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User Manual
Therapy Plus
ENG
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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 indicated 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, acupuncturists, podiatrists and speech therapists. The professional must be qualified to apply the product 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, systemic laser therapy (ILIB technique).
Infrared Laser: Orthodontia, implantodonty, periodontitis, extraction, traumatic injury, biostimulation 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, muscle injuries, cartilage injuries, peripheral nerve injuries, low back pain, osteoarthritis, facial paralysis,
paresthesias, post-surgery, nerve repair, carpal tunnel syndrome, myofascial pain syndrome, calcaneal tendinitis, patellar tendinitis and tendinopathies.
Red and Infrared Laser: Sensitivity following cavity preparation, sensitivity following scaling,
imperfect amelogenesis, dentine hypersensibility, alveolitis, edema, xerostomia, pericoronitis, anesthesia, benign migratory glossitis, simple herpes and zoster herpes, decubitus ulcers and acute
inflammation.
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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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Features Specifications
Manufactured and tested according to:
Software version
Use temperature 10 °C - 30 °C
IEC 60601-1, IEC 60601-1-2, IEC 62034, IEC 606012-22 and IEC 60685-1.
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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 irreversible 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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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.
WARNING
LASER
3B
AVOID EXPOSURE TO BEAN
Notice in handpiece:
The label below illustrates the notice for laser radiation according to IEC 60825-1.
HANDPIECE
(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.
Therapy Plus
(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.
25-ETI-538 Rev.: 00 Emission: 09/02/2017
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POSITION OF EQUIPMENT/PATIENT/OPERATOR
This equipment should be used in dental, medical or physiotherapy offices and it should be positioned 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:
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INSTALLATION
To install the battery on the handpiece, follow the procedure below:
Press the lock pulling the lid outside, to release it from the handpiece as in the figure below:
Connect the battery, as in the figure below:
Place the battery connector in the compartment as in the figure below:
Reinstall the lid of the battery compartment.
Before switching on the equipment for the first time, it is necessary to charge the battery. There are
two ways to charge the battery: connecting the power supply directly to the handpiece or to the
handpiece support.
Connect the power supply cord to an earthed socket. Full charge of the battery takes approximately 3
hours and it is indicated on the display by code “CC” and by the blue led on the handpiece blinking
slowly.
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INSPECTION BEFORE USING
Before using the equipment always check the integrity of handpiece and power supply cable. They can
be neither broken, nor twisted, nor crumpled with protection surface cut or internal conductors exposed.
The plastic housing of the handpiece shall not be broken. The optical fiber shall not be damaged.
USING
Press any button to switch on the equipment. To switch it off, press the left and the right buttons
simultaneously until it is off (code “dE” is shown on the display). After 90 seconds inactivity, the
equipment switches off automatically to save the battery.
Select the laser emitter by pressing the left button on the handpiece. Select the energy irradiated by
the respective laser emitter by pressing the right button on the handpiece. The values are indicated
on the display. The irradiation time is adjusted automatically according to the selected energy and
shown on the display, in seconds, as countdown upon pressing the activation button.
To activate the laser emitter, press the switch button. In case of the user wishes to interrupt the laser emission, just release the switch button. To start the laser emission again starting from the point of interruption,
press the switch button or press the right button to start a new application cycle. At the end of the application cycle, the time counter is restarted automatically to the last selected value and the emitter is switched off.
Code “Cb” on the display indicates the end of the battery charge, and the need to be charged. The
battery can be recharged with the handpiece on the support with the power supply connected to it
or with the power supply connected directly to the handpiece.
Full charge of the battery takes approximately 3 hours and it is indicated by one of the blue LEDs
blinking while incomplete and by the display when complete (code “CC”).
When pressing the left and the right buttons simultaneously, the level of the battery charge will be shown
on the display. The level is indicated by code “b”, followed by a number from 1 to 9 (ex. “b5”), where “b1”
indicates minimum charge and “b9”, complete charge, provided that the charger is not connected.
When not used, keep the handpiece on the support to avoid that it falls and to charge the battery.
The equipment will be always in ready mode, i.e., when pressing the switch button, laser will be emitted.
PROCEDURES FOR FINALIZATION
To switch off the equipment, press both left and right buttons simultaneously until it is off. Otherwise,
after 90 seconds inactivity, the equipment switches off automatically to save the battery.
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CHANGE OF BATTERY
The capacity of the battery to store the charge decreases over time. When the battery independence
is very reduced, it will be necessary to replace it. To replace it, the user must follow the following
steps:
Press the lock of the battery compartment lid and pull to the outside of the handpiece;
1. Remove the battery from the compartment and release the connector;
2. Connect the new battery by pressing the connector correctly in the compartment;
3. Insert the battery in the compartment and reinstall the lid.
The procedure will be illustrated in item “INSTALLATION”.
New batteries shall be acquired exclusively from DMC.
The Therapy Plus battery contains lithium in its composition and shall not be disposed in common
waste.
INSULATION OF ELECTRICAL NETWORK
In case of emergency or to clean the equipment, power cable plug must be disconnected from outlet.
CLEANING/DISINFECTION
• Before being cleaned, the equipment should be disconnected to avoid risks of shocks.
• The handpiece and handpiece support should be cleaned/desinfected with a soft cloth moistened
in alcohol 70%.
• Safety glasses can be cleaned with warm water and neutral detergent.
THE SPACER IS A SINGLE-USE PRODUCT and must be discarded after use. Contact DMC to
purchase extra spacers.
SPACER CANNOT BE STERILIZED. It should be disinfected prior to use with alcohol 70%.
Neither wash nor run liquid into handpiece or in handpiece support.
The equipment, its parts and accessories are not sterilized. Any sterilization method will damage
them, leading to cancelation of the warranty.
The cleaning/desinfection of the handpiece and handpiece support can be performed several
times, not affecting finishing surface.
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PREVENTIVE MAINTENANCE
The equipment should be gauged anually by DMC. DMC doesn’t have any responsibility regarding
safety of equipment if calibration is not performed.
All services, including technical assistance, exchanges, repair, calibration, etc., should be performed
only by DMC. DMC doesn’t provide circuit diagrams, component lists, descriptions, instructions for
calibration and gauging for unqualified people.
If maintenance or other type of technical assistance is performed by unauthorized staff, DMC doesn’t
have any responsibility regarding safety of equipment.
Before using the equipment, check the state of the handpiece and the power cords. The cords shall not
be broken, twisted, creased, with their external protection covers cut or internal conductors exposed. The
plastic housing of the handpiece shall not be broken. The optical fiber shall not be damaged.
Do not try to disassemble the handpiece or its support. In case of problem in the equipment
operation, contact the DMC technical assistance.
STORAGE AND TRANSPORTATION
The equipment should be stored in an environment without dust, avoid exposing it to direct sunlight
and keep it away from chemical products and cleaning products.
It should be stored, transported and used in the following environmental conditions:
• Temperature: 10ºC to 40ºC.
• Humidity: 30% to 75%.
• Atmospheric pressure: 700 hPa to 1060 hPa.
Avoid mechanical shocks, blows and vibration in the equipment
TROUBLES AND POSSIBLE SOLUTIONS
Trouble Possible solutions
- Check if battery is well connected.
The equipment doesn’t turn on.
The battery charge is exhausted quickly
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- Check if outlet is energized and in good condition.
- Recharge the battery.
- Call for DMC’s technical assistance.
- Check the battery charge level (see item “USING”)
and recharge it. In case of the charge level does not
change upon charging, contact DMC.
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Trouble Possible solutions
- Remove the spacer from the optical fiber and check
Apparently weak laser emission
for debris accumulation on the emission side
- Replace the spacer.
DISCARD
The end of equipment life and its components may induce to environmental contamination or if they
are unduly used. To decrease these risks, the customer should discard the equipment according to
the local legislation.
The Therapy Plus battery contains lithium and shall not be disposed in common waste.
LASER SUPPLY SYSTEM
The equipment is composed by two lasers, one red and one infrared. Laser light is conducted to
the end of handpiece by optical fiber. The luminous power emitted by laser diodes is controlled by
electric current.
BIOCOMPATIBILITY
The part applied, that touches the patient, is in accordance with the requirements of the ISO 10993-1.
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CALCULATION OF BEAM DIVERGENCE
Laser Emission
Applied Standard: 60825-1:2014 / Subclause 3.13
The beam divergence for 600 µm fiber is 0,45 rad ± 0,03 rad.
CALCULATION OF MAXIMUM IRRADIANCE
Applied Standard: 60825-1:2014 / Subclause 3.43
Eφ=
Maximum Power = 0,25 W
Area = 1,2 x 10-7m
CALCULATION OF CORNEA MPE
Applied Standard: 60825-1:2014 / Table A.2
MPE
C6 = 66,7
C4 = 1,64
T2 = 100s
CALCULATION OF SKIN MPE
Applied Standard: 60825-1:2014 / Table A.5
2
Wavelength 808 nm
= 610 W.m
MPE
−
264
=
E
E = 20 x 105 W/m
25,0
2
/18 mWTCCE
(t > T2)
-2
d
dA
mW
2
MPE
C6 = 66,7
T2 = 100s
2
]/[
Wavelength 660 nm
=
E
−
26
= 372,2 W.m
MPE
25,0
2
/18 mWTCE
(t > T2)
-2
16
Wavelength 808 nm
2000
= WmCE
MPE
C4 = 1,64
E
= 3280 W.m
MPE
Wavelength 660 nm
2
−
4
-2
E
= 2000 W.m
MPE
-2
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CALCULATION OF DNPO
Applied Standard: 60825-1 IEC 1993 + A1:1997 + A2:2001 (E) // Appendix A.5
DNPO
Po = 0,25W
E
= 610 W.m
MPE
a = 0,0006 m
= 0,45 rad.
Wavelength 808 nm
/4
π
=
MPEo
ϕ
-2
DNPO = 4,94 cm
aEP
−
Po = 0,1W
E
MPE
a = 0,0006 m
= 0,45 rad.
Wavelength 660 nm
DNPO
=
= 372,2 W.m
DNPO = 4 cm
aEP
/4
−
π
MPEo
ϕ
-2
EQUIPMENT ELECTROMAGNETIC SAFETY STANDARDS
Find below the tables which represent the adequacy to emission and electromagnetic immunity
standards.
Manufacturer standards and declaration - Electromagnetic Emissions - for every equipment
and system [IEC 60601-1-2 / 2007 – subcl. 6.8.3.201 a) 3)]
Therapy Plus is designated to be used in electromagnetic environment specified below. Therapy Plus’ customer or user shall ensure it will be used in such environment.
Immunity test Compliance Electromagnetic Environment - Standard
Therapy Plus uses RF energy only for internal
RF emissions
ABNT NBR IEC CISPR 11
Group 1
Compliance
functions. So, its RF emissions are very low and
it is not likely to cause any interference to close
electronic equipment.
RF emissions
ABNT NBR CISPR 11
Harmonic emissions
IEC 61000-3-2
Emissions due to voltage fluctuation/flicker
IEC 61000-3-3
Class “A”
Not applicable
Not applicable
Therapy Plus can be used at all establishments
which are not designated for domestic use or
which are not directly connected to a public
low-tension energy supply network which feeds
buildings used for domestic purposes.
Table 1: Information regarding compliance to the requirements for electromagnetic emission based
on Table 201 – 60601-1-2, 2007.
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Manufacturer standards and declaration - Electromagnetic Immunity - for every Therapy Plus
[IEC 60601-1-2 / 2007 – subcl. 6.8.3.201 a) 6)]
Therapy Plus is designated to be used in electromagnetic environment specified below. Therapy Plus’ customer or user shall ensure it will be used in such environment.
Immunity test
Electrostatic discharge
(ESD) IEC 61000-4-2
Fast electrical
transients/pulse train
(“burst”)
IEC 610004-4
Power surge
IEC 61000-4-5
Voltage drop, short
interruptions and voltage variation in input
supply line
IEC 61000-4-11
ABNT NBR IEC
60601 test level
± 6 kV per contact
± 8 kV by the air
± 2 kV in power lines
± 1kV in input/output lines
± 2 kV line to ground
± 1 kV line to line
<5% Ut
(>95% of voltage drop in
Ut) for 0.5 cycles.
40% Ut
(60% of voltage drop in Ut)
for 5 cycles.
70% Ut
(30% of voltage drop in Ut)
for 25 cycles.
<5% Ut
(>95% of voltage drop in
Ut) for 5 seconds.
Compliance
level
Compliance
Compliance
Compliance
Compliance
Electromagnetic
Environment - Standard
It shall be wood, concrete or ceramic floor. If floor is covered by
synthetic material, the relative humidity should be at least 30%.
Quality of energy supply should be
like a hospital or typical commercial
environment.
Quality of energy supply should be
like a hospital or typical commercial
environment.
Quality of energy supply should be
like a hospital or typical commercial environment. If Therapy Plus
user requires a continuous operation during energy drop, it’s recommended that Therapy Plus be feed
by continuous power supply or by
battery.
Magnetic field in power
frequency (50/60 Hz)
IEC 61000-4-8
Note: Ut is CA supply voltage before application of test level.
3 A/m Compliance
The magnetic fields in power frequency shall be into levels of a
typical hospital or commercial environment.
Table 2: Information regarding compliance to the requirements for electromagnetic immunity based
on Table 202 – 60601-1-2, 2007.
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Manufacturer standards and declaration - Electromagnetic Immunity - Equipment which doesn’t give
SUPPORT FOR LIFE [IEC 60601-1-2 / 2007 – subcl. 6.8
Therapy Plus is designated to be used in electromagnetic environment specified below. Therapy Plus’ customer or user shall
ensure it will be used in such environment.
Immunity test
ABNT NBR IEC
60601 test level
Compliance
level
Electromagnetic Environment - Standard
Portable and mobile RF communication equipment can’t
be used close to any part of Therapy Plus, including cables, recommending a safe distance calculated from
equation applicable to transmitter frequency.
Recommended distance:
D = 10.10 m
D = 10.10 m
(80 MHz to 800 MHz)
RF Conducted
IEC 61000-4-6
RF Radiated
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
3 V/m
80 MHz to 2.5 GHz
3 V
3 V/m
D = 20.20 m
800 MHz to 2.5 GHz
Where P is maximum nominal transmitter output power in
watts (W), according to the transmitter manufacturer and
D is the distance recommended in meters (m).
It’s recommended the intensity of the field established by
RF transmitter, as determined by an electromagnetic inspection on sitea, be lower than compliance level of each
frequency rangeb.
It may clash the equipment marked with the symbol:
Note 1: In 80 MHz and 800 MHz, the highest frequency range is applied.
Note 2: These standards can’t be applied at all situations. Electromagnetic propagation is affected by absorption and
reflection of structures, objects and people.
a
Field intensities established by fixed transmitters, such as base radio stations, telephone (mobile/wireless) and terrestrial
trunked radio, amateur radios, AM and FM radio transmission and TV transmitters can’t be predicted theoretically and
precisely. To evaluate electromagnetic environment due to fixed RF transmitters, an electromagnetic inspection on site is
recommended. If measurement of field intensity on site where Therapy Plus is used surpasses the compliance level used
above, Therapy Plus should be inspected to check whether operation is normal. If an abnormal performance is checked,
additional procedures can be required, such as Therapy Plus reorientation or replacement.
b
If the frequency range is higher than from 150 kHz up to 80 MHz, the field intensity should be lower than 3 V/m.
Table 3: Information regarding compliance to the requirements for electromagnetic immunity for
equipment which doesn’t aim LIFE-SUPPORT based on Table 204 – 60601-1-2, 2007.
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Minimal distances recommended for portable and mobile RF communication equipment and Therapy Plus.
Therapy Plus is designated to be used in electromagnetic environment in which radiated RF disturbances are controlled.
Therapy Plus’ customer or user may help avoiding electromagnetic interference keeping a minimal distance between portable or mobile RF communication equipment (transmitters) and Therapy Plus, as recommended below, according to the
maximum output power of communication equipment.
Maximum nominal
output power of trans-
mitter (W)
0.01 0.12 0.12 0.23
0.1 0.37 0.37 0.74
1 1,2 1,2 2,3
10 3,7 3,7 7,4
100 12 12 23
For transmitters with maximum nominal power not listed above, the recommended distance (in meters [m]) can be determined by equation applicable to transmitter frequency.
Note 1: In 80 MHz to 800 MHz, the distance for highest frequency range is applied.
Note 2: These standards can’t be applied at all situations. Electromagnetic propagation is affected by absorption and
reflection of structures, objects and people.
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz
Distance according to transmitter frequency (m)
Table 4: Recommendations for distances between equipment and RF emission source based on Table
206 – 60601-1-2, 2007.
USED SYMBOLS
20
Laser radiation
Attention
General symbol for warning
Single use
See user’s manual
Page 21
Applied part type B.
It identifies the positive and the negative connections (polarity) of a direct current power supply or the positive and the negative connections of a handpiece
of the equipment, which will be connected to the direct current power supply.
Continuous current
10º C
30%
I P 20
SN
75%
Protected against 12.5-mm-size solid unknown objects and not protected
against water.
Manufacture date
Manufactured by
Alternating Current
Serial number
40º C
Temperature limits
Humidity limits
Fragile.
Indicates the position for transportation.
Can’t be exposed to sunlight.
Keep dry
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Do not fall
Maximum stacking
WARRANTY
A. The equipment manufactured and/or marketed by DMC is guaranteed for twenty four (24) months
from purchase date against manufacturing defects.
B. This warranty only covers manufacturing defects or material used in the manufacturing of products. The warranty doesn’t cover shipping costs.
C. The warranty is automatically canceled in case electrical and physical abuses are performed, if
parties are changed or different application for which equipment was developed was performed.
D. In case the equipment is repaired out of warranty period, it can be only extended to exchanged
components.
E. The most common defects are physical shocks applied to the equipment, and in these cases the
warranty is cancelled.
F. DMC is not responsible for personal or material damages originating from undue use of equipment, and user should provide safety measurements in order to avoid such occurrences.
G. DMC responsibility regarding use of equipment and its consequences is limited to its replacement
value.
The equipment will be guaranteed by manufacturer if:
• Assembly, extension, adjustment, exchanges or repairs are performed by authorized staff.
• Electrical installation meets to appropriate requirements.
• Equipment was used according to the instructions mentioned.
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DMC IMPORTAÇÃO E EXPORTAÇÃO DE EQUIPAMENTOS LTDA.
Rua Sebastião de Moraes, 831 | Jardim Alvorada | São Carlos/SP
CEP 13562-030 | CNPJ 02.827.605/0001-86
ANVISA Registration: 80030810157
Tech. Responsible: Renaldo Massini Jr. CREA 0601706815
Technical Name: Laser therapy system
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For more information about our
technology and how to use it, visit:
www.nupen.com.br
Technical Assistance
DMC IMP. E EXP. DE EQUIP. LTDA.
+55 (16) 2107-2323
www.dmcgroup.com.br
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