Operator Manual
84 Pages
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Delivery Device Operator Manual
This manual is copyrighted with all rights reserved. Under copyright laws,
this manual may not be copied in whole or in part or reproduced in any other media without the express written permission of Lumenis, Inc. Permitted copies must carry the same proprietary and copyright notices as were affixed to the original. Under the law, copying includes translation into another language. Please note that while every effort has been made to ensure that the information in this document is accurate, the instructions, photos, figures, illustrations, tables, specifications, and schematics contained herein are subject to change without notice. Lumenis, the Lumenis Logo, and Novus are registered trademarks of Lumenis, Inc. Array, LaserLink, SureSpot, Varia, Spectra, and Vision One are trademarks of Lumenis, Inc.
Manufactured by:
1870 S Milestone Dr Salt Lake City, UT 84104 USA Lumenis (Germany) GmbH Heinrich-Hertz-Strasse 3 63303 Dreieich, Germany +49.6103.8335.0
© 2016 Lumenis, Inc. Published in USA UM-1098750, Rev. B Lumenis ECO: ECO-0007078 Effective Date: July 2016
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Contents Operation ... 6 Introduction ... 7 Array LaserLink Components ... 8 Array LaserLink Module ... 8 Console... 8 Touchscreen Display... 8 Remote Touchpad ... 8 3D Mouse ... 8 Array LaserLink Installation ... 10 Connecting an Eye Safety Filter ... 13 Installing Observation Equipment ... 13 Array LaserLink Operation ... 14 The Treatment Screen ... 15 Touchpad... 16 3D mouse ... 17 Setting Treatment Parameters ... 18 Selecting the Shape ... 18 Titrating ... 19 Frame Mode ... 19 Rotating a Shape ... 20 Micromanipulation ... 21 ... 21 Adjusting the Spacing between Spots ... 22 Setting the Laser Power ... 23 Setting the Spot Size... 25 About Spot Size and Fluence ... 26
4 ● Operation Setting the Aiming Beam Intensity ... 27 Setting the Duration ... 27 Setting the Interval ... 28 Setting the Treatment Beam Wavelength ... 28 Resetting the Shot Counter... 29 Selecting the Fundus Lens ... 30 Selecting the Laser Status ... 31 Setting System Options ... 32 Options Form 1 ... 32 Setting the Date & Time ... 32 Setting Time Format ... 32 Setting Date Format... 33 Adjusting Date & Time ... 33 Setting the Speaker Volume ... 33 Standby Backlight and Ready Backlight ... 33 Options Form 2 ... 34 Controlling Sound ... 34 Displaying Fluence ... 34 Resetting Rotation and Micromanipulation ... 34 Enabling the On-Retina Text ... 34 Options Form 3 ... 35 Enable Manipulation ... 35 Enable Spacing ... 35 Enable Next Pattern... 35 Enable Number of Spots ... 35 Enable Rotation ... 35 Saving and Retrieving Treatment Presets ... 36 The Preset Panel ... 36 Saving a Preset ... 36 Recalling a Preset... 37 Updating a Preset ... 37 Exporting and Printing Reports ... 38 Using the Report Panel ... 39 Preoperative Instructions ... 42 Intraoperative Instructions ... 42 Postoperative Instructions ... 44
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Maintenance ... 45 Troubleshooting Guide ... 46 Error Messages ... 50 User Maintenance ... 51 Inspecting the Delivery Device Components ... 51 Clean the External Surface of the Delivery Device ... 51 Annual Maintenance ... 51 Changing the Console Fuses ... 52 Electromagnetic Compatibility ... 53 Essential Performance ... 53 Specifications... 54 Warranty Information ... 56
Safety and Regulatory... 57 Introduction ... 58 Laser Safety Eyewear ... 59 Additional Ocular Protection ... 61 Additional Safety Considerations... 62 Electrical Hazards ... 62 Regulatory Compliance ... 63 Eye Safety Filter... 63 Location of Controls ... 63 Location of Regulatory and other System Labels ... 63
Indications for Use ... 67 Indications for Use ... 68 Contraindications in Ophthalmology ... 70 Retinal Pigmentation ... 70 Potential Side Effects or Complications ... 71 Clinical References ... 72
Appendix 1 ... 75 EMC Guidance and Manufacturer’s Declarations ... 75
Appendix 2 ... 81 Specifications for Patterns, Spacing, and Spot Size ... 81
6 ● Operation
Operation
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Introduction This manual describes the connection and operation of the Lumenis Array LaserLink delivery device. The Array LaserLink delivery device adapts to a Slit Lamp for use as a therapeutic laser delivery system, utilizing a scanning pattern generator to deliver predefined patterns of treatment. It is intended for use by an Ophthalmologist within a clinic or surgeon’s office environment on patients regardless of age, gender, weight, or race. As the Lumenis Array LaserLink is for professional use only the device qualifies for exemption per 21 CFR 801 Subpart D. CAUTION – Federal law restricts this device to sale by or on the order of a physician.
When attached to a compatible Lumenis photocoagulator, treatment parameters such as power, spot size, pattern shape, and wavelength are configurable with the included touchscreen interface and remote touchpad3D mouse. Your local Lumenis Representative initially unpacks, inspects, sets up, and installs the Array to ensure that it is working properly. In addition, Lumenis provides in-service training to ensure that your surgical staff is experienced in the performance and safety considerations of the device. CAUTION - Do not attempt to operate the system until a qualified Lumenis Representative has installed and checked it for proper operation.
Thereafter, you, or the nursing staff at your facility, will perform the daily maintenance routines associated with this device as directed in the maintenance section of this manual. Lumenis laser systems and delivery devices are precision medical instruments. They have undergone extensive testing and with proper handling are useful and reliable clinical instruments. If you have questions regarding your laser or delivery device, contact your local Lumenis Representative. WARNING - Lasers generate a highly concentrated beam of light which may cause injury if improperly used. To protect the patient and operating personnel, the entire laser and your delivery device operator manuals, including all Safety and Regulatory sections, should be carefully read and comprehended before operation.
8 ● Operation
Array LaserLink Components The Array is comprised of the following components:
a scanning Array LaserLink Module
a Console
a Touchscreen Display
a Remote Touchpad or 3D mouse (depending on customer selection and region regulatory approvals)
Optional co-observation devices are also available. System connections and controls are described in the following pages.
Array LaserLink Module The Array LaserLink module attaches to the Slit Lamp and delivers the treatment beam to the target tissue.
Console The console houses the control electronics and power supply, and integrates the Array LaserLink module with the laser system.
Touchscreen Display Use the touchscreen display to adjust laser treatment settings, such as laser mode, energy, and aiming beam intensity. It can be positioned on either side of the Slit Lamp, and duplicates the functions of the laser’s remote control so that you can verify the laser treatment parameters without moving back from the Slit Lamp binoculars.
Remote Touchpad Use the touchpad to micromanipulate the position of the aiming and treatment beams, adjust laser power, spot size, the number of spots, and several other pattern parameters.
3D Mouse Use the 3D mouse to micromanipulate the position of the aiming and treatment beams, adjust laser power and the number of spots.
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Fig. 1 Doctor and patient positioning
Array Module
Eye Safety Filter (not part of
Touchscreen Display
the Array, but required for safe operation)
Array Console
Remote Touchpad Fig. 2 Array LaserLink Components (3D Mouse not displayed)
10 ● Operation
Array LaserLink Installation The Array LaserLink delivery device must be installed by a Lumenis-certified technician, and is only compatible with specific Lumenis laser systems: Novus Spectra™ Laser System (K022327*) Novus Spectra™ Dual Port Laser System (K022327*) Vision One™ Laser System (K111213*) *Premarket FDA Clearance numbers WARNING - The Array LaserLink shall only be connected to defined laser systems. Connecting to anything else will result in a nonfunctioning delivery device.
The Array LaserLink consists of the four components which are shown in Fig. 2 on the previous page. The touch screen and touch pad3D mouse are mounted by a qualified service technician at a location chosen by the user. The array module (head) is attached to a Slit Lamp by the technician using the adjustable mounting plate shown in Fig. 3. The array module must be positioned, aligned, and focused by the technician to match the Slit Lamp’s focal point/plane.
Fig. 3 Array Head Mounting Plate
The array module, touch screen, and touch pad3D mouse are connected to the console by a service technician. The console is mounted to a laser system or at a location chosen by the user. The console is connected to a
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laser system by the service technician. An aiming beam control port is installed in the laser system.
Footswitch Port Fig. 4 Console Ports
Fig. 5 Cables
Laser Control Port
12 ● Operation
Fig. 6 Laser System Ports
After the Array LaserLink has been set up by a technician, it can be detached and reattached to the laser system by the user. The console cables will only attach one way preventing improper connection. To detach the Laser System:
Detach the laser control cables from the laser system. The cables include the aiming beam control cable, remote cable, and foot switch cable.
Detach the foot switch from the console port and attach it to the laser system.
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To attach the laser system:
Remove the foot switch from the laser system and connect it to the console.
Attach the laser control cables (foot switch, remote, and aiming beam control) to the laser system.
If the Array Module is removed from the compatible Slit Lamp for any reason, it must be reinstalled by a Lumenis-certified technician. The Array LaserLink must be installed so that the wall plug is accessible for ease of disconnecting. CAUTION - Grounding reliability can only be achieved when the equipment is connected to an equivalent receptacle marked “Hospital Grade” or “Hospital Only”.
Connecting an Eye Safety Filter The Eye Safety Filter blocks the transmission of laser light, thereby protecting the physician’s eyes from laser exposure while looking through the Slit Lamp. The Eye Safety Filter is a component that is not connected to the Array LaserLink, but is part of the Lumenis Photocoagulator Laser System that is being used in conjunction with the Array LaserLink. Operating and installation instructions for the Eye Safety Filter are located in the Operator’s Manual of the Lumenis Photocoagulator Laser System which is being used. CAUTION - During treatment, the Eye Safety Filter must be attached to the Slit Lamp. Failure to do so could result in serious ocular injury. CAUTION - Eye safety filters are labeled for laser model or wavelength compatibility. Use only Eye Safety Filters that are labeled for your laser model or wavelength. Use of an incorrect Eye Safety Filter could result in serious ocular injury.
Installing Observation Equipment Install observation equipment according to the instructions that accompany those accessories.
14 ● Operation
Array LaserLink Operation CAUTION - Before each use, inspect the system for dirt, debris, or damage. Check the Eye Safety Filter cable and the Eye Safety Filter extension cable, if applicable, to ensure that they are not frayed or split. Check the optical fiber to ensure that it is not punctured, fractured, or sharply bent. CAUTION - Check to ensure there is no debris or object in the beam path. If any problems are noticed, do not use the device until unit is in appropriate working condition. CAUTION - To prevent accidental laser exposure, always turn off the laser, as instructed in your laser operator manual, before connecting the delivery device. NOTE - Refer to the Connection Instructions section of your laser operator manual, and perform the laser operating instructions in sequence with the instructions outlined in this manual.
1. Turn the laser system on, as instructed in your laser system operator manual. 2. Turn the Array LaserLink delivery device on by pressing the | (on) switch on the Array LaserLink Console rear side and press the On/Off button on the front side.
Power Switch
Fig. 7 Power Switch Location
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The Treatment Screen The Array LaserLink provides a touch sensitive graphical user interface for controlling the Array LaserLink delivery device. Most laser treatment parameters are directly adjustable from the treatment screen, as shown in Fig. 8, making it unnecessary to interact with the laser system directly. In fact, it is recommended that you perform all treatment adjustments using the Array LaserLink treatment screen. Some treatment parameters that are adjustable on the treatment screen are also adjustable on the touchpad3D mouse. The treatment screen is composed of panels in the upper left corner. One panel is visible at a time and is selected using the tabs at the bottom of the panel. Shape:
The Shape Panel is where you will work during treatment. This panel is used for selecting the shape and setting the number of spots in the selected shape.
Options: The Options Panel is used for setting up your preferred system settings. Presets: The Presets Panel allows up to 5 doctors to customize their personal treatment settings. Report: The Report Panel generates treatment reports.
Fig. 8 The Array LaserLink Touchscreen
16 ● Operation
Touchpad Fig. 9 shows the Array LaserLink touchpad. This touchpad facilitates making adjustments without having to remove your eyes from the binoculars. It also allows you to rotate the shape and perform fine positional adjustments (micromanipulation). In addition to the touch sensitive surface, the touchpad has two buttons for controlling the power settings and a pair of “middle” buttons which control titrate mode. The setup of the touchpad is covered later in this manual in the Setting System Options section.
Titrate
Titrate
Fig. 9 The Array LaserLink Touchpad
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3D mouse Figure 10 shows the Array LaserLink 3D mouse. This device allows you to perform the following operations: -
Micromanipulation - fine positional adjustments.
-
Change laser power settings - The 3D mouse has two buttons for controlling the power settings.
-
Control Titrate mode - Pushing the main controller down toggles titrate mode on/off.
-
Change number-of-spots - Rotating the main controller clockwise will increase the number of spots. Rotating the main controller counterclockwise will decrease the number of spots.
Micromanipulation
Increase number of spots
Power-Down
Power-Up
Push-down to control titration Decrease number of spots Figure 10 – The Array LaserLink 3D Mouse controls
18 ● Operation
Setting Treatment Parameters CAUTION - Always verify that the desired treatment parameters are displayed on the touchscreen before initiating treatment. CAUTION - If there is no change in display when you interact with the touchscreen or touchpad3D mouse, or if the touchscreen appears otherwise erratic, do not use the laser. Contact your local Lumenis Representative.
Selecting the Shape Seven shapes are available: single spot, square, line, triangle, circle, quarter circle and half circle. Select the desired shape by pressing the corresponding shape selector; the shape appears in the Shape Panel as seen in Fig. 11 and is traced by the aiming beam on the retina. Press the and buttons on each side of the Spot Size display to increase or decrease the range of spots; the total number of spots is shown in the Total Spots display. You may also use the Touchpad to select the shape by sliding your finger along the left edge as shown in Fig. 9 on the previous page.
Fig. 11 The Shape Panel
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Titrating The Array LaserLink provides a shortcut to simplify titrating. After you have selected a shape, you can instantly switch to a single spot for making adjustments to power level and spot size, etc. Press the Titrate button to activate the single spot. In titrate mode, the treatment screen shows the dimmed pattern with a single spot in the center as shown in Fig. 12. On the retina, only the single spot will be visible. To return back to the orginal shape, press the Titrate button again.
Fig. 12 Titrate Preview
Frame Mode Press the Frame button to display only an outline of the shape for a less obstructed visualization of the target. When frame mode is selected, the treatment screen displays the selected shape in a bounding frame as seen in Fig. 13.
Fig. 13 Frame Mode Preview
The screen shows the spots that will be delivered during treatment. On the retina, only the outline will be visible.
NOTE – Treatment cannot be delivered in Frame Mode. User must go back to normal aim beam mode to treat.
20 ● Operation
Rotating a Shape The Array LaserLink allows you to rotate any shape, with the exception of single spot. A pair of buttons in the upper and lower right corner of the Shape panel (see Fig. 14) lets you rotate the shape in either direction in 15 degree increments.
Fig. 14 Rotation Buttons
You can also use the touchpad to rotate the shape. Rotating is performed by sliding your finger along the right edge of the touchpad as shown in Fig. 15.
Fig. 15 Rotation Zone