Visum LED 2 and StrykeCam 2 Camera Operations and Maintenance Manual Rev W Jan 2016

Visum® LED 2 Surgical Light & StrykeCam® 2/HD In-Light Camera Operations and Maintenance Manual

This manual contains confidential information that shall not be disclosed or duplicated for any reason other than to use and maintain a Stryker Visum® LED 2 or StrykeCam® 2/HD in-light camera. 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. © 2016/01 Stryker Communications. All rights reserved. Information in this document is subject to change without notice. Stryker, Stryker logo, Visum® and StrykeCam® are registered trademarks of Stryker All rights reserved. Stryker Visum® LED 2 Surgical Lights & StrykeCam® 2/HD In-Light Camera, Operations and Maintenance Manual 1004-400-185 REV W

S Contents 1. Warnings and Cautions... 8 1.1

Warnings... 8

1.2

Cautions... 9

1.3

Notes... 9

1.4

EMC Precautions... 9

1.4.1 1.4.2

Required Equipment...10 Hazards and Precautions...10

2. Product Symbol Definition... 11 3. Intended and Indications for Use... 14 4. Product Description and Use... 15 4.1

Visum® LED 2 Surgical Light and StrykeCam® 2/HD In-Light Camera... 15

4.2

An Integrated Surgical Light For Your iSuite® Operating Room... 15

4.3

An Integrated Surgical Camera For Your iSuite® Operating Room... 16

5. Visum LED 2 Surgical Lights and Accessories... 17 5.1

Positioning the Lights... 17

5.2

Adjusting the Field Diameter... 17

5.2.1 5.2.2 5.2.3 5.2.4

Adjusting the Horizontal Arm Brakes...18 Adjusting the Friction Brakes...18 Adjusting the Spring Arm Brakes (Low Ceiling Option Only)...20 Adjusting Spring Arm Tension...21

5.3

Adjusting the Cardanic Suspension... 21

5.4

In-Light Camera (Camera-Ready Lights Only)... 22

5.4.1 5.5

Swapping Weighted Handle for the In-Light Camera...22

Sterilizable Light and Camera Handle Covers... 23

5.5.1 5.5.2 5.5.3 5.5.4 5.5.5

Attaching the Sterilizable Light Handle Cover...23 Removing the Sterilizable Light Handle Cover...23 Attaching the Sterilizable Camera Handle to the SD Camera ...23 Attaching the Sterilizable Camera Handle to the HD Camera...23 Removing the Sterilizable Camera Handle...23

6. Wall Control Panel... 24 6.1

Wall Control Panel... 24

5

S 6.2

StrykeCam 2/HD In-Light Camera Controls... 25

6.2.1 6.2.2 6.2.3 6.3

White Balance Button...25 Focus/Auto...26 Iris/Auto...26

The Visum LED 2 Surgical Light Controls... 26

7. Power Supply Box Setup and Connections... 27 7.1

Connecting/Disconnecting the Visum LED 2 Surgical Light to the Power Supply Box... 27

7.2

Connecting/Disconnecting the Control Connection to the Power Supply Box... 28

7.3

Wall Connection Port, SORN, SIDNE & Expansion Port ... 29

7.3.1 7.3.2 7.3.3 7.3.4 7.4

Wall Connection Port:...29 SORN...29 SIDNE...29 Optional (Expansion Port)...29

HD Camera Decoder Box Installation... 30

8. Maintenance... 32 8.1

Replacing the Wall Control Panel... 32

8.2

Replacing the Power Supply Box... 32

8.3

Inspection Schedule... 32

8.3.1 8.3.2 8.3.3 8.3.4 8.3.5

Inspecting the M3 Safety Segment Cover Screw...33 Inspecting the Low Ceiling Spring Arm Cuff...34 Adjusting the Movement of the System...34 Light/Flat Panel Suspension - Teacup Installation...34 Replacing Rear End Spring Arm Covers...35

9. Cleaning and Disinfecting... 36 9.1

Lighting System Cleaning Compatibility... 36

9.2

Cleaning Compatibility of the HD Camera System... 38

9.3

Cleaning and Sterilization of the Reusable Handles... 38

10. Troubleshooting... 43 10.1 Light Head... 43 10.2 In-Light Camera... 44 10.3 Wall Control Error Codes... 44

11. Technical Specifications... 45

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S 11.1 Environmental Specifications... 45 11.1.1 11.1.2 11.1.3

Operating Conditions...45 Storage Conditions...45 Shipping Conditions*...45

11.2 Electrical Specifications... 45 11.3 Mechanical Specifications... 45 11.4 Illumination Specifications... 46 11.5 HD Camera Specifications... 46 11.5.1

HD Camera Components...47

11.6 EMC Information... 50 11.7 Latex Policy... 53 11.8 Removability of Batteries... 54

12. Service & Claims... 55 13. Stryker Limited Warranty... 56 14. Contact Information... 57

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S 1. 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 or user.

Caution

Special service procedures or precautions must be followed to avoid damaging the instrument.

Warning

A warning with a lightening bolt warns of hazardous voltage. All service must be performed by authorized personnel.

Note

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

Incorrect operation or negligence of safety measures may cause damage to the equipment, bodily injury, or death.

1.1

Warnings

1. Caution: Federal law restricts these devices to sale by or on the order of a physician. 2. Test this equipment prior to any procedures. This product was fully tested at the factory before shipment. 3. Do not remove or disable components. It may cause electric shock. 4. Attempt no repairs or adjustments, unless specifically instructed to do so in this operating manual. 5. Disconnect the unit from the electric outlet before inspecting or servicing system components. Note that more than one electrical supply may be used. Disconnect all power sources before inspecting. 6. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth. 7. Do not look directly into the surgical light while powered on. 8. Do not operate the surgical light if any component of the light (such as the glass) is damaged. 9. Collision of equipment against other equipment or physical structures can cause components to fall. Pay special attention when maneuvering equipment. 10. Power cable plug is used as the means to isolate the Visum LED II lights and power supply box. Do not position the equipment such that it is difficult to disconnect the power cable from mains. 11. Potential equalization connection located on the back of the power supply box is not for field connection. 12. The equipment or system should not be used adjacent to or stacked with other equipment. If adjacent or stacked use is necessary, the equipment or system should be observed to verify normal operation in the configuration in which it will be used.

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S 1.2

Cautions

Stryker trained personnel are the only personnel authorized to install the equipment described in this manual. 1. 2. 3. 4.

Do not add additional weight to the surgical lights. Do not place anything over the surgical lights. Follow the care and cleaning instructions in this manual. Adjustments, modifications, and/or repairs not described in this manual should be performed only by Stryker personnel. 5. The electrical installation of the operating room must comply with any applicable IEC, CEC, NEC requirements as well as the local codes and pre-installation manual. 6. The Visum® LED 2 Surgical Light & StrykeCam® 2 In-Light Camera must only be used in operating rooms equipped with emergency power back up systems. The emergency power backup system must have the capability to restore power in 50 milliseconds or less. 7. Connection of the Visum® LED 2 Surgical Light & StrykeCam® 2 In-Light Camera to a network with devices outside Stryker control could result in previously unidentified risks to patients, operators, or third parties. 8. The Hospital is responsible for evaluating devices connected to the network and any interactions between devices and Stryker equipment. 9. Changes to the network could introduce new risks. Changes to the network may include: a. Changes to the network configuration b. Connection of additional items to the network. c. Disconnecting items from the network. d. Update of equipment connected to the network. e. Upgrade of equipment connected to the network.

1.3

Notes

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 fixed 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. 2. All electrical services for flat panel power connections must be routed in accordance with all applicable regulations including but not limited to local building and electrical codes. Circuit breakers are not provided in this unit. System circuits must be connected to correctly rated and protected branch circuits. 3. In the event that it becomes necessary to terminate power to the flat panels, refer to hospital’s electrical diagrams to interrupt power at the mains breaker. 4. The Essential Performance of the Visum® LED Surgical Light System is the delivery of illumination and the limitation of energy to the operating field.

1.4

EMC Precautions

This 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 affect this device’s performance and must be

9

S used in accordance with the following information.

1.4.1

Required Equipment

This device must be used with the provided power cord. Additionally shielded video cables are required in order to assure proper function. WARNING Using accessories or cables other than those specified may result in increased emissions or decreased immunity of the system.

1.4.2

Hazards and Precautions Oxygen Explosion! Oxygen forms explosive mixtures with oils, greases, and lubricants. The compressed oxygen presents an explosion hazard. Exposure to overlapping light fields from multiple lamps may cause excessive heat generation.

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S 2. Product Symbol Definition The following symbols may be found on the Stryker Visum® LED 2 Surgical Light and StrykeCam® 2 In-Light Camera: This symbol is intended to refer the user to important safety operating and maintenance (service) instructions in the literature accompanying the product. 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 A lightning bolt indicates the presence of hazardous voltage. Refer all service to authorized personnel. When this symbol appears on a device, it refers the user to the Operations and Maintenance manual for important safety information. When it appears in the manual, it is meant to alert the user to the presence of important safety, operating, and maintenance instructions. Denotes temperature limits. Denotes humidity limits. Denotes relative pressure limits. Denotes product/part number. Denotes product/serial number. Denotes lot or batch number. Denotes European Representative. Denotes the manufacturing date. Denotes the manufacturer of the device. Denotes quantity. For U.S. audience only - Caution: Federal Law (USA) restricts this device to sale by or on the order of a physician.

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S 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. We request that you contact Stryker when you plan to withdraw this device from service. Denotes the device contains more than .002% cadmium.

Denotes the device contains more than .0005% mercury.

Denotes the device contains more than .004% lead.

Surgical Light Suspension Power Supply Drop Tube Cover Handle Battery Module Charger Cable Kit Repair Kit Accessories Camera Instructions for Use Wall Control/Touch Panel

12

S Power/Standby White Balance Focus Iris Zoom Brightness/Intensity Service

13

S 3. Intended and Indications for Use The Stryker Visum® LED 2 Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. The StrykeCam 2 and High-Definition In-Light Surgical Camera Systems are intended to capture images of the operative site during surgical procedures.

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S 4. Product Description and Use 4.1

Visum® LED 2 Surgical Light and StrykeCam® 2/HD In-Light Camera

The Visum LED 2 Surgical Light and StrykeCam 2/HD In-Light Camera may include some or all of the following components: Ceiling Cover: The electrical connections of the Visum LED 2 system are placed under the ceiling cover. The ceiling cover should only be removed by Stryker authorized service personnel. Down Tube: The length of the down tube compensates different room heights. Horizontal Arm: The horizontal arm holds the Spring Arm and can be rotated 330° for flat panel monitors, and 360° for lights. Spring Arm: The Spring Arm can be rotated 330° for flat panel monitors, and 360° for lights. The Spring Arm can be moved vertically 45° up or 50° down. To avoid collisions with the ceiling or with other components, the vertical stop of the Spring Arm may be limited. The stop position was set during the installation by Stryker personnel. Wall Control: The wall control panel controls the StrykeCam 2/HD In-Light Camera and the light intensity of the Visum LED 2 Surgical Lights. Decoder Assembly: The decoder assembly is used only with HD In-Light Camera and transmits video signals from the HD In-Light Camera to the Flat Panel/Monitor. Wall Mount: Wall mount assembly is used only with HD In light camera and mounts to the HI-DEF Camera Decoder assembly. Power Supply box: The power supply box plugs into the wall and provides power for the system components, such as the lights and wall control panel.

4.2

An Integrated Surgical Light For Your iSuite® Operating Room

The Stryker Visum LED 2 Surgical Light is designed to eliminate shadows, provide a large depth of field and reduce unwanted radiant heat. The light’s functions can be controlled through: • •

A wall control panel in the Operating Room. The Stryker SIDNETM device control platform in combination with or independently of the SIDNETM touch panel control devices. Refer to the Operations manual that accompanied the SIDNETM voice activation system. The light heads are fixed to a ceiling mounted suspension, which provides horizontal and vertical articulation. Use the cardanic suspension to position the light heads and camera in any direction. See the section called Positioning the Lights for further information.

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S

Figure 4.1 - Visum LED 2 Surgical Lights and Suspension

4.3

An Integrated Surgical Camera For Your iSuite® Operating Room

An optional StrykeCam 2 or HD In-Light Camera can be installed in the camera-ready Visum LED 2 surgical light with minimal effort. The Stryker camera system captures video of the surgical field, which can be displayed and recorded for documentation or teaching purposes. The camera is located within the light handle assembly in the center of the surgical light head. StrykeCam 2 or HD Camera is attached to the highest positioned light head. The camera is stationary and therefore only moves with the direction of the light handle. The light field diameter of a camera-ready light is fixed and cannot be adjusted. Use of the camera system is described in StrykeCam 2/HD In-Light Camera Controls section of this guide.

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S 5. Visum LED 2 Surgical Lights and Accessories 5.1

Positioning the Lights Caution

Prevent collisions with walls and other equipment when maneuvering the lights.

Before starting a procedure: • •

5.2

Position the surgical lights so that they can be easily maneuvered by the sterilizable handle during the procedure. Keep the light surface between 24-46 inches (61-117cm) away from the operative site for ideal shadow resolution and depth of field. The optimal distance is approximately 39 inches (99cm).

Adjusting the Field Diameter

1. Turn the sterlizable light handle clockwise to make the light field larger. 2. Turn the sterlizable light handle counter-clockwise to make the light field smaller. Warning

Note

Use caution when using multiple overlapping fields during surgical procedures to avoid wound drying. Do not overlap more than two light fields when lights are at maximum illumination setting. Non-sterile personnel may use the handles on the side of the light heads to position the lights. Sterile personnel should only use the sterilizable light handle in the center of the light to move the light heads.

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S Horizontal Arm Spring Arm

Down Tube

Cardanic Suspension

Light head handles In-Light Camera

Sterilizable Handle

Figure 5.1 - Suspension and Lights

5.2.1

Adjusting the Horizontal Arm Brakes

Warning

5.2.2

Disregarding the information regarding the adjustment of the brakes could result in injury to the patient or physician.

Adjusting the Friction Brakes

Friction brakes hold the suspension in place and prevent drifting. If the brakes are too loose, the suspension may drift during use, but if they are too tight, the suspension may be difficult to move. For each arm, there are two brake screws at the central axis and one at the Spring Arm. 1. Adjust the friction brakes by tightening the brake screw(s) until no longer drifting. 2. Drifting is checked by moving the arm into four different positions and verifying that equipment does not move after placed in any position.

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S

Brake Screw

Brake Screw

Brake Screw

Figure 5.2 - Horizontal Arm Brake Screws (SHA only) Brake Screw Brake Screws

Brake Screw

Brake Screws

Figure 5.3 - Horizontal Arm Brake Screws (EHA Only) Warning

Disregarding the information concerning the adjustment of the brakes could result in injury to the patient or physician.

Note

If the brakes require excessive tightening or frequent adjustment, follow the steps outlined in the section called, Replacing Brake Screws.

Replacing Brake Screws 1. Fill the hollow nose of the brass brake pads with Castrol Optipit grease (PN 0682-300-260) and lubricate the faces of the brake pads with a thin layer of the grease (see figure below). 2. Thread the brake screws into position using a 4mm hex wrench. Tighten the brake screws until resistance is initially felt; this indicates the brake screws are engaged.

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S 3. Tighten the brake screws to the following specifications: Screw Location SHA Shoulder Screws 1 revolution (360°) past the 1100 N-cm point of resistance Elbow Screws ¾ of a turn (270°) past the point 600 N-cm of resistance

EHA

4. Rotate the extension arm to multiple positions throughout its range of motion to check for drifting. If drifting is observed, increase the brake force by turning the brake screws clockwise until the suspension no longer drifts. 5. Finally, tighten the brake screw an additional: • Shoulder Screws: 1 revolution (360°) to allow for brake wear • Elbow Screws: ¼ of a turn (90°) to allow for brake wear

5.2.3 •

•

Adjusting the Spring Arm Brakes (Low Ceiling Option Only)

To increase the brake force, turn the brake adjustment screw clockwise at the bottom of the Spring Arm using a flat head screw driver. To decrease the brake force, turn the brake adjustment screw counter-clockwise at the bottom of the Spring Arm using a flat head screw driver.

Brake Adjustment Screw

Figure 5.4 - Brake Adjustment Screw When adjusting the brake screw after installing the light for the first time or any time after performing preventative maintenance, adjust the brake screw and rotate the joint through a minimum of five rotations. If after five rotations the joint becomes difficult to rotate, the brake screw is over tightened and needs to be readjusted.

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S 5.2.4

Adjusting Spring Arm Tension Note

The Horizontal Arm and Spring Arm should always be parallel to the floor while adjusting the tension.

1. Push the light head toward the ceiling and release it to test the Spring Arm tension. 2. If the light head drifts down, insert a 5mm Hex key in the Spring Arm (as shown below) and turn the key counter-clockwise to increase the tension. 3. Pull the light head down to the floor and release it. 4. If the light rises, insert a 5mm Hex key in the Spring Arm (as shown below) and turn the key clockwise to decrease the tension. Insert Hex key here

Figure 5.5 - Adjusting Spring Arm

5.3

Adjusting the Cardanic Suspension

Use a 4mm Hex key to adjust the brake screws on the Cardanic suspension. If the brakes are adjusted properly, the light head will not tilt when released and should be easily positioned with the sterilizable light handle. • •

To increase the brake force, turn the screw clockwise. To decrease the brake force, turn the screw counter-clockwise.

Brake Screws

Figure 5.6 - Cardanic Suspension Brake Screws (Low Ceiling Cardanic only has one brake screw)

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S 5.4

In-Light Camera (Camera-Ready Lights Only) 5.4.1

Swapping Weighted Handle for the In-Light Camera

If the light system is camera ready, the light attached to the upper-most arm segment of the suspension (Light 1) is the camera-ready light. Note

The procedure to interchange the StrykCam2 and the HD Camera is the same.

1. Remove the sterilizable handle from the Weighted Light Handle by pressing in the release button located at the bottom of the handle and pulling down. 2. Support the weighted light handle while completely loosening the three thumb screws. 3. Pull the Weighted Light Handle free from the Light Head. 4. Position the light head so that the face is perpendicular to the floor. 5. Align the connector of the In-Light Camera with that of the light head and insert it into the light head.

Weighted Light Handle

Sterilizable Light Handle Release Button

Figure 5.7 - Sterilizable Light Handle

Thumb Screws

Weighted Light Handle

Figure 5.8 - Weighted Light Handle (only two thumb screws are shown) 6. Press the In-Light Camera firmly into place, and ensure that the base of the Camera Assembly sits flush with the surface of the light. 7. Tighten the three thumb screws completely. Warning

Failure to ensure that the base of the In-Light Camera sits flush with the surface of the light and completely tightening the thumb screws could result in the camera falling.

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Thumb Screws

In-Light Camera

Figure 5.9 - In-Light Camera (only two thumb screws are shown)