Medtronic 01-0031 Operator's Manual

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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

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

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

Console Front Panel

Accessory

཰ 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

REF

཰ USB receptacles (4)

ཱ Ethernet receptacle

ི Power cord receptacle

ཱི Fuse drawer

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.

཰ 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.).

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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.

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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

General

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.

Note: An RF tag in direct contact with metal will reduce the tag signal and impair scanning. Avoid direct metal contact with 1 mm of the tag. If sponge sticks are used, wrap a layer of gauze >1 mm between the tag and the instrument.

Note: Limit the use of electrical equipment such as electrosurgical consoles while scanning. Turn off unused electronic devices and instruments, or place devices at least 94 cm (36 in.) from the scan area.

Note: Additional scanning can be performed any time during the procedure in accordance with the system’s procedural directions, especially when sponge counts are in question.

Note: Selecting Close Case from a detection scan result screen displays a prompt confirming to close the case when the last scan resulted in a detection. Selecting Yes from the prompt displays another screen to confirm or deny the sponge count was reconciled. The case is then closed.

Note: It is recommended that scan cases be closed only from a clear scan confirmation number.

Note: If the room scanner is moved within range of a tag while the scan is in progress, a red detection screen will appear. When the scanner is moved out of range of the tag, the console screen reverts to displaying the active scan screen.

Note: Each scan pattern will take between 15 and 20 seconds at a rate of at least 3 seconds per pass.

Note: Scan slowly within 5 cm (2 in.) of the body. Follow the contour of the patient’s body to ensure thorough scanning for various tag orientations.

Note: Scans must be a minimum of 7 seconds in duration for the system to report a confirmation number. Scans stopped before 7 seconds will not provide a confirmation number.

Note: Patient return electrodes that cover a major area of the body scanner (non-skin contact electrocautery gel pads) can affect the scanner’s detection range and produce fault indications. Do not use patient return electrodes that may degrade the performance of the Situate™ detection system.

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Implanted Electronic Devices (IEDs)

IEDs include, but are not limited to, pacemakers, neurostimulators, implantable cardioverter defibrillators (ICDs), ventricular assist devices (VAD), spinal cord stimulators, cochlear implants, infusion pumps, and bone-growth stimulators.

Warning

Use the device with caution when operating near external or implanted electronic medical devices. Electromagnetic interference produced by the operation of the Situate™ detection system can potentially cause a device to temporarily operate in an unsafe mode. Consult the manufacturer of the external or implanted electronic device or responsible hospital department for further information when use is planned in close proximity to such medical devices.

Refer to the pacing or defibrillator device manufacturer’s instructions, hospital protocol, and this guide to ensure optimal operation of these devices. Scanning may affect temporary cardiac pacers in demand mode settings (DDD). Temporary cardiac pacers should be in non-sensing, asynchronous mode (VOO or DOO mode) during scanning.

General

Patient and Operating Room

Safety

Do not program pacing or ICD devices while scanning. Visual and audible indicators are present while scanning is active. Follow the pacing or defibrillator device manufacturer’s instructions to achieve desired programming settings

Note: Independent laboratory testing and extensive hospital clinical experience demonstrate that the Situate™ detection system can be compatible with most commonly used pacing and defibrillator devices when used in accordance with the manufacturers’ directions and hospital protocol.

After Scanning

Note: Disconnect the main power by pulling the plug, not the cord.

Note: Store body scanner flat; otherwise damage to the body scanner may occur.

Note: Thoroughly wipe the scanner and remove all dirt periodically. Dirt may be wiped away

with isopropyl alcohol-based solutions. Follow all applicable label instructions on the products. Follow the procedures approved by your institution. Avoid excessive exposure to fluids. Do not submerge. Avoid fluid ingress to any electrical circuitry.

Situate™ Detection System 200X User's Guide 2-5

Servicing

Caution

Only connect IEC 60601-1 or Medtronic approved devices to the USB interface. The user must ensure that the interconnected system maintains leakage currents according to IEC 60601-1.

Note: Thoroughly wipe the scanner and remove all dirt periodically. Dirt may be wiped away with isopropyl alcohol-based solutions. Follow all applicable label instructions on the products. Follow the procedures approved by your institution. Avoid excessive exposure to fluids. Do not submerge. Avoid fluid ingress to any electrical circuitry.

Residual Risk Summary

While every attempt has been made to reduce patient and user risks, the use of detection systems carries some residual risk, even when used by trained physicians. The potential adverse events associated with the use of detection systems include, but are not limited to, the following risks:

• Allergic reaction

• Arrhythmia

• Carcinogen exposure

• Cardiac arrest

• Cross patient exposure to body fluids

• Fall

• Foreign body in patient

• Foreign body reaction

• Failure of implant

• Infection

• Respiratory failure

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Chapter 3

Situate™ System Setup

This chapter describes how to set up the Situate™ detection system 200X, turn it on, and prepare for a scanning session.

Caution

Read all warnings, cautions, and instructions provided with this system before use.

Setup

Select a Scanning Device

Select the appropriate Situate™ scanning device for the pending medical procedure.

Note: The role of the Situate™ detection system 200X 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 sponge counts prescribed to prevent retained objects. The system is intended as a supplement to standard counting practices.

The Situate™ detection system can simultaneously accommodate a body scanner and one hand scanner (extremity or room scanner). Scanning devices can be interchanged during a scanning case.

Body Scanner/Body Scanner Lite

Application Patient torso

Effective scanning range depth 40.64 cm (16 in.)

Situate™ Detection System 200X User's Guide 3-1

Setup

Extremity Scanner

Application Patient

Effective scanning range depth 20.32 cm (8 in.)

Room Scanner

Application Patient and surrounding operating room

Effective scanning range depth 40.64 cm (16 in.)

If the body scanner or body scanner lite is to be used, position the scanner directly on the surgical table’s torso pad and under positioning devices, drapes, and linens. Ensure the scanner lies flat on the table.

Straps (01-0040) are provided to secure the body scanner lite to the surgical table. Thread a strap through the top two slotted tabs at the top of the scanner and another through the bottom two tabs if needed.

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: 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: Do not connect unauthorized or unrecognized devices to the console.

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Set Up and Turn On the Console

From the Settings section of the Main Menu, the user has the ability to adjust the volume, the date/time, date format, and the language.

Setting the Volume

Using the (-) and (+) buttons, the user has the ability to lower and raise the audio volume.

Volume Screen

Setup

Setting the Date/Time

By clicking the Date/Time tab, the user has the ability to set the date, adjust the date format, and set the time.

Date/Time Screen

Situate™ System Setup

Situate™ Detection System 200X User's Guide 3-3

Setup

Date Format

This screen allows the user set the date format.

Date Format Screen

Set Date

This screen allows the user to set the date of the Real Time Clock (RTC) that is internal to the console. The date is used when viewing records and is included in the timestamp for log entries.

Set Day of the Month Screen

Select the day of the month.

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Set Month Screen

Select the month by touching the current month at the top of the screen and selecting the appropriate month, or by using the left and right arrows.

Set Year Screen

Setup

Select the year by touching the current year at the top of the screen and using the up and down arrows.

Situate™ System Setup

Situate™ Detection System 200X User's Guide 3-5

Setup

Set Time

The following screens allow the user to adjust the hours and the minutes of the current time. Hours are selected from a 24 hour list accessed by selecting the hours on the screen (there is no AM/PM designation and no daylight savings).

Set Hours Screen

Minutes are adjusted by selecting the minutes on the screen and choosing the appropriate minute from the list.

Set Minutes Screen

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Setting the Language

Using the up and down arrows, the user has the ability to change the device language. Once a language is selected, the user must turn off power to the console and then turn on power to the console in order to change the displayed language.

Set Language Screen

Setup

The user can select from 32 languages that are displayed in the following order:

ar_Arabic hr_Croatian pt_Portuguese

bg_Bulgarian hu_Hungarian ro_Romanian

cs_Czech it_Italian ru_Russian

da_Danish js_Japanese sk_Slovak

de_German ko_Korean sl_Slovenian

el_Greek lt_Lithuanian sr_Serbian

en_English lv_Latvian sv_Swedish

es_Spanish mt_Maltese tr_Turkish

et_Estonian nl_Dutch zh_Simplified Chinese

fi_Finnish no_Norwegian zh-t_Traditional Chinese

fr_French pl_Polish

Situate™ System Setup

Situate™ Detection System 200X User's Guide 3-7

Setup

Console Power On

Caution

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.

Electromagnetic interference caused by MRI, power transformers, or other high power sources may affect the system’s ability to detect tagged objects.

Do not reuse single-use disposables to avoid risk of cross-contamination.

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.

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.

Ensure the body scanner is placed securely on the surgery table for an 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 the full length of the torso pad and be positioned under the surgical site.

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.

Note: Inspect the Situate™ detection system 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: 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.

3-8 Situate™ Detection System 200X User's Guide

1. Place the console on a flat, stable surface such as a table, platform, boom system, or cart. Thread the retaining strap (01-0056) through the slots in the bottom of the console and secure the console to the equipment stand if desired. Refer to the procedures for your local institution or your local codes.

2. Plug the system power cord into the power input connector on the rear panel of the console.

3. Plug the system power cord into a grounded power outlet.

4. Turn the power switch on the back panel to ON.

The console displays a Medtronic splash screen as it boots up, then changes to the home screen. If no scanners are attached, the screen appears as shown.

No Scanners Attached Screen

Setup

Note: If the home screen fails to appear, check the power connections, then shut off the system and turn it back on.

Situate™ System Setup

Situate™ Detection System 200X User's Guide 3-9

Setup

Connect a Scanner to the Console

The console has two receptacles on the front panel to attach scanning devices. The right receptacle, labeled Body Scanner, is used exclusively for body scanners (Situate™ body scanner or body scanner lite). The left receptacle, labeled Accessory, is used for hand held scanners (extremity or room scanner).

A single hand held scanner and a body scanner can be attached to the console simultaneously and used interchangeably during a scanning case. Hand held scanners can be changed during a case. The results of all scanning devices used during a single case are stored in the console and can be reviewed at any time. See Viewing Console Case/Scan Records on page 4-15.

1. Connect the scanner(s) to the console. Align the red dots on the plug and connector and press to insert. Ensure the connectors are securely fastened.

Extremity or Room Scanner—Connect a hand scanner to the port labeled Accessory.

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Body Scanner/Body Scanner Lite—Connect the body scanner cable to the console port labeled Body Scanner.

Setup

Note: Move all RF-tagged items (used and unused) at least 91 cm (36 in.) from the scanning area.

2. If an extremity scanner is to be used in the sterile field, drape (01-0037) the device. If a room scanner is to be used in the sterile field, drape (01-0020) the device.

Situate™ System Setup

Situate™ Detection System 200X User's Guide 3-11

Chapter 4

Scanning for RF-Tagged Premium Cotton

This chapter includes steps for the Situate™ detection system 200X prior to surgery, during a scan, and after surgery.

Caution

Read all warnings, cautions, and instructions provided with this system before use.

Scanning with the Situate™ Detection System 200X

The Situate™ console and scanning devices provide accurate detection of sponges, packing, and towels only when used with Situate™ premium cotton. An embedded RF tag in each disposable reflects the scanner’s signal, indicating the location of a tagged item.

Surgical packing, gauze, and towels from other manufacturers cannot be detected with the Situate™ system.

A scanning case is recommended after the final count of RF-tagged sponges, packing, and towels before the final closure of the surgical site. A case can include multiple scans by different devices. The results of all scans in a single case are entered into a retrievable record stored within the console.

Warning

Risk of explosion if used in the presence of flammable anesthetics.

Situate™ Detection System 200X User's Guide 4-1

Scanning with the Situate™ Detection System 200X

Caution

Never touch a console interface connection (USB or LAN) and the patient at the same time.

Note: Limit the use of electrical equipment, such as electrosurgical consoles, while scanning. Turn off unused electronic devices and instruments, or place devices at least 91 cm (36 in.) from the scan area.

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.

Set Up Before Surgery

Situate™ premium cotton products are provided sterile. Introduce the required number and type of tagged premium cotton into the sterile field according to the hospital protocol.

Do not use Situate™ premium cotton with sponges, gauze, or packing from other manufacturers. Items without the Situate™ RF tag cannot be detected by the Situate™ detection system.

Caution

Unfolding gauze sponges can expose woven edges and radiopaque marker to damage and may release cotton fibers.

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.

Scanner drapes and surgical cotton disposables are packaged sterile. Sterility is maintained unless the package or seal has been opened

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.

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Scanning with the Situate™ Detection System 200X

Starting a Scanning Case

The home screen displays the attached scanning devices.

Touching the START button will start a new case and begin scanning.

1 2

཰ Room scanner (extremity scanner if used)

ཱ Body scanner

Note: The room scanner and extremity scanner cannot be connected at the same time. Use of the two devices in the same case requires disconnecting the active device and connecting the other to the same peripheral or 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.

Scanning for RF-Tagged

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Situate™ Detection System 200X User's Guide 4-3

Scanning with the Situate™ Detection System 200X

Scanning with a Body Scanner

The following directions apply to both the body scanner and body scanner lite.

1. Touch the START Body Scanner button.

The Situate™ system conducts the scanning process without user input. A typical scan lasts approximately 14–16 seconds. A progress screen displays during the scan, and the console will emit an audible indicator.

Touch the screen at any time to cancel the body scan.

2. The completed scan results in either a green CLEAR, or in a red DETECTION screen. The next steps will vary based on the result of the scan. See the instructions for the CLEAR and DETECTION scan results.

Caution

The body scanner should cover the full length of the torso pad and be positioned under the surgical site.

Note: Errors and scanning conditions can produce other screens than those shown in the following work flow. If other screens appear, refer to Chapter 5, Troubleshooting.

Note: Patient return electrodes that cover a major area of the body scanners (non-skin contact electrocautery gel pads) can affect the scanner’s detection range and produce fault indications. Do not use patient return electrodes that may degrade the performance of the Situate™ detection system.

Note: Additional scanning can be performed any time during the procedure in accordance with the system’s procedural directions, especially when sponge counts are in question.

CLEAR Scan Result

Scanning cases that detect no RF-tagged items display the green CLEAR screen.

1. Touch the screen to continue and view the scan confirmation number.

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Scanning with the Situate™ Detection System 200X

To perform another scan on the same patient, touch Resume Case. The screen will return to the screen displaying attached scanners. Touch the START button to initiate another scan.

2. If scanning for the case is complete, record the scan confirmation number in the patient medical record following hospital protocol. A QR code is provided for optional entry of confirmation code into an electronic medical record (EMR) using a scanner. Then press Close Case.

3. A prompt appears to confirm the case is to be closed. Select Close Case to close the case or Resume Case to return to the device selection screen to perform additional scans.

4. If closing the case is confirmed by selecting Close Case, a prompt appears to confirm the sponge count was reconciled. Select Yes to confirm and end the scanning case.

The case is now closed and the home screen is displayed.

DETECTION Scan Result

Scanning cases that detect RF-tagged items display the red DETECTION screen.

1. Touch the screen to continue. The SCAN SUMMARY window is displayed with the case confirmation number.

Scanning for RF-Tagged

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Situate™ Detection System 200X User's Guide 4-5

Scanning with the Situate™ Detection System 200X

2. Search for and retrieve missing tagged item(s) following hospital protocol.

3. Touch Resume Case to perform another scan. Repeat the scanning steps in this section until a clear scan is reported.

Note: Selecting Close Case from a DETECTION scan result screen displays a prompt confirming to close the case when the last scan resulted in a detection. Selecting Yes from the prompt displays another screen to confirm or deny the sponge count was reconciled. The case is then closed.

Note: It is recommended that scan cases be closed only from a clear scan confirmation number.

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Scanning with the Situate™ Detection System 200X

Scanning with the Situate™ Extremity Scanner

1. Inspect the extremity scanner before use. Replace if damaged or deteriorated.

2. For use in the sterile field, the extremity scanner must be covered with a sterile drape. Follow the hospital procedure for draping non-sterile devices. Ensure all portions of the extremity scanner are covered to avoid contamination and cross-contamination during the operative procedure.

3. Position the scanner within 2.54 cm (1 in.) from the area of interest.

Parallel positioning

Scanning for RF-Tagged

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Situate™ Detection System 200X User's Guide 4-7

Scanning with the Situate™ Detection System 200X

Perpendicular positioning

4. Touch the START Extremity Scanner button to initiate the scan.

5. The completed scan results in either a green CLEAR, or in a red DETECTION screen. The next steps will vary based on the result of the scan. See the instructions for the CLEAR and DETECTION scan results.

Note: Additional scanning can be performed any time during the procedure in accordance with the system’s procedural directions, especially when sponge counts are in question.

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Scanning with the Situate™ Detection System 200X

CLEAR Scan Result

Scanning cases that detect no RF-tagged items display the green CLEAR screen.

1. Touch the screen to continue and view the scan confirmation number.

To perform another scan on the same patient, touch Resume Case. The screen will return to the screen displaying attached scanners. Touch the START button to initiate another scan.

3. A prompt appears to confirm the case is to be closed. Select Close Case to close the case or Resume Case to return to the device selection screen to perform additional scans.

4. If closing the case is confirmed by selecting Close Case, a prompt appears to confirm the sponge count was reconciled. Select Ye s to confirm and end the scanning case.

The case is now closed and the home screen is displayed.

Situate™ Detection System 200X User's Guide 4-9

Premium Cotton

Scanning for RF-Tagged

Scanning with the Situate™ Detection System 200X

DETECTION Scan Result

Scanning cases that detect RF-tagged items display the red DETECTION screen.

1. Touch the screen to continue. The SCAN SUMMARY window is displayed with the case confirmation number.

2. Search for and retrieve missing tagged item(s) following hospital protocol.

3. Touch Resume Case to perform another scan. Repeat the scanning steps in this section until a clear scan is reported.

Note: It is recommended that scan cases be closed only from a clear scan confirmation number.

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Scanning with the Situate™ Detection System 200X

Scanning with a Situate™ Room Scanner

1. Inspect the room scanner before use. Replace if damaged or deteriorated.

2. For use in the sterile field, the room scanner must be covered with a sterile drape (01-

0020). Follow the hospital procedure for draping non-sterile devices. Ensure all portions of the room scanner are covered to avoid contamination and cross-contamination during the operative procedure.

Scanning procedure for the room scanner includes a side-to-side scan pattern and a superior-to-inferior pattern.

3. Touch the green Room Scanner button to initiate the scan.

Side to Side

1) Position the scanner as close as possible parallel to the side of the body at position 1.

2) With scanner remaining parallel to body, move scanner inferiorly from position 1 to

position 2.

3) Continue scanning through numeric sequence at a rate of at least 3 seconds per pass.

Pass from position 3 to 4 is performed over the front of the body, and pass from 5 to 6 is performed with the scanner positioned on the other side of the torso, and parallel to the body.

Scanning for RF-Tagged

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Situate™ Detection System 200X User's Guide 4-11

Scanning with the Situate™ Detection System 200X

Superior to Inferior

1) Position the scanner as close as possible parallel to the side of the body at position 1.

2) With scanner remaining parallel to body, move scanner to the position 1 to the

inferior position 2.

3) Continue scanning through numeric sequence at a rate of at least 3 seconds per pass.

Pass from position 3 to 4 is performed over the front of the body, and pass from 5 to 6 is performed with the scanner positioned on the other side of the torso and parallel to the body.

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.

Note: Each scan pattern will take between 15 and 20 seconds, at a rate of at least three seconds per pass.

Note: Scan slowly within 5 cm (2 in.) of the body. Follow the contour of the patient’s body to ensure thorough scanning for various tag orientations.

The screen displays an active scan screen during the scan, and the console emits an audible indicator sound.

4-12 Situate™ Detection System 200X User's Guide

Scanning with the Situate™ Detection System 200X

A feedback screen appears (for example, “Near Metal” or “Scan Obstruction”) when interference occurs.

The room scanner will continue scanning until stopped by touching the screen. It requires a minimum of 7 seconds to perform a scan, and ceases scanning after 3 minutes of inactivity.

Note: The console will not generate a clear code until 7 seconds to ensure inadvertent start/stop of the room scanner does not produce a confirmation code and maintain integrity of scan records.

4. The completed scan results in either a green CLEAR, or in a red DETECTION screen. The next steps will vary based on the result of the scan. See the instructions for the CLEAR and DETECTION scan results.

CLEAR Scan Result

Scanning cases that detect no RF-tagged items display the green CLEAR screen.

1. Touch the screen to continue and view the scan confirmation number.

Premium Cotton

To perform another scan on the same patient, touch Resume Case. The screen will return to the home screen. Select the desired scanning device, and touch START to perform another scan.

2. If scanning for the case is complete, record the scan confirmation number in the patient medical record following hospital protocol. A QR code is provided for optional entry of

Situate™ Detection System 200X User's Guide 4-13

Scanning for RF-Tagged

Scanning with the Situate™ Detection System 200X

confirmation code into an electronic medical record (EMR) using a scanner. Then touch Close Case.

3. A prompt appears to confirm the case is to be closed. Select Close Case to close the case or Resume Case to return to the device selection screen to perform additional scans.

4. If closing the case is confirmed by selecting Close Case, a prompt appears to confirm the sponge count was reconciled. Select Ye s to confirm and end the scanning case.

The case is now closed and the home screen is displayed.

DETECTION Scan Result

Scanning cases that detect RF-tagged items display the red DETECTION screen.

1. Touch the screen to continue and view the scan confirmation number.

2. Search and retrieve the missing tagged item(s) following hospital protocol.

3. Touch Resume Case to perform another scan. Repeat the scanning steps in this section until a clear scan is reported.

Note: It is recommended that scan cases be closed only from a clear scan confirmation number.

4-14 Situate™ Detection System 200X User's Guide

Viewing Console Case/Scan Records

The console stores viewable records of all completed scan records grouped by case.

1. Touch the Menu tab at the top of the console screen to view options.

After a Scanning Session

2. Touch View Records.

A record of the last scan is shown

3. Touch Close to return to the Records tab.

4. The arrows in the header bar allow the user to navigate between cases; the arrows at the bottom will allow the users to navigate between scans. Touch Close to return to the Records tab.

After a Scanning Session

Scanning for RF-Tagged

Premium Cotton

Disassembly

After all RF-tagged items have been accounted for, the procedure is complete, and the patient has been removed from the operating room, disassemble the Situate™ system.

1. Turn console power switch to off.

Situate™ Detection System 200X User's Guide 4-15

After a Scanning Session

2. Unplug the console from the wall power outlet.

3. Disconnect the scanner from the console.

4. Remove and discard any draping added to hand-held scanners.

5. If a body scanner was used, retrieve the scanner from the surgical table after it has been

6. Inspect components for damage, deterioration, abrasion, cracks, splits, punctures, and

Periodic Maintenance for Console and Components

Warning

Always turn off and unplug the console before periodic maintenance.

Note: Disconnect the main power by pulling the plug, not the cord.

cleared of all positioning devices, drapes and other coverings.

loose components. Check cables for kinks or breaks in insulation and connectors for wear or damage that can prevent secure attachment.

Note: Do not clean the console with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the console.

1. Thoroughly wipe all surfaces of the components, cords, and console with isopropyl alcohol-based wipes

2. Dry with a lint-free cloth.

Storage

Store console and components in a dry, ventilated area out of direct sunlight. Hanging of the body scanner lite when not in use is recommended.

Disposal

Dispose of used or opened sterile products (for example, drapes, gauze, and sponges) in accordance with standard hospital protocol.

Caution

Situate™ premium cotton products and drapes are supplied in sterile packaging. Dispose of used or opened sterile products (for example, drapes, gauze, and sponges) per standard hospital protocol.

Contact Medtronic technical service for the disposal of the console or system components.

Note: For disposal of the console and scanners, contact the distributor or manufacturer.

4-16 Situate™ Detection System 200X User's Guide

After a Scanning Session

Product Service

Medtronic recommends that all Situate™ systems be returned to the manufacturer for all service requirements. If any service is required without returning the system to the manufacturer, Medtronic recommends that only qualified personnel service the Situate™ system.

Medtronic defines qualified personnel as a person with equipment repair experience, such as biomedical personnel, and/or individuals who have taken official Medtronic training courses.

Caution

Only connect IEC 60601-1 or Medtronic approved devices to the USB interface. The user must ensure that the interconnected system maintains leakage currents according to IEC 60601-1.

Note: The Situate™ console has no user-serviceable parts and preventative maintenance is not required. To reduce the risk of electrical shock, do not disassemble unit. Contact manufacturer if service is required.

Returning the Situate™ Components for Service

Before returning the console, call a Medtronic sales representative for assistance. If the energy platform is to be sent to Medtronic, do the following:

1. Obtain a return authorization number.

Call the technical service center (page 4-18) to obtain a return authorization number. Have the following information ready before calling:

• Hospital/clinic name/customer number

• Telephone number

• Department/address, city, state, and zip code

• Model number

• Serial number

• Description of the problem

• Type of repair to be done

2. Perform periodic maintenance.

See Periodic Maintenance for Console and Components on page 4-16.

Scanning for RF-Tagged

Premium Cotton

Situate™ Detection System 200X User's Guide 4-17

After a Scanning Session

3. Ship the console.

Medtronic Technical Service

For service, contact Medtronic technical service or your Situate™ sales representative. Contact a Medtronic technical service representative by telephone, email, or through the internet:

• USA and Canada: +1 800 255 8522 option 2

• International: +1 303 476 7996

a. Attach a tag to the console that includes the return authorization number and the

information (hospital, phone number, and so forth) listed in step 1.

b. Be sure the console is completely dry before packing it for shipment. Package it in its

original shipping container, if available.

c. Ship Situate™ components prepaid to the Medtronic service center.

• Email: rs.technicalservicevalleylab@medtronic.com

• Internet—http://www.medtronic.com/covidien/support/service-centers

http://www.medtronic.com/covidien/support/biomed-connect/electrosurgery

4-18 Situate™ Detection System 200X User's Guide

Chapter 5

Troubleshooting

Caution

Read all warnings, cautions, and instructions provided with this system before use.

Device Notification Screens

The Situate™ scanning devices may be affected by electrical interference when a scan is being performed.

Body Scanner and the Extremity Scanner: If an interference condition occurs during scanning, the standard scan will complete and an extended scan will begin, lasting up to 20 additional seconds. The scan progress screen will indicate when extended scan mode is active.

Room Scanner: Brief exposure to interference brings up a feedback screen. Move the scanner away from the source of interference. Prolonged exposure to interference may cause the scan to stop, resulting in a fault screen.

If the system is unable to provide a valid scan result, the console will display either a feedback or notification screen. See the following table.

Situate™ Detection System 200X User's Guide 5-1

Device Notification Screens

Notification type Scanning devices Resolution

Scanner near metal Room scanner Move the wand away from the metal

Scan obstruction Room scanner Separate the scanner and the source

or the metal away from the scanning area. If the console returns to the scanning progress screen, continue the scan.

If the metal is not removed when the scan is stopped, a fault screen appears.

of interference. If the screen returns to the scanning progress, continue the scan.

If the source of interference is not removed, an interference screen will appear when the scan is stopped.

Metal fault Body scanner

Body scanner lite

Extremity scanner

Room scanner

Interference fault Body scanner

Body scanner lite

Extremity scanner

Room scanner

Transmit fault Body scanner

Body scanner lite

Extremity scanner

Room scanner

Disconnect fault Body scanner

Body scanner lite

Extremity scanner

Clear the scan area of metal objects. Scan the patient again.

Signal levels indicate presence of metal near accessory.

Move keys, badges, and electrical equipment at least 60 cm (2 ft) away from the scanning device. Scan the patient again.

The system cannot detect due to external interference.

Replace accessory. If error persists, replace console.

Signal levels extremely low.

Reconnect accessory.

System unexpectedly lost connection to accessory.

Room scanner

5-2 Situate™ Detection System 200X User's Guide

Troubleshooting

The following table identifies possible system issues and provides suggestions for resolving those issues. If an issue is not resolved after following the suggestion, please contact Medtronic technical service (page 4-17).

Fault name Description Resolution

Troubleshooting

Blank screen The system stays on a

blank white or black screen.

Boot screen The system stays on

startup screen and the application fails to load.

System error The console displays the

system error message.

Turn off power to the console and restart.

If the error persists, contact technical service.

Situate™ Detection System 200X User's Guide 5-3

Chapter 6

Service & Maintenance

Maintenance

Note: There is no scheduled maintenance for the Situate™ detection system. There are no

calibrations. The Situate™ detection system self-calibrates during use.

Thoroughly wipe the scanner and remove all dirt periodically. Dirt may be wiped away with isopropyl alcohol-based solutions. Follow all applicable label instructions on the products. Follow the procedures approved by your institution. Avoid excessive exposure to fluids. Do not submerge. Avoid fluid ingress to any electrical circuitry.

Medtronic defines qualified personnel as a person with equipment repair experience, such as biomedical personnel, and/or individuals who have taken official Medtronic training courses.

Medtronic recommends performing the biomedical department inspection and electrical safety tests annually.

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.

Caution

Only connect IEC 60601-1 or Medtronic approved devices to the USB interface. The user must ensure that the interconnected system maintains leakage currents according to IEC 60601-1.

Situate™ Detection System 200X User's Guide 6-1

Biomedical Department Inspection

General Safety Guidelines

• The AC power switch on the rear panel serves as the means of disconnection from supply mains. This switch also isolates the Situate™ detection system electrically from the supply mains on both poles simultaneously.

• Using a power cord that does not meet the specifications in this Service and Maintenance section may present a potential for an electric shock or affect the performance of the Situate™ detection system.

Environmental Conditions

For storage and transportation information see Chapter 8, Storage Parameters and Transport Parameters.

Biomedical Department Inspection

Note: The Situate™ detection system performs an internal calibration during use. No

calibration is needed and there are no internal adjustments to the detection console.

This procedure outlines setting up the Situate™ detection system to verify the system ability to determine the presence and absence of a tagged object.

Refer to Chapter 3, Situate™ System Setup and Chapter 4, Scanning for RF-Tagged Premium Cotton for detailed information for operating the system.

Set-up Procedure

• Check the Situate™ detection system console case exterior. The case exterior must have no visible damage (for example, dents, scratches, and peeling paint).

• The touch screen must have no visible foreign material or damage.

• Inspect all external connectors/receptacles for bent pins, foreign objects, a damaged case and/or improper fit.

• The AC power cord must have no obvious physical defects or damage.

• Place the console on a flat, stable surface such as a table, platform, boom system, or cart. Thread the retaining strap (01-0056) through the slots in the bottom of the console and secure the console to the equipment stand if desired. Refer to the procedures for your local institution or your local codes.

• Plug the system power cord into the power input connector on the rear panel of the console.

• Plug the system power cord into a grounded power outlet

• Turn the power switch on the back panel to ON.

6-2 Situate™ Detection System 200X User's Guide

Biomedical Department Inspection

Test Method

1. Connect the scanner(s) to the console. Align the red dots on the plug and connector and press to insert. Ensure the connectors are securely fastened.

2. Place a tagged object approximately 15 cm (6 in.) from the scanner.

3. Touch the START button.

The Situate™ system conducts the scanning process without user input.

Touch the screen at any time to cancel the body scan.

4. The completed scan results in a red DETECTION screen.

5. Place a tagged object at least 92 cm (36 in.) from the scanner.

6. Touch the START button.

The Situate™ system conducts the scanning process without user input.

Touch the screen at any time to cancel the body scan.

7. The completed scan results in a green CLEAR screen.

8. Repeat as necessary for each type of scanner.

Service & Maintenance

Situate™ Detection System 200X User's Guide 6-3

Fuse Replacement

In the event of a fuse failure, replace the fuses using the following procedure:

Caution

Fuses must be replaced with 2A/250 V fuses. Using other fuses might damage the unit.

1. Disconnect the Situate™ detection system’s AC power cord from the AC power inlet (1).

Fuse Replacement

2. Insert a small blade screwdriver into the small slot located on the top of the holder (2) and pry forward to open fuse door.

3. Pull the fuse holder drawer (3) out.

4. Replace the fuses (4).

5. Reinsert the fuse holder by pushing it until the holder’s front surface is flush with the Situate™ console surface and close the fuse door until latch engages.

6-4 Situate™ Detection System 200X User's Guide

Chassis Ground

Back Panel Chassis Ground

Chassis Ground

REF

1. Ground continuity can be checked using the screw located on the back chassis.

If the console is opened, confirm that the chassis ground is marked and intact.

Internal Chassis Ground Terminal

Service & Maintenance

Situate™ Detection System 200X User's Guide 6-5

Software Updates

Medtronic recommends that only qualified personnel perform software updates.

Software updates are available directly from Medtronic by using the Valleylab™ Exchange Remote Software System application.

Go to http://www.medtronic.com/covidien/support/valleylab-exchange to download and install the latest version of the Valleylab™ Exchange application.

Updating Console Software using Valleylab™ Exchange

Once the Valleylab™ Exchange application has been installed on the computer to be used for the update, follow these instructions:

Remotely updating software on a Situate™ console:

1. Connect an ethernet cable to the ethernet port on the back of the device.

2. Connect the other end of the LAN connector on the computer hosting the Valleylab™ Exchange application.

3. Plug in the device power cord and turn ON the power switch in the back of the device.

4. Disconnect any scanning instruments connected to the console.

5. Select the Menu option from the home screen.

6. Select the Service option.

7. When the Valleylab™ Exchange application is launched, the device will be automatically detected.

8. A screen will indicate that the software update is in progress. Do not disconnect the ethernet or power off the console. The user will be notified to power off the console and power on to complete the software update.

9. A screen will inform the user of a successful software update. Touch Back to Service, then touch Close to return to the home screen.

10. If the software update was not successful, a screen will inform the user that the update failed. Contact Medtronic technical service or your Situate™ sales representative.

Updating software on a Situate™ console using USB:

1. Connect an external USB storage device that contains a software image, which will initiate a software update. Insertion of an external USB storage device will also initiate a download of the console logs.

2. Plug in the device power cord and turn on the power switch in the back of the device.

3. Disconnect any scanning instruments connected to the console.

4. Select the Menu option from the home screen.

5. Select the Service option.

6-6 Situate™ Detection System 200X User's Guide

6. A screen will indicate that the software update is in progress. Do not disconnect the USB device or power off the console. The user will be notified to power off the console and power on to complete the software update.

7. A screen will inform the user of a successful software update. Touch Back to Service, then touch Close to return to the home screen.

8. If the software update was not successful, a screen will inform the user that the update failed. Contact Medtronic technical service or your Situate™ sales representative.

Software Updates

Service & Maintenance

Situate™ Detection System 200X User's Guide 6-7

Repairs and Returns

For Situate™ detection system repairs or returns, call the Medtronic customer service department. The Situate™ detection system may be returned to the factory.

Return for Repair

For service, contact Medtronic technical service or your Situate™ sales representative. Contact a Medtronic technical service representative by telephone, email, or through the internet:

• USA and Canada: +1 800 255 8522 option 2

• International: +1 303 476 7996

• Email: rs.technicalservicevalleylab@medtronic.com

• Internet—http://www.medtronic.com/covidien/support/service-centers

http://www.medtronic.com/covidien/support/biomed-connect/electrosurgery

Warranty

For information about the Situate™ detection system warranty and/or to obtain information about the availability of the Medtronic Extended Warranty, contact Medtronic customer service.

Opening the Situate™ detection system by anyone other than an authorized Medtronic technician voids the warranty.

Periodic Maintenance for Console and Components

The Situate™ detection system requires no scheduled maintenance other than periodic maintenance for external surfaces.

Warning

Always turn off and unplug the console before periodic maintenance.

6-8 Situate™ Detection System 200X User's Guide

Note: Do not clean the console with abrasive cleaning or disinfectant compounds, solvents, or other materials that could scratch the panels or damage the console.

1. Thoroughly wipe all surfaces of the components, cords, and console with isopropyl alcohol-based wipes.

2. Dry with a lint-free cloth.

The Situate™ detection console cannot be sterilized and must not enter a sterile surgical field.

Disposal

Do not dispose of electrical appliances as unsorted municipal waste. Use separate collection facilities.

Electrical appliances that are incorrectly disposed in dumps or landfills can leach dangerous substances causing contamination of soil and groundwater, and damaging the environment.

Disposal

Service & Maintenance

Contact your local government or point of sale for information regarding the collection of waste electrical appliances.

Situate™ Detection System 200X User's Guide 6-9

Chapter 7

Electrical Safety Tests

The Situate™ detection system has been thoroughly tested for isolation, leakage, and grounding integrity prior to shipment. The product has been tested for compliance with the IEC 60601-1 standard.

If these tests are necessary, it is mandatory that appropriate test equipment is used, and the tester has knowledge of the applicable electrical safety standards which pertain to these tests. Medtronic assumes no responsibility for damage to the unit due to improper application of the following tests.

If in doubt, consult the Safety Analyzer User’s Manual or Medtronic prior to conducting the following tests.

Electrical Safety Tests 220–240 V

Warning

Do not touch the equipment during the isolation tests.

1. Set the line voltage to 264 V and set the frequency to 50 Hz. Do not exceed 280 V.

2. Plug the line cord of the Situate™ detection system into the leakage tester for all tests.

3. For the 25 A test, connect the ROD-L leads to the chassis ground lug and to the ground pin of the power cord.

Electrical Safety Test Limits 240 V

Parameter Conditions Passing

Input voltage Rated line +10% 264 V

Line cord resistance N/A <100 mΩ

25 A chassis-cord GND 10 seconds <100 mΩ

Earth leakage Power Norm, GND open <500 μA

Earth leakage Power Rev, GND open <500 μA

Situate™ Detection System 200X User's Guide 7-1

Electrical Safety Tests 110–120 V

Warning

Do not touch the equipment during the isolation tests.

1. Use the variable autotransformer and the DVM to set the line voltage to 132 V. Do not exceed 140 V.

2. Plug the line cord of the Situate™ detection system into the leakage tester for all tests.

3. For the 25 A test, connect the ROD-L leads to the chassis ground lug and to the ground pin of the power cord.

Electrical Safety Test Limits 120 V

Parameter Conditions Passing

Input voltage Rated line +10% 132 V

Line cord resistance N/A <100 mΩ

25 A chassis-cord GND 10 seconds <100 mΩ

Earth leakage Power Norm, GND open <300 μA

Earth leakage Power Rev, GND open <300 μA

7-2 Situate™ Detection System 200X User's Guide

Chapter 8

Technical Specifications

All specifications are nominal and subject to change without notice. A specification referred to as “typical” is within ± 20% of a stated value at room temperature (25°C/77°F) and a nominal line input voltage.

Caution

Read all warnings, cautions, and instructions provided with this system before use.

Performance Characteristics

General

Situate™ Detection System 200X

Dimensions (H x W x D) 24.8 cm x 29.8 cm x 11.4 cm

(9.75 in. x 11.75 in. x 4.5 in.)

Console weight 3.2 kg (7 lb)

Console and power cord weight 3.4 kg (7.5 lb)

Power connector type Standard IEC-320 receptacle

System power input 100–240 V ~±10%, 75 VA, 50/60 Hz

Fuses (quantity 2) T 2A, 250 V

Accessory connector type Push-pull lock receptacle

Situate™ Detection System 200X User's Guide 8-1

Performance Characteristics

Length 99.06 cm (39 in. ± 0.5 in.)

Width 50.08 cm (20 in. ± 0.5 in.)

Thickness 2.54 cm (1 in. ± 0.25 in.)

Weight 5.65 kg (12.5 lb)

Connector type Push-pull lock receptacle

Cord length 3.66 m (12 ft)

Cord type Shielded

Situate™ Body Scanner

Situate™ Body Scanner Lite

Length 113.67 cm (44.75 in. ± 0.5 in.)

Width 50.93 cm (20.5 in. ± 0.5 in.)

Thickness 2.54 cm (1 in. ± 0.3 in.)

Weight 2.15kg (4.75 lb)

Connector type Push-pull lock receptacle

Cord length 3.2 m (10.5 ft) 3.66 m (12 ft: does not include

connectors)

Cord type Shielded

Situate™ Extremity Scanner

Length 31.5 cm (12.4 in.)

Width 8.89 cm (3.5 in.)

Height 8.38 cm (3.3 in.)

Weight 910 g (2 lb)

8-2 Situate™ Detection System 200X User's Guide

Connector type Push-pull lock receptacle

Cord length 3.66 m (12 ft)

Cord type Shielded

Situate™ Room Scanner

Length 48.9 cm (19.35 in.)

Width 37.5 cm (14.74 in.)

Height 1.6 cm (0.625 in.)

Weight 312 g (11 oz)

Performance Characteristics

Connector type Push-pull lock receptacle

Cord length 3.66 m (12 ft)

Cord type Shielded

Operating Parameters

Ambient temperature range 10°C to 40°C (50°F to 104°F)

Relative humidity 20% to 90% non-condensing

Atmospheric pressure 700 hPa to 1060 hPa

Warm-up time If transported or stored at temperatures outside the operating

temperature range, allow one hour for the console to reach room temperature before use.

Storage Parameters

Technical Specifications

Ambient temperature range -40°C to 70°C (-40°F to 158°F)

Relative humidity 10% to 90% (non-condensing)

Atmospheric pressure 500 hPa to 1060 hPa

Duration of storage If stored over one year, see service manual for instructions or

contact Medtronic service for further information.

Situate™ Detection System 200X User's Guide 8-3

Performance Characteristics

Transport Parameters

Ambient temperature range -30°C to 60°C (-22°F to 140°F)

Relative humidity 10% to 90% (non-condensing)

Atmospheric pressure 500 hPa to 1060 hPa

Duration of storage If stored over one year, see service manual for instructions

Safety Classification

or contact Medtronic service for further information.

Mode of operation Continuous operation

External electrical power source Class I equipment

Degree of protection against electrical shock

Medical electrical equipment safety IEC 60601-1

EMC emissions/immunity - medical electrical equipment

Type B equipment

IEC 60601-1-2

Note: The Situate™ body scanner/body scanner lite, room scanner, and extremity scanner emit a 145 kHz low power electromagnetic signal to detect the tag. The level of emitted radiation is below the prescribed levels per IEC 60601-1-2 and does not pose risk to the patient or user.

Electromagnetic Compliance (EMC)

CISPR 11:2009 (Amended by A1:2010), Industrial, scientific and medical (ISM) radiofrequency equipment - Electromagnetic disturbance characteristics - Limits and methods of measurement

IEC 61000-3-2:2009, Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for harmonic current emissions (equipment input current ≤ 16 A per phase)

IEC 61000-3-3:2013, Electromagnetic compatibility (EMC) - Part 3-3: Limits - Limitation of voltage fluctuations and flicker in low-voltage supply systems for equipment with rated current ≤ 16 A

IEC 61000-4-2:2008, Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test

8-4 Situate™ Detection System 200X User's Guide

Performance Characteristics

IEC 61000-4-3:2010, Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test

IEC 61000-4-4:2012, Electromagnetic compatibility (EMC) - Part 4-4: Testing and measurement techniques - Electrical fast transient/burst immunity test

IEC 61000-4-5:2005, Electromagnetic compatibility (EMC) - Part 4-5: Testing and measurement techniques - Surge immunity test

IEC 61000-4-6:2013, Electromagnetic compatibility (EMC) - Part 4-6: Testing and measurement techniques - Immunity to conducted disturbances, induced by radiofrequency fields

IEC 61000-4-8:2009, Electromagnetic compatibility (EMC) - Part 4-8: Testing and measurement techniques - Power frequency magnetic field immunity test

IEC 61000-4-11:2004, Electromagnetic compatibility (EMC) - Part 4-11: Testing and measuring techniques - Voltage dips, short interruptions and voltage variations immunity tests

Caution

Use of accessories, transducers, and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 in.) to any part of the Situate™ detection system, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.

Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally.

Technical Specifications

Situate™ Detection System 200X User's Guide 8-5

Performance Characteristics

Electromagnetic Emissions

Guidance and manufacturer’s declaration - electromagnetic emissions

The Situate™ detection system 200X is intended for use in the electromagnetic environment specified below. The customer or the user of the 200X console should assure that it is used in such an environment.

Emissions test Compliance Electromagnetic environment - guidance

RF emissions CISPR 11 Group 2 The 200X console must emit electromagnetic energy

RF emissions CISPR 11 Class A The 200X console is suitable for use in all

Harmonic emissions IEC 61000-3-2

Voltage fluctuations / flicker emissions IEC 61000-3-3

Class A

Complies

in order to perform its intended function. Nearby electronic equipment may be affected.

establishments other than domestic and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes.

Electromagnetic Immunity

Guidance and manufacturer’s declaration - electromagnetic immunity

The Situate™ detection system is intended for use in the electromagnetic environment specified below. The customer or the user of the 200X console should ensure that it is used in such an environment.

Immunity test IEC 60601 test

level

Electrostatic discharge (ESD) IEC 61000-4-2

Electrical fast transient/burst IEC 61000-4-4

Surge IEC 610004-5

± 8 kV contact

± 15 kV air

± 2 kV for power supply lines

± 1 kV for input/ output lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Compliance level

± 8 kV contact

± 15 kV air

± 2 kV for power supply lines

± 2 kV for input/output lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Electromagnetic environmentguidance

Floors shall be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.

Mains power quality should be that of a typical commercial or hospital environment. If disruption in power occurs, it may be necessary to reset the unit by disconnecting and reconnecting the accessory.

Mains power quality should be that of a typical commercial or hospital environment.

8-6 Situate™ Detection System 200X User's Guide

Guidance and manufacturer’s declaration - electromagnetic immunity

Performance Characteristics

Voltage dips, short interruptions, and voltage variations on power supply input lines IEC 61000-4-11

Power frequency (50/60 Hz) magnetic field IEC 61000-4-8

<5% UT (>95% dip in UT) for

0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 s

0% UT for 1 cycle

30 A/m 30 A/m Power frequency magnetic fields should

<5% UT (>95% dip in UT) for

0.5 cycle

40% UT (60% dip in UT) for 5 cycles

70% UT (30% dip in UT) for 25 cycles

<5% UT (>95% dip in UT) for 5 s

0% UT for 1 cycle

Mains power quality should be that of a typical commercial or hospital environment. If the user of the 200X console requires continued operation during power interruptions, it is recommended that the 200X console be powered from an uninterruptible power supply or a battery.

be at levels characteristic of a typical location in a typical commercial or hospital environment.

Situate™ Detection System 200X User's Guide 8-7

Technical Specifications

Performance Characteristics

Guidance and manufacturer’s declaration - electromagnetic immunity

Conducted RF IEC 61000-4-6

Radiated RF IEC 61000-4-3

3 V

150 kHz

RMS

to 80 MHz

3 V/m 80 MHz to 2.7 GHz

3 V

RMS

Portable and mobile RF communications equipment should be used no closer to any part of the Situate™ detection system 200X, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended separation distance:

d=1.2 √P

d=1.2 √P 80 MHz to 800 MHz

d=2.3 √P 800 MHz to 2.7 GHz

where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey less than the compliance level in each frequency range.

should be

Interference may occur in the vicinity of equipment marked with the following symbol:

Note: UT is the a.c. mains voltage prior to application of the test level.

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected

by absorption and reflection from structures, objects and people.

a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the RF detection system is used exceeds the applicable RF compliance level above, the RF detection system should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the RF detection system.

b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

8-8 Situate™ Detection System 200X User's Guide

Performance Characteristics

Separation Distances

Recommended separation distances between portable and mobile RF communications

equipment and the Situate™ detection system 200X

The Situate™ detection system 200X is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Situate™ detection system 200X can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Situate™ detection system 200X as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output power of

transmitter

(W)

0.01 0.1 0.1 0.2

Separation distance according to frequency of transmitter

(m)

150 kHz to 80 MHz

d=1.2 √P

80 MHz to 800 MHz

d=1. 2 √P

800 MHz to 2.7 GHz

d=2.3 √P

0.1 0.4 0.4 0.7

1 1.2 1.2 2.3

10 3.8 3.8 7.3

100 12 12 23

For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.

Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.

Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by

absorption and reflection from structures, objects and people.

Frequency ranges and text condition on transmitter bands

Bands (MHz) Test frequencies

(MHz)

380 – 390 385 Pulse – 18 Hz 27

430 – 470 450 FM ± 5 kHz Deviation 1

704 – 787 710, 745, 780 Pulse – 217 Hz 9

Modulation Claimed compliance

level (V/m)

kHZ sine

Technical Specifications

800 – 969 810, 870, 930 Pulse – 18 Hz 28

1700 – 1990 1720, 1845,1970 Pulse – 217 Hz 28

2400 – 2570 2450 Pulse – 217 Hz 28

Continued

Situate™ Detection System 200X User's Guide 8-9

Performance Characteristics

Recommended separation distances between portable and mobile RF communications

5100 – 5800 5240, 5500, 5785 Pulse – 217 Hz 9

Note 1: The minimum dwell time during test is 2 s.

Note 2: A minimum separation distance of 0.3 meters should be maintained between any device

transmitting in this band and the Situate™ detection system. This includes devices such as mobile phones, PDAs, Wireless LANs, and Bluetooth

Accessories

The following accessories are for use with the Situate™ detection system.

Accessory Cord length

equipment and the Situate™ detection system 200X

TM*.

01-0046 3.6 m (12 ft)

01-0023 3.6 m (12 ft)

01-0031 3.6 m (12 ft)

01-0044 3.6 m (12 ft)

AC power cable 100–240 VAC 3 m (10 ft)

Ethernet cable 3 m (10 ft)

USB flash drive 2.0/3.0 8-32 GB N/A

Audio Volume

The stated audio levels are at a distance of 1 meter.

Audible Tone

The audio levels stated below are for activation tones and alert tones at a distance of 1 meter.

Volume (adjustable) 40 dBa minimum

Frequency (nominal) 3000 Hz

8-10 Situate™ Detection System 200X User's Guide

Tone Types

Detection tone 3 kHz, continuous tone until screen is touched: 500ms

minimum.

Fault tone 3 kHz, continuous tone until Mute button, Information

button, or Continue button is pressed: 500 ms minimum.

Active tone 3 kHz, beep tone every 1 s.

Performance Characteristics

Dynamic fault/scan obstruction tone

System error tone 3 kHz, 3 beep sequence: 0.5 s on, 0.2 s off.

3 kHz, continuous tone until dynamic fault is no longer active.

Input Power

100 V to 240 V

50 Hz to 60 Hz, 1A

Full regulation range: 90 Vac to 130 Vac

Mains line frequency range (nominal): 50 Hz to 60 Hz

Power plug: 3-prong hospital grade connector

Full Regulation Range: 180 Vac to 264 Vac

Power Cord Specification

This system is factory equipped with a 250 VAC hospital grade NEMA 5-15 power cord. Should the AC power cord need to be replaced to match another plug configuration, the replacement plug/cable/receptacle configuration must meet or exceed the following specifications:

Cable - SJT16/3, IEC color code, maximum length 10 ft. (3.48 m) Plug - minimum 10 A - 125 VAC Unit receptacle - IEC female, minimum 10 A - 125 VAC

Technical Specifications

Use only Medtronic provided power cord for this product. For replacement contact your Medtronic representative.

Note: Contact your local Medtronic representative for alternative internationally approved power cord options.

Situate™ Detection System 200X User's Guide 8-11

Performance Characteristics

California Proposition 65 Statement

For information regarding California Proposition 65, please refer to www.Medtronic.com/ caprop65.

8-12 Situate™ Detection System 200X User's Guide

Consult

instructions

for use

Caution

Part No. PT00119220

Medtronic and Medtronic logo are trademarks of Medtronic. ™* Third party brands are trademarks of their respective owners. All other brands are trademarks of a Medtronic company.

May be covered by U.S. Patents: www.medtronic.com/patents

Made in Mexico.

Manufactured for Covidien llc, 15 Hampshire Street,

Mansfield, MA 02048 USA.

www.medtronic.com +1 303 530 2300 [T]

+1 800 255 8522 [T]

REV 03/2020

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