Invasix BodyTite User manual

Invasix BodyTite™ Service Manual DO600463F 0344 Page 1 of 52
BodyTite-TiteFx
Service Manual - DO600463F

Invasix BodyTite™ Service Manual DO600463F 0344 Page 2 of 52
Table of Contents
SECTION 1 –INTRODUCTION 6
BEFORE YOU START 6
SYSTEM OVERVIEW 6
CONVENTIONS USED IN THE MANUAL 7
EXPLANATION OF THE SYMBOLS USED ON THE SYSTEM 7
SECTION 2 –SAFETY 8
THE PATIENT 8
TREATING ATTENDANT 8
CAUTIONS 9
ELECTRICAL AND MECHANICAL SAFETY 9
FIRE HAZARDS 10
SAFETY FEATURES OF THE SYSTEM 10
ACTIVE ACCESSORIES 11
LABELS 11
EQUIPMENT CLASSIFICATION 12
SECTION 3 - SYSTEM INSTALLATION 14
ELECTRICAL REQUIREMENTS 14
ENVIRONMENTAL REQUIREMENTS 14
EQUIPMENT LIST 14
INSTALLATION 15
System parts View: 15
MOVING THE SYSTEM 17
DISPOSAL OF SYSTEM 17
SECTION 4 - DESCRIPTION OF DEVICE 18
OPERATOR CONTROL PANEL 18

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TREATMENT SCREENS 20
FUNCTIONAL KEYS 23
HAND PIECE 24
SYSTEM SPECIFICATIONS 26
SECTION 5 - SYSTEM OPERATION 28
DEVICE START-UP28
SYSTEM SHUTDOWN 28
SECTION 6 - MAINTENANCE 29
CLEANING DEVICE EXTERIOR 29
SECTION 7 –ERROR MESSAGES 30
SECTION 8 - TROUBLESHOOTING 32
SECTION 9 –ASSEMBLY INSTRUCTIONS 34
Front Cover disassembling 34
Front Cover assembling 34
AC Card Disassembling 36
AC Card Assembling 36
Power Supply Disassembling 37
Power Supply Assembling 37
RF Card Disassembling 38
RF Card Assembling 38
Fan Assembly Disassembling 40
Fan Assembly Assembling 40
Controller Card Disassembling 42
Top Assy Disassembling 44
Top Assy Assembling 44
Speaker Disassembling 46
Speaker Assembling 46

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SECTION 10 - RF CALIBRATION 48
RF TEST 50
TITEFX SYSTEM UPGRADE PROCEDURE ERROR! BOOKMARK NOT DEFINED.
1. Front Cover disassembling Error! Bookmark not defined.
2. RF Card Disassembling Error! Bookmark not defined.
3. Controller Card Disassembling Error! Bookmark not defined.
4. Top Assy Disassembling Error! Bookmark not defined.
5. RF Card Assembling Error! Bookmark not defined.
6. Controller Card Assembling Error! Bookmark not defined.
7. Connector Bracket Assembling Error! Bookmark not defined.

Invasix BodyTite™ Service Manual DO600463F 0344 Page 5 of 52
Rev.
Page
Description
Date
A
Release to service
07/04/2009
B
Typo changes in assembly instructions
20/05/2009
C
Adding of RF calibration and Testing
14/10/2009
D
Update to cover the upgrade to TiteFX
hand piece
11/07/2011
E
all
Update according to DEKRA reviewer
question TDR04/Q11 in report 3900465-
TDR04-R0
16/10/2011
F
30,31
Updated Error codes
23/01/2012

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Section 1 –Introduction
Before You Start
The manual and the equipment it describes are for use only by qualified medical
professionals trained in the particular technique and surgical procedure to be performed.
Federal (USA) law restricts this device to sale by or on the order of a physician.
Read this manual to become familiar with all safety requirements and operating procedures
before attempting to operate the System.
RF electrosurgical devices can cause injury if used improperly.
High voltage is present inside the System.
Always be aware of the possible dangers and take proper safeguards as described in the
manual.
The System must be serviced only by Invasix Ltd. qualified personnel.
System Overview
The BodyTite platform is intended multiple applications and support different hand pieces
employing RF energy.
The System provides individual adjustment of RF energy to achieve maximum efficiency and
safety for each patient.
The System provides enhanced safety while minimizing possible side effects by monitoring
tissue impedance and skin surface temperature.

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Conventions Used in the Manual
The following conventions in the form of notes and warnings are used in this manual:
Provides general information that is important to keep in mind.
WARNING: This information is extremely important.
Explanation of the Symbols used on the System
Symbol
Description
Attention Consult Accompanying Document
CSA marking (212603 CSA master contract number)
CE marking
Do not discard in trash. Electronic equipment should
be disposed of in an appropriate manner.
Fuse
Type BF applied part
HF Isolated Patient Circuit
This equipment intentionally supplies non-ionizing RF
energy for physiologic effect

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Follow operating instructions
Section 2 –Safety
This chapter describes safety issues regarding the use and maintenance of the System, with
special emphasis on electrical safety.
The System is designed for safe and reliable treatment when used in accordance with proper
operation and maintenance procedures. Only trained, qualified practitioners can use the
System. The operator and all other personnel operating or maintaining the System should be
familiar with the safety information provided in this chapter.
The primary consideration should be to maximize safety for both treating attendant and
patient.
Read this chapter to be familiar with all its safety requirements and
operating procedures prior to System operation.
RF devices can cause injury if used improperly.
High voltage is present inside the System.
Always be aware of the possible dangers and take proper safeguards as
described in the manual.
The Patient
Well-trained staff assures patient safety. A patient history should be completed prior to
scheduling. Patients should be fully informed of the treatment protocol, the likely results and
any risks associated with the treatment.
Treating Attendant
Personnel should not operate the System until they have been fully educated in its use. Make
sure that all treatment personnel are familiar with the System controls and know how to shut
down the System instantly.

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Cautions
The following cautions should be heeded for safe System use:
Do not touch the System inner parts..
Service is supplied by company authorized personal only.
Do not allow applicator to come in contact with hard materials that could damage the
RF electrodes.
Electrical and Mechanical Safety
Keep all covers and panels of the System closed. Removing the covers creates a safety
hazard.
Keep hands away from the applicator during the System start-up.
Perform maintenance procedures when the System is shut down and disconnected from
power.
The System is grounded through the grounding conductor in the power cable. This protective
grounding is essential for safe operation.
Provide as much distance as possible between system and other electronic equipment because
activated RF generator may cause interference between them.
Move the System slowly and carefully. The System weighs approximately 15kg (33lb.) and
may cause injury if proper care is not used when moving it.

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Fire Hazards
The absorption of optical energy raises the temperature of the absorbing material. Do
not use the System in the presence of explosive or flammable materials.
Keep drapes and towels moist to prevent them from igniting and burning. Use non-
Flammable prepping solutions.
Do not use flammable substances when preparing the skin for treatment. Be
especially careful with the use of oxygen.
If alcohol is used for cleaning and disinfecting, it must be allowed to dry thoroughly
before the System is used.
Safety Features of the System
The System incorporates the following safety features. All personnel operating the
System should be familiar with these features.
The power electronics can not be activated unless the applicator has been connected
to the System.
An audible tone indicates energy activation.
During activation, the System performs a self-test of the hardware.
Hardware is tested every 1 ms to ensure proper operation of electrical circuit.
Tissue impedance monitoring prevents accidental energy emission to the patient.
Skin surface is monitored during the treatment. RF energy delivery is terminated
when skin temperature reaches the cut-off level.
There is brief delay between indication of energy activation and actual emission of
RF energy.
System is starting at lower power setting.

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Active accessories
Examine all hand piece and connectors to the System before using. Ensure that
accessories function as intended. Improper connection may result in arcs and sparks,
accessory malfunction, or unintended surgical effect.
Do not wrap the hand piece cords around metal objects. It may induce current that
could lead to chocks, fire or injury to the patient or surgical personal.
Do not connect wet accessories to the System.
Hand piece are single use only. Don’t try to sterilize and reuse the hand piece.
Labels

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Figure 1: System Label
Figure 2: Hand Piece Label
Equipment Classification
The following is a list of the different equipment used and their classifications.
Electric shock protection: Class I, Type BF
Protection against ingress of liquids: Ordinary equipment
Not suitable for use in presence of flammable substance

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System is classified as a IIb device defined by the Medical Device Directive (93/42/EEC) for
CE marking.

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Section 3 - System Installation
Electrical Requirements
The System will require separate line supply of: single phase 90-254 VAC; 5A; 50-
60Hz.
Power receptacles must be within 15 feet of the System site.
The System should not share a power line with other equipment.
For continued protection against fire, replace the fuse only with one of the
same type and rating.
Proper grounding is essential for safe operation.
Environmental Requirements
Corrosive materials can damage electronic parts; therefore, the System should operate
in a non-corrosive atmosphere.
For optimal operation of the System, maintain room temperature between 20º-27ºC
(68º-79ºF) and relative humidity of less than 80%.
Equipment List
The System includes the following:
System platform
TiteFx hand piece
Foot Switch
Operator Manual
Power cord

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Installation
System parts View:
Figure 3: Front view
Main Display
On/Off switch
TiteFx Connector
Operating Keys

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Figure 4: Back View
Software Plug
Power Inlet
Foot Switch connection
Fan

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The System is designed for installation in a clinic environment. To install the System
perform the following tasks:
Unpack the System.
Check the System and all its components for visual damage.
Connect Footswitch to the footswitch connector
Connect the Power Cord to the System inlet.
Plug the System Power Cord into an appropriate electrical outlet.
Moving the System
To move the System within the facility:
Turn the System off.
Disconnect the Power Cord.
Put Footswitch with cable to the pocket located on the back panel of the system
Release the wheel brakes.
Slowly push or pull the System using the handle.
Lift the System to the vehicle and lay it carefully on its side handles.
Never lift, pull or push the System using the operating panel. Always
use the handles when moving the System.
Disposal of System
To comply with European Commission Directive 2002/96/EC on Waste Electrical and
Electronic Equipment (WEEE) and other country and state regulations, please DO NOT
dispose of this equipment in any location other than designated locations.

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Section 4 - Description of Device
Operator Control Panel
The Operator Control Panel is located on the upper side of the System. The Operator Control
Panel consists of On-Off switch, four function keys, an information screen, and hand piece
connector (Figure 3.2).
Power On-Off switch
Power switch turns system on and off.
On/Off switch
TiteFx Connector
Operating Buttons
Main Display
BodyTite and
Fractora connector

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Hand piece connectors.
Software cannot be activated if at least one of the hand pieces is not connected
to the platform.
Functional keys
Control panel comprises four functional keys. Functional keys perform
function according to information shown on the LCD screen above the each
key.
LCD screen
LCD screen shows information about machine status, treatment parameter and
titles of functional keys. LCD treatment
Scroll Key
Increase Key
Decrease Key
OK Key

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Treatment Screens
Figure 4.2 Splash screen
The Self-Test screen appears after the Power switch is turned on. Software is loaded from the
plug and self-test of the system modules is performed. After the end of the self-test, the
Treatment screen appears.