Stryker 1188HD, 1188-710-105, 1188-010-000, 1188-210-105, 1188-410-105 User Manual

1188-010-000 1188-210-105 1188-410-105 1188-710-105
User Guide
1188HD
Video Camera
EN-1
1188HD
Video Camera
Contents
Warnings and Cautions ......................................... 3
Symbol Definitions ............................................................................ 5
Product Description and Intended Use ................. 7
Indications/Contraindications ........................................................... 7
Camera Console ............................................................................... 8
Camera Head .................................................................................. 10
C-Mount Coupler ............................................................................ 11
Setup and Interconnection ................................. 12
Setting Up the Console ................................................................... 12
Setting Up the Camera Head .......................................................... 17
Setting Up the Coupler ................................................................... 17
Operation Instructions ....................................... 19
Powering the Camera On/Off ......................................................... 19
Using the Camera Buttons ............................................................. 19
Selecting the Display Language ..................................................... 21
Using the Configuration Menu ........................................................ 22
Controlling Remote Video Accessories .......................................... 22
Using the SFB Serial Interface ........................................................ 23
Using the DVI Fiber Outputs ........................................................... 23
Operating the Camera with a Light Source .................................... 24
Troubleshooting ................................................. 25
Cleaning and Sterilization .................................. 28
Cleaning the Camera Console ........................................................ 28
Reprocessing the Camera Head ..................................................... 28
User Maintenance ........................................................................... 36
EN-2
Technical Specifications .................................... 37
Electromagnetic Compatibility ........................................................ 39
Warranty ............................................................ 43
Service and Claims ............................................. 44
EN-3
Warnings and Cautions
Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meanings and should be carefully reviewed:
Warning The personal safety of the patient or physician may be
involved. Disregarding this information could result in injury to the patient or user.
Caution Special service procedures or precautions must be followed to
avoid damaging the instrument.
Note Special information to make maintenance easier or important
information more clear.
An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the literature accompanying the product.
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.
EN-4
To avoid potential serious injury to the user and patient, and/or damage to this device, the user must:
1. Carefully unpack this unit and check if any damage occurred during shipment. If damage is detected, refer to the “Service and Claims” 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.
5. Never use this equipment in the presence of flammable or explosive gases.
6. The camera head surface may exceed 41°C (106°F) in operating conditions with high ambient temperatures and should be handled with caution.
7. Avoid dissembling any part of the camera head, as doing so may break the seals, causing leakage and/or electric shock.
8. Avoid removing covers on the control unit, as doing so may cause damage to electronics and/or electric shock.
9. To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
10. Attempt no internal repairs or adjustments not specifically detailed in this operating manual.
11. Pay close attention to the care and cleaning instructions in this manual. Any deviation may cause damage.
12. The camera head and coupler are shipped non-sterile. Clean and sterilize these components prior to first use and after every subsequent use. Follow the cleaning, disinfection, and sterilization instructions provided in these instructions.
13. Never sterilize the camera console, because the delicate electronics can not withstand this procedure.
14. Never autoclave a camera head unless it is marked
AUTOCLAVABLE.
Autoclaving regular camera heads will result in permanent device damage for which Stryker will not be responsible.
15. Disconnect the control unit from the electrical outlet when inspecting the fuses.
EN-5
16. Before each use, check the outer surface of the endoscope to ensure that there are no rough surfaces, sharp edges, or protrusions.
17. Avoid dropping the camera system. The camera system contains sensitive parts that are precisely aligned.
18. Ensure that readjustments, modifications, and/or repairs are carried out by persons authorized by Stryker Endoscopy. No modification of this equipment is allowed.
19. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines.
20. Do not position the console so that it is difficult to disconnect the power cord from the supply mains.
The warranty is void if any of these warnings are disregarded.
Symbol Definitions
In addition to the cautionary symbols already listed, other symbols found on the 1188HD Camera and in this manual have specific meanings that clarify the proper use and storage of the 1188HD Camera. The following list defines the symbols associated with this product.
Refer to instruction manual.
Caution (consult instructions for use)
Cameras, couplers, and camera extension cable are shipped non­sterile and must be sterilized before use
Humidity range Legal manufacturer
Pressure range Date of manufacture
Temperature range Serial number
Country of origin Catalogue number
Stryker European representative
EN-6
Device meets requirements for safety and effectiveness set forth in MDD 93/42/EEC
Federal law (USA) restricts this device to use by, or on order of, a physician
Denotes compliance to CAN/CSA C22.2 No 601.1 and UL 60601-1
Power on/off (alternates when button is pushed)
Alternating current
1188 camera head connection
Type BF applied part
Protective ground earth
Class 1 laser product
FireWire
Equipotentiality
Fuse rating
Device recycling code (applicable to China)
This symbol indicates that the waste disposal 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.
Consult instructions for use
CLASS 1 LASER
PRODUCT
APPAREIL A LASER DE
CLASSE 1
EN-7
Product Description and Intended Use
The Stryker Endoscopy 1188HD Medical Video Camera is a high-definition camera used to capture still and video images of endoscopic surgical applications. The 1188HD Medical Video Camera consists of three main components:
• Camera console (P/N 1188-010-000)
• Camera head (P/N 1188-210-105 45° cable; 1188-410-105
autoclavable; 1188-710-105 0° cable)
• C-mount coupler (P/N 1188-020-122; 1188-410-110 autoclavable)
The 1188HD also comes with various connection cables which, like the other components, can be purchased together or separately.
Part numbers 1188-210-105 and 1188-710-105 are not intended for sale in the European Union and do not bear a CE mark.
Warning Federal law (United States of America) restricts this device to
use by, or on the order of, a physician.
Indications/Contraindications
The 1188HD 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.
EN-8
Camera Console
The camera console or Camera Control Unit (CCU) is the control center for the 1188HD Medical Video Camera and processes the video and photographic images captured during the surgical procedure. The console front panel features controls for adjusting the enhancement level, light level, zoom, and white balance. The front panel allows selection of surgical specialty settings that optimize camera performance for specific surgical procedures. The front panel also allows activation of remote outputs.
The rear panel provides ports for connecting the 1188HD Camera to viewing and recording equipment, such as video monitors, the SDC Ultra, or photo printers.
The features of the front and rear panels are listed in Figure 1.
Figure 1: 1188HD Camera console, front (top) and rear (bottom) panels
1. Power Switch: Powers the camera on and off
2. Enhance Buttons: Increase or decrease image sharpness
3. Specialty Screen: Displays which surgical preset setting has been selected
91110 12 13 14 16 17 1815
192021
12 3 4567 8
EN-9
4. Specialty Button: Selects different surgical settings
5. P Button: Controls image (picture) capture via remotes 1 and 2
6. Up and Down Arrow Buttons: Controls image light or zoom level
7. W Button: Controls white balance and image light or zoom level
8. Camera Connector: Connects to the 1188HD Camera Head
9. DVI Out 1: Digital video output
10. DVI Out 2: Digital video output
11. Remote Out 1: Connects to a video accessory remote switch
12. Remote Out 2: Connects to a video accessory remote switch
13. Fiber Outputs (optical): DVI output for connection to Lucent connector fibers
14. S-Video 1 Out: Analog video output
15. S-Video 2 Out: Analog video output
16. SFB Connectors: Enables FireWire connection with Stryker FireWire devices. Provides connection for remote diagnoses and future software upgrades.
17. AC Power Inlet: Connects to a separable power cord, which can be used for mains isolation
18. Equipotential Ground Plug: Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.
19. Fuse Panel: Contains two 1.6A 250V (slow-blow, high breaking capacity 1500A) fuses
20. SIDNE® Port: Connects to the SIDNE® Console to enable voice operation and/or graphic tablet control
21. Composite Out: Analog video output
EN-10
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).
Figure 2 below lists the features of the camera head.
Figure 2: 1188HD Camera Head
1. Camera Cable
2. Camera Head: Captures photographic and video images, provides camera controls, and connects with a focusing coupler
3. Soaking Cap: Protects the cable connector during cleaning and sterilization
4. Cable Connector: Connects the camera head to the camera console
The camera head is available in autoclavable and non-autoclavable models:
Autoclavable (1188-410-105) marked
AUTOCLAVE
Non-autoclavable 1188-210-105 (45° cable) and 1188-710-105 (0° cable)
12
34
EN-11
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 “1188 C-Mount Coupler User Guide” (P/N 1000-400-905).
Figure 3: C-Mount coupler
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
C-mount Couplers are available in autoclavable and non-autoclavable models:
Autoclavable
1188-410-110
(marked
AUTOCLAVE)
Non-autoclavable
1188-020-122
1
2
3
4
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Setup and Interconnection
Note Stryker Endoscopy considers instructional training, or inservice,
an integral part of the 1188HD 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 1188HD Camera involves three steps:
1. Setting up the console
2. Setting up the camera head
3. Setting up the coupler
Setting Up the Console
Caution Equipment which employs RF communications may affect the
normal function of the 1188HD Camera. When choosing a location for the 1188HD Camera, consult the “Electromagnetic Compatibility” section of this manual to ensure proper function.
To set up the console, make the following connections:
1. Connect 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.
Warning 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.
Caution 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.
Warning Only connect items to the camera that have been specified for
use with the camera. Connecting incompatible equipment may cause unexpected results.
To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.
EN-13
2. Connect the video output.
• The rear panel provides three analog and three digital-video outputs,
which can be used together or independently:
• Use the cables and outputs described above to connect the 1188HD to
other operating-room equipment. Wiring Diagrams 1-3 on the following pages describe typical set-ups.
• If desired, connect any remote outputs using the remote cables
supplied with the 1188HD Camera. (See Wiring Diagram 2.) Devices connected to the remote outputs of the 1188HD 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.)
Warning When the 1188HD 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.
Warning Do not touch the internal pin of the VIDEO-OUT BNC jack
and the patient simultaneously.
Output Typ e
Output Cable Connector
Analog Composite Composite BNC
(push-and-turn connectors)
*S-VHS 1 S-VHS 4 pin Mini-Din
(push-only connectors)
*S-VHS 2 S-VHS 4 pin Mini-Din
(push-only connectors)
Digital **DVI-I 1 DVI 29-pin (push-only connectors, with two
tightening knobs)
**DVI-I 2 DVI 29-pin (push-only connectors, with two
tightening knobs)
DVI over optical FIBER
Fiber (×4) 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.
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