EPK-1000 Video Processor Owner's Manual Sept 2010

Owner's Manual

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File Name: epk-1000_video_processor_owner_s_manual_sept_2010.pdf

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OWNER'S MANUAL

PENTAX VIDEO PROCESSOR

EPK-1000

INTENDED USE: The EPK-1000, Video Processor is a required accessory for Video Endoscopes and is intended to act as a light source, (providing illumination to the endoscope) air pump, (providing air to aid in insufflating body cavities and water delivery through the endoscope) and video processor (processing image data received from the endoscope into various video outputs). See unit specifications for endoscope compatibility.

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.

Symbol for “MANUFACTURER”

Symbol for “DATE OF MANUFACTURE” EC

REP

Symbol for “AUTHORISED REPRESENTATIVE IN THE EUROPEAN UNION” 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.

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 AND STORAGE ... 29 5-1 AFTER USE CARE AND STORAGE ... 29 5-2 CARE AND STORAGE OF THE WATER BOTTLE SET ... 30 (1) CLEANING ... 30 (2) STERILIZATION ... 30 5-3 CHANGING THE LAMP ... 31 5-4 RESETTING THE BREAKERS ... 32 5-5 REPAIRS ... 33 6 TROUBLE-SHOOTING GUIDE ... 34 7 SPECIFICATIONS ... 36 8 ELECTROMAGNETIC COMPATIBILITY ... 37

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.

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 of 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.

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 (Use a SEV approved plug for Switzerland)

U.K.

Australia and New Zealand

U.S.A. and Canada (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; AWARNING

: 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.

2. NOMENCLATURE, CONTROLS AND FUNCTIONS 2-1 VIDEO PROCESSOR (1) MAIN BODY

No. 1 2 3 4

NAME Ventilation Grid Water Bottle Receptacle Lamp Housing Cover Light Guide Attachment

Endoscope Electrical Connector

7 8

Scope Locking Lever

Front Panel Power Switch

FUNCTION allows for adequate ventilation and cooling lamp/unit. Do NOT block the grids. accepts air pipe from PENTAX water bottle assembly. provides access to replace lamp cartridge. 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. accepts Color video endoscope electrical connector or fiberscope video adapter module 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. 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. See the section 2-1- (2) 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.

Water Bottle

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. See the section 2-2.

(2) FRONT PANEL

No. 1

NAME Lamp Switch

FUNCTION 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.

-The auxiliary lamp is incorporated to the processor with serial number beginning UB and EB. indicates hours for Xenon lamp installed in video processor. If the indicator lights red, a lamp should be replaced before beginning the next procedure. selects AUTO (automatic) or XLUM (manual) brightness control mode. AUTO or XLUM indicators will light to indicate which is selected. 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. indicates the brightness level settled by the user. controls the brightness level. Up or Down button will change the brightness level as shown on the brightness indicator. increases the brightness level. △ descreases the brightness level. ▽

NOTE

Lamp Life Indicator

AUTO/XLUM Select Switch

AVE/PEAK Select Switch

5 6

Brightness Indicator Brightness Adjustment Switch

NOTE -Minimum reguired brightness should be used at all times to avoid risk of injury to the patient.

7 8 9

Color Balance Switch Pump on/off Pump high/low

adjusts the video image color, Blue or Red by +/- 5 steps. controls air pumps on/off. LED on the switch will light when switched ON. LED on the switch indicates the pump output pressure level, High/Low. AWARNING

White Balance Switch

-When selecting HIGH pressure, be careful not to deliver too much air.

adjusts the white balance of the video endoscope. After adjustment, “WB OK!” is displayed for about 3 seconds. 8

(3) REAR PANEL

No.

NAME

FUNCTION

Keyboard Connector

accepts the keyboard supplied by PENTAX.

Interface Connector

RS-232C serial interface connector.

Serial Bus

NTSC or PAL Serial Digital Video out connector for a still-frame video image .

Control

is activated by either the endoscope control buttons (C, V) or the keyboard copy key to control peripherals.

RGB Video Output

NTSC or PAL RGB video out connectors, 9-pin D-sub Female connectors.

Separated Video Output

Y/C video out connector (4-pin S connector)

Composite Video Output

NTSC or PAL composite video out connector, BNC type connector.

Power Input Socket

accepts AC power cord.

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.

Potential equalization terminal For safety purposes, this terminal is connected to a potential equalization busbar of the electrical installation.

Rating Plate

displays unit model number, serial number and power requirements.

2-2 WATER BOTTLE ASSEMBLY, MODEL OS-H4

2 7

No.

NAME

FUNCTION

Bottle

holds sterile water for procedure. (use up to 2/3’s full)

Water Bottle Cap Assembly

must be firmly secured to bottle to prevent air leakage. Do NOT overtighten the bottle cap.

Air Pipe Stem

inserts into video processor water bottle receptacle.

Air/Water Hose

contains (2) independent tubes - 1 for air, 1 for water.

Air/Water Connector

inserts into Air/Water socket of endoscope umbilical connector.

Air/Water- Drain Lever

must be set to upright (A/W) position for delivery of air and water.

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.

2-3 MONITOR DISPLAY SCREEN (1) NORMAL 1

5 6

9 8 7

No. 1 2 3 4 5 6 7 8 9 10

NAME NAME ID AGE SEX Date Clock Doctor’s Name Facility COMMENT Main Screen

FUNCTION Alpha-numeric field, 24 characters long. Alpha-numeric field, 12 characters long. Alpha-numeric field, 3 characters long. Alpha-numeric field, 1 character long. Numeric field Military format, Hours: Minutes: Seconds. Alpha-numeric field, 12 characters long. Alpha-numeric field, 12 characters long. Alpha-numeric field, 40 characters long. 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. 11

3. PREPARATION AND SAFETY CHECK 3-1 PREPARATION AWARNING - 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. 4. Ensure the keyboard is connected properly.

EPK-1000

●

AWARNING

• To reduce the potential for the electric shock, connect the power cord 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. • 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 UL2601-1 rated isolation transformers and/or power strips only).

Peripheral

SAT-1300

A/W

(2) CONNECTING THE WATER BOTTLE 1. Fill the water bottle approximately 2/3 full with sterile water. 2. Screw the water bottle cap assembly to the water bottle snugly.

DRAIN

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.

●

(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

●

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.

●

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.

(4) CONNECTING THE PERIPHERAL EQUIPMENT

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.

3-2 PRE-USE SAFETY CHECKLIST AWARNING

- 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. AWARNING

- 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. - 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.

NOTE

to video processor

to endoscope

● 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.

L U

● 12. Check the endoscope control buttons positioned on the

control body of the endoscope.

D R

NOTE -In combination with PENTAX 70K/72K/80K/81K/85K series endoscopes, the function of each button can be selected 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.

Air Feeding

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

Covering air venting hole on top of Air/Water button 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.

Water Feeding

If all items above appear to function satisfactorily, then the endoscopic procedure may be performed. If any functionality above is compromised, do NOT attempt to perform the endoscopic procedure. 15

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. AWARNING

(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. AWARNING

- 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. 16

(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.

AWARNING - 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 OK!” is displayed on the screen.

(5) PUMP

To turn the air pump On, press the Air Pump ON/OFF switch. The switch will beep when pressed. Then the LED on the switch will light and the sound of the air pump will be heard. To turn the air pumps OFF, press the ON/OFF switch again. The switch will beep and the LED on the switch will turn OFF. There are two (2) air pump levels, LOW and HIGH. The switches will beep when pressed and the LED on the level switch will light to indicate the selected level. The air pump level will control the pressure of both the air and water delivery. CAUTION - Regardless of the pump level setting selected, avoid delivering too much air to minimize the potential for

pneumatic perforation or barotrauma. NOTE - Should debris on the objective lens be difficult to clean, one can temporarily use a higher pump level setting on the video processor or light source. While doing so, simultaneously activate the air and suction control valves to minimize air insufflation. After the lens has been cleared, return the air pressure to its original setting for routine use. Regardless of pump level setting selected, avoid delivering too much air.

4-2 KEYBOARD•FUNCTIONS (1) CONVENTIONAL KEYS

No.

NAME

FUNCTION

Function Keys

Refer to FUNCTION KEY INDEXES.

Esc (Escape) Key

stops data entry or function menu. Returns to the normal mode.

Alpha-Numeric Keys

include keys for letters, numbers and special characters (brackets, commas, etc.) as well as command keys (Control, Shift, Enter etc.).

Back Space Key

moves cursor leftward and delete the character.

Caps Lock Key

Caps Lock indicator will light to show Caps Lock selected. When Caps Lock is ON, all alphabet keys will be typed to the monitor screen as capitals.

Enter Key

moves cursor to the next field or to store selected data.

Shift Keys

When Caps Lock is OFF, holding the Shift key and pressing alpha - numeric key will be typed to the monitor screen as a capital letter or the special character pictured on the key.

Ctrl (Control) Keys

is used to access function menus.

Space Bar

gives a space and deletes a previously typed character.

Cursor Movement Keys

Up, Down, Left and Right arrows move the cursor to each direction.

(2) SPECIAL FUNCTION KEYS No.

Function Keys

Function

Patient

makes up Patient List

New Patient

inputs patient information

Clear Patient

deletes patient data

User

makes up User List

Scope Buttons

assign function to each scope control button

Scope SW (Ctrl+Scope Buttons)

select two controls (output terminals) on the rear panel

Enhance Level

selects enhance level

Color Adj (Ctrl+Enhance Level)

adjust color

Shutter Mode

changes shutter speed automatically

Freeze Mode (Ctrl+Shutter Mode)

selects freeze image Frame or Field

Clear Screen

displays items once removed from the screen

Color Bar (Ctrl+Clear Screen)

remove or display color bar

Character Off

clears all screen information

Date (Ctrl+Character Off)

set date and clock

selects peripheral equipment to RS232C terminal

Init

initializes all data

Clear Counter

initializes the film counter

Stopwatch

activates stopwatch

19*

Multi Picture

sets number of split screens on video printer

20*

Print Quant

sets number of prints with video printer

21*

Delete Image

clears images currently stored in video printer

22*

prints data already stored in video printer

Pointer

shows a small arrow ( pointer ) on the normal screen

Editor

enables input freely without any format restriction

VTR

activates output peripheral such as VTR

Freeze

activates freeze function

Copy

activates output peripheral such as copy

Capture

transmits a “frozen” endoscopic image to the PC connected to the processor.

Scope Model

displays model name and serial number of endoscope.

* applicable only when certain brand and model printers are connected to the PENTAX Video System.

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PENTAX MEDICAL

Video Processors

EPK-1000 Video Processor Owner's Manual Sept 2010