viii Situate™ Detection System 200X User's Guide
Table of Contents
Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii
Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii
Software License. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv
Symbol Glossary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . vii
Chapter 1. Introduction to the Situate™ Detection System
200X
Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Contraindication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1
Situate™ 200X System Overview. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Console Front Panel. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-2
Console Back Panel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-3
Situate™ System Components . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-4
Chapter 2. Patient and Operating Room Safety
General. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Setting Up the System. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-1
Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-3
Implanted Electronic Devices (IEDs). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
After Scanning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-5
Servicing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Residual Risk Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2-6
Chapter 3. Situate™ System Setup
Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Select a Scanning Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1
Set Up and Turn On the Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-3
Connect a Scanner to the Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-10
Chapter 4. Scanning for RF-Tagged Premium Cotton
Scanning with the Situate™ Detection System 200X . . . . . . . . . . . . . . . . . . . 4-1
Set Up Before Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2
Starting a Scanning Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3
Scanning with a Body Scanner. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-4
Scanning with the Situate™ Extremity Scanner . . . . . . . . . . . . . . . . . . 4-7
Scanning with a Situate™ Room Scanner . . . . . . . . . . . . . . . . . . . . . . .4-11
Situate™ Detection System 200X User's Guide ix
Viewing Console Case/Scan Records . . . . . . . . . . . . . . . . . . . . . . . . . . .4-15
After a Scanning Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-15
Periodic Maintenance for Console and Components . . . . . . . . . . .4-16
Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-16
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-16
Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-17
Chapter 5. Troubleshooting
Device Notification Screens . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-1
Troubleshooting. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5-3
Chapter 6. Service & Maintenance
Maintenance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-1
General Safety Guidelines . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Biomedical Department Inspection. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Set-up Procedure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-2
Test Method . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-3
Fuse Replacement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-4
Chassis Ground . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-5
Software Updates. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-6
Updating Console Software using Valleylab™ Exchange . . . . . . . . . 6-6
Repairs and Returns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Return for Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6-8
Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8
Periodic Maintenance for Console and Components . . . . . . . . . . . . . . . . . . 6-8
Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-9
Chapter 7. Electrical Safety Tests
Electrical Safety Tests 220–240 V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-1
Electrical Safety Tests 110–120 V . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7-2
Chapter 8. Technical Specifications
Performance Characteristics. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
General . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-1
Operating Parameters. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Storage Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3
Transport Parameters . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Safety Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Electromagnetic Compliance (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4
Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10
Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10
Audible Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10
x Situate™ Detection System 200X User's Guide
Tone Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11
Input Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11
Power Cord Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11
California Proposition 65 Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-12
Situate™ Detection System 200X User's Guide xi
Chapter 1
Introduction to the Situate™ Detection System 200X
This chapter provides an overview of the features and functions of the Situate™ detection
system 200X.
Caution
Read all warnings, cautions, and instructions provided with this system before use.
Note: Do not use the system as a substitute for recommended practices for sponge counts
prescribed to prevent retained objects. The system is intended as a supplement to standard
counting practices.
Introduction
The Situate™ detection system 200X uses a low-energy radio-frequency (RF) signal to detect
surgical premium cotton (gauze, sponges, and towels) left in or around the patient within
the surgical field. Situate™ scanning devices emit an electronic impulse that, when passed
over an RF-tagged item, resonate a signal back to the scanner.
Indications for Use
The Situate™ system is indicated to detect tagged objects, such as surgical gauze, towels,
and sponges, during a surgical procedure in order to aid surgical staff in the recovery of
those objects before closing. The system is intended for use by trained surgical staff in a
surgical (operating room) setting.
The system is indicated for use as an adjunct device to complement, not replace, established
safety procedures prescribed to prevent retained objects.
Contraindication
None
Situate™ Detection System 200X User's Guide 1-1
Situate™ 200X System Overview
Situate™ 200X System Overview
Console Front Panel
Accessory
12
Accessory receptacle
ཱ Body scanner receptacle
Body Scanner
1-2 Situate™ Detection System 200X User's Guide
Console Back Panel
Situate™ 200X System Overview
Introduction to the Situate™
Detection System 200X
4
REF
SN
1
USB receptacles (4)
ཱ Ethernet receptacle
ི Power cord receptacle
ཱི Fuse drawer
2
3
Situate™ Detection System 200X User's Guide 1-3
Situate™ 200X System Overview
Situate™ System Components
The Situate™ detection system incorporates both single-use and reusable components. It
can include combinations of the components shown below.
2
5
4
1
3
Situate™ detection console 200X
ཱ Situate™ premium cotton
ི Situate™ body scanner/body scanner lite
ཱི Situate™ room scanner
ུ Situate™ extremity scanner
Note: Use sterile drapes (01-0020) if a room scanner is to be used in the sterile field.
Note: Use sterile drapes (01-0037) if an extremity scanner is to be used in the sterile field.
Note: The Situate™ detection console 200X is compatible with the Situate™ delivery stand
(01-0036).
1-4 Situate™ Detection System 200X User's Guide
Situate™ Detection Console 200X
Situate™ 200X System Overview
Introduction to the Situate™
Detection System 200X
Accessory
Body Scanner
The console is the central component of the system providing operational instructions and
scanner feedback through a touch screen interface. Data collected from scanning sessions is
stored in the console and can be accessed at any time for evaluation of a specific scan.
Situate™ Detection System 200X User's Guide 1-5
Situate™ 200X System Overview
Situate™ Premium Cotton
Situate™ premium cotton are single-use RF-tagged cotton disposables that must be used
with the Situate™ detection system. The disposables have an attached RF tag, which is an
electrically passive inductor-like device. When activated by electromagnetic impulses from
the scanning devices, the tag resonates a signal that allows for the detection of these cotton
disposables.
1-6 Situate™ Detection System 200X User's Guide
Situate™ Body Scanner/Body Scanner Lite
Situate™ 200X System Overview
Introduction to the Situate™
Detection System 200X
The body scanner is for detecting RF-tagged premium cotton in the patient’s torso. The
scanner is placed directly on the surgical table’s torso pad, under positioning devices, drapes,
and linens. It contains six radiolucent (X-ray compatible) antennas that transmit
electromagnetic impulses that stimulate RF tags, and receive a resonant signal from the tag
when it is detected.
Body scanners have a detection range of 40.6 cm (16 in.) above the body scanner surface.
Note: Body scanner lite pictured above. Body scanner not pictured.
Situate™ Detection System 200X User's Guide 1-7
Situate™ 200X System Overview
Situate™ Room Scanner
The room scanner is a hand held scanning tool for detecting missing or retained sponges in
and around the sterile field (for example, linens, drapes, and trash bins). The scanner
functions as both an antenna to transmit electromagnetic impulses that stimulate the RF tag
on sponges and packing, and as a receiver to detect the resonant signal returning from the
tagged items. The scanner is primarily used for quickly locating a missing sponge in the area
surrounding the patient. It is also used in conjunction with the Situate™ body scanner/body
scanner lite when the surgical site is beyond the effective range of the body scanner.
The room scanner is moved in specific patterns following the contour of the patient’s body
to detect the tag in various orientations. The scanner has a detection range of 40.6 cm
(16 in.).
1-8 Situate™ Detection System 200X User's Guide
Situate™ 200X System Overview
Situate™ Extremity Scanner
The extremity scanner is a hand held static scanning tool designed to locate and detect
retained sponges in procedures where in challenges exist in patient positioning.
Introduction to the Situate™
Detection System 200X
The scanner functions as both an antenna and receiver to look for and detect RF-tagged
sponges. The scanner is held motionless while it performs a three-dimensional scan to
capture the tag’s signal regardless of the tag orientation.
The extremity scanner has a detection range of 76 cm (30 in.) wide and 20 cm (8 in.) deep.
Situate™ sterile drapes (01-0037) must cover the extremity scanner when used in the sterile
field.
Catalog number Description (legacy product name)
01-0043 Situate™ detection system 200X (RF assure console model
200X)
01-0044 Situate™ extremity scanner (ArQ sphere)
01-0046 Situate™ room scanner II (Blair Port Wand X)
01-0023
01-0031
Varies Situate™ premium cotton products (RF detect premium)
Situate™ body scanner (RF Assure ConformPlus Antenna
Array body scanner)
Situate™ body scanner lite (RF Assure ConformPlus II
Antenna Array body scanner)
Situate™ Detection System 200X User's Guide 1-9
Chapter 2
Patient and Operating Room Safety
The safe and effective use of RF-detection technology in surgical procedures depends to a
large degree upon factors solely under the control of the operator. There is no substitute for
a properly trained and vigilant surgical team. It is important that the operating instructions
supplied with this or any equipment be read, understood, and followed.
General
Setting Up the System
Warning
Do not connect wet instruments to the console. Ensure that all instruments are correctly connected
and that no metal is exposed at any connection points.
Fire Hazard Do not use extension cords.
Caution
Read the instructions, warnings, and cautions provided with Situate™ detection system before using.
To avoid risk of electrical shock, connect the power cord to a properly grounded power receptacle.
Position the console so it does not block access to power switch or power plug connection.
Electromagnetic interference caused by MRI, power transformers or other high power sources may
affect the system’s ability to detect tagged objects.
Unfolding gauze sponges can expose woven edges and the radiopaque marker to damage and may
release cotton fibers.
Do not cut any Situate™ premium cotton products (for example, vaginal packing). Cutting may
damage the pouch and separate the RF-detectable tag from the product.
Scanner drapes and surgical cotton disposables are packaged sterile. Sterility is maintained unless the
package or seal has been opened
Follow the hospital procedure for draping non-sterile devices. Cover all portions of the scanner and
cord to avoid contamination and cross-contamination during the procedure.
Situate™ Detection System 200X User's Guide 2-1
General
Caution
Ensure the body scanner is placed securely on the surgery table for angled or tilted table. Straps are
provided to fasten the body scanner lite to the operating room table for cases where angular
orientation is utilized to prevent slippage.
The body scanner should cover full length of the torso pad and be positioned under the surgical site.
Remove large metal objects, trays, and Mayo stands from the scan site before scanning. Metallic
objects in the scan area or in close proximity with the tag may interfere with scanning.
Ensure all known tagged objects are more than 91 cm (36 in.) from the scan site to avoid possible false
positive detections.
Remove RFID devices (for example, badges and car keys) away from the scan area to avoid scan
interference.
Limit the use of electrical equipment such as RF-electrosurgery instruments during scanning, and
power down unused electronic devices and instruments. If possible, be sure all electronic equipment
is at least 91cm (36 in.) from the scan site. Concurrent use of some electrical equipment in close
proximity to the surgical scanning site may affect the system’s ability to detect tagged objects.
MRI usage: Follow hospital protocol, device manufacturers’ directions for use, and established clinical
practice by trained staff in the use of MRI. Independent laboratory testing with regard to translational
attraction, migration, and torque as well as MRI-related heating indicates that Situate™ premium
cotton products present no additional risk or hazard to a patient in an MRI environment of up to 3
Tesla. No authoritative testing has been conducted to date on intraoperative MRI use with Situate™
premium cotton products.
Do not stack equipment on top of other operating room devices. This is an unstable configuration.
Note: Inspect the Situate™ detection system 200X components for damage, deterioration,
abrasion, cracks, splits, punctures, and loose components before and after each use. Check
cables for kinks or breaks in insulation and connectors for wear or damage that can prevent
secure attachment. If damaged, do not use.
Note: Connect the power cord to a properly grounded power receptacle having the correct
voltage. Otherwise, product damage may result.
Note: Do not connect unauthorized or unrecognized devices to the console.
Note: In gynecological procedures using a body scanner, ensure the scanner is not covering
the pad’s perineal cutout.
Note: The room scanner can be used in cases where the body scanner cannot be utilized due
to questionable patient stability.
Note: If the home screen fails to appear, check the power connections, then shut off the
system and turn it back on.
Note: The RF tag is contained in a pouch attached to the gauze, towel, or sponge. Damage
to the tag or pouch may affect the system’s ability to detect the tag.
Note: An RF tag in direct contact with metal will reduce the tag signal and impair scanning.
Avoid direct metal contact within 1 mm of the tag. If sponge sticks are used, wrap a layer of
gauze >1 mm between the tag and the instrument.
2-2 Situate™ Detection System 200X User's Guide
Note: Do not reuse single-use disposables to avoid the risk of cross-contamination.
Note: The body scanner can be punctured by sharp objects. Replace the body scanner if it is
damaged.
Note: Place console outside of the sterile field.
Note: Do not fill the delivery stand basket with contents weighing more than 1.36 kg (3 lb).
Note: Ensure the body scanner lies flat. If a portion of the body scanner is folded over, it may
result in a scan fault.
Note: The room scanner and extremity scanner cannot be connected at the same time. Use
of the two devices in the same case required disconnecting the active device and
connecting the other to the accessory port. The newly connected device will initially
calibrate. Ensure the new device is selected on the console screen and start the scanning
process.
Note: All scans performed during a session are included in the case record. Records for
scanning cases can be viewed at any time. See Viewing Console Case/Scan Records on page 4-
15.
General
Patient and Operating Room
Safety
Note: The role of the Situate™ detection system is to serve as an adjunct technology. The
system helps validate correct counts and rectify miscounts. The system does not replace
manual counts.
Note: Do not use the system as a substitute for recommended practices for sponges
prescribed to prevent retained objects. The system is intended as a supplement to standard
counting practices.
Note: The body scanner is not a positioning device. Use standard hospital technique to
ensure the patient is secure and stable on the surgical table in all table positions expected to
be used in the surgical case.
Note: Place the body scanner on top of the table pad. Do not place the body scanner under
the pad or directly on the surgical table frame. Metal may interfere with scanning.
Note: Place other devices (such as patient positioning devices, gel pads, and electrocautery
and thermal pads) on top of the body scanner.
Note: Do not handle the body scanner by the cable; damage to the body scanner may occur.
Scanning
Warning
Risk of explosion if used in the presence of flammable anesthetics.
Caution
Do not move the room scanner at a rate faster than 15.2 cm (6 in.) per second. Exceeding this rate may
diminish the system’s ability to detect tagged objects.
Never touch a console interface connection (USB or LAN) and the patient at the same time.
Situate™ Detection System 200X User's Guide 2-3
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