ER-35 user manual
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Contents
PREFACE..................................................................................................................................................... 3
General Information.................................................................................................................................. 3
CAUTION.................................................................................................................................................... 4
WARNING...................................................................................................................................................5
INTRODUCTION.......................................................................................................................................... 6
TECHNICAL SPECIFICATION........................................................................................................................ 7
SAFETY PRECAUTIONS................................................................................................................................8
Control Panel Instruction........................................................................................................................... 9
HOW TO USE............................................................................................................................................ 10
CAP-RES THERMA-S HYPERTHERMIA.......................................................................................................12
BIOLOGICAL EFFECT................................................................................................................................. 12
THERMA-S HYPERTHERMIA APPLICATIONS.............................................................................................13
APPLICATION METHOD............................................................................................................................ 13
REMARKS..................................................................................................................................................15
FAQ...........................................................................................................................................................16
ACCESSORIES............................................................................................................................................19
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PREFACE
General Information
This section provides critical safty information to the use of the Diathermy Systems
,Follow all the Safty Precaution in this section
1 Read this manual prior before using the system.
Stay current with the latest clinical development in the fields of therefore Therapy.
Observe all applicable precautionary measures for treatment
Keep informed on appropriate indications and contraindication for the use of RF
Therapy.
Warranty
This product is warranted against defects in materials and workmanship for a
period of two years from the date of shipment
The company will at its option, repair or replace components which proves to be
defective during the warranty period. The repairs or replacements are carried out by
the Company or its approved agents.
The Company will consider itself responsible for the effect on safety, reliability and
performance of the product: only if the product is used in accordance with the
instructions for use, only if the electrical installation of the relevant room complies
with the appropriate national requirements
Should the product be returned to the Company for repairing, it must be sent carriage
paid Consumable items, for example, electrodes and plates are not included in the
above warranty.
Precautionary Instructions
The precautionary instructions in this section and throughout this manual are
indicated by specific symbols.Understand these symbols and their definitions before
operating this equipment. The definition of these symbols are as follows:
Caution Text with a "CUATION" indicator will explain possible.
Safely infractions that could have the potential to cause minor injury or damage to
equipment.
=WARNING Text with a "WARNING" indicator will explain possible Safety
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infractions that will potentially cause serious injury and equipment damage.
=DANGER Text with a "DANGE" indicator will explain possible Safety
infractions that are imminently hazardous situations that would result in death or
serious injury.
NOTE: Throughout this manual "NOTE" may be found. These Notes are helpful
information to aid in the particular area or function being described.
CAUTION
Read , understand and practise all precautionary and operating instructions
Know the limitations and hazards associated with using any electrical stimulation
,ultrasound device or any other devices. Observe all precautionary and operational
decals placed on the System and optional modules.
◆DO NOT operate the Therma-s Plus when connected to any unit other than
DAEYANDG MEDICAL devices.
◆DO NOT operate the unit in an environment of short-wave diathermy use.
◆The high frequency generator should be routinely checked before each use to make
sure that all control function normal, especially that the intensity control does actually
terminate power output in a stable manner. Also, make sure that the treatment time
control does actually terminate power output when the timer reaches zero.
DO NOT use sharp objects such as pencil point or ballpoint pen to operate the button
on the control panel as damage may occur.
◆This System.optional modules and associated accessories should be operated,
transported and stored in temperature between 59° and 104° F(15 ℃and
40℃），with Relative Humidity ranging from 30%- 60%.
◆Electrodes with inappropriate handling of the applicator may adversely affect its
characteristics.
◆Before each use, inspect applicator for cracks, which may allow the ingress of
conductive fluid.
◆Inspect electrode, cables and associated connectors before each use.
◆The Therma Plus, optional modules and some associated accessories are not
designed to prevent the ingress of water or liquids. Ingress of water or liquids could
cause malfunction of internal components of the System and therefore create a risk of
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injury to the patient
WARNING
This device should be used only under the continued supervision of a phys1c1an or
licensed practitioner.
◆For continued protection against fire hazard, replace System fuses only with ones
of the same type and rating as found in the specifications section of this manual.
◆Make sure the unit is electrically grounded by connecting only to a grounded
electrical service receptacle conforming to the applicable national and local electrical
codes.
◆This device should be kept away from children
◆Care must be taken when operating this equipment around other equipment.
Potential electromagnetic or other interference could occur to this or other equipment,
Try to minimize this interference by not using other equipment in conjunction with it.
◆Use of controls or adjustments or performance of procedures other than those
specified herein may result in hazardous conditions, causing damage to the System,
optional modules, associated accessories and hazardous exposure to energy.
◆To prevent electrical shock, disconnect from the power source(electrical
outlet) attempt any maintenance procedures to the System
◆Keep electrodes separated during treatment, electrodes in contact with each other
could result in improper stimulation or skin burns.
◆Pads should not be used with plate.
The plate must not be contact with any part of patient's skin when pads are used.
◆ Do not use cracked electrode when it has any crack on the surface.
DANGER
A user shall avoid using the product in the following cases
-In the case where such as aid as implant, pace maker or ant other artificial organ
inside the body
-Pregnancy
-.A patient with a coagulation disorder or bleeding tendency 1
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-When the patient does not feel thermal changes.
-A hypertensive
-A burn or care after such a burn.
Contraindication
◆This device should not be used for symptomatic local pain relief unless etiology is
established or unless a pain syndrome has been diagnosed.
◆This device should not be used when cancerous lesions are present in the treatment
area.
◆Other contraindications are patients suspected of carrying serious infectious disease
and disease where it is advisable for general medical purpose to suppress heat or
fevers
◆This device should not be used over or near one grow with centre until bone growth
is completed.
◆This device should not be used over the thoracic area if the patient is using a
cardiac pacemaker.
DANGER
Patient with an implanted neuro stimulation device must not be treated or be in close
proximity to any radio frequency diathermy ,shortwave diathermy, microwave
diathermy, therapeutic ultrasound diathermy or laser diathermy anywhere on their
body .Energy from diathermy(RF,shortwave,microwave ultrasound and laser) can be
transferred through the implanted neuro stimulation system, and this can cause tissue
damage and can result 1n severe injury or death. Injury, damage or death can occur
during diathermy therapy even if the implanted neuro stimulation system is turn "off"
INTRODUCTION
HYPERTHERMIA
The therapeutic effects of Hyperthermia on the human body have been well-known
since the 19th Century. It is mainly being indicated for inflammatory process, usually
accompanied with pain. Methods used made it very difficult to obtain deeply.
Controlled and harmless thermal increases and some requires "invasive" techniques.
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What is Therma-s
Therma-S is intended for therapeutic diathermy to produce deep heating without
excessive temperature elevation of the skin surface and subcutaneous tissue.
Therma-s plus is applied to any part of the human body without pain,
muscular contraction or disagreeable sensation of any kind.
The principle of RF Diathermy
◆The treatment site is placed between the plates of a capacitor and becomes the
dielectric.
◆The RF energy is diffused through the part of the body locate between the plate
electrodes.
◆The oscillating fields produce distortion of molecules, rotation of dipoles and
vibration of ions
◆The movement of the molecules and ions generates heat within the tissues.
◆These actions have been shown to have positive clinical effect on enhancing blood
flow.
TECHNICAL SPECIFICATION
◆General
Power input: 110V-224V 50/60HZ
Maximum Power Consumption: 300W
Classification(EN60601-1): Class 1. Type BF
Main Fuse: 2*T2A(5*20mm)
Size(length*width*depth): 480*460*180mm
Weight:13KG
◆Output Parameter
Carrier Frequency:0.468MHz
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Maximum Intensity: 220Va
Out Modes: Round Electodes/Rectangle Type
Treatment Time: 0-60minutes
Safety Device: Zero start
SAFETY PRECAUTIONS
Must not be applied to brain, backbone, eye, heart, testicles, ovary, pregnant
womb, good or bad tumor and tuberculosis.
Not suitable for the application to the followings: bleeding, circulation troubles
(thrombus arterial sclerosis, etc.), acute inflammation of joint and bone, suppuration
of soft tissues,etc
Patients with Heart pacemakers or other electronic implants
Electro Therapies or diagnoses should never be employed on patients with electronic
implants , such as hear pacemakers, without obtaining prior approval of a specialist.
Use only certified-safe accessory items
Use only those accessory items listed in the equipment's instruction manual. Any
other accessory items employed should be certified as safe for such use by testing
authority.
Pads should not be used with plate.
The plate must not be contacted with any part of patient's skin when pads are used.
For correct application the following factors should be taken into account.
PRESSURE
Sufficient pressure must be applied in order to maintain perfect electrical contact over
the whole surface of the electrode, whilst allowing it to be moved smoothly.(similar to
the pressure exerted with a large eraser)
SPEED
If the area to be treated is small and the electrode covers it, the electrode maintained
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in this position A light circular movement of the electrode will allow the patient to
tolerate a higher temperature. In order to cover areas larger than the electrode, you can
either:Keep the electrode still and when the maximum bearable is reached. move it to
an adjacent area.This is continuesd until the whole area is covered. Move the
electrode forming circles as in the RET but more slowly,advancing 1 centimetre per
second.
TEMPERTURE
A tolerably high temperature should be selected. It should not be too uncomfortable.
TIME
The length of the treatment depends on different factors, such as the size of the area to
be treated, the nature of the tissue in the area or the capacty of the patient to accept
different degrees of temperature.
The specialist should always determine the treatment time.
Control Panel Instruction
Picture 1 Picture 2
Picture3 Picture4
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Picture 5 Picture 6
1, Connect the power cord at the back of the machine, then power on, it shows
picture 1.
2, Press , it shows picture 2.
3, Select Treatment mode CAP or RES.Press the button or , the screen
shows Picture 3 or Picture 4.
4, Press the button , it adjust the treatment time.
5, Rotate the potentiometer to adjust the treatment intensity.
6, Press the Start/stop button to start or stop the treatment.
7, When finished the treatment, just power off the machine is OK.
HOW TO USE
The operation of Therma-S is simply.
Application Method for Round Type Electrode
The Therma-s Plus method has two electrodes connected to a high frequency
generator, A return electrode(generally in the form of a plate)that placed in a fixed
position in contact with the person to be treated and an active mobile electrode, which
is applied on the area to be treated
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It is essential to apply a thin layer of a specific moisturizing and conductive product
over the area where the active electrode is applied.
For correct application:
Sufficient pressure must be exerted to maintain a perfect electrical contact over the
entire electrode surface but one that at the same item allows
smooth movement.(Similar to the pressure exerted when
using a large easer)
The electrode must be moved in small circles, each one
advancing 50%(half) of a diameter of the electrode. The
movement is slow and uniform but without stopping (one
circle per second approximately)
It is better to reduce the power if it is unbearable and then
increase it gradually, rather than using a high power that
compeles quick movement to be made.
If body treatment is conducted, the highest bearable
temperature must be selected. In facial treatment the
temperature must be relaxing.
Active electrode position: The entire electrode surface must b
in perfect contact with the skin, i.e. the electrode must not be tited but must be
completely flat throughout the whole application.
Please go through the following steps one after another
The neutral plate surface must be perfect contact with the skin before power
"ON"
1. Press the POWER button on the back of the machine.
2. Make sure the intensity controller is at Zero, otherwise the machine will alarm.
3. Connect all the accessories.
4. Applicator Preparation: Clean applicator before each therapy session
5. Select the desired Time by pressing Time button
6. Select the desired Electrode by (RES or CAP ) button
7. Use CAP first, then RES
8. Do not use the CAP with the application electrode that is not insulated.
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9. Examine the treatment area for any wounds and clean the skin
10.Apply a liberal amount of Thermal Active Cream to the area to be treated by
Applicator
11.Apply plate to patient, make sure the plate is in complete contact with the skin.
12.Set intensity by rotating the intensity Control Knob clockwise to desired level.
13.By using the intensity knob from zero, the unit is started immediately.
14.Move the Electrode during therapy session in a circular motion. The area treated
should be two times the diameter of the Electrode
CAP-RES THERMA-S HYPERTHERMIA
Capactitive Electric Transfer(CAP) is a method that allows the RF Electrical current
to be transferred “by Capacity” （principle of the electrical capacitor) to the patient’s
body via a movealbe external application electrode. This is covered with an insulating
film which acts as dielctric and the body acts as a second plate of the capacitor. A
return plate closes the circuit.
The Resistive Electrical Transfer(RES), introduced in 1994, is different from the CAP.
The application Electrode is not insulated, allowing the current to be transferred
directly to the patient with less dispersion, thus obtaining an increase in temperature at
a greater depth.
BIOLOGICAL EFFECT
1. Increase arterial circulation vasodilatation, giving rise to increased ocygnenation
and a decreased acidity of the tissues.
2. Increase venous drainage with greater re-absorption of catabolites and decrease the
oedema in areas with inflammatory processed.
3. Increase the permeability of the cellular membrane, allowing better transfer of
metabolites through it.
4. Stimulate the immune system and decrease free radicals.
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THERMA-S HYPERTHERMIA APPLICATIONS
The Therma-s method is currently being applied in most medical specialities,
particularly in:
Traumatology and Rehabilitation.
Rheumatology
Sports Medicine
Pain Clinics
APPLICATION METHOD
The position of the patient will obviously depend on the
area to be treated. This will also determine the best
position of the neutral electrode(plate) and the area on
which to work with the active electrode.
Figures 1 and 2 show the most suitable positions for
application on the torso. The return plate is situated
opposite the area on which the active electrode is applied.
An alternative position in treatments that do not require
special depth(eg spinal column) is one where the patient
is seated on the neutral return plate in direct and total contact with the skin.
Some treatments require the electrodes in specific
positions. For example, for treatments on the shoulder the
ruturn plate is placed in the armpit and firmly held in
place by pressure from the arm.(fig.3)
For treatment on the knee an alternative to the horizontal
position on the stretcher with the plate under the thigh is
the position shown in fig.4
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The position in fig.5 is excellent for treatment on the
ankle. The position shown in fig.6 is suitable for
focusing hyperthermia on the toes.
Similar to the above, figures 7 and 8 show positions for
the treatment of wrist and fingers.
In Fig.7 the cylindrical electrode is used as return
electrode.
In each case, and in particular those shown in fig.3 to 8,
the moisturising cream applied to the area of the active
electrode must not come into contact with the neutral
plate as, being conductive, it would divert the current
flow to the surface.
CONDUCIVE GEL/CREAM
A conductive and moisturing gel should be used which will improve movement and
electrical contact of the electrode. It should liquefy with the temperature. Therma-s
Plus has developed and supplies a gel that complies with these requirement.
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INDICATION
A thorough description of the application of the Thema B plus method within general
pathology would be extremely lengthy.
Clinical indicators-areas for application, type of method. CAP and/or RES, number of
sessions and distribution guidelines in the time and length of eaca session should
always be indicated by the corresponding specialist.
However, it is valuable to provide a general idea of the possible application and some
overall concepts that maybe useful.
AREAS OF APPLICATION
1, If you have a device with CAP and RES, it is always advisable to apply systems, In
the case the treatment will start with the CAP as its surface vasodilator effect allows
greater heat dissipation and therefore a greater skin temperature tlerance, thus
providing a deeper effect of the RES.
2, In the spinal column, pain due to arthrosis processes is treated locally. When there
is a radiculo-meddular problem, neurological exploration and complementaty
examinations will determine the precise spinal level on which the treatment should be
applied.
REMARKS
◆One of the most outstanding effect of the system is the increase of blood flow in the
area treated. If the patient has a reduced vascularization in the treated area ,intense
pain and a sensation of inflammation may be felt at the beginning of the treatment.
The session should be stopped and treatment restarted again with less intensity,
extending the application to the surrounding areas in order to improve the venous
drainage of the area After a few days the system itself improves the flow and the
treatment can be performed normally
◆Bi-system device that RET have an indicator level of the RET current that
circulates through the patient. The conductivity of the muscle tissue is directly related
to the level of vascularization, If this level is very low, it is possible that at maximum
power the RET intensity indicator hardly shows the presence of any current. In this
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case, the
return plate should be moved as near as possible to the area to be treated, thus
increasing the passing of the current and improving the blood flow of the area. In
posterior treatments the plate will be moved away until it is positioned in the place
originally considered optimum.
In cases of potential lots of skin sensitivity, this possibility must be checked Applying
the treatmentShould there be insensitivity should be tested in the nearest area with
normal sensitivity. Once the appropriate tolerable levels have Been
bl treatment can be applied on the insensitive area.
FAQ
What are the differences between the capacitive and resistive methods in the RF
System?
The capacitive method causes the temperature to increase more rapidly in the
ep1dermis(superficial depth area)but it penetrates less energy internally than the
resistive method. The internal benefit is directly related to the amount of energy
absorbed by the body. Also, the resistive method uses 100% to the current
Which model of equipment provides the deepest treatment?
All models reach exactly the same depth, since all have a closed circuit from the
Application elect 「 ode through the plate or return electrode, The main difference is
that the total amount of power supplied and ,therefore, that absorbed by the body, is
greater
with a more powerful device and this applies even more to the resistive mode.
What temperature is achieved with the RF system?
Depending on the sensitivity of the area being treated ,the temperature in the
epidermis can reach 44-45℃,whether in capacitive or resistive mode, internally
this will depend on the degree of blood circulation, the better it is,The lower the
temperature will be and vice versa. For example" an increase in temperature is
achieved far more rapidly in an inflamed area than in that same area when not
inflamed. The calculation can be made from the increase in temperature in one minute
1n one cubic cm of tissue. at a depth of 5 mm in health tissue and in the liver, the
increase can be up to 4.2'C in resistive mode and in capacitive mode.
What size of electrode provides the greatest benefits with the resistive method in
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the RF system models?
If the resistance needs to be increased according to the graph. you should use the
60mm electrode, If it needs to be reduced, use e 90mm electrode
Does application in certain in certain areas hurt when using the resistive mode?
If so,why?
If it sometimes hurts, this is due to poor vascularisation in the affected area. The area
does not have sufficient drainage capacity therefore creating pressure internally, This
is what causes the discomfort, however it does not occur with the capacitive method
as it is a more superficial treatment.
Why is it that when there is inflammation, the power supplied is very low, but the
temperature rises very quickly?
Because as the circulation is adversely affected, the level of cooling is quite reduced
and the power tolerated is also very low.
Why is it that if you gently touch someone being treated it can feel like you have
received an electric shock?
Part of the energy(a very small amount, about 2 or 3 watts) absorbed by a body is
transmitted to another body, and if the contact is brief, this small concentration of
energy can cause discomfort, This problem is solved by simply making the contact
firmer
Can I be negatively affected by the radiation when giving the treatment?
Absolutely not, Firstly, the power transmitted is very low, and secondly considering
that the effects of the type of current from our machines are very beneficial for the
tissues, the effect is always beneficial. never negative.
Why do you heat the plate in RES mode and not in CAP mode?
Because the power supplied by the RES methods is much higher than in the CAP
methods.
Why, when applied to the forehead, does the RES method cause contractions and
the CAP not ?
The RES method does not penetrate the brain and the current is connected in the scalp,
leading to over-circulation which results in the contractions. This does not represent a
problem but the discomfort can be avoided by reducing the output power of the
equipment. As the CAP method has the power to penetrate the skull, the effect
described does not occur.
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What can be done about the slight dizziness which occurs when treating the
neck?
It should be stressed that this only occurs in people with hypotension and one solution
is to recommend that they have a cup of coffee 10 minutes before the treatment.
Can any product be used to enhance a treatment?
Number when applying the treatment, the products recommended by US must be used,
Afterwards, to take advantage of the casodilatation of the pores, any products
considered appropriate may be used with a manual massage.
Why is there sometimes an apparent over-inflammation in the treatment area,
especially in the joints?
This is due to poor drainage in the treated area and is not caused by inflammation, but
an accumulation of blood. Treatment should not continue in the affected area, but all
around the periphery, in order to create good drainage, for example, with a knee injury,
the treatment should be applied to the calf and the thigh and not be continued on the
knee itself. Instead, it can b gently massaged after the corresponding drainage has
been carried out.
Can one take a shower after treatment with the RF system without losing some of
the treatment's benefits?
The only recommendation is to try to regulate the temperature of the water so that it
1s warm or not excessively cold. It should be said that, if wished ,the water can be
turned to cold for 15 to 20 seconds at the end of the shower without decreasing the
benefit obtained from the treatment
Can external metals cause burns during treatment with the RF system?
Only pendants and chains can cause problems if close to the application electrode
since they do not have firm contact with the skin, it is therefore recommendable to
remove all metallic objects not in firm contact with the skin, In the case of watches ,
etc.,they are not a problem as long as they do not interfere with the treatment at a
mechanical level
Can the resistive method be used on the hair?
No. As the resistive method has a direct action with no isolation, it would products
sparks from the hair, which would be very unpleasant.
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ACCESSORIES
Main machine X 1pcs CAP、RES handpieces RES treatment head 4pcs
Negative plate 1pcs Power line 1pcs CAP treatment head 7pcs
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