Kodak EKTASCAN 160 User manual

User Guide

for the

KODAK EKTASCAN 160 Laser Imager

with the

KODAK X-OMAT 2000 Processor

Health Imaging

EASTMAN KODAK COMPANY

June 2000

Credits and Trademarks

KODAK, Ektascan, and X-Omat are trademarks of the Eastman

Kodak Company.

Other trademarked names may be used throughout this manual.

Instead of listing all the names and companies that own these

trademarks, or inserting a trademark symbol with each occurrence

of the trademarked name, Eastman Kodak Company states that

these names are used for editorial purposes, with no intent to

infringe upon trademarks.

CAUTION: Federal law restricts this device to sale to, by, or

on order of a physician.

The information contained herein is based on the experience and

knowledge relating to the subject matter gained by Eastman

Kodak Company prior to publication.

No patent license is granted by this information.

Eastman Kodak Company reserves the right to change this infor-

mation without notice and makes no warranty, express or implied,

with respect to this information. Kodak shall not be liable for any

loss or damage, including consequential or special damages,

resulting from the use of this information, even if loss or damage

is caused by Kodak’s negligence or other fault.

Pub. No. 5E2234

Printed in USA

HEALTH IMAGING

EASTMAN KODAK COMPANY

Rochester, NY 14650

Medical Device Directive (MDD)

English

This device is not medical equipment according to EN 60 601-1 and must therefore not enter

the Patient Environment as defined in EN 60 601-1-1. The following requirements have to

be met:

1. Distance from device to Patient Contact Equipment (see illustration). Horizontal = 1,83

metres; Vertical = 2,5 metres above the floor under the patient.

2. Contact of patient and device simultaneously by caregiver not allowed.

3. NO direct electrical connection between device and Patient Contact Equipment is

allowed.

AUTHORISED AGENT:

Manager, Product Safety; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, GERMANY.

1,83

m

1,83

m

1,83m

2,5m

Dansk

Denne enhed klacificeres ikke som medicinsk udstyr jævnfør standarden EN 60 601-1 og

må derfor ikke komme i nærheden af patientomgivelserne, som beskrevet i EN 60 601-1-1.

Følgende krav skal være opfyldt:

1. Afstanden fra enheden til patientlejet (se tegningen). Vandret = 1,83 meter; Lodret = 2,5

meter over gulvet under patienten.

2. Personalet må ikke berøre enheden og patienten samtidigt.

3. Der må IKKE forekomme direkte elektrisk forbindelse mellem enheden og patientlejet.

AUTORISERET FORHANDLER:

Manager, Product Safety; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, TYSKLAND

Deutsch

Dieses Gerät ist kein medizinisches Gerät nach dem Standard EN 60 601-1 und darf sich

daher nicht in der Umgebung des Patienten, die durch den Standard EN 60 601-1-1 fest-

gelegt ist, befinden. Die folgenden Anforderungen müssen erfüllt sein:

1. Abstand vom Gerät zum Patient Contact Equipment, d. h. zu mit dem Patienten in

Berührung stehenden Gerätschaften (siehe Abbildung). Horizontal = 1,83 Meter; Ver-

tikal = 2,5 Meter über dem Boden unter dem Patienten.

2. Gleichzeitige Berührung von Patient und Gerät durch das Pflegepersonal nicht zuläs-

sig.

3. KEINE direkte elektrische Verbindung zwischen Gerät und Patient Contact Equipment

zulässig.

AUTORISIERTE VERTRETUNG:

Manager, Produktsicherheit; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,

DEUTSCHLAND.

Español

Este dispositivo no constituye un equipo médico según el estándar EN 60 601-1, por lo tanto

no necesita cumplir las normas para el entorno del paciente definidas en

EN 60 601-1-1. Deben cumplirse los siguientes requisitos:

1. Distancia del dispositivo al equipo de contacto con el paciente (véase diagrama). Hor-

izontal = 1,83 metros; Vertical = 2,5 metros por encima del suelo debajo del paciente.

2. No debe permitirse el contacto del asistente con el paciente y el dispositivo al mismo

tiempo.

3. NO debe permitirse la conexión eléctrica directa entre el dispositivo y el equipo de con-

tacto con el paciente.

AGENTE AUTORIZADO:

Gerente, Seguridad de producto; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,

ALEMANIA.

Français

Ce dispositif n'est pas assimilé à un équipement médical comme défini par l'EN 60 601-1 et

ne doit donc pas se conformer aux exigences d'environnement du patient que définit

l'EN 60 601-1-1. Les exigences suivantes doivent être respectées:

1. Distance entre le dispositif et l'équipement en contact avec le patient (voir illustration):

horizontalement = 1,83 mètres ; verticalement = 2,5 mètres au-dessus du sol sous le

patient.

2. Interdiction stricte au soignant d'être simultanément en contact avec le patient et le dis-

positif.

3. INTERDICTION d'établir une connexion électrique directe entre le dispositif et l'équipe-

ment en contact avec le patient.

AUTORISATION:

Directeur, Contrôle sécurité; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,

ALLEMAGNE.

Italiano

Questo dispositivo non è un'apparecchiatura medicale ai sensi di EN 60 601-1 e quindi non

deve essere posta in prossimità del paziente, come definito in EN 60 601-1-1. Devono

essere soddisfati i requisiti elencati nel seguito:

1. Distanza tra il dispositivo e le attrezzature a contatto del paziente (vedere la figura).

Orizzontale = 1,83 metri; Verticale = 2,5 metri sopra il livello del pavimento del paziente.

2. Non deve essere consentito al personale il contatto diretto contemporaneo con il

paziente ed il dispositivo.

3. NON deve esistere alcun contatto elettrico diretto tra il dispositivo e le attrezzature a

contatto del paziente.

AGENTE AUTORIZZATO:

Manager, Sicurezza Prodotto; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,

GERMANIA.

Lietuviðkai

Ðis prietaisas nëra medicinos prietaisas pagal EN 60 601-1 ir todël privalo nepatekti á

paciento aplinkà, apibrëþtà EN 60 601-1. Bûtina laikytis ðiø reikalavimø:

1. Atstumas nuo prietaisas iki su pacientu kontaktuojanèios árangos (þr. paveikslà): hori-

zontaliai - 1.83 m; vertikaliai - 2.5 m virð grindø, po pacientu.

2. Pacientà priþiûrinèiam asmeniui vienu metu prie paciento ir prie prietaisas liestis

neleidþiama.

3. NELEIDÞIAMAS tiesioginis elektros kontaktas tarp prietaisas ir su pacientu susil-

ieèianèios árangos.

ÁGALIOTASIS ATSTOVAS:

Produkcijos saugos vadybininkas; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,

VOKIETIJA.

Nederlands

Deze apparaat is geen medische apparatuur volgens EN 60 601-1 en mag daarom niet bin-

nen de behandelingsomgeving van de patiënt staan zoals bepaald is in EN 60 601-1-1. Er

moet aan de volgende eisen worden voldaan:

1. Afstand vanaf apparaat tot behandelinstallatie patiënt (zie afbeelding). Horizontaal =

1,83 meter; Verticaal = 2,5 meter boven de vloer vanaf de vloer onder de patiënt.

2. Gelijktijdig contact met patiënt en apparaat door verzorger is niet toegestaan.

3. Directe elektrische verbinding tussen apparaat en behandelinstallatie patiënt is NIET

toegestaan.

GEVOLMACHTIGD VERTEGENWOORDIGER:

Manager, Productveiligheid; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, Duitsland.

Norsk

Denne enheten betegnes ikke som medisinsk utstyr i henhold til EN 60 601-1, og må derfor

ikke settes inn i pasientmiljø som definert i EN 60 601-1-1. Følgende krav må overholdes:

1. Avstand fra enheten til utstyr i kontakt med pasient (se illustrasjon). Horisontalt = 1,83

meter, vertikalt = 2,5 meter over gulvet under pasienten.

2. Personalet må ikke ha samtidig kontakt med pasient og enheten.

3. INGEN direkte elektrisk forbindelse mellom enheten og utstyr i kontakt med pasient er

tillatt.

AUTORISERT FORHANDLER:

Leder, produktsikkerhet; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, TYSKLAND.

Português

De dispositivo acordo com o determinado em EN 60 601-1, este processador não é consid-

erado equipamento médico e como tal não tem que obedecer às normas definidas em EN

60 601-1-1. Têm que ser cumpridos os seguintes requisitos:

1. Distância do dispositivo ao equipamento de contacto com o paciente (ver ilustração).

Horizontal = 1,83 metros; Vertical = 2,5 metros acima do chão debaixo do paciente.

2. Não é permitido o contacto simultâneo entre o assistente, o paciente e o dispositivo.

3. NÃO é permitida a ligação eléctrica directa entre o dispositivo e a equipa de contacto

com o paciente.

AGENTE AUTORIZADO:

Gerente, Segurança do Produto; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,

ALEMANHA.

Suomeksi

Tämä laite ei ole sairaanhoitolaitteistoon kuuluva laite siten kuin standardissa EN 60 601-1

asia määritellään ja siksi sitä ei tule viedä standardin EN 60 601-1-1 mukaiseen potilas-

ympäristöön. Seuraavat vaatimukset on täytettävä:

1. Etäisyys laitteesta potilaan kanssa kosketuksessa olevaan laitteistoon (ks. piirros).

Vaakatasossa = 1,83 metriä; pystytasossa = 2,5 metriä potilaan alla olevan lattian

yläpuolella.

2. Hoitohenkilö ei saa koskettaa potilasta samanaikaisesti kun hän koskettaa laitetta.

3. Laite EI saa olla suorassa sähköisessä kosketuksessa potilaan kanssa kosketuksessa

olevaan laitteistoon.

VALTUUTETTU EDUSTAJA:

Johtaja, Product Safety; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, SAKSA.

Svenska

Denna enheten utgör ej medicinsk utrustning enligt EN 60 601-1 och får därför ej införas i

patientnära miljö såsom denna definieras i EN 60 601-1-1. Följande krav måste vara upp-

fyllda:

1. Avstånd från enheten till utrustning med patientkontakt (se figuren). Horisontellt = 1,83

m; vertikalt = 2,5 m ovanför golvet under patienten.

2. Vårdgivande person får ej samtidigt vidröra patienten och enheten.

3. INGEN direkt elektrisk förbindelse mellan framkallare och utrustning med patientkon-

takt får enheten.

AUKTORISERAT OMBUD:

Manager, Product Safety; Kodak AG; Hedelfingerstr. 54-56; D-70327 Stuttgart, TYSKLAND.

Pub. No. 5E2234 Health Imaging

Printed in USA, June 2000 Rochester, New York 14653

1-1

Safety

••••••••

In this chapter

 Responsibility of the Manufacturer ....................... 1-2

 General Information.............................................. 1-3

1

1-2 5E2234 June 2000

Safety

Responsibility of the Manufacturer

IMPORTANT: To meet Electromagnetic Compatibility

requirements at a frequency of 50 Hz, the 160 Laser

Imager and the Medical Image Manager 200 were con-

nected to the Power Kit/for KODAK PACS Link Medical

Image Managers, Catalog No. 198 4160. Please refer to

“Safety Standards and Regulatory Approvals” in the Site

Specifications for the KODAK EKTASCAN 160 Laser

Imager, Publication No. 5E2235.

The manufacturer is responsible for the effects on safety,

reliability, and performance of the 160 Laser Imager when

the following conditions are followed:

 Assembly operations, extensions, readjustments,

modifications or repairs are carried out by persons

authorized by the manufacturer.

 The electrical installation of the site complies with the

site specification requirements.

 Operation of the 160 Laser Imager complies with the

instructions for use in the User Guide.

NOTE: Please refer to the Site Specifications for

the KODAK EKTASCAN 160 Laser Imager,

Publication No. 5E2235, for site preparation

information.

5E2234 June 2000 1-3

Safety

General Information

DANGER: Read and understand all instruc-

tions before using the KODAK EKTASCAN

160 Laser Imager.

 Do not use the Laser Imager for direct patient contact.

 Do not use the Laser Imager within a 6 ft. radius of an

immobilized patient.

 Do not use the Laser Imager in an explosive environ-

ment.

 Use of controls or adjustments or performance of pro-

cedures other than those specified herein may result

in hazardous radiation exposure.

CAUTION: This device is intended for use

only by professional, trained personnel.

1-4 5E2234 June 2000

Safety

WARNING: Danger, avoid laser beam. This

equipment uses an invisible infrared laser.

Laser Radiation can be present when the

machine is operated with the panels off and the inter-

locks defeated. Avoid direct exposure to the laser

beam.

H178_0141HC

promienia lasera.

sie na bezposrednie dzialanie

zabezpieczen. Unikac wystawiania

laserowe po otwarciu i pokonaniu

Uwaga: Niewidzialne promieniowanie

Radiacion laser cuando

exposicion directa al haz.

estan desactivados. Evite la

esta abierto y los enclavamientos

Peligro:

Rayonnement laser

directe au faisceau.

desactives. Eviter toute exposition

verrouillages de securite sont

lorsque l’appereil est ouvert et les

Attention:

Laser radiation when open

Laserstrahlung bei

Laserstrahl aus.

Sie sich nicht direkt dem

Sicherheitsvorrichtungen. Setzen

a b g e s h a l t e t e n

geoffnetem Gerat und

Achtung:

direct exposure to beam.

and interlocks defeated. Avoid

Danger:

BACK VIEW

INVISIBLE LASER DANGER LABEL

H178_0141HCA

5E2234 June 2000 1-5

Safety

CAUTION

 Remove the wall plug before servicing equipment.

This equipment is operated with hazardous voltage

that can shock, burn, or cause death.

 Do not pull the cord from the outlet. Grasp the plug

and pull to disconnect.

 Do not operate equipment with a damaged power

cord. Position the power cord so that it will not be

tripped over or accidentally pulled.

 Do not use extension cords to power the Laser

Imager. Connect the equipment to grounded outlets.

Refer to the Site Specifications for the KODAK

EKTASCAN 160 Laser Imager, Publication No.

5E2235 for additional details.

 This equipment generates, uses, and can radiate

radio frequency energy. If not installed and used in

accordance with the instruction manual, it may cause

interference with radio communications.

 This equipment has been tested and found to be

exempt from the limits for a Class A computing device

pursuant to Part 15, Subpart J of FCC Rules. This is

designed to provide reasonable protection against

such interference when operated in a commercial

environment.

 Operation of this equipment in a residential

environment is likely to cause interference, in which

case the user, at the user’s own expense, will be

required to take whatever measures may be required

to correct the interference.

1-6 5E2234 June 2000

Safety

This device complies with the RFI requirements of

EN55011, Class A.

H178_0063DCA

DATA PLATE LABEL

EMC LABEL

H178_0063DC

This device complies with Part 15 of the FCC rules.

Operation is subject to the following two conditions:

(1) This device may not cause harmful interference,

and (2) this device must accept any interference

received, including interference that may cause

undesired operation.

ICES-003.

This Class A digital apparatus complies with Canadian

à la norme NMB-003 du Canada.

Cet appareil numérique de la classe A est conforme

5E2234 June 2000 1-7

Safety

IMPORTANT: The KODAK EKTASCAN 160

Laser Imager is a Class 1 device. To protect the

user against electrical shock, this device com-

plies with the ground requirements as specified in the

KODAK EKSTASCAN Site Specifications for the 160

Laser Imager, Publication No. 5E2235.

Niebezpieczne napiecie.

Moze spowodowac powazne obrazenia albo

nawet smierc. Przed wykonywaniem napraw

nalezy odlaczyc zasilanie.

hacer funcionar la maquina.

Voltaje peligroso.

Puede producir lesiones graves o la muerte.

Desconecte el suministro de corriente antes de

de reparation sur la machine.

proceder a toute operation de maintenance ou

Tension dangereuse.

Peut provoquer des blessures graves ou la mort.

Debrancher le cordon d’alimentation avant de

Verletzungsund Lebensgefahr. Schalten Sie die

Stromversorgung ab, bevor Sie das Gerat warten.

Hochspannung.

Hazardous Voltage.

power supply before servicing machine.

Can cause severe injury or death. Disconnect

H178_0064HC

SEGUN NORMATIVA 825 DE LA C.E.I.-1

LASER DE CLASSE-1

ACCORDING TO IEC 825-1

CLASS 1 LASER PRODUCT

ENTSPRECHEND IEC 825-1

KLASSE 1 LASER PRODUKT

APPAREIL A RAYONNEMENT

‘‘PRODCUTO LASER TIPO UNO’’

PRODUCKT LASEROWY KLASY 1

ZGODNIE IEC 825-1

H178_0064HCA

HAZARDOUS VOLTAGE LABEL

CLASS 1 LABEL

1-8 5E2234 June 2000

Safety

2-1

Overview

••••••••

In this chapter

 Product Description .............................................. 2-2

 System Configuration ........................................... 2-3

 Single Input .................................................... 2-3

 Multiple Input and Network............................. 2-4

 Using the Control Panel........................................ 2-5

 Features......................................................... 2-8

 Screen Types............................................... 2-10

 Main Display Screen............................................2-11

 Using the “Setup Menu” and “Configure Display”2-14

2

2-2 5E2234 June 2000

Overview

Product Description

160 Laser Imager

The KODAK EKTASCAN 160 Laser Imager (Laser Imager) is a

high quality digital laser imager intended for diagnostic hardcopy

applications. The Laser Imager can be used as a stand-alone

unit (as illustrated above) or with direct docking to a KODAK X-

OMAT 2000 Processor. The Laser Imager uses EIR-23 (blue-

base) IR film in roomlight loadable 35 x 43 cm (14 x 17 in.) car-

tridges. The digital image data for the Laser Imager are provided

by a dedicated network connection to the KODAK PACS Link

Medical Image Manager (MIM).

IMPORTANT: See the User Guide for the

KODAK PACS Link Medical Image Manager 200

Publication No. 5E9764 for more information.

H178_0008GC

H178_0008GCA

ront Door Latch

Control Panel

5E2234 June 2000 2-3

Overview

System Configuration

There are many different system configurations for the

160 Laser Imager. Two examples of system configura-

tions are shown.

Single Input

The diagram above illustrates the stand-alone Laser

Imager in a Single Input configuration. In the Single Input

configuration only one Imaging Device is connected to the

KODAK PACS Link Medical Image Manager (MIM). Using

either an internal digital or video interface the MIM

acquires medical images from the Imaging Device.

The MIM formats the input signal (digitizes the video

input, for example) and transfers the data over a

100BaseT Ethernet Network. The operator sends printing

commands to the Laser Imager from the MIM keypad, or

if autofilming is supported, from the Imaging Device.

121BC

MIM

Device

Imaging

Imager

160 Laser

Ethernet

100BaseT

Modem Line (optional)

2-4 5E2234 June 2000

Overview

Multiple Input and Network

The diagram above illustrates the Laser Imager docked to

the KODAK X-OMAT 2000 Processor in a Multiple Input

configuration and in a DICOM (Digital Imaging and Com-

munications in Medicine) Network. The MIM can acquire

DICOM medical images directly from the Imaging Device

over the network or directly connected through a medical

Imaging Device.

In the Multiple Input configuration, up to 2 Imaging

Devices and a DICOM Network can be connected to a sin-

gle MIM. Using an internal video or digital interface, the

MIM formats the input signal (digitizes the video input sig-

nal, for example) and transfers the data over a dedicated

100BaseT Ethernet network.

Remote service access may be provided through a

modem in any MIM on the network.

Modem Line (optional)

100baseT

Ethernet

Imaging

Device

2000

Processor

160 Laser

Imager

Device

Imaging

Device

DICOM

Network

Device

Imaging

Device

Imaging

TCP/IP

MIM

H178_0016HC

MIM

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Kodak EKTASCAN 160 User manual

Kodak EKTASCAN 160 User manual

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