User Guide 1188HD+Aeendos
User Guide 1188HD+Aeendos
User Guide 1188HD+Aeendos
Video Camera
User Guide
1188-010-000
1188-210-105
1188-410-105
1188-710-105
1188HD
Video Camera
User Guide
Contents
Warnings and Cautions ......................................... 3
Symbol Definitions ............................................................................ 5
Troubleshooting ................................................. 25
EN-1
Technical Specifications .................................... 37
Electromagnetic Compatibility ........................................................ 39
Warranty ............................................................ 43
EN-2
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:
EN-3
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-4
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.
EN-5
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
FireWire
CLASS 1 LASER
Fuse rating
Equipotentiality
EN-6
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.
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-7
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.
1 2 3 4 5 6 7 8
9 10 11 12 13 14 15 16 17 18
21 20 19
Figure 1: 1188HD Camera console, front (top) and rear (bottom) panels
EN-8
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-9
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.
1 2
4 3
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)
EN-10
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).
2
1
Autoclavable
1188-410-110
(marked AUTOCLAVE)
Non-autoclavable
1188-020-122
EN-11
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
Warning Only connect items to the camera that have been specified for
use with the camera. Connecting incompatible equipment may
cause unexpected results.
EN-12
2. Connect the video output.
• The rear panel provides three analog and three digital-video outputs,
which can be used together or independently:
DVI over optical Fiber (×4) Lucent connector fiber (×4) (push-only)
FIBER
• 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 Do not touch the internal pin of the VIDEO-OUT BNC jack
and the patient simultaneously.
EN-13
Wiring Diagram 1: Camera and Flat-Panel Monitor
EN-14
Wiring Diagram 2: Camera, SDC, SIDNE®, and Flat-Panel Monitor
EN-15
Wiring Diagram 3: Camera, Flat-Panel Monitor and 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.
EN-16
Setting Up the Camera Head
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 (see Figure 4).
• Push in the connector until it locks in place.
Note To unplug the camera from the control unit, grasp the knobbed
portion of the connector and pull straight out.
Caution Do not severely bend the camera cable or damage may result.
EN-17
Caution When attaching or removing the coupler, grip only the rear
adapter, as twisting other parts of the coupler may result in
mechanical damage.
Caution Do not overtighten the coupler, 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.
Caution Do not overtighten a direct-coupled C-mount scope, as this
may damage the front window of the camera.
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). (See Figure 6.)
• Release the endobody clamp.
(a)
(b)
(c)
3. Attach a light cable from the light source to the light post on the
endoscope (c) as seen in Figure 6.
Warning Before each use, check the outer surface of the endoscope to
ensure there are no rough surfaces, sharp edges, or
protrusions.
EN-18
Operation Instructions
Note Before operating the 1188HD Camera, ensure all components
have been set up according to the instructions in the “Setup and
Interconnection” section of this manual.
P (Picture) Button
The P button controls up to two remote video accessories.
• Press the P button for less than one second to select Remote 1. One
beep will sound.
• Press the P button for more than one second to select Remote 2. Two
beeps will sound.
EN-19
W (White Balance) Button
The W button activates the white-balance function or the light/zoom function.
The white balance function is used to correct slight color differences that exist
between different light sources or endoscopes.
• Press the W button for more than one second to activate the white-
balance function.
• Press the W button for less than one second to increase the light or
zoom level. The camera console can be set to “light” mode or “zoom”
mode using the Options submenu of the Configuration Menu. In
“zoom” mode, each W button press will raise the light level in four
steps. In “light” mode, each press will raise the zoom level in four
steps. When either mode has reached its maximum, pressing the W
button again will cycle the level back to the lowest setting.
Perform the white balance procedure before every surgical procedure.
Note Ensure that a scope and light source are attached to the camera,
and that the camera, light source and monitor are powered on
before adjusting the white balance.
1. Point the scope at several stacked 4 × 4 white gauze pads, a white
laparoscopic sponge, or any clean white surface.
2. Look at the monitor and make sure that no glare is visible off of the
white surface.
3. Press and hold the W button until “WHITE BALANCE” begins flashing
on the video monitor.
4. Continue pointing the scope at the white surface until the video monitor
indicates that white balance is “complete.” The video picture may change
color. If you cannot achieve an acceptable white balance, refer to the
“Troubleshooting” section of this manual.
EN-20
Enhancement Buttons
The enhancement buttons increase or decrease picture sharpness. There are 16
levels of enhancement. The current enhancement level will be displayed briefly on
the monitor.
EN-21
Using the Configuration Menu
The Configuration Menu allows adjustment of some camera settings. Settings can
affect video quality, and care should be taken when altering them.
1. Enter the Configuration Menu by pressing the Enhance Up and Enhance
Down buttons on the console simultaneously for more than three
seconds. The menu will appear on the On-Screen Display (OSD).
2. Use the Enhance Up and Enhance Down buttons to scroll through the
menus and submenus:
• Shutter
• Color
• Options
3. Press the Specialty button to select an item from the Configuration
menu.
4. Use the Up and Down buttons to adjust the selection.
5. Press the P button to return to the Configuration Menu.
6. Press the P button again to exit the Configuration Menu.
EN-22
Using the SFB Serial Interface
The SFB serial connection on the console rear panel enables FireWire connection
to the Stryker Endoscopy Software Management Site (SMS). Connecting to this
site enables remote diagnostics and software updates.
Note This system feature is not necessary for regular camera system
operation.
Note This system feature requires an additional device (that is, a
computer) to connect to SMS.
EN-23
Operating the Camera with a Light Source
Warning 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 (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 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-24
Troubleshooting
Problem Possible Solution
“System Error” • Camera head temporarily shut down due to
message overcurrent.
(Color bar • Turn off the console, wait 3 seconds, and turn it back
background) on.
• After sterilization, ensure the camera head has cooled
down before connecting it to the console.
“System Error” • No video detected.
message (Light blue • After sterilization, ensure the camera head has cooled
background) down before connecting it to the console.
• Return the system for repair.
No color bar • Ensure the video-out from the console is connected to
the video-in on the monitor.
• Ensure all video systems are powered on.
• Ensure that the camera head is not connected to the
console.
• Turn off the console, wait 3 seconds, and turn it back
on.
No color bar • Same as above.
(Optical DVI only) • See the “Using the DVI Fiber Outputs” section of this
manual.
Incorrect picture • Perform the white balance procedure. (See the “W
color Button” section of this manual.)
• Check the color settings on the monitor.
White balance (WB) • See the solution for “Picture is too dark.”
quality not good • See the solution for “Picture is too bright.”
• Perform the white-balance procedure with the light
source connected to the scope. Use metal-halide or
xenon lighting (no fluorescent lighting).
Picture is too dark • Increase the camera light level with the camera head.
• Increase the light-source output.
• Check the fiber-optic light cable for excessive broken
fibers.
EN-25
Problem Possible Solution
Picture is too bright • Decrease the camera light level.
• Decrease the light-source output.
• Ensure that Shutter submenu in the Configuration
menu has the following settings:
AGC Auto
Shutter On
Noise or snow on • Plug the electrocautery generator into a separate
picture when using electrical outlet and separate the 1188HD power cord
electrocautery from the electrocautery power cord.
probes • Separate the camera cable from the electrocautery
cable.
• Reposition the electrocautery grounding pad on the
patient.
Noise or snow on
picture when not • Reduce Enhancement.
using electrocautery • Check for and replace faulty video cables.
probes
No video picture • Check to ensure that all devices in the video system are
when the camera plugged in and powered on.
head is plugged in • Check the connector on the camera-head cable for
broken pins.
• Detach the camera head from console and reconnect
or
• Turn off the console, wait 3 seconds, and turn it back
on.
Image is not well • Release the scope from the coupler and then reconnect
centered it. Make sure the scope is seated correctly in the
coupler.
Variability in color • Perform the white-balance procedure. (See the “W
reproduction Button” section of this manual.)
between different • Check the settings on video peripherals.
light sources or • Ensure the light source has a proper infrared filter
peripherals (check with manufacturer specifications).
Foggy picture (loss • Refocus the camera.
of definition and • Refocus the coupler.
clarity) • Clean and dry both the scope and the coupler windows.
• Remove the coupler from the camera head and remove
any moisture that has built up between the two
components.
EN-26
Problem Possible Solution
Optics are dirty • Rotate the scope. If dust particles in the picture rotate,
the dust is located on the scope itself. Follow the
manufacturer’s instructions for cleaning the eyepiece
and negative lens.
• If particles in the picture do not move when you rotate
the scope, the particles are located on the coupler or
camera. Remove the scope and clean the window on
the front of the coupler with a dry or alcohol-tipped
cotton swab.
• If dust particles lie between the coupler and camera,
remove the coupler and clean the coupler and camera
windows.
• Ensure all components are completely dry before
reassembling them, or fogging may result.
Blurry picture • Ensure the coupler or C-Mount scope is in focus.
• Increase the enhancement.
• Ensure the specialty switch is not set to FLEXI-SCOPE
unless you are using a flexible scope.
Note If this troubleshooting guide does not resolve the problem, call
Stryker Technical Support at 1-877-478-7953 (inside the U.S.) or
refer to the “Service and Claims” section of this manual.
EN-27
Cleaning and Sterilization
The camera console is not intended to come into contact with the patient. It may
be cleaned, but not sterilized. The camera head and coupler may contact the
patient and must both be cleaned and sterilized prior to every use.
Should the camera console need cleaning, wipe it down with a sterile cloth and
mild cleaning solution.
Caution Never immerse or sterilize the camera console as this will
damage the camera and void the warranty.
Warnings
• This device must be cleaned and sterilized prior to the first use and after
every subsequent use.
• Do not sterilize the autoclavable camera head (1188-410-105) with Steris/
Amsco V-Pro or Steris System 1E. Steam sterilization is recommended.
• Use only the sterilization cycles outlined in this document. Using
unspecified sterilization cycles may damage the device or result in
incomplete sterilization.
• Separate the camera head, coupler, and scope prior to cleaning, disinfection,
or sterilization. If the coupler and camera head are cleaned, disinfected, or
sterilized as a single unit, disconnecting the coupler during use will
compromise the sterility of the two products. (Refer to the coupler and scope
product manuals for reprocessing instructions.)
• Wear appropriate protective equipment: gloves, eye protection, etc.
EN-28
Cautions
• Always install the soaking cap prior to processing the camera.
Failure to properly tighten the soaking cap will corrode the
connector pins and void the warranty.
• Inspect the camera cable for cuts and breaks before soaking in any
fluid. Return any damaged camera to Stryker for service.
• Never soak the camera in the same tray with sharp instruments.
• Do not use brushes or pads with metal or abrasive tips during
manual cleaning, as permanent scoring or damage could result.
• To minimize galvanic corrosion, avoid soaking dissimilar metals in
close proximity.
• Only camera heads marked AUTOCLAVE can withstand steam
sterilization. Autoclaving camera heads that do not bear this
marking will result in product damage.
• Allow the device to air cool following steam sterilization. Rapid
cooling or “quenching” in a liquid will damage the device and void
the warranty.
• Allow the camera head to cool before connecting it to the console.
Connecting the camera head while it is still hot may result in
system error.
Limitations on Reprocessing
• Do not cross-sterilize the device. Using multiple sterilization
methods may significantly reduce the performance of the device.
• Do not leave the device in solutions longer than necessary. This
may accelerate normal product aging.
• Proper processing has a minimal effect on this device. End of life is
normally determined by wear and damage due to use.
• Damage incurred by improper processing will not be covered by the
warranty.
EN-29
Instructions
Point of Use
• Wipe excess soil from the device using disposable paper towels.
• If an automated reprocessing method will be used, rinse any
channels in the device with 50mL of sterile distilled water
immediately after use.
EN-30
Cleaning: Manual
1. Brush
• Thoroughly brush the exterior of the device with a soft-bristled brush,
focusing on any mated or rough surfaces.
• Inject any lumen or mated surface a minimum of five times with at least
50mL of the detergent.
• Brush any lumens a minimum of five times from each end, using an
appropriate bottle brush.
• Brush any movable parts in their extreme open and closed positions.
2. Rinse
• Rinse the device with treated water at ambient temperature to remove all
detergent residue. Flush any lumens or mated surfaces a minimum of 5
times. Once all detergent residues have been removed, continue to rinse
for a minimum of 30 seconds.
• Drain excess water from the device and dry it using a clean cloth or
pressurized air.
• Visually inspect the device for cleanliness, paying close attention to hard-
to-reach areas. If visible soil remains, repeat steps 1 and 2.
3. Soak
• Prepare a non-enzymatic detergent, according to the manufacturer’s
recommendations of 0.25 ounces/gallon tap water at 35 - 40°C.
• Fully immerse the device and inject any lumens and mated surfaces with
at least 50mL of the detergent.
• Soak the device for a minimum of 15 minutes.
4. Brush
• Thoroughly brush the exterior of the device using a soft-bristled brush.
• Inject the prepared detergent into any cannulae, lumens, or mated
surfaces a minimum of 5 times.
• Brush any lumens a minimum of 5 times from each end, using an
appropriate bottle brush.
• Actuate the device, brushing around any movable parts in all extreme
positions.
5. Rinse
• Thoroughly rinse the device with treated water until all detergent residue
is removed. Flush any lumens or crevices 5 times. After the detergent
residue is removed, continue rinsing for a minimum of 30 seconds.
• Drain the excess water from the device and dry it with a clean cloth or
pressurized air.
EN-31
Cleaning: Automated
1. Brush
• Brush both ends of any lumens a minimum of five times, using an
appropriate bottle brush.
2. Rinse
• Rinse the device with treated water at ambient temperature until
there is no visible detergent residue. Continue to rinse for a
minimum of 30 seconds after all detergent residue has been
removed.
• Place the device in the washer on an incline to facilitate drainage.
3. Automated wash
• Program the washer using the following parameters:
Disinfection (optional)
1. Disinfect the device by submerging it in a disinfection agent. Follow
the disinfection agent manufacturer’s recommended concentrations,
temperatures, and exposure times.
2. Thoroughly rinse and flush all parts and lumens with running,
demineralized water to remove the disinfectant.
3. Dry all parts with a lint-free towel immediately after rinsing.
EN-32
Drying
• For automated drying, use the drying cycle provided with the
washer/disinfector.
• For manual drying, use a lint-free cloth.
• Dry any lumens with compressed air.
Packaging
N/A
Sterilization
After performing the cleaning instructions specified above, perform one of the
following sterilization cycles.
EN-33
Steam
Note for United States users: For all autoclave-compatible devices, Stryker
recommends using steam sterilization instead of liquid chemical sterilization.
• Steam sterilization is intended only for camera heads and couplers
marked AUTOCLAVE.
• Rapid cooling, or “quenching,” the coupler after autoclaving will
result in product damage.
• The water used in the autoclave process must meet standards for
clean steam per AAMI ST 79 Appendix M – Steam Quality
requirements.
Preconditioning parameters
Exposure
Time 1 hour
Aeration parameters
EN-34
Steris System 1 / System 1E
Note: Steris® System 1™ is not intended for use in the United States.
Do not sterilize the autoclavable camera head (1188-410-105) with Steris System 1E.
1. Clean and prepare the camera head and cable as recommended in this
user guide. Ensure the soaking cap is installed.
2. Sterilize the camera head and cable using Steris® System 1™ with
Steris® 20 Sterilant, or System 1E™ with S40™ Sterilant. Follow the
manufacturer's instructions.
3. Allow the camera head, cable, coupler, and scope to completely dry
before reassembly. Any moisture on the threads will cause the camera
and coupler windows to fog during use.
Steris/Amsco V-PRO 1
Do not sterilize the autoclavable camera head (1188-410-105) with V-PRO 1. Steam
sterilization is recommended.
1. Clean and prepare the camera head and cable as recommended in this
user guide. Ensure the soaking cap is installed.
2. If using a sterilization tray (optional), follow any additional
instructions provided with the tray. Use only trays that are approved
for sterilization with Steris/Amsco® V-PRO™ 1.
3. Double-wrap the camera head and cable (or tray, if being used) prior
to sterilization.
4. Sterilize the camera head and cable using the V-PRO™ 1 Plus Sterilizer
(Non-Lumen or Standard cycle) or the V-PRO™ 1 Sterilizer (Standard
cycle).
5. Allow the camera head, cable, coupler, and scope to completely dry
before reassembly. Any moisture on the threads will cause the camera
and coupler windows to fog during use.
Sterrad
1. Clean and prepare the camera head and cable as recommended in this
user guide. Ensure the soaking cap is installed.
2. Sterilize the camera head and cable using the Sterrad™ NX or 100s
Sterilization System.
3. Allow the camera head, cable, coupler, and scope to completely dry
before reassembly. Any moisture on the threads will cause the camera
and coupler windows to fog during use.
EN-35
Storage
N/A
User Maintenance
Warning To avoid the risk of fire, use only fuses of the value specified on
the fuse label located on the rear panel of the camera console.
Every 12 months, check the earth leakage current to <500μA (<300μA in U.S.A.),
ground protective earth impedance to <0.1 ohms, and power consumption less
than or equal to rated power. Use a true RMS digital multimeter and safety
analyzer to perform this test.
Note Refer calibration and operating difficulties not detailed in this
manual to your Stryker Endoscopy sales representative.
EN-36
This product is considered electronic equipment and must not be disposed of as
unsorted municipal waste and must be collected separately. Please contact the
manufacturer or other authorized disposal company to decommission your
equipment.
Technical Specifications
60Hz settings are displayed first. (50Hz settings follow in parentheses.)
Imaging System
1/3" Progressive Scan CCDs
High Definition
Scanning System
Horizontal: 64.00 kHz (60.00 kHz)
Vertical: 60.02 Hz (50.00 Hz)
Video Outputs
Digital/Analog: Two Digital Video Interface (DVI)/RGBHV
1280 × 1024 (HD), 720p (HDTV) format
Connector: 29-pin DVI-I
Composite: One NTSC standard (PAL standard)
Connector: BNC coaxial
Y/C: Two S-VHS
Connector: 4-pin mini-DIN
Digital Fiber: HD, HDTV (R, G, B, Clk)
Connector: Four Lucent fiber connectors with 1.25 mm
ferrules
Mounting
Endoscope eyepiece used with C-mount coupler
C-mount camera head used with C-mount scopes
(C-mount coupler/scope thread: 1"-32UN-2A)
Auto Shutter Range
1/60 (1/50) – 1/50,000 second
Operating Conditions
Temperature: 10 – 30°C
Relative Humidity: 30 – 75%
Transport and Storage Conditions
Temperature: -20 – 60°C
Relative Humidity: 10 – 75%
Atmospheric Pressure: 700 – 1060 hPa
EN-37
Input Electrical Ratings
100 – 240VAC ± 10% (0.6A) @ 47 – 63Hz
Total Shipping Weight
13 lbs. (6.0 kg) Camera console
0.5 lbs. (0.226 kg) Coupler
1.5 lbs. (0.680 kg) Camera head
Dimensions
Camera Console: 12.5" w × 3.3" h × 15.25" d
(31.8 cm w × 8.4 cm h × 38.7 cm d)
Camera Head Cable to Camera Console:
10.3 ft (3.15 m) sealed cable
20.7 ft (6.30 m) cable extension available
Enhancement
16 levels (switchable)
Classification
Class I Equipment
Type BF Applied Part
Water Ingress Protection, IPX0—Ordinary Equipment
Continuous Operation
Complies with Laser Product Standards
Class 1 Laser Product
Contains four 850-nm laser diodes
This product complies with IEC 60825-1:1993+A1:1997+A2:2001.
This product complies with 21CFR, Subchapter J, Parts 1040.10 and
1040.11, except for deviations pursuant to Laser Notice No. 50, dated
July 26, 2001.
Please contact your local Stryker Endoscopy sales representative for information
on changes and new products.
EN-38
Electromagnetic Compatibility
Like other electrical medical equipment, the 1188HD Camera requires special
precautions to ensure electromagnetic compatibility with other electrical medical
devices. To ensure electromagnetic compatibility (EMC), the 1188HD Camera
must be installed and operated according to the EMC information provided in
this manual.
Note The 1188HD Camera has been designed and tested to comply
with IEC 60601-1-2 requirements for EMC with other devices.
Caution Equipment which employs RF communications may affect the
normal function of the 1188HD Camera.
1188HD Camera is intended for use in the electromagnetic environment specified below. The
customer or the user of 1188HD Camera should ensure that it is used in such an environment.
EN-39
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
1188HD Camera is intended for use in the electromagnetic environment specified below.
The customer or the user of 1188HD Camera should ensure that it is used in such an environment.
Electromagnetic
IEC 60601 Test
Immunity Test Compliance Level Environment:
Level
Guidance
Floors should be
wood, concrete, or
Electrostatic Discharge ceramic tile. If floors
±6kV contact ±2,4,6kV contact are covered with
(ESD)
±8kV air ±2,4,8kV air synthetic material,
IEC61000-4-2 the relative humidity
should be at least
30%.
Power-frequency
magnetic fields
Power frequency (50/60Hz) should be at levels
magnetic field characteristic of a
3 A/m N/A
typical location in a
IEC 61000-4-8 typical commercial
or hospital
environment.
EN-40
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
1188HD Camera is intended for use in the electromagnetic environment specified below.
The customer or the user of 1188HD Camera should ensure that it is used in such an environment.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
EN-41
Guidance and Manufacturer's Declaration: Electromagnetic Immunity
1188HD Camera is intended for use in the electromagnetic environment specified below.
The customer or the user of 1188HD Camera should ensure that it is used in such an environment.
(a) Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast, and TV broadcast,
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the 1188HD Camera system is used exceeds the applicable RF
compliance level above, the 1188HD Camera system should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as reorienting or
relocating the 1188HD Camera unit.
(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
The 1188HD Camera system is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The user of the 1188HD Camera system can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the 1188HD Camera system as recommended below,
according to the maximum output power of the communications equipment.
For transmitters rated at a maximum output power not listed above, the recommended separation
distance (d) in meters (m) can be estimated using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects, and people.
EN-42
Warranty
Stryker Endoscopy warrants the 1188HD Medical Video Camera against defects
in both materials and workmanship to the registered owner at the time of
purchase. All components including the Charge Coupled Devices (CCDs) located
in the camera head are covered by the warranty for a period of one year from the
date of purchase.
This warranty does not apply to any unit which has been subject to misuse,
neglect, improper installation or that which has been altered, adjusted, or
tampered with by any person other than Stryker Endoscopy authorized
personnel.
If upon examination by authorized service personnel, it is determined that the
malfunction is due to misuse or abuse, warranty provisions will not apply. An
estimate of the cost of repair work will be given to the customer prior to servicing
and repairing the unit.
The customer is responsible for returning the defective equipment to the factory
at his or her own expense. Stryker Endoscopy or its representative will service the
unit, repair or replace any defective parts thereof, and return the unit.
If, upon examination, it is determined that the fault has been caused by misuse or
abnormal conditions of operation, the repairs will be billed to the customer as
out-of-warranty repairs.
Instruments repaired under Stryker Endoscopy’s standard repair program will be
issued a thirty-day warranty against defects in both materials and workmanship,
provided the original warranty period has passed. Instruments submitted due to
defects in materials and workmanship during the warranty period will be
repaired at no charge to the customer.
The warranty as set forth herein is exclusive and in lieu of all other warranties,
remedies, obligations and liabilities of Stryker Endoscopy Inc., expressed or
implied, including the implied warranties of merchantability and fitness for use
and of consequential damages. These products are being sold only for the purpose
described herein, and such warranty only runs to the purchaser. In no event shall
Stryker Endoscopy be liable for any breach of warranty in any amount exceeding
the purchase price of the product.
No agent, employee or representative of Stryker Endoscopy has the authority to
bind the Company to any other warranty, affirmation, or representation
concerning this instrument.
This warranty is valid only to the original purchaser of Stryker Endoscopy
products directly from Stryker Endoscopy or from a Stryker Endoscopy
authorized agent. The warranty cannot be transferred or assigned by the original
purchaser.
EN-43
Service and Claims
Caution Never open the camera head or cable, or attempt any service
not described in this manual. These units have been factory
sealed to prevent moisture from entering the electronic
components. If the camera head or the cable seal is
intentionally broken, the equipment warranty will be void.
Furthermore, any repairs made to the camera system will
require evaluation to the requirements of applicable electrical
safety standards.
If service is needed either during or after the warranty period:
1. Contact Stryker Endoscopy at 1-800-624-4422 or phone your local
Stryker Endoscopy sales representative.
2. Package all the components carefully in the original shipping container
if possible.
3. Ship the camera, prepaid and insured to:
Stryker Endoscopy Customer Service
Attention: Repair Department
5900 Optical Court
San Jose, CA 95138
USA
© Stryker and Stryker Endoscopy are registered trademarks of Stryker
Corporation.
EN-44
Stryker Endoscopy
5900 Optical Court
San Jose, CA 95138 USA
1-800-624-4422
U.S. Patents: www.stryker.com/patents