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HELBO
PHOTODYNAMIC THERAPY
User Manual
HELBO ® TheraLite Laser
and additional accessories for the antimicrobial Photodynamic therapy
S I N C E
1 9 7 4
bredent medical GmbH & Co. KG
|
Weissenhorner Str. 2
|
89250 Senden
|
Germany
|
T: (+49) 0 73 09 / 8 72-4 41
|
F: (+49) 0 73 09 / 8 72-4 44
|
www.bredent-medical.com
|
@: info-medical@bredent.com
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Summary of Contents for bredent HELBO TheraLite
- Page 1 HELBO ® TheraLite Laser and additional accessories for the antimicrobial Photodynamic therapy S I N C E 1 9 7 4 bredent medical GmbH & Co. KG Weissenhorner Str. 2 89250 Senden Germany T: (+49) 0 73 09 / 8 72-4 41 F: (+49) 0 73 09 / 8 72-4 44 www.bredent-medical.com...
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Page 2: Table Of Contents
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY Table of contens 1. ANTIMICROBIAL PHOTODYNAMIC THERAPY (aPDT) 1.1. INTRODUCTION 1.2. COMPONENTS (AN OVERVIEW) 1.3. CLINICAL PROCEDURE (IN RED) 1.3.1. Periodontology 1.3.2. Endodontics 1.4. THE PHOTOBIOLOGICAL EFFECT 2. THE HELBO® THERALITE LASER: 2.1. -
Page 3: Antimicrobial Photodynamic Therapy (Apdt)
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 1. ANTIMICROBIAL PHOTODYNAMIC THERAPY (aPDT) 1.1. INTRODUCTION Antimicrobial photodynamic therapy represents a method of treating superficial bacterial infections locally. This therapy involves applying a dye (phenothiazine chloride) to the infected area after having mechanically cleaned it. -
Page 4: Components (An Overview)
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 1.2. COMPONENTS (an overview) HELBO® TheraLite Laser • Diode laser with integrated power control and innovative fibre optics • Exceptional light power allows short treatment times; mains-power independent for greater mobility (battery mode) •... -
Page 5: Clinical Procedure (In Red)
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 1.3. CLINICAL PROCEDURE (in red) Control of relevant process parameters with the HELBO® T-Controller Brief instructions Activity Display Acoustic Therapy stage Next stage (at device) signal Initial situation: None None None... -
Page 6: Periodontology
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 1.3.1. Periodontology Perform professional dental cleaning. Important: Removing concrement from the tooth/root surface ensures better access to the biofilm. The aPDT procedure is performed immediately or no more than 1-2 days after cleaning (aPDT is recommended on the following day in particular if there is excessive bleeding after cleaning). -
Page 7: Endodontics
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 1.3.2. Endodontics Prepare the tooth in the conventional manner forendodontic purposes. Important: Dental dam recommended; preparation to ISO 45 is best (manually or by machine), rinse afterwards (H O), then dry with paper tips, which are then left in place in the canals. -
Page 8: The Photobiological Effect
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 1.4. THE PHOTOBIOLOGICAL EFFECT What is achieved by the photobiological effect? • Inflammation is suppressed • Wounds heal faster • Pain is reduced How does the photobiological effect work? •... -
Page 9: The Helbo® Theralite Laser
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2. The HELBO® TheraLite Laser 2.1. PRODUCT DESCRIPTION AND PURPOSE The HELBO® TheraLite Laser is an • active, • electrical, • therapeutic • hand-held medical device intended for temporary use. The HELBO®... -
Page 10: Control Elements
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.2. CONTROL ELEMENTS Combination display: • Laser ready – • Emissions – • Battery warning indicator Start button Main switch The following are located on the rear side: • Laser warning label •... -
Page 11: Contraindications / Side Effects
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY The intended users of this medical device are: • Dentists • Dental assistants • Prophylaxis assistants Specifics regarding intended users: • Dental training, at least to the level of dental prophylaxis assistants •... -
Page 12: Helbo® Fibre Optics
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.4. HELBO® FIBRE OPTICS The HELBO® 3D Pocket Probe, HELBO® 2D Spot Probe and HELBO® 3D Endo Probeare used in combination with the HELBO® TheraLite Laser for two- or three-dimensional exposure of infected tissue surfaces stained with (phenothiazine chloride), in context of lethal antimicrobial photodynamic therapy. -
Page 13: Helbo® 3D Pocket Probe
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.4.1. HELBO® 3D Pocket Probe Sterile optical fibres for three-dimensional exposure of infected tissue surfaces during antimicrobial Photodynamic therapy, five units per pack. The front conical area of the optical fibre is ground as a microlens to facilitate even light distribution both vertically and horizontally. -
Page 14: Helbo® 2D Spot Probe
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.4.2. HELBO® 2D Spot Probe Sterile optical fibres for two-dimensional exposure of infected tissue surfaces during antimicrobial Photodynamic therapy, five units per pack. The HELBO® 2D Spot Probe is identical in construction to the HELBO® 3D Pocket Probe, but is surface-ground at the end and emits light forwards (see Fig. -
Page 15: Helbo® 3D Endo Probe
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.4.3. HELBO® 3D Endo Probe Sterile optical fibres for three-dimensional exposure of infected tissue surfaces during antimicrobial Photodynamic therapy, five units per pack. Laser output end Fig.5: Fig.6: HELBO® 3D Endo Probe Radial and axial exposure of area using HELBO®... -
Page 16: Start-Up
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.5. START-UP IMPORTANT: OPERATION BY AUTHORISED PERSONS ONLY! The laser device should only be operated by personnel who have received sufficient training and information on the exact processes for antimicrobial Photodynamic therapy and the handling of all necessary components (please see also the notes in the instruction manual, package insert, etc.). -
Page 17: Operating States / Displays
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.5.2. Operating states / displays STANDBY The batteries are inserted into the HELBO® TheraLite Laser. The main switch is in the OFF position. This is the “Standby” state. LASER READY NOTE: When the batteries have been inserted and the main switch is set to ON, the laser device is ready to emit laser radiation. -
Page 18: Main Switch
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.5.3. Main switch OFF position ON position The main switch should be turned to the OFF position when the HELBO® TheraLite Laser is not in use. The main switch prevents the batteries from discharging when not in use. -
Page 19: Maintenance / Service
Please ensure at all times that no dirt or liquid gets into the opening of the HELBO® TheraLite Laser. If dirt gets into the opening, please contact Customer Service at bredent medical GmbH & Co. KG. Never try to re- move dirt from the opening yourself, as this could damage the HELBO®... -
Page 20: Power Supply
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.8. POWER SUPPLY The HELBO® TheraLite Laser operates only on rechargeable battery power! The power is supplied by 2 rechargeable batteries, each with an individual voltage of 1.2 volts. With fully charged batteries from the IPC charger set, the period of operation is approx. -
Page 21: Battery Storage
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY Procedure for changing batteries: HTurn the main switch anticlockwise to the OFF position. Unscrew the main switch – caution: the top battery may fall out – and move the device into a vertical position. Remove the empty batteries (to do this, rotate the device through 180 degrees, the batteries will then fall out of the battery compartment) and insert new batteries (recharge empty batteries immediately!) –... -
Page 22: Safety Instructions / Warning Notices
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.9. SAFETY INSTRUCTIONS / WARNING NOTICES You do NOT need laser safety goggles during therapy using the HELBO® TheraLite Laser, thanks to its unique safety mechanism – this applies to anyone present in the laser area. Even though the device is a low-class laser, never look directly into the laser beam and never aim it at anyone’s eyes! When using the HELBO®... - Page 23 ® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY SAFETY MARGIN See Section 2.12 „Technical Data“ FIBRE OPTICS The innovative designs of the HELBO® 3D Pocket Probe, the HELBO® 3D Endo Probe and the HELBO®2D Spot Probe, and the specially selected materials used in their construction, make them ideally suited to use with the HELBO®...
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Page 24: Emc (Electromagnetic Compatibility)
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.10. EMC (ELECTROMAGNETIC COMPATIBILITY) The HELBO® TheraLite Laser must be isolated from powerful ionising radiation. It must also be ensured that the HELBO® TheraLite Laser is not operated in direct proximity to devices whose electromagnetic compatibility cannot be clearly defined. - Page 25 ® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY Table 202 Guidance and Manufacturer’s Declaration - Electromagnetic Immunity The HELBO® TheraLite Laser is designed for operation in the electromagnetic environment specified below. The customer or the user of the HELBO® TheraLite Laser should ensure that it is used in such an environment. Immunity test IEC 60601 test level Compliance level...
- Page 26 ® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY ∗ for 800 MHz to 2.5 GHz with P as the maximum nominal output of the transmitter in watts (W) in accordance with details from the transmitter manufacturer and d as the recommended safety margin in metres (m).
- Page 27 ® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY Table 206 Recommended safety margin between hand-held and mobile HF telecommunications devices and the HELBO® TheraLite Laser The HELBO® TheraLite Laser is intended for use in an electromagnetic environment in which the HF disturbances are controlled.
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Page 28: Technical Safety Check In Accordance With En 62353
To ensure that statutory periodic safety checks are carried out properly, please contact the manufacturer: bredent medical GmbH & Co. KG, Weissenhorner Str. 2, 89250 Senden, Germany Telefon: +49 (0) 73 09 / 872 - 6 00, Telefax: +49 (0) 73 09 / 872 - 6 35 Please send us your HELBO®... -
Page 29: Technical Data
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.12. TECHNICAL DATA Wavelength: 660nm +/- 10nm Output: ~ 40 mW from HELBO® 2D Spot Probe ~ 20 mW* from HELBO® 3D Pocket Probe ~ 17mw* from HELBO® 3D Endo Probe * frontal measurement on a flat measurement sensor Laser source: 100 mW continuous wave (CW) -
Page 30: Ce Marking
® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY 2.13. CE MARKING The HELBO® TheraLite Laser bears the CE mark of conformity for medical devices. The CE mark indicates that the HELBO® TheraLite Laser conforms to the specifications of EU Directive 93/42/EEC on medical devices. -
Page 31: Disposal
When the HELBO® TheraLite Lasers and its accessories reach the end of their service life, send them to the manufac- turer at this address for disposal: bredent medical GmbH & Co. KG, Weissenhorner Str. 2, 89250 Senden, Germany Telefon: +49 (0) 73 09 / 872 - 6 00, Telefax: +49 (0) 73 09 / 872 - 6 35 2.15. - Page 32 ® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY After pressing the button, the laser beam • The HELBO® TheraLite Laser has a locking function that will is only faint or does not appear at all if no prevent laser radiation from being emitted if no HELBO®...
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Page 33: Laser Emergency Stop
GmbH & Co. KG, Weissenhorner Str. 2, 89250 Senden, Germany Telefon: +49 (0) 73 09 / 872 - 6 00, Telefax: +49 (0) 73 09 / 872 - 6 35... -
Page 34: Warning Signs / Information Signs / General Signs
Type B application part Laser warning sign Information sign showing classification Label showing radiation emitted and wavelength ON THE CASE H E L B O Medizintechnik Manufacturer’s logo Ein Unternehmen der bredent group General safety notice Notice regarding safety inspection of the laser... -
Page 35: General Information About Laser Safety
PHOTODYNAMIC THERAPY OUTER PACKAGING: Manufacturer’s logo Manufacturer bredent medical GmbH & Co.KG Weissenhorner Str. 2 | 89250 Senden | Germany Manufacturer’s details T: (+49) 0 73 09 / 8 72-6 00 | F: (+49) 0 73 09 / 8 72-6 35 www.bredent-medical.com | @: info-medical@bredent.com... -
Page 36: Guarantee
Please always contact the manufacturer regarding repairs in order to ensure that they are carried out properly. bredent medical GmbH & Co. KG, Weissenhorner Str. 2, 89250 Senden, Germany Telefon: +49 (0) 73 09 / 872 - 6 00, Telefax: +49 (0) 73 09 / 872 - 6 35... - Page 37 ® HELBO User Manual for HELBO ® TheraLite Laser PHOTODYNAMIC THERAPY Good luck with aPDT and the ® HELBO TheraLite Laser ® Your HELBO Team Version 14 06/2017 Mistake and subject to change reserved 009892GB-20170427...
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