Stryker L10 Instructions For United States Users
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Stryker L10 Instructions For United States Users

Led light source with aim technology
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L10 LED Light Source with AIM Technology
Instructions for United States Users
0220-220-300

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  • Page 1 L10 LED Light Source with AIM Technology Instructions for United States Users 0220-220-300...

  • Page 3: Table Of Contents

    Contents Warnings and Cautions ............1 Cautions ........................2 Warnings: General ....................2 Warnings: Laser ......................3 Operating a Light Source ..................4 Product Description and Intended Use ........5 Indications ........................5 ENV Mode Requirements ..................6 IRIS Mode Requirements ..................7 General Compatibility ....................8 Console Features ......................9 Setup ..................
  • Page 4 Error Messages..............28 Troubleshooting ..............29 Maintenance ..............31 Cleaning the Light Source ................. 31 Inspection ........................ 31 Checking the ESST Feature ................32 Replacing the Fuses ..................... 33 Storage ........................33 Expected Service Life ..................33 Disposal ........................33 Recycling Diagram ....................

  • Page 5: Warnings And Cautions

    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.

  • Page 6: Cautions

    Attempt no maintenance or adjustments that are not specifically detailed in this user manual. 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: General To avoid potential serious injury to the user and the patient and/or damage to this device, please note the following general warnings.

  • Page 7: Warnings: Laser

    IMPORTANT SAFETY NOTICE - LASER RADIATION: The L10 LED Light Source with Advanced Imaging Modality Technology (or “L10 AIM Light Source”) is a laser product that uses a Class 1 laser (IRIS mode) and a Class 1M laser (ENV mode).

  • Page 8: Operating A Light Source

    Operating a Light Source Please note the following special warnings to avoid user or patient injury or product damage when using a light source. 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.

  • Page 9: Product Description And Intended Use

    For more information, see the section Checking the ESST Feature. Indications The L10 AIM Light Source and SafeLight™ Cable are indicated for use to provide real-time endoscopic visible and near-infrared fluorescence imaging. The L10 AIM Light Source and SafeLight Cable enable surgeons to perform...

  • Page 10: Env Mode Requirements

    ICG supplies. See the Using AIM IC-GREEN in ENV Mode section for more detail. Note: In the United States, the L10 LED Light Source with AIM Technology and SafeLight Fiber Optic Cable are indicated for use only with AIM IC-GREEN.

  • Page 11: Iris Mode Requirements

    Before using IRIS mode, read and be familiar with the warnings and instructions provided with each device in the system. Light Source 0220-220-300 L10 LED Light Source with AIM Technology Camera Control Unit 1588-010-000 1588 AIM Camera Control Unit 1488-010-000 1488 HD 3-Chip Camera Control Unit...

  • Page 12: General Compatibility

    Intuitive Surgical® robotic camera systems with IRIS mode. General Compatibility • All Stryker light cables are compatible with the L10 AIM Light Source when used in White Light mode or IRIS mode. ENV mode requires the AIM SafeLight cable (0233-050-300).

  • Page 13: Console Features

    Console Features The features of the L10 AIM Light Source are described below. Front Panel 1. Power Button Powers the unit on and off 2. IRIS Connectors For connecting the light source ends of the IRIS Ureteral Kit (0220-180-518). Location of Class 1 laser emissions when IRIS Ureteral Kit is connected and IRIS mode is activated.
  • Page 14 Rear Panel 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 Connects to a potential equalization conductor.

  • Page 15: Setup

    Setup Stryker considers instructional training, or inservice, an integral part of the L10 AIM 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.

  • Page 16: Connecting The Ac Power Cable

    ENV mode. Contact a Stryker representative for more information about enabling this advanced feature. Using a USB A-to-A cable, connect the CCU port on the L10 AIM Light Source to the Light Source port on the 1588 AIM Camera Control Unit.

  • Page 17: Connecting A Light Cable

    To activate ENV mode, an AIM SafeLight cable (0233-050-300) must be connected to the light source. White Light mode and IRIS mode will function when other Stryker light cables are connected. Power off the light source (or place it in Standby mode and disable ENV mode and IRIS mode) before connecting or removing the light cable or endoscope.

  • Page 18: Connecting An Iris Ureteral Kit

    The IRIS connectors on the light source emit a Class 1 laser when IRIS mode is activated. To assure proper and safe laser application in IRIS mode, connect only the Stryker IRIS Ureteral Kit to the IRIS connectors. Do not attempt to use any other fiber optic light guides or emitting fibers.

  • Page 19: Operation

    Failure to follow these warnings can result user or patient injury. Before operating the L10 AIM Light Source, ensure all system components have been set up according to the instructions in the Setup section. ENV mode requires all of the equipment listed in the ENV Mode Requirements section in order to achieve the intended results.

  • Page 20: Activating White Light Mode

    Standby. Follow the steps below to activate White Light mode. Ensure a Stryker light cable is connected to the light source. See the Connecting a Light Cable section for more information. On the default White Light screen, press the touchscreen power button so it appears green and the word “Active”...

  • Page 21: Activating Env Mode

    To place the light source in Standby mode: On the default White Light screen, press the touchscreen power button so it appears gray and the word “Standby” appears above it. Activating ENV Mode Endoscopic Near-Infrared Visualization (ENV) mode activates the Class 1M laser in the light source and enables fluorescence imaging.
  • Page 22 Press the AIM button. On the Advanced Imaging Modality screen, press the ENV mode button. Note: When the ENV mode button is green, the L10 AIM Light Source is properly connected to the 1588 AIM Camera Control Unit and the AIM SafeLight Cable, and ENV mode can be activated.
  • Page 23 On the ENV mode screen, press the touchscreen power button so it appears green, which indicates the mode is activated. Note: Press the touchscreen power button again to disable ENV mode; the button will appear gray. (When ENV mode is disabled, White Light mode will reactivate.

  • Page 24: Activating Iris Mode

    Activating IRIS Mode Infrared Illumination System (IRIS) mode activates the Class 1 laser in the light source and enables use of the IRIS Ureteral Kit. Before using IRIS mode, read and follow all warnings in this user manual and the IRIS Ureteral Kit user manual (P26059). Use of controls or performance of procedures other than those specified can result in hazardous radiation exposure.
  • Page 25 On the Advanced Imaging Modality screen, press the IRIS mode button. Note: When the IRIS mode button is red, the L10 AIM Light Source is properly connected to the IRIS Ureteral Kit and IRIS mode can be activated. If the IRIS mode button is gray, required equipment may not be properly connected and IRIS mode is not available.
  • Page 26 If IRIS mode is still activated when the user returns to the White Light screen, an IRIS indicator button appears to the left of the touchscreen power button. Press the IRIS indicator button to return to the IRIS mode screen.

  • Page 27: Using Aim Ic-Green In Env Mode

    (ICG). AIM IC-GREEN® (NDC # 17478-801-02) includes the required ICG supplies. Note: In the United States, the L10 LED Light Source with AIM Technology and SafeLight Fiber Optic Cable are indicated for use only with AIM IC-GREEN.

  • Page 28: Icg Indications For Use

    ICG Indications for Use AIM IC-GREEN is indicated for use with the Stryker L10 LED Light Source with AIM Technology and SafeLight™ Fiber Optic Cable. ICG Contraindications AIM IC-GREEN contains sodium iodide. Use with caution in patients who have a history of allergy to iodides or iodinated contrast agents.

  • Page 29: Precautions

    Precautions • Federal law (USA) restricts this device to use by, or on order of, a physician. • Observe sterile handling techniques when preparing and administering the ICG solution. The inner contents of the ICG powder vial and Sterile Water for Injection, USP capsule are sterile. Handle them aseptically during the procedure to maintain the sterile field.

  • Page 30: Required Supplies

    AIM IC-GREEN® (NDC # 17478-801-02) includes the required ICG supplies. Other items required to use AIM IC-GREEN shall be provided by the user. Note: In the United States, the L10 LED Light Source with AIM Technology and SafeLight Fiber Optic Cable are indicated for use only with AIM IC-GREEN.

  • Page 31: Administration

    Administration Ensure there is a port available for the injection of the ICG solution followed by the saline flush. Draw the required dosage of ICG solution for each planned imaging sequence into separate syringes. Draw approximately 10 –12 mL of normal saline for each planned imaging sequence into separate syringes.

  • Page 32: Error Messages

    Software All light source functionality is disabled. Return to version Stryker for service. mismatch ENV power The light source will not actively balance the balance failure backlight color until the console is rebooted.

  • Page 33: Troubleshooting

    Troubleshooting Problem Possible Solution No output in • Ensure the AC power cord is properly connected to White Light a hospital-grade power outlet and the inlet on the mode rear console panel. • Ensure the power switch on the front panel is powered on.
  • Page 34 • Check connection of AIM SafeLight cable and Imaging 1588 AIM Camera Control Unit (to activate ENV Modality mode) screen Note: 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.

  • Page 35: Maintenance

    Maintenance Cleaning the Light Source 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.

  • Page 36: Checking The Esst Feature

    Set up the L10 AIM Light Source system with a SafeLight cable (or AIM SafeLight cable) and scope, including a SafeLight scope adapter. Power on the console.

  • Page 37: Replacing The Fuses

    Never store the light source in a non-ventilated, humid environment. This can damage the delicate electronics in the device. Expected Service Life The L10 AIM Light Source has an expected service life of 2000 hours (2 years based on 1000 cases per year). Disposal This product contains electrical waste or electronic equipment.

  • Page 38: Recycling Diagram

    Recycling Diagram Item Material Qty. Comments PC Board — Touchscreen LCD — PC Board Not shown above; behind touchscreen LCD PC Board — PC Board — Power Supply — AC power cord Not shown above USB A-to-A cable Not shown above...

  • Page 39: Technical Specifications

    Technical Specifications Electrical Primary: 100 – 240 VAC, 50/60 Hz, 3.2 – 1.3 A Fuses (2): T 5.0AH 250V Dimensions and Weight Height: 4.75”(12.1 cm) Width: 12.5” (31.8 cm) Depth: 16.8” (42.7 cm) Weight: 16.0 lbs. (7.3 kg) Light Engine Type: Red LED, Green LED, Blue LED, 808 nm Laser, 830 nm Laser Operating Conditions Temperature: 10 –...

  • Page 40: Electromagnetic Compatibility

    To ensure electromagnetic compatibility (EMC), the L10 AIM Light Source must be installed and operated according to the EMC information provided in this manual. Note: The L10 AIM Light Source has been designed and tested to comply with IEC 60601-1-2 requirements for EMC with other devices.
  • Page 41 Guidance and Manufacturer’s Declaration: Electromagnetic Emissions L10 AIM Light Source is intended for use in the electromagnetic environment specified below. The customer or the user of L10 AIM Light Source should ensure that it is used in such an environment. Emissions test...
  • Page 42 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity L10 AIM Light Source is intended for use in the electromagnetic environment specified below. The customer or the user of L10 AIM Light Source should ensure that it is used in such an environment.
  • Page 43 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity L10 AIM Light Source is intended for use in the electromagnetic environment specified below. The customer or the user of L10 AIM Light Source should ensure that it is used in such an environment.
  • Page 44 Guidance and Manufacturer’s Declaration: Electromagnetic Immunity L10 AIM Light Source is intended for use in the electromagnetic environment specified below. The customer or the user of L10 AIM Light Source should ensure that it is used in such an environment.
  • Page 45 LTE Band 7 5240 Pulse WLAN 802.11 5500 5100-5800 modulation 5785 217 Hz Note: Portable RF Communication equipment should be used no closer than 30cm to the L10 AIM Light Source. Otherwise, degradation of the performance of this equipment could result.

  • Page 46: Symbol Definitions

    Symbol Definitions This device and its labeling contain symbols that provide important information for the safe and proper use of the device. These symbols are defined below. Touchscreen Interface Green=selected mode is activated Gray=Selected mode is disabled (or light source is in Standby mode) White Light brightness level (white icon) AIM button (navigate to Advanced Imaging Modality screen)
  • Page 47 Federal law (USA) restricts this device to use by, or on order of, a physician Date of manufacture Legal manufacturer Product catalog number Product serial number The device meets requirements for safety and effectiveness set forth in MDD 93/42/EEC. Stryker European representative...
  • Page 48 Denotes compliance to CAN/CSA C22.2 No 60601-1 and ANSI/AAMI 60601-1 IRIS connector icon (on front panel) Turn jaw handle in indicated direction to lock open the cable clamp Type CF applied part Power on/off (power state alternates when button is pushed) Class 1M laser product Equipotentiality Alternating current...
  • Page 52 San Jose, CA 95138 USA 1-800-624-4422 U.S. Patents: www.stryker.com/patents *P27006G* Stryker or its divisions or other corporate affiliated entities own, use or have applied for the following trademarks or service marks: SafeLight™ and the P27006G Stryker logo. IC-GREEN® is a registered trademark 2019/03 of Akorn, Inc.

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