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, orinserting atrademarksymbolwith 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
© Eastman Kodak Company, 2000
Printed in USA
HEALTH IMAGING
EASTMAN KODAK COMPANY
Rochester, NY 14650

Medical Device Directive (MDD)
English
Thisdevice is notmedical equipment according toEN 60 601-1and must thereforenot 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 tilpatientlejet (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
EstedispositivonoconstituyeunequipomédicosegúnelestándarEN60601-1,porlotanto
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 yel 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 définipar 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 connexionélectrique 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 metrisopra il livello delpavimento 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. LaiteEI 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
© Eastman Kodak Company, 2000 EASTMAN KODAK COMPANY
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: PleaserefertotheSiteSpecificationsfor
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
àla 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
highqualitydigitallaserimagerintendedfordiagnostichardcopy
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. Thedigital image data fortheLaser 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 onlyone ImagingDeviceis connectedto 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
Imaging
Device
DICOM
Network
Device
Imaging
Device
Imaging
TCP/IP
MIM
H178_0016HC
MIM