Visum XBlade LED Exam Light. Operations Manual

Visum XBlade LED Exam Light Operations Manual

Contents S 1. Indications for Use...5 1.1 Device Description...5 1.2 Intended User Profile...5 2. Warnings and Cautions...6 2.1 Warnings...6 2.2 Cautions...7 2.3 Notes...7 2.4 EMC Precautions...7 3. Product Symbol Definition...8 4. Ceiling Mount Components...9 5. Floor Stand Components...10 6. Exam Light Floor Stand Assembly...11 6.1 Unpacking the Equipment... 11 6.2 Attaching the Casters... 11 6.3 Mounting the Stand... 12 6.4 Mounting the Light Head... 12 7. Operations...14 7.1 Moving the Light... 14 7.2 Instructions for Optimal Use... 14 7.3 Adjusting the Light Head... 14 7.4 Powering the Light On and Off... 15 7.5 Positioning the Light Head/Suspension... 15 7.6 Locking the Exam Light in Place... 16 7.7 Removing and Reattaching the Sterilizable Light Handle Cover... 16 8. Cleaning and Disinfecting the System...18 8.1 Cleaning the Handle... 18 8.2 Sterilizing the Handle... 18 9. LED Exam Light System Maintenance...19 9.1 Replacing the Transformer for Floor Stand LED Exam Light System... 19 9.2 Replacing the Electrical Kit For a Floor Stand Exam Light Head... 22 9.3 Replacing Fuses For a Ceiling-Mount Exam Light Head... 24 9.4 Removing the Light Head... 25 9.5 Attaching the Light Head to the Spring Arm... 25 9.6 Lubricating the Keeper Clip... 26 9.7 Adjusting the Spring Force... 26 9.8 Retrofitting the LED Exam Light Head on a Visum 300 System... 27 10. Maintenance...28 11. Troubleshooting...29 11.1 Light Does Not Function... 29 12. Technical Specifications...29 3

12.1 Environmental Specifications... 29 12.2 Electrical Specifications... 29 12.3 Lighting Data... 29 12.4 Physical Data... 30 13. EMC Information...30 14. Spare Parts...34 15. Product Disposal...36 16. Damage Claims...36 17. Stryker Limited Warranty...36 18. Contact Information...37 4

1. Indications for Use S The Visum XBlade LED Examination Light is a device intended for medical purposes that is used to illuminate body surfaces and cavities during a medical examination. The LED Examination Light is indicated to provide illumination for the general patient population during all medical examinations in healthcare facilities where the need for illumination exists. The LED Examination Light is not intended to be used as surgical luminaires. 1.1 Device Description The Visum XBlade LED Examination Light utilizes Light Emitting Diode technology to provide illumination for non-surgical medical examinations. The light may be used in all health care facilities where the need for illumination exists. The Visum XBlade LED Examination Light is available in two configurations, a height configurable ceiling mounted or a portable roll stand option. Both options have the power control on the cardanic suspension and a sterilizable handle that is used to position the light during examinations. 1.2 Intended User Profile The primary users are hospital staff including doctors and nurses. Cleaning personnel also engage the equipment when performing routine cleaning. The Visum Xblade LED Exam Light system is not intended to interact or contact any part of the patient s body or tissue. 5

2. 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 lightening bolt 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. 2.1 Warnings 1. Read this manual thoroughly, and be familiar with its contents prior to using this equipment. 2. The primary users are hospital staff including doctors and nurses. Cleaning personnel also engage the equipment when performing routine cleaning. 3. Test this equipment prior to any procedures. This product was fully tested at the factory before shipment. 4. Avoid removing covers on the product to avoid electric shock. 5. Do not remove or disable components. It may cause electric shock. 6. Attempt no internal repairs or adjustments, unless specifically instructed to do so in this operating manual. 7. Read the entire instruction guide before assembling or connecting the unit. 8. Disconnect the unit from the electric outlet before inspecting or servicing system components. 9. Do not look directly into the exam light while powered on. 10. Do not place anything over the hood(s) of the exam light head. 11. Do not operate the exam light if any component of the light (such as the glass) is damaged. 12. The distance between the light emission surface area of the operating light and the patient surface should not be less than 24 (610mm) in order to ensure proper illumination. The distance prevents burns to the patient and wound drying. 13. The equipment is not suitable for operation in areas where there is a danger of explosion. 14. Oxygen forms explosive mixtures with oils, greases, and lubricants. The presence of oxygen presents an explosion hazard. 15. The equipment is not suitable for usage in combustible mixtures of anesthetic agents with air or oxygen or nitrous oxide gas. 16. To avoid the risk of electrical shock, the equipment must only be connected to a supply mains with protective earth. 17. The wall outlet to which the power supply cord is connected must always be accessible for disconnection. 6

2.2 Cautions 1. Do not add additional weight to the exam lights. 2. Do not place anything over the exam lights. 3. Follow the care and cleaning instructions in this manual. 4. 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. Collisions against other equipment or physical structures can damage the equipment and cause components to fall. 7. Do not obstruct the electrical outlet for the Floor Stand Exam Light System. 2.3 Notes 1. The warranty on this product is void if any of these warnings and cautions are disregarded. 2. Stryker accepts full responsibility for the effects on safety, reliability, and performance of the equipment only if readjustments, modifications, and/or repairs are carried out by persons authorized by Stryker. 3. The equipment is suitable for continuous operation. 4. The procedure for retrofitting an LED light head onto an existing Visum 300 light system is included in this manual. 5. The Essential Performance of the Visum XBlade LED Exam Light is the delivery of illumination and the limitation of energy to the operating field. 2.4 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. 7

3. Product Symbol Definition The following symbols may be found on the Stryker Exam Light: 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. This symbol is intended to refer the user to important safety operating and maintenance (service) instructions in the literature accompanying the product. Denotes temperature limits. Denotes humidity limits. Denotes usage tips and useful information. Denotes compliance to AAMI ES60601-1, CSA C22.2#60601-1, IEC 60601-1-6, IEC 60601-1-2, IEC 62366 & IEC 60601-2-41 Denotes the date the equipment was manufactured. Denotes the manufacturer of the device. Denotes product/part number. Denotes product/serial number. Denotes lot or batch number. Denotes European Representative. Indicates hot surfaces. A lightning bolt indicates the presence of hazardous voltage. Refer all service to authorized personnel. Explosion hazard. Do not to push the light while the brakes are engaged. Always use the handle to move the light and prevent the light from tipping. 8

4. Ceiling Mount Components S 1 2 3 4 5 6 7 8 9 10 11 Figure 1 - Ceiling Mounted LED Exam Light Components 1. Sheet Metal Guard 2. Down Tube Flange 3. Sheet Metal Enclosure 4. Ceiling Cover 5. Down Tube 6. Extension Arm 7. Elbow 8. Spring Arm 9. Power Switch 10. LED Light Head 11. Light Handle Assembly Figure 2 - LED Light Head Figure 3 - Sterilizable Handle 9

5. Floor Stand Components 1 2 9 3 4 5 6 7 Figure 4 - Floor Light Stand Assembly 8 1. LED Light Head 2. Spring Arm 3. Elbow 4. Handle 5. Stand 6. Transformer 7. Caster 8. Base 9. Light Handle Assembly 10

6. Exam Light Floor Stand Assembly S 6.1 Unpacking the Equipment Check to make sure that the following components have been received: Base Stand Light Head Warning When unpacking the Spring Arm, do not cut the cord right away. Assemble the stand to the base first. Hold onto the Spring Arm prior to cutting the cord to prevent sudden release. Failure to do so may cause injury to the user. 6.2 Attaching the Casters Caution Make sure to Install the grounding cable. If it is not installed, the mobile stand may become statically charged. 1. Open the packaging of the base so that the bottom of the stand is upside down on the floor or a bench. Make sure the grounding cable is installed as shown in the figure. There are two grounding cables per base. 2. Guide the caster through the ring cable lug of the grounding cable and into the base. Press in firmly until the caster is snug. Repeat for the other grounding cable and caster assembly. 3. Completely insert the two other casters into the base. 4. Check for firm seating of the casters by turning base over and pressing down firmly on each corner. 11

6.3 Mounting the Stand Warning When unpacking the Spring Arm, do not cut the tape right away. Assemble the stand to the base first. Hold onto the Spring Arm prior to cutting the tape to prevent sudden release. Failure to do so may cause injury to the user. 1. Note where the locking key feature is located inside the base. 2. Remove the stand and position the key hole on the stand so that it aligns with the keyhole of the base and insert until the stand is fully seated. 3. Insert the wing screw from the accessory bag through the bottom and turn by hand until the screw is fully threaded and is finger tight. Use a set of pliers to turn the wing screw one full rotation. Make sure that the spring washer is fully seated. 6.4 Mounting the Light Head 1. Remove the brake screw at the end of the Spring Arm (Item 2) and set aside for later use. 2. Remove the white plastic cap from the Spring Arm (Item 1). 3. Rotate the brake cover (Item 3)180 in either direction so that the keeper slot is exposed. 3 1 2 12

4. Align the end of light head with the end of the Spring Arm and push together until fully seated. 5. Place the keeper clip from the accessory bag into the fitted slot and push down until the clip is flush with the arm. 6. Rotate the brake cover 180 (in any direction) until the brake opening is face down. 7. Insert the brake screw into the brake opening and tighten with a flathead screwdriver. 8. Check to make sure assembly of light head is secure. 13

7. Operations Warning Avoid contact with damaged electrical parts to prevent electric shock. In case of damage to the plug or cord, do not connect the equipment and immediately inform the service department. 7.1 Moving the Light 1. Before moving the light, place the light head down in the lowest position. 2. Make sure the casters are not locked. 3. Move the light using the handle on the stand. Caution Only use the handle when moving the stand to prevent it from tipping over. 7.2 Instructions for Optimal Use For optimal performance, position light 29 (737mm) away from the target. 29 (737mm) 7.3 Adjusting the Light Head The light can be adjusted in the following manner with a sterilizable handle: 360 Rotation 180 Rotation 14

90 60 Rotation 90 Rotation Figure 5 - Light Head Degrees of Rotation 7.4 Powering the Light On and Off The switch to power the light on and off is located at the end of the light head. For the LED Light Head, the On setting is indicated on the switch with a I, the Max setting is indicated with a II, and the Off setting is indicated with a 0. Figure 6 - Light On/Off Switch 7.5 Positioning the Light Head/Suspension Warning The light head should be positioned at least 24 from the patient, in order to prevent burns and wound drying. The light can be positioned in various ways using the light head handle. A sterile user should not touch any part of the light system except the sterilized handle. The head itself may be rotated 360 and tilted 180. The spring arm and horizontal arm can be moved separately. The spring arm has 90 of vertical movement and 360 of horizontal movement. The extension arm also has 360 of horizontal movement. You can adjust the positioning of the light as shown in Figure 7. 15

90 180 360 360 360 Figure 7 - Positioning the Light Head/Suspension 7.6 Locking the Exam Light in Place To lock the exam light in place and prevent it from rolling, press down the brake tab at the end of each caster. 7.7 Removing and Reattaching the Sterilizable Light Handle Cover Caution Only use a Stryker-provided sterilizable handle. Perform the following steps to remove and reattach the sterilizable light handle cover. Refer to the next figure as needed. 1. To remove the detachable sterilizable handle cover, press the round metal button at the base of the handle, and pull the cover off of the handle. 2. To reattach the cover, align the hole on the cover and the button on the handle, then slide the cover into place. 3. Twist the handle cover, until you hear a click, indicating that the handle cover is locked in place. 16

1. Button 2. Handle 1 2 17

8. Cleaning and Disinfecting the System Cautions The button is not sterilizable. Power off system before cleaning. Make sure that no cleaning fluid enters the system. To avoid damage to plastic parts, do not use any scouring, alkaline, acidic, or alcohol-based cleaning agents. Allow the light to cool before disinfecting. Handles are shipped non-sterile. Clean and sterilize handles prior to use. Note: Cleaning and disinfecting must be carried out by trained personnel. Wipe the surfaces with a cloth and, if required, a mild cleaning solution to clean the system. 8.1 Cleaning the Handle 1. Rinse the handle under running lukewarm water, flushing water through all passages. 2. Submerge the entire handle in an enzyme-action detergent prepared according to the manufacturer s recommendations. Remove debris and bioburden from all surfaces using a soft brush. 3. Rinse the handle thoroughly under running lukewarm water, flushing water through all passages. 4. Dry the handle with a lint-free cloth and inspect the handle to make sure it is free of debris. 8.2 Sterilizing the Handle The sterilization methods in the following table have been validated: Sterilization Method Temperature Exposure Time Gravity-displacement steam sterilization (single-wrapped) 132 C (270 F) 10 minutes Gravity-displacement steam sterilization (double-wrapped) 121 C (250 F) 25 minutes Pre-vacuum cycle (double-wrapped) 134 C (273 F) 2 minutes Note: The handle can withstand the recommended sterilization method for the life of the product. Replace the handle if any deformation or deterioration is observed. These cleaning and sterilization instructions are only recommended instructions and may vary among hospitals depending upon the type of cleaning/sterilization equipment and possible pathogens in the particular area. These instructions represent exposure time and not total cycle time. The recommended cleaning/sterilization parameters may be modified based on standard hospital cleaning/sterilization protocol. The hospital organization must follow the national requirements for hygiene and disinfection. 18

9. LED Exam Light System Maintenance S 9.1 Replacing the Transformer for Floor Stand LED Exam Light System Warning To prevent electrical shock, power off the light and disconnect power from the unit by switching off the main switch or removing the power cord from the outlet before changing the transformer. 1. Power off the light and disconnect it from the power outlet. Remove the brake screw at the end of the Spring Arm and set aside for later use. 2. Rotate the brake cover 180 and remove the keeper clip. 3. Remove the light head. 4. Remove the wing screw from the bottom of the stand. 5. Pull the stand from the base. 6. Place the stand on a piece of cardboard or cloth to prevent surface damage. 7. Remove one small screw from the transformer clamp ring. 19

8. Detach the clamp ring. 9. Remove the two small screws from the collars as shown in the figure. 10. Detach the collars. 11. Remove the two side screws on the transformer cover. Once removed, push the cover up toward the Spring Arm to expose the transformer. 12. Unscrew the grounding cable from the stand. 13. Loosen the three screws on the top plate of the transformer with an Allen wrench. Make sure the screws are not exposed on either end. There should be enough space in the top plate for the screw to remain inside the plate. 20

14. Disconnect the wires from the connector. (Refer to Figure 8 for wiring.) Brown (Line) 115 VAC Primary Blue (Neutral) Red Black Orange White 14 VAC Secondary Violet Red Figure 8 - Wiring Diagram 15. Carefully slide the top plate and the top rubber grommet up around the wires. 16. Slide the transformer and the bottom rubber grommet up afterwards. 17. Using a Phillips screwdriver, remove the screw that holds the bottom plates together. 21

18. Pull apart the bottom plates from the stand. 19. Slide the transformer and the bottom grommet off of the stand. 20. If installing a new transformer cover, slide off the top plate, top grommet, and existing cover. 21. Slide new cover on, followed by the top plate and the top grommet. 22. If installing a new transformer, slide on the new transformer. 23. Place bottom grommet on, re-attach bottom plates. 24. Perform steps 1-20 in reverse order to re-assemble. 9.2 Replacing the Electrical Kit For a Floor Stand Exam Light Head Warning To prevent electrical shock, disconnect power by switching off the main power switch or removing the power cord from the outlet. 1. Power off the light and disconnect it from the power outlet. 2. Use a torx screwdriver to remove the two screws from the handle as shown. 3. Pull handle apart. 4. Remove the screws to release the cord. 22

5. Loosen the three screws from the fuse holder to release the cord entirely from the handle. 6. The electrical kit comes with an extra connector and fuse holder. If replacing the handle and/or fuse holder, remove the screw securing the fuse holder. 7. Loosen the screws holding the wires to the fuse holder if replacing with a new fuse holder. 8. Insert the brown wire through the fuse holder and the blue neutral wire through the other connection. Insert the green/ yellow ground wire through the connector. 9. Attach the fuse holder to the stand. Insert two 1-amp fuses into the fuse holder as shown. 10. Secure power cord with the strain relief and two screws. 23

11. Place new handle on and make sure the two extrusions fit into the two openings of the stand. Route the cord down the handle assembly. 12. Snap the handle back into place and screw the two halves together. Caution Only use the Stryker-provided power cord. 9.3 Replacing Fuses For a Ceiling-Mount Exam Light Head Warning Power off the light and disconnect power from the unit by switching off the main unit or tripping down the circuit breaker before changing the fuses. 1. Remove the ceiling cover by unscrewing the three set screws and then sliding the cover down the down tube, as shown in the picture to the right. 2. Remove the sheet metal enclosure by unscrewing the three captive screws and then sliding it down the tube. Note: It may be necessary to remove the extension arm for short down tubes in order to access to the flange. 3. Grasp the black plastic fuse holders (indicated in the picture to the right) with two fingers and pull firmly to remove. 4. Check the fuses and replace them if necessary. For 115V models, use a 1 amp fuse 5. Slide the fuse holders (see the sample to the right) back into place. Note: The fuse holders can only be inserted in one direction. If you are having difficulty inserting the fuse holders back into place, make sure that they are facing the correct direction. 24

9.4 Removing the Light Head Warning Make sure that the light is powered off and is disconnected from the suspension by switching off the main unit or tripping down the circuit breaker before performing this procedure. The spring arm is under high spring tension. If the arm is not in its highest position, when this operation is performed, it may jump suddenly, causing injury. Perform the following steps to remove the light head. 1. Push the spring arm into its highest position. 2. Turn the brake screw so that the brake cover can be rotated. 3. Rotate the brake cover 180 until the keeper clip appears in the slot. 4. Hold the light head firmly and remove the keeper clip with a narrow slotted screwdriver. 5. Remove the light head and take precautions to adequately protect the commutator from damage. Note: After the light head has been removed attach the replacement light head to the spring arm as outlined in the section, Attaching the Light Head to the Spring Arm in this manual. 9.5 Attaching the Light Head to the Spring Arm Perform the following steps to attach the light head to the spring arm. Refer to Figure 9 as needed. 1. Make sure the power to the suspension is disconnected by turning off the main switch or tripping down the circuit breaker. 2. Pull the spring arm down until it reaches the stop. Warning The spring arm is under high spring tension. Since the arm is not in its highest position when this procedure is performed, the arm may jump suddenly, causing injury. Caution Do not attempt to push the spring arm beyond its stop(s). Doing so will cause damage to the spring arm. 3. Remove and discard the protective cap on the spring arm. 4. Install the brake cover over the spring arm so that the keeper clip slots in the spring arm and brake cover are aligned. 5. Push the end of the light head into the spring arm, and install the keeper clip. 6. Rotate the brake cover 180 until it is lined up with the hole, and install the brake screw. 25

1 2 3 5 4 Figure 9 - Attaching the Light Head 1. Keeper Clip 2. Brake Screw 3. End of Light Head 4. Brake Cover 5. Slot 9.6 Lubricating the Keeper Clip Perform the following steps to lubricate the keeper clip. 1. Remove the light head according to the section, Removing the Light Head. 2. Check the thickness of the keeper clip. 3. If the keeper clip is less than 1.5 mm thick, replace it. 4. Grease both the keeper clip and the pin of the light head. 5. Reattach the light head according to the Section, Attaching the Light Head to the Spring Arm. 9.7 Adjusting the Spring Force Caution For a floor stand exam Light Head, lock all casters before adjusting the Spring Arm tension. Springs are subject to natural wear and may need to be adjusted over time (i.e., whenever the light assembly drifts from the desired position). It may be necessary to adjust the Spring Arm tension to prevent the light head assembly from drifting after being placed in the desired position. Perform the following steps to adjust the spring arm force: 26

1. Remove the elbow cap as shown to the right. 2. For a ceiling-mounted light head, pull the light head down 20 to expose the spring adjustment hole and screw in the elbow. 3. Insert a flathead screwdriver into the spring adjustment hole (indicated in the picture to the right), then let go of the spring arm. 4. If the arm drops, turn the adjusting screw counter-clockwise to increase the spring force. 5. If the arm rises, turn the adjusting screw clockwise to decrease the spring force. 9.8 Retrofitting the LED Exam Light Head on a Visum 300 System Refer to the sections on Removing the Light Head and Attaching the Light Head to the Spring Arm to replace a Visum 300 halogen light head with a new LED Exam light head. 27

10. Maintenance Warning For all test and maintenance work performed on an LED Exam light system, power off the equipment, disconnect power cord, and secure it from being switched on. Warning If this equipment is modified, appropriate inspection and testing must be conducted to ensure continued safe use of the equipment. For a ceiling-mounted exam light system, tests and maintenance must be performed by trained technicians. The LED exam light must be inspected twice a year. Use the following table as a guide for inspection: Every 6 months Visually inspect paint for damage Cracks on plastic parts Deformation of the system Check for cord damage Check for fog/mist deposition on faceglass inside the light head Check for system drift Hospital Personnel Responsibility Every Year Check the support system Check the keeper clip and grease it if necessary Perform a function test Perform an electrical safety test (based on hospital discretion; a Bio-med Engineer must perform this test) Check the wing screw on the lower side of the base and tighten it if necessary Caution Use only Stryker-provided parts. Note: Service schedules, circuit diagrams, spare parts lists, descriptions, adjustment instructions, and other documents can be made available if desired. In case of any faults or damage, or for service, contact Stryker Communications. Maintenance performed by Stryker every other year* Grease the Keeper Clip by doing the following: 1. Dismantle the light head. 2. Check the keeper clip for a minimum thickness of 1.5 mm and replace it if necessary. 3. Grease the keeper clip and the pin of the light head. 4. Re-assemble the light head. 5. Visually inspect the sterilizable handle for signs of deterioration or damage. 28

* Please contact Stryker Technical Support or your Stryker Representative to schedule your preventative maintenance service. In case of any faults or damage, or for service, contact Stryker Communications. 11. Troubleshooting 11.1 Light Does Not Function Possible Cause Solution Power switched off Make sure the power switch is in the or position Loose connections Check all terminal connections in the light fixture Note If any of these issues cannot be resolved, please contact Technical Support or your Stryker representative. 12. Technical Specifications 12.1 Environmental Specifications Operating Humidity: 30%-75% Storage and Transport Humidity 10% 95% Operating Temperature 14 104 F (10 40 C) Storage and Transport Temperature -13 140 F (-25 60 C) Operating and Storage Pressure 50kPa - 106 kpa 12.2 Electrical Specifications Rated Input Voltage Nominal Frequency Max Power Delivered by the 115 V Version Output Current at 14 V (at LED light head) 115 V 60 Hz 50 W 2.5 A 12.3 Lighting Data Central Illumination at 1m from light 55000 Lux Color Rendering Index (Ra) 90 Specific Color Rendering Index (R9) 88 ± 12 Color Temperature 4500K±500K 29

Light Field Diameter (d10) Expected Life of Light Source Total Irradiance Total UV Irradiation 140mm (5.5 in) 20,000 Hours <1000 W/m2 <=10 W/m 2 for wavelength below 400 nm 12.4 Physical Data Light Head Weight Spring Arm Max Load Suspension Arm Lengths Available Drop Tube Lengths 6.6 lbs / 3 kg 6.6 lbs / 3 kg Extension Arm: 800 mm Spring Arm: 720 mm 220 mm 268 mm 375 mm 450 mm 530 mm 680 mm 800 mm 13. EMC Information Guidance and Manufacturer's Declaration - Electromagnetic Emissions The Visum XBlade LED Exam Light is intended for use in the electromagnetic environment specified below. The customer or the user of the Visum XBlade LED Exam Light should assure that it is used in such an environment. Emissions test Compliance Electromagnetic Environment - Guidance RF emissions CISPR 11 RF emissions CISPR 11 Harmonic emissions IEC 61000-3-2 Group 1 Class A Class A The Visum XBlade LED Exam Light uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment. The Visum XBlade LED Exam Light is suitable for use in all establishments other than domestic, and may be used in domestic establishments and those directly connected to the public lowvoltage power supply network that supplies buildings used for domestic purposes, provided the following warning is heeded: Voltage fluctuations/ flicker emissions IEC 61000-3-3 Complies Warning This equipment/system is intended for use by healthcare professionals only. This equipment/ system may cause radio interference or may disrupt the operation of nearby equipment. It may be necessary to take mitigation measures, such as re-orienting or relocating the Visum XBlade LED Exam Light or shielding the location. 30

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Visum XBlade LED Exam Light is intended for use in the electromagnetic environment specified below. The customer or the user of the Visum XBlade LED Exam Light should assure that it is used in such an environment. Immunity Test Electrostatic discharge (ESD) IEC 61000-4-2 IEC 60601 Test Level Compliance Level ± 6 kv contact ± 8 kv air ± 6 kv contact ± 8 kv air Electromagnetic Environment - Guidance Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%. Electrical fast transient/burst IEC 61000-4-4 ± 2 kv for power supply lines ± 1 kv for input/ output lines ± 2 kv for power supply lines ± 1 kv for input/ output lines Mains power quality should be that of a typical commercial or hospital environment. Surge IEC 61000-4-5 ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth ± 1 kv line(s) to line(s) ± 2 kv line(s) to earth Mains power quality should be that of a typical commercial or hospital environment. Voltage dips, short interruptions and voltage variations on power supply input lines IEC 61000-4-11 <5 % U T (>95 % dip in U T ) for 0,5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (>95 % dip in U T ) for 5 s <5 % U T (>95 % dip in U T ) for 0,5 cycle 40 % U T (60 % dip in U T ) for 5 cycles 70 % U T (30 % dip in U T ) for 25 cycles <5 % U T (>95 % dip in U T ) for 5 s Mains power quality should be that of a typical commercial or hospital environment. If the user of the Visum XBlade LED Exam Light requires continued operation during power mains interruptions, it is recommended that the Visum XBlade LED Exam Light be powered from an uniterruptible power supply or battery. Power frequency (50/60 Hz) magnetic field IEC 61000-4-8 3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment. Note U T is the a.c. mains voltage prior to application of the test level. 31

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Visum XBlade LED Exam Light is intended for use in the electromagnetic environment specified below. The customer or the user of the Visum XBlade LED Exam Light should assure that it is used in such an environment. Immunity Test Conducted RF IEC 61000-4-6 Radiated RF IEC 61000-4-3 IEC 60601 Test Level 3 Vrms 150 khz to 80 MHz 3 V/m 80 MHz to 2,5 GHz Compliance Level 3 Vrms 3 V/m Electromagnetic Environment - Guidance Portable and mobile RF communications equipment should be used no closer to any part of the Visum XBlade LED Exam Light, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance d = 1,2 P d = 1,2 P 80 MHz to 800 MHz d = 2,3 P 800 MHz to 2,5 GHz where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer and d is the recommended separation distance in metres (m). Field strengths from fixed RF transmitters, as determined by an electromagnetic site survey, a should be less than the compliance level in each frequency range. b Interference may occur in the vicinity of equipment marked with the following symbol: a Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field strength in the location in which the Visum XBlade LED Exam Light is used exceeds the applicable RF compliance level above, the Visum XBlade LED Exam Light should be observed to verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the Visum XBlade LED Exam Light. b Over the frequency range 150 khz to 80 MHz, field strengths should be less than 3 V/m. 32

Note At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. Recommended separation distances between portable and mobile RF communications equipment and the Visum XBlade LED Exam Light The Visum XBlade LED Exam Light is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of the Visum XBlade LED Exam Light can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Visum XBlade LED Exam Light as recommended below, according to the maximum output power of the communications equipment. Rated Maximum Output Power of Transmitter Separation Distance According to Frequency of Transmitter 150 khz to 80 MHz m 80 MHz to 800 MHz W d = 1,2 P d = 1,2 P 0,01 0,12 0,12 0,23 0,1 0,38 0,38 0,73 1 1,2 1,2 2,3 10 3,8 3,8 7,3 100 12 12 23 800 MHz to 2,5 GHz d = 2,3 P For transmitters rated at a maximum output power not listed above, the recommended separation distance (d) in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. Note At 80 MHz and 800 MHz, the higher frequency range applies. These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, objects and people. 33

14. Spare Parts P/N Description View 0682000622 Handle VISUM 300 Sterile 0682000660 FUSE HOLDER, VISUM 300 0682000655 FUSE, DOMESTIC, VISUM 300 0682001483 FUSE HOLDER, VISUM 300 CM 0682000627 STAND HANDLE, VISUM 300 P25990 STAND, LED EXAM LIGHT 0682000626 Base, Visum 300 34

P/N Description View 0682000630 LOCKING CASTERS, VISUM 300 0682000631 MEDICAL GRADE CORD, VISUM 300 0682000636 HARDWARE KIT PACKAGE,VISUM 300 35

15. Product Disposal The device must be disposed of according to local laws and hospital practices. The device does not contain any hazardous materials. 16. Damage Claims Shipping is FOB Origin. Title transfers to customer upon shipment. Stryker assumes responsibility for loss or damage during shipping. Please contact Technical Support (866) 841-5663 or your Stryker representative if your shipment is lost or damaged. If you need to return any item, contact Customer Service for an RMA number. After receiving an RMA number, package the item as described by Customer Service. Ship the item to the following address: Stryker Communications (RMA# ) 571 Silveron Blvd. Flower Mound, TX 75028 Toll Free: (877) 789-8106 17. Stryker Limited Warranty This warranty applies to customers in the United States only. Outside of the USA, contact your Stryker sales representative or your local Stryker subsidiary. Stryker warrants that its products shall be free of defects of material and workmanship for a period of two years after date of shipment. Stryker will provide all parts and service required to restore equipment under warranty to good working condition, which may include shipment of replacement parts and phone service consultation to conduct minor repairs. Any modifications to this warranty policy are not valid unless made with explicit written approval of Stryker. This warranty covers all Stryker products with the exception of bulbs, sterilizable handles, filters and any other disposable parts. This warranty does not cover any cosmetic or superficial damage to product. Any modification to product by Customer without the approval of Stryker will immediately void this warranty in its entirety. This warranty covers only Stryker products and only such products that were installed or, if necessary, reinstalled by Stryker personnel. This warranty is valid only to the original purchaser of Stryker products directly from a Stryker authorized agent. The warranty cannot be transferred or assigned by the original purchaser. 36

18. Contact Information S Contact Stryker Customer Service with questions or concerns. Stryker Communications 571 Silveron Blvd. Flower, Mound, TX 75028 Toll Free: 1-866-841-5663 1-972-410-7100 For international service locations, refer to the Stryker website at the following URL: www.stryker.com. 37

tryker Communications 571 Silveron Blvd. Flower Mound, TX 75028 1-866-841-5663 www.stryker.com Stryker Corporation or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: the Stryker logo. All other trademarks are trademarks of their respective owners or holders. 2014/03 *P25919D* *P25919D*