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IEC Test Report

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590 views56 pages

IEC Test Report

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dutaindahabadi2020
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
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Test Report issued under the responsibility of: | a 1 65 F [zmorr iy [pe sav |oe 12v [34 4.8 pas [pnd Remark: The paris for MOOP are applied with all MOPP In this TRF for IEGB0601-1(3" Ed) INSULATION DIAGRAM CONVENTIONS and GUIDANCE: TRF No. IECE0601_16 Page 7 of 204 Report No. MDT2013.0015 C 60801-1 Clause [Requirement +1 Result - Remark Verdict A measured value must be provided in the value eolumns for the device under evaluation, The symbol > (greater than sign) must not be used, Switch-modo power supplies must be re-evaluated in the device under evaluation therefore N/A must not be used with a generic statement that the component is certified, Insulation diagram is @ graphical representation of equipment insulation barriers, protective impedance and protective earthing. If feasible, use the following conventions to generate the diagram: +All isolation barriers are identified by letters between separate parts of diagram, for example separate transformer windings, optocouplers, wire insulation, creepage and clearance distances. - Parts connected to earth with large dots are protectively earthed. Other connections to-earth are functional Applied paits aro extended beyond the equipment enclosure and terminated with an arrow. -Parts accessible to the operator only are extended outside of the enclosure, but are notterminated with an arrow. TRF No. IECE0601_16 Page 8 of 201 Report No. MDT2013.0015 ¢ 60sot-1 Clause [Requirement +Te Result -Remark Verdict 4 GENERAL REQUIREMENTS 4a Requirements of this standard applied in P Nontan Use and reasonably foreseeable misuse 42 ‘A RSK MANAGEMENT PROCESS complying with —_/ See Appended RM Results P 1SQ.14971 was performed .. Table 4.2 43 ESSENTIAL PERFORMANCE functions identified /Se® Appended RM Results P according to ManuracTunER's polloy for risk — | Talale 4.3. acceptability In RIO MANAGEMENT FILE : ESSENTIAL PERFORUANCE functions maintained | See Appended RM Results P following particular tests as applicable Table 4.3 44 EXPECTED SeRvice Lire stated in wisi The life time of Medical P MANAGEMENT FILE wn suction unitis 4 years Because life time of Suction motors 4 years as [Alternative means of addressing particular Peanrent a a Pp Fusks considered acceptable based on us bh, ee MANUFACTURER'S Justification that REsioWAL fusKs | ISM Hem RRO Section resulting from application of alternative means |&1 ™! /equal fo oF less than RESIDUAL Risks resulting {from requirements of this standard . 46 RISK MANAGEMENT PROCESS identifies parts that /See Appended RM Results P can come into contact with patientbut not |Table 4.6 sdofined as APPLIED PARTS, subjected to the Fequirements for APPLIED PARTS, except for (Clause 72.10... : 47 Me equrmenT remained sevcLe FAULT SAFE, or | See Appended RM Results e {the Risk remained acceptable as determined by | Table 4.7 Clause 42... Failure of any one component at atime that |See Appended Table 13.2 P ‘could result in a HAZARDOUS SITUATION, including {those in 13.1, simulated physically or theoretically... é sa 48 All components and wiring whose failure could | Ail components and wiring P Fesult im a HAZAROOUS SITUATION used according | properly used according to to their applicable ratings, except as specified, | their applicable rating or by RISK MANAGEMENT PROCESS iainecandutianeHe Reliability of components used as MEANS OF P PROTECTION atsessect for Conditions of use In MEEQUPHENT, and they complied with one of me following: 3) Applicable safety requirements of a relevant [See the appended critical P 1k oF wastandard eempenents table forthe related standard See Appended Table 4.8 TRF No. IECE0601_16 Page 9 of 201 Report No. MDT2013.0015 C 60801-1 Clause [Requirement + Te Result - Remark Verdict by Requirements of this standard applied in the | See above P absence of a relevant iE¢ or i80 standard a9 [A COMPONENT WITH RIGHLINTEGRITY ‘See appended Table 8.10 & WA ‘CHARACTERISTICS provided because a fault ina | RM Results Table 4.9 particular component ean generate an id paituio# ik thew i-of tunacceptable risk. sy ‘Components wir HiGH-INTEGRITY CHARACTERISTICS selected and evaluated consistent with their conditions of use and reasonable foreseeable misuse during EXPECTED SERVICE LIFE Of ME EQUIPMENT by reviewing FogK MANAGEMENT FILE components See appended Table 8.10 & WA RM Results Table 4.0 No parts of the integrity of components 410 Power supply 4.10.1 Me Equip MEWTis. suitable for connection toa SUPPLY MAINS, specified to be connected to a separate power supply, can be powered by an INTERNAL ELECTRICAL POWER SOURCE, or a ‘combination of the three Connected to a supply mains | P 4.10.2 ‘Maximum rated voltage for ME EQUPMENT intended to be connected to SUPPLY MAINS in 250 IV for HAND-HELD ite EQUIPMENT (V)... Not hand-held equipment NA |~250 V dc, orsingle-phase ac. or 500V polyphase a.c, for NE EQUIPMENT and ME SvSTEWS ‘with a RATED input $4 kVA (V) [= 500 V for all other oe equirment and me SYSTEMS: WA 4a Power input ‘Stwady-state measured input of ME EQUIPMENT Or We sysrem at RATED voltage and at operating /settings indicated in instructions for use dia hot exceed marked rating by more than 10%..: ‘See appencod Table 4.11 P |= Measurements on ME EQUIPMENT or a ME SYSTEM marked with one or more RATED voltage ranges made at both upper and lower limits of See appended Table 4.11 P Measurements made ata voltage equal to the mean value of the range when each marking of RATED input was related to the mean value of Felevant voltage range TRF No. IECE0601_16 Page 10 of 201 Report No. MDT2013.0015 TEC G0E01-1 Clause [Requirement + Test Result - Remark Verdict Power input, expressed in volt-amperes, P measured with 2 volt-ampere meter or ealeulated a6 the product ef steady state current (measured as described above) and ‘supply voltage .... serine 5 GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT aa [Type Tests determined in consideration of Considered P (Clause 4, in particular 4.2 Test not performed when analysis indicated | See Appended RM Results condition being tested was adequately Table 5.4 Not tested by other tests or methods Results of risk aNaLysis used to determine combination(s) of simultaneous faults to be 52 ‘Tyee Tests conducted on one representative sample under investigation; multiple samples used simultaneausly when validity of results 53 a) Tests conducted within the environmental [conditions specified in technical description ‘Temperature (°C), Relative Humidity (%) [Atmospheric Pressure (kPa) b) ME EQUIPMENT shiolded from other influences that might affect the validity of tosts ¢} Test conditions modified and results adjusted accordingly when ambient {temperature could not be maintained .. $4 2} Mc cauipwenr tested under least favourable | See Appended RM Results working conditions specified in instructions for | Table 54a ‘use ond identified during Risk ANALYSIS, except ne noted. ss Operation condition 1. Temperature; 0-40 0 2. Humidity: 30-80%RH 3. Atmospheric Pressure; 700-1080hPa b) Me EQUIPMENT with adjustable or controlied ‘operating values by anyone other than service PERSONNEL adjusted te values least faveurable for the relevant test per instructions for use TRF No. IECE0601_16 Page 11 of 201 Report No. MDT2013.0015 TEC G0E01-1 Clause [Requirement + Test Result - Remark Verdict 6} When teat results influenced by inlet NA, pressure.and flow or chemical composition of a cooling liquid, tosts performed within the limits in technical description 4) Potable water used for cooling BS ‘Supply voltage during tests was the least {favourable of the voltages specified in 4.10 or voltages marked on ME EQUPHENT (VW) wsin Me cqune went marked with a RATED frequency ange tested at the feast favourable frequency within the range (He)... Ss Me cquerment with more then one RATED One rated voltage provided ‘voltage, oF both a,c! d.¢, tested In conditions (Sse 6.4) relatod to the least favourable valtage, nature of supply, and type of GUrTEMb onnonnn Me equipment tested with alternative Operation condition ACCESSORIES and components specified in 1. Temperature; 0-40 ACCOMPANYING DOCUMENTS to result inthe least [2 Humidity: 30-80%RH favourable conditions... + |3- Atmospheric Pressure; 700-1060hP.a Me equiewenr connected toa separate power | No separate power supply supply as specified in instructions for provided 56 When failure occurted or probability of future | One sample used for this NA, {failure detected during sequence of tests, per | report Jagreement with manufacturer, all tests affecting results conducted on a new sample ‘Alternatively, upon repair and modification of [See above P the sample, only the relevant tests conducted 57 (Mc EQuiPwenT or parts thereof affected by ‘See Appended Rit Resul P climatic: conditions were set up completely, or | Table 5.7 partially, with covers detached and subjected {ta a humidity preconditioning prior ta tests of (Clauses 8.7.4.and 8.8.3. ;| Transport and storage condition 4. Temperature; 0~40 © 2. Humidity: 30-80%RH 3. Atmospheric Pressure; 700-4060hFa ‘Manually detachable parts removed.and Considered P {weated concurrently with major parts and manually removable acckss Covers were opened and detached Me EQuPMeNTheated to a temperature between | Considered P T and T + 4.°C fot at least 4 h and placedin a humidity chamber with a relative humidity of 93 %+3 % and an ambient within 2°G of Tin the range of # 20°C to + 32°C for 48h TRF No. IECE0601_16 Page 12 of 204 Report No. MDT2013.0015 TEC G0E01-1 Clause [Requirement + Test Result - Remark Verdict When RISKMAKAGENENT PROCESS indicated me | No exposure te high NA, EQUIPMENT can be exposed to high humidity for | humidity considered extended porlods (\e,, out-sdoor use), tost time extended propartionally (h) 58 Unless stated otherwise, tests in this standard sequenced as in Annex B to prevent results of Jone test on @ subsequent test 59 Determination of APPLIED PARTS and ACCESSIBLE PARTS 5.04 | APeuicn pants identified by inspection and Described in user's manual and Product label fer applied parts 59.2 5.9.2.1 | Accessibility, when necessary, determined | See Appended Table 5.9.2 ‘using standard test finger of Fig 6 applied in a bent or straight position ‘Openings preventing entry of test finger of Fig. P 16 mechanically tested with a straight un-jointed {test finger of the same dimensions with a force of 30.N [When the straight unjointed test finger NA, ‘entered, test with the standard test finger (Fig 6} was repeated, if necessary, by pushing the finger through the opening 5.9.2.2 | Test hook of Fig. 7 Inserted in all openings of P ME FOUIPMENT atid piilled with a force of 20 N for 10s All additional parts that became accessible P checked using standard test finger.and by inspection 5023 [Conductive parte of actuating mechaniome of [No actuaiing mechanisms | wa electrical controls accessible after removal of | that has conductive parts handica, kobe, levers and the like regarded as | Provided. Jaccessioce PARTS. The vacuum control knob is operated without electrical power. And it is not available to remove the know without atoal. ‘Conductive parts of actuating mechanisms —_ | See Appended Rid Results NA ot considered ACCESSIBLE PARTS when Table 5.9.2.3 ‘oval of handles, knobs, etc. required use ‘of a TOOL, andl inspection of RISK MANAGEMENT FLE indicated the relevant part is unlikely to ‘detach unintentionally during exeeceo SERVICE LIFE Of ME EQUIPMENT. TRF No. IECE0601_16 Page 13 of 201 Report No. MDT2013.0015 TEC 60601-1 Clause [Requirement + Test Result Remark Verdict 6 CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS P 62 ‘Cinss ime EQUPNENT. externally powered Pe (CLASS a We EQUIPMENT, externally pawered WVTERNALLY POWERED Me EQUIPMENT EQUPNENT with means of connection to a SUPPLY MAINS complied with CLASS 1 OF CLASS II ME EQUIPMENT requirements when so connected, /and when not connected to SUPPLY MAINS with INTERNALLY POWERED ME EQUIPMENT requirements TYPE BF APPLIED PART [Type cr APPLIED PART DEFIGRILLATION-PROOF APPLIED PARTS 63 Enc.osures classified according to degree of | Suction unit : IPXO Protection against Ingress of water and Foot switch ; IPXt articulate matter (1PNN2) @5. per IEG 60529 6a Me EOUIPWENT oF its parts Intencied to be No sterilization required sterilized classified according to method(s) of sterilization in instructions for use, 65 ME EQUIPMENT and ME SYSTEMS Intended for use NIA In an OXYGEN CH ENVIRONMENT classified for such use and complied with 11.2.2 66 [ConTINUOUS or Non-CONTNUOUS OPERATION... [Gontinuaus P z ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS. TAA RISK of poor USABILITY associated with the: NIA ‘design of HE EQuiFMENT'S identification and marking addressed in a USABILITY ENGINEERING PROCESS, Tad Lagibility of Markings Test for Markings ‘Sen Appondod Table 7.1.2 P specified in Clause 7.2. : a3 Required markings can be removed only with a P ‘TOOL or by appreciable force, are durable anc remain CLEARLY LEGIBLE during EXPECTED SERVICE UE of ME EQUIPMENT in NORMAL USE a) After tests, adhesive labels didn’t loosen up_|See appended Tables 7.1.3 P ‘or curl up at edges and markings complied with| and 8.10 requirements in Clause 7.1.2 bb) Markings required by 7.2-7.6 remained ‘See appended Tables 7.1.3 P CLEARLY LEGIBLE after marking durability test ..: [and 8.10 72 Marking on the outside of me EQUIPMENT or ME EUIPMENT parts TRF No. IECE0601_16 Page 14 of 204 C 60801-1 Report No. MDT2013.0015 Clause Requirement +1 Result - Remark Verdict 124 At least markings In 7-2.2, 7.2.5, 7.2.6 (not for PERMANENTLY INSTALLED ME EQUIPMENT), 7.2.40, and 7.2.13 were applied when size of EQUIPMENT, its part, an ACCESSORY, or ENCLOSURE did nat permit applicatian af all Remaining markings fully recorded in ACCOMPANYING DOCUMENTS ... impractical to apply to me EQUIPMENT required markings .. iat Described in user’s manual Markings applied to individual packaging when [See attached copy of Marking Plate NA, 1.22 ‘Armaterlal, component, ACCESSORY, oF ME EQUIPMENT Intended for a single use, or its packaging marked “Do Not Reuse” or with ‘symbol 28 of Table D.1 (180 7000-1051, DB:2004-04). MANUFACTURER'S name or trademark marked on Me EQUIPMENT and detachable components jn. No such parts provided See appended Tables 7.2.2 Manufacture's name ModG@yn Products provide on the marking plate NA, Misidentification does not present an unacceptable risk MODEL OR TYBEREFERENCE alao marked, except when misidentification would not present an unacceptable Risk. 723 ‘Software forming part of a Pems Identified with ‘a.unique identifier, such as revision level or ‘date of releasefissue, and identification are available to designated persona... ‘Symbol 11 on Table D.4 (ISO 7000-1641, DB: 2004-01) used, optionally, advice to OPERATOR to consult ACCOMPANYING DOCUMENTS: [See the attached Copy of marking plate ‘Safety sign 10 on Table D.2 (safety sign IEC 60878 Safety 01) used, advising OPERATOR that ACCOMPANYING DOGUIAENTS must be consulted NIA, 72d ‘Accessomies marked with name or trademark of MANUFACTURER or supplier, and with a woDeL or ‘TYPE REFERENCE j Markings applied to individual packaging when Not practical to apply to ACCESSORIES NA, 25 MObEL or TYPE REFERENCE of equipment to be ‘connected to NE EQUIPMENT to provide power, i marked adjacent to the relevant connection point when this connection could result in an Unacceptable Risk. No such equipment provided [See appended Tables 7.2.5 WA 1.2.6 (Connection to the Supply Mains. TRF No. IECE0601_16 Page 15 of 204 Report No. MDT2013-0015 C 60801-1 Clause [Requirement +1 Result - Remark Verdict Exeapt for PERMANENTLY INSTALLED ME P EQUIPMENT, marking appearing on the outside of part containing SUPPLY Walks connection ‘and, adjacent to connection point For PERMANENTLY INSTALLED ME EQUIPMENT, Not permanently installed WA Noweal. supply voltage or range marked insige |@aulpment or outside of me EQUIPWENT., preferably, adjacent to supply connection terminals —RaTED supply voltage(s) or RATED voltage 230v P range(s) with a hyphen (-) between minimum and maximum voltages (V, V-V).. Multiple RATED supply voltages or multiple RATED supply voltage ranges are separated by (VIM). Nature of supply (¢.¢., No.of phases, except | Alternate eurrent P single-phase) and type of current. : ibals 4-5, Table D.1 {symbols of EC 60417- | Symbol 1, Table D-1 4 P Bie SOaE-4 SOAR, 30Ot tra 2039, ad DB. (symbols of IEC 60417-8032) 2002710) used, optionally, for same parameters: [Provided = RATED supply frequency .or RATED traquency | 50HZ P range in hertz, — Symbol 9 of Table D.1 (symbol IEC 60417- NIA, 5172, DB: 2002-02) used for CLAss ime EQUIPMENT nn 727 RaTeD input in ampe or voltamps, orin watts | power factor exceeds e when power factor exceeds 0:9 (A, WA, W)_...: [0.9 RATED input for one or more RATED voltage NA ranges provided for upper and lower limits of the range or ranges when the rangels) islare ‘greater than + 10 % of the mean value of ‘specified range (A, VA.Wh. Input at mean value of range marked when Net differed by mors than P range limits do not differ by more than 10% — |10% from moan value (&y VA, W) Marking includes long-time and most relevant NIA momentary volt-ampere ratings when provided, ‘each plainly identified and indicated in ACCOMPANYING DOCUMENTS (VA)... : Marked Input of uc CaVIPMENT provided with NA ‘means for connection of supply conductors of other sloctrical equipment includes RATED and marked output of such means (A, VA, W)...... 728 (Gutput connectors NAL Soe 16.9.2.4 b) for MULTIPLE CocKET-OUTLETE NAL Integral with we coulpmeNT 7.2.8.2 |Qutput connectors are marked, except for NA MULTIPLE SOCKET-OUTLETS or connectors intended for specified ACCESSORIES oF equipment TRF No. IECE0601_16 Page 16 of 204 Report No. MDT2013.0015 C 60801-1 Clause [Requirement + Te Result - Remark Verdict Rated Voltage (Vj, Rated Current (A) Rated Pawer (W), Output Frequency (Hz 728 Mc EQUIPNENT oF its parts marked with the IP | Foot awitah : IPK1 P environmental Code per IEC 60528 according to classification in 6.3 (Tabl 0.3, Code 2... 7.2.10 | Degrees of protection against electric shock as | 8 APPLIED paRTS P ‘clagsified In 6.2 for all APPLIED PARTS marked ‘with relevant symbols as follows (not applied to parts Identified according to 4.6): TVBER APPLIED PARTS with symbol 19 of Table 0.1 P (IEC 6017.58.40, DE: 2002-10), not applied in ‘such away as to give the impression of being inscribed within a square in order to distinguish front symbol IEG 60417-5833 at ‘TYPE BF APPLIED PARTS with symbol 20 of Table NIA Dal (IEG 60417-5339, DB: 2002-10) : ‘TYPE CF APPLIED PARTS with symbol 24 of Table NIA Dat (IEC 60417-5335, DB: 2002-10) = DEFIERILLATION-PROOF APPLIED PARTS inarked with NA, ‘symbols 25-27 of Table D.1 (IEC 60417-5841, IEC 60417-6994, or IEC 60417-5396, all OB: 2002-10): Propor symbol marked adjacent to-or on P ‘connector for APFLIED PART, except marked on /ABPLIED PART when there is: no connector, or ‘connector used for more than one APPLIED PART ‘and different APPLED PARTS with diffarent classifications Safety sign 2 of Table 0.2 (ISO 7010-Wo0t) No such symbol required NA placed near relevant outlet when protection against effect of discharge of a cardiac [defibrillator is partly in the PATIENT CATE «nmi [An explanation indicating protection of we NIA EQUIPiEENT againat effects of discharge of a cards sete depends an wee ef proper ‘cables included in instructions for u 7.2.41 [Me equrneNT not marked to the contrary [Continuous operation P assumed to be suitable for cowrimvous OPERATION DUTY CYCLE for ME EQUIPMENT Intanded fornen- [See above NIA, ‘CONTINUOUS OPERATION appropriately marked to provide maximum “on” and “off” fimo... 7.2.42 | Type and full rating of a fuse marked adjacent to P ACCESSIBLE fusp-holdor Fuss ; [Flash type = 250V, 5A ‘Voltage (V) and Current (A) rating Low breaking tyre = Operating speed (s} and Breaking capacity TRF No. IECE0601_16 Page 17 of 204 Report No. MDT2013-0015 C 60801-1 Clause [Requirement +1 Result - Remark Verdict 7.243 [Asatety sign cLeamvieci@ieand visibleafter This product has not NIA INSTALLATION in NORMAL USE applied to a marking for physiological prominent location of EauipMEUT that produce effect physiolegical effects capable of causing HarM to] PATIENT OF OPERATOR Rat ebvious to OPERATOR Nature of Hazagband precautions for avolding NA, ‘or minimizing the associated risk described in instructions for use .. 7.244 | HicWvoLTAGE TERMINAL DEVICES on the outside of |No such device provided NAL Me EQUPMENT accessible without the use of a TooL marked with symbol 24 of Table 0.1 (symbol IEC 60417-5096, DB: 2002-10) 7.2.15 — |Requirements for cooling pravisions marked | No such device provided NIA, (e.g, supply of water OF al) umsunanincnnnnnsn 7.2.16 | Me EAUIPMENT with limited mechanical stability NA, 7.2.17 — |Packaging marked with special handlin; This equipment dase not NA instructions for transport and/or storage... [Pecial handling equipment Permissible environmental conditions for WA transportand storage marked on outside of BRINN a ncnccenecensnsicin aptrecempsomeccint Packaging marked with a suitable safety sign NIA indicating premature unpacking of me EQUIPNENT could resuit in an unacceptable risk... Packaging of sterile me EQUIPMENT or WA ACCESSORIES marked sterile 7248 RATED maximum supply pressure from an No pressure provided from NA external source marked on ME EQUIPMENT jenienternal soures adjacent to each input connector. rem? 7.2.19 | Symbol 7 of Table 0.1 (JEC 60417-5017, No Functional earth terminal) — N/A DIB:2002-10) marked on FUNCTIONAL EARTH TERMINAL. 7.2.20 [Protective moans, required to be removed to [No alternative.applications NIA use a particular function of ME EQUIPMENT with alternate applications, marked to indicate the necessity for replacement when the function is no longer needed... mi 5 No marking applied when an interlock provided NA ta Marking on the inside of ME EQUIPMENT -oF ME EQUIPMENT parts Tad Maximum power loading of heating elements or |No heating lamps or heater NIA, lamp-holders designed tar uae with heating lomps morked near or in the heator (W) ss..m::! [Amarking referring to ACCOMPANYING DOCUMENTS NA provided for heating elements or lamp-holders ‘designed for heating lamps that can be changed only by SERVICE PERSONNEL using a TOOL TRF No. IECE0601_16 Page 18 of 204 C 60801-1 Report No. MDT2013-0015 Clause Requirement +1 Result - Remark Verdict 7.3.2 ‘Symbol 24 of Table D.1 (aymbol IEC 60417-5036, DB: 2002-10), oF safety sigh 3 of Table D2 used to mark presence of WiGH VOLTAGE parts... Ne high voltage parts NIA, 7.33 ‘Type of battery and mode of insertion when applicable ts marked ... No battery NIA ‘An Identifying marking provided referring to Instructions in ACCOMPANYING DOCUMENTS for batteries intended to he changed only by [SERVICE PERSONNEL using @ TOOL .. ‘Awarning provided Indicating replacement of lithium battertes oF fuel cells when incorrect replacement by inadequately trained personnel ‘would result in an Unacceptable Risk (6.6. excessive temperatures, fire or explesion) uu! NA NAL 134 [An identifying marking also provided referring ‘to instructions in ACCOMPANYING DOCUMENTS......: Fuses, replaceable THERMAL GUT-OUTS and OVER- ‘CURRENT RELEASES, aceeesible by use of # TOOL, marked by type and full rating atthe component: or by reference to AccomPanvina DOCUMENTS Type Voltage (Vv) and Current (A) rating NAL NAL Operating speed (s} and Breaking capacity ... TAS PROTECTIVE EARTH TERIAL marked with eymbol 8 of Table D.4 EC 60417-5049, DB: 2002-10), ‘except for the PROTECTIVE EARTH TERMINAL In an APPLIANCE INLET according to IEC 60320-1 Markings on or adjacent to PROTECTIVE EARTH ‘TERMINALS not applied! to parts requiring removal to make the connection, and remained visible after connection made 7.3.6 73d ‘Symbol 7 of Table 0.1 (IEC 60417-5017, DB: 2002-10) marked on FUNCTIONAL EARTH TERMINALS ‘Terminals for supply conductors marked adjacent to terminals, except when no nazano would result when interchanging connections NIA, Ne Supply terminals NA ‘Terminal markings included in accompanying DOCUMENTS When ME EQUIPMENT too small to accommodate markings: NA, Terminals exclusively for neutral supply conductor in PERMANENTLY INSTALLED: ME EQUIPENT morked with Gode 1 of Table D.3 (Code in IEC 60445) Marking for connection to a 3-phase supply, if necessary, complies with IEC 60445 NAL NIA, TRF No. IECE0601_16 Page 19 of 204 C 60801-1 Report No. MDT2013.0015 Clause Requirement +1 Result - Remark Verdict Markings on or adjacent to electrical connection points not applied to farts requiring removal to make connection, and remained visible after ‘connection made NIA, 138 “For supply connections, use wiring matorials ‘suitable for at least X °G" (where X > than max temperature measured in terminal box or wiring ‘compartment under NORMAL Use), oF equivalent, marked at the point of supply connections WAL ‘Statement not applied to parts requiring removal to: make the conneetion, and CLEARLY LEGIBLE after connections made iz TAA Marking of controls aid instruments ‘The “on” & “aff” positions of switch te control power to Wie EQUIPMENT of its parts, Including mains switch, marked with symbols 12 and 13 ‘of Table D.1 (IEC 60417-5007, DB: 2002-10, and JEG 60417-8008, DB: 2002-10), er (Symbols 12 and 13 of Table D-1 provided indicated by an adjacent indicator light, or NIA, indicated by other unambiguous means NIA, ‘The “on/off” positions of push button ewiteh ‘with bi-stable positions marked with symbol 14 of Table B.1 (IEC 60417-5010 DB: 2002-10), and NIA, = status indicated by adjacent indicator light NA, — status indicated by other unambiguous means NA, ‘The “onioft” positions of push button switeh ‘with momentary on position marked with ‘symbol 15 of Table D.1 (symbol 60417-5011 DB: 2002-10), or NIA, = status indicated by adjacent indicator light NA, = status indicated by ether unambiguous. means. NA, 142 Different positions of control devices’switches indicated by figures, letters, or other visual means. [See Appended RM Results Table 7.4.2 Contrals provided with an associated indicating device when change of setting of a control could result in an unacceptable isk to PATIENT IN NORMAL USE, OF —an indication of direction in which magnitude of the function changes: 43 Numeric indications of parameters on we EQUIPMENT expressed in SI units aécording to 180.31 except the base quantities listed in Table ‘expressed in the indicated units. [Considered TRF No. IECE0601_16 Page 20 of 204 Report No. MDT2013-0015 ¢ 60sot-1 Clause [Requirement +Te Result -Remark Verdict 10.1000 applied for appiteation of si units, P their multiples, and certain other units [All Markings in Sub-clause 7.4 complied with [See Appended Tables 7.1.2 P tests and criteria of 7.1.2 and 7.1.3 and 7.1.3. 78 Safety signs Markings used to convey a warning, [See Appended RM Rosults P Prohibition or mandatory action mitigating a |Table 7.5 SK not obvious to OPERATOR are safety signs from 1S 7010 ‘Affirmative statement together with safety sign P placed in instructions for use if insufficient ‘space OME EQUEMENT ‘Specified colours in 150 2864-1 used for safety [Considered P signs. i ‘Safety notices include appropriate precautions P or instructions on how to reduce Risks) Safely Signs Including any supplementary text P ‘or symbols described in instructions for use 1.6 ‘Symbols e Fed Meanings of symbols used for marking For safety marking that is P described in instructions for use.. marked in user manual. 7.6.2 [Symbols required by this standard conform to P EC or ISO publication referenced 7.63 | Symbels used for controls and performance P ‘conform to the IEC or ISO publication where symbels are dafined, as applicable 17 Colours of the insulation of cenductors P TIA PROTECTIVE EARTH CONDUCTOR identified by P ‘green and yellow insulation 142 insulation on conductors inside ME EaUieMeNT P forming PROTECTWE EARTH CONNECTIONS identified by green and yellow at least at torminations 7.7.3 | Green and yellow insulation identify only P following conductors: PROTECTIVE EARTH CONDUCTORS P conductors specified in 7.7.2 P — POTENTIAL EQUALIZATION CONDUCTORS. NIA, | FUNCTIONAL EARTH CONDUCTORS. NIA, Tid Neutral conductors af rower suppiy conns are [Certified power cord set P “fight blue” specified im EC 60227-1 or IEC 60245-1 provided TRF No. IECE0601_16 Page 21 of 201 Report No. MDT2013-0015 ¢ 60sot-1 Clause [Requirement +Te Result -Remark Verdict TS Colours of conductors in power supply corns [Certified power cord set P In accordance with IEC 60227-1 or IEC 60245.1 [Provided 78 NA, Tad Red indicator lights mean: Warning (i.e.. NA, immodiate rosponse by operator required) Yollow indicator lights mean: Caution (Le., NA, prompt response By OPERATOR required) [Green indicator lights mean: Ready for use NA, Other colours, i used: Meaning other than red, NA, yellow. of green (colour, meaning)... 782 Red used only for emergency control NA, 79 [ACCOMPANYING DOCUMENTS P 794 Me EQUIPMENT accompanied by documents See Appended RM Results P ‘containing at laast instructions for uso, and a |Table 7.94 rach nical demerlptiory Document number (YNK-M- 001)_Operation & Maintenance Manual user's manual provide to Jcustomer. User manual Includes instruction for use Jan technigal description, This product is not provided CD IFU. ACCOMPANYING COCUMENTS identity ME EqueNeNT |Deeument number (YHK-M- P by the following, as applicable: 001)_Operation & Maintenance Manual Name or trade-name of manuractuRER and an [Deeument number :¥NK-M- ® addrass the RESPONSIBLE ORGANIZATION can be |901{Operation & ranarvad te Maintenance manual)_ Paga.A6 aun: [Document number YNK-M P 001(Qperation & Maintenance manual)_ Paget When AccoMPaNTING GOCUMENTS provided See Appended RM Results: sue electronically (e.g., on CoRoM), 3K Table 7.3.4 MANAGEMENT PROCESS Inclusles Instructions as to wht f required in hard copy ar as markings [All ocumentation will be Of ME EQUIPHENT [for emergency operation) Li iid ACCOMPANYING DOCUMENTS specify Special skills, NA training, and knowledge required of OPERATOR or RESPONSIBLE ORGANCATION and environmental restrictions on locations of use /Accompanvine bocumerTs written at a level WA, ‘consistent with education, training, and other needs of individuals for whom they are intended 792 Instructions for use include the required information P TRF No. IECE0601_16 Page 22 of 204 Report No. MDT2013-0015 Clause [Requirement +Te Result -Remark Verdict 7.9.2.4 |-imtended use of w= eouPME: Bocument number :YNK-M- P 001(Operation & Maintenance manual) Page.6(2.1 Intended Use of Device) Medical Suction Unit is used by doctor or nurse in ‘emergency! treatmont room ‘of hospltals:and clinics for suctioning through the from the airway and mouth of airway obstruction ignt by Vomit or liquid. = frequently used functions, and [Bocument number: )VNK-M- P 904(Operation & Maintenance manual) _ Page.12(3.How to seperate medical suction unit) — known contralndication(s) to use of me P EQUIPMENT ‘Classifications as in Clause 6, all markings par [Document number :YNK-M- P Clause 7.2, and explanation of safety signs and |01(Operation & symbols marked on ME EQUIPMENT Perea’: manual) _Page. (Explanation of General Danger and Explanation of General Warning) instructions for use are in a language [English version evaluated. P acceptable to the intended operator 7.9.2.2 | Instructions for use include all warning and Pee per ste P aabty ction Maintenance manwal) |_Page.s (Explanation of General Danger and Explanation of [General Warnig) Warning statement for CLASS 1MEEGUIEMENT [This Equipment are CLASS | NIA indicating: “warsano: To avoid rick of electric | ‘shock, this equipment must only be connected to a supply mains with protective earth” ‘Warnings regarding significant Risks of Bacument number :YNK-M-[p reciprocal interference posed by we EQUIFWeNT ‘during specific investigations or treatments. }001(Operation & Maintenance manual) | Pago Explanation of General wrarnia) TRF No. IECE0601_16 Page 23 of 204 Report No. MDT2013-0015 :¢ 6O60I-1 Clause [Requirement +1 Result Remark Verdict Information on potential clectromagnetic or [Document number :YNK-M-] other interference and advice on how to aveid /004(Operation & ‘or minimize such interference Maintenance manual) Paget Explanation ef General Warnig) Warming statement for Me EQUIPMENT Supplied [No Multiple socket -outlet NIA with an integral MULTIPLE SCCKET-OUTLET indicating, “connecting electrical equipment to Mao-effectively leads to creating an Me sYSTEM, and can resultin a reduced level of safety” ‘The RESPONSIBLE ORGANIZATION is referred to this, NIA standard for the requirements applicable to ME sysTens 7.8.2.3 [Statement on me caurment for connection toa [No separate power supply NIA ‘soparato power supply indicating “power provided ‘supply le specified ae a part of we EQUIPMENT oF combination is specified as a MESYSTEN” 7.2.2.4 |Waming statement for mains- operated we | This product has has not NIA EQUIPMENT with additional power source not [risk for battery ‘automatically maintained in a fully usable ‘condition indicating the necessity for periodic ‘checking or replacement of power source ‘Warning to remove primary batteries when we [This product has has not NIA EQUIPMENT is not likely to be used for some time |risk for battery ‘when leakage from battery would result in an Unacceptable Risk a el Specifications of replaceable INTERNAL This product has has not NA ELESTRIGAL POWER SOURCE when provid risk for battery ‘Warning indicating Me EQUIPMENT must be This equipment does not NIA sennected to an appropriate power source — Juuso UPS: when loss of pawer source would result in an unacceptable Risk 7.8.2.5 Instructions for use include a description of ux |Usor's manual provide to P EquiPuen, its functions, signifieant physical | eustomer and performance characteristics together with the expected positions of OPERATOR, PATIENT. or other persons near ME EOUIPMENT If NORMAL USE Information provided on materials and P Ingredients panieNT oF OPERATOR Is exposed to when such exposure can constitute an Unacceptable fase Restrictions specified on other equipment or [No Network/Data couplings | NIA NETWORKIDATA COUPLINGS, other than those forming part of an we system, to which a SiGwAL INPUTIQUTPUT PART may be connected APPLicD PARTS specified e TRF No. IECE0601_16 Page 24 of 204 C 60801-1 Report No. MDT2013.0015 Clause Requirement +1 Result - Remark Verdict 79.2.6 Information provided indiesting where the Installation instriictions may be fouind or information on qualified personnel whe can perform the installation NIA, T927 Instructions provided indicating not to position ME EQUIPMENT to: make Mt Gifficult to operate the ‘disconnection device when an APPLIANCE /CoUPLER or separable plug is used 3 Isolation. means tomeet 8.11.1 2) 7.9.2.8 Necessary information provided for oPERATOR to bring NE EQUIPMENT into operation including initiat control settings, and connection te or positioning of PATIENT prior to Use of UE EQUIPMENT, its parts, or ACESSORIES Start-up PROCEDURE should be provided in the manust 7825 Information provided to operate Me cauiemenT ineluding oxplanation of controls, displays and signals, eequence of operation, connection of detachable parts or ACCESSORIES, replacement of material consumed during operation Meanings of figures, symbols, warning ‘statements, abbreviations and indicator lights ‘described in instructions for use Document number VNK-M- }001(Operation & Maintenance manual)_ Pags.12(8.How to operate medical suction unit) 7.9.2.10 Alist of all system messages, error messages, and fault messages provided with an explanation of messages including important ‘causes and possible action(s) to be taken to resolve the problem indicated by the message No error messages NA, ra2t4 information provided for the oreRAToR to safely terminate operation of me EaUPMENT 7.9.2.12 Information provided on cleaning, disinfection, and sterilization methods, and applicable parameters that can be tolerated by ME EQUIPMENT parts oF ACCESSORIES specified [Operation manual (Components, AccEssonies-or me eoupmenT marked for single use, except when required. by MANUFACTURER to be cleaned, disinfected, or sterilized prior to use (Operation manual 7.9.2.13 Instructions provided on preventive inspection, calibration, maintenance and its. frequency [Operation manual Information provided tor sate performance of routine maintenance necessary te ensure continued safe use of ME EQUIPMENT Parts requiring preventive inspection and ‘maintenance to be performed by service PERSONNEL identified including periods of application (Operation manual TRF No. IECE0601_16 Page 25 of 204 C 60801-1 Report No. MDT2013.0015 Clause Requirement +1 Result - Remark Verdict Instructions provided to ensurs adequate ‘imaintehance of ME RGUIBMENT containing rechargeable batteries to be maintained by anyone othor than SERVICE PERSONNEL NIA, 792.14 list of ACCESsOmES, detachable parts, and materials for use with ME EQUIPMENT provided ‘Other equipment providing power to we sysTeM sufficiently described (e.g. part number, RATED VotTAGE, max or min power, protection class, Intermittent or continuous service) 78.215. 79.216 Risxs associated with disposal of waste products, residues, etc., and of me EQUIPMENT ‘and ACCESSORIES at the end ef thelr EXPECTED. [SERVIGE LIFE are identified, and instructions provided on minimizing these risks Instructions for use Include information ‘specified in 7.9.3 or identify where it ean be found (e.g. ina service manual) Operation manual 7.9.3 Technical description 7.9.3.4 All essential data provided for safe operation, {trans part, storage, and measures or conditions Necessary for installing Me EQuIFMENT, and preparing it for use including the following: [Operation manual information as in clause 7.2 — permissible environmental conditions of use Ingluding conditions for transport.and storage —all characteristics of ae EQUIPMENT including rangets), accuracy, and precision of displayed values or where they can be found [Operation manual special installation requirements such as ‘max. permissible apparent impedance of [SUPPLY MAINS — permissible range of values of inlet pressure and flow, and chemical composition of cooling liquid used for cooling = adescription of means of isolating me EQUIPMENT from SUPPLY Mains, when such means not in ME EQUIPMENT Operation manual NA, NA, —a description of means for checking oil level In partially sealed oil filed me EQUIPMENT or its parts when applicable — a warning statement addressing HAZARDS that ‘can result from unauthorized modification of ME EQUIPMENT secording to following examples [Operation manual NA “warwma: No modification of this equipment is allowed” TRF No. IECE0601_16 Page 28 of 204 Report No. MDT2013-0015 :¢ 6O60I-1 Clause [Requirement +1 Result Remark Verdict ‘uaRusia: De not modify this equipment P without authorization of the manufacturer” “WARHNG: If this equipment is modified, P ‘appropriate inspection and testing must be ‘conducted to ensure continued sate use of equipment” ‘Technical description separable from instructions for use cantains required | N/A Information, as follows = livformation a5 in clause 7.2 NIA all applicable classifications in Clause 6, NIA ‘warning and safety notices, and explanation of safety signs marked on ME EQUIPMENT —a brief description of me EQUIPMENT, how it NA functions, and Its significant physical and performance characteristics MANUFACTURER'S optional requirements for ‘minimum qualifications of SERVICE PERSONNEL documented in technical description 7.8.3.2 |The technical description contains the following required information type and full rating of fuses used in surety [See Appended RM Results NA, MAINS external to: PERMANENTLY INSTALLED ME | Table 7.9.3.2 EQUIPMENT, whan type and rating of fuses a not apparent from information on RATED current] [and mode of operation of me caupnent........: |-This equipment dose not permanently installed ‘equipment and non- dotachable power supply cord. -This equipment does not have a part that Is only replaceable bby Service Personnel =a statement for me courenent with a non- NIA DETACHABLE POWER SUPPLY CORD if POWER SUPPLY ‘coRD Is replaceable by SERVICE PERSONNEL, and if'so, instructions for correct connection and anchoring ta ensure compliance with 8.11. — instructions for correct replacement of Operation manual P interchangeable or detachable parts specified by wanuFAcTURGR as replacoablo by SERVICE PERSONNEL, and = warnings Identifying nature of HazARowhen | Operation manual P replacement of a component could result in an Unacceptable Risk, and when replaceable by [SERVICE PERSONNEL all information necessary to ‘safely replace the component TRF No. IECE0601_16 Page 27 of 201 Report No. MDT2013.0015 IEC BOBOt. Clause [Requirement + Test Result - Remark Verdict 7.9.3.3 | Technical description indicates, wanuractureR |Such statement should be P ‘will provide circuit diagrams, coniponent part | provided lists, descriptions, calibration instructions to assist to SERVICE PERSONNEL In parts repair 7.9.3.4 [Means used to comply with requiremants of P 8.11.1 clearly Identified in technical description 8 PROTECTION AGAINST ELECTRIGAL HAZARDS FROM ME EQUIPMEN’ P aa Limits specified in Clause 8.4 not exceeded for P ACCESSIBLE PARTS atid APBLIED BARTS in NORMAL Or SINGLE FAULT CONDTMONS NORMAL CONDITION considered as simultaneous e occurrence of situations identified in 8.1a) ‘SINGLE FAULT CONDITION considered to Include | See Appended RM Results P the occurrences as specified in Clause 8.1b)...: | Tables 8.1bI1). (2). (3) AOGESSIBLE PARTS determined according to 5.9 P LEAKAGE CURRENTS measured according to 8.7 P 82 Requirements related to power sources NIA 24 When ME ECuIeMENT specified for connection to NIA a separate power source other than SUPPLY MAINS, Separate power source considered as part of ME EQUIPMENT or combination considered as an ME SYSTEM Tests performed with ME EAUIPMENT connected NIA to separate power supply when one specified When a generic separate power supply NIA ‘specified, specification In AccomPanyina DOCUMENTS examined 422 No HAZARDOUS SITUATION other than absence of |Ne external d.c. power NIA ESSENTIAL PERFORMANCE developed when a source provided connection with wrong polarity made for se FQuIPMENT from an external dc. source: ‘Me equipment connected with correct polarity NIA did not present an unaceeptable RISK Protective devices that can be reset hy anyone NA ‘without a Toot restore correct apert reset a3 (Classification of APPLIED PARTS P a) ABRLIED PART specified in ACCOMPANYING No CF type applied part NIA DOCUMENTS as Suitable for DIRECT CARDIAC APPLICATION is TYPE CF 'b) An APPLIED PART provided witha Panient — [No BF type NIA CONNECTION intended to deliver electrical ‘energy or an electrophysiological signal to or from PATIENT is TYPE BF Of CF APPLIED PART TRF No. IECE0601_16 Page 28 of 204 Report No. MDT2013.0015 :¢ 6O60I-1 Clause [Requirement +1 Result Remark Verdict 5) An APPLIED PART nat covered by a) orb) isa |B type applled part P TPE, BF, OF CF 4) Requirements of a TYPE 6 APPLIED PART P applied to a part in 4.6 to be subjected to requirements for an APPLIED PART (except marking) Requirements for a TYPEGF or cF APPLcH PART [See Appended RM Results P applied 5 In RISK MANAGEMENT PROCESS Table 8.30 84 Limitation of voltage, current or energy e aa PATIENT CONNECTIONS intended to deliver Current NA Limits ih 8.4.2 net applied to currents intended |Not intended to deliver NIA to flow through body of rarienr to produce a Jeurrent physiological effect during NORMAL USE a2 ACCESSIBLE PARTS Including APPLIED PARTS P a) Gurrents trom, to, or between PATIENT [See appended Table 8,7 P ‘CONNECTIONS did ot exceed limits for PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT per Tables 3 and 4 when measured according to Clause 8.7.4, b) LEAKAGE CURRENTS from, to, or between [See appended Table .7 P ACCESSIBLE PARTS did not exceed limits for TOUGH CURRENT in Cl. 8.7.3 ¢) whon measured per Clause 8.7.4 (mA)... ¢} Limits specified in b) net applied to parts [See Appended RM Results P wien probability of a connection to.apantent, |Table 8.4.2c directly oF through body of OPERATOR, Is negligible in NORMAL USE, and the OPERATOR is appropriately instructed = accessible contacts of connectors NIA = contacts of fuseholders accessible during [Contact live part of P replacement of fuse fuseholders negligible = contacts of lamphoiders accessible after NIA removal of lamp parts inside an access.covER that can be NA, opened without 2 TOOL, or where.a TOOL is needed but the instructions for use instruct an ‘OPERATOR other than SERVICE PERSONNEL fo open the relevant ACCESS COVER Voltage to earth orto other accessipteranrs | S*°.4ppended Table 6.4.2 NA did not exceed 42.4 V peak ac. or 60 V d.c. for ‘above parts in NoRNAL oF single fault condition IV 6. OF de.) sien Limit of €0°V d.c applied with no more than | Se #ppended Table 8.4.2 NA 410% peak-to-paak ripple, and when ripple larger than specified value, 42.4 V peak limit applied (¥ dc.) TRF No. IECE0601_16

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