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Owner, S Manual: Pentax Video Processor

This document is an owner's manual for a Pentax Video Processor EPK-1000 intended for endoscopic diagnosis and treatment. It provides instructions on safety precautions, device components and functions, preparation including setup and connection of equipment, operation of processor functions and keyboard, and maintenance procedures. The manual is intended to ensure safe and proper use of the device and should be read thoroughly before use.

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Polo Razteca
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0% found this document useful (0 votes)
127 views20 pages

Owner, S Manual: Pentax Video Processor

This document is an owner's manual for a Pentax Video Processor EPK-1000 intended for endoscopic diagnosis and treatment. It provides instructions on safety precautions, device components and functions, preparation including setup and connection of equipment, operation of processor functions and keyboard, and maintenance procedures. The manual is intended to ensure safe and proper use of the device and should be read thoroughly before use.

Uploaded by

Polo Razteca
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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,

OWNER S MANUAL

PENTAX VIDEO PROCESSOR

EPK-1000

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INTENDED USE:
This electro-medical device (Video Processor) is intended to be used for endoscopic diagnosis and treatment.
Together, this Video Processor and PENTAX video endoscope may provide optical visualization of, and/or therapeutic
access to, various body cavities, organs and canals. Do NOT use this device for any purpose other than that for which it
has been designed.
This device should only be used by physicians who have thoroughly studied all the characteristics of this device and who
are familiar with the proper techniques of endoscopy.

IMPORTANT

Read this manual before operating and save this book for future reference.
This manual describes the recommended procedures for inspecting and preparing the EPK-1000 Video Processor
prior to its use and the care and maintenance after its use. It does not describe how an actual procedure is to be performed,
nor does it attempt to teach the beginner the proper technique or any medical aspects regarding the use of the equipment.
Failure to follow the instructions in this manual may result in damage to and/or malfunction of the equipment.
Do NOT use this device for any other purpose than that for which it has been designed.
If you have any questions regarding any of the information in this manual or concerns pertaining to the safety and/or use
of this equipment, please contact your local PENTAX representative.

CAUTION:
Federal (USA) law restricts this device to sale by, or on the order of a physician or other appropriately licensed medical
professional.

このCEマーキングはEC指令への適合宣言マークです。
The CE marking assures that this product complies with the requirements of the EC directive for safety.
Das CE Zeichen garantiert, daß dieses Produkt die in der EU erforderlichen Sicherheitsbestimmungen
erfüllt.
Le logo CE certifie que ce produit est conforme aux normes de sécurité prévues par la Communauté
Européenne.
II marchio CE assicura che questo prodotto è conforme alle direttive CE relative alla sicurezza.
La marca CE asegura que este producto cumple todas las directivas de seguridad de la CE.

Symbol for “MANUFACTURER”

Symbol for “DATE OF MANUFACTURE”

Symbol for “AUTHORISED


EC REP
REPRESENTATIVE”

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CONTENTS
1 SAFETY PRECAUTIONS ...............................................................................................................................................................................1
2 NOMENCLATURE, CONTROLS AND FUNCTIONS .................................................................................................................................7
2-1 VIDEO PROCESSOR .........................................................................................................................................................................7
(1) MAIN BODY ............................................................................................................................................................................7
(2) FRONT PANEL ........................................................................................................................................................................8
(3) REAR PANEL ...........................................................................................................................................................................9
2-2 WATER BOTTLE ASSEMBLY, MODEL OS-H4 ..........................................................................................................................10
2-3 MONITOR DISPLAY SCREEN ......................................................................................................................................................11
(1) NORMAL ................................................................................................................................................................................11
(2) FREEZE (SUB-SCREEN DISPLAY) .....................................................................................................................................11
3 PREPARATION AND SAFETY CHECK .....................................................................................................................................................12
3-1 PREPARATION ................................................................................................................................................................................12
(1) SETTING UP THE VIDEO PROCESSOR ............................................................................................................................12
(2) CONNECTING THE WATER BOTTLE ...............................................................................................................................12
(3) CONNECTING THE ENDOSCOPE ......................................................................................................................................13
(4) CONNECTING THE PERIPHERAL EQUIPMENT .............................................................................................................13
3-2 PRE-USE SAFETY CHECKLIST ....................................................................................................................................................14
4 OPERATION ..................................................................................................................................................................................................16
4-1 PROCESSOR FUNCTIONS .............................................................................................................................................................16
(1) MAIN LAMP...........................................................................................................................................................................16
(2) AUXILIARY LAMP ...............................................................................................................................................................16
(3) BRIGHTNESS .........................................................................................................................................................................17
(4) COLOR BALANCE ................................................................................................................................................................17
(5) PUMP ......................................................................................................................................................................................18
4-2 KEYBOARD FUNCTIONS ..............................................................................................................................................................19
(1) CONVENTIONAL KEYS ......................................................................................................................................................19
(2) SPECIAL FUNCTION KEYS ................................................................................................................................................20
5 MAINTENANCE ...........................................................................................................................................................................................29
5-1 AFTER EACH PROCEDURE ..........................................................................................................................................................29
5-2 WATER BOTTLE CLEANING .......................................................................................................................................................29
(1) CLEANING .............................................................................................................................................................................29
(2) STERILIZATION....................................................................................................................................................................30
(3) CARE DURING STORAGE ...................................................................................................................................................31
5-3 STORAGE .........................................................................................................................................................................................31
5-4 CHANGING THE LAMP .................................................................................................................................................................31
5-5 RESETING THE BREAKERS .........................................................................................................................................................32
6 TROUBLE-SHOOTING GUIDE ...................................................................................................................................................................33
7 SPECIFICATIONS .........................................................................................................................................................................................35
8 ELECTROMAGNETIC COMPATIBILITY .................................................................................................................................................36

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1. SAFETY PRECAUTIONS- IMPORTANT
The following precautions should always be exercised with the use of all electro-medical equipment to ensure safety to all
involved parties - user(s), patient(s), etc.

Please carefully read and follow this owner’s manual.

1-1. TRAINING
This equipment should only be used under the supervision of a trained physician in a medical facility. Do NOT use in other
locations or for any other purposes than the intended application.

1-2. INSTALLATION
1. This equipment should NEVER be installed or used in areas where the unit could get wet or be exposed to any environmental
conditions such as high temperature, humidity, direct sunlight, dust, salt, etc., which could adversely affect the equipment.
2. This equipment should NEVER be installed or used in the presence of flammable or explosive gases or chemicals.
3. This equipment should NEVER be installed, used or transported in an inclined position nor should it be subjected to impact
or vibration.
4. For safety reasons, this equipment must be properly grounded. (This equipment should be connected to a three (3) prong
hospital grade receptacle in U.S.A. or Canada.)
5. Ensure that all power requirements are met and conform to those specified on the rating plate located on the rear panel.
6. Do NOT block the air intake vent of this equipment.
7. Do NOT allow the power cord to become twisted, crushed or pulled taut.
8. When using an isolation transformer for any ancillary equipment, ensure that the power requirements of the devices do not
exceed the capacity of the isolation transformer. For further information, contact your local PENTAX distributor.

1-3. PRIOR TO USE


1. Confirm that this equipment functions properly and check the operation of all switches, indicators, etc.
2. To prevent electrical shock when used with endoscopes, this equipment is insulated (type BF electro-medical equipment).
Do NOT allow it to be grounded to other electrical devices being used on the patient. Rubber gloves should always be worn
to prevent grounding through user(s).
3. Confirm that other devices used in conjunction with this equipment function properly and that these other devices will not
adversely affect the operation or safety of this equipment. If any component of the endoscopic system is not properly
functioning, the procedure should not be performed.
4. Check and confirm that all cords or cables are connected correctly and securely.
5. The lamp life when used in this equipment is 400 hours. Prior to use, check the lamp life indicator on the front panel to
ensure the indicator is lit green or yellow. After 400 hours of use, the indicator turns red and the image quality will
deteriorate. Excessive use of the lamp beyond its rated 400 hours (approaching a thousand hours of use or more ) could cause
the lamp to explode resulting in damage to the video processor.
NOTE - The lamp life rated at 400 hours, is applicable to the EPK-1000 processor with serial number beginning with UB and
EB.

1-4. DURING USE


1. To prevent electric shock, the endoscope and/or any other ancillary device should NEVER be applied directly to the heart.
2. Make sure that no contact is made between the patient and this equipment.
3. To avoid damage to the luminous display and flat membrane switches, do NOT press any keys with any sharp or pointed
objects.
4. The light emitted by the Xenon lamp is extremely intense. Avoid looking directly at the light exiting the endoscope and/or
this equipment.

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5.To protect the users eyes and avoid risk of thermal injury during an endoscopic examination, use only the minimum amount
of brightness required.
6. During clinical procedures, avoid unnecessary prolonged use which could compromise patient/user safety.
7. Continually monitor this equipment and the patient for any signs of irregularities.
8. In the event that some type of irregularity is noted to the patient or this equipment, take the appropriate action to ensure
patient safety.
9. If the operation of any of the components of the endoscopic system fails during the procedure and the visualization of the
procedure is lost or compromised, place the endoscope in the neutral position and slowly withdraw the endoscope.
10. This equipment should only be used according to the instruction and operating conditions described in this manual. Failure
to do so could result in compromised safety, equipment malfunction or instrument damage.

1-5. AFTER USE


1. Refer to the operating instructions supplied with all the components of the endoscopic system to establish the right order in
which components should be turned OFF. Some peripheral devices may have to be turned OFF first to avoid compromising
their operation.
2. Wipe all surfaces clean with gauze slightly dampened with alcohol.
3. Be sure connector interfaces and ventilation ports are not allowed to become wet or splashed with liquids.

1-6. STORAGE
1. This equipment should NEVER be stored in areas where the unit could get wet or be exposed to any environmental
conditions such as high temperature, humidity, direct sunlight, dust, salt, etc., which could adversely affect the equipment.
2. This equipment should NEVER be stored in the presence of flammable or explosive gases or chemicals.
3. This equipment should NEVER be stored or transported in an inclined position, nor should it be subjected to impact or
vibration.
4. Cords, accessories, etc., should be cleaned and neatly stored.
5. This equipment should be maintained in a clean condition during storage and be ready for subsequent use.

1-7. SERVICE
1. Alterations/modifications to the equipment should NEVER be made. Repairs should only be performed by an authorized
PENTAX service facility.
2. When replacing the lamp, use only the lamp recommended by PENTAX and follow all PENTAX instructions provided.

1-8. MAINTENANCE
Periodically this equipment and any applicable accessories should be inspected for operation and safety.

1-9. DISPOSAL
The equipment should be returned for disposal to PENTAX. Contact your local PENTAX representative or service facility.
An information on Disposal for users in the European Union
This product is a medical device. In accordance with European Directive 2002/96/EC on Waste Electrical and Electronic
Equipment, this symbol indicates that the product must not be disposed off as unsorted waste, but should be collected
separately. Contact your local PENTAX distributor for correct disposal and recycling.
By disposing of this product correctly you will help ensure that the waste undergoes the necessary treatment, recovery
and recycling and thus prevent potential negative effects on the environment and human health which could otherwise
arise due to inappropriate waste handling.

1-10. FOR THE STATE OF CALIFORNIA, USA ONLY


Perchlorate Material-special handling may apply. See www.dtsc.ca.gov/hazardouswaste/perchlorate.
Perchlorate Material: Lithium battery contains perchlorate.

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POWER REQUIREMENTS
Check the standard power plug configurations that are used in your country. If the appropriate power cord is not included in your
product, notify your local PENTAX distributor.

Continental Europe U.K. Australia U.S.A. and


(Use a SEV approved and Canada
plug for Switzerland) New Zealand (Hospital Grade)
SYMBOLS ON MARKING

Alternating current

Type BF applied part (Safety degree specified by IEC 60601-1)

OFF (Power : disconnection from mains)

ON (Power : connection to the mains)

Attention, consult Owner’s Manual

Dangerous Voltage

Protective earth (ground)

Equipotentiality

CONVENTIONS
The following conventions have been established in the text of this manual to aid in the identification of potential hazards of
operation;

WARNING : Could result in death or serious injury.

CAUTION : May result in minor or moderate injury or property-damage.


NOTE : May result in property-damage. Also, advises owner/operator about important information on the use of
this equipment.

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1. PRECAUTIONS DE SECURITE-IMPORTANT
Les précautions suivantes doivent toujours être obeervées lors de l’utilisation de tout matériel médical électrique susceptible
d’être utilisé avec cet appareil, pour assurer à toutes les personnes concernées (utilisateus, patients, etc...) une sécurité maximale.

Veuillez lire et suivre attentivement les recommandations du manuel d’utilisation.

1-1. FORMATION
L’appareil ne doit être utilisé que sous la surveillance d’un médecin expérimenté, dans un établissement médical. Ne pas utiliser
dans un autre endroit ou pour toute autre application pour laquelle il n’est pas prévu.

1-2. INSTALLATION
1. L’appareil ne doit JAMAIS être placé ou utilisé dans un endroit où il serait mouillé ou exposé à l’humidité, à une température
élevée, à la lumière solaire directe, à la poussière, au sel, etc., qui pourraient l’endommager.
2. L’appareil ne doit JAMAIS être placé ou utilisé en présence de gaz ou de produits chimiques inflammables ou explosifs.
3. L’appareil ne doit JAMAIS être placé, utilisé ou transporté en position inclinée, ni être soumis à des chocs ou des vibrations.
4. Pour des raisons de sécurité, l’appareil doit être correctement relié à la terre (cet appareil doit être branché dans une prise
secteur 3 broches aux normes Hôpital aux U.S.A. et au Canada).
5. Assurez-vous que les spécifications électriques de la prise secteur sont conformes à celles indiquées à l’arrière de l’appareil.
6. Ne pas obturer les orifices de ventilation de l’appareil.
7. Ne pas écraser, plier ou tendre le cordon secteur.
8. Dans le cas ou un transformateur d’isolement est utilisé pour le matériel périphérique, vérifier que la puissance totale de
l’installation ne dépasse pas la capacité du transformateur. Pour de plus amples informations, contacter votre distributeur
PENTAX.

1-3. AVANT UTILISATION


1. Vérifier le fonctionnement de l’appareil et de ses interrupteurs, afficheurs, voyants, etc...
2. Pour prévenir les risques de chocs électriques lorsqu’il est utilisé avec des endoscopes, cet appareil doit être installé comme
“Matériel électrique médical type BF”. Ne pas le relier aux autres appareils électriques utilisés pour le même patient. Les
utilisateurs doivent s’isoler électriquement en portant des gants de caoutchouc.
3. Vérifier le fonctionnement des périphériques utilisés avec l’appareil et s’assurer qu’ils n’en perturbent pas le fonctionnement
et la sécurité. Si l’une des composantes du système endoscopique ne fonctionne pas correctement, interrompre l’utilisation.
4. Vérifier le branchement des différents câbles de liasions (vidéo, secteur, contrôle, etc...).
5. La durée de vie nominale de la lampe est de 400 heures. Avant utilisation, vérifier que le témoin de durée de vie vert ou jaune
est allumé. A partir de 400 heures, le témoin rouge s’allume et la qualité d’image diminue. Une utilisation excessive de la
lampe au-delà de 400 heures (approchant plusieurs milliers d’heures) peut être à l’origine d’une explosion de la lampe
pouvant provoquer des dommages au vidéoprocesseur.
NOTE - La duré de vie de la lampe estimée à 400 heures s’applique aux processeurs EPK-1000 dont le numéro de série
commence par UB et EB.

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1-4. PENDANT L’UTILISATION
1. Pour éviter les risques de choc électrique, l’endoscope et/ou tout autre périphérique utilisé conjointement avec l’appareil ne
doivent JAMAIS être placés directement sur le coeur.
2. Ne pas mettre le patient en contact avec l’appareil.
3. Pour conserver l’afficheur et le clavier souple en bon état, ne pas presser les touches du tableau avec un objet pointu ou
tranchant.
4. Eviter de regarder directement la lumière sortant de l’endoscope et/ou de l’appareil du fait de la forte luminosité émise par la
lampe Xénon.
5. Pour protéger l’utilisateur et éviter toute blessure thermique pendant l’examen, régler la luminosité au minimum nécessaire.
6. Eviter une utilisation prologée de l’appareil si elle n’est pas indispensable, pour ne pas compromettre la sécurité du patient
et de l’utilisateur.
7. Surveiller en permanence l’appareil et le patient pour prévenir tout signe de dysfonctionnement.
8. En cas de problème avec le patient ou l’appareil, prendre toutes les mesures nécessaires pour préserver la sécurité du patient.
9. Si un problème de fonctionnement survient sur l’un des appareils du système endoscopique et que l’image est interrompue
ou altéree, placer l’endoscope en position neutre et retirer doucement.
10. Cet appareil doit toujours être utilisé selon les instructions et conditions de fonctionnement décrites dans ce manuel. Ne pas
les suivre peut compromettre la sécurité, le fonctionnement du matériel, ou endommager l’appareil.

1-5. APRES UTILISATION


1. Veuillez vous référer aux instructions fournies avec chaque composante du système endoscopique afin d’éteindre les
composantes dans l’ordre adéquat. Certains périphériques peuvent devoir être éteints d’abord pour ne pas compromettre leur
fonctionnement.
2. Essuyer les appareils avec une compresse légèrement imbibée d’alcool.
3. Vérifier que les connecteurs et les orifices de ventilation sont à l’abris des projections de liquides.

1-6. STOCKAGE
1. L’appareil ne doit JAMAIS être rangé à l’humidité, à température élevée, à la lumière solaire directe, la poussière, le sel, etc.,
qui pourraient l’endommager.
2. L’appareil ne doit JAMAIS être rangé en présence de gaz ou de produits chimiques explosifs.
3. L’appareil ne doit JAMAIS être rangé en position inclinée ni être soumise à des chocs ou des vibrations.
4. Les accessoires et les câbles doivent être nettoyés et rangés correctement.
5. L’appareil doit être maintenu en parfait état de propreté durant le stockage, et tenu prêt pour l’utilisation suivante.

1-7. SERVICE
1. Ne JAMAIS modifier ou altérer l’appareil. Les réparations éventuelles ne doivent être effectuées que par un service aprés-
vente PENTAX.
2. Le remplacement de la lampe ne doit être effectué que par une lampe agréée par PENTAX et en sulvant les instructions
fournies par PENTAX.

1-8. MAINTENANCE
Périodiquement, cet appareil et tous les périphériques associés doivent être vérifiés en fonctionnement et en sécurité.

1-9. ÉLIMINATION
Ce matériel doit être retourné à PENTAX pour élimination. Contacter PENTAX ou votre Agence PENTAX locale.

Information concernant l’élimination des produits dans l’Union européenne.


Ce produit est un dispositif médical. En conformité avec la Directive européenne 2002/96/CE relative aux déchets d’équipements électriques et
électroniques, ce symbole indique que le produit ne doit pas être éliminé comme un déchet non trié, mais qu’il doit faire l’objet d’une collecte
sélective. Contactez votre distributeur PENTAX local pour avoir des informations concernant la procédure correcte d’élimination et de recyclage.
En éliminant ce produit correctement, vous contribuerez à garantir que ce déchet est soumis au traitement, à la valorisation et au recyclage
nécessaires, empêchant ainsi les effets négatifs potentiels pour l’environnement et la santé des personnes qui résultent de la gestion
inappropriée des déchets.

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ALIMENTATION NECESSAIRE
Vérifier le type de prise de courant utilisé dans votre pays. Si le cordon secteur approprié n’est pas fourni avec votre appareil,
contactez votre distributeur PENTAX.

Europe Continentale Royaume - Uni Australie USA et Canada


et (Normes Hôpital)
(Utiliser une tiche homologuée
SEV pour la Suisse) Nouvelle Zélande

SYMBOLES UTILISES:

Courant alternatif

Élément type BF (Niveau de sécurité spécifié par la norme IEC60 601-1)

“OFF” (Alimentation : déconnectée du secteur)

“ON” (Alimentation : connectée au secteur)

Attention : consulter le manuel d’utilisation

Voltage dangereux

Mise à la terre de protection

Equipotentialité

CONVENTIONS
Les conventions suivantes ont été adoptées dans le texte de ce manuel, afin d’aider á l’identification des risques potentiels liés à
l’utilisation;

WARNING : Peut causer la mort ou une blessure grave

CAUTION : Peut causer une blessure légère à modérée ou des dégâts au materiel

NOTE : Peut causer des désgâts au matériel. Donne aussi à l’utilisateur des informations sur les appareils

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2. NOMENCLATURE, CONTROLS AND FUNCTIONS

2-1 VIDEO PROCESSOR

(1) MAIN BODY

No. NAME FUNCTION


1 Ventilation Grid allows for adequate ventilation and cooling lamp/unit. Do NOT block the grids.
2 Water Bottle Receptacle accepts air pipe from PENTAX water bottle assembly.
3 Lamp Housing Cover provides access to replace lamp cartridge.
4 Light Guide Attachment AE-P1 adapter for standard PENTAX endoscopes. Port accepts video endoscope or
fiberscope light guide. Adapter can be changed for use as light source for other
manufacturer’s endoscopes or for use with fiberscope video adapter module.
5 Endoscope Electrical accepts Color video endoscope electrical connector or fiberscope video adapter module
Connector electrical connector.
CAUTION - Always turn ON the power switch after connecting an endoscope. Also,
remove the endoscope from the processor after turning OFF the power switch.
- When you take the light guide out of this socket, the sleeve of the light guide might be hot.
Take the light guide out of the socket with caution.
6 Scope Locking Lever Open the lever before setting or removing an endoscope.
After connecting the endoscope to the processor, close the lever.
NOTE - After connecting the endoscope to the EPK-1000 video processor, always make
sure that the endoscope is firmly secured to the scope receptacle by turning the locking
lever to the “lock” position.
7 Front Panel See the section 2-1- (2)
8 Power Switch The processor is turned | : ON, or O : OFF.
Switch lights green when switched ON. Switch should not be hit with objects like
endoscope light guides, when being switched ON or OFF.
NOTE - Always turn ON the power switch after connecting an endoscope. Also, remove
the endoscope from the processor after turning OFF the power switch.
- Before turning the EPK-1000 power ON, ensure the air flow vents are not obstructed.
NOTE -Aside from the pre-use inspection of the equipment, the lamp in the video
processor should be turned OFF when the video system is not clinically used.
9 Water Bottle See the section 2-2.

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(2) FRONT PANEL

No. NAME FUNCTION


1 Lamp Switch ignites the main lamp. The LED lights green when switched ON. When the main lamp
fails to ignite, the LED flashes. Press the lamp switch again to ignite the auxiliary lamp.
NOTE -Aside from the pre-use inspection of the equipment, the lamp in the video
processor should be turned OFF when the video system is not clinically used.
NOTE -The auxiliary lamp is incorporated to the processor with serial number beginning
UB and EB.
2 Lamp Life Indicator indicates hours for Xenon lamp installed in video processor. If the indicator lights red, a lamp
should be replaced before beginning the next procedure.
3 AUTO/XLUM Select Switch selects AUTO (automatic) or XLUM (manual) brightness control mode. AUTO or XLUM
indicators will light to indicate which is selected.
4 AVE/PEAK Select Switch Selecting AUTO will require selection of light measuring method, AVERAGE or PEAK.
AVE or PEAK indicator lights to indicate which is selected.
AVERAGE: the brightness level is adjusted with respect to an averaging of the brightness
of the video signal.
PEAK: the brightness level is adjusted with respect to the brightness of the peak of
the screen.
5 Brightness Indicator indicates the brightness level settled by the user.
6 Brightness controls the brightness level.
Up or Down button will change the brightness level as shown on the brightness indicator.
Adjustment △ increases the brightness level.
Switch ▽ descreases the brightness level.
NOTE -Minimum reguired brightness should be used at all times to avoid risk of injury
to the patient.
7 Color Balance Switch adjusts the video image color, Blue or Red by +/- 5 steps.
8 Pump on/off controls air pumps on/off. LED on the switch will light when switched ON.
9 Pump high/low LED on the switch indicates the pump output pressure level, High/Low.
WARNING -When selecting HIGH pressure, be careful not to deliver too much air.
10 White Balance Switch adjusts the white balance of the video endoscope. After adjustment, “WB OK!” is
displayed for about 3 seconds.

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(3) REAR PANEL

No. NAME FUNCTION


1 Keyboard Connector accepts the keyboard supplied by PENTAX.
2 Interface Connector RS-232C serial interface connector.
3 Serial Bus NTSC or PAL Serial Digital Video out connector for a still-frame video image .
4 Control is activated by either the endoscope control buttons (C, V) or the keyboard copy key to
control peripherals.
5 RGB Video Output NTSC or PAL RGB video out connectors, 9-pin D-sub Female connectors.
6 Separated Video Output Y/C video out connector (4-pin S connector)
7 Composite Video Output NTSC or PAL composite video out connector, BNC type connector.
8 Power Input Socket accepts AC power cord.
9 Breaker activates with a red button sticked out when abnormal current flows.
CAUTION -When the breaker is activated, try to reset first. If the breaker activates
again when the processor is turned ON, do NOT use the processor and return it to
PENTAX.
10 Potential equalization terminal For safety purposes, this terminal is connected to a potential equalization busbar of the
electrical installation.
11 Rating Plate displays unit model number, serial number and power requirements.

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2-2 WATER BOTTLE ASSEMBLY, MODEL OS-H4

3
6 5
2
7

No. NAME FUNCTION


1 Bottle holds sterile water for procedure. (use up to 2/3’s full)
2 Water Bottle Cap Assembly must be firmly secured to bottle to prevent air leakage. Do NOT overtighten the bottle cap.
3 Air Pipe Stem inserts into video processor water bottle receptacle.
4 Air/Water Hose contains (2) independent tubes - 1 for air, 1 for water.
5 Air/Water Connector inserts into Air/Water socket of endoscope umbilical connector.
6 Air/Water- Drain Lever must be set to upright (A/W) position for delivery of air and water.
7 Water Feeding Stem channel for water to be displaced from bottle and into scope.

NOTE - If the water bottle assembly has been handled roughly, the water feeding tube inside the Air/Water hose may be
disconnected at the A/W connector for the endoscope. To test, remove the cap assembly and using a syringe, inject water into
the water feeding stem. If the water comes out of both the center hole of the A/W connector and the series of holes around the
center hole, the water feeding tube is disconnected. Use another water bottle assembly.

10

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2-3 MONITOR DISPLAY SCREEN

(1) NORMAL
1 2 3 4

5
6

10

9
8

No. NAME FUNCTION


1 NAME Alpha-numeric field, 24 characters long.
2 ID Alpha-numeric field, 12 characters long.
3 AGE Alpha-numeric field, 3 characters long.
4 SEX Alpha-numeric field, 1 character long.
5 Date Numeric field
6 Clock Military format, Hours: Minutes: Seconds.
7 Doctor’s Name Alpha-numeric field, 12 characters long.
8 Facility Alpha-numeric field, 12 characters long.
9 COMMENT Alpha-numeric field, 40 characters long.
10 Main Screen Endoscopic image will be displayed on the monitor screen.

(2) FREEZE (SUB-SCREEN DISPLAY)

Sub-Screen Display

Endoscopic image will be displayed to this area of the monitor screen when freeze function is activated.

NOTE - Appearance of sub-screen covers Date and Clock.

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3. PREPARATION AND SAFETY CHECK
3-1 PREPARATION
WARNING - PENTAX video processors are electro-medical devices incorporating delicate
components and sophisticated circuitry that should not be subjected to harsh conditions,
including excessive vibrations and/or severe impact. NEVER drop this equipment or subject it to
severe impact as it could compromise the functionality and /or safety of the unit. Should this
equipment be mishandled or dropped, do NOT use it. Return it to an authorized PENTAX service
facility for inspection and repair.
(1) SETTING UP THE VIDEO PROCESSOR
1. Place the video processor on a stable and level surface (cart, counter, stand,etc..). ●

NOTE
• Avoid places where the video processor may be splashed with liquid.
• Absolutely do NOT use in any environment with explosive or flammable gases.
• Avoid places where the unit could be exposed to high temperature, humidity, direct sun light, etc.
• Do NOT install, operate or store electro-medical equipment in a dusty environment.
Accumulation of dust within these units may cause malfunction, smoke, or ignition.
• Do NOT block the venting grids on the sides of the processor.
• When moving the video processor, do NOT hold the scope locking lever.

2. Make sure the power switch is OFF.


3. Plug the power cord into the power source
using the three (3) prong plug supplied with the unit. ● EPK-1000
4. Ensure the keyboard is connected properly.

WARNING
• To reduce the potential for the electric shock, connect the power cord
Peripheral
of the following peripheral components into the medical isolation
transformer supplied.
– Any peripheral components connected to the PENTAX Processor.
– Any peripheral components connected to the PENTAX Endoscope.
– NEVER connect other components to the isolation transformer. SAT-1300
• Check that the total power consumption of all connected devices does
not exceed the isolation transformers’ power rating.
• Make sure that outputs are in compliance with IEC 60601-1-1.
• Make sure that the power cord is connected to the main with a three (3)
prong plug (In the U.S.A use UL 2601-1 rated isolation transformers
and/or power strips only). A/W

(2) CONNECTING THE WATER BOTTLE


1. Fill the water bottle approximately 2/3 full with sterile water. DRAIN
2. Screw the water bottle cap assembly to the water bottle snugly.
NOTE -Do NOT overtighten the water bottle cap
3. Set the Air/Water- Drain lever to A/W position.
4. Insert the water bottle air pipe stem into the video processor water
bottle receptacle and press until the water bottle ‘clicks’ into
position.
NOTE -Do NOT press the water bottle too forcefully into the video
processor. Rough handling may cause water to leak onto/into the
video processor.
5. Insert the Air/Water connector into the holder on the water bottle ●
cap assembly until the endoscope is connected
NOTE -Always disconnect the water bottle before moving the
processor into a position not common to normal use.
Always disconnect the water bottle before packing the video
processor for shipment.
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(3) CONNECTING THE ENDOSCOPE
CAUTION - Always turn ON the processor after connecting an endoscope. Also, remove the endoscope from the processor after
turning OFF the power switch.
1. Check to ensure that the appropriate light guide adapter is mounted to the video processor. The adapter, AE-P1 is already
attached to the video processor.
NOTE - Connecting a video endoscope without a light guide adaptor in place will reduce light output at the endoscope distal
end. Attempting to connect a fiberscope without a light guide adapter and/or an appropriate light guide sleeve in place will
damage the fiberscope and the video processor.
● 2. Check to ensure that the scope locking lever is open.
3. Connect the scope firmly into the processor until it clicks
into position.
4. Close the scope locking lever
NOTE - After connecting the endoscope to the EPK-1000
video processor, always make sure that the endoscope is firmly
secured to the scope receptacle by turning the locking lever to
the “lock” position.
NOTE - If using the fiberscope video adaptor module, make
sure the eyepiece of the fiberscope is properly connected to the
module (use adapters as required). Connect the electrical
connector of the module to the electrical connector of the video
processor, lining up the red dots on each.
● 5. Connect the water bottle Air/ Water connector to the
Air/Water receptacle on the endoscope’s umbilical connector.
● 6. Connect the suction tube of the suction device to the suction
nipple on the umbilical connector of the endoscope.

(4) CONNECTING THE PERIPHERAL EQUIPMENT


● 1. Referring to the rear panel diagram, connect a TV monitor
and other required equipment such as hard copy equipment,
VCR, etc., to the processor.
CAUTION - When used in clinical or residential areas near
radio and TV receiver units, this equipment may be subjected
to radio interference.
- To reduce electromagnetic interference, do NOT keep turning
ON the main POWER SWITCH of the equipment while a
videoscope is connected but not ready for use.
- To avoid and resolve adverse electromagnetic effects, do NOT
operate this equipment near the RF energy equipment.
CAUTION : FOR EUROPE
- This equipment is a Class B Medical Equipment (specified
EN55011) and is intended for hospital or health care districts.
- Use the connection cables as specified below.
Composite Video Cable (1.5m), RGB Video Cable (1.5m), Y/C Video Cable (1.5m), Control (1,2) Cable (1.5m), RS-232C
Cable (1.5m), Serial Bus Cable (1.5m).
CAUTION - Do NOT connect a printer simultaneously to RS232C and Control terminal located on rear panel of the processor.
CAUTION - Do NOT connect two or more processors to a computer.

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3-2 PRE-USE SAFETY CHECKLIST
WARNING - Before every use the following points should be checked. If any function or device in the video endoscope system
does not perform properly, do NOT perform the endoscopic examination. Contact the manufacturer of the device, your PENTAX
sales representative or a PENTAX service center before using the equipment for an endoscopic examination.
1. Ensure that power switch is OFF.
2. Ensure that video processor is placed in stable and level position.
3. Ensure that water bottle is properly prepared and connected.
4. Ensure that endoscope (and fiberscope video adaptor module if applicable) is connected properly.
NOTE - After connecting the endoscope to the EPK-1000 video processor, always make sure that the endoscope is firmly
secured to the scope receptacle by turning the locking lever to the “lock” position.
5. Ensure that keyboard is connected properly.
6. Turn ON monitor and other peripheral devices.
7. Turn ON video processor power switch. Ensure that switch is lighted green and the sound of the ventilation fans can be heard.
WARNING - After 400 hours of use, the image quality will deteriorate. Excessive use of the lamp beyond 400 hours
(approaching a thousand hours of use or more) could cause the lamp to explode resulting in damage to the video processor.
NOTE -The lamp life rated at 400 hours, is applicable to the EPK-1000 processor with serial number beginning with UB and EB.
8. Ensure that video processor lamp life indicator lights green or yellow. If red, replace the lamp.
CAUTION - Always turn ON the processor after connecting an endoscope. Also, remove the endoscope from the processor after
turning OFF the power switch.
NOTE -Power function switches should not be activated by contact with objects like endoscope light guides when being switched ON
or OFF. Before turning the video processor power ON, ensure the air flow vents are not obstructed.

9. Turn on the lamp switch to ignite the lamp. If lamp fails to ignite, turn video processor OFF, wait 60 seconds and repeat steps
7 and 9.
NOTE -If lamp fails to ignite, do NOT attempt to perform an endoscopic examination, contact your PENTAX service facility.
10. With lamp lit and endoscope connected, check for live endoscopic image on the monitor.

NOTE:
It should be recognized that the use of electro-surgical accessory devices employing high frequency current
may interfere with the normal endoscopic image and this interference is not indicative of a malfunction of the
video endoscope system. PENTAX has developed an earth cable, model OL-Z3 intended to reduce potential
RF interference and electronic noise that may appear in the endoscope image when using electro-surgical
devices. Ensure that cable OL-Z3 is correctly connected between the endoscope and video processor as
described in the instructions provided with the OL-Z3.

to video processor

to endoscope

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● 11. Exercise the endoscope’s automatic iris. Bring the tip of the
endoscope within 1 cm off the palm of your hand and move
it to about 5 cm away from the palm. Watch the image on
the monitor to ensure the brightness at both distances is
similar. Lift the distal end of the endoscope to the room
lights, the light being emitted at the distal end of the scope
should lower significantly (dependent on the ambient light
levels in the room). Return the distal end of the endoscope
to point at the palm and ensure that the light is being emitted
from the distal end of the endoscope.

● 12. Check the endoscope control buttons positioned on the


L U

control body of the endoscope.


F

NOTE -In combination with PENTAX 70K/72K/80K/81K/85K


series endoscopes, the function of each button can be selected
D R

with the scope buttons key on the keyboard.

13. Select brightness control auto or XLUM. If selecting


AUTO, also select light measurement mode, average or
peak. And exercise the brightness control switches to ensure
that the brightness indicator and controls are functioning.

14. Exercise the color adjustment as described below.

● Cup the distal end of the endoscope loosely in your hand. Ensure
that the monitor displays a natural color. Exercise the color adjust
switches (Red Up and Down and Blue Up and Down) to ensure
that the changes are recognizable in the image of your hand.

15. If XLUM is intended to be used during the procedure,


exercise the XLUM function. Upon selecting the switch,
LED will light and maximize the brightness level.

16. Turn ON the air pump on/off switch. The switch LED will
light and the sound of the air pump should be heard.
Select desired level, Low or High.

● 17. Exercise Air/Water delivery through the endoscope.


Air Covering air venting hole on top of Air/Water button
Feeding lightly should deliver air at the distal end of the endoscope
● by submerging the distal end in enough water to cover the
tip, air flow will be demonstrated by a trail of bubbles.
Pressing the button all the way down should deliver water
through the tip of the endoscope.

NOTE -Use only “fresh” distilled or sterile water for testing


of the endoscope air/water delivery functions.

If all items above appear to function satisfactorily, then the


Water
endoscopic procedure may be performed. If any functionality
Feeding above is compromised, do NOT attempt to perform the
endoscopic procedure.

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4. OPERATION
4-1 PROCESSOR FUNCTIONS
NOTE -Check the lamp life indicator on the front panel. If red, a lamp should be replaced before beginning a procedure.
-Before turning the processor ON, ensure the air flow vents are not obstructed.

WARNING - After 400 hours of use, the image quality will deteriorate. Excessive use of the lamp beyond 400 hours
(approaching a thousand hours of use or more) could cause the lamp to explode resulting in damage to the video processor.

NOTE -The lamp life rated at 400 hours, is applicable to the EPK-1000 processor with serial number beginning with UB and EB.

(1) MAIN LAMP


Turn ON the lamp switch to ignite main lamp and the LED on the lamp switch. The light will be emitted from the distal end of
the endoscope. When the procedure is completed, turn OFF the lamp. If the lamp fails to ignite and the LED flashes, do NOT
attempt to perform an endoscopic procedure.
NOTE -Aside from the pre-use inspection of the equipment, the lamp in the video processor should be turned OFF when the
video system is not clinically used.

(2) AUXILIARY LAMP


If the LED on the lamp switch is flashing , it indicates that main lamp is burnt out or there is a lamp failure. The message
“PUSH LAMP SWITCH” will be displayed on the monitor screen. While this error message is displayed, all function keys
(except the lamp switch) are deactivated. To ignite the lamp, press the “LAMP SWITCH” - do NOT push the “POWER
SWITCH” - while the LED is flashing. The auxiliary lamp and the LED will light.
Do NOT attempt to perform an endoscopic examination with auxiliary lamp. The auxiliary lamp is intended to assist in the safe
withdrawal of the endoscope in the event that the main lamp fails to ignite during a procedure. After igniting the auxiliary lamp,
return the endoscope to the neutral position and slowly withdraw the endoscope under controlled visualization by the auxiliary lamp.
The auxiliary lamp can be turned OFF by pressing the switch or by turning the processor OFF.
WARNING - The auxiliary lamp is intended to provide sufficient visualization to withdraw the endoscope, should the main
lamp fail. Do NOT attempt to perform an endoscopic examination with the auxiliary lamp.
NOTE -The auxiliary lamp is incorporated to the processor with serial number beginning with UB and EB.
CAUTION - The auxiliary lamp in the EPK-1000 incorporates a LED which is recognized as a class 2 laser product by
IEC60825-1. Emission from the endoscope distal tip into the human body is at a level lower than class 2 as long as the lamp and
all associated finished products are used properly according to provided instructions. To protect user’s eyes, avoid looking
directly at the light exiting the endoscope and/or the processor.
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous
radiation exposure.
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(3) BRIGHTNESS
Select the desired brightness control mode, AUTO or XLUM, using the brightness control switch.
AUTO = Automatic brightness control, where the video signal of the endoscope will automatically maintain the brightness level
selected by the brightness adjustment switches. The switch will beep when pressed and the AUTO indicator will light when the
AUTO mode is selected.
If the AUTO brightness mode is selected, select the desired brightness level and the light measurement method, AVE or PEAK,
using the light measurement switch on the front panel or the endoscope control buttons.
AVE = The brightness level is automatically adjusted with respect to an averaging of the brightness of the video signal.
PEAK= The brightness level is automatically adjusted with respect to a peak (maximum) value of the brightness of the video signal.
The switches will beep when pressed and the AVE or PEAK label will light when either is selected.
NOTE -Halation is defined as the appearance of a halo around an area of extreme brightness. Halation may occur if the AVE mode
and PEAK mode are selected. If halation is observed and if it distorts the endoscopic image, one should reduce the brightness level.
XLUM= Manual brightness control, the user will select the brightness level by using the brightness adjustment switches.
The switch will beep when pressed and the XLUM label will light when manual mode is selected.

WARNING - To protect users eyes and avoid risk of thermal injury, select the Auto mode. When the processor is used as a
light source, select the XLUM mode with the minimum required brightness. When the procedure is suspended for a while, turn
OFF the lamp switch or select the XLUM mode with the lowest brightness.
There are eleven (11) brightness levels. The brightness level will be displayed as a value -5 to +5 on the brightness indicator on
the front panel.
To change the brightness level;
Press the Up switch (△) to increase the level.
Press the Down switch (▽) to decrease the level.
The switches will beep when pressed and the brightness level indicator will change accordingly.
CAUTION - To protect the users eyes and avoid risk of thermal injury during an endoscopic examination, use only the
minimum amount of brightness required.
NOTE -The video processor has a battery backup memory and will retain the last selected brightness value even if the unit is
turned OFF or disconnected from the power outlet.

(4) COLOR BALANCE


There are eleven (11) color levels for both Red and Blue hue.
They will be displayed as a value -5 to +5 on the monitor display at either end of the color bar.
All the switches described above will beep when pressed.
NOTE -The video processor has battery backup memory and will retain the last selected color balance levels even if the unit is
turned OFF or disconnected from the power outlet.
The white balance function adjusts the white balance of each endoscope. Proper
white balance requires the use of the white balance adjuster attached to the PENTAX
System Cart. Contact your local PENTAX service center for the details if required.
1) Put the distal end of the video endoscope into the white balance adjuster which
is supplied with the processor.
2) Watching the monitor, adjust the position of the distal end of the scope in the
adjuster so that the circle at the bottom of the white balance adjuster can be
recognized on the full screen.
● 3) Press the white balance switch while keeping the scope distal end stationary in
the adjuster more than three seconds.
+ If the white balance is established, “WB OKI” is displayed on the screen.

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