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                                BodyTite Risk Management File
                                        DO600280E




                                              Project           BodyTite

                                              Date              February ,2009

                                              Written by        S.Francis-Najjar

                                              Approval          Ben Zion Levi




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      Revisions

  Rev. Description                                                              Updated by         Date

  A      Risk Identification and Assessment                                     Ben Zion Levi      04 August 2008

  B      Update medical representative name                                     S.Francis-Najjar   04 October 2008

  C      1)Update according to KEMA comments on TD /question 2                  S.Francis-Najjar   24 November
                                                                                                   2008
         2) update section 2 according to ISO14971:2007 (Annex C)
         3)Change the document name from Risk Analysis Report to Risk
         management file

  D      Correct comments according to KEMA reviewer                            S.Francis-Najjar   26 January 2009
            1) Update section 2.2 in order to answer question2 (j) from KEMA
               comments on TD –Nov 2008




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  E     Address comments of KEMA TF review – report no. 2120853-TDR01-R0             S.Francis-Najjar   03 February 2009
        1)Update section 1.9 with local depression or pits
        2) Correct section 4.13.2 page 44 “distance between internal electrode and
        internal is limited by latch” to “distance between internal electrode and
        external is limited by latch”
        3) Update section 4.14.1 page 45 “use only biocompatible and non-allergic
        materials” to “Use only biocompatible materials”.
        4) Update section 4.14.2 page 45 “Intolerance to anaesthesia” to “Allergy
        to anaesthesia”.
        5) Add to section 4.14.14, risk reduction, “Refer to section 2.2(c)”.
        6) Add reference for clarification of 4.14.15 (damage to motor nerve: what
        about sensory nerves? poor English”




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   Contents

     BODYTITE RISK ANALYSIS REPORT                                                                                         1
     DO600280C                                                                                                             1
     REVISIONS                                                                                                             2
     1     INTRODUCTION                                                                                                    6
     1.1   Purpose                                                                                                         6
     1.2   Scope                                                                                                           6
     1.3   Overview                                                                                                        6
     1.4   Applicable Standards                                                                                            6
     1.5   Core team                                                                                                       7
     1.6   Device Description                                                                                              7
     1.7   Intended use                                                                                                    8
     1.8   Contraindications                                                                                               8
     1.9   Possible Side Effects                                                                                           9
     2     FINDING POSSIBLE HAZARDS                                                                                        10
     2.1   Identification of Qualitative Characteristics Related to the BodyTite device                                   10
     2.2   Information supplied by the Chief Medical Officer of Invasix                                                   16
     3     RISK METHOD                                                                                                     19
     3.1   Levels of Risk:                                                                                                19
     3.2   Methods of Control:                                                                                            19
     3.3   Risk levels:                                                                                                   20
     4     RISK ANALYSIS                                                                                                   21

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     4.1   Chemical and biological Hazards                                                                                21
     4.2   Mechanical Hazards                                                                                             23
     4.3   Fire Hazards                                                                                                   24
     4.4   Environmental Hazards                                                                                          26
     4.5   Electrical Hazards                                                                                             27
     4.6   Radiation and Electromagnetic Hazards                                                                          30
     4.7   Human factors Hazards                                                                                          32
     4.8   Treatment Hazards                                                                                              33
     4.9   Dangerous Temperature                                                                                          35
     4.10 Energy                                                                                                          36
     4.11 Software Hazards                                                                                                37
     4.12 System Malfunction                                                                                              41
     4.13 Clinical Hazards                                                                                                43
     4.14 Problem related to patient health conditions and treatment history                                              44
     4.15 Other Hazards                                                                                                   48
     4.16 Specific Hazards of EN60601-1, Sub-Clause 52.2; 52.4.1 prohibits                                                50
     5     INFORMATION SUPPLIED BY THE MANUFACTURER                                                                        52
     6     RISK ESTIMATION OF HAZARDS ASSOCIATED TO THE BODYTITE DEVICE                                                    53
     7     CONCLUSION                                                                                                      53




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1 Introduction

1.1   Purpose

      This document is used to evaluate the risk associated with the BodyTite system.

1.2   Scope

      This document identifies and describes the potential hazards and risks of BodyTite. It also includes extensive risk analysis and describes the
      measures taken to ensure that BodyTite meets the appropriate safety requirements.

1.3   Overview

      This document describes the safety hazards associated with the BodyTite. It also describes the possible consequences of these hazards, their
      probability of occurrence, the Risk Level, how they will be mitigated and how and where that mitigation will be implemented.

1.4   Applicable Standards

          ANSI/AAMI/ISO 14971:2007, Medical devices - Application of risk management to medical devices.
          IEC 60812 Analysis techniques for system reliability - “Procedures for failure mode and effect analysis (FMEA)”.
          EN 60601-1-4:2000 General requirements for safety – Programmable electrical medical systems
          IEC 62304:2006 Medical device software – Software life-cycle processes.
      Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following
      standards;
          ANSI/AAMI/IEC 60601 -1 -2 (2001), Medical Electrical Equipment Part 1; General Requirements for the Safety.
          IEC 60601 -2-2 (Ed. 4.0; 2006), Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical
           Equipment.

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          ANSI/AAMI HF 18 (2001), American National Standard for Electrosurgical Devices
          ANSI/AAMI/ISO 14971:2007, Medical devices - Application of risk management to medical devices.

1.5   Core team

      Ben Zion Levy                          VP R&D and Engineering
      Dr. Amir Waldman                       VP Regulatory and clinical affairs
      Dr. R. Stephen Mulholland               Cosmetic Plastic Surgeon; Chief Medical Officer of Invasix
      Daniel Wainer                          Software Engineering Manager
      Zvika Kuperman                         Project Manager
      Suhair Francis-Najjar                  QA and Software Verification Manager

1.6   Device Description

      The BodyTite system is bipolar RF device where the first RF electrode is the internal electrode (delivering the RF energy to the adipose tissue
      and the sub-dermal space) and the second RF electrode is connected rigidly to the first electrode via a hand piece and is applied to the skin
      surface above the first electrode. The second electrode creates a transcutaneous pathway for the radiofrequency energy, localizing the electrical
      energy between the electrodes and eliminating the need to ground the patient. The second electrode is also able to monitor, in real time, the skin
      surface temperature, allowing for a greater degree of safety while heating skin and subcutaneous tissues.
      The BodyTite main unit comprising the following main modules:
          AC/DC power supply isolating system modules from AC voltage
          RF generator providing output of RF power to the hand piece
          Microcontroller controlling RF output, monitoring tissue electrical parameters, skin surface temperature and proper functioning of
           electronic modules.
      The device Hand Piece unit compromising the following main elements:
          Hand piece deliver RF power to the patient and have following main elements

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          Internal electrode insulated with Teflon and having treatment tip in the distal end
          External electrode with temperature sensor
          Mechanism adjusting distance between electrodes

1.7   Intended use

      The BodyTite device is intended to be a medical device, to be used by doctors in a surgical room environment, for performing RF assisted
      lipolysis, ,blood coagulation and skin tightening

1.8   Contraindications

          Pacemaker or internal defibrillator.
          Significant systemic illness or occult systemic illness
          Illness localized in area of treatment
          Other therapies or medication which may interfere with treatment
          Pregnancy
          Resent surgery in treatment area.
          Disorders of the lower abdomen (i.e. hernia, ulcerative colitis, Chron’s disease, acute cervicitis etc).
          History of Thrombophlebitis
          Acute infection
          Hart failure
          Intolerance to anesthesia




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1.9   Possible Side Effects

          Excessive bruising
          Damage to natural skin texture (crust, blister, burn)
          Change of pigmentation
          Scarring
          Excessive Swelling (Edema)
          Non symmetrical fat distribution
          Complications related to anesthesia
          Pain
          Skin redness (Erythema)
          Loose skin
          Local depression or pits




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2 Finding possible hazards

2.1     Identification of Qualitative Characteristics Related to the BodyTite device

      1) What is the intended use and how is the medical device to be used
         Refer to section 1.7
      2) Is the medical device intended to be implemented?
         No.
      3) Is the medical device intended to contact the patient or other persons?
         The hand piece of the device comes into invasive contact with the users during the treatment. Period and Frequency of contact: Transient
         normally intended for continuous use for less than 60 minutes (MDD 93/42/EEC Annex IX).
      4) What Materials and/or components are utilized in the medical device or are used with, or are in contact with, the medical device?
         The material comes in contact with human body are biocompatible and sterile able

        Part                                         Description                               Type of contact

        Internal Electrode tip                       Medical grade stainless steel 304 or      Invasive
                                                     316.

        Isolation of internal electrode              Teflon tube, used for catheters,          Invasive
                                                     sterileable: Teflon – TFE

        External electrode                           Medical grade stainless steel 304 or 316 Applied to the skin surface

        Hand piece handle                            IXEF 1022/0006 (SOLVAY) UL94 HB           Applied to the skin surface



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   5) Is energy delivered to and/or extracted from the patient?
      During the procedure the device deliver RF energy to the patient body.
      Tissue impedance monitoring prevents accidental energy emission to the patient.
      Total Energy: This indicator shows total amount of RF energy delivered from the beginning of the treatment.
   6) Are substances delivered to and/or extracted from the patient?
      The coagulated tissue is extracted.
   7) Are biological materials processed by medical device for subsequent re-use?
      No
   8) Is the medical device supplied sterile or intended to be sterilized by the user, or are other microbiological controls applicable?
      It is intended to be sterilized by the user.
   9) Is the medical device intended to be routinely cleaned and disinfected by the user?
      No, the hand piece is for single use
   10) Is the medical device intended to modify the patient environment?
      No
   11) Are measurement taken?
      The BodyTite device does not provide vital signs monitoring
   12) Is the medical device interpretative?
      The BodyTite device is an electrosurgical device used by the physician, and does not provide diagnostic
   13) Is the medical device intended for use in conjunction with medications or other medical technologies?
      No
   14) Are there unwanted outputs of energy or substances?
      Heat

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      The heat dissipation of the BodyTite is compliant with the requirements of the Clause 42 of EN 60601-1 standard.
      Radiation
      lonizing radiation.-BodyTite do not radiate ionizing radiation.
      Electromagnetic Compatibility- is compliant with regard to the harmonized standard EN60601-2-2
   15) Is the medical device susceptible to environmental influences?
      No
   16) Does the Medical device influence the environment?
      Transport environment
      Vibrations during transportation and normal use.
      Normal use vibrations: According to EN60601-1 there is no general requirement for vibrations, although the systems were designed to be
      transported on smooth surfaces.
      Electromagnetic Environment
      The device complies with the requirements of the EMC standard for medical equipment EN 60601-1-2.
      Spillage
      The upper side of the systems, (the LCD panel), is sealed to prevent spillage of liquids, Le disinfecting materials.
   17) Are the essentials consumables or accessories associated with medical device?
      Yes. The hand piece is disposable, single use part.
   18) Is maintenance and/or calibration necessary
      Calibration of the device might be needed in the manufacturing phase and after each service procedure.
   19) Does the medical device contained software?
      The BodyTite is operated and controlled by software. The software is fully verified and validated according to all relevant standards and
      installed by the manufacture.


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   20) Does the medical device have a restricted shelf time?
      Disposable hand piece shelf life is 1yr from date of production
   21) Are there any delayed and/ or long term use effects
      Skin tightening is observed during a few months after the treatment.
   22) To what mechanical forces will medical device be subjected?
      The hand piece of the device is held against the body by hand during the treatment.
   23) What determines life time of the device?
      Life time of the device is 2 years.
   24) Is the medical device intended for single use?
      Hand piece is intended for single use.
   25) Is safe decommissioning or disposal of the medical device necessary?
      It does not contain toxic material.
   26) Does installation for use of the medical device require special training?
      No
   27) How will information for safe use provided?
      By professionals.
   28) Will new manufacturing processes need to be established or introduced?
      No
   29) Is successful application of the medical device critically dependent on human factors such as the user interface?
      Yes
        I.   Can the user interface design features contribute to use error?


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             Yes. But the controls and indicators, symbols used, Buttons, visibility of warnings, audibility of events, and standardization of colour
             coding are designed according to IEC 60601-2-2 and IEC60601-1-6.
       II.   Is the medical device used in an environment where distractions can cause use error
             No
      III.   Does the medical device have connecting parts or accessories?
             Yes. Hand piece is connected to the device
      IV.    Does the medical device have a control interface?
             Yes. On/Off button and 4 functional buttons to set treatment parameters.
       V.    Does the medical device display information
             Yes LCD screen shows information about machine status, treatment parameter and titles of functional keys
      VI.    Is the medical device controlled by a menu
             The device has 2 screens (initialization screen and treatment screen)
      VII.   Will the medical device be used by persons with special needs?
             The indications for use include general, plastic and reconstructive surgery BodyTite™, Invasix recommends that all users first seek
             training that includes, but is not limited to the following elements of clinical care:
                    Basic RF science

                    Device safety and potential hazards

                    Device use and operating procedure

                    Hands-On experience

     VIII.   Can the user interface be used to initiate user actions
             Yes. The user can predetermine the following treatment parameters:

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               RF power -                  RF power deposited into the tissue. On-line monitoring of
                                           power allows precise power delivery during the treatment.

               Cut-Off temperature -       Maximal temperature of the skin. When this temperature is
                                           exceeded, the device limits RF power delivery. This
                                           feature prevents overheating of the skin and allows safe
                                           maintaining the maximal temperature.

               High impedance limit -      Maximal tissue impedance. When this high tissue
                                           impedance is exceeded, the device limits RF power
                                           delivery. This feature prevents skin damage at poor
                                           contact.

               Low impedance limit -       Minimal tissue impedance. When this low tissue
                                           impedance is exceeded, the device limits RF power
                                           delivery. This feature prevents short circuit between
                                           electrodes and skin damage from inadvertent reduction of
                                           distance between electrodes.

               Sound volume -              The sound level indicates either a bad contact audible, or
                                           normal power delivery status.

   30) Does the medical device use an alarm system?
      No, the device gives an audible signal.
   31) In what way(s) might the medical device be deliberately misused?
      Before use consider the following:

      1. Prior using or connecting the Hand Piece to the BodyTite™ system, Make sure that the
         Hand piece is properly sterilize, inspect the electrodes and the cable of the Hand Piece


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            for possible mechanical damage or damage to the insulation.

      2. Do not use BodyTite™ unless properly trained to use it in the specific procedure being
         undertaken. Use by physicians without such training has resulted in serious, unintended
         patient injury, including bowel perforation and unintended, irreversible tissue necrosis.

      3. Do not use BodyTite™ to treat patient weight less then 15[kg] (33[lbs]).


   32) Does the medical device hold data critical to patient care?
     The device does not hold data critical to patient care.
   33) Is the medical device intended to mobile or portable?
     Yes.
   34) Does the use of the medical device depend on essential performance?
     Yes. refer to section 4




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2.2   Information supplied by the Chief Medical Officer of Invasix

      (a) Metabolic disorder involving abnormal fat metabolism (“fatty liver”)”.?
      Liposuction procedures and products have been available for almost 30 years. Ultrasonic Liposuction and Laser Assisted Liposuction are all
      predicated on two stage immediate contouring procedure where the energy system (ultrasonic energy and optical energy) first coagulates the
      adipose and then the liquified adipose tissue is aspirated. There are multiple studies showing the liver ultrasound observation, liver functions,
      renal function, VLDL, LDL, HDL and Cholesteral levels do not rise and that the liposuction removes the majority of the adipose (as with
      traditional liposuction) and that the bodies own lipid mobilization pathways, albumin, chylomicrons and other binding proteins manage the
      small residual lipid left behind after any liposuction technique. There is also lots of evidence showing that after Ultrashape and/or mesotherapy
      sessions, where a significant amount of fat is destroyed but not aspirated there is no elevation in serum lipids or adverse live effects like all
      cosmetic surgical procedures, patients with liver disease of live insufficiency would not be candidates for surgery
      (b) The use of the Invasix RFAL (destruction of fat cells) can lead to the formation of free radicals?
      All coagulative therapies, electrosurgery, ultrasonic liposuction, laser liposuction destroy fat cells which are removed The amount of
      inflammation that ensues from the destruction of fat cells, whether by Invasix RFAL and RF, or Ultrasond or laser or even PAL (mechanical
      destruction) accounts for the very modest edema after surgery and this modest swelling resolves within a few days. As the Invasix RFAL
      coagulates before aspiration, the amount of tissue trauma following the Invasix RFAL is even less than traditional mechanical destruction and
      removal of fat (blunt cannula) where the free radical formation, swelling and bruising is far more pronounce. Usually prior the surgery doctor
      prescribes vitamin C which deactivates free radicals.
      (c) The risk of cell/tissue damage other than that of fat cells in adipose tissue. Tissue contains numerous small blood vessels and the
          possibility exists that, as well as fat cells, other cells will also be damaged. Via a torn blood vessel, fat can enter directly into the
          circulatory system, which can have a fatal result?
      The risk of Fat Embolisim syndrome is well described in the traditional liposuction literature and is quote as being 1:50,000 to 1:100,000 cases
      (ie very rare) Because the RFAL procedure also has documented coagulation of blood vessels, the theoretical risk of fat embolism syndrome is
      even more rare than traditional liposuction as the small and medium size vessels are coagulated synchronously with the vessels leaving no
      conduit for the embolism. If fat can come into the blood vessels: Klein tumescent anesthesia is used during treatment. This solution contains
      adrenalin and lidocaine causing vasoconstriction and preventing big objects as fat cells penetrate into the blood vessels.
      (d) How is avoided that nerves will not be damaged. No information in the hazards analysis.


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     All liposuction procedures are performed in the subcutaneous fat plane (above the muscles) and there are no motor nerves in this plane Any
     plastic and cosmetic surgeon is aware of the depth of the treatment and all forms of liposuction, when performed poorly can lead to trauma to
     the motor nerves BUT this is surgeon error and no one technique (RFAL, LAL, UAL or SAL) is at more risk than the other. All liposuction
     techniques can and do damage small sensory nerves that pass through the subcutaneous tissue and all forms of liposuction have a period of skin
     numbing over the liposuction zone until there is natural restoration of the small sensory nerves to the skin. This sensory numbness is NOT a
     complication but expected recovery in all forms of liposuction and elevated flap surgery (from facelifts to breast augmentation) Damage of
     motor nerve may cause serious problems but it located deeper. Motor nerves coming close to the surface in central face and this area is a taboo
     for plastic surgeons. Any surgeon knows that. Any way our device is not intended for central face treatment.
     (e) The effectiveness and safety of the treatment in the long term is not determined.
     The short term (12 week) effectiveness and safety of RF mediated adipose tissue coagulation and vessel coagulation followed by aspiration has
     been demonstrated at this center in about 40 patients and over 70 sites. 6 weeks follow-up showed that all these patients are in stable post
     liposuction wound healing. No complications were observed and patient downtime was even shorter than after traditional liposuction.
     All patient shows consistent and stable weight and circumferential reduction at 6 week and 12 weeks follow-up indicating short term and long-
     term fat reduction and tightening effect. 12 weeks observation can be considered as long-term effect because all post-operative healing
     processes during this time are completed and measured parameters are not correlated with post-op swelling.
     (f) Maximum acceptable temperature.
     Temperature in the range of 40-42oC can be maintained on the tissue surface during period of 10min without risk for the skin. At Cut-Off
     temperature set at 42oC, the real skin temperature measured with thermal camera has average temperature of 40.5oC to 43.5oC. This accuracy
     is determined by accuracy of thermistor and measuring circuit. Most of the patients during clinical study were treated with Cut-Off temperature
     in the range of 40-42 oC and this range is recommended in Clinical manual.
     At higher Cut-Off temperature of 43-45 oC the skin temperature cannot be maintained long time. We found that stopping the treatment when
     skin temperature is safe but maintaining it for long time may cause skin damage.




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3 Risk Method

3.1   Levels of Risk:

           Rating           Risk Level Definitions

           Negligible       Nuisance only / Cosmetic in nature / User Inconvenience / Will not cause personal injury or harm

           Minor            Loss of efficacy but patient safety not compromised / Will not cause personal injury or harm

           Moderate         Non-functional or poor functional performance of device requiring additional medical intervention to compensate
                            /Injury to patient or user requiring no or minor medical intervention to compensate

           Major            Incapacitating / Serious injury or death

3.2   Methods of Control:

           Level        Methods of control        Description

           1            Inherent safe design      This strategy includes system functionality and features that have been especially incorporated to
                                                  alleviate safety hazards.

           2            Manufacturing control     This includes protective measures in the device itself/ in the manufacturing process, and testing

           3            Adequate USER             This includes the provision of adequate user information, training, and labeling
                        information




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3.3   Risk levels:

RISK IV:      Acceptable Risk
RISK III:     Medium risk
RISK II:      High Risk.
RISK I:       Very High Risk, Intolerable risk

                                Negligible(1)    Minor(2)   Moderate(3) Major (4)

            Adequate USER       IV               IV         IV          IV
            information (3)

            Manufacturing       IV               III        III         II
            control (2)

            Inherent safe       IV               III        II          I
            design (1)




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 4 Risk Analysis

 4.1      Chemical and biological Hazards

                                                                                                                       Final Risk
Hazard Identification                         Initial risk estimation
                                                                                                                       Evaluation
                                                                                 Risk Reduction Method                                       V&V
                                                           Method                                                                   New
Item / Hazard               Cause(s) of the   Level of                  Risk                                           New Level
                                                           of                                                                       Risk
Description                 Hazard            Risk                      Level                                          of Risk
                                                           Control                                                                  Level
        Toxicity                              Minor        (1)          III      Chose proper material and             Negligible   IV       Bio
4.1.1                                                                            comply with the design                                      compatibility
                                                                                 requirements (insert the                                    test report.
                                                                                 standard ISO 10993)
        Bio Compatibility   Improper          Moderate     (1)          II       The parts in contact with the         Negligible   IV       Bio
4.1.2                       Materials                                            patient comply with bio-                                    compatibility
                                                                                 compatibility requirements of                               test report.
                                                                                 EN 10993-1
        Bio-burden/         Plastic           Moderate     (1)(2)       III      Hand piece supplied clean and         Minor        III      Operator
4.1.3   contamination                                                            sterilized. Instructions for use in                         manual
        /Inability to                                                            Operator Manual.
        maintain hygienic
        Infection           Using non         Major        (1)(2)(3)    I        Handpiece supplied clean and          Minor        III      Operator
4.1.4                       sterile                                              sterilized. Instructions for use in                         manual
                            accessories,                                         Operator Manual.
        Gases               Hazard due to     Moderate     (1)(3)       IV       No gases are used, or generated       Minor        IV
4.1.5


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                                                                                                                      Final Risk
Hazard Identification                         Initial risk estimation
                                                                                                                      Evaluation
                                                                                 Risk Reduction Method                                      V&V
                                                           Method                                                                  New
Item / Hazard               Cause(s) of the   Level of                  Risk                                          New Level
                                                           of                                                                      Risk
Description                 Hazard            Risk                      Level                                         of Risk
                                                           Control                                                                 Level
                            the presence of                                      during normal operation
                            dangerous
                            gases.
        Liquids             Hazard due to     Moderate     (1)(3)       IV       The only liquid is sealed in         Minor        IV       EN60601 test
4.1.6                       the presence of                                      approved electrolytic capacitors                           report
                            dangerous                                            (No capacitors are assembled on
                            liquids.                                             hand piece or in vicinity of
                                                                                 patient)
        Hazards of           Implosion and    Moderate     (1)          II       The Electrolytic Capacitors are      Negligible   IV       EN60601 test
4.1.7   Implosion and       Explosion                                            the only components thought to                             report
        Explosion           (Electrolytic                                        be at risk of exploding. The
        (Electrolytic       Capacitors)                                          BodyTite enclosure is believed
        Capacitors)                                                              to be stronger than needed to
                                                                                 contain any ejected parts
        Hazard due to the   Solid materials   Moderate     (1)(2)       III      All solid materials such as          Negligible   IV       Bio
4.1.8   use of solid                                                             metals, plastics, terminal strips,                         Compatibility
        materials                                                                PCB etc. are common materials                              test report
                                                                                 are proven safe by long use or
                                                                                 approved by UL (U94-0)
                                                                                 No materials known to generate
                                                                                 dangerous vapours or gases
                                                                                 when heated or burned.

 BodyTite Risk Management File                                                DO600280E                                                         Page 22 of 53
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4.2      Mechanical Hazards

 Hazard Identification                          Initial risk estimation                                                  Final Risk Evaluation

                                                                                    Risk Reduction Method                          New           V&V
                              Cause(s) of the   Level of    Method of       Risk                                         New Level
 Item / Hazard Description                                                                                                         Risk
                              Hazard            Risk        Control         Level                                        of Risk
                                                                                                                                   Level
          Sharp edge          Improper design   Minor       (1)             III     Mechanical hazards have been         Negligible   IV         EN60601 test
 4.2.1                                                                              avoided and minimized by                                     report no
          Stability hazards   The device is     Minor       (1)             III     construction and good
 4.2.2                        unstable                                              engineering practice and testing
                                                                                    according to EN60601-1.
          Accidental          Improper          Minor       (3)             IV      Packaging instruction                Negligible   IV         Packaging
 4.2.3    mechanical damage   mechanical                                                                                                         Qualification
                              packaging
          Accidental moving   Moving parts      Minor       (1)(3)          IV      Fan is protected with grid.          Negligible   IV         EN60601 test
 4.2.4    parts               (The only used                                                                                                     report no
                                                                                    User not allowed opening
                              moving part are                                       covers.
                              Fans)
          Improper system     Vibration         Minor       (1)(2)          III     No major moving parts in the         Negligible   IV         EN60601 test
 4.2.5    usage                                                                     device                                                       report no
                              Mechanical        Minor       (1)             III     The unit complies with
                              shock                                                 EN60601-1 Standard Clause 24
                                                                                    requirements




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4.3      Fire Hazards

 Hazard Identification                            Initial risk estimation                                                  Final Risk Evaluation

                                                                                      Risk Reduction Method                          New           V&V
 Item / Hazard                  Cause(s) of the   Level of      Method of     Risk                                         New Level
                                                                                                                                     Risk
 Description                    Hazard            Risk          Control       Level                                        of Risk
                                                                                                                                     Level
          General Fire          A thermo-plastic Moderate       (1)(2)        III     All thermo-plastic materials         Negligible   IV         Certification of
 4.3.1    ignition Hazards in   material located                                      used in unit have the adequate                               Origin
          normal use            near a hot spot                                       flame protection according to
                                may catch fire                                        UL94.
          Electrical Fire       Overrating,       Major         (1)(2)        II      Electrical fire hazards are          Moderate     III        EN60601 test
 4.3.2    Hazards in normal     Improper                                              avoided and minimized by                                     report
          use                   materials                                             construction and type testing
                                                                                      according EN60601-1, and good
                                                                                      engineering practice such as:
                                                                                      Proper selection fuses, thermal
                                                                                      fuses, type and wires size (UL
                                                                                      listed). Operating all electrical
                                                                                      components within their ratings.
                                                                                      Protection of wires from sharp
                                                                                      edges. All electrical components
                                                                                      (IC, Capacitors, Transformers,
                                                                                      resistor, etc) were choosing so it
                                                                                      operates below its rated
                                                                                      (Temperature, Current, Voltage,
                                                                                      etc). To verify this BodyTite
                                                                                      engineers has selected the
                                                                                      components that are hot, and

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 Hazard Identification                            Initial risk estimation                                                 Final Risk Evaluation

                                                                                      Risk Reduction Method                         New           V&V
 Item / Hazard                  Cause(s) of the   Level of      Method of     Risk                                        New Level
                                                                                                                                    Risk
 Description                    Hazard            Risk          Control       Level                                       of Risk
                                                                                                                                    Level
                                                                                      tested them with thermocouple
                                                                                      during testing of design
                                                                                      verification.
         Fire due to electric   Excessive       Major           (1)(2)        II      Electrical power and circuitry      Moderate    III         EN60601 test
 4.3.3   faults                 temperature may                                       designed conforming to                                      report
                                ignite                                                EN60601-1 and certified.
                                flammable
                                components
         Fires when the         Improper work     Moderate      (1)(3)        IV      The user manual instruct the          Minor     IV          Operator
 4.3.4   device is not in use   instruction                                           user to shut down the system                                manual
                                                                                      when it not in used, and to
                                                                                      unplug the line cord, in this
                                                                                      position it is believed to be
                                                                                      impossible for fire to start in the
                                                                                      BodyTite device, if the device is
                                                                                      plugged in but the switch is off,
                                                                                      it’s unlikely that fire can be start.




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4.4      Environmental Hazards

 Hazard Identification                           Initial risk estimation                                              Final Risk Evaluation

                                                                                     Risk Reduction Method                      New           V&V
 Item / Hazard                 Cause(s) of the   Level of      Method of     Risk                                     New Level
                                                                                                                                Risk
 Description                   Hazard            Risk          Control       Level                                    of Risk
                                                                                                                                Level
          EMI &RFI             Incompatibility   Minor         (1)           III     Tested for compatibility with    Negligible   IV         EN 60601-1-2
 4.4.1                         with other                                            RFI interference, Tested were                            Test report.
                               devices (by                                           done per EN 60601-1-2
                               radiation and
                               conducting
                               lines)
          Operation above or   Environmental     Moderate      (3)           IV      User Manual includes the         Negligible   IV         Operator
 4.4.2    beyond the pre-      specifications                                        environmental specifications                             Manual
          defined limits of    are not clear
          environmental
          conditions


          Contamination        Due to waste      Minor         (3)           IV      Cleaning procedure are defined   Negligible   IV         Operator
 4.4.3                         procedure                                             in the User Manual prior to                              Manual
                               and/or disposal                                       using the system




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4.5      Electrical Hazards

 Hazard Identification                          Initial risk estimation                                                Final Risk Evaluation

                                                                                    Risk Reduction Method                        New           V&V
 Item / Hazard                Cause(s) of the   Level of      Method of     Risk                                       New Level
                                                                                                                                 Risk
 Description                  Hazard            Risk          Control       Level                                      of Risk
                                                                                                                                 Level

          Electrical Shock    Not connecting    Major         (1)(2)        II      Grounding of the accessible        Negligible   IV         EN 60601-1
 4.5.1
          Hazards in normal   to a certified                                        metallic parts.                                            Test report.
          use.                safety ground                                         Mains Voltage isolation.
          Leakage current     High leakage      Major         (1)(2)        II      Leakage current complies with      Negligible   IV         EN 60601-1
 4.5.2                        current                                               EN60601-1                                                  Test report.
                                                                                    Each machine is tested for
                                                                                    ground continuity test.
          BOM                 Use of non-       Major         (1)(2)        II      All insulation materials and       Negligible   IV         BOM Control
 4.5.3                        safety approved                                       connections are in accordance
                              components                                            with EN60601-1.
                                                                                    Use of safety approved
                                                                                    components.
          High Potential      Output            Major         (1)(2)        II      Reinforced insulation.             Negligible   IV         BodyTite
 4.5.4                        electrodes are                                                                                                   safety
                                                                                    Each system is approved
                              not properly                                          according to the relevant safety                           certification
                              insulated                                             standards
          Manufacturing       Human error       Major         (3)           IV      Production Ground continuation     Negligible   IV         Working
 4.5.5                        during assembly                                       test                                                       instruction and

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 Hazard Identification                           Initial risk estimation                                                  Final Risk Evaluation

                                                                                     Risk Reduction Method                          New           V&V
 Item / Hazard               Cause(s) of the     Level of      Method of     Risk                                         New Level
                                                                                                                                    Risk
 Description                 Hazard              Risk          Control       Level                                        of Risk
                                                                                                                                    Level
                                                                                                                                                  BodyTite ATP
                             Fluid spilled on    Major         (1)(3)        IV      Sealed top panel                     Minor        IV         BodyTite ATP
 4.5.6                       exterior                                                Grounded chassis
                                                                                     User Manual


                             Hand piece is       Major         (1)(3)        IV      Power electronics is initiated       Minor        IV         BodyTite
 4.5.7                       not connected                                           after checking of digital port                               System and
                                                                                     connection.                                                  Software V&V
                                                                                     All connectors on system side
                                                                                     have female type.
         Electrostatic       Improper            Moderate      (1)(2)        III     Intrinsic safe design.               Negligible   IV         EN 60601-1-2
 4.5.8   phenomena           materials and                                           Certification to IEC60601-1-2                                Test report.
         (Electrostatic      grounding
         charge build-up)
         Hazards in normal   Unstable            Minor         (1)           IV      Self-test is done after power        Negligible   IV         BodyTite
 4.5.9   use                 electrical supply                                       electronics is initiated. Power on                           System and
                                                                                     does not turned on                                           Software V&V
                                                                                     automatically, system is turned
                                                                                     on in Stand By mode
                                                                                     Pooling of electrical parameters
                                                                                     every 100[ms]

BodyTite Risk Management File                                              DO600280E                                                         Page 28 of 53
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 Hazard Identification                          Initial risk estimation                                               Final Risk Evaluation

                                                                                    Risk Reduction Method                       New           V&V
 Item / Hazard               Cause(s) of the    Level of      Method of     Risk                                      New Level
                                                                                                                                Risk
 Description                 Hazard             Risk          Control       Level                                     of Risk
                                                                                                                                Level
          Heat               Due electrical     Major         (1)           I       See “Electrical Fire Hazards”     Negligible   IV         EN 60601-1
 4.5.10                      short                                                                                                            Test report.
          electrical short   Mechanical         Minor         (1)           III     Electrical short by mechanical    Negligible   IV         EN 60601-1
                             force                                                  force are avoided and minimized                           Test report.
                                                                                    by construction and production
                                                                                    testing in accordance with
                                                                                    EN60601-1, good engineering
                                                                                    and good manufacturing
                                                                                    practices
          Electrostatic      Improper design    Minor         (1)           III     BodyTite device is complies       Negligible   IV         EN 60601-1-2
 4.5.11   phenomena          of electrostatic                                       with electrostatic discharge                              Test report.
          (Electrostatic     discharge                                              requirements of EN 60601-1-2
          charge build-up)   requirements                                           Standard




BodyTite Risk Management File                                             DO600280E                                                      Page 29 of 53
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4.6      Radiation and Electromagnetic Hazards

 Hazard Identification                          Initial risk estimation                                               Final Risk Evaluation

                                                                                    Risk Reduction Method                       New           V&V
 Item / Hazard               Cause(s) of the    Level of      Method of     Risk                                      New Level
                                                                                                                                Risk
 Description                 Hazard             Risk          Control       Level                                     of Risk
                                                                                                                                Level
          Hazards of         Interruption of    Major         (1)           I       The System is designed, built     Minor        III        EN 60601-1-2
 4.6.1    interaction with   functionality of                                       and tested to conform to IEC                              test report
          external medical   external medical                                       60601-1-2 , tested to conform to:
          devices due to     devices                                                EN 60601-1-2 (EN55011
          Electromagnetic                                                           Conducted)
          interference.                                                             EN 60601-1-2 (EN55011
                                                                                    Radiated)
                                                                                    CFR 47 Class B; Part 18
          Improper           Parasitic          Moderate      (1)(2)        III     Device is designed for possible   Minor        III        EN 60601-1-2
 4.6.2    frequency of RF    capacitance in                                         variation of output parasitic                             test report
                             output                                                 capacitance
          Unwanted RF        Footswitch         Major         (1)(2)        II      Each BodyTite device is tested     Moderate    III        BodyTite
 4.6.3    radiation          failure                                                according to the RF standard                              System and
                                                                                    The RF delivery is activated by a                         Software V&V
                                                                                    low to high transition, the output
                                                                                    lasts for 16ms (hardware safety
                                                                                    constraint). In order to prolong
                                                                                    RF output, it must be retriggered
                                                                                    before the 16 ms timer elapse.


BodyTite Risk Management File                                             DO600280E                                                      Page 30 of 53
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 Hazard Identification                        Initial risk estimation                                                 Final Risk Evaluation

                                                                                  Risk Reduction Method                         New           V&V
 Item / Hazard            Cause(s) of the     Level of      Method of     Risk                                        New Level
                                                                                                                                Risk
 Description              Hazard              Risk          Control       Level                                       of Risk
                                                                                                                                Level
                          Emission s of       Moderate      (1)           II      The device is designed, built       Minor       III         BodyTite
 4.6.4                    electromagnetic                                         and tested to conform to:                                   Safety
                          interference                                            EN 60601-1-2 (EN55011                                       Certification
                                                                                  Conducted)                                                  report
                                                                                  EN 60601-1-2 (EN55011
                                                                                  Radiated)
                                                                                  CFR 47 Part 18 Class B
                          Susceptibility to   Moderate      (1)(2)        III     The device is designed, built and   Minor       III         BodyTite
 4.6.5                    electromagnetic                                         tested to conform to:                                       Safety
                          interference                                            EN 61000-4-2 (ESD)                                          Certification
                                                                                                                                              report
                                                                                  IEC 61010-1
                                                                                  EN 61000-4-4 (Radiated
                                                                                  Susceptibility)
                                                                                  EN 61000-4-4 (Electrical fast
                                                                                  Transients)
                                                                                  EN 61000-4-5 (Surge)
                                                                                  EN 61000-4-5 (Conducted RF)
                                                                                  EN 61000-4-8 (Power frequency
                                                                                  Magnetic Field)
                                                                                  EN 61000-4-11 (Voltage dips
                                                                                  and interrupts)

BodyTite Risk Management File                                           DO600280E                                                        Page 31 of 53
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4.7      Human factors Hazards

 Hazard Identification                             Initial risk estimation                                               Final Risk Evaluation

                                                                                       Risk Reduction Method                       New           V&V
 Item / Hazard                 Cause(s) of the     Level of      Method of     Risk                                      New Level
                                                                                                                                   Risk
 Description                   Hazard              Risk          Control       Level                                     of Risk
                                                                                                                                   Level
          Improper Human-      Improper            Major         (1)(3)        IV      The Man Machine Interface         Minor        III        BodyTite
 4.7.1    Machine Interface    ergonometric                                            complies with ergonometric                                Usability
                               design                                                  rules, making it natural and                              testing and
                                                                                       simple. Human-machine                                     environmental
                                                                                       requirements of EN60601-1                                 test report
                                                                                       have been met.


          Operation violates   Intended use &      Major         (3)           IV      Training is conducted with the    Minor        IV         Training
 4.7.2    the intended use     indication for                                          user.
                               use are not clear
          Improper             Instructions are    Minor         (1)(2)        III     Training is conducted with the    Negligible   IV         Training
 4.7.3    maintenance of the   not clear                                               user.
          device




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4.8      Treatment Hazards

 Hazard Identification                            Initial risk estimation                                              Final Risk Evaluation

                                                                                      Risk Reduction Method                      New           V&V
 Item / Hazard                  Cause(s) of the   Level of      Method of     Risk                                     New Level
                                                                                                                                 Risk
 Description                    Hazard            Risk          Control       Level                                    of Risk
                                                                                                                                 Level
          Hazards because of    Human errors,     Major         (3)           IV      Warnings. Operators training.    Minor        IV         BodyTite
 4.8.1    excessive or          Violation of                                                                                                   Clinical
          insufficient Output   operation                                                                                                      Manual.
          Power from hand       instructions
          piece in normal
          use
          Hazards because of    Processor or      Major         (1)(2)        II      Design validation. Warnings.     Moderate     III        BodyTite
 4.8.2    excessive or          Software                                              Operators training. The system                           System and
          insufficient Output   Program                                               recognizes irregular behaviour                           Software V&V
          Power from hand       malfunction..                                         such as overflow and array
          piece                 Controls Lose                                         bounds exceeded: Watch dog
                                Details                                               resets the CPU. Input voltage is
                                                                                      disconnected. An irregular
                                                                                      function shuts down the system
                                Processor
                                temporary                                             Treatment parameters are
                                Failure                                               monitored by HD and SW.
                                                                                      To maintain RF output processor
                                                                                      should produce RF on pulses
                                Software
                                                                                      every 20ms
                                Malfunction


BodyTite Risk Management File                                               DO600280E                                                     Page 33 of 53
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 Hazard Identification                       Initial risk estimation                                                 Final Risk Evaluation

                                                                                 Risk Reduction Method                         New           V&V
 Item / Hazard             Cause(s) of the   Level of      Method of     Risk                                        New Level
                                                                                                                               Risk
 Description               Hazard            Risk          Control       Level                                       of Risk
                                                                                                                               Level
         Treatment is      Reliability.      Moderate      (3)(2)(1)     II      Warnings. Operation                 Minor       III         BodyTite
 4.8.3   unintentionally   Environmental                                         instructions. Operators training.                           System and
         interrupted or    specifications                                        Self-test is done after power                               Software V&V
         aborted           (such as                                              electronics is initiated.
                           electricity                                           Power does not turned on
                           supply) are not                                       automatically. after user
                           met.                                                  command system is turned on in
                                                                                 Stand By mode
                                                                                 Pooling of electrical parameters
                                                                                 every 20ms




BodyTite Risk Management File                                          DO600280E                                                        Page 34 of 53
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4.9      Dangerous Temperature

 Hazard Identification                            Initial risk estimation                                              Final Risk Evaluation

                                                                                      Risk Reduction Method                      New           V&V
 Item / Hazard                 Cause(s) of the    Level of      Method of     Risk                                     New Level
                                                                                                                                 Risk
 Description                   Hazard             Risk          Control       Level                                    of Risk
                                                                                                                                 Level
          Burn Hazards by      System over        Major         (1)           I       Temperatures were measured       Minor        III        EN 60601-1
 4.9.1    accessible hot       heat                                                   during Normal and Abnormal                               test report
          component                                                                   tests According to EN60601-1
                                                                                      safety tests.
          Burn Hazards by      Inadequate         Major         (3)           IV      Warnings, User Instructions      Minor        IV         BodyTite
 4.9.2    the applicator       usage                                                                                                           System and
                                                                                      Bed coupling protection during
          during normal use.                                                          treatment                                                Software V&V
                               Software failure   Major         (1)           I       Design verification & validation. Minor       III        BodyTite
                                                                                      Compliance with standards                                System and
                                                                                      IEC62304; IEC60601-1-4:2000                              Software V&V




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4.10 Energy

 Hazard Identification                          Initial risk estimation                                              Final Risk Evaluation

                                                                                    Risk Reduction Method                      New           V&V
 Item / Hazard                Cause(s) of the   Level of      Method of     Risk                                     New Level
                                                                                                                               Risk
 Description                  Hazard            Risk          Control       Level                                    of Risk
                                                                                                                               Level
          Power delivery is   Wrong             Moderate      (1)(2)        III     -Single use of hand piece.       Minor        III        BodyTite
 4.10.1   not as displayed    calibration                                                                                                    System and
                                                                                    -Output energy is monitored.
                                                                                                                                             Software V&V
                                                                                    -The SW perform internal
                                                                                    calibration process and
                                                                                    applicable fault message is
                                                                                    presented
          RF power is greater Malfunction of    Moderate      (1)(2)        III     Design according to EN 60601-    Minor        III        En60601-1 test
 4.10.2   than 120% of        the power                                             1.                                                       report
          nominal.            supply or RF                                          Individual testing of each
                              generator                                             device.
                              Mistake during
                              assembly




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4.11 Software Hazards

 Hazard Identification                           Initial risk estimation                                                Final Risk Evaluation

                                                                                     Risk Reduction Method                        New           V&V
 Item / Hazard                 Cause(s) of the   Level of      Method of     Risk                                       New Level
                                                                                                                                  Risk
 Description                   Hazard            Risk          Control       Level                                      of Risk
                                                                                                                                  Level

          Firmware Code        RAM failure       Minor         (1)           III     MCU load firmware software;        Negligible   IV         BodyTite
 4.11.1
          corruption (total                                                          but watchdog reset the MCU.                                System and
          code corruption).                                                                                                                     Software V&V


          Firmware Code        Errors in few     Minor         (1)           III     MCU load firmware but              Negligible   IV         BodyTite
 4.11.2   corruption (errors   bytes                                                 software checks CRC and error                              System and
          in a few bytes)                                                            led turn on.                                               Software V&V


          Defective MCU is     Watchdog          Major         (1)(2)        II      Verification test in production    Minor        III        BodyTite
 4.11.3   not identified       hardware                                                                                                         System and
                               defective                                                                                                        Software V&V
          Undefined            Momentary         Major         (1)(2)        II      Continuous voltage monitoring      Minor        III        BodyTite
 4.11.4   processor            voltage fall                                                                                                     System and
          performance due to                                                                                                                    Software V&V
          defective PC
          voltage supply



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 Hazard Identification                             Initial risk estimation                                               Final Risk Evaluation

                                                                                       Risk Reduction Method                       New           V&V
 Item / Hazard                   Cause(s) of the   Level of      Method of     Risk                                      New Level
                                                                                                                                   Risk
 Description                     Hazard            Risk          Control       Level                                     of Risk
                                                                                                                                   Level
          Omission – the                           Minor         (1)           III     Hardware watchdog expires, the    Minor        III        BodyTite
 4.11.5   system produce no                                                            watchdog de-energizes the                                 System and
          flow at a time when                                                          system.                                                   Software V&V
          one would be
          expected
          Commission – the                         Minor         (1)           III     Watchdog uses logical program     Negligible   IV         BodyTite
 4.11.6   system produces a                                                            flow monitoring, the watchdog                             System and
          flow when a                                                                  de-energizes the system.                                  Software V&V
          perfect system
          would not have
          The software turns                       Moderate      (1)           II      Hardware control pulse            Minor        III        BodyTite
 4.11.7   on energy when                                                               activation only when three                                System and
          hand piece is not in                                                         conditions are met:                                       Software V&V
          the system.                                                                  HP push button.
                                                                                       Cartridge switch is pressed.
                                                                                        A software pulse is enabled.


          LCD graphic            Short circuit in  Major         (1)(3)        IV      The Operator Manual contains      Minor        IV         BodyTite
 4.11.8   display burnout        the cable leading                                     troubleshooting table                                     System and
                                 from the                                                                                                        Software V&V
                                 controller to the
                                 display

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 Hazard Identification                           Initial risk estimation                                                Final Risk Evaluation

                                                                                     Risk Reduction Method                        New           V&V
 Item / Hazard                Cause(s) of the    Level of      Method of     Risk                                       New Level
                                                                                                                                  Risk
 Description                  Hazard             Risk          Control       Level                                      of Risk
                                                                                                                                  Level
                              Grounding/Disp
                              lay failure
                              Electronics in
                              the display or
                              controller
                              failures
          Buttons are not     Improper man       Moderate      (1)           II      Design reviews ; and production    Minor        III        BodyTite
 4.11.9   functioning         machine                                                test                                                       System ATP
                              interface design
          Error in                               Minor         (1)           III     Verification test in production    Negligible   IV         BodyTite
 4.11.10 downloading   the                                                                                                                      System ATP
          software
          User Confusion on   Improper           Major         (1)           I       Error indication shall have        Minor        III        BodyTite
 4.11.11 the  status of the   software error                                         explanation in the operation                               System and
          system              handling design                                        manual.                                                    Software V&V


          No Indication of    Software failure   Minor         (1)           III     Continuous monitoring of the       Minor        III        BodyTite
 4.11.12 HW   malfunction     in Monitoring                                          correct behaviour of the                                   System and
                              the HW status                                          hardware, by high rate scanning                            Software V&V
                                                                                     the signals of all the sensors;
                                                                                     detection of errors as soon as
                                                                                     they occur and shutting down

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 Hazard Identification                               Initial risk estimation                                                Final Risk Evaluation

                                                                                          Risk Reduction Method                       New           V&V
 Item / Hazard                   Cause(s) of the     Level of      Method of      Risk                                      New Level
                                                                                                                                      Risk
 Description                     Hazard              Risk          Control        Level                                     of Risk
                                                                                                                                      Level
                                                                                          the system.
           Improper hand         Software does       Minor         (1),(3)        IV      Software routinely displays       Minor        IV         BodyTite
 4.11.13 piece                   not indicate that                                        indication if hand piece is                               System and
                                 hand piece was                                           disconnected                                              Software V&V
                                 not replaced                                             Hand piece removal is forbidden
                                 after previous                                           during system power on.
                                 treatment.
           Late – a flow is                          Minor         (1)            III     Hardware watchdog expires, the    Negligible   IV         BodyTite
 4.11.14 produced     after it                                                            watchdog de-energizes the                                 System and
           should                                                                         system.                                                   Software V&V
           Corrupted SW is                           Minor         (1)            III     Check sum is performed            Negligible   IV         BodyTite
 4.11.15 read   from external                                                                                                                       System and
           flash memory                                                                                                                             Software V&V
           Hand piece not        Corrupted           Minor         (1)            III     Software does not allow           Negligible   IV         BodyTite
 4.11.16 operated                information in                                           operation with unrecognized                               System and
                                 hand piece ID                                            hand piece                                                Software V&V
           Corrupted SW in       Mechanical          Moderate      (1), (2)       III     Check Sum test is performed       Minor        III        BodyTite
 4.11.17 SW    plug              damage of plug                                                                                                     System and
                                                                                                                                                    Software V&V
           Wrong SW version      Shipment or         Moderate      (1), (2),(3)   IV      Configuration management          Minor        IV         BodyTite
 4.11.18                         assembling                                               control tool is used                                      System and
                                 mistake                                                                                                            Software V&V

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4.12 System Malfunction

 Hazard Identification                           Initial risk estimation                                               Final Risk Evaluation

                                                                                     Risk Reduction Method                       New           V&V
 Item / Hazard                 Cause(s) of the   Level of      Method of     Risk                                      New Level
                                                                                                                                 Risk
 Description                   Hazard            Risk          Control       Level                                     of Risk
                                                                                                                                 Level
          Power delivery is    RF Generator      Moderate      (1)(2)        III     Out parameters are monitored by Minor          III        BodyTite
 4.12.1   not as displayed     fault.                                                CPU                                                       System and
                                                                                                                                               Software V&V
                               Line voltage      Moderate      (1)(2)        III                                       Minor        III        BodyTite
                               problems,                                                                                                       System and
                                                                                                                                               Software V&V
                               Software fault.   Moderate      (1)(2)        III                                       Minor        III        BodyTite
                                                                                                                                               System and
                                                                                                                                               Software V&V
          RF power is higher Capacitor           Moderate      (1)(2)        III     Capacitor voltage are monitored   Minor        III        BodyTite
 4.12.2   by 20% of nominal. voltage fault                                           by the system, and if fault are                           System and
                                                                                     detected the system stops                                 Software V&V
                                                                                     charger power supply
                               Acoustic          Moderate      (1)           II      Closed console design, rubber     Negligible   IV
 4.12.3
                               pressure                                              buttons for vibrating modules.
          Scratched            Improper Hand     Moderate      (1)(3)        IV      Hand piece is replaced after      Minor        IV         BodyTite
 4.12.4   insulation on hand   piece                                                 single use                                                System and
          piece.                                                                                                                               Software V&V

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 Hazard Identification                              Initial risk estimation                                                Final Risk Evaluation

                                                                                        Risk Reduction Method                        New           V&V
 Item / Hazard                  Cause(s) of the     Level of      Method of     Risk                                       New Level
                                                                                                                                     Risk
 Description                    Hazard              Risk          Control       Level                                      of Risk
                                                                                                                                     Level
          System is not         Specifications      Moderate      (1)(2)        III     Specification is validated with    Minor        III        BodyTite
 4.12.5   working as desired.   do not meet the                                         the clinical data as an ongoing                            System and
                                application.                                            process.                                                   Software V&V
          Loss of mechanical    (poor               Minor         (1)(2)        III     The machine was designed by        Negligible   IV         BodyTite
 4.12.6   integrity             mechanical                                              competent mechanical engineers                             Mechanical
                                design or lack of                                       and manufactured by high                                   V&V
                                QC)                                                     quality shops. QC checks each
                                                                                        module and the whole machine
                                                                                        in the critical points of the
                                                                                        manufacturing process.
          Inadequate            Lack of             Minor         (1)(2)        III     Packaging procedures were         Negligible    IV         BodyTite
 4.12.7   packaging             Packaging                                               written and controlled by the QC                           Packaging
                                Procedure.                                              personnel.All packaging are                                instruction
                                                                                        specially treated and disinfected
                                                                                        against termites, fungus and fire
                                                                                        according to the Israeli standard
                                                                                        IS262
          Liquid spillage       The upper side    Minor           (1)           III     The upper side of the system is   Negligible    IV         EN 60601-1
 4.12.8                         of the system is                                        sealed to prevent spillage of                              test report
                                sealed to prevent                                       liquids. The enclosure provides a
                                spillage of                                             protection of IP20 according to
                                liquids.                                                IEC529, degrees of protection
                                                                                        provided by enclosures

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4.13 Clinical Hazards

 Hazard Identification                            Initial risk estimation                                                 Final Risk Evaluation

                                                                                      Risk Reduction Method                         New           V&V
 Item / Hazard                Cause(s) of the     Level of      Method of     Risk                                        New Level
                                                                                                                                    Risk
 Description                  Hazard              Risk          Control       Level                                       of Risk
                                                                                                                                    Level
          Skin burn created                       Moderate      (1)(3)        II      Skin temperature is monitored.      Minor       IV          BodyTite
 4.13.1   by touching from                                                            Output power is reduced prior                               System and
          inside                                                                      the reaching temperature limit to                           Software V&V
                                                                                      avoid over heating due to                                   Clinical study
                                                                                      measurements delay.                                         evaluation
          Patient internal    Internal            Major         (1)(3)        I       Distance between internal           Minor       III         BodyTite
 4.13.2   injury              electrode is                                            electrode and external is limited                           System and
                              going too deep                                          by latch                                                    Software V&V
                              into the body
                              below treated                                                                                                       Clinical study
                              zone                                                                                                                evaluation
          Treatment is        Unstable            Moderate      (1)(3)        II      Self-test is done after power       Minor       III         BodyTite
 4.13.3   unintentionally     electrical supply                                       electronics is initiated.                                   System and
          interrupted                                                                 Power does not turned on                                    Software V&V
                                                                                      automatically, system is turned
                                                                                      on in Stand By mode                                         Clinical study
                                                                                      Pooling of electrical parameters                            evaluation
                                                                                      conducted periodically



BodyTite Risk Management File                                               DO600280E                                                        Page 43 of 53
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4.14 Problem related to patient health conditions and treatment history

                                                                                                                          Final Risk
 Hazard Identification                            Initial risk estimation
                                                                                                                          Evaluation
                                                                                      Risk Reduction Method                                     V&V
                                                                                                                                    New
 Item / Hazard              Cause(s) of the       Level of      Method of     Risk                                        New Level
                                                                                                                                    Risk
 Description                Hazard                Risk          Control       Level                                       of Risk
                                                                                                                                    Level
          Patient has       Patient is allergic   Moderate      (1)           II      Use only biocompatible              Minor        III      Biocompatibility
 4.14.1   allergic                                                                    materials                                                 test or use of
                            to hand piece
          reaction from     materials                                                                                                           materials with
          contact with                                                                                                                          known
          hand piece                                                                                                                            biocompatible
                                                                                                                                                properties
          Patient does not Allergy to             Moderate      (3)           IV      Record patient history and          Minor        IV       Contraindication
 4.14.2   react well to    anaesthesia                                                exclude the patient                                       in User manual
          anaesthesia
          During or post    Significant           Moderate      (3)           IV      Record patient history of           Minor        IV       Contraindication
 4.14.3   the surgery       systemic illness or                                       systemic illnesses and exclude                            in User manual
          health problems   occult systemic                                           the patient
          not related to    illness
          procedure
          directly are
          appeared
                            Therapies or          Moderate      (3)           IV      Record patient history of           Minor        IV       Contraindication
 4.14.4                     medication which                                          treatments and medication                                 in User manual
                            may interfere with                                        taking and exclude the patient

BodyTite Risk Management File                                               DO600280E                                                        Page 44 of 53
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                                                                                                                             Final Risk
 Hazard Identification                               Initial risk estimation
                                                                                                                             Evaluation
                                                                                         Risk Reduction Method                                    V&V
                                                                                                                                       New
 Item / Hazard               Cause(s) of the         Level of      Method of     Risk                                        New Level
                                                                                                                                       Risk
 Description                 Hazard                  Risk          Control       Level                                       of Risk
                                                                                                                                       Level
                             treatment
                             Resent surgery in       Moderate      (3)           IV      Record patient history of surgery Minor          IV      Contraindication
 4.14.5                      treatment area                                              and exclude the patient                                  in User manual
           Un-expected       Illness localized in    Moderate      (3)           IV      Record patient history of illness   Minor        IV      Contraindication
 4.14.6    reaction in the   area of treatment                                           and exclude the patient                                  in User manual
           treated area
                             Disorders of the        Moderate      (3)           IV      Record patient history of           Minor        IV      Contraindication
 4.14.7                      lower abdomen                                               disorders and exclude the patient                        in User manual
                             (i.e. hernia,
                             ulcerative colitis,
                             Chron’s disease,
                             acute cervicitis etc)
           Cardio-vascular Moving tromb in           Moderate      (3)           IV      Record patient history of           Minor        IV      Contraindication
 4.14.8    problems        blood vessel                                                  trombophlebits and exclude the                           in User manual
           appeared after                                                                patient
           the procedure
                             Heart does not          Moderate      (3)           IV      Record patient history of heart     Minor        IV      Contraindication
 4.14.9                      stand the operation                                         failure and exclude the patient                          in User manual
                             shock
           Procedure         Surgical                Moderate      (3)           IV      Exclude pregnant patient            Minor        IV      Contraindication
 4.14.10   effect            intervention,                                                                                                        in User manual

BodyTite Risk Management File                                                  DO600280E                                                       Page 45 of 53
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                                                                                                                           Final Risk
 Hazard Identification                             Initial risk estimation
                                                                                                                           Evaluation
                                                                                       Risk Reduction Method                                    V&V
                                                                                                                                     New
 Item / Hazard                Cause(s) of the      Level of      Method of     Risk                                        New Level
                                                                                                                                     Risk
 Description                  Hazard               Risk          Control       Level                                       of Risk
                                                                                                                                     Level
           pregnancy          anaesthesia, shock
           process
           Spreading of       Acute infection      Moderate      (3)           IV      Record patient history of acute     Minor        IV      Contraindication
 4.14.11   infection in the                                                            infection and exclude the patient                        in User manual
           body
           Patient has        Abnormal fat         Moderate      (3)           IV      Refer to section 2.2(a)             Minor        IV      The use of the
 4.14.12   “fatty liver”      metabolism                                                                                                        device is
                                                                                                                                                restricted to a
                                                                                                                                                trained user only
           Formation of       destruction of fat   Moderate      (3)           IV      Refer to section 2.2(b)             Minor        IV      The use of the
 4.14.13   free radicals      cells                                                                                                             device is
                                                                                                                                                restricted to a
                                                                                                                                                trained user only
           Damage other       fat can come into    Moderate      (3)           IV      Refer to section 2.2(c)             Minor        IV      The use of the
 4.14.14   than that of fat   the blood vessels                                                                                                 device is
           cells in adipose                                                                                                                     restricted to a
           tissue.                                                                                                                              trained user only
           Damage of          Surgeon is not       Moderate      (3)           IV      Refer to section 2.2(d)             Minor        IV      The use of the
 4.14.15   motor nerves       aware of the depth                                                                                                device is
           (main nerves       of the treatment                                                                                                  restricted to a
           going in the                                                                                                                         trained user only

BodyTite Risk Management File                                                DO600280E                                                       Page 46 of 53
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                                                                                                                       Final Risk
 Hazard Identification                            Initial risk estimation
                                                                                                                       Evaluation
                                                                                      Risk Reduction Method                                  V&V
                                                                                                                                 New
 Item / Hazard                Cause(s) of the     Level of      Method of     Risk                                     New Level
                                                                                                                                 Risk
 Description                  Hazard              Risk          Control       Level                                    of Risk
                                                                                                                                 Level
           leg) Note: refer
           to 2.2; question
           d for more
           clarification of
           what we mean
           by nerve
           damaged
           Effectiveness      Missing follow-up   Moderate      (3)           IV      Refer to section 2.2(e)          Minor        IV       The use of the
 4.14.16   and safety of                                                                                                                     device is
           the treatment in                                                                                                                  restricted to a
           the long term is                                                                                                                  trained user only
           not determined                                                                                                                    and they trained
                                                                                                                                             to perform
                                                                                                                                             follow-up




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4.15 Other Hazards

                                                                                                                             Final Risk
 Hazard Identification                             Initial risk estimation
                                                                                                                             Evaluation
                                                                                     Risk Reduction Method                                         V&V
                                                               Method                                                        New          New
 Item / Hazard                Cause(s) of the      Level of                  Risk
                                                               of                                                            Level of     Risk
 Description                  Hazard               Risk                      Level
                                                               Control                                                       Risk         Level
          System Confuse      Human-Machine        Moderate (1)              II      Considerable thought has been           Negligible   IV       EN 60601-1-6
 4.15.1                       Interface                                              devoted to making the interface                               test report
                                                                                     natural and simple. The read-out                              60601-1 &
                                                                                     device is a set of LEDs, with good                            60601-2-2
                                                                                     brightness. In addition, an audible                           TR881236184
                                                                                     emission tone alerts the user of an                           6.pdf
                                                                                     emission in process.
                                                                                     All Human-machine requirements of
                                                                                     EN60601-1-6 have been met.
          Improper system     System is used       Moderate (3)              IV      Intended use is described in user       Minor        IV       Operation
 4.15.2   usage               not according                                          manual.. Each doctor is trained.                              manual and
                              inclusion criteria                                     System is sold to certify MD.                                 training
          Treatment is        System is used in    Major       (3)           IV      Contraindications are described in      Minor        IV       Operation
 4.15.3   unintentionally     contraindicated                                        user manual.                                                  manual
          interrupted         cases
          Treatment           Wrong treatment      Moderate (3)(1)           II      Energy range is automatically adjusted Minor         III      Operation
 4.15.4   parameters is out   parameters are                                         for connected hand piece intended for                         manual
          of range            used                                                   specific application. User manual
                                                                                     describe the treatment procedure and

BodyTite Risk Management File                                                 DO600280E                                                         Page 48 of 53
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                                                                                                              Final Risk
 Hazard Identification                     Initial risk estimation
                                                                                                              Evaluation
                                                                             Risk Reduction Method                                 V&V
                                                       Method                                                 New          New
 Item / Hazard           Cause(s) of the   Level of                  Risk
                                                       of                                                     Level of     Risk
 Description             Hazard            Risk                      Level
                                                       Control                                                Risk         Level
                                                                             recommended parameters




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4.16 Specific Hazards of EN60601-1, Sub-Clause 52.2; 52.4.1 prohibits

                                                                                                                 New          New
                                               Level of   Method of Risk
 Cause Of the Hazard                                                        Risk Reduction Method                Level of     Risk        V&V
                                               Risk       Control   Level
                                                                                                                 Risk         Level

           Emission of flames, molten metal,   Moderate   (1)(2)    III     The BodyTite will not do this,       Negligible   IV          EN 60601-1
 4.16.1
           and poisonous or ignitable gas                                   These matters have been addressed                             test report
                                                                            in Fire Hazards, and they were
                                                                            the subjects of various abnormal
                                                                            tests during the EN60601-1 Safety
                                                                            Tests.

           Excessive deformation of covers     Moderate   (1)(2)    III     The strength of the BodyTite covers Negligible    IV          EN 60601-1
 4.16.2
                                                                            was evaluated by the ITL engineers                            test report
                                                                            for EN60601-1

           Excessive temperatures              Moderate   (1)(2)    III     The temperature was measured       Negligible     IV          EN 60601-1
 4.16.3
                                                                            during Normal and Abnormal tests                              test report
                                                                            made by Invasix and ITL inspecting
                                                                            engineer for the EN60601-1 safety
                                                                            tests.

           System is used not according        Moderate   (3)       II      Intended use is described in user    Negligible               Operation
 4.16.4
           inclusion criteria                                               manual..                                                      manual

           System is used in contraindicated   Major      (3)       IV      Contraindications are described in   Minor        IV          Operation
 4.16.5
           cases                                                            user manual.                                                  manual

           Wrong treatment parameters are      Moderate   (1)        II     Energy produced by the system is     Negligible   IV          Operation
 4.16.6


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                                                                                                   New        New
                                Level of   Method of Risk
 Cause Of the Hazard                                         Risk Reduction Method                 Level of   Risk        V&V
                                Risk       Control   Level
                                                                                                   Risk       Level
           used                                              limited and cannot exceed the                                manual
                                                             preset significantly. User manual
                                                             describe the treatment procedure to
                                                             avoid significant damage




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5    Information supplied by the manufacturer

Hazard Event                        Risk Reduction Method                                                  Risk Level

Manufacturer not identified         Manufacturer Identified in the User Manual                             Negligible

Lack of safety information in the   Safety instructions are defined in the User Manual                     Negligible
instructions manual

Use of symbols non harmonized       Use of symbol according to EN980                                       Negligible

Intended use not obvious for user   Intended use is defined in the User Manual                             Negligible

Lack of check-list following        User Manual                                                            Negligible
installation

Lack of preventive maintenance      Preventive maintenance instruction are defined in the User Manual      Negligible
instructions to keep the device
safe




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6 Risk Estimation of Hazards Associated to the BodyTite device

   Through hazard analysis, we determined that electric shock, clinical hazards, biological hazards and system used in contraindicated cases are the
   four significant hazards present with the Device. Neither of the hazards identified has been determined to be unacceptably high.
   The risk of electric shock hazard is considered to be LOW. It is mostly limited to Service personnel because the only hazardous live parts are
   contained within the Device console.
   The risks related to infection is solving with routine of single use sterile hand piece.


7 CONCLUSION

   No known hazards have been identified. The hazard prevention features does not limit the product efficiency and defined specification




BodyTite Risk Management File                                             DO600280E                                                        Page 53 of 53

				
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