Stryker Visum 300 Assembly, Operation And Maintenance Instructions

Stryker Visum 300® Ceiling-Mounted Exam Light
Assembly, Operations, and Maintenance Manual
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Contents
1. Indications for Use .............................................................................................................................................4
1.1 Item Installation Package List .......................................................................................................................... 4
2. Warnings and Cautions .....................................................................................................................................5
2.1 Warnings .................................................................................................................................................................5
2.2 Cautions ................................................................................................................................................................... 5
3. Product Symbol Denition ...............................................................................................................................6
4. VISUM® 300 Components .................................................................................................................................7
5. Installation ........................................................................................................................................................... 8
5.1 Installing the Down Tube Assembly .............................................................................................................. 8
5.3 Attaching the Light Head ................................................................................................................................12
6. Operations .........................................................................................................................................................14
6.1 Turning the Light On and O .........................................................................................................................14
6.2 Positioning the Light Head/Suspension ....................................................................................................14
6.3 Removing and Reattaching the Sterilizable Light Handle Cover......................................................14
6.4.1 Cleaning .................................................................................................................................................16
6.4.2 Sterilization ........................................................................................................................................... 16
6.5 Replacing the Halogen Bulb ..........................................................................................................................17
6.6 Replacing Fuses ..................................................................................................................................................19
6.7 Replacing the Transformer ..............................................................................................................................20
6.8 Replacing the Aesthetic Covers ....................................................................................................................22
6.9 Removing the Light Head ...............................................................................................................................24
6.10 Removing the Extension Arm with the Spring Arm ..............................................................................24
6.11 Removing the Down Tube Assembly ..........................................................................................................25
6.12 Lubricating the Keeper Clip ............................................................................................................................25
6.13 Adjusting the Spring Force .............................................................................................................................25
7. Troubleshooting ...............................................................................................................................................27
7.1 Light Does Not Function .................................................................................................................................27
8. Technical Specications ..................................................................................................................................28
8.1 Environmental Specications ........................................................................................................................28
8.2 Electrical Specications ...................................................................................................................................28
8.3 Lighting Data .......................................................................................................................................................28
8.4 Physical Data ........................................................................................................................................................28
9. Maintenance......................................................................................................................................................29
10. Product Disposal ............................................................................................................................................30
11. Damage Claims ...............................................................................................................................................30
12. Stryker Limited Warranty .............................................................................................................................30
13. Contact Information ......................................................................................................................................31
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1. Indications for Use
The intended use of the Stryker VISUM® Lighting system is to illuminate the patient’s surroundings, as well as the body of the patient to support diagnosis and treatment. It has not been designed as a surgical light, or for use by the patient.
The VISUM® is considered a Class I medical device. It is a luminaire for diagnosis meant to illuminate the body of the patient locally in order to support diagnosis or treatment which could be interrupted without any hazard for the patient in case of failure of the light. It is not intended for use in operating rooms.
1.1 Item Installation Package List
1. Down Tube Assembly (see Figure 5)
• Down Tube
• Ceiling Cover
• Protective Cover
2. Extension Arm and Spring Arm Assembly (see Figures 1, 8, 9):
• Plug
• C-Clip / Retaining Ring
• C-Clip / Retaining Ring Installation Pliers
• Light Head Keeper Clip
• Brake Screw
• Brake Cover
• Protective Cap
• Keyed Washer
• Flat Washer
3. Light Head Assembly:
• Light Head (see Figure 2)
• Sterilizable Handle (see Figure 3)
4. Installation, Operations, and Maintenance Manual
5. Installation Hardware Kit:
3/8” UNC Threaded Rods, 12”
Long
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Flat Washers Lock/Spring Washers 3/8” Nuts
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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. This equipment can only be used by (or on the order of) a physician.
3. Test this equipment prior to any procedures. This product was fully tested at the factory before shipment.
4. Do not remove or disable components. It may cause electric shock.
5. Attempt no repairs or adjustments, unless specically instructed to do so in this operating manual.
6. Disconnect the unit from the electric outlet before inspecting or servicing system components.
7. Do not look directly into the exam light while powered on.
8. Do not operate the exam light if any component of the light (such as the glass) is damaged.
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, modications, 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.
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3. Product Symbol Denition
The following symbols may be found on the Stryker VISUM® 300 Ceiling-Mounted 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.
Denotes temperature limits.
Denotes humidity limits.
Denotes usage tips and useful information.
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.
Denotes product/part number.
Denotes product/serial number.
Denotes lot or batch number.
Denotes European Representative.
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4. VISUM® 300 Components
REVISIONS
REV. DESCRIPTION ECO DATE CHECK APPROVED
1
2
3
4
5
6
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8
9
7
11
Figure 1 - VISUM® 300 Components
1. Sheet Metal Guard 7. Elbow
2. Down Tube Flange 8. Spring Arm
3. Sheet Metal Enclosure 9. Power Switch
4. Ceiling Cover 10. Light Head
5. Down Tube 11. Light Handle Assembly
6. Extension Arm
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Figure 2 - VISUM® 300 Light Head Figure 3 - Sterilizable Handle
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5. Installation
Warning
• The light should be installed down circuit from a circuit breaker, or should be installed with a switch to turn the main power o.
• Make sure that the power to the installation site is o during all installation procedures.
Refer to the VISUM® 300 Ceiling-Mounted Exam Light Pre-Installation Manual for load data on the VISUM® 300 CM. (Installation hardware is provided with all products and should be in the nal package.)
5.1 Installing the Down Tube Assembly
The following steps assume a ceiling structure with the hole pattern specied in the VISUM® 300 Ceiling­Mounted Exam Light Pre-Installation Manual. Refer to Figures 4-7 as needed.
1. Loosen the three set screws and remove the retaining ring and ceiling cover.
2. Inspect the ceiling structure.
Warning
Make sure that the super structure is at least 3-8” above the false ceiling, as shown in Figure 4.
3. Attach the down tube assembly to the ceiling super structure as follows:
• Insert and fasten the threaded rods into the ceiling super structure as shown in Figure 5.
• Install the upper 3/8” nuts and at washers onto the threaded rods as shown in Figure 5. Depending
on down tube length, ensure that the bottom of the washer is the correct height above the bottom of the false ceiling.
• Raise the down tube assembly into the ceiling while guiding the threaded rods into the holes in the down tube ange shown in Figure 6.
• Install the lower at washers, spring washers, and 3/8” nuts onto the threaded rods as shown in Figure
7.
4. Make sure the ceiling plate is level in two directions.
5. Have an electrician:
• Run conduit with ¾” tting into the sheet metal guard.
• Run 6’ power cable through the conduit and connect the lines at the junction box.
6. Raise the sheet metal enclosure and hand tighten the three screws to the sheet metal guard. Use a Phillips screw driver to tighten the remainder.
7. Raise the ceiling cover and retaining ring to the ceiling and fasten the three set screws. Make sure the ceiling cover is ush with the bottom of the false ceiling.
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Access Panel
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Super Structure Customer Provided
3-8”
FALSE CEILING
Down Tube Flange with Ceiling
Ceiling Cover
Figure 4 - Down Tube, Super Structure, and False Ceiling
Down Tube Height H
110mm 1”
220-800mm 1”-2”
1
+ .25”
- 0
Figure 5 - Down Tube Assembly Preparation
1. Spring Washer
2. Flat Washer
3. Nut
4. Upper Nut
5. Upper Flat Washer
2
3
4
5
H
Bottom of False Ceiling
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1
2
3
4
5
6
7
8
9
10
11
12
13
14
15
Figure 6 - Detail of Installation Without Ceiling Cover
1. Access Panel 9. Transformer Clamping Nut and Washer
2. Junction Box 10. Ceiling Structure
3. Conduit and Fitting
(Customer Supplied)
4. Conduit Fitting Nut
(Customer Supplied
5. Transformer Mounting
Screw
6. Transformer Insulating
Ring
7. Transformer 15. Sheet Metal Enclosure
8. Transformer Clamping
Ring
11. Threaded Rod
12. False Ceiling
13. Sheet Metal Guard
14. Down Tube Flange
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