Stryker 1288010000 User manual
1288 HD Video Camera
Volume I of II
User Guide
1288010000
1288010001
1288210105
1288710105
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Contents
User Guide.........................................................................................1
Guide de l’utilisateur.................................................................49
Benutzerhandbuch...................................................................101
Manuale d’uso.............................................................................153
Manual do Utilizador ...............................................................205
Guía del usuario.........................................................................257
Gebruikershandleiding...........................................................307
Brugervejledning .......................................................................363
1
Contents
Warnings and Cautions......................................3
Critical Safety Warnings...............................................................3
Warnings......................................................................................3
Symbol Definitions ............................................5
Product Description and Intended Use ..............6
Indications/Contraindications......................................................7
The Camera Console ...................................................................8
The Camera Head......................................................................10
The C-Mount Coupler................................................................11
Setup and Interconnection ..............................12
Setting Up the Console..............................................................12
Setting Up the Camera Head.....................................................17
Setting Up the Coupler ..............................................................18
Operation ........................................................20
Powering the Camera On/Off ....................................................20
Using the Camera Head Buttons...............................................20
Using the Touchscreen Interface ...............................................22
Controlling Remote Video Accessories .....................................26
Using the SFB Serial Interface...................................................26
Using the DVI Fiber Outputs......................................................26
Operating the Camera with a Light Source......27
Troubleshooting...............................................28
Cleaning and Reprocessing .............................31
Cleaning the Camera Console...................................................31
Reprocessing the Camera Head................................................31
Using Sterile Drapes ..................................................................37
Replacing the Fuses ..................................................................38
Periodic Maintenance Schedule ................................................38
Electromagnetic Compatibility ........................41
Warranty and Return Policy.............................45
3
Warnings and Cautions
Please read this manual and follow its instructions carefully. e words warning, caution, and note
carry special meaning and should be carefully reviewed:
Warning Indicates risks to the safety of the patient or user. Failure to follow warnings may
result in injury to the patient or user.
Caution Indicates risks to the equipment. Failure to follow cautions may result in product
damage.
Note Provides special information to clarify instructions or present additional useful
information.
An exclamation mark within a triangle is intended to alert the user to the presence of
important operating and maintenance instructions in the manual.
A lightning bolt within a triangle is intended to warn of the presence of hazardous
voltage. Refer all service to authorized personnel.
IMPORTANT SAFETY NOTICE:
Before operating this device, please read this operating manual thoroughly and carefully. When
using this device with a light source, 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 signicant 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. e scope tip, scope light post, light cable adapter, and light cable tip will take
several minutes to cool o aer being placed in standby mode, and therefore may still result in
re or burns to the patient, user, or inanimate objects.
Critical Safety Warnings
ese warnings indicate risk to the safety of the patient or user. Failure to follow warnings may
result in injury to the patient or user.
1. e camera head surface may exceed 41°C (106°F) in operating conditions with high ambient
temperatures and should be handled with caution.
2. To avoid the risk of electric shock, this equipment must only be connected to a supply mains
with protective earth.
Warnings
To avoid potential serious injury to the user and the patient and/or damage to this device, please
note the following warnings.
4
3. Carefully unpack this unit and check if any damage occurred during shipment. If damage is
detected, refer to the Warranty and Return Policy section of this manual.
4. Read this operating manual thoroughly, especially the warnings, and be familiar with its
contents before connecting and using this equipment.
5. Be a qualied physician, having complete knowledge of the use of this equipment.
6. Test this equipment prior to a surgical procedure. is unit was fully tested at the factory
before shipment. Never use this equipment in the presence of ammable or explosive gases.
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. Attempt no internal repairs or adjustments not specically detailed in this operating manual.
No modication of this equipment is allowed.
10. Pay close attention to the care and cleaning instructions in this manual. Any deviation may
cause damage.
11. Never sterilize the camera console, because the delicate electronics cannot withstand this
procedure.
12. e camera head and coupler are shipped non-sterile. Clean and sterilize these components
prior to rst use and aer every subsequent use. Follow the instructions provided in the
appropriate manuals.
13. Do not position the console so that it is dicult to disconnect the power cord from the supply
mains.
14. Disconnect the control unit from the electrical outlet when inspecting the fuses.
15. Before each use, check the outer surface of the endoscope to ensure that there are no rough
surfaces, sharp edges, or protrusions.
16. Avoid dropping the camera system. e camera system contains sensitive parts that are
precisely aligned.
17. Ensure that readjustments, modications, and/or repairs are carried out by persons
authorized by Stryker Endoscopy.
18. Ensure that the electrical installation of the relevant operating room complies with the NEC
and CEC guidelines.
19. Multiple portable socket-outlets shall not be placed on the oor.
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 Camera
and in this manual have specic meanings that clarify the proper use and storage of the 1288 HD
Camera. e following list denes the symbols associated with this product:
Refer to instruction manual Cameras, couplers, and camera
extension cables are shipped non-
sterile and must be sterilized before
use.
Caution (consult instructions for use) Federal law (USA) restricts this device
to use by, or on order of, a physician.
Operating humidity range Operating pressure range
Operating temperature range Type BF applied part
Date of manufacture Legal manufacturer
Denotes compliance to CAN/CSA
C22.2 No601.1-M90 UL60601-1.
Catalogue number
Device recycling code (applicable in
China)
Device meets requirements for safety
and eectiveness set forth in MDD
93/42/EEC
Equipotentiality Serial number
Alternating current Power on/o (alternates when button
is pushed)
Protective ground earth 1288 Camera head icon
FireWire Country of origin
Fuse rating CLASS 1 LASER
PRODUCT
APPAREIL A LASER DE
CLASSE 1 Class 1 laser product
Stryker European representative
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.
6
Product Description and Intended Use
e Stryker Endoscopy 1288 HD Medical Video Camera is a high-denition camera used to capture
still and video images of endoscopic surgical applications. e 1288 HD Medical Video Camera
consists of three main components:
Component Stryker Part Number
Camera console 1288010000; 1288010001
Camera head 1288210105, 1288710105
C-mount coupler 1288020122
e 1288 HD also comes with various connection cables which, like the other components, can be
purchased together or separately.
Federal law (United States of America) restricts this device to use by, or on the order
of, a physician.
7
Indications/Contraindications
e 1288 HD Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy,
sinuscopy, and plastic surgery wherevera 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
graing 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.
8
The Camera Console
e camera console or Camera Control Unit (CCU) is the control center for the 1288 HD Medical
Video Camera and processes the video and photographic images captured during the surgical
procedure. e console front panel features a touch screen, where dierent menus can be accessed,
including the controls for adjusting the enhancement level, light level, zoom, and white balance,
as well as allows the selection of surgical specialty settings that optimize camera performance for
various, specic surgical procedures. e front panel also allows activation of remote outputs. e
rear panel provides ports for connecting the 1288 HD Camera to viewing and recording equipment,
such as video monitors, the SDC Ultra, or photo printers.
Front Panel
3
1 2
1. Power Switch Powers the camera ON and OFF
2. Touch Screen Allows navigation through dierent menus for
controlling the camera and adjusting the system settings
3. Camera Connector Port Connects to the 1288 HD Camera Head
9
Rear Panel
2
1
3 64 5 7 8 9 10 11
12
1. SFB Connectors Enables FireWire connection with Stryker FireWire devices;
provides connection for remote diagnoses and future soware
upgrades
2. SIDNE® Port Connects to the SIDNE® Console to enable voice operation
and/or graphic tablet control
3. Remote Out 1 Connects to a video accessory remote switch
4. Remote Out 2 Connects to a video accessory remote switch
5. S-Video Out Analog video output
6. DVI Out 1 Digital video output
7. DVI Out 2 Digital video output
8. Display Port Digital video output
9. AC Power Inlet Connects to separable power cord, which can be used for
mains isolation
10. Fuse Panel Contains two 1.6A 250V (slow blow, high breaking capacity
1500A) fuses
11. Equipotential Ground
Plug
Connects to a potential equalization conductor. e resulting
medical electrical system shall follow all applicable IEC
60601-1 requirements.
12. Fiber Outputs (optical) DVI output for connection to Lucent connector bers
(optional: 1288010001)
10
The Camera Head
e camera head connects to the camera console and captures video and photographic images,
which it relays to the camera console. It features several controls that are accessible through a button
keypad located on the top of the camera head (see the “Operation Instructions” section of this
manual).
1 42 3
1. Soaking Cap Protects the cable connector during cleaning and sterilization
2. Cable Connector Connects the camera head to the camera console
3. Camera Cable
4. Camera Head Captures photographic and video images, provides camera
controls, and connects with a focusing coupler
11
The C-Mount Coupler
e 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. e features of the coupler are
listed in Figure 3 below. Additional instructions are available in the “1288 C-Mount Coupler User
Guide” (P/N 1000401152).
23
14
1. Rear Adapter reads 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
12
Setup and Interconnection
Note: Stryker Endoscopy considers instructional training, or inservice, an integral part of the 1288
HD Medical Video Camera. Your local Stryker Endoscopy sales representative will perform at least
one inservice at your convenience to help set up your equipment and instruct you and your sta
on its operation and maintenance. To schedule an inservice, contact your local Stryker Endoscopy
representative aer your equipment has arrived.
Setting Up the 1288 HD Camera involves three steps:
1. Setting up the console
2. Setting up the camera head
3. Setting up the coupler
Setting Up the Console
Caution
Always connect the camera to an appropriate power source, using a hospital-
grade power cord. Loss of AC power will cause the camera to shut down and
the surgical image to be lost.
Only connect items to the camera that have been specied for use with the
camera. Connecting incompatible equipment may cause unexpected results.
When the 1288 HD Camera is used with other equipment, leakage currents
may be additive. Ensure that all systems are installed according to the
requirements of IEC60601-1-1.
Equipment which employs RF communications may aect the normal function
of the 1288 HD Camera. When choosing a location for the 1288 HD Camera,
consult the “Electromagnetic Compatibility” section of this manual to ensure
proper function.
Always set up the console in a location that allows adequate ventilation
(airow) to the console. Insucient ventilation may cause the console to
overheat and shut down.
To set up the console, make the following connections:
1. Connect the AC power.
• Connect the AC power cord to the AC inlet on the rear console panel.
• Connect the other end to a hospital-grade outlet.
2. Connect the video output.
• e rear panel provides one analog and three (or four with the optional ber digital-
video outputs, which can be used together or independently:
Output Type Output Cable Connector
Analog *S-VHS 1 S-VHS 4 pin Mini-Din
(push-only connectors)
13
Digital **DVI-I1 DVI 29 pin (push-only connectors,
with two tightening knobs)
**DVI-I2 DVI 29 pin (push-only connectors,
with
two tightening knobs)
Displayport Displayport 20 pin Displayport
(auto-locking connector)
Optional DVI over
optical Fiber
Fiber (×4) Lucent connector ber
(× 4) (push only)
* On some monitors, S-VHS inputs may be labeled Y/C.
** e DVI connectors can also output analog SXGA signals through a DVI-I to VGA adapter.
Use the cables and outputs described above to connect the 1288 HD to other operating-room
equipment. Wiring Diagrams 1-3 describe typical set-ups.
• If desired, connect any remote outputs using the remote cables supplied with the
1288 HD Camera. (See Wiring Diagram 2.) Devices connected to the remote outputs
of the 1288 HD Camera can be operated using the P buttons on the camera head
and/or console. See the “Operation Instructions” section of this manual for details.
• If desired, connect the SIDNE® interface as well. (See Wiring Diagram 2.)
14
Wiring Diagram 1: Camera and Flat-Panel Monitor
WiSe 26" HDTV Surgical Display
1288 HD Video Camera
DVI-I/VGA
Adapter
DVI
DVI
15
Wiring Diagram 2: Camera, SDC, SIDNE®, and Flat-Panel Monitor
DVI
USB
DVI
Stryker European Rep. -
RA/QA Manager
ZAC Satolas Green Pusignan
Av.De Satolas Green
69881 MEYZIEU Cedex, France
WiSe 26" HDTV Surgical Display
1288 HD Video Camera
SIDNE®
SDC
DVI
REMOTE
16
Wiring Diagram 3: Camera, Flat-Panel Monitor, and CRT Monitor
WiSe 26" HDTV Surgical Display
1288 HD Video Camera
DVI-I/VGA
Adapter
DVI
DVI
CRT Monitor
S-VHS
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