ML6710i Laser Device INSTRUCTIONS FOR USE
Document ID: 35569 Document revision: ML6710i-IFU-Rev.
Preface Professional clinical information Intended use The intended use for the ML6710i laser is photoactivation of a light-activated drug used in photodynamic therapy (PDT) for the treatment of patients with disorders of the retina and choroid. Please consult the prescribing information of the drug for additional information on intended use, recommended drug and light dose, administration instructions, contraindications, warnings and precautions, and side effects of the treatment.
1. Contents 1. 2. Information for safety . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.1 Symbols used . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6 1.2 General safety notices and warnings . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1.3 Ventilation holes . . . . . . . . . . . . . . . . . . . . .
4.2 4.3 4.4 5. 5 Graphical user interface (GUI) . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 4.2.1 Network Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 4.2.2 iPad requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 4.2.3 Login . . . . . . . . . . . .
Information for safety 1. Information for safety This section describes how to operate the ML6710i safely and which precautions to take into account when preparing the ML6710i and use environment into use. This section includes the general information for safety. More specific information related to detailed use of the device are given are in other section within the corresponding description of the functionality. Please read the information for safety carefully and follow the given safety instructions.
Information for safety 1.2 General safety notices and warnings PROHIBITED PROHIBITED WARNING: No modification of this equipment is allowed. The unauthorized modification or alteration of the equipment, or the use of non-approved accessories, or parts with the equipment, or unauthorized service personnel are prohibited and shall relieve the manufacturer/distributor from any warranty, service obligation or other liability for damages to, or failure of, the equipment caused by such unauthorized acts.
WARNING WARNING Information for safety Extravasation of the photosensitizer may cause burns and other severe reactions in the tissue, especially if the affected area is exposed to light. Please refer to the prescribing information of the drug for instructions. ML6710i is a combination equipment utilizing a photochemical reaction between laser light and a photosensitive drug.
Information for safety 1.3 Ventilation holes The ventilation holes in the rear panel and bottom side of the device should not be blocked in any way to ensure sufficient airflow and therefore to avoid excess heating of the device. To emphasize this, the device has been marked with the text “DO NOT BLOCK VENTILATION HOLES”. Please note that ventilation holes are not protected against harmful ingress of water from splashes, dripping or sprayed water. Such exposure must be avoided.
MANDATORY MANDATORY MANDATORY MANDATORY MANDATORY MANDATORY WARNING Information for safety Make sure to follow laser safety regulations and principles and ensure that there is no possibility of scattered or direct laser light being transmitted outside the application areas. Laser safety eyewear (689 nm, OD 4+) is mandatory for all personnel (physician giving the treatment may be excluded when the SLA is equipped with a safety filter) within the reach of emitted direct or scattered light.
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The ML6710i 2. The ML6710i 2.1 Description This section describes the ML6710i. This section is not meant to describe every operating feature in detail. It is simply a guide to become familiar with the essential components of the laser device. Operating the laser device is described in more detail in sections 3 and 4.
The ML6710i The following radio field/electromagnetic disturbances may affect the essential performance of ML6710i: Communication loss between main unit and GUI may occur in case of a strong disturbance at 2.4 GHz Major mains supply voltage dips and interruptions may cause the main unit to shut down or reboot PROHIBITED 2.2 Approved beam delivery systems The ML6710i is designed for PDT treatments of the retina and to be used together with a slit lamp.
The ML6710i 2.4 Specification 2.4.1 Electro-optical and electrical performance The ML6710i has a specific usable output power range, which limits the available spot size depending on the selected contact lens magnification and irradiance. Spot diameter is limited by the SLA properties. Settings outside these ranges are indicated on the GUI. Table 2. Electro-optical characteristics at 59–86 °F (15–30 °C).
The ML6710i Table 3. Electrical characteristics for ML6710i. Parameter Range Unit Comment Input voltage 15 V ± 5% Input power ≤ 60 W Current consumption ≤4 A Input voltage of power supply 100–240 VAC Input frequency of power supply 50–60 Hz 1.5 Max current consumption A 0.7 115 VAC 230 VAC Bluetooth Low Energy frequency of reception & transmission 2400–2483.5 MHz Bandwidth 2 MHz Effective radiated power 6 dBm Nominal 2.4.
Product delivery package and installation 3. Product delivery package and installation Follow the device installation and setup protocol defined in these Instructions For Use. MANDATORY 3.1 Product delivery package The ML6710i is delivered in a transport case shown in Figure 1. The transport case is equipped with a handle and wheels for temporary movement. Leave the case in a position as instructed by the labels whenever ML6710i is stored inside it. Figure 1. ML6710i transport case..
Product delivery package and installation 3.1.1 Post-shipment inspection protocol Follow the instructions in this section to ensure the device has not damaged during transit. Transport case ML6710i Inspect the transport case for cracks, dents and big scratches.
Product delivery package and installation 3.2 Items supplied Table 5. The items supplied together with ML6710i. Part number Item Description Main unit ML6710i main unit - Power supply Medical power supply AP0201, rev. 1 Power cord Power cord provided with US plug AP0307, rev. 1 Instructions For Use Instructions for use and safety ML6710i-IFURev.6-2020-03-19 Foot switch 1-pedal foot switch integrated LASER STOP button AP1130, rev.
Product delivery package and installation When receiving the product, unpack all parts carefully. Pay special attention to handling of the ML-SLA cable that incorporates an optical fiber sensitive to bending. For later use, place all plastic bags and similar supplies back to the transport case after all functional items have been unpacked. Should the device setup need to be decommissioned e.g., for temporary storage, pack all items as they were when received. See Figure 3 for reference.
Product delivery package and installation 3.3 Product installation and setup ML6710i is not a permanently installed device i.e. it doesn’t require permanent (detachable by the use of a tool only) electrical connection to supply mains. The device does not have or require a separate supply mains switch and is isolated from the supply mains simply by pulling the plug from the mains socket. Setup of the ML6710i is to be done at the treatment site by personnel authorized by the manufacturer (Figure 4).
Product delivery package and installation 21 3.3.1 Treatment station The ML6710i is installed on top of a separate ophthalmic treatment table equipped with a separate slit lamp. When operating the slit lamp, follow manufacturer’s instructions provided with the slit lamp. MANDATORY When operating the ophthalmic table, follow manufacturer’s instructions provided with the table. MANDATORY 3.3.
Product delivery package and installation Supporting the SLA cable to the slit lamp (to avoid tight bends and breakage of the optical fiber) Fold a velcro around the ML-SLA cable and place the cable next to the slit lamp headrest so that the velcro is between the cable and the headrest (Figure 6) Wrap the velcro around the headrest and tighten to fix the ML-SLA cable position (Figure 6) Support the cable from two positions (Figure 7) Figure 6.
Product delivery package and installation 23 3.4 Rear panel The ML6710i is powered by connecting the AP0201 medical power supply to a wall socket with an AP0307 power cord. The power supply is then connected to the inlet at the right side on rear panel of the device. The power supply automatically detects 100–240 V operating voltage and is protected against short circuiting and overloading.
Product delivery package and installation 3.4.1 Connection and disconnection of SLA, interlock and foot switch The SLA, foot switch and the interlock are connected to the rear panel of the ML6710i with push-pull type connectors (Figure 9). Connection While connecting the push-pull connectors to rear panel, please keep the red dot on the connector to upwards direction. Push gently until the connector is all the way in its place.
Product delivery package and installation MANDATORY CAUTION 25 Before running a treatment, please inspect functionality of the interlock by removing the interlock connector or by releasing the remote interlock. The change of the interlock state must be visible on the GUI (see Figure 21). After confirming the functionality, place the interlock connector/remote interlock back to the original position. It is recommended to repeat this procedure each time when starting the main unit.
Product delivery package and installation Figure 11. Connecting the optical fiber of the SLA to the ML6710i rear panel. 3.4.2 Connecting power supply to DC IN The power supply’s DC cable is attached to the DC IN inlet as presented in Figure 12. In order to reduce of damaging of the power supply of the power cord by overstepping or overrunning, they shall be placed so that they are not on isles or on typical floor areas where people or equipment move frequently. Should the device e.g.
Product delivery package and installation Power OFF Power ON 3.4.3 Connecting power key The power key is symmetrical and can be inserted either way into the power switch. Figure 13 shows how the key is used for switching device power on ( | ) and off (O). Figure 13. Connecting the power key to the ML6710i rear panel. 3.
Operating the laser device 4. Operating the laser device This section contains instructions on how to operate the ML6710i. The examples cover the normal operation of the device as well as various error situations. Figure 14. Laser status indicators. 4.1 User interface on the main unit 4.1.1 ML6710i chassis On the main unit chassis upper edge there are LED’s indicating laser and device status. The middle LED is for indicating device status as explained in Table 6.
Operating the laser device 4.1.2 Foot switch LASER STOP button The foot switch in Figure 15 is used for starting treatment i.e. enabling laser emission with the orange pedal. The LASER STOP button is designed to disable all lasers rapidly in case of an emergency and is integrated on the foot switch. Laser emission switch Figure 15. Foot switch for enabling laser emission. Laser stop button is integrated into the foot switch.
Operating the laser device 4.2.2 iPad requirements Operating system requirements The ML6710i application is compatible only with specific versions of the iPad operating system. The Compatibility details are found in App Store under Information section of the ML6710i application. To enable safe and efficient use of the device also when new operating system versions are released, remember to disable automatic software updates from your iPad as shown in Figure 16. Figure 16.
Operating the laser device 31 Table 7. Supported iPad models. Type Model iPad mini 4 A1538, A1550 iPad, 6th generation A1893, A1954 This warning reappears until the ML6710i application and iPadOS version have been validated to be compatible with each other. To enable automatic update of the ML6710i application (e.g.
Operating the laser device Figure 19. Login failure e.g., due to incorrect password. 4.2.4 Navigation and status bars The ML6710i application is navigated via tabs with specific functionalities. Figure 20 shows the available tabs. Various device status information is given on the status bar displayed at the screen bottom. Figure 21 shows some examples of the messages. 4.2.5 Laser tab The main unit communicates with the iPad wirelessly via Bluetooth. Figure 22.
Operating the laser device 33 The ML6710i application remembers the last ML6710i connected. If the application is opened while the same previously connected laser device is available nearby, the application reconnects with the device automatically. Bluetooth pairing There are cases when you need to pair the iPad with the main unit, such as: Figure 23. Confirmation pop-up when pairing a new main unit with the GUI.
Operating the laser device available ML6710i is proposed. You may do this as many times as is needed to find the right device. When the desired laser device is proposed, the connection is done by tapping connect. The ML6710i is ready for use when the connection is established (status connected) and device State is Ready for operation as in Figure 22. 4.2.6 Treatment tab When you log in to the ML6710i application the treatment tab is selected by default.
Operating the laser device 35 Treatment log Treatment log lists previous treatments that have been done with the ML6710i (Figure 27). Treatment list is sorted by the treatment date starting from the latest treatment. Scroll down the list to see the older treatments. Tap a treatment in the list to see the detailed view of a treatment. As seen in Figure 28, the comments given after the treatment are displayed in the treatment details view.
Operating the laser device Figure 29. Password change window. Figure 30. Confirmation pop-up after selecting Logout. As internet connection is required for uploading treatment logs into the cloud service, it is not guaranteed that all executed treatments are successfully recorded in treatment history.
Operating the laser device Figure 31. Support tab. 4.2.8 Support tab 4.3 Running a treatment Support tab shown in Figure 31 provides means of contacting technical support and access to various instructions. This is a living feature with continuous updates. Treatment tab functionality is illustrated as a flow chart in Figure 32. Using ML6710i follows the same basic process: TREATMENT PLANNING Parameter invalid, warning message is shown. Treatment cannot be started.
Operating the laser device Set the treatment parameters Adjust the spot size Start the treatment Control the laser by using the foot switch. 4.3.1 Treatment planning Treatment planning screen in Figure 33 allows you to modify dose and irradiance values and set the correct contact lens specific to each patient. The available value range for each parameter is shown in Table 9. Treatment duration is calculated automatically according to dose and irradiance values set.
Operating the laser device 39 Figure 35. The spot size is selected by rotating the grip wheel on the SLA. Spot size view on GUI Figure 34. The spot size is selected by rotating the grip wheel on the SLA. Spot size selection Spot size is adjusted by turning the adjustment ring on the SLA (Figure 34). You may observe the spot size value from the GUI screen while adjusting the spot size from the SLA.
Operating the laser device Preparing the patient for the treatment Please consult the prescribing information for instructions regarding the drug administration before giving the laser dose. Please consult the instructions for use of the contact lens for proper use and maintenance. Please consult instructions for use of the slit lamp for proper use and maintenance. It is not mandatory to have laser safety eyewear on the untreated eye of the patient.
Operating the laser device Pausing a treatment You must press the orange pedal on the foot switch down to activate the laser. The laser is active as long as the foot switch pedal is pressed down and there is treatment time remaining. The remaining time is counted down only when the laser is active (Figure 38). You may release the foot switch emission pedal at any time during the treatment if needed. If the emission pedal is released the laser is set off immediately and the treatment is paused (Figure 39).
Operating the laser device Ending a treatment You may also end the treatment early. If you need to end the treatment before the full time has elapsed, tap the end treatment button. Please note that the treatment cannot be continued after this even though there is treatment time remaining. A confirmation is required if the user decides to end the treatment before full time has elapsed (Figure 40).
Operating the laser device 43 Commenting a treatment You may add a comment after ending the treatment. When selecting add comment, the commenting pop-up in Figure 42 is displayed. Here you can record notes or any other useful information related to the given treatment. The comment text may still be edited by tapping it, which opens the commenting pop-up again. After writing the comments and selecting save, the GUI returns to the treatment completed window.
Operating the laser device 4.3.3 Interrupted treatment The ML6710i is able to continue an interrupted treatment e.g., in case of power failure in the building. When the device is again powered and the Bluetooth connection between the main unit and iPad is re-established, the GUI shows the message given in Figure 44. After tapping continue treatment, the confirmation pop-up in Figure 45 is shown.
Operating the laser device CAUTION MANDATORY 45 Please note that when the GUI is disconnected some device features that are performed by the GUI will have limited availability. For example, error messages or elapsed time are not displayed and ending treatment early on the GUI is not possible. In the case of a disconnected GUI, treatment may be continued with the foot switch pedal until planned treatment time has elapsed or can be paused by releasing the foot switch pedal.
Operating the laser device Figure 48. Warning displayed when device calibration due date has passed and calibration has expired. Figure 49. Warning displayed when device calibration is overdue 30 days or more and device is disabled from use. After the due date has passed, a warning message of expired calibration (Figure 48) is given. Please note that the laser calibration cannot be guaranteed after calibration overdue.
Operating the laser device MANDATORY CAUTION 47 Follow the SLA inspection and cleaning protocol to avoid incorrect beam characteristics and wrong dose. Do not touch the optical surfaces of the SLA with bare hands. If the SLA optics seem damaged or cannot be cleaned with the methods specified in these Instructions For Use, please contact the manufacturer. For loose dirt, try an air duster first. For stains, wear rubber gloves and wipe the mirror with a dust-free cloth (e.g.
Operating the laser device 4.4.2 Preventive and periodic maintenance The ML6710i will show and alert for an approaching calibration/maintenance due date. Please contact the manufacturer authorized service personnel for ordering and scheduling of the preventive maintenance to avoid disabling of the calibration past-due device. The device is disabled from use after 30 days overdue. The service life of ML6710i is generally seven (7) years. Figure 51.
Operating the laser device 4.4.4 SLA output spot re-focus protocol In case of misaligned SLA output spot, follow the re-focus protocol below to avoid incorrect spot characteristics and wrong dose. MANDATORY 1. b. Set the slit lamp eyepieces to 0. Make sure the laser emission is off. 2. Turn the slit lamp on and adjust a proper illumination brightness. c. 3. d. Move and lock the slit lamp to a position where the slit lamp beam is in focus (beam edges are sharp).
Operating the laser device Beam focus reminder given in Figure 54 is displayed every now and then. An example of a focused beam is given in Figure 55. Figure 55. Beam adjusted to focus. Figure 54. Beam focus reminder.
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Labels and markings Manufactured by: Modulight, Inc. Hermiankatu 22 33720 Tampere, Finland 5. Labels and markings YYYY-MM-DD EID1234567 5.1 Device labels ML6710i FCC ID: 2ATGS-ML6710I Manufactured by: Modulight, Inc. Hermiankatu 22 33720 Tampere, Finland EID1234567 ML6710i AVOID EXPOSURE TO BEAM CLASS 3B LASER PRODUCT MAXIMUM OUTPUT: 400 mW (01)00000000000000 (21)1234567 (11)YYMMDD IC: 25072-ML6710I MODEL: ML6710i IEC 60825-1:2014 Manufacturer identification and address.
Labels and markings Key chain. Rev. X Laser warning sign that can be hung e.g., on the handle of the laser hazard area door. Mobile device cover label. Identification label on the laser safety goggles. Rev. X 5.2 Storage and transportation markings This side up. 50 °C 122 °F -20 °C -4 °F Acceptable temperature range of surroundings is -4° to 122° Fahrenheit (-20° to 50° Celcius). Identification label on the SLA. Handle with care, fragile material inside. Laser aperture label on the SLA.
Guidance and manufacturer’s declaration – electromagnetic emissions 6. Guidance and manufacturer’s declaration – electromagnetic emissions MANDATORY WARNING WARNING CAUTION CAUTION In order to prevent adverse events to the patient and yourself due to electromagnetic disturbances, please make sure all equipment in the room where this device is used are compliant with prevalent electromagnetic compatibility (EMC) standards and regulations and that the supply mains is suitable for this device.
Guidance and manufacturer’s declaration – electromagnetic emissions 55 Table 9. Electromagnetic emissions – ML6710i device. Emission tests Compliance RF emissions CISPR 11 Group 1 Class A Harmonic emissions IEC 61000-3-2 Voltage fluctuations/flicker emissions IEC 61000-3-3 Complies Electromagnetic environment – guidance The laser system uses RF energy only for its internal function. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration — electromagnetic safety The ML6710i is intended for use in the electromagnetic environment specified below. The owner/ user of this device is responsible for assuring that it is used in such an environment. Table 10. Electromagnetic safety – ML6710i device.
Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration — electromagnetic immunity The ML6710i is intended for use in the electromagnetic environment specified below. The owner/ user of this device is responsible for assuring that it is used in such an environment. Table 11. Electromagnetic immunity – ML6710i device.
Troubleshooting 7. Troubleshooting 7.1 Solving problem and error situations Problems, warnings and notifications given by the GUI and ML6710i indicators are explained in Table 13. In case any of these events, follow the instructions given on the GUI and this table. Table 13. ML6710i warnings and notifications. Description Required action iPad doesn’t connect to the main Make sure main unit power is on (see section 3.4.5 and that Bluetooth is enabled in unit the iPad settings.
Troubleshooting MANDATORY 59 If even after the instructed actions a problem/warning message reappears, please disable the device from use and contact the manufacturer for service. The functionality of the device may have been compromised due to an internal or external factor (e.g., electromagnetic disturbances). Description Required action Desired lens is not available in treatment planning Please go to my settings tab and tap My lenses row.
Troubleshooting Description Required action Foot switch is disconnected. Foot switch is not detected. You must properly plug in the foot switch connector. If the problem persists, please contact technical support. SLA is not detected. SLA is not detected. You must properly plug in the SLA connector. If the problem persists, please contact technical support. Interlock / optical fiber / foot switch / SLA are disconnected Multiple items are not connected.
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FINLAND USA Modulight, Inc. Hermiankatu 22 33720 Tampere, Finland Tel. +358 20 743-9000 sales@modulight.com Modulight USA, Inc. 2033 Gateway Place Suite 500 San Jose, CA 95110 Tel. (408) 573-6291 iPad is a registered trademark of Apple, Inc. and is included herein for information purposes only; no sponsorship or endorsement by, or affiliation with, Apple, Inc. is implied. © 2020, Modulight, Inc. All rights reserved.
