Stryker 1288010000, 1288010001, 1288210105, 1288710105 User Manual

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1288 HD Video Camera

User Guide

1288010000

1288010001

1288210105

1288710105

Contents

Warnings and Cautions ...................................... 3

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, Reprocessing, and Maintenance ...... 31

Cleaning the Camera Console ...................................................31

Reprocessing the Camera Head ................................................31

Using Sterile Drapes ..................................................................38

Replacing the Fuses ..................................................................39

Periodic Maintenance Schedule ................................................39

Electromagnetic Compatibility ........................ 42

Warranty and Return Policy ............................. 46

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 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

To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings:

1. 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.

2. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this equipment.

3. Be a qualied physician, having complete knowledge of the use of this equipment.

4. 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.

5. Avoid dissembling any part of the camera head, as doing so may break the seals, causing leakage and/or electric shock.

6. Avoid removing covers on the control unit, as doing so may cause damage to electronics and/or electric shock.

7. Attempt no internal repairs or adjustments not specically detailed in this operating manual.

8. Pay close attention to the care and cleaning instructions in this manual. Any deviation may cause damage.

9. Never sterilize the camera console, because the delicate electronics cannot withstand this procedure.

10. Disconnect the control unit from the electrical outlet when inspecting the fuses.

11. Before each use, check the outer surface of the endoscope to ensure that there are no rough surfaces, sharp edges, or protrusions.

12. Avoid dropping the camera system. e camera system contains sensitive parts that are precisely aligned.

13. Ensure that readjustments, modications, and/or repairs are carried out by persons authorized by Stryker Endoscopy.

14. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines.

15. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

16. Multiple portable socket-outlets shall not be placed on the oor.

e 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 1288 HD Camera and in this manual have specic meanings that clarify the proper use and storage of the 1288 HD Camera. e following list denes the symbols associated with this product:

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

Equipotentiality

Protective Ground Earth

FireWire

Fuse rating

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.

Product Description and Intended Use

e Stryker Endoscopy 1288 HD Medical Video Camera is a high-denition 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.

Indications/Contraindications

e 1288 HD 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.

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 dierent 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, specic 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

1 2

1. Power Switch Powers the camera ON and OFF

2. Touch Screen Allows navigation through dierent menus

for controlling the camera and adjusting the system settings

3. Camera Connector Port Connects to the 1288 HD Camera Head

Rear Panel

213 64 5 7 8 9 10 11

1. SFB Connectors Enables FireWire connection with Stryker

FireWire devices; provides connection for remote diagnoses and future soware 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 seperable power cord, which can be

used for mains isolation

10. Fuse Panel Contains two 0.63 A fuses

11. Equipotential Ground Plug

12. Fiber Outputs (optical)

DVI output for connection to Lucent connector bers (optional: 1288010001)

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

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).

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

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 aer 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

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 specied 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 IEC60601-1-1.

Caution Equipment which employs RF communications may

aect 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 (airow) to the console. Insucient 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)

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.)

Wiring Diagram 1: Camera and Flat-Panel Monitor

WiSe 26" HDTV Surgical Display

1288 HD Video Camera

DVI-I/VGA

Adapter

DVI

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

Wiring Diagram 3: Camera, Flat-Panel Monitor, and CRT Monitor

WiSe 26" HDTV Surgical Display

1288 HD Video Camera

DVI-I/VGA

Adapter

DVI

CRT Monitor

S-VHS

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: e 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 conguration menu. See the “Using the Conguration 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.

Setting Up the Camera Head

Caution Do not severely bend the camera cable or damage may result.

Note: To unplug the camera from the control unit, grasp the knobbed portion of

the connector and pull straight out.

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.

• Push in the connector until it locks in place.

Setting Up the Coupler

1. Attach the coupler to the camera head.

• Grasping the rear adapter, screw the coupler onto the camera head (clockwise) until it forms a tight seal.

Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions.

Caution When attaching or removing the coupler, grip only the rear

adapter, as twisting other parts of the coupler may result in mechanical damage.

Do not overtighten the coupler, as this may damage the front window of the camera.

Do not overtighten a direct-coupled C-mount scope, 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.

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).

• Release the endobody clamp.

(a)

(b)(c)

3. Attach a light cable from the light source to the light post on the endoscope (c).

Operation

Warning: Before using the 1288 HD 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.

Note: Before operating the 1288 HD Camera, ensure all components have been

set up according to the instructions in the “Setup and Interconnection” section of this manual.

Powering the Camera On/Off

Press the power switch on the console to power the camera on or o.

Using the Camera Head Buttons

e camera head features a cross-shaped, four-button keypad for controlling the 1288 camera. Shown below, these buttons are labeled P, W, Up, and Down.

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 less than two seconds to activate the white balance function.

• Press the W button for more than two seconds to increase the light or zoom level. e camera console can be set to “light” mode or “zoom” mode using the Buttons submenu of the Conguration 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 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 “Troubleshooting” section of this manual.

Up and Down Buttons

e up and down buttons work together to increase or decrease the light/zoom level.

e camera console can be set to “light” mode or “zoom” mode using the Buttons submenu of the Conguration Menu. In “light” mode, pressing the arrow buttons will raise or lower the automatic-shutter light-level setting in 8 steps. In “zoom” mode, pressing the arrow buttons will raise or lower the zoom level in 8 steps. Press the arrow button once to adjust the light level by one step or hold down the button for a quicker transition.

Using the Touchscreen Interface

e touchscreen interface on the console provides controls for operating the camera and selecting system settings. Controls are located in a series of menus shown below and described hereaer.

Home Menu

Language

ENGLISH

LANGUAGE

Home Screen

e Home screen is the default screen. Use the buttons below to choose surgical specialties, operate the camera head, and navigate to other menus.

Home Menu

Language

ENGLISH

LANGUAGE

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.

Menu Screen

e Menu screen provides options for adjusting the camera picture.

Home Menu

Language

ENGLISH

LANGUAGE

• Press once to return to the Home screen.

• Hold for 5 seconds to proceed to the Language screen.

Increase or decrease:

• Enhance (picture sharpness)

• Light (automatic-shutter light level)

• Zoom (magnication)

Enhance/Light/Zoom Meter

Appears on the monitor, indicating the selection level.

Language Screen

e Language screen allows you to choose the default language for the user interface.

Home Menu

Language

ENGLISH

LANGUAGE

ENGLISH

LANGUAGE

Scroll through available interface languages.

Choose from:

• Danish

• German

• Polish

• Dutch

• Greek

• Portuguese

• English

• Italian

• Simplied Chinese

• Finnish

• Japanese

• Spanish

• French

• Korean

• Swedish

• Norwegian

• Press the Home button to exit the language screen. Power cycle the unit for the change to take eect.

• To initiate black balance, hold for 5 seconds until “BLACK BALANCE” begins ashing on the video monitor.

Controlling Remote Video Accessories

e 1288HD Camera can remotely control up to two video accessories (such as the SDC Ultra, a VCR, or a photo printer), enabling the user to capture images or start and stop video recording by pressing the P button. (See also the “Using the Camera Buttons” section of this manual.)

1. Connect the video accessory to one of the remote outputs on the rear console panel. Use the provided remote cables. (See Wiring Diagram 2 in the “Setting Up the Console” section of this manual.)

2. Press the P button for less than one second to select Remote 1. One beep will sound.

3. Press the P button for more than one second to select Remote 2. Two beeps will sound.

Using the SFB Serial Interface

e SFB serial connection on the console rear panel enables FireWire connection to the Stryker Endoscopy Soware Management Site (SMS). Connect to the L9000 Light Source for “Run/Standby” controls from the Camera Head.

Note: is system feature is not necessary for regular camera system operation.

is system feature requires an additional device (that is, a computer) to connect to SMS.

Using the DVI Fiber Outputs

Using controls or adjustments or performing procedures dierently than specied in this manual may result in hazardous radiation exposure.

e 1288 HD Camera has the optional upgrade, the ber output, for model

1288010001. is upgrade contains four laser diodes to transmit a DVI output over beroptic cables.

1. Connect four individual bers (terminated in Lucent connectors) to the red (R), green (G), blue (B) and clock (C) laser diodes on the console rear panel.

2. Connect the four bers to a compatible beroptic DVI receiver.

• e four bers should be connected to the camera console in the labeled order: RGBC

• e bers should be connected to the monitor in one of two congurations: CBGR (reverse order) or BGRC (R/B switched).

3. Ensure the beroptic output is enabled (on) via the Options Submenu in the Conguration Menu. (See the section “Using the Conguration Menu”.)

Note: e 1288 HD Camera model 1288010001 is a Class 1 laser product per IEC 60825-1 and 21CFR.

Operating the Camera with a Light Source

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.

Troubleshooting

Problem Possible Solution

“Restart Camera Console” message (Color bar background)

• Camera head temporarily shut down due to overcurrent. Turn o the console, wait 3 seconds, and turn it back on.

• Aer sterilization, ensure the camera head has cooled down before connecting it to the console

“System Error” message (Light blue background)

• No video detected.

• Aer sterilization, ensure the camera head has cooled 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 o the console, wait 3 seconds, and turn it back on.

No color bar (Optical DVI only)

• Same as above.

• See the “Using the DVI Fiber Outputs” section of this manual.

Incorrect picture color

• Perform the white balance procedure. (See the “W Button” section of this manual.)

• Check the color settings on the monitor.

White balance (WB) quality not good

• See the solution for “Picture is too dark.”

• See the solution for “Picture is too bright.”

• Perform the white-balance procedure with the light source connected to the scope. Use metal-halide, xenon, or LED lighting (no uorescent lighting).

Picture is too dark

• Increase the camera light level with the camera head.

• Increase the light-source output.

• Check the ber-optic light cable for excessive broken bers.

Picture is too bright

• Decrease the camera light level.

• Decrease the light-source output.

• Ensure that Shutter submenu in the Conguration menu has the following settings:

BRT CNTRL AUTO Shutter On

Noise or snow on picture when using electrocautery probes

• Plug the electrocautery generator into a separate electrical outlet and separate the 1288 HD power cord from the electrocautery power cord.

• Separate the camera cable from the electrocautery cable.

• Reposition the electrocautery grounding pad on the patient.

Noise or snow on picture when not using electrocautery probes

• Reduce Enhancement.

• Check for and replace faulty video cables.

No video picture when the camera head is plugged in

• Check to ensure that all devices in the video system are plugged in and powered on.

• Check the connector on the camera-head cable for broken pins.

• Detach the camera head from console and reconnect

• Turn o the console, wait 3 seconds, and turn it back on.

Image is not well centered

• Release the scope from the coupler and then reconnect it. Make sure the scope is seated correctly in the coupler.

Variability in color reproduction between dierent light sources or peripherals

• Perform the white-balance procedure. (See the “W Button” section of this manual.)

• Check the settings on video peripherals.

• Ensure the light source has a proper infrared lter (check with manufacturer specications).

Foggy picture (loss of denition and clarity)

• Refocus the camera.

• Refocus the coupler.

• 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.

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 exible 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 “Warranty and Return Policy” section of this manual.

Cleaning, Reprocessing, and Maintenance

e camera console is not intended to come into contact with the patient. It may be cleaned, but not sterilized. e camera head and coupler may contact the patient and should both be cleaned and sterilized prior to every use.

Cleaning the Camera Console

Disconnect the console from the AC power source before cleaning.

Caution Never immerse or sterilize the camera console as this will

damage the camera and void the warranty.

Should the camera console need cleaning, wipe it down with a sterile cloth and mild cleaning solution.

Reprocessing the 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 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.

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 uid. 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  can withstand steam sterilization. Autoclaving camera heads that do not bear this marking will result in product damage.

• 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 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.

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.

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.

Cleaning: Automated

1. Brush

• Using a syringe, inject 50mL of the enzymatic detergent (from the “Preparation for Cleaning” section) into any lumen and mated surface aminimum of one time.

• Brush from both ends of any lumens a minimum of 1 time, using an appropriate bottle brush.

2. Rinse

• Rinse the device with RO/DI water at ambient temperature until there is no visible detergent residue. Continue to rinse for a minimum of 30seconds aer 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:

Phase Recirculation

Time

Water

Temperature

Detergent Type and

Concentration

(if applicable)

Pre Wash 2 minutes Cold tap

water

N/A

Enzyme

Wash

2 minutes Hot tap water Enzymatic Detergent

Wash 1 2 minutes Set point

(66˚C)

Non-enzymatic

Detergent

Rinse 1 2 minutes Hot tap water N/A

Dry Phase 7 minutes 115˚C N/A

• Upon completion of the draining phase aer Rinse 1, stop the cycle and open the washer door.

• Remove the device from the washer during the thermal phase and place the device back into the washer for the dry phase.

• If necessary, use pressurized air to aid in drying. Visually inspect each device for cleanliness.

ENZOL® Enzymatic Detergent is validated for cleaning ecacy.

Renu-Klenz® is validated for cleaning ecacy.

Low Level Disinfection (optional)

1. Disinfect the device in a disinfecting solution that has one of the following active Ingredients:

• ≥ 2.4% glutaraldehyde4 with a minimum soaking time of 45 minutes at 25 °C or

• >= 3.4% glutaraldehyde5 with a minimum soaking time of 20 minutes at 25 °C or

• ≥ 0.55% ortho-phthalaldehyde6 with a minimum soaking time of 12minutes at 25 °C.

2. Prepare the disinfecting solution according to the manufacturer’s instructions.

3. Per manufacturer’s recommendations, immerse the device, lling all lumens, in the disinfecting solution for the required time at the appropriate temperature.

4. oroughly rinse and ush all parts and lumens with running, demineralized water to remove the disinfectant.

5. Dry all parts with a lint-free towel immediately aer rinsing.

CIDEX Activated® is validated for disinfection ecacy.

CIDEX Plus® is validated for disinfection ecacy.

CIDEX® OPA is validated for disinfection ecacy.

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.

Maintenance, Inspection, and Testing

• Inspect the device on a continual basis. If a problem is observed or suspected, the device should be returned for repair.

• Inspect all components for cleanliness. If uid or tissue buildup is present, repeat the above cleaning and disinfection procedures.

• Inspect the camera cable for cuts and breaks. Return any damaged camera to Stryker for service.

Packaging

N/A

Sterilization

Aer performing the cleaning instructions specied above, perform one of the following sterilization cycles.

Ethylene Oxide (EtO)

• Double wrap camera head and cable prior to sterilization.

Preconditioning parameters

Temperature 55°C (131°F)

Chamber Humidity 70% RH

Vacuum Set Points 1.3 psia

Time 30 minutes

Exposure

Concentration (100% EtO) 725 mg/L

Temperature 55 ± 2°C (131 ± 5°F)

Time 1 hour

Chamber Humidity 70% RH (50–80%) ± 5%

Aeration parameters

Aeration Time 12 hours

Temperature 35–54°C (95–129°F)

Steris® System 1

1. Clean and prepare the camera head and cable as recommended in the Cleaning and Disinfection sections. Ensure the soaking cap is installed.

2. Sterilize the camera head and cable using Steris® System 1 with Steris® Sterilant 20.

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.

Sterrad®

1. Clean and prepare the camera head and cable as recommended in the “Cleaning and Disinfection” section. Ensure the soaking cap is installed.

2. Double wrap the camera head and cable prior to sterilization.

3. Sterilize the camera head and cable following the instructions of the manufacturer, using the STERRAD® 100S, 200, NX™, or 100NX™ Sterilization System. Select the standard cycle.

Warning: Not all sterilization trays are compatible with STERRAD® systems. Using an incompatible tray may result in incomplete device sterilization. Consult the instructions that came with your sterilization tray to determine which sterilization method is compatible with your tray and devices. Ifacompatible tray is not available, the devices can be double-wrapped priortousing the STERRAD® system.

4. 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.

Storage

Never store the device in a non-ventilated, humid environment such as a carrying case. is may present an infection control risk.

Using Sterile Drapes

Using sterile drapes will ensure maximum longevity of your 1288 HD Camera Head. For best results, follow the instructions provided by the drape manufacturer.

User Maintenance

Replacing the Fuses

To avoid the risk of re, use only fuses of the value specied on the fuse label located on the rear panel of the transmitter.

1. Unplug the power cord from the wall outlet and remove the cord from the transmitter console.

2. Unlatch the fuse holder above the AC inlet and remove it. (You may need to press the tab on the fuse holder with a slender screwdriver to release the latch.)

3. Replace the fuse with the same value and rating.

4. Reinstall the fuse holder until the tab snaps in place.

Periodic Maintenance Schedule

To ensure safe operation of the Model 1288 HD Video Camera you should periodically perform the following procedure:

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 diculties not detailed in this manual to your Stryker Endoscopy sales representative.

Disposal

is product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately in accordance with applicable national or institutional related policies relating to obsolete electronic equipment.

e 1288 HD must be disposed of according to local laws and hospital practices.

Technical Speciﬁcations

60Hz settings are displayed rst. (50Hz settings follow in parentheses.)

Imaging System 1/3” Progressive Scan CCDs

High Denition

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, 1080p (HDTV) format

Connector: 29-pin DVI-I

Y/C: One S-VHS

Connector: 4-pin mini-DIN

Digital Fiber: HD, HDTV (R, G, B, Clk)

Connector: Four Lucent ber connectors

with 1.25 mm ferrules

Digital One Displayport 1280 × 1024

(HD), 720p, 1080p (HDTV) format

Connector 20 pin Displayport

Mounting Endoscope eyepiece used with C-mount coupler

C-mount camera head used with C-mount scopes

(C-mount coupler/scope thread: 1-32" UN 2A)

Auto Shutter Range 1/60 (1/50) – 1/50,000 second

Operating Conditions Temperature: 5 – 40°C

Relative Humidity: 30 – 95%

Transport and Storage Conditions

Temperature: -10 – 60°C

Relative Humidity: 10 – 75%

Atmospheric Pressure: 700 – 1060 hPa

Input Electrical Ratings 100 – 240VAC (0.6A) @ 50 – 60Hz

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 × 4.0” h × 15.25” d

(31.8 cm w × 10.2 cm h × 38.7 cm d)

Camera Head Cable to Camera Console:

10.3  (3.15 m) sealed cable

20.7  (6.30 m) cable extension available

Enhancement 16 levels (switchable)

Classication Class I Equipment

Type BF Applied Part

Water Ingress Protection, IPX0—Ordinary Equipment

Continuous Operation

Complies with Medical Safety Standards

IEC 60601-1:1988 + A1:1991 + A2:1995

IEC 60601-2-18:1996 + A1:2000

CAN/CSA C22.2 No 601.1-M90

UL 60601-1:2003

AS/NZS 3200.1.0:1998

CSA 22.2.601.1.1:2002

CAN/CSA C22.2 No. 601.2.18:1990

Complies with Medical EMC Standard

IEC 60601-1-2:2001 + A1:2004

Complies with Laser Product Standards

Class 1 Laser Product

Contains four 850-nm laser diodes

is product complies with IEC 608251:1993+A1:1997+A2:2001.

is 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.

Electromagnetic Compatibility

Like other electrical medical equipment, the 1288 HD Camera requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the 1288 HD Camera must be installed and operated according to the EMC information provided in this manual.

Note: e 1288HD Camera has been designed and tested to comply with IEC60601-1-2:2001 requirements for EMC with other devices.

Do not use cables or accessories other than those provided with the 1288 HD Camera, as this may result in increased electromagnetic emissions or decreased immunity to such emissions.

If the 1288 HD Camera is used adjacent to or stacked with other equipment, observe and verify normal operation of the 1288 HD Camera in the conguration in which it will be used prior to using it in a surgical procedure. Consult the tables below for guidance in placing the 1288 HD Camera.

Caution Equipment which employs RF communications may aect the

normal function of the 1288 HD Camera.

Guidance and Manufacturer’s Declaration: Electromagnetic Emissions

1288 HD Camera is intended for use in the electromagnetic environment specied below. The

customer or the user of 1288 HD Camera should ensure that it is used in such an environment.

Emissions test Compliance Electromagnetic Environment -

guidance

RF emissions CISPR 11 Group 1 1288 HD Camera uses RF energy only

for its internal function; therefore, its

RF emissions are very low and are not

likely to cause any interference in nearby

electronic equipment.

RF emissions CISPR 11 Class B The 1288 HD Camera is suitable for

use in all establishments other than domestic establishments and those

directly connected to the public low-

voltage power supply network that

supplies buildings used for domestic

purposes, provided the following warning

is heeded:

Warning: This system is intended

for use by health care professionals

only. This system may cause radio

interference or may disrupt the operation

of nearby equipment. It may be

necessary to take mitigation measures,

such as reorienting or relocating the

system or shielding the location.

Harmonic emissions

IEC61000-3-2

Class A

Voltage Fluctuations/ icker

emissions IEC61000-3-3

Complies

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

1288 HD Camera is intended for use in the electromagnetic environment specied below.

The customer or the user of 1288HD Camera should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic

Environment:

Guidance

Electrostatic Discharge

(ESD) IEC61000-4-2

±6kV contact

±8kV air

±2,4,6kV contact

±2,4,8kV air

Floors should be

wood, concrete, or

ceramic tile. If oors

are covered with

synthetic material,

the relative humidity

should be at least

30%.

Electrical fast transient/

burst IEC61000-4-4

±2kV for power supply

lines

±1kV for input/output

lines

±2kV line to ground

±1kV line to line

Mains power quality

should be that of a typical commercial or hospital environment.

Surge

IEC61000-4-5

±1kV differential mode

±2kV common mode

±0.5, 1kV differential

mode

±0.5, 1, 2kV common

mode

Mains power quality

should be that of a typical commercial or hospital environment.

Voltage dips, short

interruptions and

voltage variations on

power supply input lines

IEC61000-4-11

<5% Ut (>95% dip in

Ut) for 0.5 cycle

40% Ut (60% dip in

Ut) for 5 cycles

70% Ut (30% dip in

Ut) for 25 cycles

<5% Ut (>95% dip in

Ut) for 5 sec.

<5% Ut (>95% dip in Ut)

for 0.5 cycle

40% Ut (60% dip in Ut)

for 5 cycles

70% Ut (30% dip in Ut)

for 25 cycles

<5% Ut (>95% dip in Ut)

for 5 sec.

Mains power quality

should be that of a typical commercial or hospital environment.

If the user of 1288

HD Camera requires

continued operation

during power mains

interruptions, it is

recommended that

1288 HD Camera

be powered from an

uninterruptible power

supply or a battery.

Power frequency

(50/60Hz) magnetic eld

IEC 61000-4-8

3 A/m N/A Power-frequency

magnetic elds

should be at levels

characteristic of a

typical location in a typical commercial or hospital environment.

NOTE: Ut is the AC mains voltage prior to application of the test level.

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

1288 HD Camera is intended for use in the electromagnetic environment specied below.

The customer or the user of 1288 HD Camera should ensure that it is used in such an environment.

Immunity Test IEC 60601 Test Level Compliance

Level

Electromagnetic Environment:

Guidance

Conducted RF

IEC 61000-4-6

Radiated RF

IEC 61000-4-3

3 Vrms

150 kHz to 80 MHz

3 V/m

80MHz to 2.5 GHz

3 V

3 V/m

Portable and mobile RF communications equipment should be used no closer to any part of the 1288 HD Camera system, including its cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter.

Recommended Separation Distance

d = 1.17 √P

d = 1.17 √P 80 MHz to 800 MHz d = 2.23 √P 800 MHz to 2.5

GHz where P is the maximum output

power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in meters (m).

Field strengths from xed RF transmitters, as determined by an electromagnetic site survey

(a)

, should be less than the compliance level in each frequency range

(b)

. Interference may occur in the vicinity of equipment marked with the following:

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 reection from structures, objects, and people.

Guidance and Manufacturer’s Declaration: Electromagnetic Immunity

1288 HD Camera is intended for use in the electromagnetic environment specied below.

The customer or the user of 1288 HD Camera should ensure that it is used in such an environment.

(a) Field strengths from xed 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 xed RF transmitters, an electromagnetic site survey should be considered. If the measured eld strength in the location in which the 1288 HD Camera system is used exceeds the applicable RF compliance level above, the 1288 HD 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 1288 HD Camera unit.

(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m.

Recommended Separation Distances Between Portable and Mobile RF Communications

Equipment and the 1288 HD Camera System

The 1288 HD Camera system is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The user of the 1288 HD Camera system can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the 1288 HD Camera system as recommended below, according to the maximum output power of the communications equipment.

Rated maximum output

power (W) of transmitter

Separation distance (m) according to frequency of transmitter

150 kHz to 80 MHz

d = 1.17 √P

80MHZ to 800 MHz

d = 1.17 √P

800 MHz to

2.5 GHz

d = 2.33 √P

0.01 0.12 0.12 0.23

0.1 0.37 0.37 0.74

1 1.17 1.17 2.33

10 3.70 3.70 7.37

100 11.70 11.70 23.30

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 reection from structures, objects, and people.

Warranty and Return Policy

Product Warranty

Stryker Endoscopy warrants all products, subject to the exceptions provided herein, to be free from defects in design, materials, and workmanship and to substantially conform to the product specications contained in the documentation provided by Stryker Endoscopy with the products for a period of one year from the date of purchase (the “Warranty Period”). is warranty shall apply only to the original end-user purchaser of products directly from Stryker Endoscopy or a Stryker Endoscopy authorized distributor. is warranty may not be transferred or assigned without the express written consent of Stryker Endoscopy.

If a valid warranty claim is received within the Warranty Period, Stryker will, in its sole discretion: (1) repair the product at no charge, (2) replace the product at no charge with a product that is at least functionally equivalent to the original product, or (3) refund the purchase price of the product. In any event, Stryker’s liability for breach of warranty shall be limited to the replacement value of the defective or non-conforming part or component.

is warranty does not apply to: (1) products that have been misused, neglected, modied, altered, adjusted, tampered with, improperly installed or refurbished; (2) products that have been repaired by any person other than Stryker Endoscopy personnel without the prior written consent of Stryker Endoscopy; (3) products that have been subjected to unusual stress or have not been maintained in accordance with the instructions in the user manual or as demonstrated by a Stryker Endoscopy representative; (4) products on which any original serial numbers or other identication marks have been removed or destroyed; or (5) products that have been repaired with any unauthorized or non-Stryker components, including replacement lamps.

If Stryker determines in its reasonable discretion that the claimed defect or nonconformance in the product is excluded from warranty coverage as described hereunder, it will notify the customer of such determination and will provide an estimate of the cost of repair of the product. In such an event, any repair would be performed at Stryker’s standard rates.

Products and product components repaired or replaced under this warranty continue to be warranted as described herein during the initial Warranty Period or, if the initial Warranty Period has expired by the time the product is repaired or replaced, for thirty (30) days aer delivery of the repaired or replaced product. When a product or component is replaced, the item provided in replacement will be the customer’s property and the replaced item will be Stryker’s property. If a refund is provided by Stryker, the product for which the refund is provided must be returned to Stryker and will become Stryker’s property.

e inspection, testing, acceptance, or use of the products and services furnished hereunder shall not aect Stryker’s obligation under this warranty, and such warranty shall survive inspection, test, acceptance, and use.

Notwithstanding the above, the following products are warranted for a period of ninety (90) days from the date of purchase: Scopes, Associated Scope Hardware, Fiber Optic Cables, Laparoscopic Instruments, VCRs, Monitors, and Printers; replacement light bulbs are warranted for a period of sixty (60) days from the date of purchase.

TO THE FULLEST EXTENT PERMITTED BY LAW, THE EXPRESS WARRANTY SET FORTH HEREIN IS THE ONLY WARRANTY APPLICABLE TO THE PRODUCTS AND IS EXPRESSLY IN LIEU OF ANY OTHER WARRANTY BY STRYKER, EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, ANY IMPLIED WARRANTY OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. EXCEPT AS SPECIFICALLY PROVIDED IN THIS WARRANTY AND TO THE EXTENT PERMITTED BY LAW, STRYKER IS NOT RESPONSIBLE FOR INDIRECT, SPECIAL, INCIDENTAL OR CONSEQUENTIAL DAMAGES RESULTING FROM ANY BREACH OF WARRANTY OR UNDER ANY OTHER LEGAL THEORY.

Return Policy

Stryker Endoscopy values customer relationships and strives for satisfaction in purchases made by our customers. erefore, we oer a return policy for most products. Under this policy, customers may return purchased products to Stryker Endoscopy, within 90 days of customer’s receipt of the product, for a credit or a refund of the purchase price paid, less shipping and handling and applicable restocking fees. Products that fail aer the rst 90 days may be covered by and are subject to the terms of applicable product warranty. Sterile products may not be returned for credit or refund unless they are in their original, unopened packaging or unless they are in breach of the applicable warranty.

Restocking Fees: Unless the product is defective or the return is the direct result of a Stryker Endoscopy error, a restocking fee of 10% may be charged on all returned products.

A Returned Merchandise Authorization (RMA) number must be obtained from Stryker Endoscopy before returning product. To obtain an RMA number, please contact Stryker Endoscopy Customer Service at 1.800.624.4422.

Please send any returned products to:

Stryker Endoscopy

Attn: Returns 5900 Optical Court San Jose, CA 95138

With the return, please include the following:

1. RMA number

2. Purchase order number

3. Original invoice number

4. Name, address, and account number (of the organization returning the product)

5. Itemized list of the items being returned

6. Reason for the return

7. Product Experience Report/Complaint number, if applicable

Please carefully package the product being returned. Credit will not be given foritems that are damaged in return shipment due to inadequate packaging.

Stryker Endoscopy does not accept any COD returns. Return shipping costs are borne by the customer unless Stryker Endoscopy specically agrees otherwise.

Please clean and sterilize all potentially contaminated products prior to returning them to Stryker Endoscopy. It is unlawful to transport bio-contaminated products through interstate commerce, unless they are properly packaged and labeled as such. Stryker Endoscopy reserves the right to destroy contaminated product at the customer’s expense and charge the customer for a replacement unit.

If a return does not comply with these terms, Stryker Endoscopy reserves the right to destroy the product at the customer’s expense. Any replacement would be at the customer’s expense.

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-408-754-2000, 1-800-624-4422 www.stryker.com

European Representative: Regulatory Manager, Stryker France ZAC Satolas Green Pusignan Av. De Satolas Green 69881 MEYZIEU Cedex, France

1000401140 D

2010/08

Products referenced with a ™ designation are trademarks of Stryker. Products referenced with a ® designation are registered trademarks of Stryker. STERRAD® is a registered trademark of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson and Johnson company. STERRAD NX™ and STERRAD 100NX™ are trademarks of Advanced Sterilization Products, Division of Ethicon Inc., a Johnson and Johnson company.

Stryker 1288010000, 1288010001, 1288210105, 1288710105 User Manual

Specifications and Main Features

Frequently Asked Questions

User Manual