Stryker 0700010000, 0700410105, 0700010001 User Manual

Precision AC Video Camera
0700010000
0700010001
0700410105
Contents
Warnings and Cautions ........................................................................... 1
Product Description and Intended Use ................................................. 4
Indications ..................................................................................................................5
Contraindications ....................................................................................................5
The Camera Console ...............................................................................................6
The Camera Head ....................................................................................................8
The C-Mount Coupler ............................................................................................. 9
Setup and Interconnection ................................................................... 10
Setting Up the Console ...................................................................................... 11
PrecisionAC Wiring Diagram ............................................................................ 12
Setting Up the Camera Head ............................................................................ 13
Setting Up the Coupler ....................................................................................... 14
Connecting the DVI Fiber Outputs ................................................................. 16
Installing the Soaking Cap ................................................................................ 16
Operation ............................................................................................... 17
Operating the Camera with a Light Source ................................................. 17
Powering the Console On/O .......................................................................... 18
Controlling Remote Video Accessories ......................................................... 18
Using the Camera Head Buttons ..................................................................... 19
Using the Touchscreen Interface..................................................................... 20
Menu Screen........................................................................................................... 21
Performing the White-Balance Test ................................................................ 22
Advanced Features ............................................................................................... 22
Troubleshooting .................................................................................... 23
Reprocessing ..........................................................................................27
Cleaning the Console .......................................................................................... 27
Cleaning, Disinfecting, and Sterilizing the Camera Head ...................... 28
Limitations on Reprocessing ............................................................................ 29
Materials and Equipment .................................................................................. 30
User Maintenance .................................................................................. 39
Maintenance, Inspection, and Testing .......................................................... 39
Using Sterile Drapes ............................................................................................ 39
Storage ..................................................................................................................... 39
Replacing the Fuses ............................................................................................. 39
Periodic Maintenance Schedule ...................................................................... 40
Expected Service Life .......................................................................................... 40
Disposal and Recycling Information .............................................................. 40
Diagrams .................................................................................................................. 41
Technical Specications ........................................................................ 43
Electromagnetic Compatibility ........................................................................ 45
Symbol Denitions ................................................................................ 49
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: Claries the instructions or presents 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, re 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 signicant amounts of heat (exceeding 41°C/106°F) 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 ammable material, as doing so may result in re.
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 o after being placed in standby mode, and therefore may still result in re or burns to the patient, user, or inanimate objects.
Warnings
To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings:
1. Must be a qualied physician to use this equipment.
2. Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, refer to the standard warranty.
3. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device.
4. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines.
5. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
6. Do not position the console so that it is dicult to disconnect the power cord from the supply mains.
7. Multiple portable socket-outlets shall not be placed on the oor.
8. Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment.
9. Never use the camera system in the presence of ammable or explosive gases.
10. Always treat the camera system with care. The camera system contains sensitive parts that are precisely aligned and may suer damage if dropped or mistreated.
11. The camera head surface may exceed 41°C (106°F) in operating conditions with high ambient temperatures and should be handled with caution.
12. The camera head and coupler are shipped non-sterile. Clean and sterilize these components prior to rst use and after every subsequent use. Follow the cleaning, disinfection, and sterilization instructions provided in these instructions. Any deviation can cause damage.
13. Never autoclave a camera head or coupler unless it is marked AUTOCLAVE. Autoclaving camera heads or couplers that do not bear this marking will result in non-sterile product and permanent device damage. Refer to the “Product Description and Intended Use” section for the location of the AUTOCLAVE marking on the Precision AC Camera.
14. Never sterilize the camera console, because the delicate electronics cannot withstand this procedure.
15. Disconnect the console from the electrical outlet when inspecting fuses.
16. Do not remove covers on the console, as doing so may cause damage to electronics and/or electric shock.
17. Do not disassemble any part of the camera head; doing so may break the seals, causing leakage and/or electric shock.
18. Attempt no internal repairs or adjustments not specically detailed in this operating manual.
19. Ensure that readjustments, modications, and/or repairs are carried out by persons authorized by Stryker Endoscopy.
20. The warranty is void if any of these warnings are disregarded.
Product Description and Intended Use
The Stryker Precision AC Camera System is a high-denition endoscopic camera system that is used to produce still and video images in the surgical eld during surgical procedures. The camera is sensitive in the visible and infrared spectrum. The optical image is transferred from the surgical site to the camera head by a variety of rigid and exible scopes which are attached to the camera head. The system consists of a camera control unit (CCU) and a camera head with an integral cable that connects to the CCU. The camera will provide a high quality image while remaining lightweight and easy to use.
A coupler is also available for attaching a scope to the camera head. The available models for each part are listed below.
Consoles
0700010000 PrecisionAC Camera Control Unit
0700010001 PrecisionAC Camera Control Unit with DVI Fiber Output
Camera Head
0700410105 PrecisionAC Camera Head, C-Mount
Coupler
0700020122 PrecisionAC 20 mm Coupler, C-Mount
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Complete instructions are available in Stryker user guide P26183.
The PrecisionAC console is also packaged with the following connection cables:
• Remote cables, 2.5 mm to 3.5 mm (Qty: 2)
• DVI-I cable (Qty: 1)
• Hospital-grade power cord (Qty: 1)
Contact your Stryker representative for availability of other cables that may be required for alternate congurations.
Indications
The PrecisionAC 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 listed below.
• 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 xation
• 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
• 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.
Contraindications
There are no known contraindications.
The Camera Console
The camera console—or Camera Control Unit (CCU)—is the control center for the PrecisionAC Camera, and it processes the video and photographic images produced during the surgical procedure.
Front Panel
The console front panel features a touchscreen, where dierent menus can be accessed, including the controls for adjusting the light level, zoom, and white balance, as well as allowing the selection of surgical specialty settings that optimize camera performance for specic surgical procedures. The touchscreen also allows activation of remote outputs, which are commonly used with a Stryker digital capture console to record images and video.
See the “Operation” section for more detail on using the front panel.
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1. Power Switch Powers the camera ON and OFF
2. Touchscreen Allows navigation through dierent menus
for controlling the camera and adjusting the video settings
3. Camera-Connector Port Connects to the PrecisionAC Camera Head
Rear Panel
The console rear panel provides ports for connecting the PrecisionAC Camera to viewing and recording equipment, such as video monitors and Stryker device control consoles.
See the “Product Description” section for the dierent console models that are available. The PrecisionAC Camera Control Unit with DVI Fiber Output (0700010001) is shown below.
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87654321
1. Device Control Port Connects to a Stryker device control console (such as the SDC3 or SIDNE®) to enable voice operation and/or graphic tablet control
2. Remote Out 1 Connects to a video accessory remote input
3. Remote Out 2 Connects to a video accessory remote input
4. S-Video Out Analog video output
5. DVI Out 1 Digital video output
6. DVI Out 2 Digital video output
7. Light Source Port Connects to Stryker light source
8. AC Power Inlet Connects to AC mains with separable power
cord
9. Fuse Panel Contains two 1.6A 250V fuses (slow blow, high breaking capacity 1500A, size 5mm x 20mm)
10. Equipotential
Ground Plug
Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.
11. Fiber Outputs
(optical)
DVI output for connection to Lucent connector bers (optional: 0700010001)
The Camera Head
The camera head connects to the camera console and produces video and photographic images, which it relays to the camera console. Several controls are accessible through a button keypad located on the top of the camera head (see the “Operation” section).
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“AUTOCLAVE”
1 2 3
1. Soaking Cap Protects the cable connector during cleaning,
disinfection, and sterilization
2. Cable Connector Connects the camera head to the camera console
3. Camera Cable The camera cable length is 10 feet (3.05 m)
4. Camera Head Produces photographic and video images,
provides camera controls, and connects with a focusing coupler. Note that the bottom of the camera head is marked “AUTOCLAVE” to indicate compatibility with steam sterilization.
The C-Mount Coupler
The 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.
Refer to Stryker user guide P26183 for complete coupler instructions.
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2
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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
Stryker Endoscopy considers instructional training, or inservice, an integral part of the PrecisionAC 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 sta on its operation and maintenance. To schedule an inservice, contact your local Stryker Endoscopy representative after your equipment has arrived.
Setting up the PrecisionAC Camera involves three steps:
1. Setting up the console
2. Setting up the camera head
3. Setting up the coupler
• Always connect the console 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 PrecisionAC Camera that have been specied for use with the camera system. Connecting incompatible equipment may cause unexpected results.
• When the camera system is used with other equipment, leakage currents may be additive. Ensure that all systems are installed according to the requirements of IEC60601-1.
• Equipment which employs RF communications may aect the normal function of the PrecisionAC Camera. When choosing a location for the camera system, consult the “Electromagnetic Compatibility” section to ensure proper function.
• Always set up the console in a location that allows adequate ventilation (airow) to the console. Insucient ventilation may cause the console to overheat and shut down.
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Setting Up the Console
Refer to the instructions below and the wiring diagram on the following page for a typical PrecisionAC Camera conguration.
1. Connect the console’s AC power to a hospital-grade outlet.
2. Connect one of the console’s DVI outputs to an available DVI input on a Stryker digital capture console such as the SDC3.
• The PrecisionAC console can also be connected to additional SDC
video inputs or directly to one or more display monitors; the rear panel provides one analog and two digital-video outputs (or three with
0700010001):
Output Type Output Cable Connector
Analog S-VHS 1* S-VHS 4 pin Mini-Din
(push-only connectors)
Digital (standard) DVI-I1** and
DVI-I2**
DVI 29 pin (push-only
connectors, with two tightening knobs)
Digital (optional in 0700010001)
DVI over optical Fiber
Fiber (×4) Lucent connector
ber (×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. When using any device with unterminated analog video inputs, connect a cable from the VIDEO OUT of that device to the VIDEO IN on the monitor.
3. Connect the DVI output from the Stryker digital capture console to the DVI input on the display monitor.
4. Using the provided remote cables, connect remote outputs 1 and 2 from the PrecisionAC console to a Stryker digital capture console. (The remote inputs should be connected to the same channel as the video input.)
• Devices connected to the remote outputs can be operated using the
console touchscreen or the P button on the camera head. See the “Operation” section for details.
5. Connect a USB A-to-B cable (also available from Stryker, part 0105187988) from the console’s Light Source output to the SIDNE input on the Stryker L9000 Light Source.
• The PrecisionAC camera head can be programmed to toggle “Run/
Standby” controls on the L9000. Contact a Stryker representative for more information about enabling this advanced feature.
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PrecisionAC Wiring Diagram
SDC3
PrecisionAC Camera
L9000 Light Source
VisionPro 26" LED Surgical Display
(underside shown)
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2
5
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Setting Up the Camera Head
Do not severely bend the camera cable or damage may result.
1. Unscrew the soaking cap from the cable connector on the camera head.
2. Align the arrow on the cable connector with the arrow above the camera­connector port on the front console panel.
3. Push in the connector until it locks in place.
Note: To unplug the camera from the console, grasp the knobbed portion of the connector and pull straight out.
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