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713-80 Vanquish User Manual EN200
713-80 Vanquish User Manual EN200
USER´S MANUAL
Vanquish
User’s Manual
BEFORE YOU START
Dear Customer,
Since the effects of high-frequency fields on unborn life have not yet been
sufficiently researched, we recommend that pregnant persons are not within 14 meters
(45 feet) of the applicator when the unit is activated.
• Metal objects within the treatment area that cannot be removed should be avoided.
These include, but are not limited to:
• External metal: orthodontic braces, dental fillings, staples, external fixation
devices.
• Internal metal: valves, joint replacements, metal IUDs, shrapnel, metal implants,
internal fixation devices-rods, plates, screws, wires, etc.
Before treatment, determine the maximum nominal output power of the respective accessory
in order to avoid overheating the tissue. Speak with the patient to verify that:
• The patient is in a comfortable position during the entire treatment.
• The patient is not in contact with the unit, the applicator cable, the applicator or other
devices or metal objects.
After the treatment, ask the patient about the tolerance of the treatment.
* The affected parts of the body should be unclothed during treatment, since accumulation of moisture on the skin
or in folds can cause local overheating of the skin. This is especially important in the event that the patient is
wearing clothing made of moisture-resistant fabric such as silk or synthetic fibres.
2.2 CONTRAINDICATIONS
Do not treat (or expose) patients if the following conditions are present:
• Implanted electronic device such as a cardiac pacemaker, bladder stimulator, spinal
cord stimulator or electrodes for a myoelectric prosthesis, or implanted metallic leads.
Do not treat patients who have had an implant in the past unless you are absolutely
certain that the implant and all leads in their entirety have been removed. Note that
leads are often left implanted after the implant is removed. The effects of the applied
high frequency on the pacemaker could cause ventricular fibrillation. Any other
persons with pacemakers must also remain outside of the treatment area. No one
wearing a cardiac pacemaker should be within 14 meters (45 feet) of an operating
unit.
• Negative affection by heat.
• Haemorrhages or risk of haemorrhage.
• Septic conditions and emphysema.
• Malignant tumours and undiagnosed tumours.*
• Implants, areas where implants have been removed, damaged implants, and metal
inclusions.†
• Implants that could be impaired by electromagnetic field.
• Swellings that still feel warm.
• Thermohypesthesia (diminished perception of temperature differences).
• Thermohyperesthesia (very acute thermoesthesia or temperature sense; exaggerated
perception of hot and cold).
• Acute inflammations.
• Severe arterial obstructions (stage III and IV).
*According to Schneider (in Elektromedizin 7/62): Tissue and organ sections with inflammations, necroses, pus
formation and abscesses. In such cases, the therapist must choose between the application of cold or heat in
accordance with general pathological considerations, depending on the degree of inflammation. Inflammatory
conditions that are still in status nascendi are treated with cold. Inflammatory conditions with necroses and a
cavitary tendency are treated with therapeutic means that generate heat and hyperaemia. Chronic and unspecific
inflammations are treated in the same way (heat and hyperaemia), as this supports resorption, reparation and
regeneration. Specific chronic inflammations (such as tuberculosis), however, are activated by heat. Accordingly,
they represent a contraindication. The same applies in the case of malignant tumorous conditions. Heat
application in the case of a tumorous disease can only be regarded as malpractice. Moreover, cardiac
congestions must be removed prior to any heat application.
†
The higher conductivity of metals causes concentration of the field, producing a high temperature in the border
area of the tissue. This, in turn, can cause excessive local heat, leading to (irreparable) third-degree burns.
Therefore, caution is also necessary in case of long-existing metal inclusions, such as shell fragments.
* Further contraindications relating to gynecological disorders include (see Möbius, Gynecological University
Clinic, Jena): genital tuberculosis, endometriosis, pyosalpinx or pyoovarium, tubal carcinoma.
†
The mean age for skeletal maturity is 15 ½ years in females and 17 ½ years in males.
2.3 PRECAUTIONS
When administering the device, keep in mind the following:
• Caution is advised in patients who cannot perceive or report pain or heat sensation
accurately. Absent or diminished sensation should be avoided or, if unavoidable,
treated with caution. Establishment of acceptable intensity levels for desensitized
areas may be related to the intensity levels tolerated on normal skin in opposite or
related body parts. Frequent monitoring of intensity level and skin response should
occur during all treatments.
• If there is a surgical history there is a possibility of decreased sensation; proceed with
caution. If a scar is present, the scar tissue will heat more quickly than the
surrounding tissue due to its higher resistance or impedance and decreased blood
flow of the tissue. Because of decreased blood circulation, the scarred skin is unable
to cool itself as quickly and effectively as healthy skin.
• Caution is suggested when using Vanquish immediately after the application of
superficial and deep heat or cold modalities. The application of thermal modalities
prior to treatment with Vanquish can alter the patient's perception of warmth and pain.
• Caution is advised when applying thermal Vanquish directly to an area with impaired
arterial blood supply because the compromised blood flow may not meet the
increased metabolic demand placed on the tissues by the thermal energy dose.
Always start with a low dose and observe patient response. Increase in dose may be
made in subsequent treatments if the patient can tolerate the dosage given.
• Caution should be exercised when treating over adipose tissue.
• Vanquish should be applied with caution over bone where minimal (bony prominence)
or no (Stage IV wounds) soft tissue is present.
• The function of other patient connected equipment may be adversely affected by the
operation of the Vanquish. Maintain maximum distance between units in order to
reduce any tendency to interaction.
• Any bleeding tendency is increased by heating because of the increase in blood flow
and vascularity of the heated tissues. Care, therefore, should be used in treating
patients with bleeding disorders.
• Heating of the joint capsule in acute or subacute arthritis should be avoided.
• Vanquish may interfere with other electronic therapeutic devices such as
neuromuscular stimulators and therapeutic ultrasound units. Never use another
electronic device on the same patient when Vanquish is being applied.
• Serious injury or death to patients with implanted devices with leads (e.g. deep brain
stimulator, implantable infusion pumps), even if the implanted device is not turned on,
and even if the lead is no longer connected to an implanted system.
• Oedema of the skin, subcutaneous fat, and muscle tissue due to excessive heating.
• Exacerbation of symptoms, especially when higher doses are used.
• Spread of existing pathologies, e.g. tumours, tuberculosis or infection.
• Superficial burns due to excessive exposure, reduced thermal sensation,
hypersensitive skin, impaired blood flow, moisture in the treatment area.
• Deep burns due to non-uniform heating of different tissue layer or to reduced heat
dissipation mechanisms.
• Heat injury to the tissue surrounding a metal-containing IUD.
• Temporary sterility or permanent damage of the testes due to temperature increase.
• Teratogenic effects due to significant temperature increase of the foetus.
• Faintness due to sudden fall in blood pressure.
• Increased menstrual flow in female patients receiving treatment to the lower back or
pelvic area.
• Erythema.
Caution
Exterior cleaning of the device: Never use cleaning agents containing alcohol, ammonia,
petrol, thinners, etc. Never use abrasive cleaning materials, which will scratch the device
surfaces.
No parts of the device require sterilization. Care should be given to prevent water or other
liquids from getting inside the device.
Applicator cables, power cord and plug: Check for frays and kinks. Ensure that the
insulation is not damaged in any way.
Do not use damaged components and contact your BTL authorized service provider for
service. Always route electrical cords and cables away from staff or patient foot-traffic areas
where they could increase the chance of a tripping related accident.
All maintenance by the operator must only take place when the system is shut down and
disconnected from the power source.
Caution
With the exception of surface cleaning of the console and components and the
replacement of the fuse, the Vanquish system has no user-serviceable parts or
assemblies. Do not remove the instrument covers under any circumstances. Call
your distributor for advice about any malfunction.
The Vanquish is equipped with a protection system that prevents the connection of
accessories other than those supplied by the manufacturer.
The Vanquish system does not use any drugs, creams, gels or other substances which are
applied during its use.
It is the responsibility of the health care facility to verify that the unit complies with
the facility, local and national Earth Leakage limits.
Non-ionizing Radiation
Date of manufacture
Batch code
Catalogue number
Personnel operating the system must read this manual thoroughly and become
familiar with all its safety requirements and operating procedures prior to use of the device.
• The Vanquish system is not intended for use in wet environmental conditions.
• Keep the equipment out of the reach of children.
• The Vanquish system should only be repaired by BTL authorized service personnel.
• The Vanquish system should be transported and stored in temperatures between
-10 °C to +55 °C (+14 °F to +131 °F) to prevent damage to the device or its
components.
• The unit, applicator and cables may not be sterilized using steam or gas.
• Make sure all operators are familiar with the Vanquish system’s controls.
• Improper installation, operation or maintenance of the Vanquish system may result in
malfunctions of this unit or other devices.
• The Vanquish system console has a touch screen. Do not use sharp objects or
ballpoint pens to operate the touch screen. A special, soft tip stylus is provided for
this purpose. Alternatively, the user may use their fingers to operate the touch screen
buttons.
• Malfunction of the system could result in an unintended increase of power output and
unintended injury to the patient. If the system shows any deviations from a normal
operating situation, discontinue use and report the fault to BTL authorized service
personnel.
• Accessories that are not manufactured by BTL for use with the Vanquish system
must not be attached to the system to prevent potential harm to the patient and/or
damage to the unit.
• Avoid the use of liquids in the immediate vicinity of the system. Any liquid spilled onto
the cabinet may cause serious damage to the system’s internal components. Never
spray aerosol cleaners directly onto the system.
• Do not cover the cooling vents to avoid the equipment overheating.
• Keep the applicator and its cables separated during treatment. Applicator or its cables
in contact with each other during treatment could result in improper stimulation, skin
burns, or damage to the cable or applicator. Do not cross cables.
• Do not let the cable touch the applicator during the treatment.
• Remove the applicator by pulling the cable connector only. Do not remove by pulling
the cable. To remove the cable from the applicator, make certain the power is off.
Hold the applicator while removing the cable to prevent the applicator from dropping
to the floor.
• Inappropriate handling of the accessories may adversely affect their characteristics.
• Use of controls or adjustments or performance of procedures other than those
specified in this manual may result in hazardous exposure to electromagnetic energy.
• Do not operate the system in the presence of volatile solvents, such as alcohol,
gasoline or other solvents to prevent explosions and/or fire.
• A possible explosion hazard exists if the system is used in the presence of flammable
anaesthetics mixture with air, oxygen, or nitrous oxide.
• Make sure the electrical network in your facility complies with the applicable national
and local electrical codes, and that the equipment is electrically earthed.
• Do not dismantle the equipment under any circumstances. Removal of protective
covers can result in danger of electrical injury.
• The connectors must only be used for what they are designed for, otherwise there is
a danger of electrical shock injury and serious damage to the equipment.
• Allow access to the treatment room only to personnel who have been well trained in
the required safety procedures.
• Do not operate Vanquish system together with other devices that intentionally radiate
electromagnetic energy in an unshielded manner. Portable and mobile RF
communications equipment can affect medical electrical equipment.
• This unit generates, uses, and can radiate radio frequency energy and, if not installed
and used in accordance with the instructions, may cause harmful interference to other
devices in the vicinity. However, there is no guarantee that interference will not occur
• Before putting the unit into operation, make sure that the cables and applicator are
undamaged and correctly connected to the unit.
• Do not operate the unit without a patient.
• Pay attention to the routing of the applicator connection cables. These must always
be in the air and must never lie on surfaces.
• Keep chip cards, magnetic cards, hard disks, and other data media susceptible to
interference away from the unit.
• Never perform unauthorized service. Only service technicians authorized by the
manufacturer are allowed to perform service work.
For cleaning and disinfection instructions, please refer to Chapter 3.1.2 and 3.1.3.
8a. Applicator 713/1; 686 x 192 x 105 mm (27 x 7.6 x 4.1 in)
8b. Applicator 713/2; 732 x 287 x 124 mm (28 x 11.3 x 4.8 in)
• When loosening the control knobs during handling the arm, always hold the arm with
one hand and loosen the knob with the other, to prevent the injury of the operator or
patient and damage to the arms. Before the start of therapy, always make sure that
the control knobs are firmly tightened, to prevent the arm from moving during the
therapy.
• Keep applicator, accessories, and their cables separated. Applicator or their cables in
contact with each other during treatment could result in improper stimulation, skin
burns, or damage to the cable or applicator.
The operator can resume the therapy by pressing the continue button. Please refer to
Chapter 6.4 for further details.
4.5 SOFTWARE
To view the software version, press the menu button on the home screen. Then scroll down
and select unit settings. Scroll down again and select unit information.
• In case of damage from transport that could endanger personal safety, the unit must
not be connected to the mains before inspection is complete.
• When bringing the device from a cold environment into a warm one, do not plug it into
the mains until the device has adapted itself to room temperature (minimum 2 hours).
Place the unpacked device on a stable horizontal surface suitable for its weight. The unit
must not be positioned in direct sunlight or near direct heat sources. The device is self-
cooled by forced air circulation. The cooling vents are located on the rear panel and on the
bottom. Do not cover or block these vents. Allow a minimum of 10 cm (4 in) clearance behind
the rear panel. Do not place the device on a soft surface (such as a towel) which may
obstruct air flow to the bottom cooling vents. Do not put any heat-producing devices or any
objects containing water or other liquids onto the device. Do not place the device close to
appliances producing strong electromagnetic, electric or magnetic field (X-rays, etc.)
otherwise it could be undesirably influenced.
In the event of any questions, please contact BTL authorized personnel.
selected voltage
2. The selected value is always below the triangle (arrow) indicating the set voltage value
(see picture above).
3. Should you need to switch the voltage, use a screwdriver to turn the voltage switch (14) to
the desired position. Do not forget to replace the fuses (15) in the device with those
designed for the selected voltage!
applicator lock
applicator holder
d) Connect the applicator cable to the unit. The applicator is connected to connectors (13)
on the rear side of the unit.
applicator lock
applicator holder
channel tab
The items on the touch screen can be pressed by a finger or by using a special pointer with a
soft tip which is included in the accessories of the device. Press a button to perform desired
action or to set-up a value. The esc and start buttons have similar function as start/stop
key (5) on the front panel.
Caution: Do not use sharp objects or ballpoint pens to operate the touch screen.
A special, soft tip stylus is provided for this purpose.
• Never treat a patient on metal chairs, tables or beds. For safety reasons, check that
the patient has removed all metal objects (chains, earrings, watches, glasses, metal
implants...) from his/her vicinity before the start of the therapy. During the therapy the
patient must not be wearing hearing aids.
• Synthetic fibres (perlon, nylon, etc.) are characterized by low absorbency which can
cause the skin beneath such fabrics to quickly become moist. Therefore, it is
recommended that the body areas to be treated be completely unclothed and the
patient’s skin dried, particularly where perspiration accumulates in folds of the skin.
This applies especially when a higher dosage is being applied.
• Check the patient for perspiration regularly. Should you notice any signs of
perspirations, use a single layer of absorbent towelling between the patient and the
applicator.
• Make sure the patient’s skin is free of any creams, lotions, make-up, etc before any
type of procedure. Either ask the patient to come in “lotion-free” or suggest cleansing
in office before treatment.
• For further precautions and safety information please refer to Chapter 2.
Before the start of therapy hand the safety switch to the patient and instruct him/her in its
use. Patient should shut off the Vanquish if any discomfort is felt such as overheating or
nausea. Please refer to the Chapter 4.4 for further details.
• Do not leave patients who cannot use the Patient Safety Switch unattended while
operating this device.
The method of application transforms the electromagnetic energy into heat in tissues of low
blood circulation. The tissues near the skin’s surface are heated so that not only the
transformed energy but also the distance between applicator and skin is important for the
subjective sensation of heat.
For best results place the applicator parallel to the skin’s surface. This will spread out the
energy over the entire treatment area and prevent hot spots.
• Do not allow applicator cables to come into contact with the patient. Use cable holder
to insulate the patient from the cables.
• Local overheating can also occur due to applicator’s constrictions. We recommend
that spacer be used to determine proper distance from the affected body part and the
applicator.
Treatment times depend on the required depth and area of treatment. Shorter times should
be used for areas of small tissue volume. Longer times should be used for larger tissue
volume.
• During the therapy, you can modify the output power using the select knob.
• The patient can turn the unit off by pulling the Patient Safety Switch. For further
details, please refer to Chapter 4.4.
• The Vanquish control unit automatically monitors the system to help ensure the safety
of the patient and the device. Should any error occur, the output is shut off.
select
The default output power is 10 points. After any therapy interruption (pause), the therapy re-
starts at the output of 10 points.
The Vanquish automatically tunes to the patient when the select knob (2) is turned
clockwise. The energy transfer to the patient is initiated when at least 75 % tuning is
achieved. The Vanquish continuously monitors the intensity level. If the patient moves, the
intensity is automatically readjusted. When patient coupling to the applicator is not sufficient,
the tuning bar indicator is only partially lit. If there is insufficient coupling, the intensity cannot
be adjusted to the maximum level. The desired intensity will never be exceeded even when
The output power must always be set according to the subjective response of the patient.
Refer to "Dosage Levels” as stated in the table below:
• The energy tuning is indicated by loud clicking and it is displayed on the screen.
Output power is limited until Vanquish is tuned at least to 75%.
• Before increasing the output in response to inadequate patient heating, verify that the
cables are properly routed and away from metal or grounded objects. The heating
effect may be misdirected and heating an unwanted area may occur.
Password Setting. Set and change password required by the Vanquish after the switch-on.
The Vanquish comes with this function disabled.
In case you forgot your password, please contact your authorized BTL service
personnel.
Sound Setting. Set acoustic signalling for when buttons or the touch screen are pressed as
well as for certain operations such as therapy start, therapy interruption, end of therapy, etc.
All audio tones can be muted (no sound) or modified as required. Edit individual audio
schemes, create new ones and modify audio tones for each operation. The user-created
data will be displayed at the end of the list of sound schemes. The sound volume can be set
under the User options menu.
Screen Saver and Auto Switch-off. Set up the screen saver type, the screen saver
activation time, the period of time before which the screen will switch off and idle time for the
system. To cancel the screen saver mode, press the esc key on the device. Save the
settings by pressing the enter key.
Colour Setting. Set the colours of all items displayed on the screen. Select from wide range
of factory preset colour schemes, or personalize your own colour scheme.
Setting display contrast. Adjust the display contrast by turning the select knob. To quickly
change the contrast, turn the select knob while simultaneously holding the keys enter and
esc.
Touch Panel Calibration. If the touch screen buttons do not react when pressed, the touch
screen needs to be calibrated. A simple wizard controls the entire process. During
calibration, use the touch-pen (stylus) and follow the on-screen instructions. Calibration can
be interrupted at any time by pressing the esc button. To verify the touch screen
adjustments, use the touch panel function test function.
User Options. This submenu allows the setting and displaying of the following parameters:
• direction of movement of menu (standard/reverse)
• tabs position (top/bottom)
• speaker volume
Style of Operation. This submenu allows the setting and displaying of the following
parameters:
• set zero time – you can select whether after the end of therapy, the time values on
the screen shall remain zero, or whether the values of the last performed therapy will
be displayed
• repeat sound for end – you can enable or disable the repeating audio signal which
indicates the end of therapy session
Unit Information. This submenu contains information about the device: the serial number,
the device type, the firmware version, etc. If the operation of the device is time restricted, this
submenu will indicate the date until when the device remains fully functional.
Unlock Code. Time restrictions imposed on the use of the Vanquish system operation can
be removed by entering the unlock code. Unlock code can be obtained from your BTL dealer
or service technician.
Service Functions
• Repair of files – Checks the file storage system. It repairs errors, deletes empty files,
etc. Use in case of a lack of memory space, if you have difficulties saving data, or if
you suspect data loss.
• File system formatting – Use only if the repair of files did not help. When used, the
entire memory is re-formatted and all the user-data and the user setup are lost.
• Delete accessories – Deletes all the previously installed accessory data. Use in case
of incorrectly installed applicator, or when the connected applicator cannot be
detected (question mark on the tab).
• Default setting without loss of the user data – Restores all functions of the device to
the factory default settings. User-created data will not be deleted.
• Unit log data export
Standard accessories:
• mains power cord
• 2x spare fuses T6.3AL/250 V (for 100-120 V, 50-60 Hz)
• 2x spare fuses T3.15AL/250 V (for 200-240 V, 50-60 Hz)
• stylus (touch-pen)
• user’s manual
• arm with applicator 713/1
• cable for the connection of applicator
• cable holder
• IR Thermometer
• box of spacers
Optional accessories:
• applicator 713/2
Accessories not manufactured by BTL for use with the Vanquish system must not
be attached to the system to prevent potential harm to the patient and/or damage the unit.
Note 1: The rated power is measured by means of a load at the nominal impedance of 25Ω
Applicator must be placed in distance of 0 to 10 mm from the sensing metal plates of the
load.
RF emissions
Class A
CISPR 11 The device is suitable for use in all
Harmonic emissions establishments, other than domestic, and those
Class A directly connected to the public low-voltage
IEC 61000-3-2
power supply network that supplies buildings
Voltage fluctuations/ used for domestic purposes.
Flicker Emissions Complies
IEC 61000-3-3
For transmitters rated at a maximum output power not listed above, the recommended
separation distance d in meters (m) can be estimated using the equation applicable to the
frequency of the transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
NOTE 1: At 80 MHz and 800 MHz the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects and people.
ID: 713-80MANEN200
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