Related Manuals for Stryker 1688 Series
Summary of Contents for Stryker 1688 Series
- Page 1 1688 4K Camera System with Advanced Imaging Modality 1688010000 1688210105 1688310130 1688610122 1688710105...
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Page 3: Table Of Contents
Contents Warnings and Cautions ................1 Cautions ........................1 Warnings: General ....................1 Warnings: SPY Mode ....................3 Operating a Light Source ..................4 Product Description and Intended Use ..........5 Indications ........................6 The Camera Console ....................7 The Camera Head ....................9 Additional Features of the Pendulum Camera Head ....... 10 The C-Mount Coupler .................. - Page 4 Inspecting the Camera Head ................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 ................
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Page 5: Warnings And Cautions
Repairs and equipment modifications shall be performed 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. - Page 6 18. Do not repair or adjust the device through a third-party service organization. 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.
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Page 7: Warnings: Spy Mode
Warnings: SPY Mode IMPORTANT SAFETY NOTICE - LASER RADIATION: SPY mode controls a Class 1M laser emitted from the L11 LED Light Source with Advanced Imaging Modality (0220230300), also referred to as the “L11 LED Light Source. ” Use of controls or performance of procedures other than those specified herein can result in hazardous laser radiation exposure and can cause severe eye injury to the patient or user. -
Page 8: Operating A Light Source
Operating a Light Source Please note the following warnings to avoid user or patient injury or product damage when using a system with a light source. Note that the light source adjustments described apply only to operating the light source manually (i.e., with Auto Light off ). -
Page 9: Product Description And Intended Use
1688-020-122 4K Coupler, C-Mount, with Advanced Imaging Modality Complete instructions are available in Stryker user manual P45082. Note that 1688210080 does not have the same intended use or indications as stated in this user manual. Not intended for use with SPY/ENV modes. -
Page 10: Indications
Contact your Stryker representative for availability of other cables that may be required for alternate configurations. Indications The 1688 Video Camera is indicated for use in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and plastic surgery wherever a laparoscope/endoscope/arthroscope/sinuscope is indicated for use. -
Page 11: The Camera Console
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. - Page 12 1. HUB Port Connects to a Stryker device control console to enable voice operation and/or graphic tablet control 2. Remote Out 1 Connects to a video accessory remote input 3.
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Page 13: The Camera Head
The Camera Head The camera head connects to the camera console and produces video and photographic images, which it relays to the camera console. Several controls are accessible through a button keypad located on the top of the camera head (see the Operation section). See the Product Description section for the different camera head models that are available. -
Page 14: Additional Features Of The Pendulum Camera Head
Additional Features of the Pendulum Camera Head The 1688 4K Pendulum Camera Head with Integrated Coupler (1688310130) utilizes each of the features described in the previous section, The Camera Head, and it has additional features that are described below. The Pendulum Camera is designed with a 90° angle between the camera head and the scope to allow for easier access during urological procedures. - Page 15 Rotating the Image (1688310130 only) To allow rotation of the endoscope inside the endobody clamp, release the endobody brake by rotating it counterclockwise (when facing the camera head buttons). The endoscope can then be rotated as needed To prevent the endoscope from rotating inside the endobody clamp, lock the endobody brake by rotating it clockwise (when facing the camera head buttons).
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Page 16: The C-Mount Coupler
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 instructions. 1. Scope End Receives the endoscope 2. -
Page 17: Device Compatibility
The 1688 Video Camera is also compatible with other light sources and digital capture devices that are listed below. The features and instructions that are different than the rest of this user manual are noted below. Please contact a Stryker representative for assistance with alternate system configurations. Alternate Light Sources 0220220300 L10 LED Light Source with AIM Technology • Connect to the camera console using the USB A-to-A... - Page 18 Alternate Digital Capture Device 0240060100 SDC3 HD Information Management System • Send the video signal from the camera console to the SDC3 by connecting an HDMI-to-DVI adapter cable (P32235) from one of the camera console’s HDMI outputs to one of the SDC3’s DVI inputs • Send the video signal from 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...
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Page 19: Setup
Setup Stryker Endoscopy considers instructional training, or inservice, an integral part of the 1688 Video Camera. Your local Stryker Endoscopy sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your staff on its operation and maintenance. -
Page 20: Setting Up The Console
Setting Up the Console Refer to the following instructions and wiring diagram for a typical 1688 Video Camera configuration. Using the provided power cord, connect the camera console’s AC power inlet to a hospital-grade outlet. Using the provided HDMI cable, connect the HDMI 1 output from the camera console to the HDMI 4K/HD IN 1 input on the Connected OR Hub (0240200100). - Page 21 CCU input on the L11 LED Light Source (0220230300). It is recommended to use the USB cable provided with the Stryker light source (P40171), as use of third-party cables may prevent the devices from properly communicating.
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Page 22: Wiring Diagram
Wiring Diagram 0240-031-050 0240200100 1688010000 0220230300... -
Page 23: Setting Up The Camera Head
Setting Up the Camera Head Do not severely bend the camera cable or damage may result. Unscrew the soaking cap from the cable connector on the camera head. Align the arrow on the cable connector with the arrow above the camera- connector port on the front console panel. -
Page 24: Setting Up The Coupler
Setting Up the Coupler Steps 1–3 below provide instructions for connecting 1688 Camera Heads to the 4K Coupler, C-Mount, with Advanced Imaging Modality (1688-020-122) and to an endoscope and a light cable. Refer to the bullets below for possible system variations: • When using the 1688 4K Pendulum Camera Head with Integrated Coupler (1688310130) or the 1688 4K Camera Head, Integrated Coupler, with Advanced Imaging Modality (1688610122), skip to... - Page 25 Attach an endoscope to the coupler. Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions. For 1688210105, 1688610122, and 1688710105: Note: For a list of endoscopes that are compatible with SPY mode, see the user manual for the L11 LED Light Source.
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Page 26: Installing The Soaking Cap
Note: A scope adapter may be required to connect the cable to the endoscope. See the light cable user manual for more detail. Note: Only the Stryker AIM SafeLight cable (0233-050-300) is compatible with SPY mode. SPY mode will not function if other cables are used. Refer to the AIM SafeLight cable user manual for complete cable instructions. -
Page 27: Spy Mode Requirements
SPY Mode Requirements In SPY mode, the camera can visualize near-infrared light produced by the L11 LED Light Source (0220230300). Before using SPY mode, be familiar with the Warnings: SPY Mode section of this user manual and all warnings and instructions in the light source user manual. -
Page 28: Operation
Operation Note: Before operating the device, ensure all system components have been set up according to the instructions in the Setup section. Powering the Console On/Off Before using the camera in a surgical procedure, test all system components to ensure proper function. Ensure that a video image appears on all display monitors before beginning any procedure. -
Page 29: Controlling Remote Video Accessories
Controlling Remote Video Accessories When connected with the provided remote cables, the camera can remotely control up to two functions of a video accessory such as a Stryker digital capture console. Commonly this enables the user to capture images or start and stop video recording. -
Page 30: Using The Touchscreen Interface
Using the Touchscreen Interface The touchscreen interface on the console provides access to menus and controls for adjusting or capturing the video image. The features are described below. Navigation Bar The Navigation Bar appears on the left side of each screen described in this Operation section. - Page 31 Home Screen The Home Screen is the default screen. It displays the current surgical specialty and it provides access to common camera functions. 1. Surgical Specialty: Use the arrows to scroll through surgical specialties that optimize camera performance for specific surgical procedures. Choose from: • Arthroscopy • Laparoscopy...
- Page 32 SPY Screen SPY mode allows the camera to visualize near-infrared light produced by the L11 LED Light Source (0220230300). The SPY screen allows the user to adjust image settings within SPY mode. Note: White Light must be activated on the L11 LED Light Source as a preliminary step to activate SPY mode.
- Page 33 2. Gain: Press the plus or minus button to increase or decrease the SPY Gain level, which affects the fluorescing green appearance of the camera image. Range: 1-10. 3. Brightness: Press the plus or minus button to increase or decrease the brightness appearance of the white light image in SPY mode.
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Page 34: Using The Camera Head Buttons
Stryker digital capture console, this will capture a photo. • Long press: Start/Stop Video Recording. Press and briefly hold the Camera button to select Remote 2. Two beeps will sound. When the camera is connected to a Stryker digital capture console, this will start or stop video recording. - Page 35 Menu Button The Menu button opens a display monitor menu with options for device control , or (depending on the selected surgical specialty) it cycles through zoom levels or toggles SPY mode on and off. • Short press: Zoom Cycle (in all surgical specialties except Laparoscopy and Standard).
- Page 36 Conditions Functionality of Up/Down buttons • English selected as • Scroll list. Press the up and down language buttons to scroll up and down the list on the • Menu is open on the display monitor. display monitor • SPY mode is on •...
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Page 37: Using The Display Monitor Menu
Using the Display Monitor Menu Press and briefly hold the Menu button to open a series of menus on the display monitor with image settings and device control options. The menus are described below. English must be selected as the language in the Advanced Settings. While the Menu feature is open, the camera head buttons will change function to navigate the menus and lists on the display monitor. - Page 38 SHUTTER MANUAL Turns off automatic shutter (overall, image is more overexposed) BRIGHTER Increase brightness level DARKER Decrease brightness level SPY Menu Description Turn on SPY mode, which allows the camera to visualize near-infrared light Turn off SPY mode MODE Navigate to SPY Mode menu GAIN UP Increase SPY Gain level, which uses the camera processor to adjust the fluorescing appearance of...
- Page 39 IRIS Menu Description Turn on Infrared Illumination System (IRIS) mode on the light source, which enables use of the IRIS Ureteral Kit when connected to a compatible light source Turn off IRIS mode CONTINUOUS Set the IRIS light output to continuous (the laser energy is continuous) PULSATING Set the IRIS light output to pulsating (the laser...
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Page 40: Programming Camera Head Buttons
Programming Camera Head Buttons The camera head buttons can be customized differently for each surgical specialty. Contact a Stryker representative for assistance with button programming. The button configuration for the selected surgical speciality will appear on the display monitor when the camera head is connected to the console. The button configuration will disappear once the Camera button is pressed. -
Page 41: Advanced Features
• Video image settings • Language settings • Light source Run/Standby controls • Other system settings These advanced features require in-depth knowledge of the device and should be performed only by trained personnel. For access to advanced features, contact a Stryker representative. -
Page 42: Troubleshooting
• Turn off the console, wait 3 seconds, and turn (“Software Mismatch”) it back on. • Return the device to Stryker for service if the problem persists. E-04 error code (“Error • Turn off the console, wait 3 seconds, and turn Occurred”) - Page 43 Problem Possible Solution “System Error” • No video detected. message (Light blue • After sterilization, ensure the camera head background) 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 display monitor.
- Page 44 Problem Possible Solution Noise or snow on • Plug the electrocautery generator into picture when using a separate electrical outlet and separate electrocautery probes the camera console power cord from the electrocautery power cord. • Separate the camera cable from the electrocautery cable.
- Page 45 • Turn off Auto Light from the camera, and observed when Auto manually reduce the brightness from the Light is on light source. Note: If this Troubleshooting section does not resolve the problem, call Stryker Technical Support at 1-877-478-7953 (inside the U.S.) or refer to the warranty.
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Page 46: Reprocessing
Reprocessing The camera console is not intended to come into contact with the patient. It may be cleaned, but not sterilized. Follow the instructions below. Camera heads 1688210105, 1688310130, 1688610122, and 1688710105 are used in the sterile field and shall be cleaned and sterilized prior to every use. Follow the instructions below. -
Page 47: Cleaning, Disinfecting, And Sterilizing The Camera Head
These reprocessing instructions are provided in accordance with ISO 17664, ISO 15883, AAMI TIR12, and AAMI TIR30. The instructions have been validated by Stryker as being capable of preparing the device for re-use. To achieve the desired result, the processor shall ensure that the following instructions are performed as written in their entirety and as appropriate in the processor’s facility. - Page 48 • 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.
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Page 49: Materials And Equipment
Materials and Equipment All materials and equipment required to reprocess the camera head shall be supplied by the user unless otherwise noted. Item Description All phases Gloves, eye protection, Wear protective equipment as required by the medical etc. facility and procedure. Cleaning Wash basin Large enough to accommodate camera head without... - Page 50 For United States users: when sterilizing the device, use only sterilization wraps and sterilization trays that have been cleared by the FDA to use with the selected sterilization cycle. Stryker sterilization trays 0233-032-301, 0233-032-302, 0233-032-105, 0233-032-107, and 0233-410-002 are validated 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.
- Page 51 Note: See the Materials and Equipment table for validated detergents with their minimum concentration. Gently mix the detergent into the water by hand. Submerge the device into the prepared wash basin. With the device immersed in the solution, thoroughly brush the exterior with a soft-bristled brush, focusing on any mated or rough surfaces.
- Page 52 Place the device in the automated washer on an incline to facilitate drainage. Program the washer using the following parameters: Phase Recirculation Temperature Detergent Type Time Pre-Wash 2 minutes Cold Water Wash 1 5 minutes Set Point 60 °C See Materials (140 °F) and Equipment table...
- Page 53 Sterilization After performing the cleaning instructions specified above, perform one of the following sterilization cycles. Note: For necessary materials and equipment, see the Materials and Equipment table. Sterrad Clean and prepare the device as recommended in this user manual. Ensure the soaking cap is installed. If using a sterilization tray (optional), follow any additional instructions provided with the tray.
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Page 54: Maintenance
Inspect the console before each use. If a problem listed below is observed or suspected, contact your Stryker representative or return the device to Stryker for service. • If the console is unresponsive to touchscreen button presses or cannot power on • Visible cuts or breaks in any cables... -
Page 55: Using Sterile Drapes
Using Sterile Drapes Using sterile drapes will ensure maximum longevity of the camera. For best results, follow the instructions provided by the drape manufacturer. Storage Store the device in a dry, clean, and dust-free environment at room temperatures. Replacing the Fuses 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. -
Page 56: Periodic Maintenance Schedule
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 repair. Repair through Stryker, the equipment manufacturer, brings the device back to manufacturer specifications. -
Page 57: Recycling Diagrams
Recycling Diagrams Console Item Material Qty. Comments AC Power Cord Cable length abbreviated in diagram HDMI Cable Cable length abbreviated in diagram Remote Cable Cable length abbreviated in diagram PC Board Behind front panel (not shown in diagram) PC Board —... - Page 58 Camera Head Camera head model 1688210105 is shown below to represent features that are common to each camera head. Item Material Qty. Comments Cable — 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.
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Page 59: Technical Specifications
Technical Specifications Imaging System 1/2.8″ Progressive Scan CMOS Ultra High Definition Scanning System Horizontal: 135.00 kHz Vertical: 60.00 Hz Video Outputs Two HDMI 2.0 outputs Formats: 1080p (HDTV), 4K UHD (3840 x 2160) Mounting Endoscope eyepiece used with C-mount coupler C-mount camera head used with C-mount scopes (C-mount coupler/scope thread: 1-32″... -
Page 60: Electromagnetic Compatibility
Electromagnetic Compatibility All electrical medical equipment requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the device must be installed and operated according to the EMC information provided in this manual. Note: • The device has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices. - Page 61 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions RF emissions CISPR 11 Group 1 The device 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. Guidance and Manufacturer’s Declaration: Electromagnetic Immunity The device is intended for use in the electromagnetic environment specified below.
- Page 62 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 such an environment. Immunity Test IEC 60601 Test Level Compliance Electromagnetic Environment: Level...
- Page 63 Tested Specifications for Immunity to RF Wireless Communications Equipment Test Band Service Modulation Maximum Distance Immunity frequency (MHz) Power Test Level (MHz) (V/m) – TETRA 400 Pulse modulation 18 Hz – GMRS 460, FRS 460 ± 5 kHz deviation 1 kHz sine –...
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Page 64: Symbol Definitions
Symbol Definitions This device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are defined below. Touchscreen Interface/Display Monitor WB button (turn on White Balance test) Camera button (capture photo) Record button (start/stop video recording) Home button (navigate to Home screen) AIM button (navigate to SPY screen) - Page 65 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)
- Page 66 Device recycling 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...
- Page 68 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents Stryker or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service P38139G marks: SafeLight and the Stryker logo. All...