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6 Monitoring the medical device

Before and after use, check the medical device and its accessories entirely for any problems. This is necessary to
detect any isolation fault or damage. If necessary, replace damaged parts.
Check the cleanliness of the handpiece nozzle. It must be clean, smooth and corrosion-free. The optical guide must fit
easily and firmly inside it.
Check the handpiece electrical connectors. These must be clean, smooth and corrosion-free. The battery must be able
to be screwed in easily.

User Manual • Mini LED™ • J02541 • V6 • (07) • 07/2016 • NG13EN010F - Page 17/30

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Summary of Contents for Mini LED

Page 1: ...User Manual Mini LED ...

Page 2: ...This document is an English translation of the original French version Reference J02540 version V6 and drawing number NG13FR010F ...

Page 3: ...tor 12 4 6 Buttons 12 4 7 Charging 12 4 8 Mains adapter 12 4 9 Operating modes 13 4 9 1 Wave peak 13 4 9 2 Waveform 13 4 9 3 Cure depth 14 4 10 Switching off the medical device 14 4 11 Disconnecting the medical device 14 5 Cleaning disinfecting and sterilising 15 5 1 Cleaning and disinfecting the Mini LED 15 5 2 Cleaning disinfecting and sterilising accessories 15 6 Monitoring the medical device 1...

Page 4: ...Applicable standards and regulations 23 9 2 Medical class of the device 23 9 3 Symbols 23 9 4 Manufacturer identification 24 9 5 Branch addresses 25 9 6 Disposal and recycling 26 10 Index 27 11 Glossary 29 ...

Page 5: ...roup Mini LED for information about the following l documentation format l documentation archiving period l warnings concerning user and patient populations l treatment area l medical device usage interactions contraindications and prohibitions l disposal and recycling of the medical device l manufacturer responsibility Please refer to the cleaning disinfection and sterilisation instructions for a...

Page 6: ......

Page 7: ...ed documentation This document must be used in association with the following documents Document title References Protocole de nettoyage désinfection et stérilisation du guide optique Mini LED Acteon J02940 Protocole de nettoyage et désinfection de l écran de protection rigide Mini LED Acteon J05540 Notice générale relative à l ensemble de la gamme des lampes à polymériser de table Acteon J02920 M...

Page 8: ...Page 6 30 User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F ...

Page 9: ...upplier of your device Using the services of an unapproved repairer could render your device dangerous for you and your patients Do not repair or modify the device without seeking the prior permission of SATELEC a company of Acteon group If the device is modified or repaired specific checks and tests must be carried out to ensure that the medical device is still safe to use In the event of doubt c...

Page 10: ...Page 8 30 User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F ...

Page 11: ... l depending on the option a 7 5 mm diameter amber coloured multi fibre optical guide with its ferrule l a Mini LED handpiece l two protection plugs for the handpiece l a charging base with an integrated power tester l a Lithium ion battery l a rigid protection shield l a mains adapter 3 2 Installing the medical device Adjust the position of your medical device to correspond to your angle of visio...

Page 12: ...rth Do not plug the medical device into an extension lead and do not put the mains cord in a cable cover or cable tray 3 4 Installing the mains adapter The mains adapter and its cord are only designed to charge the Mini LED Check that the cord does not hinder the movement or free circulation of anyone whilst the Mini LED is charging Make sure that it is not possible to wheel over or walk on the co...

Page 13: ...l guides and check the power output as indicated in the chapitre Checking the lamp power level page 19 The patient and the practitioner must wear class II safety goggles when the Mini LED is in operation l Remove the Mini LED from the base l Press the on off button l Install the rigid protection shield l Programme the Mini LED to select the required mode l Position the end of the optical guide as ...

Page 14: ...per indicator Charging Green upper indicator Charge fully completed Red lower indicator Power measured at less than 605 mW cm2 is insufficient for required operation Off lower indicator Power measured is insufficient for required operation Green lower indicator Power measured equal to or greater than 785 mW cm2 Charging base light indicators 4 6 Buttons The Mini LED has two buttons located near th...

Page 15: ...ull power 4 9 1 Wave peak The waveform and its peak are identical in all three operating modes Opalescent optical guide Amber coloured optical guide Wave peak 447 5 nm 447 5 nm Maximum irradiance at 2 mm 1900 mW cm2 1300 mW cm2 Mean spectral irradiance in relation to the nominal value and over time 1 250 mW cm2 925 mW cm2 4 9 2 Waveform Waveform nominal value irradiance duration Average irradiance...

Page 16: ...am Ivoclar Vivadent 2 mm 1 5 mm 1 5 mm 1 5 mm 2 mm 2 mm Charisma Heraeus Kulzer 2 mm 2 mm 2 mm 1 5 mm 2 5 mm 2 mm 4 10 Switching off the medical device Press the ON OFF button to stop a cure cycle The Mini LED switches off after three minutes of inactivity Press the button to restart 4 11 Disconnecting the medical device Before a long absence or when not in use the medical device must be cleaned i...

Page 17: ...l left on the medical device and its accessories before switching it on Do not use an abrasive product to clean the medical device Never apply sprays directly to the medical device to clean it Always spray the product onto a wipe then clean the medical device Use alcohol disinfectant wipes l Unplug the power cord from the base l Remove the rigid protection shield l Remove the optical guide l Block...

Page 18: ...Page 16 30 User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F ...

Page 19: ...e If necessary replace damaged parts Check the cleanliness of the handpiece nozzle It must be clean smooth and corrosion free The optical guide must fit easily and firmly inside it Check the handpiece electrical connectors These must be clean smooth and corrosion free The battery must be able to be screwed in easily User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F Page 17 30 ...

Page 20: ...Page 18 30 User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F ...

Page 21: ... Do not use the medical device if it appears to be damaged or faulty Isolate the medical device and make sure that it cannot be used 7 2 1 Not working Symptoms The Mini LED does not switch on and does not emit blue light Possible causes Solutions The on off button is set to off Press the on off button to switch on the Mini LED The battery is flat Charge the battery The charging base is incorrectly...

Page 22: ...ni LED has changed Check the power using a purpose designed tester 7 4 Other malfunctions If the Mini LED is not working for any other reason contact the Acteon Customer Services Team If you need to return your Mini LED please ensure the optical guide and battery are suitably packed to prevent any impact damage during transportation Page 20 30 User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F ...

Page 23: ...ength 94 mm Distal end diameter 7 5 mm Active diameter 6 8 mm Optical cross section 0 36 cm2 8 4 Mini LED handpiece Length 112 mm Maximum outer diameter 23 mm Weight 72 g Ingress protection rating IPX0 Distance with user 0 cm 70 cm Number of LED lights 4 Wavelength range 440 nm 460 nm Centre wavelength 450 nm Irradiance with opalescent optical guide 1125 mW cm2 2400 mW cm2 Irradiance with amber co...

Page 24: ... restrictions Usage premises Designed for use in all medical establishments the medical device cannot be used outside Use in gas filled atmosphere The Mini LED is not designed to be used in an AP or APG gas filled atmosphere Immersion The Mini LED must not be immersed 8 9 Main performance characteristics Wavelength between 440 and 460 nm Irradiance of 1125 mW cm2 to 2400 mW cm2 calculated based on...

Page 25: ...ccording to 93 42 EEC directive 9 3 Symbols Symbols Meaning On off button Programme selection button Always wear safety goggles Always wear protective gloves Refer to the supporting documentation Consult the User Manual The accompanying documentation is available in electronic format Do not use the medical device if the patient or practitioner are fitted with an implantable device Sterilisation at...

Page 26: ...range X no ingress of protection rating claim against the penetration of solids 0 no protection against the penetration of liquids IP40 IP ingress protection ratings procured by a range 4 protection rating against the penetration of solids of a diameter greater than 1 mm 0 no protection against the penetration of liquids 9 4 Manufacturer identification SATELEC A Company of ACTEON Group 17 avenue G...

Page 27: ...A Tel 86 10 646 570 11 2 3 Fax 86 10 646 580 15 info cn acteongroup com THAILAND ACTEON THAILAND LTD 23 45 Sorachai Building 16th floor Sukumvit 63 Road Klongton Nua Wattana BANGKOK 10110 THAILAND Tel 66 2 714 3295 Fax 66 2 714 3296 info th acteongroup com Hong Kong Re Office 21 F On Hing Building Central Hong Kong Tel 852 66 962 134 vianney ruellan acteongroup com INDIA ACTEON INDIA 1202 PLOT NO ...

Page 28: ... obligations to reclaim and dispose of its electrical and electronic equipment through the means established by the approved organisation Récylum NOR approval DEVP1427651A As a producer our Company is listed in the National Register of Producers kept by the ADEME French Environment and Energy Management Agency Professionals buying our products directly from the distribution chain are responsible f...

Page 29: ...relating to the complete range of Mini LED 3 I incorrect operation 19 instructions d emploi électroniques 5 L light curing 7 M mains adapter 12 Mains power 10 Manufacturer 21 medical class 23 O optical guide 7 P peak 13 power tester 12 pressure 22 progressive mode 13 pulsed mode 13 R rapid mode 13 recycling 26 Récylum 26 repair 7 repairer 7 restorative 7 risk of dropping 10 T temperature 22 U upda...

Page 30: ...Page 28 30 User Manual Mini LED J02541 V6 07 07 2016 NG13EN010F ...

Page 31: ... watts per square metre Often confused with the power of a light source L LED electroluminescent diode more commonly known as Led light emitting diode Designates an optoelectronic component that allows the emission of monochromatic light O Optical guide light conductor fitted to the handpiece nosepiece and transmitting light to the cure site Can be cleaned and is suitable for autoclaving P Protect...

Page 32: ... A Company of ACTEON Group 17 av Gustave Eiffel BP 30216 33708 MERIGNAC cedex FRANCE Tel 33 0 556 34 06 07 Fax 33 0 556 34 92 92 E mail satelec acteongroup com www acteongroup com Ref J02541 V6 07 07 2016 NG13EN010F ...

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