Stryker SYNK 0240031065 User manual

DRAFT
SSYYNNKK®® 44KK WWiirreelleessss SSyysstteemm
UUsseerr GGuuiiddee
0240031065
0240031061
0240031075
EN
P43596 E 2022/05

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 user’s 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 Display’s 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
124
5
3
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

DRAFT
SSYYNNKK®® 44KK WWiirreelleessss TTrraannssmmiitttteerr RReeaarr PPaanneell
123567
4
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

DRAFT
SSYYNNKK®® 44KK WWiirreelleessss RReecceeiivveerr FFrroonntt PPaanneell
124
5
3
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

DRAFT
SSYYNNKK®® 44KK WWiirreelleessss RReecceeiivveerr RReeaarr PPaanneell
123456
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

DRAFT
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 MMaaxxiimmuumm NNuummbbeerr ooff AAccttiivvee TTrraannssmmiitttteerrss
US 4 Transmitters
Canada 3 Transmitters
EU 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 adapter’s outlet plug into the transmitter’s or receiver’s DC power
inlet.
P43596 E 15 EN

DRAFT
CCoonnnneeccttiinngg PPoowweerr ttoo tthhee RReecceeiivveerr ffrroomm aa DDiissppllaayy
WWAARRNNIINNGG -- Periodically check the display’s 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 display’s power supply from the 24 V input on the display.
2. Using the provided Y cable (P43614), connect the display’s power supply to the 24 V input on
the display.
1
2
3
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 receiver’s 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

DRAFT
GGeenneerriicc VViiddeeoo SSoouurrccee DDiirreecctt ttoo DDiissppllaayy
Refer to the following instructions and wiring diagram for a typical wireless configuration.
Display
Video
Source Transmitter Receiver
Display
HDMI HDMI
HDMI
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

DRAFT
Camera
Control
Unit
Transmitter
Transmitter
Receiver
Display
Connected OR
HUB
HDMI HDMI
HDMI
Remote Cables
Remote
Cables
HDMI
HDMI
Display
Receiver
Display
(Optional)
(Optional)
HDMI Receiver
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