Stryker WiSe 0240030972 User Manual

WiSe™ HDTV Receiver
User Guide
0240030972
WiSe™ HDTV Receiver
Table of Contents
1 Warnings and Cautions
3 Symbols
3 Intended Use
4 Indications and Contraindications
4 Package Content
5 Device Features
5 Front Panel 5 Rear Panel
6 Setup
6 Connecting AC Power 6 Wall Mount Adapter Mounting Options 7 Routing Video Conguration Setup #1 9 Routing Video Conguration Setup #2
10 Instructions for Use
10 Link the Transmitter to the Receiver
11 Cleaning
12 Troubleshooting
13 Technical Specications
14 Electromagnetic Compatibility
Warnings and Cautions
Please read this manual and follow its instructions carefully. e words warning, caution, and note carry special meanings and should be carefully reviewed:
Warning e personal safety of the patient
may be involved. Disregarding this information could result in personal injury.
Caution Special service procedures or
precautions must be followed to avoid damaging the device.
Note Special information to make
maintenance easier or important information more clear.
An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the literature accompanying the device.
A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel.
Warnings
To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following warnings:
• Read the operating manual thoroughly and be familiar with its contents prior to using this device.
• Carefully unpack the device and check if any damage occurred during shipment.
• Test this device prior to a surgical procedure. is device was fully tested at the factory before shipment.
• Do not put any liquid into the device. If this occurs, unplug the device and have it checked by qualied personnel before operating it any further.
• Avoid disassembling any part of the WiSe HDTV Receiver or the WiSe R1-R2 adapter cover, as doing so may break the seals, causing leakage and/or electric shock.
• Avoid removing the WiSe HDTV Receiver or the WiSe R1-R2 adapter cover, as doing so may cause damage to electronics and/or electric shock.
• Ensure that the electrical installation of the relevant operating room complies with NEC and CEC guidelines.
• Do not attempt internal repairs or adjustments not specically detailed in this operating manual. Ensure that readjustments, modications, and/or repairs are carried out by persons authorized by Stryker Endoscopy.
• Use appropriate caution to prevent contact with uids if the device is being used with a power supply in patient environments.
• Federal law (Deviceed States of America) restricts this device to sale by, or on the order of, a physician.
• Ensure the device is mounted securely. Damage to the device or personal injury can occur if the device is not installed as instructed.
EN-1
Cautions
• Plug the AC adapter into a grounded power outlet.
• Use only the proprietary power supply. Completely
secure the connection between the DC power cord and the extension cord.
• To connect to an international power supply, use an attachment plug appropriate for the power outlet.
• Power o the device when it is not in use.
• Remove the power module and connection when
transporting the device.
• Unplug the device if it is not to be used for an extended period of time.
• Never operate the device immediately aer transportation from a cold location to a warm location.
• Pay close attention to the care and cleaning instructions in this manual. A deviation may cause damage.
• Do not expose the WiSe HDTV Receiver console to moisture. Spray the cleaning solution into a so cloth and clean gently.
• Do not sterilize the WiSe HDTV Receiver console, as the delicate electronics cannot withstand this procedure.
• Allow adequate air circulation to prevent internal heat buildup. Do not place the device on surfaces (rugs, blankets, etc.) or near materials (curtains, draperies) that may block the ventilation slots. e WiSe HDTV Receiver console is cooled by natural convection and has no fan.
• Do not install the device near sunlight or excessive dust.
• Do not touch the patient with signal input or output connectors. Equipment with SIP/SOP connectors should either comply with IEC60601­1 and/or IEC 60601-1-1 harmonized national standards or the combination should be evaluated for safety.
• To ensure electromagnetic compatibility, refer to the “Electromagnetic Compatibility” section of this manual. e WiSe HDTV Receiver (REF#0240030972) must be installed and operated according to the EMC information provided in this manual.
• e WiSe HDTV Receiver (REF#0240030972) has been tested under the UL 60601-1 standard and is UL listed for medical application. e warranty is void if any of these warnings or cautions are
disregarded.
• Changes or modications not expressly approved by the party responsible for compliance could void the user’s authority to operate the device.
Note: is device has been tested and found to comply with the limit for a Class B digital device, pursuant to Part 15 of the FCC Rules. ese limits are designed to provide reasonable protection against harmful interference in a residential installation. is device generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. ere is no guarantee that interference will not occur in a particular installation, which can be determined by turning the device o and on. e user is encouraged to try to correct the interference by one of the methods listed in the Troubleshooting section under the listed possible cause, “Interference.”
EN-2
Symbols
e following symbols appear on the device, its labeling, or the device packaging. Each symbol carries a special denition, as dened below:
Degrees of protection against the ingress of
Direct Current
Wireless Transmission For physician use only
Tested to comply with FCC Class B standards Protection against electrical shock - Class II
IPX0
water
Denotes compliance to CAN/CSA C22.2 No
601.1-M90 UL60601-1
Operating Humidity Ratings European Authorized Representative
Operating Temperature Ratings Serial Number
For indoor use only Reference Number
Fragile Manufacturer
is symbol indicates that the waste of electrical and electronic equipment must not be disposed as unsorted municipal waste and must be collected separately. Please contact the manufacturer or other authorized disposal company to decommission your device.
Read Instructions for Use
Made in the USA
Product Description
e WiSe HDTV Receiver (Receiver) is an extension of the WiSe HDTV System and uses a radio frequency (RF) link to receive high denition video and remote signals from the WiSe HDTV Transmitter (Transmitter). e Receiver has one DVI and two remote outputs which allow it to be used with the Stryker Digital Capture (SDC) device and Stryker surgical viewing displays with DVI input. It uses the same wireless technology as in the WiSe HDTV System. e Receiver has a bi-color LED for device status, the same token and token slot as the current WiSe HDTV system, compact wireless router style design with multiple placement options, and simple mode of operation. e R1-R2 adapter (Optional Accessory) will be used on the Transmitter side to accept R1 and R2 cable connections.
Intended Use
e WISE HDTV Receiver, when connected with the compatible Stryker monitors/DVI devices, is intended for wireless video display during surgical procedures including arthroscopy orthopedic surgery, laparoscopy (general and gynecological surgery), thorascopy, endoscopy (general, gastroenterological and ENT surgery), and general surgery.
e WISE HDTV Receiver, when connected with the SDC, is intended for wireless transfer of image data including video and remote signal between medical devices (optional).
e WISE HDTV Receiver is a non-sterile reusable accessory not intended for use in the sterile eld. e WISE HDTV Receiver is intended for use by qualied physicians having complete knowledge of these surgical procedures.
EN-3
Indications and Contraindications
e WiSe HDTV Receiver, when connected with the Stryker display(s), as an accessory to the surgical camera, is intended for visualization during surgical procedures including:
• General surgery
• General laparoscopy
• Nasopharyngoscopy
• Ear endoscopy
• Sinuscopy
• Plastic surgery wherever a laparoscope/endsocsope/arthroscope is indicated for use
• Other endoscopic surgeries including:
Laparoscopic cholecystectomy, laparoscopic hernia repair, laparoscopic appendectomy, laparoscopic pelvic anterior spinal fusion, anterior cruciate ligament reconstruction, knee arthroscopy, shoulder arthroscopy, small joint arthroscopy, decompression xation, wedge resection, exible endoscopy, urology, gynecology, lung biopsy, pleural biopsy, dorsal sympathectomy, pleurodesis, internal mammary artery dissection for coronary artery bypass, coronary artery bypass graing where endoscopic visualization is indicated and examination of the evacuated cardiac chamber during performance of valve replacement.
ere are no known contraindications.
Package Content
REF# 0240030972 REF# P11883 REF# P11281 REF# P11139
(1) WiSe HDTV Receiver (1) Base Stand (1) Wall Mount Adapter (1) Wall Mount Plate
REF# P11142 REF# 0105033001 REF# 0105207131 REF# P12866
(1) AC Adapter (1) Hospital-grade
AC power cord
REF# P13014 REF# 0105207102
(1) USB A to B Cable (Optional Accessory)
EN-4
(2) 6-32 x 5/16" Philips Pan Split/Flat Washer Sems
(1) DVI Cable, 3FT (1) R1-R2 Adapter
(Optional Accessory)
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