Visum Exam Light Model LL305 Operations and Maintenance Manual Rev D April 2006

Table of Contents Introduction Intended Use... 2 Operating Mode... 2 Warning / Caution / Note Definition... 2 Safety Tips and Guidelines... 3 Symbols... 4 Specifications... 5 Electrical Schematic... 6 Light Assembly, Overview... 7 Mounting the Casters... 8 Mounting the Stand... 9 Mounting the Light Head... 10 Attaching the Light Handle Assembly... 11 Operations Adjusting the Light Head... 12 Moving the Light... 13 Preventative Maintenance Preventative Maintenance Checklist... 14 Cleaning and Disinfection... 15 Troubleshooting... 16−17 Service Information Setting the Spring Force... 18 Attaching/Removing the Sterilizable Light Handle Cover... 18 Changing the Halogen Light Bulb... 19−20 Replacing the Aesthetics Kit... 20−22 Replacing the Electrical Kit... 22−24 Replacing the Transformer... 25−27 Greasing the Keeper Clip... 27 Replacement Parts... 28−32 Warranty... 33

Introduction Introduction Whether in the doctor’s office, examination rooms, emergency facilities, intensive care clinics, pre− or post−operative rooms, the Stryker LL305 Visum Examination Light provides high intensity light wherever it’s needed. Outstanding features of this light include the unique shape of the lamp housing, the combination faceted and parabolic technology of its reflector, and its smooth operating and spring−loaded articulating arm. Highlights of the Examination Lamp: S

Smooth operation and adjustability

S S S

Precise positioning Compact and enclosed articulation system with counterbalance system. A specially designed reflector system to ensure a precise light source that renders true colors.

Intended use: Examination light for use in the patient’s surroundings, to illuminate the body of the patient locally to support diagnosis or treatment. It has not been designed as a surgery light or for use by the patient.

Operating Mode: This light is designed for continuous service.

Warning / Caution / Note Definition 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 These instructions point out special procedures or precautions that must be followed to avoid damaging the equipment.

NOTE This provides special information to make maintenance easier or important instructions clearer.

2

Safety Tips and Guidelines

WARNING Maintenance must be performed by qualified service personnel. Always verify the power cord is unplugged from the wall outlet before performing service. The Stryker LL305 Visum Examination Light is equipped with a hospital grade plug for protection against shock hazard. It must be plugged directly into a properly grounded three−prong receptacle. Grounding reliability can be achieved only when a hospital grade receptacle is used. For use only in dry rooms not subject to risk of explosion. Maintain a distance of at least 24 inches between the patient and the light head. Maintain a distance of at least 24 inches from flammable objects when operating the light. Do not leave the light unattended while in operation. The light is hot while in operation. Do not touch the protective glass, reflector, or bulb while the light is turned on or immediately after turning it off. Allow the light to cool before attempting maintenance. Do not operate the light if any components are damaged. When replacing the halogen light bulb, use only the bulb specified in this manual. Use only manufacturer approved replacement parts. Do not add additional weight on the Exam Light. Do not place items on or over the hood of the Exam Light. Do not look driectly into the Exam Light while powered on.

CAUTION Potential electromagnetic interference can cause steady, momentary, or intermittend disruption of medical devices. Prevent known sources of interference (i.e cell phones) from coming too close to patient monitors and other medical devices.

3

Symbols and Definitions

Warning, Refer to Operations / Maintenance Manual

Risk of burns.

Hazardous Voltage.

Explosion Hazard. Oxygen forms explosive mixtures with oils, grease and lubricants. The presence of oxygen presents an explosion hazard.

Medical Equipment Classified by ETL with Respect to Electric Shock, Fire, Mechanical and Other Specified Hazards Only in Accordance with UL 60601−1 and CAN/CSA C22.2 No. 601.1

4

Specifications Fitted with:

1 halogen bulb 12V/ 50W

Luminous power Ec

approximately 3484 ft. candle (37,500 Lux)

Illuminated field size 30 inches (.8 m) distance D10

∅ = 6.8“ (17 cm)

Color temperature

approximately 3978 K

Color rendering index, central light field size, light field ø 92 Supply voltage

115 VAC, 60Hz, .5A

Power Cord

15 feet with hospital grade plug

Net weight

approximately 55.6lbs (25.3kg)

Power consumption

approximately 60VA

Environmental Conditions Temperature Relative Humidity

Operation 10 − 40 degrees C 30% − 75%

Storage and Transportation −20 − 40 degrees C 10% − 75%

Protection class

I (with hospital grade plug)

Standards

IEC 60601−2−41, IEC 60601−1−2, IEC 60601−1 CAN/CSA C22.2 No. 601.1−M90, UL 60601−1

5

Electrical Schematic Visum 300 Electrical Schematic

6

Assembling the Light Examination Light: Part Number 8500−000−001

Light Head Assembly

Elbow

Light Handle Assembly

Handle for Stand

Stand and Spring Arm Assembly

Transformer Base

Caster

7

Assembling the Light Mounting the Casters

CAUTION Static Charge − If the grounding cable is not installed, the mobile stand may get statically charged and the charge may get transferred to the user. Install the grounding cable.

1. Open the packaging of the base so that the bottom is upside down on the floor or bench. 2. Make sure the grounding cable is installed as shown in Figure 1. There are two grounding cables per base.

Figure 1. Proper positioning of grounding cable.

3. Guide the caster through the ring cable lug of the grounding cable and into the base. Press in firmly until the caster is snug. (Figure 2)

Figure 2.

4. Repeat for the other grounding cable and caster assembly. 5. Completely insert the two other casters into the base. 6. Check for firm seating of the casters by turning base over and pressing down firmly on each corner.

8

Assembling the Light Mounting the Stand Tools Required: Slip Joint Pliers

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 do may cause injury to the user.

Keyhole 1

Note where the locking key feature is located inside the base. (Figure 3)

Keyhole 2

Figure 3.

1. Remove the stand and position the key hole on the stand so that it aligns with keyhole 1 of the base and inset until the stand is fully seated. (figure 4)

Keyhole

Figure 4.

2. Locate the wing screw from the accessory bag and insert it through the bottom of the stand. Turn the wing screw by hand until the screw is fully threaded and finger tight. Using slip joint pliers, turn the wing screw one full rotation. (Figure 5)

Figure 5.

9

Assembling the Light Mounting the Light Head Tools Required: Regular Screwdriver

1. Using a regular screwdriver, remove the brake screw at the end of the spring arm as shown in Figure 6 and set aside for later use. Remove the white plastic cap from the spring arm. Rotate the locking cover 180 degrees in either direction so that the keeper slot is exposed.

Figure 6.

2. Align the end of the light head to the end of the spring arm and push together until fully seated. (Figure 7)

Figure 7.

3. Place the keeper clip from the accessory bag into the fitted slot and push down until the clip is flushed with the arm. (Figure 8)

Figure 8.

4. Rotate the locking cover 180 degress in either direction until the brake opening is faced down. (Figure 9)

Figure 9.

5. Using a regular screwdriver, insert the brake screw into the brake opening and check to make sure assembly of light head is secure. (Figure 10)

10

Figure 10.

Assembling the Light Attaching the Light Handle Assembly

1. Position the system as shown in Figure 11.

Figure 11.

2. Lock the system into position by pressing down the tab on the end of each roller. (Figure 12)

Figure 12.

3. Connect the light bulb into the socket of the light handle assembly. (Figure 13)

Figure 13.

4. With one hand on the light handle assembly and one hand on the back of the light head, carefully insert the light handle assembly into the light head. Align the banana clips to the power receptacles and the screws to the threaded holes as shown in figure 14. Screw the two thumbscrews until fully seated.

Figure 14. 11

Operations Guide Adjusting the Light Head The light can be used with or without a sterilizable handle. Position the light in the following manner.

1. 360 degrees of rotation. (Figure 15)

Figure 15.

2. 180 degrees of rotation. (Figure 16)

Figure 16.

3. 90 degrees of rotation. (Figure 17)

Figure 17.

4. 60 degrees of rotation (Figure 18)

Figure 18. 12

Operations Guide Moving the Light Before moving the light, put the light head down to its lowest position. Make sure the casters are released from locked position. NOTE It is important to move the light only by the handle on the stand.

CAUTION − Instruction Do not push, or pull the stand in any other areas other than the handle on the stand, otherwise tipping of the stand may occur.

Turning On and Off

1. Light is shown in the Off position. (Figure 19)

Figure 19.

Locking the Exam Light

1. To lock the exam light into position, simply press down the tab on the end of each caster. (Figure 20)

Figure 20.

13

Preventative Maintenance

WARNING Maintenance must be performed by qualified service personnel. Always verify the power cord is unplugged from the wall outlet before performing service. The Stryker LL305 Visum Examination Light is equipped with a hospital grade plug for protection against shock hazard. It must be plugged directly into a properly grounded three−prong receptacle. Grounding reliability can be achieved only when a hospital grade receptacle is used. The light is hot while in operation. Do not touch the protective glass, reflector, or bulb while the light is turned on or immediately after turning it off. When replacing the halogen light bulb, use only the bulb specified in this manual. Allow the light to cool before attempting maintenance. Do not touch the glass surface of the either the old or the new bulb. Use a soft cloth to remove the old bulb and install the new one Use only manufacturer approved replacement parts.

Preventative Maintenance Checklist Preventative maintenance should be performed at a minimum of annually. All fasteners secure on the lamp head and column All casters secure and swivelling properly Casters lock properly Power cord not frayed On/Off switch functions properly Ground impedance not more than 100 milliohms Current leakage not more than 300 microamps Verify the spring force of arm and light head are proper. Lubricate keeper clip.

14

Preventative Maintenance Cleaning And Disinfecting NOTE − Qualifications of the personnel: Cleaning and disinfecting must only be carried out by trained personnel. WARNING − Electrical Shock For all cleaning work, power off equipment, disconnect power cord from outlet. Take care that no fluid runs into the equipment. CAUTION − Damage to the product: To avoid damage to plastic parts, do not use scouring agents, alkali, acidic or alcohol−containing cleaning agents. Do not use disinfectant alcohol. Cleaning S S

Turn the light off Disconnect from power outlet

S

Wipe the surfaces with a lightly moistened piece of cloth, if required, add a mild solution of soap (washing agent).

Disinfecting S

Disinfect the equipment only when it is cool.

Sterile Handle NOTE The handle can easily be removed for cleaning or sterilization. CAUTION − Handles are shipped non−sterile. Please clean and sterilize the handles prior to use. Cleaning S S S S

Rinse handle under running lukewarm water, flushing water through all passages. Submerge 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. Rinse handle thoroughly under running lukewarm water, flushing water through all passages. Dry handle with a lint free cloth. Inspect handle to make sure it is free of debris.

Sterilization The following sterilization methods have been validated: S

S

S

Gravity Displacement Steam sterilization(single wrapped) Temperature: 132 degrees C (270 degrees F) Exposure Time: 10 minutes Gravity Displacement Steam sterilization (double wrapped) Temperature: 121 degrees C (250 degrees F) Exposure Time: 25 minutes Pre−Vacuum Cycle (double wrapped) Temperature: 134 degrees C (273 degrees F) Exposure Time: 4 minutes

15

Troubleshooting Guide

Light is not working

Yes

Check the bulb

No

for continuity.

Replace Bulb.

Yes

ref. pg. 23−24

Yes

Is there 115V at the brown and blue wires coming

No

into the terminal block

Replace Power Cord.

Yes

Test the Light for functionality.

ref. pg. 26−28

in the handle assembly?

Yes Return Light

Yes

to Service.

Check continuity of the 1A fuses at the terminal block in

No

Replace Fuse. ref. pg. 28

the handle assembly. ref. pg. 26−27

Yes

A 16

Yes

Troubleshooting If problem still exists, please contact Stryker Technical Support

A

at 1−800−327−0770 (option 2).

Check for 115V at the violet and black wires coming

No

Replace the Stand Assembly.

Yes

No

Replace the Transformer.

Yes

into the transformer. ref. pg. 29−30

Yes

Check for 14 VAC on the red wires coming out of the transformer.

Test the Light for functionality.

Yes

Yes Check for 14 VAC at the commutator.

No

Replace the Stand Assembly.

Yes Return Light to Service.

Yes

Check Light Handle Assembly.

No

Replace the Light Handle Assembly.

17

Yes

Service Information Setting the Spring Force Tools Required Regular Screwdriver

CAUTION − Instruction Make sure to lock the casters before adjusting the spring tension. NOTE Adjust the spring force such that the spring arm with the light head assembly does not drift when placed in any desired position.

1. Pull off the elbow cap as shown in Figure 21.

Figure 21.

2. Using a regular screwdriver, turn the knob shown until the desired tension is reached. (Figure 22) NOTE If the spring arm drops, the spring force is too low and the screw must be rotated counter−clockwise. If the spring arm rised, the spring fcrce is too high and the screw must be rotated clockwise.

Figure 22.

Attaching/Removing the Sterilizable Light Handle Cover

1. To remove the optional sterilizable handle, press the metal button and pull down on the handle. To attach the handle, align the locking tab feature on the light handle assembly and the optional sterilizable handle. Slide the handle onto the light handle assembly and twist until the button secures the sterilizable handle into place. A locking click will be heard when secured. (Figure 23)

Figure 23 18

Service Information Changing the Halogen Light

WARNING − High Temperature Allow the light to cool before attempting maintenance. The light is hot while in operation. Do not touch the protective glass or bulb while the light is turned on or immediately after turning it off. CAUTION − Instruction If the optional sterile handle is on the light handle assembly, remove the sterile handle first (refer to section Attaching/Removing the Sterilizable Light Handle Cover). Only use the bulb specified in the Spare Parts section. The use of a bulb other than the one specified may result in poor color reproduction or higher operating temperatures.

1. Turn off the light and disconnect from the power outlet. Set the braking mechanism on the casters. For easy access, place the light head in the position as shown in Figure 24.

Figure 24.

2. Unscrew the two thumbscrews simultaneously until the screws spin freely without resisitance. Carefully pull the light handle assembly straight out. (Figure 25)

Figure 25.

3. Firmly grasp the bulb and pull straight out to remove it. Connect the replacment bulb into the socket of the light handle assembly. (Figure 26)

Figure 26. 19