Precision LED Light Source User Guide Rev E July 2020

Table of Contents Warnings and Cautions ... 2 Cautions ... 2 Warnings... 2 Operating a Light Source ... 3

Product Description and Intended Use ... 4 Indications ... 4 General Compatibility ... 4 Console Features ... 5 Front Panel... 5 Rear Panel ... 5

Setup ... 7 Connecting the AC Power Cable ... 8 Connecting to the Camera Control Unit ... 8 Connecting a Light Cable ... 8

Operation ...10 Powering the Console On and Off ...11 Activating White Light Mode ...11 Placing the Light Source in Standby Mode...11

Error Messages ...13 Troubleshooting ...14 Maintenance ...15 Cleaning and Disinfection...15 Inspection...15 Checking the ESST Feature ...17 Replacing the Fuses...17 Storage. ...17 Expected Service Life ...18 Adverse Event Reporting ...18 Disposal...18 Recycling Diagram. ...19

Technical Specifications ...21 Electromagnetic Compatibility ...21

Symbol Definitions ...28

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Warnings and Cautions Please read this manual and follow its instructions carefully. The words warning, caution, and note carry special meaning and should be carefully reviewed:

Warning

Indicates risks to the safety of the patient or user. Failure to follow warnings may result in injury to the patient or user.

Caution

Indicates risks to the equipment. Failure to follow cautions may result in product damage.

Note

Clarifies the instructions or presents additional useful information.

An exclamation mark within a triangle is intended to alert the user to the presence of important operating and maintenance instructions in the manual. A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage. Refer all service to authorized personnel.

Cautions To avoid potential damage to this device, please note the following cautions. 1. Carefully unpack this device and check if any damage occurred during shipment. If damage is detected, see the standard warranty. 2. Never sterilize the console. The delicate electronics cannot withstand a sterilization procedure. 3. Ensure that the electrical installation of the relevant operating room complies with the NEC and CEC guidelines. 4. Attempt no maintenance or adjustments that are not specifically detailed in this user manual. 5. Ensure that any modifications or repairs are carried out by persons authorized by Stryker. No modification of this equipment is allowed by the user.

Warnings To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following general warnings. 1. Must be a qualified physician to use this equipment. 2. Read this operating manual thoroughly, especially the warnings, and be familiar with its contents before connecting and using this device. 3. Test this equipment prior to a surgical procedure. This unit was fully tested at the factory before shipment. 4. Do not position the console so that it is difficult to disconnect the power cord from the supply mains.

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5. Never block the rear or side vents of the console. Failure to follow this instruction can result in device damage or a possible fire. 6. To avoid the risk of electric shock, this equipment must only be connected to a supply mains with protective earth ground. 7. Multiple portable socket-outlets shall not be placed on the floor. 8. Never use this equipment in the presence of flammable or explosive gas. 9. Power off the light source (or place it in Standby mode) before connecting or removing the light cable or endoscope. 10. Disconnect the console from the electrical outlet when inspecting fuses or making any repairs. Refer all repairs to authorized personnel. 11. Do not remove covers on the console, as doing so may cause damage to electronics and/or electric shock.

Operating a Light Source Please note the following special warnings to avoid user or patient injury or product damage when using a light source. WARNING - IMPORTANT SAFETY NOTICE - HIGH TEMPERATURES: •

Before operating this device, please read this operating manual thoroughly and carefully. When using a light source, fire and/or severe injury may result to the patient, user or inanimate objects if the instructions in this manual are not followed.

•

All light sources can generate significant amounts of heat (exceeding 41 °C/106 °F) at the scope tip, the scope light post, the light cable tip, and/or near the light cable adapter. Higher levels of brightness result in higher levels of heat. Adjust the brightness level of the camera and the monitor to the minimum brightness necessary to adequately illuminate the surgical site.

•

In addition, adjust the internal shutter of the camera higher in order to run the light source at a lower intensity. Avoid touching the scope tip or the light cable tip to the patient, and never place them on top of the patient, as doing so may result in burns to the patient or user. In addition, never place the scope tip, the scope light post, the light cable adapter, or the light cable tip on the surgical drapes or other flammable material, as doing so may result in fire.

•

Always place the light source in Standby mode before the scope is removed from the light cable or the device is unattended. The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in Standby mode, and therefore may still result in fire or burns to the patient, user, or inanimate objects.

The warranty is void if any of the above warnings or cautions are disregarded.

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Product Description and Intended Use The Stryker Precision LED Light Source is a light-generating unit intended for use in illuminating surgical sites during endoscopic applications. The Precision LED Light Source uses light-emitting diode (LED) technology to generate bright, crisp light in the visible light spectrum, which it delivers to the surgical site through an endoscope via a fiber optic light cable. The light source is equipped with a safety feature that minimizes light output if the fiber optic light cable is not connected to the scope adapter, which prevents exposure to high-intensity light and accidental burns. For more information, see the section Checking the ESST Feature.

Indications The Stryker Precision LED Light Source is indicated for use to illuminate the site of surgery during minimally invasive surgical procedures in arthroscopy (orthopedic surgery), laparoscopy (general and gynecological surgery) and in endoscopy (general, gastroenterological and ENT surgery). The light is transmitted from the source through an optical cable and a scope. The light source is an integral component of a visualization system which consists of a video camera, video monitor, video recorder, video printer, light cable and scope.

General Compatibility •

All Stryker light cables are compatible with the Precision LED Light Source.

•

The SafeLight™ Fiber Optic Cable (0233-050-100 or 0233-050-200) or AIM SafeLight™ Fiber Optic Cable (0233-050-300) must be used to enable the ESST safety feature.

•

Using the proper scope adapter, the Stryker light cable can connect the light source system to any flexible or rigid endoscope. Before using another manufacturer’s equipment, thoroughly read the accompanying documents for all warnings and instructions.

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Console Features The features of the Precision LED Light Source are described below.

Front Panel PRECISION LED LIGHT SOURCE

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1. Powe r Butt on

Powers the unit on and off

2. Touchscreen

Provides user controls and system feedback

3. Light Cable Connection

For connecting the light-source end of the light cable.

4. Jaw Handle

Opens and closes the clamp in the light cable connection

Rear Panel

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SDC

CCU

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1. SDC connection

Connects to Stryker SDC for voice and device control with a USB A-to-B cable

2. CCU connection

Connects to Stryker 1588 AIM Camera Control Unit with the provided USB A-to-A cable

3. Equipotential Ground Plug

Connects to a potential equalization conductor. The resulting medical electrical system shall follow all applicable IEC 60601-1 requirements.

4. Fuse Pa nel

Contains two T 5.0AH 250V (slow blow, high breaking capacity 1500A) fuses

5. AC Inlet

Connects to AC mains with the provided, separable power cord

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Setup Stryker considers instructional training, or inservice, an integral part of the Precision LED Light Source. Your local Stryker sales representative will perform at least one inservice at your convenience to help set up your equipment and instruct you and your staff on its operation and maintenance. To schedule an inservice, contact your local Stryker representative after your equipment has arrived. Setting up the Precision LED Light Source involves three steps: •

Connecting the AC power cable

•

Connecting a USB cable to the Camera Control Unit

•

Connecting a Light Cable

WARNING •

Always connect the light source to an appropriate power source, using a hospital-grade power cord. Loss of AC power will cause the camera to shut down and the surgical image to be lost.

•

Only connect items to the light source that have been specified for use with the light source. Connecting incompatible equipment may cause unexpected results.

•

When the light source is used with other equipment, leakage currents may be additive. To minimize leakage current that may travel to the patient or user, any Type CF applied part should be used only with other Type CF applied parts. Ensure that all systems are installed according to the requirements of IEC 60601‑1.

•

Equipment which employs RF communications may affect the normal function of the light source. When choosing a location for the console, consult the Electromagnetic Compatibility section to ensure proper function.

•

Always set up the console in a location that allows adequate ventilation (airflow) to the console. Insufficient ventilation may cause the console to overheat and shut down. The console must also be positioned on its feet; do not operate the unit upside down or on its side.

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Connecting the AC Power Cable 1. Plug in the AC power cord to the AC Inlet on the rear console panel. 2. Plug in the other end of the AC cord to a hospital-grade outlet.

Connecting to the Camera Control Unit Connecting the Precision LED Light Source to the 1588 AIM Camera allows the user to control some light source functions (such as toggling Active/Standby) from the 1588 AIM camera head. Contact a Stryker representative for more information about programming the camera head buttons. 1. Using a USB A-to-A cable, connect the CCU port on the Precision LED Light Source to the Light Source port on the 1588 AIM Camera Control Unit.

1588-010-000

0220-220-000 SDC

CCU

Connecting a Light Cable All Stryker light cables are compatible with the Precision LED Light Source.

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The SafeLight™ Fiber Optic Cable (0233-050-100 or 0233-050-200) or AIM SafeLight™ Fiber Optic Cable (0233-050-300) must be used to enable the ESST safety feature. For more information, see the section Checking the ESST Feature. WARNING •

Power off the light source or place it in Standby mode before connecting or removing the light cable or endoscope.

•

Keep fingers away from the light cable connection as the clamp may inadvertently deploy and cause injury.

1. Make sure the light source is powered off, or place it in Standby mode. 2. Lock open the clamp in the light cable connection by turning the jaw handle clockwise until it stops.

PRECISION LED LIGHT SOURCE

3. Insert a clean, dry light cable into the cable connection until the jaw clamps the cable in place. Pull gently on the cable to test that it is securely seated in the cable connection. 4. Connect an endoscope to the opposite end of the light cable. N o t e - A scope adapter may be required to connect the cable to the endoscope. See the light cable user manual for more detail. W A R N I N G - Before each use, check the outer surface of the endoscope to ensure there are no rough surfaces, sharp edges, or protrusions. N o t e - To remove the light cable, place the light source in Standby mode. Then, turn the jaw handle clockwise until the latch opens.

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Operation W A R N I N G - Before operating the light source, read and be familiar with all warnings in this user manual. Failure to follow these warnings can result user or patient injury. Before operating the Precision LED Light Source, ensure all system components have been set up according to the instructions in the Setup section.

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Powering the Console On and Off 1. To power on the console, press the power button on the front panel. The touchscreen will display the default White Light screen and indicate that the light source is in Standby mode. N o t e - The light source will not illuminate unless a light cable is connected to the cable port. 2. To power off the console, press the power button on the front panel.

Activating White Light Mode White Light mode activates the LED diodes in the light source so it can generate visible light. Follow the steps below to activate White Light mode. 1. Ensure a Stryker light cable is connected to the light source. See the Connecting a Light Cable section for more information. 2. On the default White Light screen, press the t o u c h s c r e e n p o w e r b u t t o n so it appears green and the word “Active” appears above it. 3. Adjust the W h i t e L i g h t b r i g h t n e s s l e v e l by pressing the plus or minus buttons.

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Placing the Light Source in Standby Mode Standby mode reduces white light output to a minimum, thereby reducing the heat generated at the tip of the light cable or scope when the light source is not being used.

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WARNING •

To help prevent burns to the patient, user or inanimate objects and possible fire, always put the light source in Standby mode whenever the endoscope is removed from the light cable.

•

The scope tip, scope light post, light cable adapter, and light cable tip will take several minutes to cool off after being placed in Standby mode and therefore may still result in fire and/or burns to the patient, user or inanimate objects if not used properly. Do not place the scope or the light cable on the patient, on the drapes, or other flammable material, even when the device is in Standby mode.

To place the light source in Standby mode: 1. On the default White Light screen, press the t o u c h s c r e e n p o w e r b u t t o n so it appears gray and the word “Standby” appears above it.

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Error Messages In the event of a light source error, an error message will display on the touchscreen. See the table below for details. If the light source d ispla ys an y error message, reboo t the co nsole . If the e rror recu rs, it is recommended that the device be returned for service. Code

Definition

Details

E-1

Over temperature (safety shutoff)

Output in White Light mode is disabled due to excessive heat in the console. All functionality is disabled.

E-2

Failure to color balance

The light source will not actively balance the light output color.

E-3

Power supply fan failure

The light source continues operating but generates excessive heat which may result in additional damage and/ or compromised functionality.

E-4

Heat sink fan failure

The light source continues operating but generates excessive heat which may result in additional damage and/ or compromised functionality.

E-5

Overcurrent LED failure

The light output color may drastically change, and the light source will not actively balance the light output color.

E-6

Software version mismatch

All light source functionality is disabled. Return to Stryker for service.

E-10

System initiation error

All light source functionality is disabled. Return to Stryker for service.

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Troubleshooting Prob lem

Possible Solution

No output in White Light mode

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Ensure the AC power cord is properly connected to a hospitalgrade power outlet and the inlet on the rear console panel.

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Ensure the power switch on the front panel is powered on. (It will illuminate when powered on.)

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Ensure all fuses are operating. See the Replacing the Fuses section of this manual for further instructions.

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Ensure the light cable is correctly engaged with the cable port. As a safety feature, the light source will provide no light output unless the light cable is properly seated in the cable port.

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Check that vents are not obstructed.

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Ensure the light cable is correctly engaged with the cable port.

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Ensure that White Light mode is activated. (The brightness level should appear on the LCD.)

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If necessary, press the White Light touchscreen power button to switch from Standby to Active. If the unit remains in Standby: (1) Ensure the light cable is correctly engaged with the cable port. (2) Ensure the light cable is attached to the scope using the appropriate scope adapter.

•

Ensure the light cable can transmit light properly. While the cable is completely disconnected, hold the light-source end of the cable up to an overhead room light and look into the scope end of the cable. If the pattern contains any black spots, the light cable may be worn out and may require replacement.

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Ensure the electronic shutter on the camera is operating properly to control the video signal brightness.

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Decrease the White Light brightness level.

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Ensure a light cable is properly connected to the Precision LED Light Source.

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Place the light source in Standby mode, then remove the light cable from the light source. Reattach the light cable.

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Turn off the console, wait 30 seconds, and then turn it back on.

Too much or too little output in White Light mode

Excessive glare in the video

Flickering light in the video

Frozen Touchscreen

N o t e : If this troubleshooting guide does not resolve the problem, call Stryker Technical Support at 1-877-478-7953 (inside the U.S.) or see the standard warranty.

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Maintenance Cleaning and Disinfection Should the light source console need cleaning, follow the warnings, cautions, and instructions below. The user shall provide the mild detergent (or standard disinfectant) and sterile cloth required for cleaning.

To avoid electric shock and potentially fatal injury, disconnect the console from the AC power source before cleaning. C A U T I O N - Observe the following cautions to avoid damaging the console: •

Do not sterilize the console.

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Do not immerse the console in any liquid.

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Do not allow liquid to drip onto the console or collect on any of its surfaces.

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Do not spray cleaning liquid directly onto the console, power buttons, or connectors. Spray the cleaning liquid onto a cloth, and use the cloth to wipe the console.

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Do not clean the console with abrasive products or corrosive cleaning solutions.

1. Spray a mild detergent or standard disinfectant onto a dry, sterile cloth. Do not saturate the cloth. 2. Wipe the console. Do not allow liquid to drip from the cloth or collect on the console. 3. When cleaning the front LCD screen, use extra care to prevent liquid from dripping or pooling on the bottom of the screen. Excess liquid can enter the console and cause product damage. 4. Visually inspect the external surface of the device for cleanliness, focusing on hard-to-reach areas. If visible soil remains, repeat steps 1– 3.

Inspection Inspect light sources before each use. If applicable, verify SafeLight functionality following the instructions in the Checking the ESST Feature section. If a problem relating to functionality or significant appearance degradation, such as but not limited to the following, is observed or suspected, discontinue use immediately and contact your Stryker representative. 1. Unresponsive touch screens 2. Jaw mechanism sticking, too loose, or unable to activate 3. SafeLight feature not activating to enable or disable light output 4. Other light source failures related to non-white light image, IRIS output or ICG output 5. Significant physical damage to exterior of device, including connectors: 5.1. Unacceptable deterioration 5.2. Corrosion or discoloration

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5.3. Pitting 5.4. Cracked seals

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Checking the ESST Feature The Precision LED Light Source is equipped with a safety feature called Electronic Scope Sensing Technology (ESST). The ESST feature prevents exposure to high-intensity light that can cause accidental fires or burns. The ESST feature will work only if the light source is used with a Stryker SafeLight cable or AIM SafeLight cable. The ESST feature senses when the cable and SafeLight scope adapter are separated, and it places the light source in Standby mode. In this state, the light source reduces light output to a minimum, protecting the user and patient from high-intensity light. To verify the ESST feature is functioning properly, perform the following test before every surgical procedure: WARNING •

During the test, do not point the scope or light cable at anyone. Do not look directly into the scope tip or the end of the light cable. The high-intensity light emitted from the light source can cause eye injury.

•

Other than performing the ESST test while observing these precautions, the user should never disconnect a light cable when the light source is activated.

1. Set up the Precision LED Light Source system with a SafeLight cable (or AIM SafeLight cable) and scope, including a SafeLight scope adapter. 2. Power on the console. 3. Activate White Light mode. 4. Disconnect the cable from the SafeLight scope adapter. The light source should return to Standby mode. This indicates the ESST feature is functioning properly. W A R N I N G - Always check to ensure that the unit has switched into Standby mode before assuming ESST safety protection. If the unit fails to return to this state, there may be a fault with the ESST feature. In this case, do not assume ESST safety protection, and return the unit for service.

Replacing the Fuses W A R N I N G - To avoid the risk of fire, use only fuses of the value specified on the fuse label located on the rear panel of the console. 1. Unplug the power cord from the wall outlet and remove the cord from the light source console. 2. Unlatch the fuse holder above the AC inlet and remove it. (You may need to press the tab on the fuse holder with a slender screwdriver to release the latch.) 3. Replace the fuse with the same value and rating. 4. Reinstall the fuse holder until the tab snaps in place.

Storage Store the device in a clean, dry, dust-free environment at room temperatures.

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Expected Service Life The device’s service life is largely determined by wear, processing methods, and any damage resulting from use. To extend the time between device servicing, always follow the care and handling instructions in this user manual. Before each use, test the device functionality and inspect it for any sign of damage per the Inspection section. If the device does not properly function or appears to be damaged, return it to Stryker for evaluation and possible repair or replacement. Repairs through Stryker as the equipment manufacturer bring the device back to manufacturer specifications. Clean and (when applicable) sterilize all potentially contaminated devices before returning them to Stryker.

Adverse Event Reporting Any serious incident that has occurred in relation to this device should be reported to Stryker and, in the European Union, to the competent authority of the Member State in which the affected person resides.

Disposal The device contains electrical or electronic equipment that must be collected separately for recycling. Recycling must be in accordance with applicable national or institutional policies relating to obsolete electronic equipment, including the European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE) as amended. Refer to the recycling diagram(s) below to identify components that must be recycled. Prior to recycling, ensure the device is decontaminated per the Cleaning and Disinfection section. The device must not be disposed of as unsorted municipal waste. Contact the local distributor for disposal information and follow local laws and hospital practices.

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Recycling Diagram

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Item

Mate ri al

Qty.

Comments

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PC Board

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-

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Touchscreen LCD

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PC Board

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Not shown above; behind touchscreen LCD

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PC Board

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-

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Power Supply

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