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.

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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.

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•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.