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1. used 5 Energy to from patient O fiere costole INA patient orocessed Sterile Intended to be N A T Hee M Gsimededbytneuer Ne disinfected by the user Mese CSC environment 11 Measurements NA N A 12 use in conjunction with medicines or other medical technologies energy or substances environmental influences influence the N A environment S associated maintenance calibration 19 20 Restricted shelf life Delayed and or long No effect unless the device is damaged term use effect Z E Mechanical forces Mechanical forces Lifetime of the device Wear and tear of the device components determined disposal to install or use ical Fi MEM UM Efi Date July 11 2018 Information for safe use By symbol and label new manufacturing New manufacturing processes was established processes need to be established or introduced successful application of N A the medical device critically dependent on human factors such as user Interface N A Yes N A User interface design features contribute to use error Used in distraction ON CC C E i accessories display information controlled by a menu special needs Initiate user actions Alarm system Deliberately misused care To be mobile or portable Depend on essential Depend on device s physical essential performance performance Letters in the first column refer to EN ISO 14971 2012 Annex C 2
2. ls material same as in an existing commercially available device Yes 4 3 4 24 Sufficient justification and or test data available Device characterization a Nature of contact n BIOLOGICAL EVALUATION b Duration of contact 3 5 3 6 and 62 selection of blalogical evaluation tests Testing and or Tables 1 and 2 rationale justification Final assessment Yes Standard requirements met for SO 10993 1 a Refers to clause subclause in main text 4 Checklist of EN ISO 10993 1 2009 EN ISO 10993 1 2009 Biological Reference TMTW1506165750 Page 3 of 13 evaluation of medical devices Part 1 Evaluation and testing Clause Requirement test Result Verdict 1 Scope This part of ISO 10993 describes The general principles governing the biological evaluation of medical devices The categorization of devices based on the nature and duration of their contact with the body The selection of appropriate tests This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient s body nor does it cover biological hazards arising from any mechanical failure The device contacts with patient s body indirectly General principles applying to biological evaluation of medical devices 3 1 The selection and evaluation of any material or device intended for use in h
3. SjJOJ D RL 4 J J 13 Degradation N A D4 Environmental hazards and contributory factors electromagnetic fields Inadequate supply of i power or coolant Susceptibility to Electromagnetic hazard may 1 2 7 3 No electronic electromagnetic happen component provided interference Emissions of Electromagnetic hazard may 1 2 7 3 Noelectronic electromagnetic happen component provided interference power N A inadequate supply of coolant Storage or operation outside prescribed environmental conditions Incompatibility with other devices Accidental mechanical Contamination due to waste products and or device disposal D5 Hazards resulting from incorrect output of energy and substances 1 electricity Electricity leakage hazard may 2 31 8 No electronic Symbol Reference TMTW1506165750 Page 6 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Products ORTHOPAEDIC BRACES amp SUPPORT NN SJOJDIRL j JDl J 6 supply of anaesthetic N A i agents D6 Hazards related to the use of the device and contributory factors coli Inadequate labeling A 1 9 2 4 19 Preventing wrong label Labels and Instruction No Yes_ Inadequate operating Inadequate operating instructions 6 2 4 26 Preventing wrong label Labels and Instruction No Yes instructions may caus
4. bottom Details of HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA View X general front rear right left top bottom End of Photo Documentation TMTW1506165750 Page 1 of 1 Annex IV The suppliers information 1 FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C
5. Reference TMTW1506165750 Page 4 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Products ORTHOPAEDIC BRACES amp SUPPORT Risk Evaluation Risk Reduction Measure ALOR General Identifyhazards SjOJ D RL __ D2 Energy Hazards 1 Electricity Electricity leakage hazard may neglectable risk no further actions 2 Heat 3 Mechanical force Mechanical force during operation neglectable risk no Li Pr ii5 5b i isla q oo li collides patients body ll l further actions Linn 2 4 _Jonizing radiation N A e cc ef 5 Non ionizing radiation N A 6 Electromagnetic fields Electromagnetic hazard may neglectable risk no i further actions 9 Patient support device i failure 10 Pressure vessel i rupture 12 Vibration NA aaa ooo 13 Magnetic fields e g _MRI D3 Biological hazards 1 Bio contamination N A ASA IL LL D 2 Bio incompatibility NA 57 4 285 o lo 3 Incorrect N A formulation chemical Composition Lp s NE 4 Toxicity L a 0 0 dL M 9 allergenicity ee s pc pr ceci pn E 6 mutagenicity N A nn E 7 oncogenibity amp 5 N A LLL NE 8 teratogenicity INVASA 9 Carcinogenicty N A fap ef 10 Re and or cross N A i infection Reference TMTW1506165750 Page 5 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Products ORTHOPAEDIC BRACES amp SUPPORT General i Identify hazars
6. a a Moderate Process is monitored SPC and manually inspected METH High SPC is used with an immediate reaction to out of control conditions SPC as above with 100 inspection sourrounding out of control conditions Very High All units are automatically inspected 02 Almost Certain Defect is obvious and can be kept from affecting the customer End of Risk Analysis Report Reference TMTW1506165750 Page 1 of 2 Chapter 5 Comprehensive description of the product 5 1 Product specification and pictures SAKAE 380MA HIGH VOLTAGE ELECTRIC SAKAE 380MA Model SAKAE 380MA ne op a 08 o8 OOl oi di OF OF OF OF 08 OZ PP dupl tutu uela Reference TMTW1506165750 5 2 Production procedure and quality control 5 2 1 Production procedure R amp D Dept P amp S Dept Peripherals Workshop mi End of Comprehensive Description of the Product Page 2 of 2 Reference TMTW1506165750 Page 1 of 2 Chapter 6 Requirements for language and labels 6 1 design of the label The product produced by our company labeled with the following information a Product name type and quantity b CE mark pieced with two semi circles with its diameter no less than 5mm c Batch number production date and valid time d Manufacturer name e Manufacturer address telephone number and fax number f Name and address of the EC representative 6 2 conformity and accuracy of the label According to the require
7. amp EFTA For the following product categories Type of product HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Model SAKAE 380MA Signature Signature Name and Position Company A Name and Position Company B Technical and Quality Manger General Manager Place date Place Date July 11 2015 July 11 2015 Reference TMTW1506165750 Page 1 of 13 Biological evaluation test report 1 Introduction This biological evaluation is performed on HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA SAKAE 380MA for the purpose of investigating the biological risk of this device This evaluation was planned at the beginning stage of device design Main methods and procedures we selected herewith are focused on EN ISO 10993 1 2009 EN ISO 10993 5 2009 EN ISO 10993 10 2009 2 Intended use intended purpose 2 1 Device Name High Voltage Electric Fleld Therapy SAKAE 380ma 2 2 Standards concerned EN ISO 15223 1 2012 EN 1041 2008 EN ISO 10993 1 2009 AC 2010 EN ISO 10993 5 2009 EN ISO 10993 10 2009 EN ISO 14971 2012 2 3 Intended use 3 Biological evaluation flow chart Reference TMTW1506165750 Page 2 of 13 Flow chart to aid in ensuring a systematic approach to biological evaluation of medical devices START Does the device contact the body directly or indirectly No Biological evaluation not applicable Does davice have same properties a Manufacturing b Body contact c Sterilization
8. 19 Checklist according to annex I of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body The measurements made by devices with a measuring function must be expressed in legal units conforming to the provisions of Council Directive 80 181 EEC r Protection against radiation General 11 4 Devices shall be designed and manufactured such that 1 exposure of patients users and other persons to radiation shall be reduced as far as possible compatible with the N A N A N A intended purpose whilst not restricting the application of appropriate specified levels for therapeutic and diagnostic purposes 412 Intended radiation 11 2 Where devices are designed to emit hazardous levels of 1 radiation necessary for a specific medical purpose the benefit of which is considered to outweigh the risks N A N A N A inherent in the emission it must be possible for the user to control the emissions Such devices shall be designed and manufactured to ensure reproducibility and tolerance of relevant variable parameters 11 2 Where devices are intended to emit potentially 2 hazardous visible and or invisible radiation they must be N A N A N A fitted where practicable with visual displays and or audible warnings of such emissions 113
9. 204 08 10 Standards other directives and other rules applied by Requirements fulfilled manufacturer Reference TMTW1506165750 Page 19 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body sterilisation final assembly etc j in the case of devices emitting radiation for medical purpose details of the nature type intensity and distribution of this radiation The instruction for use must also include details allowing the medical staff to brief the patient on any contra indications and any precautions to be taken These details should cover in particular k precautions to be taken in the event of changes in the performance of the device I precautions to be taken as regards exposure in reasonably foreseeable environmental conditions to magnetic fields external electrical influences electrostatic discharge pressure or variations in pressure acceleration thermal ignition sources etc m adequate information regarding the medicinal product or products which the device in question is designed to administer including any limitations in the choice of substances to be delivered n precautions to be taken against any special unusual risks related to the disposal of the device 0 medicina
10. N A N A Any change in the final product during storage It complies with the requirement Pass Any change in the intended use of the product It complies with the requirement Pass Any evidence that the product may produce adverse effects when used in humans It complies with the requirement Pass 3 8 The biological evaluation performed in accordance with the part of ISO 10993 should be considered in conjunction with the nature and mobility of ingredients in the materials used to manufacture the device and other information other non clinical tests clinical studies and post market experience for an overall assessment It complies with the requirement Pass Categorization of medical devices General Following the general principles laid down in Clause 3 medical devices can be categorized to facilitate the selection of appropriate tests The testing of any device that does not fall into one of the categories described should follow the general principles contained in this part of ISO 10993 Certain devices may fall into more than one category in which case testing appropriate to each category should be considered Medical devices shall be categorized according to the nature and duration of body contact as described in 4 2 and 4 3 4 2 Categorization by nature of body contact Reference TMTW1506165750 EN ISO 10993 1 2009 Biological eval
11. Page 3 of 3 Others Immediately report not more than 30 days 8 4 9 Reporting to medical devices authority 8 4 9 1 If happened in EU countries should report to the accidents happened country s authority 8 4 9 2 If happened in outside EU countries report to the authority of the country where the NB located 8 4 9 3 If happened in China report to local medicine supervision managerial authority 8 4 9 4 If necessary the company will inform its EU representative or others institutes to report accidents in vigilance system 8 5 Relevant documents Quality tracking quality accident emergency treatment and adverse reaction reporting system 8 6 Quality Record None Reference TMTW1506165750 Page 1 of 1 Chapter 9 Packaging instruction 9 1 Packaging for High Voltage Electric Fleld Therapy SAKAE 380ma Packaging materials Gift Box Plastic Packaging dimensions 170x100x40 Packaging method 1 pcs 1 carton 9 2 Sealing test 1 Check the quality of carton in the production process the substandard ones are forbidden to use 2 The inspector checks the sealing of the carton in the packaging process 3 The inspectors check the sealing and confirm intact and then stick the label Reference TMTW1506165750 Page 1 of 2 Chapter 10 Pre market clinical evaluation report Product history Since FUWEI HIGH SCIENTIFIC CO LTD was founded HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA System become the most important prod
12. Unintended radiation N A N A N A 11 3 Devices shall be designed and manufactured in such a 4 OJ No L 39 15 2 1980 p 40 Dir No L 39 15 2 1980 p 40 Directive as last amended by Directive 89 617 EEC OJ No L 357 7 12 19889 p 28 TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 12 of 19 Checklist according to annex I of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body way that exposure of patients users and other persons to the emission of unintended stray or scattered radiation is be reduced as far as possible Instructions The operating instructions for devices emitting radiation must give detailed information as to the nature of the emitted radiation means of protecting the patient and the user and on ways of avoiding misuse and of eliminating the risks inherent in installation lonising radiation Devices intended to emit ionising radiation must be designed and manufactured in such a way as to ensure that where practicable the quantity geometry and quality of radiation emitted can be varied and controlled taking into account the intended uses Devices emitting ionising radiation intended for diagnostic radiology shall be designed and manufactur
13. a way that when used under the conditions and for the purposes intended they will not compromise the clinical condition or the safety of patients or the safety and health of users or where applicable other persons provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety A This shall include reducing as far as possible the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used design for patient safety and consideration of the technical knowledge experience education and training and where applicable the medical and physical conditions of intended users design for lay professional disabled or other users The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles taking account of the generally acknowledged state of the art In selecting the most appropriate solutions the manufacturer must apply the following principles in the following order eliminate or reduce risks as far as possible inherently safe design and construction where appropriate take adequate protection measures including alarms if necessary in relation to risks that cannot be eliminated TMTW1506165750 05 TMTW1506165750 05 Chapter 3 Essential re
14. accordance with Regulation EC No 726 2004 on the quality and safety of the substance including the clinical benefit risk profile of the incorporation of the substance into the device When issuing its opinion the competent authority or the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body Where a device incorporates as an integral part a human blood derivative the notified body shall having verified the usefulness of the substance as part of the medical device and taking into account the intended purpose of the device seek a scientific opinion from the EMEA acting particularly through its committee on the i Regulation EC No 726 2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency OJ L 136 30 4 2004 p 1 Regulation as last amended by Regulation EC No 1901 2006 TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 6 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be f
15. filled in by Notified Body Standards other directives and other rules applied by manufacturer EN ISO 15223 1 2012 EN ISO 14971 2009 EN 60601 1 2006 Label Hisk analysis report Test report EN ISO 15223 1 2012 EN 1041 2008 EN 60601 1 2006 Label Instruction Risk analysis report Test report No animal tissue is used in manufacturing this product No sterlization device Rev 2 204 08 10 Reference TMTW1506165750 Page 9 of 19 Checklist according to annex I of the Medical Device Standards other directives Documentation test Directive MDD and other rules applied by reports protocols manufacturer literature or reason for no Requirements ox fulfilled Fail to be filled in by applicability Notified Body Devices delivered in a sterile state must have been manufactured and sterilised by an appropriate validated N A method N A No sterlization device 8 5 Devices intended to be sterilised must be manufactured in appropriately controlled e g environmental conditions No sterlization device Packaging systems for non sterile devices must keep the product without deterioration at the level of cleanliness stipulated and if the devices are to be sterilised prior to use minimise the risk of microbial contamination The packaging system must be suitable taking account of the method of sterilisation indicated by the manufacturer No sterlization device The packaging and or lab
16. reproduction of category 1 or 2 in accordance with Annex to Directive 67 548 EEC these devices must be labelled on the device itself and or on the packaging for each unit or where appropriate on the sales packaging as a device containing phthalates N A N A N A If the intended use of such devices includes treatment of children or treatment of pregnant or nursing women the manufacturer must provide a specific justification for the use of these substances with regard to compliance with the essential requirements in particular of this paragraph within the technical documentation and within the instructions for use information on residual risks for these patient groups and if applicable on appropriate precautionary measures Internal note replaced by EC 1272 2008 OJ 196 16 8 1967 p 1 Directive as last amended by Directive 2006 121 EC of the European Parliament and of the Council OJ L 396 30 12 2006 p 850 TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Checklist according to annex of the Medical Device Directive MDD taking into account the device and the nature of the The devices must be designed and manufactured in such a way as to reduce as much as possible risks posed by the unintentional ingress of substances into the device environment in which it is intended to be used rM Infection and microbial contamination 8 1 The devices and their manufacturing processes
17. u o Aoa m a a am yi Dun y SITE t m nl n n LD a nr i nag eens Shs um fr MITT ME Details of View X general front rear right left top OE PI LJ P xh I ha M m Delia k NEM i LL i i A LA A 4 i ji LU h i IN AM x At A As NN bottom i a 08 0800401 08 08 o 2 Ge de v cda OL WM NB invia TTET 1X1 1 1 j i 1 ART IM 14 AM 14 AN AA War di td iud s ar 08 OF 09 09 ot Jiu londone luhal mMM Details of View X general front rear right left top bottom View X general front Details of Annex III Photo documentation Ref No TMTW1506165750 HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA IGE VOLTAGE ELECTRIC FLELD THERAPY SAK io m mA s i F ii 6 EN nana TRENE di BIET d i f a tl EA EPE iind m GAPE LEENT a LET Maiei HE ETT ee Ay D a e a alia MO EE TN LETT M uite i i CC d w 300 TAN Le adus ex ALU liu ACT tei arse F piuid i DURA at ee ile E xem Page 2 of 3 i di i Pm fl T eee LE one i o SE y dra i E Li M pere ee eee es a le ic adum E w Annex III Photo documentation Ref No TMTW1506165750 Page 3 of 3 Details of HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA View X general front rear right left top
18. 012 Label h if the device is intended for clinical investigations the A EN 1041 2008 Instruction words exclusively for clinical investigations z ff i any special storage and or handling conditions TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 17 of 19 Standards other directives Documentation test Requirements and other rules applied by reports protocols fulfilled manufacturer literature or reason for no to be filled in by applicability Notified Body Checklist according to annex of the Medical Device Directive MDD j any special operating instructions k any warnings and or precautions to take I year of manufacture of active devices other than those covered by e This indication may be included in the batch or serial number m where applicable method of sterilisation n in the case of a device within the meaning of Article 1 4a an indication that the device contains a human blood derivative If the intended purpose of the device is not obvious to the user the manufacturer must clearly state it on the label and in the instructions for use Wherever reasonable and practicable the devices and detachable components must be identified where EN ISO 15223 1 2012 Label EN ISO 15223 1 2012 Label EN 1041 2008 Instruction EN 1041 2008 Instruction appropriate in terms of batches to allow all appropriate action to detect an
19. 710 Taiwan R O C Reference TMTW1506165750 Page 1 of 2 Chapter2 Product introduction 1 Product brief introduction Product name HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Intended use HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA dia The Manual TMTW1506165750 2012 2 Classification of the product According to the requirements of the intended use of the product and MDD 93 42 EEC Product name HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Classification The above products belong to Class I Non sterile medical devices according to Rule 4 of Classification in Annex IX of MDD 93 42 EEC Reference TMTW1506165750 Page 2 of 2 3 List of European Union Harmonized Standards which this product applies 93 42 EEC 1993 Medical device directive Symbols for use in the labeling of medical devices Medical devices Symbols to be used with medical EN ISO 15223 1 device labels labelling and information to be supplied Part 1 General requirements EN 1041 2008 Information supplied by the manufacturer of medical devices EN ISO 14971 Medical devices Application of risk management to medical devices EN 60601 1 2006 A1 2013 Medical electrical equipment Part 1 General requirements for basic safety and essential performance EN ISO 10993 1 2009 AC 2010 Biological evaluation of medical devices Part 1 Evaluation and testing within a risk management process Fourth Edition Biological evaluation of me
20. A Blood devices principally contacting blood examples include pacemaker electrodes artificial arteriovenous fistulae heart valves vascular grafts internal durg delivery catheters and ventricular assist devices N A N A 4 3 Categorization by duration of contact Medical devices shall be categorized according to the duration of contact as follows Limited exposure A devices whose single or multiple use or contact is likely to be up to 24 h N A N A Prolonged exposure B devices whose single multiple or long term use or contact is likely to exceed 24 h but not 30 days The devices are likely to exceed 24h but not 30 days Pass Permanent contact C devices whose single multiple or long term use or contact exceeds 30 days N A N A If a material or device may be placed in more than one duration category the more rigorous testing requirements shall apply With multiple exposure to the device the decision into which category a device is placed should take into account the potential cumulative N A N A Reference TMTW1506165750 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Page 8 of 13 Clause Requirement test Result Verdict effect bearing in mind the period of time over which these exposures occur Testing General In addition to the general principles laid down
21. A Limited Nature of body contact lt 24 h see 4 2 B prolonged 24 h to 30 days Carcinogenicity Biodegradation C permanent gt 30 days Reproductive developmental Category Surface device Breached or compromised surface Blood path indirect External communicating Tssue bone dentin device Circulating blood Implant device NOTE This table is a framework for the development of an assessment programme and is not a checklist see Clause 6 End of Biological evaluation test report Annex III Photo documentation Page 1 of 3 Ref No TMTW1506165750 SAKAE 380MA HIGH VOLTAGE ELECTRIC FLELD THERAPY Type of ME SAKAE 380MA Details of alela i ELECTRIC FLELD THERAPY SAKAE E View HI E TI Ta LE X general bha front risi Sea rear BR iUm E 3 F E Sen i a a i LI 200 16 A adipis y right PPP d tay d amp EUM e a bili n d irs ELI E arr i i Na m A 1 8 n hai eli T Si gy TES T dg SAVED I nghi imd ER d ndis d 9 E UE AN Te i 1 talk D zw iiu I1 UIT TIT il 115 Ea Torn t RT i I iti 100 1a ren Ea IL TITTEN left n LLLA Hamm ee ee si JATIN l top bottom NU ini m LE ER i B uoi mw iT ao SUPR La mamm Kii j i ODI git TI ami i M d GE ce o op 00 Kcott COOOL Amen a a m a a h T ail ammo
22. Essential requirement 200747EC Hev 2 204 08 10 Reference TMTW1506165750 Page 14 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body 12 7 Way as to protect the patient and user against mechanical 1 risks connected with for example resistance stability and moving parts 127 Devices must be designed and manufactured in such a 2 way as to reduce to the lowest possible level the risks arising from vibration generated by the devices taking account of technical progress and of the means available for limiting vibrations particularly at source unless the vibrations are part of the specified performance 42 7 Devices must be designed and manufactured in such a 3 way as to reduce to the lowest possible level the risks arising from the noise emitted taking account of technical EN ISO 14971 2009 Risk analysis report progress and of the means available to reduce noise Test report particularly at source unless the noise emitted is part of the specified performance has to handle must be designed and constructed in such 127 The terminals and connectors to the electricity gas or A hydraulic and pneumatic energy supplies which the user a way as to minimise all possible risks the
23. It complies with the requirement Pass 7 2 Continued assurance The assurance that a material is initially acceptable for its intended use in a medical device and its continued acceptability in the long term is an aspect of a quality management system It complies with the requirement Pass Reference TMTW1506165750 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Page 12 of 13 Table 1 Initial evaluation tests for consideration Medical device categorization by Contact duration see 4 3 A Limited Mature of body contact 24 h see 4 2 B prolonged 24 h ta 30 days C permanent 30 days C A mm Biological effect Implantation Cytotoxicity Sensitization Irritation or intracutaneous Systemic toxicity acute Genotoxicity Hemocom patibility Subacute and su bchronic Mucosal Breached or compromised surface C A Blood path indirect Tissue bone dentmn Imglant device E a NOTE This table is a framework for ihe development of an assessment programme and is not a checklist see Clause 6 Reference TMTW1506165750 Page 13 of 13 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Table 2 Supplementary evaluation tests for consideration Medical device categorization by Biological effect Contact duration see 4 3
24. Reference TMTW1506165750 Page 1 of 1 Technical Construction File File No TMTW1506165750 Version 01 HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Model SAKAE 380MA According to Medical Directive 93 42 EEC including 2007 47 EC Issued Date July 23 2015 FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Chapter 7 Chapter 8 Chapter 9 Reference TMTW1506165750 Contents Company introduction Product introduction Checklist of essential requirements Risk Analysis Report Comprehensive description of the product Requirements for language and labels Instructions for use Product vigilance system Packaging instruction Chapter 10 Pre clinical evaluation Chapter 11 Declaration of conformity Annex I Annex II Annex III Authorized representative of EU agreement EN ISO 10993 1 2009 report Photo documentation Annex IV The suppliers information Page l of 1 Reference TMTW1506165750 Page 1 of 1 Chapter 1 Company introduction FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C FUWEI HIGH SCIENTIFIC CO LTD will sincerely cooperate with you and joint your hands to create a splendid future Contact information FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County
25. act on selling products b Quality problems inside the company an analysis would have a significant impact on selling products 8 4 6 2 Management representative to convene the heads of departments and relevant personnel to discuss the withdrawal program the preparation of a written withdrawal of the file 8 4 6 3 Management representative responsible for drafting a written notice promptly notify the customer Notified Body to facilitate the lowering of the consequences 8 4 6 4 To withdraw the product may not solve the problem the product may not withdrawn the manager on behalf of the preparation of a written report to inform the note informing customers and Notified Body to attract attention 8 4 7 Withdrawal of the product processing 8 4 7 1 Quality Department to withdraw the product re testing analyze the causes and the preparation of a written report on the use of the product can not be unified by the Department arranged for the destruction of production facilities 8 4 7 2 To deal with the results note prepared by the management representative notice informing customers and the Notified Body 8 4 8 Reporting time of accidents The company should inform the local authority and its European representative the NB institute in following time To seriously damage public health Immediately report not more than 2 days Death or unpredicted serious health damage Immediately report not more than 10 days Reference TMTW1506165750
26. ating or adjustment N A N A N A parameters by means of a visual system such information must be understandable to the user and as appropriate the patient ra Information supplied by the manufacturer 13 1 Each device must be accompanied by the information needed to use it safely and properly taking account of the training and knowledge of the potential users and to identify the manufacturer This information comprises the details on the label and the data in the instructions for use As far as practicable and appropriate the information needed to use the device safely must be set out on the EN ISO 15223 1 2012 Label device itself and or on the packaging for each unit or A EN 1041 2008 where appropriate on the sales packaging If individual packaging of each unit is not practicable the information must be set out in the leaflet supplied with one or more devices Instruction Instructions for use must be included in the packaging for every device By way of exception no such instruction leaflet is needed for devices in Class or Class lla if they can be used completely safely without any such instructions l on l EN ISO 15223 1 2012 Label TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 16 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Directive MDD and other rules applied by repo
27. bbreviation N A of instructions 5 Complex or confusing N A control system J 4 ffeil fb 6 Ambiguous or unclear N A NEN device state 1 ee ee ee up 7 Ambiguous or unclear N A presentation of settings measurements or other information 8 Mispresentation of N A mu es ee ee ee b ee oe 9 Insufficient visibility N A NEN S audibility ortactility es pc ap pn 10 Poor mapping of N A controls to action or of displayed information to actual state Reference TMTW1506165750 Page 8 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Products ORTHOPAEDIC BRACES amp SUPPORT Risk Evaluation Risk Reduction Measure ALOR General Identifyhazards SjOJD RL 3 4 J 11 Controversial modes or N A mappings as compared i to existing equipment D8 Hazards arising from functional failure maintenance and ageinc Erroneous data transfer Lack of or inadequate Specification for maintenance including inadequate specification of post maintenance functional checks Inadequate Inadequate maintenance damages oymbol and instruction Symbol and instruction maintenance the device influencing its use life Lack of adequate N A determination of end of device life Loss of electrical N A Inadequate N A packaging contaminatio n and or deterioration of Deterioration in function e g gradual occ
28. by the manufacturer Any undesirable side effects must constitute an acceptable risk when weighed against the performances intended Demonstration of conformity with the essential requirements must include a clinical evaluation in accordance with Annex X A NA Standards other directives and other rules applied by manufacturer EN 60601 1 2006 As above EN ISO 15223 1 2012 EN 1041 2008 EN 60601 1 2006 EN ISO 14971 2009 93 42 EEC EN 15014971 Reference TMTW1506165750 Page 3 of 19 Requirements fulfilled to be filled in by Notified Body Documentation test reports protocols literature or reason for no applicability Biological evaluation report Test report Label Instruction Risk analysis report Test report Label Instruction Risk analysis report Test report Label Instruction Risk analysis report Test report Risk analysis report REQUIREMENTS REGARDING DESIGN AND CONSTRUCTION TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Hev 2 204 08 10 Reference TMTW1506165750 Page 4 of 19 Checklist according to annex I of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body Chemical Chemical physical and biological properties and biological pro
29. ceptable range It is proven that the product s usage value and security is far beyond potential risks Clinical usage situation The clinical usage of medical institutions confirmed that the product can prevent cross contamination and is convenient to use and secure The clinical usage of all our clients has shown that the product never cause allergy poisoning and other adverse reactions Product information feedback Reference TMTW1506165750 Page 2 of 2 oales condition of our product and evaluation of the client for our company s production capability production environment and quality system all have demonstrated that the medical technology production capability and quality system can guarantee the security and use of the product Conclusion The medical device pre clinical study and evaluation of clinical data collected from customers can indicate that the mask function and usage value already has proven completely and satisfied the intended requirements Chapter 11 Declaration of conformity TMTW1506165750 Version 01 Page 1 of 1 EC Declaration of Conformity Manufacturer whose single Authorized Representative FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C We the manufacturer herewith declare that the products HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA SAKAE 380MA meet the provisions of Directive 93 42 EEC including 2007 47 EC which apply t
30. city carcinogenicity tumorigenicity and effects on reproduction including teratogenicity The products have no long term effects N A 3 5 All potential biological hazards should be considered for every material and final product but this does not imply with that testing for all potential hazards will be necessary or practical It complies with the requirement Pass 3 6 Any in vitro or in vivo tests shall be based on end use applications and appropriate good laboratory practice followed by evaluation by competent informed persons Whenever possible in vitro screening should be carried out N A N A EN ISO 10993 1 2009 Biological Reference TMTW1506165750 evaluation of medical devices Part 1 Evaluation and testing Page 5 of 13 Clause Requirement test Hesult Verdict before in vivo tests are commenced Test data complete to the extent that an independent analysis could be made shall be retained N A N A 3 7 The materials or final product shall be considered for biological re evaluation if any of the following occurs Any change in the source or in the specification of the materials used in the manufacture of the product The device materials comply with the requirement The device materials comply with the requirement Pass Pass Any change in the formulation processing primary packaging or sterilization of the product
31. count the principles of development lifecycle risk management validation and verification Devices where the safety of the patients depends on an internal power supply must be equipped with a means of determining the state of the power supply Devices where the safety of the patient depends on an external power supply must include an alarm system to signal any power failure Devices intended to monitor one or more clinical parameters of a patient must be equipped with appropriate alarm systems to alert the user of situations which could lead to death or severe deterioration of the patient s state of health 12 5 Devices must be designed and manufactured in such a way as to minimise the risks of creating electromagnetic fields which could impair the operation of other devices or equipment in the usual environment Protection against electrical risks Devices must be designed and manufactured in such a way as to avoid as far as possible the risk of accidental electric shocks during normal use and in single fault condition provided that the devices are installed correctly N A N A EN 60601 1 2006 EN ISO 14971 2009 EN 60601 1 2006 EN ISO 14971 2009 N A Risk analysis report Test reports Risk analysis report Test reports Protection against mechanical and thermal risks n EN 60601 1 2006 LEE dns report Devices must be designed and manufactured in such a EN ISO 14971 2009 TMTW1506165750 05 Chapter 3
32. d to minimize the number and exposure of test animals It complies with the requirement Pass If extracts of the devices are prepared the solvents and conditions of extraction used shall be appropriate to the nature and use of the final product It complies with the requirement Pass Positive and negative controls shall be used where appropriate It complies with the requirement Pass Test results cannot ensure freedom from Reference TMTW1506165750 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Page 9 of 13 Clause Requirement test Result Verdict Potential biological hazard thus biological investigations shall be followed by careful observations for unexpected adverse reactions or events in human during clinical use of the device It complies with the requirement Pass A bibliography of international standards and guidelines on biological response test methods is given at the end of the text It complies with the requirement Pass 9 2 Initial evaluation tests 9 2 1 General The test that shall be considered for initial biological response are given in 5 2 2 to 5 2 10 It complies with the requirement Pass 9 2 2 Cytotoxicity 5 2 3 With the use of cell culture techniques these tests determine the lysis of cells cell death the inhibition of cell growth a
33. dical devices Part 5 Tests for in vitro cytotoxicity Biological evaluation of medical devices Part 10 Tests for irritation and skin sensitization 4 Application method The above product adopts the module of EC Declaration of Conformity according to Annex VII of MDD 93 42 EEC 5 The authorized representative of European Union 93 42 EEC including 2007 47 EC Reference TMTW1506165750 Annex Essential Requirements Checklist Product name HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Type s Model s SAKAE 380MA Product group Issue date of Technical File July 23 2015 Revision of Technical File Version 01 Legal Manufacturer FUWEI HIGH SCIENTIFIC CO LTD Name No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C Street 710 Taiwan County Postal code Place Taiwan R O C Country Accessories July 23 2015 Date Name Reviewer Signature Reviewer 1 July 23 2015 Date Name Reviewer Signature Reviewer 2 TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Checklist according to annex of the Medical Device Directive MDD Reference TMTW1506165750 Page 2 of 19 Standards other directives and other rules applied by manufacturer Documentation test reports protocols literature or reason for no Requirements ox fulfilled Fail to be filled in by Notified Body applicability The devices must be designed and manufactured in such
34. e material has a demonstrable history of use in a specified role that is equivalent to that of the device under design N A It complies with the requirement N A Pass Reference TMTW1506165750 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Page 11 of 13 Clause Requirement test Result Verdict Table 1 identifies the initial evaluation test that shall be considered for each device and duration category It complies with the requirement Pass Table 2 identifies the supplementary evaluation tests that shall be considered for each device and duration category It complies with the requirement Pass Due to the diversity of medical devices it is recognized that not all tests identified in a category will be necessary or practical for any given device It is indispensable for testing that each device be considered on its own merits additional tests not indicated in the table may be necessary It complies with the requirement Pass The test considered and the rationale for selection and or waiving of tests shall be recorded It complies with the requirement Pass Assurance of test methods Test method assurance The test methods used in the biological evaluation shall be sensitive precise and accurate The test results should be reproducible interlaboratory as well as repeatable intralaboratory
35. e described in ISO 10993 10 It complies with the requirement in EN ISO 10993 10 2009 Pass 5 2 6 Systemic toxicity acute toxicity Systemic toxicity tests are described in ISO 10993 11 N A N A 5 2 7 Subacute and subchronic toxicity Subacute and subchronic toxicity tests are described in ISO 10993 11 N A N A 5 2 8 Genotoxicity Genotoxicity tests are described in ISO 10993 3 N A N A 5 2 9 Implantation Implantation tests are described in ISO 10993 6 N A N A 9 2 10 Haemocompatibility Haemocompatibility tests are described in ISO 10993 4 N A N A 9 3 Supplementary evaluation tests 5 3 1 General The supplementary biological evaluation tests shall be considered are given in 5 3 2 to 5 3 5 5 3 2 Chronic toxicity Chronic toxicity tests are described in ISO 10993 11 N A N A 5 3 3 Carcinogenicity Carcinogenicity tests are described in ISO 10993 3 N A N A 5 3 4 Reproductive and developmental toxicity Reproductive and developmental toxicity tests are described in ISO 10993 3 N A N A 5 3 0 Biodegradation Biodegradation tests are described in ISO 10993 9 Selection of biological evaluation tests Evaluation may include both a study of relevant experience and actual testing Such an evaluation may result in the conclusion that no testing is needed if th
36. e wrong use of the device inadequate resulting in hurting patients specification of accessories inadequate Specification of pre use checks over complicated operating instructions inadequate specification of service and maintenance Use by Unskilled untrained personnel may 5 2 4 19 Preventing wrong label Labels and Instruction No Yes unskilled untrained cause wrong use of the device personnel resulting in hurting patients 5 ef _ Reasonably foreseeable Misuse may cause wrong use of 2 2 1 neglectable risk no Labels misuse the device resulting in hurting further actions li mm_m_mmmm_ _ __ patients A _ ln Insufficient warning of N A side effects L_z Inadequate warning of N A hazards likely with re use of single use i devices Reference TMTW1506165750 Page 7 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Products ORTHOPAEDIC BRACES amp SUPPORT NE SJOJDIRL j J _ 8 Incompatibility with N A consumables accessori NEN es other devices J bop ni dn 9 sharp edges or points Sharp edges hurts patients body 5 1 30 Removing all sharp No edeges or points in No Yes i edges or points the device C7 Inappropriate inadequate or over complicated user interface man machine communication 1 Mistakes and judgement N A la 7 BE recall errors 4 Violation or a
37. ed in such a way as to achieve appropriate image and or output quality for the intended medical purpose whilst minimising radiation exposure of the patient and user Devices emitting ionising radiation intended for therapeutic radiology shall be designed and manufactured in such a way as to enable reliable monitoring and control of the delivered dose the beam type and energy and where appropriate the quality of the radiation Requirements for medical devices connected to or equipped with an energy source Devices incorporating electronic programmable systems 12 1 ii LA must be designed to ensure the repeatability reliability N A N A N A and performance of these systems according to their TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Checklist according to annex of the Medical Device Directive MDD intended use In the event of a single fault condition in the system appropriate means should be adopted to Standards other directives and other rules applied by manufacturer Reference TMTW1506165750 Page 13 of 19 Requirements fulfilled to be filled in by Notified Body Documentation test reports protocols literature or reason for no applicability eliminate or reduce as far as possible consequent risks 121 For devices which incorporate software or which are medical software in themselves the software must be validated according to the state of the art taking into ac
38. el of the device must distinguish between identical or similar products sold in both sterile and non sterile condition Construction and environmental properties 9 1 If the device is intended for use in combination with other devices or equipment the whole combination including Klo comibinstien with the connection system must be safe and must not impair N A other devices No sterlization device the specified performance of the devices Any restrictions on use must be indicated on the label or in the instruction for use Devices must be designed and manufactured in such a i P ease 2012 Label way as to remove or minimise as far as possible 7 EN 60601 1 5006 Instruction Risk analysis report e the risk of injury in connection with their physical EN ISO 14971 2009 Test report features including the volume pressure ratio dimensional and where appropriate the ergonomic TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 10 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Directive MDD and other rules applied by reports protocols fulfilled manufacturer literature or reason for no to be filled in by applicability Notified Body features risks connected with reasonably foreseeable environmental conditions such as magnetic fields external electrical influences electrosta
39. ent in the EU market with products of CE mark The vigilance is also available in other countries though products have CE mark or don t have CE mark 8 3 Responsibility 8 3 1 Market Development Department is responsible for the delivery of the product s market monitoring tracking and timely processing of customer complaints and are able to deliver timely information to relevant departments 8 3 2 Quality Department is responsible for customer complaints returns processing and instructed relevant departments to promptly resolve 8 3 3 Management representative is responsible for any product quality problems quality system changes and announcements agencies with customer liaison work 8 3 4 Other relevant departments according to their respective responsibility in implementing the provisions of the program file 8 4 Procedures 8 4 1 Market Supervision 8 4 1 1 Customers with product delivery the product packing box or boxes marked attention to ensure the correct use of products can be 8 4 1 2 Market Development Department released the end of each questionnaire to customers timely understanding of the actual usage in order to take corrective measures 8 4 1 3 Market Development Department will investigate the situation of customers aggregated compiled a report on top management and relevant departments 8 4 2 Customer Complaints 8 4 2 1 Market Development Department after receiving complaints from customers timely registration classi
40. fied and sorted 8 4 2 2 On the views of users through timely completion of quality information feedback from a single on product quality issues will be reflected the quality of the Department 8 4 2 3 The Ministry of the facts reflected in the quality of analysis by the relevant departments of the responsibility to take timely corrective and preventive measures 8 4 2 4 The completion of corrective and preventive measures to track and inspect the quality of the Department until the completion of the measures will be the completion of feedback to the market development department in writing inform the customer 8 4 2 5 On major issues should be kept duly informed about the quality management representative general manager to assess the possible impact if the need for product withdrawal should be conducted 8 4 2 6 When the customer complaints against the companies did not take the necessary corrective and preventive measures the quality of the Department must state the reasons for review by the management representative and general manager of the approval in writing inform the customer at the same time 8 4 2 7 Customer complaints when the investigation found that other agencies involved by Reference TMTW1506165750 Page 2 of 3 the Quality Department to the relevant information to relevant agencies to take initiatives if necessary the quality of the measures taken by the Department will verify 8 4 3 The supervision of relevant institut
41. if the devices are intended to administer medicinal products they must be designed and manufactured in such a way as to be compatible with the medicinal products concerned according to the provisions and restrictions governing those products and that their performance is maintained in accordance with the intended use Reference TMTW1506165750 Page 5 of 19 Checklist according to annex I of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body 7 4 Where a device incorporates as an integral part a substance which if used separately may be considered to be a medicinal product as defined in Article 1 of Directive 2001 83 EC and which is liable to act upon the body with action ancillary to that of the device the quality safety and usefulness of the substance must be verified by analogy with the methods specified in Annex I to Directive 2001 83 EC For the substances referred to in the first paragraph the notified body shall having verified the usefulness of the substance as part of the medical device and taking account of the intended purpose of the device seek a scientific opinion from one of the competent authorities designated by the Member States or the European Medicines Agency EMEA acting particularly through its committee in
42. illed in by applicability Notified Body quality and safety of the substance including the clinical benefit risk profile of the incorporation of the human blood derivative into the device When issuing this opinion the EMEA shall take into account the manufacturing process and the data related to the usefulness of incorporation of the substance into the device as determined by the notified body Where changes are made to an ancillary substance incorporated in a device in particular related to its manufacturing process the notified body shall be informed of the changes and shall consult the relevant medicines competent authority i e the one involved in the initial consultation in order to confirm that the quality and safety of the ancillary substance are maintained The competent authority shall take into account the data related to the usefulness of incorporation of the substance into the device as determined by the notified body in order to ensure that the changes have no negative impact on the established benefit risk profile of the addition of the substance in the medical device When the relevant medicines competent authority i e the one involved in the initial consultation has obtained information on the ancillary substance which could have an impact on the established benefit risk profile of the addition of the substance in the medical device it shall provide the notified body with advice whether this information has an impac
43. in Clause 3 the following shall apply to biological testing of medical devices Testing shall be performed on the final product or on representative samples taken from the final product or from materials processed in the same manners as the final product It complies with the requirement Pass The choice of test procedures shall take into account The nature degree duration frequency and conditions of exposure to or contact of humans with the device in the normal intended use It complies with the requirement Pass The chemical and physical nature of the final product It complies with the requirement Pass The toxicological activity of the chemical elements or compounds in the formulation of the final product It complies with the requirement Pass That certain tests e g those designed to assess systemic effects may not be applicable where the presence of leachable materials has been excluded or where leachables have a known and acceptable toxicity profile It complies with the requirement Pass The relationship of device surface area to recipient body size It complies with the requirement Pass The existing information based on the literature experience and non clinical tests It complies with the requirement Pass That the protection of humans is the primary goal of this document a secondary goal being to ensure animal welfare an
44. ions Regular liaison with relevant government agencies and accept their supervision in the oversight process problems that occur will have to deal with in accordance with the relevant procedures within the company and ensure that their products meet the minimum adverse effects 8 4 4 Product of internal warning system 8 4 4 1 The establishment of quality inspection point the operator s rigorous training and documentation requirements in accordance with regulations to operate 8 4 4 2 Enhance process control improve the process provisions of the various documents 8 4 4 3 Analysis of product quality status on a regular basis 8 4 4 4 Approach to the problem on a regular basis in accordance with regulations 8 4 4 5 As a result of certain conditions within the company quality system caused major changes it will immediately convene management reviews and timely notification bulletins to specific institutions in order to facilitate announcement institutions have sufficient time for evaluation 8 4 5 Change of product 8 4 5 1 When the product of any form of change changes in the content management representative should review approval by the General Manager 8 4 5 2 Timely changes in information in order to notice the form passed to the customer and the relevant medical device authorities Notified Body 8 4 6 Product withdrawn 8 4 6 1 Product withdrawal of conditions a The analysis of customer complaints would have a significant imp
45. ir surroundings must not attain potentially dangerous temperatures under normal use Accessible parts of devices excluding any parts or areas 12 7 No high temperature intended to supply heat or reach given temperatures and possibility 12 8 Protection against the risks posed to the patient by energy supplies or substances Devices for supplying the patient with energy or substances must be designed and constructed in such a 12 8 way that the flow rate can be set and maintained 1 accurately enough to guarantee the safety of the patient and of the user Devices must be fitted with the means of preventing N A N A o and or indicating any inadequacies in the flow rate which TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 15 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body could pose a danger Devices must incorporate suitable means to prevent as far as possible the accidental release of dangerous levels of energy from an energy and or substance source The function of the controls and indicators must be clearly specified on the devices Where a device bears instructions required for its operation or indicates oper
46. l substances or human blood derivatives incorporated into the device as an integral part in accordance with Section 7 4 p degree of accuracy claimed for devices with a measuring function q date of issue or the latest revision of the instructions for use TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Hev 2 204 08 10 Technical File Eff D ly 11 201 4 Risk Management ay 2 gt Page Page 1 of 11 Risk Analysis Report a Name FUWEI HIGH SCIENTIFIC CO LTD mese Address No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R o C Product NE High Voltage Electric Fleld Therapy SAKAE 380ma EN ISO 14971 2012 All risks associated with the identified hazards have been evaluated After appropriate measures to reduce these risks have been taken the overall level of risk of the product is acceptable with regard to the intended application and use of the application Compiled by Name Title Dept Quality Engineer Date July 11 2015 Reviewed by Name Title Dept Quality Chief Engineer Date July 11 2015 Approved by Name Title Dept Technical amp Quality Manager Date July 11 2015 ical Fi MEM Eft Date July 11 2075 acc to EN ISO 14971 2012 Annex C 2 Identification of qualitative and quantitative characteristics acc to EN ISO 14971 2012 Annex C 2 Intended use and how to t e o II NN patient or other person fee
47. lusion of fluid gas path or change in resistance to flow electrical conductivity as a result of repeated use Reference TMTW1506165750 Page 9 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Products ORTHOPAEDIC BRACES amp SUPPORT Risk Evaluation Risk Reduction Measure ALOR General i Identifyhazards SjOJD RL J J J Common interfering i factors 4 Specimen identification NEN ECC 5 Stability problems in storage in shipping in use after first opening 6 Problems related to taking preparation and 8 scene ace Inadequate test characteristics Post production information Post production experience Establishing a system to collect and review information about the medical device and all these information were collected by QC department from customers and being considered i Review of risk management experience It is acceptable Reference TMTW1506165750 Page 10 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Product ORTHOPAEDIC BRACES amp SUPPORT Abbreviations used Hisk Evaluation Severity 10 very severe 1 not severe Occurrence 10 often 1 never Detection 10 impossible to detect before risk occurs 1 will be certainly detected before risk occurs Risk Level Severity x Occurrence x Detection 1 9 neglectable risk no further actions 9 24 moderate minimal
48. ments of MDD 93 42 EEC the medical products supplied to European market should be labeled in line with the specification Label content Product name and Quantity Type Symbol D for DO NOT REUSE The product is for single use Symbol for BATCH CODE the symbol should be attached with batch code and be close to the graph batch code lot number and batch number Examples ABC123 Symbol for DATE OF MANUFACTURE the symbol should be close to the number Symbol ul for MANUFACTURE DI Symbol for EC REPRESENTATIVE Symbol N for ATTENTION SEE INSTRUCTIONS FOR USE Attaching CE marking indicates that This device meets the basic requirements of MDD This device can be legally put on the market of Europe This device has passed a relevant conformity estimation program There are two types of CE Marking attached on the medical devices CE marking without identified number of Notified Body and CE marking with identified number of Notified Body CE marking without identified number only apply to the Class I medical devices which needn t to be sterilized and have no measure function 6 3 Translation procedures and control The labeling must use local official language to avoid accidents caused by inadequate translation 6 3 1 The international trade department and the technology department are accountable for the labeling translation and check 6 3 2 If labeling translation is done by other compan
49. must be designed in such a way as to eliminate or reduce as far as possible the risk of infection to the patient user and third parties The design must allow easy handling and where necessary minimise contamination of the device by the patient or vice versa during use 7 6 8 2 Tissues of animal origin must originate from animals that have been subjected to veterinary controls and surveillance adapted to the intended use of the tissues Notified Bodies shall retain information on the geographical origin of the animals Processing preservation testing and handling of tissues cells and substances of animal origin must be carried out 8 3 So as to provide optimal security In particular safety with regard to viruses and other transmissible agents must be addressed by implementation of validated methods of elimination or viral inactivation in the course of the manufacturing process Devices delivered in a sterile state must be designed manufactured and packed in a non reusable pack and or according to appropriate procedures to ensure they are sterile when placed on the market and remain sterile under the storage and transport conditions laid down until the protective packaging is damaged or opened TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Reference TMTW1506165750 Documentation test reports protocols literature or reason for no applicability Page 8 of 19 Requirements ox fulfilled Fail to be
50. nd other effects on cells caused by medical devices materials and or their extracts Cytotoxicity tests are described in ISO 10993 5 Sensitization These tests estimate using an appropriate model the potential of medical devices materials and or their extracts for contact sensitization These tests are appropriate because exposure or contact to even minute amounts of potential leachables can result in allergic or sensitization reactions Sensitization tests are described in ISO 10993 10 It complies with the requirement in EN ISO 10993 5 2009 It complies with the requirement in EN ISO 10993 10 2009 Pass Pass 5 2 4 Irritation These tests estimate the irritation potential of medical devices materials and or their extracts using appropriate site for implant tissue such as skin eye and mucous membrane in a suitable model The test s performed should be appropriate for the route skin eye mucosa and duration of exposure or contact to determine irritant effects of devices materials and potential leachables Irritation tests are described in ISO 10993 10 It complies with the requirement in EN ISO 10993 10 2009 Pass 5 2 5 Intracutaneous reactivity Reference TMTW1506165750 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Page 10 of 13 Clause Requirement test Result Verdict Intracutaneous reactivity ar
51. ng and where appropriate details of appropriate methods of re sterilisation h if the device is reusable information on the appropriate processes to allow reuse including cleaning disinfection packaging and where appropriate the method of sterilization of he device to be resterilized and any restriction on the number if reuses Where devices are supplied with the intention that they be sterilized before use the instructions for cleaning and sterilization must be such that if correctly followed the device will still comply with the requirements in Section If the device bears an indication that the device is for single use information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re used If in accordance with Section 13 1 no instructions for use are needed the information must be made available to the user upon request i details of any further treatment or handling needed data otany ter senmentor nanna resosi a ENGNG DC EN before the device can be used for example TMTW1506165750 05 TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 3 Essential requirement 200747EC Reference TMTW1506165750 Page 18 of 19 Documentation test reports protocols literature or reason for no to be filled in by Ok Fail applicability Notified Body EN ISO 15223 1 2012 Label EN 1041 2008 Instruction Rev 2
52. o them The medical device has been assigned to class I non sterile according to Annex IX of the Directive 93 42 EEC including 2007 47 EC It bears the mark CE The product concerned has been manufactured according to Annex VII of Directive 93 42 EEC including 2007 47 EC following the procedure relating to the EC Declaration of Conformity set out in Annex VII of Directive 93 42 EEC including 2007 47 EC The above mentioned declaration of conformity is exclusively under the responsibility of FUWEI HIGH SCIENTIFIC CO LTD ROOM 201 NO 179 TONGAN PARK TONGAN INDUSTRY CLUSTER XIAMEN CITY FUJIAN PROVINCE CHINA Technical amp Quality Manager Place date Legally binding signature Function EC Declaration of Conformity Reference TMTW 1506165750 Page 1 of 1 MDD Agreement FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C hereinafter referred to as Company A hereinafter referred to as Company B have agreed as follows with regard to the handling of all products hereinafter called products manufactured and supplied by Company A to Company B in order to comply to the requirements set out in the Council Directive 93 42 EEC concerning Medical Devices MDD and Guidelines on a Medical Devices Vigilance System 1 Appointment Company A hereby appoints Company B who accepts such appointment as a representative for the Business Area and Product Categories set ou
53. perties The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section 1 on the General requirements Particular attention must be paid to EN ISO 15223 1 2012 EN 1041 2008 Label EN 60601 1 2006 P Risk analysis report EN ISO 14971 2009 Test report e the choice of materials used particularly as regards toxicity and where appropriate flammability the compatibility between the materials used and biological tissues cells and body fluids taking account of the intended purpose of the device Where appropriate the results of biophysical or modelling research whose validity has been demonstrated beforehand 7 2 The devices must be designed manufactured and packed in such a way as to minimise the risk posed by contaminants and residues to the persons involved in the transport storage and use of the devices and to the patients taking account of the intended purpose of the product Particular attention must be paid to the tissues exposed and the duration and frequency of the exposure Label Instruction Risk analysis report As above Test report d TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Hev 2 204 08 10 The devices must be designed and manufactured in such a way that they can be used safely with the materials substances and gases with which they enter into contact during their normal use or during routine procedures
54. quirement 200747EC Rev 2 204 08 10 3 Essential requirement 200747EC General Requirements EN ISO 15223 1 2012 EN 1041 2008 EN 60601 1 2006 Label Instruction Risk analysis report Test reports EN ISO 14971 2009 EN ISO 15223 1 2012 EN 1041 2008 EN 60601 1 2006 Label Instruction Risk analysis report Test report EN ISO 14971 2009 Rev 2 204 08 10 Checklist according to annex of the Medical Device Directive MDD e Inform users of the residual risks due to any shortcomings of the protection measures adopted The devices must achieve the performances intended by the manufacturer and be designed manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 2 a as specified by the manufacturer The characteristics and performances referred to in sections 1 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and where applicable of other persons are compromised during the lifetime of the device as indicated by the manufacturer when the device is subjected to the stresses which can occur during normal conditions of use The devices must be designed manufactured and packed in such a way that their characteristics and performances during their intended use will not be adversely affected during transport and storage taking account of the instructions and information provided
55. r entry into the vascular system examples include solution administration sets extension sets transfer sets and blood administration sets N A N A Tissue bone dentin devices that contact tissue bone or pulp dentin systems examples include laparoscopes arthroscopes draining systems dental cements dental filling materials and skin Staples N A N A Circulating blood devices that contact circulating blood examples include intravascular catheters temporary pacemaker electroder oxygenators N A N A Reference TMTW1506165750 EN ISO 10993 1 2009 Biological evaluation of medical devices Part 1 Evaluation and testing Page 7 of 13 Clause Requirement test Hesult Verdict tubing and accessories dialysers dialysis tubing and accessories haemoadsorbents and immunoadsorbents N A N A 4 2 4 Implant devices These include medical devices in contact with the following application sites N A N A Tissue bone Devices principally contacting bone examples include orthopaedic pins plates replacement joints bone prostheses bone cements and introsseous devices N A N A Devices principally contacting tissue and tissue fluid examples include pacemakers drug supply devices neuromuscular sensors and stimulators replacement tendons breast implants artificial larynxes subperiostal implants and ligation clips N A N
56. risk preventive action recommended 25 48 moderate risk preventive action required gt 48 risk is usually not acceptable Risk Reduction Measure New hazard generated no yes if yes then number of new hazard indicated ALOR Acceptable Level of Risk SEVERITY of Effect Injure a customer or employee Be illegal Render product or service unfit for use Cause extreme customer dissatisfaction Result in partial malfunction Cause a loss of performance which is likely to result in a complaint Cause minor performance loss Cause a minor nuisance but can be overcome with no performance loss Be unnoticed and have only minor effect on performance ELEM Be unnoticed and not affect the performance 001 Reference TMTW1506165750 Page 11 of 11 Risk Analysis Company FUWEI HIGH SCIENTIFIC CO LTD Product ORTHOPAEDIC BRACES amp SUPPORT PROBABILITY of Failure Failure Prob Ranking Very High Failure is almost inevitable stive 10 ie a High Repeatedfaiures ms 8 dine a Moderate Occasional falures 1m9 8 dine 8 dimo 4 Low Relativelyfewfailures 1m1500 3 o 3m 2 Remote Failure ts unlikely stint 500000 1 Likelihood of DETECTION by Design Control Ranking Absolute Defect caused by failure is not cetectable Uncertainty Very Remote Occasional units are checked orae Remote Unts are systematcaly sampledandinspecied g Weyton Alunisaremanualyingpocted
57. roducts can be performed at any time upon request Records shall included The following information a Name and address of the customer b Quantity dispatched C Date transferred to the customer d Serial or product lot numbers It is agreed that these records shall be available for inspection upon request by Company A or by the relevant authorities 5 Technical Documentation Company A shall establish necessary procedures to prepare and maintain Technical Documentation including the declaration of conformity for the Product Categories set out in Appendix A to be able to comply with the MDD requirements Company A shall transfer the agreed Technical documentation and Declaration of Conformity to Company B Company B shall maintain the Technical Documents including the Declaration of Conformity available to the relevant Competent Authority for at least five years after the last products have seen sold Company A shall have the responsibility to provide to company B and additional documentation as required by the Competent Authority 6 Instruction Manual Company A shall be responsible for the content of instruction user s manuals and shall ensure the English language instruction manuals are available to Company B Company B shall ensure that the required local language instruction manual are provided to the customers Appendix A The following countries represent Company B s Business Areas For all countries are located at EU
58. rts protocols fulfilled Ok Fail manufacturer literature or reason for no to be filled in by applicability Notified Body of symbols Any symbol or identification colour used must conform to the harmonised standards In areas for which no standards exist the symbols and colours must be described in the documentation supplied with the device The label must bear the following particulars a the name or trade name and address of the manufacturer For devices imported into the Community in view of their distribution in the Community the label or the outer packaging or instructions for use shall contain in addition the name and address of the authorised representative where the manufacturer does not have a registered place of business in the Community b the details strictly necessary to identify the device and EN ISO 15223 1 2012 Label the contents of the packaging especially for the users A EN 1041 2008 Instruction c where appropriate the word STERILE d where appropriate the batch code preceded by the word LOT or the serial number e where appropriate an indication of the date by which the device should be used in safety expressed as the year and month f where appropriate an indication that the device is for single use A manufacturer s indication of single use must be consistent across the Community g if the device is custom made the words custom made device EN ISO 15223 1 2
59. t in Appendix A The responsibility of both parties are as stated hereafter 2 Claim Handling Company B shall be responsible to record all customers and market claims related to the products of Company A and transfer the information to Company A upon receiving such claims 3 Accident Handling On Receiving information of an incident accident or a near incident as defined in the MDD and Guideline on a Medical Device Vigilance System The following procedures shall be applied Company B shall report occurrence of an incident or near incident in its business are to relevant Competent Authority as defined in the following time frame a Within 10 days after receiving information of an incident b Within 30 days after receiving information of an near incident Upon receiving information of an incident or near incident Company A shall perform the necessary analysis of the incident and report to Company B in the time frame defined by the Competent Authority Based on analysis Company A shall instruct Company B of the necessary countermeasures to be taken Company B shall inform the relevant Competent Authority and customer as required in the countermeasure plan issued by Company A 4 Traceability of sold products Company A shall keep records of serial numbers of production lot numbers for all products delivered to Company B Company B shall keep records of the products delivered to and users or distribution so that the traceability of sold p
60. t on the established benefit risk profile of the addition of the substance in the medical device or not The notified body shall take the updated scientific opinion into account in reconsidering its assessment of the conformity assessment procedure TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 7 of 19 Checklist according to annex of the Medical Device Standards other directives Documentation test Requirements Ok Directive MDD and other rules applied by reports protocols fulfilled Fail manufacturer literature or reason for no to be filled in by applicability Notified Body 7 5 The devices must be designed and manufactured in such a way as to reduce to a minimum the risks posed by substances leaking from the device Special attention shall be given to substances which are carcinogenic mutagenic or toxic to reproduction in accordance with N A N A N A Annex I to Council Directive 67 548 EEC of 27 June 1967 on the approximation of laws regulations and administrative provisions relating to the classification packaging and labelling of dangerous substances If parts of a device or a device itself intended to administer and or remove medicines body liquids or other substances to or from the body or devices intended for transport and storage of such body fluids or substances contain phthalates which are classified as carcinogenic mutagenic or toxic to
61. tic discharge pressure temperature or variations in pressure and acceleration the risks of reciprocal interference with other devices normally used in the investigations or for the treatment given risks arising where maintenance or calibration are not possible as with implants from ageing of the materials used or loss of accuracy of any measuring or control mechanism 9 3 Devices must be designed and manufactured in such a EN ISO 15223 1 2012 er i l Label way as to minimise the risks of fire or explosion during EN 1041 2008 neruda normal use and in single fault condition Particular EN 60601 1 2006 Risk analysis report attention must be paid to devices whose intended use Test report includes exposure to flammable substances which could cause combustion nes Devices with a measuring function 10 1 Devices with a measuring function must be designed and manufactured in such a way as to provide sufficient accuracy and stability within appropriate limits of N A N accuracy and taking account of the intended purpose of the device The limits of accuracy must be indicated by EN ISO 14971 2009 gt N A the manufacturer 10 2 The measurement monitoring and display scale must be designed in line with ergonomic principles taking account N A N of the intended purpose of the device gt N A TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 Reference TMTW1506165750 Page 11 of
62. uation of medical devices Part 1 Evaluation and testing Page 6 of 13 Clause Requirement test Hesult Verdict 4 2 1 Non contact devices Medical devices that do not contact the patient s body directly or indirectly are not included in the scope of ISO 10993 N A N A 4 2 2 Surface contacting devices These include medical devices in contact with the following surfaces okin devices that contact inact skin surface only examples include electrodes external prostheses fixation tapes compression bandages and monitors of various types The device indirectly contacts with people skin Mucosal membranes devices that contact inact mucosal membranes examples include contact lenses urinary catheters intravaginal and intraintestinal devices stomach tubes sigmoidoscopes colonoscopes gastroscopes endotracheal tubes bronchoscopes dental prostheses orthodontic devices and intrauterine devices N A N A Breached or compromised surfaces devices that contact breached or otherwise compromised body surfaces examples include dressings healing devices and occlusive patches for ulcers burns and granulation tissue N A N A 4 2 3 External communicating devices These include medical devices in contact with the following application sites N A N A Blood path indirect devices that contact the blood path at one point and serve as a conduit fo
63. ucts of the company The company also is one of the earliest companies in China who manufacture HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Thanks to the long history of production and its profession The product has received good reputation from customers both in domestic and overseas Product evaluation after coming into market As the product that exported to Korea Japan and other ASEAN countries should meet high quality requirement we from the beginning formulate high quality standard which reach to the GB Chinese National Standard Standard and formulate relevant standard on the product details and control strictly So the product has been receiving good reputation after entering into the market in other places To conclusion the product is manufactured and tested firmly according to the relevant national standards and enterprise standards We rigorously control the whole process from raw materials entering into the factory to the finished product dispatching from the factory In addition we establish detailed quality standard according to customers requirements and then rigorously control in the production process Therefore we have been maintaining good reputation in product quality Clinical risk assessment For HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA manufactured by our company we conducted risk assessment for potential risks and also adopted effective methods to control potential risks to reduce them to ac
64. ufacture Leather stainless steel materials Pass Intended additives process contaminants and residues It complies with the requirement Pass Leachable substances N A N A Degradation products N A N A Other components and their interactions in the final product It complies with the requirement Pass The properties and characteristics of the final product It complies with the requirement Pass Tests to be used in biological evaluation and the interpretation of the results of such tests should take into account the chemical composition of the materials including the conditions of exposure and the nature degree frequency and duration of exposure of the device or its constituents to the body By following these principles devices can be categorized to facilitate the selection of appropriate tests see Clause 4 This part of ISO 10993 is concerned with the tests to be carried out on materials and or the final product It complies with the requirement Pass The range of potential biological hazards is wide and may include Short term effects e g acute toxicity irritation to the skin eye and mucosal Surfaces sensitization haemolysis and thrombogenicity The short term effects is no or limited in the acceptable range of the Standard Pass Long term or specific toxic effects e g subchronic and chronic toxic effects sensitization genotoxi
65. umans requires a structured programme of assessment It complies with the requirement Pass In the design process an informed decision shall be made and documented that weighs the advantages disadvantages of the various choices of material and test procedure To give assurance that the final product will perform as intended and be safe for human use the programme shall include a biological evaluation It complies with the requirement Pass The biological evaluation shall be planned carried out and documented by knowledgeable and experienced individuals capable of making informed decisions based on the advantages and disadvantages of the various materials and test procedures available It complies with the requirement Pass 3 2 In the selection of materials to be used in device manufacture the first consideration should be fitness for purpose with regard to characteristics and properties of the material which include chemical toxicological physical electrical morphological and mechanical nronerties It complies with the requirement Pass 3 3 The following should be considered for their relevance to the overall biological EN ISO 10993 1 2009 Biological Reference TMTW1506165750 evaluation of medical devices Part 1 Evaluation and testing Page 4 of 13 Clause Requirement test Result Verdict evaluation of the device The material s of man
66. y the international trade department and the technology department are responsible for checking Reference TMTW1506165750 Page 2 of 2 6 4 special requirements In addition to meet the special requirement of the clients about the label if they had the left content should be design as the above form ud Ie FUWEI HIGH SCIENTIFIC CO LTD Product Name HIGH VOLTAGE ELECTRIC FLELD THERAPY SAKAE 380MA Q Model XX Specs XX Lot Number XX Quantity XX C oo User Manual Reference No TMTW1506165750 Revision 2014 08 Page 1 of 1 Applicant Holder FUWEI HIGH SCIENTIFIC CO LTD No 77 Lane 311 Nangong St Yonukang City Taiwan County 710 Taiwan R O C Manufacturer Ahead Electrical Co Ltd No 6 56 Nanjin Rd Wanluan Township Pingtung County 92341 Taiwan R O C Product Type High Voltage Electric Fleld Therapy SAKAE 380ma Models SAKAE 380ma AB ARS BAIA Reference TMTW1506165750 Page 1 of 3 Chapter 8 Product vigilance system 8 1 Purpose The purpose of this vigilance system is to decrease repeatedly happen of accidents which are informed reported and evaluated also releasing relevant information so that the safety and health of patients or users will be guaranteed 8 2 Scope The vigilance is used for a products with CE mark b products not with CE mark but accidents of these products will adopt the same revised measurements and the same informing and report commitm
67. y potential risk posed by the devices and detachable components Where appropriate the instructions for use must contain the following particulars a the details referred to in 13 3 with the exception of d and e b the performances referred to in section 3 and any undesirable side effects EN ISO 15223 1 2012 Label EN 1041 2008 Instruction C if the device must be installed with or connected to other medical devices or equipment in order to operate as required for its intended purpose sufficient details of its characteristics to identify the correct devices or equipment to use in order to obtain a safe combination TMTW1506165750 05 TMTW1506165750 05 Chapter 3 Essential requirement 200747EC Rev 2 204 08 10 3 Essential requirement 200747EC Rev 2 204 08 10 Checklist according to annex of the Medical Device Directive MDD d all the information needed to verify whether the device is properly installed and can operate correctly and safely plus details of the nature and frequency of the maintenance and calibration needed to ensure that the devices operate properly and safely at all times e where appropriate information to avoid certain risks in connection with implantation of the device f information regarding the risks of reciprocal interference posed by the presence of the device during specific investigations or treatment g the necessary instructions in the event of damage to the sterile packagi

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