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sterilization tray, consult the instructions provided with the tray for proper

sterilization parameters. Stryker recommends sterilizing the device inside

of a sterilization tray.

•

Sterilize only one camera head per tray, or incomplete sterilization may

result. Follow any instructions provided with the sterilization tray or system

regarding tray setup and other devices that may be sterilized within the

same tray.

•

Devices repaired by or purchased from third-party service organizations

could expose patients to significant risk. These devices are no longer

validated by Stryker for cleanliness, disinfection, and sterilization, or for

safety and efficacy.

•

The user shall defer to the facility’s procedures regarding occupational

exposure to bloodborne pathogens.

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. Refer to the Installing the Soaking Cap section for more detail

about installing the cap.

•

Inspect the camera cable for cuts and breaks before soaking in any fluid.

Return any damaged camera to Stryker for service.

•

Never store the camera in the same tray with sharp instruments. Do not

soak the camera while it is inside a tray.

•

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.

•

The device cannot withstand an automated disinfection method.

•

The 1688 camera heads are not autoclavable. Steam sterilizing camera

heads that are not marked

AUTOCLAVE

will result in product damage.

•

Allow the camera head to cool before connecting it to the console.

Connecting the camera head while it is hot may result in system error.

Limitations on Reprocessing

•

Do not cross-sterilize the device. Using multiple sterilization methods may

significantly reduce the performance of the device.

•

Repeated automated cleaning can degrade the product’s cosmetic

appearance.

•

Damage caused by improper processing is not covered by the warranty.

Содержание 1688 Series

Страница 1: ...1688 4K Camera System 1688010000 1688210105 1688310130 1688610122 1688710105 with Advanced Imaging Modality ...

Страница 2: ......

Страница 3: ...era Head 19 Setting Up the Coupler 20 Installing the Soaking Cap 22 SPY Mode Requirements 23 Operation 24 Powering the Console On Off 24 Performing the White Balance Test 24 Controlling Remote Video Accessories 25 Using the Touchscreen Interface 26 Using the Camera Head Buttons 30 Using the Display Monitor Menu 33 Programming Camera Head Buttons 36 Advanced Features 37 Troubleshooting 38 Reprocess...

Страница 4: ... 50 Using Sterile Drapes 51 Storage 51 Replacing the Fuses 51 Periodic Maintenance Schedule 52 Service Life 52 Disposal 52 Recycling Diagrams 53 Technical Specifications 55 Electromagnetic Compatibility 56 Symbol Definitions 60 ...

Страница 5: ...formed only by Stryker authorized personnel Stryker Endoscopy assumes no product liability or warranty responsibility for devices repaired by or purchased from third party service organizations Warnings General To avoid potential serious injury to the user and the patient and or damage to this device please note the following general warnings 1 Federal USA law restricts this device to sale by or o...

Страница 6: ...ot be used with the equipment 11 Use of third party HDMI cables with the camera console is not recommended due to potential problems with secure connections or electromagnetic compatibility Use the provided HDMI high speed cable or other Stryker approved HDMI cable with the camera console 12 Never use the camera system in the presence of flammable or explosive gases or in an oxygen rich environmen...

Страница 7: ...tions or standards for personal protective equipment 4 Do not manipulate tissue while Contrast mode a SPY mode is on 5 When using SPY mode do not view the light output with optical instruments for example microscopes or magnifiers Do not direct the light output in SPY mode into an area where such instruments are likely to be used 6 Do not turn on SPY mode when the endoscope is outside of the patie...

Страница 8: ...If the brightness level of the light source can be adjusted set it 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 bur...

Страница 9: ...5 1688 4K Camera Head C Mount with Advanced Imaging Modality 1688310130 1688 4K Pendulum Camera Head with Integrated Coupler3 1688610122 1688 4K Camera Head Integrated Coupler with Advanced Imaging Modality 1688710105 1688 4K Inline Camera Head C Mount with Advanced Imaging Modality Coupler 1688 020 122 4K Coupler C Mount with Advanced Imaging Modality4 1 Complete instructions are available in Str...

Страница 10: ...copic pelvic lymph node detection laparoscopically assisted hysterectomy laparoscopic and thorascopic anterior spinal fusion anterior cruciate ligament reconstruction knee arthroscopy small joint arthroscopy decompression fixation wedge resection lung biopsy pleural biopsy dorsal sympathectomy pleurodesis internal mammary artery dissection for coronary artery bypass coronary artery bypass grafting...

Страница 11: ...evel and White Balance select surgical specialties that optimize camera performance for specific surgical procedures and turn on SPY mode The touchscreen also allows activation of remote outputs which are commonly used with a Stryker digital capture console to record images and video See the Operation section for more information about using the front panel 3 2 1 1 Power Switch Powers the camera o...

Страница 12: ...ry remote input 3 Remote Out 2 Connects to a video accessory remote input 4 HDMI Out 1 HDMI 2 0 output supports 4K UHD video resolution 5 HDMI Out 2 HDMI 2 0 output supports 4K UHD video resolution 6 Light Source Port Connects to Stryker light source 7 AC Power Inlet Connects to AC mains with separable power cord 8 Fuse Panel Contains two 1 6A 250V fuses slow blow high breaking capacity 1500A size...

Страница 13: ...able The 1688 4K Camera Head C Mount with Advanced Imaging Modality 1688210105 is shown below with a list of features that are common to each camera head 4 1 2 3 1 Soaking Cap Protects the cable connector during cleaning disinfection and sterilization 2 Cable Connector Connects the camera head to the camera console 3 Camera Cable The camera cable length is 10 feet 3 05 m 4 Camera Head Produces pho...

Страница 14: ...e scope to allow for easier access during urological procedures The camera also incorporates image focusing and rotation features described in the following sections 1 2 3 1 Endobody Clamp Secures the endoscope to the camera head 2 Endobody Brake Prevents rotation of the endoscope 3 Focusing Knob Adjusts the focus of the camera head Adjusting the Focus 1688310130 only To adjust the focus of the Pe...

Страница 15: ...htly rotate the endobody clamp in either direction until the lock engages with an audible click Automatic Image Flip 1688310130 only By default the Pendulum Camera Head will automatically flip the video image back to the initial orientation when the camera is rotated 180 1 Hold the camera head with the endoscope axis parallel to the ground 1 2 Rotate the camera head from the cable down position 2 ...

Страница 16: ...nto the face of the camera head enabling a scope to be attached to the camera It provides a focusing ring to adjust image sharpness It is recommended to use the camera with the 4K Coupler C Mount with Advanced Imaging Modality 1688 020 122 The 4K Coupler enables use of SPY mode when the camera is connected to the the proper system Refer to Stryker user manual P40880 for complete 4K Coupler instruc...

Страница 17: ...e P30883 required to use ENV mode Auto Light function is not available Overlay mode and Contrast mode SPY modes are not available although ENV mode is still available No camera control over ENV laser level although the camera can control the Backlight level No camera control over IRIS mode and settings Some display monitor menu options are not available options that appear in grey 0220220000 Preci...

Страница 18: ...rom the SDC3 to a compatible display monitor by connecting a DVI cable from one of the SDC3 s DVI outputs to an available DVI input on the display monitor The SDC3 does not have device control over the 1688 Video Camera or other devices that could be controlled by the camera head Although the user can still capture images and record video when SDC3 is connected to the camera console with remote ca...

Страница 19: ...pital 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 1688 Video Camera that have been specified for use with the camera system Connecting incompatible equipment may cause unexpected results When the camera system is used with other equipment leakage currents may be additive Ensure that all systems are installed accor...

Страница 20: ... firmware version 1 3 12 or higher If not available the camera resolution shall be operated in 1080p resolution This setup is required to avoid degraded camera performance To determine the 32 4K Surgical Display s firmware version a Power on the Connected OR Hub and the 32 4K Surgical Display They must be connected as described in step 3 b Press the Specialty button on the display front panel c Th...

Страница 21: ...devices from properly communicating Once connected to the 1688 Video Camera the Connected OR Hub can control SPY mode and other camera functions The user can also customize 1688 Camera Head button configurations through the Connected OR Hub See the Connected OR Hub user manual for more details 6 Connect a USB 3 0 A to B cable from the Light Source output on the camera console to the CCU input on t...

Страница 22: ...18 Wiring Diagram 0240200100 1688010000 0220230300 0240 031 050 3 4 2 6 1 5 ...

Страница 23: ... from the cable connector on the camera head 2 Align the arrow on the cable connector with the arrow above the camera connector port on the front console panel 3 Push in the connector until it locks in place Note To unplug the camera from the console grasp the knobbed portion of the connector and pull straight out ...

Страница 24: ...ad the endoscope directly into the camera head until it forms a tight seal and skip to step 3 C Mount endoscopes are not compatible with camera heads that have an integrated coupler When attaching or removing the coupler grip only the rear adapter as twisting other parts of the coupler with force may result in mechanical damage Do not overtighten the coupler or a direct coupled C mount endoscope a...

Страница 25: ...obody 2 Release the endobody clamp to secure the endoscope For 1688310130 1 2 3 Lock the endobody brake 1 by rotating it clockwise when facing the camera head buttons Twist the endobody clamp 2 as shown and hold it open Insert the endoscope into the endobody clamp Release the endobody clamp It will return to the original position and hold the endoscope If the endoscope is not secured in a fixed po...

Страница 26: ...pe before connecting the adapter to the cable If SPY mode is on and the adapter is not connected to the scope laser radiation will emit from the adapter that can cause severe eye injury to the patient or user Installing the Soaking Cap Before reprocessing the camera head the soaking cap must be installed to avoid damaging the cable connector Caution Failure to properly tighten the soaking cap will...

Страница 27: ...console must be model 1688210105 1688610122 or 1688710105 The Laparoscopy or Standard surgical specialty is selected on the camera console The camera console is connected to the L11 LED Light Source using a USB 3 0 A to B cable provided with the light source The light source is connected to an AIM SafeLight cable 0233 050 300 A SafeLight scope adapter is connected to the SafeLight cable see the ca...

Страница 28: ...s refer to the Setting Up the Camera Head section to connect the camera head Performing the White Balance Test Before each surgical procedure perform the White Balance test to adjust the camera s perception of white so it can display other colors correctly When a camera head is connected to the console and the console is powered on the display monitor will automatically prompt the user to perform ...

Страница 29: ...inue pointing the scope at the white surface until WHITE BALANCE COMPLETE appears on the display monitor The image may change color If you cannot achieve an acceptable White Balance refer to the Troubleshooting section Note The White Balance test is not available when SPY mode is on Controlling Remote Video Accessories When connected with the provided remote cables the camera can remotely control ...

Страница 30: ... screen AIM Press the AIM button to navigate to the SPY screen Settings Press the Settings button to navigate to the Camera Settings screen Auto Light button The Auto Light button appears in the bottom right corner of each screen described in this Operation section Press the button to toggle Auto Light on or off Note To enable the Auto Light feature the camera must be connected to the L11 LED Ligh...

Страница 31: ...ar in the top left corner of the display monitor 2 White Balance Press and briefly hold the WB button to activate the White Balance test See the Performing the White Balance Test section for more detail ü ü A checkmark appears on the button after White Balance is completed successfully 3 Picture Press the camera button to capture a photo ü ü A single beep will sound to indicate that a signal for c...

Страница 32: ...tructions in the light source user manual Failure to follow all warnings can result in severe eye injury to the patient or user 1 SPY Mode selection Press and briefly hold the arrows to scroll through the following SPY modes The icon shown next to each SPY mode appears in the top left corner of the display monitor when the mode is active red green and blue Overlay The console outputs a white light...

Страница 33: ... to increase or decrease the level of magnification Range 1 7 1 Note As the Zoom level changes the camera will optimize the image by automatically adjusting the Enhancement level 1 3 Enhancement Press the plus or minus button to increase or decrease the enhancement level the apparent sharpness of the image Range 1 8 1 Information provided is for software version 3 0 7 and higher In previous softwa...

Страница 34: ... head button is pressed Camera Button The Camera button controls up to two functions of a remote video accessory Commonly this enables the user to capture images or start and stop video recording See the Controlling Remote Video Accessories section for connection requirements Short press Capture Photo Press and quickly release the Camera button to select Remote 1 One beep will sound When the camer...

Страница 35: ...enu Press and briefly hold the Menu button to open a Menu on the display monitor with image settings and device control options 1 See the Display Monitor Menu section for detail 1 English must be selected as the language in the Advanced Settings Up and Down Buttons The up and down buttons change functionality depending on the conditions Conditions Functionality of Up Down buttons Default Short pre...

Страница 36: ...o affect the video image Long press Brightness Cycle Press and briefly hold the up button to activate the Brightness Cycle function Each press raises the brightness level in eight steps pressing it again cycles the level back to the lowest setting Short press SPY Gain Cycle Press and quickly release the down button to activate the SPY Gain Cycle function which uses the camera processor to adjust t...

Страница 37: ...e available if the console is not connected to the L11 LED Light Source The options that are not available appear in grey When the console is connected to the Devices input on the Connected OR Hub more options for device control will appear in the menus Refer to the Connected OR Hub user manual for information about the additional options Top Level Menu Description IMAGING MODES Navigate to Imagin...

Страница 38: ...a processor to adjust the fluorescing appearance of the camera image BACKLIGHT UP Increase Backlight level which affects the brightness of surrounding anatomy in the camera image that is not displayed as fluorescing green available only when used with the L10 LED Light Source BACKLIGHT DOWN Decrease Backlight level which affects the brightness of surrounding anatomy in the camera image that is not...

Страница 39: ...icated by the color green CONTRAST Change the SPY mode to Contrast the console outputs an image with ICG fluorescence indicated by the color white all other areas of the image appear dark ENV Change the SPY mode to ENV the console outputs a greyscale white light image with ICG fluorescence indicated by the color green Light Source Menu Description ACTIVATE Turn on white light from the light source...

Страница 40: ...ghtness of surrounding anatomy in the camera image that is not displayed as fluorescing green BACKLIGHT DOWN Decrease Backlight level BACKLIGHT CYCLE Increase Backlight level until maximum level then cycle back to minimum level BRIGHTNESS UP Increase brightness level BRIGHTNESS DOWN Decrease brightness level BRIGHTNESS CYCLE Increase brightness until maximum level then cycle back to minimum level ...

Страница 41: ...on for Overlay Contrast or ENV mode to affect the video image SPY TOGGLE Toggle SPY mode on off WHITE BALANCE Start White Balance test ZOOM IN Increase zoom level ZOOM OUT Decrease zoom level ZOOM CYCLE Increase zoom until maximum level then cycle back to minimum level Advanced Features The 1688 Video Camera has additional features that are not detailed in this manual Button programming Video imag...

Страница 42: ...nds and turn it back on Contact Stryker if the problem persists E 04 error code Warning Occurred Turn off the console wait 3 seconds and turn it back on Contact Stryker if the problem persists E 05 error code Unauthorized Component warning Return the camera head to Stryker for service Warning This error indicates an unauthorized component is detected within the camera head including its cable whic...

Страница 43: ...tor White Balance quality is not good See the solution for Picture is too dark See the solution for Picture is too bright Perform the White Balance test with the light source connected to the scope Use metal halide xenon or LED lighting no fluorescent lighting White Balance Fail message on display monitor Using the camera head click the Start button on the display monitor to repeat the White Balan...

Страница 44: ...o system are plugged in and powered on Check the connector on the camera head cable for broken pins Detach the camera head from the console and reconnect Turn off 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 different...

Страница 45: ...ing them or fogging may result Blurry picture Ensure the coupler or C mount scope is in focus On the Home screen ensure the surgical specialty is not set to FLEXI SCOPE unless you are using a flexible scope Disassemble the scope coupler and camera head and clean and dry all windows on the components SIDNE device does not recognize camera head Contact your Stryker representative for compatibility s...

Страница 46: ...ns below to clean and disinfect the console The user shall provide the germicidal disposable wipes or germidical spray and sterile cloth To avoid electric shock and potentially fatal injury disconnect the console from the AC power source before cleaning Observe the following cautions to avoid damaging the console Do not sterilize the console Do not immerse the console in any liquid Do not allow li...

Страница 47: ...evice involves manual or automated cleaning with either an enzymatic or a non enzymatic detergent optional disinfection and sterilization Step 1 required Cleaning with Enzymatic or Non Enzymatic Detergent Step 2 optional Disinfection Step 3 required Sterilization Warnings This device must be cleaned and sterilized prior to the first use and after every subsequent use Separate the camera head coupl...

Страница 48: ...nstalling the Soaking Cap section for more detail about installing the cap Inspect the camera cable for cuts and breaks before soaking in any fluid Return any damaged camera to Stryker for service Never store the camera in the same tray with sharp instruments Do not soak the camera while it is inside a tray Do not use brushes or pads with metal or abrasive tips during manual cleaning as permanent ...

Страница 49: ... Reverse osmosis deionized water3 To rinse device Clean cloth or filtered pressurized air 40 psi To assist with drying Automated washer For using the automated cleaning procedure Disinfection Wash basin Large enough to accommodate camera head without excessive bending of cable Disinfecting solution4 2 4 glutaraldehyde Water To prepare disinfecting solution Reverse osmosis deionized water3 To rinse...

Страница 50: ...idated as compatible with camera heads 1688210105 1688610122 and 1688710105 The same sterilization trays except for 0233 032 107 are validated as compatible with camera head 1688310130 Instructions for Reprocessing Point of Use Disassemble the camera head from the coupler 1688210105 and 1688710105 only and from the endoscope To disconnect the coupler grip the rear adapter of the coupler and unscre...

Страница 51: ... validated detergents with their minimum concentration and soak time 2 Wipe the entire surface of the device using a soft clean cloth dipped in the detergent solution 3 Immerse the device in the detergent solution ensuring the solution contacts all inner and outer surfaces 4 Soak the device in the solution according to the manufacturer s recommendations 5 With the device immersed in the solution t...

Страница 52: ... to the patient Note For necessary materials and equipment see the Materials and Equipment table The device can be disinfected using a disinfecting solution that has the following active ingredient 2 4 glutaraldehyde 1 Clean and prepare the device as recommended in this user manual Ensure the soaking cap is installed 2 Prepare the disinfecting solution and verify the minimum effective concentratio...

Страница 53: ...e or the console can produce a system error Steris Amsco V PRO 1 Clean and prepare the device as recommended in this user manual Ensure the soaking cap is installed 2 If using a sterilization tray optional follow any additional instructions provided with the tray Use only trays that are approved for sterilization with V PRO 3 Double wrap the device or tray prior to sterilization 4 Sterilize the de...

Страница 54: ...o touchscreen button presses or cannot power on Visible cuts or breaks in any cables Unacceptable deterioration such as but not limited to corrosion discoloration pitting cracked seals or abnormal noises Inspecting the Camera Head Inspect all components of the camera head for cleanliness before each use If fluid or tissue buildup is present repeat the above cleaning and sterilization procedures In...

Страница 55: ...ses To avoid the risk of fire use only fuses of the value specified on the fuse label located on the rear panel of the device 1 Unplug the power cord from the wall outlet and remove the cord from the device 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 valu...

Страница 56: ...by wear reprocessing methods and any damage resulting from use To extend the time between device servicing always follow the care and handling instructions in this user manual Before each use test the device functionality and inspect it for any sign of damage per the Inspection section If the device does not properly function or appears to be damaged return it to Stryker for evaluation and or repa...

Страница 57: ... AC Power Cord 1 Cable length abbreviated in diagram 2 HDMI Cable 1 Cable length abbreviated in diagram 3 Remote Cable 2 Cable length abbreviated in diagram 4 PC Board 2 Behind front panel not shown in diagram 5 PC Board 1 6 Power Supply 1 7 PC Board 1 8 PC Board 1 9 PC Board 1 ...

Страница 58: ...Qty Comments 1 Cable 1 Note In accordance with the European REACH Regulation and other environmental regulatory requirements lead metal is present in a concentration above 0 1 weight by weight w w in some components of the cable assembly for the 1688 Camera Heads This declaration is made in good faith and is based upon supplier data ...

Страница 59: ... 10 30 C Relative Humidity 25 75 Atmospheric pressure 700 1060 hPA Transport and Storage Conditions Temperature 18 60 C Relative Humidity 15 90 Input Electrical Ratings 100 240V 50 60Hz 1 2A Device Weight 12 0 lb 5 44 kg Camera Console 1 0 lb 0 5 kg Camera Head approximate weight Dimensions Camera Console 13 0 w 4 458 h 16 627 d 33 02 cm w 11 32 cm h 42 23 cm d Camera Head Cable 10 ft 3 05 m seale...

Страница 60: ... or decreased immunity to such emissions If the device is used adjacent to or stacked with other equipment observe and verify normal operation of the device in the configuration which it will be used prior to a surgical procedure Equipment which employs radio frequency RF communications may affect the normal function of the device Guidance and Manufacturer s Declaration Electromagnetic Emissions T...

Страница 61: ...r supply lines 1kV for input output lines if applicable 2kV line to ground 1kV for input output lines if applicable Mains power quality should be that of a typical commercial or hospital environment Surge IEC61000 4 5 1kV differential mode 2kV common mode 1kV differential mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment Voltage dips short inte...

Страница 62: ... than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following Radiated RF IEC 61000 4 3 3 V m 80MHz to 2 7 GHz 3 V m Guidance and Manufacturer s Declaration Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below The customer or user of the device should ensure that it is used in...

Страница 63: ...50 LTE Band 5 Pulse modulation 18 Hz 2 0 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9 5500 5785 Note Portable RF communications equipment including pe...

Страница 64: ...recording Home button navigate to Home screen AIM button navigate to SPY screen Settings button navigate to Camera Settings screen Auto Light button blue feature is on black feature is off Flexi Scope surgical specialty is selected Overlay SPY mode is active icon colors are red green and blue Contrast SPY mode is active icon colors are all grey ENV SPY mode is active icon colors are all green Devi...

Страница 65: ...turer Product catalog number Product serial number Quantity Made in USA The device meets European Union medical device requirements Stryker European representative Denotes compliance to CAN CSA C22 2 No 60601 1 and ANSI AAMI 60601 1 Type BF applied part 1688 Camera Head connection Power on off alternates when button is pushed Equipotentiality Alternating current Fuse rating ...

Страница 66: ...cycling code applicable in China This product contains electrical waste or electronic equipment It must not be disposed of as unsorted municipal waste and must be collected separately User Manual Radiation emitting ...

Страница 67: ......

Страница 68: ...www stryker com patents Stryker or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks SafeLight and the Stryker logo All other trademarks are trademarks of their respective owners or holders P38139G 2020 02 WCR NONE ...

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