BTL VANQUISH ME User manual

BTL VANQUISH ME
OPERATOR´S MANUAL

BEFORE YOU START
Dear Customer,
Thank you for purchasing the BTL Vanquish ME
system for your clinic. All of us at BTL wish you every
success with your new device. We pride ourselves on
being as responsive as possible to our customer’s
needs. Your suggestions and comments are always
welcome since we believe an ongoing relationship with
our customers is critically important to our future
product line.
While we would like you to start using your new
equipment right away, we encourage a thorough
reading of this manual in order to fully understand the
operational features of the system.
BTL Industries, Inc.

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CONTENTS
1 GENERAL CHARACTERISTICS ........................................................................................................................ 4
1.1 ABOUT BTL VANQUISH ME......................................................................................................................4
1.2 INDICATIONS FOR USE............................................................................................................................4
1.3 USA PRESCRIPTION USE DEVICE..........................................................................................................4
1.4 DEVICE LABELS........................................................................................................................................5
2 TREATMENT SAFETY........................................................................................................................................6
2.1 PATIENT AND OPERATOR SAFETY ........................................................................................................6
2.2 CONTRAINDICATIONS .............................................................................................................................8
2.3 PRECAUTIONS........................................................................................................................................10
2.4 POTENTIAL SIDE EFFECTS AND ADVERSE EVENTS..........................................................................10
3 SAFETY PRECAUTIONS.................................................................................................................................. 11
3.1 MAINTENANCE .......................................................................................................................................11
3.1.1 GENERAL MAINTENANCE............................................................................................................ 11
3.1.2 CLEANING OF THE SYSTEM CONSOLE .....................................................................................12
3.1.3 CLEANING AND DISINFECTION OF THE ACCESSSORIES........................................................ 12
3.2 SAFETY INSPECTIONS ..........................................................................................................................13
3.2.1 VISUAL INSPECTION (DAILY)....................................................................................................... 13
3.2.2 FUNCTIONAL TEST (DAILY)......................................................................................................... 13
3.3 FUSE REPLACEMENT............................................................................................................................ 13
3.4 SYMBOLS AND ABBREVIATIONS USED................................................................................................14
3.5 GENERAL SAFETY INFORMATION AND PRECAUTIONS.....................................................................15
3.5.1 GENERAL CAUTIONS ................................................................................................................... 15
3.5.2 EXPLOSION AND FIRE HAZARDS ...............................................................................................16
3.5.3 HIGH VOLTAGE HAZARDS........................................................................................................... 16
3.5.4 ELECTROMAGNETIC ENERGY OPERATIONAL SAFETY...........................................................16
3.6 SELECTING APPROPRIATE LOCATION FOR THE UNIT.......................................................................17
3.7 PROTECTION OF THE UNIT...................................................................................................................18
4 SYSTEM DESCRIPTION................................................................................................................................... 19
4.1 THE FRONT PANEL OF THE BTL VANQUISH ME..................................................................................19
4.2 THE BTL VANQUISH ME APPLICATORS................................................................................................20
4.3 THE REAR PANEL OF THE BTL VANQUISH ME ....................................................................................21
4.4 PATIENT SAFETY SWITCH.....................................................................................................................22
4.5 SOFTWARE.............................................................................................................................................22
5 ASSEMBLY AND SET-UP ................................................................................................................................ 23
5.1 UNPACKING THE UNIT...........................................................................................................................23
5.2 PACKAGE CONTENTS............................................................................................................................24
5.3 REQUIREMENTS FOR INSTALLATION..................................................................................................24
5.4 CONNECTING TO THE MAINS................................................................................................................24
5.5 TURNING THE UNIT ON..........................................................................................................................24
5.6 INSTALLING THE APPLICATOR.............................................................................................................25
5.7 TOUCH SCREEN..................................................................................................................................... 28
5.7.1 MAIN SCREEN...............................................................................................................................28
5.7.2 TOUCH SCREEN ELEMENTS AND OPERATION ........................................................................ 28
5.7.3 NUMERIC KEYPAD........................................................................................................................ 29
6 OPERATING INSTRUCTIONS.......................................................................................................................... 30
6.1 PREPARATION OF THE PATIENT BEFORE THE THERAPY.................................................................30
6.2 ADJUSTING THE APPLICATOR..............................................................................................................30
6.3 SETTING THERAPY PARAMETERS....................................................................................................... 31
6.3.1 TREATMENT TIME ........................................................................................................................31
6.4 START, INTERRUPTION AND END OF THERAPY.................................................................................32
6.5 OUTPUT POWER .................................................................................................................................... 32
6.6 UNIT SETTINGS: THE “MENU” BUTTON ................................................................................................33
6.6.1 UNIT SETTINGS............................................................................................................................. 34
6.6.2 SPECIFIC SETTINGS ....................................................................................................................35
6.6.3 TREATMENT RECORDS...............................................................................................................35
7 LIST OF STANDARD AND OPTIONAL ACCESSORIES................................................................................. 36
8 TECHNICAL PARAMETERS ............................................................................................................................ 37
8.1 DEVICE PARAMETERS...........................................................................................................................37
8.2 MODEL PARAMETERS ........................................................................................................................... 38
8.3 EMC TABLES...........................................................................................................................................39
8.4 MANUFACTURER ...................................................................................................................................43

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1 GENERAL CHARACTERISTICS
1.1 ABOUT BTL VANQUISH ME
The BTL Vanquish ME is an aesthetic device designed for reduction of of abdominal
circumference by disruption of adipocyte cells by means of high frequency electromagnetic field.
The multi-jointed arm firmly supports the applicator during treatment. Large knobs lock and
unlock the joints to make positioning the applicators to the patient quick, easy and secure.
The control unit consists of the control system and the electronic system. The control system
contains the main microcomputer and software for control of the entire equipment; the electronic
system contains the complete electronics for electromagnetic field generation. Easy-to-use color
touch screen allows for maximum operator comfort. A large control knob is provided to increase
and decrease output power.
The BTL Vanquish ME system is placed in a specially designed cart, the shape of which
provides maximum operator comfort and easy movement of the device in the office.
1.2 INDICATIONS FOR USE
The BTL Vanquish ME is indicated for temporary reduction in circumference of the abdomen.
1.3 USA PRESCRIPTION USE DEVICE
Prescription Use Only. Caution :US Federal Law restricts this device to sale
by or on the order of a practitioner licensed by the law of the State in which they practice to use
or order the use of this device.
The device should only be used under the continued supervision of a physician or licensed
practitioner.
BTL makes no representations regarding federal, state or local laws or regulations that might
apply to the use and operation of this medical device.

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 5 OF 44
1.4 DEVICE LABELS
Device labels are attached on the rear side of the unit.
The labels attached on the applicators:

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2 TREATMENT SAFETY
The information provided in this manual is not intended to replace the professional knowledge,
experience, and/or training of the healthcare professional regarding the clinical use of the
system.
2.1 PATIENT AND OPERATOR SAFETY
In case of improper or unauthorized use of the unit, the operator, the patient or other persons
may be subjected to the danger of electric shock due to high voltage produced by the unit, the
danger of influence on active implantations by electromagnetic fields produced by the unit and
the danger of being burned due to erroneously positioned applicator or false parameters such as
the duration of treatment, power output or operating mode.
Before operating the unit, please read this Operator‘s Manual carefully and observe the
information contained therein.
Refer to Contraindications in Chapter 2.2, Precautions in Chapter 2.3 and Safety
Precautions in Chapter 3.
Since the effects of high-frequency fields on unborn life have not yet been
sufficiently researched, we recommend that pregnant persons are not within 45 feet of the
applicator when the unit is activated.
Before operating the unit each time, verify that:
•The unit has been correctly connected to the mains.
•The unit is freestanding and the patient is not in direct contact with metal objects such as
heating radiators, metal beds, or other equipment.
•The insulation of the RF output jack and applicator connection cables is not damaged.
•The applicator connection cable is connected properly and is not cross-routed (which
may cause short circuits).
•Only accessories (cables, applicator) approved by the manufacturer are connected.
•The patient to be treated and the personnel have removed all electric devices (e. g.
hearing aids, electrotherapy electrodes, mobile telephones) and all conductive objects
(e.g. rings, chains, watches, earrings or other jewelry, and eyeglasses) and that they are
not in the immediate vicinity of the unit.
•The patient is in a composed state and the bodily areas to be treated are dry on the
exterior.
•There are no superfluous personnel in the room.
•To test the Patient Safety Switch, follow the procedures listed in Chapter 4.4.

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Make sure that the patient does not come into any contact with metal during treatment. Metal
objects within the treatment area should be removed and placed outside the electromagnetic
field. These include, but are not limited to:
•Metal in the environment:
•Within 1 foot of beds, treatment tables, standard chairs, wheelchairs, swivel stools,
step stools, splints, braces, scissors, forceps, and scalpels.
•Within 36 feet (see Chapter 3.5.4 for more information) of electronically controlled
medical devices, such as CPM devices, electric wheelchairs, electrotherapy devices
or other electrical systems, computers, etc.
•Metal near the patient:
•Jewelry, body piercing earrings, watches, keys, coins, belt buckles, underwire bra,
hearing aids, zipper in clothing or pillow cases. Any metal contained in the clothing
may cause burning.
•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.
At regular intervals during the treatment, verify that:
•The unit is functioning properly.
•There is no moisture development (perspiration) in the area of the applicator.
•The patient feels well and the treatment is tolerable.
After the treatment, ask the patient about the tolerance of the treatment.
•This equipment has an output that is capable of producing a physiological effect.
•Observe the precautionary and operational decals placed on the unit.
•Do not operate BTL Vanquish ME system in conjunction with any other devices on the
patient.
•Metal in treatment area will provide low impedance paths to the induced radio frequency
current, producing local heating and the possibility of burning. Never treat in the area of
metal implants. In addition, patients must remove metal jewelry, buckles, cell phones,
etc.
•Do not administer the BTL Vanquish ME to a patient who has 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 the leads are often left implanted after the
implant is removed.
•Do not treat on a metal treatment table, mattress with metal springs, wheel chair or a
metal stool. Make sure that the patient cannot come into any contact with metal during
treatment.

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 8 OF 44
•Do not treat with clothing containing metal. Any metal contained in the clothing, such as
zippers, bra hooks or rivets may cause burning. In addition, remove jewelry, watches and
hearing aids during treatment.
•Treatment should not be given through clothing.
•The unit should be routinely checked before each use to determine that all controls
function normally, especially that the output control does properly adjust the intensity of
the power output in a stable manner.
•Use of a unit that indicates an Error may pose a risk of injury to the patient, user, or
extensive internal damage to the system.
•Tighten the arm so it does not move during therapy. Observe the patient and the position
of the arm at all times during therapy. Inform the patient that the arm is not supposed to
move during therapy.
•Patients should not come into contact with conductive parts which are earthed or which
have an appreciable capacitance to earth and which may provide unwanted pathways for
the radio frequency current. In particular, do not treat patients placed on metal framed
couches, chairs, or beds. Do not use conductive mattresses or mattress covers.
•Before increasing the output in response to a report of inadequate patient heating, verify
that the cables are properly routed, spaced correctly, and away from metal or grounded
objects. The heating effect may be misdirected and heating may be occurring in an
unwanted area.
•Internal burns can occur with the incorrect application of BTL Vanquish ME due to
excessive intensity and/or excessive exposure time.
•The operator should not use BTL Vanquish ME over the heart in order to prevent
theoretical cardiac signal interference.
•Determine that the treatment time control does actually terminate power output when the
timer reaches zero.
•Do not leave your patient unattended during the therapy.
2.2 CONTRAINDICATIONS
Do not treat (or expose) patients if the following conditions are present:
•Implanted electronic devices 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 45 feet of an operating unit.
•Hemorrhages or risk of hemorrhage.
•Septic conditions and empyema.
•Malignant tumors and undiagnosed tumors.
•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).

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•Thermohyperesthesia (very acute thermoesthesia or temperature sense; exaggerated
perception of hot and cold).
•Acute inflammations.
•Severe arterial obstructions (stage III and IV).
•Gynecological disorders involving acute inflammation.
•Wetness, perspiration, or damp bandages.
•Permeating irradiation of the thorax in cases of severe heart diseases (heart valve
diseases, myocardial insufficiency, myocardial infarct, severe coronary sclerosis).
•Pregnancy, since irradiation could cause teratogenous damage due to alterations of
blood circulation and diffusion.
•Menstruation.
•Nursing.
•Sudeck’s syndrome, stage I and II.
•Basedow’s disease (irradiation could cause serious states of agitation).
•Varicose veins (irradiation could cause congestive pain).
•Cardiac conditions.
•Deep vein thrombosis, phlebitis, varices.
•Arterial disease, circulatory insufficiency.
•Occlusive vascular disease, such as arteriosclerosis obliterans and thromboangitis
obliterans, in which organic occlusion and ischemia are evident.
•Ischemic tissues in individuals with vascular disease where the blood supply would be
unable to follow the increase in metabolic demand and tissue necrosis might result.
BTL Vanquish ME must not be applied:
•Over eyes, testes, head and neck.
•Over the pelvic or low back area when an IUD is present.
•Over cardiac pacemakers and defibrillators, cochlear implants, bone growth stimulators,
deep brain stimulators, spinal cord stimulators, and other nerve stimulators.
•Over open lamina (after laminectomy; spina bifida).
•Over superficial endoprosthesis or metal implants.
•Directly over the carotid sinuses, cervical stellate ganglion, or vagus nerve located in the
anterior neck triangle.
•Directly over cancerous tumors or lesions due to its potential to increase blood flow to the
area of malignancy.
•Over neoplastic tissues or space occupying lesions.
•In the presence of systemic or local infection (sepsis, osteomyelitis, tuberculosis) or if the
patient has an elevated temperature.
•If there is a scar in or near the treatment area, check with the patient and/or the patient's
chart to determine if there is metal under the scar.
•BTL Vanquish ME should not be applied over the uterus unless specific assurance can
be attained from the patient that she is not pregnant.
•The device is cleared for patients 22 years and older and that safety and effectiveness
have not been established in pediatric patients or patients younger than 22 years.

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2.3 PRECAUTIONS
When administering the device, keep in mind the following:
•The efficacy of BTL Vanquish ME was not established at power level settings below
maximum power of 200 points.
•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 BTL Vanquish ME immediately after the application of
superficial and deep heat or cold modalities. The application of thermal modalities prior to
treatment with BTL Vanquish ME can alter the patient's perception of warmth and pain.
•Caution is advised when applying BTL Vanquish ME 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.
•The function of other patient connected equipment may be adversely affected by the
operation of the BTL Vanquish ME. Maintain maximum distance between units in order to
reduce any 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.
•BTL Vanquish ME may interfere with other electronic therapeutic devices. Never use
another electronic device on the same patient when BTL Vanquish ME is being applied.
•Be aware that some synthetics and plastics, though assumed to be non-conductive, may
be heated by this system.
•Frequent monitoring of heat intensity level and skin response should occur during all
treatments.
2.4 POTENTIAL SIDE EFFECTS AND ADVERSE EVENTS
Adverse effects may include, but are not limited to:
•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.
•Burns due to excessive exposure, reduced thermal sensation, hypersensitive skin,
impaired blood flow, moisture in the treatment area.
•Heat injury to the tissue surrounding a metal-containing IUD.
•Increased menstrual flow in female patients receiving treatment to the lower back or
pelvic area.
•Erythema.

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3 SAFETY PRECAUTIONS
3.1 MAINTENANCE
3.1.1 GENERAL MAINTENANCE
All maintenance and service must be carried out by BTL authorized technical personnel.
BTL bears no responsibility for repairs or service performed by personnel not directly trained by
the company.
Improper installation, operation or maintenance of this system may result in malfunctions of this
unit or other devices.
In case of display failure or other obvious defects, switch the unit off immediately by means of
the power switch, disconnect the power cord from the power outlet, and notify BTL authorized
service personnel.
Adjustment or replacement of components may result in the equipment failing to meet the
requirements for interference suppression.
If the system cannot be installed immediately after delivery, the unit and its external components
or accessory elements must be stored in their original packaging in a dry place.
Do not store or operate the unit in a dusty environment. Do not immerse it in any liquid. Do not
place it near running water. Avoid placing the device in direct sunlight.
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.

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 12 OF 44
Caution
With the exception of surface cleaning of the console and components and the replacement of
the fuse, the BTL Vanquish ME 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 BTL Vanquish ME is equipped with a protection system that prevents the connection of
accessories other than those supplied by the manufacturer.
The BTL Vanquish ME system does not use any drugs, creams, gels or other substances which
are applied during its use.
3.1.2 CLEANING OF THE SYSTEM CONSOLE
Switch the unit off and unplug the power plug from the power outlet. Use a soft cloth slightly
moistened with water or with a 2 % detergent solution to clean the exterior of the
BTL Vanquish ME device and its parts. Never use cleaning agents containing alcohol, ammonia,
benzine, thinners, etc. Never use abrasive cleaning materials, which will scratch the device's
surfaces.
•In order to prevent electrical shock, unplug the power plug from the power outlet before
cleaning or disinfecting the unit.
•Never spray aerosol cleaners directly onto the equipment. Aerosol spray cleaners are
permitted to clean the cabinet, but the cleaner should be sprayed onto a clean cloth,
which may then be used to wipe the dirty area.
3.1.3 CLEANING AND DISINFECTION OF THE ACCESSSORIES
After each patient use, clean the accessories using a soft clean cloth dampened with water and
a commercially available surface disinfectant, or use a pre-moistened wipe such as “Sani-Cloth
HB”. Avoid the use of abrasive materials, strong organic acids, oxygen-splitting compounds and
cleaning solvents.
•Follow your local rules and regulations for appropriate disinfectant choice.
•Wait until the console and accessories are completely dry before operating it again.

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3.2 SAFETY INSPECTIONS
Safety inspections must be performed by persons who, based on training, knowledge or
practical experience, are capable of conducting the inspections correctly and independently.
3.2.1 VISUAL INSPECTION (DAILY)
When performing daily inspections of the system, pay particular attention to the following areas
of potential damage:
•Unit housing
•Power cord
•Applicator connection
•Applicator cables
•Applicator
3.2.2 FUNCTIONAL TEST (DAILY)
When performing daily inspections of the system, pay particular attention to the following areas
of potential damage:
•Touch screen display
•Patient Safety Switch
It is the responsibility of the health care facility to verify that the unit complies with
the facility, local and national Earth Leakage limits.
3.3 FUSE REPLACEMENT
The fuses for the BTL Vanquish ME system are located in the black fuse housing (15) on the
rear panel of the console (see Chapter 4.3). Ensure that the type and rating of the new and the
replaced fuses match.
1. Turn off the system and disconnect the power cord from the system and the outlet.
2. Remove the fuse housing by using a screwdriver.
3. Remove the burnt fuse.
4. Insert the new fuse. Make sure the fuse is properly seated within the fuse housing.
5. Connect the power cable to the system and to the mains outlet.
6. Turn on the system.

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3.4 SYMBOLS AND ABBREVIATIONS USED
General Warning Sign
Non-ionizing Radiation
Type BF Applied Part
Follow Instructions for Use
Name and Address of the Manufacturer
Date of Manufacture
Serial Number
Prescription Use Only Caution: (US) Federal law restricts this device to
sale by or on the order of a physician.
Caution

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 15 OF 44
3.5 GENERAL SAFETY INFORMATION AND PRECAUTIONS
3.5.1 GENERAL CAUTIONS
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 BTL Vanquish ME system is not intended for use in wet environmental conditions.
•Keep the equipment out of the reach of children.
•The BTL Vanquish ME system should only be repaired by BTL authorized service
personnel.
•The BTL Vanquish ME 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 BTL Vanquish ME system’s controls.
•Improper installation, operation or maintenance of the BTL Vanquish ME system may
result in malfunctions of this unit or other devices.
•The BTL Vanquish ME 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 BTL Vanquish ME 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.
•You should never, under any circumstances, attempt to hold the applicator in your hands
during therapy.

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 16 OF 44
•Always position the unit and the applicator in such a way that there is no danger to the
patient, the operator or other persons. Therefore, you must read and observe the safety
instructions and the list of contraindications before putting the system into operation.
•Keep all unnecessary persons out of the treatment location.
3.5.2 EXPLOSION AND FIRE HAZARDS
•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
anesthetics mixture with air, oxygen, or nitrous oxide.
3.5.3 HIGH VOLTAGE HAZARDS
•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.
3.5.4 ELECTROMAGNETIC ENERGY OPERATIONAL SAFETY
•Allow access to the treatment room only to personnel who have been well trained in the
required safety procedures.
•Do not operate BTL Vanquish ME 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 in a
particular installation. Harmful interference to other devices can be determined by turning
this equipment on and off. Try to correct the interference using one or more of the
following: reorient or relocate the receiving device, increase the separation between the
equipment, connect the equipment to an outlet on a different circuit from that to which the
other device(s) are connected, and consult the BTL authorized personnel.
•Medical devices that are to be used within 36 feet of BTL Vanquish ME should have an
electromagnetic site survey completed.
•To determine the distance of separation for all equipment operating near the
BTL Vanquish ME, consult the EMC tables applicable to the other equipment. If the

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 17 OF 44
distance cannot be determined, make certain that the other equipment is operated from a
distance of no less than 36 feet.
•Harmful interference can be completely eliminated when BTL Vanquish ME is installed in
a shielded room, i.e. one containing a Faraday cage. (A Faraday cage is enclosed by a
metal housing or grid that prevents the penetration of electric fields.) Use of absorbing
curtains is enough for most treatment rooms.
•Do not lean on or hold the cables during treatment.
•Keep all line cords away from the BTL Vanquish ME unit cables. Do not store or coil line
cords where they can come close to the cables on an operating unit.
•This unit generates non-ionizing radiation. Patients with implanted electronic
devices, such as cardiac pacemakers and defibrillators, cochlear implants, bone
growth stimulators, deep brain stimulators, spinal cord stimulators, and other
nerve stimulators, must not be treated, even if the device has been turned off.
•Other equipment, including patient connected devices, may be adversely affected when
in close proximity to BTL Vanquish ME.
•Adhere to federal, state, and local rules, regulations, and ordinances concerning the
appropriate use of high-powered radio frequency fields.
•Any persons with pacemakers or implants must remain outside of the treatment
area during therapy. No one wearing a cardiac pacemaker should be within 45 feet
of an operating BTL Vanquish ME.
3.6 SELECTING APPROPRIATE LOCATION FOR THE UNIT
Observe the following instructions in order to prevent malfunctions:
•In order to prevent electromagnetic disturbances, place the unit at least 36 feet (see the
Cautions in Chapter 3.5.4 for more information) from other devices. Also, make sure that
there is sufficient distance between the BTL Vanquish ME and Mains Power Supply or
data cables in walls, ceilings and floors, since the electromagnetic radiation from the unit
can pass these essentially without hindrance.
•In selecting the location for the unit, make sure that the patient has contact during the
treatment to the non-earthed application element and that the patient is never in contact
with metal elements (especially if they are earthed), such as heating radiators, metal
beds or other earthed devices.
•Floors should be wood, concrete, or ceramic tile. If floors are covered with synthetic
material, the relative humidity should be at least 30 %.
•Place the device in such a way that enables quick and easy disconnection of the power
cord from the device and from the mains.
Before connecting the unit, make sure that:
•The Voltage Rating on the safety label corresponds to the available system voltage.
•The Frequency Rating on the rating plate corresponds to the system frequency.
•An earthed socket outlet with earthing contact conforming to the applicable electrical
codes is available for connecting the unit.

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 18 OF 44
•The routing of the power cord from the unit to the socket outlet with grounding contact
does not pose a danger for personnel or the patient.
•The mains power supply is designed for the comparatively high peak power input of the
unit (~ 3000 VA) and the line is sufficiently protected in accordance with regulations. It is
recommended that the BTL Vanquish ME be connected to a dedicated circuit breaker
with appropriate characteristics.
•After bringing the unit and/or applicator from a cold environment into a warm one, do not
plug it into the power source until the unit and/or applicator has had to equilibrate to room
temperature (2 hours minimum).
It is advisable to post warnings for wearers of pacemakers in the rooms where the
BTL Vanquish ME therapy is applied.
3.7 PROTECTION OF THE UNIT
Improper installation, operation or maintenance of the BTL Vanquish ME system
may result in malfunctions of this unit or other devices.
Do not connect the unit to the Mains Power Supply until the following requirements have been
met:
•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 Chapters 3.1.2 and 3.1.3.

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 19 OF 44
4 SYSTEM DESCRIPTION
4.1 THE FRONT PANEL OF THE BTL VANQUISH ME
1. touch screen display
2. select knob (to select individual parameters)
3. enter key
4. esc key
5. start/stop key (to start and stop therapy)
6. on/off switch (back lit, in blue, when the control unit is ‘’on’’ )
7. USB port (for service purposes only)

BTL VANQUISH ME - OPERATOR’S MANUAL I PAGE 20 OF 44
4.2 BTL VANQUISH ME APPLICATOR
8. applicator, 686 x 192 x 105 (27 x 7.6 x 4.1 in)
8