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 COMP ANY
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
© Eastman Kodak Company, 2000
Printed in U SA
HEAL TH IMAGING
EASTMAN KODAK COMPANY
Rochester, NY 14650
Medical Device Directive (MDD)
m
m
1,83
2,5m
1,83m
1,83
English
This device is not medica l equipment a ccording to EN 6 0 601-1 and mus t therefore not e nter
the Patient Environment as defined in EN 60 601-1-1. The following requirements have to
be met:
1. Distance from devi ce to Pat ien t Cont act Equi pment (see il lustrat ion). H orizon tal = 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.
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 p atientlejet (se tegningen). V and ret = 1,83 meter; Lo dret = 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 festgelegt 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; Vertikal = 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 elektrisc he Verbindung zwischen Gerät und Pati ent Cont act Equi pment
zulässig.
AUTORISIERTE VERTRETUNG:
Manager, Produktsicherheit; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,
DEUTSCHLAND.
Español
Este dispositi vo no constituye un equipo médi co 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 permitirs e la conex ión eléc trica direc ta entre e l disposi tivo y el e quipo de co n-
tacto con el paciente.
AGENTE AUTORIZADO:
Gerente, Seguridad de producto; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,
ALEMANIA.
Français
Ce dispositif n' est p as assimil é à un équip ement méd ical comm e défini p ar l'EN 60 6 01-1 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 ent re le dispositif et l'é qui pem en t en con t ac t av ec le p a tie nt (v oir i llu stration):
horizontalement = 1,83 mètres ; verticalement = 2,5 mètres au-dessus du sol sous le
patient.
2. Interdiction stric te au soigna nt d'être simult anémen t en cont act avec le patient et le di s-
positif.
3. INTERDICTION d' établi r une conn exion éle ctrique di recte entre le dispo sitif et l' équipe-
ment en contact avec le patient.
AUTORISATION:
Directeur, Contrôle sécurité; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart,
ALLEMAGNE.
Italiano
Questo disposi tivo non è un 'appa recchiat ura medica le ai sens i di EN 60 601 -1 e quindi n on
deve essere posta in prossimità del paziente, come definito in EN 60 601-1-1. Devono
essere soddisfati i requisiti elencati nel segui to:
1. Distanza tra il dispositivo e le attrezzature a contatto del paziente (vedere la figura).
Orizzonta le = 1,83 metri; V erticale = 2 ,5 metri sopra i l livello del pavimen to del pazi ente.
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 app araat i s geen medisc he app ara tuu r volge ns EN 60 601-1 en ma g d aarom nie t bi nnen 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 apparaa t en behandelinstallatie patiënt is NIET
toegestaan.
GEVOLMACHTIGD VERTEGENWOORDIGER:
Manager, Productveiligheid; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, Duitsland.
Norsk
Denne enheten betegnes i kke som medi sinsk ut styr i henhold ti l EN 60 601-1, og m å 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 e lek tris k forbindelse mellom enheten og ut sty r i k ontakt med pasient er
tillatt.
AUTORISERT FORHANDLER:
Leder, produktsikkerhet; Kodak AG; Hedelfingerstr. 54-56; 70327 Stuttgart, TYSKLAND.
Português
De dispositiv o aco rdo com o dete rmina do em EN 6 0 601-1 , este proce ssad or não é con siderado 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 e i ole sairaan hoi tol aitt eis too n kuuluva laite siten kuin st andardissa EN 60 601-1
asia määritellään ja siksi sitä ei tule viedä standardin EN 60 601-1-1 mukaiseen potilasympäristöön. 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 s uorassa s ähköises sä kosk etukses sa potilaa n kanssa kosketuk sessa
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 uppfyllda:
1. Avstånd från enhete n till u trustni ng med pat ientko nta kt (se fi guren). Ho risont ellt = 1,8 3
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 S tuttgart , TYSKLAND.
Pub. No. 5E2234 Health Imaging
© Eastman Kodak Company, 2 000 EASTMAN KODAK COMPANY
Printed in USA, June 2000 Rochester, New York 14653
1
Safety
••••••••
In this chapter
Responsibility of the Manufacturer ....................... 1-2
General Information.............................................. 1-3
1-1
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 connected 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 manuf actur er is re sponsi ble 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 specifica tio n requ ir em ents.
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.
1-2 5E2234 June 2000
General Information
DANGER: Read and understand all instructions 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.
Safety
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.
5E2234 June 2000 1-3
Safety
BACK VIEW
H178_0141HCA
H178_0141HC
Laser radiation when open
Danger:
and interlocks defeated. Avoid
direct exposure to beam.
Laserstrahlung bei
Achtung:
geoffnetem Gerat und
a b g e s h a l t e t e n
Sicherheitsvorrichtungen. Setzen
Sie sich nicht direkt dem
Laserstrahl aus.
Attention:
lorsque l’appereil est ouvert et les
verrouillages de securite sont
desactives. Eviter toute exposition
directe au faisceau.
Peligro:
esta abierto y los enclavamientos
estan desactivados. Evite la
exposicion directa al haz.
Rayonnement laser
Radiacion laser cuando
Uwaga: Niewidzialne promieniowanie
laserowe po otwarciu i pokonaniu
zabezpieczen. Unikac wystawiania
sie na bezposrednie dzialanie
promienia lasera.
INVISIBLE LASER DANGER LABEL
1-4 5E2234 June 2000
W ARNING: 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 interlocks defeated. Avoid direct exposure to the laser
beam.
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.
5E2234 June 2000 1-5
Safety
This device complies with the RFI requirements of
EN55011, Class A.
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.
This Class A digital apparatus complies with Canadian
ICES-003.
Cet appareil numérique de la classe A est conforme
à la norme NMB-003 du Canada.
H178_0063DCA
H178_0063DC
DATA PLATE LABEL
EMC LABEL
1-6 5E2234 June 2000
Hazardous Voltage.
Can cause severe injury or death. Disconnect
power supply before servicing machine.
Hochspannung.
Verletzungsund Lebensgefahr. Schalten Sie die
Stromversorgung ab, bevor Sie das Gerat warten.
Tension dangereuse.
Peut provoquer des blessures graves ou la mort.
Debrancher le cordon d’alimentation avant de
proceder a toute operation de maintenance ou
de reparation sur la machine.
Voltaje peligroso.
Puede producir lesiones graves o la muerte.
Desconecte el suministro de corriente antes de
hacer funcionar la maquina.
Niebezpieczne napiecie.
Moze spowodowac powazne obrazenia albo
nawet smierc. Przed wykonywaniem napraw
nalezy odlaczyc zasilanie.
Safety
CLASS 1 LASER PRODUCT
ACCORDING TO IEC 825-1
KLASSE 1 LASER PRODUKT
ENTSPRECHEND IEC 825-1
APPAREIL A RAYONNEMENT
LASER DE CLASSE-1
‘‘PRODCUTO LASER TIPO UNO’’
SEGUN NORMATIVA 825 DE LA C.E.I.-1
CLASS 1 LABEL
PRODUCKT LASEROWY KLASY 1
ZGODNIE IEC 825-1
HAZARDOUS VOLTAGE LABEL
IMPORTANT: The KODAK EKTASCAN 160
Laser Imager is a Class 1 device. To protect the
user against electrical shock, this device complies with the ground requirements as specified in the
KODAK EKSTASCAN Site Specifications for the 160
Laser Imager, Publication No. 5E2235.
H178_0064HCA
H178_0064HC
5E2234 June 2000 1-7
Safety
1-8 5E2234 June 2000
2
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
2-1
Overview
Product Description
160 Laser Imager
Control Panel
ront Door Latch
H178_0008GCA
H178_0008GC
The KODAK EKTASCAN 160 Laser Imager (Laser Imager) is a
high quality di gital laser image r intended for diagnost ic hardcopy
applications. The Laser Imager can be used as a stand-alone
unit (as illustrated above) or with direct docking to a KODAK XOMAT 2000 Processor. The Laser Ima ger use s EIR- 23 (blu ebase) IR film in roomlight loadable 35 x 43 cm (14 x 17 in.) cartridges. The dig ital image d ata for the Las er Imager are prov ided
by a dedicated network connection to the KODAK PACS Link
Medical Image Manager (MIM).
IMPORTANT: See the User Guide for the
KODAK P ACS Link Medical Image Manager 200
Publication No. 5E9764 for more information.
2-2 5E2234 June 2000
System Configuration
There are many different system configurations for the
160 Laser Imager. Two examples of system configurations are shown.
Single Input
160 Laser
Imager
MIM
Overview
Imaging
Device
121BC
100BaseT
Ethernet
Modem Line (optional)
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.
5E2234 June 2000 2-3
Overview
Multiple Input and Network
Imaging
Device
Imaging
Device
MIM
TCP/IP
Imaging
Device
DICOM
Network
H178_0016HC
2000
Processor
160 Laser
Imager
MIM
100baseT
Ethernet
Modem Line (optional)
Imaging
Device
Imaging
Device
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 Communications 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.
2-4 5E2234 June 2000
In the Multiple Input configuration, up to 2 Imaging
Devices and a DICOM Network can be connected to a single MIM. Using an internal video or digital interface, the
MIM formats the input signal (digitizes the video input signal, 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.
Using the Contro l Panel
The Control Panel allows the user to enter commands and
view the status of the Laser Imager.
Overview
160 Laser Imager
H178_0127BCA
H178_0127BC
Control Panel
x
Main Display
Screen
F2F1 F3 F4
MENU
5E2234 June 2000 2-5
Overview
Indicator Functions
ACCESS FILM SUPPLY
FILM
F2F1 F3 F4
ACCESS RECEIVE
ERROR
x
H178_0017GCA
H178_0017GC
MENU
2-6 5E2234 June 2000
Overview
Access
Receive
Access
Film Supply
The LED is on steady when the Receive
Magazine is safe to access. The illumination of the Access Receive Indicator does
not ensure safe access of the Film Supply Cartridge. See the Access Supply
Indicator. WARNING: DO NOT OPEN
THE TOP COVER UNTIL THE ACCESS
RECEIVE INDICAT OR IS ILLUMINATED.
FOGGED FILM WILL RESULT.
The LED is on steady to indicate to the
operator when the Laser Imager film
path, including the film supply cartridge
and the receive magazine, may be safely
accessed. WARNING: DO NOT OPEN
THE FILM SUPPLY UNTIL THE
ACCESS FILM SUPPLY INDICATOR IS
ILLUMINATED. FOGGED FILM WILL
RESULT.
Film When illuminated, indicates to the opera-
tor that the Laser Imager is out of film or
the receive magazine is full.
Error Illuminates whenever a Laser Imager
error occurs. The Error Indicator is turned
off either after the operator has cleared
the error from the Error Recover Screen
or when the Laser Imager software
senses that the Laser Imager has been
accessed.
5E2234 June 2000 2-7
Overview
Features
The Control Panel consists of an LCD display, four F1
through F4 Buttons, Menu Button,
▲ and ▼ Buttons and
four LED functions.
LEDs
Menu
H178_0125ACA
H178_0125AC
The Button LEDs indicate whether the Button is enabled
(illuminated) or disabled (not illuminated).
Menu
2-8 5E2234 June 2000
H178_0126AC
The Menu Button allows you to select a menu option or
complete an operation.
Overview
Each time you press the Menu Button, with the cursor on
an Exit Menu row, the previous screen appears.
H178_0124AC
The Up and Down Arrow Buttons allow you to scroll
through items on the screen. Press the up “
scroll up, press the down “
Press the up “
▲” Button to increment, press the down“▼”
Button to decrement
H178_0132AC
.
▼” Button to scroll down.
F4F3F1 F2
▲” Button to
5E2234 June 2000 2-9
The F1 - F4 Buttons allow you to move directly to the
main display screen by pressing any function button that
is not programmed.
Overview
Screen Types
To move directly to a screen of your choice you have to
program a function button to display to that screen:
Navigate to the screen.
Press and hold the function button for two seconds.
When you hear one beep, the button is programmed.
When you press the function key, the screen displays.
Initialization
Actuations
H178_9001HC
View
Setup Menu
Changing
Decimal Point
Convention
* This screen will appear when docked to a 2000 Processor.
*
Destination
Adjusting
Screen
Contrast
Film
Main Display
Main Menu
Print Cal
Film
Calibrate
Printer
Calibration
Density
Values
Data Entry
Film Supply
Data
Calibration
Recovery
Access
Compute
Error
Access
Receive
2-10 5E2234 June 2000
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