Invasix BodyTite Manual de usuario
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
Invasix BodyTite™ Service Manual DO600463F 0344 Page 3 of 52
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
Invasix BodyTite™ Service Manual DO600463F 0344 Page 4 of 52
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
Invasix BodyTite™ Service Manual DO600463F 0344 Page 6 of 52
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.
Invasix BodyTite™ Service Manual DO600463F 0344 Page 7 of 52
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
Invasix BodyTite™ Service Manual DO600463F 0344 Page 8 of 52
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.
Invasix BodyTite™ Service Manual DO600463F 0344 Page 9 of 52
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.
Invasix BodyTite™ Service Manual DO600463F 0344 Page 10 of 52
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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