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draft report SUPERIOR PRODUCT CONSULTING

1. Issue Date 2014 03 27 Page 180 of 181 Report Reference 1402012 draft report Diagrams ID 4 05 Issue Date 2014 03 27 Page 181 of 181 Report Reference 1402012 draft report Miscellaneous ID 7 01 Environmental conditions Temperature 10 40 Operating 20 60 C Transport Storage Humidity 30 75 Operating 10 90 Transport Storage Pressure 700 1060hPa Operating 700 1060hPa Transport Storage
2. Supplementary information 1 T1 10 C above the maximum temperature of relevant part determined per 11 1 1 or 85 C the higher of the two 10 C not added to T1 when temperature measured by an embedded thermocouple Used gradual transition from one temperature to another Dielectric test voltage V Test voltage in 8 8 3 times 1 6 Dielectric strength test after humidity preconditioning per Cl 5 7 except for 48 h only Breakdown Yes No Supplementary information 1 T1 10 C above the maximum temperature of relevant part determined per 11 1 1 or 85 C the higher of the two 10 C not added to T1 when temperature measured by an embedded thermocouple Used gradual transition from one temperature to another 8 10 TABLE list of critical components Pass object part or manufacturer type model technical data standard mark s of Description trademark Edition year conformity 01 Power HITRON HEMP152G Input 100 ANSI AAMI ES UL cUL CB Adapter ELECTRONICS S240060 7 240Vac 50 60601 1 2005 issued by TUV CORP 60Hz 1 9 0 8A IEC60601 RH TUV Issue Date 2014 03 27 Page 122 of 181 Report Reference 1402012 draft report 8 10 TABLE list of critical components Pass object part or manufacturer type model technical data standard mark s of Description trademark Edition year conformity Output DC 24V
3. 2 Sparks resulted in ignition Yes No Supplementary information Test procedure of 11 2 2 1 a 5 amp Figs 35 37 used for tests For circuits not in Figs 35 37 test voltage or current set at 3 times the worst case values with other parameters set at worst case values to determine if ignition can occur Issue Date 2014 03 27 Page 144 of 181 Report Reference 1402012 draft report 11 3 RM TABLE Constructional requirements for fire enclosures of ME equipment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph ONYX 122 121DT The RMF mention the Intended use intended Pass series_RMF_2012_6_28 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 02 C 02 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 01 H 02 C 02 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 02 C 02 ONYX 122 121DT series_RMF_2012_6_28 Section Risk graph before measures VENUS The risk control measures selected were Pass 191_RMF_2014_02_24 recorded in the ri
4. Clause of Document Ref in RMF Result Remarks Verdict SO 14971 Document No and paragraph RM TABLE Supply Terminals Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 4 VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 07 both normal and fault conditions H 01 H 02 H 03 Issue Date 2014 03 27 Page 109 of 181 Report Reference 1402012 draft report 7 4 2 RM TABLE Control devices Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph The manufacturer had compiled a list of known or Pass 191_ RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis F 07 both normal and fault conditions H 01 H 02 H 03 RM TABLE Safety signs N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE General accompanying documents See Table C 4 Pass Clause of Document Ref in RMF Result Remarks Verdict SO 14971 Document No and paragraph 4 2 VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 02_24 foreseeable hazards associated with the unit in Section Risk analysis F
5. draft report 15 4 4 RM TABLE Indicators Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RM mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 06 both normal and fault conditions H 01 C 01 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02_24 risk management file Section Evaluation of risk before measures F 06 H 01 C 01 15 4 5 RM TABLE Pre set controls N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 6 TABLE actuating parts of controls of ME EQUIPMENT torque amp axial pull tests Rotating control Gripping diameter Torque from Axial force Unacceptable Remarks under test d of control knob Table 30 Nm applied N RISK occurred mm 1 Yes No Supplementary information 1 Gripping diameter d is the maximum width of a control knob regardless of its shape e g control knob with pointer 15 4 7 3 bb RM TABLE Entry of liquids N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 158 of 181 Report Reference 1402012 draft report T
6. eeeeeeeeeceeeeeeeeeeeetteeeeeeeeeee N A PROTECTIVE measures prevented TRAPPING ZONE from reach or when it was reached SYSTEM movement stopped once ME EQUIPMENT started to move and in the latter case no HAZARD or damage resulted N A when PROTECTIVE measure was in a single FAULT CONDITION and an unacceptable RISK could arise one or more emergency stopping device s provided N A RISK MANAGEMENT FILE reviewed and all conditions confirmed N A 9 2 2 5 Continuous activation N A TRAPPING ZONE not considered to present a MECHANICAL HAZARD where impractical to make TRAPPING ZONE inaccessible when a movement was in OPERATOR S field of view N A N A b movement of ME EQUIPMENT or its parts was possible only by continuous activation of control by OPERATOR as long as OPERATOR response to deactivate device relied upon to prevent HARM N A Manually operated movements complied with this clause since mass and velocity allowed adequate control of positioning without causing an unacceptable RISK N A c when in a SINGLE FAULT CONDITION of continuous activation system an unacceptable RISK could arise one or more emergency stopping device s provided in ME EQUIPMENT 0 N A 9 2 2 6 Speed of movement s positioning parts of ME EQUIPMENT or PATIENT when contact with ME EQUIPMENT could result in a HAZARDOUS SITUATION limited to allow OPERATOR control of p
7. 8 9 2 a Short circuiting of each single one of CREEPAGE DISTANCES and CLEARANCES in turn did not result in a HAZARDOUS SITUATION for insulation in MAINS PART between parts of opposite polarity therefore min CREEPAGE and CLEARANCES not applied cceceeeeeeeeeee Evaluated in part of power supply N A b Contribution to CREEPAGE DISTANCES of grooves or air gaps less than 1 mm wide limited to widths Pass c Relative positioning of CLEARANCE providing a MEANS OF PROTECTION is such that the relevant parts are rigid and located by molding or there is no reduction of a distance below specified value by deformation or movement of parts Normal or likely limited movements of relevant parts taken into consideration when calculating minimum AIR CLEARANCE Pass Pass 8 9 3 Spaces filled by insulating compound N A 8 9 3 1 Only solid insulation requirements applied where distances between conductive parts filled with insulating compound were such that CLEARANCES and CREEPAGE DISTANCES don t exist No insulating compound provided N A Thermal cycling humidity preconditioning and dielectric strength tests in 8 9 3 2 and 8 9 3 4 or 8 9 3 3 and 8 9 3 4 conducted N A 8 9 3 2 For insulating compound forming solid insulation N A Issue Date 2014 03 27 Page 42 of 181 Report Reference 1402012 draft report between conductive parts a single sa
8. EQUIPMENT was de energized after removal of ACCESS COVERS didn t exceed 60V or calculated stored charge didn t exceed 45uC A device manually discharging capacitors used N A when automatic discharging was not possible and ACCESS COVERS could be removed only with aid of a TOOL Capacitor s and connected circuitry marked with N A symbol 24 of Table D 1 IEC 60417 5036 DB 2002 10 and manual discharging device specified in technical description ccceceeeeeeeeeeeeeeeeee 8 5 Separation of parts Pass 8 5 1 MEANS OF PROTECTION MOP Pass 8 5 1 1 Two MEANS of PROTECTION provided for ME Pass EQUIPMENT to prevent APPLIED and other ACCESSIBLE PARTS from exceeding limits in 8 4 Each MEANS OF PROTECTION categorized as a Evaluated in part of power Pass MEANS OF PATIENT PROTECTION or a MEANS supply 2 MOPP provided OF OPERATOR PROTECTION taking into between primary to secondary account Clause 4 6 and flow chart in Fig A 12 circuit Varnishing enameling oxidation and similar N A protective finishes and coatings with sealing compounds replasticizing at temperatures expected during operation and sterilization disregarded as MEANS OF PROTECTION Coatings and other insulation intended as a N A MEANS OF PROTECTION complying with IEC 60950 1 2001 considered acceptable as a MEANS OF OPERATOR PROTECTION but not automatically as a MEANS OF PATIENT PROTECTION RISK MANAGEMENT PROCESS
9. IEC 60417 5032 Pass RATED supply frequency or RATED frequency range in hertz eee eee e cece eeeeeeeeeeeeeeeeeeeeeeeteeeeeeeeee Symbol 9 of Table D 1 symbol IEC 60417 5172 DB 2003 02 used for CLASS II ME EQUIPMENT 50 60Hz Class equipment Pass N A 7 2 7 RATED input in amps or volt amps or in watts when power factor exceeds 0 9 A VA W 5 For adapter 1 9 0 8A For computer unit 6 25A Pass RATED input for one or more RATED voltage ranges provided for upper and lower limits of the range or ranges when the range s is are greater than 10 of the mean value of specified rangen AG VAUW Jaa antes a T No such marking N A Input at mean value of range marked when range limits do not differ by more than 10 from mean value A VA W ohei esien ania N A Marking includes long time and most relevant momentary volt ampere ratings when provided each plainly identified and indicated in ACCOMPANYING DOCUMENTS VA N A Marked input of ME EQUIPMENT provided with means for connection of supply conductors of other electrical equipment includes RATED and marked output of such means A VA W ssessssssseese 24Vdc 6 25A for unit input rating Pass 7 2 8 Output connectors Pass 7 2 8 1 See 16 9 2 1 b for MULTIPLE SOCKET OUTLETS integral with ME EQUIPMENT No multiple socket outlets used N A 7 2 8 2 Output connectors a
10. ME EQUIPMENT RATED to operate at an altitude specified by MANUFACTURER M 3000 m Pass Operating altitude corresponding to actual air pressure for ME EQUIPMENT intended for pressurized environments e g aircraft used to determine multiplication factor from Table 8 and AIR CLEARANCE was multiplied by this factor Pass CREEPAGE DISTANCES not subjected to multiplication factors but were at least as large as the resulting value for AIR CLEARANCE Pass 8 9 1 6 When WORKING VOLTAGE was between those in Tables 11 to 16 inclusive CREEPAGE and CLEARANCES calculated as follows Pass CREEPAGE DISTANCES determined by linear interpolation between the nearest two values and the calculated spacing rounded off to the next higher 0 1 mm increment MM eee See Insulation Diagram Table Pass CLEARANCES for PEAK WORKING VOLTAGES above 2800 V peak or d c determined by linear interpolation between the nearest two values and the calculated spacing rounded off to the next higher 0 1 mm increment MM eee Evaluated in part of power supply N A for AIR CLEARANCES corresponding to PEAK WORKING VOLTAGE up to 2800 V peak or d c the higher of the two values applied N A 8 9 1 7 Material groups classified in accordance with Table 9 Material Group 0 eeeeeeceeeeeeeeeeeeetteeeeetteeeeeenaees Material group evaluated using 50 drops of solution A based on test data fo
11. The results complied with the requirements of the Standard REVERSED BATTERY CONNECTION OVERCHARGING IEC 60601 1 3rd Edition Clause 15 4 3 Issue Date 2014 03 27 Page 161 of 181 Report Reference 1402012 draft report Enclosure National Differences Austria Belgium Canada Czech Republic Denmark Finland France Germany Hungary Italy Netherlands Norway Poland Slovakia Slovenia Sweden Switzerland Turkey USA Ukraine United Kingdom No National Differences Declared Only Group Differences Issue Date 2014 03 27 Page 162 of 181 Report Reference 1402012 draft report Canada Differences to IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 1 Scope object and related documents Noted Pass 1 1 Scope Noted Pass 1 1 This standard applies to the BASIC SAFETY and _ Noted Pass ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be installed in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 CAN CSA C22 2 No 0 and CAN CSA Z3z2 1 1 NOTE 1A In the IEC 60601 standards series Noted Pass adopted for use in Canada the Canadian particular standards may modify replace or delete requirements contained in this standard as appropriate for the particular ME EQUIPMENT and ME SYSTEMS under consideration and may add other BASIC SAFETY and ESSENTIAL PERFORMANCE requirements 1 3 Collateral standards Noted
12. Equipment symbol 7 6 2 Symbols required by this standard conform to IEC Complied with table D 1 Pass or ISO publication referenced 7 6 3 Symbols used for controls and performance No such function N A conform to the IEC or ISO publication where symbols are defined as applicable 7 7 Colours of the insulation of conductors Pass 7 7 1 PROTECTIVE EARTH CONDUCTOR identified by N A green and yellow insulation 7 7 2 Insulation on conductors inside ME EQUIPMENT N A forming PROTECTIVE EARTH CONNECTIONS identified by green and yellow at least at terminations 7 7 3 Green and yellow insulation identify only following N A conductors PROTECTIVE EARTH CONDUCTORS N A conductors specified in 7 7 2 N A POTENTIAL EQUALIZATION CONDUCTORS No potential equalization N A terminals used FUNCTIONAL EARTH CONDUCTORS No functional earth terminals N A used 7 7 4 Neutral conductors of POWER SUPPLY CORDS N A are light blue specified in IEC 60227 1 or IEC 60245 1 7 7 5 Colours of conductors in POWER SUPPLY Pass CORDS in accordance with IEC 60227 1 or IEC 60245 1 7 8 Indicator lights and controls N A 7 8 1 Red indicator lights mean Warning i e immediate No red color indicator light N A response by OPERATOR required Yellow indicator lights mean Caution i e prompt N A response by OPERATOR required Green indicator lights mean Ready for use Green LED used N A Other colours if used Meaning other than red N A yellow or green colour meaning 7 8
13. Medical electrical equipment Part 1 General requirements for basic safety and essential performance ANSI AAMI ES60601 1 2005 1st Edition including national differences of USA CAN CSA C22 2 No 60601 1 08 2nd Edition including national differences of Canada e The product was not investigated to the following standards or clauses Clause 17 Electromagnetic Compatibility IEC 60601 1 2 Clause 7 1 1 7 1 2 Usability IEC 60601 1 6 Clause 11 7 Biocompatibility ISO 10993 1 Clause Environmentally Conscience Design IEC 60601 1 9 e The degree of protection against harmful ingress of water is Ordinary e The following accessories were investigated for use with the product None e The mode of operation is Continuous e The product is suitable for use in the presence of a flammable anesthetics mixture with air or oxygen or with nitrous oxide No e Clause 14 Software PEMS is relied upon for meeting Basic Safety and Essential Performance No e The product is sutiable for use in an Oxygen Rich Environment No e Manufacturer s Recommended Ambient 40 deg C Issue Date 2014 03 27 Page 6 of 181 Report Reference 1402012 draft report Issue Date 2014 03 27 Page 7 of 181 Report Reference 1402012 draft report INSULATION DIAGRAM SIP SOP LCD panel D Integrated LCD Systems Issue Date 2014 03 27 Page 8 of 181 Report Reference 1402012 draft report Table to ins
14. No unacceptable RISK due to unwanted lateral movement resulted when MOBILE ME EQUIPMENT placed in its transport position or worst case NORMAL USE position with SAFE WORKING LOAD and locking device activated on a 10 inclined hard flat surface with castors in the worst case position Should be evaluated as part of the end product N A Following initial elastic movement creepage and pivoting of castors no further movement of MOBILE ME EQUIPMENT gt 50 mm in relation to inclined plane occurred mm Should be evaluated as part of the end product N A RISK due to any initial movement assessed taking into consideration NORMAL USE of ME EQUIPMENT Should be evaluated as part of the end product N A 9 4 3 2 Instability excluding transport N A a Further movement of ME EQUIPMENT after initial elastic movement was less than 50 mm when MOBILE ME EQUIPMENT with a SAFE WORKING LOAD positioned on a 5 inclined hard flat surface with wheel locked or braking system activate GTIN Jee iaa Ea EEEE EA f Should be evaluated as part of the end product N A RISK due to initial movements assessed taking into consideration NORMAL USE of ME EQUIPMENT Should be evaluated as part of the end product N A b TRANSPORTABLE or STATIONARY ME EQUIPMENT for use on the floor and with a SAFE WORKING LOAD prepared as in 9 4 2 2 and placed on a horizontal plane with locking device activated and castors when
15. Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 01 H 02 C 02 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 02 C 02 VENUS 191_RMF_2014_02_24 Section Risk graph before measures Issue Date 2014 03 27 Page 154 of 181 Report Reference 1402012 draft report 15 3 3 RM TABLE Impact test Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RM mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 02 C 02 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 01 H 02 C 02 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 02 C 02 VENUS 191_RMF_2014 02_24 Section Risk graph before measures Issue Date 2014 03 27 Page 155 of 181 Report Reference 1402012 draft report 15 3 4 2 RM TABLE
16. SAFETY and ESSENTIAL PERFORMANCE to be treated as defibrillation following exposure to defibrillation voltage and protected applied parts recovery time stated in ACCOMPANYING DOCUMENTS ieira teal a eaei 8 5 5 2 Means provided to limit energy delivered to a 100 No defibrillation protected N A Ohm load to at least 90 of energy delivered to applied parts or parts needed this load with ME EQUIPMENT disconnected to be treated as defibrillation protected applied parts 8 6 Protective and functional earthing and potential equalization of ME EQUIPMENT Pass 8 6 1 Requirements of 8 6 2 to 8 6 8 applied N A Parts complying with IEC 60950 1 for protective No protective earth N A earthing and serving as MEANS OF OPERATOR PROTECTION but not PATIENT PROTECTION exempted from requirements of 8 6 2 to 8 6 8 8 6 2 PROTECTIVE EARTH TERMINAL is suitable for Evaluated in part of power N A connection to an external protective earthing supply system by a PROTECTIVE EARTH CONDUCTOR ina POWER SUPPLY CORD and a suitable plug or by a FIXED PROTECTIVE EARTH CONDUCTOR aaa Sis eel pete a aaa eh diane diadayt Clamping means of PROTECTIVE EARTH No clamping N A TERMINAL of ME EQUIPMENT for FIXED supply conductors or POWER SUPPLY CORDS comply with 8 11 4 3 and cannot be loosened without TOOL Screws for internal PROTECTIVE EARTH No Screw provided N A CONNECTIONS completely covered or protected against accidental loosening from outside Earth pin of APPL
17. Type SVr SVRO SVE or equivalent or similar N A multiple conductor appliance wiring material 8 11 iii An assembly of insulated wires each with a N A nominal insulation thickness of 0 8 mm 1 32 inch or more 8 11 enclosed in acceptable insulating tubing having a N A nominal wall thickness of 0 8 mm 1 32 inch or more 8 11 Receptacles provided as part of me equipment and N A me systems for use in the patient care areas of Issue Date 2014 03 27 Page 168 of 181 Report Reference 1402012 draft report pediatric wards rooms or areas are Listed tamper resistant 8 11 or employ a Listed tamper resistant cover in N A accordance with NEC 8 11 3 2 Addition The flexible cord is a type acceptable for N A the particular application 8 11 3 2 and it is acceptable for use at a voltage not less N A than the rated voltage of the appliance 8 11 3 2 and has an ampacity as in NEC not less than the N A current rating of the appliance Issue Date 2014 03 27 Page 169 of 181 Report Reference 1402012 draft report Enclosures Type Supplement ld Description Marking Plate 13 01 Label Photographs 3 01 Overall View 1 for VENUS 191 Photographs 3 02 Overall View 2 for VENUS 191 Photographs 3 03 Overall View for all External I O ports of Computer Photographs 3 04 Internal View for VENUS 191 Diagrams 4 01 Enclosure dimension drawing for VENUS 191 Diagrams 4 02
18. 07 both normal and fault conditions H 01 H 02 H 03 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 07 H 01 H 02 H 03 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 07 H 01 H 02 H 03 VENUS The results of this risk evaluation were recorded Pass 191_ RMF 2014 02 24 in the risk management file Section Release protocols of measures F 07 H 01 H 02 H 03 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Release protocols of measures RC 010 Issue Date 2014 03 27 Page 110 of 181 Report Reference 1402012 draft report 7 9 2 4 RM TABLE Electrical power source Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph 7 9 3 2 RM TABLE Replacement of fuses power supply cords other parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph interruption of any one power carrying conductor Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The manufacturer had compiled a list of known or Pass 191_ RMF 2014 02 24 foreseeable hazards associated with the unit in S
19. 1 2005 6 25A EN60601 1 2006 02 Various Various Rated minimum UL 758 UL444 UL Interconnecting 30 V 60 degree Cable optional C maximum 3 05 m long jacketed 03 Secondary Various Various Rated 60 degree UL 758 UL Internal Wiring C minimum Low Voltage minimum 30 V FEP PTFE PVC TFE neoprene polyimide or marked VW 1 FT 1 04 Insulating Various Various FEP PTFE UL 1441 UL 224 UL Tubing Sleeving PVC TFE neoprene polyimide or marked VW 1 or FT 1 105 degree C 300V and openings see enclosure 4 02 for dimension 05 Connectors Various Various Metal Plastic QMFZ2 ECBT2 UL and Receptacles Copper alloy RTRT2 XCFR2 secondary pins housed in DUXR or ELV SELV bodies of plastic DUXR2 circuits rated V 2 minimum 06 Label CAR TONG CO CT M002 Application to UL969 UL MH19370 plastic enclosure min 60 degree C 07 LCD Panel AU OPTRONICS M190ETNO 1 0 19 inch TFT For Model CORP LCD Module with VENUS 191 LED backlight 08 Plastic Various Various Plastic V 1 min UL94 UL Enclosure For 2 0 thickness Model VENUS 80 C overall see 191 enclosure for dimension details 09 Speaker Two provided Optional 4 0 ohm 1 5 W 10 Outer a Aluminium alloy ini Metal Enclosure 1 0 mm For Model thickness VENUS 191 minimum overall Issue Date 2014 03 27 Page 123 of 181
20. 10 of d c voltage and N A CIRCUITS in INTERNALLY powered ME EQUIPMENT N A 8 9 1 13 For PEAK WORKING VOLTAGES above 1400 V peak or d c Table 15 not applied since all the following conditions were met Evaluated in part of power supply N A Issue Date 2014 03 27 Page 41 of 181 Report Reference 1402012 draft report CLEARANCE was at least 5 mm N A insulation complied with dielectric strength test of 8 8 3 using an a c test voltage with an r m s value equal to 1 06 times PEAK WORKING VOLTAGE or N A a d c test voltage equal to peak value of a c test voltage with an r m s value equal to 1 06 times PEAK WORKING VOLTAGE and N A CLEARANCE path was partly or entirely through AIR or along the surface of an insulating material of material group N A Dielectric strength test conducted only across part s of the path that are through air when CLEARANCE path was also partly along surface of a non group material N A 8 9 1 14 Minimum CREEPAGE DISTANCES for two MEANS OF OPERATOR PROTECTION obtained by doubling values in Table 16 for one MEANS OF OPERATOR PROTECTION MOPP provided N A 8 9 1 15 CREEPAGE DISTANCES and AIR CLEARANCES for DEFIBRILLATION PROOF APPLIED PARTS are 4 mm or more to meet 8 5 5 1 No defibrillation protected applied parts or parts needed to be treated as defibrillation protected applied parts N A
21. 13 1 2 Constructional requirements were met or Pass constructional requirements specifically analysed See appended RM Results Pass in RISK MANAGEMENT FILE Table 11 3 Justification when requirement not met The constructional Pass requirements were met a Flammability classification of insulated wire See appended Table 8 10 Pass within fire ENCLOSURE is FV 1 or better based on IEC 60695 series as determined by examination of data on materials Flammability classification of connectors printed Pass circuit boards and insulating material on which See appended Table 8 10 components are mounted is FV 2 or better based on IEC 60695 11 10 as decided by examination of materials data If no FV Certification FV tests based on IEC N A 60695 11 10 conducted on 3 samples of complete parts or sections of it including area with min thickness ventilation openings b Fire ENCLOSURE met following Pass 1 No openings at bottom or as specified in Fig 39 Numerous openings provided Pass constructed with baffles as in Fig 38 or made of perforated metal as in Table 25 or a metal screen No hazardous part within projection area at a 50 angle Issue Date 2014 03 27 Page 66 of 181 Report Reference 1402012 draft report with a mesh 2x2 mm centre to centre and wire diameter of at least 0 45 mm from edge of the opening Meet Table 25 2 No openings on the sides within the area included within the
22. 2 Red used only for emergency control No such function N A with an integral MULTIPLE SOCKET OUTLET Issue Date 2014 03 27 Page 21 of 181 Report Reference 1402012 draft report 7 9 ACCOMPANYING DOCUMENTS Pass 7 9 1 ME EQUIPMENT accompanied by documents User manual provided Pass containing at least instructions for use and a technical description ACCOMPANYING DOCUMENTS identify ME Pass EQUIPMENT by the following as applicable Name or trade Name of MANUFACTURER and ONYX HEALTHCARE INC Pass an address the RESPONSIBLE ORGANIZATION Can be referred tO ccccceeeeeeeeeeeceeeeeeeeseteeenteeees MODEL or TYPE REFERENCE See report page 1 for details Pass When ACCOMPANYING DOCUMENTS provided See Appended RM Results Pass electronically e g on CDROM RISK Table 7 9 1 MANAGEMENT PROCESS includes instructions as to what is required in hard copy or as markings on ME EQUIPMENT for emergency operation ACCOMPANYING DOCUMENTS specify special N A skills training and knowledge required of OPERATOR or RESPONSIBLE ORGANIZATION and environmental restrictions on locations of use ACCOMPANYING DOCUMENTS written at a level N A consistent with education training and other needs of individuals for whom they are intended 7 9 2 Instructions for use include the required information Pass 7 9 2 1 intended use of ME EQUIPMENT See User Manual Safety
23. 2014 03 27 Page 138 of 181 Report Reference 1402012 draft report 1 2 3 5 Test on Model VENUS 191 Horizontal 90 degree charging mode Ambient Shift to 40 degree O oa e ances ouside nerui a w a E S oa ED EFES aJa aAa za O o 45 9 61 6 39 5 55 2 28 4 44 1 5 oe FrontPaneinear Power buon 71 Test on Model VENUS 191 Horizontal charging mode Ambient Shift to 40 degree 4 75 71 85 75 71 71 71 56 75 71 PCB near U40 51 6 65 5 L20 coil 105 52 0 65 9 Issue Date 2014 03 27 Page 139 of 181 Report Reference 1402012 draft report Lob de ee The temperatures obtained did not exceed the specified limits Issue Date 2014 03 27 Page 140 of 181 Report Reference 1402012 draft report 11 1 1 RM TABLE Maximum temperature during normal use Table 23 or 24 Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014_02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 02 C 01 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 01 H 02 C 01 VENUS The results
24. 25 14 or N A ME EQUIPMENT placed such that axis of cord guard projected at an angle of 45 with cord free from stress and a mass equal 10 x D2 gram attached to the free end of Cord 9 N A Cord guard of temperature sensitive material tested at 23 C 2 C and flat cords bent in the plane of least resistance N A Curvature of the cord radius immediately after mass attached was not less than 1 5 x D N A 8 11 4 MAINS TERMINAL DEVICES N A 8 11 4 1 PERMANENTLY INSTALLED and ME EQUIPMENT with non DETACHABLE POWER SUPPLY CORD replaceable by SERVICE PERSONNEL provided with MAINS TERMINAL DEVICES ensuring reliable connection Appliance inlet was provided N A Terminals alone are not used to keep conductors in position except when barriers are provided such that CREEPAGE and CLEARANCES cannot be reduced below 8 9 if any conductor breaks away N A Terminals of components other than terminal blocks complying with requirements of this Clause and marked according to 7 3 7 used as terminals intended for external conductors N A Issue Date 2014 03 27 Page 47 of 181 Report Reference 1402012 draft report Screws and nuts clamping external conductors do N A not serve to secure any other component except they also clamp internal conductors when unlikely to be displaced when fitting the supply conductors 8 11
25. 4 2 Arrangement of MAINS TERMINAL DEVICES N A a Terminals provided for connection of external No mains terminal devices N A cords or POWER SUPPLY CORDS together with used PROTECTIVE EARTH TERMINAL grouped to provide convenient means of connection b PROTECTIVE EARTH CONDUCTOR No mains terminal devices N A connections complied with 8 6 used c Marking of MAINS TERMINAL DEVICES No mains terminal devices N A complied with 7 3 used d MAINS TERMINAL DEVICES not accessible No mains terminal devices N A without use of a TOOL used e AMEANS OF PROTECTION are not short No mains terminal devices N A circuited when one end of a flexible conductor with used NOMINAL cross sectional area is stripped 8 mm and a single free wire is bent in each possible direction 8 11 4 3 Internal wiring not subjected to stress and No mains terminal devices N A CREEPAGE and CLEARANCES not reduced used below 8 9 after fastening and loosening a conductor of largest cross sectional area 10 times 8 11 4 4 Terminals with clamping means for a rewirable No mains terminal devices N A flexible cord did not require special preparation of used conductors and conductors were not damaged and did not slip out when clamping means tightened as verified by test of 8 11 3 4 8 11 4 5 Adequate space provided inside ME EQUIPMENT No mains terminal devices N A designed for FIXED wiring or a re wirable POWER used SUPPLY CORD to allow for connection of conductors and covers fitted without dama
26. 7 but not less than 3000 V r m s or 4200 V peak for BASIC and N A SUPPLEMENTARY INSULATION 6000 V r m s or 8400 V peak for REINFORCED N A INSULATION Issue Date 2014 03 27 Page 99 of 181 Report Reference 1402012 draft report 4 2 RM TABLE Risk Management Process for ME Equipment or ME Systems Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The Risk Management Procedure define the Pass 191_RMF_2014_ 02_24 policy for determining acceptable risk taking into Section Definition of risk account relevant International Standards and graph national or regional regulations VENUS 191_RMF_2014 02_24 Section Additional documents VENUS The Risk Management Plan defined the criteria Pass 191_ RMF 2014 02 24 for risk acceptability Section Criteria for release of risk analysis VENUS 191_RMF_ 2014 02_24 Section Criteria for release of risk analysis VENUS Risk analysis procedure Pass 191 _RMF_2014 02 24 Section Criteria for release of risk analysis VENUS Intended use and identification of characteristics Pass 191_RMF_2014_02_24 are well defined Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191 RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis both normal and fault conditions VENUS The estimates of the risk s were record
27. A coverage criteria for verification N A 14 11 A pems validation plan containing validation of N A basic safety amp essential performance and requiring checks for unintended functioning of pems to perform and document pems validation The person with overall responsibility for pems N A validation is independent of design team and no member of a design team is responsible for pems validation of their own design All professional relationships of members of pems N A validation team with members of design team documented in risk management file providing methods amp results of pems validation 14 12 Continued validity of previous design N A documentation assessed under a documented modification change procedure 14 13 Technical description includes the following N A information when pems is to be connected to other equipment outside control of pems manufacturer by network data coupling eccceeeeseteeeeesteeeeeeenaeees a characteristics of network data coupling N A necessary for pems to achieve its intended use b list of hazardous situations resulting from a N A Issue Date 2014 03 27 Page 76 of 181 Report Reference 1402012 draft report c instructions to responsible organization containing required information and warnings N A connection of pems to a network data coupling that includes other equipment could result in previously unidentified risks and responsible organization shall identify ana
28. A within a fire ENCLOSURE complying with 11 3 as verified by review of design documentation After tests of this Clause settings of THERMAL N A Issue Date 2014 03 27 Page 70 of 181 Report Reference 1402012 draft report CUT OUTS and OVER CURRENT RELEASES did not change sufficiently to affect their safety function 13 1 3 limits for LEAKAGE CURRENT in SINGLE FAULT CONDITION based on 8 7 3 did not exceed See appended Table 8 7 Pass voltage limits for ACCESSIBLE PARTS including APPLIED PARTS in 8 4 2 did not exceed 1 See appended Table 8 7 Pass 13 1 4 ME EQUIPMENT complied with the requirements of 9 1 to 9 8 for specific MECHANICAL HAZARDS Pass 13 2 SINGLE FAULT CONDITIONS Pass 13 2 1 During application of SINGLE FAULT CONDITIONS in 13 2 2 13 2 13 inclusive NORMAL CONDITIONS in 8 1 a applied in least favourable combination cccceeeeeeceeeeeeteeee See appended Table 13 2 Pass 13 2 2 13 2 12 ME EQUIPMENT complied with 13 2 2 13 2 12 See appended Table 13 2 Pass 13 2 13 ME EQUIPMENT remained safe after tests of 13 2 13 2 to 13 2 13 4 inclusive and cooling down to room temperature ME EQUIPMENT examined for compliance or appropriate tests such as dielectric strength of motor insulation according to 8 8 3 conducted Pass Pass For insulation of thermoplastic materials relied upon as a
29. AUXILIARY current not measured in single FAULT CONDITION of short circuiting of one constituent PART of DOUBLE insulation No Applied Part N A SINGLE FAULT CONDITIONS not applied at same time as special test conditions of MAXIMUM MAINS VOLTAGE on APPLIED PARTS and non PROTECTIVELY EARTHED parts of ENCLOSURE N A 8 7 3 Allowable Values Pass a Allowable values in 8 7 3 b c and d measured based on and are relative to currents in Fig 12 a or by a device measuring frequency contents of currents as in Fig 12 b See appended Table 8 7 Pass b Allowable values of PATIENT LEAKAGE and AUXILIARY CURRENTS are according to Tables 3 amp 4 and values of a c are relative to currents having a frequency not less than 0 1Hz No applied parts N A c TOUCH CURRENT did not exceed 100 pA in NORMAL CONDITION and 500 pA in SINGLE FAULT CONDITION ITNC ITSFC See appended Table 8 7 Pass d EARTH LEAKAGE CURRENT did not exceed 5 See appended Table 8 7 Pass Issue Date 2014 03 27 Page 36 of 181 Report Reference 1402012 draft report mA in NORMAL CONDITION and 10 mA in SINGLE FAULT CONDITION IENC IESFC Higher values of EARTH LEAKAGE CURRENT permitted for PERMANENTLY INSTALLED ME EQUIPMENT connected to a supply circuit supplying only this ME EQUIPMENT according to local regulations or IEC 60364 7 710 00 0 Not permanently installed me equipment
30. CONDITIONS Pass 13 1 Specific HAZARDOUS SITUATIONS Pass 13 1 1 None of HAZARDOUS SITUATIONS in 13 1 2 Pass 13 1 4 inclusive occurred when SINGLE FAULT CONDITIONS applied one at a time as in 4 7 and 13 2 13 1 2 Emissions deformation of ENCLOSURE or exceeding maximum temperature Pass Emission of flames molten metal poisonous or Pass ignitable substance in hazardous quantities did not occur Deformation of ENCLOSURE impairing Pass compliance with 15 3 1 did not occur Temperatures of APPLIED PARTS did not No applied part N A exceed allowable values in Table 24 when measured aS in 11 13 misein Temperatures of ME EQUIPMENT parts that are See Test table 13 2 7 for detail Pass not APPLIED PARTS likely to be touched did not exceed values in Table 23 when measured and adjusted as in 11 1 3 ooo eeeeneeeeeeeteeeeeetteeeeeeneel Allowable values for other components and Evaluated in part of power N A materials in Table 22 times 1 5 minus 12 5 C supply were not exceeded Limits for windings in Tables 26 27 and 31 not N A exceeded Table 22 not exceeded in all other cases Pass Temperatures measured according to 11 1 3 Pass SINGLE FAULT CONDITIONS in 4 7 8 1 b 8 7 2 N A and 13 2 2 relative to emission of flames molten metal or ignitable substances not applied to parts and components where Supply circuit was unable to supply 15 W one N A minute after 15 W drawn from supply circuit or Parts and components completely contained N
31. Date 2014 03 27 Page 57 of 181 Report Reference 1402012 draft report PRESSURE when pressure was gt 50 kPa and product of pressure and volume was more than ZOO IKPal ierre cee atin eat ed ee rae 9 7 6 Pressure control device regulating pressure in ME EQUIPMENT with pressure relief device completed 100 000 cycles of operation under RATED load and prevented pressure from exceeding 90 of setting of pressure relief device in different conditions of NORMAL USE eeeeeeeeee N A 9 7 7 Pressure relief device s used where MAXIMUM PERMISSIBLE WORKING PRESSURE could otherwise be exceeded met the following as confirmed by MANUFACTURER S data ME EQUIPMENT RISK MANAGEMENT FILE and functional tests tr unirsi a a N A a Connected as close as possible to pressure vessel or parts of system it is to protect N A b Installed to be readily accessible for inspection maintenance and repair N A c Could be adjusted or rendered inoperative without a TOOL d With discharge opening located and directed as to not to release material towards any person N A N A e With discharge opening located and directed as to not to deposit material on parts that could result in an unacceptable RISK N A f Adequate discharge capacity provided to ensure that pressure will not exceed MAXIMUM PERMISSIBLE WORKING PRESSURE of system it is connected to by more than 10 when failure occurs i
32. Metal part dimension drawing for VENUS 191 Diagrams 4 03 Heat Sink for CPU Miscellaneous 7 01 Carton label Issue Date 2014 03 27 Page 170 of 181 Report Reference 1402012 draft report Marking Plate ID 13 01 Issue Date 2014 03 27 Page 171 of 181 Report Reference 1402012 draft report Photographs ID 3 01 Issue Date 2014 03 27 Page 172 of 181 Report Reference 1402012 draft report Photographs ID 3 02 Issue Date 2014 03 27 Page 173 of 181 Report Reference 1402012 draft report Photographs ID 3 03 Issue Date 2014 03 27 Page 174 of 181 Report Reference 1402012 draft report Photographs ID 3 04 Issue Date 2014 03 27 Page 175 of 181 Report Reference 1402012 draft report Diagrams ID 4 01 D E Issue Date 2014 03 27 Page 176 of 181 Report Reference 1402012 draft report Diagrams ID 4 01 ree marema ma PART No MDAVEIINO Se S83 ec rom owon wn s 03 on EFE Na NA CHECKED DESONED an w LPAINTING IRAWING PRINTING DRAWING Issue Date 2014 03 27 Page 177 of 181 Report Reference 1402012 draft report Diagrams ID 4 01 Issue Date 2014 03 27 Page 178 of 181 Report Reference 1402012 draft report Diagrams ID 4 02 Issue Date 2014 03 27 Page 179 of 181 Report Reference 1402012 draft report Diagrams ID 4 02 A B i c i D i E i F G i H a Pop ee Eee ee E eg pe p Ap E Ts 3 200 05 OD 208
33. N A 1 3 Applicable Canadian collateral standards become Noted Pass normative at the date of their publication and apply together with this standard 1 3 NOTE 1 When evaluating compliance with Noted Pass CAN CSA C22 2 No 60601 1 it is permissible to assess independently compliance with the adopted Canadian collateral standards 1 4 Particular standards Noted N A 1 4 A requirement of a Canadian particular safety Noted Pass standard takes precedence over this standard 3 Terminology and definitions Noted Pass 3 41 HIGH VOLTAGE No high voltage used or N A present 3 41 any voltage above 750 V 1 050 V peak as defined No high voltage used or N A in the Canadian Electrical Code CEC Part present 48 a the applicable safety requirements of a relevant Pass CSA IEC or ISO standard or 4 8 NOTE 1 For the components it is not necessary to Pass carry out identical or equivalent tests already performed to check compliance with the component standard 4 8 b where there is no relevant CSA IEC or ISO Pass standard the requirements of this standard have to be applied 4 8 NOTE 2 If there are neither requirements in this Pass standard nor in a CSA IEC or ISO standard any other applicable source e g standards for other types of devices national standards could be used to demonstrate compliance with the RISK Issue Date 2014 03 27 Page 163 of 181 Report Reference 140
34. N A e LEAKAGE CURRENTS regardless of waveform and frequency did not exceed 10 mA r m s in NORMAL or in SINGLE FAULT CONDITION measured with a non frequency weighted device Not non frequency weighted device N A 8 7 4 LEAKAGE and PATIENT AUXILIARY CURRENTS measurements See appended Table 8 7 Pass 8 8 Insulation Pass 8 8 1 Insulation relied on as MEANS OF PROTECTION including REINFORCED INSULATION and insulation between parts of opposite polarity of MAINS PART on SUPPLY MAINS side of mains fuse or OVER CURRENT RELEASE Pass Insulation exempted from test complies with clause 4 8 Insulation forming MEANS OF OPERATOR PROTECTION and complying with IEC 60950 1 for INSULATION CO ORDINATION not tested as in 8 8 Pass N A 8 8 2 Distance through solid insulation or use of thin sheet material N A Solid insulation forming SUPPLEMENTARY or REINFORCED INSULATION for a PEAK WORKING VOLTAGE greater than 71 V provided with N A a 0 4 mm min distance through insulation or N A b does not form part of an ENCLOSURE and not subject to handling or abrasion during NORMAL USE and comprised of N A at least two layers of material each passed the appropriate dielectric strength test or N A three layers of material for which all combinations of two layers together passed the appropriate dielectric strength test N A Dielectric strength t
35. No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 02_24 foreseeable hazards associated with the unit in Section Risk analysis F 07 both normal and fault conditions H 01 H 02 H 03 VENUS The estimates of the risk s were recorded in the Pass 191_RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 07 H 01 H 02 H 03 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_ 02_24 in the risk management file Section Evaluation of risk before measures F 07 H 01 H 02 H 03 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 07 H 01 H 02 H 03 VENUS 191_RMF_2014 02_24 Section Residual risk evaluation VENUS 191_RMF_2014 02_24 Section Summary of risk control RM TABLE ME EQUIPMENT powered from other equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 7 2 13 RM TABLE Physiological effects safety signs and warning N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 2
36. Portable ME equipment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RM mention the Intended use intended Pass 191_RMF_2014 02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_ RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis F 03 both normal and fault conditions H 01 C 01 C 02 C 03 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 03 H 01 C 01 C 02 C 03 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_ 02_24 in the risk management file Section Evaluation of risk before measures F 03 H 01 C 01 C 02 C 03 VENUS 191_RMF_2014_02_24 Section Risk graph before measures 15 3 5 RM TABLE Rough handling test N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 1 RM TABLE Construction of connectors N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 2 1a RM TABLE THERMAL CUT OUTS and OVER CURRENT RELEASES N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 2 1b RM TABLE THERMAL CUT OUTS with a safety function N A Clause of Document Ref
37. Pressure relief device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Hazards associated with support systems General Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Tensile safety factor Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 134 of 181 Report Reference 1402012 draft report 9 8 3 1 RM TABLE Strength of patient or operator support or suspension systems N A General Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 8 3 2 TABLE Patient support suspension system Static forces ME Equipment part Position Load Area Remarks or area Supplementary Information 9 8 3 2a b RM TABLE Static forces due to loading from persons N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 8 3 3 TABLE Support Suspension System Dynamic forces due to loading from N A persons ME Equipment part Position Safe Working Load Area Remarks or area Supplementary Information 9 8 4 1 RM TABLE Systems with mechanical protective devices General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 8 4 3 RM TABLE Mechanical protective device for single
38. Report Reference 1402012 draft report 8 10 TABLE list of critical components Pass object part or manufacturer type model technical data standard mark s of Description trademark Edition year conformity details 11 Printed Various Various V 1 minimum UL796 UL Wiring Board 105 degree C minimum 12 RTC Battery MITSUBISHI CR2032 3 Vdc maximum UL 1642 UL ELECTRIC abnormal charge CORP current 10 mA 12a RTC HITACHI CR2032 Same as above UL 1642 UL Battery MAXELL LTD Alternate 12b RTC SONY ENERGY CR2032 Same as above UL 1642 UL Battery BAT1 DEVICES CORP Alternate 12c RTC Battery PANASONIC CR2032 Same as above UL 1642 UL Alternate CORPORATION PANASONIC CORPORATION OF NORTH AMERICA 12d RTC MITSUBISHI CR2032 Same as above UL 1642 UL Battery ELECTRIC Alternate HOME APPLIANCE CO LTD 13 Solid State Various Various 5Vdc maximum Drive SSD 1 6A 14 Heat Sink for Aluminium alloy CPU overall and openings see enclosure 4 03 for dimension details 15 Battery Pack GALLOPWIRE OPM P01T 00 10 8Vdc UL 2054 UL CB ENTERPRISE 5800mAh 62 64 IEC 60950 1 CO LTD Wh IEC 62133 16 Power Various Various Listed Hospital UL817 UL Supply Cord Grade optional maximum 6 m long rated 105 C Type SJT flexible cord No 18 AWG min 3C One end terminates with NEMA 5 15P or NEMA 6 15P grounding type t
39. See User Manual Introduction Pass Meanings of figures symbols warning statements abbreviations and indicator lights described in instructions for use See User Manual Intended of Use Pass 7 9 2 10 A list 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 N A 7 9 2 11 Information provided for the OPERATOR to safely terminate operation of ME EQUIPMENT See User Manual Safety Instructions Pass 7 9 2 12 Information provided on cleaning disinfection and sterilization methods and applicable parameters that can be tolerated by ME EQUIPMENT parts or ACCESSORIES specified Components ACCESSORIES or ME EQUIPMENT marked for single use except when required by MANUFACTURER to be cleaned disinfected or sterilized prior to use See User Manual Safety Instructions Pass N A 7 9 2 13 Instructions provided on preventive inspection calibration maintenance and its frequency N A Information provided for safe performance of routine maintenance necessary to ensure continued safe use of ME EQUIPMENT N A Parts requiring preventive inspection and maintenance to be performed by SERVICE PERSONNEL identified including periods of application N A Instructions provided to ensure adequate maintenance of ME EQUIPMENT cont
40. The equipment did not overbalance ME EQUIPMENT Test Condition excluding transport preparation position Test either 5 incline and verify Warning marking or 10 incline 5 degree Incline 9 4 2 2 LCD system with base front side Supplementary information The equipment did not overbalance 9 4 2 3 TABLE Instability overbalance from horizontal and vertical forces ME EQUIPMENT Test Condition force used direction of Remarks preparation force weight of equipment location of force Supplementary information 9 4 2 4 2 TABLE Castors and wheels Force for propulsion ME EQUIPMENT Test Condition force location and height Remarks preparation Supplementary information 9 4 2 4 3 TABLE Castors and wheels Movement over a threshold ME EQUIPMENT Test Condition speed of movement Remarks preparation Supplementary information Issue Date 2014 03 27 Page 132 of 181 Report Reference 1402012 draft report 9 4 2 4 3 RM TABLE Movement over a threshold Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph 9 4 3 1 TABLE Instability from unwanted lateral movement including sliding in transport position ME EQUIPMENT Test Condition transport position working Remarks preparation load locking device s caster position Supplementary information 9 4 3 2 TABLE Instability from unwanted lateral movement including sliding excluding transpo
41. Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 _02_24 foreseeable hazards associated with the unit in Section Risk analysis both normal and fault conditions VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures Issue Date 2014 03 27 Page 105 of 181 Report Reference 1402012 draft report 5 7 RM TABLE Humidity preconditioning treatment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 _02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 01 C 09 VENUS The estimates of the risk s were recorded in the Pass 191_RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 01 H 01 C 09 ONYX 122 221DT The results of this risk evaluation were recorded Pass series_RMF_2013_11_29 in the risk management file Section Evaluation of risk before measures F 01 H 01 C 09 VENUS The ri
42. activation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 135 of 181 Report Reference 1402012 draft report 9 8 5 RM TABLE Systems without mechanical protective devices Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014_02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 02 both normal and fault conditions H 01 C 01 C 02 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 02 H 01 C 01 C 02 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 02 H 01 C 01 C 02 VENUS 191_RMF_2014 02_24 Section Risk graph before measures VENUS The risk control measures selected were Pass 191_RMF_2014_02_24 recorded in the risk management file Section Release protocols of measures RC 009 RC 012 VENUS The effectiveness of the risk control measures Pass 191_RMF _ 2014 02 24 had be verified and the results of the verification Sectio
43. bidien N A Combinations of currents and corresponding voltages within the limitations IZR UZR lt 50 W extrapolated from Fig G 1 N A Issue Date 2014 03 27 Page 92 of 181 Report Reference 1402012 draft report No extrapolation made for voltages above 42 V N A Combinations of capacitances and corresponding N A voltages within limitations of C 2U2 lt 1 2 mJ extrapolated from Fig G 2 No extrapolation made for voltages above 242V N A Umax additionally determined using actual N A resistance R when the equivalent resistance R was less than 8000 Q Combinations of currents and corresponding N A inductances within limitations L 212 lt 0 3 mJ extrapolated from Fig G 3 No extrapolation made for inductances larger than N A 900 mH Umax was the highest supply voltage occurring in N A circuit under investigation with sparking contact open taking into consideration MAINS VOLTAGE variations in 4 10 Imax was the highest current flowing in circuit N A under investigation with sparking contact closed taking into consideration MAINS VOLTAGE variations required in 4 10 Cmax and Lmax taken as values occurring at the N A component under investigation producing sparks Peak value considered when a c supplied N A An equivalent circuit calculated to determine N A equivalent max capacitance inductance and equivalent Umax and Imax either as d c or a
44. c Carrying handles and grips and their means of attachment withstood loading test N A 9 5 Expelled parts HAZARD N A 9 5 1 Suitability of means of protecting against unacceptable RISK of expelled parts determined by assessment and examination of RISK MANAGEMENT FILE ccceeeeeeeeeeteeeeeeeeeee N A 9 5 2 Cathode ray tube s complied with IEC 60065 2001 Clause 18 or IEC 61965 ee N A 9 6 Acoustic energy including infra and ultrasound and vibration N A 9 6 1 Human exposure to acoustic energy and vibration from ME EQUIPMENT doesn t result in unacceptable RISK as confirmed in RISK MANAGEMENT FILE including audibility of auditory alarm signals PATIENT sensitivity and tests Of 9 6 2 ANd 9 6 3 0 cece etteeeeeetnteeeeeenel N A 9 6 2 Acoustic energy N A 9 6 2 1 PATIENT OPERATOR and other persons are not exposed to acoustic energy from ME EQUIPMENT in NORMAL USE except for auditory alarm signals 80 dBA for a cumulative exposure of 24 h over a 24 h period ABA eeeceeeeeeeeeseteeeeeeteteeeeeenneeeereney no such parts N A 83 dBA when halving the cumulative exposure time ABA cnet aa nies heel a sie Ad 140 dB un weighted sound pressure level for impulsive or impact acoustic energy dB 1 9 6 2 2 RISK MANAGEMENT FILE examined for RISKS associated with infrasound or ultrasound when present addre
45. equal to or less than RESIDUAL RISKS resulting from requirements of this standard 46 RISK MANAGEMENT PROCESS identifies parts No such parts N A that can come into contact with PATIENT but not defined as APPLIED PARTS subjected to the requirements for APPLIED PARTS except for Clause F210 nits ented tallies a 4 7 ME EQUIPMENT remained SINGLE FAULT SAFE See appended RM Results Pass or the RISK remained acceptable as determined by Table 4 7 Clase 4 2 ida i detente elas tee een anced Failure of any one component at a time that could See appended RM Results Pass result ina HAZARDOUS SITUATION including Table 4 7 those in 13 1 simulated physically or theoretically RISK associated with failure of component during See appended RM Results Pass EXPECTED SERVICE LIFE of ME EQUIPMENT _ Table 4 7 taken into account to evaluate if a component should be subjected to failure simulation 48 All components and wiring whose failure could See appended RM Results Pass result ina HAZARDOUS SITUATION used Table 4 8 according to their applicable ratings except as specified or by RISK MANAGEMENT PROCESS Reliability of components used as MEANS OF See appended RM Results Pass PROTECTION assessed for conditions of use in Table 4 8 ME EQUIPMENT and they complied with one of the following a Applicable safety requirements of a relevant IEC See appended Table 8 10 Pass or ISO standard b Requirements of this standard applied in the Power adapt
46. has been followed throughout the pems development life cycle and a record of process has been made available as confirmed by risk management file review and assessment of processes cited in this Clause N A Issue Date 2014 03 27 Page 73 of 181 Report Reference 1402012 draft report Manufacturer considered the need for additional N A risk control measures when unable to follow all processes identified in Clause 14 for each constituent component of pems as confirmed by risk management file review and assessment of processes cited in this Clause Assessment of processes cited in this Clause N A made by internal audits 14 2 Documents produced from application of Clause 14 N A are maintained and form a part of risk management file in addition to records and documents required by ISOsT49 T deste cotta edad deena 14 3 Risk management plan required by 3 5 of ISO N A 14971 includes reference to pems validation plan 14 4 A pems development life cycle including a set of N A defined milestones has been documented At each milestone activities to be completed and N A verification methods to be applied to activities have been defined Each activity including its inputs and outputs N A defined and each milestone identifies risk management activities that must be completed before that milestone Pems development life cycle tailored for a specific N A development by making plans detailing a
47. in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 156 of 181 Report Reference 1402012 draft report 15 4 2 1c RM TABLE Independent non SELF RESETTING THERMAL CUT OUT Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph 15 4 2 1d RM TABLE Loss of function of ME EQUIPMENT N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 2 1h RM TABLE ME EQUIPMENT with tubular heating elements N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 3 1 RM TABLE Housing N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 3 2 RM TABLE Connection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 3 3 RM TABLE Protection against overcharging N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 3 4 RM TABLE Lithium batteries N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 15 4 3 5 RM TABLE Excessive current and voltage protection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 157 of 181 Report Reference 1402012
48. inclined line C in Fig 39 Pass 3 ENCLOSURE baffles and flame barriers have adequate rigidity and made of appropriate metal or of non metallic materials except constructions based on Table 25 and a mesh FV 2 or better for TRANSPORTABLE ME EQUIPMENT FV 1 or better for fixed EQUIPMENT or STATIONARY EQUIPMENT per IEC 60695 11 10 determined by ENCLOSURE examination or flammability classification based on 11 3a ceeeeeeeeeee See appended Table 8 10 Pass ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT ME SYSTEMS and parts described in ACCOMPANYING DOCUMENTS for use with flammable anaesthetics CATEGORY AP or anaesthetics with oxidants CATEGORY APG comply with Annex G Not evaluated for use in the presence of flammable anesthetics N A N A ME EQUIPMENT and ME SYSTEMS intended for use in conjunction with flammable agents MANUFACTURER S RISK MANAGEMENT PROCESS addresses possibility of fire and associated mitigations as confirmed by examination of RISK MANAGEMENT FILE N A N A Overflow spillage leakage ingress of water or particulate matter cleaning disinfection sterilization and compatibility with substances used with the ME EQUIPMENT Pass 11 6 1 Sufficient degree of protection provided against overflow spillage leakage ingress of water or particulate matter cleaning disinfection and sterilization and compatibilit
49. included in ENCLOSURES complying with G 5 4 or G 5 5 N A G 5 G 5 1 ME EQUIPMENT its parts or components do not ignite FLAMMABLE AESTHETIC MIXTURES WITH AIR under NORMAL USE and CONDITIONS based on compliance with G 5 2 to G 5 5 inclusive Requirements and tests for CATEGORY AP ME EQUIPMENT parts and components N A N A Alternatively ME EQUIPMENT its parts and components complied with requirements of IEC 60079 0 for pressurized ENCLOSURES IEC 60079 2 for sand filled ENCLOSURES IEC 60079 5 or for oil immersed equipment IEC 60079 6 and with this standard excluding G 5 2 to G 5 5 0 eel N A G 5 2 ME EQUIPMENT its parts and components in contact with gas mixtures in NORMAL USE and CONDITIONS not producing sparks and not resulting in surface temperatures above 150 C in case of restricted or 200 C in case of unrestricted vertical air circulation measured at 25 C comply with G 5 1 N A G 5 3 ME EQUIPMENT its parts and components producing sparks in NORMAL USE and CONDITION complied with temperature requirements of G 5 2 and Umax and Imax occurring in their circuits and complied as follows N A Measured Umax lt Uzr with lzr as in Fig G 1 N A Measured Umax lt Uc with Cmax as in Fig G 2 Measured Imax lt lzr with Uzr as in Fig G 1 N A N A Measured Imax lt Iz with Lmax and a Umax lt 24 V as IN Fig G Setini bidentate
50. mass of PATIENTS or mass of OPERATORS plus mass of ACCESSORIES supported by ME EQUIPMENT or its parts No support systems used N A Supporting and suspending parts for adult human PATIENTS or OPERATORS designed for a PATIENT or OPERATOR with a min mass of 135 kg and ACCESSORIES with a min mass of 15 kg unless stated by MANUFACTURER No support systems used N A Maximum mass of PATIENT included in SAFE WORKING LOAD of ME EQUIPMENT or its parts supporting or suspending PATIENTS adapted when MANUFACTURER specified applications No support systems used N A Max allowable PATIENT mass lt 135 kg marked on No support systems used ME EQUIPMENT and stated in ACCOMPANYING N A Issue Date 2014 03 27 Page 59 of 181 Report Reference 1402012 draft report DOCUMENTS Max allowable PATIENT mass gt 135 kg stated in ACCOMPANYING DOCUMENTS No support systems used N A Examination of markings ACCOMPANYING DOCUMENTS and RISK MANAGEMENT FILE confirmed compliance ecceeeeeeeeeeeeeeeeeeeeeeeee No support systems used N A 9 8 3 2 Part of SAFE WORKING LOAD representing mass of PATIENTS or OPERATORS is distributed on support suspension surface representing human body as in Fig A 19 No support systems used N A Part of SAFE WORKING LOAD representing mass of ACCESSORIES deployed as in NORMAL USE and when not defined at worst case position permi
51. of 181 Report Reference 1402012 draft report 13 2 11 Failures of components in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS 13 2 12 Failure of parts that might result in a gt MECHANICAL HAZARD See 9 amp 15 3 Supplementary information 1 Test with short circuited capacitor not performed when motor provided with a capacitor complying with IEC 60252 1 and the ME EQUIPMENT not intended for unattended use including automatic or remote control See Attachment and appended Table 8 10 The measured temperatures did not exceed those allowable See Table 11 for Temperatures obtained during the indicated Abnormal Operation tests 13 2 6 RM TABLE Leakage of liquid NA Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Programmable electrical medical systems General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 14 6 1 RM TABLE Identification of known and foreseeable hazards N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 14 6 2 RM TABLE Risk control N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Requirement specification N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 151
52. of 181 Report Reference 1402012 draft report 14 8 RM TABLE Architecture Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph RM TABLE Design and Implementation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 14 10 RM TABLE Verification N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 14 11 RM TABLE PEMS validation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 14 13 RM TABLE Connection of PEMS by NETWORK DATA COUPLING to other N A equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 152 of 181 Report Reference 1402012 draft report 15 1 RM TABLE Construction of ME equipment Arrangements of controls and Pass indicators of ME equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 06 H 01 C 01 VENUS The results of this risk evaluation were recorded Pass 191_ RMF 2014 02 24 in the risk managem
53. of ME Table 7 2 17 EQUIPMENT could result in an unacceptable RISK Packaging of sterile ME EQUIPMENT or N A ACCESSORIES marked sterile 7 2 18 RATED maximum supply pressure from an No such construction N A external source marked on ME EQUIPMENT adjacent to each input Connector 7 2 19 Symbol 7 of Table D 1 IEC 60417 5017 DB 2002 No functional earth terminals N A 10 marked on FUNCTIONAL EARTH TERMINAL used 7 2 20 Protective means required to be removed to use a N A particular function of ME EQUIPMENT with alternate applications marked to indicate the necessity for replacement when the function is no longer needed 000 eee eeteeeeeeeteeeeeetaeeeeeenateeeeenaees No marking applied when an interlock provided No interlocks N A 7 3 Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts Pass 7 3 1 Maximum power loading of heating elements or No heating elements or lamp N A lamp holders designed for use with heating lamps holders provided marked near or in the heater W A marking referring to ACCOMPANYING N A DOCUMENTS provided for heating elements or lamp holders designed for heating lamps that can be changed only by SERVICE PERSONNEL using a TOOL 7 3 2 Symbol 24 of Table D 1 symbol IEC 60417 5036 No high voltage used or N A DB 2002 10 or safety sign 3 of Table D 2 used ie present mark presence of HIGH VOLTAGE parts 7 3 3 Type of battery and mode of insertion when The Computer is provided with Pass applicab
54. of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 08 both normal and fault conditions H 01 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 08 H 01 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 08 H 01 VENUS 191_RMF_2014 02 24 Section Risk graph before measures 8 3 d RM TABLE Requirements of Type BF or CF Applied Parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph TABLE Working Voltage Power Measurement N A Test supply voltage frequency V Hz 1 Measured values Location Vrms Vpk or Vdc Peak to peak Power Energy J Remarks From To ripple 2 W VA Supplementary Information 1 The input supply voltage to the ME EQUIPMENT shall be the RATED voltage or the voltage within the RATED voltage range which results in the highest measured value See clause 8 5 4 2 If the d c peak to peak ripple gt 10 waveform considered as a c See clause 8 4 2 2 Issue Date 2014 03 27 Page 112 of 181 Report Reference 1402012 draft report 8 4 2 c RM TABLE Accessible parts including applied parts Pass Clause of Document Ref in RMF Result Remarks Verdic
55. of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 02 C 01 VENUS 191_RMF_2014_02_24 Section Risk graph before measures VENUS The risk control measures selected were Pass 191_RMF_2014_02_24 recorded in the risk management file Section Release protocols of measures RC 031 VENUS The effectiveness of the risk control measures Pass 191_RMF_2014_02_24 had be verified and the results of the verification Section Release protocols of were recorded in the risk management file measures RC 031 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 02 C 01 VENUS 191_RMF_2014_02_24 Section Risk graph after measures VENUS 191_RMF_2014_02_24 Section Summary of risk control No reduction of risk through Risk benefit analysis N A Issue Date 2014 03 27 Page 141 of 181 Report Reference 1402012 draft report 11 1 2 1 RM TABLE Applied parts intended to supply heat to patient Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph 11 1 2 2 RM TABLE Applied parts not intended to supply heat to patient Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and pa
56. supplied in their worst case position Should be evaluated as part of the end product N A Further movement of ME EQUIPMENT after initial elastic movement was no more than 50 mm when a force of 25 of weight of unit but less than 220 N applied in different directions except a direction with an upwards component at highest point of ME EQUIPMENT but 1 5 m from floov 0 cee Should be evaluated as part of the end product N A RISK due to initial movements assessed taking into consideration NORMAL USE of ME EQUIPMENT Should be evaluated as part of the end product N A 9 4 4 Grips and other handling devices N A a ME EQUIPMENT other than PORTABLE EQUIPMENT or its part with a mass of over 20 kg requiring lifting in NORMAL USE or transport provided with suitable handling means or ACCOMPANYING DOCUMENTS specify safe lifting method except when handling is obvious and causing HAZARDS N A Handles when supplied suitably placed to enable N A Issue Date 2014 03 27 Page 55 of 181 Report Reference 1402012 draft report ME EQUIPMENT or its part to be carried by two or more persons and by examination of EQUIPMENT its part or ACCOMPANYING DOCUMENTS b PORTABLE ME EQUIPMENT with a mass gt 20 kg provided with one or more carrying handles suitably placed to enable carrying by two or more persons as confirmed by actual carrying N A
57. taken into Pass consideration for MEANS OF PATIENT PROTECTION Components and wiring forming a MEANS OF Pass PROTECTION comply with 8 10 Insulation CREEPAGE CLEARANCES Pass components or earth connections not complying Issue Date 2014 03 27 Page 29 of 181 Report Reference 1402012 draft report with 8 5 1 2 and 8 5 1 3 not considered as MEANS OF PROTECTION and failure of these parts regarded as NORMAL CONDITION 8 5 1 2 MEANS OF PATIENT PROTECTION MOPP MOPP considered and Pass provided Solid insulation forming a MEANS OF PATIENT Evaluated in part of power Pass PROTECTION complied with dielectric strength supply test of Clause 8 8 at test voltage of Table 6 CREEPAGE and CLEARANCES forming a MOPP provided Pass MEANS OF PATIENT PROTECTION complied with Table 12 PROTECTIVE EARTH CONNECTIONS forming a Evaluated in part of power Pass MEANS OF PATIENT PROTECTION complied supply with Cl 8 6 A Y1 capacitor complying with IEC 60384 14 and Evaluated in part of power Pass having passed dielectric strength test for two supply MEANS OF PATIENT PROTECTION considered equivalent to one MEANS OF PATIENT PROTECTION Two capacitors used in series each RATED for Evaluated in part of power Pass total WORKING VOLTAGE across the pair and supply have the same NOMINAL capacitance Voltage Total Working V and C Nominal uF 600Vpk 8 5 1 3 MEANS OF OPERATOR PROTECTIO
58. two MEANS OF PROTECTION No Cord connected hand held parts and cord connected foot operated control devices N A d c limit of 60 V applied to d c with no more than 10 peak to peak ripple N A 42 4 V peak limit applied when ripple exceeded 10 peak to peak limit N A 8 10 4 2 Connection and anchorage of a flexible cord to a HAND HELD or foot operated control device of ME EQUIPMENT at both ends of cable to control device complied with 8 11 3 when breaking free or shorting between conductors could result in a HAZARDOUS SITUATION N A 8 10 5 This requirement applied to other HAND HELD parts when disturbance or breaking of one or more of connections could result in a HAZARDOUS SITUATION Mechanical protection of wiring No hand held parts N A Pass a Internal cables and wiring adequately protected against contact with a moving part or from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS See Appended RM Results Table 8 10 5 Pass b Wiring cord forms or components are not likely to be damaged during assembly or during opening or closing of ACCESS COVERS where such damage could result ina HAZARDOUS SITUATION as shown by manual tests and RISK MANAGEMENT FILE Pass 8 10 6 8 10 7 Guiding rollers of insulated conductors prevent bending of movable insulated conductors around a radius of less than five times the outer diameter of the
59. 0 pA Type together with external voltage on metal CF N A Accessible Part not Protectively Earthed Supplementary information Note 1 For EARTH LEAKAGE CURRENT see 8 7 3 d and 8 7 4 5 Issue Date 2014 03 27 Page 118 of 181 Report Reference 1402012 draft report Note 2 For TOUCH CURRENT see 8 7 3 c and 8 7 4 6 Note 3 For PATIENT LEAKAGE CURRENT SEE 8 7 3 b and 8 7 4 7 Note 4 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS of the same type See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values Note 5 In addition to conditions indicated in the Table tests conducted at operating temperature and after humidity preconditioning of 5 7 EQUIPMENT energized in stand by condition and fully operating max rated supply frequency at 110 of the max RATED MAINS VOLTAGE and after relevant tests of Clause 11 6 i e overflow spillage leakage ingress of water and particulate matter cleaning and disinfection and sterilization ER Earth leakage current A After humidity conditioning TC Touch current B Before humidity conditioning P Patient leakage current 1 Switch closed or set to normal polarity PA Patient auxiliary current 0 Switch open or set to reversed polarity TP Total Patient current NC Normal condition PM Patient leakage current with mains on the applied parts SFC Single fault condition MD Measuring de
60. 1 Mold stress relief push impact drop and rough handling tests did not result in unacceptable RISK and ME EQUIPMENT displayed adequate mechanical strength See appended Table 15 3 Pass 15 3 2 Push test conducted by subjecting external parts of ENCLOSURE to a steady force of 250 N 10 N for 5 s applied to a circular 30mm plane surface except bottom of ENCLOSURE of an ME EQUIPMENT gt 18 kg using a suitable test tool See appended Table 15 3 Pass No damage resulting in an unacceptable RISK sustained as determined by examination of RISK MANAGEMENT FILE See appended RM Results Table 15 3 2 Pass 15 3 3 Impact test conducted by subjecting a complete See appended RM Results Pass Issue Date 2014 03 27 Page 77 of 181 Report Reference 1402012 draft report ENCLOSURE or its largest non reinforced area except for HAND HELD ME EQUIPMENT and parts to a free falling 500 g 25 g solid smooth steel ball approx 50 mm in diameter from a height lo AES A a eee eae ei eden ey fin eta ana Table 15 3 3 Test not applied to flat panel displays platen glass of ME EQUIPMENT or cathode ray tubes See appended RM Results Table 15 3 3 Pass No damage resulting in an unacceptable RISK sustained as shown in RISK MANAGEMENT FILE See appended RM Results Table 15 3 3 Pass 15 3 4 Drop test Pass 15 3 4 1 Sample of HAND HELD ME EQUIPMENT and HA
61. 1 for a twisted pair with test voltages at least twice Tables 6 amp 7 but not less than below with no breakdown 3000 V for BASIC and SUPPLEMENTARY INSULATIO N A 6000 V for REINFORCED INSULATION V N A L 3 2 Flexibility and adherence N A Sample subjected to flexibility and adherence test 8 N A Issue Date 2014 03 27 Page 97 of 181 Report Reference 1402012 draft report of IEC 60851 3 1996 clause 5 1 1 using mandrel diameters of Table L 1 Sample examined according to IEC 60851 3 1997 N A clause 5 1 1 4 followed by dielectric test of clause 8 8 3 except test voltage applied between wire and mandrel with no breakdown Test voltage was at least the voltage in Tables 6 N A and 7but not less than the following 1500 V for BASIC and SUPPLEMENTARY INSULATION N A 3000 V for REINFORCED INSULATION V N A Tension applied to wire during winding on mandrel N A calculated from the wire diameter equivalent to TIR MPa t TLE MPA roaie TE AA TR L 3 3 Heat Shock N A Sample subjected to heat shock test 9 of IEC N A 60851 6 1996 followed by dielectric strength test of clause 8 8 3 except test voltage applied between the wire and mandrel Test voltage was at least the voltage in Tables 6 N A and 7 but not less than the following 1500 V for BASIC and SUPPLEMENTARY INSULATION N A 3000 V for REINFORCED INSULATION V N A Oven temperature ba
62. 14 03 27 Page 149 of 181 Report Reference 1402012 draft report TABLE Single Fault Conditions in accordance with 13 2 2 to 13 2 13 Pass inclusive Clause No Description of SINGLE FAULT Results observed Hazardous CONDITION Situation Yes No 13 2 2 Electrical SINGLE FAULT CONDITIONS per Clause 8 1 13 2 3 Overheating of transformers per Clause 15 5 13 2 4 Failure of THERMOSTATS according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or interrupted the less favourable of the two Ce P oa Failure of temperature limiting devices according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or interrupted the less favourable of the two Leakage of liquid RISK MANAGEMENT FILE examined to determine the appropriate test conditions sealed rechargeable batteries exempted 2 Impairment of cooling that could result in a HAZARD using test method of 11 1 13 2 7 Single ventilation fans locked consecutively 13 2 7 Ventilation openings blocked Unit operation Normally No hazardous No Locking of moving parts Only one part locked at a time Also see 13 2 10 below Interruption and short circuiting of motor capacitors Motor capacitors short amp open circuited 1 Also see 13 10 13 2 10 Additional test criteria for motor operated ME EQUIPMENT in 13 2 8 amp 13 2 9 _h _ _ _ W W X N X oO CO N O Issue Date 2014 03 27 Page 150
63. 181 Report Reference 1402012 draft report sample only the relevant tests conducted 5 7 ME EQUIPMENT or parts thereof affected by climatic conditions were set up completely or partially with covers detached and subjected to a humidity preconditioning prior to tests of Clauses BEA ANG 875 a IRANE A ORNE Manually detachable parts removed and treated concurrently with major parts and manually removable ACCESS COVERS were opened and detached See Appended RM Results Table 5 7 Pass N A ME EQUIPMENT heated to a temperature between T and T 4 C for at least 4 h and placed in a humidity chamber with a relative humidity of 93 3 and an ambient within 2 C of T in the range of 20 C to 32 C for 48 h 25 degree C 93 RH Pass When RISK MANAGEMENT PROCESS indicated ME EQUIPMENT can be exposed to high humidity for extended periods i e out door use test time extended proportionally h eseese 48h Pass 5 8 Unless stated otherwise tests in this standard sequenced as in Annex B to prevent results of one test on a subsequent test Pass 5 9 Determination of APPLIED PARTS and ACCESSIBLE PARTS Pass 5 9 1 APPLIED PARTS identified by inspection and reference to ACCOMPANYING DOCUMENTS N A 5 9 2 ACCESSIBLE PARTS Pass 5 9 2 1 Accessibility when necessary determined using standard test finger of Fig 6 applied in a bent or straight
64. 1_RMF _ 2014 02_24 the risk management file Section Evaluation of risk before measures F 01 H 01 C 11 VENUS 191_RMF_2014_02_24 Section Risk graph before measures VENUS The risk control measures selected were recorded pass 191_RMF_2014_02_24 in the risk management file Section Release protocols of measures RC 018 VENUS The effectiveness of the risk control measures had Pass 191_RMF_2014_02_24 been verified and the results of the verification fi is poe were recorded in the risk management file Section Release protocols of measures RC 018 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after Criteria that defined in the risk management plan measures F 01 H 01 C 11 VENUS 191_RMF_2014_02_24 Section Risk graph after measures VENUS 191_RMF_2014 02_24 Section Summary of risk control No reduction of risk through Risk benefit analysis N A Issue Date 2014 03 27 Page 126 of 181 Report Reference 1402012 draft report 8 10 2 RM TABLE Fixing of wiring Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in ti ee annie both normal and fault conditions Section Risk analysis F 01 H 01 C 1
65. 2012 draft report MANAGEMENT PROCESS 4 10 2 and shall be in accordance with the Canadian Electrical Code CEC Part CSA C22 1 Pass 7 7 1 and shall be in accordance with the Canadian Electrical Code CEC Part 1 CSA C22 1 N A 7 7 1 A PROTECTIVE EARTH CONDUCTOR ora PROTECTIVE EARTH CONNECTION or insulation shall be identified by either green or green and yellow colour Colours of neutral and POWER SUPPLY CORD conductors shall be in accordance with the Canadian Electrical Code CEC Part l CSA C22 2 No 21 and CSA C22 2 No 49 N A 7 7 2 and shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 N A 7 7 2 7 7 3 A PROTECTIVE EARTH CONDUCTOR or a PROTECTIVE EARTH CONNECTION or insulation shall be identified by either green or green and yellow colour Colours of neutral and POWER SUPPLY CORD conductors shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 2 No 21 and CSA C22 2 No 49 and shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 N A N A 7 7 3 A PROTECTIVE EARTH CONDUCTOR or a PROTECTIVE EARTH CONNECTION or insulation shall be identified by either green or green and yellow colour Colours of neutral and POWER SUPPLY CORD conductors shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 2 No 21 and CSA C22 2 No 49 N A 7 7 4 and shall b
66. 4 Based on review of EQUIPMENT ACCOMPANYING DOCUMENTS specifications and processing of materials and MANUFACTURER S relevant tests or calculations corrosion ageing mechanical wear degradation of biological materials due to bacteria plants animals and the like will not result in an unacceptable RISK ME EQUIPMENT components and general assembl N A Pass 15 4 1 Incorrect connection of accessible connectors removable without a TOOL prevented where an unacceptable RISK exists in particular 25 N A a Plugs for connection of PATIENT leads cannot be connected to other outlets on same ME EQUIPMENT intended for other functions except when RISK MANAGEMENT FILE provides proof that no unacceptable RISK could result No applied parts N A b Medical gas connections on ME EQUIPMENT for different gases to be operated in NORMAL USE are not interchangeable as verified by review of RISK MANAGEMENT FILE saene No gas connections N A 15 4 2 15 4 2 1 Temperature and overload control devices a THERMAL CUT OUTS and OVER CURRENT RELEASES with automatic resetting not used in ME EQUIPMENT when their use could result in a HAZARDOUS SITUATION by resetting action as verified by review of RISK MANAGEMENT FILE N A N A b THERMAL CUT OUTS with a safety function to be reset by a soldering operation affecting operating value not fitted in ME EQUIPMENT as verified by exam
67. 4 02 24 in the risk management file Section Evaluation of risk before measures F 02 H 01 C 03 VENUS 191_RMF_2014 02_24 Section Risk graph before measures VENUS The risk control measures selected were Pass 191_RMF 2014 02 24 recorded in the risk management file Section Release protocols of measures RC 017 VENUS The effectiveness of the risk control measures Pass 191_RMF _ 2014 02 24 had be verified and the results of the verification Section Release protocols of were recorded in the risk management file measures RC 017 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 02 H 01 C 03 VENUS 191_RMF_2014_02_24 Section Residual risk evaluation VENUS 191_RMF_2014_02_24 Section Summary of risk control No reduction of risk through Risk benefit analysis Pass Issue Date 2014 03 27 Page 131 of 181 Report Reference 1402012 draft report 9 4 2 1 TABLE Instability overbalance in transport position ME EQUIPMENT preparation Test Condition transport position LCD system with base 10 degree Incline 9 4 2 1 back side LCD system with base 10 degree Incline 9 4 2 1 rear side LCD system with base 10 degree Incline 9 4 2 1 front side Supplementary information
68. 6 9 Class Il ME EQUIPMENT N A Third conductor of POWER SUPPLY CORD connected to protective earth contact of MAINS PLUG provided with CLASS II ME EQUIPMENT with isolated internal screens used as functional earth connection to the screen s FUNCTIONAL EARTH TERMINAL coloured green and yellow Not class II equipment N A Two MEANS OF PROTECTION provided by insulation of internal screens and all internal wiring connected to them with a related explanation in technical description 0 ccccecceeeeeeeeeteteeeeeeeeeel Not class Il equipment N A 8 7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS Pass 8 7 1 a Electrical isolation providing protection against electric shock limits currents to values in 8 7 3 See appended Tables 8 7 Pass b Specified values of EARTH LEAKAGE TOUCH PATIENT LEAKAGE and PATIENT AUXILIARY CURRENTS applied in combination of conditions in appended Table 8 7 ccceccccccccccececeeeseeeseeeeeeeeeeeess See appended Tables 8 7 Pass 8 7 2 Allowable values specified in 8 7 3 applied under SINGLE FAULT CONDITIONS of 8 1 b except Pass where insulation used in conjunction with a PROTECTIVE EARTH CONNECTION insulation short circuited only under conditions in 8 6 4 b N A the only single FAULT CONDITION for EARTH LEAKAGE current was interruption of one supply conductor at a time Pass LEAKAGE CURRENTS and PATIENT
69. 7 2 5 MODEL or TYPE REFERENCE of equipment to be connected to ME EQUIPMENT to provide power is marked adjacent to the relevant connection point when this connection could result in an unacceptable RISK ccecceeeeeeeeeeeteteeeeeeeeeee No such construction N A 7 2 6 Connection to the Supply Mains Pass Except for PERMANENTLY INSTALLED ME EQUIPMENT marking appearing on the outside of Pass Issue Date 2014 03 27 Page 15 of 181 Report Reference 1402012 draft report part containing SUPPLY MAINS connection and adjacent to connection point For PERMANENTLY INSTALLED ME EQUIPMENT NOMINAL supply voltage or range marked inside or outside of ME EQUIPMENT preferably adjacent to supply connection terminals RATED supply voltage s or RATED voltage range s with a hyphen between minimum and maximum voltages V V V eeeeeseeeetteeeeenee Not permanently installed For adapter 100 240 Vac For unit 24Vdc N A Pass Multiple RATED supply voltages or multiple RATED supply voltage ranges are separated by No Multiple rated supply voltages or multiple rated supply voltage N A Nature of supply e g No of phases except single phase and type of Current 0 eee Single phase Pass Symbols 1 5 Table D 1 symbols of IEC 60417 5032 5032 1 5032 2 5031 and 5033 all DB 2002 10 used optionally for same parameters
70. 7 Page 108 of 181 Report Reference 1402012 draft report 7 2 17 RM TABLE Protective packaging Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_ RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 01 C 20 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluation of risk before measures F 01 H 01 C 20 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 01 C 20 VENUS The effectiveness of the risk control measures Pass 191_RMF 2014 02 24 had been verified and the results of the Section Release protocols of verification were recorded in the risk measures RC 028 management file VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 01 C 20 VENUS 191_RMF_2014 02_24 Section Residual risk evaluation RM TABLE Batteries N A
71. 8 VENUS The estimates of the risk s were recorded inthe Pass 191_RMF_2014 02 24 risk management file Section Evaluation of risk before measures F 01 H 01 C 18 VENUS The results of this risk evaluation were recorded in Pass 191_RMF_2014 02 24 the risk management file Section Evaluation of risk before measures F 01 H 01 C 18 VENUS 191_RMF_2014 02_24 Section Risk graph before measures VENUS The risk control measures selected were recorded pass 191_RMF_2014_02_24 in the risk management file Section Release protocols of measures RC 025 VENUS The effectiveness of the risk control measures had pass 191_RMF_2014_02_24 been verified and the results of the verification ti a arate were recorded in the risk management file Section Release protocols of measures RC 025 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 01 C 18 VENUS 191_RMF_2014_02_24 Section Risk graph after measures VENUS 191_RMF_2014_02_24 Section Summary of risk control No reduction of risk through Risk benefit analysis pags Issue Date 2014 03 27 Page 127 of 181 Report Reference 1402012 draft report 8 10 5 RM TABLE Mechanical protection of wiring Pass Clause of Document Ref in RMF Result Remarks
72. A 15 4 6 1 a Actuating parts cannot be pulled off or loosened up during NORMAL USE No Actuating parts N A b Indication of scales e g on off positions etc always corresponds to position of controls with adjustment that can result ina HAZARDOUS SITUATION for PATIENT or OPERATOR while ME EQUIPMENT is in use c Incorrect connection of indicating device to relevant component prevented by adequate construction when it could be separated without use of a TOOL N A N A When torque values per Table 30 applied between control knob and shaft of rotating controls for not less than 2 s 10 times in each direction knobs did Not rotate iene eae ee ea ee ee N A Tests conducted by applying an axial force of 60 N for electrical components and 100 N for other components for 1 min when an axial pull was required in NORMAL USE with no unacceptable N A 15 4 6 2 Stops of adequate mechanical strength provided on rotating movable parts of controls of ME EQUIPMENT where necessary to prevent an unexpected change from max to min or vice versa of the controlled parameter when this could cause a HAZARDOUS SITUATION oieee N A Torque values in Table 30 applied 10 times in each direction to rotating controls for 2 Sec eee N A 15 4 7 Application of an axial force of 60 N for electrical components and 100 N for other components to rotating or movable parts of controls for 1 min when an axial
73. A 8 5 4 WORKING VOLTAGE Pass Input supply voltage to ME EQUIPMENT was RATED voltage or voltage within RATED range resulting in highest measured value V e 240Vac Pass WORKING VOLTAGE for d c voltages with superimposed ripple was average value when peak to peak ripple less than 10 of average value or peak voltage when peak to peak ripple exceeding 10 of average value V N A WORKING voltage for each means of PROTECTION forming DOUBLE insulation was voltage DOUBLE insulation as a whole subjected to V See Insulation Diagram and Insulation Table Evaluated in part of power supply Pass Intentional or accidental earthing of PATIENT regarded as a NORMAL CONDITION for WORKING voltage involving a PATIENT connection not connected to EARTH No patient connections N A WORKING voltage between PATIENT CONNECTIONS of an F TYPE APPLIED PART and ENCLOSURE was highest voltage appearing across insulation in NORMAL use including earthing of any PART of APPLIED PART V No patient connections N A WORKING voltage for DEFIBRILLATION PROOF APPLIED parts determined disregarding possible presence of DEFIBRILLATION voltages No Defibrillation proof applied parts N A WORKING voltage was equal to resonance voltage in case of motors provided with capacitors between the point where a winding and a capacitor are connected together and a terminal for external CONDUC
74. ABLE transformer short circuit test short circuit applied at end of windings N A or at the first point that could be short circuited under SINGLE FAULT CONDITION Primary voltage most adverse value from 90 to 110 of RATED voltage V 1 RATED input frequency Hz Class of Type of Protective Time to Maximum Maximum insulation A protective device THERMAL allowed winding B E F or H device fuse operated STABILITY temp from temp circuit Yes No when Table 31 measured breaker protective C CC Ratings device did not operate Min Ambient CC Supplementary information 1 Loads on other windings between no load and their NORMAL USE load Short circuit applied at end of windings or at the first point that could be short circuited under SINGLE FAULT CONDITION 15 5 1 3 TABLE transformer overload test conducted only when protective device N A under short circuit test operated Primary voltage most adverse value between 90 to 110 of RATED voltage V 1 RATED input frequency Hz Test current just below minimum current that would activate protective device amp achieve THERMAL STABILITY under method a A Test current based on Table 32 when protective device that operated under method a is external to transformer and it was shunted A Winding tested Class of insulation Type of Maximum Maximum winding Ambient C protective allowed temp temp measured device used fr
75. ABLE ME EQUIPMENT allows for expansion of oil and is adequately sealed to prevent loss of oil in any position No Aluminum wires No such construction N A N A b Oil containers in MOBILE ME EQUIPMENT sealed to prevent loss of oil during transport Not mobile equipment N A A pressure release device operating during NORMAL USE is optionally provided c Partially sealed oil filled ME EQUIPMENT and its parts provided with means for checking the oil level to detect leakage Not mobile equipment N A N A ME EQUIPMENT and technical description examined and manual tests conducted to confirm compliance with above requirements N A 15 5 MAINS SUPPLY TRANSFORMERS OF ME EQUIPMENT and transformers providing separation in accordance with 8 5 N A 15 5 1 Overheating N A 15 5 1 1 Transformers of ME EQUIPMENT are protected against overheating in the event of short circuit or overload of output windings and comply with this Clause and tests of 15 5 1 2 3 eee Evaluated in part of power supply N A During tests windings did not open no HAZARDOUS SITUATION occurred and maximum temperatures of windings did not exceed values in Table 31 N A Dielectric strength test of 8 8 3 conducted on transformer after short circuit and overload tests Evaluated in part of power supply N A 15 5 1 2 Transformer output winding short circuited and test continued until p
76. ANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE ccceeeeeteeeetereeeeeeeee N A 12 4 5 Diagnostic or therapeutic radiation N A 12 4 5 1 Adequate provisions to protect OPERATORS PATIENTS other persons and sensitive devices in vicinity of unwanted or excessive radiation emitted by ME EQUIPMENT designed to produce radiation for diagnostic therapeutic purposes N A 12 4 5 2 Radiation safety ensured by compliance with requirements of appropriate standards RISKS associated with diagnostic X rays addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE Not X ray equipment N A N A 12 4 5 3 RISKS associated with radiotherapy addressed in N A Issue Date 2014 03 27 Page 69 of 181 Report Reference 1402012 draft report RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE 268 12 4 5 4 RISKS associated with ME EQUIPMENT producing N A diagnostic or therapeutic radiation other than diagnostic X rays and radiotherapy addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE 12 4 6 When applicable RISKS associated with N A diagnostic or therapeutic acoustic pressure addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE 13 HAZARDOUS SITUATIONS AND FAULT
77. Date 2014 03 27 Page 2 of 181 Testing procedure and testing location x Testing Procedure WMT Complied by name signature Reviewed by signature Approved by signature Testing location address 1 Report Reference 140201 2 draft report Superior Product Consulting Inc 3rd Fl 10 Alley 6 Lane 235 Pao Chiao Rd Hsin Tien Taipei Taiwan Summary Of Testing Unless otherwise indicated all tests were conducted at Underwriters Laboratories Taiwan Co Ltd 260 Da Yeh Road 112 Peitou Taipei City Chinese Taipei Tests performed name of test and test clause Testing location Comments Power Input Test 4 11 Test located at SPC Humidity Preconditioning Treatment 5 7 Test located at SPC Legibility of Markings 7 1 2 Test located at SPC Durability of Marking Test 7 1 3 Test located at SPC Dielectric Voltage Withstand 8 8 3 Test located at SPC Ball Pressure 8 8 4 1 Test located at SPC Suspension Systems Without Safety Device Loading Test 9 8 5 Test located at SPC Stability and Transportability 9 4 2 Test located at SPC Temperature Test 11 Test located at SPC Overflow Spillage Leakage Cleaning Sterilization and Disinfection Harmful Ingress of Liquids 11 6 Test located at SPC Interruption of Power Supply 11 8 Test located at SPC Abnormal Oper
78. ECTION where Pass connection between SUPPLY MAINS and ME EQUIPMENT or between separate parts of ME EQUIPMENT made via a plug and socket was made before and interrupted after supply connections APPLIED also where interchangeable parts are N A PROTECTIVELY EARTHED 8 6 7 Terminal for connection of a POTENTIAL EQUALIZATION CONDUCTOR N A terminal is accessible to OPERATOR with ME No potential equalization N A EQUIPMENT in any position of NORMAL use terminals used RISK of accidental disconnection minimized in No potential equalization N A NORMAL use terminals used terminal allows conductor to be detached without No potential equalization N A a TOOL terminals used terminal not used fora PROTECTIVE EARTH No potential equalization N A connection terminals used Terminal marked with symbol 8 of Table D 1 i e No potential equalization N A symbol IEC 60417 5021 terminals used instructions for use contain information on No potential equalization N A function and use of POTENTIAL EQUALIZATION terminals used conductor together with a REFERENCE to requirements of this standard POWER SUPPLY CORD does not incorporate a No potential equalization N A POTENTIAL EQUALIZATION CONDUCTOR terminals used Issue Date 2014 03 27 Page 35 of 181 Report Reference 1402012 draft report 8 6 8 FUNCTIONAL EARTH TERMINAL not used to provide a PROTECTIVE EARTH CONNECTION No functional earth terminals used N A 8
79. EM in NORMAL CONDITION did not exceed values specified for ME EQUIPMENT in Tables 3 and 4 00 0 eeceeeereeeeeee N A Measurements made using a device as in clause 8 7 4 4 N A ME SYSTEM complied with applicable requirements of Clause 9 when a MECHANICAL HAZARD existed N A Interruption and restoration of relevant power connections of ME SYSTEM one at a time and all connections simultaneously did not result in a HAZARDOUS SITUATION other than interruption of its intended function N A ME SYSTEM connections and wiring N A 16 9 1 Incorrect connection of accessible connectors removable without a TOOL prevented where a HAZARDOUS SITUATION could otherwise exist N A Connectors complied with Clause 15 4 1 N A 16 9 2 Plugs for connection of PATIENT leads could not be connected to other outlets of the same ME SYSTEM likely to be located in PATIENT ENVIRONMENT except when examination of connectors and interchanging them proved no HAZARDOUS SITUATION could result MAINS PARTS components and layout N A N A Issue Date 2014 03 27 Page 87 of 181 Report Reference 1402012 draft report 16 9 2 1 a MULTIPLE SOCKET OUTLET only allows N A connection using a TOOL or MULTIPLE SOCKET OUTLET is of a type that cannot N A accept MAINS PLUGS of any of the kinds specified in IEC TR 60083 or M
80. ENCLOSURE and other external parts of See appended RM Results Pass insulating material except insulation of flexible cords and parts of ceramic material subjected to Table 8 8 4 1 Issue Date 2014 03 27 Page 38 of 181 Report Reference 1402012 draft report ball pressure test using apparatus of Fig 21 b Parts of insulating material supporting uninsulated parts of MAINS PART subjected to ball pressure test in a except at 125 C 2 C or ambient indicated in technical description 2 C plus temperature rise determined during test of 11 1 of relevant part if higher C eel Evaluated in part of power supply Pass Test not performed on parts of ceramic material insulating parts of commutators brush caps and similar and on coil formers not used as REINFORCED INSULATION N A 8 8 4 2 Resistance to environmental stress N A Insulating characteristics and mechanical strength of all MEANS OF PROTECTION not likely to be impaired by environmental stresses including deposition of dirt resulting from wear of parts within EQUIPMENT potentially reducing CREEPAGE and CLEARANCES below 8 9 N A Ceramic and similar materials not tightly sintered and beads alone not used as SUPPLEMENTARY or REINFORCED INSULATION Insulating material with embedded heating conductors considered as one MEANS OF PROTECTION but not two MEANS OF PROTECTION N A N A Parts of natural
81. H CURRENT measured i e from TOUCH TOUCH CURRENT in event of CURRENT in event of or between parts of ME CURRENT CURRENT interruption of interruption of SYSTEM within PATIENT in in PROTECTIVE EARTH PROTECTIVE EARTH ENVIRONMENT NORMAL NORMAL CONDUCTOR pA CONDUCTOR uA CONDITIO CONDITIO N HA N HA Supplementary information 16 9 1 RM TABLE Connection terminals and connectors N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Electromagnetic compatibility of ME equipment and ME systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 160 of 181 Report Reference 1402012 draft report SP TABLE Additional or special tests conducted Pass Clause and Name of Test type and condition Observed results Test HUMIDITY Humidity preconditioning treatment PRECONDITIONING temperature 25 degree C humidity TREATMENT IEC 93 48 hours 60601 1 3rd Edition Clause 5 7 INTERRUPTION OF POWER SUPPLY IEC 60601 1 3rd Edition Clause 11 8 Interrupted and restored Equipment Unit operation normally state Loaded operating mode Supplementary information HUMIDITY PRECONDITIONING TREATMENT IEC 60601 1 3rd Edition Clause 5 7 There was no dielectric breakdown INTERRUPTION OF POWER SUPPLY IEC 60601 1 3rd Edition Clause 11 8
82. IANCE INLET forming supply Evaluated in part of power N A connection to ME EQUIPMENT regarded as PROTECTIVE EARTH TERMINAL supply Issue Date 2014 03 27 Page 34 of 181 Report Reference 1402012 draft report PROTECTIVE EARTH TERMINAL not used for Evaluated in part of power N A mechanical connection between different parts of supply ME EQUIPMENT or securing components not related to protective or functional earthing 8 6 3 PROTECTIVE EARTH CONNECTION not used for Evaluated in part of power N A a moving part except when MANUFACTURER supply demonstrated in RISK MANAGEMENT FILE connection will remain reliable during EXPECTED SERVICE LIFE peenar e e Ea aR 8 6 4 a PROTECTIVE EARTH CONNECTIONS carried Evaluated in part of power N A fault currents reliably and without excessive voltage supply drop b Allowable TOUCH CURRENT and PATIENT N A LEAKAGE CURRENT in SINGLE FAULT CONDITION were not exceeded when impedance of PROTECTIVE EARTH CONNECTIONS exceeded values in 8 6 4 a and Table 8 6 4 due to limited current capability of relevant circuits 8 6 5 Surface coatings N A Poorly conducting surface coatings on conductive No conductive coatings used N A elements removed at the point of contact Coating not removed when requirements for No conductive coatings used N A impedance and current carrying capacity met 8 6 6 Plugs and sockets N A PROTECTIVE EARTH CONN
83. Issue Date 2014 03 27 Page 1 of 181 Report Reference 1402012 draft report Ee C SUPERIOR PRODUCT CONSULTING INC TEST REPORT IEC 60601 1 Medical Electrical Equipment Part 1 General requirements for basic safety and essential performance Report Reference No 1402012 draft report Date of issue cceeeeeeeeeeeeeeees 2014 03 27 Total number of pages 189 Testing Laboratory Superior Product Consulting Inc Address ee 3rd FI 10 Alley 6 Lane 235 Pao Chiao Rd Hsin Tien Taipei Taiwan Applicant s name gt ONYX HEALTHCARE INC Address re a 2 FL 135 LN 235 PAO CHIAO RD HSIN TIEN NEW TAIPEI 231 TAIWAN Test specification Standard 0 cecccceeeeeeeeeeeeeeeeeeeeeees IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 EN 60601 1 2006 CORR 2010 Non standard test method gt N A Test item description Mobile cart computer Trade Mark ccsceeeeeeeteeeees Manufacturer oscene ONYX HEALTHCARE INC 2 FL 135 LN 235 PAO CHIAO RD HSIN TIEN NEW TAIPEI 231 TAIWAN Model Type reference 0065 VENUS 191 FRAUNOS a5 eepcctiss artiecadscuseresstarenaes Mobile cart computer 24V 6 25A Power Adapter HITRON ELECTRONICS CORP Type HEMP152G 240060 7 LF Adaptor input rating 100 240Vac 50 60Hz 1 9 0 8A Adapter output rating 24Vdc 6 25A Issue
84. KING LOAD when applicable No support systems used N A Has TENSILE SAFETY FACTORS for all parts not less than Table 21 row 7 Activated before travel movement produced an unacceptable RISK No support systems used No support systems used N A N A Takes into account Clauses 9 2 5 and 9 8 4 3 No support systems used N A Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing No support systems used N A 9 8 4 2 Activation of MECHANICAL PROTECTIVE DEVICE is made obvious to OPERATOR when ME EQUIPMENT can still be used after failure of suspension or actuation means and activation of a MECHANICAL PROTECTIVE DEVICE e g a secondary cable No support systems used N A 9 8 4 3 MECHANICAL PROTECTIVE DEVICE requires use of a TOOL to be reset or replaced No support systems used MECHANICAL PROTECTIVE DEVICE intended to function once N A N A Further use of ME EQUIPMENT not possible until replacement of MECHANICAL PROTECTIVE device No support systems used N A ACCOMPANYING DOCUMENTS instruct once MECHANICAL PROTECTIVE device is Activated SERVICE PERSONNEL shall be called and MECHANICAL PROTECTIVE device must be replaced before ME EQUIPMENT can be used No support systems used N A ME EQUIPMENT permanently marked with safety sign 2 of Table D 2 i e safety sign 7010 W001 N
85. LEGIBLE and visible after INSTALLATION in NORMAL USE applied to a prominent location of EQUIPMENT that produce physiological effects capable of causing HARM to PATIENT or OPERATOR not obvious to No physiological effects N A Issue Date 2014 03 27 Page 17 of 181 Report Reference 1402012 draft report Nature of HAZARD and precautions for avoiding or N A minimizing the associated RISK described in instructions fOr USC eeeeeeeeeeceeeeeeeeeeeeetteeeeeeeeee 7 2 14 HIGH VOLTAGE TERMINAL DEVICES on the No such construction N A outside of ME EQUIPMENT accessible without the use of a TOOL marked with symbol 24 of Table D 1 symbol IEC 60417 5036 DB 2002 10 7 2 15 Requirements for cooling provisions marked e g No special air shall be N A supply of water OF QIN ec eeeeeeeeeeeeeeteeeeeetteeeeeenaees provided for cooling but nature air no marking is required 7 2 16 ME EQUIPMENT with limited mechanical stability No special limitation in N A mechanical stability 7 2 17 Packaging marked with special handling Packaging with special Pass instructions for transport and or storage transportation and storage condition see carton for detail Permissible environmental conditions for transport See carton for detail Pass and storage marked on outside of packaging Packaging marked with a suitable safety sign See appended RM Results Pass indicating premature unpacking
86. LTIPLE SOCKET OUTLET S used with ME SYSTEM N A instructions indicating MULTIPLE SOCKET OUTLETS provided with the ME SYSTEM to be used only for supplying power to equipment intended to form part of ME SYSTEM N A an explanation indicating RISKS of connecting non ME EQUIPMENT supplied as a part of ME SYSTEM directly to wall outlet when non ME EQUIPMENT is intended to be supplied via a MULTIPLE SOCKET OUTLET with a separating transformer N A an explanation indicating RISKS of connecting any equipment supplied as a part of ME SYSTEM to MULTIPLE SOCKET OUTLET N A permissible environmental conditions of use for ME SYSTEM including conditions for transport and storage N A instructions to OPERATOR not to simultaneously touch parts referred to in 16 4 and PATIENT N A d the following instructions provided for use by RESPONSIBLE ORGANIZATION N A adjustment cleaning sterilization and disinfection PROCEDURES N A assembly of ME SYSTEMS and modifications during actual service life shall be evaluated based on the requirements of this standard Instructions for use of ME EQUIPMENT intended to receive its power from other equipment in an ME SYSTEM describe the other equipment to ensure compliance with these requirements N A N A Parts of non ME EQUIPMENT in PATIENT ENVIRONMENT subject to contact by OPERATOR during maintenance calibration after
87. M is capable of displaying or printing these documents a ACCOMPANYING DOCUMENTS provided for each N A item of ME EQUIPMENT supplied by MANUFACTURER b ACCOMPANYING DOCUMENTS provided for each N A item of non ME EQUIPMENT supplied by MANUFACTURER c the required information is provided N A specifications instructions for use as intended by N A MANUFACTURER and a list of all items forming the ME SYSTEM instructions for installation assembly and N A modification of ME SYSTEM to ensure continued compliance with this standard instructions for cleaning and when applicable N A disinfecting and sterilizing each item of equipment or equipment part forming part of the ME SYSTEM additional safety measures to be applied during N A installation of ME SYSTEM identification of parts of ME SYSTEM suitable for N A use within the PATIENT ENVIRONMENT additional measures to be applied during N A preventive maintenance a warning forbidding placement of MULTIPLE N A SOCKET OUTLET when provided and it is a separate item on the floor a warning indicating an additional MULTIPLE N A SOCKET OUTLET or extension cord not to be connected to ME SYSTEM a warning to connect only items that have been N A Issue Date 2014 03 27 Page 85 of 181 Report Reference 1402012 draft report specified as part of ME SYSTEM or specified as being compatible with ME SYSTEM maximum permissible load for any MU
88. MEANS OF PROTECTION see 8 8 the ball pressure test specified in 8 8 4 1 a performed at a temperature 25 C higher than temperature of insulation measured during tests of 13 2 13 2 to 13 2 13 4 inclusive Pass 13 2 13 2 ME EQUIPMENT with heating elements N A a 1 thermostatically controlled ME EQUIPMENT with heating elements for building in or for unattended operation or with a capacitor not protected by a fuse connected in parallel with THERMOSTAT contacts met tests of 13 2 13 2 b amp 13 2 13 2 c N A a 2 ME EQUIPMENT with heating elements RATED for non CONTINUOUS OPERATION met tests of 13 2 13 2 b and 13 2 13 2 c N A a 3 other ME EQUIPMENT with heating elements met test of 13 2 13 2 b N A When more than one test was applicable to same ME EQUIPMENT tests performed consecutively N A Heating period stopped when a heating element or an intentionally weak part of a non SELF RESETTING THERMAL CUT OUT ruptured or current interrupted before THERMAL STABILITY without possibility of automatic restoration N A Test repeated on a second sample when interruption was due to rupture of a heating N A Issue Date 2014 03 27 Page 71 of 181 Report Reference 1402012 draft report element or an intentionally weak part Both samples met 13 1 2 and open circuiting of a heating element or an intentionally weak part in second sample not considered a fa
89. N MOOP N A Solid insulation forming a MEANS OF OPERATOR N A PROTECTION complied with dielectric strength test of 8 8 at test voltage of N A Table 6 or requirements of IEC 60950 1 for INSULATION N A CO ORDINATION CREEPAGE and CLEARANCES forming a N A MEANS OF OPERATOR PROTECTION complied with limits of Tables 13 to 16 inclusive or Evaluated in part of power N A supply 2 MOPP provided between primary to secondary circuit requirements of IEC 60950 1 for INSULATION N A CO ORDINATION PROTECTIVE EARTH CONNECTIONS forming a Evaluated in part of power N A MEANS OF OPERATOR PROTECTION complied supply with Cl 8 6 or requirements and tests of IEC 60950 1 for Evaluated in part of power N A protective earthing ceeetteeeeeeeeee SUPPly A Y2 capacitor complying with IEC 60384 14 and N A passing dielectric strength test for one MEANS OF OPERATOR PROTECTION considered equivalent to one MEANS OF OPERATOR PROTECTION A Y1 capacitor complying with IEC 60384 14 and N A Issue Date 2014 03 27 Page 30 of 181 Report Reference 1402012 draft report having passed dielectric strength test for two MEANS OF OPERATOR PROTECTION considered equivalent to two MEANS OF OPERATOR PROTECTION ccceceeeeeerereee Two capacitors used in series each RATED for Evaluated in part of power N A total WORKING VOLTAGE across the pair and supply 2 MOPP provided have the sam
90. N to N A Issue Date 2014 03 27 Page 90 of 181 Report Reference 1402012 draft report distinguish between CATEGORY AP and APG parts G 3 5 Marking clearly indicates which parts are CATEGORY AP or APG when only certain ME EQUIPMENT parts are CATEGORY AP or APG N A G 4 Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT N A G 4 1 a CREEPAGE and CLEARANCES between points of POWER SUPPLY CORD connection are according to Table 12 for one MEANS OF PATIENT PROTECTION N A b Connections except those in circuits described in G 5 3 and G 6 3 protected against accidental disconnection in NORMAL USE or connection and disconnection can be performed only with a TOOL N A G 4 2 c CATEGORY AP and APG not provided with a DETACHABLE POWER SUPPLY CORD except when circuit complied with G 5 3 and G 6 3 Construction details N A N A a Opening of an ENCLOSURE providing protection against penetration of gases or vapours into ME EQUIPMENT or its parts possible only with a TOOL N A b ENCLOSURE complies with requirements to minimize arcing and sparking due to penetration Of TOFEIQNODjSCtS maaa N A no openings on top covers of ENCLOSURE except for openings for controls covered by control knobs N A openings in side covers prevented penetration of a solid cylindrical test rod of 4 mm in diameter applied in all possible directions
91. ND HELD part with SAFE WORKING LOAD allowed to fall freely once from each of 3 different positions as in NORMAL USE from height specified in ACCOMPANYING DOCUMENTS or from 1m onto a 50 mm 5 mm thick hardwood board lying flat on a concrete or rigid DaSe eee No hand held parts N A No unacceptable RISK resulted No hand held parts N A 15 3 4 2 Sample of PORTABLE ME EQUIPMENT and PORTABLE part with SAFE WORKING LOAD lifted to a height as in Table 29 above a50 5 mm thick hardwood board lying flat on a concrete floor or rigid base dropped 3 times from each orientation in NORMAL USE CM See appended Table 15 3 Pass No damage resulting in an unacceptable RISK sustained as determined by examination of sample and RISK MANAGEMENT FILE See appended RM Results Table 15 3 4 2 Pass 15 3 5 Each sample of MOBILE ME EQUIPMENT and MOBILE part with SAFE WORKING LOAD and in most adverse condition in NORMAL USE passed Rough Handling tests ce ecceeeeeeeeeeeeeeeeeeeeae N A a Ascending step shock test conducted on the sample by pushing it 3 times in its normal direction of travel at 0 4 m s 0 1 m s against an ascending hardwood step obstruction without the sample going over the obstruction N A b Descending step shock test conducted on the sample by pushing it 3 times in its normal direction of travel at 0 4 m s 0 1 m s in order to fall over a vertical step affixed flat o
92. NORMAL USE except transport positions on a 5 inclined plane from horizontal hard and flat surface A warning provided stating Transport only under conditions described in instructions for use or marked on ME EQUIPMENT with an indication of RESIDUAL RISK if ME EQUIPMENT or its parts overbalances when overbalance occurred during 10 inclined plane test N A N A 9 4 2 3 Instability from horizontal and vertical forces N A a ME EQUIPMENT with a mass of 25 kg or more other than FIXED ME EQUIPMENT for use on floor did not overbalance due to pushing or resting N A Surfaces of ME EQUIPMENT where a RISK of overbalancing exists from pushing leaning resting etc permanently marked with a CLEARLY LEGIBLE warning of the RISK e g safety sign 5 of Table D 2 safety sign ISO 7010 P017 ME EQUIPMENT did not overbalance when placed on a horizontal plane and a force of 25 of its weight but not more than 220 N applied in different directions except a direction with an upward component N A N A b ME EQUIPMENT other than FIXED ME N A Issue Date 2014 03 27 Page 53 of 181 Report Reference 1402012 draft report EQUIPMENT for use on the floor or on a table did not overbalance due to sitting or stepping except when a legible warning of this RISK provided on ME EQUIPMENT e g safety signs 6 and 7 of Table D 2 safety signs ISO 7010 P018 or ISO 7010 P019 as appro
93. OR or a min 80 kg placed on support or suspension system with centre of load 60 mm from outer edge of support or suspension system for at least one minute Kg Deflection of support suspension system resulting in an unacceptable RISK not occur No support systems used No support systems used N A N A 9 8 3 3 Dynamic forces that can be exerted on equipment parts supporting or suspending a PATIENT or OPERATOR in NORMAL USE did not result in an No support systems used N A Issue Date 2014 03 27 Page 60 of 181 Report Reference 1402012 draft report unacceptable RISK as confirmed by following test PATIENT support suspension system set in most unfavourable NORMAL USE position and a mass equal to SAFE WORKING LOAD simulating PATIENT or OPERATOR dropped from 150 mm above seat area on an area of support Suspension a PATIENT or OPERATOR can Sit 0e No support systems used N A 9 8 4 Systems with MECHANICAL PROTECTIVE DEVICES N A 9 8 4 1 a A MECHANICAL PROTECTIVE DEVICE provided when a support system or its parts impaired by wear have a TENSILE SAFETY FACTOR to values in Table 21 rows 5 and 6 but less than 3 and 4 ieii anann e inian No support systems used N A b MECHANICAL PROTECTIVE complies with the requirements as follows No support systems used N A Designed based on TOTAL LOAD and includes effects of Safe WOR
94. ORY or ME EQUIPMENT intended for a single use or its packaging marked Do Not Reuse or with symbol 28 of Table D 1 ISO 7000 1051 DB 2004 01 No such construction N A 7 2 2 MANUFACTURER s name or trademark marked on ME EQUIPMENT and detachable components Pass Misidentification does not present an unacceptable risk See appended RM Results Table 7 2 2 Pass MODEL OR TYPE REFERENCE also marked except when misidentification would not present an unacceptable RISK ccecceeeeeeeeeeetrteeeeeeteee See report page 1 for details Pass 7 2 3 Software forming part of a PEMS identified with a unique identifier such as revision level or date of release issue and identification are available to designated Persons cceccceeceeeeeeeeeeteeeeeteteeeeeeeey Symbol 11 on Table D 1 ISO 7000 1641 DB 2004 01 used optionally advice to OPERATOR to consult ACCOMPANYING DOCUMENTS no such parts Provided on label see label for detail N A Pass Safety sign 10 on Table D 2 safety sign IEC 60878 Safety 01 used advising OPERATOR that ACCOMPANYING DOCUMENTS must be consulted N A 7 2 4 ACCESSORIES marked with name or trademark of MANUFACTURER or supplier and with a MODEL or TYPE REFERENCE ccccceeeseeeeeseeeeeeeee No accessories N A Markings applied to individual packaging when not practical to apply to ACCESSORIES N A
95. OUS OXIDE provided with a non SELF RESETTING THERMAL CUT OUT and complied with 15 4 2 1 Current carrying part of heating element is not in N A direct contact with FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE G 7 Test apparatus for flammable mixtures N A Test apparatus used was in accordance with this N A Clause and Fig G 7 ANNEX L INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVED Pass INSULATION L 1 BASIC SUPPLEMENTARY DOUBLE and REINFORCED Evaluated in part of power Pass INSULATION in wound components without supply interleaved insulation complied with this Annex covering round winding wires between 0 05 mm and 5 00 mm diameters L 2 Wire construction Pass Overlap of layers when wire is insulated with two or Evaluated in part of power Pass more spirally wrapped layers of tape is adequate to supply ensure continued overlap during manufacture of wound component Layers of spirally wrapped wire insulation are Evaluated in part of power Pass sufficiently secured to maintain the overlap supply L 3 Type Test N A The wire subjected to tests of L 3 1 to L 3 4 ata N A temperature and a relative humidity specified Temperature C oo eeccceeeeeeteeeeeeeieeeeettteeeertneeeeees FUMI Yo oii a ce suass ee saeetee ew Aapee L 3 1 Dielectric strength N A Dielectric strength test of Clause 8 8 3 for the N A appropriate type and number of MoP s conducted by preparing the sample according to IEC 60851 5 1996 Clause 4 4
96. PLY CORD arranged to prevent PROTECTIVE EARTH CONDUCTOR against strain as long as phase conductors are in contact with their terminals when cord anchorage fails N A Issue Date 2014 03 27 Page 46 of 181 Report Reference 1402012 draft report f Cord anchorage prevents POWER SUPPLY CORD from being pushed into ME EQUIPMENT or MAINS CONNECTOR N A Conductors of POWER SUPPLY CORD supplied by MANUFACTURER disconnected from terminals or from MAINS CONNECTOR and cord subjected 25 times to a pull applied with no jerks each time for 1 s on sheath of the value in Table 18 N A Cord subjected to a torque in Table 18 for 1 min immediately after pull tests N A Cord anchorage did not allow cord sheath to be longitudinally displaced by more than 2 mm or conductor ends to move over a distance of more than 1 mm from their connected position CREEPAGE and CLEARANCES not reduced below limits in 8 9 N A N A It was not possible to push the cord into ME EQUIPMENT or MAINS CONNECTOR to an extent the cord or internal parts would be damaged N A 8 11 3 6 POWER SUPPLY CORDS other than for STATIONARY ME EQUIPMENT protected against excessive bending at inlet opening of equipment or of MAINS CONNECTOR by means of an insulating cord guard or by means of an appropriately shaped opening Not stationary ME equipment N A Cord guard complied with test of IEC 60335 1 2001 Clause
97. PPLIED PARTS N A 11 1 2 1 Temperatures hot or cold surfaces and when appropriate clinical effects of APPLIED PARTS supplying heat to a PATIENT determined and documented in RISK MANAGEMENT FILE and instructions fOr USC ccececcecceceeseseeeeeeeeeanensneeeeeeel N A 11 1 2 2 APPLIED PARTS not supplying heat to a PATIENT met Table 24 with max surface temperatures gt 41 C disclosed in instructions for use and clinical effects regarding maturity of PATIENTS body surface surface pressure medications taken as shown in RISK MANAGEMENT FILE 08 Surfaces of APPLIED PARTS cooled below ambient temperatures that can also result in HAZARD evaluated as part of RISK MANAGEMENT PROCESS N A N A 11 1 3 Measurements not made when engineering judgment and rationale by MANUFACTURER See appended RM Results Table 11 1 3 Pass Issue Date 2014 03 27 Page 63 of 181 Report Reference 1402012 draft report indicated temperature limits could not exceed as documented in RISK MANAGEMENT FILE Test corner not used where engineering judgment and rationale by MANUFACTURER indicated test corner will not impact measurements as documented in RISK MANAGEMENT FILE Probability of occurrence and duration of contact for parts likely to be touched and for APPLIED PARTS documented in RISK MANAGEMENT FILE N A N A 11 1 4 GUARDS preventing conta
98. Pass Instructions frequently used functions and No specified function be N A defined as frequently use known contraindication s to use of ME N A EQUIPMENT Classifications as in Clause 6 all markings per Pass Clause 7 2 and explanation of safety signs and symbols marked on ME EQUIPMENT Instructions for use are in a language acceptable to Written in English which is Pass the intended operator international common used language 7 9 2 2 Instructions for use include all warning and safety Pass notices Warning statement for CLASS ME EQUIPMENT See User Manual Safety Pass indicating WARNING To avoid risk of electric Instructions shock this equipment must only be connected to a supply mains with protective earth Warnings regarding significant RISKS of reciprocal N A interference posed by ME EQUIPMENT during specific investigations or treatments Information on potential electromagnetic or other _ To be evaluated in the end N A interference and advice on how to avoid or system assembly minimize such interference Warning statement for ME EQUIPMENT supplied No multiple socket outlet N A Issue Date 2014 03 27 Page 22 of 181 Report Reference 1402012 draft report indicating connecting electrical equipment to MSO effectively leads to creating an ME SYSTEM and can result in a reduced level of safety 7 9 2 3 The RESPONSIBLE ORGANIZATION is referred to this standard for the requirements applicable to ME SY
99. R N A d Emergency stopping device s are not part of normal operation of ME EQUIPMENT N A e Emergency switching operation or stopping means neither introduced further HAZARD nor interfered with operation necessary to remove original HAZARD N A f Emergency stopping device was able to break full load of relevant circuit including possible stalled motor currents and the like N A g Means for stopping of movements operate as a result of one single action h Emergency stopping device provided with an actuator in red and easily distinguishable and identifiable from other controls N A N A i An actuator interrupting opening mechanical movements marked on or immediately adjacent to face of actuator with symbol 18 of Table D 1 symbol IEC 60417 5638 DB 2002 10 or STOP j Emergency stopping device once actuated maintained ME EQUIPMENT in disabled condition until a deliberate action different from that used to actuate it was performed N A N A k Emergency stopping device is suitable for its application N A 9 2 5 Means provided to permit quick and safe release of PATIENT in event of breakdown of ME EQUIPMENT or failure of power supply activation of a protective measure or emergency stopping and N A Uncontrolled or unintended movement of ME EQUIPMENT that could result in an unacceptable RISK prevented N A Situations where PATIENT is subjected to u
100. RD when distances separating OPERATOR PATIENT and others from TRAPPING ZONES exceeded values in ISO Distances measured from expected positions of N A OPERATOR PATIENT and others near EQUIPMENT in NORMAL USE or under foreseeable misuse 9 2 2 4 GUARDS and protective measures N A 9 2 2 4 1 A TRAPPING ZONE considered not to present a N A MECHANICAL HAZARD when GUARDS and protective measures were of robust construction not easy to bypass or render non operational and did not introduce additional unacceptable RISK based on results of applicable tests in 15 3 for ENCLOSURES arre ree a eera EA TEE 9 2 2 4 2 FIXED GUARDS held in place by systems that N A cannot be dismantled without a TOOL 9 2 2 4 3 Movable GUARDS that can be opened without a N A TOOL remained attached when GUARD was open they are associated with an interlock preventing N A relevant moving parts from starting to move while TRAPPING ZONE is accessible and stops movement when the GUARD is opened absence or failure of one of their components N A prevents starting and stops moving parts Movable GUARDS complied with all applicable N A tests as confirmed by review of RISK Issue Date 2014 03 27 Page 50 of 181 Report Reference 1402012 draft report MANAGEMENT FILE 9 2 2 4 4 Protective measures provided in control system prevented moving parts from starting to move while in reach Of PErSONS
101. RISK protected against harmful external effects N A Reservoirs and similar vessels leading to an unacceptable RISK are automatically depressurized when ME EQUIPMENT is isolated from its POWER supply Means provided for isolation or local depressurizing reservoirs and similar vessels and pressure indication when above not possible N A N A all Elements remaining under pressure after isolation of ME EQUIPMENT or an ACCESSORY from its POWER supply resulting in an unacceptable RISK provided with clearly identified exhaust devices and a warning to depressurize these Elements before setting or maintenance activity N A 9 7 3 Maximum pressure a part of ME EQUIPMENT can be subjected to in NORMAL and SINGLE FAULT CONDITIONS considered to be highest of following N A a RATED maximum supply pressure from an external source N A b Pressure setting of a pressure relief device provided as part of assembly N A c Max pressure that can develop by a source of pressure that is part of assembly unless pressure limited by a pressure relief device N A 9 7 4 Max pressure in NORMAL and SINGLE FAULT CONDITIONS did not exceed MAXIMUM PERMISSIBLE WORKING PRESSURE for EQUIPMENT part except as allowed in 9 7 7 confirmed by examination of ME EQUIPMENT and RISK MANAGEMENT FILE and by functional tests N A 9 7 5 A pressure vessel withstood a HYDRAULIC TEST N A Issue
102. RISKS associated with moving parts reduced to an acceptable level RISK from contact with moving parts reduced to an acceptable level using protective measures access function shape of parts energy speed of motion and benefits to PATIENT considered No moving parts N A N A RESIDUAL RISK associated with moving parts considered acceptable when exposure was needed N A Issue Date 2014 03 27 Page 49 of 181 Report Reference 1402012 draft report for ME EQUIPMENT to perform its function Warnings marked on ME EQUIPMENT or included N A in instructions for use when HAZARDS persisted after implementing all reasonable protective Meast S e E aa aa aa gated dieestaa 9 2 2 TRAPPING ZONE N A 9 2 2 1 ME EQUIPMENT with a TRAPPING ZONE No trapping zones N A complied with one or more of the following as feasible Gaps in Clause 9 2 2 2 or N A Safe distances in Clause 9 2 2 3 or N A GUARDS and protective measures in 9 2 2 4 or N A Continuous activation in Clause 9 2 2 5 N A Control of relevant motion complied with 9 2 2 6 N A when implementation of above protective measures were inconsistent with INTENDED USE of ME EQUIPMENT or ME SYSTEM 9 2 2 2 A TRAPPING ZONE considered not to present a N A MECHANICAL HAZARD when gaps of TRAPPING ZONE complied with dimensions per Table 20 9 2 2 3 A TRAPPING ZONE considered not to present a N A MECHANICAL HAZA
103. S Pass 6 2 CLASS ME EQUIPMENT externally powered Class Pass CLASS II ME EQUIPMENT externally powered Class equipment N A INTERNALLY POWERED ME EQUIPMENT N A EQUIPMENT with means of connection to a N A SUPPLY MAINS complied with CLASS or CLASS II ME EQUIPMENT requirements when so connected and when not connected to SUPPLY MAINS with INTERNALLY POWERED ME EQUIPMENT requirements TYPE B APPLIED PART No applied parts used N A TYPE BF APPLIED PART No applied parts used N A TYPE CF APPLIED PART No applied parts used N A DEFIBRILLATION PROOF APPLIED PARTS No applied parts used N A 6 3 ENCLOSURES classified according to degree of Front Panel IP65 Rear IPX1 N A protection against ingress of water and particulate matter IPN1N2 as per IEC 60529 ee 6 4 ME EQUIPMENT or its parts intended to be N A sterilized classified according to method s of sterilization in instructions for use ee 6 5 ME EQUIPMENT and ME SYSTEMS intended for Equipment not suitable for use N A use in an OXYGEN RICH ENVIRONMENT in the presence of oxygen rich classified for such use and complied with 11 2 2 environment 6 6 CONTINUOUS or Non CONTINUOUS Continuous Pass OPERATION tics en eieinch eines 7 ME EQUIPMENT IDENTIFICATION MARKING AND DOCUMENTS Pass 7 1 1 RISK of poor USABILITY associated with the The product is a LCD system N A design of ME EQUIPMENT S identification and which used for information marking addressed in a USABILITY display and it
104. STEMS Statement on ME EQUIPMENT for connection to a separate power supply indicating power supply is specified as a part of ME EQUIPMENT or combination is specified as a ME SYSTEM No system been defined Specified power supply was indicated on the label N A N A 7 9 2 4 Warning statement for mains operated ME EQUIPMENT with additional power source not automatically maintained in a fully usable condition indicating the necessity for periodic checking or replacement of power source The power supply is full usable condition no warning statement is required N A Warning to remove primary batteries when ME EQUIPMENT is not likely to be used for some time when leakage from battery would result in an unacceptable RISK cceececeeeeeeeeetreeeeeeeeeeee No primary battery used N A Specifications of replaceable INTERNAL ELECTRICAL POWER SOURCE when provided Warning indicating ME EQUIPMENT must be connected to an appropriate power source when loss of power source would result in an unacceptable RISK cecceeeeeeeeeeeeeeeeeeeeeeee N A N A 7 9 2 5 Instructions for use include a description of ME EQUIPMENT its functions significant physical and performance characteristics together with the expected positions of OPERATOR PATIENT or other persons near ME EQUIPMENT in NORMAL USE Information provided on materials and ingredients PATIENT or OPERATOR is exposed to
105. Swiss Noted Pass domestic installation system 4 See TRF template regulatory requirements Noted Pass Switzerland on IECEE Website R R TRF templates USA Differences to IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 4 8 Replacement where there was no relevant N A IEC ISO standard the relevant US ANSI standard applied 4 8 when no relevant US ANSI standard existed the Pass requirements of this standard applied 4 10 2 Replacement Rated voltage not exceeding 250V N A dc or single phase ac or 600V poly phase ac for me equipment and me systems up to 4kVA 4 10 2 Rated voltage not exceeding 600 V for all other me N A equipment and me systems 8 2 Addition All fixed me equipment amp permanently N A installed me equipment are class me equipment 8 7 3 Earth leakage current values are not higher than Pass the stated values 8 7 3 5 mA in normal condition Pass 8 7 3 10 mA in single fault condition Pass 8 11 Addition permanently connected me equipment N A provided with field wiring provision in accordance with NEC 8 11 Installation of connecting cords between equipment N A parts comply with NEC 8 11 Cable used as external interconnection between N A units 8 11 1 Exposed to abuse Type SJT SJTO SJO ST N A SO STO or equivalent or similar multiple conductor appliance wiring material 8 11 2 Not exposed to abuse The cable was as in item N A 1 above or 8 11 i Type SPT 2 SP 2 or SPE 2 or equivalent N A 8 11 ii
106. T shall be gas specific and clearly identified so that errors are avoided when a replacement is made Medical gas inlet connectors on EQUIPMENT shall be i gas specific yoke type or nut and nipple type valve connections complying with CGA V 1 for pressures over 1 380 kPa 200 psi OF e ee N A N A 15 4 1 15 4 1 ii DISS type complying with CGA V 5 for pressures 1 380 kPa 200 psi or less and configured to permit the supply of medical gases from low pressure connecting assemblies complying with CAN CSA Z5359 NOTE 1A Users of this standard should consult the CSA Z305 series of standards CAN CSA Z9170 1 CAN CSA Z9170 2 CAN CSA Z10524 and CAN CSA Z15002 for further information regarding inlet connectors ISO 407 for requirements addressing yoke type valve connections and ISO 32 for colour coding N A N A 15 4 8 Internal wiring of ME EQUIPMENT shall be in accordance with the Canadian Electrical Code CEC Part lf CSA C22 Tau au ai see Table 8 10 Pass General requirements for the ME SYSTEMS The ME Equipment is not part of an ME System as defined by the manufacturer N A An ME SYSTEM shall provide The ME Equipment is not part of an ME System as defined by the manufacturer N A within the PATIENT ENVIRONMENT the level of safety equivalent to ME EQUIPMENT complying with this standard and The ME Equipment is not part of an ME System as defined by the manufacture
107. TORS V No motors used N A 8 5 5 DEFIBRILLATION PROOF APPLIED PARTS No defibrillation protected applied parts or parts needed to be treated as defibrillation N A Issue Date 2014 03 27 Page 33 of 181 Report Reference 1402012 draft report protected applied parts 8 5 5 1 Classification DEFIBRILLATION PROOF No defibrillation protected N A APPLIED PART applied to one APPLIED PART in applied parts or parts needed its entirety but not separate functions of same to be treated as defibrillation APPLIED PART protected applied parts Possibility of an OPERATOR receiving a shock No defibrillation protected N A from such parts taken into consideration in RISK applied parts or parts needed MANAGEMENT PROCESS to be treated as defibrillation protected applied parts Isolation of PATIENT CONNECTIONS of a No defibrillation protected N A DEFIBRILLATION PROOF APPLIED PART from applied parts or parts needed other parts of ME EQUIPMENT accomplished as to be treated as defibrillation follows protected applied parts a No hazardous electrical energies appear during No defibrillation protected N A a discharge of cardiac defibrillator 008 applied parts or parts needed to be treated as defibrillation protected applied parts b ME EQUIPMENT complied with relevant No defibrillation protected N A requirements of this standard providing BASIC applied parts or parts needed
108. ULTIPLE SOCKET OUTLET is supplied via a N A separating transformer b MULTIPLE SOCKET OUTLET marked with safety N A sign 2 of Table D 2 i e safety sign ISO 7010 W001 visible in NORMAL USE and marked either individually or in combinations N A with the maximum allowed continuous output in amperes or volt amperes or marked to indicate the equipment or equipment N A parts it may safely be attached to MULTIPLE SOCKET OUTLET is a separate item or an N A integral part of ME EQUIPMENT or non ME EQUIPMENT c MULTIPLE SOCKET OUTLET complied with IEC N A 60884 1 and the following requirements CREEPAGE and CLEARANCES complied with 8 9 N A It is CLASS I and PROTECTIVE EARTH CONDUCTOR is N A connected to earthing contacts in socket outlets PROTECTIVE EARTH TERMINALS and PROTECTIVE N A EARTH CONNECTIONS comply with 8 6 except total impedance for ME SYSTEM was up to 400 mQ or higher when conditions of 8 6 4 b met mQ ENCLOSURE complied with 8 4 2 d N A MAINS TERMINAL DEVICES and wiring complied with N A 8 11 4 when applicable RATINGS of components are not in conflict with N A Conditions Of USE ieie eonek aa anaa ienis Electrical terminals and connectors of MULTIPLE N A SOCKET OUTLETS prevent incorrect connection of accessible connectors removable without a TOOL POWER SUPPLY CORD complied with 8 11 3 N A d Additional requirements applied when MULTIPLE N A SOCKET OUTLET combined with a separ
109. Verdict ISO 14971 Document No and paragraph VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 01 C 18 C 21 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 01 H 01 C 18 C 21 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 01 C 18 C 21 VENUS 191_RMF_2014 02 24 Section Risk graph before measures VENUS The risk control measures selected were Pass 191_RMF_2014_02_24 recorded in the risk management file Section Release protocols of measures RC 007 RC 025 VENUS The effectiveness of the risk control measures Pass 191_RMF_2014_02_24 had been verified and the results of the Section Release protocols of Verification were recorded in the risk measures RC 007 RC 025 management file VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after Criteria that defined in the risk management plan measures F 01 H 01 C 18 C 21 VENUS 191_RMF_2014 02_24 Section Risk graph after measures VENUS 191_RMF_2014 02_24 Section S
110. XYGEN RICH ENVIRONMENT as determined by application of RISK MANAGEMENT PROCESS is based on following configurations or in combination Not used with oxygen or oxygen enriched environments Not used with oxygen or oxygen enriched environments N A N A 1 Electrical components in an OXYGEN RICH ENVIRONMENT provided with power supplies having limited energy levels lower than those considered sufficient for ignition in 11 2 2 1 a as determined by examination measurement or calculation of power energy and temperatures in NORMAL and SINGLE FAULT CONDITIONS Identihed ini 1 122 3 ainaani aana aaa Not used with oxygen or oxygen enriched environments N A 2 Max oxygen concentration measured until it did not exceed 25 in ventilated compartments with parts that can be a source of ignition only in SINGLE FAULT CONDITION and can be penetrated by oxygen due to an undetected leak Not used with oxygen or oxygen enriched environments N A 3 A compartment with parts or components that can be a source of ignition only under SINGLE FAULT CONDITION separated from another compartment containing an OXYGEN RICH ENVIRONMENT by sealing all joints and holes for cables shafts or other purposes Not used with oxygen or oxygen enriched environments N A Effect of possible leaks and failures under SINGLE FAULT CONDITION that could cause ignition evaluated using a RISK ASSESSMENT to determine maintenance intervals by examin
111. _ the end product determined by examination of RISK MANAGEMENT FILE ME EQUIPMENT and its Parts niece Ane dee dane There was no reduction of CREEPAGE and Should be evaluated as part of N A CLEARANCES below 8 9 no access to parts the end product exceeding limits in 8 4 and no access to moving parts capable of causing HARM and Assessment criteria in Clause 9 and 11 6 used Should be evaluated as part of N A the end product Dielectric strength test of 8 8 3 conducted to Should be evaluated as part of N A evaluate integrity of solid SUPPLEMENTARY or the end product REINFORCED INSULATION CREEPAGE DISTANCES and AIR Should be evaluated as part of N A CLEARANCES measured compared favourably the end product with min distances in clause 8 9 Small chips not adversely affecting protection Should be evaluated as part of N A against electric shock or moisture disregarded the end product 9 4 3 Instability from unwanted lateral movement including sliding N A 9 4 3 1 a Brakes of power driven MOBILE ME Should be evaluated as part of N A Issue Date 2014 03 27 Page 54 of 181 Report Reference 1402012 draft report EQUIPMENT normally activated and could only be released by continuous actuation of a control the end product b MOBILE ME EQUIPMENT provided with locking means to prevent unwanted movements of ME EQUIPMENT or its parts in transport position Should be evaluated as part of the end product N A c
112. aft report Report Reference Portable or Fixed Equipment The equipment is intended to be used as an equipment of a medical patient monitoring system Continuous Appliance coupler Accessories and detachable parts included None Other options include cccecceeeeeeeeeeeeeeeeeeel None Possible test case verdicts test case does not apply to the test object N A test object does meet the requirement i P Pass test object was not evaluated for the requirement N E test object does not meet the requirement F Fail Abbreviations used in the report normal condition oo eee eeeeeeeeteeeeteel N C single fault condition gt S F C means of Operator protection 0 06 MOOP_ means of Patient protection MOPP General remarks see Attachment refers to additional information appended to the report see appended table refers to a table appended to the report The test results presented in this report relate only to the object tested This report shall not be reproduced except in full without the written approval of the testing laboratory List of test equipment must be kept on file and available for review Additional test data and or information provided in the attachments to this report Throughout this report a point is used as the decimal separator Name and address of Factory ie
113. age symbol 10 of Table D 1 is insufficient Not exceed allowable voltage no warning is required N A For a part that could not be disconnected from supply by an external switch or a plug device accessible at all times the required cover or warning notice complied with this clause N A Standard test finger of Fig 6 applied N A 8 11 2 MULTIPLE SOCKET OUTLETS integral with ME EQUIPMENT complied with 16 2 d second dash and 16 9 2 No such parts N A 8 11 3 POWER SUPPLY CORDS Pass Issue Date 2014 03 27 Page 45 of 181 Report Reference 1402012 draft report 8 11 3 1 MAINS PLUG not fitted with more than one POWER SUPPLY CORD Evaluated in part of power supply N A 8 11 3 2 POWER SUPPLY CORDS are no less robust than ordinary tough rubber sheathed flexible cord IEC 60245 1 2003 Annex A designation 53 or ordinary polyvinyl chloride sheathed flexible cord IEC 60227 1 1993 Annex A design 53 1 UL listed SJT type Hospital grade power supply cord used with no less than 18AWG internal wire IEC 60245 1 IEC 60227 1 optional provided Pass Only polyvinyl chloride insulated POWER SUPPLY CORD with appropriate temperature rating used for ME EQUIPMENT having external metal parts with a temperature gt 75 C touchable by the cord in NORMAL USE aone ansehen See appended Table 8 10 N A 8 11 3 3 NOMINAL cross secti
114. aining rechargeable batteries to be maintained by anyone other than SERVICE PERSONNEL N A 7 9 2 14 A list of ACCESSORIES detachable parts and materials for use with ME EQUIPMENT provided N A 7 9 2 15 Other equipment providing power to ME SYSTEM sufficiently described e g part number RATED VOLTAGE max or min power protection class intermittent or continuous service RISKS associated with disposal of waste products residues etc and of ME EQUIPMENT and ACCESSORIES at the end of their EXPECTED SERVICE LIFE are identified and instructions provided on minimizing these RISKS See User Manual Explanation of Graphical Symbols N A Pass 7 9 2 16 Instructions for use include information specified in Pass Issue Date 2014 03 27 Page 24 of 181 Report Reference 1402012 draft report 7 9 3 or identify where it can be found e g ina service manual 7 9 3 Technical description Pass 7 9 3 1 All essential data provided for safe operation Pass transport storage and measures or conditions necessary for installing ME EQUIPMENT and preparing it for use including the following information as in clause 7 2 N A permissible environmental conditions of use See User Manual Pass including conditions for transport and storage SPECIFICATIONS all characteristics of ME EQUIPMENT including See User Manual Pass range s acc
115. al and may use a non polarized attachment plug or a polarized attachment plug CSA configuration type 1 15P shall be required and shall meet all applicable requirements in CSA C22 2 No 21 and CSA C22 2 No 42 Where a polarized attachment plug is used the POWER SUPPLY CORD shall be connected to the wiring of the EQUIPMENT on the ungrounded side of the line when any of the following devices are used in the primary Circuit 0 ceeeeeeeeee 8 11 3 2 1 the centre contact of an Edison base N A lampholder 8 11 3 2 2 a single pole switch N A 8 11 3 2 3 an automatic control with a marked off position N A 8 11 3 2 4 a solitary fuse fuse holder or N A 8 11 3 2 5 any other single pole overcurrent protective N A device 8 11 3 2 b Detachable POWER SUPPLY CORD for non N A PERMANENTLY INSTALLED EQUIPMENT cord connected equipment shall be of a type that 8 11 3 2 i can be shown to be unlikely to become detached N A accidentally unless it can be shown that detachment will not constitute a safety HAZARD to a PATIENT or OPERATOR 8 11 3 2 ii can be shown that the impedance of the earth N A ground circuit contacts will not constitute a safety HAZARD to a PATIENT or OPERATOR and 8 11 3 2 iii has a terminal configuration or other N A constructional feature that will minimize the possibility of its replacement by a detachable POWER SUPPLY CORD which could create a HAZARDOUS SITUATION 8 11 3 2 c A detachable POWER SUPPLY CORD sha
116. al overpressure N A Issue Date 2014 03 27 Page 94 of 181 Report Reference 1402012 draft report of 400 Pa was created and 30 pulls of the value in Table G 1 applied to each flexible cord in axial direction of cord inlet and in the least favourable direction for 1 s Overpressure not reduced below 200 Pa N A Tests waived when examination of ENCLOSURE indicated it is completely sealed or gas tight without a doubt 100 degree of certainty N A Operating temperature of external surface of ENCLOSURE was lt 150 C in 25 C C eee N A Steady state operating temperature of ENCLOSURE also measured C eceeeeeeeeeeeeeeteeeeeenteeeeees N A G 6 CATEGORY APG ME EQUIPMENT parts and components thereof N A G 6 1 ME EQUIPMENT its parts and components did not ignite FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE under NORMAL USE and SINGLE FAULT CONDITION N A ME EQUIPMENT its parts and components not complying with G 6 3 subjected to a CONTINUOUS OPERATION test after attaining thermal steady state max 3 h over a period of 10 min in a 12 2 0 4 ether by volume oxygen mixture N A G 6 2 Parts and components of CATEGORY APG ME EQUIPMENT operating in a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE supplied from a source isolated from earth by insulation equal to one MEANS OF PATIENT PROTECTION and from electrical parts
117. alysis N A VENUS The risk control measures have been reviewed to Pass 191_RMF 2014 02 24 identify if other hazards are introduced Section New evaluation after measures VENUS 191_RMF 2014 02_24 Section Residual risk evaluation VENUS The manufacturer assures that the risk s from all Pass 191 RMF 2014_02 24 identified hazards have been evaluated Section Summary of risk control VENUS After all risk control measures have been Pass 191 RMF 2014 02 24 implemented and verified the manufacturer Section Residual risk decide the overall residual risk posed by the evaluation monitor is acceptable using the criteria defined in the risk management plan TABLE Essential Performance List of Essential Performance Manufacturer s document number reference Remarks functions or reference from this standard or collateral or particular standard s Supplementary Information Essential Performance is performance the absence or degradation of which would result in an unacceptable risk 43 RM TABLE Essential Performance N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Equivalent Safety for ME Equipment of ME System N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 101 of 181 Report Reference 1402012 draft report 4 6 RM TABLE ME Equipment or system p
118. anagement file Risk associated with microwave radiation when applicable addressed in risk management process as indicated in risk management file N A Relevant requirements of IEC 60825 1 1993 applied to lasers light emitting diodes LEDs and laser light barriers or similar products N A Risk associated with visible electromagnetic radiation other than emitted by lasers and leds when applicable addressed in risk management process as indicated in risk management file N A Risk associated with infrared radiation other than emitted by lasers and leds as applicable addressed in risk management process as indicated in risk management file i N A Risk associated with ultraviolet radiation other than emitted by lasers and leds as applicable addressed in risk management process as indicated in risk management file No UV N A PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS Pass 11 1 Excessive temperatures in ME EQUIPMENT Pass 11 1 1 Temperatures on ME EQUIPMENT parts did not exceed values in Tables 22 and 23 operating in worst case NORMAL USE at maximum rated ambient operating temperature T 0 cee See appended Table 11 1 1 Pass Surfaces of test corner did not exceed 90 C See appended Table 11 1 1 Pass THERMAL CUT OUTS did not operate in NORMAL CONDITION No thermal cut outs used N A 11 1 2 Temperature of A
119. arate 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 parts are extended beyond the equipment enclosure and terminated with an arrow Parts accessible to the operator only are extended outside of the enclosure but are not terminated with an arrow Issue Date 2014 03 27 Page 9 of 181 Report Reference 1402012 draft report 4 GENERAL REQUIREMENTS Pass 4 1 Requirements of this standard applied in NORMAL Pass USE and reasonably foreseeable misuse 4 2 A RISK MANAGEMENT PROCESS complying mith See appended RM Results Pass ISO 14971 was performed cceeeeeeeeteeree Table 4 2 4 3 ESSENTIAL PERFORMANCE functions identified N A according to MANUFACTURER S policy for RISK acceptability in RISK MANAGEMENT FILE ESSENTIAL PERFORMANCE functions N A maintained following particular tests as applicable 44 EXPECTED SERVICE LIFE stated in RISK The LCD system expected Pass MANAGEMENT FILE Service life was 3 years that it is specified in RM report 45 Alternative means of addressing particular RISKS No alternative means applied N A considered acceptable based on in the evaluation of RM report MANUFACTURER S justification that RESIDUAL RISKS resulting from application of alternative means
120. arts contacting the patient Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph RM TABLE Single Fault Condition for ME Equipment Pass Clause of Document Ref in RMF Result Remarks Verdict SO 14971 Document No and paragraph 4 2 VENUS The RMF mention the Intended use intended Pass 191_RMF_2014_02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191 RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis both normal and fault conditions VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 01 H 01 H 02 F 02 H 01 H 02 F 03 H 01 F 04 H 01 F 05 H 01 F 06 H 01 F 07 H 01 H 02 H 03 F 08 H 01 F 09 H 01 F 10 H 01 Issue Date 2014 03 27 Page 102 of 181 Report Reference 1402012 draft report 4 8 RM TABLE Components of ME Equipment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RM mention the Intended use intended Pass 191_RMF 2014 02_24 Section Version Data VENUS 191_RMF_2014 02_24 Section Risk analysis VENUS 191_RMF_2014_02_24 Section Evaluation of risk before measures F 01 H 01 C 07 C 08 VENUS 191_RMF 2014 02 24 Section Evaluation of risk befo
121. ated from N A all PATIENT CONNECTIONS did not come into contact with a flat conductive plate of not less than 100 mm diameter CLEARANCE between connector pins and a flat N A surface is at least 0 5 mm conductive part pluggable into a mains socket N A protected from making contact with parts at MAINS VOLTAGE by insulation with a CREEPAGE DISTANCE of at least 1 0 mm a 1500 V dielectric strength and complying with 8 8 4 1 required test finger did not make electrical contact N A with conductive part when applied against access Issue Date 2014 03 27 Page 32 of 181 Report Reference 1402012 draft report openings with a force of 10 N except when RISK MANAGEMENT PROCESS indicated no unacceptable RISK existed from contact with objects other than a MAINS ce eeeeeeteteeeeeeel 8 5 3 MAXIMUM MAINS VOLTAGE Pass MAXIMUM MAINS voltage determined to be the highest RATED supply voltage for single phase or d c supply MAINS powered ME EQUIPMENT as well as INTERNALLY powered ME EQUIPMENT with a means of connection to a supply MAINS V 240Vac Pass When less than 100 V MAXIMUM MAINS VOLTAGE was 250 V N A MAXIMUM MAINS voltage was the highest RATED phase to neutral supply voltage for poly phase ME EQUIPMENT V Not poly phase ME equipment N A for other INTERNALLY POWERED ME EQUIPMENT maximum mains voltage was 250 V Not internally powered me equipment N
122. ating transformer Separating transformer complied with IEC 61558 N A 2 1 except requirements of maximum RATED output Issue Date 2014 03 27 Page 88 of 181 Report Reference 1402012 draft report power of 1 kVA and degree of protection IPX4 were not applied ce kee kaa ee eS Separating transformer is CLASS N A Degree of protection against ingress of water N A specified as in IEC 60529 Separating transformer assembly marked N A according to 7 2 and 7 3 MULTIPLE SOCKET OUTLET permanently connected N A to separating transformer or socket outlet of separating transformer assembly cannot accept MAINS PLUGS as identified in IEC TR 60083 16 9 2 2 Removal of any single item of equipment in ME N A SYSTEM will not interrupt the protective earthing of any other part without simultaneous disconnection of electrical supply to that part Additional PROTECTIVE EARTH CONDUCTORS can be N A detachable only by use of a TOOL 16 9 2 3 Conductors connecting different items within an ME N A SYSTEM protected against mechanical damage 17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND ME SYSTEMS N A RIsks associated with items addressed in RISK N A MANAGEMENT PROCESS as confirmed by review electromagnetic phenomena at locations where N A ME EQUIPMENT or ME SYSTEM is to be used as stated in ACCOMPANYING DOCUMENTS c eeceeeeeeeeeeeeeee introduction
123. ation and Single Fault Conditions 13 Test located at SPC Enclosure Mechanical Strength 15 3 Test located at SPC Drop Test 15 3 4 Test located at SPC Mold Stress Relief Test 15 3 6 Test located at SPC Leakage Current Test 8 7 Test located at SPC Summary of Compliance with National Differences List of countries addressed AT BE CA CH CZ DE DK FI FR GB HU IT NL NO PL SE SI SK TR UA US Issue Date 2014 03 27 Page 3 of 181 Report Reference 1402012 draft report The product fulfills the requirements of ANSI AAMI ES60601 1 2005 C1 09 A2 10 includes Deviations for United States CAN CSA C22 2 No 60601 1 08 2nd Edition including national differences of Canada EN 60601 1 2006 CORR 2010 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Copy of Marking Plate Refer to Enclosure titled Marking Plate for copy Issue Date 2014 03 27 Page 4 of 181 Test item particulars see also Clause 6 Classification of installation and use 04 Device type component sub assembly equipmen SYSLOM sort oraka a eare ore SAT A E EAA AETA EA Intended use Including type of patient application JOCAUION oriori e AoE ERE ARERR E ATRA Mode of operation c cceeeececeeeteeeeeeeteeeteeees Supply connection ssssseeseeeessre neren nsrnneerereneee maT 1402012 dr
124. ation of documentation and RISK MANAGEMENT FILE Not used with oxygen or oxygen enriched environments N A 11 2 2 2 4 Fire initiated in ENCLOSURE of electrical components in a compartment with OXYGEN RICH ENVIRONMENT that can become a source of ignition only under SINGLE FAULT CONDITIONS self extinguished rapidly and no hazardous amount of toxic gases reached PATIENT as determined by analysis Of gases 0 0 eceeeceeeeeeeeeteeeeettteeeeeetteeeeeeel RISK of ignition under least favourable conditions did not occur and oxygen concentration did not exceed 25 in immediate surroundings due to location of external exhaust outlets of an OXYGEN RICH ENVIRONMENT when electrical components mounted outside of ME EQUIPMENT or ME SYSTEM Not used with oxygen or oxygen enriched environments Not used with oxygen or oxygen enriched environments N A N A 11 2 2 3 Electrical connections within a compartment containing an OXYGEN RICH ENVIRONMENT under NORMAL USE did not produce sparks due to loosening or breaking except when limited in Not used with oxygen or oxygen enriched environments N A Issue Date 2014 03 27 Page 65 of 181 Report Reference 1402012 draft report power and energy to values in 11 2 2 1 a 5 Screw attachments protected against loosening Not used with oxygen or N A during use by varnishing use of spring washers or o
125. by insulation twice the MEANS OF PATIENT PROTECTION 0e ceeseeeeeeeeeeereeseteeteeeeeel N A 6 6 3 Test of G 6 1 waived when the following requirements were met in NORMAL USE and under NORMAL and SINGLE FAULT CONDITIONS ce00 N A a no sparks produced and temperatures did not exceed 90 C or N A b a temperature limit of 90 C not exceeded sparks produced in NORMAL USE and SINGLE FAULT CONDITIONS except Umax and Imax occurring in their circuits complied with requirements taking Cmax and Lmax into consideration Measured Umax lt Uzr with Izr as in Fig G 4 N A N A Measured Umax lt Uzc with Cmax as in Fig G 5 N A Measured Imax lt lzr with Uzr as in Fig G4 N A Issue Date 2014 03 27 Page 95 of 181 Report Reference 1402012 draft report Measured Imax lt Iz with Lmax and a Umax lt 24 V as N A IN Fig GG iene Ape tei ane i diet Extrapolation from Figs G 4 G 5 and G 6 was N A limited to areas indicated Umax was the highest no load voltage occurring in N A the circuit under investigation taking into consideration mains voltage variations as in 4 10 Imax was the highest current flowing in the circuit N A under investigation taking into account MAINS VOLTAGE variations as in 4 10 Cmax and Lmax are values occurring in relevant N A circuit Umax additionally dete
126. c peak values in case of a complicated circuit 51 Temperature measurements made according to N A 11 1 and Umax Imax R Lmax and Cmax determined with application of Figs G 1 G 3 ieena Alternatively compliance was verified by N A examination of design data ceeeeeeeeeeee G 5 4 External ventilation with internal overpressure N A ME EQUIPMENT its parts and components enclosed N A in an ENCLOSURE with external ventilation by means of internal overpressure complied with the following requirements a FLAMMABLE AESTHETIC MIXTURES WITH AIR that N A might have penetrated into ENCLOSURE of ME EQUIPMENT or part removed by ventilation before EQUIPMENT energized and penetration of such Issue Date 2014 03 27 Page 93 of 181 Report Reference 1402012 draft report mixtures during operation was prevented by maintenance of overpressure by means of air without flammable gases or by physiologically acceptable inert gas e g nitrogen b Overpressure inside ENCLOSURE was 75 Pa min in NORMAL CONDITION Pa cceeesteeeeeee N A Overpressure maintained at the site of potential ignition even when air or inert gas could escape through openings in ENCLOSURE necessary for normal operation of ME EQUIPMENT or its parts N A ME EQUIPMENT could be energized only after the required minimum overpressure was present long enough to ventilate the ENCLOSURE so that the displace
127. ct with hot or cold accessible surfaces removable only with a TOOL No such parts N A 11 2 Fire prevention Pass 11 2 1 ENCLOSURE has strength and rigidity necessary to prevent a fire caused by reasonably foreseeable misuse and met mechanical strength tests for ENCLOSURES in 15 3 Pass 11 2 2 Me equipment and me systems used in conjunction ENVIRONMENTS with OXYGEN RICH N A 11 2 2 1 RISK of fire inan OXYGEN RICH ENVIRONMENT reduced by means limiting spread of fire under NORMAL or SINGLE FAULT CONDITIONS when source of ignition in contact with ignitable material Not used with oxygen or oxygen enriched environments N A Requirements of 13 1 1 applied to oxygen concentrations up to 25 at one atmosphere or partial pressures up to 27 5 kPa for higher atmospheric pressures Not used with oxygen or oxygen enriched environments N A a No sources of ignition discovered in an OXYGEN RICH ENVIRONMENT in NORMAL and SINGLE FAULT CONDITIONS under any of the following conditions eee a Not used with oxygen or oxygen enriched environments N A 1 when temperature of material raised to its ignition temperature Not used with oxygen or oxygen enriched environments N A 2 when temperatures affected solder or solder joints causing loosening short circuiting or other failures causing sparking or increasing material temperature to its ignition temperature Not u
128. ctivities milestones and schedules Pems development life cycle includes N A documentation requirements 14 5 A documented system for problem resolution within N A and between all phases and activities of pems development life cycle has been developed and maintained where appropriate Problem resolution system meets the prescribed N A criteria depending on type of product it is documented as a part of pems development N A life cycle it allows reporting of potential or existing N A problems affecting basic safety or essential performance it includes an assessment of each problem for N A associated risks it identifies criteria that must be met for the issue N A to be closed it identifies the action to be taken to resolve each N A problem 14 6 Risk management process N A 14 6 1 Manufacturer considered hazards associated with N A software and hardware aspects of pems including network data coupling components of third party Issue Date 2014 03 27 Page 74 of 181 Report Reference 1402012 draft report origin legacy subsystems when compiling list of known or foreseeable hazards In addition to the material in ISO 14971 Annex D N A list of possible sources for hazards associated with pems includes specified causes failure of network data coupling to provide N A characteristics necessary for pems to achieve its basic safety or essentia
129. d tests performed within the limits in technical o 1ce iT 0111o a VRAE E eee d Potable water used for cooling no such parts no such parts N A N A 5 5 Supply voltage during tests was the least favourable of the voltages specified in 4 10 or voltages marked on ME EQUIPMENT V Rated voltage 100 240Vac Tested at 90 100 240 264Vac Pass ME EQUIPMENT marked with a RATED frequency range tested at the least favourable frequency within the range HZ cecceeeeeeeeeeeeteeeeeeeeee Rated frequency 50 60Hz Pass ME EQUIPMENT with more than one RATED voltage or both a c d c tested in conditions see 5 4 related to the least favourable voltage nature of supply and type of current sssesssseereerenneee Tested at 90 100 240 264Vac Single phase supply AC current N A ME EQUIPMENT tested with alternative ACCESSORIES and components specified in ACCOMPANYING DOCUMENTS to result in the least favourable CONGItIONS ecccceeeeeeeeeeeeeeeel N A ME EQUIPMENT connected to a separate power supply as specified in instructions for use N A 5 6 When failure occurred or probability of future failure detected during sequence of tests per agreement with manufacturer all tests affecting results conducted on a new sample Alternatively upon repair and modification of the Pass Pass Issue Date 2014 03 27 Page 12 of
130. d volume of air or inert gas was at least five times the volume of ENCLOSURE N A ME EQUIPMENT energized at will or repeatedly when overpressure was continuously present N A c Ignition sources de energized automatically by means used where G 4 does not apply or complied with G 5 when during operation overpressure dropped below 50 Pa Pa 5 N A d External surface of ENCLOSURE in which internal overpressure was maintained did not exceed 150 C in 25 C ambient under NORMAL USE and CONDITION CG esiecsdesttlets acndeeiat desea ee aaeladees N A G 5 5 ENCLOSURES with restricted breathing N A ME EQUIPMENT its parts and components enclosed in an ENCLOSURE with restricted breathing complied with the following N A a A FLAMMABLE AESTHETIC MIXTURE WITH AIR did not form inside ENCLOSURE with restricted breathing when it was surrounded by a FLAMMABLE AESTHETIC MIXTURE WITH AIR of a high concentration for at least 30 min without any pressure difference inside ENCLOSURE N A b Gasket or sealing material used to maintain tightness complied with aging test B b of IEC 60068 2 2 Clause 15 at 70 C 2 C and 96 h N A c Gas tightness of ENCLOSURE containing inlets for flexible cords maintained when the cords were stressed by bending or pulling N A Cords are fitted with adequate anchorages to limit stresses N A After the test in G 5 4 b an intern
131. ded Table 8 10 Pass c ASUPPLY MAINS switch used to comply with 8 11 1 a complies with CREEPAGE and CLEARANCES in IEC 61058 1 for a MAINS TRANSIENT VOLTAGE of 4 KV 0 ccceeeeteeeeeel See appended Table 8 10 N A d A SUPPLY MAINS switch not incorporated in a POWER SUPPLY CORD or external flexible lead N A e Direction of movement of actuator of a SUPPLY MAINS switch used to comply with 8 11 1 a complies with IEC 60447 No such parts N A f A suitable plug device such as an APPLIANCE COUPLER or a flexible cord with a MAINS PLUG used in non PERMANENTLY INSTALLED ME EQUIPMENT to isolate it from SUPPLY MAINS considered to comply with 8 11 1 a eee See appended Table 8 10 N A g A fuse or a semiconductor device not used as an isolating means Not used Pass h ME EQUIPMENT not provided with a device causing disconnection of ME EQUIPMENT from SUPPLY MAINS by producing a short circuit resulting in operation of an overcurrent protection device N A i Parts within ENCLOSURE of ME EQUIPMENT with a circuit gt 42 4 V peak a c or 60 V d c that cannot be disconnected from its supply by an external switch or a plug device accessible at all times is protected against touch even after opening ENCLOSURE by an additional covering Evaluated in part of power supply N A A clear warning notice is marked on outside of ME EQUIPMENT to indicate it exceeds allowable touch volt
132. draft report 12 4 3 RM TABLE Accidental selection of excessive output values Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph 12 4 4 RM TABLE Incorrect output N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 12 4 5 2 RM TABLE Diagnostic X ray equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 12 4 5 3 RM TABLE Radiotherapy equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 12 4 5 4 RM TABLE Other ME equipment producing diagnostic or therapeutic N A radiation Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 12 4 6 RM TABLE Diagnostic or therapeutic acoustic pressure N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 13 2 2 relative to emission of flames molten metal or ignitable substances 13 1 2 TABLE measurement of power or energy dissipation in parts amp components to waive SINGLE FAULT CONDITIONS in 4 7 8 1 b 8 7 2 and Power dissipated less than W Part or component tested Measured power Calculated SINGLE FAULT Remarks issi energy CONDITIONS waived dissipated J Yes No Energy dissipated less than J Supplementary information Issue Date 20
133. drive circuits maintained a substantially constant drive current No motors used N A Test not conducted based on other justifications JUSUITICAION t5 5 hie iAs aes dacs c ME EQUIPMENT with 3 phase motors operated with normal load connected to a 3 phase SUPPLY MAINS with one phase disconnected and periods of operation per 13 2 10 No motors used Not connected to a multiphase AC input source N A N A 13 2 13 4 ME EQUIPMENT RATED for NON CONTINUOUS OPERATION N A ME EQUIPMENT other than HAND HELD operated under normal load and at RATED voltage or at upper limit of RATED voltage range until increase in temperature was 5 C in one hour or a protective device operated Not non continuous operation N A When a load reducing device operated in NORMAL USE test continued with ME EQUIPMENT running idle Not non continuous operation N A Motor winding temperatures did not exceed values Not non continuous operation N A Insulation Classi aana a an a i Not non continuous operation Maximum temperature measured Not non continuous operation PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS PEMS N A 14 1 Requirements of this clause not applied to pess when it provided no basic safety or essential performance or N A when application of ISO 14971 showed that failure of pess does not lead to unacceptable risk N A Every process
134. e NOMINAL capacitance between primary to secondary circuit Voltage Total Working V and C Nominal uF Points at which impedances of components N A CREEPAGE CLEARANCES PROTECTIVE EARTH CONNECTIONS or insulation prevent ACCESSIBLE PARTS from exceeding limits in 8 4 examined whether a failure at any of these points is to be regarded as a NORMAL or SINGLE FAULT CONDITION A MEANS OF PROTECTION protecting APPLIED N A PARTS or parts identified by 4 6 as parts subject to the same requirements considered MEANS OF PATIENT PROTECTION cceeseeeeseeeeeeeteee A MEANS OF PROTECTION protecting other parts N A considered MEANS OF OPERATOR PROTECTION ote o Aes habe eae 8 5 2 Separation of PATIENT CONNECTIONS N A 8 5 2 1 PATIENT CONNECTIONS of F TYPE APPLIED No type F applied parts used N A PART separated from all other parts by equivalent or parts needed to be treated to one MEANS OF PATIENT PROTECTION fora as type F applied parts WORKING VOLTAGE equal to maximum MAINS VOLTAGE and complied with limit for PATIENT LEAKAGE CURRENT at 110 of max MAINS Separation requirement not applied between No type F applied parts used N A multiple functions of a single F TYPE APPLIED or parts needed to be treated PART as type F applied parts PATIENT CONNECTIONS treated as one No type F applied parts used N A APPLIED PART in the absence of electrical or parts needed to be treated separation between PATIENT CONNECTIONS of as type F applied part
135. e in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 N A 7 7 4 A PROTECTIVE EARTH CONDUCTOR ora PROTECTIVE EARTH CONNECTION or insulation shall be identified by either green or green and yellow colour Colours of neutral and POWER SUPPLY CORD conductors shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 2 No 21 and CSA C22 2 No 49 N A 7 7 5 and shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 N A 7 7 5 A PROTECTIVE EARTH CONDUCTOR or a PROTECTIVE EARTH CONNECTION or insulation shall be identified by either green or green and yellow colour Colours of neutral and POWER SUPPLY CORD conductors shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 2 No 21 and CSA C22 2 No 49 N A 8 7 3 Allowable values shall be in accordance with the Canadian Electrical Code CEC Part I CSA C22 1 Pass Issue Date 2014 03 27 Page 164 of 181 Report Reference 1402012 draft report 8 11 3 2 a The MAINS PLUG of non PERMANENTLY N A INSTALLED EQUIPMENT shall be 8 11 3 2 i if molded on type hospital grade mains plug N A complying with CSA C22 2 No 213 0 8 11 3 2 ii hospital grade disassembly attachment plug type N A complying with CSA C22 2 No 42 or 8 11 3 2 iii Class Il equipment having fuses on the line N A side sides and neutr
136. easures RC 021 VENUS 191_RMF_2014 02_24 Section Release protocols of measures RC 021 VENUS 191_ RMF 2014 02 24 Section New evaluation after measures F 01 H 01 C 23 VENUS 191_RMF_2014_02_24 Section Risk graph after measures VENUS 191_RMF_2014_02_24 Section Summary of risk control purpose The manufacturer had compiled a list of known or Pass foreseeable hazards associated with the unit in both normal and fault conditions Pass The estimates of the risk s were recorded in the risk management file The results of this risk evaluation were recorded Pass in the risk management file The risk control measures selected were Pass recorded in the risk management file The effectiveness of the risk control measures Pass had be verified and the results of the verification were recorded in the risk management file All residual risk that remains after the risk control Pass measure s are applied and evaluated using the criteria that defined in the risk management plan No reduction of risk through Risk benefit analysis N A 11 6 7 RM TABLE Sterilization of ME equipment and ME systems N A Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph Verdict Issue Date 2014 03 27 Page 147 of 181 Report Reference 1402012 draft report 11 6 8 RM TABLE Compatibility with substances used Clause of Document Ref in RMF Result Remar
137. ection Evaluation of risk both normal and fault conditions 8 1 b 1 RM TABLE Fundamental rule of protection against electric shock Pass 4 3 before measures F 01 H 01 4 4 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 01 H 0l 8 1 b 2 RM TABLE Fundamental rule of protection against electric shock N A unintended movement of a component Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 8 1 b 3 RM TABLE Fundamental rule of protection against electric shock Pass accidental detachment of conductors and connectors Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 4 3 VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Evaluation of risk both normal and fault conditions before measures F 01 H 0l Issue Date 2014 03 27 Page 111 of 181 Report Reference 1402012 draft report 8 2 2 RM TABLE Connection to an external d c power sources Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list
138. ed in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures VENUS The results of this risk evaluation were recorded Pass 191_ RMF 2014 02 24 in the risk management file Section Evaluation of risk before measures VENUS 191_RMF_2014_02_24 Section Risk graph before measures VENUS The manufacturer follow the process specified in Pass 191_RMF_2014 _02_24 6 2 to 6 7 of ISO 14971 to control the risk s so Section Decision about that the residual risk s associated with each measures hazard is judged acceptable VENUS The risk control measures selected were recorded Pass 191_ RMF 2014 02 24 in the risk management file Section Risk control 6 3 VENUS The effectiveness of the risk control measures Pass 191 RMF 2014_02_24 had been verified and the results of the Section Release protocols verification were recorded in the risk of measures management file Issue Date 2014 03 27 Page 100 of 181 Report Reference 1402012 draft report VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation criteria that defined in the risk management plan after measures VENUS 191_RMF_2014 02_24 Section Risk graph after measures VENUS 191_RMF_2014 02 24 Section Summary of risk control No reduction of risk through Risk benefit an
139. ed service personnel should open the equipment N A 7 9 3 4 Means used to comply with requirements of 8 11 1 clearly identified in technical description Isolation power supply provided as source of electricity N A PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT Limits specified in Clause 8 4 not exceeded for ACCESSIBLE PARTS and APPLIED PARTS in NORMAL or SINGLE FAULT CONDITIONS See Appended RM Results Table 8 1b 1 Pass Pass NORMAL CONDITION considered as simultaneous occurrence of situations identified in 8 1a Pass SINGLE FAULT CONDITION considered to include the occurrences as specified in Clause 8 1b See appended RM Results Table 8 1b 1 Pass ACCESSIBLE PARTS determined according to 5 9 Pass LEAKAGE CURRENTS measured according to 8 7 See appended Table 8 7 Pass 8 2 Requirements related to power sources Pass 8 2 1 When ME EQUIPMENT specified for connection to a separate power source other than SUPPLY MAINS separate power source considered as part of ME EQUIPMENT or combination considered as an ME SYSTEM Separated power supply was considered as part of ME Equipment Pass Tests performed with ME EQUIPMENT connected to separate power supply when one specified Pass Issue Date 2014 03 27 Page 26 of 181 Report Reference 1402012 draft report Whe
140. eeeeenees See appended RM Results Table 8 10 1 Pass 8 10 2 Conductors and connectors of ME EQUIPMENT adequately secured or insulated to prevent accidental detachment in a HAZARDOUS See appended RM Results Table 8 10 2 Pass Conductors and connectors of ME EQUIPMENT when breaking free at their joint are not capable of touching circuit points resulting in a HAZARDOUS SITUATION as indicated in RISK MANAGEMENT FILE Considered Pass Breaking free of one means of mechanical restraint considered a SINGLE FAULT CONDITION Considered Pass Stranded conductors are not solder coated when secured by clamping means to prevent HAZARDOUS SITUATIONS due to poor contact No such construction N A 8 10 3 Flexible cords detachable without a TOOL used to interconnect different parts of ME EQUIPMENT provided with means for connection to comply with requirements for metal ACCESSIBLE PARTS of 8 4 when a connection is loosened or broken as shown by measurement or using test finger No such construction N A Issue Date 2014 03 27 Page 43 of 181 Report Reference 1402012 draft report 8 10 4 Cord connected HAND HELD parts and cord connected foot operated control devices N A 8 10 4 1 Control devices of ME EQUIPMENT and their connection cords contain only conductors and components operating at 42 4 V peak a c max or 60 V d c in circuits isolated from MAINS PART by
141. elevant Pass openings with minimal force of no more than 1 N Test rod inserted in every possible position through Pass openings provided for adjustment of pre set controls that can be adjusted in NORMAL USE with a force of 10 N Test repeated with a TOOL specified in instructions N A for use Test rod freely and vertically suspended through N A openings on top of ENCLOSURE e Devices used to de energize parts when an Need tool to open access N A ACCESS COVER opened without a TOOL gives cover access to parts at voltages above levels permitted by this Clause comply with 8 11 1 for mains isolating switches and remain effective in SINGLE FAULT CONDITION Issue Date 2014 03 27 Page 28 of 181 Report Reference 1402012 draft report A TOOL is required when it is possible to prevent N A the devices from operating 8 4 3 Worst case voltage between pins of plug and Evaluated in part of power N A between either supply pin and ENCLOSURE did supply not exceed 60 V one s after disconnecting the plug of ME EQUIPMENT or its parts V eel A triggering circuit used to ensure disconnection N A occurred at peak of supply voltage waveform When voltage exceeded 60 V calculated or Evaluated in part of power N A measured stored charge didn t exceed 45 uC supply 8 4 4 Residual voltage of conductive parts of capacitive Evaluated in part of power N A circuits having become accessible after ME supply
142. ent file Section Risk analysis F 06 H 01 C 01 VENUS 191_RMF_2014_02_24 Section Risk graph before measures 15 3 TABLE Mechanical Strength tests 1 Pass Clause Name of Test Test conditions Observed results Remarks 15 3 2 Push Test rear side Force 250 N 10N for5s No damage 15 3 3 Impact Test rear Steel ball 50 mm in dia 500 g No damage side 25 g falling from a 1 3 m 15 3 4 2 Drop Test portable Drop height cm 5 Test on rear No damage side 15 3 6 Mold Stress Relief 7 h in oven at temperature C No damage 70 Supplementary information 1 As applicable Push Impact Drop Mould Stress Relief and Rough Handling Tests delete not applicable rows Enclosure material Bayer Materials Science AG Type FR3010 There was no cracking of the enclosure There were no live parts that became accessible Issue Date 2014 03 27 Page 153 of 181 Report Reference 1402012 draft report 15 3 2 RM TABLE Push test Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RM mention the Intended use intended Pass 191_RMF_2014_02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 02 C 02 VENUS The estimates of the risk s were recorded in the
143. er complied with Pass absence of a relevant IEC or ISO standard the requirements of IEC 60601 1 2005 49 A COMPONENT WITH HIGH INTEGRITY No high integrity was used N A CHARACTERISTICS provided because a fault in a Issue Date 2014 03 27 Page 10 of 181 Report Reference 1402012 draft report particular component can generate an unacceptable RISK ccecceeeeeeeeeeeeteeeeeeeeteee COMPONENTS WITH 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 RISK MANAGEMENT FILE neeese N A 4 10 Power supply Pass 4 10 1 4 10 2 ME EQUIPMENT is suitable for connection to a SUPPLY MAINS specified to be connected to a separate power supply can be powered by an INTERNAL ELECTRICAL POWER SOURCE ora combination of the three scceceeeeeeeeereeeee Maximum rated voltage for ME EQUIPMENT intended to be connected to SUPPLY MAINS is 250 V for HAND HELD ME EQUIPMENT V The product is specified to be connected to a separate power supply No hand held parts Pass N A 250 V d c or single phase a c or 500 V polyphase a c for ME EQUIPMENT and ME SYSTEMS with a RATED input 4 kVA V 28 500 V for all other ME EQUIPMENT and ME SYSTEMS For Adaptor single phase input rating 100 240Vac 50 60Hz 1 9 0 8A o
144. erating Conditions Ratings Voltage V Frequency Current A Power W or Power factor Hz VA cos Test on Model VENUS 191 For Power Adapter HITRON ad a ee G ELECTRONICS CORP Type HEMP152G S240060 7 Mex nomalioaded oova o or eat Max nomaltoaded 19 100vec so oe so Max nomalioaded 9A rovas 60 om 620 z Max normalioaded 08A zavas 0 ose 702 Max nomaltoaded zeva 0 098 a Max normal loaded 24Vde fe 2 53 60 72 a Supplementary information Max normal loaded as below The unit continuously crossed reading each USB port loaded 2 5W dummy load contrast of display adjust to full brightness RM TABLE Type Tests Pass Clause of Document Ref in RMF Result Remarks Verdict SO 14971 Document No and paragraph 4 2 VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_ RMF 2014 02_24 foreseeable hazards associated with the unit in Section Risk analysis both normal and fault conditions VENUS The estimates of the risk s were recorded in the Pass 191_RMF 2014 02 24 risk management file Section Evaluation of risk before measures Issue Date 2014 03 27 Page 104 of 181 Report Reference 1402012 draft report 5 4 a RM TABLE Other Conditions Pass Clause of Document Ref in RMF Result Remarks
145. ervice life will not be impacted since cleaning test shows solution will cause no harm degradation to device insulation Pass N A 11 6 7 Sterilization of ME EQUIPMENT and ME SYSTEMS N A ME EQUIPMENT ME SYSTEMS and their parts or ACCESSORIES intended to be sterilized assessed and documented according to ISO 11134 ISO 11135 or ISO 11137 as appropriate 005 Not intended to be sterilized N A After the test ME EQUIPMENT complied with the appropriate dielectric strength and LEAKAGE CURRENT tests and there was no deterioration resulting in an unacceptable RISK c eee N A 11 6 8 RISKS associated with compatibility of substances used with ME EQUIPMENT addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE N A ME EQUIPMENT ME SYSTEM and ACCESSORIES coming into direct or indirect contact with biological tissues cells or body fluids assessed and documented per ISO 10993 Component to be evaluated as part of the end product N A Issue Date 2014 03 27 Page 68 of 181 Report Reference 1402012 draft report Interruption and restoration of power supply did not result ina HAZARDOUS SITUATION except interruption of its intended function See appended Table 11 8 N A AGAINST HAZARDOUS OUTPUTS ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTION Pass 12 1 RISKS assoc
146. est for one or two layers was same as for one MEANS OF PROTECTION for SUPPLEMENTARY INSULATION N A Dielectric strength test for one or two layers was same as for two MEANS OF PROTECTION for REINFORCED INSULATION N A BASIC SUPPLEMENTARY and REINFORCED INSULATION required between windings of wound components separated by interleaved insulation complying with a or b or both except when N A Issue Date 2014 03 27 Page 37 of 181 Report Reference 1402012 draft report c Wire with solid insulation other than solvent No such construction N A based enamel complying with a d Wire with multi layer extruded or spirally Evaluated in part of power N A wrapped insulation complying with b and supply complying with Annex L e Finished wire with spirally wrapped or multi layer Evaluated in part of power N A extruded insulation complying with Annex L supply BASIC insulation minimum two wrapped layers or No multi layer or spirally N A one extruded layer wrapped wire insulation in any wound components used SUPPLEMENTARY insulation minimum two No multi layer or spirally N A layers wrapped or extruded wrapped wire insulation in any wound components used REINFORCED insulation minimum three layers N A wrapped or extruded In d and e for spirally wrapped insulation with No multi layer or spirally N A CREEPAGE DISTANCES between layers less wrapped
147. f in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Other visible electromagnetic radiation Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 10 6 RM TABLE RISK associated with infrared radiation other than emitted by N A lasers and LEDs 10 1 2 RM TABLE ME equipment intended to produce diagnostic or therapeutic X N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 10 7 RM TABLE RISK associated with ultraviolet radiation other than emitted by N A lasers and LEDs Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 137 of 181 Report Reference 1402012 draft report 11 1 1 TABLE Excessive temperatures in ME EQUIPMENT Testament Od Test supy votagotrequeney Wri eov o oo Model No Thermocouple location 3 Max allowable Max measured Remarks temperature 1 temperature 2 from Table 22 C 23 or 24 or RM file for AP 5 CC Test on Model VENUS 191 Desktop Charging mode p poen J o J o p porem w o 3 PCB near U40 105 52 0 66 4 Ambient Shift to 40 degree o fhe Enclosure outside near Battery i 59 2 Test on Model VENUS 191 Discharging mode Ambient Shift to 40 degree alala D olalo RK alwlo 6 HDD body 105 42 8 57 0 Issue Date
148. faults to be tested See appended RM Results Table 5 1 Pass 5 2 5 3 TYPE TESTS conducted on one representative sample under investigation multiple samples used simultaneously when validity of results was not Significantly affected 0 eeeceeeeeeeeeeereeeettteeeeeeel a Tests conducted within the environmental conditions specified in technical description Multiple samples used Pass Pass Temperature C Relative Humidity 0 0 8 40 degree C 5 95 RH Atmospheric Pressure KPa eessen 700 1060hPa b ME EQUIPMENT shielded from other influences that might affect the validity of tests No such situation N A c Test conditions modified and results adjusted accordingly when ambient temperature could not be maintained oorr ainar AE TRAT No such situation N A 5 4 a ME EQUIPMENT tested under least favourable working conditions specified in instructions for use and identified during RISK ANALYSIS except as NOt a EEEE Me E O E b ME EQUIPMENT with adjustable or controlled operating values by anyone other than SERVICE PERSONNEL adjusted to values least favourable for the relevant test per instructions for use See appended RM Results Table 5 4a This Integrated LCD Systems was tested with the maximum normal load see test results table for detail Pass N A c When test results influenced by inlet pressure and flow or chemical composition of a cooling liqui
149. ference 1402012 draft report 9 2 2 5 c RM TABLE Continuous activation Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph 9 2 2 6 RM TABLE Speed of movement s N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 2 3 2 RM TABLE Over travel N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 2 4 RM TABLE Emergency stopping devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Release of patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 130 of 181 Report Reference 1402012 draft report 9 3 RM TABLE Hazards associated with surfaces corners and edges Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 02 both normal and fault conditions H 01 C 03 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 02 H 01 C 03 VENUS The results of this risk evaluation were recorded Pass 191_RMF 201
150. formation The equipment complied with the requirements of Clause 11 6 The equipment did not show signs of wetting of uninsulated live parts There were no dielectric breakdown and or leakage current test non compliances 11 6 2 RM TABLE Overflow in ME equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 11 6 3 RM TABLE Spillage on ME equipment and ME system N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 11 6 5 RM TABLE Ingress of water or particulate matter into ME EQUIPMENT and N A ME SYSTEMS Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 146 of 181 Report Reference 1402012 draft report 11 6 6 RM TABLE Cleaning and disinfection of ME equipment and ME systems Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF 2014 02_24 Section Version Data VENUS 191_RMF_2014_02_24 Section Risk analysis F 01 H 01 C 23 VENUS 191_RMF_2014_02_24 Section Evaluation of risk before measures F 01 H 01 C 23 VENUS 191_RMF_2014_02_24 Section Risk analysis F 01 H 01 C 23 VENUS 191_RMF_2014_02_24 Section Risk graph before measures VENUS 191_RMF_2014 02_24 Section Release protocols of m
151. ge to conductors or their insulation Correct connection and positioning of conductors No mains terminal devices N A before ACCESS COVER was fitted verified by an used installation test 8 11 5 Mains fuses and OVER CURRENT RELEASES Pass A fuse or OVER CURRENT RELEASE provided in Not permanently installed ME N A each supply lead for CLASS I and CLASS II ME equipment EQUIPMENT with a functional earth connection per clause 8 6 9 and in at least one supply lead for other single phase CLASS II ME EQUIPMENT neutral conductor not fused for PERMANENTLY No such situation N A INSTALLED ME EQUIPMENT fuses or OVER current RELEASES omitted due N A to provision of two means of PROTECTION between all parts of opposite polarity within MAINS PART and between all parts of MAINS PART and EARTH and such provisions continued within all Issue Date 2014 03 27 Page 48 of 181 Report Reference 1402012 draft report components Effect of short circuit fault conditions in other circuits taken into consideration before eliminating fuses or OVER CURRENT RELEASES N A Protective devices have adequate breaking capacity to interrupt the maximum fault current including the available short circuit 0000 008 See appended Table 8 10 Pass A fuse or OVER CURRENT RELEASE not provided ina PROTECTIVE EARTH CONDUCTOR Pass Fuses complying with IEC 60127 have high breaking capacity 1 500 A and prospec
152. he other end with an appliance coupler Issue Date 2014 03 27 Page 124 of 181 Report Reference 1402012 draft report 8 10 TABLE list of critical components Pass object part or manufacturer type model technical data standard mark s of Description trademark Edition year conformity 17 VESA Steel alloy mounting 3 0mm thickness Optional minimum overall dimension 90 0mm by 90 0mm 4 screws diameter 3 9mm fit the mounting together with back plastic enclosure Supplementary information 1 Provided evidence ensures the agreed level of compliance See OD CB2039 Issue Date 2014 03 27 Page 125 of 181 Report Reference 1402012 draft report 8 10 1 RM TABLE Fixing of components Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014_02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 01 C 11 VENUS The estimates of the risk s were recorded inthe Pass 191_RMF _ 2014 02_24 risk management file Section Evaluation of risk before measures F 01 H 01 C 11 VENUS The results of this risk evaluation were recorded in pass 19
153. ia A NEA Front Panel IP65 Rear IPX1 Pass Proper symbol marked adjacent to or on connector for APPLIED PART except marked on APPLIED PART when there is no connector or connector used for more than one APPLIED PART and different APPLIED PARTS with different classifications ce eeeecececeeece ease eeeeeeecesaeeeseeeeeeeeanes No applied parts used N A Safety sign 2 of Table D 2 ISO 7010 W001 placed near relevant outlet when protection against effect of discharge of a cardiac defibrillator is partly in the PATIENT cable cccceseeseeeeseeesterteee No applied parts used N A An explanation indicating protection of ME EQUIPMENT against effects of discharge of a cardiac defibrillator depends on use of proper cables included in instructions for use 041 No applied parts used N A 7 2 11 ME EQUIPMENT not marked to the contrary assumed to be suitable for CONTINUOUS OPERATION continuous operation Pass DUTY CYCLE for ME EQUIPMENT intended for non CONTINUOUS OPERATION appropriately marked to provide maximum on and off time N A 7 2 12 Type and full rating of a fuse marked adjacent to ACCESSIBLE fuse holder Evaluated in part of power supply N A FUSC Ypes asiera ended iia NENANA Voltage V and Current A rating ee Operating speed s and Breaking capacity 7 2 13 A safety sign CLEARLY
154. iated with accuracy of controls and instruments stated in RISK MANAGEMENT PROCESS confirmed by RISK MANAGEMENT FILE TEVIEW se ssancctet niet ea ea a e AEE See appended RM Results Table 12 1 Pass 12 2 RISK of poor USABILITY including identification marking and documents addressed in a USABILITY ENGINEERING PROCESS as confirmed by review of provided records N A 12 3 The need for alarm systems as a means of RISK CONTROL and RISKS associated with operation or failure of alarm system addressed in RISK MANAGEMENT PROCESS neern N A 12 4 Protection against hazardous output N A 12 4 1 RISKS associated with hazardous output arising from intentional exceeding of safety limits addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE No hazardous output N A 12 4 2 When applicable need for indication of parameters associated with hazardous output addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE ceeescsteeeeeeeeee N A 12 4 3 RISKS associated with accidental selection of excessive output values for ME EQUIPMENT with a multi purpose unit designed to provide low and high intensity outputs for different treatments addressed in RISK MANAGEMENT PROCESS confirmed in RISK MANAGEMENT FILE N A 12 4 4 When applicable RISKS associated with incorrect output addressed in RISK M
155. ilure by itself N A b ME EQUIPMENT with heating elements tested per 11 1without adequate heat discharge and supply voltage set at 90 or 110 of RATED supply voltage least favourable of the two V N A Operating period stopped when a non SELF RESETTING THERMAL CUT OUT operated or current interrupted without possibility of automatic restoration before THERMAL STABILITY N A ME EQUIPMENT switched off as soon as THERMAL STABILITY established and allowed to cool to room temperature when current not interrupted N A Test duration was equal to RATED operating time for non CONTINUOUS OPERATION N A c Heating parts of ME EQUIPMENT tested with ME EQUIPMENT operated in NORMAL CONDITION at 110 of RATED supply voltage and as in 11 1 and N A 1 Controls limiting temperature in NORMAL CONDITION disabled except THERMAL CUT OUTS N A 2 When more than one control provided they were disabled in turn N A 3 ME EQUIPMENT operated at RATED DUTY CYCLE until THERMAL STABILITY achieved regardless of RATED operating time N A 13 2 13 3 ME EQUIPMENT with motors N A a 1 For the motor part of the ME EQUIPMENT compliance checked by tests of 13 2 8 13 2 10 13 2 13 3 b 13 2 13 3 c and 13 2 13 4 as applicable No motors used N A To determine compliance with 13 2 9 and 13 2 10 motors in circuits running at 42 4 V peak a c 60 V d c or less are covered with a
156. imum allowed values 100 yA Maximum allowed values TC NC S1 1 S5 R S7 1 ae 100 pA TC SFC Neutral Open S1 0 S5 N 18 19 Maximum allowed values S7 1 500 pA TC SFC Neutral Open S1 0 S5 R Maximum allowed values S7 1 264 1 9 1 9 500 pA TC SFC Ground Open S1 1 S5 N Maximum allowed values S7 0 264 10 2 10 3 500 pA TC SFC Ground Open S1 1 S5 R Maximum allowed values S7 0 264 10 1 10 2 500 pA MD between LCD Plastic Enclosure covered with metal foil and LCD SIP SOP TC NC S1 1 S5 N S7 1 24 25 Maximum allowed values 100 pA TC NC S1 1 S5 R S7 1 29 24 Maximum allowed values 100 pA TC SFC Neutral Open S1 0 S5 N 16 15 Maximum allowed values S7 1 500 pA TC SFC Neutral Open S1 0 S5 R Maximum allowed values S7 1 264 2 1 2 0 500 yA TC SFC Ground Open S1 1 S5 N Maximum allowed values S7 0 264 1 5 1 4 500 pA TC SFC Ground Open S1 1 S5 R Maximum allowed values S7 0 264 1 6 1 5 500 uA Fig 15 Patient Leakage Current P Maximum allowed values Type B or BF AP 10 pA NC 50 pA SFC d c current 100 pA NC 500 pA SFC a c Type CF AP 10 pA NC 50 UA SFC d c or a c current Fig 16 Patient leakage current with Maximum allowed values mains on the F type applied parts PM Type B N A Type BF AP Issue Date 2014 03 27 Page 117 of 181 Report Reference 1402012 draft report 5000 pA Type CF AP 50
157. ination of design and RISK MANAGEMENT FILE laane N A c An independent non SELF RESETTING THERMAL CUT OUT is additionally provided where a failure of a THERMOSTAT could constitute a HAZARD as verified by examination of N A Issue Date 2014 03 27 Page 79 of 181 Report Reference 1402012 draft report design and RISK MANAGEMENT FILE d Based on design and RISK MANAGEMENT FILE review loss of function of ME EQUIPMENT due to operation of THERMAL CUT OUT or OVER CURRENT RELEASE doesn t result in a HAZARDOUS SITUATION e Capacitors or other spark suppression devices not connected between contacts of THERMAL CUT OUTS N A N A f Use of THERMAL CUT OUTS or OVER CURRENT RELEASES do not affect safety of ME EQUIPMENT as verified by following tests N A Positive temperature coefficient devices PTC s complied with IEC 60730 1 1999 clauses 15 17 J 15 and J 17 as applicable N A ME EQUIPMENT containing THERMAL CUT OUTS and OVER CURRENT RELEASES operated under the conditions of Clause 13 N A SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent functions other than PTC s Certified according to appropriate standards N A In the absence of Certification in accordance with IEC standards SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent fu
158. ional CLEARANCE in Table 14 for PEAK WORKING VOLTAGE MOPP provided Pass 8 9 1 11 SUPPLY MAINS overvoltage category Il applied according to IEC 60664 1 Overvoltage category II Pass For ME EQUIPMENT intended for overvoltage category Ill Tables 13 to 15 inclusive not used for clearance instead values in the next MAINS TRANSIENT VOLTAGE column upwards used When PATIENT protection Table 12 is required for use of ME EQUIPMENT on overvoltage category lIl SUPPLY MAINS guidance provided on values required in the rationale for Cl 8 9 used N A N A 8 9 1 12 A SECONDARY CIRCUIT derived from a SUPPLY MAINS normally considered to be overvoltage category according to IEC 60664 1 when the MAINS PART is overvoltage category II Table 15 Pass Table 15 applied to earthed SECONDARY CIRCUIT or INTERNALLY POWERED ME EQUIPMENT N A Requirements for primary circuits in Tables 13 and 14 used for an unearthed SECONDARY CIRCUIT derived from a SUPPLY MAINS N A Table 15 applied when SECONDARY CIRCUIT was separated from MAINS PART by a functionally earthed or PROTECTIVELY EARTHED metal screen or transients in SECONDARY CIRCUIT were below the levels expected for overvoltage category N A Table 15 column for circuits not subject to transient overvoltages applied to N A d c SECONDARY CIRCUITS reliably connected to earth and have capacitive filtering limiting peak to peak ripple to
159. ks ISO 14971 Document No and paragraph RM TABLE Accuracy of controls and equipment Pass Clause of Document Ref in RMF Result Remarks Verdict SO 14971 Document No and paragraph 4 2 VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 _02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis F 09 both normal and fault conditions H 01 C 01 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_ 02_24 risk management file Section Evaluation of risk before measures F 09 H 01 C 01 VENUS The results of this risk evaluation were recorded Pass 191_ RMF 2014 02 24 in the risk management file Section Risk analysis F 09 H 01 C 01 VENUS 191_RMF_2014_02_24 Section Risk graph before measures RM TABLE Alarm systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 12 4 1 RM TABLE Intentional exceeding of safety limits N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 12 4 2 RM TABLE Indication of parameters relevant to safety N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 148 of 181 Report Reference 1402012
160. l performance undesired feedback physical and data such as N A unsolicited out of range inconsistent input or input from electromagnetic interference unavailable data N A lack of integrity of data N A incorrect data N A incorrect timing of data N A unintended interactions within amp among pess N A unknown aspects or quality of third party N A software unknown aspects or quality of third party pess N A lack of data security particularly vulnerability to N A tampering unintended interaction with other programs and viruses 14 6 2 Suitably validated tools and procedures assuring N A each risk control measure reduces identified risk s satisfactorily provided in addition to pems requirements in Clause 6 1 of ISO 14971 14 7 A documented requirement specification for pems N A and each of its subsystems e g for a pess which includes essential performance and risk control measures implemented by that system or SUDSYSLOMIM oarra ee ae oe eee ces aE a baee aa EEEE 14 8 An architecture satisfying the requirement is N A specified for pems and each of subsystems The architecture specification makes use of N A considers the specified items to reduce risk to an acceptable level where appropriate a Components with high integrity characteristics N A b fail safe functions N A c redundancy N A d diversity N A e partitioning of functionality N A f defensive design potentially
161. latex rubber aged by suspending samples freely in an oxygen cylinder containing commercial oxygen to a pressure of 2 1 MPa 70 kPa with an effective capacity of at least 10 times volume of samples N A There were no cracks visible to naked eyes after samples kept in cylinder at 70 C 2 C for 96h and afterwards left at room temperature for at least 16h N A 8 9 CREEPAGE DISTANCES and AIR CLEARANCES Pass 8 9 1 1 CREEPAGE DISTANCES and AIR CLEARANCES are to values in Tables 11 to 16 inclusive except as specified in Clauses 8 9 1 2 to 8 9 1 15 Table 12 distance for MOPP is considered Pass 8 9 1 2 Tables 11 to 16 inclusive not applied to CREEPAGE and CLEARANCES forming MEANS OF OPERATOR PROTECTION per IEC 60950 1 for INSULATION CO ORDINATION and used under conditions compliance was tested No such construction N A 8 9 1 3 Specified min CLEARANCE applied as min CREEPAGE for CREEPAGE DISTANCES across glass mica ceramic and other inorganic insulating materials with similar tracking characteristics No such material N A 8 9 1 4 When min CREEPAGE derived from Tables 11 to 16 inclusive was less than min applicable CLEARANCE value of min CLEARANCE applied as min CREEPAGE DISTANCE N A Issue Date 2014 03 27 Page 39 of 181 Report Reference 1402012 draft report 8 9 1 5 ME EQUIPMENT RATED to operate at an altitude of 2000 m N A
162. le D 1 IEC 60417 5019 DB 2002 Evaluated in part of power supply N A 7 3 6 Markings on or adjacent to PROTECTIVE EARTH TERMINALS not applied to parts requiring removal to make the connection and remained visible after connection made Symbol 7 of Table D 1 IEC 60417 5017 DB 2002 10 marked on FUNCTIONAL EARTH TERMINALS No functional earth terminals used N A N A 7 3 7 Terminals for supply conductors marked adjacent when interchanging connections to terminals except when no HAZARD would result Evaluated in part of power supply N A Terminal markings included in ACCOMPANYING DOCUMENTS when ME EQUIPMENT too small to accommodate markings No functional earth terminals N A Terminals exclusively for neutral supply conductor in PERMANENTLY INSTALLED ME EQUIPMENT marked with Code 1 of Table D 3 Code in IEC 60445 N A Marking for connection to a 3 phase supply if necessary complies with IEC 60445 Single phase N A Markings on or adjacent to electrical connection points not applied to parts requiring removal to make connection and remained visible after connection made N A 7 3 8 For supply connections use wiring materials suitable for at least X C where X gt than max temperature measured in terminal box or wiring N A placed in instructions for use if insufficient space
163. le capacitor or circuit parts voltage V charge uC Supplementary information 8 5 2 2 RM TABLE Type B applied parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 113 of 181 Report Reference 1402012 draft report 8 5 2 3 RM TABLE PATIENT Leads Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph TABLE Defibrillation proof applied parts measurement of hazardous electrical energies Test Measurement made Applied part with test Test Measured voltage Remarks Condition on accessible part between Y1 and Y2 Figs 9 and mV 10 Supplementary information 8 5 5 1b TABLE Defibrillation proof applied parts verification of recovery time Applied part with test Recovery time from Measured Remarks voltage documents s recovery time s Supplementary information TABLE Defibrillation Proof Applied Parts or Patient Connections of Defibrillation Proof Applied Parts Energy reduction test measurement of Energy delivered to a 100 ohm load Test Voltage applied to Measured Measured Energy E1 as of E2 Energy E2 mJ Supplementary information For compliance E1 must at least 90 of E2 E1 Measured energy delivered to 100 ohm with ME Equipment connected E2 Measured energy delivered to 100 ohm without ME equipment connected RM TABLE Protecti
164. le is Marked eseesecceeeeeeeeeeteeneeteee a battery powered real time clock circuit Issue Date 2014 03 27 Page 18 of 181 Report Reference 1402012 draft report An identifying marking provided referring to batteries intended to be changed only by SERVICE PERSONNEL using a TOOL instructions in ACCOMPANYING DOCUMENTS for Do not replace battery yourself Please contact a qualified technician or your retail Pass A warning provided indicating replacement of lithium batteries or fuel cells when incorrect replacement by inadequately trained personnel would result in an unacceptable RISK e g excessive temperatures fire or explosion Discard used batteries according to the manufacturer s instructions Pass An identifying marking also provided referring to instructions in ACCOMPANYING DOCUMENTS See user s manual Safety Instructions Pass 7 3 4 Fuses replaceable THERMAL CUT OUTS and OVER CURRENT RELEASES accessible by use of a TOOL marked by type and full rating at the component or by reference to ACCOMPANYING DOCUMENTS Evaluated in part of power supply N A Voltage V and Current A rating eee 7 3 5 Operating speed s and Breaking capacity PROTECTIVE EARTH TERMINAL marked with 10 except for the PROTECTIVE EARTH TERMINAL in an APPLIANCE INLET according to IEC 60320 1 symbol 6 of Tab
165. lead concerned in NORMAL USE a Insulating sleeve that can only be removed by breaking or cutting or secured at both ends is used on internal wiring of when needed See Table 8 10 N A Pass b Sheath of a flexible cord not used as a MEANS OF PROTECTION inside ME EQUIPMENT when it is subject to mechanical or thermal stresses beyond its RATED characteristics N A c Insulated conductors subject to temperatures gt 70 C in NORMAL USE provided with insulation of heat resistant material when compliance is likely to be impaired due to deterioration of insulation See appended Table 8 10 N A 8 11 MAINS PARTS components and layout Pass 8 11 1 a ME EQUIPMENT provided with means of See appended Table 8 10 Pass Issue Date 2014 03 27 Page 44 of 181 Report Reference 1402012 draft report electrically isolating its circuits from SUPPLY MAINS simultaneously on all poles cee PERMANENTLY INSTALLED ME EQUIPMENT connected to a poly phase SUPPLY MAINS equipped with a device not interrupting neutral conductor provided local installation conditions prevent voltage on neutral conductor from exceeding limits in 8 4 2 c Not Permanently installed me equipment N A b Means of isolation incorporated in ME EQUIPMENT and external means described in technical description 0 cccceceeeeeseeeeeeeeeeeeeeeeel See appen
166. lied parts PROTECTION from metal ACCESSIBLE PARTO not PROTECTIVELY EARTHED except when metal ACCESSIBLE PART is No type B applied parts or N A physically close to APPLIED PART and can be parts needed to be treated as regarded as a part of APPLIED PART and type B applied parts RISK that metal accessible PART will make No type B applied parts or N A contact with a source of voltage or LEAKAGE parts needed to be treated as current above permitted limits is acceptably low type B applied parts LEAKAGE CURRENT tests conducted per 8 7 4 No type B applied parts or N A parts needed to be treated as type B applied parts Dielectric strength test conducted per 8 8 3 No type B applied parts or N A parts needed to be treated as type B applied parts Relevant CREEPAGE and CLEARANCES No type B applied parts or N A measured per 8 9 and Tables 11 to 16 as parts needed to be treated as applicable type B applied parts The RISK MANAGEMENT FILE reviewed No type B applied parts or N A parts needed to be treated as type B applied parts 8 5 2 3 A connector on a PATIENT lead located at the end of the lead remote from N A PATIENT with conductive part not separated from all PATIENT CONNECTIONS by one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to MAXIMUM MAINS VOLTAGE cannot be connected to EARTH or hazardous N A voltage while the PATIENT CONNECTIONS are in contact with PATIENT aerarii aaea a esaa conductive part of connector not separ
167. limiting hazardous N A effects by restricting available output power or by introducing means to limit travel of actuators g allocation of risk control measures to N A subsystems and components of pems failure of network data coupling to provide the specified characteristics Issue Date 2014 03 27 Page 75 of 181 Report Reference 1402012 draft report h failure modes of components and their effects N A i common cause failures N A j systematic failures N A k test interval duration and diagnostic coverage N A I maintainability N A m protection from reasonably foreseeable misuse N A n network data coupling specification when N A applicable 14 9 Design is broken up into subsystems each with a N A design and test specification where appropriate and descriptive data on design environment included in risk management file 0e08 14 10 A verification plan containing the specified N A information used to verify and document functions implementing basic safety essential performance or risk Control measures cceceeeeeereeeeeeeteee milestone s when verification is to be performed N A for each function selection and documentation of verification N A strategies activities techniques and appropriate level of independence of the personnel performing the verification selection and utilization of verification tools N
168. ll N A 8 11 3 2 i comply with the applicable requirements of CSA N A C2222 NO 212 ANG ois ceicassitionedaetn ieee 8 11 3 2 ii not be smaller than No 18 AWG and the N A mechanical serviceability shall be not less than 8 11 3 2 1 Type SJ or equivalent for mobile or exposed to N A abuse ME EQUIPMENT and 8 11 3 2 2 Type SV or equivalent for ME EQUIPMENT not N A exposed to abuse or Type HPN if required because of temperature Issue Date 2014 03 27 Page 165 of 181 Report Reference 1402012 draft report 8 11 3 2 NOTE 1A See CSA C22 2 No 49 for requirements on the cord types mentioned in Sub item 2 N A 8 11 3 2 d Power supply cords shall meet the requirements of the Canadian Electrical Code Part as applicable N A 8 11 3 2 Connecting cords between equipment parts shall meet the requirements of the Canadian Electrical Code Part I as applicable N A 8 11 5 Mains fuses and OVER CURRENT RELEASES shall be in accordance with the Canadian Electrical Code CEC Part l CSA C22 1 l enn Evaluated in part of power supply Pass 9 7 5 Pressure vessels shall comply with the requirements of CSA B51 as applicable N A 9 7 7 A pressure relief device shall also comply as applicable to the requirements of ASME PTC 25 or equivalent Canadian requirements 00 N A 15 4 1 15 4 1 bA The point of connection of gas cylinders to EQUIPMEN
169. lyze and control such risks N A subsequent changes to network data coupling introducing new risks and requiring new analysis and changes to network data coupling include N A network data coupling configuration change N A connection of additional items to network data coupling N A disconnecting items from network data coupling N A update of equipment connected to network data coupling N A upgrade of equipment connected to network data coupling N A 15 CONSTRUCTION OF ME EQUIPMENT Pass 15 1 RISKS associated with arrangement of controls and indicators of ME EQUIPMENT addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE Arrangement of controls and indicators of this device only display the status of device and will not impact the basic safety N A 15 2 Parts of ME EQUIPMENT subject to mechanical wear electrical environmental degradation or ageing resulting in unacceptable RISK when unchecked for a long period are accessible for inspection replacement and maintenance No unacceptable risk after examining see test table 15 for related test results Pass 15 3 Inspection servicing replacement and adjustment of parts of ME EQUIPMENT can easily be done without damage to or interference with adjacent parts or wiring Mechanical strength N A Pass 15 3
170. metal foil TC NC S1 1 S5 N S7 1 264 BB yed M eximum alowed values 100 pA TC NC S1 1 S5 R S7 1 264 Bees an Arowed Vales 100 pA TC SFC Neutral Open S1 0 S5 N Maximum allowed values S7 1 264 8 1 8 0 500 pA TC SFC Neutral Open S1 0 S5 R Maximum allowed values S7 1 264 8 1 8 2 500 pA TC SFC Ground Open S1 1 S5 N Maximum allowed values S7 0 264 8 3 8 2 500 pA TC SFC Ground Open S1 1 S5 R 77 78 Maximum allowed values 7 0 f 500 pA MD between Earth and LCD Plastice Enclosure surface covered with metal foil N O AK Maximum allowed values TC NC 1 1 S5 N S7 1 264 1 1 1 2 100 yA TC NC 1 1 S5 R S7 1 264 0 9 0 8 i allowed values TC SFC Neutral Open S1 0 S5 N 264 60 1 3 1 2 Maximum allowed values A A Maximum allowed values A A 401 4 Maximum allowed values 402 5 m 395 2 Maximum allowed values 395 1 mA 402 1 Maximum allowed values Maximum allowed values 0 _ 0 0 0 Issue Date 2014 03 27 Page 116 of 181 Report Reference 1402012 draft report eT TC SFC Neutral Open S1 0 S5 R Maximum allowed values S7 1 264 1 4 1 5 500 pA TC SFC Ground Open S1 1 S5 N Maximum allowed values S7 0 264 3 4 3 2 500 pA TC SFC Ground Open S1 1 S5 R Maximum allowed values S7 0 264 3 3 3 2 500 uA MD between Earth and LCD SIP SOP TC NC S1 1 S5 N S7 1 13 12 Max
171. mple subjected to thermal cycling PROCEDURE of 8 9 3 4 followed by humidity preconditioning per 5 7 for 48 hours followed by dielectric strength test clause 8 8 3 test voltage multiplied by 1 6 Cracks or voids in insulating compound affecting homogeneity of material didn t occur N A 8 9 3 3 Where insulating compound forms a cemented joint with other insulating parts three samples tested for reliability of joint N A A winding of solvent based enameled wire replaced for the test by a metal foil or by a few turns of bare wire placed close to cemented joint and three samples tested as follows One sample subjected to thermal cycling PROCEDURE of 8 9 3 4 and immediately after the last period at highest temperature during thermal cycling it was subjected to dielectric strength test of 8 8 3 except at 1 6 times the test voltage N A N A 8 9 3 4 The other two samples subjected to humidity preconditioning of 5 7 except for 48 hours only followed by a dielectric strength test of 8 8 3 at 1 6 times the test voltage One sample containing the cemented joint subjected to a sequence of temperature cycling tests for TO UMES ce sensi cs sacha a N A N A 8 10 Components and wiring Pass 8 10 1 Components of ME EQUIPMENT likely to result in an unacceptable RISK by their movements mounted securely as indicated in RISK MANAGEMENT FILE 0 eceeeceeeeeeeeeeeeeete
172. mulation and ignition as verified by review of design and RISK MANAGEMENT FILE 5 Battery compartments prevent accidental short circuiting of battery when this could result in a HAZARDOUS SITUATION as verified by examination of design and RISK MANAGEMENT FILE N A N A 15 4 3 2 Means provided to prevent incorrect connection of polarity when a HAZARDOUS SITUATION may develop by incorrect connection or replacement of a battery era a ana a iiaa N A 15 4 3 3 Overcharging of battery prevented by virtue of design when it could result in an unacceptable RISK as verified by review of design e N A 15 4 3 4 Lithium batteries that could become a HAZARD complied with appropriate tests of IEC 60086 4 N A Tests of IEC 60086 4 waived on the lithium battery based on examination of design N A 15 4 3 5 A properly RATED protective device provided within INTERNAL ELECTRICAL POWER SOURCE to protect against fire caused by excessive currents when in case of a short circuit layout of internal wiring cross sectional area rating of connected components can result in a fire N A Protective device has adequate breaking capacity to interrupt the maximum fault current N A Justification for OVER CURRENT RELEASES or FUSE exclusion is included in RISK MANAGEMENT FILE N A 15 4 4 Indicator lights provided to indicate ME EQUIPMENT is ready for NORMAL USE excep
173. n Release protocols of were recorded in the risk management file measures RC 009 RC 012 VENUS All residual risk that remains after the risk control N A 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 02 H 01 C 01 C 02 VENUS 191_RMF_2014 02_24 Section Risk graph after measures VENUS 191_RMF_2014 _02_24 Section Summary of risk control N A Issue Date 2014 03 27 Page 136 of 181 Report Reference 1402012 draft report TABLE Measurement of X radiation Maximum allowable radiation pA kg uSv h mR h 36 5 uSv h 0 5 mR h Surface area under test Surface no Description Remarks Measured Radiation pA kg uSv h mR h Supplementary information 1 Measurements made at a distance of 5 cm from any surface to which OPERATOR other than SERVICE PERSONNEL can gain access without a TOOL is deliberately provided with means of access or is instructed to enter regardless of whether or not a TOOL is needed to gain access radiation Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Alpha beta gamma neutron amp other particle radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 10 3 RM TABLE Microwave radiation N A Clause of Document Re
174. n a generic separate power supply specified Specification of specified Pass specification in ACCOMPANYING DOCUMENTS power supply examined examined 8 2 2 No HAZARDOUS SITUATION other than absence Design of plug will prevent Pass of ESSENTIAL PERFORMANCE developed when _ wrong polarity connection and a connection with wrong polarity made for ME no hazardous situation even EQUIPMENT from an external d c source absence of Essential performance ME EQUIPMENT connected with correct polarity Pass did not present an unacceptable RISK Protective devices that can be reset by anyone No resettable protective device N A without a TOOL restore correct operation on reset 8 3 Classification of APPLIED PARTS N A a APPLIED PART specified in ACCOMPANYING No applied parts used N A DOCUMENTS as suitable for DIRECT CARDIAC APPLICATION is TYPE CF b An APPLIED PART provided with a PATIENT No applied parts used N A CONNECTION intended to deliver electrical energy or an electrophysiological signal to or from PATIENT is TYPE BF or CF APPLIED PART c An APPLIED PART not covered by a orb is a_ No applied parts used N A TYPE B BF or CF d Requirements of a TYPE B APPLIED PART No parts that are not applied N A applied to a part in 4 6 to be subjected to parts that need to be treated requirements for an APPLIED PART except as applied parts used marking Requirements for a TYPE BF or CF APPLIED No parts that are not applied N A PART applied as in RISK MANAGEMENT part
175. n a rigid base with direction of movement perpendicular to face of the step until full descent achieved N A c Door frame shock test conducted on the sample by moving it 3 times in its normal direction of travel at 0 4 m s 0 1 m s or for motor driven EQUIPMENT at maximum possible speed against a hardwood vertical obstacle higher than EQUIPMENT contact point s N A No damage resulting in an unacceptable RISK sustained as determined by examination of sample and RISK MANAGEMENT FILE N A Issue Date 2014 03 27 Page 78 of 181 Report Reference 1402012 draft report 15 3 6 Examination of ENCLOSURE made from molded or formed thermoplastic material indicated that material distortion due to release of internal stresses by molding or forming operations will not result in an unacceptable RISK Pass Mold stress relief test conducted by placing one sample of complete ME EQUIPMENT ENCLOSURE or a portion of larger ENCLOSURE for 7 hours in a circulating air oven at 10 C over the max temperature measured on ENCLOSURE in 11 1 3 but no less than 70 C See Appended Table 15 3 Pass No damage resulting in an unacceptable RISK Pass 15 3 7 INTENDED USE EXPECTED SERVICE LIFE and conditions for transport and storage were taken into consideration for selection and treatment of materials used in construction of ME EQUIPMENT See RM report R13003 for details Pass 15
176. n associated indicating No setting control will result N A device when change of setting of a control could risk to patient when normal result in an unacceptable RISK to PATIENT in use NORMAL USE or an indication of direction in which magnitude of N A the function changes 7 4 3 Numeric indications of parameters on ME N A EQUIPMENT expressed in SI units according to ISO 31 except the base quantities listed in Table 1 expressed in the indicated units ISO 1000 applied for application of SI units their N A multiples and certain other units All Markings in Sub clause 7 4 complied with tests N A and criteria of 7 1 2 and 7 1 3 7 5 Safety signs N A Markings used to convey a warning prohibition or No such function N A mandatory action mitigating a RISK not obvious to OPERATOR are safety signs from ISO 7010 Affirmative statement together with safety sign N A Issue Date 2014 03 27 Page 20 of 181 Report Reference 1402012 draft report ME EQUIPMENT Specified colours in ISO 3864 1 used for safety N A SIQMWIS E T E A E T E Safety notices include appropriate precautions or N A instructions on how to reduce RISK S Safety signs including any supplementary text or N A symbols described in instructions for use 7 6 Symbols Pass 7 6 1 Meanings of symbols used for marking described in Explanation provided for each Pass instructions fOr USE ee ttteeeees related marking see
177. n control of supply pressure N A g No shut off valve provided between a pressure relief device and parts it is to protect N A 9 8 h Min number of cycles of operation 100 000 except for one time use devices bursting disks HAZARDS associated with support systems N A Pass 9 8 1 ME EQUIPMENT parts designed to support loads or provide actuating forces when a mechanical fault could constitute an unacceptable RISK 22 See appended RM Results Table 9 8 1 Pass Construction of support suspension or actuation system complied with Table 21 and TOTAL LOAD Pass means of attachment of ACCESSORIES prevent possibility of incorrect attachment that could result in an unacceptable RISK N A RISK ANALYSIS of support systems included HAZARDS from static dynamic vibration impact and pressure loading foundation and other movements temperature environmental manufacture and SERVICE conditions N A Issue Date 2014 03 27 Page 58 of 181 Report Reference 1402012 draft report RISK ANALYSIS included effects of failures such as excessive deflection plastic deformation ductile brittle fracture fatigue fracture instability buckling stress assisted corrosion cracking wear material creep and deterioration and residual stresses from manufacturing PROCESSES See appended RM Results Table 9 8 1 Pass instructions on attachment of struc
178. n of risk before measures F 01 H 02 C 01 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Version Data VENUS The risk control measures selected were Pass 191_RMF_2014_02_24 recorded in the risk management file Section Risk analysis F 01 H 02 C 01 VENUS The effectiveness of the risk control measures Pass 191_RMF 2014 02 24 had be verified and the results of the verification Section Evaluation of risk were recorded in the risk management file before measures F 01 H 02 C 01 VENUS All residual risk that remains after the risk control Pass No reduction of risk through Risk benefit analysis N A RM TABLE Risk of fire in an oxygen rich environment Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph N A Verdict Issue Date 2014 03 27 Page 143 of 181 Report Reference 1402012 draft report 11 2 2 1 TABLE Alternative method to 11 2 2 1 a 5 to determine existence of an N A ignition source Areas where sparking might cause ignition Remarks Materials of the parts between which sparks could occur Composition Grade Remarks Designation Manufacturer Test parameters selected representing worst case conditions for ME EQUIPMENT Remarks Oxygen concentration Current A Voltage V Capacitance uF Inductance or resistance h or Ohms No of trials 300 Min
179. nacceptable RISKS due to proximity of moving N A Issue Date 2014 03 27 Page 52 of 181 Report Reference 1402012 draft report parts removal of NORMAL exit routes or other HAZARDS prevented 9 3 measures provided to reduce RISK to an acceptable level when after removal of counterbalanced parts other parts of ME EQUIPMENT can move in a hazardous way Rough surfaces sharp corners and edges of ME EQUIPMENT that could result in an unacceptable RISK avoided or Covered ccccceceeeesereeeeteee See appended RM Results Table 9 3 N A Pass 9 4 Instability HAZARDS Pass 9 4 1 ME EQUIPMENT other than FIXED and hand held for placement on a surface did not overbalance tip over or move unexpectedly to the degree that it could present an unacceptable RISK to PATIENT or OPERATOR as tested in 9 4 2 to 9 4 4 N A 9 4 2 Instability overbalance Pass 9 4 2 1 ME EQUIPMENT or its parts did not overbalance when prepared per ACCOMPANYING DOCUMENTS or when not specified as in 9 4 2 2 and placed on a 10 inclined plane from horizontal consisting of a hard and flat surface e g concrete floor covered with 2 to 4 mm thick vinyl material See Appended Table 9 4 2 1 Pass 9 4 2 2 Instability excluding transport Pass ME EQUIPMENT or its parts prepared based on a to g inclusive did not overbalance when placed in different positions of
180. nctions other than PTC s operated 200 times N A Manual reset THERMAL CUT OUTS and OVER CURRENT RELEASES Certified in accordance with appropriate IEC standards N A When certification based on IEC standards or data from MANUFACTURER demonstrating reliability of component to perform its safety related function is not available manual reset THERMAL CUT OUTS and OVER CURRENT RELEASES operated 10 times N A Thermal protective devices tested separately from ME EQUIPMENT when engineering judgment indicated test results would not be impacted N A g Protective device provided on ME EQUIPMENT incorporating a fluid filled container with heating means operated when heater switched on with container empty and prevented an unacceptable RISK due to overheating N A h ME EQUIPMENT with tubular heating elements provided with protection against overheating in both leads where a conductive connection to earth could result in overheating as verified by review of design and RISK MANAGEMENT FILE 65 N A 15 4 2 2 Temperature settings clearly indicated when means provided to vary setting of THERMOSTATS N A Issue Date 2014 03 27 Page 80 of 181 Report Reference 1402012 draft report 15 4 3 Batteries N A 15 4 3 1 Battery housings from which gases can escape during charging or discharging likely to result in a HAZARD ventilated to minimize RISK of accu
181. o support systems used N A Marking is adjacent to MECHANICAL PROTECTIVE device or its location relative to MECHANICAL PROTECTIVE device is obvious to SERVICE PERSONNEL compliance confirmed by examination of ME No support systems used No support systems used N A N A Issue Date 2014 03 27 Page 61 of 181 Report Reference 1402012 draft report EQUIPMENT ACCOMPANYING DOCUMENTS RISK MANAGEMENT FILE specifications and processing of materials and following test A chain cable band spring belt jack screw nut pneumatic or hydraulic hose structural part or the like employed to support a load defeated by a convenient means causing maximum normal load to fall from most adverse position permitted by construction of ME EQUIPMENT No support systems used N A Load included SAFE WORKING LOAD in 9 8 3 1 when system was capable of supporting a PATIENT or OPERATOR No support systems used N A No evidence of damage to MECHANICAL PROTECTIVE DEVICE affecting its ability to perform its intended function No support systems used N A 9 8 5 Systems without MECHANICAL PROTECTIVE DEVICES Pass Support system parts have TENSILE SAFETY FACTORS to values in Table 21 rows 1 and 2 and are not impaired by wear N A Support system parts impaired by wear however they have TENSILE SAFETY FACTORS to values in Table 21 rows 3 and 4 Equipment 5 6 kg with
182. of electromagnetic phenomena into N A environment by ME EQUIPMENT or ME SYSTEM that might degrade performance of other devices electrical equipment and systems ANNEX G PROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE N A ANESTHETIC MIXTURES G 2 Locations and basic requirements N A G 2 1 Parts of CATEGORY APG ME EQUIPMENT in which a Recognized component the N A FLAMMABLE ANESTHETIC MIXTURE WITH AIR occurs are environment of end application CATEGORY AP or APG ME EQUIPMENT and complied is unclear to be evaluated in with G 3 G 4 and G 5 end product G 2 2 FLAMMABLE AESTHETIC MIXTURE WITH AIR occurring N A due to a leakage or discharge of a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN Or NITROUS OXIDE from an ENCLOSURE considered 5 to 25 cm from point of occurrence Issue Date 2014 03 27 Page 89 of 181 Report Reference 1402012 draft report 6 2 3 A FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE contained in a completely partly enclosed ME EQUIPMENT part and in PATIENT S respiratory tract 5 cm from an ENCLOSURE part where leakage or discharge occurs N A G 2 4 ME EQUIPMENT or parts thereof specified for use with FLAMMABLE AESTHETIC MIXTURE WITH AIR in a location as in G 2 2 are CATEGORY AP or APG ME EQUIPMENT and complied with G 4 and G 5 N A G 2 5 ME EQUIPMENT or parts thereof for use with FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE location per G 2 2 a
183. om Table 31 C fuse circuit C breaker Ratings Supplementary information 1 Loads on other windings between no load and their NORMAL USE load Time durations IEC 60127 1 fuse 30 min at current from Table 32 Non IEC 60127 1 fuse 30 min at the current based on characteristics supplied by fuse manufacturer specifically 30 min clearing time current When no 30 min clearing time current data available test current from Table 32 used until THERMAL STABILITY achieved Other types of protective devices until THERMAL STABILITY achieved at a current just below minimum current operating the protective device in a This portion concluded at specified time or when a second protective device opened Issue Date 2014 03 27 Page 159 of 181 Report Reference 1402012 draft report TABLE Transformer dielectric strength after humidity preconditioning of 5 7 N A Transformer Model Type Part No Test voltage applied between Supplementary information Tests conducted under the conditions of 11 1 in ME EQUIPMENT or under simulated conditions on the bench See Clause 15 5 2 for test parameters amp other details RM TABLE General requirements for ME Systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 16 6 1 TABLE Leakage Currents in ME System _ Touch Current Measurements Specific area where TOUCH Allowable Measured Allowable TOUCH Measured TOUC
184. on Issue Date 2014 03 27 Page 19 of 181 Report Reference 1402012 draft report compartment under NORMAL USE or equivalent marked at the point of supply connections Statement not applied to parts requiring removal to N A make the connection and CLEARLY LEGIBLE after connections made 7 4 Marking of controls and instruments Pass 7 4 1 The on amp off positions of switch to control power No ON OFF switch provided N A to ME EQUIPMENT or its parts including mains switch marked with symbols 12 and 13 of Table D 1 IEC 60417 5007 DB 2002 10 and IEC 60417 5008 DB 2002 10 or indicated by an adjacent indicator light or Indicator light provided in front Pass panel to indicate the power ON and OFF indicated by other unambiguous means N A The on off positions of push button switch with bi N A stable positions marked with symbol 14 of Table D 1 IEC 60417 5010 DB 2002 10 and status indicated by adjacent indicator light N A status indicated by other unambiguous means N A The on off positions of push button switch with N A momentary on position marked with symbol 15 of Table D 1 symbol 60417 5011 DB 2002 10 or status indicated by adjacent indicator light N A status indicated by other unambiguous means N A 7 4 2 Different positions of control devices switches Push bottom provided in front Pass indicated by figures letters or other visual means panel to indicate the power ON and OFF Controls provided with a
185. onal area of conductors of POWER SUPPLY CORDS of ME EQUIPMENT is not less than in Table 17 mm2 Cu Evaluated in part of power supply Pass 8 11 3 4 APPLIANCE COUPLERS complying with IEC 60320 1 are considered to comply with 8 11 3 5 and 6 1 1 3 6 konki ei aeni N A 8 11 3 5 Cord anchorage for APPLIANCE COUPLERS not complying with IEC 60320 1 N A a Conductors of POWER SUPPLY CORD provided with strain relieve and insulation protected from abrasion at point of entry to ME EQUIPMENT or a MAINS CONNECTOR by a cord anchorage N A b Cord anchorage of POWER SUPPLY CORD is made of and arranged as follows when a total insulation failure of POWER SUPPLY CORD caused conductive non PROTECTIVELY EARTHED ACCESSIBLE PARTS to exceed limits of 8 4 N A insulating material or N A metal insulated from conductive accessible parts non PROTECTIVELY EARTHED by a means of PROTECTION or N A metal provided with an insulating lining affixed to cord anchorage except when it is a flexible bushing forming part of the cord guard in 8 11 3 6 and complying with the requirements for one MEANS OF PROTECTION N A c Cord anchorage prevents cord from being clamped by a screw bearing directly on cord insulation N A d Screws to be operated when replacing POWER SUPPLY CORD do not serve to secure any components other than parts of cord anchorage N A e Conductors of POWER SUP
186. ositioning without resulting in an unacceptable N A Over travel stopping distance of such movement occurring after operation of a control to stop movement did not result in an unacceptable RISK N A 9 2 3 9 2 3 1 Other HAZARDS associated with moving parts Controls positioned recessed or protected by other means and could not be accidentally actuated to result in unacceptable RISK except when ergonomic considerations for a PATIENT with special needs require otherwise N A N A 9 2 3 2 RISK due to over travel past range limits of ME EQUIPMENT parts reduced to an acceptable level and stops or other means with mechanical strength N A Issue Date 2014 03 27 Page 51 of 181 Report Reference 1402012 draft report to withstand intended loading in NORMAL USE and foreseeable misuse provided limiting measure in NORMAL and SINGLE FAULT CONDITION 9 2 4 Emergency stopping devices N A Where necessary to have one or more emergency stopping device s emergency stopping device complied with all the following except for actuating switch capable of interrupting all power N A a Emergency stopping device reduced RISK to an acceptable level N A b Proximity and response of OPERATOR to actuate emergency stopping device could be relied upon to prevent HARM N A c Emergency stopping device actuator was readily accessible to OPERATO
187. out stand with safety factor 4 22 4 kg No hazardous Pass Examination of ME EQUIPMENT and RISK MANAGEMENT FILE confirmed compliance N A 10 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZARDS N A 10 1 1 X radiation dose rate was lt 36 pA kg 5 uSv h 0 5 mR h 5 cm from surface of me equipment including background radiation for me equipment not producing therapeutic diagnostic X radiation but producing ionizing radiation No X Radiation N A Amount of radiation measured by means of an ionizing chamber radiation monitor with an effective area of 10 cm2 or by other instruments producing equal results N A Me equipment operated as in normal use at most unfavourable rated mains voltage and controls adjusted to emit maximum radiation N A Internal pre set controls not intended for adjustment during expected service life of me equipment not taken into consideration N A 10 1 2 Risk from unintended X radiation from me equipment producing X radiation for diagnostic and therapeutic purposes addressed in risk management process as indicated in risk management file see IEC 60601 1 3 amp 1 3 N A Risk associated with alpha beta gamma neutron and other particle radiation when applicable N A Issue Date 2014 03 27 Page 62 of 181 Report Reference 1402012 draft report addressed in risk management process as shown in risk m
188. pA Fig 17 Patient leakage current with Maximum allowed values external voltage on Signal Input Output Type B or BF AP 10 pA NC part SIP SOP 50 pA SFC d c current 100 pA NC 500 pA SFC a c Type CF AP 10 pA NC 50 UA SFC d c or a c current Fig 18 Patient leakage current with Maximum allowed values external voltage on metal Accessible Part Type B or BF AP 500 pA that is not Protectively Earthed Type CF N A Maximum allowed values Type B or BF AP 10 pA NC 50 pA SFC d c current 100 pA NC 500 pA SFC a c Type CF AP 10 pA NC 50 UA SFC d c or a c current Fig 15 and 20 Total Patient Leakage Maximum allowed values Current with all AP of same type connected Type B or BF AP 50 pA NC 100uA SFC d c current 500 pA NC 1000 pA SFC a c Type CF AP 50 pA NC 100 pA SFC d c or a c current Fig 17 and 20 Total Patient Leakage Maximum allowed values Current with all AP of same type connected Type B or BF AP 50 pA NC together with external voltage on SIP SOP 100uA SFC d c current 500 pA NC 1000 pA SFC a c Type CF AP 50 pA NC 100 yA SFC d c or a c current Fig 16 and 20 Total Patient Leakage Maximum allowed values Current with all AP of same type connected Type B NA Type BF 5000 uUA together with external voltage on F type AP Type CF 100 pA Fig 18 and 20 Total Patient Leakage Maximum allowed values Current with all AP of same type connected Type B amp BF 100
189. parts that could result ina HAZARDOUS SITUATION were NOUWet EA E EE Sai ie ens Does not use liquids in normal use N A 11 6 4 Leakage N A 11 6 5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS N A ME EQUIPMENT with IP Code placed in least favourable position of NORMAL USE and subjected to tests of IEC 60529 IP Code Rated with no ingress protection IPOX or IPX0 N A ME EQUIPMENT met dielectric strength and LEAKAGE CURRENT tests and there were no bridging of insulation or electrical components that could result ina HAZARDOUS SITUATION in NORMAL CONDITION or in a SINGLE FAULT CONDITION Rated with no ingress protection IPOX or IPX0 N A 11 6 6 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS ME EQUIPMENT ME SYSTEM and their parts and ACCESSORIES cleaned or disinfected once using methods specified in instructions for use including any cooling or drying period ceeeeeeeeeee See appended RM Results Table 11 6 6 Pass Pass ME EQUIPMENT met dielectric strength and LEAKAGE CURRENT tests with no deterioration resulting in an unacceptable RISK present Effects of multiple cleanings disinfections during EXPECTED SERVICE LIFE of EQUIPMENT evaluated by MANUFACTURER and assurance that no unacceptable RISK will occur verified by RISK MANAGEMENT FILE review See appended RM Results Table 11 6 6 Expected s
190. position See Appended Table 5 9 2 Pass Openings preventing entry of test finger of Fig 6 mechanically tested with a straight un jointed test finger of the same dimensions with a force of 30 N N A When the straight un jointed test finger entered test with the standard test finger Fig 6 was repeated if necessary by pushing the finger through the opening N A 5 9 2 2 Test hook of Fig 7 inserted in all openings of ME EQUIPMENT and pulled with a force of 20 N for 10 S Openings designed to prevent the possibility for test hook to insert Pass 5 9 2 3 All additional parts that became accessible checked using standard test finger and by inspection Conductive parts of actuating mechanisms of electrical controls accessible after removal of handles knobs levers and the like regarded as ACCESSIBLE PARTS naia aa No accessible conductive part N A N A Conductive parts of actuating mechanisms not considered ACCESSIBLE PARTS when removal of handles knobs etc required use of a TOOL and inspection of RISK MANAGEMENT FILE indicated N A Issue Date 2014 03 27 Page 13 of 181 Report Reference 1402012 draft report the relevant part is unlikely to detach unintentionally during EXPECTED SERVICE CIPE of ME EQUIPMENT 0 cccceeeeeeeceeeeeeteeeeeeeeel CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEM
191. priate ME EQUIPMENT did not overbalance when placed N A on a horizontal plane and a constant force of 800 N applied at the point of maximum moment to working surfaces offering an foothold or sitting surface of a min 20 x 20 cm area and at a height 1 m from the flOOF ccccceeeeeeceeceeeeeeeeeeeettteeeeeeeee 9 4 2 4 Castors and wheels N A 9 4 2 4 1 Means used for transportation of MOBILE ME Should be evaluated as part of N A EQUIPMENT e g castors or wheels did not the end product result in an unacceptable RISK when MOBILE ME EQUIPMENT moved or parked in NORMAL USE 9 4 2 4 2 Force required to move MOBILE ME EQUIPMENT Should be evaluated as part of N A along a hard and flat horizontal surface did not the end product exceed 200 N applied at a height of 1 m above floor or highest point on ME EQUIPMENT when lt 1 m high except when instructions indicated more than one person needed N 9 4 2 4 3 IMOBILE ME EQUIPMENT exceeding 45 kg Should be evaluated as part of N A configured with a SAFE WORKING LOAD moved the end product 10 times in forward direction over a solid vertical plane obstruction with wheels impacting the obstruction at a speed of 0 4 m s 0 1 m s for manual or with max speed for motor driven MOBILE ME EQUIPMENT cece ME EQUIPMENT went up the obstruction without Should be evaluated as part of N A overbalancing or any other unacceptable RISK as_
192. provides the level of safety outside N A PATIENT ENVIRONMENT equivalent to equipment complying with their respective IEC or ISO safety standards tests performed in NORMAL CONDITION except as N A specified tests performed under operating conditions N A specified by MANUFACTURER of ME SYSTEM Safety tests previously conducted on individual N A equipment of ME SYSTEM according to relevant standards not repeated RISK MANAGEMENT methods optionally used by N A MANUFACTURER Of an ME SYSTEM reconfigurable by RESPONSIBLE ORGANIZATION or OPERATOR to determine configurations with highest RISKS and measures to ensure any configuration of ME SYSTEM will not present unacceptable RISKS Non ME EQUIPMENT used in ME SYSTEM complied N A with applicable IEC or Iso safety standards Equipment relying only on BASIC INSULATION for N A Issue Date 2014 03 27 Page 84 of 181 Report Reference 1402012 draft report protection against electric shock not used in ME SYSTEM 16 2 ACCOMPANYING DOCUMENTS of an ME SYSTEM N A Documents containing all data necessary for ME N A SYSTEM to be used as intended by MANUFACTURER including a contact address accompany ME SYSTEM or modified ME SYSTEM ACCOMPANYING DOCUMENTS regarded as a part of N A ME SYSTEM ACCOMPANYING DOCUMENTS are optionally N A provided in electronic format e g electronic file format or CD ROM and ME SYSTE
193. pull was required in NORMAL USE Cord connected HAND HELD and foot operated control devices N A N A 15 4 7 1 a HAND HELD control devices of ME EQUIPMENT complied with 15 3 4 1 Not Cord connected hand held and foot operated control devices N A b Foot operated control device supported an actuating force of 1350 N for 1 min applied over an N A Issue Date 2014 03 27 Page 82 of 181 Report Reference 1402012 draft report area of 30 mm diameter in its position of NORMAL USE with no damage to device causing an unacceptable RISK ceeceeeeeeeeeeeeeeeeeeeteeee 15 4 7 2 Control device of HAND HELD and foot operated control devices turned in all possible abnormal positions and placed on a flat surface 28 No unacceptable RISK caused by changing control setting when accidentally placed in an abnormal position N A N A 15 4 7 3 a Foot operated control device is at least IPX1 amp complies with tests of IEC 60529 IP Code N A b ENCLOSURE of foot operated control devices containing electrical circuits is at least IPX6 and complies with IEC 60529 if in NORMAL USE liquids are likely to be found IP Code N A Probability of occurrence estimated as part of RISK MANAGEMENT PROCESS N A 15 4 8 15 4 9 Aluminum wires less than 16 mm2 in cross sectional area are not used a Oil container in PORT
194. r N A outside the PATIENT ENVIRONMENT the level of safety equivalent to equipment complying with The ME Equipment is not part of an ME System as defined N A Issue Date 2014 03 27 Page 166 of 181 Report Reference 1402012 draft report their respective CSA IEC or ISO safety standards by the manufacturer 16 1 Non ME EQUIPMENT when used in an ME The ME Equipment is not part N A SYSTEM shall comply with CSA IEC or ISO of an ME System as defined safety standards that are relevant to that by the manufacturer equipment 16 9 2 1 c The MULTIPLE SOCKET OUTLET shall comply No multiple socket outlets N A with the requirements of CSA C22 2 No 42 CSA used C22 2 No 49 and the following requirements 16 9 2 1 The separating transformer shall comply with the No multiple socket outlets N A requirements of CAN CSA E61558 2 1 with a rated used output not exceeding 16 9 2 1 1 kVA for single phase transformers and No multiple socket outlets N A used 16 9 2 1 5 kVA for polyphase transformers No multiple socket outlets N A used 16 9 2 1 The separating transformer shall also have a No multiple socket outlets N A degree of protection not exceeding IPX4 used Switzerland Differences to IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 4 Ordinance on environmentally hazardous N A substances SR 814 081 Annex 1 7 Mercury Annex 1 7 of SR 814 81 applies for mercury S
195. r material according to IEC N A N A Material of unknown group considered IIIb Pass 8 9 1 8 Pollution degree 1 Micro environment sealed to exclude dust and moisture N A Pollution degree 2 Micro environment with non conductive pollution except occasional conductivity caused by condensation Pass Pollution degree 3 Micro environment subject to conductive pollution or dry non conductive pollution that could become conductive due to expected condensation Pollution degree 4 Micro environment where continuous conductivity occurs due to conductive dust rain or other wet conditions N A N A Pollution degree 4 not used for insulation providing a MEANS OF PROTECTION N A Where insulation between MAINS PART and earth might be compromised measures such as N A Issue Date 2014 03 27 Page 40 of 181 Report Reference 1402012 draft report maintenance ensure that micro environment is mitigated to a lower pollution degree 8 9 1 9 Overvoltage category classification value of MAINS TRANSIENT VOLTAGE determined from overvoltage category per IEC60664 1 and NOMINAL a c MAINS VOLTAGE using Table 10 V MT Peak V sancutn lh piace ete na stiann ae N A Mi MN rS WV an eari a oni 8 9 1 10 AIR CLEARANCE for MAINS PARTS operating on RATED MAINS VOLTAGES up to 300 V were values for r m s or d c RATED MAINS VOLTAGE in Table 13 plus addit
196. ragraph 11 1 3 TABLE Temperature of windings by change of resistance method Temperature T of winding t1 C R1 t2 C R2 ohm T C Allowed ohm Tmax C Supplementary information Insulatio n class Test procedure of 11 2 2 1 a 5 amp Figs 35 37 used for tests For circuits not in Figs 35 37 test voltage or current set at 3 times the worst case values with other parameters set at worst case values to determine if ignition can occur 191_RMF_2014_02_24 Section New evaluation after measures F 01 H 02 C 01 VENUS 191_RMF_2014_02_24 Section Risk graph after measures VENUS 191_RMF_2014_02_24 Section Summary of risk control measure s are applied and evaluated using the criteria that defined in the risk management plan Issue Date 2014 03 27 Page 142 of 181 Report Reference 1402012 draft report 11 1 3 RM TABLE Measurements Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_ RMF 2014 02 24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 02 C 01 VENUS The estimates of the risk s were recorded in the Pass 191_ RMF 2014 02 24 risk management file Section Evaluatio
197. re CATEGORY APG ME EQUIPMENT and comply with G 4 and G 6 N A ME EQUIPMENT in G 2 3 to G 2 5 met appropriate tests of G 3 G 5 conducted after tests of 11 6 6 and 11 6 7 N A G 3 Marking ACCOMPANYING DOCUMENTS N A G 3 1 CATEGORY APG ME EQUIPMENT prominently marked with a green coloured band gt 2 cm wide with letters APG according to symbol 23 in Table D 1 N A Length of green coloured band is 4 cm and size of marking is as large as possible for particular case When above marking not possible relevant information included in instructions for use N A N A Marking complied with tests and criteria of 7 1 2 and 7 1 3 N A G 3 2 CATEGORY AP ME EQUIPMENT prominently marked with a green coloured circle gt 2 cm in diameter with characters AP according to symbol 22 in Table D a R lend eed N A Marking is as large as possible for the particular case N A When above marking not possible the relevant information included in instructions for use N A Marking complied with tests and criteria of 7 1 2 and 7 1 3 N A G 3 3 The marking according to G 3 2 and G 3 3 placed on major part of ME EQUIPMENT for CATEGORY AP or APG parts and not repeated on detachable parts that can only be used with the marked EQUIPMENT N A G 3 4 ACCOMPANYING DOCUMENTS contain an indication enabling the RESPONSIBLE ORGANIZATIO
198. re marked except for MULTIPLE SOCKET OUTLETS or connectors intended for specified ACCESSORIES or equipment Pass Rated Voltage V Rated Current A Rated Power W Output Frequency H2 45 7 2 9 ME EQUIPMENT or its parts marked with the IP Rated with ingress protection Pass Issue Date 2014 03 27 Page 16 of 181 Report Reference 1402012 draft report environmental Code per IEC 60529 according to classification in 6 3 Table D 3 Code 2 0 Front Panel IP65 Rear IPX1 7 2 10 Degrees of protection against electric shock as classified in 6 2 for all APPLIED PARTS marked with relevant symbols as follows not applied to parts identified according to 4 6 TYPE B APPLIED PARTS with symbol 19 of Table D 1 IEC 60417 5840 DB 2002 10 not applied in such a way as to give the impression of being inscribed within a square in order to distinguish it from symbol IEC 60417 5333 eeeeeetettee No applied parts used No applied parts used N A N A TYPE BF APPLIED PARTS with symbol 20 of Table D 1 IEC 60417 5333 DB 2002 10 No applied parts used N A TYPE CF APPLIED PARTS with symbol 21 of Table D 1 IEC 60417 5335 DB 2002 10 No applied parts used N A DEFIBRILLATION PROOF APPLIED PARTS marked with symbols 25 27 of Table D 1 IEC 60417 5841 IEC 60417 5334 or IEC 60417 5336 All DB 2002 10 ar
199. re measures F 01 H 01 C 07 C 08 VENUS 191_ RMF 2014 02 24 Section Risk control RC 002 RC 030 RC 032 VENUS 191_RMF_2014_02_24 Section Release protocols of measures RC 002 RC 030 R 032 VENUS 191_RMF_2014 02_24 purpose The manufacturer had compiled a list of known or Pass foreseeable hazards associated with the unit in both normal and fault conditions Pass The estimates of the risk s were recorded in the risk management file The results of this risk evaluation were recorded Pass in the risk management file The risk control measures selected were Pass recorded in the risk management file The effectiveness of the risk control measures Pass had been verified and the results of the verification were recorded in the risk management file All residual risk that remains after the risk control Pass measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 01 C 07 C 08 VENUS 191_ RMF 2014 02 24 Section Residual risk evaluation No reduction of risk through Risk benefit analysis Pass RM TABLE Use of components with high integrity characteristics N A Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph Verdict Issue Date 2014 03 27 Page 103 of 181 Report Reference 1402012 draft report 4 11 TABLE Power Input Pass Op
200. removal of covers connectors etc without use of a TOOL operated at a voltage lt voltage in 8 4 2 c supplied from a source separated from SUPPLY MAINS by two MEANS OF OPERATOR PROTECTION Safety measures incorporating a SEPARATION DEVICE applied when FUNCTIONAL CONNECTION between ME EQUIPMENT and other items of an ME SYSTEM or other systems can cause allowable values of LEAKAGE CURRENT to exceed N A N A Issue Date 2014 03 27 Page 86 of 181 Report Reference 1402012 draft report SEPARATION DEVICE has dielectric strength CREEPAGE and CLEARANCES required for one MEANS OF OPERATOR PROTECTION appropriate for highest voltage occurring across SEPARATION DEVICE during a fault condition N A WORKING VOLTAGE was highest voltage across SEPARATION DEVICE during a fault condition but not less than MAXIMUM MAINS VOLTAGE V N A LEAKAGE CURRENTS N A 16 6 1 TOUCH CURRENT in NORMAL CONDITION from or between parts of ME SYSTEM within the PATIENT ENVIRONMENT did not exceed 100 PA 00000 N A TOUCH CURRENT did not exceed 500 pA in event of interruption of any non PERMANENTLY INSTALLED PROTECTIVE EARTH CONDUCTOR from or between parts of ME SYSTEM within PATIENT ENVIRONMENT N A 16 6 2 Current in PROTECTIVE EARTH CONDUCTOR of MULTIPLE SOCKET OUTLET did not exceed 5 mA N A 16 6 3 PATIENT LEAKAGE CURRENT and total PATIENT LEAKAGE CURRENT of ME SYST
201. rmined with actual N A resistance R when equivalent resistance R in Fig G 5 was less than 8000 Q Peak value taken into consideration when a c N A supplied An equivalent circuit calculated to determine max N A capacitance inductance and Umax and Imax either as d c or a c peak values in case of a complicated CINCUIL 2 200 wai edie en at eee When energy produced in an inductance or N A capacitance in a circuit is limited by voltage or current limiting devices two independent components applied to obtain the required limitation even when a first fault short or open circuit in one of these components Above requirement not applied to transformers N A complying with this standard Above requirement not applied to wire wound N A current limiting resistors provided with a protection against unwinding of the wire in case of rupture Compliance verified by examination of CATEGORY N A APG ME EQUIPMENT parts and components or Temperature measurements made in accordance N A with 11 1 or Umax Imax R Lmax and Cmax determined together N A with application of Figs G 4 G 6 cceeeee Alternatively compliance verified by comparison N A wWithdesign data se erisa ran EAR f G 6 4 ME EQUIPMENT its parts and components heating a N A FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR Issue Date 2014 03 27 Page 96 of 181 Report Reference 1402012 draft report NITR
202. rotective device operated or THERMAL STABILITY achieved n Evaluated in part of power supply N A Short circuit applied directly across output windings N A Issue Date 2014 03 27 Page 83 of 181 Report Reference 1402012 draft report for transformers not tested according to 5X frequency and 5X voltage test of 15 5 2 15 5 1 3 Multiple overload tests conducted on windings with Evaluated in part of power N A more than one protective device to evaluate worst supply case NORMAL USE loading and protection 15 5 2 Transformer windings provided with adequate N A insulation to prevent internal short circuits that could cause overheating which could result in a HAZARDOUS SITUATION Dielectric strength tests were conducted in N A accordance with requirements of this clause with no breakdown of insulation system and no detectable deterioration of transformer 1 15 5 3 Transformers forming MEANS OF PROTECTION N A as required by 8 5 comply with IEC 61558 1 1997 Clause 5 42 caewine Ani suai 16 ME SYSTEMS N A 16 1 After installation or subsequent modification ME N A SYSTEM didn t result in an unacceptable RISK Only HAZARDS arising from combining various N A equipment to form a ME SYSTEM considered ME SYSTEM provides the level of safety within the N A PATIENT ENVIRONMENT equivalent to ME EQUIPMENT complying with this standard ME SYSTEM
203. rt position ME EQUIPMENT Test Condition working load locking preparation device s caster position force force location force direction Supplementary information TABLE Grips and other handling devices Clause and Name of Test Test Condition Supplementary information RM TABLE Protective means Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph RM TABLE Acoustic energy General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 6 2 2 RM TABLE Infrasound and ultrasound energy N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 133 of 181 Report Reference 1402012 draft report 9 7 2 RM TABLE Pneumatic and hydraulic parts Clause of Document Ref in RMF Result Remarks ISO 14971 Document No and paragraph RM TABLE Pressure rating of ME equipment parts Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph TABLE Pressure vessels Hydraulic Vessel Burst Pneumatic or Suitable Media and Test Pressure Supplementary Information Permanent Vessel fluid Remarks Deformation substance 97 6 7 6 RM TABLE Pressure control device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 977 7 7 RM TABLE
204. ry information The results were less 2 mm Cracks were visible to the naked eye Issue Date 2014 03 27 Page 120 of 181 Report Reference 1402012 draft report 8 8 4 1 RM TABLE Mechanical strength and resistance to heat Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph VENUS The RMF mention the Intended use intended Pass 191_RMF_2014 02_24 purpose Section Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014 02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 01 C 17 VENUS The estimates of the risk s were recorded in the Pass 191_RMF 2014 02 24 risk management file RMF Section Evaluation of risk before measures F 01 H 01 C 17 VENUS The results of this risk evaluation were recorded Pass 191_RMF_2014_02_24 in the risk management file Section Evaluation of risk before measures F 01 H 01 C 17 VENUS 191_RMF_2014 02_24 Section Risk graph before measures VENUS The risk control measures selected were Pass 191_RMF_2014_02_24 recorded in the risk management file Section Release protocols of measures RC 004 RC 019 VENUS The effectiveness of the risk control measures Pass 191_ RMF 2014 02 24 had be verified and the results of the verification Section Release protocols of were recorded in the ri
205. s ONYX HEALTHCARE INC 2 FL 135 LN 235 PAO CHIAO RD HSIN TIEN NEW TAIPEI 231 TAIWAN GENERAL PRODUCT INFORMATION Report Summary All applicable tests according to the referenced standard s have been carried out Product Description Issue Date 2014 03 27 Page 5 of 181 Report Reference 1402012 draft report The Mobile cart computer are based on Intel Atom N2800 Dual Core processor one 2 5 SATAII SSD and 4GB DDRIII SODIMM a 19 250 nits TFT display unit side mount USB 3 0 ports x2 a smart card reader and 2 Hot swappable batteries provided with USB2 0 x5 RS 232 x2 Gigabit LAN x1 Display Port x1 Mic in Line out and all components were soldered on PWB and enclosed in metal chassis and plastic enclosure The Mobile cart computer can use with VESA stand for installing The Unit can only use with switching power adapter from HITRON ELECTRONICS CORP Type HEMP152G S240060 7 LF input rating 100 240Vac 50 60Hz 1 9 0 8A output rating 24Vdc 6 25A Model Differences N A Additional Information According to ISO IEC 14971 2007 Risk Management report and file were provided by the client The documents were reviewed to meet the requirements of ISO IEC 14971 2000 IEC 60601 1 3rd Edition ANSI AAMI ES 60601 1 1st Edition and CAN CSA C22 2 No 60601 1 08 2nd Edition Technical Considerations e The product was investigated to the following additional standards EN 60601 1 2006 CORR 2010
206. s same or another function MANUFACTURER has defined if multiple functions No type F applied parts used N A are to be considered as all within one APPLIED or parts needed to be treated PART or as multiple APPLIED PARTS as type F applied parts Classification as TYPE BF CF or No type F applied parts used N A DEFIBRILLATION PROOF applied to one entire or parts needed to be treated APPLIED PART as type F applied parts LEAKAGE CURRENT tests conducted per 8 7 4 No type F applied parts used N A or parts needed to be treated as type F applied parts Dielectric strength test conducted per 8 8 3 No type F applied parts used N A or parts needed to be treated as type F applied parts Issue Date 2014 03 27 Page 31 of 181 Report Reference 1402012 draft report CREEPAGE and CLEARANCES measured per 8 9 No type F applied parts used N A and Tables 11 to 16 as applicable or parts needed to be treated as type F applied parts A protective device connected between PATIENT No type F applied parts used N A CONNECTIONS of an F TYPE APPLIED PART or parts needed to be treated and ENCLOSURE to protect against excessive as type F applied parts voltages did not operate below 500 V r m s 8 5 2 2 PATIENT CONNECTIONS of a TYPE B APPLIED No type B applied parts or N A PART not PROTECTIVELY EARTHED are parts needed to be treated as separated by one MEANS OF PATIENT type B app
207. s intended ENGINEERING PROCESS 00 ceeeeeeetreee performance will not be affect by usability 7 1 2 Legibility of Markings Test for Markings specified ir in See Appended Table 7 1 2 Pass Clause f 2 7 6 ioe weiner eed 7 1 3 Required markings can be removed only with a See below Pass TOOL or by appreciable force are durable and remain CLEARLY LEGIBLE during EXPECTED SERVICE LIFE of ME EQUIPMENT in NORMAL USE a After tests adhesive labels didn t loosen upor See appended Tables 7 1 3 Pass curl up at edges and markings complied with requirements in Clause 7 1 2 cccccccceeeeeeeeeeeeeee and 8 10 Issue Date 2014 03 27 Page 14 of 181 Report Reference 1402012 draft report b Markings required by 7 2 7 6 remained CLEARLY LEGIBLE after marking durability test See appended Tables 7 1 3 and 8 10 Pass 7 2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts Pass 7 2 1 At least markings in 7 2 2 7 2 5 7 2 6 not for PERMANENTLY INSTALLED ME EQUIPMENT 7 2 10 and 7 2 13 were applied when size of EQUIPMENT its part an ACCESSORY or ENCLOSURE did not permit application of all required markings essersi nn iE See attached copy of Marking Plate Pass Remaining markings fully recorded in ACCOMPANYING DOCUMENTS osel N A Markings applied to individual packaging when impractical to apply to ME EQUIPMENT N A A material component ACCESS
208. s that need to be treated PROCESS as applied parts used 8 4 Limitation of voltage current or energy Pass 8 4 1 PATIENT CONNECTIONS intended to deliver Current N A Limits in 8 4 2 not applied to currents intended to _ No applied parts used N A flow through body of PATIENT to produce a physiological effect during NORMAL USE 8 4 2 ACCESSIBLE PARTS including APPLIED PARTS Pass a Currents from to or between PATIENT N A CONNECTIONS did not exceed limits for PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT per Tables 3 and 4 when measured according to Clause 8 7 4 leessen b LEAKAGE CURRENTS from to or between See appended Table 8 7 Pass ACCESSIBLE PARTS did not exceed limits for TOUCH CURRENT in Cl 8 7 3 c when measured per Clause 8 7 4 MA cc cceeeeeeeeenieeeeeeneeeeeenaees c Limits specified in b not applied to parts when See Appended RM Results Pass probability of a connection to a PATIENT directly or through body of OPERATOR is negligible in NORMAL USE and the OPERATOR is appropriately instructed Table 8 4 2c Issue Date 2014 03 27 Page 27 of 181 Report Reference 1402012 draft report accessible contacts of connectors Pass contacts of fuseholders accessible during N A replacement of fuse contacts of lampholders accessible after removal N A of lamp parts inside an ACCESS COVER that can be N A opened without a TOOL or where a TOOL is needed but the instructions for use in
209. sed on Table L 2 C Mandrel diameter and tension applied as in clause N A L 3 2 MPa N MM2 0 ccceeeeeeeeeeeeeeeeeeeeeeereeeeel Dielectric strength test conducted at room N A temperature after removal from the oven L 3 4 Retention of electric strength after bending N A Five samples prepared as in L 3 2 subjected to N A dielectric strength and bending tests Test voltage was at least the voltage in Tables 6 N A and 7 but not less than the following 1500 V for BASIC and SUPPLEMENTARY INSULATION N A 3000 V for REINFORCED INSULATION V N A Test voltage applied between the shot and N A Issue Date 2014 03 27 Page 98 of 181 Report Reference 1402012 draft report conductor Mandrel diameter and tension applied as in L 3 2 N A MPa N MM Jenna ara L 4 Tests during manufacture N A L 4 1 Production line dielectric strength tests conducted N A by the manufacture according to L 4 2 and L 4 3 L 4 2 Test voltage for routine testing 100 testing is at N A least the voltage in Tables 6 and 7 but not less than the following 1500 V r m s or 2100 V peak for BASIC and N A SUPPLEMENTARY INSULATION V 3000 V r m s or 4200 V peak for REINFORCED N A INSULATION V ieten iniintindi L 4 3 Sampling tests conducted using twisted pair N A samples IEC 60851 5 1996 clause 4 4 1 Minimum breakdown test voltage at least twice the N A voltage in Tables 6 and
210. sed with oxygen or oxygen enriched environments N A 3 when parts affecting safety cracked or changed outer shape exposing temperatures higher than 300 C or sparks due to overheating Not used with oxygen or oxygen enriched environments N A 4 when temperatures of parts or components exceeded 300 C atmosphere was 100 oxygen contact material solder and fuel cotton 5 when sparks provided adequate energy for ignition by exceeding limits of Figs 35 to 37 inclusive atmosphere was 100 oxygen contact material solder and fuel cotton Not used with oxygen or oxygen enriched environments Not used with oxygen or oxygen enriched environments N A N A Deviations from worst case limits in 4 and 5 above based on lower oxygen concentrations or less flammable fuels justified and documented in RISK MANAGEMENT FILE Not used with oxygen or oxygen enriched environments N A Issue Date 2014 03 27 Page 64 of 181 Report Reference 1402012 draft report Alternative test in this clause did not identify existence of ignition sources at highest voltage or Current respectively ccceceeeeeeceeeeeeeeeeeeeeeteeeee Not used with oxygen or oxygen enriched environments N A A safe upper limit determined by dividing upper limit of voltage or current respectively with safety margin factor Of three 0 0 eeeeeeeeeeeeeeeeeetteeeeeeneaees b RESIDUAL RISK of fire in an O
211. single layer of cheesecloth which did not ignite during the test No motors used N A a 2 Tests on ME EQUIPMENT containing heating parts conducted at prescribed voltage with motor amp heating parts operated simultaneously to produce the least favourable condition No motors used N A a 3 Tests performed consecutively when more tests were applicable to the same ME EQUIPMENT No motors used N A b Motor met running overload protection test of this clause when No motors used N A 1 it is intended to be remotely or automatically No motors used N A Issue Date 2014 03 27 Page 72 of 181 Report Reference 1402012 draft report controlled by a single control device with no redundant protection or 2 it is likely to be subjected to CONTINUOUS OPERATION while unattended No motors used N A Motor winding temperature determined during each steady period and maximum value did not exceed Table 27 Insulation Class Maximum temperature measured OI nran dai aah deli oni No motors used N A Motor removed from ME EQUIPMENT and tested separately when load could not be changed in appropriate steps No motors used N A Running overload test for motors operating at 42 4 V peak a c 60 V d c or less performed only when examination and review of design indicated possibility of an overload No motors used N A Test not conducted where electronic
212. sk control measures selected were Pass 191_ RMF 2014 02 24 recorded in the risk management file Section Release protocols of measures RC 023 VENUS The effectiveness of the risk control measures Pass 191_ RMF 2014 02 24 had been verified and the results of the Section Release protocols of verification were recorded in the risk measures RC 023 management file VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 01 C 09 VENUS 191_RMF 2014 02_24 Section Residual risk evaluation VENUS 191_RMF_2014_02_24 Section Summary of risk control No reduction of risk through Risk benefit analysis Pass Issue Date 2014 03 27 Page 106 of 181 Report Reference 1402012 draft report TABLE Determination of ACCESSIBLE parts Location Determination method NOTE1 Comments Unit outer enclosure rigid test finger jointed test finger test Pass hook Supplementary information NOTE 1 The determination methods are visual rigid test finger jointed test finger test hook 5 9 2 3 RM TABLE Actuating mechanisms Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Markings tested Remarks Label Viewpoint angle 30 degree Label Viewpoint angle 30 degree Supplementar
213. sk management file Section Release protocols of measures RC 005 VENUS The effectiveness of the risk control measures Pass 191_ RMF 2014 02 24 had be verified and the results of the verification Section Release protocols of were recorded in the risk management file measures RC 005 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_ 02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 02 C 02 VENUS 191_RMF_2014 02_24 Section Risk graph after measures VENUS 191_RMF_2014 02_24 Secti on Summary of risk control No reduction of risk through Risk benefit analysis N A Issue Date 2014 03 27 Page 145 of 181 Report Reference 1402012 draft report 11 5 RM TABLE ME equipment and ME systems intended for use in conjunction N A with flammable agents Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 11 6 1 TABLE overflow spillage leakage ingress of water cleaning disinfection Pass sterilization compatibility with substances Clause Test Name Test Condition Part under test Remarks 11 6 6 Cleaning A soft non abrasive cloth Medical integrated LCD moistened with water system 11 6 6 Cleaning A soft non abrasive cloth Medical integrated LCD moistened with rubbing alcohol system Supplementary in
214. sk management file measures RC 004 RC 019 VENUS All residual risk that remains after the risk control Pass 191_RMF_2014_02_24 measure s are applied and evaluated using the Section New evaluation after criteria that defined in the risk management plan measures F 01 H 01 C 17 VENUS 191_RMF_2014 02_24 Section Risk graph after measures VENUS 191_RMF_2014 02_24 Section Summary of risk control No reduction of risk through Risk benefit analysis N A Issue Date 2014 03 27 Page 121 of 181 1402012 draft report Report Reference TABLE Short circuiting of each single one of the CREEPAGE DISTANCES and AIR CLEARANCES for insulation in the MAINS PART between parts of opposite polarity in lieu of complying with the required measurements in 8 9 4 HAZARDOUS SITUATION observed i e fire hazard shock hazard explosion discharge of parts etc Yes No Test in lieu of Remarks CREEPAGE DISTANCE or AIR CLEARANCE 1 Specific areas of circuits short circuited and test conditions Supplementary information Note 1 AC AIR CLEARANCE CD CREEPAGE DISTANCE 8 9 3 2 TABLE Thermal cycling tests on one sample of insulating compound forming solid insulation between conductive parts Each test duration and temperature Dielectric test voltage Dielectric strength test V Test voltage in after humidity 8 8 3 times 1 6 preconditioning per Cl 5 7 except for 48 h only Breakdown Yes No
215. ssed in RISK MANAGEMENT PROCESS N A 9 6 3 Hand transmitted vibration N A Means provided except for INTENDED USE vibrations to protect PATIENT and OPERATOR when hand transmitted frequency weighted r m s acceleration generated in NORMAL USE exceeds specified values measured at points of hand contact with PATIENT or OPERATOR N A 2 5 m s2 for a cumulative time of 8 h during a 24 h period m S2 2 2 a en eg nasil N A Accelerations for different times inversely proportional to square root of time m S2 N A 9 7 Pressure vessels and parts subject to pneumatic and hydraulic pressure N A Issue Date 2014 03 27 Page 56 of 181 Report Reference 1402012 draft report 9 7 1 Requirements of this clause applied to vessels and parts of ME EQUIPMENT subject to pressure resulting in rupture and unacceptable RISK no such parts N A Parts of a pneumatic or hydraulic system used as a support system comply with 9 8 N A 9 7 2 Pneumatic and hydraulic parts of ME EQUIPMENT or ACCESSORIES met following requirements based on examination of RISK MANAGEMENT N A no unacceptable RISK resulted from loss of pressure or loss of vacuum N A no unacceptable RISK resulted from a fluid jet caused by LEAKAGE or a component failure N A Elements of ME EQUIPMENT or an ACCESSORY especially pipes and hoses leading to an unacceptable
216. struct an OPERATOR other than SERVICE PERSONNEL to open the relevant ACCESS COVER Voltage to earth or to other ACCESSIBLE PARTS _ Evaluated in part of power N A did not exceed 42 4 V peak a c or 60 V d c for supply above parts in NORMAL or single fault condition x A C Ea K eD ESE E A E ieiedibesgenebnel Limit of 60 V d c applied with no more than 10 N A peak to peak ripple and when ripple larger than specified value 42 4 V peak limit applied V d c Energy did not exceed 240 VA for longer than 60 s N A or stored energy available did not exceed 20 J ata a potential up to 2 V VA OF J sessesseseisseerrsseenss LEAKAGE CURRENT limits referred to in 8 4 2 b N A applied when voltages higher than limits in 8 4 2 c were present IMA eeccceeceeeeeeeeeettneeeeeeeeeee d Voltage and energy limits specified in c above Pass also applied to the following internal parts other than contacts of plugs Product was designed with Pass connectors and socket outlets touchable by test construction that internal live pin in Fig 8 inserted through an opening in an part cannot be touch by test ENCLOSURE and pin rod and hook internal parts touchable by a metal test rod with a Pass diameter of 4 mm and a length of 100 mm inserted through any opening on top of ENCLOSURE or through any opening provided for adjustment of pre set controls using a TOOL Test pin or the test rod inserted through r
217. t ISO 14971 Document No and paragraph ONYX 122 121DT The RMF mention the Intended use intended Pass series_2013_11_29 Section purpose Version Data VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 04 both normal and fault conditions H 01 VENUS The estimates of the risk s were recorded in the Pass 191_RMF_2014_02_24 risk management file Section Evaluation of risk before measures F 04 H 0l 8 4 3 TABLE ME Equipment for connection to a power source by a plug N A measurement of voltage or calculation of stored charge 1 s after disconnection of plug from mains supply Maximum allowable voltage V 60 Voltage measured V Vors mease H e e e e e r pee Maximum allowable stored charge when measured voltage exceeded 60 v uc 45 Calculated stored charge uc Notagenessureazaween J e pf e e r e efo Supplementary information TABLE Internal capacitive circuits measurement of residual voltage or calculation of the stored charge in capacitive circuits i e accessible capacitors or circuit parts after de energizing ME EQUIPMENT Maximum allowable residual voltage V Maximum allowable stored charge when residual voltage exceeded 60 V Remarks Description of the capacitive circuit i e Measured residual Calculated stored accessib
218. t when apparent to OPERATOR from normal operating position and marking of 7 4 1 are insufficient for this purpose eeeeeeeeeetteee N A An additional indicator light provided on ME EQUIPMENT with a stand by state or a warm up state exceeding 15 s except when apparent to OPERATOR from normal operating position No stand by or warm up state N A Indicator lights provided on ME EQUIPMENT incorporating non luminous heaters to indicate heaters are operational when a HAZARDOUS SITUATION could exist except when apparent to OPERATOR from normal operating position N A Requirement not applied to heated stylus pens for recording purposes N A Indicator lights provided on ME EQUIPMENT to N A Issue Date 2014 03 27 Page 81 of 181 Report Reference 1402012 draft report indicate an output exists where an accidental or prolonged operation of output circuit could constitute a HAZARDOUS SITUATION Colours of indicator lights complied with 7 8 1 N A Charging mode visibly indicated in ME EQUIPMENT incorporating a means for charging an INTERNAL ELECTRICAL POWER SOURCE N A 15 4 5 RISKS associated with pre set controls addressed in RISK MANAGEMENT PROCESS when applicable as verified by review of RISK MANAGEMENT FILE 0 ccceesseeeeeesteeeeeenee No pre set controls function N A 15 4 6 Actuating parts of controls of ME EQUIPMENT N
219. tions and its significant physical and performance characteristics MANUFACTURER S optional requirements for N A minimum qualifications of SERVICE PERSONNEL documented in technical description Issue Date 2014 03 27 Page 25 of 181 Report Reference 1402012 draft report 7 9 3 2 The technical description contains the following required information N A TYPE and full rating of fuses used in supply MAINS external to PERMANENTLY INSTALLED ME EQUIPMENT when TYPE and rating of fuses are not apparent from information on RATED current and mode of operation of ME EQUIPMENT a statement for ME EQUIPMENT with a non DETACHABLE POWER SUPPLY CORD if POWER SUPPLY CORD is replaceable by SERVICE PERSONNEL and if so instructions for correct connection and anchoring to ensure compliance with 8 11 3 N A N A instructions for correct replacement of interchangeable or DETACHABLE parts specified by MANUFACTURER as replaceable by SERVICE PERSONNEL and N A warnings identifying Nature of HAZARD when replacement of a component could result in an unacceptable RISK and when replaceable by SERVICE PERSONNEL all information necessary to safely replace the component N A 7 9 3 3 Technical description indicates MANUFACTURER will provide circuit diagrams component part lists descriptions calibration instructions to assist to SERVICE PERSONNEL in parts repair See User Manual only qualifi
220. tive short circuit current gt 35 A or 10 times current rating of the fuse whichever is greater No such situation N A Justification for omission of fuses or OVER CURRENT RELEASES is in RISK MANAGEMENT FILE Evaluated in part of power supply N A 8 11 6 Internal wiring of the MAINS PART N A a Cross sectional area of internal wiring in a MAINS PART between MAINS TERMINAL DEVICE and protective devices is not less than minimum required for POWER SUPPLY CORD as in clause 8 11 3 3 MM2 CU eter eeeeee Evaluated in part of power supply N A b Cross sectional area of other wiring in MAINS PART and sizes of tracks on printed wiring circuits sufficient to prevent fire in case of fault currents Evaluated in part of power supply N A When necessary ME EQUIPMENT connected to a SUPPLY MAINS with max available short circuit fault and subsequent simulation of a fault ina single insulation in MAINS PART did not result in any of the HAZARDOUS SITUATIONS in 13 1 2 Evaluated in part of power supply N A PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT AND ME SYSTEMS Pass 9 1 ME EQUIPMENT complies with Clause 4 for design and manufacture and mechanical strength 15 3 Pass 9 2 HAZARDS associated with moving parts N A 9 2 1 When ME EQUIPMENT with moving parts PROPERLY INSTALLED used per ACCOMPANYING DOCUMENTS or under foreseeable misuse
221. tted by configuration or ACCESSORIES attachment on support suspension parts No support systems used N A a Entire mass of PATIENT or OPERATOR distributed over an area of 0 1 m2 on a foot rest temporarily supporting a standing PATIENT or OPERATOR No support systems used N A Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing and tests No support systems used N A PATIENT support suspension system positioned horizontally in most disadvantageous position in NORMAL USE and a mass 2 x 135 kg or twice intended person s load the greater used applied to foot rest over an area of 0 1 m2 for 1 min Kg No support systems used N A Damage or deflection resulting in an unacceptable RISK did not occur on foot rest and its secured joints No support systems used N A b Deflection of a support surface from PATIENT or OPERATOR loading on an area of support suspension where a PATIENT or OPERATOR can sit did not result in an unacceptable RISK No support systems used N A Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing ANG Dya testien adnan a A No support systems used N A PATIENT support suspension system set in most unfavourable NORMAL USE position and a mass of 60 of part of SAFE WORKING LOAD simulating PATIENT or OPERAT
222. tures to a floor wall ceiling included in ACCOMPANYING DOCUMENTS making adequate allowances for quality of materials used to make the connection and list the required materials N A Additional instructions provided on checking adequacy of surface of structure parts will be attached to N A 9 8 2 Support systems maintain structural integrity during EXPECTED SERVICE LIFE and TENSILE SAFETY FACTORS are not less than in Table 21 except when an alternative method used to demonstrate structural integrity throughout EXPECTED SERVICE LIFE or for a foot rest Pass Compliance with 9 8 1 and 9 8 2 confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications and material DFOCESSING v3 EE E E ie es When test results were part of information testing consisted of application of a test load to support assembly equal to TOTAL LOAD times required TENSILE SAFETY FACTOR while support assembly under test was in equilibrium after 1 min or not resulted in an unacceptable RISK See appended RM Results Table 9 8 2 Pass N A 9 8 3 Strength of PATIENT or OPERATOR support or sus pension systems N A 9 8 3 1 ME EQUIPMENT parts supporting or immobilizing PATIENTS minimize RISK of physical injuries and accidental loosening of secured joints No support systems used N A SAFE WORKING LOAD of ME EQUIPMENT or its parts supporting or suspending PATIENTS or OPERATORS is sum of
223. ulation diagram Pollution Degree Overvoltage Altitude Additional details on parts considered as Category applied parts See clause 4 6 for details 2 II 3000m None Area Number and CTI Working Working Required Required Measured Measured Remarks type of Means lllb Voltage Voltage Creepage Clearance Creepage Clearance of Protection unless Vrms Vpk mm mm mm mm MOOP MOPP is known A Functional Ib 12 Vdc B Functional Ib 12 Vdc C Functional Ib 12 Vdc D 1 MOPP IIIb 240 340 4 0 2 5 Approval component for Power Adapter E 2 MOPP IIIb 240 340 8 0 5 0 Approval component Supplementary information Refer to CTL Decision DSH 0791 for circumstances when gt greater than or lt less than symbols are permitted INSULATION DIAGRAM CONVENTIONS and GUIDANCE A measured value must be provided in the value columns for the device under evaluation The symbol gt greater than sign must not be used Switch mode 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 a 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 sep
224. ummary of risk control VENUS The manufacturer had compiled a list of known or Pass 191_RMF_2014_02_24 foreseeable hazards associated with the unit in Section Risk analysis F 01 both normal and fault conditions H 01 C 18 C 21 Issue Date 2014 03 27 Page 128 of 181 Report Reference 1402012 draft report TABLE Cord anchorages Cord under test Mass of Remarks equipment kg Torque Nm Supplementary information 8 11 3 6 TABLE Cord guard Supplementary information ISO 14971 Document No and paragraph RM TABLE HAZARDS associated with moving parts General Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9 2 2 2 TABLE Measurement of gap a according to Table 20 ISO 13852 1996 Part of body Allowable adult Measured adult gap Allowable children gap1 mm mm gap1 mm Supplementary information 1 In general gaps for adults used except when the device is specifically designed for use with children values for children applied Measured children gap mm 9 2 2 4 19 2 2 4 3 RM TABLE Movable guards N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph 9224 4 RMTABLE Protective measures Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 129 of 181 Report Re
225. uracy and precision of displayed SPECIFICATIONS values or where they can be found special installation requirements such as max N A permissible apparent impedance of supply MAINS permissible range of values of inlet pressure and N A flow and chemical composition of cooling liquid used for cooling a description of means of isolating ME Medical grade power supply Pass EQUIPMENT from supply MAINS when such provided as means of means not in ME EQUIPMENT insulation a description of means for checking oil level in N A partially sealed oil filled ME EQUIPMENT or its parts when applicable a warning statement addressing HAZARDS that See below Pass can result from unauthorized modification of ME EQUIPMENT according to following examples WARNING No modification of this equipment is N A allowed WARNING Do not modify this equipment without See User Manual Safety Pass authorization of the manufacturer Instructions WARNING If this equipment is modified N A appropriate inspection and testing must be conducted to ensure continued safe use of equipment Technical description separable from instructions for use contains required N A information as follows information as in clause 7 2 The technical description in N A part of the installation instructions all applicable classifications in Clause 6 warning N A and safety notices and explanation of safety signs marked on ME EQUIPMENT a brief description of ME EQUIPMENT how it N A func
226. utput rating 24Vdc 6 25A For Mobile cart computer input rating 24Vdc 6 25A Pass N A Power input Pass Steady state measured input of ME EQUIPMENT or ME SYSTEM at RATED voltage and at operating settings indicated in instructions for use did not exceed marked rating by more than 10 See appended Table 4 11 Pass Measurements on ME EQUIPMENT or a ME SYSTEM marked with one or more RATED voltage ranges made at both upper and lower limits of the See appended Table 4 11 Pass Measurements made at a voltage equal to the mean value of the range when each marking of RATED input was related to the mean value of relevant voltage range N A Power input expressed in volt amperes measured with a volt ampere meter or calculated as the product of steady state current measured as described above and supply voltage 081 N A GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT Pass TYPE TESTS determined in consideration of Clause 4 in particular 4 2 See appended RM Results Table 5 1 Pass Test not performed when analysis indicated condition being tested was adequately evaluated by other tests or methods ceeeeeeeeeeeeeeeeee See appended RM Results Table 5 1 Pass Issue Date 2014 03 27 Page 11 of 181 Report Reference 1402012 draft report Results of RISK ANALYSIS used to determine combination s of simultaneous
227. ve earthing of moving parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No and paragraph Issue Date 2014 03 27 Page 114 of 181 Report Reference 1402012 draft report TABLE Impedance and current carrying capability of PROTECTIVE EARTH CONNECTIONS Type of ME EQUIPMENT and impedance measured between parts Test current A Duration s Maximum calculated impedance m ohm Voltage drop measured between parts V Maximum allowable impedance m ohm Supplementary information Issue Date 2014 03 27 Page 115 of 181 Report Reference 1402012 draft report 8 7 TABLE Leakage current Pass Type of leakage current and test condition Suppl Measured Remarks including single faults y frequency max value voltag Hz uA e V Fig 13 Earth Leakage ER Maximum allowed values Test on Model VENUS 191 mA NC 10 mA SFC ER NC S1 1 S5 N 264 228 7 Maximum allowed values 228 6 m ER NC S1 1 S5 R 264 226 3 Maximum allowed values 226 2 m 394 5 ER SFC Neutral Open S1 0 S5 N 264 304 2 a ER SFC Neutral Open S1 0 S5 R 264 with non frequency weighted device ER SFC Neutral Open S1 0 S5 N 264 ER SFC Neutral Open S1 0 S5 R_ 264 402 3 Fig 14 Touch Current TC 100 pA NC 500 pA SFC MD between Earth and Power Adapter Plastice Enclosure surface covered with
228. vice TABLE Dielectric strength test of solid insulating materials with safety function MEANS OF OPERATOR PROTECTION MOOP MEANS OF PATIENT PROTECTION MOPP Insulation under test Insulation Type PEAK PEAK A C test Dielectric area from insulation 1 or 2 WORKING WORKING voltages in V breakdown diagram MOOP MOPP VOLTAGE U VOLTAGE U r m s1 after 1 minute V peak V d c Yes No2 DI RI 2 MOPP 340 Vpk 5656Vdc No Primary to Plastic enclosure with foil DI RI 2 MOPP 340 Vpk 5656Vdc Primary to SIP SOP BI 1 MOPP 340 Vpk 2121Vdc Primary to earth Supplementary information No 1 Alternatively per the Table i e _ dc a d c test voltage equal to the peak value of the a c test voltage used 2 A Immediately after humidity treatment of 5 7 ME EQUIPMENT de energized B after required sterilization PROCEDURE ME EQUIPMENT de energized C after reaching steady state operating temperature as during heating test of 11 1 1 and D after relevant tests of 11 6 i e overflow spillage leakage ingress of water cleaning disinfection and sterilization Issue Date 2014 03 27 Page 119 of 181 Report Reference 1402012 draft report 8 8 4 1 TABLE Resistance to heat Ball pressure test of thermoplastic parts Allowed impression diameter mm lt 2 mm a 2c Part material Test temperature Impression diameter a C mm Plastic Enclosure 75 Jog Supplementa
229. when such exposure can constitute an unacceptable RISK See User Manual Safety Instructions Pass N A Restrictions specified on other equipment or NETWORK DATA COUPLINGS other than those forming part of an ME SYSTEM to which a SIGNAL INPUT OUTPUT PART may be connected N A APPLIED PARTS specified No applied parts used N A 7 9 2 6 Information provided indicating where the installation instructions may be found or information on qualified personnel who can perform the installation See User Manual Introduction Pass 7 9 2 7 Instructions provided indicating not to position ME EQUIPMENT to make it difficult to operate the disconnection device when an APPLIANCE COUPLER or separable plug is used as isolation means to meet 8 11 1 a See User Manual I O Panels amp Function Buttons Pass 7 9 2 8 Necessary information provided for OPERATOR to bring ME EQUIPMENT into operation including initial control settings and connection to or See User Manual Introduction Pass Issue Date 2014 03 27 Page 23 of 181 Report Reference 1402012 draft report positioning of PATIENT prior to use of ME EQUIPMENT its parts or ACCESSORIES 7 9 2 9 Information provided to operate ME EQUIPMENT including explanation of controls displays and signals sequence of operation connection of detachable parts or ACCESSORIES replacement of material consumed during operation
230. wire insulation in any than in Table 12 or 16 Pollution Degree 1 wound components used depending on type of insulation path between layers sealed as a cemented joint in 8 9 3 3 and test voltages of TYPE TESTS in L 3 equal 1 6 times of normal values Protection against mechanical stress provided N A where two insulated wires or one bare and one insulated wire are in contact inside wound component crossing at an angle between 45 and 90 and subject to winding tension Finished component complied with routine N A dielectric strength tests Of 8 8 3 00 eeel Tests of Annex L not repeated since material data N A sheets confirm Compliance cccccceeeereeee 8 8 3 Dielectric Strength Pass Solid insulating materials with a safety function See appended Table 8 8 3 Pass withstood dielectric strength test voltages 8 8 4 Insulation other than wire insulation Pass 8 8 4 1 Resistance to heat retained by all insulation and Pass insulating partition walls during EXPECTED SERVICE LIFE of ME EQUIPMENT ME EQUIPMENT and RISK MANAGEMENT FILE See appended RM Results Pass examined in conjunction with resistance to Table 8 8 4 1 moisture dielectric strength and mechanical strength tests issn edie taeda Satisfactory evidence of compliance provided by See Appended RM Results Pass manufacturer for resistance to heat Table 8 8 4 1 Tests conducted in absence of satisfactory Pass evidence for resistance to heat a
231. witches containing mercury such as thermostats relays and level controllers are not allowed 4 Ordinance on chemical hazardous risk reduction No batteries containing N A SR 814 81 Annex 2 15 Batteries Annex 2 15 of SR cadmium and mercury used 814 81 applies for batteries containing cadmium and mercury 4 Note Ordinance relating to environmentally N A hazardous substances SR 814 013 of 1986 06 09 is not longer in force and superseded by SR 814 81 of 2009 02 01 ChemRRV 4 Supply cords of portable electrical appliances N A having a rated current not exceeding 10 A shall be provided with a plug complying with IEC 60884 1 3 ed am1 SEV 1011 and one of the following dimension sheets SEV 6533 2 2009 Plug type 11 L N 250V 10A SEV 6534 2 2009 Plug type 12 L N PE 250V 10A SEV 6532 2 2009 Plug type 15 3L N PE 250 400V 10A 4 Supply cords of portable electrical appliances N A having a rated current not exceeding 16 A shall be provided with a plug complying with IEC 60884 1 3 ed am1 SEV 1011 and one of the following dimension sheets SEV 5933 2 2009 Plug type 21 L N 250 V 16A SEV 5934 2 2009 Plug type 23 L N PE 250 V 16A SEV 5932 2 2009 Plug type 25 3L N PE Issue Date 2014 03 27 Page 167 of 181 Report Reference 1402012 draft report 250 400V 16A 4 NOTE 16 A plugs are not often used in
232. without appreciable force openings in base plates prevented penetration of a solid cylindrical test rod of 12 mm in diameter applied in all directions without appreciable force N A N A c Short circuiting conductor s to a conductive part without presence of explosive gasses where insulation may contact a part containing a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE ignitable gases alone or oxygen did not result in loss of integrity of the part an unacceptable temperature or other HAZARD N A G 4 3 a Electrostatic charges prevented on CATEGORY AP and APG ME EQUIPMENT by a combination of appropriate measures N A Use of antistatic materials with a limited electrical resistance as specified in G 4 3 b N A Issue Date 2014 03 27 Page 91 of 181 Report Reference 1402012 draft report Provision of electrically conductive paths from ME EQUIPMENT or its parts to a conductive floor protective earth or potential equalization system or via wheels to an antistatic floor of medical room N A b Electrical resistance limits of aesthetic tubing mattresses and pads castor tires and other antistatic material complied with ISO 2882 based on measurements according to ISO 1853 ISO 2878 and ISO 23529 o oo eee E N A G 4 4 Corona cannot be produced by components or parts of ME EQUIPMENT operating at more than 2000 V a c or 2400 V d c and not
233. xygen enriched environments adequate torques Soldered crimped and pin and socket Not used with oxygen or N A CONNECTIONS of cables exiting ENCLOSURE oxygen enriched environments include additional MECHANICAL securing means 11 2 3 SINGLE FAULT CONDITIONS related to OXYGEN RICH ENVIRONMENTS ME N A EQUIPMENT and ME SYSTEMS considered Failure of a ventilation system constructed in Not used with oxygen or N A accordance with 11 2 2 1 b 2 OXygen enriched environments Failure of a barrier constructed in accordance wih Not used with oxygen or N A VA 22 A a O EAE E ars ale E E E oxygen enriched environments Failure of a component creating a source of Not used with oxygen or N A ignition as defined in 11 2 2 1 a OXygen enriched environments Failure of solid insulation or creepage and Not used with oxygen or N A clearances providing equivalent of at least one oxygen enriched environments MEANS OF PATIENT PROTECTION but less than two MEANS OF PATIENT PROTECTION that could create a source of ignition defined in 11 2 2 1 EErEE EEE E T E E tee weld acon waa det failure of a pneumatic component resulting in Not used with oxygen or N A LEAKAGE of oxygen enriched g s 0 oxygen enriched environments 11 3 Constructional requirements for fire ENCLOSURES of ME EQUIPMENT Pass ME EQUIPMENT met this clause for alternate See appended RM Results Pass means of compliance with selected HAZARDOUS Table 11 3 SITUATIONS and fault conditions in
234. y information Observer with a visual acuity of 0 on the log Minimum Angle of Resolution log MAR scale or 6 6 20 20 reads marking at ambient illuminance least favourable level in the range of 100 Ix to 1 500 Ix The ME EQUIPMENT or its part was positioned so that the viewpoint was the intended position of the OPERATOR at any point within the base of a cone subtended by an angle of 30 to the axis normal to the centre of the plane of the marking and at a distance of 1 m 7 1 3 TABLE Durability of marking test Pass Characteristics of the Marking Label tested Remarks Material of Marking Label Ink other printing material or process Material composition of Warning Label Ink other printing material or process Other ae Marking Label Certification Label T w 15s T m 15s T i 15s Supplementary information Marking rubbed by hand first for 15 s with a cloth rag soaked with distilled water then for 15 s with a cloth rag soaked with methylated spirit and then for 15 s with a cloth rag soaked with isopropyl alcohol T w Time with distilled water T m Time with methylated spirit T i Time with isopropyl alcohol The markings did not work did not curl at the edges The markings were clearly readable Issue Date 2014 03 27 Page 107 of 181 Report Reference 1402012 draft report 7 2 2 RM TABLE Identification Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document
235. y with substances used with ME EQUIPMENT cccccceceeeeeeeeeeee See appended Table 11 6 1 Pass 11 6 2 Overflow in ME EQUIPMENT Does not use liquids in normal use N A Liquid reservoir liable to overflow in NORMAL USE completely filled and 15 of its capacity poured in for over 1 min and except when restricted TRANSPORTABLE ME EQUIPMENT tilted through an angle of 15 in least favourable direction s and when necessary refilled starting from position of NORMALC USE ued Does not use liquids in normal use N A ME EQUIPMENT met dielectric strength and LEAKAGE CURRENT tests and uninsulated electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were SIAN E E E E EEEE EERE ATE T Does not use liquids in normal use N A 11 6 3 Spillage on ME EQUIPMENT and ME SYSTEM Does not use liquids in normal use N A ME EQUIPMENT and ME SYSTEMS handling liquids in NORMAL USE positioned as in 5 4 a and Does not use liquids in normal use N A Issue Date 2014 03 27 Page 67 of 181 Report Reference 1402012 draft report liquid with composition volume duration of spill point of contact and test conditions based on RISK MANAGEMENT PROCESS poured steadily on a point on top of ME EQUIPMENT ME EQUIPMENT met dielectric strength and LEAKAGE CURRENT tests and uninsulated electrical parts or electrical insulation of

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