560P High Definition Camera System Operations and Service Manual Rev H

Glossary of Symbols

Glossary of Symbols Catalog number

Color Camera

TUV Certification

On/Off

Color Bar

Serial number

Up and Down Buttons

HD-SDI output DVI output

Type CF equipment

White balance

YPrPb output

Fuse Rating T 10AH 250V

Menu

Composite video output

EU: Not for general waste

Enhancement

Bidirectional port

CE Mark

Select button

Y/C output

Ethernet port

Brightness

Power plug

Environmentally friendly use period

Do not plug in wet

Equipotentiality

Authorized representative in the European community

Alternate current

Fragile; handle with care

This way up

USB output

USB error

Temperature limitation

Humidity limitation

Lot number

Keep dry

Follow instructions for use

Operations/Service Manual   560P High Definition Camera System

10600443 Rev. H    3

Preface

Preface This manual provides the information needed to operate and maintain the Smith & Nephew 560P High Definition Camera System. Prior to using this equipment, read this manual thoroughly, paying particular attention to the operating instructions, warnings, and precautions. Smith & Nephew surgical equipment is designed for use only by medical professionals who are completely familiar with the appropriate surgical techniques and video procedures.

Table of Contents

Glossary of Symbols... 3 Preface... 4 Table of Contents... 4 Device Description... 5 Intended Use... 5 Indications for Use... 5 Contraindications... 5 Warnings... 5 Precautions... 6 System Components... 7 Accessories... 7 Unpacking and General Inspection... 7 560P High Definition Camera System... 7 Front Panel Layout... 8 Rear Panel Layout... 9 Camera Head Controls... 10 Default Live Video Functions... 10 Default OSD Menu Functions... 10 Equipment Setup... 11 IEC 60601-1 Compliant System Configuration... 11 Setup Configurations Summary... 11 Cable Connectors... 12 Connect the Video Accessories... 12 Connecting to Digital Storage Using the USB Output Connection... 13 Adjust the Monitor to the Color Bars (Optional)... 13 Tips for Adjusting Color Monitors... 14 Setup 1... 14 Equipment Used... 14 Procedure... 14 Setup 2... 16 Equipment Used... 16 Procedure... 16 Setup 3... 17 Equipment Used... 17 Procedure... 17 Preoperative Setup... 19 Safety and Service Life Checklist... 19 Initial Setup for 50/60 Hz... 19 Turn the Camera Control Unit On... 19 Power-Up Initialization... 19 Adjust the Monitor to Color Bars (optional)... 19 Prepare the Camera Head... 19 Inspect the System Components... 20 Light Source... 20 Electrical Connections... 20 Connect the Camera Head... 20 System Configuration... 20 Setting Default Startup Procedure... 20 Setting Password Protection... 20 Entering a Password... 21

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Peripheral Ports... 21 Setting Language... 21 Operation... 22 Connect the Coupler/Videoendoscope to the Camera Head... 22 Select Procedure and White Balance the Camera... 22 Live Video... 22 Camera Control Menus... 23 Startup/MAIN MENU... 24 Customize Procedure Settings... 25 System Configuration... 26 MAIN MENU and Submenus... 26 Brightness... 26 Enhancement... 27 Zoom... 27 Procedure Selection... 27 White Balance... 28 System Configuration... 28 Show Button Setup... 28 Exit... 28 Customize Procedure Settings... 29 Button Setup... 29 Display in STARTUP Menu... 29 Changing the Name of a Custom Procedure... 29 Customizing Image Quality Settings... 30 Setting Image Capture On-Screen Display... 30 USB Recording... 30 Resetting Factory Defaults... 30 Cleaning and Sterilization... 31 Cleaning the 560P High Definition Camera Control Unit... 31 Cleaning and Sterilizing the 560H 3-CCD High Definition Camera Head... 31 Troubleshooting... 32 Service and Maintenance... 33 Recommended Annual Performance Checks... 33 Replacing Fuses... 33 Technical Specifications... 34 Environmental Conditions... 34 Ordering Information... 35 560P High Definition Camera System... 35 Compatible Camera Head... 35 Guidance and Manufacturer’s Declaration... 36-37 Electromagnetic Emissions... 36 Separation Distances... 36 Electromagnetic Immunity... 37 Special Environment... 37 Warranty... Back Cover Service Replacement Units Warranty... Back Cover Service Replacement Program... Back Cover Repair Service Program... Back Cover

560P High Definition Camera System  Operations/Service Manual

Device Description

Device Description The Smith & Nephew 560P High Definition Camera System (“560P camera system”) is a state-of-the-art video system designed for use in endoscopic surgical applications. Fingertip control of camera features (enhancement features and zoom capabilities) and accessories (VCRs, video printers, and image management systems) maximize surgeon documentation. The 560P camera system operates in 60 Hz NTSC or 50 Hz PAL. The 560P camera system’s advanced high-definition digital circuitry provides exceptional color rendition and high-definition images. Advanced automatic features offer enhanced ability to customize Smith & Nephew cameras to meet individual procedural requirements. The camera system offers optimum light sensitivity to ensure sufficient light output at all times in endoscopic surgical applications. Improved camera shutters allow for smoother light compensation. Variable controls such as automatic shutter settings and light adjustments permit adaptation of the camera system to address changing conditions during surgery. Enhancement control allows enhancement of the contrast and edges of anatomical features. The digital zoom feature provides visual access to surgical sites previously difficult to visualize. The camera system incorporates four digital output ports: two HD-SDI (serial digital interface) ports, a USB (Universal Serial Bus) port, and a HD-DVI (digital visual interface) port. The USB port allows direct connection with storage devices compatible with USB 2.0 or USB 1.1. The HD-SDI ports allow high quality 1080i video to be distributed up to 300 feet using a single HD-SDI-rated coaxial cable. The HD-DVI port allows high-definition video to be directly displayed on a 1920 x 1080 pixel HD digital flat panel display in 16:9 wide screen format.

Intended Use The Smith & Nephew 560P High Definition Camera System is intended for use in endoscopic surgical procedures to allow visualization of the articular cavities, thoracic, and body cavities, hollow organs, and canals when used with an appropriately indicated endoscope.

Indications for Use The Smith & Nephew 560P High Definition Camera System is indicated for use in endoscopic surgical procedures to allow visualization of the articular cavities, body cavities, hollow organs, and canals when used with an appropriately indicated endoscope. Additionally, when used in conjunction with a Smith & Nephew light source and light cable, the 560P camera system is indicated for use in endoscopic surgical procedures in the thoracic cavity when used with an appropriately indicated thoracoscope.

Contraindications None known.

Warnings • It is the surgeon’s responsibility to be familiar with the appropriate surgical techniques prior to use of this device. • Read these instructions completely prior to use. • DANGER: Risk of explosion if used in the presence of flammable anesthetics. • Do not use this device in oxygen rich environments (>25%). • Use aseptic technique in accordance with standard operating room procedures. • To prevent electric shock, do not remove any covers or screws from the camera control unit (“CCU”) or camera head. There are no user-serviceable components inside. Dismantling the equipment will void the warranty. • To prevent electric shock, unplug the unit from the electrical outlet before attempting to replace the fuses. • To avoid fire hazard, use only fuses of the correct type, voltage rating, and current rating. • If this unit is configured as part of a system, the entire system should be tested for compliance with the medical electrical system requirements of the applicable national/regional of IEC 60601-1. • If the leakage current of the configured system exceeds the limits of the applicable national/regional version of IEC 60601-1, install an appropriately approved medical isolation transformer and retest the system. • The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety. Consider the following when choosing accessory devices: –– Use of the accessory in the patient vicinity –– Evidence that the safety certification of the accessory has been performed in accordance with the applicable national/ regional version of IEC 60601-1 and if endoscopic equipment, IEC 60601. • The use of handpieces and powered instruments, cables, and other accessories, with this equipment, other than those specified or provided by the Smith & Nephew could result in increased electromagnetic emissions or decreased electromagnetic immunity and result in improper operation. • To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. • When energized endoscopes are used with energized endotherapy devices, patient leakage currents may be additive. It should be noted that this is particularly important if a Type CF applied part endoscope is used, in which case a Type CF applied part energized endotherapy device should be used in order to minimize total patient leakage current.

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Precautions

• When energized endoscopes and/or energized endotherapy devices is/are used with laser equipment, advice concerning their safe use shall be given, including avoidance of potential eye damage to the operator by, example, wearing suitable protective filtering spectacles, or by inserting a suitable filter in the eyepiece of the energized endoscope.

Precautions

• When energized endotherapy devices are used with HF surgical equipment, the user shall refer to the user instructions provided with the surgical equipment before use.

• Prior to use, ensure that the camera control unit’s (CCU’s) air vents are clean and unobstructed. If air circulation around the CCU is insufficient, the CCU may overheat, causing degraded video or loss of video. If the CCU’s internal temperature exceeds 50° C, the message “WARNING: CCU OVERHEATING” will flash on the video display. The CCU should be shut down at the first safe opportunity and allowed to cool.

• The mains inlet is used as the means of isolation from mains. Ensure the equipment allows access to the inlet. • Electrical Interference. This equipment is designed to be used as a stand-alone, in proximity too, or in a stacked configuration with other medical equipment. Although this equipment is designed and tested to minimize interference with, or by, other electrical equipment; interference may occur. If interference occurs with other equipment it may be corrected by one or more of the following measures: –– Reorient or relocate this equipment, the other equipment, or both. –– Increase the separation between the pieces of equipment. –– Connect the pieces of equipment into different outlets or circuits. –– Consult a biomedical engineer. • Abnormal performance, due to Electromagnetic Disturbances, may be manifested by a failure to properly maintain the speed of operation of the hand pieces and powered instruments. If abnormal performance is observed, it may be corrected by one or more of the following measures. –– Reorient or relocate this equipment, the other equipment, or both. –– Increase the separation between the pieces of equipment –– Connect the pieces of equipment into different outlets or circuits. –– Consult a biomedical engineer. • High Frequency (HF) Interference: This equipment was designed and tested to be used with HF Electrical Surgical Unit (ESU) equipment. If interference occurs with other equipment it may be corrected by one or more of the following measures:

U.S. Federal law restricts this device to sale by or on the order of a physician. • Prior to each use, inspect the device to ensure it is functioning properly and is not damaged. Do not use a damaged device.

• Do not allow fluids to enter the device. Damage can result. • Electrical safety testing should be performed by a biomedical engineer or other qualified person. • All products used in conjunction with this CCU, such as video monitors, video printers, etc., are likely to have an inherent leakage current at their video connections. Connection to this CCU likely will increase the leakage current at the CCU’s chassis. • When looping the video output to more than one piece of equipment, the termination switch on the last looping piece of equipment should be in the 75U (ohm) or the ON position if the equipment provides that option. • Do not plug the camera cable connector into the CCU if wet. Moisture on the connector pins of the camera cable will damage the circuitry and void the warranty. Ensure that the connector pins are completely dry before plugging the camera head into the camera control unit. • Environmental Protection: This equipment contains electronic printed circuit assemblies. At the end of the useful life of this equipment, it should be disposed of in accordance with any applicable national or institutional policy relating to obsolete electronic equipment. • Products may wear over time as a result of normal use. Periodic retesting to the applicable national/regional version of IEC 60601-1 is recommended. • If the arthroscope becomes too hot during use, light source brightness is set too high and should be decreased. • Before each use, the compatibility of the endoscopic equipment, with any accessories and/or energized endotherapy devices should be checked according to any criteria for safe use defined in the instructions for use.

–– Reorient or relocate this equipment, the other equipment, or both. –– Increase the separation between the pieces of equipment. –– Connect the pieces of equipment into different outlets or circuits. –– Consult a biomedical engineer.

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560P High Definition Camera System  Operations/Service Manual

System Components

System Components

560P High Definition Camera System

The 560P camera system is configured to be connected as a stand-alone system on an endoscopic cart or tower. It is designed for use with the Smith & Nephew 560H 3-CCD High Definition Camera Head (“560H camera head”).

1 ea

Smith & Nephew 560P Camera Control Unit, 50/60 Hz (REF 72201919)

1 ea

Hospital-grade power cord, country-specific

1 ea

Smith & Nephew 560P Camera System Operations/Service Manual, country-specific version (REF 10600443)

1 ea

HD-SDI coaxial cable, 10 ft (REF 72201420)

For more information regarding any of these devices, see the Instructions for Use included with the device.

2 ea

3.5 mm mini-phono plug to 3.5 mm mini-phono plug accessory cable, (1.8 m) (REF 7206083)

The 560P camera system provides controls for setting brightness, enhancement, zoom, procedure selection, white balance, system configuration, button setup, and procedure customization.

1 ea

USB cable, 3 ft extension (REF 91001602)

The 560P camera system is designed to be used in conjunction with various peripheral devices, including the 560H camera head, Smith & Nephew’s 300 watt xenon light source, various flat panel displays, image capture devices, and print and video recording devices.

The following parts should have been received:

The camera system has been designed to meet IEC 60601 safety and performance standards for medical equipment. The CE mark on the camera system signifies compliance to the Medical Device Directive 93/42/EEC.

Accessories See the “Ordering Information” section of this manual for more information about cameras, couplers, video cables, and other cables.

Unpacking and General Inspection Prior to using the 560P camera system, it is essential that all system components be inspected for damage, which can negatively impact the system’s performance. Inspection should include all equipment to be used in surgery, including cables and peripheral devices. 1. Remove the CCU and accessories from the shipping container. Be certain to open and inspect all boxes and sealed plastic bags to ensure that all components are accounted for. Save the carton and packing materials in the event a component needs to be returned for repair. 2. Inspect all video components for damage during shipment. Contact an authorized Smith & Nephew representative if damage is noticed. If any parts are missing or damaged, contact an authorized Smith & Nephew representative. For more information regarding a component, consult the Instructions for Use provided with the component.

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Front Panel Layout

Front Panel Layout

Figure 1.  Smith & Nephew 560P Camera Control Unit Front Panel

Front Panel Control/Connector/Display

Function

1

Power Up/Power Down

Turns the control unit on and off. The power switch illuminates green when the control unit is on.

2

OSD MENU Button (UP)

The UP button causes the cursor to scroll up through the available menu selections after the OSD (On-Screen Display) menu has been accessed via the SELECT button. When the end of a menu is reached, the next UP button press will bring the user to the bottom of the menu.

3

OSD MENU Button (SELECT)

The SELECT button calls up the top-level OSD menu. When the OSD menu is present, the SELECT button selects the highlighted menu choice.

4

OSD MENU Button (DOWN)

The DOWN button causes the cursor to scroll down through the available menu selections after the OSD menu has been accessed via the SELECT button. When the end of a menu is reached, the next DOWN button press will bring the user to the top of the menu.

5

Selected Procedure/Name Display

The top line of the LCD (liquid crystal display) displays the name of the default or custom procedure that is currently selected.

6

Brightness Level Display

The number at the bottom left of the LCD screen, above the BRIGHTNESS buttons, indicates the current Brightness setting.

7

Enhancement Level Display

The number at the bottom right of the LCD screen, above the ENHANCEMENT buttons, indicates the current Enhancement setting.

8

WHITE BALANCE Button

The WHITE BALANCE button automatically adjusts the camera for optimal white balance when the button is depressed. The camera must be focused on a white object.

9

COLOR BAR Button

The COLOR BAR button displays the SMPTE color bar on the monitor. Press the button a second time to remove the color bar from the monitor.

10

BRIGHTNESS UP/DOWN Buttons

The BRIGHTNESS UP and DOWN buttons increase or decrease the brightness of the image.

11

ENHANCEMENT UP/DOWN Buttons

The Enhancement function enhances the appearance of detail in the image. Set the desired enhancement level using the ENHANCEMENT UP and DOWN buttons. When one of the buttons is pressed, a bar graph on the left side of the display indicates the current enhancement level.

12

Camera Cable Connector Receptacle

Compatible Smith & Nephew camera heads can be connected via the card edge connector. Be sure the connector cable side labeled UP faces up ( ). Then firmly push the cable connector into the keyed receptacle.

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Rear Panel Layout

Rear Panel Layout

Figure 2. 560P High Definition Camera Control Unit Rear Panel

Rear Panel Connections

Function

1

YPrPb Output

Video output format to provide 1080i format displayable only on HDTV equipment. HD-15 connector/YPrPb.

2

Y/C Outputs (2)

Video output providing standard definition Y/C (S-Video or S-VHS (Super VHS)) analog output for video peripherals that use Y/C (S-Video) signals, such as S-VHS VCRs and Y/C monitors. Mini-DIN 4-pin connector.

3

USB Output

Video output provides communication with USB 2.0 or USB 1.1-compatible storage devices.

4

HD-DVI Output

High definition digital visual interface (1080i) output for DVI-compatible HD digital displays. DVI-I connectors support DVI-D (DVI-Digital) single-link interfaces.

5

HD-SDI Output (2)

Two HD serial digital interfaces with 1080i digital video output for HD-SDI-compatible video displays or video transmission equipment. HD-SDI/BNC connector.

6

Peripheral Controls (2)

Two standard 3.5 mm mini-phono plug peripheral cable connectors allow control of peripheral devices such as printers and image capture devices from the camera head.

7

Composite

Standard composite video (CV) provides color video output for use with composite video input of the video monitor. BNC connector.

8

Ethernet Port

Ethernet network connection for firmware updates. CCU firmware updates should be performed only by qualified personnel.

9

RS-232 Output

RS-232 serial communication port provides the following: •

Communication with external devices such as printers or image capture devices enabling OSD messages on one or more video displays for visual feedback

•

Serial communication with the Digital OR server including button activation signals

•

Setting CCU control parameters using an external laptop with a terminal program

•

Communication with 500XL light source for light standby control and Brightness control from the 560H camera head buttons.

10

Equipotential Compensator Terminal (case ground)

Used to bring other equipment to the same case potential as the device.

11

Fuse Holder

Clip holds dual fuse. See “Technical Specifications.”

12

Power Cord Connector

Accommodates the hospital grade power cord accessory. This receptacle is an integral part of the power input module.

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Camera Head Controls

Camera Head Controls The camera head buttons perform two different sets of functions, depending upon whether the OSD menu or live video is displayed on the screen. Middle Bezel

Right

Left

Figure 3.  560H Camera Head

Default Live Video Functions Camera Head Control

Short Press (<1.5 seconds)

Long Press (>1.5 seconds)

Left Button

Single image capture (ACC1)

Light mode standby (500XL only)

Middle Button

Brightness (Up/Down)

Main menu

Right Button

Video loop capture (ACC2)

White balance

Default OSD Menu Functions Camera Head Control

Default Button Function

Left Button

Move the cursor UP to highlight a menu choice.

Middle Button

SELECT the highlighted menu choice.

Right Button

Move the cursor DOWN to highlight a menu choice.

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560P High Definition Camera System  Operations/Service Manual

Equipment Setup

Equipment Setup IEC 60601-1 Compliant System Configuration

Setup

Equipment Used

Setup 1

560P Camera Control Unit Smith & Nephew 660HD Image Management System

Warnings

HD Flat Panel Display

• If this unit is configured as part of a system, the entire system should be tested for compliance with the medical electrical system requirements of the applicable national/regional of IEC 60601-1.

Setup 2

• If the leakage current of the configured system exceeds the limits of the applicable national/regional version of IEC 60601-1, install an appropriately approved medical isolation transformer and retest the system.

Setup 3

560P Camera Control Unit USB Media Device (customer-supplied) USB Cable, 3-foot extension 560P Camera Control Unit Video Printer Flat Panel Display

• The use of accessory equipment not complying with the equivalent safety requirements of this equipment may lead to a reduced level of safety. Consider the following when choosing accessory devices: –– Use of the accessory in the patient vicinity –– Evidence that the safety certification of the accessory has been performed in accordance with the applicable national/ regional version of IEC 60601-1 and if endoscopic equipment, IEC 60601.

Setup Configurations Summary The 560P camera system can be used with a wide variety of peripheral components to broaden the capabilities of the video system. Each setup is dependent upon the peripherals included in the video system. The following pages explain and illustrate how to set up the CCU and peripheral equipment. Three variations of equipment configurations are presented. Select the most appropriate configuration. If none of these configurations is appropriate, contact an authorized Smith & Nephew representative for assistance with assembling the system to optimize system function.

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Equipment Setup

Cable Connectors The 560P camera system uses the following types of cables: BNC/SDI/ HD-SDI coaxial cables; mini-phono plug cables; S-VHS cables with a 4‑pin mini-DIN connector, RS-232 DB-9 connector, HD-DVI, HD-SDI, or YPrPb HD-15 connectors. The illustrations below show how to connect these video cable connectors.

USB Type A

To connect, push in firmly.

Connect the Video Accessories

BNC/SDI/HD-SDI

Install the video accessories using the diagrams in this section as a guideline. See the diagrams for multiple peripheral setups and configurations. Below are some tips regarding video setup:

To connect, push in and turn.

RS-232 DB-9

• When connecting video accessories (monitors, VCRs or printers) to the 560P camera system, always connect the cables using the video camera outputs to the video inputs of the peripheral equipment. CAUTION: When looping the video output to more than one piece of equipment, the termination switch on the last looping piece of equipment should be in the 75U (ohm) or the ON position if the equipment provides that option.

To connect, align pins properly, push in firmly, and hand-tighten the thumbnail screws.

Mini-Phono Plug

To connect, push in firmly.

• If there is not a 75U or ON switch, the equipment is self-terminating and this step is not required. • When using monitors or printers having YPrPb settings, connect the YPrPb outputs on the CCU directly to the YPrPb inputs of the accessory monitor or printer. Use a HD-15/RGB cable because the CCU’s YPrPb output is standard on HD-15 cable connectors. • When connecting Super VHS recorders (S-VHS), monitors or printers, connect the 4-pin mini-DIN Y/C (S-Video) connectors directly to the Y/C (S‑Video) input of the accessory equipment. • Y/C hue is adjusted using the hue (tint or phase) button on the monitor. Adjust the hue until desired color is achieved.

4-Pin Mini DIN

To connect, align pins properly, then push in firmly.

HD-DVI

To connect, align pins properly, push in firmly, and hand-tighten the thumbnail screws.

YPrPb HD-15

To connect, align pins properly, push in firmly, and hand-tighten the thumbnail screws.

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Equipment Setup

Connecting to Digital Storage Using the USB Output Connection

Adjust the Monitor to the Color Bars (Optional)

When connecting a digital video storage device to the control unit via the USB output port, please be aware of the following communication requirements: • Use a USB flash drive (2 GB minimum) or an external USB hard drive.

Use the color bars to test and adjust the color on the monitor to the desired contrast, sharpness, and color levels. 1. Turn the monitor power on. 2. Color bars will display on the monitor.

• USB hard drives that require more than 2.5 W (0.5 Amp) must have a separate power supply.

3. Set the monitor display to the desired viewing levels by adjusting the contrast, sharpness, and color levels. If the monitor has a Reset button, pressing the Reset button to adjust the colors to the factory setting will often produce the desired quality.

• The maximum recording time for each MPEG4 is 1.5 hours and 2 GB. Multiple MPEG4 files may be recorded.

Tips for Adjusting Color Monitors

• The USB device must have a minimum of 256 MB of free space.

• Wait at least 30 seconds after camera system power-up before beginning USB recording. When the system is ready to record, a green USB icon will appear in the lower right corner of the flat panel display. • Do not remove USB media while actively recording. • Do not use a multiplex USB HUB or multicard reader. These will not function correctly and will interfere with USB recordings.

• Connect the monitor in accordance with its instruction manual, setting the termination switch as explained in the “Electrical Connections” section. • Begin with contrast (picture) and brightness controls in the middle or mid-detent position. Adjust brightness slightly so that darker parts of the image are visible but not milky or washed out. • Set the contrast so that the overall image brightness is desirable. In most cases, contrast set to 50% or higher is preferable. Note: Long term use with the contrast set too high will reduce the life of the monitor.

Software Requirements PC with Windows Operating System Mplayer Portable 1.0 RC2 and Elecard MPEG Player will play back the video captured from the 560P Camera System (REF 72201919). Mplayer Portable 1.0 RC2 is freeware that can be downloaded from the internet and installed to the PC, USB flash drive, or portable USB hard drive to which the video will be saved. If downloaded to the hard drive, the video can be played back on any PC. Mplayer Portable 1.0 RC2 can be downloaded from http://portableapps.com/apps/music_video/mplayer_portable.

• Y/C color saturation is adjusted with the chroma (color) adjustment knob or button. Decreasing this setting will reduce the amount of overall color perceived in the image. In the fully decreased position, the image will be black and white. Too much color saturation makes the image uncomfortable to view and the colors will appear noisy or smeared. • Y/C hue is adjusted using the hue button on the monitor. Adjust the hue until desired color is achieved.

The Elecard MPEG Player trial version can be downloaded from http://www.elecard.com download/index.php and installed to the PC.

Mac Computer Mplayer 2.0b8r5 is required to play back video captured from the 560P Camera System (REF 72201919). This freeware can be downloaded and installed on a Mac computer from http://www.download.com/ MPlayer/3000-7970_4-10199667.html?tag=mncol. See the “Operation” section of this manual for details of the USB recording procedure.

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Equipment Setup

Setup 1

4. To record still images from the camera, connect the 3.5 mm mini-phono plug from the CCU’s Peripheral Controls 1 output to the image management system’s Still Capture IN port.

Equipment Used • 560P Camera Control Unit • Smith & Nephew 660HD Image Management System • HD Flat Panel Display

Procedure Note: For best image, use a HD-DVI signal (CCU output to monitor input). A direct connection between the CCU and a high definition monitor will always produce the highest quality image. Note: It is strongly recommended that a minimum of two outputs be connected at all times to provide a back-up signal if necessary. 1. Connect the supplied hospital-grade power cord to the power receptacle on the CCU’s rear panel. 2. Connect the supplied hospital-grade power cord to the power receptacle on the 660HD Image Management System and plug it in.

5. To record live video images from the camera, connect the 3.5 mm mini-phono plug from the CCU’s Peripheral Controls 2 output to the image management system’s Video Capture IN port. Optional: If not using a direct HD-SDI connection between the CCU and the HD flat panel display, connect the HD‑DVI cable from the DVI OUT port on the CCU to the DVI-D IN port on the flat panel display. Then connect the HD-SDI OUT port on the CCU to the HD-SDI IN port on the image management system. 6. Connect the supplied hospital-grade power cord to the power receptacle on the flat panel display and plug it in. 7. If the flat panel display has a termination switch, set it to the 75Ω or ON position. 8. After connecting all peripheral components, turn the video components on using the appropriate power switches.

3. Loop the CCU through the HD flat panel display by connecting the supplied HD-SDI coaxial cable from the HD-SDI OUT port on the CCU’s rear panel to the HD flat panel display’s HD-SDI IN port. Connect the supplied HD-SDI coaxial cable from the HD-SDI OUT port on the HD flat panel display’s rear panel to the HD-SDI IN port on the 660HD Image Management System. Note: Alternatively, the 560P CCU can be connected to the 660HD Image Management System, then to the flat panel display, using HD-SDI connectors.

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Equipment Setup

Endoscopy Smith & Nephew, Inc. 150 Minuteman Road Andover, MA 01810 USA 85000960 Rev. F 06/2012

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Equipment Setup

Setup 2

3. Route the USB cable to the front panel of the CCU. 4. Connect either a USB flash drive or external USB hard disc drive to the USB cable.

Equipment Used • 560P Camera Control Unit • USB Media Device (customer-supplied) • USB Cable, 3-foot extension

Note: If the external USB hard disc drive requires more than 2.5 W (0.5 amp), plug the device into an isolation transformer power supply. 5. Turn on the CCU. Wait 30 seconds for the USB to start up. When the green USB icon appears on the display screen, begin recording.

Procedure Note: Use only USB flash drives (2 GB minimum) or an external USB hard drive. Do not use a multiplex USB HUB or multicard reader. These will not function correctly and will interfere with USB recordings. 1. Connect the supplied hospital-grade power cord to the power receptacle on the rear panel of the CCU. 2. Connect a USB, 3-foot extension cable to the USB output connector on the rear panel of the CCU.

560P Control Unit

External USB Hard Drive Flash

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Equipment Setup

Setup 3

4. Loop the CCU through the video printer or other device to provide a backup connection or if screen overlays from a video printer or other peripheral device are desired.

Equipment Used

Connect a Y/C coaxial cable from the Y/C-Video OUT connector on the rear panel of the CCU to the S-Video IN port on the rear panel of the video printer. Then connect a Y/C cable from the S-Video OUT port on the video printer to the S-Video IN port on the rear of the flat panel display.

• 560P Camera Control Unit • Flat Panel Display • Video Printer

Procedure Note: For best image, use a HD-DVI signal (CCU output to monitor input). A direct connection between the CCU and a high definition monitor will always produce the highest quality image. Note: It is strongly recommended that a minimum of two outputs be connected at all times to provide a back-up signal if necessary. 1. Connect the supplied hospital-grade power cord to the power receptacle on the CCU rear panel. 2. Connect the supplied hospital-grade power cord to the power receptacle on the flat panel display and plug it in. Note: One or more monitors may be connected to the available YPrPb, video, Y/C, HD-DVI, and HD‑SDI output ports on the rear panel of the CCU.

Note: Use Y/C/S-Video connection only as a backup line in the event of difficulties with the picture in DVI or HD-SDI. 5. If the flat panel display has a termination switch, set it to 75U or ON position. 6. Connect the video printer to the CCU using the supplied 1/8‑inch (3.5 mm) mono mini plug cable. Connect the cable from the Peripheral Controls 1 on the CCU to Remote 1 on the video printer. Note: The printer may need to be turned on after the camera system is turned on. 7. Turn on the video components using the appropriate power switches and verify proper operation.

3. Connect the CCU to the flat panel monitor. Connect the HD-DVI/HD-SDI DVI cable supplied with the flat panel display to the HD-DVI/HD-SDI DVI output port on the rear of the CCU. Press the input button on the front panel of the flat panel display to select DVI or A-1/HD-SDI to display the digital video.

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Equipment Setup

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560P High Definition Camera System  Operations/Service Manual

Preoperative Setup

Preoperative Setup

4. Turn on the CCU by pressing the power button on the front panel of the CCU. The power button illuminates green and color bars will appear on the monitor screen.

Safety and Service Life Checklist

Note: Color bars will not appear if the camera head is already plugged into the CCU.

Before each case begins, check the following items to ensure that they function properly and are safe to use: Plug in the light guide and ensure that the light illuminates. Confirm that the video works correctly and that visualization is correct. Check front panel to ensure that all buttons and connectors are functioning properly.

Power-Up Initialization Upon power-up, the Smith & Nephew logo flashes on the surgical display screen, then a startup screen appears. The startup screen remains on the display until a procedure is selected.

Check the OSD status bar to confirm that the USB device is detected. Check for any damage to the camera head and cable (burn holes, cracks, button damage, corrosion, buildup or damage to the card edge connector). Check that the labeling information on the camera head connector is still readable. Ensure there are no deposits, scratches, or fogging/humidity on the front window of the camera head.

Initial Setup for 50/60 Hz All new or serviced 560P camera control units are shipped in 60 Hz NTSC. If 50 Hz PAL is required, follow the steps below to set the unit to 50 Hz PAL. 1. Set up the CCU and flat panel display and plug them in. 2. Simultaneously press and hold the WHITE BALANCE and COLOR BAR buttons on the front panel of the CCU while turning on the CCU. Hold the WHITE BALANCE and COLOR BAR buttons until the message “CHANGE 50/60 Hz” appears on the top line of the LCD screen. Note: Do not turn on the flat panel display. 3. Release WHITE BALANCE and COLOR BAR buttons. 4. Press the MENU UP or DOWN buttons to highlight 50 Hz. 5. Press the MENU SELECT button to select 50 Hz. The message “PASSED/RESTART CCU” will appear on the LCD screen. 6. Turn off the CCU. 7. Turn on the CCU. The CCU is now set to 50 Hz PAL mode and is ready for use.

After a procedure is selected, the screen displays either live video or a color bar pattern, depending on whether or not a camera head is plugged in. If a camera head is plugged into the CCU when the CCU is turned on, the screen will display live video. If a camera head is not plugged in, or if the camera head is unplugged while the CCU is on, the screen will display a color bar pattern. If the camera head is plugged in while the color bar is displayed, the CCU switches to live video, and live video will be displayed.

Adjust the Monitor to Color Bars (optional) Adjust the color bars on the flat panel display if desired. See “Adjust the Monitor to the Color Bars” and “Tips for Adjusting Color Monitors” in the “Equipment Setup” section of this manual.

Prepare the Camera Head Clean and sterilize the 560H camera head (REF 72200561) following the Cleaning and Sterilization procedures received with the camera head. Dry the card edge before inserting into the CCU. Ensure that no moisture remains on the camera cable connector card edge.

8. Turn on the flat panel display. To reset the CCU to 60 Hz NTSC, follow the same steps, except in Step 4 select 60 Hz.

Turn the Camera Control Unit On 1. Plug the female end of the power cord into the power receptacle on the CCU rear panel. 2. Verify that the power outlet corresponds to the data specified on the rear panel label and that the third pin on the plug is properly grounded. 3. Plug the power plug into a hospital-grade AC power outlet.

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Preoperative Setup

Inspect the System Components

To change the default startup procedure

CAUTION: Prior to each use, inspect the device to ensure it is functioning properly and is not damaged. Do not use a damaged device.

1. From the SYSTEM CONFIGURATION MENU, select SET DEFAULT START UP PROCEDURE. 2. Press UP or DOWN to highlight the desired procedure.

Light Source Verify that the light source is producing the correct amount of light. Factors that can affect the light output include: • Improper bulb placement • Blown fuses and/or thermocouples • Worn-out or burned-out bulbs If problems occur, refer to the light source manufacturer’s Operations Manual.

Electrical Connections Examine the electrical connections: • Electrocautery and other electrical noise-inducing medical equipment can interfere with the performance of CCUs and monitors. To prevent interference, plug monitors and camera equipment into an outlet on a wall separate from noise-inducing equipment.

3. Press SELECT to select the procedure.

Setting Password Protection Use this function to configure the system to require a password or to change the password. Passwords must be between one and eight characters long.

To turn on password protection 1. From the SYSTEM CONFIGURATION MENU, select SET/CHANGE PASSWORD PROTECTION. 2. Press SELECT to activate PASSWORD REQUIRED. 3. Use the UP or DOWN button to select YES. 4. Press SELECT to activate the setting. 5. Enter the new password by pressing the UP or DOWN button to scroll to the desired character. The following characters are available for use: A BCD EFGH IJKL M N OP QR STUV WX Y Z8 ! . , '

• Check that the electrical equipment is properly grounded (i.e., plugs contain a ground prong). The camera must be plugged into a hospitalgrade AC outlet.

6. Press SELECT to select the character.

• If the monitor has a termination switch, it needs to be set to 75U. If two or more monitors are used, only the termination switch on the last monitor needs to be on. If there is no termination switch on the last monitor, the monitor is self-terminating.

8. When the entire password has been entered, use the UP or DOWN button to scroll to the “enter” arrow (8 ) and press SELECT.

7. Repeat Steps 5 and 6 for additional characters. To delete a mistake, select the backspace arrow (!).

• Double-check the equipment setup diagrams to ensure that all connections are correct.

9. Select ENTER to save the password and return to the SYSTEM CONFIGURATION MENU. Select CANCEL to exit the screen without saving any changes.

Connect the Camera Head

Once a password has been established, the password will be required in order to change a procedure or reset factory defaults.

Connect the camera cable to the CCU by inserting the card edge at the end of the camera cable connector, with the arrow facing up, into the CCU’s front panel camera cable receptacle (Figure 1). Push in firmly. Note: If you are unfamiliar with cable connectors, see the “Equipment Setup” section of this manual.

System Configuration The SYSTEM CONFIGURATION MENU allows access to many of the system settings, including the default startup procedure, password protection, accessory ports, language, and service. Factory defaults for system settings may also be reset using the SYSTEM CONFIGURATION MENU. To access the SYSTEM CONFIGURATION MENU, select MENU ACCESS from the STARTUP menu to access the MAIN MENU. From the MAIN MENU, select SYSTEM CONFIGURATION.

Setting Default Startup Procedure By default, the HIGH DEFINITION procedure loads during startup unless a different procedure is selected. The default startup procedure may be changed to any procedure.

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To change the password 1. From the SYSTEM CONFIGURATION MENU, select SET/CHANGE PASSWORD PROTECTION. 2. Press SELECT to activate PASSWORD REQUIRED. 3. Use the UP or DOWN button to select YES. 4. Press SELECT to activate the setting. 5. Enter the old password by pressing the UP or DOWN button to scroll to the desired character. 6. Press SELECT to select the character.

560P High Definition Camera System  Operations/Service Manual

Preoperative Setup

7. Repeat Steps 5 and 6 for additional characters. To delete a mistake, select the backspace arrow (!).

4. When the entire password has been entered, use the UP or DOWN button to scroll to the “enter” arrow (8 ) and press SELECT.

8. When the entire password has been entered, use the UP or DOWN button to scroll to the “enter” arrow (8 ) and press SELECT.

5. Select ENTER to save the password and exit the ENTER PASSWORD menu. Select CANCEL to exit the screen without entering a password.

9. Press SELECT to enter the new password. Select CANCEL to exit CHANGE PASSWORD and return to the SYSTEM CONFIGURATION MENU.

Note: If an incorrect character is selected, the system will delete the entire password. Re-enter the password from the beginning.

10. Enter the new password by pressing the UP or DOWN button to scroll to the desired character. 11. Press SELECT to select the character. 12. Repeat Steps 10 and 11 for additional characters. To delete a mistake, select the backspace arrow (!). 13. When the entire password has been entered, use the UP or DOWN button to scroll to the “enter” arrow (8) and press SELECT. 14. Select ENTER to save the new password and return to the SYSTEM CONFIGURATION MENU. Select CANCEL to exit the screen without saving any changes.

To turn off password protection 1. From the SYSTEM CONFIGURATION MENU, select SET/CHANGE PASSWORD PROTECTION. 2. Press SELECT to activate PASSWORD REQUIRED. 3. Use the UP or DOWN button to select NO. 4. Press SELECT to activate the setting. 5. Enter the current password by pressing the UP or DOWN button to scroll to the desired character.

Peripheral Ports Two peripheral ports are provided on the rear panel of the CCU. These ports can be activated by a short-press of a camera head button. Ports 1 and 2 can be configured to activate either of the following functions: FRAME CAPTURE: One still frame is captured when the button is pressed. The three-digit counter in the top left corner of the monitor increases by one if the CCU has initiated image capture, and if OSD is set to ON. If Freeze Frame is enabled as a customized setting, the video freezes for 0.5 seconds when the button is pressed. VIDEO CAPTURE: A video loop or clip capture begins when VIDEO CAPTURE is enabled and the button is pressed. The word REC will appear in the top right corner of the monitor while recording if OSD is set to ON. When the button is pressed again, the recording stops and REC disappears. Still frame capture or video capture devices can be connected to Port 1 and Port 2. The image counter or REC message for the device connected to Port 1 will display in the upper left corner of the monitor. The image counter or REC message for the device connected to Port 2 will display in the upper right corner of the monitor. The OSD must be set to ON for this information to appear.

6. Press SELECT to select the character.

Setting Language

7. Repeat Steps 5 and 6 for additional characters. To delete a mistake, select the backspace arrow (!).

Use the LANGUAGE MENU to change the system language from the default setting. Select a language from the following menu:

8. When the entire password has been entered, use the UP or DOWN button to scroll to the “enter” arrow (8) and press SELECT. 9. Select ENTER to return to the previous menu. 10. Select ENTER to turn off password protection. Select CANCEL to retain the password and return to the SYSTEM CONFIGURATION MENU.

Entering a Password If the system is configured to require a password, the password must be entered before the procedure settings can be changed.

To enter a password 1. Press the UP or DOWN button to scroll to the desired character. 2. Press SELECT to select the character. 3. Repeat Steps 1 and 2 for additional characters. To delete a mistake, select the backspace arrow (!).

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