EPK-i7010 Video Processor Instructions for Use July 2018

INDICATION FOR USE: The PENTAX Medical EPK-i7010 Video Processor is intended to be used with the PENTAX camera heads, endoscopes, light sources, monitors and other ancillary equipments for endoscopic diagnosis, treatment and video observation. The PENTAX Medical EPK-i7010 includes a digital post-processing imaging enhancement technology (PENTAX i-Scan™) and a optical imaging enhancement technology (OE). These imaging enhancement technologies are intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. i-Scan and OE are compatible with PENTAX video endoscopes.

DEVICE DESCRIPTION: The PENTAX Medical EPK-i7010 video processor consists of a video system, integrated light source, monitor, and ancillary equipment. This processor is intended for endoscopic diagnostic, treatment and video observation. The PENTAX Medical EPK-i7010 video processor contains two types of contrast enhancement techniques: PENTAX i-Scan technology, and optical enhancement (OE) technology. PENTAX i-Scan technology is a digital filter-based contrast enhancement technique, while OE technology combines the band limited light and the digital processing. PENTAX i-Scan technology has three modes, i-Scan 1, 2 and 3. i-Scan 1 enhances image topography and edges and i-Scan 2 and 3 enhances the color tone of the image by dissecting and recombining the individual red, green and blue (RGB) components of a white light image. PENTAX i-Scan modes 1, 2, and 3, are intended to give the user an enhanced view of the texture of the mucosal surface and blood vessels. i-Scan 1 provides the user with a view that sharpens surface vessels and enhances surface texture of the mucosa. i-Scan 2 provides the user with increased visibility of blood vessels while also providing the same enhancements to the mucosa achieved in i-Scan 1. i-Scan 3 provides the user with increased visibility of blood vessels including dimly illuminated far-field regions while also providing the same enhancement to the mucosa achieved in i-Scan 1. The user can select either white light image or i-Scan modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. i-Scan is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling. The PENTAX Medical EPK-i7010 video processor is equipped with two optical filters placed inside Xenon lamp light path to provide optical enhancement (OE), which combines the band limited light and the digital processing. PENTAX OE technology has two modes, OE Mode1, 2. In addition to i-Scan, OE Mode1 and 2 are intended to provide alternative methods to improve blood vessel visibility (emphasizes mucosal microvasculature and fine mucosal structures) on the mucosal surface by combination of band limited light illumination source. OE Mode1 uses a spectral filter that transmits band limited green and blue light and is intended to provide the user with enhanced image of blood vessels and fine structure of mucosa. OE Mode2 uses a different spectral filter that transmits band limited red, green and blue light and is intended to provide the user with enhanced image of blood vessels and fine structure of mucosa in an image closer to white light image. The user can select either white light image or OE modes by pressing a pre-programmed button on the scope, by using a pre-programmed foot pedal or by pressing a keyboard button. OE is intended to be used as an optional adjunct following traditional white light endoscopy and is not intended to replace histopathological sampling.

White light is captured from a 300 Watt xenon lamp housed in the PENTAX Medical EPK-i7010 video processor. All visualization is done with the white light mode first. White light (BGR) illuminates the tissue and transfers the captured light through the video scope or a charged coupled device (CCD). Note that the white light visualization mode is always used first by the physician. For i-Scan image enhancement, the modification of the combination of RGB components for each pixel occurs when the i-Scan function is turned on in the PENTAX Medical EPK-i7010 video processor. The resulting i-Scan image is then displayed on the observation monitor. For OE image enhancement, one of the two optical filters corresponding to Mode1 and Mode2 are inserted into illumination light path when the OE function is turned on in the PENTAX Medical EPK-i7010 video processor. The resulting OE image is then displayed on the observation monitor.

FUNCTIONS USED FREQUENTLY: The functions used frequently on this equipment are the still image display function, image capture function, white balance adjustment function, and patient information registration/display function.

APPLICATION: 1 Intended medical use: Observation of body cavities (Lighting and air/water supply through a connected

endoscope and monitor output of observed images from the endoscope itself) 2 Patient populations: Patients ranging from pediatric to adult (Patients who are considered suitable for the application of equipment by the physician) 3 Intended anatomical area (tissues/organs): Pharynx; Larynx; Esophagus; Stomach; Duodenum; Small Intestine; Large Intestine; Pancreatic and Biliary Duct; Trachea; Bronchial Tree; Ear; Nasal Passage; Kidney; Renal Cavity; Renal Calyces; Urethra; Endometrial Canal (all require endoscope connection) 4 User: An operator with experience, or an operator working under the supervision of someone with experience 5 Usage environment: Hospitals, Ambulatory Surgery Centers, and Medical Clinics

IMPORTANT: This Instructions for Use (IFU) describes the recommended procedures for inspecting and preparing this 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 IFU may result in damage to and/or malfunction of the equipment. If you have any questions regarding any of the information in this IFU or concerns pertaining to the safety and/or use of this equipment, please contact your local PENTAX Medical service facility.

CAUTION After the product has been delivered, promptly install, set up, and start using the equipment. Avoid storing the equipment over an extended period of time without using.

TRADEMARKS: • PENTAX is either registered trademark or trademark of HOYA Corporation. • PENTAX Medical is the trademark of HOYA Corporation. • Windows 7, Windows 7 Ultimate, Windows Media Player are either registered trademarks or trademarks of Microsoft Corporation in the United States and/or other countries. • All other product names mentioned in this IFU provided with this processor are registered trademarks or trademarks of their respective manufacturers.

Contents 1

Safety Precautions - Important

1

2

Nomenclature, Controls, and Functions

5

Main Unit ... 5 Touch Panel ... 6 Rear Panel... 7 PENTAX Medical Water Bottle Assembly (OS-H5) ... 8

3

Preparation

9

System Configuration ... 9 Installation ... 10 Connecting a Video Endoscope ... 17

4

Pre-use Inspections

19

Power-On and Lamp Inspection ... 19 On-screen Image Check... 20 Automatic Brightness Control Inspection... 20 Endoscope Control Button... 20 Exposure and Measurement Inspection ... 21 Color Adjustment ... 21 Suction Inspection ... 21 Air/Water Supply Inspection ... 22

5

Operating Procedure

23

Turning On/Off the Processor... 23 Monitor Screens ... 23 Touch Panel Operation... 25 i-scan ... 30 Optical Enhancement (OE)... 32 Image Processing Settings... 33 Setup Menu Operations... 35 [i-scan] Tab ... 35 [Image] Tab... 39 [Customize] Tab... 44 [System] Tab... 58 [Peripheral] Tab ... 71 Keyboard Operations... 72 Operations in the Keyboard Menu Screen ... 75 Operations in the [Patient list preset] Tab... 75 Operations in the [User list preset] Tab ... 77 Settings in the [Setup] Tab ... 78

6

Maintenance

80

After Use... 80 Cleaning and Storage of the Water Bottle Assembly ... 81 Storage ... 81 Replacing the Lamp... 82 Replacing the Fuses ... 84 Repair ... 85

7

Troubleshooting

86

8

Specifications

91

9

Electromagnetic Compatibility

92

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 IFU.

1

1-1. TRAINING 1. 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. Failure to observe this precaution may result in personal injury.

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. 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 grid 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 the power requirements of the devices do not exceed the capacity of the isolation transformer. For further information, contact your local PENTAX Medical service facility.

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 500 hours. Prior to use, check the lamp life indicator on the operation panel to ensure the indicator is lit green. After 500 hours of use, the indicator turns red and the image quality will deteriorate. The lamp life could be affected by frequency of use. In which case, the lamp life might become shorter than 500 hours. 6. Right after turning on the power of the processor, wait till the backlight of the touch panel comes on. Using the operation panel or the keyboard before the backlight comes on would result in system malfunction.

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.

1

Safety Precautions - Important

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 IFU. Failure to do so could result in compromised safety, equipment malfunction or instrument damage. 11. The equipment may become hot during use. Take special care when touching the equipment. 12. If an error message is displayed on the monitor, follow the message instruction. Failure to do so could result in compromised safety for patient and/or user or equipment malfunction. 13. When the observation object moves quickly, the after image might appear on the monitor. 14. The processor's performance could be negatively affected by electromagnetic waves emitted from cellular phones or other portable wireless equipments. Recommended separation distance between the processor and the portable/mobile equipment is shown on a table near the end of this IFU. Follow these recommendation to avoid electromagnetic interference by the portable/mobile equipments.

1-5. AFTER USE 1. The equipment may become hot immediately after use. Take special care when touching the equipment. 2. Refer to the operating instructions provided 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. 3. Wipe all surfaces clean with gauze slightly dampened with alcohol. 4. Be sure connector interfaces and air intake vents are not allowed to become wet or splashed with liquids. 5. Clean this equipment regularly. Remove substances on movable units as well as dirt on the surface. Substances on endoscope locking lever and/or endoscope electrical connector may cause malfunction.

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 by wiping the surface with alcohol-dampened gauze 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 Medical service facility. 2. When replacing the lamp, use only the lamp recommended by PENTAX Medical and follow all PENTAX Medical instructions provided. Safety Precautions - Important

2

1

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

1-9. DISPOSAL 1. The equipment should be returned for disposal to PENTAX Medical. Contact your local PENTAX Medical representative or service facility.

1

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 Medical service facility 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.

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 Medical service facility.

SOFTWARE VERSION The software version of the products corresponding to this IFU is described on its back cover.

SYMBOLS ON MARKING Manufacturer

Date of manufacture

Alternating current

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

Switches the power on and off.

Warning

Warning, electricity

Caution

Warning; Hot surface

3

Safety Precautions - Important

Protective earth (ground)

Equipotentiality

Instructions for Use

1 Follow the Instructions for Use

Endoscope

Illumination lamp model

Authorized representative in the European Community

CONVENTIONS The following conventions have been established in the text of this IFU 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.

Safety Precautions - Important

4

2

Nomenclature, Controls, and Functions

Main Unit Endoscope Electrical Connector Insert the electrical connector of a video endoscope or video module (fiberscope).

Water Bottle Socket Insert the air pipe of a PENTAX Medical water bottle assembly.

2

Endoscope Locking Lever Open the lever before connecting or removing an endoscope. After connecting an endoscope to the processor, close the lever.

Air Intake Vent Allows for ventilation and cooling of the lamp/unit. Do not block the grids.

Touch Panel I "Touch Panel"(P.6)

Note Install the processor in a location where the air intake vents will not be blocked.

Lamp Protective Cover

Water Bottle Assembly I "PENTAX Medical Water Bottle Assembly (OS-H5)"(P.8)

Power Switch R

Open this cover when you want to replace the lamp cartridge.

Light Guide Receptacle (AE-P2) Insert the light guide of a video endoscope or fiberscope. Use in combination with a video module of a fiberscope is possible. When using an adapter other than AE-P2, contact a PENTAX Medical service facility.

Press this switch to turn the processor on or off.

USB Port Connect "Image Recording Media"(P.91) or USB printer.

NOTE  Always insert an endoscope prior to turning on the processor. Also, always turn off the processor before removing an endoscope.  Before turning on the processor, make sure the air intake vents are not blocked.  The lamp of the processor should be turned off except during pre-use inspections and clinical use.  After connecting an endoscope to the processor, check that the endoscope is firmly secured and that the endoscope locking lever is in the LOCK position.

CAUTION  Immediately after use, the metal light guide prong and the electrical contacts/pins of the endoscope may be hot. To avoid burns, do not touch these parts immediately after use. For safe handling after a procedure, grasp the PVE connector housing of the endoscope.  The light emitted by the Xenon lamp is extremely intense. Avoid looking directly at the light exiting this equipment without Light Guide Receptacle being attached.

5

Nomenclature, Controls, and Functions

Touch Panel COLOR BALANCE Button c

Brightness Setting Buttons

Use this button to display the color balance adjustment screen. I "Color Balance Button"(P.28)

Customize Buttons Each press of a button changes the setting of the indicated function. You can set the functions you use very frequently for these four buttons. Depending on the function, the setting may be displayed on the top right of a button. I "Customize Buttons"(P.29)

Use UV to adjust the brightness level. I "Brightness Setting Buttons"(P.26)

XLUM ON/OFF Button d Use this button to maximize the light intensity of the endoscope. I "XLUM ON/OFF Button"(P.29)

2

Pump Level Setting Buttons Use UV to adjust the strength of the pump. I "Pump Level Setting Buttons"(P.27)

LAMP Button S Use this button to turn the lamp on or off. I "Lamp Button"(P.26)

MODE Button b Use this button to select the light measuring method. AVERAGE: Adjust the [BRIGHTNESS] level in relation to the average value of the brightness of the video signal. PEAK: Adjust the [BRIGHTNESS] level in relation to the maximum value of the brightness of the screen. I "Mode Button"(P.28)

PUMP Button Q Use this button to operate or stop the air/water pump. I "Pump Button"(P.26)

EXPOSURE CONTROL Button a Use this button to change the method of adjusting the screen brightness. AUTO: Adjust the screen brightness automatically. MANUAL: Adjust the screen brightness manually. I "Exposure Control Button"(P.28)

SETUP Button e Use this button to display the setting menus. I "Setup Button"(P.29)

WHITE BALANCE Button P Use this button to adjust the white balance. I "White Balance Button"(P.27)

Lamp Life Indicator [LIFE] The lamp usage time is indicated by this indicator. 3 green circles: Less than 400 hours 2 green circles: 400 hours to 449 hours 1 yellow circle: 450 hours to 499 hours 1 red circle: 500 hours or more (the lamp needs to be replaced) I "Replacing the Lamp"(P.82)

NOTE  The lamp life is 500 hours. Check the LIFE indicator (lamp life indicator) on the touch panel before using the processor. Replace the lamp cartridge if a red circle is displayed on the LIFE indicator. The lamp life may not be as long as 500 hours depending on the method of use and operating environment. I "Replacing the Lamp"(P.82)  When pressing a button on the touch panel, make sure to press the center of the button. If the edge of the button is pressed, the system might activate the button that is next to the button you intended to press.  When pressing a button on the touch panel, make sure that the setting/configuration change that was intended to be made in the previous press has been correctly applied. Pressing a button in succession may cause a system error. If a system error occurs, turn the power off and then on again.

Nomenclature, Controls, and Functions

6

Rear Panel RS-232C This connector (D-sub 9-pin connector) is for connecting an external output device. It is an RS-232C compliant interface.

RJ45 This connector is exclusively for RJ45 communication.

USB These connectors are for connecting "Image Recording Media"(P.91) or a USB printer.

DVI This connector is for outputting video signals (DVI signals [digital] and VGA signals [analog]) to send to a monitor or image processor.

2

RGB This connector is for outputting video signals (RGB color signals and synchronous signals) to send to a monitor or image processor.

KEYBOARD This connector is for connecting a keyboard. Connect the supplied keyboard (OS-A83) designed specifically for use with this processor.

Y/C These connectors (separated video outputs) are for outputting separate video signals (video signals separated into luminance signals and color signals) to send to a monitor, printer, or image processor.

AUDIO IN This connector is for inputting audio signals when recording video images to "Image Recording Media"(P.91).

VIDEO OUT/ SYNC OUT

FTSW

This connector (BNC) is for outputting composite video signals and strobe synchronous signals to send to a monitor or image processor.

This connector is for connecting foot switches (OS-A61) for operating peripheral devices.

REMOTE These connectors are for outputting operation trigger signals to remotely operate peripheral devices.

HD-SDI These connectors (BNC) are for outputting digital video signals (HD-SDI signals) to send to a monitor or image processor.

VIDEO IN This input connector (BNC) is for P-in-P (Picture in Picture). It inputs composite video signals to send to a monitor when P-in-P mode is set.

Air Intake Vent Note

Rating Plate This plate shows the processor rating specifications, acquired standards, etc.

Install the processor in a location where the air intake vents will not be blocked.

Fuse Box This fuse box contains two fuses.

Power Input Socket Connect the AC power cord.

Air Intake Vent Note Install the processor in a location where the air intake vents will not be blocked.

Potential Equalization Terminal This terminal is used with a potential equalization busbar to equalize the potential of other equipment connected to the processor.

WARNING  To avoid the risk of electric shock, this equipment must only be connected to a power supply with protective earth.  This equipment must be connected to an appropriate power supply.

CAUTION Make sure to firmly connect each connector to the specified position. Failing to do so could cause certain function to be unavailable.

7

Nomenclature, Controls, and Functions

PENTAX Medical Water Bottle Assembly (OS-H5)

Air/Water Hose The inside of the hose is split into two for the air and water supply.

Air Pipe Stem Insert this into the processor.

Water Bottle Cap Attach this so that no air leaks out.

A/W DRAIN Lever Use this to switch between the air/water supply and drain. Align the switch to the A/W position before use.

Air/Water Connector

2

Connect this to the air/ water connector of the endoscope.

Water Feeding Stem Bottle

Used for suctioning of water from inside the bottle.

Contains sterile water for lens cleaning.

NOTE When cleaning and sterilizing the water bottle assembly (OS-H5), follow the instruction given in the Instructions for Use for OS-H5.

Nomenclature, Controls, and Functions

8

3

Preparation

System Configuration The following shows examples of system configurations for using the processor.

Patient Environment Display Devices

PENTAX Medical Video Endoscopes and Fiberscopes L

U

F

F

D

R

LCD Monitor Radiance 19 (NDS Surgical Imaging)

LCD Monitor 26”Radiance G2 HB (NDS Surgical Imaging)

3

LCD Monitor LMD-2451MD (Sony Business Solutions Corporation)

Water Bottle Assembly OS-H5 (PENTAX Medical)

Condenser Earth Cable OL-Z4 (PENTAX Medical)

EPK-i7010 Video Processor (This Unit)

Medical Cart

Recording Devices*

External Hard Drive WDBBGB0030HBK (Western Digital Corporation)

USB Flash Memory TS32GJF600 (Transcend Information, Inc)

*:

Printer UP-55MD UP-25MD UP-D25MD (Sony Business Solutions Corporation)

HD Video Recorder HVO-1000MD (Sony Business Solutions Corporation)

Medical Grade Isolation Transformer Input Devices

Keyboard OS-A83 (PENTAX Medical)

Foot Switches OS-A61 (PENTAX)

NOTE Recording devices specified in the diagram have been tested for compatibility with the EPK-i7010. Equivalent devices can be used but may not be compatible with the EPK-i7010.

9

Preparation

NOTE  For peripheral devices, use the recommended devices shown above or equivalent products.  PENTAX Medical recommends the devices shown above based on the independent test results.  The processor or the peripheral devices may not operate normally by the combination of their connections including the recommended devices.  When any connected peripheral devices are added, use the processor and the peripheral devices after confirming their normal operations by checking their connected combinations.  The data may not be recorded properly if non-compatible external hard drive or non-compatible USB flash memory is used, or if the USB flash memory is connected to the USB port of this product using USB extension cable.

Installation  Installing the Processor in a Cart Install the processor and peripheral devices in a cart while referring to the installation examples in "System Configuration" (P.9). Place the cart on a stable and level surface.

WARNING  The processor is an electro-medical device incorporating precision components and sophisticated circuitry so do not install it in a location where it will be subject to harsh conditions, including excessive vibrations and/or severe impact. Never drop the processor or subject it to a severe impact as doing so 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 Medical service facility for inspection and repair.  Because of the adverse effect that one equipment could cause to another equipment, it is possible that the correct operation of this processor could be compromised if another equipment is placed right nearby or stacked on top of the processor. If such situations cannot be avoided for extenuating reasons, be sure to check the correct operation of each equipment before using them in clinical use.  Do NOT block the ventilation grids on the sides and at the back of the processor. In particular make sure to separate the ventilation grids on the processor’s left side at least 15 cm (6 inches) from the wall. Blocking ventilation may cause equipment temperature to rise.

CAUTION  When you raise this processor, hold the portion from the both sides shown in the figure.  Make sure to firmly connect each connector to the specified position. Failing to do so could cause certain function to be unavailable.  Install the processor on a stable and level surface (cart, counter, stand, etc.). - Avoid places where the processor may be splashed with liquid. - Never use the processor where explosive or flammable gases are present. - Do not install the processor where it will be exposed to high temperature and humidity or direct sunlight. - Do NOT use this equipment by installing it to stand vertically. Doing so will hinder the air to vent through the ventilation grid, and eventually it will become the cause of product damage.  Never install, operate, or store electro-medical equipment in a dusty place. The accumulation of dust within the equipment may cause a malfunction, smoke, or ignition.  Do not block the air intake vents on the back and the sides of the processor.  When moving the processor, do not hold the endoscope locking lever.  Connect a water bottle assembly (OS-H5) before using the processor.  When loading the processor on a shelf of the cart, provide sufficient space for attaching or detaching the water bottle assembly (OS-H5) easily.

Preparation

10

3

 Connecting a Power Supply Connect the power cord to a suitable power outlet with a protective earth terminal that meets the power rating indicated on the rating plate or a medical grade isolation transformer. When peripheral devices are used, connect the devices to the medical grade isolation transformer of the appropriate power rating in order to reduce the risk of electric shock.

WARNING  To reduce the risk of electric shock, connect the power cord of the equipment into a power outlet with protective earth.  When peripheral devices such as a monitor are used, connect the devices to the medical grade isolation transformer of the appropriate power rating. Do not connect the devices which are not used to the isolation transformer.

CAUTION  Check that the total power consumption of all connected devices does not exceed the isolation transformer’s power rating.  Make sure that output is in compliance with IEC 60601-1.  Make sure that the power cord is connected to a suitable power outlet with a protective earth terminal.

3

Processor Peripheral Device

AC Power Cord Isolation Transformer

1 2

Power Outlet

Connect the AC power cord to the power input socket of the processor. Connect the power cord to a suitable power outlet with a protective earth terminal that meets the power rating indicated on the rating plate or a medical grade isolation transformer. • Make sure the processor is turned off beforehand. If the switch has “looseness”, the processor is turned on. If the switch has “looseness”, push the switch again and confirm there is no “looseness”. • When connecting peripheral devices to an isolation transformer, make sure the peripheral devices are turned off beforehand. For details, refer to the IFU for the peripheral devices.

11

Preparation

 Connecting Peripheral Devices Connect the peripheral devices to the processor. Make sure the processor and peripheral devices are turned off beforehand.

WARNING When connecting peripheral equipments to the processor, use only the cables specified in this IFU. If different cables are used, the equipments' resistance to the electromagnetic waves will change, and the equipments could cause adverse effect to each other. If you use different cables, please contact your local PENTAX Medical service facility.

CAUTION  Before connecting peripheral devices, check that the devices operate correctly.  Before connecting or removing peripheral devices, make sure the processor and peripheral devices are turned off.  To avoid malfunction caused by changing the connecting configuration, use after confirming the normal operation of the processor and the peripheral devices by checking adequately.  Since the processor may not operate normally if the peripheral devices are removed while in use, be sure to remove them after turning off the power.  To avoid malfunction caused by updating or upgrading of the peripheral devices, use after confirming the normal operation of the processor and the peripheral devices by checking adequately.  When used near a radio or TV receiver in clinical or residential areas, the processor may be subjected to radio interference.  To reduce electromagnetic interference, do not keep turning on the main power switch of the processor while an endoscope is connected but not ready for use.  To avoid and resolve adverse electromagnetic effects, do not operate the processor near RF (Radio Frequency) generating equipment.

 Connecting a Monitor or Recorder Connect a monitor or recorder to the processor. For details, refer to the IFU for the monitor and recorder. HD-SDI Cable OS-A85 DVI Cable OS-A78 VGA Cable OS-A74 RGB Cable OS-A25 Y/C Cable OS-A24 BNC Cable OS-A17

Monitor

CAUTION  The range of display may not match with the following connection methods because the image output specifications differ.

Connecting a monitor or recorder with an HD-SDI input connector (BNC) (recommended) Use the PENTAX Medical HD-SDI cable (OS-A85) to connect an HD-SDI connector to an HD-SDI input connector on the monitor(26”Radiance G2 HB).

Preparation

12

3

Connecting a monitor or recorder with a DVI or VGA input connector Use the PENTAX Medical DVI cable (OS-A78) to connect the DVI connector to a DVI input connector of the recorder(HVO1000MD), or use the PENTAX VGA cable (OS-A74) to connect the DVI connector to a VGA input connector on the monitor(Radiance19). Connecting a monitor or recorder with a composite video input connector Use the PENTAX Medical BNC video cable (OS-A17) to connect the VIDEO OUT/SYNC OUT connector to a video input connector on the monitor or recorder. Connecting a monitor or recorder with an RGB input connector (BNC) Use the PENTAX Medical RGB cable (OS-A25) to connect the RGB connector to the RGB input connector on the monitor. Connecting a monitor or recorder with a 4-pin female mini-DIN connector Use the PENTAX Medical Y/C cable (OS-A24) to connect a Y/C connector to the 4-pin female mini-DIN connector on the monitor or recorder.

NOTE Depending on the setting of the monitor screen, endoscopic image or text information might spill out of the screen. Adjust the display position by performing overscan/underscan adjustment or vertical/horizontal adjustment and make sure that the image as well as text is correctly displayed on the screen.

3

13

Preparation

 Connecting a Printer, USB Flash Memory or External Hard Disk Drive Connect a printer or "Image Recording Media" (P.91) to the processor. For details on a printer, refer to the IFU for the printer.

USB Cable RGB Cable OS-A25 Y/C Cable OS-A24

3

Printer

PENTAX Medical Control Cable OS-A58

USB Flash Memory or External Hard Disk Drive

Using RGB output method Use an RGB cable (OS-A25) to connect the RGB connector to the connector on the printer. Using Y/C output method Use a Y/C cable (OS-A24) to connect the Y/C connector to the connector on the printer(UP-55MD). Connecting a printer with an video input connector Connect the VIDEO OUT/SYNC OUT terminal of the processor with video input terminal of the printer (UP-25MD) using a BNC cable (OS-A17). Connecting a USB printer Use a USB cable(2.0m) to connect a USB port on the front or rear of the processor to the port on the USB printer(UP-D25MD ).

CAUTION  When using a printer, be sure to adjust the settings of the printer so that the colors in images appear the same on the monitor and in printouts.  Compatible USB printer with the processor is UP-D25MD (Sony Business Solutions Corporation).

Preparation

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Connecting USB flash memory Connect the USB flash memory(TS32GJF600) to a USB port on the front or rear of the processor. Connecting an external hard disk drive Connect the external hard disk drive (WDBBGB0030HBK) to a USB port on the front or rear of the processor.

NOTE  Some Image Recording Media may not be recognized by the processor.  It is possible that the correct data recording could be compromised because of using the USB3.0 compatible cable.

 Connecting Other Peripheral Devices For details, refer to the corresponding IFU. External network equipment

LAN Cable

Endonet system

3

RS-232C Cable External Strobe Equipment

Keyboard OS-A83 BNC Cable OS-A17

Microphone

Peripheral devices supporting remote (trigger) input Foot Switch OS-A61

Control Cable OS-A58

Connecting a keyboard Connect the PENTAX Medical keyboard (OS-A83) to the KEYBOARD connector. Connecting foot switches Connect the PENTAX foot switches (OS-A61) to the FTSW connector. Connecting a peripheral devices supporting remote (trigger) input When you want to use a peripheral device that includes support for remote (trigger) input, use a control cable (OS-A58) to connect the REMOTE connector to the remote connector on the peripheral device. For details on a peripheral device, refer to the IFU for the peripheral device. Connecting an external strobe device Connect the VIDEO OUT/SYNC OUT connector to the signal connector on an external strobe device recommended by PENTAX Medical. For details on connecting a compatible device, refer to the IFU for the compatible device. Connecting a microphone If you want to record video images with audio, connect a microphone to the AUDIO IN connector. Use a microphone (with the following specifications) recommended by PENTAX Medical. Type: Stereo mini-plug (three pins) Support for plug-in-power Microphone characteristics: Sensitivity of -40 to -50 dB(0dB = 1V/1Pa, 1kHz)

15

Preparation