N-LINEpro User Manual

User Manual & Technical Description N-LINEpro

USER MANUAL & TECHNICAL DESCRIPTION Table of Contents 1 GENERAL INFORMATION............................................................................................................................4 1.1 Delivery Contents .................................................................................................................................4 1.2 Manual Use ..........................................................................................................................................4 1.3 Device Description................................................................................................................................5 1.4 Intended Use ........................................................................................................................................5 1.5 Symbols & Definitions ..........................................................................................................................6 2 WARNINGS & SAFETY REGULATIONS .........................................................................................................6 2.1 Definitions ............................................................................................................................................6 2.2 Electrical Shock Hazards.......................................................................................................................7 2.3 Light Exposure Hazards ........................................................................................................................7 2.4 Other Hazards.......................................................................................................................................8 3 OPERATION & HANDLING...........................................................................................................................8 3.1 Handling ...............................................................................................................................................8 3.1.1 Optional Features ........................................................................................................................9 3.2 Operation .......................................................................................................................................... 10 3.2.1 Stand-By Mode ......................................................................................................................... 10 3.2.2 Therapy Type ............................................................................................................................ 11 3.2.3 Dose or Time Input ................................................................................................................... 11 3.2.4 Ready State............................................................................................................................... 12 3.2.5 Therapy..................................................................................................................................... 13 3.3 Menus & Settings .............................................................................................................................. 13 3.3.1 Settings ..................................................................................................................................... 13 3.3.2 Protocol .................................................................................................................................... 14 3.3.3 Info............................................................................................................................................ 14 3.3.4 Set Dose Units........................................................................................................................... 15 3.3.5 Dose Limits & Dose Warnings................................................................................................... 15 3.3.6 Assigning a Cabin Identifier ...................................................................................................... 15 3.3.7 Set PIN Code ............................................................................................................................. 15 3.3.8 Change Therapy Steps .............................................................................................................. 16 3.4 System Messages .............................................................................................................................. 16 3.4.1 Warning Level Exceeded........................................................................................................... 16 3.4.2 PIN Code Required.................................................................................................................... 17 3.4.3 Maintenance Required ............................................................................................................. 17 3.4.4 UV Output Low ......................................................................................................................... 18 3.4.5 No Connection .......................................................................................................................... 18 4 INDICATIONS ........................................................................................................................................... 19 4.1 UVB 311 nm – Indications ................................................................................................................. 19 4.2 UVA1 – Indications ............................................................................................................................ 19 4.3 UVA (PUVA) – Indications.................................................................................................................. 19 5 CONTRAINDICATIONS.............................................................................................................................. 19 6 SIDE EFFECTS ........................................................................................................................................... 20 6.1 UVB – Side Effects ............................................................................................................................. 20 N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 2 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 6.2 UVA – Side Effects ............................................................................................................................. 20 7 TREATMENT RECOMMENDATIONS......................................................................................................... 22 7.1 Treatment Instructions...................................................................................................................... 22 7.2 UVB – Treatment Recommendations................................................................................................ 22 7.3 UVA (PUVA) – Treatment recommendations.................................................................................... 24 8 TECHNICAL SPECIFICATIONS & INFORMATION ....................................................................................... 25 8.1 Technical Data ................................................................................................................................... 25 8.2 Conditions for Transport, Storage & Operation................................................................................ 26 8.3 Cleaning & Disinfection ..................................................................................................................... 26 8.3.1 Cleaning of Lamps & Lamp Covers ........................................................................................... 27 8.3.2 Cleaning underneath the Cabin................................................................................................ 27 8.4 Electromagnetic Compatibility (EMC) ............................................................................................... 27 8.5 Spectral Ranges ................................................................................................................................. 28 8.6 Accuracy ............................................................................................................................................ 28 8.7 Maintenance & Repair ...................................................................................................................... 28 8.8 Lamp Ageing & Replacement ............................................................................................................ 29 9 OTHER INFORMATION............................................................................................................................. 29 9.1 Warranty ........................................................................................................................................... 29 9.2 Expected Service Life......................................................................................................................... 29 9.3 Disposal Note .................................................................................................................................... 30 9.4 Equipment Classification ................................................................................................................... 30 9.5 Contact Details .................................................................................................................................. 30 N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 3 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 1 GENERAL INFORMATION 1.1 Delivery Contents Item-No. Description Quantity The particular device type can be 4557 N-LINEpro UVB 311 nm identified by the corresponding name 4558 N-LINEpro UVA 1 plate on the device. 4559 N-LINEpro UVA + UVB 311 nm 80100 Patient goggles 2 80200 Personnel safety goggles 1 User manual 1 Optionally available accessories & spare parts 80100 Patient goggles 80200 Personnel safety goggles 83270 UVA tube 100 W 83221 UVB 311 nm tube 100 W 90810 UVA1 tube 100 W 86963 Intercom system 84002 Surveillance camera 4560 SKINdex software 1.2 Manual Use This user manual & technical description is an integral part of this device. Anyone operating this device must read and understand this manual in its entirety before operating the device, including all warnings, cautions, and instructions. Instructions vital to the safety of persons operating the device, receiving treatment from the device and property, including but not limited to the device, are contained in this manual. If these instructions are not understood and followed, damage and serious injury, including death, can be caused. This manual conforms to all regulatory standards applicable to the device at the time of manufacture of the device and the original printing of the manual. All rights are reserved for the device design and all associated materials, including software and mechanical applications and methods, trade names and logos used. The device and manual are subject to change without notification. No part of this manual may be reproduced or used for any purpose other than operating the device unless expressed written consent is obtained from MEDlight GmbH. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 4 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 1.3 Device Description The N-LINEpro from MEDlight is a medical full body UV phototherapy cabin. The device is available with the spectra UVA and UVB 311nm, and can be equipped with 40 lamps of the same type, or with a combination of two different spectra with 20 lamps each. For accurate dose application the cabin is equipped with a UV dosimetry which measures the irradiance in real time, and corrects the exposure time accordingly. The device is operated via a modern touch screen, which allows simple, practice oriented input of therapy parameters. 1.4 Intended Use The device may only be used for such application areas, as described in the manual. The device finds application in dermatology, and is intended for the treatment of skin diseases like psoriasis, atopic dermatitis, and vitiligo on all skin types. It may only be operated by such persons who can ensure a proper handling, due to their profession or their knowledge and practical experience. The device may only be operated under permanent supervision of the user. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 5 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 1.5 Symbols & Definitions ATTENTION Sections marked with this symbol must be read with special attention TYPE B EQUIPMENT PROTECTIVE EYEWEAR MUST BE WORN REFER TO USER MANUAL MANUFACTURER DATE OF MANUFACTURE SERIAL NUMBER CATALOGUE NUMBER DO NOT DISPOSE OF ELECTRICAL APPLIANCES AS UNSORTED MUNICIPAL WASTE 2 WARNINGS & SAFETY REGULATIONS Note: Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established. 2.1 Definitions Warning: Indicates a hazard. If not avoided, the hazard can result in death or serious injury. Caution: Indicates a potentially hazardous situation. If not avoided, this hazard may result in minor personal injury and/or product/property damage. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 6 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 2.2 Electrical Shock Hazards Warning: To avoid the risk of an electric shock, the device must only be connected to a power supply with a protective earth. The power supply must be in accordance with all national and local installation regulations. The device may only be operated with the power supply voltage specified on the nameplate. Warning: Prior to each use, always verify that the device is in correct working order and operating condition. Therefore check also plugs, wires, switches and other control devices, as well as the irradiation unit and all mechanical components. Upon discovery of faulty, worn, or damaged component(s), MEDlight authorised service personnel must replace the component(s) and test the device prior to placing the device in use again. Warning: If you notice unusual noises, smoke, sparks or burning smell from the device, immediately switch it off and do not put it back in operation. Contact MEDlight for a repair, and do not use the device again until it is repaired, tested and released by MEDlight authorised service personnel. Warning: Open under no circumstances the device housing. Turn off the device when it is not used. Warning: Place the device in such a way that the mains plug or the mains connection remains easily accessible at all times in order to enable a disconnection from the mains. Warning: Ensure that the device is serviced at least annually, by MEDlight authorised service personnel. 2.3 Light Exposure Hazards Warning: The UV light of the device can lead to serious eye injury. To protect the eyes during operation, patients must wear tightly fitting UV blocking goggles, and the operator and anyone in view of the device must wear protective UV blocking glasses or goggles. Suitable UV blocking glasses and goggles are included in the delivery contents. It is recommended to provide an individual pair of glasses for ever user, and an individual pair of goggles for every patient. If required, further goggles can be obtained from MEDlight. Furthermore it should be avoided to look directly into the light, during operation. In order to protect personnel from stray UV in the vicinity of the device, it is recommended to operate the device only in a designated treatment room. Operating personnel exposed to UV radiation for any prolonged periods of time should wear long-sleeved clothing and gloves and use barrier creams with a high light protection factor on exposed skin areas. Caution: To ensure an all-around homogenous light exposure, the patient must stand in the middle of the cabin. Instruct your patients to remain in this position throughout the entire treatment to avoid partial overdosing. Caution: Use of controls or adjustment or performance of procedures other than those specified in this user manual may result in hazardous radiation exposure. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 7 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 2.4 Other Hazards Warning: Modifications of the device are not allowed. Operate the unit therefore only with original equipment, supplied by MEDlight. Warning: Do not store or operate the device in humid areas. The device must never be directly exposed to flowing or splashing liquid or water. Also, be careful when cleaning with a damp cloth to ensure that no liquid enters the device. Warning: The device must not be operated in the presence of a flammable anesthetic mixture with air, oxygen or nitrous oxide or where flammable substances such as alcohol, fuel or similar substances are used. Caution: Make sure that the UV sensors of the cabin are not covered during the treatment. Especially with very large patients, make sure that there is always a minimum clearance of 5 cm (2\") between the patient and the cabin roof. Otherwise, the patient's head could interfere with the measurements of the UV sensors. Caution: Patients with a body weight of more than 180 kg (395 lb) must not be treated in this cabin. Caution: Lay the power cord so that there is no danger of tripping up a person. Caution: Ensure that the ventilation slots of the device are not covered, so that sufficient air circulation is ensured. Caution: For reasons of hygiene, we recommend to lay a new disposable paper towel on the floor plate of the cabin before each treatment. 3 OPERATION & HANDLING 3.1 Handling The device shall only be installed by authorised MEDlight technicians. A detailed device training usually takes place immediately after installation. Additional trainings can be arranged upon request. Plug the mains plug of the cabin in a protectively earthed CEE outlet which is fused with 16 amps fuses. As soon as the cabin is switched on via the green mains switch on the left side of the touch screen console and the touch screen booted up, the cabin is ready for use. Please, switch the device always off via the green mains switch, if the cabin is not in use for a longer time and at the end of each working day. To protect the cabin against unauthorised use is also recommended to set up a PIN code (see section 3.3.7). The well-structured menus of the touch screen allow an easy intuitive operation of the device. To navigate through the menus just tap the desired button or a menu or use swipe gestures to go back and forth between different menus. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 8 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION For enhanced safety and comfort during operation the onscreen navigation is accompanied by voice messages of the system. These voice messages warn you e.g. if certain dose levels are exceeded, and inform the patient about the remaining treatment time. When you open the cabin door and look up, you will see an oval casing mounted on top of the cabin roof. This casing holds the UV measuring unit of the cabin's dosimetry with a total of four sensors, which continuously monitor the irradiance of the UV tubes during treatments. This ensures a precise application of doses, even if the irradiance of the UV tubes changes, because the exposure times will be accordingly adjusted in real time by the dosimetry. The cabin door is equipped with a door contact which shuts off the UV tubes and pauses the treatment whenever the cabin door is opened. This protects the operator from UV exposure and allows the patient to interrupt the treatment if necessary. Inside the cabin are two long handrails to which the patient can hold on to during treatment. On the right handrail is a patient panel mounted, which is equipped with an emergency off ripcord switch. The end of the ripcord can be affixed to the patient's upper arm with the aid of a Velcro noose to automatically actuate the emergency off switch in case the patient collapses during treatment. In this event the UV tubes shut off and an audible alarm is activated. On top of the cabin is a patient fan mounted, that comes on automatically with the other fans of the cabin during treatment. This fan delivers an airstream which makes in particular longer treatments more comfortable for patients. In case a patient doesn't want this airstream, the patient fan can be switched off with the switch in the patient panel. 3.1.1 Optional Features The N-LINEpro cabin is network capable and therefore equipped with an according network connector on the rear side of the left cabin module. This allows to connect the cabin via a network cable (at least Cat6) to a Windows® PC from which it can be remotely operated in conjunction with the MEDlight SKINdex software. To prevent an unauthorised use of the cabin’s touch screen it is automatically locked during remote operation. Besides the remote operation of the cabin, the SKINdex software offers an extensive set of practice approved features for patient management and treatment planning. To keep in touch with patients also during remote operation, MEDlight offers an optional intercom system that enables a bidirectional communication via network. For this purpose the patient panel inside the cabin is already equipped with a microphone and a speaker. The microphone in the cabin becomes active at a certain sound threshold, and therefore works automatically as soon as the patient says something. Some patients might need special attention and therefore require to be checked from time to time during treatment. For this reason the cabin is equipped with a viewing window. To provide the same level of attention also during remote operation, MEDlight offers an optional surveillance camera for the N-LINEpro. The video signal is broadcasted via network, and can be viewed right in the SKINdex software. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 9 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.2 Operation 3.2.1 Stand-By Mode After switching on the device, the touch screen shows the display shown on the right. If your cabin is equipped with only one lamp type, only the output of the corresponding spectrum will be displayed. The green bar to the right of the mW/cm² value is for orientation with respect to the condition of the UV tubes. The more the UV tubes lose power over time due to wear, the more the green bar decreases. At very low output of the UV tubes, the colour of the bar then changes to red. In order to ensure an uninterrupted use of the cabin, it is advisable to replace the UV tubes when the green bar is only half the original length. To proceed with the selection of the desired therapy parameters, please press the CONTINUE button. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 10 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.2.2 Therapy Type If the cabin is equipped with only one UV tube type, this menu item is omitted and you can proceed directly to section 3.2.3. For devices that are equipped with a combination of UVA and UVB tubes, you can select the desired type of therapy in this menu. For a treatment with UVA please press the UVA BUTTON (as shown in this example) and for a treatment with UVB press the UVB button. If a UVA and UVB treatment are to be combined, swipe from right to left over the screen or select COMBINED THERAPY by tapping on the corresponding menu tab. In this menu, you can specify the order in which the treatment should take place. In the example shown, the UVA treatment would be carried out first, followed by the UVB treatment. For a reverse order (UVB first, followed by UVA), please push the lower of the two selection buttons. After you have made your settings for a single therapy or a combined therapy, please press the CONTINUE button to go to the next menu item. If you want to switch back to the previous menu (3.2.1), press the arrow button ← in the upper left corner of the screen. 3.2.3 Dose or Time Input In this menu you can set the desired dose. To do this, first touch the input field to open the numeric keyboard of the touch screen. Now enter the desired dose and press the enter key ( ) of the keyboard. Below the input field, the expected treatment time is now displayed and on the bottom right of the screen a green CONTINUE button appears. In addition to the direct entry of a dose, it is also possible to select a dose N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 11 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION via pre-set therapy steps. For this input option, swipe from right to left across the screen or tap on the THERAPY STEPS menu tab. The twelve pre-set dose values in this menu can also be individually adapted to your needs (see section 3.3.8). Select the desired dose by tapping on the corresponding field, then press the CONTINUE button to confirm the selection. However, if you prefer to enter an exposure time instead of a dose, swipe again from right to left across the screen, or tap the TIME ENTRY menu tab. Tap on the input field and enter the desired treatment time in minutes and seconds via the on-screen keyboard and press the enter key ( ). The dose that corresponds to the set treatment time is displayed below the input field. To confirm the entered treatment time and to go to the next program step, press the CONTINUE button. 3.2.4 Ready State The cabin is now ready for treatment. Before the therapy is started, check in this menu again the correctness of your previously set therapy parameters. In case that a correction is required, press the arrow button ← to return to the previously described menu. However, if all entries are correct, the patient can now enter the cabin. Please read section 7.1 TREATMENT INSTRUCTIONS before you press the START button to start the therapy and switch on the UV tubes! N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 12 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.2.5 Therapy During therapy, all relevant treatment parameters such as dose, treatment time and light output of the currently active UV tubes are displayed on the screen. The exposure time is calculated in real time according the actual UV output, which is continuously measured by four sensors. It is therefore normal that the displayed time is slightly bouncing instead of elapsing continuously in one-second increments. The end of the therapy is indicated by an acoustic signal, the UV tubes switch off automatically and the program returns to the menu described in section 3.2.1. Should it be necessary to cancel an ongoing therapy, you can do this by pressing the CANCEL TREATMENT button. In this case the lamps switch off immediately, and the program also returns to the menu described in section 3.2.1. However, if you only want to interrupt the treatment for a short while rather than to cancel it completely, press the SUSPEND THERAPY button or simply open the cabin door. In this case, the UV tubes switch off and the exposure time is paused. As soon as the SUSPEND THERAPY button is pressed again, respectively the door is closed, the UV tubes switch on again and the therapy continues. 3.3 Menus & Settings 3.3.1 Settings In this menu you can set the date and time and select the desired system language. The cabin has a notification system with spoken announcements. The user and the patient are thus provided with warning and safety instructions in a comfortable manner as well as useful information on the treatment (e.g. announcement of the remaining treatment time). This announcement system considerably increases the operational safety of the device and is therefore activated by default. If these announcements are not desired, they can also be deactivated by pressing the AUDIO NOTIFICATIONS button. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 13 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION In the lower right-hand corner of the screen you will see the text EXTENDED, which you can tap to open a menu with further, extensive setting options. The contents and functions of this menu are described below in sections 3.3.4 - 3.3.8. 3.3.2 Protocol In the PROTOCOL menu you will find an overview of the last 100 treatments that were carried out with the cabin. The entries are sorted by date and each line contains all treatment- relevant information such as the spectrum of UV tubes used, dose and treatment time. For treatments that have not been completed, the corresponding entry is shown in red. To view older entries simply swipe your finger from the bottom to the top of the list area. 3.3.3 Info In the INFO menu you can see the operating hours of the UV tube types used. You will also find information about the next required maintenance date, as well as the software version and IP address of the cabin. With the TUBE CHECK button the UV tubes can be switched on even with the door open, so that their function can be checked. However, this is only permitted with the use of appropriate UV protective equipment (UV protective eyewear, UV protective clothing and sunscreen with a high sun protection factor). Always follow the safety instructions in section 2.3 of this manual. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 14 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.3.4 Set Dose Units In this menu, you can set the desired dose unit for each available UV tube type. To do this, select J/cm² or mJ/cm² from the corresponding dropdown menu. 3.3.5 Dose Limits & Dose Warnings To avoid the accidental input of excessive doses, the device has adjustable dose limits. The maximum dose limit for UVA is 12.0 J/cm² and for UVB 6.0 J/cm². To change these values according to your requirements tap on the corresponding DOSE LIMIT input field and enter the desired dose limit. As an additional safety measure, a DOSE WARNING threshold can also be set in the correspondingly marked input field. In this case, a warning message will appear on the screen as soon as a dose is entered that is equal to or greater than the value set for the dose warning threshold. The dose can still be used, but the user must confirm the message so that entering a higher dose becomes a conscious act. 3.3.6 Assigning a Cabin Identifier In particular, if more than one cabin is operated, it makes sense to assign an identifier to the cabins in order to avoid confusion of the devices. Do this, tap the input field CABIN IDENTIFIER and enter a unique name for the device using the on-screen keyboard. If the cabin is used in conjunction with the SKINdex software, the assigned name automatically appears in the SKINdex software as well. 3.3.7 Set PIN Code To prevent unauthorized use of the cabin, as well as changes to the EXTENDED SETTINGS menu, a PIN code should be set. Press the SET button below the text PIN QUERY to open the corresponding menu. Select the conditions for which you would like a PIN query by tapping the appropriate button. Then press the CHANGE PIN CODE button, enter the desired PIN and confirm with the enter key ( ). To ensure that the desired PIN was entered correctly, you must enter the PIN a second time and confirm again with Enter. By pressing the OK button, your PIN settings become active and the menu closes. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 15 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.3.8 Change Therapy Steps When you are in the EXTENDED SETTINGS menu, swipe from right to left across the screen or tap the THERAPY STEPS menu tab. Depending on the UV tube types the cabin is equipped with, you have either a THERAPY STEPS menu tab for UVA or one for UVB. In cabins that are equipped with two different types of tubes, both menu tabs are available, as shown in the example. To change the dose values for the therapy steps simply tap on the respective input field and enter the desired dose. After making the desired changes in the EXTENDED SETTINGS menu, press the arrow button ← in the upper left corner of the screen to exit the menu. 3.4 System Messages 3.4.1 Warning Level Exceeded If a dose warning level has been set as described in section 3.3.5 and a dose equal to or greater than the set warning threshold is entered, this message is displayed. Please make absolutely sure that the selected dose is actually correct. If this is the case, you can close the message by tapping the  in the upper right corner of the message window. Subsequently, you can proceed with the selected dose as usual. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 16 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.4.2 PIN Code Required If you have set up a PIN code protection, as described in section 3.3.7, then this window appears for the respectively defined menu items. Enter the assigned PIN and press the enter key ( ). The window with the PIN prompt closes and you can now continue with the operation as usual. 3.4.3 Maintenance Required To ensure the safe operation of the device, annual maintenance is recommended. To ensure that maintenance is not forgotten, an authorized technician can set a service interval in the service menu as needed. In this case a corresponding reminder appears on the screen each time the cabin is switched on. You can close this reminder by tapping the  in the upper right corner of the message window. Afterwards the cabin can be operated as usual. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 17 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 3.4.4 UV Output Low The device is equipped with a so called dosimetry which continuously measures the irradiance during therapy, and adjusts the exposure time accordingly in real time. If this measuring system detects a fault during treatment, e.g. if some UV tubes or a sensor have failed or a sensor has been covered, the device aborts the treatment and a corresponding message appears on the display. In this case check if all UV tubes are actually working (see section 3.3.3). Afterwards carry out a test treatment without patient, which takes more than two minutes. Should the fault still persist after the test treatment, please contact the MEDlight service! 3.4.5 No Connection The touchscreen is connected to the controller of the cabin via an internal network connection. If communication over this network connection is interrupted, e.g. because a network cable or the internal network switch is defective, the message NO CONNECTION is displayed. In this case, contact an authorised MEDlight service technician immediately to resolve the issue. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 18 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 4 INDICATIONS 4.1 UVB 311 nm – Indications Indication UVB 311 nm Psoriasis ++ Atopic Dermatitis ++ Parapsoriasis en plaques + Prophylaxis of polymorphic light dermatosis ++ Vitiligo ++ + recommendable ++ superior Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 4.2 UVA1 – Indications  Atopic Dermatitis Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 4.3 UVA (PUVA) – Indications Indication PUVA orally PUVA bath PUVA hand / foot bath Psoriasis vulgaris ++ Palmoplantar Psoriasis ++ + Atopic Dermatitis ++ Dyshidrotic hand and foot eczema + Parapsoriasis en plaques Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 5 CONTRAINDICATIONS  Tumorous skin lesions  Porphyrinic disease  Pathological photosensitivity of the skin  Florid tubercuosis or other florid processes  Hyperthyreosis  Lupus erythematodes N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 19 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION  Accompanying medication with the potential of causing skin damage or increasing photosensitivity Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 6 SIDE EFFECTS 6.1 UVB – Side Effects The most common acute side effects include sunburn-like erythema after UVB irradiation. Without eye protection acute conjunctivitis and keratitis may occur. After UVB phototherapy, however, no reliable increase in the risk for basal cell carcinoma was so far observed. Recent works confirm this also for the narrowband-spectrum application in contrast to theoretical considerations that want to ascribe a 50% risk increase for carcinoma to the narrowband spectrum UVB therapy. Side Effect UVB ++ Erythema if overdosed Phototoxic reaction due to unintentional intake of a photosensitizer ± Conjunctivitis and keratitis (if no eye protection is used) ++ Provocation of photodermatoses + UV-Lentigines + Photoaging of the skin ++ Actinic keratoses and squamous-cell carcinoma + Melanoma ? ++ high risk + moderate risk ± low risk ? in principle possible, but no data available Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 6.2 UVA – Side Effects The most common acute side effects are phototoxic reactions due to an overdose irradiation in the context of photochemotherapy. Without eye protection acute conjunctivitis, keratitis and for UVA or PUVA treatment a chronic cataract may occur. The provocation of photodermatoses, mainly polymorphic light eruption, is possible, particularly in the higher dosed UVA therapy. If inadvertently phototoxic substances or drugs are supplied externally or systemically, excessive phototoxic skin reactions may occur, especially in UVA treatments or photochemotherapy. Occasionally, a PUVA-itching may occur, which can therapeutically hardly be influenced, and sometimes leads to the discontinuation of the therapy. Rarely, acral blisters appear during PUVA treatment due to a loosening of the dermo-epidermal border zone with strong mechanical stress. The potential systemic toxicity of the photochemotherapy encompasses nausea after the tablet intake and occasional N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 20 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION headache or dizziness, caused by the photosensitizer. The nausea can be avoided by using of 5-MOP instead of 8-MOP. As chronic damage of the photo(chemo)therapy occur UV-induced lentigines, light-induced skin aging and especially the development of actinic keratoses and invasive squamous cell carcinomas. Statistically secured is the development of squamous carcinoma after systemic PUVA treatment with high cumulative UVA doses, or with a high number of individual treatments. In modern PUVA therapy, cancer risk is probably much lower than in the prospectively conducted American PUVA cohort from the 70s, because nowadays a much more careful patient selection is performed, and improved irradiation protocols with only rare excessive phototoxic reactions and the consequent use of combination therapies, and the avoidance of maintenance treatments lead to a significantly lower phototoxic burden of the skin. After bath PUVA treatments, an increased carcinoma risk has so far not been observed. This may be based on statistical deficiencies of the present studies, or a still too short follow-up period. Until this question is resolved, a strict indication selection for bath-PUVA therapy must be demanded. Basal cell carcinomas are probably not induced by the photo(chemo)therapy; controversial is the induction of melanoma due to PUVA treatment or higher dosed UVA irradiation. Side Effect UVA / UVA1 UVA / UVA1 PUVA <20 J/cm² >20 J/cm² ++ Erythema or phototoxic reaction due to overdosing -- -- ++ Phototoxic reaction due to unintentional intake of a photosensitizer + ++ ++ Conjunctivitis and keratitis (if no eye protection is ± used) -- -- Provocation of photodermatoses + ++ UV-Lentigines ± + ++ Photoaging of the skin ± ++ ++ Actinic keratoses and squamous-cell carcinoma ? ± ++ Melanoma ? ?? ++ high risk + moderate ± low risk -- due to known mechanisms ? in principle possible, risk of action not likely but no data available Because of the potential, acute and chronic risks of photochemotherapy, the indication must be kept strict. This requires also particular demands on the participation of the patient. Besides the general guidelines, following recommendations apply:  A combination treatment with Cyclosporine A, has to be avoided.  Particular caution is advised for the pre-treatment with arsenic or X-rays, with concomitant use of photosensitizing drugs, with more pronounced liver damage (delays in metabolic insufficiency the sensitization phase, which must be taken into account) and at high cumulative UVA doses (more than 150-200 individual treatments). In some cases, these circumstances may constitute a contraindication.  Regarding the risk of combination with systemic fumarates, no field reports exist. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 21 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION  A combination of photochemotherapy with Methotrexate is possible. The rare reactivation of UV erythemas, due to MTX intake, must be taken into account.  Under treatment with Azathioprine, UVA may have a mutagenic effect by oxidative DNA damage. Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 7 TREATMENT RECOMMENDATIONS 7.1 Treatment Instructions Already before a treatment starts, and of course whenever the UV tubes are on, anyone in view of the device must wear protective UV blocking glasses. The patient must wear tightly fitting UV blocking goggles before the cabin is entered, and at all times during treatment. The operator must ensure that the patient takes the correct treatment position and remains in that position throughout the treatment. For this, the patient must stand on the corresponding foot markings of the floor plate and face the door. In addition, the patient should hold on to the handrails on the left and right of the door. As additional safety measure the Velcro noose of the ripcord emergency switch should be affixed to the right upper arm of the patient. The patient can turn the patient fan on or off himself as needed via the correspondingly marked switch in the patient panel. The patient must be instructed to stand as still as possible in the middle of the cabin, to ensure all around uniform exposure distances to the UV tubes during treatment. Special attention must be paid to very tall patients, who are 2 meter (6.5') or taller. There should always be a clearance of at least 5 cm (2\") between the head of the patient and the roof of the cabin. This ensures, that the head of the patient does not impair the measurements of the sensors, which could otherwise lead to interferences of the dosimetry. If necessary, the patient must slightly crouch down during treatment to ensure a sufficient distance to the sensors. For corpulent patients, it must be ensured that there's a distance of at least 15 cm (6\") between pronounced body areas (e.g. belly, buttocks) and the acrylic lamp covers, otherwise the shorter exposure distances might lead to partial erythemas. In order to avoid erythemas in these cases, a reduction of the required dose might be a viable option. However, patients with a body weight of more than 180 kg (395 lb) must not be treated in the N-LINEpro. 7.2 UVB – Treatment Recommendations In order to avoid any undesirable interaction between light and any topical preparations and to make full use of the photo therapeutically effect, the patient's skin should be free from such topical preparations before phototherapy is performed. Cutaneous scales should be thoroughly removed. At least 20-30 sessions will be necessary before disappearance of symptoms, depending on their clinical appearance. Irregularly performed treatments can impair or even jeopardize the therapeutically success. Regular treatment will assure a satisfactory healing process until symptoms disappear. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 22 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION There is no treatment scheme uniformly applicable to all patients. Phototherapy should always be adapted to the individual needs of a patient. All dosage indications are mean values which may vary according to skin condition and sensitivity. UVB – Initial Doses Skin Type UVB 311 nm (J/cm²) I 0.20 II 0.30 III 0.50 IV 0.60 Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur Phototherapie und Photochemotherapie‘ DDG Berlin 2009 Depending on the photosensitivity of the patient and the clinical picture, the treatment dose can be individually further increased accordingly. Due to individual skin sensitivity, itching / skin irritation may occur following initial treatment. Patients should be informed of this prior to the commencement of therapy. Should itching / irritation occur, doses should not be increased for several days until these complaints have subsided. Emollient treatment of the skin is recommended after every phototherapy treatment. UVB 311 nm - Dose Examples Treatment scheme: Example for skin type II Day 1 0.30 J/cm² Day 6 0.60 J/cm² Day 2 0.35 J/cm² Day 7 0.60 J/cm² Day 3 0.40 J/cm² Day 8 0.70 J/cm² Day 4 0.45 J/cm² Day 9 0.70 J/cm² Day 5 0.50 J/cm² Day 10 0.80 J/cm² Depending on the individual response of the patient the dose can be accordingly increased in smaller or bigger steps. An increase of more than 0.2 J/cm² should never be exceeded. UVB - Follow-Up Treatment After the treated lesions have healed, treatment should be phased out using the protocol set out below. This gradual withdrawal is needed to achieve a prolonged recurrence-free period. 1st follow-up week: 3 x the last selected dose of the therapy 2nd follow-up week: 2 x the last selected dose of the therapy 3rd follow-up week: 1 x the last selected dose of the therapy 4th follow-up week: 1 x the last selected dose of the therapy N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 23 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 7.3 UVA (PUVA) – Treatment recommendations Recommendations on the initial dose in photochemotherapy PUVA orally PUVA orally PUVA-bath (1.0 mg/l 8-MOP) Skin Type (8-MOP) (5-MOP) J/cm² J/cm² J/cm² 0.2 I 0.3 0.4 0.3 II 0.5 1.0 0.4 III 0.8 1.5 0.6 IV 1.0 2.0 Alternatively, the initial dose can be specified by determining the minimal phototoxic dose (MPD). The initial phase of the treatment extends almost to the absence of clinical symptoms. Irradiations are carried out two to four times per week, but at least twice a week. Dose increases should not be made more frequently than at intervals of 72 hours (European PUVA protocol). There is no fixed scheme for dose increases, the essential parameters should be the response of the treated skin disorder and the individual sensitivity to photochemotherapy. A barely recognizable erythema is seen, as clinical indicator for an adequate UVA dosage. Ahead of each UV-treatment patients should be asked regarding subjective signs of intolerance or overdosage. The below described procedure has proven in practice. Photochemotherapy treatment regimen Steps Determination of PUVA orally PUVA-bath the minimal 1 phototoxic dose Evaluation after Evaluation after (optional) (MPD) 72-96 hours 96-120 hours 2 Start of treatment Initial dose Standard dose Standard dose according to skin type according to skin type No erythema, respectively 50-70% of respectively 30% of good response MPD MPD Increase by Increase by Minimal 30% max. 30% max. twice per week twice per week Continuation of the erythema No increase No increase 3 treatment, two to Persistent No increase No increase four times per asymptomatic No treatment until No treatment until remission remission week erythema Reduction of last dose Reduction of last dose Painful erythema by 50%, further by 50%, further increase by 10% increase by 10% with or without edema or blistering 4 Resumption of After remission of treatment symptoms N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 24 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION Because of the risk of accumulation of the phototoxic effect of successive PUVA treatments due to the much-delayed phototoxic reaction, after two days of irradiation, an irradiation-free day is provided. This avoids strong excessive phototoxic reactions. Thus results in a scheme by which patients are treated on Monday, Tuesday, Thursday and Friday. Wednesday, Saturday and Sunday provide rest and observation days. During the initial phase, at least three treatments per week are desirable. During PUVA treatment occurs as a result of the increasing pigmentation and thickening of the epidermis, a habituation effect (tolerance). The extent of the tolerance development depends on the skin type. In patients with skin type I or II, the tolerance development is slow, therefore the dose should be increased very carefully. In patients with skin types III, IV, V and VI, the UV tolerance develops rapidly, accordingly quickly can the UVA dose be increased. To avoid an overdosing by accumulation, it must be taken into account for the dose adjustments, that the maximum PUVA erythema appears 72 to 120 hours after irradiation. Because of the higher level of sensibilization, the irradiation doses for bath PUVA treatments are generally lower. It has to be noted that the MPD can drop by up to 50% during the first therapy week, but later rises again. The reason for this is not known, it is believed that psoralen monoadducts persist in the DNA and being transformed in subsequent irradiations into phototoxic effective biadducts. Generally, it is recommended to increase in the bath PUVA treatment only once a week the dose. Source: Prof. Dr. E. Hölze, et Al. ‚Empfehlungen zur UV-Phototherapie und Photochemotherapie‘ DDG Berlin 2009 8 TECHNICAL SPECIFICATIONS & INFORMATION 8.1 Technical Data Power supply: 400 V, 50 Hz, 16 amps, 3 phase Mains fuses in device: 10 amps (time-lag) Power consumption: 4900 VA Dimensions W x D x H: 121 x 114 x 222 cm (47.6\" x 44.9\" x 87.4\") Weight: 330 kg (728 lb) Mode of operation: Continuous Electrical appliance class: Applied parts classification: Class I Equipment Ingress protection classification: The appliance is a Type B Applied Part IPX0 N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 25 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 8.2 Conditions for Transport, Storage & Operation After each transport, check the device for damage. Do not operate a damaged unit, but immediately inform our customer service department! Transport and storage conditions must be adhered to. Storage Conditions (these values apply in the appropriate packaging for a period of 10 weeks) Ambient temperature: -30 °C to +55 °C Humidity: 10% to 90% Atmospheric pressure: 500 hPa to 1060 hPa Operation Conditions +5 °C to +35 °C Ambient temperature: 30% to 75% Humidity: 700 hPa to 1060 hPa Atmospheric pressure: 8.3 Cleaning & Disinfection The device and in particular all components made of plastic should not be cleaned with abrasive cleaners, solvents, or alcohol-containing agents. For cleaning we recommend the use of a normal household cleaner, such as dishwasher liquid. For surface disinfection we recommend \"Mikrozid sensitive liquid®\" (Schülke & Mayr GmbH, Germany), which can also be obtained from MEDlight. Clean or disinfect the equipment only when it is switched off. All surfaces should only be wiped with a slightly damp cloth to avoid liquid entering the device. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 26 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 8.3.1 Cleaning of Lamps & Lamp Covers A dust layer on the acrylic lamp covers and the UV tubes can reduce the irradiance. Therefore, it is recommended to wipe these parts clean whenever needed, preferably with a dry soft microfibre cloth. To remove an acrylic lamp cover you first need to open Unlock quick-release fasteners Remove acrylic lamp cover the black plastic caps of the two quick-release fasteners. Then unlock the fasteners by turning these by 90° e.g. with the aid of a coin. The other side of the acrylic cover is held by lugs which are inserted into the cabin module. Pull the open side of the acrylic cover slightly forward, then sideways to release the lugs out of the cabin module, as shown in the adjacent figure. 8.3.2 Cleaning underneath the Cabin For cleaning the floor under the cabin, the floor plate of the cabin can be removed. To do so open the cabin door, and unscrew the knob on the front side below the floor plate. Then lift the foot plate, with the rear side first, upwards from the base frame, and out of the cabin. 8.4 Electromagnetic Compatibility (EMC) This device has been tested and found to comply with the EMC limits of the international standard EN 60601-1-2. These limits are designed to provide reasonable protection against interference in a typical medical installation. The System can radiate radio frequency energy if not installed in accordance with the instructions, and may cause harmful interference to other devices in the vicinity. There is no guarantee that interference will not occur in a particular installation. If the System does cause interference with other devices, which can be determined by turning the System off and on, the user is encouraged to try to correct the interference by one or more of the following measures: a) Re-orient or relocate the receiving device. b) Increase the separation between the equipment. c) Connect the system to an outlet socket on a circuit different from that to which the other device(s) is connected. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 27 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 8.5 Spectral Ranges The device is available with the spectra UVA or UVB narrowband 311nm, and can be equipped with 40 lamps of the same type, or with a combination of two different spectra with 20 lamps each. Spectrum of UVA Lamps: Spectrum of UVA1 Lamps: Spectrum of UVB 311 nm narrowband lamps: 8.6 Accuracy The dosimetry of the device will maintain a 5% level of accuracy if the device is calibrated annually, or at least every one hundred (100) hours as recommended. The spatial variation of the output across the treatment area complies with EN 60601-2-57: 2011 and does not deviate by more than ±20% from the average irradiance. A reduced output greater than 20% is possible for the edges of the treatment area (ends of the UV tubes). 8.7 Maintenance & Repair MEDlight devices are high-quality medical devices for which an annual maintenance is strongly recommended. As part of the maintenance safety tests and measurements of the irradiance are carried out, which are necessary to ensure the safe functioning of the equipment. All work must be carried out only by an authorized MEDlight technician. Circuit N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 28 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION diagrams, service manuals etc. are available upon request. If required, get in touch with MEDlight to arrange an appointment with one of our service technicians. 8.8 Lamp Ageing & Replacement The used UV lamps are high quality products, but which are of course also subject to aging and therefore lose power over time. It is therefore recommended to have the device checked in the course of an annual maintenance. A lamp replacement must only be performed by a MEDlight authorized technician, as this always requires the measurement of the actual irradiance. This is the only way to ensure that the relevant irradiation intensity for the application is correctly measured and taken into account. 9 OTHER INFORMATION 9.1 Warranty MEDlight uses only high-quality, tested components. We work closely with our suppliers. All devices are manufactured and tested according to our high quality standards. For the Product described in this user manual we provide a one (1) year warranty from the date of delivery. Deviating from that, the warranty for the lamps used is limited on six (6) months and does not include glass breakage. Prerequisite is the normal use and the compliance with the required maintenance in the designated intervals. The warranty covers defects due to workmanship or material defects. Signs of use are excluded. MEDlight bears all costs, related to parts and labor, during the term of the warranty. MEDlight reserves the right that defective devices might be sent back to the factory for repair. MEDlight takes care of the settlement of the repair or a complete replacement of equipment. It will be at MEDlight’s discretion whether subcontractors or MEDlight technicians perform any required work. The warranty is void, if maintenance or repairs were performed by a technician who was not authorized in writing by MEDlight, and if components, test equipment and procedures are used that were not recommended by MEDlight. This warranty does not apply to any unit which has been used, repaired or altered outside the factory in any way so as to affect the design, or which has been subject to misuse negligence or accident, or operated in any way other than in accordance with our operating instructions. In these cases MEDlight will not accept any liability for any consequential damages, even if MEDlight has been informed about the possibility of such damages. MEDlight may require the return of devices claimed to be defective for its examination and shall be the sole judge as to whether material is in fact defective under the terms of this warranty. MEDlight reserves the right to bill for travel time, expenses and service cost for requested \"warranty\" service trips which result in work not covered by the warranty. This may include, but is not limited to, a blown fuse, or an unplugged device. 9.2 Expected Service Life For legal reasons the service life of the device is set to ten (10) years. MEDlight also guarantees, for a period of ten (10) years from the date of delivery, the supply of original spare parts or adequate alternatives. The date of manufacture of the device is indicated on the nameplate next to the adjacently shown symbol, in the format YYYY-MM. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 29 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu

USER MANUAL & TECHNICAL DESCRIPTION 9.3 Disposal Note The European Directive 2012/19/EU on Waste Electrical and Electronic Equipment (WEEE), requires that old household electrical appliances must not be disposed of in the normal unsorted municipal waste stream. Old appliances must be collected separately in order to optimise the recovery and recycling of the materials they contain and reduce the impact on human health and the environment. The crossed out wheelie bin symbol on the device reminds you of your obligation, that when you dispose of the device it must be separately collected. Consumers should contact their local authority or retailer for information concerning the correct disposal of their old appliance. WEEE-Reg.-Number: DE 11726256 9.4 Equipment Classification MEDlight phototherapeutic systems for skin treatment are devices of Class IIa, Rule 9, Annex IX of the Medical Device Directive 93/42/EEC, implemented into German law by the Medical Products Act ‘MPG’. Compliance with the essential requirements, annex I of the directive, is met by the use of the relevant standards EN 60601-1:2006+A1:2013 and EN 60601-1-2:2015. The product quality assurance of our manufacture conforms to standard ISO 13485:2003. A copy of the relevant certificate can be found on our website at www.medlight.eu. 9.5 Contact Details MEDlight GmbH Werrestr. 94 32049 Herford Germany Phone: +49 5221 99429-0 Fax: +49 5221 99429-40 E-Mail: [email protected] Internet: www.medlight.eu All rights for the device design and the materials associated with it, including software, trade names and logos are owned by MEDlight GmbH. N-LINEpro_User Manual_2018-09-20.doc MEDlight GmbH Phone: +49 5221 99429-0 Page 30 of 30 Werrestr. 94 Fax: +49 5221 99429-40 32049 Herford e-mail: [email protected] Germany www.medlight.eu