Stryker 1288 User manual

User Guide
1288 HD Urology
Camera Head
1288310130

Contents
User Guide ......................................................................................... 1
Guide de l’utilisateur................................................................. 23
Benutzerhandbuch ..................................................................... 45
Manuale d’uso ............................................................................... 67
Manual do Utilizador ................................................................. 89
Guía del usuario ......................................................................... 113
Gebruikershandleiding ........................................................... 135
Brugervejledning ....................................................................... 157
Käyttöohje ..................................................................................... 179
Brukerhåndbok ........................................................................... 201
Användarhandbok ..................................................................... 223
Podręcznik użytkownika ......................................................... 245
Οδηγός χρήσης ........................................................................... 267
用户指南 .............................................................................................. 289
ユーザーガイド .................................................................................. 311
사용 설명서 ........................................................................................ 333

Contents
Warnings and Cautions ........................................................3
Symbol Definitions .................................................................5
Product Description and Intended Use ......................6
Indications/Contraindications ......................................................6
Product Features .........................................................................6
Setup ...............................................................................................8
Operation ...................................................................................10
Using the Urology Camera Head Buttons .................................10
Adjusting the Focus ...................................................................13
Cleaning, Reprocessing, and Maintenance ...........14
Reprocessing the Urology Camera Head ..................................14
Using Sterile Drapes ..................................................................20
Technical Specifications ...................................................21

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Warnings and Cautions
Please read this manual and follow its instructions carefully.
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 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. e scope tip, scope light post, light cable
adapter, and light cable tip will take several minutes to cool o aer being
placed in standby mode, and therefore may still result in re or burns to the
patient, user, or inanimate objects.
Warnings and Cautions
To avoid potential serious injury to the user and the patient and/or damage
tothis device, please note the following warnings:
1. Be a qualied physician, having complete knowledge of the use of this device.
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. Read the entire instruction section of the manual before assembling
orconnecting the camera.
5. Pay close attention to the care, cleaning, disinfection, and sterilization
instructions in this manual. Any deviation may cause damage.
6. Test this device prior to a surgical procedure. is device was fully tested
at the factory before shipment. Never use this device in the presence of
ammable or explosive gases.

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7. Avoid disassembling any part of the camera head, as doing so may break the
seals, causing leakage and/or electric shock. is device has been factory
sealed to prevent moisture from entering electronic components. If the
camera head or cable seal is intentionally broken, the warranty will be void.
8. Before each use, check the outer surface of the camera and endoscope to
ensure that there are no rough surfaces, sharp edges, or protrusions.
9. Using the camera head with broken connector tabs may damage the CCU. If
any tab is missing or damaged, please refer to the Stryker Standard Warranty.
10. Ensure that readjustments, modications, and/or repairs are carried out by
persons authorized by Stryker Endoscopy. Attempt no internal repairs or
adjustments not specically detailed in this operating manual. Doing so may
result in unintended performance or product damage.
11. Always treat the urology camera with care. e camera system contains
sensitive parts that are precisely aligned and may suer damage if dropped
ormistreated.
12. Repeated sterilization via Ethylene Oxide may result in degradation in image
quality.
e warranty is void if any of these warnings are disregarded.

5
Symbol Definitions
In addition to the cautionary symbols already listed, other symbols found on the
1288 HD Urology Camera Head and in this manual have specic meanings that
clarify the proper use and storage of the 1288 HD Urology Camera Head. e
following list denes the symbols associated with this product:
Warns of presence of important operating and maintenance
instructions in the manual
Date of manufacture
Legal manufacturer
SN Serial number
Catalogue number
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
is 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.

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Product Description and Intended Use
e 1288 HD Urology Camera Head is a high-denition camera used to capture
still and video images of endoscopic urology procedures. It is designed with a 90°
angle between the camera head and the scope to allow for easier access during
urology procedures.
e urology camera head is used in conjunction with the 1288 HD Camera
Console (REF 1288010000; REF 1288010001).
Indications/Contraindications
e 1288 HD Urology 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
xation, wedge resection, lung biopsy, pleural biopsy, dorsal sympathectomy,
pleurodesis, internal mammary artery dissection for coronary artery bypass,
coronary artery bypass graing where endoscopic visualization is indicated
and examination of the evacuated cardiac chamber during performance of
valve replacement. e users of the camera are general surgeons, gynecologists,
cardiac surgeons, thoracic surgeons, plastic surgeons, orthopedic surgeons, ENT
surgeons and urologists.
ere are no known contraindications.
Product Features
e urology 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
urology camera head (see the “Operation Instructions” section of this manual).

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8
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1
4
2 3
5
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1. Endoscope —
2. Endobody clamp Secures the scope to the camera head
3. Endobody brake Prevents rotation of scope
4. Focusing knob Adjusts the focus of the camera head
5. 1288 HD Urology
camera head
Captures photographic and video images and provides
camera controls
6. Urology camera
cable
—
7. Cable connector Connects the camera head to the camera console
8. Soaking cap Protects the cable connector during cleaning and
sterilization

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Setup
1. Set up the 1288 HD Camera Console according to the instructions provided
in its user manual.
2. Connect the urology 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 urology camera-connector port on the front console panel.
• Push in the connector until it locks in place.
• (To unplug the urology camera from the control unit, grasp the
knobbed portion of the connector and pull straight out.)
3. Attach an endoscope to the urology camera head.
• Remove the red dust cap if it is present.
• Lock the endobody brake by pushing it to the right.
• Twist the endobody clamp and hold it open.

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• Insert the endoscope into the endobody clamp.
• Twist the endobody brake in the reverse direction to secure the
endoscope.
4. Attach a light cable from the light source to the light post on the endoscope.

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Operation
Warning: Before using the 1288 HD Urology 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.
e 1288 HD Urology Camera can be controlled using buttons on the camera
head or the touchscreen interface on the console.
Using the Urology Camera Head Buttons
e urology camera head features an oval, two-button keypad for controlling the
1288 urology camera. ese buttons are labeled P and W.
P (Picture) Button
e P button controls up to two remote video accessories.
• Press the P button for less than two seconds to select Remote 1. One beep
will sound.
• Press the P button for more than two seconds to select Remote 2. Two beeps
will sound.
W (White Balance) Button
e W button activates the white-balance function or the light/zoom function.
e white balance function is used to correct slight color dierences that exist
between dierent light sources or endoscopes.
• Press the W button for more than two seconds to activate the white balance
function.
• Press the W button for less than two seconds to increase the zoom one of
eight levels. (e zoom will cycle to the lowest level aer completing the
cycle.)
Perform the white balance procedure before every surgical procedure.

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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 o of the white
surface.
3. Press and hold the W button until “WHITE BALANCE IN PROGRESS”
begins ashing on the video monitor.
4. Continue pointing the scope at the white surface until the video monitor
indicates that white balance is “WHITE BALANCE COMPLETE.” e video
picture may change color. If you cannot achieve an acceptable white balance,
refer to the 1288 HD Camera Console user guide.
Using the Touchscreen Interface
e touchscreen interface on the console provides controls for operating the
camera and selecting system settings. From the touchscreen, you can:
• choose camera settings for urology procedures
• capture photos
• capture video
• activate white balance

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Scroll through preset camera settings designed for
surgical specialties. Choose from:
• Arthroscopy
• Cystoscopy
• ENT
• Flexi-Scope
• Hysteroscopy
• Laparoscopy
• Laser
• Microscope
• Standard
Capture photo.
Press and hold button for two seconds before
itactivates.
Capture video.
Press and hold button for two seconds before
itbegins recording. Press again to stop.
Activate white balance.
Press and hold button for two seconds before
itactivates.
• Press once to proceed to the Menu screen.

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Adjusting the Focus
Slide the focusing knob to the le or right to adjust the focus.

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Cleaning, Reprocessing, and
Maintenance
Reprocessing the Urology Camera Head
ese reprocessing instructions are provided in accordance with ISO 17664,
AAMI TIR12, AAMI ST79, and AAMI ST81. While they have been validated
by Stryker as being capable of preparing the device for re-use, it remains the
responsibility of the processor to ensure that the reprocessing as actually
performed, using equipment, materials, and personnel in the reprocessing
facility, achieves the desired result. is normally requires validation and
routine monitoring of the process. Stryker recommends users observe these
standards when reprocessing medical devices.
Warnings
• is device must be cleaned and sterilized prior to the rst use and aer
every subsequent use.
• Use only the sterilization cycles outlined in this document. Using
unspecied sterilization cycles may damage the device or result in
incomplete sterilization.
• Separate the urology camera head and scope prior to cleaning,
disinfection, or sterilization.
• Wear appropriate protective equipment: gloves, eye protection, etc.
Cautions
• Always install the soaking cap prior to processing the urology 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 uid.
Return any damaged camera to Stryker for service.
• 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.
• Never soak the camera in the same tray with sharp instruments.
• Repeated sterilization via Ethylene Oxide may result in degradation
inimage quality.

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Limitations on Reprocessing
• Do not cross-sterilize the device. Using multiple sterilization methods
may signicantly reduce the performance of the device.
• Do not leave the device in solutions longer than necessary. is may
accelerate normal product aging.
• Proper processing has a minimal eect 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.
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 aer use.
Containment and Transportation
• Reprocess the device as soon as reasonably practical following use1.
• Transport the device in a tray to avoid damage.
1 A 30 minute wait time was used during cleaning validation.
Preparation for Cleaning
1. Disassemble the coupler from the scope and camera head.
2. Prepare an enzymatic detergent according to the manufacturer’s
recommendations (one ounce per gallon of tap water at 35 - 40°C)2.
3. Wipe the entire device with the detergent, using a clean cloth.
4. Immerse the device in the detergent. Using a syringe, inject any inside
regions of the device with 50mL of the detergent to ensure all parts of the
device are reached.
5. Soak the device in the detergent for a minimum of 15 minutes.

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Cleaning: Manual
1. Brush
• Prepare a fresh solution of enzymatic detergent according to the
manufacturer’s recommendations (one ounce per gallon of tap water
at35 - 40°C)2.
• oroughly brush the exterior of the device with a so-bristled brush,
focusing on any mated or rough surfaces.
• Using a syringe, inject any lumen or mated surface a minimum of
5times with 50mL of the detergent.
• Brush any lumens a minimum of 5 times from each end, using an
appropriate bottle brush.
• Brush any movable parts in all extreme positions.
2. Rinse
• Rinse the device with reverse osmosis/de-ionized (RO/DI) water at
ambient temperature until all detergent residue is removed. Flush any
lumens or mated surfaces a minimum of 5 times. Once all detergent
residue is 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 (0.25 ounces per gallon of tap water at 35 - 40°C)3.
• Fully immerse the device and use a syringe to inject any lumens and
mated surfaces with 50mL of the detergent.
• Soak the device for a minimum of 15 minutes.
4. Brush
• oroughly brush the exterior of the device using a so-bristled brush.
• Using a syringe, inject 50mL of the 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
• oroughly rinse the device with RO/DI water until all detergent
residue is removed. Flush any lumens or crevices a minimum of 5 times.
Once all detergent residue is removed, continue to rinse for a minimum
of 30 seconds.
• Drain the excess water from the device and dry it using a clean cloth or
pressurized air.