Visum Surgical Lights Halogen and and Flat Panel Arms-Halogen and LED Rev K Pre-Installation Manual Dec 2010

Visum™ Surgical Lights and Flat Panel Arms (Halogen and LED) Pre-Installation Manual

This manual contains confidential information that shall not be disclosed or duplicated for any reason other than to use and maintain Visum™ Surgical Lights and Flat Plane Arms. This restriction does not limit the right to use information contained in this manual if it is obtained from another source without restriction. The information subject to this restriction is contained in all pages of this manual. © December 2010 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 Stryker Visum Surgical Lights and Flat Panel Arms Pre-Installation Manual 1001-400-008 REV K

S Contents 1. General Warnings and Cautions... 7 1.1

Warnings... 7

1.2

Cautions... 7

2. Product Symbol Definition... 8 3. Scope... 9 4. Guidelines and Responsibilities... 10 4.1

Hospital/Contractor Responsibility... 10

4.1.1 4.1.2 4.1.3 4.1.4 4.1.5

Support Structure/Mounting Support...10 Delivery and Storage...10 Drawings and Information...11 Electrical and Data Infrastructure...11 Stryker’s Responsibilities...11

5. Mounting Plate Descriptions... 12 5.1

Mounting (Interface) Plate... 12

5.2

Universal Mounting Plate... 13

6. Visum 450 and Visum 600 (Halogen) Part Descriptions... 15 6.1

Visum 450 & 600 (Halogen) Light Power Supply Box ... 15

6.2

Visum 450 & Visum 600 (Halogen) Light and Camera Wall Control Panel... 16

7. Visum LED Part Descriptions... 17 7.1

Power Supply Box for Visum LED ... 17

7.2

Power Supply Box Wall Mount (Optional)... 17

7.3

Visum LED Wall Control Panel... 18

8. Site Preparation... 20 8.1

Support Structure... 20

8.1.1 8.2

Ceiling Access...22

Electrical Installation... 22

8.2.1 8.2.2 8.2.3 8.2.4 8.2.5

Power Supply Box Mounted in Documentation Station...23 Wall-Mounted Power Supply Box (Visum LED only)...25 Suspensions with Flat-Panel Arms...27 Single/Dual Flat-Panel Arms...27 Navigation Arms...27

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S 9. Specifications... 30 9.1

Environmental Specifications... 30

9.2

Electrical Specifications... 30

9.3

Mechanical Specifications... 30

9.4

Critical Distances... 30

9.5

Support Structure Loads ... 31

9.6

Light Suspension Specifications... 32

Appendix A: Seismic Calculations (Flat Panel Arms)... 33 Appendix B: Seismic Calculations (LED and Halogen Surgical Lights) ... 36

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S 1. General Warnings and Cautions Please read this manual and follow its instructions carefully. The words WARNING, CAUTION, and Note carry special meanings and should be carefully reviewed: WARNING The 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 damaging the instrument.

WARNING A lightening bolt within a triangle is intended to warn of the presence of hazardous voltages. Refer all service to authorized personnel. Note

Special information to make maintenance easier or important information more clear.

To avoid potential serious injury to the user and the patient and/or damage to this device, the user must adhere to the following warnings and cautions.

1.1

Warnings

1. Read this manual thoroughly, and be familiar with its contents prior to installing this equipment. 2. Test this equipment before release for use by hospital personnel. 3. Energized electrical circuits can cause severe injury or death. Ensure that all personnel working around energized circuits have been trained in and follow proper lock-out/tag-out and other applicable safety procedures.

1.2

Cautions

1. Use caution when lifting heavy objects to avoid serious bodily injury or damage to equipment. 2. All Stryker-supplied equipment should be stored in a clean, dry environment prior to installation. Failing to comply with this requirement may lead to equipment damage.

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S 2. Product Symbol Definition The following symbols may be found on the Stryker Visum LED and Flat Panel Arms: 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 oxygen explosion hazard. Denotes usage tips and useful information. Denotes compliance to European Community Directive 93-42-EEC. Indicates hot surfaces. Denotes compliance to CSA Standard C22.2, 60601.1 - M90, AS 3200, IEC 60601, IEC 60601-2-41, UL 60601, EN 60601 Denotes the date the equipment was manufactured. Denotes the manufacturer of the device. A yellow box with a hand within a triangle is intended to warn the user of the presence of an electrostatic sensitive device. Follow ESD prevention procedures. 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: The device does not contain any hazardous materials. Legal regulations may include specifications regarding the disposal of this product. We request that you contact Stryker when you plan to withdraw this device from service for discard.

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S 3. Scope This Pre-Installation Guide describes the requirements for assembling and installing components used in the support of Stryker ceiling-mounted surgical lighting and monitor carrying assemblies prior to installation. This guide covers all mechanical and electrical pre-installation requirements for the lights, control panel, power supply, surgical light suspensions, and flat panel/navigation suspensions. This guide does not describe the installation of the surgical monitors or support arm assemblies.

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S 4. Guidelines and Responsibilities 4.1

Hospital/Contractor Responsibility 4.1.1

Support Structure/Mounting Support

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. Service charges related to inadequate support structure design is 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 steelwork is only to compare its position to ceiling plans. 1. Design and install the support structure to: • Support (Stryker-supplied) weight and moment loads of each equipment piece. • Satisfy all applicable regulations including, but not limited to, building and electrical codes. 2. Install the Stryker-supplied Mounting (Interface) Plate at the bottom of each support structure in accordance with the recommended method. 3. Loosely install (Stryker-supplied 5/8-11 UNC, M16 if provided) all thread, nuts and washers into the six (6) holes of the Mounting (Interface) Plate to avoid loss of hardware prior to installation. 4. Ensure that Stryker equipment and infrastructure is not impeded by the design of the support structure. 5. Verify that the diameter of the mounting site is 21-22in (53-56cm) to install the Surgical Light System (LED or Halogen). 6. Install access panels directly adjacent to each mounting point for future access for service and maintenance as described in this manual. • Each access panel must be a minimum of 18in x 18in (450mm x 450mm).

4.1.2

Delivery and Storage

1. Accept delivery of Stryker crates and equipment to the proper room prior to the installation date. 2. All Stryker-supplied equipment should be stored in a clean, dry environment prior to installation. Failing to comply with this requirement may lead to damage of equipment. 3. Remove and dispose of the pallets and boxes after completing the installation.

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S 4.1.3 •

•

Drawings and Information

The hospital must supply Stryker with up-to-date drawings in .dwg format (CAD) including but not limited to: a. Room layout plans (current and proposed) b. Electrical services drawings c. Mechanical services drawings d. Elevation drawings e. Structural steel (support structure) drawings f. Ceiling drawings The hospital must ensure that Stryker is notified of all revisions and changes to drawings prior to and during the scope of the project.

4.1.4

Electrical and Data Infrastructure

1. Provide and install the Mains power, junction boxes, Ethernet drops and grounded power outlets as described in this manual, CAD drawings and applicable regulations and standards. Note

For Flat Panel and Light/Flat Panel installations: Install a 5 amp fuse for 100V120V applications, or a 2.5 amp fuse for 200V-240V applications, if required by local electrical code. These fuses must be provided by the contractor.

2. Provide an uninterruptible, grounded and isolated power to the surgical light system. 3. Install the appropriate conduit, catenaries and cable trays between mains power, surgical light power supply box, wall control panel and the support structure mounting points. • For Visum LED Lights: Install the back box for the wall-mounted Visum LED Surgical Lights application. 4. Provide access for all Stryker personnel to route Stryker-supplied cables from locations within each room to the termination locations, as specified in the CAD drawings. 5. Verify the capacity of electrical infrastructure is capable of meeting the requirements as specified by Stryker for the project. 6. Perform final electrical testing and validation for all electrical cables and power outlets, including those on Stryker-supplied booms. 7. Make all connections of Stryker equipment to Mains Power.

4.1.5 • • • • • • • •

Stryker’s Responsibilities

Provide the hospital or designated contractor with CAD drawings including elevation and room configuration drawings for Stryker-supplied equipment. Advise the hospital of a proposed time-frame for installation of Stryker-supplied infrastructure. Check in with hospital personnel and/or contractor to announce arrival. Install the surgical lights and calibrate the brakes according to Stryker specifications. Connect low voltage electrical and data cables for surgical lights and adjust lighting (voltage, field diameter adjustments, etc.) to Stryker specifications. Install the flat panel monitor arm (if applicable) and calibrate the brakes to Stryker specifications. Route and terminate all audio visual cables required for Stryker-supplied equipment. Install flat panel monitor (if applicable) and connect audio visual wiring kit to the flat panel.

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S 5. Mounting Plate Descriptions 5.1

Mounting (Interface) Plate

The Mounting Plate is the primary mounting component for new surgical light installations. The plate must be welded or bolted to the support structure by the hospital/contractor.

Figure 5.1 - Stryker-supplied Mounting (Interface) Plate WARNING The mounting plate is part of the support structure. It is the hospital’s responsibility to ensure that the mounting plate can sufficiently support the loads defined for the support structure. Note

Ensure that the area inside the Clear Zone and at least one of the 2X M6 holes remain unobstructed by the support structure or weld slug.

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S 5.2

Universal Mounting Plate

The Universal Mounting Plate adapts the hole-pattern of existing ceiling plates to accommodate Stryker equipment. At least one hole pattern in the existing mounting plate must align with one hole pattern in the Universal Mounting Plate. WARNING The Universal Mounting plate is only intended for use with light suspensions and flat panel suspensions. It cannot be used to mount a boom. For all references in this guide, the Universal Mounting Plate only adapts Stryker equipment to existing mounting plates supplied by Steris®, Berchtold® or Getinge. It is the hospital responsibility to determine whether their existing plate is compatible with the Universal Mounting Plate prior to site preparation. WARNING The existing mounting plate is part of the support structure. It is the hospital’s responsibility to ensure that the existing plate is sufficiently strong to support the loads defined in this manual.

Support Structure

Existing Mounting Plate

Universal Mounting Plate

Finished Ceiling

Figure 5.2 - Mounting & Universal Plate Diagram

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S 6. Visum 450 and Visum 600 (Halogen) Part Descriptions 6.1

Visum 450 & 600 (Halogen) Light Power Supply Box

(Weight: 36.5 lbs/16.5 kg) 1. The power supply box provides 24V DC power to the surgical lights from a 115/230 VAC source. 2. Mount the power supply box at the documentation station. Note

Single and dual-light configurations require one power supply box. Three or four-light configurations require two power supply boxes.

3. Use a Three-Bay Documentation Station to accommodate the power supply box and a SwitchPoint Infinity® unit. Note

The power supply box can be configured with an optional 24V inlet for battery backup, if required by the hospital.

Front View of Power Supply Box

Back View of Power Supply Box Figure 6.1 - Power Supply Box

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S 6.2

Visum 450 & Visum 600 (Halogen) Light and Camera Wall Control Panel

The wall control panel provides control for lighting levels as well as control for cameras where applicable. 1. Vertically mount the wall control panel at conventional light switch height. Note

Single and dual-light configurations require one wall control. Three or four-light configurations require two wall controls.

2. Attach the wall control panel to the three-gang box (use the provided screws).

Figure 6.2 - Wall Control Panel Note

It is not required to install the wall control panel inside the documentation station. Consult the hospital to determine ideal placement near or in the documentation station. For proper installation of the wall control panel, a standard RACO 942 three-gang box should be mounted vertically.

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S 7. Visum LED Part Descriptions 7.1

Power Supply Box for Visum LED

(Weight: 20lbs/9.09 kg) The power supply box provides 24 VDC power to the surgical lights from a 100-230 VAC source. 1. Mount the power supply box at the documentation station or near a power outlet and Ethernet drop. Note

Single and dual-light configurations require one power supply box. Three or fourlight configurations require two power supply boxes.

2. Use a Three-Bay Documentation Station to accommodate a power supply box and a SwitchPoint Infinity® unit. Wall SORN Connection Port Port

SIDNE Expansion Port Port

Control Panel Mount

Control Panel Mount

Light Power Panel Mount

Light Power Panel Mount

Front View 12.5 (317.5) Circuit Breaker Electrical Inlet

7.0 (177.8)

Depth 15.5 (393.7)

INCHES (mm)

Back View Figure 7.1 - Power Supply Box & Ports (for Visum LED Surgical Lights)

7.2

Power Supply Box Wall Mount (Optional)

The Power Supply Box Wall Mount should be used to securely install and mount a Visum LED power supply box to a wall.

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S Exploded View of Power Supply Box

Vertical Side View of Power Supply Box & Back Box Power Supply Box

Customer Supplied Back Box*

Power Supply Box Customer Supplied Back Box*

Wall Mount Plate

Control Panel

Wall *The Back Box is concealed within the wall.

Figure 7.2 - Exploded/Side View of Power Supply Box Note

7.3

Mount a standard Hubbell Wiegmann (P/N SC101004) junction box for proper installation of a wall-mounted power supply box. Consult the hospital to determine ideal placement for the power supply box.

Visum LED Wall Control Panel

The Visum LED Wall Control Panel enables users to control light intensity as well as In-Light camera functions. 1. Vertically mount the panel at conventional light switch height. The wall control panel comes with four screws to attach the panel to a three-gang box. Note

Single and dual-light configurations require one wall control. Three or four-light configurations require two wall controls.

2. For three or four light installations, mount the power supplies side by side at a distance of 16 in (406mm) from center to center between back boxes.

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S 8. Site Preparation Installation of the support structure (as outlined in the Guidelines and Responsibilities section of this guide), electrical conduits, junctions boxes, video, data, and other services should 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.

8.1

Support Structure

1. Position the support structure according to the room layout provided by Stryker. WARNING The maximum allowed deflection of the ceiling plate under maximum load is 1˚(¹/300 deflection ratio). Note

The support structure must adequately support the loads specified for each application. Structure designs can vary significantly based on load, interstitial space, obstructions, and building codes.

2. Weld the Mounting (Interface) Plate to the support structure along the outer edge of the plate or use the six .83in (21mm) holes along the outer edge of the plate to bolt it to the support structure (see Figure 1). 3. Do not use Stryker-supplied thread-all rods to attach the suspension to the Mounting (Interface) Plate. The bolts must be supplied by the contractor. 4. The Mounting (Interface) Plate must be level within 0.25in (6.4mm). The bottom of the mounting plate must be 2-4in (50mm-100mm) above the finished ceiling. Allow enough space to route cables to the surgical light and Flat Panel Navigation Arm (see Figure 9). WARNING Caution must be exercised when lifting heavy objects to avoid serious bodily injury or damage to equipment. Note

Dynamic (seismic) loads per California Building Code 1632A are available in Appendices A and B. If seismic calculations are required for a local region, they must be determined by the structural engineer.

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Figure 8.1 - Support Structure

S

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S WARNING Proper design and manufacture of the support structure is the hospital and contractor’s responsibility and is not covered through warranty by Stryker. Insufficient structure support may result in poor performance or damage to equipment as well as injury to the user. Service charges related to inadequate structure support are the hospital’s responsibility. WARNING The mounting plate is part of the support structure. It is the hospital’s responsibility to ensure that the mounting plate is sufficiently supported to carry the loads defined for the support structure.

8.1.1 • •

8.2

Note

The support structure must be designed and installed to avoid obstruction of or interference with the six tapped holes [5/8-11 UNC (M16)] located adjacent to the inner diameter of the Mounting (Interface) Plate as well as the 9.06in (230 mm) diameter center hole.

Note

“Bolt-together,” prefabricated, structural members are highly discouraged and considered an unacceptable solution for the support structure design. This approach generally allows considerable flexing of the structure resulting in poor performance and possible equipment damage.

Ceiling Access

An 18in x 18in (450mm x 450mm) minimum access panel must be installed in the ceiling within 18in (450mm) of the Mounting (Interface) Plate to allow connection of electrical and data cables during final installation. An 21-22in diameter (533mm-558mm) hole, concentric with the Mounting (Interface) Plate center is required for the light assembly installation. A 24in (600mm) diameter ceiling cover (Stryker-supplied) will conceal the hole after the suspension has been completely installed.

Electrical Installation WARNING Energized electrical circuits can cause severe injury or death. Ensure that all personnel working around energized circuits have been trained in and follow proper lock out/tag out and other applicable safety procedures. Note

Electrical installation and components must conform to all applicable regulations.

Note

All contractor-provided components must be UL-approved or UL-recognized.

Note

Maximum cable lengths specified in Conduit Schedules (Figures 10, 11 and 12) indicate the maximum length of cables routed through conduits. Ensure that the cable distance between the components (e.g., suspension and power supply box) does not exceed the specified lengths.

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S 8.2.1

Power Supply Box Mounted in Documentation Station

1. Install a vertically-mounted, three-gang junction box (e.g., RACO 942) for each wall control panel. Note

One and two-light configurations require one junction box; three and four-light configurations require two junction boxes.

Note

It is not necessary to install the wall control panel inside the documentation station. Consult the hospital to determine ideal placement near or in the documentation station for the wall control panel.

2. Install an 18in x 18in (45cm x 45cm) back box behind the documentation station where the power supply box will be located. 3. (Visum LED only) Verify that an Ethernet drop is available within 72in (1.8m) of the power supply box. 4. Verify that a grounded, uninterruptible and isolated power outlet 115/230V (Halogen) and 100230V (LED) is available within 48in (1.2m) of each power supply box. 5. Install conduits as specified in Figure 10. 6. Provide pull-strings and terminate all conduits with bushings. Note

All components must be located so that conduits do not exceed the maximum lengths specified in Figure 10.

Note

Suspensions with flat panel monitors require additional electrical components (see Suspensions with Flat Panel Arms).

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Figure 8.2 - Electrical Installation with Power Supply Box & Documentation Station

S

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