Stryker Operating Room Information System, ORIS Preinstallation Manual

Operating Room Information System
Pre-Installation Manual
July 2014 1004-400-059 REV K www.stryker.com
Operating Room
Information System
Pre-Installation Manual
is manual contains condential information that shall not be disclosed or duplicated for any reason other than to use and maintain a STRYKER OPERATING ROOM INFORMATION SYSTEM. is restriction does not limit the right to use information contained in this manual if it is obtained from another source without restriction. e information subject to this restriction is contained in all pages of this manual.
© July 2014 Stryker Communications. All Rights Reserved. Information in this document is subject to change without notice.
Stryker and Stryker logo are registered trademarks of Stryker. Endosuite® OR and iSuite® are registered trademarks of Stryker.
All Rights Reserved
Operating Room Information System Pre-Installation Manual
1004-400-059 REV K
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Contents
1. Scope .................................................................................................................................................................... 4
2. Warnings and Cautions ......................................................................................................................................... 5
2.1 Warnings ............................................................................................................................ 5
3. Product Symbol Denition.................................................................................................................................... 6
3.1 EMC Precautions .................................................................................................................. 7
4. Party Responsibilities ........................................................................................................................................... 8
4.1 Hospital Responsibilities ..................................................................................................... 8
4.2 Contractor Responsibilities ................................................................................................. 8
4.3 Stryker Responsibilities ...................................................................................................... 9
5. iSuite Operating Room ....................................................................................................................................... 10
5.1 Documentation Station (Stryker Provided) ......................................................................... 10
5.1.1 Receiving and Assembling the Documentation Station ................................................10
5.1.2 Additional Documentation Station Notes ...................................................................11
5.1.3 Installing the Documentation Station ........................................................................12
5.2 Documentation Station (Hospital Provided) ........................................................................ 16
5.3 Documentation Station Equipment Requirements .............................................................. 16
5.4 iSuite Equipment Integration Notes ................................................................................... 19
5.4.1 Wall Mounted 46" or 55" LCD Monitor or 42" TouchPanel ..............................................19
5.4.2 Wall/Ceiling Mounted Room Status Camera (WRC, CRC) LA ..........................................19
5.4.3 Wall Plates ...............................................................................................................20
5.4.4 Observation Room Touch Panel, Microphone and Speaker (OBS) LA .............................20
5.4.5 Cable Run to Video Network Hub (HRN).......................................................................20
5.4.6 Equipment Boom Cable Kit (Brand) (EQB)....................................................................21
5.4.7 Anesthesia Boom Cable Kit (Brand) (ANB) ...................................................................21
5.4.8 Navigation Arm (NAM) ...............................................................................................21
5.4.9 Stryker Single Flat Panel Arm Cable Kit .......................................................................22
5.4.10 Stryker Dual Flat Panel Arm Cable ...............................................................................22
5.4.11 Single Flat Panel Arm Cable Kit (Non-Stryker Flat Panel Arm) (NAM) ..............................22
5.4.12 Dual Flat Panel Arm Cable Kit (Non-Stryker Flat Panel Arm) .........................................22
6. Innity Based Conference System (IBC) Rooms LA ............................................................................................. 23
6.1 SPI3 Customer Supplied Casework (SCW) ............................................................................ 23
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6.2 IBC Unit with Tower (ICW1) LA............................................................................................ 23
6.3 IBC Unit with Stryker Credenza (ICW2) LA .......................................................................... 23
6.4 IBC with Customer Supplied Casework (ICW3) LA ................................................................ 24
6.5 Casework Equipment ......................................................................................................... 24
6.5.1 SwitchPoint Innity 2 (A2) LA ...................................................................................24
6.5.2 SPI2 Touch Panel, 19" (B2) .........................................................................................24
6.5.3 Wireless Microphone Receiver (M) ..............................................................................24
6.5.4 SD CODEC (L1) ............................................................................................................25
6.6 IBC Podium with Touch Panel LA........................................................................................ 25
7. Level Systems Room ............................................................................................................................................26
7.1 Customer Supplied Casework (CSC) ...................................................................................... 26
7.2 Casework Equipment ........................................................................................................ 26
7.2.1 Level One System (S1) LA ..........................................................................................26
7.2.2 Level Two System (S2) LA ..........................................................................................26
7.2.3 Level System Touch Panel (T) .....................................................................................27
7.3 Remote Level System Touch Panel (LTP) .............................................................................. 27
8. Equipment Integration Notes .............................................................................................................................. 28
8.1 Wall Mounted 46" or 55" LCD Monitor, or 42" Touch Panel LA ................................................ 28
8.1.1 SPI3 Cable Specications ...........................................................................................28
8.1.2 SPI3 42” Touch Panel Cable Specications ...................................................................28
8.1.3 IBC Cable Specications LA .......................................................................................28
8.1.4 Level System Cable Specications ..............................................................................29
8.2 Motorized Projection Screen (MPS) ...................................................................................... 29
8.3 Motorized Projection Screen Wall Switch (SWS) .................................................................... 29
8.4 Ceiling Mounted Projector ................................................................................................... 29
8.4.1 SPI3 Cable Specications ...........................................................................................29
8.4.2 IBC Cable Specications .............................................................................................30
8.4.3 Level System Cable Specications ..............................................................................30
8.5 Bracket Mounted Wall /Ceiling Speaker ................................................................................ 30
8.6 Flush Mounted Rectangular Wall/Ceiling Speaker ................................................................. 31
8.7 Flush Mounted Circular Ceiling Speaker ................................................................................ 31
8.8 Wall/Ceiling Mounted Pan/Tilt/Zoom Camera LA .................................................................. 31
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8.9 Wall/Ceiling Mounted HD Pan/Tilt/Zoom Camera LA ............................................................. 32
8.10 Echo Canceling Microphone with Internal Speaker LA ......................................................... 32
8.11 Ceiling Mounted Microphone ............................................................................................. 33
8.12 Lutron Controller (LTC) ....................................................................................................... 33
8.13 Lutron Lighting Control Integration Series .......................................................................... 33
8.14 Outside the OR Touch Panel, Keyboard, Mouse for SPI3 ........................................................ 33
9. ConnectSuite ..................................................................................................................................................... 35
9.1 SuiteStream...................................................................................................................... 35
9.2 SuiteLink/SuiteView .......................................................................................................... 35
9.3 Osite Package ................................................................................................................. 35
10. Status Systems LA ........................................................................................................................................... 36
10.1 Operating Room Status Systems ......................................................................................... 36
10.1.1 Partial Floor and Elevation Drawings ..........................................................................36
10.1.2 Site Preparation Requirements ..................................................................................37
10.2 SuiteStatus Systems .......................................................................................................... 38
10.3 Site Preparation Requirements .......................................................................................... 39
10.3.1 SuiteStatus System ...................................................................................................39
10.3.2 Power ......................................................................................................................39
10.3.3 Mounts .....................................................................................................................39
10.3.4 External Display ........................................................................................................39
Appendix A: PRI Provisioning Instructions and Form ............................................................................................... 41
A.1 Setting Up a PRI Line ......................................................................................................... 42
A.2 PRI Setup Responsibility Matrix ......................................................................................... 42
Appendix B: ORIS Network Connectivity .................................................................................................................. 45
B.1 Network Connectivity Information .................................................................................... 45
B.1.1 Ports and Bandwidth ................................................................................................45
B.1.2 Gateway/Session Border Controller (V2IU) ..................................................................45
B.1.3 Bridging Services ......................................................................................................45
B.2 Network Connectivity Questionnaire (Response Required) ......................................46
Appendix C: Remote Device Management Network Security SORN ......................................................................... 47
Appendix D: OSHPD Pre-Approved Mounting Solution ............................................................................................ 49
Contact Information ................................................................................................................................................ 51
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1. Scope
is document describes the rough-in requirements and specications for Stryker Operating Room Information System (ORIS) equipment. It covers pre-installation requirements for all electrical and information systems services needed. It does not describe in detail the installation of this equipment which is accomplished by Stryker Communications' technicians.
Note Please refer to the Boom and Lights Pre-Installation Manuals for mechanical and
structural requirements for Stryker equipment booms, surgical lights, at panel arms, and navigation arms.
Note Junction boxes are called out in this manual. e term dual gang junction box
with single gang mud ring refers to an actual dual gang junction box with an adaptor that is designed for attachment of a single gang wall plate. is provides more internal room for cabling and wire termination. e exact type used de­pends on local building codes and electrical standards.
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2. 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 or user may be involved. Disregarding
this information could result in injury to the patient.
Caution Special service procedures or precautions must be followed to avoid dam-
aging the instrument.
Note Special information to make maintenance easier or important information more
clear.
2.1 Warnings
To avoid potential serious injury to the user and the patient, the user must:
1. Read this manual thoroughly, and be familiar with its contents prior to using this equipment.
2. Be qualied physician/technician or medical personnel, having complete knowledge of the use of this equipment.
3. Test this equipment prior to a surgical procedure. is product was fully tested at the factory before shipment.
4. DO NOT remove covers on the product, to avoid an electric shock.
5. DO NOT perform internal repairs or adjustments unless specically instructed to do so in this manual.
6. e electrical installation of relevant operating room equipment must comply with the appli­cable IEC, CEC, and NEC requirements, and any other applicable international requirements where this product is sold. In the case where the information in this manual conicts with local building/electrical regulations, local regulations will take precedence.
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3. Product Symbol Denition
e following symbols may be found on the Stryker SwitchPoint Innity® 3 equipment:
An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance (service) instructions in the literature ac­companying the product.
A lightning bolt within a triangle indicates the presence of hazardous voltage. Refer all service to authorized personnel.
Denotes temperature limits.
Denotes humidity limits.
Denotes pressure limits.
Denotes usage tips and useful information.
Denotes compliance to European Community Directive 93/42/EEC.
Denotes compliance to CSA Standard C22.2, 60601-1 - M90, AS 3200, IEC 60601-1, UL 60601-1, EN 60601-1
Denotes the date the equipment was manufactured.
Denotes the manufacturer of the device.
Denotes product/part number.
Denotes product/serial number.
Denotes lot or batch number.
Denotes European Representative.
For U.S. audience only - Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.
Denotes quantity.
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Denotes Class 1
Class 1 Equipment: equipment in which the protection against electric shock does not rely on Basic Insulation only, but includes an additional safety precaution in such a way that means are provided for the connection of Accessible Conductive Parts to Protective (ground) Conductor in the xed wiring of the installation in such a way that Accessible Conductive Parts cannot become Live in the event of a failure of the Basic Insulation.
In accordance with European Community Directive 2002/96/EC on Waste Electri­cal and Electronic Equipment, this symbol indicates that the product must not be disposed of as unsorted municipal waste but should be collected separately.
Note: e device does not contain any hazardous materials.
Legal regulations may include specications regarding the disposal of this prod­uct. We request that you contact Stryker when you plan to withdraw this device from service for discard.
Denotes the device contains more than .002% cadmium.
Denotes the device contains more than .0005% mercury.
Denotes the device contains more than .004% lead.
LA
NSP
Limited Availability - Equipment may not be available in all regions.
Not Stryker Provided - Doc Stations must be provided by the customer outside the U.S.
3.1 EMC Precautions
is device is considered medical electrical equipment and requires special precautions regarding EMC and needs to be installed and put into service according to the information provided.
Portable and mobile RF communications equipment can aect this device's performance and must be used in accordance with the following information.
WARNING e use of accessories, transducers, or cables other than those specied,
with the exception of those sold by Stryker, may result in increased emis­sions or decreased immunity of the equipment or system.
WARNING e equipment should not be used adjacent to or stacked with other equip-
ment. If stacking or adjacent placement is necessary, the equipment should be observed to verify normal operation in the conguration in which it will be used.
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4. Party Responsibilities
e responsibilities associated with planning and preparation for installation of Operating Room Information System equipment will be shared between the Hospital, Contractor, and Stryker. ese responsibilities are outlined below.
4.1 Hospital Responsibilities
1. Fill out the Ship and Installation Conrmation Form provided by the Stryker Representative. is must be completed eight (8) weeks prior to the requested installation date.
2. e hospital must supply Stryker with up-to-date drawings in .dwg format (CAD) including but not limited to:
Room layout plans (current and proposed)
Electrical services drawings
Mechanical services drawings
Elevation drawings
Structural steel (support structure) drawings
Ceiling drawings
3. e hospital must ensure Stryker is notied of all revisions and changes to drawings prior to and during the scope of the project.
4. Accept delivery of Stryker equipment.
5. All Stryker-supplied equipment should be stored in a clean, temperature-controlled, dry envi­ronment prior to installation. Failure to comply may result in damage to the equipment, failure of life support components, damage, and the.
6. On or before the installation start date, deliver Stryker crates and equipment to the proper room(s).
7. Remove and dispose of the pallets, boxes, and trash during and aer the installation.
8. On the nal day of installation, sign Stryker Installation Acknowledgement Form. is form must be signed before the room can be turned over to the hospital.
4.2 Contractor Responsibilities
1. Coordinate subcontractors.
2. Prior to the installation start date, provide all rough-in requirements as explained in this manual and the Stryker rough-in drawings.
3. Prior to the installation start date, run all cabling, electrical, and data as instructed in this manual and the Stryker Communications drawings.
4. Provide and pull all cables outside the operating room as specied in this manual.
5. Prior to the installation start date, connect all the required electrical circuits.
6. Prior to the installation start date, complete all work involving dust, paint, and ooring.
7. All non-Stryker equipment that is going to be connected to Stryker's ORIS equipment must be installed prior to Stryker's installation start date.
8. All Stryker equipment that attaches to the building structure, such as Documentation Sta­tions, Plasma/LCD display mounting brackets, and LCD projector mounting brackets, must be mounted prior to Stryker's installation date. Exceptions are Stryker's booms and lights.
9. Prior to installation start date, any documentation station or cabinets that will house Stryker
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ORIS equipment must be fully assembled and connected to phone, data and power.
10. e proper Stryker cable kits must be pulled through any non-Stryker ceiling-mounted equip­ment prior to the Stryker installation date.
- International Only: If Stryker technicians are requested to pull cables through non-Stryker ceiling-mounted equipment, the vendor of the equipment must be present to assist and pro­vide instructions. e vendor will maintain responsibility for the nished, combined product.
11. All rooms must be reserved for Stryker Installation technicians only at all times during the installation dates.
4.3 Stryker Responsibilities
1. Provide design assistance and recommendations.
2. Provide rough-in, cabling, electrical, and voice/data requirements listed in this manual.
3. Provide rough-in drawings.
4. Provide the hospital with a scope of work for Stryker's equipment installation.
5. Inventory all Stryker ORIS System components.
6. Pull all cables within the operating room. Hospital provides and pulls all cables outside of the operating room, including auditoriums and conference rooms.
7. Terminate and test all low voltage cabling used to connect ORIS equipment with actual equip­ment or functionally equivalent signal generators.
8. Break down packaging material and gather all trash in a central location in the work area for Hospital/Contractor removal.
9. Perform a nal review and "walk through" of the installation to ensure all equipment is func­tioning and all installation requirements have been met.
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5. iSuite Operating Room
e Stryker iSuite may consist of, but is not limited to, the following Stryker Communications equip­ment: SwitchPoint Innity, SwitchPoint Element, Documentation Station, Stryker Booms and Lights, Speakers, PTZ Camera, and Wall Mounted Plasma/LCD. e operating room may also integrate with an ORIS Video Network Hub and may contain a Fixed OR Status Camera. is section describes site preparation requirements necessary for the installation phase of all Stryker ORIS equipment in the operating room.
Note All electrical circuits called out in this manual are single Branch Circuits. For
example: 20 Amp/115 VAC within the US and 16/13 Amp 230 VAC in Europe or equivalent per local electrical codes.
5.1 Documentation Station (Stryker Provided)
e Stryker-provided documentation station houses all the essential components of the iSuite. Prior to receiving the documentation station the customer/Contractor must complete the Documentation Station Order Conrmation Form (Provided by the Stryker Project Manager) and return to the PM at least eight (8) weeks prior to the desired delivery date.
5.1.1 Receiving and Assembling the Documentation Station
Note Hospital/Contractor is responsible for receiving and assembling the documenta-
tion station prior to Stryker installation. e assembly may require up to four people to complete the lis.
e documentation station will be delivered in three large wooden crates (top, middle, and base). is is a large delivery and may require extra labor.
Dimensions of the Shipping Crates:
3-Bay: 40 x 80 x 36 40 x 80 x 42 40 x 80 x 48
2-Bay: 40 x 54 x 36 40 x 54 x 42 40 x 54 x 48
1-Bay: 40 x 60 x 48
Shipping crates:
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Upon delivery, uncrate the Stryker Documentation Station, transport to the appropriate location, and assemble the three sections:
1. Roll the base section into place.
2. Li and level the base by adjusting the four leg levelers, found at each corner, with a screw driver.
3. Li the middle section and set it on top of the base.
4. Center the middle section over the base and then push the middle section back until it stops.
5. Use the 2" #10 fasteners provided by the manufacturer to screw the middle section to the base section. Use the pre-drilled holes at the top of each of the four corners of the base section to at­tach the two sections.
6. Repeat steps 2-5 to attach the top section to the middle section.
Note OSPHD anchoring details available from project manager upon request.
5.1.2 Additional Documentation Station Notes
e right side of the documentation station is the standard side for the Innity router.
Stryker provides the back boxes for all the outlets in the documentation station. All electrical outlets and face plates must be provided and installed by the hospital/Contractor.
Stryker does not engrave or label circuit IDs on faceplates.
Use the duplex outlet, in the bottom le cabinet of the documentation station, for the Ethernet/ Comm connection plate. Stryker only supplies the metal back box for this outlet.
e bottom section is on casters and will easily roll into place. is allows for the electrician to easily run power to the documentation station before rolling into place.
ere will be a 1" gap between the base of the cabinet and the nished oor. Stryker recom­mends coving/ashing up the oor for cleaning purposes.
Once in place, Stryker recommends sealing or caulking the sides of the documentation station to the wall.
e top of the documentation station is a at surface and Stryker does not provide a sot.
Stryker recommends one circuit to feed the top and middle outlets, one circuit to feed the Inn­ity side of the cabinet, and one circuit for the Power Supply box side of the cabinet.
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5.1.3 Installing the Documentation Station
Note All conduits should be provided with pull strings and should have minimum
bends or curves. All conduits have a maximum length of 45'. Conduits must have insulated bushings on all open ends.
Install two (2) Ethernet connections for the SORN (Stryker's Remote Device Management System) and SDC, respectively. A telephone connection may be desired for a nurse’s phone. Similarly, additional Ethernet connections may be desired for a Nurses Computer and/or PACS Computer. If local Video Conferencing via a CODEC is installed, an additional Ethernet connection is required. All additional telephone/Ethernet connections will be specied by the Hospital.
ONE-BAY DOCUMENTATION STATION (DOC1)
US
Dimensions 25.5"W x 90"H x 30.2"D Power ree (3) – 20 Amp circuits
One (1) circuit for quad outlet in lower section.
One (1) circuit for 2 duplex outlets in lower section.
One (1) circuit for quad outlet in upper section.
All documentation station circuits require critical power. Data Per listed equipment Backbox Per listed equipment
TWO-BAY DOCUMENTATION STATION (DOC2)
US
Dimensions 48"W x 90"H x 37"D Power Recommend Six (6) - 20 amp circuits:
One (1) circuit for quad outlet in lower section behind video router.
One (1) circuit for quad outlet in lower section behind the light power sup­ply box (if required).
One (1) circuit for duplex outlet in lower section under touch panel.
One (1) circuit for quad outlet in middle section behind digital capture de­vice.
One (1) circuit for quad outlet in upper le section (if required).
One (1) circuit for quad outlet in upper right section (if required).
All documentation station circuits require critical power.
Data Per listed equipment Backbox Per listed equipment
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THREE-BAY DOCUMENTATION STATION (DOC3)
US
Dimensions 72"W x 90"H x 37"D Power Recommend seven (7) - 20 amp circuits
One (1) circuit for quad outlet in lower section behind video router.
One (1) circuit for quad outlet in lower section behind light PSB (if re­quired).
One (1) circuit for duplex outlet in lower section under touch panel.
One (1) circuit for quad outlet in middle section behind digital capture device.
One (1) circuit for quad outlet in upper le section (if required).
One (1) circuit for quad outlet in upper middle section (if required).
One (1) circuit for quad outlet in upper right section (if required).
All documentation station circuits require critical power.
Data Per listed equipment Backbox Per listed equipment
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