Instructions for Use
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INSTRUCTION MANUAL SUN-LED
Instruction Manual SUN-LED LED Examination Light
INSTRUCTION MANUAL SUN-LED
1250
Manufacturer: BPR Swiss GmbH Weststrasse 16 CH-3672 Oberdiessbach Switzerland Tel.: 0041 31 506 06 06 E-Mail: [email protected] Web: www.bpr-swiss.com EU importer: BPR Swiss Europe GmbH Bergstedter Chaussee 122 D-22395 Hamburg Germany European Authorized Representative: managementsysteme Seiler Klaus Seiler Zum Saibling 3 D-88662 Überlingen / Bodensee Germany
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Table of Contents 1.
Introduction ... 4
2.
Terms and symbols ... 5
3.
Safety precautions ... 6
4.
Power Supply... 7
5.
Brief description ... 7
6.
Operation ... 7
7.
Use of the bluelight filter ... 9
8.
Support systems ... 10
9.
Maintenance and cleaning / disinfection ... 12
10. Disposal ... 15 11. Technical data ... 16 12. Declaration of electromagnetic compatibility ... 17 13. Troubleshooting ... 19 14. Service center ... 19
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1.
Introduction
Intended use The LED examination light SUN-LED (light intensity 50,000 Lux) is used for local and optimal lighting of a patient's body - preferably in general medical examination and treatment in dental and medical practices, dental treatments, dermatological examinations, wound care, minor surgical procedures and dental technical. The lighting intensity can be adjusted according to the situation (dimming). The examination light can be dimmed with a contactless sensor. SUN-LED meets the requirements of directive 93/42/EEC (medical devices, class I); IEC/EN 60601-1 and IEC/EN 60601-2-41 (see table 201.101: requirements for “Luminaires for diagnosis”).
Technical details
Light intensity: 50,000 Lux @ 100cm distance Colour temperature: 4,500 K (daylight quality) Colour rendering index (CRI): 97 Energy efficiency: max. 25 W Adjustable light field diameter: 28 cm (round / oval) LED service life of over 70,000 hours
Features
Dimmable using the control panel or the built-in non-contact sensor Housing made from the highest quality materials, with gloss coated and homogeneous surfaces Detachable, sterilisable handle Dental treatment: Bluelight filter to prevent rapid and premature curing of the composite material Different support systems are offered.
Guarantee: SUN-LED head Support system
5 years 2 years
Applications: general examination and treatment in dental and medical practices, dental treatments, dermatological examinations, wound care and minor surgical procedures, dental treatments and technical, etc.
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2.
Terms and symbols
The following symbol emphasizes the importance of the relevant point in the instructions for use. Instructions The sections marked with this symbol contain instructions that must be followed to avoid damage to the SUN-LED and injuries to the user and possibly even to the patient.. Danger The sections marked with this symbol contain instructions regarding potentially dangerous electrical voltage. These instructions must be followed to avoid possible damage to the SUN-LED as well as injuries to the user and possibly even to the patient.
Manufacturer’s address.
Year of manufacture.
Correct disposal according to the European Directive WEEE 2012/19/EU (Waste Electrical and Electronic Equipment).
The CE mark as per EU law on product safety. CE conformity confirms that the product corresponds with the applicable European directives.
This symbol is affixed on the unit rating plate Meaning: When operating the unit, observe the operating instructions. IP54
Classified as protection rating IP54
Connection for earth.
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Ambient temperature (0 to 60°C). This shows the maximum permitted temperature during transportation and storage.
Relative air humidity (10 to 75%). This shows the maximum permitted air humidity during transportation and storage.
Air pressure (500 to 1060hPa). This shows the maximum permitted air pressure during transportation and storage.
3.
Safety precautions
The user must have read the instructions for use before using the SUN-LED. These instructions for use must be carefully stored, so it is possible to look up the safety instructions and important information. No installation or maintenance work must be carried out on the SUN-LED while it is connected to the power supply.
Country-specific installation instructions and standards must be observed.
For fixed installed model only. The device must be connected in such a way that all poles can be disconnected from the mains simultaneously. This means fixed installations must include an appropriate switch. Other versions: Make sure, that mains plug is easily reachable to the operator. Mains plug is considered as disconnecting device from the mains. No maintenance work must be carried out on the SUN-LED and no parts must be replaced. Otherwise there are hazards for the safety of the device, the user and/or the patient.
The requirements of national standards and directives for hygiene and disinfection must be respected!
For the assembly, using and maintenance of the support system it is necessary to precede according to the respective installation instructions. All instructions are to be followed.
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INSTRUCTION MANUAL SUN-LED Missing installation instructions must be requested from BPR Swiss (see chapter 14. "Service center").
4.
Power Supply
The SUN-LED use the external power supply GSM40B24-P1M from supplier Mean Well. The power supply GSM40B24-P1M from Mean Well is part of the system. It is not allowed to use other power supply as GSM40B24-P1M!
5.
Brief description Contact-free sensor
Control elements and status LED
Handgripp
Sterilisable handle The SUN-LED is equipped with a membrane keypad with five buttons (ON/OFF, dim-, dim+, light field and sensor IN/OFF. There is a sensor on the edge of the SUN-LED, which can be used for contactless dimming of the SUN-LED in pre-defined steps. This sensor can be switched off.
6.
Operation Do not look directly into the SUN-LED - it is very dazzling and it can damage your eyes.
For dental treatments or medical facial treatments principally use the small oval light field (4 LED)
Before each use, ensure that the SUN-LED is in perfect condition. The SUNLED must not be used if there are visible cracks in parts of the SUN-LED or the glass is broken.
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INSTRUCTION MANUAL SUN-LED When using more than one SUN-LED, there is a risk that too much heat will be generated by the superposition of light in the examination or operating field.
6.1.
Positioning the SUN-LED
To position the light field, use the handgrip or the handle to point the SUN-LED approximately in the direction of the area to be illuminated. After switching on the SUN-LED you can adjust the definite position of the SUN-LED. Use the handgrip or the handle to position the light field in the right direction.
6.2.
Switching on and off
Press the “ON/OFF” button to switch on the SUN-LED. Press the button again to turn off the SUN-LED. If the green power status LED is lit, this means that the SUN-LED is on. When the SUN-LED is switched on, the lighting intensity is always set to 100%, even if the SUN-LED was dimmed when it was switched off the last time. Note: When the supply voltage is applied (for example, plugging the power plug, after a voltage interruption, etc.), all the green control LEDs are briefly switched on and off.
6.3.
Membrane keypad
On the SUN-LED there is a membrane keypad which can be used for switching the SUNLED on and off and controlling several functions. On the same keypad there are blue LEDs indicating the dimming intensity. power status
dimming intensity
LED light ON / OFF Aus
6.4.
DIM-
sensor status
+
DIM+
sensor
light field oval / round
sensor ON / OFF
Dimming the lighting intensity
You can reduce the lighting intensity using the DIM- button, and increase it using the DIM+ button. Five intensity levels are defined (20%, 40%, 60%, 80%,100%) which can be either switched up or down by pressing the corresponding button (DIM+, DIM-). The intensity level "0%" means that the light is switched on but is not lit. The currently set dimming level is displayed in the display field with blue LEDs.
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INSTRUCTION MANUAL SUN-LED The dimming function can also be controlled using the sensor that is integrated below, where the light is emitted. If you bring the back of your hand near this sensor, you can change the lighting intensity of the SUN-LED („ring-connection“: … 80% 60% 40% 20% 0% 100% 80% 60%, etc.). The sensor is triggered at distances of about 10 cm or less; this position must be maintained for longer than 1 second to activate the change. If the SUN-LED is set on dimming level 0% (light switched off, green status LED switched on), the LED switches off automatically after 4 hours. Then the lamp must be switched on again with the "SUN-LED ON / OFF" button.
6.5.
Oval or round light field
With the button “light filed oval / round” is possible to choose an oval or round light field. For dental treatments or medical facial treatments principally use the small oval light field (4 LED). The selection is saved and it remains even the lamp has been switched off.
6.6.
Deactivating / activating the sensor
The sensor can be activated or deactivated using the button “sensor ON/OF”. In active state the dimming function can be controlled using the sensor. This status is saved and it remains even after the lamp has been switched off.
6.7.
Resetting the SUN-LED
The SUN-LED can be reset disconnect and reconnect from the mains voltage. All the control LEDs are briefly switched on and off The SUN-LED is reset.
7.
Use of the bluelight filter
The bluelight filter filters out the blue part of the light. The blue light filter is used in dental treatment with composite to prevent rapid and premature curing of the composite material. The bluelight filter is held by magnets and can be attached quickly and easily to the LED lamp. When using the bluelight filter, the sensor must be switched off (see chap. 6.6 “Deactivating / activating the sensor“).
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8.
Support systems
The product SUN-LED is offered with different support systems. The detailed assembly instructions for the different support systems are enclosed with the respective delivery. For the assembly, using and maintenance of the support system it is necessary to precede according to the respective installation instructions. All notes and instructions have to be followed!
8.1.
Support system „Regular“
The "Regular" support system consists of a base unit, which consists of the combination of a support arm and a SUN-LED head. Depending on the application, this combination can be used with a BPR Swiss Denta-Chair 303, a table adapter (supplied with the basic version), with a wall adapter, with a ceiling adapter or with a mobile stand. The power supply GSM40B24-P1M (Mean Well) is used within this support system as described in chapter 4 "Power Supply".
SUN-LED on Denta-Chair 303
Base unit with table adapter
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Wall adapter
Ceiling adapter
Mobile stand
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„Table system“
8.2.
„Wall system“
„Ceiling system“
„Mobile stand“
Ceiling system „ONDAL Acrobat Swing“
The ceiling support system "OD" consists of a ceiling mount fixture, an extender arm and a spring arm. The SUN-LED is connected to the ceiling support system by means of a swivel bracket. The power supply GSM40B24-P1M (Mean Well) is used within this support system as described in chapter 4 "Power Supply".
8.3. Safety instructions for mobile stand system During movement of the mobile stand, it must not be tilted more than 5 degrees; otherwise there is a risk of injury! When moving the mobile stand: Please ensure that all rollers are mobile (no brakes) and that there are no cables or other objects in the movement area of the mobile stand. The SUN-LED may only be connected to the mains supply after the complete mounting of the mobile stand. Installation and maintenance work may only be carried out when the main plug is pulled (disconnected)!
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INSTRUCTION MANUAL SUN-LED Please follow the details below: Mobile Stand SUN-LED
Please install the additional load (2 kg)!
8.4.
Safety instructions for the mobile stand “Regular” During movement of the mobile stand, it must not be tilted more than 5 degrees; otherwise there is a risk of injury! When moving the mobile stand: Please ensure that all rollers are mobile (no brakes) and that there are no cables or other objects in the movement area of the mobile stand. The SUN-LED light may only be connected to the mains supply after the complete mounting of the mobile stand. Installation and maintenance work may only be carried out when the main plug is pulled (disconnected)!
9.
Maintenance and cleaning / disinfection
The SUN-LED has been developed and produced using the latest LED technology. The SUN-LEDs and the built-in electronic systems are maintenance-free. Maintenance is limited to cleaning the SUN-LED. The SUN-LED and the support systems have been constructed in such a way that regular maintenance is not necessary. The requirements of national standards and directives for hygiene and disinfection must be respected! Page 12/19
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9.1.
Cleaning / disinfecting the SUN-LED
The SUN-LED must be cleaned regularly. Disinfection is always carried out by wiping with a disinfection solution from the dosing device. The housing must be cleaned with a soft cloth and a cleaning agent / disinfectant. The surface to be disinfected is wiped with a moist cloth and it must be left to air dry - do not wipe it a second time! Areas with visible contamination must always be wiped down immediately with a single-use cloth soaked in disinfectant. The procedure used must be recognised [e.g. included in the lists of tested and recognised disinfectants and disinfection procedures from the Robert Koch Institute (RKI), the Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) or the Association Française de Normalisation (AFNOR)] and it must always be validated. No abrasive materials must be used to clean the SUN-LED!
Tested disinfectant: TEGO-CID (Aqueous solution of microbicide amphotensides and cation-active biocide) 100g contain: 10% didecyldimethylammonium chloride 10% aminoacetic acid
9.2. Fitting and removing the sterilisable handle Lock button To remove the handle, you have to press the lock button at the top of the handle and pull the handle at the same time. To fit the handle, push it onto the aluminium holder. The lock button must click visibly into place. sterilisable handle
Twist the handle firmly to check that it has clicked into place and it is sitting firmly.
When used in a sterile environment: You must not touch the aluminium holder after removing the handle. The SUN-LED must not be used without the handle.
You must only use the handle supplied from BPR Swiss.
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9.3.
Cleaning and sterilizing the sterile handle
9.3.1. Basic principles Effective cleaning / disinfecting is an essential requirement for effective sterilization of the handle. As part of your responsibility for product sterility, you must ensure that all cleaning / disinfection and sterilization processes used have been sufficiently validated for the devices and products, and that the validated parameters are observed for each cycle. The hygiene regulations of the hospital / clinic must also be observed. 9.3.2. Cleaning / disinfection Before sterilization the handle must be cleaned then disinfected. During pre-cleaning, cleaning and disinfection, you must ensure to use a procedure that does not lead to residues / proteins (e.g. blood, secretions, tissue residue) sticking to the handle. For this reason the cleaning and disinfection must be carried out immediately after use. A machine-based procedure (disinfector) should be used for cleaning / disinfection. The procedure used must be recognised [e.g. included in the lists of tested and recognised disinfectants and disinfection procedures from the Robert Koch Institute (RKI), the Deutsche Gesellschaft für Hygiene und Mikrobiologie (DGHM) or the Association Française de Normalisation (AFNOR)] and it must always be validated. If using other procedures (e.g. a manual procedure) you must prove that they should be effective in the framework of the validation. Alkaline cleaning is highly effective for removal of protein and fat residues and anti-microbial action. The cleaning agent and disinfectant must be authorized for use on polyphenylsufone (PPSU). 9.3.3. Sterilization The handles can be sterilized in an autoclave (steam sterilization). The requirements of national standards and directives for hygiene and disinfection must be respected! The requirements of the corresponding organization (e.g. hospital, medical practice) for hygiene and disinfection must be respected! Use only the sterilization procedure mentioned below. Other sterilization procedures as “steam sterilization” are not permitted!
Recommended parameters for steam sterilization:
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134°C / 18 minutes
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INSTRUCTION MANUAL SUN-LED 9.3.4. Sterilization cycles The sterilisable handle is subject to natural wear, so it must be regularly checked for cracks or material defects and replaced with a new handle if necessary. Do not use damaged sterile handles. The operator must personally ensure the necessary level of hygiene and disinfection. The sterile handle must be replaced with a new one after 100 cleaning or sterilization cycles at the latest. The sterile handles are not delivered in sterile condition. They must be sterilized as per Section 9.3 “Cleaning and sterilizing the sterile handle” (autoclaved) before they are used for the first time.
10. Disposal At the end of the product service life, the components of our SUN-LEDs have to be disposed of in accordance with the law. Within the European Union and EFTA (Switzerland, Norway, Iceland and Lichtenstein), our SUN-LEDs and their components are subject to the European Directive WEEE 2012/19/EU (Waste Electrical and Electronic Equipment) and may not be disposed of together with domestic waste. BPR Swiss takes back the SUN-LEDs and their components for proper disposal or recycling according to the requirements of the European Directive WEEE 2012/19/EU. Please contact the country representative or the service center (see chapter 14 "Service center"). Outside of the EU: Follow the disposal requirements of your country.
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11. Technical data Lighting intensity Ec @ 100 cm 50,000 Lux Total irradiance Ee 174 W/m2 Quotient Ee/Ec 3.48 mW/m2/Lux Light field diameter d10 (oval field / round field) 280 mm Colour temperature 4,500 K Colour rendering index Ra 97 R9 84 Illumination depth L1 + L2 (@60% Ec) 1000 mm + 380 mm Power supply (only LED light head) 24 VDC ±2V Power consumption (only LED light head) max. 25 W (typ. <23 W) External power supply (MEAN WELL GSM40B24-P1M) 100-240 VAC; 50/60 Hz Power consumption (incl. external power supply) 1.0-0,5 A Minimum service life (LEDs) 70,000 h Ambient temperature (operation) 0 °C to 40 °C Relative air humidity (operation) 30% to 75% Air pressure (operation) 700 hPa to 1060 hPa Ambient temperature (storage and transportation) -10°C to +50°C Relative air humidity (storage and transportation) 10% to 90% Air pressure (storage and transportation) 500 hPa to 1060 hPa IP protection rating IP54 Housing temperature according to IEC/EN 60601-2-41 Weight (only LED light head) 0.9 kg Dimensions (only LED light head) 240 mm x 170 mm x 30 mm Weight mobile stand with light head ("NV" / "Flex") 9 kg / 10 kg Directive 93 / 42 / ECC (medical devices); Class I Standards (IEC/EN) 60601-1; 60601-1-2; 60601-2-41; 60601-1-6 / 62366 Notes: Do to technical and manufacturing reasons the technical data (values) above are subject to fluctuations. The value for the colour temperature can differ with approx. ± 250K. The value for Ra or R9 can differ with approx. ± 5%.
11.1. Accessories and spare parts Item no. D-254507 D-254508 D-254509
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Description Sterilisable handle Power Supply, MEAN WELL GSM40B24-P1M Bluelight-Filter SUN-LED
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12. Declaration of electromagnetic compatibility 12.1.
General information The SUN-LED is an electrical medical device. To fulfill all requirements of IEC 60601-1-2:2014 (4th edition) all the installation instructions has to be observed. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the SUN-LED including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
It is compulsory to use the power supply defined in chapter 4 “Power Supply”.
Electromagnetic disturbances outside the reasonably foreseeable values (defined by the standard specification) can lead to the switching off of the SUN-LED lamp. The light can then be switched on again via the membrane keypad.
12.2.
Electromagnetic emission
Test Conducted emission Radiated emission Harmonic current emissions Voltage fluctuations and flicker
Limit CISPR 11, Group 1, Class B CISPR 11, Group 1, Class B IEC 61000-3-2, Class A IEC 61000-3-3
Notes:
The SUN-LED 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.
The SUN-LED is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The customer or the user of the SUN-LED should assure that it is used in such an environment.
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12.3.
Electromagnetic immunity test levels
Test Electrostatic Discharge (IEC 61000-4-2) Radiated RF EM filed (IEC 61000-4-3) Proximity fields form RF wireless communications equipment (IEC 61000-4-3)
Electrical fast transients / bursts (IEC 61000-4-4) Surges (IEC 61000-4-5) Conducted disturbances inducted by RF fields (IEC 61000-4-6) Rated power frequency magnetic fields (IEC 61000-4-8) Voltage dips / Voltage interruptions (IEC 61000-4-11)
Test level Contact Discharge: ±8 kV Air Discharge: ±2 kV, ±4 kV, ±8 kV, ±15 kV 80-2700 MHz; 1kHz AM 80 %; 10 V/m 385 MHz; Pulse Modulation: 18 Hz; 27 V/m 450 MHz, FM + 5Hz deviation: 1 kHz sine; 28 V/m 710, 745, 780 MHz; Pulse Modulation: 217 Hz; 9 V/m 810, 870, 930 MHz; Pulse Modulation: 18 Hz; 28 V/m 1720, 1845, 1970 MHz; Pulse Modulation: 217 Hz; 28 V/m 2450 MHz; Pulse Modulation: 217 Hz; 28 V/m; 5240, 5500, 5785 MHz; Pulse Modulation: 217 Hz; 9 V/m Power lines: 2 kV; 100 kHz repetition frequency L-PE and N-PE: 2kV L-N: 1kV 0.15-80 MHz; 1kHz AM 80 %; 3 Vrms , 6 Vrms in ISM and Amateur band 30 A/m, 50 Hz and 60 Hz 0 % UT for 0.5 cycle at 8 phase angles 0 % UT for 1 cycle at 0° 70 % UT for 25/30 cycles at 0° 0 % UT for 250/300 cycles 0°
Notes:
The SUN-LED is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes. The customer or the user of the SUN-LED should assure that it is used in such an environment.
Floors should be wood, concrete or ceramic tile. If floors are covered with synthetic material, the relative humidity should be at least 30%.
Mains power quality should be that of a typical commercial or hospital environment or public low-voltage power supply network that supplies buildings used for domestic purposes.
If the user of the SUN-LED requires continued operation during power mains interruptions, it is recommended that the SUN-LED is powered from an uninterruptible power supply or battery.
Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment or of a public low-voltage power supply network that supplies buildings used for domestic purposes.
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13.
Troubleshooting
Fault
Possible causes
Narrow down the fault using this table
SUN-LED does not light up
Red flashing power status LED
The sensor doesn’t work
The brightness of the SUNLED keeps changing.
Some LEDs do not light
14.
Solution
Supply voltage out of range
Use correct power supply
Power supply is defective
Change the power supply
The sensor is deactivated
Activate the sensor
The glass is dirty
Clean the glass
The glass is dirty
Clean the glass
The sensor is defective
Deactivate the sensor
with bluelight filter
Deactivate the sensor
LEDS are defective
Contact the service center chapter 14
Service center
If you have any problems with the product that cannot be solved using the troubleshooting table, or there is a defect, contact the service center listed below:
Manufacturing, repair and service:
BPR Swiss GmbH Weststrasse 16 CH-3672 Oberdiessbach Switzerland +41 31 506 06 06 www.bpr-swiss.com [email protected]
© BPR SWISS GMBH 2021
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