1288 HD Camera Head User Guide Rev D Aug 2010

Contents Warnings and Cautions... 3 Product Description and Intended Use... 6 Indications/Contraindications...7 The Camera Console...8 The Camera Head...10 The C-Mount Coupler...11

Setup and Interconnection... 12 Setting Up the Console...12 Setting Up the Camera Head...17 Setting Up the Coupler...18

Operation... 20 Powering the Camera On/Off...20 Using the Camera Head Buttons...20 Using the Touchscreen Interface...22 Controlling Remote Video Accessories...26 Using the SFB Serial Interface...26 Using the DVI Fiber Outputs...26

Operating the Camera with a Light Source... 27 Troubleshooting... 28 Cleaning, Reprocessing, and Maintenance... 31 Cleaning the Camera Console...31 Reprocessing the Camera Head...31 Using Sterile Drapes...38 Replacing the Fuses...39 Periodic Maintenance Schedule...39

Electromagnetic Compatibility... 42 Warranty and Return Policy... 46

Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meaning and should be carefully reviewed: Warning

Indicates risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user.

Caution

Indicates risks to the equipment. Failure to follow cautions may result in product damage. Note: Provides special information to clarify instructions or present additional useful information. An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual. A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel. IMPORTANT SAFETY NOTICE: Before operating this device, please read this operating manual thoroughly and carefully. When using this device with a light source, fire and/or severe injury may result to the patient, user, or inanimate objects if the instructions in this manual are not followed. All light sources can generate significant amounts of heat at the scope tip, the scope light post, the light cable tip, and/ or near the light cable adapter. Higher levels of brightness from the light source result in higher levels of heat. Always adjust the brightness level of the camera and the monitor before adjusting the brightness level of the light source. Adjust the brightness level of the light source to the minimum brightness necessary to adequately illuminate the surgical site. In addition, adjust the internal shutter of the camera higher in order to run the light source at a lower intensity. Avoid touching the scope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user. In addition, never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other flammable material, as doing so may result in fire. Always place the light source in standby mode whenever the scope is removed from the light cable or the device is unattended. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in standby mode, and therefore may still result in fire or burns to the patient, user, or inanimate objects.

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Warnings

To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings: 1. Carefully unpack this unit and check if any damage occurred during shipment. If damage is detected, refer to the Warranty and Return Policy section of this manual. 2. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this equipment. 3. Be a qualified physician, having complete knowledge of the use of this equipment. 4. Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment. Never use this equipment in the presence of flammable or explosive gases. 5. Avoid dissembling any part of the camera head, as doing so may break the seals, causing leakage and/or electric shock. 6. Avoid removing covers on the control unit, as doing so may cause damage to electronics and/or electric shock. 7. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. 8. Pay close attention to the care and cleaning instructions in this manual. Any deviation may cause damage. 9. Never sterilize the camera console, because the delicate electronics cannot withstand this procedure. 10. Disconnect the control unit from the electrical outlet when inspecting the fuses. 11. Before each use, check the outer surface of the endoscope to ensure that there are no rough surfaces, sharp edges, or protrusions. 12. Avoid dropping the camera system. The camera system contains sensitive parts that are precisely aligned. 13. Ensure that readjustments, modifications, and/or repairs are carried out by persons authorized by Stryker Endoscopy. 14. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines. 15. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 16. Multiple portable socket-outlets shall not be placed on the floor. The warranty is void if any of these warnings are disregarded. 4

Symbol Definitions In addition to the cautionary symbols already listed, other symbols found on the 1288 HD Camera and in this manual have specific meanings that clarify the proper use and storage of the 1288 HD Camera. The following list defines the symbols associated with this product: Operating humidity ratings

Operating pressure ratings Operating temperature ratings

Denotes compliance to CAN/CSA C22.2 No 601.1- M90 UL60601-1. Type BF applied part

Equipotentiality

Protective Ground Earth

FireWire

Fuse rating

This symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your equipment. 5

Product Description and Intended Use

The Stryker Endoscopy 1288 HD Medical Video Camera is a high-definition camera used to capture still and video images of endoscopic surgical applications. The 1288 HD Medical Video Camera consists of three main components: Component

Stryker Part Number

Camera console

1288010000; 1288010001

Camera head

1288210105, 1288710105

C-mount coupler

1288020122

The 1288 HD also comes with various connection cables which, like the other components, can be purchased together or separately. Federal law (United States of America) restricts this device to use by, or on the order of, a physician.

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Indications/Contraindications

The 1288 HD Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope is indicated for use. A few examples of the more common endoscopic surgeries are laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic lymph node dissection, laparoscopically assisted hysterectomy, laparoscopic and thorascopic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression fixation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass grafting where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement. The users of the camera are general surgeons, gynecologists, cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT surgeons and urologists. There are no known contraindications.

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The Camera Console

The camera console or Camera Control Unit (CCU) is the control center for the 1288 HD Medical Video Camera and processes the video and photographic images captured during the surgical procedure. The console front panel features a touch screen, where different menus can be accessed, including the controls for adjusting the enhancement level, light level, zoom, and white balance, as well as allows the selection of surgical specialty settings that optimize camera performance for various, specific surgical procedures. The front panel also allows activation of remote outputs. The rear panel provides ports for connecting the 1288 HD Camera to viewing and recording equipment, such as video monitors, the SDC Ultra, or photo printers.

Front Panel

1

2

3

1. Power Switch

Powers the camera ON and OFF

2. Touch Screen

Allows navigation through different menus for controlling the camera and adjusting the system settings

3. Camera Connector Port

Connects to the 1288 HD Camera Head

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Rear Panel

12 1

2 3 4 5 6 7 8 9 10 11 1. SFB Connectors

Enables FireWire connection with Stryker FireWire devices; provides connection for remote diagnoses and future software upgrades

2. SIDNE® Port

Connects to the SIDNE® Console to enable voice operation and/or graphic tablet control

3. Remote Out 1

Connects to a video accessory remote switch

4. Remote Out 2

Connects to a video accessory remote switch

5. S-Video Out

Analog video output

6. DVI Out 1

Digital video output

7. DVI Out 2

Digital video output

8. Display Port

Digital video output

9. AC Power Inlet

Connects to seperable power cord, which can be used for mains isolation

10. Fuse Panel

Contains two 0.63 A fuses

11. Equipotential Ground Plug 12. Fiber Outputs (optical)

DVI output for connection to Lucent connector fibers (optional: 1288010001)

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The Camera Head The camera head connects to the camera console and captures video and photographic images, which it relays to the camera console. It features several controls that are accessible through a button keypad located on the top of the camera head (see the “Operation Instructions” section of this manual).

1

2

3

4

1. Soaking Cap

Protects the cable connector during cleaning and sterilization

2. Cable Connector

Connects the camera head to the camera console

3. Camera Cable 4. Camera Head

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Captures photographic and video images, provides camera controls, and connects with a focusing coupler

The C-Mount Coupler The C-Mount coupler threads onto the face of the camera head, enabling a scope to be attached to the camera. It provides a focusing ring to adjust image sharpness. The features of the coupler are listed in Figure 3 below. Additional instructions are available in the “1288 C-Mount Coupler User Guide” (P/N 1000401152).

2

3

4

1

1. Rear Adapter

Threads onto the camera head

2. Focusing Ring

Adjusts the coupler focus

3. Endobody Clamp

Secures the scope to the coupler

4. Scope End

Receives the endoscope

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Setup and Interconnection Note: Stryker Endoscopy considers instructional training, or inservice, an integral part of the 1288 HD Medical Video Camera. Your local Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your staff on its operation and maintenance. To schedule an inservice, contact your local Stryker Endoscopy representative after your equipment has arrived. Setting Up the 1288 HD Camera involves three steps: 1. Setting up the console 2. Setting up the camera head 3. Setting up the coupler

Setting Up the Console Always connect the camera to an appropriate power source, using a hospital-grade power cord. Loss of AC power will cause the camera to shut down and the surgical image to be lost. Only connect items to the camera that have been specified for use with the camera. Connecting incompatible equipment may cause unexpected results. When the 1288 HD Camera is used with other equipment, leakage currents may be additive. Ensure that all systems are installed according to the requirements of IEC 60601- 1-1. Caution

Equipment which employs RF communications may affect the normal function of the 1288 HD Camera. When choosing a location for the 1288 HD Camera, consult the “Electromagnetic Compatibility” section of this manual to ensure proper function. Always set up the console in a location that allows adequate ventilation (airflow) to the console. Insufficient ventilation may cause the console to overheat and shut down.

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To set up the console, make the following connections: 1. Connect the AC power. • Connect the AC power cord to the AC inlet on the rear console panel. • Connect the other end to a hospital-grade outlet. 2. Connect the video output. • The rear panel provides one analog and three (or four with the optional fiber digital-video outputs, which can be used together or independently: Output Type

Output

Cable

Connector

Analog

*S-VHS 1

S-VHS

4 pin Mini-Din (push-only connectors)

Digital

**DVI-I1

DVI

29 pin (push-only connectors, with two tightening knobs)

**DVI-I2

DVI

29 pin (push-only connectors, with two tightening knobs)

Displayport

Displayport

20 pin Displayport (auto-locking connector)

Optional

DVI over Fiber (× 4) optical Fiber

Lucent connector fiber (× 4) (push only)

* On some monitors, S-VHS inputs may be labeled Y/C. ** The DVI connectors can also output analog SXGA signals through a DVI-I to VGA adapter. Use the cables and outputs described above to connect the 1288 HD to other operating-room equipment. Wiring Diagrams 1-3 describe typical set-ups. • If desired, connect any remote outputs using the remote cables supplied with the 1288 HD Camera. (See Wiring Diagram 2.) Devices connected to the remote outputs of the 1288 HD Camera can be operated using the P buttons on the camera head and/or console. See the “Operation Instructions” section of this manual for details. • If desired, connect the SIDNE® interface as well. (See Wiring Diagram 2.)

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Wiring Diagram 1: Camera and Flat-Panel Monitor

WiSe 26" HDTV Surgical Display

DVI-I/VGA Adapter DVI DVI

1288 HD Video Camera

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Wiring Diagram 2: Camera, SDC, SIDNE®, and Flat-Panel Monitor WiSe 26" HDTV Surgical Display

DVI SIDNE®

USB

Stryker European Rep. RA/QA Manager ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France

DVI

1288 HD Video Camera

REMOTE

SDC

DVI

15

Wiring Diagram 3: Camera, Flat-Panel Monitor, and CRT Monitor WiSe 26" HDTV Surgical Display

DVI-I/VGA Adapter DVI DVI

1288 HD Video Camera S-VHS

16

CRT Monitor

Note: If you are using any device with unterminated analog video inputs, you must connect a cable from the VIDEO OUT of that device to the VIDEO IN on the monitor. Note: An additional monitor may be connected using an open camera output. Note: The camera console is shipped from the factory in NTSC video format. If necessary, the video format can be changed to PAL by using the “Options” submenu in the configuration menu. See the “Using the Configuration Menu” section of this manual. 1. Power on the monitor. 2. Power on the camera. Note: A color bar pattern will appear on the monitor when the camera head is not connected to the camera console. Follow the instructions in the “Setting Up the Camera Head” section of this manual to connect the camera head to the console.

Setting Up the Camera Head Caution

Do not severely bend the camera cable or damage may result.

Note: To unplug the camera from the control unit, grasp the knobbed portion of the connector and pull straight out. 1. Connect the camera head to the console. • Unscrew the soaking cap from the cable connector if necessary. • Align the blue arrow on the cable connector with the blue arrow on the camera-connector port on the front console panel. • Push in the connector until it locks in place.

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Setting Up the Coupler

1. Attach the coupler to the camera head. • Grasping the rear adapter, screw the coupler onto the camera head (clockwise) until it forms a tight seal.

Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions. Caution

When attaching or removing the coupler, grip only the rear adapter, as twisting other parts of the coupler may result in mechanical damage. Do not overtighten the coupler, as this may damage the front window of the camera. Do not overtighten a direct-coupled C-mount scope, as this may damage the front window of the camera.

Note: For direct-coupled C-mount scopes (scopes that require no coupler), thread the endoscope directly into the camera head until it forms a tight seal.

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2. Attach an endoscope to the coupler. • Remove the red dust cap if it is present. • Push down on the endobody clamp (a) and insert the scope into the scope end of the coupler (b). • Release the endobody clamp.

(a)

(c)

(b)

3. Attach a light cable from the light source to the light post on the endoscope (c).

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Operation Warning: Before using the 1288 HD Camera in a surgical procedure, test all components to ensure proper function. Ensure that a video image appears on all video monitors before beginning any procedure. Note: Before operating the 1288 HD Camera, ensure all components have been set up according to the instructions in the “Setup and Interconnection” section of this manual.

Powering the Camera On/Off

Press the power switch on the console to power the camera on or off.

Using the Camera Head Buttons

The camera head features a cross-shaped, four-button keypad for controlling the 1288 camera. Shown below, these buttons are labeled P, W, Up, and Down.

P

20

W