SituateTM - Janet Harrington · User’s Guide Situate TM Detection System 200E For use with...

User’s Guide

SituateTM

Detection System 200E

User’s Guide

SituateTM

Detection System 200E

For use with software version 1.X

Part Number: PT00062281

ii Situate™ Detection System 200E User's Guide

Preface

Preface

This guide and the equipment it describes are for use only by qualified medical professionals

trained in the particular technique and surgical procedure to be performed. It is intended as

a guide for using the Medtronic Situate™ Detection System 200E only.

Equipment covered in this manual

Situate™ Detection System 200E with software version 1.x.

Conventions Used in this Guide

Warning

Indicates a potentially hazardous situation which, if not avoided, could result in death or serious

injury.

Precaution

Indicates a hazardous situation which, if not avoided, may result in minor or moderate injury.

Notice

Indicates a hazard which may result in product damage.

Important

Indicates an operating tip or maintenance suggestion.

Situate™ Detection System 200E User's Guide iii

Limited Warranty

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:

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.

SituateTM Detection Console 200E One year from date of shipment

iv Situate™ Detection System 200E User's Guide

Software License

Software License

Medtronic llc, (collectively called “Medtronic” herein) own the entire right, title, and interest

in and to all of the computer programs and all portions thereof, and associated

documentation (collectively, the “Software”) provided to Customer as may be installed in the

Products and equipment addressed herein or provided separately, and it has the sole right

to grant licenses hereunder.

The evaluation allowance herein and any ultimate price paid by Customer for the products

incorporating the Software include as a portion of that evaluation allowance, or price, a

license fee granting Customer only the rights set forth in this Software License. Customer

further acknowledges and agrees that the Software is owned exclusively by Medtronic. The

Software is licensed to be used on only one computing device or Product, and a valid license

must be purchased for each computing device on which the Software is installed.

Single User License Grant: Medtronic grants to Customer a limited, nonexclusive, non-

sublicensable, 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

Situate™ Detection System 200E User's Guide v

Software License

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.

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

vi Situate™ Detection System 200E User's Guide

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 ABOVE-

STATED 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.

Table of Contents

Situate™ Detection System 200E User’s Guide vii

Preface . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Conventions Used in this Guide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . ii

Limited Warranty . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iii

Software License. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv

Chapter 1. Introduction to the Situate™ Detection System 200E

Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Indications for Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Contraindication. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1-1

Situate™ 200E 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

Chapter 3. Situate System Setup

Setup. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Select a Scanning Device . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-1

Set Up and Turn On the Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-2

Connect a Scanner to the Console . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3-9

Chapter 4. Scanning for RF-Tagged Premium Cotton

Scanning with the Situate™ Detection Console 200E . . . . . . . . . . . . . . . . . . 4-1

Set Up Before Surgery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-2

Starting a Scanning Case . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4-3

After a Scanning Session . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Disassembly . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-11

Periodic Maintenance for Console and Components . . . . . . . . . . .4-12

Storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-12

Product Service . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .4-13

viii Situate™ Detection System 200E User’s Guide

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

Repairs and Returns. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Return for Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Warranty. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-7

Periodic Maintenance for Console and Components . . . . . . . . . . . . . . . . . . 6-7

Disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6-8

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 . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-3

Safety Classification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Electromagnetic Compliance (EMC). . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8-4

Accessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Audio Volume . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Audible Tone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-10

Tone Types . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

Input Power . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

Power Cord Specification. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-11

Standards and IEC Classifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12

Symbols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .8-12

Chapter 1

Situate™ Detection System 200E User's Guide 1-1

Introduction to the Situate™ Detection System 200E

This chapter provides an overview of the features and functions of the Situate™ Detection

System 200E.

Precaution

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

Important

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 200E uses a low-energy radio-frequency (RF) signal to detect

tagged objects (such as 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 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

1-2 Situate™ Detection System 200E User's Guide

Situate™ 200E System Overview


Console Front Panel

Accessory receptacle

Body Scanner receptacle

Situate Detection System

Accessory Body Scanner

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Situate™ 200E System OverviewIn

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Console Back Panel

USB receptacles (4)

Ethernet receptacle

Power-cord receptacle

Fuse drawer

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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 200E

Situate™ premium cotton

Situate™ Body Scanner/Body Scanner Lite

Situate™ Room Scanner

Notice

Use sterile drapes (01-0020) if Room Scanner is to be used in the sterile field.

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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

Accessory

Body Scanner



Situate™ Premium Cotton Products

Situate™ premium cotton products 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.



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Situate™ Body Scanner/Body Scanner Lite

The Body Scanners detect 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 40.6cm (16 in.) above the Body Scanner surface.

Notice

Body Scanner Lite pictured above. Body Scanner not pictured.




The Situate™ Room Scanner is a hand held scanning tool for detecting missing or retained

sponges in and around the sterile field (i.e., linens, drapes, 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 40.6cm

(16 in.).

Catalogue Number Description (Legacy Product Name)

01-0030 Situate™ Detection Console 200E (RF Assure Console

Model 200E - e+ Boost)

01-0049/02-0029R Situate™ Room Scanner (Blair Port Wand)

01-0023 Situate™ Body Scanner (RF Assure ConformPlus Antenna

Array Body Scanner)

01-0031 Situate™ Body Scanner Lite (RF Assure ConformPlus II

Antenna Array Body Scanner)

Varies Situate™ Premium Cotton Products (RF Detect Premium)

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

Electric Shock Hazard 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.

Precaution

Read the instructions, warnings, and precautions 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 (e.g., vaginal packing). Cutting may damage the

pouch and separate the RF detectable tag from the product.

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.

Scanner drapes and surgical cotton disposables are packaged sterile. Sterility is maintained unless the

package or seal has been opened


General

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

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 angled or tilted table. Straps are

provided to fasten the Body Scanner Lite to the OR 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 (badges, car keys, etc.) 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.

Place console outside of the sterile field.

Do not stack equipment on top of other OR devices. This is an unstable configuration.

Notice

Inspect the Situate™ Detection Console 200E 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.

Connect the power cord to a properly grounded power receptacle having the correct voltage.

Otherwise, product damage may result.

Do not connect unauthorized or unrecognized devices to the console.

In gynecological procedures using a Body Scanner, ensure the scanner is not covering the pad’s

perineal cutout.

The Room Scanner can be used in cases where the Body Scanner cannot be utilized due to

questionable patient stability.

Precaution

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General

Scanning

If the home screen fails to appear, check the power connections, then shut off the system and turn it

back on.

An RF tag in direct contact with metal will reduce the tag signal and impair scanning. Avoid direct

metal contact within 1mm of the tag. If sponge sticks are used, wrap a layer of gauze >1mm between

the tag and the instrument.

The Body Scanner can be punctured by sharp objects. Replace the Body Scanner if it is damaged.

Ensure the Body Scanner lies flat; if a portion of the Body Scanner is folded over, it may result in a scan

fault.

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 Scan Records on page 4-10.

Important

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.

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.

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.

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.

Place other devices (patient positioning devices, gel pads, electrocautery and thermal pads etc.) on

top of the Body Scanner.

Do not handle the Body Scanner by cable; damage to the Body Scanner may occur.

Warning

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

Precaution

Do not move the Room Scanner at a rate faster than 15.2cm (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.

Notice


General

Notice



An RF tag in direct contact with metal will reduce the tag signal and impair scanning. Avoid direct


the tag and the instrument.

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.

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.

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.

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

Important

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.

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

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.

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.

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General

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.

After Scanning

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.

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

Notice

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.

Notice

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

Important

Store Body Scanner flat; otherwise damage to the Body Scanner may occur.

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.


Servicing

Servicing

Precaution

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.

Important

The Situate™ Console has no user serviceable parts, and preventative maintenance is not required. To

reduce the risk of electrical shock, do not disassemble the unit. Contact the manufacturer if service is

required.

Chapter 3


Situate™ System Setup

This chapter describes how to set up the Situate™ Detection Console 200E, turn it on, and

prepare for a scanning session.

Setup

Select a Scanning Device

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

The Situate™ Detection Console can simultaneously accommodate a Body Scanner and one

hand scanner (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.)

Precaution


Important

The role of the Situate™ Detection System 200E is to serve as an adjunct technology. The system helps

validate correct counts and rectify miscounts. The system does not replace manual counts.




Setup

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 2 slotted tabs at the top of the scanner and another through the

bottom two tabs if needed.

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

Notice

Ensure the Body Scanner lies flat; if a portion of the Body Scanner is folded over, it may result in a scan

fault.

In gynecological procedures using a Body Scanner, ensure the scanner is not covering the pad’s

perineal cutout.

The Room Scanner can be used in cases where the Body Scanner cannot be utilized due to

questionable patient stability.

Do not connect unauthorized or unrecognized devices to the console.

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Setup

Setting the Date/Time

By clicking the Date/Time tab, the user has the ability to Set Date, adjust the Date Format,

and Set Time.

Date/Time

Date Format

This screen allows the user set the Date Format.


Setup

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.

Select the day of the month.

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.

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Setup

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

down arrows.

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).

Minutes are adjusted by selecting the minutes on the screen and choosing the appropriate

minute from the list.


Setup

Setting the Language

Using the up and down arrows, the user has the ability to change the console language.

Once a language is selected, turn off power to the console and then turn on power to the

console in order to change the displayed language.

Language

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

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Setup

Console Power On

Precaution

Ensure all known tagged objects are more than 91 cm (36 in.) from the scan site to avoid possible false

positive detections.

Move RFID devices (badges, car keys, etc.) 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.

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 (e.g. 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 angled or tilted table. Straps are

provided to fasten the Body Scanner Lite to the OR 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.

Notice

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.

Important

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.

Place the Body Scanner on top of the table pad. Do not place the Body Scanner under pad or directly

on the surgical table frame: metal may interfere with scanning.

Place other devices (patient positioning devices, gel pads, electrocautery and thermal pads etc.) on

top of the Body Scanner.

Do not handle the Body Scanner by cable; damage to the Body Scanner may occur.


Setup

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

Notice

If the home screen fails to appear, check the power connections, then shut off the system and turn it

back on.

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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 (room scanner).

A Room Scanner and a Body Scanner can be attached to the console simultaneously and

used interchangeably during a scanning 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

Scan RecordsViewing Console Scan Records on page 4-10.

1. Connect the scanner(s) to the console. Connect the BNC cable. Ensure the connectors are

securely fastened.

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

Accessory


Setup

Body Scanner/Body Scanner Lite—Connect the Body Scanner cable to the console

port labeled Body Scanner. Align the red dots on the plug and connector and press to

insert.

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

Notice

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

Chapter 4


Scanning for RF-Tagged Premium Cotton

This chapter includes steps for the Situate™ Detection Console 200E prior to surgery, during

a scan, and after surgery.

Scanning with the Situate™ Detection Console 200E

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.

Precaution


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.

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

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



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.

Precaution

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

Notice

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.

The RF tag in direct contact with metal will reduce the tag signal and impair scanning. Avoid direct


tag and instrument.

Limit the use of electrical equipment such as electrosurgical consoles, while scanning. Turn off

unused electronic devices and instruments, or place devices at least 36 in. from the scan area.

Important



Precaution

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.

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

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Starting a Scanning Case

The home screen displays the attached scanning devices.

Touch the START screen for a device to start a new scanning case.

Room Scanner

Body Scanner

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.

Important



Precaution

The Body Scanner should cover the full length of the torso pad and be positioned under the surgical

site.

Important

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.

1 2



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 Continue. The screen will return to

the screen displaying attached scanners. Touch the device’s 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.

3. Touch Continue. The case is now closed.

Notice

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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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 Continue to perform another scan. Repeat the scanning steps in this section until

a clear scan is reported.

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.

3. Open a new scanning case and select the Room Scanner as the scanning device.

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

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.

Precaution

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.



Scanning procedure for the Room Scanner includes a side-to-side scan pattern and a

superior-to-inferior pattern.

Side to Side

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

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

position 1 to position 2.

Important

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.

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

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.

Important

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.

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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.

Superior to Inferior

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

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

the inferior position 2.

3) Continue scanning through the 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.

The screen displays an active-scan screen during the scan, and the console emits an

audible indicator sound.

A feedback screen appears (e.g., “Near Metal” or “Scan Obstruction”) when interference

occurs.

The pace of the audible indicator sound also doubles. The console reverts to the active-

scan screen when wand is moved away from the source of noise.

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.

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CLEAR Scan Result

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


To perform another scan on the same patient, touch Continue. The screen will return to

the home screen. Select the desired scanning device, and press 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.

3. Touch Continue. The case is now closed.

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DETECTION Scan Result

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


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

3. Touch Continue to perform another scan. Repeat the scanning steps in this section until

a clear scan is reported.



Viewing Console Scan Records

The console stores viewable records of all completed scan records.

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

2. Touch View Records.

A record of the last scan is shown.

3. The arrows in the header bar allow the user to navigate between cases. Touch Close to

return to the Records tab.

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After a Scanning Session


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.

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

cleared of all positioning devices, drapes and other coverings.

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

loose components. Check cables for kinks or breaks in insulation and connectors for wear

or damage that can prevent secure attachment.

Notice

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



Periodic Maintenance for Console and Components

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 (drapes, gauze, sponges, etc.) in accordance with

standard hospital protocol.

Contact Medtronic Technical Service for the disposal of the console or system components.

Warning

Electric Shock Hazard Always turn off and unplug the console before periodic maintenance.

Notice

Do not clean the console with abrasive cleaning or disinfectant compounds, solvents, or other

materials that could scratch the panels or damage the console.

Precaution

Situate™ Premium Cotton Products and drapes are supplied in sterile packaging. Dispose of used or

opened sterile products (drapes, gauze sponges, etc.) using standard hospital protocol.

Important

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

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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.

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 4-14) 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 4-12.

Precaution

Only connect IEC 60601-1 or Medtronic-approved devices to the USB interface. The user must ensure


Important


reduce the risk of electrical shock, do not disassemble unit. Contact manufacturer if service is

required.



3. Ship the console.

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

information (hospital, phone number, etc.) 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.

Medtronic Technical Service

For service, contact Medtronic Technical Service or your Situate™ sales representative.

Contact a Medtronic technical-service representative by telephone, e-mail, or through the

Internet:

• USA and Canada: 1 800 255 8522 Option 2

• International: +1 303 476 7996

• E-mail: [email protected]

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

or

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

Chapter 5


Troubleshooting

Device Notification Screens

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

being performed.

Body 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:

Precaution



Device Notification Screens

Notification Type Scanning Device Resolution

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

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.

Metal fault Body Scanner

Body Scanner Lite

Room Scanner

Clear the scan area of metal objects.

Scan the patient again.

Signal levels indicate the presence of

metal near accessory.

Interference fault Body Scanner

Body Scanner Lite

Room Scanner

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.

Transmit fault Body Scanner

Body Scanner Lite

Room Scanner

Replace device. If error persists,

replace the console.

Signal levels extremely low.

Disconnect fault Body Scanner

Body Scanner Lite

Room Scanner

Reconnect device.

System unexpectedly lost

connection to device.


TroubleshootingTro

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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 4-14).

Fault Name Description Resolution

Blank screen The system stays on a

blank white or black

screen.

Turn off power to the console and

restart.

Boot screen The system stays on the

startup screen and the

application fails to load.

Turn off power to the console and

restart.

System error The console displays the

system error message.

If the error persists, contact technical

service.

Chapter 6


Service & Maintenance

Maintenance

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.

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.

Important

There is no scheduled maintenance for the Situate™ Detection Console. There are no calibrations. The

Situate™ Detection Console self-calibrates during use.

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.

Precaution

Only connect IEC 60601-1 or Medtronic-approved devices to the USB interface. The user must ensure


Important

The Situate™ Console has no user-serviceable parts and preventative maintenance is not required. To


required.


Biomedical Department Inspection

General Safety Guidelines

• The AC power switch on the back panel serves as the means of disconnection from

supply mains. This switch also isolates the Situate™ Detection Console 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 Console.

Environmental Conditions

For storage and transportation information see, Storage Parameters on page 8-3 and

Transport Parameters on page 8-3.


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 Chapters 3 and 4 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 (e.g., dents, scratches, 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.

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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.


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.


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

8. Repeat as necessary for each type of scanner.


Fuse Replacement

Fuse Replacement

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

1. Disconnect the Situate™ Detection Console’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™ Detection Console surface and close the fuse door until latch engages.

Precaution

Fuses must be replaced with 500 mA/250 V, 5x20 mm fuses. Using other fuses might damage the unit.

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Chassis Ground

Chassis Ground

Back Panel Chassis Ground

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

Important

The Situate™ Console has no user-serviceable parts and preventative maintenance is not required. To


required.

REFSN

1


Software Updates

Software Updates

Medtronic recommends that only qualified personnel perform software updates. Software

updates are available directly from Medtronic.

To perform a software update, touch Menu then touch Service. Verify that the software tab

is selected.

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.

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.

A screen will inform the user of a successful software update. Touch Back to Service, then

touch Close to return to the home screen.

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.

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Repairs and Returns

Repairs and Returns

For Situate™ Detection Console repairs or returns, call the Medtronic Customer Service

Department. The Situate™ Detection Console 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, e-mail, or through the

Internet:

• USA and Canada: 1 800 255 8522 Option 2

• International: +1 303 476 7996

• E-mail: [email protected]

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

or

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

Warranty

For information about the Situate™ Detection Console warranty and/or to obtain

information about the availability of the Medtronic Extended Warranty, contact Medtronic

Customer Service.

Opening the Situate™ Detection Console by anyone other than an authorized Medtronic

technician voids the warranty.

Periodic Maintenance for Console and Components

The Situate™ Detection Console requires no scheduled maintenance other than periodic

maintenance external surfaces.

Important



required.

Warning

Electric Shock Hazard Always turn off and unplug the console before periodic maintenance.


Disposal

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

Follow local governing ordinances and recycling plans regarding disposal or recycling of

components.

Important

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.

Notice

Do not clean the console with abrasive cleaning or disinfectant compounds, solvents, or other

materials that could scratch the panels or damage the console.

Chapter 7


Electrical Safety Tests

The Situate™ Detection Console 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

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 Console 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

Warning

High Voltage Do not touch the equipment during the isolation tests.

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




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 Console 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

Warning

High Voltage Do not touch the equipment during the isolation tests.

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

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.

Performance Characteristics

General

Precaution



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 & Power Cord Weight 3.4 kg (7.5 lb.)

Power Connector Type Standard IEC-320 Receptacle

System Power Input 100–240 V ~± 10%, 60 VA, 50/60 Hz

Fuses (Quantity 2) T500 mA, 250 V

Accessory Connector Type Push-Pull Lock Receptacle



Situate™ Body Scanner

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 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 2.15 kg (4.75 lb.)


Cord Length 3.2 m (10.5 ft) 3.66 m (12 ft - does not

include connectors)

Cord Type Shielded


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)

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Operating Parameters

Storage Parameters

Transport Parameters


Cord Length 3.66 m (12 ft)

Cord Type Shielded

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

Relative humidity 20% to 90% non-condensing

Atmospheric pressure 700 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.

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

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


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

contact Medtronic Service for further information.

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

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


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

or contact Medtronic Service for further information.



Safety Classification

Note: The Situate™ Body Scanner/Body Scanner Lite and Room 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 a risk to the patient or user.

Electromagnetic Compliance (EMC)

CISPR 11:2009 (Amended by A1:2010), Industrial, scientific and medical (ISM) radio-

frequency 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


measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test


measurement techniques - Electrical fast transient/burst immunity test


measurement techniques - Surge immunity test


measurement techniques - Immunity to conducted disturbances, induced by radio-

frequency fields


measurement techniques - Power frequency electromagnetic field immunity test

Mode of Operation Continuous operation

External Electrical Power Source Class I Equipment

Degree of Protection against

Electrical Shock

Type B Equipment

Medical Electrical Equipment Safety IEC 60601-1

EMC Emissions/ Immunity - Medical

Electrical Equipment

IEC 60601-1-2

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measuring techniques - Voltage dips, short interruptions and voltage variations immunity

tests

Precaution

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.



Electromagnetic Emissions

Electromagnetic Immunity

Guidance and manufacturer’s declaration - electromagnetic emissions

The Situate™ Detection Console 200E is intended for use in the electromagnetic environment

specified below. The customer or the user of the 200E console should assure that it is used in such

an environment.

Emissions Test Compliance Electromagnetic environment - guidance

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

in order to perform its intended function. Nearby

electronic equipment may be affected.

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

establishments other than domestic and those directly

connected to the public low-voltage power supply

network that supplies buildings used for domestic

purposes.

Harmonic emissions IEC

61000-3-2

Class A

Voltage fluctuations/

flicker emissions IEC

61000-3-3

Complies

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 200E console should ensure that it is used in such an

environment.

IMMUNITY test IEC 60601 test

level

Compliance

level

Electromagnetic environment

guidance

Electrostatic

discharge (ESD)

IEC 61000-4-2

± 8 kV contact

± 15 kV air

± 8 kV contact

± 15 kV air

Floors shall be wood, concrete or

ceramic tile. If floors are covered with

synthetic material, the relative humidity

should be at least 30%.

Electrical fast

transient/burst

IEC 61000-4-4

± 2 kV for

power supply

lines

± 1 kV for input

/ output lines

± 2 kV for

power supply

lines

± 2 kV for

input/output

lines

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.

Surge IEC 61000-

4-5

± 1 kV line(s) to

line(s)

± 2 kV line(s) to

earth

± 1 kV line(s) to

line(s)

± 2 kV line(s) to

earth



environment.

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Voltage dips,

short

interruptions and

voltage

variations on

power supply

input lines IEC

61000-4-11

<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

<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



environment. If the user of the 200E

console requires continued operation

during power interruptions, it is

recommended that the 200E console be

powered from an uninterruptible power

supply or a battery.

Power frequency

(50/60 Hz)

electromagnetic

field IEC 61000-4-

8

30 A/m 30 A/m Power frequency electromagnetic fields

should be at levels characteristic of a

typical location in a typical commercial

or hospital environment.




Conducted RF

IEC 61000-4-6

3 VRMS150 kHz

to 80 MHz

3 VRMS Portable and mobile RF

communications equipment should be

used no closer to any part of the

Situate™ Detection Console 200E,

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 surveya should be

less than the compliance level in each

frequency range.b

Interference may occur in the vicinity of

equipment marked with the following

symbol:

Radiated RF IEC

61000-4-3

3 V/m 80 MHz

to 2.7 GHz

3 VRMS

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.


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Separation Distances

Recommended separation distances between portable and mobile RF communications

equipment and the Situate™ Detection Console 200E

The Situate™ Detection Console 200E is intended for use in an electromagnetic environment in

which radiated RF disturbances are controlled. The customer or the user of the Situate™ Detection

Console 200E can help prevent electromagnetic interference by maintaining a minimum distance

between portable and mobile RF communications equipment (transmitters) and the Situate™

Detection Console 200E as recommended below, according to the maximum output power of the

communications equipment.

Rated maximum

output power of

transmitter

W

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

0.01 0.1 0.1 0.2

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

distanced 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)

Modulation Claimed Compliance

Level V/m

380 – 390 385 Pulse – 18 Hz 27

430 – 470 450 FM ± 5 kHz Deviation 1

kHZ sine

28

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

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

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



Accessories

The following accessories are for use with the Situate™ Detection System.

Audio Volume

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

Audible Tone

The audio levels stated below are for activation tones and alert tones at a distance of one

meter.

Continued

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.TM*

Accessory Cord Length

01-0049/02-0029R 3.6 m (12 ft)

01-0023 3.6 m (12 ft)

01-0031 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

Volume (adjustable) 40 dBA minimum

Frequency (nominal) 3000 Hz

Recommended separation distances between portable and mobile RF communications

equipment and the Situate™ Detection Console 200E

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Tone Types

Input Power

Power Cord Specification

This system is factory equipped with a 220 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

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

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 1s.

Dynamic Fault/Scan

Obstruction Tone

3 kHz, continuous tone until dynamic fault is no longer

active

System Error Tone 3 kHz, 3 beep sequence –.5 s on, .2 s off

100 to 240 V

50 to 60 Hz, 1A

Full regulation range:

90 to 130 Vac

Full Regulation Range:

180 to 264 Vac

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

Power plug:

3-prong hospital grade connector

Important

Contact your local Medtronic representative for alternative internationally approved power cord

options.


Standards and IEC Classifications


The console meets all pertinent clauses of the IEC 60601-1.

Symbols

Unit produces non-ionizing 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.

Catalogue number

Consult instructions for use

Manufacturer

Date of manufacture

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Alternating current

Serial number

Not made with natural rubber latex

Temperature storage limitations

Humidity storage limitations

Atmosphere pressure storage limitations

For sale by prescription only

Equipment should not be disposed in trash. Dispose of

this product according to local regulation.

-40°F-40°C

158°F70°C

10%

90%

500hPa

1060hPa

Consultinstructions

for use

Part No. PT00062281

MEDTRONIC, MEDTRONIC with logo, and Medtronic logo are U.S. and internationally registered trademarks of Medtronic. Other brands are trademarks of a Medtronic company, ™* brands are trademarks of their respective owner.

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

©2016 Medtronic.

Made in USA. Printed in USA.

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 09/2017

SituateTM - Janet Harrington · User’s Guide Situate TM Detection System 200E For use with...

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Transcript of SituateTM - Janet Harrington · User’s Guide Situate TM Detection System 200E For use with...