Attachment RFI 115 A - 700000162 L_Pre-Install CHR F-GenChromoViewVPAUDM_EN.pdf

CHROMOPHARE® F-Generation Surgical Lights, VPA™, ChromoView Products and Universal Display Mount

Pre-Install Manual

Table of Contents 1 Warnings and Cautions

1.1 Definition of symbols used

1.2 Warnings

1.2.1 Electrical Safety

1.2.2 Electrical Current

1.3 Cautions

2 Product symbol definition

3 Options and accessories

4 Introduction

4.1 CHROMOPHARE Mount and Suspension Options

5 Intended Use

6 Site readiness: Owner´s checklist

7 Conduit and Wiring Checklist

7.1 For each suspension with Surgical Lights (F 528, F 628)

7.2 For each suspension with Universal Display Mount (UDM) or ChromoView ... 16

7.3 For each suspension with StrykeCam HD Camera

7.4 For each suspension with Video Power Arm (VPA - US/Canada only)

7.5 For each TC mounted suspension (on S-Series or Teletom – US/Canada only)

7.6 For upgrades of suspension with Universal Display Mount or ChromoView

8 Pre-Installation Responsibilities

8.1 Stryker’s Responsibilities

8.2 Hospital’s Responsibilities

8.2.1 Support Structure Design and Construction

8.2.2 Wiring/Electrical Requirements

8.2.3 Testing

8.2.4 Transport, Packaging, Handling and Storage

9 Structural Requirements

9.1 Support Structure Design Loads

9.2 Weight and Design Specifications

9.3 Mounting Scenarios

9.3.1 Single Common Plate

9.3.2 CHROMOPHARE Standard Plate

9.3.3 Tandem Common Plate (US/Canada only)

9.3.4 Shoulder Mount Plate (US/Canada only)

9.3.5 Universal Adapter Plate

9.3.6 Ceiling anchor plate (outside of US/Canada only)

10 Electrical Requirements

10.1 Testing and Certifications

10.2 Electrical, Wiring, Conduit Requirements

10.2.1 Power Requirements

10.2.2 Additional Suspensions in the Same Room

10.2.3 Wall Control

10.2.4 Flat Panels

10.2.5 StrykeCam

10.2.6 Video/Power Arm (VPA, US/Canada only)

10.2.7 TC Mount (US/Canada only)

10.3 Owner Electrical Responsibilities

10.3.1 High-Voltage Conduit

10.3.2 High-Voltage Circuit Connections

10.4 Connecting the electricity

10.5 SK Electronics Enclosure

10.5.1 Overall and Mounting Dimensions for SK Enclosure

10.5.2 Single, Recess mounted SK Enclosure with Decorative Trim Frame

10.6 Wall Control Unit

10.6.1 Surface Mount Wall Control Unit

10.6.2 Recessed Mount Wall Control Unit

10.6.3 SK Enclosure Integrated Wall Control Unit

11 Technical Data

11.1 Connecting ratings

11.2 Operating conditions

11.3 Transport and storage conditions

11.4 Emissions

12 Terms of Use

12.1 Product Warranty

12.2 Copyright protection

12.3 Contact information

13 Appendix

13.1 Circuit and Conduit Layout for Sample Configurations

13.2 Connecting the electricity (outside of US/Canada only)

13.2.1 Electrical connection to the ceiling tube

13.2.2 Electrical connections on the mounting plate

13.2.3 Electrical connections for the StrykeCam HD for F-Gen

13.2.4 Electrical connections with wall-mounted control unit

13.2.5 Connect the adapter board (StrykeCam HD for F-Gen)

13.2.6 Electrical connections wall mounted SK Enclosure

13.3 Installing the ceiling anchor plate

13.3.1 Ceiling anchor plate with reinforcement plate

13.3.2 Ceiling anchor plate with heavy-duty anchors

13.4 Installing Instructions for Spacer

13.4.1 Spacer

13.4.2 Installing the spacer

13.5 Installing Wall Mounted SK Enclosure

13.6 Installation plate for the supply unit

13.7 Fuses

13.7.1 Terminal voltages

Warnings and Cautions

1.1 Definition of symbols used

Warnings

Warnings in this user manual are marked with symbols. A signal word that reflects the extent of the danger precedes each warning. Observe all warning notices and exercise extreme caution to prevent accidents, injuries and property damage.

Danger:

The patient or user can be involved in an immediately dangerous situation. Disregarding this information can result in death or serious bodily injury.

Warning:

Possible injury to the patient or user.

Caution:

Possible damage to the equipment.

Note:

More information to clarify the instructions.

Special safety notices

To draw attention to particular dangers, the following symbol is used in combination with safety notices:

Warning:

Dangerous voltage. Refer all servicing to approved personnel.

1.2 Warnings

These safety precautions must be followed to install the CHROMOPHARE system.

WARNINGS identify possible dangerous situations to personnel. It is important to read these precautions before use. The user must also read and follow all instructions, warnings and cautions supplied with or shown on the CHROMOPHARE products.

• Only Stryker trained personnel are authorized to install the equipment described in this manual.

• Use proper lifting equipment and procedures. Loaded shipping pallets are heavy and can cause injury to people or damage to the equipment if not handled properly.

• Do not attach objects (for instance, sprinkler pipes, electrical conduit, utility piping, duct work) to the CHROMOPHARE support structure, unless approved by the structural engineer or mechanical contractor.

• Live electrical circuits can cause injury or death. To prevent work on live electrical circuits, lock out and tag out power supplies.

• Drifting of the equipment can cause injury.

• The hospital/contractor has final responsibility for the strength and rigidity of the support structure system to the building. An inadequate support structure will affect the ability of the CHROMOPHARE unit to perform in the manner intended. An inadequate support structure design can also result in damage to the equipment.

Equipment warranty service charges related to an inadequate support structure design or installation are at the customer’s expense.

• Transport and store CHROMOPHARE components out of the elements and away from dust, debris, and moisture to protect them from damage. Do not expose them to corrosive media, and avoid mechanical vibrations (see section Transport and storage conditions [} 67]). Failure to protect the components can lead to damage that will prevent proper installation and service performance. Certain boxes may be labeled with storage instructions that are more extensive than the requirements cited here. Follow them accordingly.

• When storing for 15 weeks or longer, periodically check the general condition of all components and the packaging.

• Caution must be exercised when lifting heavy objects to avoid serious bodily injury or damage to equipment.

1.2.1 Electrical Safety

Warning:

Always use caution when working on electrical systems.

Note: The hospital/contractor is responsible for running electrical power from the building supply to the CHROMOPHARE system (SK enclosure and/or mounting ring as indicated), and connecting the main power and hospital ground at this point.

• Touching uninsulated, live electrical components is life threatening. Damage to insulation or individual components can cause fatal injury.

• If insulation is damaged, immediately switch off the power supply and initiate repairs.

• Electrical work is to be performed only by skilled electricians.

• Before performing any electrical work, disconnect the mains power and verity that it is not live.

• To avoid risk of electric shock, this equipment must only be connected to a supply mains with protective earth.

• Know the electrical power rating of the unit being worked on.

• Use properly rated voltmeter/multimeter test equipment.

• Grip electrical test-probe leads only by their insulated handles.

• Do not attempt repairs on any live electrical circuits.

• Use lock-out, tag-out procedures before servicing any electrical component.

• Install or replace wiring only with the appropriate AWG size wire(s).

• Do not override or by-pass fuses.

• Ensure that numbered outlets are identified and wired to the appropriate circuit.

• Do not reroute or rewire circuits in a way that will allow operators to connect excess loads.

1.2.2 Electrical Current

The label below indicates electrical current warning.

Warning:

Only skilled electricians and trained, skilled personnel can work with electrical components inside the ceiling cover.

1.3 Cautions

• Do not attach items to the support structure unless approved by the structural engineer or mechanical contractor. Additional attachments have the potential to load the structure and can allow the CHROMOPHARE system to drift.

• Do not allow any component of the CHROMOPHARE system to collide with walls or other equipment.

Product symbol definition The device and its packaging can be marked with the following symbols:

Warning, electricity Electrical voltage Only skilled electricians may work in these areas.

Load limit Never exceed the indicated permissible load limit.

Products bearing the UL-Classified Mark for the U.S. and Canada are covered by UL's Classification and Follow-Up Ser-vice and meets the appropriate U.S. and Canadian require-ments.

Consult instructions for use The book symbol is intended to refer the user to important oper-ating and maintenance (service) instructions in the literature ac-companying the product.

Refer to instruction manual This symbol is intended to refer the user to important safety op-erating and maintenance (service) instructions in the literature accompanying the product.

Dangerous voltage A lightning bolt indicates the presence of hazardous voltage.

Refer all service to authorized personnel.

Alternating current

Temperature limitation Denotes temperature limits.

Humidity limitation Denotes humidity limits.

Pressure limitation Denotes relative pressure limits.

Denotes compliance to European Community Directive 93-42-

EEC.

Date of manufacture Denotes the date the equipment was manufactured.

Manufacturer Denotes the manufacturer of the device.

Catalogue number Denotes product/part number.

Serial number Denotes product/serial number.

Batch code Denotes lot or batch number.

For U.S. audience only - Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

Denotes quantity.

In accordance with European Community Directive 2002/96/EC on Waste Electrical and Electronic Equipment, this symbol indic-ates that the product must not be disposed of as unsorted muni-cipal waste but should be collected separately. We request that you contact Stryker when you plan to withdraw this device from service.

Indicates hot surfaces.

Device contains a battery.

Denotes oxygen explosion hazard.

Denotes made in USA with components of Germany.

Denotes made in USA with components of Germany and USA.

Denotes made in Germany.

Denotes the assembled to order number.

CAUTION: Before removing the cover, disconnect the power supply

CAUTION: Do not remove the screw!

Attention ! Do not pull out locking button before assembly is completed.

Attention! Ensure that locking button is plugged in before remov-ing device!

Denotes maximum allowed payload (total weight of the monitor, its power supply and cables).

Up The tips of the arrows indicate the top of the package. They must always point upwards or the contents could be damaged.

Fragile, handle with care Identifies packages with fragile or sensitive contents. Handle the package with care, do not drop it, and keep it from being bumped.

Keep dry Packages identified in this way must be protected from high levels of humidity. The package must therefore be stored covered. If particularly large or bulky packages cannot be stored in warehouses or sheds, they must be carefully covered with tar-paulins.

Options and accessories Throughout this Pre-Installation Manual, certain items will be labeled "US/Canada only" or "outside of US/Canada only". These designations are made to consider different standards in different regions. If there are any questions about what applies to your region, please contact your Stryker project team.

Some examples include:

Solutions for US/Canada only

• Shoulder Mount

• Tandem Mount

• TC Mount (Teletom and S-Series mounting options)

• Video/Power Arm (VPA)

Introduction Note: All CHROMOPHARE configurations are site/room specific and there can be multiple configurations with different requirements in the same project.

This CHROMOPHARE Pre-Install Manual details and describes the structural, mechanical, and electrical requirements of the room or site to allow proper installation of CHROMOPHARE Surgical Lights and Flat Panel products. It also provides installation instructions for the SK Box where the power supply and light control back box housing is located. The SK Box is mounted before the installation of the CHROMOPHARE Surgical Light.

Note:

This Pre-Install Manual applies also for the E-Series surgical lights. However, in case an existing CHROMOPHARE system is to be relocated, please contact Stryker or your Stryker representative for weight and design specifications.

Note:

Throughout this manual, metric and/or imperial values are stated. The parenthetical values are conversions from the original values. Conversions may be approximate where appropriate.

4.1 CHROMOPHARE Mount and Suspension Options

This section is provided for product option reference only.

Single Mount Dual Mount Triple Mount

Quad Mount Shoulder Mount (US/Canada only)

S-Series Standard/ TELETOM Tandem Mount

(US/Canada only)

Intended Use This CHROMOPHARE Pre-Install Manual is intended for use by technical professionals, installation and service personnel (e.g., architects, structural engineers, contractors, electricians, and pipe fitters) involved in the specification, design, and construction of the installation site.

The illustrations in this Pre-Install Manual are intended to provide a better understanding of the device; they are not necessarily drawn to scale and may deviate slightly from the actual model.

Warning:

Danger if not used as intended. Dangerous situations can occur any time the device is used for purposes beyond or other than those intended. Therefore, use the device only as intended.

• Strictly adhere to all specifications in this Pre-Install Manual.

• Only personnel authorised and certified by Stryker may install, readjust, modify or repair the devices.

• Do not operate with damaged components.

• It is the hospital/contractor’s responsibility to install pre-installation items safely using the appropriate personal protective equipment.

• The intended use and misuse of the appropriate Operating Manual which is delivered with each device must also be complied with.

Claims of any kind due to damage resulting from improper use are excluded.

The operator is solely responsible for damages resulting from improper use.

Site readiness: Owner´s checklist It is CRITICAL that all relevant items be completed before the scheduled installation date.

Use the checklist below to make sure all requirements are met.

Site visitation requirements: Stryker has been notified about any required safety training classes, hospital ID/badge requirements, parking instructions, and union re-quirements.

The access point for receiving equipment is clear, allowing enough room for large, full size semi-truck/trailer and room to off load via lift gate if required.

Floor protection is installed from delivery location to installation area as needed/re-quired by the hospital and/or contractor.

All needed elevators, doorways, and hallways are ready-to-use and wide enough for movement of equipment from the delivery/storage area to installation location. Fail-ure to prepare and identify adequate ceiling heights in the pathway and Operating Room/Intensive Care Unit prior to installation can prevent or cause significant delays to equipment installation.

The mounting site is prepared; ceiling support structures are built in accordance with Stryker pre-install manual specifications, and the ceiling support structures are ad-equate to support the weight, moment, and rotation specifications of the equipment

The room is clear; all other equipment, material, and any other trades working at time of installation have been removed.

The room is properly lit for the installation by means of temporary or permanent fix-tures; lighting should not conflict with the installation/movement of equipment.

The environment is dust free; use plastic sheeting to protect equipment.

Electrical circuits are provided per Stryker pre-installation manual specifications and room CAD/elevations.

Staging/transfer of equipment from unloading area to rooms.

Removal of shipping containers/trash to customer/contractor supplied dumpster or drop off location.

Storage facilities for equipment containers must be available prior to installation.

Note: If a return trip is required due to incomplete items, Stryker reserves the right to bill the hospital at the normal service rate.

Conduit and Wiring Checklist

Note:

Wherever conduit sizes are listed in inches, use the following metric sizes. These sizes are approximate.

• For 1" conduit, use 25 mm.

• For 1.25" conduit, use 32 mm.

• For 2" conduit, use 50 mm.

Note:

See section Appendix [} 71] for sample room configurations of circuit and conduit layouts.

See section Electrical Requirements [} 47] for more details.

7.1 For each suspension with Surgical Lights (F 528, F 628)

SK Enclosure

Stryker-supplied SK enclosure is installed and easily accessible

AC circuits available at SK enclosure for power to lights

DC supply wire from SK enclosure to mounting plate for power to lights

Two 1” conduits from SK enclosure to mounting plate (for Stryker use)

For wall control: One 1” conduit from SK enclosure to wall control box (for Stryker use)

Electronics on Tube

AC circuits available at mounting plate for power to lights

For wall control: One 1” conduit from mounting plate to wall control box (for Stryker use)

For multiple mounts in one room

One 1” conduit from one mounting plate to another mounting plate (for Stryker use)

7.2 For each suspension with Universal Display Mount (UDM) or ChromoView

Universal Display Mount (UDM)

For AC power only: AC circuits available at mounting plate for power to monitor

For Stryker integration: Stryker-supplied UDM junction box is installed within 18” (450 mm) of mounting plate

For Stryker integration: One 1 ¼” conduit from UDM junction box to documentation station (for Stryker use)

For NEC cable separation (US only): One 1 ¼” conduit from mounting plate to docu-mentation station (for Stryker use)

ChromoView

For AC power only (outside of US/Canada only): AC circuits available at mounting plate for power to monitor

For Stryker integration: One 1 ¼” conduit from mounting plate to documentation sta-tion (for Stryker use) For dual flat panel (DFP): Use one 2" and one 1 1/4" conduit instead (for Stryker use)

For NEC cable separation (US only): One 1 1/4" conduit from mounting plate to doc-umentation station (for Stryker use)

7.3 For each suspension with StrykeCam HD Camera

Space for the converter box is available in the documentation station

For documentation station: One 1” conduit from mounting plate to converter box in documentation station (for Stryker use)

For device control: One 1" conduit from wall control to documentation station (for Stryker use)

7.4 For each suspension with Video Power Arm (VPA - US/Canada only)

AC circuits available as indicated at VPA outlet box for VPA power

For Stryker integration: One 1 ¼” conduit from mounting plate to documentation sta-tion (for Stryker use)

7.5 For each TC mounted suspension (on S-Series or Teletom – US/Canada only) The following details are for CHROMOPHARE items only. See S-Series or Teletom product manuals for requirements.

Surgical Lights (F 628, F 528)

Stryker-supplied SK enclosure is installed and easily accessible

AC circuits available at SK enclosure for power to lights

DC supply wire from SK enclosure to TC junction box for power to lights

When no other surgical lights in room: One 1” conduit from SK enclosure to wall con-trol box (for Stryker use)

When other surgical lights in room: One 1” conduit from boom mounting plate to other CHROMOPHARE mounting plate (for Stryker use)

Examination Light (F 300)

AC circuits available at mini SK box for power to lights

Universal Display Mount (UDM)

For AC power: AC circuits available at TC junction box for power to monitor

For Stryker integration: Stryker supplied UDM junction box is installed within 18” (450 mm) of mounting plate

For Stryker integration: One 1 ¼” conduit from mounting plate to documentation sta-tion (for Stryker use)

For NEC cable separation (US only): One 1 1/4" conduit from mounting plate to doc-umentation station (for Stryker use)

ChromoView

For AC power (outside of US/Canada only): AC circuits available at TC junction box for power to monitor

For Stryker integration: One 1 ¼” conduit from mounting plate to documentation sta-tion (for Stryker use)

For NEC cable separation (US only): One 1 1/4" conduit from mounting plate to doc-umentation station (for Stryker use)

7.6 For upgrades of suspension with Universal Display Mount or ChromoView

Universal Display Mount (UDM)

For Stryker integration: Stryker supplied UDM junction box is installed within 18” (450 mm) of mounting plate

For NEC cable separation (US only): One 1 1/4" conduit from mounting plate to doc-umentation station (for Stryker use)

ChromoView

For NEC cable separation (US only): One 1 1/4" conduit from mounting plate to doc-umentation station (for Stryker use)

Pre-Installation Responsibilities

8.1 Stryker’s Responsibilities

Stryker is responsible for:

• Advising the hospital of a proposed time-frame for installation of Stryker-supplied infrastructure.

• Checking in with hospital personnel and/or contractor to announce arrival.

• Running and terminating all Stryker-supplied audio visual cables required for Stryker equipment.

• Inspecting all installed suspensions for quality assurance.

Stryker supplies the following components to the hospital/contractor for pre-installation:

• Equipment Configuration Drawings (including elevations, CAD, and room layouts), as applicable

• Mounting plate

• Mounting plate with concrete anchors (outside of US/Canada only)

• SK Enclosures

• Junction box (10x8x4” [254x203.2x101.6 mm]) for Universal Display Mount (rubber grommets for junction box are available upon request)

• Back box for recessed wall control

• Tube Combination (TC) junction box for TC mounted lights (US/Canada only)

Note: Stryker will not be responsible for the support structure design or the materials used. For technical questions, contact Stryker or your Stryker representative.

8.2 Hospital’s Responsibilities

Review this manual in its entirety before proceeding with pre-installation construction.

Hospital/contractor responsibilities are outlined and specified throughout the entire manual.

Caution:

The hospital/contractor has final responsibility for the strength and rigidity of the support structure.

An inadequate support structure will affect the ability of products to perform in the manner intended. An inadequate support structure design can also result in damage to the equipment.

Equipment warranty service charges related to an inadequate support structure design or installation are at the customer’s expense.

Caution:

Disclaimer If the integration cables are provided by the customer or by third parties contracted by the customer, Stryker does not assume any liability for the general and application-specific operability and operational suitability of said cables.

ü Therefore:

• The customer is responsible for testing the cables for suitability of the respective application. This primarily applies to the unusual loads said cables are subjected to, particularly at pivot points.

The owner must design, supply, and install all components above the finished ceiling.

These components include the supporting support structure, high-voltage/ low-voltage/ data/video conduits.

To function safely and effectively, the CHROMOPHARE products must be installed on a strong and rigid ceiling support. It requires a significant support structure above the ceiling.

An installed unit must support large weights and moments and must meet stringent rotational criteria. Stryker strongly recommends that the owner consult a structural engineer before designing and installing the support structure.

The owner or the owner’s consulting structural engineer must verify the following to ensure a safe and satisfactory installation:

• The building structure must be capable of supporting the loads involved, see section Weight and Design Specifications [} 27].

• The building structure must be capable of supporting any additional loading (e.g., earthquakes) required by local building codes.

• All electrical designs and installations must meet appropriate code requirements.

8.2.1 Support Structure Design and Construction

While in service, even the slightest deviation of the CHROMOPHARE mounting plate and support structure, out of the required horizontal plane, can cause the CHROMOPHARE to drift. To prevent this, the mounting plate must be properly installed in a horizontal plane (± 0.1 degree), with the studs pointing down. The support structure must also be rigid enough to prevent the mounting plate from rotating more than 0.1 degree when the specified design load is applied.

Factors such as building structure (e.g., concrete, steel, brick, etc.), the amount of space available above the finished ceiling, obstructions within the ceiling cavity, owner restrictions (e.g., welding within the ceiling cavity), economics, and contractor preferences may require different approaches to the design and installation of CHROMOPHARE support structures.

See section Structural Requirements [} 26] for details.

8.2.2 Wiring/Electrical Requirements

The hospital/contractor must install the power lines between the main supply and the CHROMOPHARE Surgical Light. Refer to the Equipment Configuration Drawings (provided by Stryker) for the type and quantity of circuits required.

Note: Wiring must be installed and power must be able to be turned on prior to installation of the CHROMOPHARE Surgical Light.

After the installation of the CHROMOPHARE Surgical Light is complete, the hospital/ contractor must make all final AC and DC connections (live, neutral, protective earth) to the equipment. Electrical work is to be performed only by skilled electricians. See section Electrical Requirements [} 47] for details.

8.2.3 Testing

The hospital/contractor must test and certify all system components before installation of the CHROMOPHARE is scheduled. Testing and certification must include support structure and electrical wiring.

8.2.4 Transport, Packaging, Handling and Storage

Note:

Only personnel authorized and certified by Stryker may install and perform the initial start-up of the product.

However, users, hospital staff or maintenance personnel from the responsible organization may be required to handle packages before or during installation and thereafter. The following instructions must be followed when performing such tasks.

Refer to section Transport and storage conditions [} 67] for conditions that must be observed during transport and storage.

See also 2 Transport and storage conditions [} 67]

8.2.4.1 Safety instructions

Warning:

Injury to personnel or material damage due to improper unloading, loading and transport!

Improper unloading, loading and transport as well as unloading, loading and transport by untrained personnel can result in components falling or toppling over. This can cause injury to personnel or damage to the property.

ü Therefore:

• The unloading and loading of packages during delivery and transport should be performed by trained personnel only.

• Exercise due care when unloading and loading of packages during delivery and transport and be sure to comply with the symbols and instructions on the packaging.

• Use proper lifting equipment and procedures. Loaded shipping pallets are heavy and can cause injury to people or damage to equipment if not handled properly.

• Lift equipment only from designated points to prevent tipping and damage to property.

• Packaging should only be removed by personnel authorized and certified by Stryker.

Warning:

Stryker ships CHROMOPHARE Surgical Lighting components via LTL truck or moving van in specially constructed reinforced packaging. The equipment and its packaging require a pallet jack for safe transportation. Pallet jack to be made available upon arrival.

Handle and store the equipment properly to avoid injury to personnel or damage to the components.

Note:

Boxes are to be opened only by Stryker personnel, and are labeled as such. Any missing components resulting from unauthorized entry into the boxes are the responsibility of the owner and will be invoiced with a change order.

8.2.4.2 Symbols on the packaging

See section Product symbol definition [} 7].

8.2.4.3 Transport inspection

Check the delivery immediately for completeness and any damage during transport.

For obvious transport damage, do the following:

• Do not accept the delivery, or accept it only conditionally.

• Note the extent of the damage on the shipping documents or on the transporter's delivery note.

• File a complaint.

Note:

Report every defect as soon as it is found. Claims for damages may be submitted only within the applicable claim period.

• To limit transport damage as far as possible, the original packaging should be used when returning a product to Stryker or your Stryker representative. Provide the following information: Owner's name and address, serial number (see model plate), a description of the defect.

• For any queries, please contact Stryker or your Stryker representative.

Please see section Product Warranty [} 68] for details on product returns.

8.2.4.4 Packaging

Packaging notes

Packaging is commensurate with expected transport conditions. Only environmentally safe materials were used for packaging.

The packaging is intended to protect individual components from transport damage, corrosion and other damage until installation is complete. Therefore, do not destroy the packaging and remove it only immediately prior to installation.

Working with packaging materials

Dispose of packaging materials in accordance with legal regulations and local ordinances.

Caution:

Incorrect disposal presents an environment hazard Packaging is made of valuable raw materials. In many cases, additional uses for the materials are possible, or they can be appropriately recycled for further use.

ü Therefore:

• Dispose of packaging in an environmentally safe manner.

• Follow local disposal ordinances. If necessary, hire a professional disposal service.

8.2.4.5 Transport

Transporting pallets with a forklift truck

Figure 1. Transport Boxes on pallets can be moved using a forklift provided that:

• The construction of the forklift truck must be appropriate to the weight of the units for transport.

• The item must be firmly secured to the pallet.

• The driver must be authorized to drive the forklift truck.

Loading onto the forklift:

1. Drive the forklift truck forward, positioning the forks between or beneath the pallet rails.

2. Drive forward until the forks protrude from the opposite side.

3. If the centre of gravity is off-centre, make sure the pallet cannot tip over.

4. Lift the pallet and begin transporting.

8.2.4.6 Pre-Installation Components

Upon request, Stryker ships the applicable, pre-installation items listed in Section Stryker’s Responsibilities [} 19], in advance of the other CHROMOPHARE Surgical Lighting components. All pre-installation components should be delivered to the hospital/ contractor upon receipt.

Structural Requirements This section provides information required to design the support structure for the CHROMOPHARE Surgical Lights.

Responsibility for proper design of support structure lies entirely with the hospital/ contractor and is not covered through warranty by Stryker.

The illustrations in this section are suggestions for the support structure design, but design and materials used are at the discretion of the structural engineer based upon specific site requirements.

The support structure, electrical conduits, junctions boxes, video, data, and other services are to be installed by the hospital or contractor and are not contained within the scope of work for Stryker. Stryker assumes all work has been performed in accordance with all applicable engineering and electrical building codes.

For questions regarding pre-installation requirements for any CHROMOPHARE product, contact Stryker or your Stryker representative.

Note:

Prior to the assembly of the CHROMOPHARE system, qualified certification of the fulfilment of the structural requirements must be carried out.

9.1 Support Structure Design Loads

The weights and moments are transferred to the supporting ceiling via the ceiling mount.

An installed unit must support large weights and moments and must meet stringent rotational criteria. To function safely and effectively, the CHROMOPHARE system must be installed on a strong and rigid ceiling support. It requires a significant support structure above the ceiling.

The structural engineer must provide proof of stability for each particular case. When determining the necessary static load capacity of the ceiling, it may be necessary to take additional loads on the ceiling into account, as well as the required safety factor. The transfer of forces to the ceiling must be secured. The load capacity of the ceiling must be confirmed by a structural engineer.

Weights and moments must never be exceeded. Adhere to the applicable regional building regulations. The anchorage types described in section Appendix [} 71] refer to reinforced concrete ceilings of an appropriate and professional standard according to DIN 1045. For other types of ceiling, safe and viable ceiling anchoring must be planned on site.

Warning:

Responsibility for proper design of the support structure lies entirely with the hospital/ contractor and is not covered through warranty by Stryker. An improperly designed support structure may result in poor performance or damage to equipment and possible injury to the user.

Incorrect drilling (e.g., drilling into a reinforcement bar) may compromise the load capacity and load distribution in buildings. This can lead to the collapse of building parts and cause severe personal injury.

Service charges related to inadequate support structure design are at the customer’s expense.

Stryker will not review or approve customer support structures. This is the responsibility of the customer’s architect and designated structural engineer. Any visit by Stryker personnel to view the support structure is only to compare its position to ceiling plans.

It is the hospital/contractor's responsibility to:

Make sure that Stryker equipment and infrastructure is not impeded by the design of the support structure.

Design and install the support structure to:

• Support weight and moment loads as required, see section Weight and Design Specifications [} 27] for specific details.

• Satisfy all applicable regulations including, but not limited to, building and electrical codes.

In case of incorrect drilling, immediately consult the structural engineer responsible.

Install Stryker-supplied mounting plate at the bottom of each support structure as specified in section Weight and Design Specifications [} 27]. THIS MUST BE INSTALLED

PRIOR TO STRYKER ARRIVING ON-SITE FOR INSTALLATION.

Install a 24” x 24” (609.6 x 609.6 mm) access panel directly adjacent to each mounting point for installation, maintenance, and future service.

9.2 Weight and Design Specifications

Weights and Moments

The support structure must be designed to the weights and moments shown in the table below. Designing for the heaviest model with the highest rotational moment will provide adequate support for the heaviest model. Weights, moments and center of gravities for specific configurations are available upon request.

The installed weights and moments shown below include the CHROMOPHARE components and payload.

Mounting Plate Recommended Design Specifications

Maximum Weight kg/lb Maximum Moment Nm/ ft-lb

Single Common 498/1,100 7,660/5,650

Tandem Common 997/2,200 15,320/11,300

Universal 250/555 2,700/1,992

Shoulder 250/555 2,700/1,992

Standard 250/555 2,700/1,992

When required, detailed system weights can be provided. It is recommended to design and construct structural supports to meet the design specifications above.

While in service, even the slightest deviation of the CHROMOPHARE mounting plate, out of the required horizontal plane, can cause the CHROMOPHARE to drift.

To prevent this, the mounting plate must be properly installed in a horizontal plane (± 0.1 degree), with the studs pointing down. The support structure must also be rigid enough to prevent the mounting plate from rotating more than 0.1 degree when the specified design load is applied.

Note: If designing a CHROMOPHARE system to be tandem mounted with a boom (US/ Canada only), check appropriate manual to determine mounting plate/structural requirements.

Note:

This Pre-Install Manual applies also for the E-Series surgical lights. However, in case an existing CHROMOPHARE system is to be relocated, please contact Stryker or your Stryker representative for weight and design specifications.

9.3 Mounting Scenarios

The Stryker-supplied mounting plate is the approved surface for mounting the CHROMOPHARE system. It is the responsibility of the hospital/contractor to install the plate, as it is a considered part of the structure. The mounting plate MUST be installed by the hospital/contractor prior to the installation start date.

It is the responsibility of the structural engineer to design and specify materials for proper construction of the support structure. These diagrams are intended to demonstrate the relative location of the mounting plate to the finished ceiling. Orientation of the mounting plate other than that shown in the diagram could cause delays in installation or require modification to the support structure.

Note: Contact Stryker personnel for information on which mounting plate is applicable to a specific project.

Danger:

Danger from collapsing building parts if installation is not properly carried out Improper installation of the CHROMOPHARE system may result in it working loose from the ceiling mount and falling. This can cause life-threatening injuries for the patient and surgical staff.

ü Therefore:

• Strictly adhere to all specifications in this Pre-Install manual.

• Make sure that structural requirements are fulfilled.

9.3.1 Single Common Plate

9.3.1.1 Mounting Plate Dimensions

Note: Indicated holes are used for mounting Stryker equipment to the mounting plate and may not be used or obstructed while mounting the plate to the support structure.

Figure 2. Single Common Plate P29282 Notes

• Available weld and bolt locations: marked dark gray

• UNC: Unified National Coarse

• B.C.: Bolt Hole Center

9.3.1.2 No-Fly Zone

Caution:

The hospital and/or contractor must make sure that structural/utility components do not interfere with ANY part of the CHROMOPHARE System

The following areas must be left clear for Stryker to be able to properly install the complete CHROMOPHARE System:

• 12” (304.8 mm) above the CHROMOPHARE System components within the interstitial space

• 0.5” (12.7 mm) around the outside of the CHROMOPHARE System ceiling cover boundary.

• The only items that can be within the no fly zone are the support structure elements above the designed mounting areas outlined in the Single and Common Tandem Plate sections. The risers will also be mounted in this zone.

Consideration should be given for structural/utility components that can interfere with the system installation, such as:

• Lighting fixtures

• Heating, ventilation, and air conditioning

• Sprinkler system heads

• Mechanical systems

• Speakers

• Fire/smoke detector systems

• Structural beams

9.3.1.3 Ceiling Cover/Cutout (Top View)

1 Single common plate 2 Ceiling cover boundary Ø 590 mm (23.23”)

Note:

If the single common plate is being installed in existing ceiling, the ceiling cutout will need to be 539 mm (21.23”) in diameter to fit the plate.

9.3.1.4 Installation (Front View)

Figure 3. Single Common Plate

1 Raised from finished ceiling 3” (76.2 mm) 3 Cover

2 Single common plate 4 CHROMOPHARE product

9.3.2 CHROMOPHARE Standard Plate

9.3.2.1 Mounting Plate Dimensions

The plate can be ordered and installed with or without the conduit tab, which is shown here.

Note: Indicated holes are used for mounting Stryker equipment to the mounting plate and may not be used or obstructed while mounting the plate to the support structure.

Figure 4. CHROMOPHARE Standard Mount Plate CB 5108675 Notes

• Material: A36 Steel Plate

• Dimensions are in inches [mm]

• UNC-2B: Unified National Coarse, Class 2B

• B.C.: Bolt Hole Center

• 5/8-11 UNC and ½-13 UNC are equally spaced apart on a 10.63 BC

9.3.2.2 Ceiling Cover/Cutout (Top View)

1 Ceiling cover boundary 23in (590 mm) 3 Conduit tab

2 Single standard plate 4 Ceiling cutout Ø 18in (457.2 mm)

9.3.2.3 Installation (Front View)

1 CHROMOPHARE product 3 Single standard plate

2 Flush with finished ceiling 4 Cover

9.3.3 Tandem Common Plate (US/Canada only)

Ensure that the tandem structure is mounted in the proper orientation by referring to the Equipment Configuration Drawings specifically related to the project.

9.3.3.1 Mounting Plate Dimensions

Note: Indicated holes are used for mounting Stryker equipment to the mounting plate and may not be used or obstructed while mounting the plate to the support structure.

Figure 5. Tandem Common Plate P29280 Notes

• Available weld and bolt locations: marked dark gray

9.3.3.2 No-Fly Zone

The hospital and/or contractor must make sure that structural/utility components do not interfere with ANY part of the CHROMOPHARE System

The following areas must be left clear for Stryker to be able to properly install the complete CHROMOPHARE System:

• 12” (304.8 mm) above the CHROMOPHARE System components within the interstitial space

• 0.5” (12.7 mm) around the outside of the CHROMOPHARE System ceiling cover boundary.

• The only items that can be within the no fly zone are the support structure elements above the designed mounting areas outlined in the Single and Common Tandem Plate sections. The risers will also be mounted in this zone.

Consideration should be given for structural/utility components that can interfere with the system installation, such as:

• Lighting fixtures

• Heating, ventilation, and air conditioning

• Sprinkler system heads

• Mechanical systems

• Speakers

• Fire/smoke detector systems

• Structural beams

9.3.3.3 Ceiling Cover/Cutout (Top View)

1 Ceiling cover boundary 25x32” rect-angle (635x813 mm)

3 Ceiling cutout 23x27” (584x686 mm)

2 Common plate

9.3.3.4 Installation (Front View)

1 CHROMOPHARE product 4 7/8” threaded rod

2 Raised from finished ceiling 3” (76.2 mm) 5 Cover

3 Common plate 6 S-Series standard or Teletom product

9.3.4 Shoulder Mount Plate (US/Canada only)

9.3.4.1 Mounting Plate Dimensions

Note: Indicated holes are used for mounting Stryker equipment to the mounting plate and may not be used or obstructed while mounting the plate to the support structure.

Figure 6. Dimensions are in inches

Figure 7. Dimensions are in mm

9.3.4.2 Ceiling Cover/Cutout (Top View)

1 Mounting plate 3 Ceiling cover

2 Ceiling cutout

9.3.4.3 Installation (Front View)

1 CHROMOPHARE product 4 Flush with finished ceiling

2 Cover 5 Flange

3 Shoulder plate

9.3.5 Universal Adapter Plate

9.3.5.1 Mounting Plate Dimensions

Note: Indicated holes are used for mounting Stryker equipment to the mounting plate and may not be used or obstructed while mounting the plate to the support structure.

Figure 8. CHROMOPHARE Universal Adapter Plate CB 5109175 Notes

• Material: A36 Steel Plate

• Dimensions are in mm (inches)

• UNC-2B: Unified National Coarse, Class 2B

• B.C.: Bolt Hole Center

• All holes are equally spaced in their respective bolt circles

• All mounting plates shipped with (6) 5/8-11 UNC studs and leveling nuts

9.3.5.2 Ceiling Cover/Cutout (Top View)

1 Ceiling cover 23 in. (590 mm) 3 Universal plate

2 Ceiling cutout Ø 20 in. (508 mm)

9.3.5.3 Installation (Front View)

1 Product flange 4 Finished ceiling

2 Existing structure 5 Ceiling cover

3 Universal plate flush with finished ceiling

9.3.6 Ceiling anchor plate (outside of US/Canada only)

Note: These mounting plates are not approved for use in seismic regions.

Ceiling anchor plate Item No. CB 5105304

Reinforcement plate Item No. CB 5105504

Figure 9. Dimension sheet for ceiling anchor plate CB 5105304 (dimensions are in mm)

Electrical Requirements The hospital’s electrical contractor must provide and install supply wiring from the panels to the CHROMOPHARE System in code-compliant conduit. The following sections include requirements per equipment to be used as a reference. If CAD drawings for the project are provided, refer to the specific conduit schedule indicated.

Low-voltage and video cables will be run from points designated by the hospital/contractor or third party integration company to designated outlets to the suspension for monitor. Use as required.

The hospital/contractor is responsible for making sure that all installed electrical, low voltage/data, and video components comply with applicable electrical codes and that all wiring and conduit runs described for the specific installation are complete before product installation.

For installations in the US, cables may need to be separated per NEC requirements. For installations outside of the US, installers should check with their local Stryker project team to follow country/region specific standard codes.

Electrical work is to be performed only by skilled electricians.

For technical questions, contact Stryker or your Stryker representative.

See section Connecting the electricity [} 57] for information on how to connect the electricity following installation.

Note:

Wherever conduit sizes are listed in inches, use the following metric sizes. These sizes are approximate.

• For 1" conduit, use 25 mm.

• For 1.25" conduit, use 32 mm.

• For 2" conduit, use 50 mm.

10.1 Testing and Certifications

The hospital/contractor must test and certify all system components before installation of the CHROMOPHARE products will be scheduled.

This testing and certification must include the following items:

• Electrical testing to meet local codes

Note: The hospital/contractor is responsible to ensure that the electrical components and installation complies with all applicable electrical codes. All wiring and conduit runs described for the type of installation involved must be completed before the product can be installed.

For questions regarding the electrical requirements for the pre-installation of any CHROMOPHARE Surgical Light, contact Stryker or your Stryker representative.

10.2 Electrical, Wiring, Conduit Requirements

Note: The room layout drawings in this section provide conduit requirements for the CHROMOPHARE Surgical Light. All illustrations are representative of Stryker/ BERCHTOLD products, but are provided for reference only.

It is not recommended to power all lights in a room on a single AC circuit.

It is not recommended to power lights on the same AC circuit as a flat panel.

Note: Local codes apply to the selection of conduit, wire sizes and type, terminal boxes, and other electrical equipment.

Note: High voltage AC power supplied to the system by electrical mains will vary based on region. For the US/Canada, 120 VAC and 50/60 Hz is used. Outside of the US and Canada, refer to regional requirements or work with your Stryker project team to confirm supply voltage and frequency.

Note: For plenum rated cables, conduit may not be required.

10.2.1 Power Requirements

Power

For each suspension with lights, one of the following electronics systems will be present:

SK Enclosure

• The CHROMOPHARE Surgical Light’s power supply and controls are housed within an SK Enclosure mounted separately from the CHROMOPHARE light suspension.

This is the preferred, low-profile mounting style in most locations.

• The SK Enclosure must have a maximum length of 45 ft (15 m) of conduit run to both the mounting plate and wall control box (if present).

• The SK Enclosure must be easily accessible. It can be installed into a wall or in the interstitial space with an access panel.

• The SK Enclosure will be provided as a Pre-Install item and must be installed prior to Stryker’s arrival for installation.

• To power the system, AC power runs from a mains source to the SK Enclosure.

Control signals and DC power are routed through wires from the SK Enclosure to a terminal strip on the light suspension plate.

• Conduit and Circuits required:

– One 1” conduit from SK Enclosure to Mounting Plate (for Stryker use)

– One 1” conduit from SK Enclosure to Wall Control Box (for Stryker use)

– AC circuit(s) available at SK Enclosure for power to lights

– DC supply wire from SK enclosure to mounting plate for power to lights

• AC Requirements:

From Electrical Panel to SK Enclosure:

– Main AC supply should be 120 VAC and 50/60 Hz. Outside of the US and

Canada, refer to regional requirements or work with your Stryker project team to confirm supply voltage and frequency.

– Wiring should be 3 wire, 16 AWG to 12 AWG (1.5 mm² to 4 mm²), and 600 V, terminated to the fused terminal block inside the SK Enclosure.

– Each light head draws 2 Amps at 120 VAC (or 220 VAC outside US).

• DC Requirements:

From SK Enclosure to Suspension:

– Wiring should be 12 AWG (4 mm²), 600 V.

– Wires should consist of 1 pair per light head and 1 ground wire per suspension

(outside US – 1 ground wire per light head).

– Wires terminate at the non-fused terminal block inside the SK Enclosure.

– Wiring should be run through flexible conduit exiting the ceiling at the mounting ring and falling a minimum of 18” (450 mm) below the ceiling.

The terminal blocks shown here are used in the US/Canada only. For a photo of the blocks used outside of US/Canada, see section Connecting the electricity (outside of US/ Canada only) [} 86].

Note: The 120 V, 20A AC input as shown here is used in the US/Canada only. Refer to regional requirements or work with your Stryker project team to determine correct supply voltage outside of the US/Canada.

Electronics on Tube

• The CHROMOPHARE Surgical Light’s power supply and controls can be housed on the flange of the suspension when specified at the time of order.

• To power the system, AC power runs from a mains source directly to the CHROMOPHARE light ceiling mounting plate.

• Conduit and Circuits required:

– One 1” conduit from Mounting Plate to Wall Control Box (for Stryker use)

– AC circuit(s) available at Mounting Plate for power to lights

• AC Requirements:

– AC power is delivered from a mains source directly to the CHROMOPHARE

Surgical Light’s ceiling mounting plate.

– Wiring should be 3-wire, 16 AWG to…