FCC ID: SSH-SYNK4KTX SYNK 4K Wireless Transmitter

SSYYNNKK 44KK WWiirreelleessss SSyysstteemm UUsseerr GGuuiiddee 0240031065 0240031061 0240031075 P43596 E 2022/05 EN DRAFT DRAFT TTaabbllee ooff CCoonntteennttss Warnings and Cautions ................................................................................. 3 Warnings................................................................................................. 3 Cautions ................................................................................................. 4 Product Description ...................................................................................... 6 Intended Use ............................................................................................ 6 Contraindications ....................................................................................... 6 SYNK 4K Wireless Transmitter...................................................................... 6 SYNK 4K Wireless Receiver......................................................................... 7 System Features .......................................................................................... 8 SYNK 4K Wireless Transmitter Front Panel ....................................................... 8 SYNK 4K Wireless Transmitter Rear Panel........................................................ 9 SYNK 4K Wireless Receiver Front Panel .........................................................10 SYNK 4K Wireless Receiver Rear Panel..........................................................11 Standby Mode..........................................................................................11 Setup........................................................................................................12 Device Compatibility ...................................................................................12 Maximum Number of Active Transmitters ...........................................................12 Mounting the Receiver on a Display .................................................................13 Connecting Power from the AC/DC Power Adapter................................................15 Connecting Power to the Receiver from a Display .................................................16 Setting up the SYNK 4K Wireless System ........................................................16 Generic Video Source Direct to Display ........................................................17 Generic Remote Port Routing. ..................................................................17 Wireless Configuration .................................................................................19 Using the Region Token (Orange) - International Only ............................................19 Using the Bandwidth Toggle Token (Gray) .........................................................20 Using the Channel Configuration Token ............................................................20 Operation ..................................................................................................21 Pairing the Devices Using a Temporary Token (Blue) .............................................21 Pairing the Devices Using a Permanent Token (Red) .............................................21 Breaking a Temporary Link ...........................................................................21 Breaking a Permanent Link ...........................................................................22 Powering off the Devices..............................................................................22 Troubleshooting ..........................................................................................23 Cleaning....................................................................................................25 Cleaning and Disinfecting the Transmitter, Receiver, and Tokens ...............................25 Materials and Equipment .............................................................................25 Maintenance ..............................................................................................27 Inspecting the Transmitter and Receiver ............................................................27 Storage. ................................................................................................27 Periodic Maintenance Schedule .....................................................................27 Service Life .............................................................................................27 Adverse Event Reporting .............................................................................28 Disposal and Recycling Information.................................................................29 Disposal.................................................................................................29 Recycling Information .................................................................................29 Technical Specifications ...............................................................................31 Electromagnetic Compatibility ........................................................................33 Symbols and Definitions ...............................................................................40 P43596 E 1 EN DRAFT Contact Information .....................................................................................42 EN 2 P43596 E DRAFT WWaarrnniinnggss aanndd CCaauuttiioonnss In this manual, the terms and definitions below apply. Warning: Possible injury to the patient or user. Caution: Possible damage to the equipment. Note: More information to clarify the instructions. WWaarrnniinnggss To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings. 1. Read this manual thoroughly and know its contents prior to using the device. 2. This system is not suitable for use in the presence of flammable anesthetic gases. 3. The device is for indoor use only. 4. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20 cm

(7.9 inches) between the radiator and your body. 5. Install this system in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. Any installation or connection with other devices shall be evaluated for electrical safety according to the IEC 60601-1. 6. This product is non-sterile and therefore should not be placed in the sterile field. 7. Although the device was fully tested at the factory before shipment, the user should always test it for proper function prior to a surgical procedure. 8. To achieve grounding reliability, connect the product to an AC/DC power adapter that is connected to a hospital-grade power cord, and ensure the power cord is plugged into a grounded power outlet. Do not use extension power cords. 9. To avoid risk of electric shock, use only the hospital-grade power cord furnished with the receiver and/or transmitter. Disconnect the receiver and/or transmitter from the power supply to make connections or to inspect the equipment. 10. Use Stryker HDMI cable only provided with the product. 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 SYNK 4K Wireless System. 11. Only connect items that have been specified as part of the SYNK 4K Wireless System or that have been specified as being compatible with the system. 12. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 13. Do not place any heavy object on the power cord. Damage to the power cord can cause fire or electric shock. 14. Do not put any liquid or solid object into the device. If this occurs, unplug the device and have it checked by qualified personnel before operating it any further. 15. Use appropriate caution to prevent contact with fluids if the receiver or transmitter is being used with a power supply in patient environments. 16. To avoid electric shock, do not open the receiver or transmitter housings. P43596 E 3 EN DRAFT 17. Do not modify this equipment without authorization of the manufacturer. 18. Attempt no internal repairs or adjustments not specifically detailed in this operating manual. Refer any adjustments, modifications, and/or repairs to Stryker Endoscopy or its authorized representatives. 19. Do not touch the device and a patient simultaneously, as there is a risk of electric shock. 20. Do not touch the patient with signal input or output connectors. Equipment with SIP/SOP connectors should either comply with IEC 60601-1 harmonized national standard or the combination should be evaluated for safety. 21. For optimal operation of the SYNK 4K Wireless System, leave a minimum of 1 m (3.3 ft) between any part of the System and portable RF communications equipment. 22. To prevent tampering with the SYNK 4K Wireless System device settings, setup, or information, ensure only authorized personnel have access to the device or physically secure the devices when they are not in use. 23. Any serious incident that has occurred in relation to the devices should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. CCaauuttiioonnss To avoid potential damage to this device, please note the following cautions. 1. Carefully unpack the system and check if any damage occurred during shipment. If damage is detected, refer to the warranty. 2. Do not install the devices near sunlight, excessive dust, mechanical vibration, or shock. 3. Keep the devices away from equipment that uses strong magnets (i.e., large loudspeakers). 4. To ensure electromagnetic compatibility, refer to the Electromagnetic Compatibility section of this manual. The devices must be installed and operated according to the EMC information provided in this manual. 5. Do not position the devices so that it is difficult to disconnect the power cords from the supply mains. 6. Connect the devices to a hospital grade receptacle to achieve grounding reliability. 7. To connect to an international power supply, use an attachment plug appropriate for the power outlet. 8. Remove the power cord when transporting the devices. 9. Never operate the devices immediately after transportation from a cold location to a warm location. 10. Power off the devices when they are not in use. 11. Unplug the receiver and transmitter if they are not to be used for an extended period of time. 12. Pay close attention to the care and cleaning instructions in this manual. A deviation may cause damage. 13. Changes or modifications not expressly approved by the party responsible for compliance could void the users authority to operate the devices. NNoottee -- This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. EN 4 P43596 E DRAFT The user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiver. Increase the separation distance between the transmitter and receiver. Connect the transmitter to an outlet on a circuit different from that to which the receiver(s) are connected. Consult the manufacturer or field service technician for help. The warranty is void if any of these warnings or cautions are disregarded. These products contain electrical waste or electronic equipment. They must not be disposed of as unsorted municipal waste and must be collected separately. NNoottee -- This device complies with RSS-247 of the Industry Canada Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. This device is only for indoor use. P43596 E 5 EN DRAFT PPrroodduucctt DDeessccrriippttiioonn The SYNK 4K Wireless System wirelessly transfers video data from a transmitter to up to two linked receivers. The transmitter provides an HDMI input that supports 1080p and 4K video formats, and the receiver provides an HDMI output supporting the same formats. Once the devices are linked, the transmitter wirelessly transfers high-definition video to the receiver for output on a secondary display. At least one transmitter, one receiver, and a pairing token are required for full functionality of the system. A link between the transmitter and the receiver(s) is established by manually inserting a token in the transmitter and then in the receiver(s). Encrypted network data is written onto the token from the transmitter, and the data is decrypted in the receiver to establish a private and secure connection. A token is a small memory device that is programmed with frequencies allowed to establish a link. The receiver can optionally be mounted to the back of the 32 4K Surgical Display (0240031050), and it comes with the necessary mounting hardware. A dedicated power supply is included with the transmitter and the receiver to provide power. Alternatively, a Y-cable is provided with the receiver so it can share the 32 4K Surgical Displays power supply (use when the receiver is mounted to the back of that display). The system transfers video data without controlling or altering the functions or parameters of any connected devices. IInntteennddeedd UUssee The SYNK 4K Wireless System is intended for wireless transmission of high definition video data to secondary displays in a professional healthcare setting. The system is a non-sterile reusable device not intended for use in the sterile field. The system is intended for use by qualified physicians and qualified OR personnel having complete knowledge of surgical procedures in the operating room. CCoonnttrraaiinnddiiccaattiioonnss There are no contraindications for these devices. SSYYNNKK 44KK WWiirreelleessss TTrraannssmmiitttteerr REF: 0240031065 (U.S.), 0240031061 (International) Package Contents

(1) SYNK 4K Wireless Transmitter (0240031065)

(1) Hospital-grade power cord (0105033001) EN 6 P43596 E DRAFT

(1) HDMI high speed cable, 2M (P39077)

(2) Remote cables (0105206758)

(1) Power supply (P27315)

(2) Temporary tokens (blue) (0105208884) SSYYNNKK 44KK WWiirreelleessss RReecceeiivveerr REF: 0240031075 Package Contents

(1) Receiver (0240031075)

(1) Hospital-grade power cord (0105033001)

(1) Power supply (P27315)

(2) Shoulder bolts (P44094)

(1) Y cable (P43614)

(1) HDMI high speed cable, 2M (P39077) P43596 E 7 EN DRAFT SSyysstteemm FFeeaattuurreess This section outlines the features of the SYNK 4K Wireless Transmitter and Receiver. SSYYNNKK 44KK WWiirreelleessss TTrraannssmmiitttteerr FFrroonntt PPaanneell 1. Power switch (hard) Powers transmitter ON and OFF 2. Power Indicator Steady Green - Power is ON 3. Token Status Indicator Blinking White - Waiting for normal token Green - Ready for pairing or Wireless link is established Blue - Standby mode, see Standby Mode section Amber - Warning, see Troubleshooting section Red - Error, contact service representative 4. Token Slot Token insertion site used to establish a wireless connection 5. Token Initializes a wireless connection after insertion into the transmitter and receiver NNoottee -- The transmitter emits a pairing sound when a wireless link is established. The transmitter emits a link drop sound when one or both receiver links have been dropped. EN 8 P43596 E DRAFT12453 SSYYNNKK 44KK WWiirreelleessss TTrraannssmmiitttteerr RReeaarr PPaanneell 1. HUB Port Maintenance port (Stryker use only) 2. Remote 1*

Connects to video source remote output 1 3. Remote 2*

Connects to video source remote output 2 4. Micro USB Port Maintenance port (Stryker use only) 5. HDMI Out Connects to a primary display 6. HDMI In Connects to a digital input source 7. DC Power Inlet Connects to AC/DC power adapter NNoottee -- *Remote ports are only used when the Camera Control Unit (CCU) and the capture device are set up at different locations (e.g., CCU on a boom and Connected OR Hub at a nurse station). See the Generic Remote Port Routing section for more details. P43596 E 9 EN DRAFT1235674 SSYYNNKK 44KK WWiirreelleessss RReecceeiivveerr FFrroonntt PPaanneell 1. Power switch (hard) Powers receiver ON and OFF 2. Power Indicator Steady Green - Power is ON 3. Token Status Indicator Blinking White - Waiting for normal token Blinking Green - Attempting to pair Green - Wireless link is established Blue - Standby mode, see Standby Mode section Amber - Warning, see Troubleshooting section Red - Error, contact service representative 4. Token Slot Token insertion site used to establish a wireless connection 5. Token Initializes a wireless connection after insertion into the transmitter and receiver NNoottee -- The transmitter emits a pairing sound when a wireless link is established. The transmitter emits a link drop sound when one or both receiver links have been dropped. EN 10 P43596 E DRAFT12453 SSYYNNKK 44KK WWiirreelleessss RReecceeiivveerr RReeaarr PPaanneell 1. HUB Port Maintenance port (Stryker use only) 2. Remote 1*

Connects to Connected OR Hub Remote 1 3. Remote 2*

Connects to Connected OR Hub Remote 2 4. Micro USB Port Maintenance port (Stryker use only) 5. HDMI Out Connects to a primary display 6. DC Power Inlet Connects to AC/DC power adapter NNoottee -- *Remote ports are only used when the Camera Control Unit (CCU) and the capture device are set up at different locations (e.g., CCU on a boom and Connected OR Hub at a nurse station). See the Generic Remote Port Routing section for more details. SSttaannddbbyy MMooddee If the transmitter does not receive an active video signal from the video source for more than five minutes (e.g., HDMI input is unplugged or video source is turned off ), the system will enter Standby Mode. The transmitter and receiver token status indicators will turn blue (see Note). The transmitter will temporarily stop transferring video to the receiver(s). When an active video signal to the transmitter resumes (e.g., HDMI input is inserted or video source is turned back on), the transmitter token status indicator will turn green and the transmitter will automatically attempt to relink with the receivers. After the links are re-established, the receiver(s) token status indicator will turn green. NNoottee -- In the initial launch version of the SYNK 4K Wireless System, the token status indicators will remain green during Standby Mode. You can enable the blue LED by updating the system with a software upgrade token. Please contact a Stryker representative for assistance. P43596 E 11 EN DRAFT123456 SSeettuupp WWAARRNNIINNGG When the SYNK 4K Wireless System is interconnected with other electrical devices, leakage currents may be additive, resulting in electromagnetic emissions that can interfere with the normal function of electronic medical equipment. To properly control electromagnetic emissions and avoid potential harm to the patient or user, ensure all electrical devices are installed and interconnected according to the requirements of IEC 60601-1. RF and other mobile communications equipment may affect the normal function of the SYNK 4K Wireless System. When placing the SYNK 4K Wireless System, follow the instructions located in the Electromagnetic Compatibility section of this manual. DDeevviiccee CCoommppaattiibbiilliittyy WWAARRNNIINNGG -- Only connect items that have been specified as part of the SYNK 4K Wireless System or that have been specified as being compatible with the system. For optimal use, the SYNK 4K Wireless System is designed to work with the 1688 Camera Control Unit (1688010000), the Connected OR Hub (0240200100) with software version 1.2.3 or higher, the 32 4K Surgical Display (0240031050), the VPI (PC9001), the SDC3 HD information management system (0240060100), and the 1588 AIM Camera Control Unit (1588010000). All features and instructions described in this user manual apply to this system unless otherwise noted. The following table lists alternate video sources that are compatible with the SYNK 4K Wireless System. Please contact a Stryker representative for assistance. MMaaxxiimmuumm NNuummbbeerr ooff AAccttiivvee TTrraannssmmiitttteerrss The SYNK 4K Wireless System supports a maximum number of transmitters operating at the same time in close proximity (same floor and operating room area) based on wireless channels available in each region. The following table lists the maximum number of active transmitters in close proximity per region. Please contact your Stryker sales representative for assistance if more transmitters are needed to operate at the same time. RReeggiioonn US Canada EU MMaaxxiimmuumm NNuummbbeerr ooff AAccttiivvee TTrraannssmmiitttteerrss 4 Transmitters 3 Transmitters 2 Transmitters Australia and New Zealand 2 Transmitters EN 12 P43596 E DRAFT MMoouunnttiinngg tthhee RReecceeiivveerr oonn aa DDiissppllaayy The receiver can be mounted on the back of a 32 4K Surgical Display (0240031050), on a roll stand or cart. CCAAUUTTIIOONN -- Power off and unplug the receiver and display from the electrical outlets before mounting. 1. Insert the provided shoulder bolts into the back of the display. NNoottee -- (2) Shoulder bolts (P44094) are included in the receiver package. 2. Ensure the shoulder bolts are secured before proceeding. P43596 E 13 EN DRAFT 3. Align the key holes on the bottom of the receiver with the shoulder bolts on the display. 4. Push the receiver forward, then rotate it clockwise until you hear two clicks that indicate both bolts were locked firmly into place. 5. Ensure the receiver is positioned perpendicular to the display, with token slot positioned to the left (shown in the two images below). EN 14 P43596 E DRAFT CCoonnnneeccttiinngg PPoowweerr ffrroomm tthhee AACC//DDCC PPoowweerr AAddaapptteerr The transmitter must be powered by the AC/DC power adapter provided in its packaging. The receiver may be powered by the AC/DC power adapter provided in its packaging or by using the provided Y-cable to draw power from the 32 4K surgical display. To power the receiver from the display, see the next section. Follow these instructions to connect power to the transmitter and receiver from the AC/DC power adapter. 1. Using the provided power cord, connect the AC/DC power adapter to a hospital-grade outlet. 2. Insert the AC/DC power adapters outlet plug into the transmitters or receivers DC power inlet. P43596 E 15 EN DRAFT CCoonnnneeccttiinngg PPoowweerr ttoo tthhee RReecceeiivveerr ffrroomm aa DDiissppllaayy WWAARRNNIINNGG -- Periodically check the displays power supply for usability. Replace the power supply if needed. Follow these instructions to connect power to a receiver that is mounted on the back of a 32 4K Surgical Display. 1. Disconnect the displays power supply from the 24 V input on the display. 2. Using the provided Y cable (P43614), connect the displays power supply to the 24 V input on the display. 1. Plugs into monitor power supply 2. Plugs into SYNK 4K receiver 3. Plugs into monitor 3. Insert the Y cable outlet plug into the receivers DC power inlet. SSeettttiinngg uupp tthhee SSYYNNKK 44KK WWiirreelleessss SSyysstteemm WWAARRNNIINNGG -- Before connecting any device to the SYNK 4K Wireless System, all devices must be installed according to their respective instructions, and the combination of devices must meet the electrical safety requirements of IEC 60601-1. The SYNK 4K Wireless System can be set up in a number of different ways, depending upon which video sources and other visualization equipment are available. This section describes two generic configurations. NNoottee -- When the Connected OR Hub and two camera control units are used, you can switch between Channels 1 and 2. Review the Connected OR Hub Instructions for Use (P35947) for more information. Please contact a Stryker representative for assistance. EN 16 P43596 E DRAFT123 GGeenneerriicc VViiddeeoo SSoouurrccee DDiirreecctt ttoo DDiissppllaayy Refer to the following instructions and wiring diagram for a typical wireless configuration. 1. Using the provided HDMI cable, connect the HDMI OUT on the video source to the HDMI IN on the transmitter. NNoottee -- The HDMI OUT on the transmitter can be connected to the HDMI IN on a secondary display. 2. Using the provided HDMI cable, connect the HDMI OUT on the receiver to the HDMI IN on the primary display. 3.

(Optional) Repeat Step 2 for a second receiver. 4. Link the receiver to the transmitter with the token. (If using a temporary token, linking is required each time the receiver or transmitter is powered on.) 5.

(Optional) Link a second receiver. GGeenneerriicc RReemmoottee PPoorrtt RRoouuttiinngg Refer to the following instructions and wiring diagram for a wireless configuration where the camera control unit is located separately from the Connected OR Hub. NNoottee -- Obtain a second set of remote cables from another Stryker visualization system before proceeding. P43596 E 17 EN DRAFTDisplayVideoSourceTransmitterReceiverDisplayHDMIHDMIHDMI CCAAUUTTIIOONN -- Ensure the remote cables are connected as described in the instructions. 1. Using the provided HDMI cable, connect the HDMI OUT on the camera control unit to the HDMI IN on the transmitter. NNoottee -- The HDMI OUT on the transmitter can be connected to the HDMI IN on a secondary display. 2. Using a provided remote cable, connect the Remote Out 1 on the camera control unit to the Remote 1 on the transmitter. 3. Using a provided remote cable, connect the Remote Out 2 on the camera control unit to the Remote 2 on the transmitter. 4. Using the provided HDMI cable, connect the HDMI OUT on the receiver to the HDMI IN 1 (4K) on the Connected OR Hub. 5. Using a remote cable, connect the Remote 1 on the receiver to the Remote 1 on the Connected OR Hub. 6. Using a remote cable, connect the Remote 2 on the receiver to the Remote 2 on the Connected OR Hub. 7. Link the receiver to the transmitter with the token. (If using a temporary token, linking is required each time the receiver or transmitter is powered on. EN 18 P43596 E DRAFTCameraControlUnitTransmitterTransmitterReceiverDisplayConnected ORHUBHDMIHDMIHDMIRemote CablesRemoteCablesHDMIHDMIDisplayReceiverDisplay(Optional)(Optional)HDMIReceiver WWiirreelleessss CCoonnffiigguurraattiioonn The SYNK 4K Wireless System uses a radio-frequency (RF) link to deliver high-definition video signals in real time. Each system uses a portion of the RF spectrum commonly referred to as a channel to broadcast its signal. The list of allowed channels is regulated and varies by region. The SYNK 4K Wireless System uses 40 MHz channels in the 5.170-5.850 GHz spectrum. The 5.170-5.850 GHz spectrum is also used by 802.11a/n/ac devices as well as 5.8 GHz cordless phones. The System uses an automatic frequency selection (AFS) mechanism in combination with a passive scanning capability to maintain compatibility with these devices and identify unoccupied channels for use. Each linked SYNK 4K Wireless System requires two 40 MHz channels to properly operate. The System is designed to transmit video on a single 40 MHz channel and allocate an additional 40 MHz channel as a backup in case of co-channel interference. Systems that are separated by a large distance may use the same channel. NNoottee -- The SYNK 4K Wireless System uses a proprietary transmission method, which cannot connect to or be accessed by 802.11 devices or 5.8 GHz cordless phones. In order to make sure that there are enough free channels for each SYNK 4K Wireless System, follow the steps outlined below:

1. Contact your IT administrator to determine if 802.11a or 802.11n WiFi is in use at your facility. If so, note which channels are in use in or near each SYNK 4K Wireless System installation location. 2. Determine if any 5.8 GHz cordless phones are in use at your facility. If so, note their locations. 3. For each SYNK 4K Wireless System installation location, ensure that there are two unused 40 MHz channels per SYNK 4K Transmitter installed. If a 5.8 GHz cordless phone is used in the vicinity, assume that channels 149-165 are occupied. Contact your Stryker sales representative for more details. UUssiinngg tthhee RReeggiioonn TTookkeenn ((OOrraannggee)) -- IInntteerrnnaattiioonnaall OOnnllyy REF: P46267 (Canada), P25600 (EU), P25603 (Australia and New Zealand) WWAARRNNIINNGG -- In accordance with the European REACH Regulation and other environmental regulatory requirements, the orange region token contains 2-(2H-benzotriazol-2-yl)-4,6-

ditertpentylphenol (UV-328). This declaration is made in good faith and is either based upon a technical evaluation, supplier data and/or laboratory testing. The orange region token configures wireless settings correctly for your region. This procedure only needs to be done once per transmitter by your Stryker sales representative. To configure wireless settings correctly:

1. Power on the transmitter. 2. Insert the orange region token into the transmitter. 3. Wait until the token LED changes from fast pulsing white to slow pulsing white. 4. Remove the token from the transmitter. 5. Power cycle the transmitter. P43596 E 19 EN DRAFT UUssiinngg tthhee BBaannddwwiiddtthh TTooggggllee TTookkeenn ((GGrraayy)) REF: 0240031095 The SYNK 4K bandwidth toggle token changes bandwidth modes on SYNK 4K transmitters from 20MHz to 40MHz, or from 40MHz to 20MHz. Toggling to 20MHz saves wireless bandwidth and allows more systems to be set up simultaneously in the operating room. Toggling to 40MHz enables the use of 4K video resolution. The 20MHz bandwidth mode only supports 1080p video resolution. The bandwidth mode is passed to a receiver when it is paired with the transmitter. Please contact your Stryker representative to perform this procedure. UUssiinngg tthhee CChhaannnneell CCoonnffiigguurraattiioonn TTookkeenn The channel configuration token bans the use of specific wireless frequencies (see table below). This procedure only needs to be done once per transmitter by your Stryker sales representative. To ban wireless frequencies correctly:

1. Power on the transmitter. 2. Insert the channel configuration token into the transmitter. 3. Wait until the token LED changes from fast pulsing white to slow pulsing white. 4. Remove the token from the transmitter. 5. Power cycle the transmitter. TTookkeenn PPaarrtt NNuummbbeerr BBaannnneedd FFrreeqquueennccyy RRaannggeess CCoommppaattiibbllee DDeevviicceess TTookkeenn CCoolloorr 0240030976 All unbanned (as per region) 0240030975 UNII-1: 5170 5250 MHz UNII-3: 5710 5850 MHZ WiSe, SYNK 4K WiSe, SYNK 4K Yellow Green 0240030978 UNII-1: 5170 5250 MHz WiSe, SYNK 4K Black UNII-2: 5250 5330 MHz UNII-3: 5710 5850 MHZ EN 20 P43596 E DRAFT OOppeerraattiioonn Pairing is the act of creating a wireless link between a transmitter and a receiver. A token is used to create the link, by inserting it into the token slot of the transmitter to write discrete pairing data and then inserting the token into the token slot of the receiver to read the pairing data. A transmitter can pair with up to two (2) receivers. The same token may be used to create each pair, or a different token may be used for each pair. Once paired, a transmitter can wirelessly transmit video data to a receiver, which can send the video data from its HDMI OUT port to a display. The transmitter can also wirelessly transmit data to a receiver, which can send the data from its remotes ports to a digital capture device. PPaaiirriinngg tthhee DDeevviicceess UUssiinngg aa TTeemmppoorraarryy TTookkeenn ((BBlluuee)) REF: 0105208884 To pair a transmitter with a receiver:

1. Power on the transmitter and receiver. The token LED remains off as the devices perform startup functions. 2. When the LED pulses white, insert the temporary token into the token slot on the transmitter. 3. When the token LED is green, remove the token from the transmitter. 4. Within 2 minutes and 30 seconds, insert the token into the token slot on the receiver. 5. Remove the token from the token slot on the receiver when the token LED flashes green. An audible tone sounds from the transmitter. The video feed appears on the display. 6. By repeating steps 4 and 5, you can link one additional receiver. NNoottee -- Link a second receiver directly after linking the first receiver. Do not reconnect the token to the transmitter. 7. Store the token in the transmitter token slot when not in use. PPaaiirriinngg tthhee DDeevviicceess UUssiinngg aa PPeerrmmaanneenntt TTookkeenn ((RReedd)) REF: 0240030977 (Sold separately) A permanent link may be desirable in certain cases. Please contact your Stryker representative in order to permanently link the receiver(s) with a specific transmitter, as deemed appropriate. Once the transmitter/receiver set has been permanently linked, the set will automatically link when powered on. Keep transmitter/receiver sets that are in permanent link mode in the same operating room. BBrreeaakkiinngg aa TTeemmppoorraarryy LLiinnkk To break a link between a receiver and transmitter, either power off the devices or disconnect the HDMI cable from the display for more than 5 minutes. An active link cannot be broken by inserting a token into either device. P43596 E 21 EN DRAFT BBrreeaakkiinngg aa PPeerrmmaanneenntt LLiinnkk To return a receiver and transmitter to the default linking mode:

1. Turn on the devices. 2. Insert the temporary token into the transmitter and remove when the token LED turns green. 3. Power cycle the transmitter. 4. Insert the token into the receiver and remove the token when the token LED turns green. 5. Power cycle the receiver after removing the token. 6. Repeat Steps 4 and 5 for a second receiver. 7. The system is ready to be linked as described in the temporary linking mode procedure. PPoowweerriinngg ooffff tthhee DDeevviicceess CCAAUUTTIIOONN -- Unplug the receiver and transmitter if they are not to be used for an extended period of time. To power off the receiver or transmitter:

1. Press and hold the power switch on the device. 2. Release the power switch. NNoottee -- The Power LED on the device turns off when the device is powered off. EN 22 P43596 E DRAFT TTrroouubblleesshhoooottiinngg Before returning your receiver or transmitter for service, consult the troubleshooting list below:

PPrroobblleemm CCuurrrreenntt SSttaattuuss RReemmeeddyy No video Power LED off Make sure that the power cord is properly connected to the device. Power LED on Make sure the HDMI video cables are connected to the Transmitter and Receiver. Token LED pulsing white Insert the token to link Transmitter and Receiver. Blue screen on the display connected to Receiver This indicates that the Receiver is not receiving any video from the Transmitter. Make sure the Transmitter and Receiver are paired and both have green LEDs. Token LED blinking amber Make sure the device is well ventilated and air vents are not blocked. Conditions are not sufficient for optimal wireless performance. Reorient or relocate the unit. Increase separation distance between units. Increase separation between other SYNK 4K units, Connected OR Hub and other wireless capable devices in the room and adjacent rooms. Cycle the power switch on the device and re-link. If none of these remedies resolve the problem, switch to a wired video input on the display and contact your Stryker representative. Applies if using SYNK 4K unit with the Connected OR Hub:

If the Connected OR Hub WiFi feature is not required for connection to any external systems or networks, please set the WiFi to the OFF position in the network settings for optimized compatibility. Transmitter is set to 20 MHz mode, but video source is 4K. Switch to a 1080p video source or use the bandwidth toggle token to set the bandwidth to 40 MHz. Token LED solid red Please contact your Stryker representative. P43596 E 23 EN DRAFT PPrroobblleemm CCuurrrreenntt SSttaattuuss RReemmeeddyy Wireless link established, but then drops within ten seconds Wireless link not established within 2.5 minutes Transmitter is set to 20 MHz mode, but video source is 4K. Switch to a 1080p video source or use the bandwidth toggle token to set the bandwidth to 40 MHz. Cycle the power switch on the device. Re-

orient or relocate the unit. Increase separation distance between units. Increase separation between other SYNK 4K units, Connected OR Hub and other wireless capable devices in the room and adjacent rooms. Wireless link established with some but not all Receivers Cycle the power switch on the device. Ensure that the Receiver is within 10 meters of the Transmitter. Re-insert token into Receiver. EN 24 P43596 E DRAFT CClleeaanniinngg The SYNK 4K Transmitter and Receiver are not intended to come into contact with the patient or to be used in the sterile field. The devices may be cleaned and disinfected, but not sterilized. Follow the instructions below. The temporary token or permanent token may also be cleaned and disinfected, if soiled. Follow the instructions below. CClleeaanniinngg aanndd DDiissiinnffeeccttiinngg tthhee TTrraannssmmiitttteerr,, RReecceeiivveerr,, aanndd TTookkeennss Follow the warnings, cautions, and instructions below to clean and disinfect the SYNK 4K Transmitter, SYNK 4K Receiver, and tokens. WWAARRNNIINNGG -- To avoid electric shock and potentially fatal injury, unplug the transmitter from the electrical outlet before cleaning. CCAAUUTTIIOONN -- Observe the following cautions to avoid damaging the transmitter, receiver, or tokens and rendering them inoperable:

Do not wipe the rear and bottom of the transmitter or receiver. Do not wipe the connecting end of the tokens. Do not spray cleaning liquid directly onto the devices. Spray cleaning liquid onto a cloth before wiping the devices. Do not saturate the cloth. Do not allow liquid to collect on the devices. Do not immerse the devices in any liquid. Do not clean the devices with abrasive products or corrosive cleaning solutions. Do not sterilize the devices. 1. Clean and disinfect the device using a germicidal disposable wipe1 (or equivalent combination or germicidal spray and sterile cloth) according to the manufacturers instructions. 2. Visually inspect the external surface of the device for cleanliness, focusing on hard-to-reach areas. If visible soil remains, repeat cleaning and disinfection until all visible soil is removed. 1Cleaning and disinfection were validated using PDI Super Sani-Cloth Germicidal Disposable Wipes. MMaatteerriiaallss aanndd EEqquuiippmmeenntt The user shall provide all materials and equipment required to clean and disinfect the SYNK 4K Transmitter, SYNK 4K Receiver, and tokens. P43596 E 25 EN DRAFT IItteemm DDeessccrriippttiioonn Gloves, eye protection, etc. Wear protective equipment as required by the medical facility Germicidal disposal wipes (or germicidal spray and sterile cloth) To clean exterior of devices EN 26 P43596 E DRAFT MMaaiinntteennaannccee Follow the instructions in this section for proper care of the devices. NNoottee -- 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. IInnssppeeccttiinngg tthhee TTrraannssmmiitttteerr aanndd RReecceeiivveerr Inspect the transmitter and receiver regularly for cleanliness. If the device appears dirty, repeat the cleaning procedure described in the previous section. Inspect the transmitter and receiver before each use. If a problem listed below is observed or suspected, contact your Stryker representative or return the device to Stryker for service. Device does not 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 SSttoorraaggee Store the device in a dry, clean, and dust-free environment at room temperatures. PPeerriiooddiicc MMaaiinntteennaannccee SScchheedduullee WWAARRNNIINNGG -- To ensure safe operation of the device, you should periodically perform the following procedure:

Every 12 months, check the earth leakage current to <500 A. NNoottee -- If you encounter operating difficulties not detailed in this manual, refer them to your Stryker representative. SSeerrvviiccee LLiiffee The transmitter has an expected service life of 4 years. The receiver has an expected service life of 4 years. Expected service life is determined by the number of times the device can be expected to be reused and/or reprocessed before it may require repair. In addition, the devices service life is largely determined 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 repair. Repair through Stryker, the equipment manufacturer, brings P43596 E 27 EN DRAFT the device back to manufacturer specifications. Clean all potentially contaminated devices before returning them to Stryker. AAddvveerrssee EEvveenntt RReeppoorrttiinngg Any serious incident that has occurred in relation to this device should be reported to Stryker and, in the European Union, to the competent authority of the Member State in which the affected person resides. EN 28 P43596 E DRAFT DDiissppoossaall aanndd RReeccyycclliinngg IInnffoorrmmaattiioonn DDiissppoossaall In accordance with the European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended, the device(s) should be collected separately for recycling. Do not dispose of the device(s) as unsorted municipal waste. Contact your local distributor for disposal information. Ensure the device(s) is cleaned disinfected prior to recycling. RReeccyycclliinngg IInnffoorrmmaattiioonn The graphics and table below show the parts to recycle as electrical waste. Product Name: SYNK 4K Wireless Transmitter International Release Year: 2020 Model Name: 0240031061 Product Name: SYNK 4K Wireless Receiver Release Year: 2020 Model Name: 0240031075 P43596 E 29 EN DRAFT312 IItteemm DDeessccrriippttiioonn QQuuaannttiittyy TTyyppee 1 2 3 4 Assembly, PCBA, Transmitter

(P43576) Assembly, Speaker (P44039) Assembly, Fan (P43585) Assembly, PCBA, Receiver

(P43605) 1 1 2 1 Circuit Board Speaker Fan Circuit Board In addition to the items listed in the table, the following components and materials must also be recycled as electrical waste:

(2) Hospital-grade power cord (0105033001)

(2) Remote cables (0105206758)

(2) Power supply (P27315)

(1) Y cable (P43614)

(2) HDMI high speed cable, 2M (P39077)

(2) Temporary tokens (blue) (0105208884)

(1) Region token (orange) (P46267, P25600, P25603)

(1) Software upgrade token (black) (0240031085)

(1) SYNK 4K bandwidth toggle token (20MHz / 40MHz) (0240031095) EN 30 P43596 E DRAFT34 TTeecchhnniiccaall SSppeecciiffiiccaattiioonnss SSYYNNKK 44KK TTrraannssmmiitttteerr Video Digital Input / Outputs Input: One High-Definition Multimedia Interface (HDMI) Connector Output: One High-Definition Multimedia Interface (HDMI) Connector Video Formats 1080p: 1920 x 1080 @ 60 fps 4K: 3840 x 2160 @ 60 fps Weight 1.4 lbs (0.6 kg) Total Shipping Weight 3.8 lbs (1.7 kg) Dimensions 7.7 W x 7.2 D x 1.8 H (19.6 cm W x 18.3 cm D x 4.5 cm H) SSYYNNKK 44KK RReecceeiivveerr Video Digital Input / Outputs Output: One High-Definition Multimedia Interface (HDMI) Connector Video Formats 1080p: 1920 x 1080 @ 60 fps 4K: 3840 x 2160 @ 60 fps Weight 1.4 lbs (0.6 kg) Total Shipping Weight 4.5 lbs (2.0 kg) Dimensions 7.7 W x 7.2 D x 1.8 H (19.6 cm W x 18.3 cm D x 4.5 cm H) WWiirreelleessss Frequencies of Operation 5.170 GHz to 5.850 GHz Maximum Power Output 10 dBm (SYNK 4K Wireless Transmitter) 12 dBm (SYNK 4K Wireless Receiver) P43596 E 31 EN DRAFT WWiirreelleessss Channel Bandwidth 40 MHz or 20 MHz Channel Allocation Automatic frequency selection with Wi-Fi avoidance Encoding Antenna EElleeccttrriiccaall Orthogonal Frequency Division Multiplexing with AES 128-bit encryption Contact us for more information Electrical Input Ratings Power Supply Input: 100 240 V ~ 50-60 Hz 1.1 A AC/DC Adapter Manufacturer: XP Power / Bridge Power Model: AFM30US12 / BPM150S24F11 12V 2.5A / 24V 2.0A OOppeerraattiinngg CCoonnddiittiioonnss Temperature Range 10 40C (50 104F) Relative Humidity Range 25% to 75%

Atmospheric Pressure 700 to 1060 hPa TTrraannssppoorrtt aanndd SSttoorraaggee CCoonnddiittiioonnss Temperature Range

-18 60C (-0.4 140F) Relative Humidity Range 15% to 90%

Atmospheric Pressure 500 to 1060 hPa CCllaassssiiffiiccaattiioonn aanndd AApppprroovvaallss Class I Medical Equipment Medical equipment with respect to electric shock, fire, and mechanical hazards only in accordance with IEC 60601-1 and CAN/CSA C22.2 No. 60601-1 Continuous Operation IPX0 EN 32 P43596 E DRAFT CCoommpplliiaannccee FCC Regulations FCC Identifier (SYNK 4K Wireless Transmitter): SSH-

SYNK4KTX FCC Identifier (SYNK 4K Wireless Receiver): SSH-

SYNK4KRX IC Regulations IC (SYNK 4K Wireless Transmitter): 4919C-SYNK4KTX IC (SYNK 4K Wireless Receiver): 4919C-SYNK4KRX Radio Equipment Declaration of Conformity Hereby, Stryker Endoscopy declares that the radio equipment type SYNK 4K Wireless System is in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address:

endoifu.stryker.com. EElleeccttrroommaaggnneettiicc CCoommppaattiibbiilliittyy WWAARRNNIINNGG Do not use cables or accessories other than those provided with the devices, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. If the devices are 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. All electrical medical equipment requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility

(EMC), the devices must be installed and operated according to the EMC information provided in this manual. NNoottee The devices have been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices. This equipment is for use in a professional healthcare environment. It is not for use in the radio frequency (RF) shielded room of a medical electrical system for magnetic resonance imaging, where the intensity of electromagnetic disturbances is high. The devices are unlikely to experience interference by being in close proximity to an active high-frequency (HF) surgical instrument. In the case that HF surgical interference is observed, adjust the separation distance of the equipment. P43596 E 33 EN DRAFT GGuuiiddaannccee aanndd MMaannuuffaaccttuurreerrss DDeeccllaarraattiioonn:: EElleeccttrroommaaggnneettiicc EEmmiissssiioonnss The devices are intended for use in the electromagnetic environment specified below. The customer or user of the devices should ensure that they are used in such an environment. Emissions test Compliance Electromagnetic Environment - guidance RF emissions CISPR 11 Harmonic emissions IEC61000-3-2 Voltage Fluctuations/

flicker emissions IEC61000-3-3 Group 1 Class B Class A The devices are 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:

Complies WWAARRNNIINNGG -- 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. EN 34 P43596 E DRAFT GGuuiiddaannccee aanndd MMaannuuffaaccttuurreerrss DDeeccllaarraattiioonn:: EElleeccttrroommaaggnneettiicc IImmmmuunniittyy The devices are intended for use in the electromagnetic environment specified below. The customer or user of the devices should ensure that they are used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment:

Guidance Electrostatic Discharge

(ESD) IEC61000-4-2 8kV contact 8kV contact 15kV air 15kV air Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/ burst 2kV for power supply lines 2kV line to ground IEC61000-4-4 1kV for input/

output lines 1kV for input/

output lines

(if applicable)

(if applicable) Mains power quality should be that of a typical commercial or hospital environment. Surge IEC61000-4-5 1kV differential mode 1kV differential mode 2kV common mode 2kV common mode Mains power quality should be that of a typical commercial or hospital environment. 0% Ut; 0.5 cycle 0% Ut; 1 cycle 70% Ut; 25 cycles 0% Ut: 5 seconds 30 A/m 30 A/m Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11 Power frequency (50/

60Hz) magnetic field IEC 61000-4-8 Mains power quality should be that of a typical commercial or hospital environment. If the user of the devices requires continued operation during power mains interruptions, it is recommended that the devices be powered from an uninterruptible power supply or a battery. Power-frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. NNoottee -- Ut is the AC mains voltage prior to application of the test level. P43596 E 35 EN DRAFT GGuuiiddaannccee aanndd MMaannuuffaaccttuurreerrss DDeeccllaarraattiioonn:: EElleeccttrroommaaggnneettiicc IImmmmuunniittyy The devices are intended for use in the electromagnetic environment specified below. The customer or user of the devices should ensure that they are used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment:

Guidance Conducted RF 6 Vrms 6 Vrms IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m IEC 61000-4-3 80MHz to 2.7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance d = 2P 80 MHz to 2.7 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 fixed 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:

EN 36 P43596 E DRAFT GGuuiiddaannccee aanndd MMaannuuffaaccttuurreerrss DDeeccllaarraattiioonn:: EElleeccttrroommaaggnneettiicc IImmmmuunniittyy The devices are intended for use in the electromagnetic environment specified below. The customer or user of the devices should ensure that they are used in such an environment.

(a) Field strengths from fixed 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 fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the devices are used exceeds the applicable RF compliance level above, the devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the devices.

(b) Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m. P43596 E 37 EN DRAFT TTeesstteedd SSppeecciiffiiccaattiioonnss ffoorr IImmmmuunniittyy ttoo RRFF WWiirreelleessss CCoommmmuunniiccaattiioonnss EEqquuiippmmeenntt Service Modulation Maximum Power (W) Distance

(m) Immunity Test Level

(V/m) Test frequency

(MHz) Band

(MHz) 385 380390 450 430470 710 745 780 810 870 930 1720 1845 1970 800960 1700 1990 2450 2400 2570 704787 LTE Band 13, 17 1.8 0.3 27 2.0 0.3 28 0.2 0.3 9 2.0 0.3 28 Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz 2.0 0.3 28 Pulse modulation 217 Hz 2.0 0.3 28 Pulse modulation 217 Hz TETRA 400 GMRS 460, FRS 460 GSM 800/

900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 GSM 1800;

CDMA 1900;

GSM 1900;

DECT;

LTE Band 1, 3, 4, 25;

UMTS Bluetooth, WLAN, 802.11 b/

g/n, RFID 2450, LTE Band 7 5100 5800 WLAN 802.11 a/n Pulse modulation 217 Hz 0.2 0.3 9 5240 5500 EN 38 P43596 E DRAFT TTeesstteedd SSppeecciiffiiccaattiioonnss ffoorr IImmmmuunniittyy ttoo RRFF WWiirreelleessss CCoommmmuunniiccaattiioonnss EEqquuiippmmeenntt 5785 NNoottee -- Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the devices, including cables specified by the manufacturer, otherwise the devices performance could degrade. P43596 E 39 EN DRAFT SSyymmbboollss aanndd DDeeffiinniittiioonnss The devices and labeling contain symbols that provide important information for the safe and proper use of the devices. These symbols are defined below. DDeevviiccee//PPaacckkaaggee LLaabbeelliinngg Consult Instructions for Use Date of manufacture Legal manufacturer Catalog number Serial Number Quantity Made in the USA Denotes compliance to CAN/CSA C22.2 No 60601-1 and ANSI/AAMI 60601-1 Medical device in the European Union The device meets European Union medical device requirements Radio Equipment Directive 2014/53/EU precaution: In all EU member states, operation of 5150-5350MHz is restricted to indoor use only Authorized representative in the European Community Complies with Australian regulatory requirements Power on/off (alternates when button is pushed) EN 40 P43596 E DRAFT UUsseerr MMaannuuaall This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately Radiation emitting Direct current P43596 E 41 EN DRAFT CCoonnttaacctt IInnffoorrmmaattiioonn Stryker EMEA Supply Chain Services B.V. Frans Maasweg 2 Venlo 5928 SB, The Netherlands EN 42 P43596 E DRAFT DRAFT Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: SSYYNNKK,, WWiiSSee,, CCrroossssFFllooww,, FFoorrmmuullaa,, tthhee SSttrryykkeerr llooggoo. All other trademarks are trademarks of their respective owners or holders. MMaannuuffaaccttuurreedd BByy::

Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 P43596 E WCR: AA.9 2022/05 DRAFT

SYNK 4K Wireless System Transmitter:

Receiver:

0240031065 0240031075 DRAFT DRAFT Contents Warnings and Cautions ........................................................................... 1 Warnings .....................................................................................................................1 Cautions ......................................................................................................................2 Product Description ................................................................................ 4 Intended Use .............................................................................................................4 System Features ....................................................................................... 6 SYNK 4K Wireless Transmitter Front Panel ....................................................6 SYNK 4K Wireless Transmitter Rear Panel ......................................................7 SYNK 4K Wireless Receiver Front Panel ..........................................................8 SYNK 4K Wireless Receiver Rear Panel ............................................................9 Setup ...................................................................................................... 10 Device Compatibility ........................................................................................... 10 Mounting the Receiver on a Display .............................................................. 11 Connecting Power from the AC Adapter ..................................................... 13 Connecting Power to the Receiver from a Display ................................... 13 Setting up the SYNK4K Wireless System .................................................... 13 Wireless Confi guration .......................................................................... 16 Operation ............................................................................................... 17 Pairing the Devices Using a Temporary Token (Blue) .............................. 17 Pairing the Devices Using a Permanent Token (Red) ............................... 17 Removing a Permanent Link ............................................................................ 18 Troubleshooting .................................................................................... 19 Cleaning ................................................................................................. 21 Cleaning and Disinfecting the Transmitter, Receiver, and Tokens ...... 21 Materials and Equipment .................................................................................. 22 Maintenance .......................................................................................... 23 Inspecting the Transmitter and Receiver ..................................................... 23 Storage ..................................................................................................................... 23 Periodic Maintenance Schedule ...................................................................... 23 Service Life .............................................................................................................. 23 Disposal .................................................................................................................... 24 Technical Specifi cations ........................................................................ 25 DRAFT Electromagnetic Compatibility ........................................................................ 28 Symbol Defi nitions ................................................................................ 32 DRAFT Warnings and Cautions In this manual, the terms and defi nitions below apply. Warning: Possible injury to the patient or user. Caution: Possible damage to the equipment. Note: More information to clarify the instructions. Warnings To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings. 1. Read this manual thoroughly and know its contents prior to using the 2. Federal law (United States of America) restricts this device to sale by, or device. on the order of, a physician. anesthetic gases. 3. This system is not suitable for use in the presence of fl ammable 4. This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment. This equipment should be installed and operated with minimum distance 20 cm (7.9 inches) between the radiator and your body. 5. Install this system in an operating room that complies with all applicable IEC, CEC, and NEC requirements for safety of electrical devices. Any installation or connection with other devices shall be evaluated for electrical safety according to the IEC 60601-1. 6. This product is non-sterile and therefore should not be placed in the sterile fi eld. 7. Although the device was fully tested at the factory before shipment, the user should always test it for proper function prior to a surgical procedure. 8. To achieve grounding reliability, connect the product to an AC adapter that is connected to a hospital-grade power cord, and ensure the power cord is plugged into a grounded power outlet. Do not use extension power cords. 9. To avoid risk of electric shock, use only the hospital-grade power cord furnished with the receiver and/or transmitter. Disconnect the receiver and/or transmitter from the power supply to make connections or to inspect the equipment. 10. Use Stryker HDMI cable only provided with the product. Use of third-

party HDMI cables with the camera console is not recommended due 1 DRAFT to potential problems with secure connections or electromagnetic compatibility. Use the provided HDMI high speed cable (or other Stryker-

approved HDMI cable) with the SYNK 4K Wireless System. 11. Only connect items that have been specifi ed as part of the SYNK 4K Wireless System or that have been specifi ed as being compatible with the system. 12. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 13. Do not place any heavy object on the power cord. Damage to the power cord can cause fi re or electric shock. 14. Do not put any liquid or solid object into the device. If this occurs, unplug the device and have it checked by qualifi ed personnel before operating it any further. 15. Use appropriate caution to prevent contact with fl uids if the receiver or transmitter is being used with a power supply in patient environments. 16. To avoid electric shock, do not open the receiver or transmitter housings. 17. Do not modify this equipment without authorization of the manufacturer. 18. Attempt no internal repairs or adjustments not specifi cally detailed in this operating manual. Refer any adjustments, modifi cations, and/or repairs to Stryker Endoscopy or its authorized representatives. 19. Do not touch the device and a patient simultaneously, as there is a risk of electric shock. 20. Do not touch the patient with signal input or output connectors. Equipment with SIP/SOP connectors should either comply with IEC60601-1 harmonized national standard or the combination should be evaluated for safety. 21. For optimal operation of the SYNK 4K Wireless System, leave a minimum of 1m (3.3 ft) between any part of the System and portable RF communications equipment. 22. To prevent tampering, physically secure the device when not in use. Cautions To avoid potential damage to this device, please note the following cautions. 1. Carefully unpack the system and check if any damage occurred during shipment. If damage is detected, refer to the warranty. 2. Do not install the devices near sunlight, excessive dust, mechanical 3. Keep the devices away from equipment that uses strong magnets (i.e., vibration, or shock. large loudspeakers). 2 DRAFT 4. To ensure electromagnetic compatibility, refer to the Electromagnetic Compatibility section of this manual. The devices must be installed and operated according to the EMC information provided in this manual. 5. Do not position the devices so that it is diffi cult to disconnect the power cords from the supply mains. 6. Connect the devices to a hospital grade receptacle to achieve grounding reliability. 7. To connect to an international power supply, use an attachment plug appropriate for the power outlet. 8. Remove the power cord when transporting the devices. 9. Never operate the devices immediately after transportation from a cold location to a warm location. 10. Power off the devices when they are not in use. 11. Unplug the receiver and transmitter if they are not to be used for an 12. Pay close attention to the care and cleaning instructions in this manual. A extended period of time. deviation may cause damage. 13. Changes or modifi cations not expressly approved by the party responsible for compliance could void the users authority to operate the devices. Note: This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. The user is encouraged to try to correct the interference by one or more of the following measures:

Reorient or relocate the receiving unit. Connect the unit to an outlet on a circuit diff erent from that to which Increase the separation distance between the units. the other unit(s) are connected. Consult the manufacturer or fi eld service technician for help. The warranty is void if any of these warnings or cautions are disregarded. These products contain electrical waste or electronic equipment. They must not be disposed of as unsorted municipal waste and must be collected separately. 3 DRAFT Product Description The SYNK 4K Wireless System wirelessly transfers video data from a transmitter to up to two linked receivers. The transmitter provides an HDMI input that supports 1080p and 4K video formats, and the receiver provides an HDMI output supporting the same formats. Once the devices are linked, the transmitter wirelessly transfers high-defi nition video to the receiver for output on a secondary display. At least one transmitter, one receiver, and a pairing token are required for full functionality of the system. A link between the transmitter and the receiver(s) is established by manually inserting a token in the transmitter and then in the receiver(s). Encrypted network data is written onto the token from the transmitter, and the data is decrypted in the receiver to establish a private and secure connection. A token is a small memory device that is programmed with frequencies allowed to establish a link. The receiver can optionally be mounted to the back of the 32 4K Surgical Display (0240031050), and it comes with the necessary mounting hardware. A dedicated power supply is included with the transmitter and the receiver to provide power. Alternatively, a Y-cable is provided with the receiver so it can share the 32 4K Surgical Displays power supply (use when the receiver is mounted to the back of that display). The system transfers video data without controlling or altering the functions or parameters of any connected devices. Intended Use The SYNK 4K Wireless System is intended for wireless transmission of high defi nition video data to secondary displays in a professional healthcare setting. The system is a non-sterile reusable device not intended for use in the sterile fi eld. Contraindications There are no contraindications for these devices. 4 DRAFT SYNK 4K Wireless Transmitter Package Contents

(1) SYNK 4K Wireless Transmitter (0240031065)

(1) Hospital-grade power cord (0105033001)

(1) HDMI high speed cable, 2M (P39077)

(2) Remote cables (0105206758)

(1) Power supply (P27315)

(2) Temporary tokens (blue) (0105208884) SYNK 4K Wireless Receiver

(1) Hospital-grade power cord (0105033001) Package Contents

(1) Receiver (0240031075)

(1) Power supply (P27315)

(2) Shoulder bolts (P44094)

(1) Y cable (P43614)

(1) HDMI high speed cable, 2M (P39077) 5 DRAFT System Features This section outlines the features of the SYNK 4K Wireless Transmitter and Receiver. SYNK 4K Wireless Transmitter Front Panel 1 2 3 4 5 1. Power switch Powers transmitter ON and OFF.

(hard) 2. Power Indicator Steady Green - Power is ON 3. Token Status Indicator Blinking White - Waiting for normal token Green - Ready for pairing or Wireless link is established Amber - Warning, see Troubleshooting Red - Error, contact service representative 4. Token Slot Token insertion site used to establish a wireless connection 5. Token Initializes a wireless connection after insertion into the transmitter and receiver Note: The transmitter emits a pairing sound when a wireless link is established. The transmitter emits a link drop sound when one or both receiver links have been dropped. 6 DRAFT SYNK 4K Wireless Transmitter Rear Panel 1 2 3 4 5 6 7 1. HUB Port Maintenance port (Stryker use only) 2. Remote 1 Connects to video source remote output 1 3. Remote 2 Connects to video source remote output 2 4. Micro USB Port Maintenance port (Stryker use only) 5. HDMI Out Connects to a primary display 6. HDMI In Connects to a digital input source 7. AC Power Inlet Connects to AC power adapter 7 DRAFT SYNK 4K Wireless Receiver Front Panel 1 2 3 4 5 1. Power switch Powers receiver ON and OFF

(hard) 2. Power Indicator Steady Green - Power is ON 3. Token Status Indicator Blinking White - Waiting for normal token Blinking Green - Attempting to pair Green - Wireless link is established Amber - Warning, see Troubleshooting Red - Error, contact service representative 4. Token Slot Token insertion site used to establish a wireless connection 5. Token Initializes a wireless connection after insertion into the transmitter and receiver 8 DRAFT SYNK 4K Wireless Receiver Rear Panel 1 2 3 4 5 6 1. HUB Port Maintenance port (Stryker use only) 2. Remote 1 Connects to Connected OR Hub Remote 1 3. Remote 2 Connects to Connected OR Hub Remote 2 4. Micro USB Port Maintenance port (Stryker use only) 5. HDMI Out Connects to a primary display. 6. AC Power Inlet Connects to AC power adapter 9 DRAFT Setup When the SYNK 4K Wireless System is interconnected with other electrical devices, leakage currents may be additive, resulting in electromagnetic emissions that can interfere with the normal function of electronic medical equipment. To properly control electromagnetic emissions and avoid potential harm to the patient or user, ensure all electrical devices are installed and interconnected according to the requirements of IEC 60601-1. RF and other mobile communications equipment may aff ect the normal function of the SYNK 4K Wireless System. When placing the SYNK 4K Wireless System, follow the instructions located in the Electromagnetic Compatibility section of this manual. Device Compatibility For optimal use, the SYNK 4K Wireless System is designed to work with the 1688 Camera Control Unit (1688010000), the Connected OR Hub

(0240200100) with software version 1.2.3 or higher, and the 32 4K Surgical Display (0240031050). All features and instructions described in this user manual apply to this system unless otherwise noted. The following table lists alternate video sources that are compatible with the SYNK 4K Wireless System. Please contact a Stryker representative for assistance. Alternate Video Sources 1588010000 1588 AIM Camera Control Unit (CCU) Connect to the system using an HDMI to DVI Cable

(P32235) 0240099250 S-Video/Composite to HDMI Converter 0240099255 VGA/RGB to HDMI Converter 0240099260 3G-SDI to HDMI Converter 0240099265 DVI to HDMI Converter 10 DRAFT Mounting the Receiver on a Display The receiver can be mounted on the back of a 32 4K Surgical Display

(0240031050), on a roll stand or cart. Power off and unplug the receiver and display from the electrical outlets before mounting. 1. Insert the provided shoulder bolts into the back of the display. 2. Ensure the shoulder bolts are secured before proceeding. 3. Align the key holes on the bottom of the receiver with the shoulder bolts 11 DRAFT 4. Push the receiver forward, then rotate it clockwise until you feel it lock fi rmly into place. on the display. 12 DRAFT Connecting Power from the AC Adapter The transmitter must be powered by the AC adapter provided in its packaging. The receiver may be powered by the AC adapter provided in its packaging or by using the provided Y-cable to draw power from the 32 4K surgical display. To power the receiver from the display, see the next section. Follow these instructions to connect power to the transmitter and receiver from the AC power adapter. 1. Using the provided power cord, connect the AC power adapter to a hospital-grade outlet. 2. Insert the AC power adapters outlet plug into the transmitters or receivers AC power inlet. Connecting Power to the Receiver from a Display Follow these instructions to connect power to a receiver that is mounted on the back of a 32 4K Surgical Display. Periodically check the displays power supply for usability. Replace the power supply if needed. 1. Disconnect the displays power supply from the 24 V input on the display. 2. Using the provided Y cable, connect the displays power supply to the 24 V input on the display. 3. Insert the Y cable outlet plug into the receivers AC power inlet. Setting up the SYNK4K Wireless System The SYNK4K Wireless System can be set up in a number of diff erent ways, depending upon which video sources and other visualization equipment are available. This section describes two generic confi gurations. Note: When the Connected OR Hub and two camera control units are used, you can switch between Channels 1 and 2. Review the Connected OR Hub Instructions for Use (P35947) for more information. Please contact a Stryker representative for assistance. Before connecting any device to the SYNK4K Wireless System, all devices must be installed according to their respective instructions, and the combination of devices must meet the electrical safety requirements of IEC 60601-1. 13 DRAFT Generic Video Source Direct to Display Refer to the following instructions and wiring diagram for a typical wireless confi guration. Display Display HDMI HDMI Video Source HDMI Transmitter Receiver 1. Using the provided HDMI cable, connect the HDMI OUT on the video source to the HDMI IN on the transmitter. The HDMI OUT on the transmitter can be connected to the HDMI IN on a secondary display. 2. Using the provided HDMI cable, connect the HDMI OUT on the receiver to the HDMI IN on the primary display. 3.

(Optional) Repeat Step 2 for a second receiver. 4. Link the receiver to the transmitter with the token. (If using a temporary token, linking is required each time the receiver or transmitter is powered on.) 5.

(Optional) Link a second receiver directly after linking the fi rst receiver. Do not reconnect the token to the transmitter. 14 DRAFT Generic Remote Port Routing Refer to the following instructions and wiring diagram for a wireless confi guration where the camera control unit is located separately from the Connected OR Hub. Note: Obtain a second set of remote cables from another Stryker visualization system before proceeding. Display Connected OR HUB HDMI Remote Cables HDMI Camera Control Unit Remote Cables HDMI Transmitter Receiver 1. Using the provided HDMI cable, connect the HDMI OUT on the camera control unit to the HDMI IN on the transmitter. The HDMI OUT on the transmitter can be connected to the HDMI IN on a secondary display. 2. Using a provided remote cable, connect the Remote Out 1 on the camera control unit to the Remote 1 on the transmitter. 3. Using a provided remote cable, connect the Remote Out 2 on the camera control unit to the Remote 2 on the transmitter. 4. Using the provided HDMI cable, connect the HDMI OUT on the receiver to the HDMI IN 1 (4K) on the Connected OR Hub. 5. Using a remote cable, connect the Remote 1 on the receiver to the Remote 1 on the Connected OR Hub. 6. Using a remote cable, connect the Remote 2 on the receiver to the Remote 2 on the Connected OR Hub. 7. Link the receiver to the transmitter with the token. (If using a temporary token, linking is required each time the receiver or transmitter is powered on.) 15 DRAFT Wireless Confi guration The SYNK 4K Wireless System uses a radio-frequency (RF) link to deliver high-defi nition video signals in real time. Each system uses a portion of the RF spectrum commonly referred to as a channel to broadcast its signal. The list of allowed channels is regulated and varies by region. The SYNK 4K Wireless System uses 40 MHz channels in the 5.170-5.850 GHz spectrum. The 5.170-5.850 GHz spectrum is also used by 802.11a/n/ac devices as well as 5.8 GHz cordless phones. The System uses an automatic frequency selection (AFS) mechanism in combination with a passive scanning capability to maintain compatibility with these devices and identify unoccupied channels for use. Each linked SYNK 4K Wireless System requires two 40 MHz channels to properly operate. The System is designed to transmit video on a single 40 MHz channel and allocate an additional 40 MHz channel as a backup in case of co-channel interference. Systems that are separated by a large distance may use the same channel. Note: The SYNK 4K Wireless System uses a proprietary transmission method, which cannot connect to or be accessed by 802.11 devices or 5.8 GHz cordless phones. In order to make sure that there are enough free channels for each SYNK 4K Wireless System, follow the steps outlined below:

1. Contact your IT administrator to determine if 802.11a or 802.11n WiFi is in use at your facility. If so, note which channels are in use in or near each SYNK 4K Wireless System installation location. 2. Determine if any 5.8 GHz cordless phones are in use at your facility. If so, note their locations. 3. For each SYNK 4K Wireless System installation location, ensure that there are two unused 40 MHz channels per SYNK 4K Transmitter installed. If a 5.8 GHz cordless phone is used in the vicinity, assume that channels 149-

165 are occupied. Contact your Stryker sales representative for more details. 16 DRAFT Operation Pairing is the act of creating a wireless link between a transmitter and a receiver. A token is used to create the link, by inserting it into the token slot of the transmitter to write discrete pairing data and then inserting the token into the token slot of the receiver to read the pairing data. A transmitter can pair with up to two (2) receivers. The same token may be used to create each pair, or a diff erent token may be used for each pair. Once paired, a transmitter can wirelessly transmit video data to a receiver, which can send the video data from its HDMI OUT port to a display. The transmitter can also wirelessly transmit data to a receiver, which can send the data from its remotes ports to a digital capture device. Pairing the Devices Using a Temporary Token (Blue) REF: 0105208884 To pair a transmitter with a receiver:

1. Power on the transmitter and receiver. The token LED remains off as the devices perform startup functions. 2. When the LED pulses white, insert the temporary token into the token slot on the transmitter. 3. When the token LED is green, remove the token from the transmitter. 4. Within 2 minutes and 30 seconds, insert the token into the token slot on 5. Remove the token from the token slot on the receiver when the token the receiver. LED fl ashes green. An audible tone sounds from the transmitter. The video feed appears on the display. 6. By repeating steps 4 and 5, you can link one additional receiver. Note: Link a second receiver directly after linking the fi rst receiver. Do not reconnect the token to the transmitter. 7. Store the token in the transmitter token slot when not in use. Pairing the Devices Using a Permanent Token (Red) REF: 0240030977 (Sold separately) A permanent link may be desirable in certain cases. Please contact your Stryker representative in order to permanently link the receiver(s) with a specifi c transmitter, as deemed appropriate. Once the transmitter/receiver set has been permanently linked, the set will automatically link when powered 17 DRAFT on. Keep transmitter/receiver sets that are in permanent link mode in the same operating room. Removing a Permanent Link To return a receiver and transmitter to the default linking mode:

1. Turn on the devices. 2. 4. Insert the temporary token into the transmitter and remove when the token LED turns green. 3. Power cycle the transmitter. Insert the token into the receiver and remove the token when the token LED turns green. 5. Power cycle the receiver after removing the token. 6. Repeat Steps 4 and 5 for a second receiver. 7. The system is ready to be linked as described in the temporary linking mode procedure. Breaking an Active Link To break a link between a receiver and transmitter, either power off the devices or disconnect the HDMI cable from the display for more than 5 minutes. An active link cannot be broken by inserting a token into either device. Powering off the Devices Unplug the receiver and transmitter if they are not to be used for an extended period of time. To power off the receiver or transmitter:

1. Press and hold the power switch on the device. 2. Release the power switch. Note: The Power LED on the device turns off when the device is powered off . 18 DRAFT Troubleshooting Before returning your receiver or transmitter for service, consult the troubleshooting list below:

Problem No video Current Status Remedy Power LED off Power LED on Make sure that the power cord is properly connected to the device. Make sure the HDMI video cables are connected to the Transmitter and Receiver. Token LED pulsing white Insert the token to link Transmitter and Receiver. Token LED blinking amber Make sure the device is well ventilated and air vents are not blocked. Conditions are not suffi cient for optimal wireless performance. Re-

orient or relocate the unit. Increase separation distance between units. Increase separation between other SYNK 4K units, Connected OR Hub and other wireless capable devices in the room and adjacent rooms. Cycle the power switch on the device and re-link. If none of these remedies resolve the problem, switch to a wired video input on the display and contact your Stryker representative. Please contact your Stryker representative. Cycle the power switch on the device. Re-orient or relocate the unit. Increase separation distance between units. Increase separation between other SYNK 4K units, Connected OR Hub and other wireless capable devices in the room and adjacent rooms. 19 Token LED solid Red Wireless link not established within 2.5 minutes DRAFT Wireless link established with some but not all Receivers Cycle the power switch on the device. Ensure that the Receiver is within 10 meters of the Transmitter. Re-insert token into Receiver. 20 DRAFT Cleaning The SYNK 4K Transmitter and Receiver are not intended to come into contact with the patient or to be used in the sterile fi eld. The devices may be cleaned and disinfected, but not sterilized. Follow the instructions below. The temporary token or permanent token may also be cleaned and disinfected, if soiled. Follow the instructions below. Cleaning and Disinfecting the Transmitter, Receiver, and Tokens Follow the warnings, cautions, and instructions below to clean and disinfect the SYNK 4K Transmitter, SYNK 4K Receiver, and tokens. To avoid electric shock and potentially fatal injury, unplug the transmitter from the electrical outlet before cleaning. Observe the following cautions to avoid damaging the transmitter, receiver, or tokens and rendering them inoperable:

Do not wipe the rear and bottom of the transmitter or receiver. Do not wipe the connecting end of the tokens. Do not spray cleaning liquid directly onto the devices. Spray cleaning liquid onto a cloth before wiping the devices. Do not saturate the cloth. Do not allow liquid to collect on the devices. Do not immerse the devices in any liquid. Do not clean the devices with abrasive products or corrosive cleaning solutions. Do not sterilize the devices. Devices cannot withstand automated disinfection 1. Clean and disinfect the device using a germicidal disposable wipe1 (or equivalent combination or germicidal spray and sterile cloth) according to the manufacturers instructions. 2. Visually inspect the external surface of the device for cleanliness, focusing on hard-to-reach areas. If visible soil remains, repeat cleaning and disinfection until all visible soil is removed. 1 Cleaning and disinfection were validated using PDI Super Sani-Cloth Germicidal Disposable Wipes. 21 DRAFT Materials and Equipment The user shall provide all materials and equipment required to clean and disinfect the SYNK 4K Transmitter, SYNK 4K Receiver, and tokens. Item Description Cleaning and Disinfection Gloves, eye protection, etc. Wear protective equipment as required by the medical facility Germicidal disposal wipes (or germicidal spray and sterile cloth) To clean exterior of devices 22 DRAFT Maintenance Follow the instructions in this section for proper care of the devices. Note: Repairs and equipment modifi cations 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. Inspecting the Transmitter and Receiver Inspect the transmitter and receiver regularly for cleanliness. If the device appears dirty, repeat the cleaning procedure described in the previous section. Inspect the transmitter and receiver before each use. If a problem listed below is observed or suspected, contact your Stryker representative or return the device to Stryker for service. Device does not 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 Storage Store the device in a dry, clean, and dust-free environment at room temperatures. Periodic Maintenance Schedule To ensure safe operation of the device, you should periodically perform the following procedure:

Every 12 months, check the earth leakage current to <500 A. Note: If you encounter calibration and operating diffi culties not detailed in this manual, refer them to your Stryker representative. Service Life The transmitter has an expected service life of 4 years. The receiver has an expected service life of 4 years. Expected service life is determined by the number of times the device can 23 DRAFT be expected to be reused and/or reprocessed before it may require repair. In addition, the devices service life is largely determined 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 repair. Repair through Stryker, the equipment manufacturer, brings the device back to manufacturer specifi cations. Clean all potentially contaminated devices before returning them to Stryker. Disposal This 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 policies relating to obsolete electronic equipment. Contact the local distributor for disposal information and follow local laws and hospital practices. 24 DRAFT Technical Specifi cations SYNK 4K Transmitter Video Digital Input /

Outputs Input: One High-Defi nition Multimedia Interface

(HDMI) Connector Output: One High-Defi nition Multimedia Interface (HDMI) Connector Video Formats 1080p: 1920 x 1080 @ 60 fps 4K: 3840 x 2160 @ 60 fps Weight 1.4 lbs (0.6 kg) Total Shipping Weight 3.8 lbs (1.7 kg) Dimensions 7.7 W x 7.2 D x 1.8 H (19.6 cm W x 18.3 cm D x 4.5 cm H) SYNK 4K Receiver Video Digital Input /

Outputs Output: One High-Defi nition Multimedia Interface (HDMI) Connector [which type]

Video Formats 1080p: 1920 x 1080 @ 60 fps 4K: 3840 x 2160 @ 60 fps Weight 1.4 lbs (0.6 kg) Total Shipping Weight 4.5 lbs (2.0 kg) Dimensions 7.7 W x 7.2 D x 1.8 H (19.6 cm W x 18.3 cm D x 4.5 cm H) Wireless Frequencies of Operation Maximum Power Output 5.170 GHz to 5.850 GHz 10 dBm (SYNK 4K Wireless Transmitter) 12 dBm (SYNK 4K Wireless Receiver) 25 DRAFT Channel Bandwidth 40 MHz Channel Allocation Automatic frequency selection with Wi-Fi avoidance Encoding Orthogonal Frequency Division Multiplexing with AES 128-bit encryption Antenna 5x4 MIMO Electrical Electrical Input Ratings Power Supply Input: 100 240 V ~ 50-60 Hz 1.1 A AC/DC Adapter Manufacturer: XP Power / Bridge Power Model: AFM30US12 / BPM150S24F11 12V 2.5A / 24V 2.0A Operating Conditions Temperature Range 10 40C (50 104F) Relative Humidity Range 25% to 75%

Atmospheric Pressure 700 to 1060 hPa Transport and Storage Conditions Temperature Range

-18 60C (-0.4 140F) Relative Humidity Range 15% to 90%

Atmospheric Pressure 500 to 1060 hPa 26 DRAFT Classifi cation and Approvals Class I Medical Equipment Medical equipment with respect to electric shock, fi re, and mechanical hazards only in accordance with IEC 60601-1 and CAN/CSA C22.2 No. 60601-1 Continuous Operation IPX0 Compliance FCC Regulations IC Regulations FCC Identifi er (SYNK 4K Wireless Transmitter):

SSH-SYNK4KTX FCC Identifi er (SYNK 4K Wireless Receiver):

SSH-SYNK4KRX IC (SYNK 4K Wireless Transmitter):

4919C-SYNK4KTX IC (SYNK 4K Wireless Receiver):

4919C-SYNK4KRX 27 DRAFT Electromagnetic Compatibility All electrical medical equipment requires special precautions to ensure electromagnetic compatibility with other electrical medical devices. To ensure electromagnetic compatibility (EMC), the devices must be installed and operated according to the EMC information provided in this manual. Note:

The devices have been designed and tested to comply with IEC60601-1-2 requirements for EMC with other devices. This equipment is for use in a professional healthcare environment. It is not for use in the radio frequency (RF) shielded room of a medical electrical system for magnetic resonance imaging, where the intensity of electromagnetic disturbances is high. The devices are not likely susceptible to interference from high-frequency

(HF) surgical instruments in the Special Environment of being in close proximity to an active HF surgical instrument. In the case that HF surgical interference is observed, adjust the separation distance of the equipment. Do not use cables or accessories other than those provided with the devices, as this may result in increased electromagnetic emissions or decreased immunity to such emissions. If the devices are used adjacent to or stacked with other equipment, observe and verify normal operation of the device in the confi guration which it will be used prior to a surgical procedure. Equipment which employs radio frequency (RF) communications may aff ect the normal function of the device. Guidance and Manufacturers Declaration: Electromagnetic Emissions The devices are intended for use in the electromagnetic environment speci ed below. The customer or user of the devices should ensure that they are used in such an environment. Emissions test Compliance Electromagnetic Environment - guidance RF emissions CISPR 11 Group 1 Class B The devices are suitable for use in all Harmonic emissions Class A IEC61000-3-2 Voltage Fluctuations/ icker emissions IEC61000-3-3 Complies 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. 28 DRAFT Guidance and Manufacturers Declaration: Electromagnetic Immunity The devices are intended for use in the electromagnetic environment speci ed below. The customer or user of the devices should ensure that they are used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electrostatic Discharge

(ESD) IEC61000-4-2 8kV contact 8kV contact 15kV air 15kV air Electrical fast transient/

burst 2kV for power supply lines IEC61000-4-4 2kV line to ground 1kV for input/output lines Mains power quality should be that of a typical commercial or hospital environment. 1kV for input/output lines

(if applicable)

(if applicable) Surge 1kV differential mode 1kV differential mode IEC61000-4-5 2kV common mode 2kV common mode Voltage dips, short interruptions and voltage variations on power supply input lines IEC61000-4-11 0% Ut; 0.5 cycle 0% Ut; 1 cycle 70% Ut; 25 cycles 0% Ut: 5 seconds Power frequency

(50/60Hz) magnetic eld 30 A/m 30 A/m IEC 61000-4-8 NOTE: Ut is the AC mains voltage prior to application of the test level. Electromagnetic Environment:

Guidance Floors should be wood, concrete, or ceramic tile. If oors are covered with synthetic material, the relative humidity should be at least 30%. Mains power quality should be that of a typical commercial or hospital environment. Mains power quality should be that of a typical commercial or hospital environment. If the user of the devices requires continued operation during power mains interruptions, it is recommended that the devices be powered from an uninterruptible power supply or a battery. Power-frequency magnetic elds should be at levels characteristic of a typical location in a typical commercial or hospital environment. 29 DRAFT Guidance and Manufacturers Declaration: Electromagnetic Immunity The devices are intended for use in the electromagnetic environment speci ed below. The customer or user of the devices should ensure that they are used in such an environment. Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment:

Guidance Conducted RF 6 Vrms 6 Vrms IEC 61000-4-6 150 kHz to 80 MHz Radiated RF 3 V/m 3 V/m d = 2P IEC 61000-4-3 80MHz to 2.7 GHz Portable and mobile RF communications equipment should be used no closer to any part of the devices, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended Separation Distance 80 MHz to 2.7 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:

Guidance and Manufacturers Declaration: Electromagnetic Immunity The devices are intended for use in the electromagnetic environment speci ed below. The customer or user of the devices should ensure that they are 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 devices are used exceeds the applicable RF compliance level above, the devices should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as reorienting or relocating the devices.

(b) Over the frequency range 150 kHz to 80 MHz, eld strengths should be less than 3 V/m. 30 DRAFT Tested Speci cations for Immunity to RF Wireless Communications Equipment Test frequency

(MHz) Band

(MHz) Service Modulation Maximum Power

(W) Distance

(m) Immunity Test Level

(V/m) 380390 TETRA 400 1.8 0.3 27 28 430470 GMRS 460, FRS 460 2.0 0.3 704787 LTE Band 13, 17 0.2 0.3 9 800960 2.0 0.3 28 385 450 710 745 780 810 870 930 1720 1845 1970 2450 5240 5500 5785 Pulse modulation 18 Hz FM 5 kHz deviation 1 kHz sine Pulse modulation 217 Hz Pulse modulation 18 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz Pulse modulation 217 Hz GSM 800/900, TETRA 800, iDEN 820, CDMA 850, LTE Band 5 17001990 GSM 1800;

CDMA 1900;

GSM 1900;

DECT; LTE Band 1, 3, 4, 25; UMTS 24002570 Bluetooth, WLAN, 802.11 b/g/n, RFID 2450, LTE Band 7 51005800 WLAN 802.11 a/n 2.0 0.3 28 2.0 0.3 28 0.2 0.3 9 Note: Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the devices, including cables speci ed by the manufacturer, otherwise the devices performance could degrade. 31 DRAFT Symbol Defi nitions The devices and labeling contain symbols that provide important information for the safe and proper use of the devices. These symbols are defi ned below. Device/Package Labeling Consult instructions for use Date of manufacture Legal manufacturer Product catalog number Product serial number Quantity Made in USA Denotes compliance to CAN/CSA C22.2 No60601-1 and ANSI/AAMI 60601-1 Power on/off (alternates when button is pushed) This product contains electrical waste or electronic equipment. It must not be disposed of as unsorted municipal waste and must be collected separately Radiation emitting Direct Current User Manual Caution 32 DRAFT 33 DRAFT 34 DRAFT DRAFT Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents Stryker Corporation or its divisions or other corporate affi liated entities own, use or have applied for the following trademarks or service marks: CrossFlow, Formula, and the Stryker logo. All other trademarks are trademarks of their respective owners or holders. P43596B 2020/07 WCR: NONE DRAFT

Stryker Endoscopy 05-20-2022 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA FCC Agent Authorization Letter Applicant Model Name Stryker Endoscopy 0240031065, 0240031061 Product Description SYNK4K Wireless Transmitter FCC ID SSH-SYNK4KTX We, the undersigned, hereby authorize Hyundai C-Tech, Inc. dba HCT America Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by Hyundai C-Tech, Inc. dba HCT America Inc. on our behalf shall have the same effect as acts of our own. We, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). We recognize that we are still responsible for the terms and conditions outlined in the HCT America Client Services Agreement. This authorization is valid until further written notice from the applicant. Sincerely, Steven Maulick Director of Engineering Services Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 steve.maulick@stryker.com Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

+1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1

05-20-2022 Stryker Endoscopy Cover Letter Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA We would like to apply for FCC C2PC:

Applicant Model Name(s) FCC ID Stryker Endoscopy 0240031065, 0240031061 SSH-SYNK4KTX Please find enclosed our Claim Report, which includes the following:

Agent Authorization Letter Antenna Specification / Data Sheet Confidential Request Letter EMC Test Report with Test Setup Photos Users Manual Product External and Internal Photos RF Test Report Block Diagram and Operational Description Add 20MHz bandwidth capabilities to existing 40MHz bandwidth. No hardware changes. Should you have any questions, please contact us. Sincerely, _________________________________ ___ ______________________ __ Steven Maulick Director of Engineering Services Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 steve.maulick@stryker.com Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

+1.510.933.8848 || Fax: +1.510.933.8849 Page 1 of 1

Stryker Endoscopy 05-20-2022 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046, USA FCC Confidentiality Request Letter Applicant Model Name FCC ID Stryker Endoscopy 0240031065, 0240031061 SSH-SYNK4KTX Pursuant to the provisions of Section 0.457 and 0.459 of the commissions rules (47 CFR 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely.

Block Diagram

Technical Operation Description The above-mentioned documents contain detailed system and equipment description that are considered propriety information in operation of the equipment. The public disclosure of the above documents might be harmful to our company and would give competitors an unfair advantage in the market. In addition to the above mentioned documents, pursuant to Public Notice DA 04-1705 of the Commissions policy, in order to comply with marketing regulations in 47 CFR 2.803 ad the importation rules in 47 CFR 2.1204 while ensuring that business sensitive information remains confidential until the actual marketing of newly authorized devices. We request that the Commission to grant Short-Term Confidentiality on the following attachments for 180 days after the grant as outlined in Public Notice DA 04-1705.

Internal Photos External Photos Test Setup Photos Users Manual Sincerely, Steven Maulick Director of Engineering Services Stryker Endoscopy 5900 Optical Court San Jose, CA 95138 steve.maulick@stryker.com Hyundai C-Tech, Inc. dba HCT America, Inc. 1726 Ringwood Avenue San Jose, CA 95131 TEL:

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Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com 775 Montague Expressway Milpitas, CA 95035 Project and Product Certification Representative Authorization Letter Reason for Amendment (current / obsolete) Initial Release (obsolete) Revised wording (obsolete) Updated company template (obsolete) Updated letter information (obsolete) Added FCC ID field (obsolete) Updated company name & logo (current) Revision History From 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 Sept25-2007 Jan-31-2012 May-23-2014 Sep-16-2014 Jun-27-2018 August 20, 2020 To: BVCPS, INC. 775 Montague Expressway, Milpitas, CA 95035 USA Dear Sir/Madam, Re: Project and Product Certification Representative Authorization Letter We, Stryker Endoscopy hereby authorize Bureau Veritas Consumer Product Services, Inc. to act as a Certification Body for certifying for the following project(s):

FCC ID: SSH-SYNK4KTX Product Description: SYNK 4K Wireless Transmitter Model: SYNK 4K (0240031065,0240031061) We affirm that between Bureau Veritas Consumer Product Services, Inc. and Stryker Endoscopy, any difference in understanding, including test plan, measurement methods, applicable standards and relevant procedures and processes have been resolved prior to commencement of testing activities. Sincerely, StevenMaulick StrykerEndoscopy Director, Engineering Services steve.maulick@stryker.com Stryker Endoscopy 5900OpticalCourt SanJose,CA95138 SCS-F18: Project and Product Certification Representative Authorization Letter Page 2 of 2 Rev 6.0

775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com Confidentiality Request Letter Revision History From Reason for Amendment (current / obsolete) Initial Release (obsolete) Adding CFR 2.459 (obsolete) Updated company template & Added text box Added IC confidentiality letter form (obsolete) Corrections to STC form. Added reference to KDB

(obsolete)

(obsolete) Updated company logo (current) 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 August 11 - 2008 Jan-31-2012 March-26-2015 Nov-19-2015 Jun-26-2019 August 20, 2020 To:

Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD Subject: Permanent Confidentiality Request for FCC ID: SSHSYNK4KTX Pursuant to sections 0.457 and 0.459 of CFR 47, we respectfully request permanent confidential treatment of the following Exhibits accompanying this application as:

- e.g. Block Diagram

- e.g. Schematics

- e.g. Operational Description The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. The applicant understands that disclosure of this application and all accompanying documentation will not be made before the date of the Grant for this application. Sincerely, StevenMaulick StrykerEndoscopy Director, Engineering Services steve.maulick@stryker.com Stryker Endoscopy 5900OpticalCourt SanJose,CA95138 SCS-F19: Confidentiality Request Letter Page 2 of 2 Rev 6.0

775 Montague Expressway Milpitas, CA 95035 Tel: 408-526-1188 Fax: 408-526-1088 Email: sales.eaw@us.bureauveritas.com Confidentiality Request Letter Revision History From Reason for Amendment (current / obsolete) Initial Release (obsolete) Adding CFR 2.459 (obsolete) Updated company template & Added text box Added IC confidentiality letter form (obsolete) Corrections to STC form. Added reference to KDB

(obsolete)

(obsolete) Updated company logo (current) 1.0 1.0 2.0 3.0 4.0 5.0 To 1.0 2.0 3.0 4.0 5.0 6.0 Approved Date Nov-14-2006 August 11 - 2008 Jan-31-2012 March-26-2015 Nov-19-2015 Jun-26-2019 August 20, 2020 To: Federal Communications Commission Office of Engineering and Technology Equipment Authorization Division 7345 Oakland Mills Road Columbia, Maryland 21046 Subject: Short Term Confidentiality Request for FCC ID: SSH-SYNK4KTX To Whom It May Concern:

Pursuant to sections 0.457 and 0.459 of CFR 47, and to avoid premature release of sensitive information prior to marketing or release of the product to the public, the applicant requests the following documents contained in this certification application be temporarily withheld from public disclosure for an initial period of 45 days; or for a specified date of not to exceed 180 days from the Grant Date. See KDB 726920. or 180

e.g. User Manual e.g. Internal Photos e.g. Test Setup photos e.g. External Photos The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these materials may be harmful to the applicant and provide unjustified benefits to its competitors. Sincerely, StevenMaulick StrykerEndoscopy Director, Engineering Services steve.maulick@stryker.com Stryker Endoscopy 5900OpticalCourt SanJose,CA95138 SCS-F19: Confidentiality Request Letter Page 2 of 2 Rev 6.0

August 20, 2020 Declarationletter FCCID:SSHSYNK4KTX ProductDescription:SYNK4KWirelessTransmitter Model:SYNK4K(0240031065,0240031061) We,StrykerEndoscopy,declarethattheoriginaltestreportsoftheAMN41012module,FCCID:

VQSAMN41012,accuratelyrepresentstestresultsunderthenewapplicationSYNK4KWireless Transmitter,FCCID:SSHSYNK4KTX. TheAMN41012module(FCCID:VQSAMN41012)isusedandintegratedaccordingmodulesupplier applicationnotesandrepresentsthenewdevice,SYNK4KWirelessTransmitter,FCCID:SSH SYNK4KTX. ThefollowinglistshowsthemodulewiththereferringFCCIDandtheassociatedFCCTestreports:

ModuleModel:AMN41012 FCCID:VQSAMN41012Date of Grant: 02/17/2020) NameofGrantee:AmimonLtd. FCCTestReports:

EMC101258BFCC407UNII1Rev.6 EMC101258BFCC407UNII2DFSRev.3 EMC101258BFCC407UNII2Rev.5 EMC101258BFCC407UNII3Rev.6 Ifyouhaveanyquestionorconcerns,pleasecontactus. StevenMaulick StrykerEndoscopy Director, Engineering Services steve.maulick@stryker.com Stryker Endoscopy 5900OpticalCourt SanJose,CA95138