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User Manual
ENERGY-LASER™ PRO
Model: L500 PRO – 500 mW / 808 nm
Model: L800 PRO – 4 x 200 mW / 660 nm
Model: L2000 PRO – 4 x 500 mW / 808 nm
Low Level Laser Therapy – LLLT
PhotoBioModulation – PBM
English
NOTE: Please read this User Manual thoroughly before use. For further assistance & advice
please contact Akeda Sp. z o.o. or your local dealer direct!
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Summary of Contents for Energy-Laser L500 PRO
- Page 1 User Manual ENERGY-LASER™ PRO Model: L500 PRO – 500 mW / 808 nm Model: L800 PRO – 4 x 200 mW / 660 nm Model: L2000 PRO – 4 x 500 mW / 808 nm Low Level Laser Therapy – LLLT PhotoBioModulation –...
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Page 2: Table Of Contents
Treatment ENERGY-LASER™ PRO dosage schedule Treatment guidelines Therapeutic dose: Device Description ENERGY-LASER™ PRO Error Messages Selection of program by ENERGY-LASER™ Tablet (Bluetooth) Battery and charger Service and maintenance of your ENERGY-LASER™ PRO PRO - Label symbol information ENERGY-LASER Technical data ENERGY-LASER™ PRO Warranty Accessories for ENERGY-LASER™... -
Page 3: Dear Customer
1½ hours of treatment per fully charged battery. ENERGY-LASER™ PRO is with electronic control for overheating. ENERGY-LASER™ PRO has a built-in Light guide with red LED light (650 nm) so you can clearly see the treatment area. -
Page 4: Energy For Life - Supportive Laser Therapy For Wounds And Pain
Model: PERSONAL-LASER™L200 – 200 mW / 660 nm [LLLT/PBM] • Model: ENERGY-LASER™ L800 PRO – 4 x 200 mW / 660 nm [LLLT/PBM] Intended use for laser treatment with use lasers diode 660 nm includes: Recurrent aphthous stomatitis (pain and wound healing) Lasers with 808 nm beam (invisible/infrared light, 3-4 cm penetration): •... -
Page 5: Certifications
Certifications ENERGY-LASER™ PRO is approved as a medical laser device used for LLLT/PBM treatment. The laser system complies with the rules in the EU Directive 93/42/. ENERGY-LASER™ PRO is Medical CE certified – CE 2274. GMDN – Classification (Global Medical Device Nomenclature) -
Page 6: Laser Light For Therapeutic Use
Laser Light for Therapeutic use For more than 40 years lasers have been used to treat various ailments. This has now led to what is known today as Low Level Laser Therapy (LLLT) or PhotoBioModulation (PBM). The mechanism behind LLLT is the laser’s ability to transfer energy to the cells without the risk of overheating the tissue which may result in tissue damage or injury. -
Page 7: Treatment Using Laser Light
Treatment Using Laser light When using lasers therapeutically, the energy delivered to 1 cm skin should never exceed 500 mW. If this threshold is exceeded the laser energy will be converted into heat in the tissue being treated. The energy will be deposited in the tissues containing pigment, for example in the skin, hair and blood vessels, possibly resulting in tissue damage. - Page 8 Laser light ranging from around 600 nm (visible spectrum) to 1000 nm (infrared, invisible spectrum) is referred to as the “Biological Window”. Laser light in this particular range is able to penetrate the skin and permeate underlying tissue, thereby reach and treat the cells.
- Page 9 Effects of laser light There are numerous positive effects associated with laser light. The tissue treated with the laser will have an increased blood flow through the treated and dilated blood vessels, increased oxygenation of the surrounding tissue, increased synthesis of fibroblasts, accelerated synthesis of collagen connective tissue as well as formation of granulated tissue in deep wounds.
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Page 10: Lllt/Pbm Is Approved As A Medical Treatment
ENERGY-LASER™PRO are all Class 3B lasers! This laser class exceeds the power of Class 3R (5 mW), but not exceeding 500 mW. If exposed directly to Class 3B the laser beam produced may cause eye damage and, in some cases, cause skin damage. -
Page 11: Contraindications- Contraindications - General Precautions
Contraindications- Contraindications – General Precautions LLLT/PBM laser treatment • Never aim at or attempt to treat the eyes! This can in unfortunate cases result in the lens gathering the laser light at a single point on the retina resulting serious damage! •... - Page 12 This means that the risk of eye damage from the laser light depends primarily on the beam’s parallelism and it´s diameter. In summary, if one does not look directly at the laser light from a Class 3B laser, you do not need to use eye protection as practitioner.
- Page 13 Radiation treatment: Patients receiving radiation therapy have previously been considered counter-indicative of laser therapy. It is not obvious why since the radiation they are exposed to has a different characteristic than LLLT/PBM. Laboratory studies on animals receiving X-rays have shown that they made greater progress if they received laser therapy first.
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Page 14: General Safety Warnings Lllt/Pbm Laser Treatment
General Safety Warnings LLLT/PBM laser treatment WARNING NOTICE! - Never look directly into the laser light! - The sight may be permanently damaged! - When treating the face with laser light, always use laser safety goggles! WARNING! Do not point the laser at reflective or polished surfaces (especially mirrors). If the laser light hits such a surface, the laser light will reflect and would pose a serious threat to safety. - Page 15 WARNING! A Patient’s pain level and general discomfort should be monitored and noted throughout the treatment process. If discomfort or pain is experienced, treatment should be stopped immediately. WARNING! If the lens / laser optics is getting hot, pause of treatment has to be conducted and laser has to be turned off. It will feel very uncomfortable when the laser is held directly on the skin, and it can be so hot that it can damage the skin! The lasers are designed for a treatment time of 5 minutes and max.
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Page 16: Safety In General
Safety in General Never use the laser without optics! • Do not use the laser with, under, or near water, explosive or flammable materials, flammable anesthetics or oxidizing gases (oxygen, nitrous oxide etc.). Flammable liquids such as propyl alcohol used for cleaning and disinfection should have completely evaporated before the laser is turned on. - Page 17 Hygiene IMPORTANT NOTICE! To avoid infection, always clean the laser and optics before and after use, with the recommended disinfection method! Disinfection of laser probe, battery and optics: Wipe with isopropyl alcohol or pure (100% ethanol) alcohol and then wipe afterwards with chlorhexidine. Chlorhexidine is a chemical antiseptic substance and is a strong antibacterial agent.
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Page 18: Treatment Energy-Laser™ Pro Dosage Schedule
4 x 150 = 600 4 x 300 = 1200 1 Joule = 1 W per sec. / 1000 mW per sec. ENERGY-LASER™ PRO gives beep for every 10 / 60 / 300 seconds. Each point is considered 1 cm ²... -
Page 19: Therapeutic Dose
Therapeutic dose: Dosage for laser treatments using 660 nm diode lasers includes: Recurrent aphthous stomatitis (pain and wound healing), (acceleration of the healing process): 4 J/cm - 3 or 4 times a week, (every second day) for a week. 1. Start treatment outside the wound in areas with intact skin: 2. -
Page 20: Device Description Energy-Laser™ Pro
The lasers effect = 100% The L500 PRO laser is active for 300 sec. (5 min.) / L800 PRO and L2000 PRO laser is active for 600 sec. (10 min.), after which the laser stops automatically while giving off a long beep followed by a high / low beep. -
Page 21: Error Messages
Red LED light (4.) continuously lit. This indicates that a laser diode error exists MODE: ERROR. info@akeda.com.pl Contact Customer support: Selection of program by ENERGY-LASER™ Tablet (Bluetooth) The laser is preprogrammed with the following settings: Laser: Laser Power mW: Timer: Joule tot.:... - Page 22 Programming and operation of the laser Start laser: 1. Switch on the ENERGY-LASER Tablet! 2. Attach the battery onto the laser probe so that it switches on. Immediately, unscrew and reattach the battery. This activates the laser’s programming mode MODE: LASER program mode.
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Page 23: Battery And Charger
Make sure the small micro-USB connector is properly seated and gently insert the plug, without twisting or breaking the plug! MAXI Li-Ion battery is dedicated only for ENERGY-LASER™ L500 PRO MEGA Li-Ion battery can be used only with ENERGY-LASER™ L800 PRO + ENERGY-LASER™ L2000 PRO... - Page 24 The charging system automatically ensures that the Li-Ion battery is fully charged. If the Li-Ion battery is connected to the charger, the system will ensure that the Li-Ion battery will not be overcharged. A fully charged battery will last approx.: L500 PRO L800 PRO L2000 PRO MAXI Li-Ion battery 3,7V / 650 mAh 1½...
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Page 25: Service And Maintenance Of Your Energy-Laser™ Pro
Do not use the laser probe, battery, or lens if it is damaged. ENERGY-LASER™PRO must be recalibrated annually. It is recommended that all Akeda's laser products be returned to the manufacturer or an authorized servicing dealer for repairs or recalibration. Recalibration is also recommended after the replacement or repair of any major component. - Page 26 The laser probe, batteries, and charger Wipes clean with a slightly damp cloth and/or with a cloth dampened with isopropyl alcohol and wipe over with a chlorhexidine solution with cloth. See also the section on hygiene! Troubleshooting Low battery Yellow LED light (4.) flashing slowly MODE: Low battery. Battery must be charged soon. SOLUTION: Battery should be charged.
- Page 27 All units returned to the manufacturer for service must include the following: WARRANTY REPAIR/OUT OF WARRANTY REPAIR Written statement containing the following information: 1. Unit Model Number 2. Unit Serial Number 3. Contact person with Phone and Email 4. Billing Address (for Out of Warranty Repair) 5.
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Page 28: Energy-Laser Tm Pro - Label Symbol Information
ENERGY-LASER PRO - Label symbol information... - Page 29 Attention! Follow the instructions when using this item. Read the following documents. Indoor For indoor use only. Type BF The part which is used to the treat the patient is elevated power supply. The device does not require grounding. BLUETOOTH Ver.
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Page 30: Technical Data Energy-Laser™ Pro
Technical data ENERGY-LASER™ PRO ENERGY-LASER™ PRO Following is standard in aluminum carrying case with: • 1 pcs. Laser probe with optics • 1 pcs. Li-Ion battery • 1 pcs. Li-Ion charger • 1 pcs. USB cable • 1 pcs. USB power adapter •... - Page 31 Length: Dia.: Weight: Dimensions of laser device: 102 mm 27 mm 60 grams ENERGY-LASER™ L500 PRO: 125 mm 32/56 mm 200 grams ENERGY-LASER™ L800 PRO: 125 mm 32/56 mm 200 grams ENERGY-LASER™ L2000 PRO: Important information about Li-Ion battery! °...
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Page 32: Warranty
Warranty Akeda ("Company") warrants that the ENERGY-LASER™ PRO: ("Product") is free of defects in material and ∗ workmanship. This warranty shall remain in effect for two years (24 months) from the date of original consumer purchase. If this Product fails to function during the two-year warranty period due to a defect in material or... -
Page 33: Accessories For Energy-Laser™ Pro
Accessories for ENERGY-LASER™ PRO Flat Optics All-round optics that have no focus point. The optics spread the laser energy more and are suitable for dark skin, and sensitive areas. - Can be used on all models! All models of lasers are delivered in default scheme with Flat Optics. -
Page 34: Ec Declaration Of Conformity
71-784 Szczecin Poland As the manufacturer of medical devices hereby declares that: MEDICAL DEVICES: ENERGY-LASER™ L500 PRO, ENERGY-LASER™ L800 PRO, ENERGY-LASER™ L2000 PRO which are the subject of this declaration are class IIa medical devices (UMDNS/GMDN 60409) compliant with the... - Page 35 PN-ETSI EN 300 328 V2.1.1:2017- Wideband transmission systems; Data transmission equipment operating in the 2,4 GHz ISM band and using wide band modulation techniques. PN-EN 62133-2:2017-08 Secondary cells and batteries containing alkaline or other non- acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems PN-EN 60068-2-31:2010...
- Page 36 Signature...
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