ESCO Technologies ETS-LINDGREN SuiteSentry Technisches Datenblatt

SuiteSentry™ Single Screener

Operation and Installation Manual

September 2018 PNPNPNP Rev A

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Page 3 of 34

TABLEOFCONTENTSPAGE

TABLE OF CONTENTS 3

LIST of FIGURES 4

Acronyms used in this manual ..............................................................................................4

Symbols and Terms ...............................................................................................................4

Damage in Transportation .....................................................................................................4

Language Policy – Service Documentation...........................................................................5

1.0INTRODUCTION & OVERVIEW 6

1.1Background...................................................................................................................6

1.2The Current Situation ...................................................................................................6

2.0PRE-INSTALLATION CHECKLIST 7

2.1Product Identification and Shipping List.....................................................................7

2.2Tools Required for Assembly and Installation............................................................7

2.3Summary of Tasks........................................................................................................8

3.0SITE SELECTION & INSTALLATION GUIDELINES 9

3.1Overview .......................................................................................................................9

3.2Functional Siting Requirements-Location...................................................................9

3.3Operational Siting Requirements-Performance........................................................10

3.4Operational Considerations-Usage ...........................................................................10

4.0INSTALLATION, MOUNTING and POWER-UP 11

4.1Installation and Mounting of SuiteSentry Single Screener ......................................11

Reference Documents - Installation Wiring Diagram .........................................................14

4.2Power-Up and Diagnostic Instructions......................................................................18

5.0OPERATION PROCEDURES 19

5.1General Description of Operation of SuiteSentry Single Screener..........................19

5.2Operation and Usage of SuiteSentry Single Screener .............................................20

6.0CALIBRATION & DIAGNOSTIC PROCEDURES 23

6.1Sensitivity Adjustment................................................................................................24

6.2Motion Detector Adjustment ......................................................................................25

7.0ROUTINE MAINTENANCE and SERVICE 26

7.1Cleaning of SuiteSentry Single Screener..................................................................26

7.2Periodic Testing of SuiteSentry Single Screener......................................................26

8.0CUSTOMER SERVICE 26

9.0SPECIFICATIONS, CLASSIFICATION & REFERENCE DOCUMENTS 27

9.1Specifications .............................................................................................................27

9.2Device Classification..................................................................................................27

9.3Reference Documents - Installation Wiring Diagram................................................28

9.4Mounting Dimensions - SuiteSentry Single Screener ..............................................29

10.0 Typical Installation Pictures 30

WARRANTY POLICY 33

Revision Date Author Primary Reason for Change

A September

2018 MS Initial Release

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LISTofFIGURES

PAGE

Figure 1: Temporary set up in shipping crate ....................................................................................................12

Figure 2: Connect Power Supply to SuiteSentry Single Screener in Shipping Crate .....................................12

Figure 3: SuiteSentry Single Screener standing – Ready to TEST Location....................................................12

Figure 4: Drill Locations for Mounting Brackets ...............................................................................................14

Figure 5: Typical Installation ...............................................................................................................................14

Figure 6.1, 6.2, 6.3, 6.4 Fastening Wall Toggler to Wall ...................................................................................15

Figure 7: Fastening Wall Toggler through Mounting Block and into wall. ...................................................... 16

Figure 8: Exploded view of Mounting Block, toggle, screw and washer into wall...........................................16

Figure 9: a, b, c, d, Exploded views of Mounting Block+Mtg Block Extension over Rub Rail. ......................16

Figure 10: Fastening Mounting Block to SuiteSentry Single Screener ...........................................................17

Figure 11: Completed Installation.......................................................................................................................17

Figure 12: SuiteSentry Single Screener - 3 Modes of Operation......................................................................20

Figure 13: a., b., c. - SuiteSentry Single Screener Operation and Usage .......................................................22

Figure 14: SuiteSentry Single Screener Controls.............................................................................................23

Figure 15: SuiteSentry Single Screener top cap and PIR access/adjustment.................................................25

Figure 16: Typical Installation .............................................................................................................................28

Acronyms used in this manual

ACR: .........American College of Radiology

TJC: ..........The Joint Commission

Zone II: .....ACR definition of area immediately outside the MRI control room

Zone III: ....ACR definition of area immediately outside the MRI magnet room

Zone IV: ....ACR definition of area inside the MRI magnet room

FMD: .........Ferromagnetic Detector

LED: ..........Light Emitting Diode; electronic replacement for lamp

PIR: ...........Passive Infra-Red-Detects body heat and motion and

...................enables SuiteSentry Single Screener to go into Active Mode

Symbols and Terms

NOTE: The following Symbols and Terms may be used in this manual:

Damage in Transportation

All packages should be closely examined at time of delivery. If damage to outer package is visible,

make certain the notation “damaged in shipment” was written on all copies of the freight or express

bill when delivery is accepted by your receiving agent. Whether noted or concealed, damage must

be reported to the carrier immediately upon discovery, or in any event, within 14 days after

receipt, and the contents and containers held for inspection by the carrier. Transportation

company will not pay a claim for damage if an inspection is not requested within this 14 day

period. Transport this product for a period not to exceed 4 weeks. The following environmental

conditions must be adhered to in order to avoid damage to the product.

Ambient Temperature: -34°C (-11°F) to +60°C (+140°F)

Relative Humidity: 15% TO 95% (Non-Condensing)

Atmospheric Pressure: 50 kPa (0.5 atm) to 127 kPa (1.25 atm)

WARNING!

Warning statements identify conditions or practices that could result in injury or death.

CAUTION!

Caution statements identify conditions or practices that could result in damage to the product or

other

ert

TIP or HINT:

The following is a recommendation and may help simplfy efforts during the installation.

Page 5 of 34

Language Policy – Service Documentation

WARNING

 This Service Manual is available in English only.

 If a customer’s service provider requires a language other than English, it is the customer’s responsibility to

provide translation services.

 Do not attempt to service the equipment unless this service manual has been consulted and is understood.

 Failure to heed this Warning may result in injury to the service provider, operator or patient from electric

shock, mechanical or other hazards.

AVERTISSEMENT

 Ce Manuel de maintenance n’est disponible qu’en anglais.

 Si le technicien du client a besoin de ce manuel dans une autre langue que l’anglais, c’est au client qu’il

incombe de le faire traduire.

 Ne pas tenter d’intervention sur les équipements tant que le manuel Service n’a pas été consulté et compris.

 Le non–respect de cet avertissement peut entraîner chez le technicien, l’opérateur ou le patient des blessures

dues à des dangers électriques, mécaniques ou autres.

WARNUNG

 Dieses Kundendienst-Handbuch existiert nur in englischer Sprache.

 Falls ein fremder Kundendienst eine andere Sprache benötigt, ist es Aufgabe des Kunden für eine

entsprechende Übersetzung zu sorgen.

 Versuchen Sie nicht, das Gerät zu reparieren, bevor dieses Kundendienst-Handbuch nicht zu Rate gezogen

und verstanden wurde.

 Wird diese Warnung nicht beachtet, so kann es zu Verletzungen des Kundendiensttechnikers, des Bedieners

oder des Patienten durch elektrische Schläge, mechanische oder sonstige Gefahren kommen.

AVISO

 Este Manual de Servicio sólo existe en inglés

 Si algún proveedor de servicios ajeno a KDI solicita un idioma que no sea el inglés, es responsabilidad del

cliente ofrecer un servicio de traducción.

 No se deberá dar servicio técnico al equipo, sin haber consultado y comprendido este manual de servicio.

 La no observancia del presente aviso puede dar lugar a que el proveedor de servicios, el operador o el

paciente sufran lesiones provocadas por causas eléctricas, mecánicas o de otra naturaleza.

ATENÇÃO

 Este Manual de Assistência Técnica só se encontra disponível em Inglês.

 Se qualquer outro serviço de assistência técnica, que não a KDI, solicitar estes manuais noutro idioma, é da

responsabilidade do cliente fornecer os serviços de tradução.

 Não tente reparar o equipamento sem ter consultado e compreendido este Manual de Assistência Técnica.

 O não cumprimento deste aviso pode por em perigo a segurança do técnico, operador ou paciente devido a‘

choques elétricos, mecânicos ou outros.

AVVERTENZA

 Il presente manuale di manutenzione è disponibile soltanto in inglese.

 Se un addetto alla manutenzione esterno alla KDI richiede il manuale in una lingua diversa, il cliente è tenuto

a provvedere direttamente alla traduzione.

 Si proceda alla manutenzione dell’apparecchiatura solo dopo aver consultato il presente manuale ed averne

compreso il contenuto.

 Non tenere conto della presente avvertenza potrebbe far compiere operazioni da cui derivino lesioni

all’addetto alla manutenzione, all’utilizzatore ed al paziente per folgorazione elettrica, per urti meccanici od

altri rischi.

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1.0INTRODUCTION&OVERVIEW

SuiteSentry™ Single Screener is a revolutionary patented Ferromagnetic Detector (FMD) system

designed to help keep ferromagnetic material from accidentally entering the Magnetic Resonance

Imaging magnet room. The system primarily consists of an array of sensors and microprocessors

built into a walk-up Sensor Array Column.

This product is intended to reduce the risk from an ordinary object that might suddenly become an

unintended projectile due to its attraction to the magnetic field of the MR scanner magnet.

SuiteSentry Single Screener incorporates the following features:

 Accurately and Rapidly Locates Ferromagnetic Hazards Anywhere on the Body

 Uniform Sensitivity with Six (6) Sensor Zones placed equidistant in the Sensor Array

Column

 No-Touch Activation for the ultimate in convenience and hygiene

 Highly Sensitive - Can detect small items down to hairpin size

 Used to Self-screen or for Supervised Screening

 Variety of Simple Installation Options



1.1 Background

MR Super-Conducting Scanners generate an enormously strong magnetic field, typically 30,000 to

60,000 times the Earth’s magnetic field. Due to the significant technical and economic hurdles in

generating the magnetic field, it is never purposely turned off; it is always in the ‘ON’ condition, 24

hours a day, 7 days a week. This extremely powerful magnetic field, invisible but ever-present,

continuously attracts anything which is ferromagnetic (generally containing iron or steel). It can and

will attract and pull any ferromagnetic object such as hand tools, oxygen bottles, scissors, chairs,

IV stands, and even floor buffers toward the magnet.

1.2 The Current Situation

All personnel who may come in close proximity of the MR scanner, within the four (4) progressively

restricted zones of danger, are supposed to receive training about the risks the MRI magnetic field

presents, what kind of objects contain ferromagnetic material, and therefore the danger of bringing

these materials in close proximity to the magnet. Since the MR static fields is never shut down, this

must include maintenance and security personnel who may come in close proximity during non-

scanning hours.

The patient procedures adopted in operating these MR devices have evolved into a careful pre-

screening of patients to make sure they do not have anything on their person or active/passive

implants in their person, which would be attracted by the very strong magnetic field; and, in the case

of some heart pacemakers or defibrillators, potentially have their function changed by the scanner’s

magnetic field.

Even with training and copious use of warning signs, people forget or are unaware that an object

may contain ferromagnetic material, thereby increasing the risk of a disaster.

Even small ferrous objects pose a risk of injury. A hairpin, for example, can travel at 40 MPH into a

1.5T magnet. Larger objects have injured and even caused fatalities.

Even if no injury occurs, the financial costs from downtime and re-imaging can be very large.



Page 7 of 34

2.0PRE‐INSTALLATIONCHECKLIST

2.1 Product Identification and Shipping List

The SuiteSentry Single Screener hardware is shipped in one corrugated carton. This long carton

contains all the items required for assembly and installation of the SuiteSentry Single Screener

System. The contents are listed below.

Component Qty P/N

SuiteSentry Single Screener - Sensor Array Column Assembly 1 400151

Power Supply - Digital w/ 12’ output cable / connector 1 9910-A-01427-C

AC mains power cord – w/ 90° Plug - 3 ft long -- USA 1 6608-A-01497-A

Installation Hardware Kit - SuiteSentry Single Screener 1 9993-A-02760-A

Surface Conduit Accessory Kit – Ivory – SuiteSentry Single Screener 1 9993-A-02041-B

Document Package – SuiteSentry Single Screener 1 0550-A-02016-D

Spacer, Mounting Block Extension 2 2973-A-02778

Mat, Floor, Solo Instructive 1 0540-A-02050

Box, Return Materials, 14” x 8” x 5” (w/ UPS Return Label) 1 2840-A-02838



2.2 Tools Required for Assembly and Installation

1. #2 Phillips screwdriver 6 inches long (15 cm)

2. Box cutting knife with replacement blades

1. Medium duty electric or battery drill with at least 2 spare charged batteries

2. 1/4 inch nut driver/1/4 inch wrench (ratcheting wrench is best)

3. 3/8 inch nut driver/3/8 inch wrench (ratcheting wrench is best)

4. Drill bit index with at least two (2) 1/8 inch drill bits and ½ inch bit for wall togglers

5. Measuring tape up to 12 feet (4 meters)

6. Micro screwdrivers, flat head and Phillips

7. 6 inch (15 cm) bubble level

8. Heavy Duty PVC cutters for wire trim moldings (Sears 3-1 Accu-Cut Model 37310 recommended)

9. Painter’s tape (for detector) and clear packing tape (for parts return box)

Page 8 of 34

2.3 Summary of Tasks

The following steps are a general guideline and actual workflow may differ depending on the specific

site and installation area. This section is provided so the installer has a general outline of the steps in

the installation and training process.

Select and verify the desired mounting location, method of attachment and

location of the power outlet. Always Ask!

(a dedicated outlet might have been put in specifically for the detector)

Select method and routing for Power cables to Sensor Column

Leave Sensor Column in shipping container for next step!

Test Sensor Array Column in desired location before permanent mounting

Mount Sensor Array Column

Adjust final calibration of Sensor Array Column

Mount laminated copy of Short Form Instructions near detector (SAP)

(Only if facility permits, ask first!)

Clean area and remove installation debris

Train the MRI staff and have them sign provided “Training Record” roster

10.

Take pictures of installed detector

11.

Complete “Quality Assurance Document”

12.

Complete ”Installation and Training Acceptance Document”

13.

Have responsible party sign all documents and provide copy to signee

14.

Send all documents and pictures to ETS-Lindgren

(Same day preferred, immediately following installation)

*These items are required for permanent warranty registration file!

Please make detailed notes on each document as they will be added to the device

TIP! Test SuiteSentry Single Screener in desired installation area prior to

permanent mounting to ensure it is viable for that installation location otherwise

you may have to relocate due to electromagnetic interference!!!

HINT: The installer should request that the SuiteSentry Single Screener be

brought to the installation area by the facility staff prior to arrival at the site.

Page 9 of 34

3.0SITESELECTION&INSTALLATIONGUIDELINES

3.1 Overview

The SuiteSentry Single Screener Ferromagnetic Detector consists of an array of sensors and

microprocessors built into a walk-up Sensor Array Column. The detector analyzes objects on

patients or personnel passing in front of the Sensor Array Column, screening for the object’s

potential risk as a ferromagnetic projectile.

If an object made of ferromagnetic material approaches the Sensor Array Column, the system

detects the object’s ferrous content, analyzes its ferromagnetic mass and threat potential; and, if

the mass exceeds the preset sensitivity threshold, an audible alarm is activated and ferrous object

indicator lights is illuminated in the vertical sensor array column of the portal.

Since the device detects only those materials that will be attracted to the magnet, items made of

aluminum, titanium, copper, brass and other non-ferrous materials will not trigger an alarm. Please

note, however, that seemingly non-ferrous materials may have enough ferrous properties to activate

the audible and visual alarms.

The detector only analyzes moving objects containing ferromagnetic material. Stationary

ferromagnetic objects will be ignored.

The SuiteSentry Single Screener is typically installed in Zone 2. The sensitivity should be set to

detect objects reliably without exhibiting “false positives”. The device is intended to detect and

alarm for smaller ferromagnetic objects approximately the size of a typical hair pin or larger when

the object is approximately 12 inches from the Sensor Array Column.

SuiteSentry Single Screener has no detection limitations with regard to locating ferromagnetic

material inside an object or human body. Therefore, if a ferrous non-superficial or subcutaneous

object is detected, further investigation is recommended following your facility’s standard practice.

Even if our product does NOT react, one should NOT automatically assume that there are no

ferromagnetic risks.

3.2 Functional Siting Requirements-Location

In order to ensure the system will provide detection and alert for ferromagnetic objects, the unit

should be positioned so that all equipment, patients, and personnel entering the magnet room have

been screened and can proceed directly to the magnet room. Do not screen patients and then have

them sit in waiting area as they may pick up a ferrous object that they did not possess during the

screening process. The Sensor Array Column should also be positioned to provide the most useful

opportunity for screening patients and staff, if that is your policy or desire.

Summary of Functional Siting Requirements:



The location should have a measured magnetic fringe field of less than 2 Gauss.



The preferred location to install SuiteSentry Single Screener is near the Zone 2 patient

changing area or another location before entry into Zone 3.



Keep detector away from magnet room (Unit CANNOT be above 2 Gauss)



Locate the detector within the area so as not to interfere with patient transport and to prevent

possible damage from patient transport impact.



If location is on wall with bumper rail guards; modify them to accommodate SOLO installation.

TIP! To ensure the unit is functional in the desired area of operation TEST unit

at the desired location PRIOR to permanent mounting!

WARNING!

This device has not yet been fully evaluated for its efficacy in detection of

ferromagnetic objects inside the body, such as IMPLANTS

Page 10 of 34

3.3 Operational Siting Requirements-Performance

Since SuiteSentry Single Screener is designed to detect moving ferrous objects passing near or

approaching the Sensor Array Column, the selected site should be away from extraneous moving

objects such as printers, office chairs, and file cabinet drawers. Special hardware and software

design reduces the sensitivity to moving ferromagnetic objects on the sides and behind the Sensor

Array Column, but separation of movable ferromagnetic masses from the sides of the Detector

System is also desirable.

Maintain separation from electrical devices, especially those which contain transformers, electrical

motors or other moving parts as these devices create magnetic fields which can mimic moving

ferromagnetic objects. Distance should be maintained from electrically locked or electrically

opening doors. Some doors have magnets mounted on them to activate switches used to indicate

that the door is closed. Plan your installation to maintain separation from these doors and devices.

Summary of Operational Siting Requirements:



Remove electrical devices 9 feet (3 meters) away from the installed detector to prevent false

positive alarms.



Ensure area of installation is free from electrical and electromagnetic interference when

possible.



If electronic equipment is within 9 feet (3 meters) the detector may very well exhibit false

positives. Determine the object/device that causes this condition and remove from immediate

vicinity of the detector and allow the detector to stabilize to the environment.

3.4 Operational Considerations-Usage

The highest sensitivity to moving objects occurs within 3 inches of the Sensor Array Column. All

efforts should be made to minimize traffic in the area of the Sensor Array Column during the

screening process as this traffic may have ferromagnetic objects which can cause unintended

alarms.

The change from standby to active mode is determined by adjusting the Passive Infrared (PIR)

motion sensor located in the Top Control Panel display. Even small ferromagnetic objects on a

person or staff member that routinely enter the magnet room may trigger an alarm as these ferrous

objects will be magnetized by exposure to the MRI’s magnetic field. Once magnetized, some small

objects will cause an alarm identical to a larger-in-mass object. To minimize these alarms, staff

should be trained to minimize wearing of ferrous objects; such as, underwire bras, shoes with steel

shanks or springs, belt buckles, pens, badges, eyeglasses, and hair clips.

Summary of Operational Considerations:



Staff wearing ferrous material in their clothing will cause the detector to alarm. REMOVE all

clothing that exhibits alarms to ensure consistent screening results.



The detector will alarm for attire such as watches, belts, shoes, and underwire bras. If you feel

it pull at or near the bore, the detector will alarm on the object within several feet (5’) or more.



The SuiteSentry Single Screener is to be used only as a prescreening device.



All staff should acknowledge the detector alarms and not enter zone III if an alarm is displayed

until offending ferrous object is removed.



CAUTION!

The SuiteSentry Single Screener detector MUST be placed in area that has LESS

than a 2 Gauss field strength. Ensure that it is functionally capable of performing

in the preferred area of operation prior to permanent mounting!

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