DMC Therapy Plus Manuel utilisateur

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

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.

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

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

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

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

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.

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

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.

(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.

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:

The spacer inserted in the handpiece must be in contact with the patient and the operator should

hold the handpiece as shown below:

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