Product Information. No High Definition Video Processor EPK-i5000

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Product Information No. 16-2011 Hamburg, October 20, 2011 Dear colleagues, We would like to call attention to the following new PENTAX product: High Definition Video Processor EPK-i5000 Please pass on this information to your colleagues. NOTE: According to Traceability Agreement you are obliged to give your approval for manual translations if existing. The availability of this product for sales and demo depends on your translation approval. Please communicate this to your management and all other people involved. For further questions, please do not hesitate to contact us. Best regards, PENTAX Europe GmbH LIFE CARE Steffen Helms Product Manager

PENTAX High Definition Video Processor EPK-i5000 1. Description Fig. 1: EPK-i5000 Fig. 2: Operation Panel For users that require standard functions offered by state-of-the art imaging technology in their day-to-day clinical work, the PENTAX EPK-i5000 video processor is the ideal device. This processor combines excellent illumination (Xenon 300Watt) and unique HD+ quality. It also features the innovative i-scan image processing technology which provides outstanding precision when assessing surface structures. i-scan Preset For the customer the three i-scan profiles i-scan 1, 2, 3 will be preset on the EPKi5000 and can be selected at the touch of a button either from the endoscope, the keyboard or direct from the operation panel. Fig. 3: i-scan Preset This puts an affordable technology which fulfils the customer needs for an advanced examination at its disposal. 2 / 10

Implementation of i-scan Preset As a specific feature of this video processor the presetting of three i-scan profiles is offered to the customer. These i-scan profiles correspond to the recommended settings as described in our Key Feature Card (Fig. 4) and must be set-up before or during the first installation of the video processor over the keyboard by a PENTAX authorised person. Fig. 4: Recommended i-scan Settings Card Note: Enhancement setting low for EPK-I correspond to setting +2 for EPK-i5000 Operation Panel All essential functions are easily accessible via the operation panel. Fig. 5: Operation Panel EPK-i5000 (pages refer to according owner s manual) 3 / 10

Two features to be pointed out are the Custom Button and the i-scan Buttons 1, 2, 3. Custom Button Pressing this button activates the function that was assigned by the user. The function to be assigned can be selected from the followings: No operation, SE, CE, TE, Enhancement, Counter reset, Stopwatch, Character display, Shutter mode, Freeze, USB capture, PC capture, USB printer, Out 1, Out 2, Out 3, Scope button 1, Scope button 2, Scope button 3, Scope button 4 and Procedure history. i-scan Buttons The i-scan Buttons 1, 2, 3 are placed on both the operation panel (Fig. 5) and the keyboard (Fig. 6) and will activate the according preset mode. Keyboard Fig. 6: OS-A79 Keyboard A special keyboard (OS-A79) is dedicated to the EPK-i5000 video processor and enables for an easy set-up of the menu. In particular i-scan keys 1, 2, 3 are integrated for quick and comfortable access of the three preset i-scan profiles. OSD-On Screen Display An appealing and intuitive OSD (On Screen Display) will lead through the menu setup. Selections can easily be chosen by the keyboard keys. Fig. 7: OSD On Screen Display 4 / 10

Rear Panel The video processor offers a wide range of connections: Fig. 8: Rear Panel EPK-i5000 Video Out Via DVI-D and VGA connections the HD+ video signal quality SXGA is available in conjunction with 90i endoscopes. Fig. 9: Monitor Connection 5 / 10

File Storage The video processor offers the option to transmit still images to a USB printer and a USB flash memory drive via the two serial out ports (Fig. 10). Fig. 10: File Storage The file format and compression ratio for when endoscopic images are saved can be specified from bmp, jpg(low) and jpg(high). Note: Since JPEG images are irreversibly compressed, details in the endoscopic images may sometimes be lost. Selecting the format bmp or a low compression for JPEG format is recommended. 2. Clinical applications Applications i-scan functionality (as known from EPK-i) was recognized as being very valuable The continuous light output was well accredited Reference Customers University Mainz, Germany, Prof. Kiesslich University Maastricht, The Netherlands, Dr. Sanduleanu Spedali Civili di Brescia, Italy, Dott. Foccoli/ Dr.ssa Bezzi Original Quotations excellent product! this processor perfectly fits to my needs storage on USB is easy excellent design of processor this is all I need! 6 / 10

3. Specifications Technical Specifications Lamp Xenon lamp (300 W) Model: OL-X27, OL-X28 Illumination Color temperature 6,000 K Brightness control Selection - Automatic/Manual Auxiliary lamp IEC 60825-1 White LED (Class 1) Air Feed System Air pump system DC Diaphragm Pressure setting at flow rate of 0 45-70 KPa (6.5-10.2 PSI) Standard air feed volume at inlet of water bottle Level 1: 2.0-2.8 L/min Level 2: 2.9-3.4 L/min Level 3: 3.5-4.0 L/min Level 4: 4.1-4.5 L/min Level 5: 4.6-7.2 L/min Water Feed Water bottle assembly Bottle capacity = 200ml System pressurized by pump Brightness Control Automatic Selection - Average/Peak System Manual ±5 step adjustment Color System Color correction Red/Bl ue ±5 step adjustment each Freeze Function Live video image provided while freeze mode activated. Cooling Forced air cooling Digital output DVI 1 set RGB 1 sets Video Signals Y/C 2 sets Analog output VIDEO OUT 1 set (combined SYNC OUT connector) VGA 1 set i-scan virtual chromoendoscopy Quick access via i-scan keys 1,2,3 Synchronous SYNC OUT 1 set (combined VIDEO OUT connector) Signal RS-232C 1 set RJ45 1 set Control Signals Remote 3 sets Keyboard 1 set Foot switches 1 set Image Recording USB flash memory (use Serial Output connector) Media Type of protection against Class I equipment, 3 prong plug electric shock Classification as Electro Medical Equipment Degree of protection against electric shock Degree of explosion proofing BF Type (Body Floating), using insulated endoscope. Use on heart is prohibited. Do not use in potentially flammable surroundings. The processor is not suitable for use in a mixture of air and flammable anesthetic gas or a mixture of nitrous oxide and flammable anesthetic gas. Compliance Designed in accordance with IEC60601-1 Size (excluding protrusions) 400 mm (W) 205 mm (H) 485 mm (D) Weight 22.0 kg Electro Magnetic Compatibility EN60601-1-2 7 / 10

Compatibility Endoscope Compatibility Add On Camera Compatibility PENTAX color video endoscopes (i series*, 70K**, 80K, and 90K series) PENTAX fiberscopes (with video adapter module) PENTAX PVK-1070, PVK-1070Z *The light control method of the EPK-i5000 is equal as to the EPK-1000 method (Actuator method). This method requires specific software of the 90i endoscopes which can easily be updated in field by a PENTAX authorised service technician. Actually purchased 90i endoscopes are automatically be compatible with the EPK-i5000 video processor. An update needed 90i series endoscope will display a cyan image on the monitor only when connected to the EPK-i5000 video processor. Please refer to according service note [SN622 90i series scope software update (35C014)] and the notice of modification [NOM C0-063-R1] in case of the software update is needed for previous supplied 90i endoscopes. A list of according SN is to be found in the latter document. Both documents are available from PENTAX service. **PENTAX Confocal and Ultrasound endoscopes excluded Standard Accessories Art.-No. Model Quantity Description 84513 OS-A79 1 KEYBOARD 86481 OS-A43H 1 WHITE BALANCE ADJUSTER 85006 OS-A17 1 BNC-BNC CABLE 86764 OS-A78 1 DVI CABLE 86365 OS-H4 1 WATER BOTTLE 83359 OS-I3 1 ENDOIMAGE2 86389 OL-Z3 1 CAPACITOR GROUNDING CABLE 1 POWER CABLE 2 FUSE 88258 Z964 1 OWNER'S MANUAL 88200 Z912 1 OWNER'S MANUAL FOR OS-I3 1 STANDARD SET LIST 8 / 10

The following items can be purchased separately: Art.-No. Model Quantity Description 84513 OS-A79 1 KEYBOARD 84527 OL-X27 1 LAMP CARTRIDGE 84528 OL-X28 1 300W XENON LAMP Warning: Replacement of the cartridge or lamp should only be undertaken by a PENTAX authorised person. When the lamp needs to be replaced, in order to ensure the most optimal brightness as well as the safety, PENTAX recommends the replacement of both lamp and cartridge as a set using PENTAX lamp cartridge OL- X27. However, in case only the lamp itself is replaced, the replacement lamp PENTAX OL-X28 is to be used. There is a possibility that the use of non-pentax brand lamp could cause excessive brightness and/or heat. And it is not known as to what type of adverse effect that could cause to the patients. 4. Sales Arguments Comparison to PENTAX portfolio regarding the technical specifications PENTAX PENTAX PENTAX EPK-1000 EPK-i5000 EPK-i HD+ Video* N/A SXGA (native resolution) parallel via DVI-D, VGA SXGA (native resolution) via DVI-D i-scan N/A Preset profiles 1,2,3 Full access via touch screen User Interface Operation panel, keyboard Operation panel, keyboard Intuitive touch screen, keyboard Lamp 100W Xenon 300W Xenon 300W Xenon Light Control Actuator methodcontinuous light Actuator methodcontinuous light Rotary methodstrobing light Digital Zoom N/A N/A 1.0x - 2.0x Picture in Picture (PiP) N/A N/A possible Fiberscope Connector changeable PENTAX only PENTAX only Freeze mode Field / Frame Field Field / Frame Size [mm] 380x155x420 400x205x485 430x205x485 Weight [kg] 15 22 26,5 *HD+ image quality in conjunction with 90i endoscopes 9 / 10

Comparison to competitor PENTAX EPK-i5000 OLYMPUS CV/CLV-180 FUJINON EPX-4400HD Lamp 300W Xenon 300W Xenon 300W Xenon HD Video Signal Output DVI-D, VGA HD-SDI, RGB or YpbPr DVI-D, HD-SDI SD Video Signal Output RGB, Y/C, Composite VBS composite, RGB, Y/C RGB, Y/C, Composite Advanced Imaging Processing i-scan (3 settings) NBI (one filter) FICE (10 settings) Image Recording Media USB Drive XD-Picture Card CF Memory Card Weight [kg] 22 25 (CV+CLV) 24 (VP+XL) Keywords for sales argumentation The processor combines excellent illumination and unique HD+ quality Operate i-scan quickly and comfortably by the support of the preset i-scan profiles The latest image processing technology and an outstanding price-performance ratio 5. Marketing Activities Brochure Inlay and Recommended i-scan Settings Card 10 / 10