DMC Therapy Plus Manuale utente
User Manual
Therapy Plus
ENG
Aiming at the practicality and ease of access to the information contained in the
User Manual of our products, DMC® in accordance with IN nº 4/2012 established by
ANVISA, provides the documents for download at the following electronic address
www.dmcgroup.com.br, in the “USE INSTRUCTIONS” page.
Check the revision of the User Manual and ANVISA registration number indica-
ted on the User Guide to correctly identify the desired file.
21-MAN-237 REV. 03
Review date: 07/12/2017
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Therapy Plus is a high-technology equipment which meets the most recent national manufacturing standards
required by ANVISA - Agência Nacional de Vigilância Sanitária [National Agency for Sanitary Vigilance].
Therapy Plus was developed to be used by doctors, nurses, dental surgeons, physiotherapists, acu-
puncturists, podiatrists and speech therapists. The professional must be qualified to apply the prod-
uct techniques. Improper use may lead to irreversible damage.
EQUIPMENT FUNCTIONS
Therapy Plus emits red and infrared laser light for the following purposes: tissue repair, inflammatory
process modulation and analgesia.
EQUIPMENT WORKING
By means of a small display and three keys, the operator views and performs all settings and features
of the equipment.
INDICATIONS
Therapy Plus has the following indications:
Red Laser: Aphthae and traumatic ulcer, oral manifestation of systemic diseases, lichen planus,
lupus erythematosus, pemphigus vulgaris, gingival hyperplasia (diabetes), cheilitis angular, gingivitis,
postoperative, ATM dysfunction, healing, lower limb ulcers, venous ulcers, arterial ulcers, diabetic
ulcers, cutaneous ulcers of different etiologies, venous stasis ulcer, skin scores, vascular microcurrent
diabetes, post-surgery, contact dermatitis, burns, pressure ulcer, diabetic ulcer and varicose ulcer,
Left Femur Fracture and Middle Third Closed Fracture, Faster Consolidation of Fractured Bone, sys-
temic laser therapy (ILIB technique).
Infrared Laser: Orthodontia, implantodonty, periodontitis, extraction, traumatic injury, biostimula-
tion of bones, Cartilage and Bone Regeneration and Sjögren’s Syndrome, neuralgias, paresthesias,
paralysis and pain syndrome, hand articulation, arthritis, rheumatoid arthritis, biomodulation, neck
pain, DMED pain, epicondylitis, fasciitis plantar, fibromyalgia, gonarthrosis, rotator cuff injury, mus-
cle injuries, cartilage injuries, peripheral nerve injuries, low back pain, osteoarthritis, facial paralysis,
paresthesias, post-surgery, nerve repair, carpal tunnel syndrome, myofascial pain syndrome, calcane-
al tendinitis, patellar tendinitis and tendinopathies.
Red and Infrared Laser: Sensitivity following cavity preparation, sensitivity following scaling,
imperfect amelogenesis, dentine hypersensibility, alveolitis, edema, xerostomia, pericoronitis, an-
esthesia, benign migratory glossitis, simple herpes and zoster herpes, decubitus ulcers and acute
inflammation.
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Therapy Plus | User’s Manual
Note: DMC provides scientific information about the subject as described in the flyer attached to the
product.
CONTRAINDICATIONS
Laser Therapy:
• On pregnant uterus;
• Neoplasm in the region to be irradiated;
• Clinical lesions without diagnosis;
• On the skin of patients who make topical use of photosensitive substances (e.g., isotretinoin, retinoic acid, etc.).
ILIB:
Patients with:
• Complex arrhythmias and heart failure;
• Hematologic neoplasms (tumors of hematopoietic and lymphoid tissues);
• Uncontrolled glaucoma;
• Pregnant patients;
• Do not apply the laser on tattoos.
Aesthetic phototherapy:
• On pregnant uterus;
• Neoplasm in the region to be irradiated;
• Clinical lesions without diagnosis;
• Patients receiving isotretinoin;
• Patients receiving retinoic acid;
• Do not apply on tattoos or micropigmentation;
• Do not apply on the thyroid gland from patients with hyperthyroidism.
CLASSIFICATION
Standard Classification
IEC 60601-1 Internally Powered Equipment and Applied Part Type B
MDD 93/42 (European Union) IIa
RDC 185/2001 (ANVISA) III
IEC 60825-1 3B
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SPECIFICATIONS
Infrared Laser Features
Wavelength 808 nm ± 10 nm
Emitter net power 250 mW ± 20%
Red Laser (Laser Beam) Features
Wavelength 660 nm ± 10 nm
Emitter net power 0,5 mW - 2,5 mW
Red Laser Features
Wavelength 660 nm ± 10 nm
Emitter net power 100 mW ± 20%
GENERAL FEATURES
Features Specifications
Supply voltage 100-240 V~
Input current Alternating current
Output current Continuous current
Input power 25 VA
Working mode Continuous
Voltage frequency 50/60 Hz
Protection against shock Internally Powered
Protection degree regarding water and solid object
penetration IP20
Uncertainty of time (seconds) ± 4%
Uncertainty of energy (Joules) ± 20.4%
Handpiece size 3 cm (length) x 5 cm (width) x 21 cm (height)
Handpiece support size 6 cm (length) x 19 cm (width) x 11 cm (height)
Handpiece weight 0,18 Kg
Handpiece support weight 0,12 Kg
Optic fiber diameter 600 µm each fiber
Battery Li-ion 3,7V 18650 with protection circuit
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Therapy Plus | User’s Manual
Features Specifications
Manufactured and tested according to: IEC 60601-1, IEC 60601-1-2, IEC 62034, IEC 60601-
2-22 and IEC 60685-1.
Software version 12
Use temperature 10 °C - 30 °C
SAFETY - IMPORTANT PRECAUTIONS
• Please read the whole manual before using the equipment.
• Attention - Using other controls, setting or running not specified in this manual may result in the
exposure to hazardous radiation.
• Attention - Laser smoke may present living tissue particles.
• As the equipment will be used by qualified professional, an additional specific training for its using
is not required. However, the reading of whole manual before its using is recommended.
• If the equipment is not used for some time, the battery shall be removed.
• The replacement of the battery by a personnel with inadequate training might result in a danger
(such as excessive temperature, fire or explosion).
• Laser lights may cause eye injuries. People who are on site should protect themselves against laser
lights emission. Therapy Plus supplies three green glasses (one for operator, the other for assistant
and the other one for patient). Only glasses supplied by DMC should be used with the equipment.
• Never look directly to laser light. Never direct it for any person, except he/she is on treatment.
• Bright surfaces may reflect laser light towards the eyes.
• Never radiate tumor processes directly, the laser can stimulate them.
• Never radiate an undiagnosed injury.
• Only skilled professionals should handle the equipment. An inappropriate use may bring irrevers-
ible injuries.
• Only components mentioned in this manual should be used together with equipment.
• This equipment cannot be used with power cable not supplied by DMC because it may provoke an
increase of emission or decrease of immunity of equipment.
• To avoid risks of shocks, the equipment should be connected only in grounded outlets.
• Do not connect power cable in difficult-to-access outlets.
• Disconnect the power cable from outlet by plug.
• No change should be made in the equipment.
• Do not obstruct equipment air input/output.
• Do not apply any protector film on handpiece in order to obstruct air input/output.
• Do not install the equipment directly on sunlight, dusty places or mechanical vibration.
• There are risks of fire and/or explosion when laser exit is used with flammable materials, solutions or gases
or in an environment full of oxygen. Avoid using flammable or oxidizable anesthetic gases, such as nitrous
oxide (N20). Due to high temperatures, some materials, like cotton, when saturated with oxygen, may be
ignited. Adhesive solvents and flammable solutions used for cleaning and disinfection should be evaporated
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before using equipment. Pay attention to the ignition of endogenous gases.
• The user should be exposed to the equipment noise during a maximum period of 8 hours/day.
• Due to the reduced size of the equipment, some safety items could not be inserted, such as: means
of protection against non-authorized use, control switch and emergency stop for the laser. Thus, the
user shall keep the equipment in a safe and protected place.
EQUIPMENT SAFETY ITEMS
Laser Beam
The equipment uses a low intensity laser beam (red laser) to indicate the infrared laser irradiation
point of the laser therapy handpiece.
As the laser beam passes through the same delivery system as the working beam, it offers a good
way to check the integrity of the delivery system. If the target beam is not present in the distal end
of the delivery system, if its integrity is reduced or if it seems diffuse, this is a possible indication that
the delivery system is damaged or not working properly.
Alerts
For operator’s safety, during emission of laser light, the equipment sounds an alarm.
Spacer
A spacer is sent to be inserted into the tip of the optical fiber, so as to have a contact application,
i.e., the spacer is an applied part of the product. To replace the spacer, simply pull out the one that
has already been used, clean the equipment and the new spacer, according to item “CLEANING/
DISINFECTING”, and insert it into the end of the optical fiber.
Handpiece Led
When the led of the handpiece is blinking fast, the laser has been activated.
LIST OF COMPONENTS
Therapy Plus is composed by:
PIECES:
Handpiece Handpiece support Power cable
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Therapy Plus | User’s Manual
Spacer Power supply Battery
ACCESSORIES:
02 Safety glasses 01 Eye protector ILIB bracelet
User’s Manual / Warranty term Suitcase for transportation
Additional parts or accessories may be purchased from the DMC through the following codes:
Code Description
010130131 Power cable
010990317 Power Supply
050020001 Safety glasses
050020004 Eye protector
110010371 Spacer
010160008 Battery
121040002 ILIB bracelet
All accessories and pieces described above are for exclusive use of Therapy Plus.
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NOTICES LASER
Notice on handpiece support:
The label below indicates the exposition to laser radiation, class 3B.
25-ETI-538 Rev.: 00 Emission: 09/02/2017
LASER
3B
WARNING
AVOID EXPOSURE TO BEAN
Notice in handpiece:
The label below illustrates the notice for laser radiation according to IEC 60825-1.
HANDPIECE
Therapy Plus
(A) Blue LED: it indicates that the red laser (R) is selected. When this
led is blinking fast, the laser is active and when it is slow, the battery is
charging.
(B) Blue LED: it indicates that the infrared laser (IR) is selected. When
this led is blinking fast, the laser is active and when it is slow, the battery
is charging.
(C) Left button: it selects the red or infrared laser.
(D) Right button: it selects the energy (in Joules) and the Ilib technique.
(E) Display: it indicates the energy to be applied in Joules and the appli-
cation time in seconds.
(F) Ventilation holes: they cannot be clogged.
(G) Optical fiber: it conducts the laser beam.
(H) Activation button: it activates or interrupts the laser emission.
(I) Battery compartment lid: The image of the withdrawable component of
the equipment is shown below with reference to the Manufacturer (DMC) and
the Model (Therapy Plus).
(J) Connector for battery charge: use this connection to charge the
battery and use the equipment at the same time.
(K) Laser output/opening.
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Therapy Plus | User’s Manual
POSITION OF EQUIPMENT/PATIENT/OPERATOR
This equipment should be used in dental, medical or physiotherapy offices and it should be posi-
tioned over a bench and connected to power outlet according illustrated below:
1M
The spacer inserted in the handpiece must be in contact with the patient and the operator should
hold the handpiece as shown below:
Indice
Altri manuali DMC Attrezzature mediche
