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Stryker L10, Instructions For United States Users

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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 .................................................................................. 11

Connecting the AC Power Cable  .................................................................... 12

Connecting to the Camera Control Unit ...................................................... 12

Connecting a Light Cable .................................................................................. 13

Connecting an IRIS Ureteral Kit ....................................................................... 14

Operation ........................................................................... 15

Powering the Console On and Off .................................................................. 15

Activating White Light Mode ........................................................................... 16

Placing the Light Source in Standby Mode ................................................. 16

Activating ENV Mode .......................................................................................... 17

Activating IRIS Mode ........................................................................................... 20

Using AIM IC-GREEN in ENV Mode ................................... 23

ICG Indications for Use ........................................................................................ 24

ICG Contraindications ......................................................................................... 24

Pharmacology ........................................................................................................ 24

Warning .................................................................................................................... 24

Adverse Reactions ................................................................................................ 24

Precautions ............................................................................................................. 25

Required Supplies ................................................................................................ 26

ICG Preparation ..................................................................................................... 26

ICG Dosage .............................................................................................................. 26

Administration ....................................................................................................... 27

ICG Overview .......................................................................................................... 27

ICG Storage ............................................................................................................. 27

Summary of Contents for L10

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

Page 2: ......

Page 3: ...he Camera Control Unit 12 Connecting a Light Cable 13 Connecting an IRIS Ureteral Kit 14 Operation 15 Powering the Console On and Off 15 Activating White Light Mode 16 Placing the Light Source in Standby Mode 16 Activating ENV Mode 17 Activating IRIS Mode 20 Using AIM IC GREEN in ENV Mode 23 ICG Indications for Use 24 ICG Contraindications 24 Pharmacology 24 Warning 24 Adverse Reactions 24 Precaut...

Page 4: ... 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 34 Technical Specifications 35 Electromagnetic Compatibility 36 Symbol Definitions 40 ...

Page 5: ...jury 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 w...

Page 6: ...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 5 Nev...

Page 7: ...tivated The 1588 AIM Video Camera is intended to visualize tissue manipulation only while ENV mode is off 5 Do not view the laser output in ENV mode with telescopic optical instruments for example microscopes or magnifiers Do not direct the laser output in ENV mode into an area where such instruments are likely to be used 6 Do not activate ENV mode when the endoscope is outside of the patient s bo...

Page 8: ... 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 adap...

Page 9: ...reter during open or laparoscopic surgical procedures The light is delivered to the surgical site via a disposable fiber 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 laser radiation high intensity light and accidental burns For more information see the section Checking ...

Page 10: ...ar 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 Unit1 Camera Head 1588 210 105 1588 AIM Camera Head C Mount1 1588 610 122 1588 AIM Camera Headwith Integrated Coupler1 1588 710 105 1588 AIM Inline Camera Head C Mount1 Coupler 1588 020 122 AIM Coup...

Page 11: ... AIM Technology Camera Control Unit 1588 010 000 1588 AIM Camera Control Unit1 1488 010 000 1488 HD 3 Chip Camera Control Unit2 1488 010 001 1488 HD 3 Chip Camera Control Unit with DVI Fiber Output2 Camera Head 1588 210 105 1588 AIM Camera Head C Mount1 1588 610 122 1588 AIM Camera Headwith Integrated Coupler1 1588 710 105 1588 AIM Inline Camera Head C Mount1 1488 210 105 1488 HD 3 Chip Camera Hea...

Page 12: ...vity is enhanced in the Intuitive Surgical da Vinci System by the use of Firefly mode The Stryker light source and disposable fiber listed above are required to use 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 0...

Page 13: ...it 0220 180 518 Location of Class 1 laser emissions when IRIS Ureteral Kit is connected and IRIS mode is activated 3 Touchscreen Provides user controls and system feedback 4 Light Cable Connection For connecting the light source end of the light cable Location of Class 1M laser emissions when AIM SafeLight cable is connected and ENV mode is activated 5 Jaw Handle Opens and closes the clamp in the ...

Page 14: ...mera 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 Panel 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 ...

Page 15: ...age 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...

Page 16: ...and IRIS mode do not require connection to the camera Note The 1588 AIM camera head can be programmed to control some functions of the L10 AIM Light Source such as toggling Active Standby or adjusting some settings in ENV mode Contact a Stryker representative for more information about enabling this advanced feature 1 Using a USB A to A cable connect the CCU port on the L10 AIM Light Source to the...

Page 17: ...ght cable that is cut or damaged If the AIM SafeLight cable breaks during operation place the light source in Standby mode and disable ENV mode then replace the cable 1 Make sure the light source is powered off or place it in Standby mode and disable ENV mode 2 Lock open the clamp in the light cable connection by turning the jaw handle clockwise until it stops 3 Insert a clean dry light cable into...

Page 18: ...bers Do not attempt to operate the light source with an IRIS Ureteral Kit that is cut or damaged If the IRIS Ureteral Kit breaks during operation disable IRIS mode then replace the Kit Before connecting or using an IRIS Ureteral Kit read and be familiar with all warnings in this user manual and the IRIS Ureteral Kit user manual P26059 Use of controls or performance of procedures other than those s...

Page 19: ... Mode Requirements section in order to achieve the intended results IRIS mode requires all of the equipment listed in the IRIS Mode Requirements section in order to achieve the intended results 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 Stand...

Page 20: ... and the word Active appears above it 3 Adjust the White Light brightness level by pressing the plus or minus buttons 2 3 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 To help prevent burns to the patient user or inanimate objects and po...

Page 21: ...t source in ENV mode can cause injury to the user or patient s eyes See the ENV Mode Requirements section for equipment requirements Use ENV mode only with the specified equipment Note See the 1588 AIM Video Camera user manual P29923 English P29924 multilingual for additional controls over ENV fluorescence Follow the steps below to activate ENV mode 1 Ensure an AIM SafeLight cable is connected to ...

Page 22: ...nced Imaging Modality screen press the ENV mode button 4 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 If the ENV mode button is gray required equipment may not be properly connected and ENV mode is not available Refer to the Setup section ...

Page 23: ... 1 6 Adjust the backlight level by pressing the plus or minus buttons Backlight increases or decreases the brightness of the surrounding anatomy that is not displayed as glowing green on the display monitor 7 Adjust the ENV laser level by pressing the plus or minus buttons ENV laser level affects the fluorescing green appearance of the camera image 8 Press the Home button to return to the White Li...

Page 24: ...ed it must be disabled before activating IRIS mode Follow the steps below to activate IRIS mode 1 Ensure an IRIS Ureteral Kit is connected to the light source IRIS mode will not function unless an IRIS Ureteral Kit is properly connected See the Connecting an IRIS Ureteral Kit section for more information Note When an IRIS Ureteral Kit is properly connected to the light source an image of two red f...

Page 25: ...n so it appears green which indicates the mode is activated Note Press the touchscreen power button again to disable IRIS mode the button will appear gray 1 7 6 8 5 6 Adjust the IRIS brightness level by pressing the plus or minus buttons 7 Press the solid line or the dotted line to toggle the IRIS light output between the continuous or pulsating setting respectively In the continuous setting the l...

Page 26: ...ode 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 9 ...

Page 27: ...dium iodide ICG is administered intravenously Under sterile conditions the ICG powder should be dissolved with the provided Sterile Water for Injection USP AIM IC GREEN has a pH of approximately 6 5 when reconstituted Use of the ICG dye promotes the fluorescing appearance of the camera image in ENV mode Each AIM IC GREEN kit contains the following items Six 25 mg vials of indocyanine green ICG ima...

Page 28: ... shown negligible renal peripheral lung or cerebrospinal uptake of the dye ICG is taken up from the plasma almost exclusively by the hepatic parenchymal cells and is secreted entirely into the bile ICG does not undergo significant extrahepatic or enterohepatic recirculation Warning Anaphylactic deaths have been reported following ICG administration during cardiac catheterization Adverse Reactions ...

Page 29: ...r for injection may be incompatible and should not be used Each preparation of the ICG solution should be used in only one patient Once the ICG solution is prepared it must be used within 6 hours ICG is not stable in aqueous solution Heparin preparations that contain sodium bisulfite reduce the absorption peak of ICG in blood Do not use heparin preparations with sodium bisulfite as an anticoagulan...

Page 30: ...tion Minimum volume of syringes 3 or 5 mL Syringes for each saline flush after ICG injection Minimum volume of syringes 12 mL ICG Preparation Prepare the ICG solution following the steps below The instructions yield a 2 5 mg mL solution 1 Open the Sterile Water for Injection USP ampule 2 Draw 10 mL of the solvent into a syringe 3 Remove the flip cap off the vial containing 25 mg of the ICG powder ...

Page 31: ...ar infrared imaging For visual assessment of vessels blood flow and related tissue perfusion administer ICG immediately before near infrared imaging 5 Immediately follow each ICG injection with a tight bolus injection of approximately 10 12 mL of normal saline After each injection of ICG solution the ENV mode should be able to visualize a fluorescence response in blood vessels and tissue within se...

Page 32: ...tes 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...

Page 33: ...cable is correctly engaged with the cable port Ensure that White Light mode is activated The brightness level should appear on the LCD 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 sco...

Page 34: ...light cable Frozen Touchscreen Turn off the console wait 30 seconds and then turn it back on Cannot advance past Advanced Imaging Modality screen Check connection of disposable fiber to activate IRIS mode Check connection of AIM SafeLight cable and 1588 AIM Camera Control Unit to activate ENV mode Note If this troubleshooting guide does not resolve the problem call Stryker Technical Support at 1 8...

Page 35: ...loth and use the cloth to wipe the console 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 p...

Page 36: ... look directly into the scope tip or the end of the light cable The laser radiation or high intensity light emitted from the light source can cause severe 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 L10 AIM Light Source system with a SafeLight cable or AIM SafeLight c...

Page 37: ...e 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 It must not be disposed of as unsorted municipal waste and must be collected separately i...

Page 38: ... 6 1 Item Material Qty Comments 1 PC Board 1 2 Touchscreen LCD 1 3 PC Board 1 Not shown above behind touchscreen LCD 4 PC Board 1 5 PC Board 1 6 Power Supply 1 7 AC power cord 1 Not shown above 8 USB A to A cable 1 Not shown above ...

Page 39: ...ons and Approvals Class I Equipment Continuous Operation Type CF Applied Part Ingress Protection IPX0 Ordinary Equipment Class 1M Laser Product Laser product classified per IEC 60825 1 2007 Safety of laser products Part 1 Equipment classification and requirements This product complies with IEC 60825 1 2007 This product complies with 21 CFR Subchapter J Parts 1040 10 and 1040 11 except for deviatio...

Page 40: ...sturbances is high Note This equipment is not likely susceptible to interference from HF surgical instruments in the Special Environment of being in close proximity to an active HF surgical instrument In the case that HF surgical interference is observed adjust the separation distance of the equipment Do not use cables or accessories other than those provided with the L10 AIM Light Source as this ...

Page 41: ... in all establishments other than domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used for domestic purposes provided the following warning is heeded Warning This system is intended for use by health care professionals only This system may cause radio interference or may disrupt the operation of nearby equipment It may be ...

Page 42: ...pical commercial or hospital environment Surge IEC61000 4 5 1kV differential mode 2kV common mode 1kV differential mode 2kV common mode 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 IEC61000 4 11 0 UT 0 5 cycle 0 UT 1 cycle 70 UT 25 cycles 0 UT 5 sec 0 UT 0 5 cycle 0 UT 1 cycle ...

Page 43: ...nications equipment should be used no closer to any part of the L10 AIM Light Source system including its cables than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter Recommended Separation Distance d 2 P 80 MHz to 2 7 GHz where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer...

Page 44: ...d 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 L10 AIM Light Source system is used exceeds the applicable RF compliance level above the L10 AIM Light Source system should be observed to verify normal o...

Page 45: ...80 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse modulation 18 Hz 2 0 3 28 870 930 1720 1700 1990 GSM 1800 CDMA 1900 GSM 1900 DECT LTE Band 1 3 4 25 UMTS Pulse modulation 217 Hz 2 0 3 28 1845 1970 2450 2400 2570 Bluetooth WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation 217 Hz 0 2 0 3 9 5500 5785 Note Por...

Page 46: ...brightness level white icon AIM button navigate to Advanced Imaging Modality screen Home button navigate to White Light screen Green ENV mode is available Gray ENV mode is not available connect required equipment to make the mode available Red IRIS mode is available Gray IRIS mode is not available connect required equipment to make the mode available AIM SafeLight cable is properly connected Backl...

Page 47: ... is activated press to return to IRIS mode screen Device Package Labeling Consult instruction manual Caution consult instructions for use 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 ...

Page 48: ...on is pushed Class 1M laser product Equipotentiality Alternating current Fuse rating Device recycling code applicable in China This product contains electrical waste or electronic equipment It must not be disposed of as unsorted municipal waste and must be collected separately User Manual A lightning bolt within a triangle is intended to warn of the presence of hazardous voltage Refer all service ...

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Page 52: ...ker or its divisions or other corporate affiliated entities own use or have applied for the following trademarks or service marks SafeLight and the Stryker logo IC GREEN is a registered trademark of Akorn Inc All other trademarks are trademarks of their respective owners or holders 2019 03 WCR NONE P27006G P27006G ...

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