Home

Test report link - 163 pages Medical Electrical

1. Supplementary information No defibrillation proof applied part Page 112 of 163 Report No TRS11120147 8 6 4 TABLE Impedance and current carrying capability of PROTECTIVE EARTH N CONNECTIONS Type of ME EQUIPMENT amp impedance measured Test current Voltage drop Maximum Maximum between parts A measured calculated allowable between impedance impedance parts V mQ mQ PERMANENTLY INSTALLED ME EQUIPMENT 100 impedance between PROTECTIVE EARTH TERMINAL and a PROTECTIVELY EARTHED part ME EQUIPMENT with an APPLIANCE INLET 100 impedance between earth pin in the APPLIANCE INLET and a PROTECTIVELY EARTHED part ME EQUIPMENT with a non DETACHABLE POWER 200 SUPPLY CORD impedance between the protective earth pin in the MAINS PLUG and a PROTECTIVELY EARTHED part Supplementary information Internally powered Equipment and no PROTECTIVE EARTH CONNECTIONS Page 113 of 163 Report No TRS11120147 8 7A TABLE PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under N NORMAL amp SINGLE FAULT CONDITIONS TYPE B APPLIED PARTS A Current Description Clause Measuring a c NC NC actual SFC SFC actual Type Ref Circuit d c allowed allowed PATIENT d c 10 50 AUX 8 7 4 8 Fig 19 CURRENT a c 100 500 From PATIENT d c 10 50 PATIENT ee to 8 7 4 7a Fig 15 at 100 500 LEAKAGE CURRENT Caused by d c 10 50
2. Temperature measurements made according to 11 1 and Umax Imax R Lmax and Cmax determined together with application of Figs G 1 G 3 i Alternatively compliance was verified by examination of design data External ventilation with internal overpressure ME EQUIPMENT its parts and components enclosed in an ENCLOSURE with external ventilation by means of internal overpressure complied with the following requirements a FLAMMABLE ANESTHETIC MIXTURES WITH AIR that might have penetrated into ENCLOSURE of ME EQUIPMENT or part removed by ventilation before EQUIPMENT energized and penetration of such 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 ceceeeeeeeees 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 Page 103 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict ME EQUIPMENT could be energized only after the required minimum overpressure was present long enough to ventilate the ENCLOSURE so that the displaced volume of air or inert gas was at least five times the volume of ENCLOSURE c Ignition source
3. 8 7C TABLE PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under N NORMAL amp SINGLE FAULT CONDITIONS TYPE CF APPLIED PARTS uA Current Description Clause Measuring a c NC NC actual SFC SFC actual Type Ref Circuit d c allowed allowed PATIENT d c 10 50 AUX 8 7 4 8 Fig 19 CURRENT a c 10 50 From PATIENT d c 10 50 Patient CONNECTION to 8 7 4 7a Fig 15 at 10 50 earth LEAKAGE CURRENT Caused by d c 10 50 an extemal g 7476 Fig 17 voltage on a a c 10 50 SIP SOP With same d c 50 100 types of 8 7 4 7a Fig 15 Total APPLIED PART and and patient connected 8 7 4 7h Fig20 ac 50 100 LEAKAGE together CURRENT ais d c 50 100 ee aused by NoTeE3 an external orate ig a voltage on a ong and 50 100 i a c SIROP 8 7 4 7h Fig 20 Supplementary information No TYPE CF APPLIED PART 1 For EARTH LEAKAGE CURRENT see 8 7 3 d 2 For TOUCH CURRENT see 8 7 3 c 3 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 4 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 Subclause 11
4. Class of Type of Protective Time to Maximum Maximum insulation protective device THERMAL allowed winding A B E device fuse operated STABILITY when temp from temp F or H circuit breaker Yes No protective Table 31 measured Ratings device did not C C operate Min Winding tested Ambient C Supplementary information No Transformer 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 Page 137 of 163 Report No TRS11120147 15 5 1 3 TABLE transformer overload test conducted only when protective device N under short circuit test operated Primary voltage most adverse value between 90 to 110 of RATED voltage v wi RATED input frequency HZ esi ce cients ation tentials f Test current just below minimum current that would activate protective device amp achieve THERMAL STABILITY under method a A esssssesssssssrssrssrsrrsrrsrrsrrsrrsrrsrrsrrsersres Test current based on Table 32 when protective device that operated under method a is external to transformer and it was shunted A ceceeeeeeeeeeeeeeeeeeeeeeneetneetneeeeees Class of Type of protective Maximum allowed Maximum Ambient Winding tested insulation device used fuse temp from winding temp C 9 A B E F H circuit breake
5. Allowable Measured Allowable TOUCH Measured TOUCH Specifi h TOUCH CURRENT TOUCH CURRENT in event of CURRENT in event of poeme arco We Te in NORMAL CURRENT in interruption of any non interruption of any non on ore ee ire irem or CONDITION A NORMAL PERMANENTLY INSTALLED PERMANENTLY INSTALLED ONS ane SYSTEM CONDITION uA PROTECTIVE EARTH PROTECTIVE EARTH within PATIENT ENVIRONMENT CONDUCTOR uA CONDUCTOR uA 100 500 100 500 100 500 100 500 100 500 100 500 100 500 100 500 100 500 100 500 Supplementary information Not ME SYSTEM Page 139 of 163 Attachment No 1 Report No TRS11120147 ISO 14971 Gap Analysis Checklist optional Clause Title Item Comments 3 2 Risk Management Procedure describing the risk See Risk management process management process procedure 3 3 Management Policy for determining acceptable See section 6 n Chapter 2 of Responsibilities risk the Risk management Report Assignment of group individual with See section 5 in Chapter 2 of risk management responsibility the Risk management Report Procedure for assigning staff to risk See section 5 amp 7 in Chapter 2 management work of the Risk management Report and Risk management procedure Procedure s for review of risk See Risk management management e g management procedure design reviews internal audits etc 3 4 Qualification of Training
6. 0 2mm Blood Pressure Monitor Upper Arm Type ORA211 ORA219000001 Powered by 4 1 5V AA Baltesties 6Vd c wil Ningbo Oun New Material Technology Development Co Lid No 9 Xlahengdal Road Lanjang Street Yuyao Znegang China papag CONEY Home Canton Way Stevenage Herticie SGI 20F UK TEL 4401438351600 IAN THORNE 0 2m TX CE WUT 0 F uug Labelling of arm cuff Ningbo Ourui New Material Technology Development Co Ltd A Arm cuff A1 22 32cm Put the cuff on your bare left upper arm place the gt _ gt gt air tube at your main artery Keep 1 2cm between L gt d gt 12cm the edge of the cuff and elbow joint Make sure the cuff is at the same level as your heart Page 3 of 163 GENERAL INFORMATION Test item particulars see also Clause 5 Classification of installation and USC l a Device type Clinical application Mode of operation Surface temperature of APPLIED PART Supply connection Accessories and detachable parts included Other options include Testing Date of receipt of test item s Dates tests performed Report No TRS11120147 Hand held equipment Internal powered equipment Automatic Blood Pressure Monitor is intended to measure the systolic and diastolic blood pressure and pulse rate of an adult individual Babies young children or individuals who cannot express their consent are not suitable to take blood pressure measurement
7. information information into risk management review e Manufacturing e CAPA e Servicing e Purchasing e etc b Records implementing procedures management Report See the related Procedures and their related records Note Bold letters indicate critical elements that should be present even at the very beginning of implementation Page 141 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Erak 4 General requirements Risk Management Compliance is checked by inspection of the risk management file The requirements of this clause and all Process for ME requirements of this standard referring to inspection of the risk management file are considered to be Equipment or ME satisfied if the manufacturer has Systems established a risk management process and established acceptable levels of risks and demonstrated that the residual risk is acceptable Does the manufacturer have a risk management process according to IS014971 in place Was this process used for the device being considered If so a limited number of more detailed questions can be addressed at this point e Are all risk management procedures that meet the requirements of IS014971 including acceptability criteria developed and applied for the device considered clauses 4 9 of 18014971 Is
8. 4 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 mater cleaning amp disinfection amp sterilization Page 120 of 163 Report No TRS11120147 8 7 4 7 TABLE PATIENT LEAKAGE CURRENTS under special test conditions identified in P 8 7 4 7 uA TYPEB TYPEB TYPEBF TYPEBF TYPECF TYPE CF Current Description Clause Measuring APPLIED APPLIED APPLIED APPLIED APPLIED APPLIED Type Note 1 Ref Circuit PART PART PART PART PART PART allowed actual allowed actual allowed actual Caused by an external voltage on PATIENT CONN of an F TYPE Patient APPLIED PART LEAKAGE Caused by an CURRENT external voltage on ACCESSIBLE 8 7 4 7d Fig 18 500 N A 500 N A metal part not PROTECTIVELY EARTHED 8 7 4 7b Fig 16 N A N A 5000 1 50 N A See See Note 3 Note 3 Caused by an external voltage on PATIENT CONN of an F TYPE APPLIED PART 8 7 4 7b Fig 16 and and N A N A 5000 N A 100 N A Total 8 7 4 7h Fig 20 PATIENT LEAKAGE CURRENT Caused by an external voltage on 8 7 4 7d Fig 18 ACCESSIBLE and and 1000 N A 1000 N A metal part not 8 7 4 7h Fig 20 PROTEC
9. 9 4 2 1 ME EQUIPMENT or its parts did not overbalance Hand held equipment 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 ME EQUIPMENT or its parts prepared based on a to g inclusive did not overbalance when placed in different positions of NORMAL USE except transport positions on a 5 inclined plane from horizontal consisting of a hard and flat surface A warning notice provided stating Transport only under conditions clearly 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 9 4 2 3 Instability from horizontal and vertical forces 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 resting etc 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 comp
10. Transformer T2 voltage set at 110 of MAXIMUM MAINS VOLTAGE and specific pin configuration used when applying external voltage determined to be worst case based on test or circuit analysis a ME EQUIPMENT with an APPLIED PART tested See appended Table 8 7 4 7 based on Fig 15 and an ENCLOSURE other than an APPLIED PART of insulating material placed in a position of NORMAL USE on a flat metal surface and connected to earth Page 40 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict b ME EQUIPMENT with an F TYPE APPLIED PART additionally tested based on Fig 16 and SIGNAL INPUT OUTPUT PARTS not previously permanently earthed connected to earth Transformer T2 voltage in Fig 16 set at 110 of MAXIMUM MAINS VOLTAGE Non PROTECTIVELY EARTHED metal ACCESSIBLE PARTS including PATIENT CONNECTIONS of other APPLIED PARTS when present connected to earth c ME EQUIPMENT with an APPLIED PART and a SIGNAL INPUT OUTPUT PART additionally tested according to Fig 17when required Transformer T2 voltage set at 110 of MAXIMUM MAINS VOLTAGE and specific pin configuration used when applying external voltage was worst case based on test or circuit analysis d ME EQUIPMENT with a PATIENT CONNECTION ofa type BF applied part without TYPE B APPLIED PART not PROTECTIVELY EARTHED or metal accessible parts a not PROTECTIVELY EARTHED additionally tested based on Fig 18 Transformer T2 volt
11. B double reinforced 6 0Vdc 3 4 1 6 gt 3 4 gt 3 4 Applied part to Live 2MOPP part battery C Basic 1MOPP 250Vrms 4 2 5 gt 4 0 gt 4 0 Type BF Applied part to Enclosure INSULATION DIAGRAM CONVENTIONS 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 separate parts of diagram for example separate transformer windings optocouplers wire insulation creepage and clearance distances Parts connected to earth with large dots are protectively earthed Other connections to earth are functional Applied 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 Blocks containing the letter Z indicate protective impedance Operational Insulation OP indicates insulation that may be required for function of the equipment but is not required or relied on for compliance with the requirements of clauses 17 20 and 57 Page 6 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 4 GENERAL REQUIREMENTS 4 1 Requirements of this standard applied in NORMAL USE and reasonably foreseeable misuse Definitions requireme
12. Documentation Page 154 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Ano eae Programmable Does the risk management plan include a reference to the PEMS validation plan electrical medical systems Risk management plan PEMS Development Does each milestone in the PEMS development life cycle identify the risk management activities that Life Cycle must be completed before that milestone Identification of known Has the manufacturer considered those hazards associated with the software and hardware aspects of and foreseeable the PEMS including those associated with Network Data coupling and legacy subsystems hazards 14 6 2 Risk control Has the manufacturer identified suitable tools and procedures to implement risk control measures Are these tools and procedures appropriate to ensure that each risk control measure effectively reduces the identified risks 14 7 Requirement Does the requirement specification include and distinguish any risk control measures specification 14 8 Architecture Does the architecture specification reduce the risk to an acceptable level where appropriate using 4to6 levels a f Does the architecture specification take into consideration allocation of risk control measures 14 9 Design and Is descriptive data regarding the design environment include
13. HYDRAULIC TEST PRESSURE was MAXIMUM PERMISSIBLE WORKING PRESSURE times a factor obtained from Fig 32 and pressure was gradually raised to specified test value and held for 1 min No leakage occurred at a gasket at a pressure below 40 of required test value or below MAXIMUM PERMISSIBLE WORKING PRESSURE No leakage occurred for pressure vessels intended for toxic flammable or otherwise hazardous substances and for other pressure vessels leakage resulting in an unacceptable RISK did not occur e g high pressure fluid jet When unmarked pressure vessels and pipes could not be hydraulically tested integrity verified by other suitable tests 0 0 eeeeeeeeeeeeeeeeeneeees 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 under different conditions of NORMAL USE Page 65 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Pressure relief device s used where MAXIMUM No possible overpressure as PERMISSIBLE WORKING PRESSURE Could otherwise the equipment has be exceeded met the following as confirmed by overpressure protective MANUFACTURER S data ME EQUIPMENT RISK function and no Pressure MANAGEMENT FILE and functional tests relief device requirements a Connected as close as possible to pressure N vessel or parts of system it is
14. Shenzhen Huatongwei International Inspection Co Ltd Keji Nan No 12 Road Hi tech Park Shenzhen China Phone 86 755 26748019 Fax 86 755 26748089 http www szhtw com cn EN 60601 1 2006 Medical electrical equipment Part 1 General requirements for safety Report reference No cc00 gt TRS11120147 Ll CIE ta we CNAS 1225 Compiled by signature Mustang Wu Reviewed by signature Ivy Chen Approved by signature Tiger Jiang Date of issue eeeeeeeeeeeeeeees January 18 2012 Testing laboratory 8 Shenzhen Huatongwei International Inspection Co Ltd Address sicher ce Keji Nan No 12 Road Hi tech Park Shenzhen China Testing location Paa Shenzhen City China Applicant s name 00 Ningbo Ourui New Material Technology Development Co Ltd AddTOSS a Aoa A oaan No 9 Xiahengdai Road Lanjiang Street Yuyao City Zhejiang China Test specification Stangard Mi eee eee Meee EN 60601 1 2006 AC 2010 Test procedure cceceeeeee CB Non standard test method gt NA Test Report Form No 1EC60601_1E Test Report Form Originator Underwriters Laboratories Inc Master TRF eee Dated 2009 01 Copyright 2009 IEC System for Conformity Testing and Certification of Electrical Equipment IECEE Geneva Switzerland All rights reserved
15. roe Accowrmwnooooments OO o e ME EQUIPMENT accompanied by documents See User manual containing at least instructions for use and a technical description ACCOMPANYING DOCUMENTS identify ME EQUIPMENT by the following as applicable name or trade name of MANUFACTURER and an Making plate and User address the RESPONSIBLE ORGANIZATION can be manual referred tO vs i scces eaPeaiectassaes dhstatecaubeais eadeatedeesaneetaes MODEL Or TYPE REFERENCE eerren See making plate When ACCOMPANYING DOCUMENTS provided Accompanying documents electronically e g on CDROM RISK MANAGEMENT provided by paper PROCESS includes instructions as to what is required in hard copy or as markings on ME EQUIPMENT to cover emergency operation ACCOMPANYING DOCUMENTS specify special skills See SAFETY training and knowledge required of OPERATORor PRECAUTIONS in the User RESPONSIBLE ORGANIZATION and environmental manual restrictions on locations of use ACCOMPANYING DOCUMENTS written at a level consistent with education training and other needs of individuals for whom they are intended Instructions for use include the required information intended use of ME EQUIPMENT See Operating Instructions about the intended use in the User manual frequently used functions and known contraindication s to use of ME See Operating Instructions EQUIPMENT in the User manual Classifications specified in Cl
16. Kg Systems with MECHANICAL PROTECTIVE DEVICES 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 Page 68 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a A MECHANICAL PROTECTIVE DEVICE provided N when a support system or its parts impaired by wear have a TENSILE SAFETY FACTOR 2 to values in Table 21 rows 5 and 6 but less than 3 and 4 b MECHANICAL PROTECTIVE complies with the N requirements as follows Designed based on TOTAL LOAD and includes N effects of SAFE WORKING LOAD when applicable Has TENSILE SAFETY FACTORS for all parts not less than Table 21 row 7 Activated before travel movement produced an eae RISK Takes into account Clauses 9 2 5 and 9 8 4 3 pem confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing Activation of MECHANICAL PROTECTIVE DEVICE S 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 MECHANICAL PROTECTIVE DEVICE requires use of a TOOL to be reset or replaced 9 8 4 3 MECHANICAL PROTECTIVE DEVICE intended to function once m Further use of ME EQUIPMENT not possible until replacement of MECHA
17. Measured Umax lt Uzr with Izr as in Fig G 4 Measured Umax lt Uzc with Cmax as in Fig G 5 Measured Imax lt lzr with Uzr as in Fig G 4 Measured Imax lt Iz with Lmax and a Umax lt 24 V as INFIG G 6 5 acs eee viverra lease Guede Extrapolation from Figs G 4 G 5 and G 6 was limited to areas indicated Umax was the highest no load voltage occurring in the circuit under investigation taking into consideration mains voltage variations as in 4 10 Imax Was the highest current flowing in the circuit under investigation taking into account MAINS VOLTAGE variations as in 4 10 Cmax and Lmax are values occurring in relevant aa circuit Umax additionally determined with actual ae resistance R when equivalent resistance R in Fig G 5 was less than 8000 Q Peak value taken into consideration when a c supplied Page 105 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict An equivalent circuit calculated to determine max capacitance inductance and Umax and Imax either as d c or a c peak values in case of a Complicated circuit ceccccecceeeeeeeeeeeeeeeeeeeeeeees When energy produced in an inductance or capacitance in a circuit is limited by voltage limiting or current limiting devices preventing limits of Figs G 4 G 6 from exceeding two independent components applied to obtain the required limitation even in c
18. R2 Q T C Allowed Insulation Tmax C class Supplementary information No used such methods Page 132 of 163 Report No TRS11120147 11 2 2 1 TABLE alternative method to 11 2 2 1 a 5 to determine existence of an N ignition source Areas where sparking might cause ignition Remarks 1 2 3 5 6 Materials of the parts between which sparks could occur Composition Grade Remarks Designation Manufacturer 1 2 3 4 5 6 Test parameters selected representing worst case conditions for ME EQUIPMENT Remarks Current A ien eire iire heehee Voltage V ee A a E Capacitance UF ceccseeeseeteeeeeieetetee Inductance or resistance h or Q wu ee No of trials 300 Min eee eeeeeeeeeeeeeee Sparks resulted in ignition Yes No Supplementary information Not used in conjunction with OXYGEN RICH ENVIRONMENTS 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 Page 133 of 163 Report No TRS11120147 13 1 2 TABLE measurement of power or energy dissipation in parts amp components N to waive SINGLE FAULT CONDITIONS in 4 7 8 1 b 8 7 2 and 13 2 2 rela
19. Test Result Remark Verdict The wire subjected to tests of L 3 1 to L 3 4 ata temperature between 15 C and 35 C and a relative humidity between 45 and 75 unless otherwise specified C Humidity 0 f Dielectric strength test of 8 8 3 for the appropriate type and number of moP s conducted by preparing the sample according to IEC 60851 5 1996 Clause 4 4 1 for a twisted pair with test voltages at least twice Tables 6 and 7 but not less than following with no breakdown 3000 V for BASIC and SUPPLEMENTARY INSULATION V cccccscccessseecstececseeceseeecseeecsseeesseeenes Sample subjected to flexibility and adherence test 8 of IEC 60851 3 1996 clause 5 1 1 using mandrel diameters of Table L 1 Sample examined according to IEC 60851 3 1997 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 1500 V for BASIC and SUPPLEMENTARY INSULATION V ois oiactacidinct ai Aenemnnheonacas Tension applied to wire during winding on mandrel calculated from the wire diameter equivalent to 118 MPa 11 8 MPa Sample subjected to heat shock test 9 of IEC 60851 6 1996 followed by dielectric strength test of clause 8 8 3 except test voltage applied between the wire and mandrel 1500 V for BASIC and SUPPLEMENTARY INSULATION WW scsi ccesndan acme tiv dcenitteunnte Five samples prepared as in L 3 2 subjected to dielectr
20. This publication may be reproduced in whole or in part for non commercial purposes as long as the IECEE is acknowledged as copyright owner and source of the material IECEE takes no responsibility for and will not assume liability for damages resulting from the reader s interpretation of the reproduced material due to its placement and context If this Test Report Form is used by non IECEE members the IECEE IEC logo shall be removed This report is not valid as a CB Test Report unless signed by an approved CB Testing Laboratory and appended to a CB Test Certificate issued by an NCB in accordance with IECEE 02 Test item description Blood Pressure Monitor TradeMark ete ae erier eon w e Manufacturer seniii NINGBO OURUI NEW MATERIAL TECHNOLOGY DEVELOPMENT CO LTD Model Type reference ORA210 ORA211 RAN GS niei e a 6 0V 4X1 5V AA batteries Page 2 of 163 Report No TRS11120147 Summary of testing Tests performed name of test and test clause Testing location SHENZHEN HUATONGWEI All the requirements of IEC 60601 1 2005 were evaluated in this report INTERNATIONAL INSPECTION except the following clauses Co Ltd 11 7 Biocompatibility of ME EQUIPMENT and ME SYSTEMS Keji Nan No 12 Road Hi tech 17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS Park Shenzhen China Copy of marking plate Labelling of Digital Blood Pressure Monitor 29 6mm
21. an Exteel 67 A Tey Paz voltage on a ac 100 500 SIP SOP With same ee d c 50 100 types of 8 7 4 7a 9 Total APPLIED PART and and patient Connected 8 7 4 7h Fig 20 a c 500 1000 LEAKAGE together CURRENT ais d c 50 100 ee aused by NoTeE3 an external orate Fig 17 voltage on a ang w 500 1000 j a c SIPISOP 8 7 4 7h Fig 20 Supplementary information No TYPE B APPLIED PART Note 1 For EARTH LEAKAGE CURRENT see 8 7 3 d Note 2 For TOUCH CURRENT see 8 7 3 c Note 3 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values Note 4 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 mater cleaning amp disinfection amp sterilization Page 114 of 163 Report No TRS11120147 8 7B TABLE PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under P NORMAL amp SINGLE FAULT CONDITIONS TYPE BF APPLIED PARTS uA Current Description Clause Measuring a c NC NC actual SFC SFC actual Type Ref
22. components other than parts of cord anchorage e Conductors of POWER SUPPLY CORD arranged to prevent PROTECTIVE EARTH CONDUCTOR against strain as long as phase conductors are in contact with their terminals when cord anchorage fails f Cord anchorage prevents POWER SUPPLY CORD from being pushed into ME EQUIPMENT or MAINS CONNECTOR 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 Page 53 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 Cord anchorage did not allow cord sheath to be N longitudinally displaced by more than 2 mm or conductor ends to move over a distance of more than 1 mm from their normally connected position a ss CREEPAGE and CLEARANCES not reduced below limits in 8 9 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 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 a
23. or by a device measuring frequency contents of currents as in Fig 12 b and limits apply to d c a c composite waveforms and unless otherwise stated they are d c or r m s b Allowable values of PATIENT LEAKAGE and See appended Tables 8 7B amp AUXILIARY CURRENTS are according to Tables 3 8 7 4 7 and 4 and values of a c are relative to currents having a frequency not less than 0 1 Hz c TOUCH CURRENT did not exceed 100 pA in Itnc OA Itsrc OA NORMAL CONDITION and 500 pA in SINGLE FAULT CONDITION lqyo leg ssssseesseceeeeesteeeeeeneeeeeeseeeeeeeas i d EARTH LEAKAGE CURRENT did not exceed 5 mA No protective earth in NORMAL CONDITION and 10 mA in SINGLE FAULT connection CONDITION lenc lesfe Diada Sch ei Gin ei bei pit lee a a E Higher values of EARTH LEAKAGE CURRENT No protective earth permitted for PERMANENTLY INSTALLED ME connection EQUIPMENT connected to a supply circuit supplying only this ME EQUIPMENT according to local regulations or IEC 60364 7 710 10 lenc lesfe e LEAKAGE CURRENTS regardless of waveform Not measured with a non and frequency did not exceed 10 mA r m s in frequency weighted device NORMAL or in SINGLE FAULT CONDITION measured with a non frequency weighted device 3 LEAKAGE and PATIENT AUXILIARY CURRENTS measurements Figs 13 19 used to measure LEAKAGE and PATIENT See Tables 8 7B 8 7 3B and AUXILIARY CURRENTS 8 7 4 7 When other test Figs yielding accurate
24. parts in NORMAL or single fault condition V a c or OG E ee lace A dade evict Limit of 60 V d c applied with no more than 10 peak to peak ripple and when ripple gt specified value 42 4 V peak limit applied V d c Energy did not exceed 240 VA for longer than 60 s or stored energy available did not exceed 20 J at a potential up to 2 V VA or J eessen LEAKAGE CURRENT limits referred to in 8 4 2 b No voltages were higher than applied when voltages higher than limits in 8 4 2 limits in 8 4 2 c C were present MA ccceeeeteeeeeeeeeeeeeenteeeeeeeaes d Voltage and energy limits specified in c above also applied to the following internal parts other than contacts of plugs Test pin can t be touched connectors and socket outlets touchable by test internal live part pin in Fig 8 inserted through an opening in an ENCLOSURE and a diameter of 4 mm and a length of 100 mm internal live part or pre set inserted through any opening on top of controls ENCLOSURE or through any opening provided for adjustment of pre set controls using a TOOL Page 28 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Test pin or the test rod inserted through relevant N openings with minimal force of no more than 1 N Test rod inserted in every possible position N through openings provided for adjustment of pre set controls that can be adjusted in NO
25. symbols of IEC 60417 5032 5032 1 5032 2 5031 and 5033 all DB 2002 10 used optionally for same parameters RATED supply frequency or RATED frequency Supplied by internal batteries N range in hertz symbol 9 of Table D 1 symbol IEC 60417 5172 Not such equipment N DB 2003 02 used for CLASS II ME EQUIPMENT RATED input in amps or volt amps or in watts when Only powered by internal N power factor exceeds 0 9 A VA W batteries 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 range VA Input at mean value of range marked when range limits do not differ by more than 10 from mean value VA Marking includes long time and most relevant Not included such condition momentary volt ampere ratings when provided each plainly identified and indicated in ACCOMPANYING DOCUMENTS VA Marked input of ME EQUIPMENT provided with No such connection of supply means for connection of supply conductors of other conductors of other electrical electrical equipment includes RATED and marked _ equipment output of such means VA Output connectors See 16 9 2 1 b for MULTIPLE SOCKET OUTLETS No multiple socket outlets integral with ME EQUIPMENT integral with me equipment Output connectors of ME EQUIPMENT except No applicable MULTIPLE SOCKET OUTLETS or connectors intended
26. 10 LEAKAGE together CURRENT A ji d c 10 10 ee aused by NoTE3 an external eA fc Fig 17 voltage on a aa aS ac 10 10 sIP SOP cia AD ig 20 l Supplementary information Not measured with a non frequency weighted device 1 For EARTH LEAKAGE CURRENT see 8 7 3 d 2 For TOUCH CURRENT see 8 7 3 c 3 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 4 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 Subclause 11 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 119 of 163 Report No TRS11120147 8 7 3D TABLE PATIENT LEAKAGE CURRENTS under special test conditions identified in N 8 7 4 7 mA r m s measurement with a non frequency weighted device yA TYPEB TYPEB TYPE BF TYPE BF TYPE CF TYPE CF Current Description Clause Measuring APPLIED APPLIED APPLIED APPLIED APPLIED APPLIED Type Note 1 Ref Circuit PART PART PART PART PART PART allowed actual allowed actual allowed actual Caused by an external voltage on PATIENT CONN 8
27. 13 2 10 motors in circuits running at 42 4 V peak a c 60 V d c or less are covered with a single layer of cheesecloth which did not ignite during the test a 2 Tests on ME EQUIPMENT containing heating No heating parts N parts conducted at prescribed voltage with motor and heating parts operated simultaneously to produce the least favorable condition Page 80 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a 3 Tests performed consecutively when more tests were applicable to the same ME EQUIPMENT b Motor met running overload protection test of this clause when 1 it is intended to be remotely or automatically Not such motor The NIBP controlled by a single control device with no measurement Motor was redundant protection or controlled by manual 2 it is likely to be subjected to CONTINUOUS continuous operation with OPERATION while unattended attended Motor winding temperature determined during each steady period and maximum value did not exceed Table 27 Insulation Class Maximum temperature measured C ce eeeeeeeeneeeeeeeee 3 Motor removed from ME EQUIPMENT and tested separately when load could not be changed in appropriate steps 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 Test not conducted where electronic drive circuits
28. 142 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Auer ones Compliance is checked by inspection of the RISK MANAGEMENT FILE ME equipment or ME i a l l i Have parts been identified during the risk management process which can come into contact with the system parts that contact the patient patient but fall outside the definition of applied parts If so are all the relevant requirements and tests of this standard applied If so are there residual risks which are not acceptable If so are risk controls measures implemented that make the residual risk acceptable Single Fault Condition Compliance is determined by applying the specific requirements and tests associated with the single fault 4 to 9 for ME Equipment conditions identified in 13 2 and tests for the failures identified from evaluation of the results of the risk analysis Compliance is determined if the introduction of any of the single fault conditions described in 13 2 one at the time does not lead directly to the hazardous situations described 13 1 or any other outcome that results in an unacceptable risk Are there single fault conditions which lead directly to hazardous situations described in 13 1 or to risks that are unacceptable Components of ME Compliance is checked by inspection and where necessary by t
29. 9 10 Supplementary information No X radiation 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 pA kg Page 128 of 163 Report No TRS11120147 11 1 TABLE Excessive temperatures in ME EQUIPMENT Model No Part No Type No 00 Maximum rated ambient operating temperature T C ay Supply voltage 110 of max RATED No heating voltage for ME EQUIPMENT with heating elements elements operated as in NORMAL USE all heating elements energized unless prevented by switching interlocks V Supply voltage least favorable voltage 4 AA batteries between 90 of min RATED voltage and 6Vd c 110 of max RATED voltage for motor operated ME EQUIPMENT operated under normal load and normal DUTY CYCLE V Normal DUTY CYCLE for motor operated Not duty cycle ME EQUIPMENT s on s off operated me equipment Supply voltage 110 of max RATED No heating voltage for combined heating motor element operated and other ME EQUIPMENT V Supply voltage 90 of min RATED No heating voltage for combined heating motor element operated and other ME EQUIPMENT V Class of insulation system A E B F H N A Classifi
30. CLEARLY LEGIBLE during EXPECTED SERVICE LIFE of ME EQUIPMENT in NORMAL USE a After tests adhesive labels didn t loosen up or curl up at edges and markings complied with 7 1 2 At least markings in 7 2 2 7 2 5 7 2 6 not for See marking plate and the PERMANENTLY INSTALLED ME EQUIPMENT 7 2 10 marking on the ENCLOSURE and 7 2 13 were applied when size of EQUIPMENT its part an ACCESSORY Or ENCLOSURE did not permit application of all required markings Remaining markings fully recorded in All required markings can be ACCOMPANYING DOCUMENTS 0 eeceeeeeeeseeeenaeees seen marking plate and the markings on the enclosure Markings applied to individual packaging when impractical to apply to ME EQUIPMENT 2 065 A material component ACCESSORY 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 Name or trademark of MANUFACTURER marked on ME EQUIPMENT and its detachable components MODEL OR TYPE REFERENCE also marked except See marking plate when misidentification would not present an unacceptable RISK e ccceceeeeeseeeeceeeeeeeeeteees Software forming part of a PEMS identified witha See Software vision in the unique identifier such as revision level or date of software validation report release issue and identification are available to designated persons g SERVICE PERSO
31. Circuit d c allowed allowed PATIENT d c 10 N A 50 N A AUX 8 7 4 8 Fig 19 CURRENT a c 100 N A 500 N A From PATIENT d c 10 0 50 0 Patient CONNECTION to 8 7 4 7a Fig 15 ae 100 0 500 earth LEAKAGE CURRENT Caused by d c 10 N A 50 N A ENON NZA Zey Fa 17 voltage on a a c 100 N A 500 N A SIP SOP With same d c 50 N A 100 N A types of 8 7 4 7a Fig 15 Total APPLIED PART and and PATIENT connected 8 7 4 7h Fig20 ac 500 N A 1000 N A LEAKAGE together CURRENT at d c 50 N A 100 N A ee aused by NoTE3 an external SL Te pigi voltage ona g 7175 oh 500 N A 1000 N A i a c SBOE 8 7 4 7h Fig 20 Supplementary information 1 For EARTH LEAKAGE CURRENT see 8 7 3 d 2 For TOUCH CURRENT see 8 7 3 C 3 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 4 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 Subclause 11 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 115 of 163 Report No TRS11120147
32. 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 For insulation of thermoplastic materials relied upon as a MEANS OF PROTECTION see 8 8 the ball pressure test specified in 8 8 4 1 a performed ata temperature 25 C higher than temperature of insulation measured during tests of 13 2 13 2 to 13 2 13 4 inclusive 13 2 13 2 ME EQUIPMENT with heating elements N 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 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 a 3 other ME EQUIPMENT with heating elements met test of 13 2 13 2 b Page 79 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict When more than one test was applicable to same N ME EQUIPMENT tests performed consecutively Heating period stopped when a heating element N 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 Test repeated on a second sample when N interruption was due to
33. Individuals with serious arteriosclerosis are not suitable to take blood pressure measurement Continuous operation Less than 41 degree C 4 x AA batteries used in appliance NIBP cuff N A December 20 2011 December 20 2011 to January 10 2012 Possible test case verdicts test case does not apply to the test object test object does meet the requirement test object does not meet the requirement Abbreviations used in the report normal CONItION eee eeeee NLC operational insulation basic insulation between parts of opposite polarity double insulation General remarks N A N Pass P Fail F single fault condition S F C basic insulation 00000000000000 Bl supplementary insulation Sl reinforced insulation RI see Attachment refers to additional information appended to the report see appended table refers to a table appended to the report Throughout this report a point is used as the decimal separator The tests 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 Page 4 of 163 Report No TRS11120147 General product informa
34. Lmax and a Umax lt 24 V as NFIG S ennan hea A Combinations of currents and corresponding voltages within the limitations IZR UZR lt 50 W extrapolated from Fig G 1 Combinations of capacitances and corresponding voltages within limitations of C 2U lt 1 2 mJ extrapolated from Fig G 2 Page 102 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a No extrapolation made for voltages above 242 V i N Umax additionally determined using actual resistance R when the equivalent resistance R was less than 8000 Q Combinations of currents and corresponding inductances within limitations L 2I lt 0 3 mJ extrapolated from Fig G 3 No extrapolation made for inductances larger a 900 mH Umax was the highest supply voltage occurring in circuit under investigation with sparking contact open taking into consideration MAINS VOLTAGE variations in 4 10 Imax Was the highest current flowing in circuit 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 component under investigation producing sparks Peak value taken into account when a c supplied An equivalent circuit calculated to determine equivalent max capacitance inductance and equivalent Umax and Imax either as d c or a c peak values in case of a complicated circuit
35. ME EQUIPMENT displayed adequate mechanical strength 15 3 2 Push test conducted by subjecting external parts of ENCLOSURE to a steady force of 250 N 10N for 5 s applied to a circular plane surface 30 mm in diameter except bottom of ENCLOSURE of an ME EQUIPMENT gt 18 kg using a suitable test tool No damage resulting in an unacceptable RISK No damage sustained as determined by examination of RISK MANAGEMENT FILE Impact test conducted by subjecting a complete hand held me equipment N 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 of 1 3 m Test not applied to flat panel displays platen Not applied to LCD N glass of ME EQUIPMENT or cathode ray tubes No damage resulting in an unacceptable RISK No damage N sustained as shown in RISK MANAGEMENT FILE Ba pos S Page 86 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 15 3 4 1 Each sample of HAND HELD ME EQUIPMENT and hand held me equipment HAND 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 1 m onto a 50 mm 5 mm thick hardwood board hardwood gt 600 kg m3 lying flat on a concrete or rigid base 15 3 4 2 Each sample of PORTABLE ME EQUIPMENT and hand held me equip
36. MEANS OF PROTECTION MOP Two MEANS of PROTECTION provided for ME EQUIPMENT to prevent APPLIED and other ACCESSIBLE PARTS from exceeding limits in Cl 8 4 Each MEANS OF PROTECTION categorized as a MEANS OF PATIENT PROTECTION Or a MEANS OF OPERATOR PROTECTION taking into account 4 6 and flow chart in Fig A 12 Capacitor s and connected circuitry marked with symbol 24 of Table D 1 IEC 60417 5036 DB 2002 10 and manual discharging device 8 5 1 1 Page 29 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Varnishing enameling oxidation and similar 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 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 taken into consideration for MEANS OF PATIENT PROTECTION Components and wiring forming a MEANS OF PROTECTION comply with 8 10 Insulation CREEPAGE CLEARANCES components or earth connections not complying 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 Solid insulation forming a MEANS OF PATIENT PROTECTION complied with dielectric strength test of 8 8 at tes
37. OF ME EQUIPMENT and transformers providing separation in accordance with 8 5 Overheating Transformers of ME EQUIPMENT are protected No Mains supply transformers against overheating in the event of short circuit or of me equipment and overload of output windings and comply with this transformers providing Clause and tests of 15 5 1 2 and 15 5 1 3 separation in accordance with 8 5 N N pw During tests windings did t open no HAZARDOUS SITUATION occurred and maximum temperatures of windings did not exceed values in Table 31 Dielectric strength test of 8 8 3 conducted on transformer after short circuit and overload tests Transformer output winding short circuited and test continued until protective device operated or THERMAL STABILITY achieved Short circuit applied directly across output windings for transformers not tested according to 5X frequency and 5X voltage test of 15 5 2 Multiple overload tests conducted on windings with more than one protective device to evaluate worst case NORMAL USE loading and protection Page 92 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict Transformer windings provided with adequate insulation to prevent internal short circuits that could cause overheating which could result in a HAZARDOUS SITUATION Dielectric strength tests were conducted in accordance with requirements of this Subclause with no breakdown of insulation system a
38. Report No TRS11120147 Clause Title Item Comments b Method s for dealing with non See table in Chapter 4 of the quantifiable risks Risk management Report 6 1 Risk reduction Procedure for risk control activities See table in Chapter 4 of the Risk management Report 6 2 Option analysis Record of risk control option analysis See table in Chapter 5 of the including risk benefit analysis if Risk management Report appropriate 6 3 Implementation of Design inputs from risk management See table in Chapter 4 of the risk control activities Risk management Report measures 6 4 Residual risk Evidence e g from design See table in Chapter 4 of the evaluation verification activities Risk management Report 6 5 Risk Benefit Evidence as necessary see 6 2 See the tables in Chapter 4 of Analysis the Risk management Report 6 6 Other generated Record of review of all risk controls See the tables in Chapter 4 of hazards for impact on new hazards the Risk management Report 7 Overall risk Records of related meetings See Chapter 5 in the Risk evaluation analysis etc management Report 8 Risk management a Procedure for generating a See the Risk management report Risk Management report Report provided by the manufacture b Summary of risk management activities c Traceability of hazards to residual risks d Clearances 9 Post production a Procedures for linking See Chapter 6 of the Risk
39. Result Remark Verdict Limits specified in 8 4 2 not applied to currents intended to flow through body of PATIENT to produce a physiological effect during NORMAL USE a Currents from to or between PATIENT See appended Tables 8 7B CONNECTIONS did not exceed limits for PATIENT 8 7 3B and 8 7 3D amp 8 7 4 7 LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT per Tables 3 and 4 when measured per Cl 8 7 4 b LEAKAGE CURRENTS from to or between ACCESSIBLE PARTS did not exceed limits for TOUCH CURRENT in Cl 8 7 3 c when measured per Clause 8 7 4 MA cceceeeceeeeeeeeeeeetteeeeeeeneeeeeeaas c Limits specified in b not applied to parts when N probability of a connection to a PATIENT directly or through body of OPERATOR was negligible in NORMAL USE and the OPERATOR is instructed not to touch relevant part and PATIENT simultaneously accessible contacts of connectors No such connector used N contacts of fuseholders accessible during No fuseholder used in replacement of fuse equipment N contacts of lampholders accessible after No lampholders used in N removal of lamp equipment parts inside an ACCESS COVER that can be No such access cover used N opened without a TOOL or where a TOOL is needed but the instructions for use instruct an OPERATOR other than SERVICE PERSONNEL to open the relevant ACCESS COVER Voltage to earth or to other ACCESSIBLE PARTS did not exceed 42 4 V peak a c or 60 V d c for above
40. TOUCH CURRENT see 8 7 3 C 3 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 4 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 Subclause 11 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 118 of 163 Report No TRS11120147 8 7 3C TABLE PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under N NORMAL amp SINGLE FAULT CONDITIONS TYPE CF APPLIED PARTS mA r m s measurements made with a non frequency weighted device uA Current Description Clause Measuring a c NC NC actual SFC SFC actual Type Ref Circuit d c allowed allowed PATIENT d c 10 10 AUX 8 7 4 8 Fig 19 CURRENT a c 10 10 From PATIENT d c 10 10 Patient CONNECTION to 8 7 4 7a Fig 15 ae 10 10 earth LEAKAGE CURRENT Caused by d c 10 10 an extemal g zA re FAT voltage on a a c 10 10 SIP SOP With same ae i 10 types of 8 7 4 7a Fig 15 Total APPLIED PART and and PATIENT connected 8 7 4 7h Fig20 ac 10
41. 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 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 10 times Measurement of CREEPAGE DISTANCES AND AIR CLEARANCES CREEPAGE AND CLEARANCES measured using Figs 22 to 31 inclusive Corners with included angles less than 80 assumed to be bridged with an insulating link of 1 mm moved into the least favorable position Distance of 1 mm or more across the top of a groove did not constitute a CREEPAGE DISTANCE CREEPAGE and CLEARANCES between parts moving relative to each other measured with the parts in their least favorable positions Calculated CREEPAGE DISTANCE was never less than measured AIR CLEARANCE Coatings of varnish enamel or oxide disregarded Coverings of insulating materials equivalent to a sheet of insulating material of equal thickness with respect to their electrical thermal and mechanical properties
42. been employed to comply with cl 13 1 2 requirements for fire Has the manufacturer analysed and addressed risks of not complying with the constructional enclosures of ME requirements and showed than an equivalent level of risk benefit has been provided equipment ME equipment and ME s the ME Equipment intended to or can it through foreseeable misuse come into contact with systems intended for _ flammable agents use in conjunction with flammable agents Spillage on ME Does the ME Equipment require the handling of liquids in normal or foreseeable misuse equipment and ME Could the wetting of the ME equipment result in a hazardous situation system ee a manufacturer identified hazardous situations relating to the worst case volume and type of iquid Has the manufacturer identified hazardous situations relating to the worst location for the equipment to spill Cleaning and Has the manufacturer identified the parts of the ME equipment which may be subject to cleaning or disinfection of ME disinfection in normal or foreseeable misuse and the type of cleaning or disinfection equipment and ME Based on the ESL of the ME equipment has the manufacturer extrapolated the number of cleaning systems processes to which the equipment will be subjected Has the manufacturer identified all related hazards and addressed such risks in the RMF Sterilization of ME Has the manufacturer identified the parts of the ME equipment which may be subject to sterilization
43. by inspection of the design and the risk management file and no additional testing is required 15 4 5 Pre set controls Where applicable has the manufacturer addressed the risk associated with pre set controls Page 157 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Goan ee Considerations for application of RM criteria ke 15 4 7 3 Entry of liquids Has the manufacturer conducted risk analysis for foot operated control devices during their risk management process If so is the probability of occurrence of the intended normal use in areas where liquids are likely to be found low enough such that foot operated control devices that contain electrical circuits do not have to be classified IPX6 according to IEC 60529 If so then perform testing at the manufacturer s lesser IPX_ rating Note IPX1 is the minimum rating If not then verify compliance to IPX6 classification 16 ME Systems General Requirements _ After installation or subsequent modification does the ME system result in an unacceptable risk for ME Systems Have hazards arising from combining various equipment to constitute an ME system been considered Is the level of safety equivalent to ME system complying with this standard IEC 60601 1 within the patient environment If the ME System is reconfigurable have risk management methods been used to determine which conf
44. conducted to ensure continued safe use of equipment Technical description separable from instructions for use contains required information as follows information in Clause 7 2 all applicable classifications specified in Clause 6 and warning and safety notices and explanation of safety signs marked on ME EQUIPMENT a brief description of ME EQUIPMENT how it Lo functions and its significant physical and performance characteristics MANUFACTURER S optional requirements for Not included such minimum qualifications of SERVICE PERSONNEL requirements documented in technical description The technical description contains the following required information type and full rating of fuses used in SUPPLY MAINS No powered by mains only external to PERMANENTLY INSTALLED ME EQUIPMENT internally battery equipment when type and rating of fuses are not apparent from information on RATED current and mode of operation of ME EQUIPMENT anchoring to ensure compliance with 8 11 3 instructions for correct replacement of No such interchangeable or interchangeable or detachable parts specified by detachable parts MANUFACTURER as replaceable by SERVICE PERSONNEL and warnings identifying nature of HAZARD when No such parts result in an replacement of a component could result in an unacceptable RISK unacceptable RISK and when replaceable by SERVICE PERSONNEL all information necessary to safely replace the compo
45. considered as insulation Minimum values in Tables 11 to 16 inclusive applied to sum of sections for CREEPAGE or CLEARANCES for one or two MEANS OF PROTECTION interrupted by one or more floating conductive parts distances less than 1 mm disregarded Walls of grooves transverse to CREEPAGE DISTANCE counted as CREEPAGE DISTANCE only when width of the groove was more than 1 mm otherwise grooves disregarded m M Page 49 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict CREEPAGE DISTANCES for a barrier placed on surface of insulation or held in a recess measured over barrier only when dust and moisture could not penetrate into the joint or recess Measurements for ME EQUIPMENT with an APPLIANCE INLET made with an appropriate connector inserted For other ME EQUIPMENT with POWER SUPPLY CORDS measurements made with conductors of largest cross sectional area specified by MANUFACTURER and without conductors Movable parts placed in the least favorable position and nuts and screws with non circular heads tightened in the least favorable position CREEPAGE and CLEARANCES through slots or openings in external parts measured to the standard test finger of Fig 6 Measurements made applying a 2 N force on points of bare conductors using a standard test finger as in Fig 6 complied with requirements for CREEPAGE DISTANCES and AIR CLEARANCES Measurements made applying a 30 N force to outs
46. description ececeeceeceeeeeeeeeeeeeneees LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS a Electrical isolation providing protection against See appended Tables 8 7 3B electric shock limits currents to values in 8 7 3 b Specified values of EARTH LEAKAGE TOUCH See appended Tables 8 7B PATIENT LEAKAGE and PATIENT AUXILIARY CURRENTS amp 8 7 4 7 applied in combination of conditions in appended Tables 8 7A 8 7B 8 7C and 8 7 4 7 Allowable values specified in 8 7 3 applied under SINGLE FAULT CONDITIONS of 8 1 b except where insulation used in conjunction with a No protective earth PROTECTIVE EARTH CONNECTION insulation short connection circuited only under conditions in 8 6 4 b the only SINGLE FAULT CONDITION for EARTH No protective earth LEAKAGE CURRENT was interruption of one supply connection conductor at a time Page 37 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENT not measured in SINGLE FAULT CONDITION of short circuiting of one constituent part of DOUBLE INSULATION 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 a Allowable values in 8 7 3 b c and d See appended Tables 8 7B amp measured based on and are relative to currents 8 7 4 7 in Fig 12 a
47. detachable parts removed and treated concurrently with major parts and manually removable ACCESS COVERS opened and detached 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 When RISK MANAGEMENT PROCESS indicated ME No such risk as it s an indoor EQUIPMENT can be exposed to high humidity for use equipment extended periods i e out door use test time extended proportionally h ME EQUIPMENT reassembled after humidity Reassembled the ultrasound treatment when necessary probes Unless stated otherwise tests in this standard sequenced as in Annex B to prevent results of one test on a subsequent test APPLIED PARTS identified by inspection and NIBP Cuff reference to ACCOMPANYING DOCUMENTS ACCESSIBLE PARTS Accessibility when necessary determined using standard test finger of Fig 6 applied in a bent or straight position as follows Page 12 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict for all positions in NORMAL USE except ME The equipments were much EQUIPMENT for use on the floor with a mass in any lower than 45kg operational condition gt 45 kg not tilted Cabinet mounted ME EQUIPMENT tested in final mounting position after opening of ACCESS COVERS and
48. equipment N parts it may safely be attached to MULTIPLE SOCKET OUTLET is a separate item or an integral part of ME EQUIPMENT or non ME EQUIPMENT c MULTIPLE SOCKET OUTLET complied with IEC 60884 1 and the following requirements CREEPAGE and CLEARANCES complied with 8 9 It is CLASS I and PROTECTIVE EARTH CONDUCTOR is connected to earthing contacts in socket outlets PROTECTIVE EARTH TERMINALS and PROTECTIVE 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 MAINS TERMINAL DEVICES and wiring complied with 8 11 4 when applicable Page 98 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict RATINGS of components are not in conflict with N conditions of use Electrical terminals and connectors of MULTIPLE N SOCKET OUTLETS prevent incorrect connection of accessible connectors removable without a TOOL d Additional requirements applied when MULTIPLE N SOCKET OUTLET combined with a separating transformer Separating transformer complied with IEC N 61558 2 1 except requirements of maximum RATED output power of 1 kVA and degree of protection IPX4 were not applied Degree of protection against ingress of water N specified as in IEC 60529 N Separating transformer assembly marked according to 7 2 and 7 3 MU
49. function PART or as multiple APPLIED PARTS Classification as TYPE BF CF Or DEFIBRILLATION type BF applied part PROOF applied to one entire APPLIED PART LEAKAGE CURRENT tests conducted per 8 7 4 See appended Table 8 7 4 i tes Dielectric strength test conducted per 8 8 3 See appended Table 8 8 3 oP CREEPAGE and CLEARANCES measured per 8 9 and Tables 11 to 16 as applicable A MEANS OF PROTECTION protecting other parts considered MEANS OF OPERATOR PROTECTION 8 5 2 1 Page 31 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict A protective device connected between PATIENT Only one patient connection CONNECTIONS of an F TYPE APPLIED PART and ENCLOSURE to protect against excessive voltages did not operate below 500 V r m s PATIENT CONNECTIONS of a TYPE B APPLIED PART not type BF applied part PROTECTIVELY EARTHED are separated by one MEANS OF PATIENT PROTECTION from metal ACCESSIBLE PARTS not PROTECTIVELY EARTHED except when metal ACCESSIBLE PART is physically close to APPLIED PART and can be regarded as a part of APPLIED PART and RISK that metal ACCESSIBLE PART will make contact with a source of voltage or LEAKAGE CURRENT above permitted limits is acceptably low LEAKAGE CURRENT tests conducted per 8 7 4 Dielectric strength test conducted per 8 8 3 Relevant CREEPAGE and CLEARANCES measured per 8 9 and Tables 11 to 16 as applicable The RISK MANAGEMENT F
50. hazards associated with a pressure relief device been addressed Hazards associated Have the risks caused by hazards arising from static dynamic vibration impact and pressure loading with support systems foundation and other movements temperature environmental manufacture and service conditions been General addressed Were all of the following failures considered excessive deflection plastic deformation ductile or brittle fracture fatigue fracture instability buckling stress assisted corrosion cracking wear material creep and material deterioration Were the following residual stresses resulting from the manufacturing process e g machining assembling welding heat treatment or surface coating considered Tensile safety factor When not according to Table 21 what alternative method was used to determine the tensile safety factor Have the risks related to the value of the tensile factor been addressed Strength of patient or Have the risks caused by mechanical hazards associated with support or suspensions of the patient operator support or including particular applications been addressed suspension systems General 9 8 3 2 Static forces due to Have the risks caused by mechanical hazards associated with static forces due to loading from persons 3 to9 a amp b loading from persons been addressed 9 8 4 1 Systems with Does the MEE use mechanical protective devices 3 to9 mechanical protecyve Does the mechanical pr
51. in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS No conjunction with OXYGEN RICH ENVIRONMENTS N 13 2 12 Failure of parts that might result in a MECHANICAL HAZARD See 9 amp 15 3 No parts that might result in a MECHANICAL HAZARD N 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 15 4 6 TABLE actuating parts of controls of ME EQUIPMENT torque amp axial pull tests N Rotating control under test Torque Gripping Axial force Unacceptable Remarks from diameter d of applied RISK occurred Table 30 control knob Nm mm N Yes No Supplementary information Gripping diameter d is the maximum width of a control knob regardless of its shape e g control knob with pointer Page 136 of 163 Report No TRS11120147 TABLE transformer short circuit test short circuit applied at end of windings or at the first point that could be short circuited under SINGLE FAULT CONDITION Primary voltage most adverse value between 90 to 110 of RATED voltage V LATRIN AAT SEAT BAE AEE A EAA IAE ieee f RATED input frequency HZ 2 cccecceeeeeeeeeeeeeeeeeeeeeeeeneeeeaeeseaeeseteaeeesireess
52. in RISK MANAGEMENT PROCESS Hand transmitted vibration Means provided except for INTENDED USE N vibrations to protect PATIENT and OPERATOR when hand transmitted frequency weighted r m s acceleration generated in NORMAL USE exceeds specified values measured per ISO 5349 1 at points of hand contact with PATIENT or OPERATOR 2 5 m s for a cumulative time of 8 h during a 24 h period m s sige eT Mell eA ated ede Accelerations for different times inversely proportional to square root of time m s EEE Requirements of this clause applied to vessels It has pneumatic pressure and parts of ME EQUIPMENT subject to pressure such as cuff pressure resulting in rupture and unacceptable RISK Parts of a pneumatic or hydraulic system used as No such part N a support system additionally complied with 9 8 Pneumatic and hydraulic parts of ME EQUIPMENT or ACCESSORIES met following requirements based on examination of RISK MANAGEMENT FILE No unacceptable RISK resulted from loss of No unacceptable RISK resulted pressure or loss of vacuum from loss of pressure No unacceptable RISK resulted from a fluid jet No fluid used N caused by leakage or a component failure Elements of ME EQUIPMENT or an ACCESSORY See Risk Management especially pipes and hoses leading to an Report unacceptable RISK protected against harmful external effects Reservoirs and similar vessels leading to an No Reservoirs and sim
53. maintained a substantially constant drive current Test not conducted based on other justifications justification necerteso reiii 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 ME EQUIPMENT other than HAND HELD EQUIPMENT EQUIPMENT kept switched on manually or kept under load by hand and with a timer and a back up timer system operated under normal load and at RATED voltage or at upper limit of RATED voltage range until increase in temperature was lt 5 C in one hour or a protective device operated When a load reducing device operated in NORMAL USE test continued with ME EQUIPMENT running idle Motor winding temperatures did not exceed values in 13 2 10 Insulation Class Maximum temperature measured C c ce eeeeeeeeeeeteeeeeeeee j Requirements of this clause not applied to PESS_ These requirements of clause when it provided no BASIC SAFETY or ESSENTIAL 14 applied to this device PERFORMANCE or Page 81 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict provide by manufacture for ISO 14971 information by examination of RISK MANAGEMENT FILE and assessment of PROCESSES cited in this Clause and nternal audit report provided by the manufacture constituent component of PEMS as confirmed by examination of RISK MANAGEMENT FILE and assessmen
54. not result in a hazardous situation No guiding rollers No such requirements No insulated conductors subject to temperatures gt 70 C in normal use Page 51 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict PERMANENTLY INSTALLED ME EQUIPMENT connected Not Permanently installed me to a poly phase SUPPLY MAINS equipped with a equipment device not interrupting neutral conductor provided local installation conditions prevent voltage on neutral conductor from exceeding limits in 8 4 2 c b Means of isolation incorporated in ME EQUIPMENT and external means described in technical description c A SUPPLY MAINS switch used to comply with No supply mains switch 8 11 1 a complies with CREEPAGE and CLEARANCES in IEC 61058 1 for a MAINS TRANSIENT VOLTAGE of 4 kV d A SUPPLY MAINS switch not incorporated in a No supply mains switch N POWER SUPPLY CORD or other external flexible lead e Direction of movement of actuator of a SUPPLY No supply mains switch MAINS switch used to comply with 8 11 1 a complies with IEC 60447 f A suitable plug device such as an APPLIANCE Only Internally powered COUPLER or a flexible cord with a MAINS PLUG used equipment no mains parts in NON PERMANENTLY INSTALLED ME EQUIPMENT to isolate it from SUPPLY MAINS considered to comply with 8 11 1 a g A fuse or a semiconductor device not used as No used such parts an isolating means
55. of routine maintenance necessary to ensure continued safe use of ME EQUIPMENT Parts requiring preventive inspection and maintenance to be performed by SERVICE PERSONNEL identified including periods of application but not necessarily details of actual performance of such maintenance Instructions provided to ensure adequate No rechargeable batteries maintenance of ME EQUIPMENT containing used in equipment rechargeable batteries intended to be maintained by anyone other than SERVICE PERSONNEL Other equipment providing power to ME SYSTEM No other equipment providing sufficiently described e g part number RATED power to ME SYSTEM VOLTAGE max or min power protection class intermittent or continuous service to ensure compliance with this standard RISKS associated with disposal of waste products See Operating Instructions in residues etc and of ME EQUIPMENT and the User manual ACCESSORIES at the end of their EXPECTED SERVICE LIFE are identified and instructions provided on minimizing these RISKS Information specified in 7 9 3 or where it can be Service manual is included in found e g in a service manual included in the User manual instructions for use Technical description All essential data provided for safe operation See User manual transport storage and measures or conditions necessary for installing ME EQUIPMENT and preparing it for use including the following information in clause 7 2 See c
56. of ceramic material subjected to ball pressure test using apparatus of Fig 21 Ly i Lo Surface of part placed in a heating cabinet at 75 N C 2 C or ambient temperature indicated in technical description 2 C plus temperature rise of relevant part of insulating material measured during test of 11 1 higher of the two C A steel ball 5 mm in diameter pressed against the surface with a force of 20 N IEC 60384 14 Certified capacitors across No capacitors used N insulation under test disconnected during test 8 8 4 1 Page 44 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict b Parts of insulating material supporting uninsulated parts of MAINS PART subjected to ball pressure test in a except at 125 C 2 Cor ambient indicated in technical description 2 C plus temperature rise determined during test of 11 1 of relevant part higher of the two C j Impression made by the ball after 1h was 2 mm or less in diameter MM ccceeeeeeeeeeeeeteeeeeenaes 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 Insulating characteristics and mechanical strength of all MEANS OF PROTECTION not likely to be impaired by environmental stresses including deposition of dirt or dust resulting from wear of parts within ME EQUIPMEN
57. only for specified equipment or ACCESSORIES marked with RATED output voltage RATED current or power and output frequency when applicable Page 16 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict ME EQUIPMENT or its parts marked with the IP IPXO equipment environmental Code per IEC 60529 according to classification in 6 3 Table D 3 Code 2 Marking of IPXO and IPOX Codes optional No marked with IPXO 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 Only with Type BF applied IEC 60417 5840 DB 2002 10 not applied to part give impression of being inscribed within a square to differentiate with symbol IEC 60417 5333 TYPE BF APPLIED PARTS with symbol 20 of Table D A IEC 60417 5333 DB 2002 10 TYPE CF APPLIED PARTS with symbol 21 of Table D 1 Not such applied parts IEC 60417 5335 DB 2002 10 DEFIBRILLATION PROOF APPLIED PARTS marked with No Defibrillation proof applied symbols 25 27 of Table D 1 IEC 60417 5841 IEC parts 60417 5334 or IEC 60417 5336 all DB 2002 10 Proper symbol marked adjacent to or on connector Proper symbol marked for APPLIED PART except marked on APPLIED PART adjacent to the connector for when there is no connector or connector used for ap
58. possible abnormal positions and placed on a flat surface No unacceptable Risk caused by changing control setting when accidentally placed in an abnormal position Page 91 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 15 4 7 3 a Foot operated control device is at least IPX1 N and complies with tests of IEC 60529 IP Code b ENCLOSURE of foot operated control devices N containing electrical circuits is at least IPX6 and complies with IEC 60529 if in NORMAL USE liquids are likely to be found IP Code j Probability of occurrence estimated as part of RISK N MANAGEMENT PROCESS ACCOMPANYING DOCUMENTS design and RISK N MANAGEMENT FILE examined to confirm compliance 15 4 8 Aluminium wires less than 16 mm in cross No aluminium wires used N sectional area not used N a Oil container in PORTABLE ME EQUIPMENT allows No Oil container used for expansion of oil and is adequately sealed to prevent loss of oil in any position b Oil containers in MOBILE ME EQUIPMENT sealed to N prevent loss of oil during transport A pressure release device operating during N NORMAL USE is optionally provided c Partially sealed oil filled ME EQUIPMENT and its N parts provided with means for checking the oil level to detect leakage ME EQUIPMENT and technical description examined and manual tests conducted to confirm compliance with above requirements MAINS SUPPLY TRANSFORMERS
59. results used but results appeared close to permissible values or when validity of results was in question applicable test Figs used as deciding factor a EARTH LEAKAGE TOUCH PATIENT LEAKAGE and AUXILIARY CURRENTS measured with ME EQUIPMENT running at operating temperature of 11 1 3 c b Number of tests reduced when examination of circuit arrangement components and materials of ME EQUIPMENT indicated no possibility of any HAZARDOUS SITUATION 8 7 4 2 ME EQUIPMENT for connection to a SUPPLY MAINS No connection to supply N connected to an appropriate power source mains Page 38 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Tests on single phase ME EQUIPMENT conducted at both supply polarities INTERNALLY POWERED ME EQUIPMENT tested without connections to a measuring supply circuit a CORD connected ME EQUIPMENT tested using the cord b ME EQUIPMENT with an APPLIANCE INLET connected to measuring supply circuit via a 3 m DETACHABLE POWER SUPPLY CORD or a length and type specified in instructions for use m j 1 APPLIED PARTS including PATIENT cables when present placed on an insulating surface with a dielectric constant of approximately 1 e g expanded polystyrene and approximately 200 mm above an earthed metal surface 2 Reference earth of measuring circuits connected to protective earth of SUPPLY MAINS when an isolating transformer was not use
60. shaft of rotating controls for not less than 2 s 10 times in each direction knobs did not rotate with respect to shaft 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 RISK Stops of adequate mechanical strength provided Not such rotating or movable on rotating or movable parts of controls of ME parts of controls of me EQUIPMENT where necessary to prevent an equipment unexpected change from maximum to minimum or vice versa of the controlled parameter when this could cause a HAZARDOUS SITUATION Torque values in Table 30 applied 10 times in N each direction to rotating controls for minimum 2 s Application of an axial force of 60 N for electrical N components and 100 N for other components to rotating or movable parts of controls for 1 min when an axial pull was required in NORMAL USE 15 4 7 Cord connected HAND HELD and foot operated control devices N 15 4 7 1 a HAND HELD control devices of ME EQUIPMENT No Cord connected hand held complied with 15 3 4 1 or foot operated control b Foot operated control device supported an actuating force of 1350 N i e weight of an adult human being for 1 min applied over an area of 30 mm diameter in its position of NORMAL USE with no damage to device causing an unacceptable RISK Control device of HAND HELD and foot operated control devices turned in all
61. the manufacturer identified hazards and hazardous situations associated with production of microwave radiation in the risk management file electromagnetic production of visible electromagnetic radiation in the risk management file radiation Infrared radiation When applicable has the manufacturer identified hazards and hazardous situations associated with production of infrared radiation in the risk management file Ultraviolet radiation When applicable has the manufacturer identified hazards and hazardous situations associated with production of ultraviolet radiation in the risk management file Other visible When applicable has the manufacturer identified hazards and hazardous situations associated with 11 Protection against excessive temperatures and other hazards Maximum temperature during normal use Page 150 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Aner eae Table 23 Has the manufacturer identified parts of the ME Equipment that are likely to be touched in normal or foreseeable misuse that can contact more than 10 of the surface area operator or patient s body or 10 of the surface area of the patient s or operator s head Has the manufacturer identified the duration of continuous or aggregate contact Has the manufacturer identified and addressed such risk
62. two MEANS OF OPERATOR PROTECTION Two capacitors used in series each RATED for total No capacitor used WORKING VOLTAGE across the pair and have the same NOMINAL capacitance Vw Cn Points where insulation CREEPAGE CLEARANCES impedances of components or PROTECTIVE EARTH CONNECTIONS prevent ACCESSIBLE PARTS from exceeding limits in 8 4 identified for tests relative to 8 5 1 1 to 8 5 1 3 and if a failure at that point regarded as a NORMAL or SINGLE FAULT CONDITION Each MEANS OF PROTECTION categorized relative to ME EQUIPMENT part s it protects from exceeding the allowable limits A MEANS OF PROTECTION protecting APPLIED PARTS or parts identified by 4 6 as parts subject to the same requirements as APPLIED PARTS considered MEANS OF PATIENT PROTECTION Separation of PATIENT CONNECTIONS PATIENT CONNECTIONS of F TYPE APPLIED PART 0 001 separated from all other parts by equivalent to one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to MAX MAINS VOLTAGE and complied with limit for PATIENT LEAKAGE CURRENT with 110 of MAX MAINS VOLTAGE applied mA Separation requirement not applied between multiple functions of a single F TYPE APPLIED PART PATIENT CONNECTIONS treated as one APPLIED PART in the absence of electrical separation between PATIENT CONNECTIONS of same or another function MANUFACTURER has defined if multiple functions Only one applied par with one N are to be considered as all within one APPLIED
63. when a MECHANICAL HAZARD existed a b ME SYSTEM connected to a supply at highest Page 97 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 ME SYSTEM connections and wiring Incorrect connection of accessible connectors removable without a TOOL prevented where a HAZARDOUS SITUATION could otherwise exist Plugs for connection of PATIENT leads could not N 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 16 9 2 MAINS PARTS components and layout PN 16 9 2 1 a MULTIPLE SOCKET OUTLET only allows N connection using a TOOL or MULTIPLE SOCKET OUTLET is of a type that cannot N accept MAINS PLUGS of any of the kinds specified in IEC TR 60083 or MULTIPLE SOCKET OUTLET is supplied via a N separating transformer b MULTIPLE SOCKET OUTLET marked with safety sign 2 of Table D 2 i e safety sign ISO 7010 W001 visible in NORMAL USE and marked either individually or in combinations with the maximum allowed continuous output in amperes or volt amperes or marked to indicate the equipment or
64. 0601 1 Clause Requirement Test Result Remark Verdict 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 ME EQUIPMENT RATED to operate at an altitude of 2000 m ME EQUIPMENT RATED to operate at an altitude specified by MANUFACTURER M e2seeeeeeeees f Operating altitude corresponding to actual air pressure for ME EQUIPMENT intended for pressurized environments e g aircraft used in determining multiplication factor from Table 8 and AIR CLEARANCE was multiplied by this factor CREEPAGE DISTANCES not subjected to multiplication factors but were at least as large as the resulting value for AIR CLEARANCE When WORKING VOLTAGE was between those in No working voltage was Tables 11 to 16 inclusive CREEPAGE and between those in Tables 11 to CLEARANCES calculated as follows 16 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 CLEARANCES for PEAK WORKING VOLTAGES above _ No peak working voltages 2800 V peak or d c determined by linear above 2800Vpeak or d c interpolation between the nearest two values and the calculated spacing rounded off to the next higher 0 1 mm increment MM for AIR CLEARANCES corresponding to PEAK No peak working voltage up to WORKING VOLT
65. 1 Clause Requirement Test Result Remark Verdict a Terminals provided for connection of external cords or POWER SUPPLY CORDS together with PROTECTIVE EARTH TERMINAL closely grouped to provide convenient means of connection b PROTECTIVE EARTH CONDUCTOR connections complied with 8 6 c Marking of MAINS TERMINAL DEVICES complied d MAINS TERMINAL DEVICES not accessible without use of a TOOL e A MEANS OF PROTECTION are not short circuited when one end of a flexible conductor with NOMINAL cross sectional area in Table 17 stripped 8 mm and with a single free wire bent in every possible direction without pulling back insulating sheath or making sharp bends around partitions Internal wiring not subjected to stress and CREEPAGE and CLEARANCES not reduced below 8 9 after fastening and loosening a conductor of largest cross sectional area 10 times Terminals with clamping means for a rewirable flexible cord did not require special preparation of conductors and conductors were not damaged and did not slip out when clamping means tightened as verified by test of 8 11 3 4 Adequate space provided inside ME EQUIPMENT designed for FIXED wiring or a rewirable POWER SUPPLY CORD to allow easy introduction and connection of conductors and covers fitted without damage to conductors or their insulation Correct connection and positioning of conductors before ACCESS COVER was fitted verified by an installation test A fuse or OVER CUR
66. 11120147 TABLE Dielectric strength test of solid insulating materials with safety function MEANS OF OPERATOR PROTECTION MOOP 1 min duration A C test voltages in V r m s PEAK PEAK T Aimat MEANS OF OPERATOR PROTECTION MOOP Dielectric WORKING WORKING ype oTnSuaton z breakdown VOLTAGE VOLTAGE tested Protection from MAINS Protection from Yes No U U area from insulation PART SECONDARY CIRCUITS V peak V d c dagran One moop Two MOOP One MOOP Two MOOP 6 Double insulation A N A N A N A 500 No Supplementary information 1 Alternatively as specified in the Table i e __dc a d c test voltage equal to the peak value of the a c test voltage used 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 Subclause 11 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 122 of 163 Report No TRS11120147 TABLE Dielectric strength test of solid insulating materials with safety function MEANS OF PATIENT PROTECTION MOPP 1 min duration A C test voltages in V r m s PEAK PEAK T aai MEANS OF PATIENT PROTECTION MOO
67. 3 2 Page 78 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict SINGLE FAULT CONDITIONS in 4 7 8 1 b 8 7 2 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 minute after 15 W drawn from supply circuit or Parts and components completely contained See Appended table 8 10 and within a fire ENCLOSURE complying with 11 3 as related certification for fire verified by examination of design documentation enclosure material After tests of this Clause settings of THERMAL No thermal cut outs or over CUT OUTS and OVER CURRENT RELEASES did not current releases used change sufficiently to affect their safety function 13 1 3 limits for LEAKAGE CURRENT in SINGLE FAULT See appended Tables 8 7 3A CONDITION based on 8 7 3 did not exceed through 8 7 3D voltage limits for ACCESSIBLE PARTS including See Tables 8 7B 8 7 3B and APPLIED PARTS in 8 4 2 did not exceed 8 7 4 7 13 1 4 ME EQUIPMENT complied with the requirements of See 9 1 to 9 8 9 1 to 9 8 for specific MECHANICAL HAZARDS 13 2 1 During application of SINGLE FAULT CONDITIONS in See appended Table 13 2 13 2 2 13 2 13 inclusive NORMAL CONDITIONS in 8 1 a also applied in least favorable combination 13 2 2 ME EQUIPMENT complied with 13 2 2 13 2 12 See appended Table 13 2 13 2 12 13 2 13 ME
68. 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 116 of 163 Report No TRS11120147 8 7 3A TABLE PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under N NORMAL amp SINGLE FAULT CONDITIONS TYPE B APPLIED PARTS mA r m s measurements made with a non frequency weighted device uA Current Description Clause Measuring a c NC NC actual SFC SFC actual Type Ref Circuit d c allowed allowed PATIENT d c 10 10 AUX 8 7 4 8 Fig 19 CURRENT a c 10 10 From PATIENT d c 10 10 Patient CONNECTION to 8 7 4 7a Fig 15 ae 10 10 earth LEAKAGE CURRENT Caused by d c 10 10 an extemal g zA re FAT voltage on a a c 10 10 SIP SOP With same ae i 10 types of 8 7 4 7a Fig 15 Total APPLIED PART and and PATIENT connected 8 7 4 7h Fig20 ac 10 10 LEAKAGE together CURRENT A ji d c 10 10 ee aused by NoTE3 an external eA fc Fig 17 voltage on a aa aS ac 10 10 sIP SOP cia AD ig 20 l Supplementary information Not measured with a non frequency weighted device 1 For EARTH LEAKAGE CURRENT see 8 7 3 d 2 For TOUCH CURRENT see 8 7 3 c 3 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 4 In addition to conditions indi
69. 7 4 7b Fig 16 N A N A 10 10 of an F TYPE PATIENT APPLIED PART LEAKAGE Caused by an CURRENT external voltage on ACCESSIBLE l See See metal part not oo Pige 10 19 Note 3 Note 3 PROTECTIVELY EARTHED Caused by an external voltage 8 7 4 7b Fig 16 Total 00 PATIENT CONN and and N A N A 10 10 Disa ofan F TYPE 8 7 4 7h Fig 20 APPLIED PART LEAKAGE CURRENT Caused by an See external voltage NOTE3 on ACCESSIBLE metal part not PROTECTIVELY EARTHED 8 7 4 7d Fig 18 and and 10 10 8 7 4 7h Fig 20 See See Note 3 Note 3 Supplementary information Not measured with a non frequency weighted device 1 The condition referred to in Table IV of the second edition as MAINS VOLTAGE ON APPLIED PART and treated in that edition as a SINGLE FAULT CONDITION is treated in this edition as a special test condition The test with MAXIMUM MAINS VOLTAGE on a non PROTECTIVELY EARTHED ACCESSIBLE PART is also a special test condition but the allowable values are the same as for SINGLE FAULT CONDITION See the rationales for 8 5 2 2 and 8 7 4 7d 2 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 3 This condition is not tested with TYPE CF APPLIED PARTS because it is covered by the test with MAXIMUM MAINS VOLTAGE on the APPLIED PART See also the rationale for 8 7 4 7 d
70. 7 except for 48 h only i Breakdown Yes No 68hatT1 2 C __ C 1 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C 2 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C 3 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C 4 1hat25 C 2 C 2hatO0 C 2 C 1 or more h at 25 C 2 C Supplementary information See the remark in clause 8 9 3 4 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 Page 126 of 163 Report No TRS11120147 8 10 TABLE List of critical components P Component Manufacturer Type Technical data Standard No Mark s amp Part No Trademark No model Edition Certificates of No conformity PCB various various V 0 130 degree UL796 UL C Enclosure CHI MEI PA 757 HB Min UL 94 UL E56070 CORPORATION 1 5mm UL746C 80degree C Silicon Shenzhen Pravance US9111 Max excitation Pressure S amp T Development Co voltage 10V Sensor Ltd max excitation current 2 0 mA Max operating temperature 125 degree C Pump Yuyao Bozhong BZPO6A 6 0Vdc max Electronic Factory operating temperature 40 degree C Electronma Yuyao Bo
71. AGE up to 2800 V peak or d c the 2800 Vpeak or d c higher of the two values applied Material groups classified in accordance with Table 9 Material Group Material group evaluated using 50 drops of solution A based on test data for material according to IEC 60112 8 9 1 8 Pollution degree 1 Micro environment sealed to exclude dust and moisture Pollution degree 2 Micro environment with non conductive pollution except occasional temporary conductivity caused by condensation 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 Page 46 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Pollution degree 4 not used for insulation providing a MEANS OF PROTECTION Where insulation between MAINS PART and earth No mains part might be compromised measures such as maintenance ensure that micro environment is mitigated to a lower pollution degree Applicable value of MAINS TRANSIENT VOLTAGE No mains transient determined from overvoltage category according to IEC 60664 1 and NOMINAL a c MAINS VOLTAGE using Table 10 V wr peak V wn l M S e 3 8 9 1 10 Required CLEARANCE for MAINS PARTS operating on No ma
72. ARTH TERMINAL of ME EQUIPMENT for FIXED supply conductors or POWER SUPPLY CORDS comply with 8 11 4 3 and clamping means cannot be loosened without TOOL Screws for internal PROTECTIVE EARTH CONNECTIONS are completely covered or protected against accidental loosening from outside Earth pin of APPLIANCE INLET forming supply connection to ME EQUIPMENT regarded as PROTECTIVE EARTH TERMINAL PROTECTIVE EARTH CONNECTION not used for a moving part except when MANUFACTURER demonstrated in RISK MANAGEMENT FILE connection will remain reliable during EXPECTED SERVICE LIFE a PROTECTIVE EARTH CONNECTIONS carried fault currents reliably and without excessive voltage drop b Allowable TOUCH CURRENT and PATIENT 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 Poorly conducting surface coatings on conductive elements removed at the point of contact Coating not removed when requirements for impedance and current carrying capacity met PROTECTIVE EARTH CONNECTION where 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 PROTECTIVE EARTH TERMINAL not used for mechanical connection between different parts of ME EQUIPMENT or securing components not relat
73. CTION 1 with 2 3 amp 4 connected to earth Vp eccceesseeeeseeeeeeeteeeeeees Peak voltage at Y1 and Y2 after operation of S N V applied to PATIENT CONNECTION 2 with 1 3 amp 4 connected to earth Vp ceeeseeeeesteeeeesteeeeeeaes j Peak voltage at Y1 and Y2 after operation of S N V applied to PATIENT CONNECTION 3 with 1 2 amp 4 connected to earth Vp sssssseeeriessrrrieerirreerinrssees f Peak voltage at Y1 and Y2 after the operation of N S Vz applied to PATIENT CONNECTION 4 with 1 2 amp 3 connected to earth Vp esseesseserseeerrsseerese Peak voltage at Y1 and Y2 after operation of S N V applied to PATIENT CONNECTION 1 with 2 3 amp 4 connected to earth Vy reversed Vp 00 i Peak voltage at Y1 and Y2 after operation of S N V applied to PATIENT CONNECTION 2 with 1 3 amp 4 connected to earth Vy reversed Vp 0 0c 0 Peak voltage at Y1 and Y2 after operation of S N Vr applied to PATIENT CONNECTION 3 with 1 2 amp 4 connected to earth Vy reversed Vp 0 0 3 Peak voltage at Y1 and Y2 after operation of S Vz applied to PATIENT CONNECTION 4 with 1 2 amp 3 connected to earth Vy reversed Vp ME EQUIPMENT continued to provide BASIC SAFETY and ESSENTIAL PERFORMANCE after the recovery time stated in ACCOMPANYING DOCUMENTS Means provided to limit energy delivered to a 100 Q load to at least 90 of energy delivered to this load with ME EQUIPMENT disconne
74. DS when applicable addressed in RISK MANAGEMENT PROCESS as PATIENTS medications taken surface pressure as instructions for use 11 1 2 2 APPLIED PARTS not supplying heat to a PATIENT met See appended Table 11 1 2 2 Table 24 with max surface temperatures gt 41 C disclosed in instructions for use and clinical effects with respect to body surface maturity of documented in RISK MANAGEMENT FILE Surfaces of APPLIED PARTS cooled below ambient Surfaces of applied parts was temperatures that can also result in HAZARD not below ambient evaluated as part of RISK MANAGEMENT PROCESS temperatures 11 1 3 Measurements not made when engineering Measurement was made judgment and rationale by MANUFACTURER indicated temperature limits could not exceed as documented in RISK MANAGEMENT FILE Test corner not used where engineering judgment Used Test corner and rationale by MANUFACTURER indicated test corner will not impact measurements as documented in RISK MANAGEMENT FILE Probability of occurrence and duration of contact See Risk Management for parts likely to be touched and for APPLIED Report PARTS documented in RISK MANAGEMENT FILE a ME EQUIPMENT positioned for tests in accordance with this clause b Supply voltage was in accordance with this See appended Tables 11 1 1 clause and 11 1 2 2 Page 71 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict c Thermal stabilization for tempe
75. E CURRENT and total PATIENT LEAKAGE CURRENT of ME SYSTEM in NORMAL CONDITION did not exceed values specified for ME EQUIPMENT in Tables 3 and 4 Total PATIENT LEAKAGE CURRENT optionally N measured at installation a Measurements made using a device as in 8 7 4 4 PN 16 6 4 1 a TOUCH CURRENT PATIENT and total EARTH LEAKAGE CURRENTS of MULTIPLE SOCKET OUTLET measured after ME SYSTEM reached operating temperature as follows ME SYSTEMS intended for non CONTINUOUS OPERATION operated in standby quiescent mode until THERMAL STABILITY and then ME SYSTEM operated in NORMAL USE over consecutive cycles at RATED on off periods until THERMAL STABILITY was again achieved or for 7h whichever shorter ME SYSTEMS intended for CONTINUOUS OPERATION operated until THERMAL STABILITY RATED MAINS VOLTAGE ME SYSTEM connected to local SUPPLY MAINS prior to its clinical use when characteristics of SYSTEM could only be measured properly after installation at RESPONSIBLE ORGANIZATION Number of tests reduced where examination of circuit arrangement components and materials of ME SYSTEM indicated no possibility of HAZARD 16 6 4 2 a ME SYSTEM tested after assembly based on N ACCOMPANYING DOCUMENTS b The reference earth of measuring circuits N connected to protective earth of SUPPLY MAINS when an isolating transformer not used for LEAKAGE CURRENT measurements ME SYSTEM complied with applicable requirements N of Clause 9
76. ECTIVE EARTH CONDUCTOR identified by green No Protective earth conductor N and yellow insulation 7 7 2 Insulation on conductors inside ME EQUIPMENT No protective earth N forming PROTECTIVE EARTH CONNECTIONS identified connections 7 7 3 7 7 4 by green and yellow at least at terminations Green and yellow insulation identify only following No such conductors used N conductors lo sd PROTECTIVE EARTH CONDUCTORS a conductors specified in 7 7 2 POTENTIAL EQUALIZATION CONDUCTORS ft Neutral conductors of POWER SUPPLY CORDS are Only power by internal battery light blue specified in IEC 60227 1 or IEC no power supply cords used 60245 1 Page 21 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 7 7 5 Colors of conductors in POWER SUPPLY CORDS are N in accordance with IEC 60227 1 or IEC 60245 1 7 8 Indicatorlights andcontros TP Indicator lights and controls 7 8 1 Colors of indicator lights and their meanings are __ No indicator lights used N as follows Dot matrix and other alphanumeric displays not considered indicator lights Red Warning i e immediate response by N OPERATOR required Yellow Caution i e prompt response by N OPERATOR required PJoreensRescyiorue a Other color Meaning other than red yellow or N green Color MEANING eceeceeeesteeeeetteeeeeenaes Red used only for emergency control No emergency control used
77. EE where the hazards persist been implemented 9 2 2 4 3 Movable guards The risks caused by mechanical hazards associated with moving parts and reduced by use of the 3to9 movable guards are addressed Page 147 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Baer eae 9 2 2 4 4 Protective measures The risks caused by mechanical hazards associated with moving parts and reduced by the use of 3to9 protective measures incorporated in the control system are addressed 9 2 2 5c Continuous activation The risks caused by mechanical hazards associated with accessibility to a trapping zone and reduced qe use of the continuous activation of the movement control are addressed 9 2 2 6 Speed of movement s The risks caused by mechanical hazards associated with the speed of movement are addressed 9 2 3 2 The risks caused by mechanical hazards associated with the over travel are addressed Emergency stopping Does the MEE use emergency stopping devices 3 to9 devices Are risks caused by mechanical hazards which are reduced by the use of the emergency stopping devices reduced to an acceptable level Release of patient The risks caused by mechanical hazards associated with release of patient are addressed Stoo to 9 Hazards associated The risks caused by mechanical hazards associat
78. ES not applied b Contribution to CREEPAGE DISTANCES of grooves or air gaps less than 1 mm wide limited to widths 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 Only solid insulation requirements applied where No Space filled by insulating distances between conductive parts filled with compound insulating compound were such that CLEARANCES and CREEPAGE DISTANCES do not exist 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 For insulating compound forming solid insulation between conductive parts a single sample 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 Page 48 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict Cracks or voids in insulating compound affecting homogeneity of material did not occur For situations where insulating compound forms a cemented joint with other insulating parts three samples tested for reliability of joint A winding of solvent
79. ETY FACTORS to values in Table 21 rows 3 and 4 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION N HAZARDS X Radiation N X radiation dose rate was lt 36 pA kg 5 uSvw h _ No X Radiation produced N 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 Amount of radiation measured by means of an ionizing chamber radiation monitor with an effective area of 10 cm or by other instruments producing equal results ME EQUIPMENT operated as in NORMAL USE at most unfavorable RATED MAINS VOLTAGE and controls adjusted to emit maximum radiation Internal preset controls not intended for adjustment during EXPECTED SERVICE LIFE of ME EQUIPMENT not taken into consideration RISK from unintended X radiation from ME No X Radiation produced 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 RISK associated with alpha beta gamma No these related radiation neutron and other particle radiation when applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE RISK associated with microwave radiation when Not applicable applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE Relevant requirements of IEC 60825 1 1993 No such
80. GEMENT FILE 12 4 6 When applicable RISKS associated with diagnostic No such output or therapeutic acoustic pressure addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE HAZARDOUS SITUATIONS AND FAULT CONDITIONS Specific HAZARDOUS SITUATIONS N N N N N 13 1 2 Emissions deformation of ENCLOSURE or exceeding maximum temperature Emission of flames molten metal poisonous or Not possible to occur such ignitable substance in hazardous quantities did HAZARDOUS SITUATIONS not occur Deformation of ENCLOSURE impairing Not possible to occur such compliance with 15 3 1 did not occur HAZARDOUS SITUATIONS Temperatures of APPLIED PARTS did not exceed See appended Tables 11 1 1 allowable values in Table 24 when measured as and 11 1 2 2 in 11 1 3 Temperatures of ME EQUIPMENT parts that are See appended Tables 11 1 1 not APPLIED PARTS likely to be touched did not and 11 1 2 2 exceed values in Table 23 when measured and adjusted as in 11 1 3 Allowable values for other components and materials in Table 22 times 1 5 minus 12 5 C were not exceeded Limits for windings in Tables 26 27 and 31 not No winding in the circuit N exceeded Table 22 not exceeded in all other cases Po Temperatures measured according to 11 1 3 13 1 1 None of HAZARDOUS SITUATIONS in 13 1 2 13 1 4 inclusive occurred when SINGLE FAULT CONDITIONS applied one at a time as in 4 7 and 1
81. ILE reviewed A connector on a PATIENT lead located at the end of the lead remote from 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 voltage while the PATIENT CONNECTIONS are in contact with PATIENT conductive part of connector not separated from all PATIENT CONNECTIONS did not come into contact with a flat conductive plate of not less than 100 mm diameter required test finger did not make electrical contact with conductive part when applied against access 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 socket or a flat surface MAXIMUM MAINS VOLTAGE MAXIMUM MAINS VOLTAGE determined to be the internally powered me highest RATED supply voltage for single phase or equipment d c SUPPLY MAINS powered ME EQUIPMENT including INTERNALLY POWERED ME EQUIPMENT with a means of connection to a SUPPLY MAINS V g Page 32 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict MAXIMUM MAINS VOLTAGE was the highest RATED internally powered me phase to neutral supply voltage for polyphase ME equipment EQUIPMENT V 0 ccceeeeeeeeeeeceeeeeeeeeeeeeeeneneeeeeeereees Input supply voltage to ME EQUIPMENT was i
82. Intentional exceeding Has the manufacturer identified risks associated with the intentional exceeding of safety limits of safety limits Has the manufacturer addressed such risks to comply with the manufacturer s risk acceptability criteria 12 42 Indication of Has the manufacturer identified all functions related to the delivery of energy or substances to the 3 9 parameters relevant to Patient Re Ms Abs oes safety Has the manufacturer explored such functions for hazardous situations in which these functions can 9 produce an output to the patient 12 4 3 Accidental selection of Has the manufacturer identified all features of the ME Equipment that provide an output to the patient for 3 excessive output therapeutic purposes values Has the manufacturer identified which of these features have multiple purposes that require different intensities for different treatments Has the manufacturer identified hazards associated with accidental selection of excessive output values Incorrect output Has the manufacturer identified all features of the ME Equipment that provide an output Has the manufacturer identified hazards associated with incorrect output Page 153 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Considerations for application of RM criteria 14971 2000 12 4 5 2 Diagnostic X ray Has the manufacturer identified if the pr
83. LTIPLE SOCKET OUTLET permanently N connected to separating transformer or socket outlet of separating transformer assembly cannot accept MAINS PLUGS as identified in IEC TR 60083 Removal of any single item of equipment in ME N SYSTEM will not interrupt the protective earthing of any other part of ME SYSTEM without simultaneous disconnection of electrical supply to that part Additional PROTECTIVE EARTH CONDUCTORS can be N detachable only by a TOOL 16 9 2 3 Conductors connecting different items within an N ME SYSTEM protected against mechanical damage 17 ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND ME SYSTEMS RISKS associated with items addressed in RISK See EMC Test Report N MANAGEMENT PROCESS as confirmed by review electromagnetic phenomena at locations where N ME EQUIPMENT Or ME SYSTEM is to be used as stated in ACCOMPANYING DOCUMENTS e 0008 f introduction of electromagnetic phenomena into environment by ME EQUIPMENT or ME SYSTEM that might degrade performance of other devices electrical equipment and systems G 2 Locations and basic requirements N Page 99 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict Parts of CATEGORY APG ME EQUIPMENT in which a No Parts of category apg me FLAMMABLE ANESTHETIC MIXTURE WITH AIR occurs equipment are CATEGORY AP or APG ME EQUIPMENT and complied with G 3 G 4 and G 5 FLAMMABLE ANESTHETIC MIX
84. MAINS TERMINAL DEVICE and equipment no mains part protective devices is not lt minimum required for POWER SUPPLY CORD as in 8 11 3 3 mm Cu j b Cross sectional area of other wiring in MAINS N PART and sizes of tracks on printed wiring circuits sufficient to prevent fire in case of fault currents 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 PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT AND ME SYSTEMS 9 1 ME EQUIPMENT complies with Clause 4 for design and manufacture and mechanical strength 15 3 9 2 HAZARDS associated with moving parts When ME EQUIPMENT with moving parts PROPERLY A motor used to inflate air for INSTALLED used per ACCOMPANYING DOCUMENTS or cuff under foreseeable misuse RISKS associated with moving parts reduced to an acceptable level RISK from contact with moving parts reduced to See Risk management an acceptable level using protective measures Report access function shape of parts energy speed of motion and benefits to PATIENT considered RESIDUAL RISK associated with moving parts No Residual risk considered acceptable when exposure was needed for ME EQUIPMENT to perform its function Warnings marked on ME EQUIPMENT or included in N instructions for use when HAZARDS persisted after implementi
85. MEE in the risk management file 3to4 c If so inspect for an independent non self resetting thermal cut out with a setting outside the maximum range of the thermostat but within the safe temperature limit for its intended function 15 4 2 1 Application Has the manufacturer identified that loss of function of the MEE could result in a hazardous situation 3 to 4 d If so ensure that the operation of a thermal cut out or over current release does not result in an unacceptable risk 15 4 2 1 Application Has the manufacturer identified the need for fusing each lead for the use of tubular heating elements 3 to5 h in the risk management file If so inspect for fuses in both leads and fault either lead to ground and ensure over heating does not occur 15 4 3 1_ Housing Has the manufacturer identified the need for ventilated battery housings where gases that could result 3 to 5 in a hazard can escape during charging or discharging If so inspect the battery housings for proper ventilation Has the manufacturer identified the need for battery polarity connection construction such that short circuiting is not possible If so inspect the battery connection and ensure that incorrect connection is not possible 15 4 3 5 Excessive current and Has the manufacturer provided justification for the omission of fuses or over current releases in the 3to5 voltage protection risk management file If so protection against fire caused by excessive currents is
86. MENT FILE 4 10 Power supply 4 10 1 ME EQUIPMENT is suitable for connection to a Powered by an internal SUPPLY MAINS specified to be connected to a electrical power source separate power supply can be powered by an See User manual INTERNAL ELECTRICAL POWER SOURCE or a combination of the three cceeceeeeeeeeeeeeeees 4 10 2 Maximum rated voltage for ME EQUIPMENT Not intended to be connected N intended to be connected to SUPPLY MAINS is 250 x to supply mains for HAND HELD ME EQUIPMENT V 250 V d c or single phase a c or 500 V Only 6 0Vd c P polyphase a c for ME EQUIPMENT and ME SYSTEMS with a RATED input lt 4 KVA V ceeeeeeeeeteeeeeeees j 500 V for all other ME EQUIPMENT and ME N SYSTEMS SUPPLY MAINS characteristics are as follows overvoltage category II for mains transients Supplied by internal batteries except when a higher category specified by MANUFACTURER iielienesiistess Aten stdeseevlnaaesenteaeens f no voltage gt 110 or lt 90 of NOMINAL voltage N between any of the conductors of the system or between any of these conductors and earth of NOMINAL VORGE Jesrira t j Page 9 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict voltages that are practically sinusoidal and forming a practically symmetrical supply system in case of poly phase supply N a freq
87. Minimum breakdown test voltage is at least twice N the voltage in Tables 6 and 7 but not less than 3000 V r m s or 4200 V peak for BASIC and N SUPPLEMENTARY INSULATION 6000 V r m s or 8400 V peak for REINFORCED N INSULATION Page 108 of 163 4 11 TABLE Power Input Report No TRS11120147 N Voltage Vv Operating Conditions Ratings Frequency Current Hz A Remarks Characteristics of the Marking Label tested Remarks Material composition of Marking Label Polyester label P Ink other printing material or process 22 Ink Paint P Method of application of ink to the Label Print Silk print P NO R E E is Marking Label on NIBP cuff P Material composition of Warning Label No Warning Label N Ink other printing material or process 0 ce N Method of application of ink to the Label N Supplementary information i Marking rubbed by hand without undue pressure 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 Page 109 of 163 Report No TRS11120147 8 4 3 TABLE ME EQUIPMENT intended to be connected to a power source by a plug N measurement of voltage or calculation of stored charge 1 s afte
88. N Different positions of control devices switches See User manual indicated by figures letters or other visual means Controls provided with an associated indicating Result in an unacceptable device when change of setting of a control could RISK to PATIENT result in an unacceptable RISK to PATIENT in NORMAL USE or an indication of direction in which magnitude of the function changes Numeric indications of parameters on ME See User manual and the EQUIPMENT expressed in SI units according to isO equipment 31 except the base quantities listed in Table 1 expressed in the indicated units ISO 1000 applied for application of S units their multiples and certain other units All Markings in Subclause 7 4 complied with tests and criteria of 7 1 2 and 7 1 3 Safety signs Markings used to convey a warning prohibition or See User manual mandatory action mitigating a RISK not obvious to OPERATOR are safety signs from ISO 7010 One of the following methods used when a safety sign was not available to indicate a particular desired meaning i a A safety sign constructed according to safety No such safety signs used signs 1 4 and 8 of Table D 2 i e ISO 3864 1 2002 Clause 7 Page 20 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict b Safety sign 2 of Table D 2 general warning See the Marking plate sign ISO 7010 2003 W001 placed together with a supplemen
89. NICAL PROTECTIVE DEVICE ACCOMPANYING DOCUMENTS instruct once N MECHANICAL PROTECTIVE DEVICE is activated SERVICE PERSONNEL shall be called and MECHANICAL PROTECTIVE DEVICE must be replaced before ME EQUIPMENT can be used again ae A ME EQUIPMENT permanently marked with safety sign 2 of Table D 2 i e safety sign 7010 W001 Marking is adjacent to MECHANICAL PROTECTIVE N DEVICE or its location relative to MECHANICAL PROTECTIVE DEVICE is obvious to service personnel Compliance confirmed by examination of ME N EQUIPMENT ACCOMPANYING DOCUMENTS RISK MANAGEMENT FILE specifications and processing of materials and following test A chain cable band spring belt jack screw nut N 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 Load included SAFE WORKING LOAD in 9 8 3 1 when N system was capable of supporting a PATIENT or OPERATOR Page 69 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict No evidence of damage to MECHANICAL N PROTECTIVE DEVICE affecting its ability to perform its intended function N Support system parts have TENSILE SAFETY FACTORS to values in Table 21 rows 1 and 2 and are not impaired by wear Support system parts impaired by wear however they have TENSILE SAF
90. NNEL Symbol 11 on Table D 1 ISO 7000 1641 DB 2004 01 used optionally advice to OPERATOR to consult ACCOMPANYING DOCUMENTS Safety sign 10 on Table D 2 safety sign IEC 60878 Safety 01 used advising OPERATOR that ACCOMPANYING DOCUMENTS must be consulted ACCESSORIES marked with name or trademark of their MANUFACTURER or supplier and with a MODEL or TYPE REFERENCE MODEL or TYPE REF 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 Page 15 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict Following markings appear on outside of part Only Powered by Internal containing SUPPLY MAINS connection and batteries preferably adjacent to connection point except for PERMANENTLY INSTALLED ME EQUIPMENT Mopar containing SOEREN MAINS connection NOMINAL supply voltage or range marked inside or outside of ME EQUIPMENT preferably adjacent to supply connection terminals for PERMANENTLY INSTALLED ME EQUIPMENT V V V ecese RATED supply voltage s or RATED voltage range s with a hyphen between minimum and maximum voltages V V V Multiple RATED supply voltages or multiple RATED supply voltage ranges are separated by V V nature of supply e g No of phases except single phase and type of current Symbols 1 5 Table D 1
91. P Dielectric WORKING WORKING YRS fe auco reer TER AF breakdown Ware VOLTAGE este l rotection from MAINS rotection from Yes No U U area from insulation PART SECONDARY CIRCUITS V peak V d c diagrarn One MmoPP Two MoPP One moppP Two MOPP 6 Double insulation A N A N A N A 1000 No 6 Double insulation B N A N A N A 1000 No 354 Basic insulation C N A N A 1500 N A No Alternatively as specified in the Table i e test voltage used Supplementary information __dc a d c test voltage equal to the peak value of the a c 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 Subclause 11 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 123 of 163 Report No TRS11120147 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 Test in lieu of HAZARDOUS SITUATION Specific areas of circuits short circuited eee dosaen es die heare a EE DISTANCE or AIR shock hazard explosion CLEARANCE disc
92. R from normal operating position Requirement not applied to heated stylus pens for No heated stylus pens recording purposes Indicator lights provided on ME EQUIPMENT to No such risk indicate an output exists where an accidental or prolonged operation of output circuit could constitute a HAZARDOUS SITUATION Colors of indicator lights complied with 7 8 1 Ee e 4 Charging mode visibly indicated in ME EQUIPMENT No chargeable battery used N incorporating a means for charging an INTERNAL ELECTRICAL POWER SOURCE N N N Page 90 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 15 4 5 RISKS associated with pre set controls addressed No such pre set control used in RISK MANAGEMENT PROCESS when applicable as verified by review of RISK MANAGEMENT FILE 15 4 6 Actuating parts of controls of ME EQUIPMENT 15 4 6 1 a Actuating parts cannot be pulled off or loosened up during NORMAL USE b Indication of scales e g on off positions No such control etc always corresponds to position of controls with adjustment that can result in a HAZARDOUS SITUATION for PATIENT Of OPERATOR while ME EQUIPMENT is in use c Incorrect connection of indicating device to Can not be separated without relevant component prevented by adequate use of a tool construction when it could be separated without use of a TOOL When torque values in Table 30 applied between control knob and
93. RENT RELEASE provided in Only Internally powered each supply lead for CLASS and CLASS II ME equipment no Mains fuses EQUIPMENT with a functional earth connection and over current releases according to 8 6 9 and in at least one supply lead for other single phase CLASS II ME EQUIPMENT neutral conductor not fused for PERMANENTLY INSTALLED ME EQUIPMENT fuses or OVER CURRENT RELEASES omitted due 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 components Effect of short circuit fault conditions in other circuits taken into consideration before eliminating fuses or OVER CURRENT RELEASES Page 55 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Protective devices have adequate breaking capacity to interrupt the maximum fault current including the available short circuit A fuse or OVER CURRENT RELEASE not provided in a PROTECTIVE EARTH CONDUCTOR Fuses complying with IEC 60127 have high breaking capacity 1 500 A and prospective short circuit current gt 35 A or 10 times current rating of the fuse whichever is greatero Justification for omission of fuses or OVER N CURRENT RELEASES is in RISK MANAGEMENT FILE Internal wiring of the MAINS PART N a Cross sectional area of internal wiring in a Only Internally powered MAINS PART between
94. RMAL USE with a force of 10 N Test repeated with a TOOL specified in instructions N for use Test rod freely and vertically suspended through openings on top of ENCLOSURE e Devices used to de energize parts when an Can not access to parts at ee COVER opened without a TOOL gives voltages above levels access to parts at voltages above levels permitted permitted by this Clause when by this Clause comply with 8 11 1 for mains an access cover opened isolating switches and remain effective in SINGLE without a tool FAULT CONDITION A TOOL is required when it is possible to prevent the devices from operating Worst case voltage between pins of plug and Not intended connected to between either supply pin and ENCLOSURE did not power source by a plug exceed 60 V one s after TON the plug of ME EQUIPMENT or its parts V A triggering circuit used to ensure disconnection occurred at peak of supply voltage waveform When voltage exceeded 60 V measured or calculated stored charge did not exceed 45 uC Residual voltage of conductive parts of Bef circuits having become accessible after ME EQUIPMENT was de energized after removal of ACCESS COVERS did not exceed 60 V or calculated stored charge did not exceed 45 UC eee A device manually discharging capacitors used when automatic discharging was not possible and ACCESS COVERS Could be removed only with aid of a TOOL specified in technical description Separation of parts
95. Remark Verdict 11 2 2 2 RISK of ignition under least favorable conditions did not occur and oxygen concentration did not exceed 25 in immediate surroundings due to appropriate location of external exhaust outlets of an OXYGEN RICH ENVIRONMENT when electrical components mounted on the outside of ME EQUIPMENT or an ME SYSTEM 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 power and energy to values in 11 2 2 1 a 5 Screw attachments protected against loosening during use by varnishing use of spring washers or adequate torques Soldered crimped and pin and socket connections of cables exiting ENCLOSURE include additional mechanical securing means Failure of a ventilation system constructed in Not OXYGEN RICH accordance with 11 2 2 1 b 2 aseeseen ENVIRONMENTS ME EQUIPMENT or ME SYSTEMS Failure of a barrier constructed in accordance WIth 14 2 2 1 D 3 eee cect ceed ai asid Failure of a component creating a source of ignition as defined in 11 2 2 1 a eee Failure of solid insulation or creepage and clearances providing equivalent of at least one 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 a Failure of a pneumatic component resulting in leakage of oxy
96. T to the extent CREEPAGE and CLEARANCES would be reduced below 8 9 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 Parts of natural latex rubber aged by suspending samples freely in an oxygen cylinder containing commercial oxygen not less than 97 pure toa pressure of 2 1 MPa 70 kPa with an effective capacity of at least 10 times volume of samples Samples kept in cylinder at 70 C 2 C for 96 h and immediately afterwards taken out of cylinder and left at room temperature for at least 16 h There were no cracks visible to naked eyes CREEPAGE DISTANCES and AIR CLEARANCES 8 9 1 1 CREEPAGE DISTANCES and AIR CLEARANCES are gt to values in Tables 11 to 16 inclusive except as specified in Clauses 8 9 1 2 to 8 9 1 15 8 9 1 2 Tables 11 to 16 inclusive not applied to No such means of operator CREEPAGE and CLEARANCES forming MEANS OF protection per IEC 60950 1 for OPERATOR PROTECTION per IEC 60950 1 for insulation co ordination INSULATION CO ORDINATION and used under conditions compliance was tested 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 Page 45 of 163 Report No TRS11120147 EN6
97. TIVELY EARTHED See NOTE 3 See See Note 3 Note 3 Supplementary information Only one Type BF applied part and no ACCESSIBLE metal part 1 The condition referred to in Table IV of the second edition as MAINS VOLTAGE ON APPLIED PART and treated in that edition as a SINGLE FAULT CONDITION is treated in this edition as a special test condition The test with MAXIMUM MAINS VOLTAGE on a non PROTECTIVELY EARTHED ACCESSIBLE PART is also a special test condition but the allowable values are the same as for SINGLE FAULT CONDITION See the rationales for 8 5 2 2 and 8 7 4 7d 2 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values 3 This condition is not tested with TYPE CF APPLIED PARTS because it is covered by the test with MAXIMUM MAINS VOLTAGE on the APPLIED PART See also the rationale for 8 7 4 7 d 4 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 mater cleaning amp disinfection amp sterilization Page 121 of 163 Report No TRS
98. TOR receiving a shock from such parts taken into consideration in RISK MANAGEMENT PROCESS Isolation of PATIENT CONNECTIONS of a DEFIBRILLATION PROOF APPLIED PART from other parts of ME EQUIPMENT accomplished as follows Page 33 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a Hazardous electrical energies during a discharge of a cardiac defibrillator to a PATIENT connected to a DEFIBRILLATION PROOF APPLIED PART as determined by peak voltage measured between points Y1 and Y2 of Figs 9 and 10 exceeding 1 V did not appear on ENCLOSURE including connectors in PATIENT leads and cables when connected to ME EQUIPMENT and excluding connecting lead from a DEFIBRILLATION PROOF APPLIED PART or its connector when it was disconnected from ME EQUIPMENT Vp 0 ccccceeeeeeeececeeceeeeeseeeenaeeeeeeeeeeees SIGNAL INPUT OUTPUT PARTS Vp sccscssseseeseseeees test metal foil with minimum area equal to base of ME EQUIPMENT where ME EQUIPMENT was placed Or PATIENT CONNECTIONS of other APPLIED PARTS regardless of classification as a DEFIBRILLATION PROOF APPLIED PART Vp f b ME EQUIPMENT complied with relevant requirements of this standard providing BASIC SAFETY and ESSENTIAL PERFORMANCE following exposure to defibrillation voltage and recovery time stated in ACCOMPANYING DOCUMENTS ME EQUIPMENT connected to circuit of Fig 9 for common mode test and t
99. TURE WITH AIR occurring No Flammable anesthetic due to a leakage or discharge of a FLAMMABLE mixture used ANESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE from an ENCLOSURE considered 5 to 25 cm from point of occurrence A FLAMMABLE ANESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE contained in a completely or partly enclosed ME EQUIPMENT part and in PATIENT S respiratory tract 5 cm from an ENCLOSURE part where leakage or discharge occurs ME EQUIPMENT or parts thereof specified for use with FLAMMABLE ANESTHETIC MIXTURE WITH AIR in a location defined in G 2 2 are CATEGORY AP or APG ME EQUIPMENT and complied with G 4 and G 5 ME EQUIPMENT or parts thereof for use with FLAMMABLE ANESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE location per G 2 2 are CATEGORY APG ME EQUIPMENT and comply with G 4 and G 6 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 CATEGORY APG ME EQUIPMENT marked on a prominent location with a green colored band gt 2 cm wide imprinted with characters APG according to symbol 23 in Table D 1 i e symbol IEC Lg 9332 DB 2002210 tect ioc tetead EARE Length of green colored band is gt 4 cm and size of marking is as large as possible for particular When above marking not possible relevant information included in instructions for use CATEGORY AP ME EQUIPMENT marked ona N prominent location with a green colored circle gt 2 cm in diamete
100. UFACTURER including a contact address accompany ME SYSTEM or modified ME SYSTEM ACCOMPANYING DOCUMENTS regarded as a part of ME SYSTEM ACCOMPANYING DOCUMENTS are optionally provided in electronic format e g electronic file format or CD ROM and ME SYSTEM is capable of displaying or printing these documents a ACCOMPANYING DOCUMENTS provided for each N item of ME EQUIPMENT supplied by MANUFACTURER b ACCOMPANYING DOCUMENTS provided for each N item of non ME EQUIPMENT supplied by MANUFACTURER es eee N c the required information is provided specifications instructions for use as intended by MANUFACTURER and a list of all items forming the ME SYSTEM instructions for installation assembly and modification of ME SYSTEM to ensure continued compliance with this standard instructions for cleaning and when applicable disinfecting and sterilizing each item of equipment or equipment part forming part of the ME SYSTEM additional safety measures to be applied during N installation of ME SYSTEM identification of parts of ME SYSTEM suitable for N use within the PATIENT ENVIRONMENT additional measures to be applied during N preventive maintenance a warning forbidding placement of MULTIPLE SOCKET OUTLET when provided and itis a separate item on the floor a warning indicating an additional MULTIPLE SOCKET OUTLET or extension cord not to be connected to ME SYSTEM a warning to connect o
101. UIPMENT externally powered INTERNALLY POWERED ME EQUIPMENT 6 1 6 2 EQUIPMENT with means of connection to a SUPPLY MAINS complied with the requirements for CLASS Or CLASS II ME EQUIPMENT when so connected and with the requirements for INTERNALLY POWERED ME EQUIPMENT when not connected to SUPPLY MAINS TYPE B APPLIED PART TYPE BF APPLIED PART TYPE CF APPLIED PART Page 13 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict part ENCLOSURES Classified according to degree of IPXO equipment protection against ingress of water and particulate matter IPN Nz2 as detailed in IEC 60529 ME EQUIPMENT or its parts intended to be sterilized No part is intended to be classified according to method s of sterilization in sterilized instructions for use e g by ethylene oxide gas gamma ray irradiation etc 00 eeeeeeeeeeereeteees ME EQUIPMENT and ME SYSTEMS intended for use in Not intended for use in an an OXYGEN RICH ENVIRONMENT Classified for such oxygen rich environment use and complied with 11 2 2 ME EQUIPMENT IDENTIFICATION MARKING AND DOCUMENTS RISK of poor USABILITY associated with the design See Risk management report of ME EQUIPMENT S identification and marking and the USABILITY addressed in a USABILITY ENGINEERING PROCESS ENGINEERING related documents provided by the manufacture Markings specified in 7 2 7 6 met the requirement
102. age set at 110 of MAXIMUM MAINS VOLTAGE Due to adequate separation of parts involved this test was not conducted e An APPLIED PART with an insulating surface tested using metal foil as in 8 7 4 6 or it was immersed in a 0 9 saline solution i Size of foil increased corresponding to area of The surface of applied part in contact when surface of APPLIED PART in contact contact with patient was with PATIENT was larger than 20 cm x 10 cm cm x smaller than 20 cm x 10 cm CIM E E E 3 f Fluid used as PATIENT CONNECTION replaced by 0 9 saline solution and electrode placed in saline solution considered as PATIENT CONNECTION for APPLIED PART concerned g PATIENT LEAKAGE CURRENT for TYPE B and TYPE BF APPLIED PARTS measured from and to all PATIENT CONNECTIONS of a single function connected directly together or loaded as in NORMAL USE PATIENT LEAKAGE CURRENT for TYPE CF APPLIED PARTS measured from and to every PATIENT CONNECTION in turn PATIENT LEAKAGE CURRENT measurements made with the least favorable detachable part specified in instructions for use Page 41 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict h Total PATIENT LEAKAGE CURRENT measured from Only one applied part and to all PATIENT CONNECTIONS of all APPLIED PARTS of the same type TYPE B BF Or CF APPLIED PARTS connected together Functional earth disconnected before the test when
103. alculated as the product of steady state current measured as described above and supply voltage A supplier certification used in place of the above measurement as the basis for steady state current or power input specification GENERAL REQUIREMENTS FOR TESTING ME EQUIPMENT 5 1 TYPE TESTS determined in consideration of Clause Type tests 4 in particular 4 2 by other tests or methods ceeeeeeeeeeereeeneeees f Test not performed when analysis indicated All tests have been performed condition being tested was adequately evaluated Page 10 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Results of RISK ANALYSIS used to determine See Risk Management report combination s of simultaneous faults to be tested provided by the manufacture RISK ANALYSIS revised necessarily based on test See the version record of the results Risk Management report 5 2 TYPE TESTS conducted on one representative sample under investigation Multiple samples used simultaneously when No significantly affected Used validity of results was not significantly affected one representative sample a Tests conducted within the range of See manufacturer instruction environmental conditions specified in the technica description ecient ma a dhahea tet pected ae a saaal b ME EQUIPMENT shielded from other influences Me equipment shielded from that might affect the validity of tests other in
104. and all conditions confirmed 9 2 5 Means provided to permit Quick and safe release D of PATIENT in event of breakdown of ME EQUIPMENT Press the 3 button can or failure of power supply activation of a release the cuff pressure protective measure or emergency stopping and quickly and safely Uncontrolled or unintended movement of ME EQUIPMENT that could result in an unacceptable RISK prevented Situations where PATIENT is subjected to unacceptable RISKS due to proximity of moving parts removal of normal exit routes or other HAZARDS prevented Page 59 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 RISK MANAGEMENT FILE reviewed and all conditions See Risk management report confirmed Rough surfaces sharp corners and edges of ME EQUIPMENT that could result in an unacceptable RISK avoided or covered RISK MANAGEMENT FILE reviewed and all conditions See Risk management report confirmed Instability HAZARDS ME EQUIPMENT other than FIXED and hand held Hand held equipment 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 Instability overbalance
105. ase of a first fault short or open circuit in one of these components Above requirement not applied to wire wound current limiting resistors provided with a protection against unwinding of the wire in case of rupture Compliance verified by examination of CATEGORY N APG ME EQUIPMENT parts and components or Temperature measurements made in accordance N with 11 1 or Umax Imax R Lmax and Cmax determined together with application of Figs G 4 G 6 eeee Alternatively compliance verified by comparison with design data ME EQUIPMENT its parts and components heating a FLAMMABLE ANESTHETIC MIXTURE WITH OXYGEN OR NITROUS 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 direct contact with FLAMMABLE ANESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Test apparatus for flammable mixtures Test apparatus used was in accordance with this Clause and Fig G 7 BASIC SUPPLEMENTARY DOUBLE and REINFORCED No such insulated winding INSULATION in wound components without wires used interleaved insulation complied with this Annex covering round winding wires between 0 05 mm and 5 00 mm diameters Overlap of layers when wire is insulated with two or more spirally wrapped layers of tape is adequate to ensure continued overlap during manufacture of wound component Page 106 of 163 Report No TRS11120147 EN60601 1 Requirement
106. ation proof applied parts measurement of hazardous N electrical energies Test Measurement made Applied part with test Test voltage Measured Remarks Condition on accessible part voltage polarity voltage between Figs 9 amp 10 Y1 and Y2 mV Supplementary information No defibrillation proof applied part Page 111 of 163 Report No TRS11120147 TABLE defibrillation proof applied parts verification of recovery time Applied part Test voltage Recovery time Measured with test voltage polarity from documents recovery time s Remarks s Supplementary information No defibrillation proof applied part TABLE DEFIBRILLATION PROOF APPLIED PARTS Or PATIENT CONNECTIONS of DEFIBRILLATION PROOF APPLIED PARTS Energy reduction test measurement of Energy delivered to a 100 Q load M E M E E E1 Test Voltage applied to eee a rae a Bei E2 mJ mJ PATIENT CONNECTION 1 or APPLIED PART with PATIENT CONNECTIONS 2 3 and 4 of the same APPLIED PART connected to earth PATIENT CONNECTION 2 or APPLIED PART with PATIENT CONNECTIONS 1 3 and 4 of the same APPLIED PART connected to earth PATIENT CONNECTION 3 or APPLIED PART with PATIENT CONNECTIONS 1 2 and 4 of the same APPLIED PART connected to earth PATIENT CONNECTION 4 or APPLIED PART with PATIENT CONNECTIONS 1 2 and 3 of the same APPLIED PART connected to earth
107. ause 5 12 ME SYSTEM did not result in an unacceptable Risk Not Me system N after installation or subsequent modification Only HAZARDS arising from combining various N equipment to form a ME SYSTEM taken into account ME SYSTEM provides the level of safety within the N PATIENT ENVIRONMENT equivalent to ME EQUIPMENT complying with this standard ME SYSTEM provides the level of safety outside PATIENT ENVIRONMENT equivalent to equipment complying with their respective IEC or ISO safety standards tests performed under operating conditions specified by MANUFACTURER of ME SYSTEM Safety tests previously conducted on individual N equipment of ME SYSTEM according to relevant standards not repeated RISK MANAGEMENT methods optionally used by N MANUFACTURER Of an ME SYSTEM reconfigurable by RESPONSIBLE ORGANIZATION Or OPERATOR to determine configurations with highest RISKS and measures needed to ensure ME SYSTEM will not present an unacceptable RISK in any configuration Non ME EQUIPMENT used in ME SYSTEM complied N with applicable IEC or Iso safety standards tests performed in NORMAL CONDITION except as specified Page 94 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Equipment relying only on BASIC INSULATION for protection against electric shock not used in ME SYSTEM 16 2 Documents containing all data necessary for ME SYSTEM to be used as intended by MAN
108. ause 6 all markings See Symbols information in specified in 7 2 and explanation of safety signs the User manual and symbols marked on ME EQUIPMENT Page 22 of 163 EN60601 1 Requirement Test Report No TRS11120147 Result Remark Verdict Instructions for use are in a language acceptable to the intended operator nstructions for use include all warning and safety notices Warning statement for CLASS ME EQUIPMENT indicating WARNING To avoid risk of electric shock this equipment must only be connected to a supply mains with protective earth Warnings regarding significant RISKS of reciprocal interference posed by ME EQUIPMENT during specific investigations or treatments Information on potential electromagnetic or other interference and advice on how to avoid or minimize such interference Warning statement for ME EQUIPMENT supplied with an integral MULTIPLE SOCKET OUTLET indicating connecting electrical equipment to MSO effectively leads to creating an ME SYSTEM and can result in a reduced level of safety The RESPONSIBLE ORGANIZATION is referred to this standard for the requirements applicable to ME SYSTEMS Statement on ME EQUIPMENT for indicating power supply is specified as a part of ME EQUIPMENT or combination is specified as a ME SYSTEM Warning statement for mains operated ME EQUIPMENT with additional power source not automatically maintained in a fully usable condition in
109. cated 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 Subclause 11 6 i e overflow spillage leakage ingress of water and particulate mater cleaning amp disinfection amp sterilization Page 117 of 163 Report No TRS11120147 8 7 3B TABLE PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS under N NORMAL amp SINGLE FAULT CONDITIONS TYPE BF APPLIED PARTS mA r m s measurements made with a non frequency weighted device uA Current Description Clause Measuring a c NC NC actual SFC SFC actual Type Ref Circuit d c allowed allowed PATIENT d c 10 10 AUX 8 7 4 8 Fig 19 CURRENT a c 10 10 From PATIENT d c 10 10 Patient CONNECTION to 8 7 4 7a Fig 15 ae 10 10 earth LEAKAGE CURRENT Caused by d c 10 10 an external 374 76 POAT voltage on a ac 10 10 SIP SOP With same d c 10 10 types of 8 7 4 7a Fig 15 Total APPLIED PART and and PATIENT Connected 8 7 4 7h Fig 20 a c 10 10 LEAKAGE together CURRENT d c 10 10 See Causedby 874 7c Fig17 NOTE 3 aa And nd voltage ona i a c 10 10 Siplsor 8 7 4 7h Fig 20 Supplementary information Not measured with a non frequency weighted device 1 For EARTH LEAKAGE CURRENT see 8 7 3 d 2 For
110. cation of individual insulating N A materials or Relative Thermal Index C Supplementary information Page 129 of 163 Report No TRS11120147 11 1 1 TABLE Excessive temperatures in ME EQUIPMENT measurement of maximum P temperature during NORMAL USE for parts other than APPLIED PARTS and parts likely to be touched Model Noi a eeendeantcad elie ORA211 Test ambient C cccceceeseseseeteeeees 26 5 RATED supply voltage V aaeeea 6 0Vdc Model No Thermo Max allowable Max Ambient couple TC MHECOURIC temperature from measured temperature Remarks No S Table 22 or 23 temperature Adjust to C C 40 C C ORA211 111 PCB 130 31 8 45 3 ORA211 112 battery 60 29 1 42 2 ORA211 113 LCD 60 28 3 41 8 ORA211 114 Enclosure 60 28 6 42 1 ORA211 115 Pump 105 32 8 46 3 Supplementary information Maximum allowable temperature on surfaces of test corner is 90 C Max temperature determined in accordance with 11 1 3 e When thermocouples used to determine temperature of windings limits of Table 22 reduced by 10 C Page 130 of 163 Report No TRS11120147 11 1 2 1 TABLE Excessive temperatures in ME EQUIPMENT measurement of N temperatures hot or cold surfaces during NORMAL USE for APPLIED PARTS intended to supply heat to a PATIENT Model NOS esesevscesvecc
111. ct HIGH VOLTAGE TERMINAL DEVICES on the outside of No High voltage terminal ME EQUIPMENT accessible without the use of a TOOL devices of me equipment marked with symbol 24 of Table D 1 symbol IEC outside accessible without the 60417 5036 DB 2002 10 use of a tool Requirements for cooling provisions marked e g supply of water or air No such cooling provisions ME EQUIPMENT with limited mechanical stability Hand held equipment Packaging marked with special handling No such requirements instructions for transport and or storage Permissible environmental conditions for transport and storage marked on outside of packaging Refer to the packaging Packaging marked with a suitable safety sign No such risk indicating premature unpacking of ME EQUIPMENT or its parts could result in an unacceptable RISK Packaging of sterile ME EQUIPMENT or ACCESSORIES Not sterile me equipment or marked sterile accessories RATED maximum supply pressure from an external No supply pressure from an source marked on ME EQUIPMENT adjacent to each _ external source IMNpUt CONNECHON ceecceeeceeeeeeeeeeeeeeeeeeeeeeteneeesaees Symbol 7 of Table D 1 IEC 60417 5017 DB 2002 10 marked on FUNCTIONAL EARTH TERMINAL Protective means required to be removed to use No applications a particular function of ME EQUIPMENT with alternate applications marked to indicate the necessity for replacement whe
112. ct Liquid reservoir liable to be overfilled or to No Liquid used N overflow in NORMAL USE completely filled and 15 of its capacity poured in over a period of 1 min and except when restricted TRANSPORTABLE ME EQUIPMENT tilted through an angle of 15 in least favorable direction s and when necessary refilled starting from position of NORMAL USE ME EQUIPMENT met dielectric strength and N LEAKAGE CURRENT tests and uninsulated electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were not wet 168 Spilage on we couruenrendvesrsren n ME EQUIPMENT and ME SYSTEMS handling liquids in No need to handle liquids in N NORMAL USE positioned as in 5 4 a and liquid with normal use 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 N LEAKAGE CURRENT tests and uninsulated electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were not wet 11 6 5 Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS N ME EQUIPMENT with IP Code placed in least IPX0 no need to label favorable position of NORMAL USE and subjected to tests of IEC 60529 IP Code ME EQUIPMENT met dielectric strength and LEAKAGE CURRENT tests and there were no bridging of insulation or electrical components that could res
113. cted J Test voltage applied to each PATIENT CONNECTION or APPLIED PART in turn with all remaining PATIENT CONNECTIONS of same APPLIED PART connected to earth using circuit of Fig 11 and ACCESSORIES recommended by instructions as follows a APPLIED PART or PATIENT CONNECTION connected to test circuit b Capacitor C charged to 5 kV d c with switch S in position A c Capacitor C discharged by actuating switch S to position B and measured energy E1 delivered to 100 O load ET J scscicuess steeutiedectvitecdeetsndiezetnen d ME EQUIPMENT under test removed from test circuit and repeated steps b and c measuring energy E2 delivered to 100 Q load E2 J Page 35 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict EEEE S dYtC lt StSC Be Protective earthing functional earthing and potential equalization of ME EQUIPMENT 8 6 1 Requirements of 8 6 2 to 8 6 8 applied No such construction in N equipment Parts complying with IEC 60950 1 for protective earthing and serving as MEANS OF OPERATOR PROTECTION but not PATIENT PROTECTION exempted from requirements of 8 6 2 to 8 6 8 PROTECTIVE EARTH TERMINAL is suitable for connection to an external protective earthing system by a PROTECTIVE EARTH CONDUCTOR in a POWER SUPPLY CORD and a suitable plug or by a FIXED PROTECTIVE EARTH CONDUCTOR 0 2 008 f Clamping means of PROTECTIVE E
114. d for LEAKAGE CURRENT measurements a Source of LEAKAGE CURRENT loaded with measuring device or PATIENT AUXILIARY CURRENT with an impedance of approximately 1000 Q for d c a c and composite waveforms lt 1 MHz b Evaluation of current and current components based on 8 7 3 a obtained automatically when a measuring device in Fig 12a or a similar circuit used allowing measurement of total effect of all frequencies with a single instrument When currents and current components with frequencies gt 1 kHz exceeded 10 mA limit in 8 7 3 e they were measured by appropriate means c Voltage measuring instrument in Fig 12 a used with a min input resistance of 1M Q and a max input capacitance of 150 pF indicating true r m s value of voltage with an indicating error lt 5 of indicated value Scale indicates current through measuring device including automatic evaluation of components with frequencies gt 1 kHz enabling direct comparison of reading with limits in 8 7 3 Requirements limited to a frequency lt than 1 MHz when proven by oscilloscope frequencies gt such an upper limit do not occur in measured current Max Frequency HZ j 8 7 4 5 a CLASS ME EQUIPMENT tested based on Fig 13 Only Internally powered me N equipment Page 39 of 163 Report No TRS11120147 Clause EN60601 1 Requirement Test Result Remark Verdict b Current measured on more than one PROTECTIVE EARTH CONDUCTOR was aggregat
115. d in the risk management file 4 and Implementation 6 14 10 Verification Is the result of the verification activity documented 4to6 Have all functions that implement risk control measures been verified 14 11 Programmable Has the manufacturer documented the professional relationships of the members of the PEMS 3 3 electrical medical Validation team with members of the design team Ato6 systems PEMS validation Is a reference to the methods and results of the PEMS Validation included in the risk management file Page 155 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Buon oaee 15 Construction of MEE Construction of ME Has the manufacturer identified in the risk management process the risks associated with the equipment arrangement of controls and indicators Arrangements of If so inspect for the arrangement of controls and indicators controls and indicators of ME equipment 15 3 2 Push test After the push test were damages sustained that result in an unacceptable risk identified 15 3 3 Impact test After the impact test were damages sustained that resulted in an unacceptable risk identified 15 3 4 2 Portable ME After the drop test were damages sustained that resulted in an unacceptable risk identified equipment 15 3 5 Rough handling test After the rough handli
116. ded with solid insulation required b does not form part of an ENCLOSURE and not subject to handling or abrasion during NORMAL USE and comprised of three layers of material for which all combinations of two layers together passed the appropriate dielectric strength test Page 42 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Dielectric strength test for one or two layers was same as for one MEANS OF PROTECTION for SUPPLEMENTARY INSULATION Dielectric strength test for one or two layers was same as for two MEANS OF PROTECTION for REINFORCED INSULATION basic supplementary and reinforced insulation No such components required between windings of wound components separated by interleaved insulation complying with a or b or both except when N N c Wire with solid insulation other than solvent No such wire N based enamel complying with a d Wire with multi layer extruded or spirally No such wire N wrapped insulation complying with b and complying with Annex L e Finished wire with spirally wrapped or multi No such wire N layer extruded insulation complying with Annex L BASIC INSULATION minimum two wrapped layers N or one extruded layer SUPPLEMENTARY INSULATION minimum two N layers wrapped or extruded REINFORCED INSULATION minimum three layers N wrapped or extruded pf Table 12 or 16 Pollution Degree 1 depending on type of insula
117. dentifying marking also provided referring to instructions in ACCOMPANYING DOCUMENTS Fuses and replaceable THERMAL CUT OUTS and No fuses replaceable thermal OVER CURRENT RELEASES accessible only by a cut outs or over current TOOL identified by type and full rating adjacent to _ releases used component V A operating speed and breaking capacity or by a reference to information in ACCOMPANYING DOCUMENTS of Table D 1 IEC 60417 5019 DB 2002 10 except for the PROTECTIVE EARTH TERMINAL in an APPLIANCE INLET according to IEC 60320 1 Markings on or adjacent to PROTECTIVE EARTH TERMINALS not applied to parts requiring removal to make the connection and remained visible after connection made Symbol 7 of Table D 1 IEC 60417 5017 DB 2002 10 marked on FUNCTIONAL EARTH TERMINALS Terminals for supply conductors marked adjacent No such Terminals to terminals except when interchanging connections would not result in a HAZARD Terminal markings included in ACCOMPANYING No Terminals DOCUMENTS when ME EQUIPMENT too small to accommodate markings Terminals exclusively for neutral supply conductor Not permanently installed me in PERMANENTLY INSTALLED ME EQUIPMENT marked equipment Markings on or adjacent to electrical connection points not applied to parts requiring removal to make connection and remained visible after connection made Statement For supply connections use wiring Not permanently installed me mat
118. devices used applied to lasers light emitting diodes LEDs and laser light barriers or similar products RISK associated with visible electromagnetic Not applicable radiation other than emitted by lasers and LEDs when applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE Page 70 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 6 Risk associated with infrared radiation other than Not applicable emitted by lasers and LEDS when applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE T 1 indicated in RISK MANAGEMENT FILE PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS Excessive temperatures in ME EQUIPMENT 11 1 1 Temperatures on ME EQUIPMENT parts did not See appended Table 11 1 1 exceed values in Tables 22 and 23 operating in worst case NORMAL USE at maximum rated ambient operating temperature T 4 Surfaces of test corner did not exceed 90 C THERMAL CUT OUTS did not operate in NORMAL No thermal cut outs used in CONDITION equipment 11 1 2 Temperature of APPLIED PARTS oP 11 1 2 1 Temperatures hot or cold surfaces and when No supplying heat to a PATIENT appropriate clinical effects of APPLIED PARTS supplying heat to a PATIENT determined and documented in RISK MANAGEMENT FILE and 10 Risk associated with ultraviolet radiation other Not applicable than emitted by lasers and LE
119. dicating the necessity for periodic checking or replacement of power source 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 Specifications of replaceable INTERNAL ELECTRICAL POWER SOURCE when provided ceeeeee Warning indicating ME EQUIPMENT must be connected to an appropriate power source when loss of power source would result in an unacceptable RISK Instructions for use includes a description of ME EQUIPMENT its functions and significant physical and performance characteristics together with the expected positions of OPERATOR PATIENT and other persons near ME EQUIPMENT in NORMAL USE Information provided on materials and ingredients PATIENT Or OPERATOR is exposed to when such exposure can constitute an unacceptable RISK See User manual Not CLASS ME EQUIPMENT See Operating Instructions in the User manual See Operating Instructions in the User manual Not supplied with an integral MULTIPLE SOCKET OUTLET Not ME SYSTEMS No connection to a separate power supply No additional power source used Internal batteries used in ME equipment Not result in an unacceptable RISK See User manual No such unacceptable RISK Page 23 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Restrictions specified on other equi
120. e current in protective earthing system of installation c MANUFACTURER specified a test PROCEDURE and configuration for measurement of EARTH LEAKAGE CURRENT for FIXED ME EQUIPMENT with connections to earth through building structure Measurement made with MD between earth and each part of the ENCLOSURE not PROTECTIVELY EARTHED Measurement made with MD between earth and No protectively earthed any part of ENCLOSURE normally PROTECTIVELY EARTHED under SINGLE FAULT CONDITION of interruption of any PROTECTIVE EARTH CONDUCTOR INTERNALLY POWERED ME EQUIPMENT investigated _ Internally powered me for TOUCH CURRENT only between parts of equipment ENCLOSURE not between ENCLOSURE and earth except when 8 7 4 6 c was applicable b A metal foil 20x10 cm max applied in contact with ENCLOSURE or relevant part of ENCLOSURE made fully or partly of insulating material Metal foil was not in touch with any PROTECTIVELY EARTHED metal parts of ENCLOSURE except metal parts of ENCLOSURE not PROTECTIVELY EARTHED partly or fully covered by metal foil Metal foil arranged to contact parts of ENCLOSURE normally PROTECTIVELY EARTHED when measuring TOUCH CURRENT under SINGLE FAULT CONDITION of interruption of a PROTECTIVE EARTH CONDUCTOR Foil size increased based on area of contact when surface of ENCLOSURE in contact with PATIENT or OPERATOR was larger than 20x10 cm cmxcm additionally tested using transformer T2 when required see 8 1 a
121. e Debugging Flow Chart PEMS used to perform and document PEMS and Certification and VALIDATION Verification records in Software Validation Report See the information about the person with overall responsibility for PEMS VALIDATION in related management procedure The person with overall responsibility for PEMS VALIDATION is independent of design team and no member of a design team can be responsible for PEMS VALIDATION of their own design All professional relationships of members of PEMS VALIDATION team with members of design team documented in RISK MANAGEMENT FILE referencing methods and results of PEMS VALIDATION Continued validity of previous design documentation assessed under a documented modification change PROCEDURE Technical description includes the following Not intended to be connected information when PEMs is intended to be connected to other equipment outside control of PEMS MANUFACTURER by NETWORK DATA COUPLING a characteristics of NETWORK DATA COUPLING necessary for PEMS to achieve its INTENDED USE b list of HAZARDOUS SITUATIONS resulting from a failure of NETWORK DATA COUPLING to provide the specified characteristics c instructions to RESPONSIBLE ORGANIZATION containing following information and warnings connection of PEMS to a NETWORK DATA COUPLING that includes other equipment could result in previously unidentified RISKS to PATIENTS Or OPERATORS and RESPONSIBLE ORGANIZATION should iden
122. e RISK 4 8 All components and wiring whose failure could P result in a HAZARDOUS SITUATION used in accordance with their applicable ratings except as specified or by RISK MANAGEMENT PROCESS Page 8 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Reliability of components used as MEANS OF No MEANS part N PROTECTION assessed for conditions of use in ME EQUIPMENT and they complied with one of the following a applicable safety requirements of a relevant IEC See appended Table 8 10 P OF ISO standard sasesana lates Mate tt aaie b requirements of this standard applied in the See appended Table 8 10 amp P absence of a relevant IEC or ISO standard risk management report Tests conducted on motors 13 28 amp 13 2 13 3 P and transformers 15 5 3 together with evaluation of their insulation system according to Table 22 represent all required tests ME SYSTEM components providing isolation from P non ME EQUIPMENT evaluated to Clause 16 4 9 A COMPONENT WITH HIGH INTEGRITY See appended Table 8 10 amp P CHARACTERISTICS provided because a fault in a risk management report particular component can generate an unacceptable RISK COMPONENTS WITH HIGH INTEGRITY P CHARACTERISTICS selected and evaluated consistent with their conditions of use and reasonable foreseeable misuse during EXPECTED SERVICE LIFE Of ME EQUIPMENT by reviewing RISK MANAGE
123. ed to protective or functional earthing Page 36 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict This requirement applied also where N interchangeable parts are PROTECTIVELY EARTHED 8 6 7 Terminal for connection of a POTENTIAL N EQUALIZATION CONDUCTOR complies with following Terminal is accessible to OPERATOR with ME N EQUIPMENT in any position of NORMAL USE Risk of accidental disconnection minimized in N NORMAL USE Terminal allows conductor to be detached N without a TOOL Terminal not used for a PROTECTIVE EARTH N CONNECTION Terminal marked with symbol 8 of Table D 1 N i e symbol IEC 60417 5021 DB 2002 10 Instructions for use contain information on N function and use of POTENTIAL EQUALIZATION CONDUCTOR together with a reference to requirements of this standard POWER SUPPLY CORD does not incorporate a N POTENTIAL EQUALIZATION CONDUCTOR FUNCTIONAL EARTH TERMINAL not used to provide a PROTECTIVE EARTH CONNECTION 8 6 8 8 6 9 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 only as functional earth connection to the screen s FUNCTIONAL EARTH TERMINAL and colored green and yellow Two MEANS OF PROTECTION provided by insulation N of internal screens and all internal wiring connected to them with a related explanation in technical
124. ed with surfaces corners and edges are addressed SNAN to 9 with surfaces corners and edges 9 4 2 4 3 Are the risks caused by mechanical hazards associated with movement over a threshold addressed ae to 9 e 9 5 1 5 1 Have the risks caused by mechanical hazards associated with expelled parts been addressed wale to 9 9 6 1 Acoustic energy Have the risks caused by mechanical hazards associated with acoustic energy and vibration been LAN to 9 General addressed 9 6 2 2 Infrasound and Have the risks caused by mechanical hazards associated with infrasound and ultrasound energy been 3 to 9 ultrasound energy addressed T Pneumatic and Have the risks caused by mechanical hazards associated with pneumatic and hydraulic parts been 3to9 hydraulic parts addressed Pressure rating of ME Have the risks caused by mechanical hazards associated with pressure rating of MEE parts been 3to9 equipment parts addressed Page 148 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria 14971 2000 Pressure control Have the risks caused by mechanical hazards associated with pressure control device been 3 to9 device Se ee eee Pressure relief device Have the risks caused Have the risks caused by mechanical hazards associated with a pressure relief device been addressed mechanical
125. egligible Two failures resulting from a SINGLE FAULT P CONDITION causing a secondary SINGLE FAULT CONDITION considered as one SINGLE FAULT CONDITION Only one fault applied at a time during the tests P under SINGLE FAULT CONDITION Results of RISK ANALYSIS used to determine which P failures should be tested Failure of any one component at a time that could P result in a HAZARDOUS SITUATION including those in 13 1 simulated physically or theoretically Risk associated with failure of component during P EXPECTED SERVICE LIFE Of ME EQUIPMENT taken into account to evaluate if a component should be subjected to failure simulation Evaluation done by applying the principles of RISK P MANAGEMENT taking into account reliability TENSILE SAFETY FACTORS and rating of components During simulation of SINGLE FAULT CONDITIONS P highly probable or undetectable component failures simulated Requirements and relevant tests of this clause not P applied to failures of DOUBLE or REINFORCED INSULATION Or COMPONENTS WITH HIGH INTEGRITY CHARACTERISTICS Specific requirements and tests associated with P SINGLE FAULT CONDITIONS in 13 2 applied together with the tests for failures identified from evaluation of the results of RISK ANALYSIS SINGLE FAULT CONDITIONS applied one at a time as P described in 13 2 did not lead directly to the HAZARDOUS SITUATIONS in 13 1 or any other outcome resulting in an unacceptabl
126. ement creepage and pivoting of castors no further movement of MOBILE ME EQUIPMENT gt 50 mm in relation to inclined plane occurred MM j 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 activated mm 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 supplied in their worst case position 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 lt 1 5 m from floor RISK due to initial movements assessed taking into consideration NORMAL USE of ME 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 Handles when supplied suitably placed to enable ME EQUIPMENT or its part to be carried by two or more persons and by examination of EQUIPMENT its part or ACCOMPANYING DOCUMENTS Page 62 of 163 Report N
127. er current releases used Page 88 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict e Capacitors or other spark suppression devices not connected between contacts of THERMAL CUT f Use of THERMAL CUT OUTS or OVER CURRENT RELEASES do not affect safety of ME EQUIPMENT as verified by following tests Positive temperature coefficient devices PTC s complied with IEC 60730 1 1999 clauses 15 17 J 15 and J 17 as applicable ME EQUIPMENT containing THERMAL CUT OUTS and OVER CURRENT RELEASES operated under the conditions of Clause 13 SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent functions other than PTC s Certified in accordance with appropriate IEC standards In the absence of Certification in accordance with IEC standards SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent functions other than PTC s operated 200 times Manual reset THERMAL CUT OUTS and OVER CURRENT RELEASES Certified in accordance with appropriate IEC standards In the absence of certification per IEC standards or data from MANUFACTURER demonstrating reliability of component to perform its safety related function manual reset THERMAL CUT OUTS and OVER CURRENT RELEASES operated 10 times Thermal protective devices tested separately from me equipment when engineering judgment indicated test resu
128. erability to Not including NETWORK DATA tampering unintended interaction with other COUPLING programs and viruses Suitably validated tools and PROCEDURES assuring each RISK CONTROL measure reduces identified RISK S satisfactorily provided in addition to PEMS requirements in Clause 6 1 of ISO 14971 Page 83 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict There is a documented requirement specification See Software requirements for PEMS and each of its subsystems e g fora specification and Device PESS which includes ESSENTIAL PERFORMANCE Hazard Analysis in Software and RISK CONTROL measures implemented by that validation Report system or subsystem An architecture satisfying the requirement is See Software architecture specified for PEMS and each of its subsystems specifications in Software validation Report The architecture specification makes use of See Software architecture considers the specified items to reduce RISK to an SPecifications and Device acceptable level where appropriate Hazard Analysis in Software validation Report COMPONENTS WITH HIGH INTEGRITY CHARACTERISTICS And also see the software related risk management in Risk management report loo cal d diversity Not appropriate E e partitioning of functionality i f defensive design potentially limiting hazardous effects by restricting available output power or by introducing means to limit t
129. ered by internal voltage or for both a c and d c tested in battery tested with batteries conditions see 5 4 related to the least favorable voltage nature of supply and type of current f Some tests performed to determine the least favorable supply configuration Page 11 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict d ME EQUIPMENT with a MAINS PART for connection Not such equipment N to d c SUPPLY MAINS tested with d c only Possible effects of polarity on operation of ME N EQUIPMENT was taken into account based on instructions for use e ME EQUIPMENT tested with alternative NIBP cuff ACCESSORIES and components specified in ACCOMPANYING DOCUMENTS to result in the least favorable conditions ceeceeeeeeeeeeeeeteteeteteeees f ME EQUIPMENT connected to a separate power No separate power supply N supply as specified in instructions for use used with equipment 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 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 8 7 4 and 8 8 3 Manually
130. erials suitable for at least X C X gt than max equipment temperature measured in terminal box or wiring compartment under NORMAL USE and CONDITIONS or equivalent marked at or near the point supply connections made under conditions of this clause Statement not applied to parts requiring removal to make the connection and CLEARLY LEGIBLE after connections made Marking of controls and instruments he ihe Page 19 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict The on and off positions of switch used to No mains switch used in control power to ME EQUIPMENT or its parts equipment including mains switch marked with symbols 12 and 13 of Table D 1 IEC 60417 5007 a 2002 10 and IEC 60417 5008 DB 2002 10 indicated by an adjacent indicator light or indicated by other unambiguous means The on off positions of push button switch with bi stable positions marked with symbol 14 of Table D 1 IEC 60417 5010 DB 2002 10 and P status indicated by an adjacent indicator light or a Ee status indicated by other unambiguous means __ Indicated by LCD display The on off positions of push button switch with momentary on position marked with symbol 15 of Table D 1 symbol 60417 5011 DB 2002 10 or ae status indicated by an adjacent indicator light or E Pea status indicated by other unambiguous means P
131. est The tests of this standard for motors 4 to 9 Equipment see 13 2 8 and 13 2 13 3 and transformers see 15 5 3 are considered to be comprehensive and together with the evaluation of the motor or transformer insulation system according to Table 22 represent all testing required by this standard ME system components that provide isolation from non ME equipment are evaluated to clause 16 Are specific exceptions made for any component of the device under investigation to allow it to be used not in accordance with its specified rating If so are these exceptions formulated as the result of the risk management process If so have inspection or test requirements been formulated to make the hazardous situations acceptable Use of components Compliance is checked by inspection of the risk management file and the selection criteria for the 4 with high integrity components with high integrity characteristics 5 characteristics in ME Are components with high integrity characteristics applied If so have the risks associated with its use been identified as such during the risk assessment process or in other words are they selected and evaluated consistent with their conditions of use and reasonably foreseeable misuse during the expected service life of the ME equipment 5 General requirements for testing MEE Page 143 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the applicatio
132. est voltage applied to all PATIENT CONNECTIONS Of DEFIBRILLATION PROOF APPLIED PART connected together excluding those PROTECTIVELY EARTHED or functionally earthed Peak voltage at Y1 and Y2 after operation of S Vib stents htoves haut vied ndee a Peak voltage at Y1 and Y2 after operation of S with Vy reversed Vp ccceceeeseeeeceeeeeeeeeeeenteees ME EQUIPMENT connected to circuit of Fig 10 for differential mode test and voltage applied to each PATIENT connection of DEFIBRILLATION PROOF APPLIED PART in turn with all remaining PATIENT CONNECTIONS of the same DEFIBRILLATION PROOF APPLIED PART connected to earth A single PATIENT CONNECTION APPLIED PART not subjected to differential mode test ME EQUIPMENT except for PERMANENTLY INSTALLED ME EQUIPMENT tested with and without PROTECTIVE EARTH CONDUCTOR connected insulating surfaces of APPLIED PARTS covered N with metal foil or when appropriate immersed in a 0 9 saline solution external connections to a FUNCTIONAL EARTH N TERMINAL removed i pd ah ae LO pf ee a i Page 34 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict parts specified in 8 5 5 1 a not PROTECTIVELY N EARTHED connected in turn to a display device N ME EQUIPMENT connected to SUPPLY MAINS and operated in accordance with instructions for use Peak voltage at Y1 and Y2 after operation of S N V applied to PATIENT CONNE
133. exceeded 10 peak to peak limit 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 This requirement applied to other HAND HELD parts when disturbance or breaking of one or more of connections could result in a HAZARDOUS SITUATION 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 in a HAZARDOUS SITUATION as shown by manual tests and RISK MANAGEMENT FILE Guiding rollers of insulated conductors prevent bending of movable insulated conductors around a radius of less than five times the outer diameter of the 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 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 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 No Cord connected HAND HELD parts and cord connected foot operated control devices
134. exible cord IEC 60245 1 2003 Annex A designation 53 or ordinary polyvinyl chloride sheathed flexible cord IEC 60227 1 1993 Annex A designation 53 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 8 11 3 3 NOMINAL cross sectional area of conductors of POWER SUPPLY CORDS of ME EQUIPMENT is not less than in Table 17 MM Cay sera tazeacnasesetes tensed 8 11 3 4 APPLIANCE COUPLERS complying with IEC 60320 1 are considered to comply with 8 11 3 5 and 8 11 3 6 8 11 3 5 Cord anchorage for APPLIANCE COUPLERS not complying with IEC 60320 1 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 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 insulating material or metal insulated from conductive ACCESSIBLE PARTS NON PROTECTIVELY EARTHED by a MEANS OF PROTECTION or MEANS OF PROTECTION c Cord anchorage prevents cord from being clamped by a screw bearing directly on cord insulation d Screws to be operated when replacing POWER SUPPLY CORD do not serve to secure any
135. f anesthetic 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 eeccceceeeeeeeeeteteeestteeeeneeees Corona cannot be produced by components or parts of ME EQUIPMENT operating at more than 2000 V a c or more than 2400 V d c and not included in ENCLOSURES complying with G 5 4 or G 5 5 ME EQUIPMENT its parts or components do not Not category ap me ignite FLAMMABLE ANESTHETIC MIXTURES WITH AIR equipment under NORMAL USE and CONDITIONS based on compliance with G 5 2 to G 5 5 inclusive 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 oe f 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 vertical air circulation by convection or 200 C in case of unrestricted vertical air circulation measured at 25 C comply with G 5 1 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 Measured Imax lt lz with
136. facture coming into direct or indirect contact with biological tissues cells or body fluids assessed and documented according to ISO 10993 Interruption and restoration of power supply did Not result in a HAZARDOUS not result in a HAZARDOUS SITUATION except SITUATION interruption of its intended function ACCURACY OF CONTROLS AND INSTRUMENTS AND PROTECTION AGAINST HAZARDOUS OUTPUTS confirmed by RISK MANAGEMENT FILE review RISK of poor USABILITY including those associated See Risk Management Report with identification marking and documents and Report based on IEC addressed in a USABILITY ENGINEERING PROCESS as 60601 1 6 provided by the confirmed by review of provided records manufacture The need for alarm systems as a means of RISK No need for alarm systems CONTROL and RISKS associated with operation or failure of alarm system addressed in RISK MANAGEMENT PROCESS RISKS associated with accuracy of controls and See the table in chapter 4 in instruments stated in RISK MANAGEMENT PROCESS Risk Management Report 12 4 Protection against hazardous output 12 4 1 RISKS associated with hazardous output arising No hazardous output from intentional exceeding of safety limits addressed in RISK MANAGEMENT PROCESS as 7 8 41 2 3 confirmed by review of RISK MANAGEMENT FILE confirmed by review of RISK MANAGEMENT FILE 12 4 3 RISKS associated with accidental selection of excessive output values for ME EQUIPMENT with a mu
137. fluences during the test c Test conditions modified and results adjusted accordingly when ambient temperature could not be maintained P N a ME EQUIPMENT tested under least favorable working conditions specified in instructions for use and identified during RISK ANALYSIS except as noted N b ME EQUIPMENT with adjustable or controlled operating values by anyone other than SERVICE PERSONNEL adjusted to values least favorable for the relevant test according to instructions for use c When test results influenced by inlet pressure No such influence and flow or chemical composition of a cooling liquid tests performed within the limits of these characteristics based on technical description d Potable water used for cooling Not used such way for cooling a Effects of deviations of supply voltage from its RATED value on test results taken into account Supply voltage during tests was the least 6 0Vdc favorable of the voltages specified in 4 10 or voltages marked on ME EQUIPMENT V n se b ME EQUIPMENT with a MAINS PART intended for Supplied by internal batteries N connection to a c SUPPLY MAINS tested only with a c at marked RATED frequency 1 Hz up to and including 100 Hz and 1 above 100 HZ ME EQUIPMENT marked with a RATED frequency range tested at the least favorable frequency within the range HZ ccecceeeeeeeseeeeeeteeeeeeeees c ME EQUIPMENT with more than one RATED Only pow
138. gen enriched gaS Constructional requirements for fire ENCLOSURES of ME EQUIPMENT ME EQUIPMENT met this clause for alternate means of compliance with selected HAZARDOUS SITUATIONS and fault conditions in 13 1 2 Following constructional requirements were met Po Or following constructional requirements Following constructional N specifically analyzed in RISK MANAGEMENT FILE requirements were met Specific justification provided when requirement N not met a Flammability classification of insulated wire No such insulated wire within N within fire ENCLOSURE is FV 1 or better based on fire ENCLOSURE IEC 60695 series as determined by examination of data on materials Page 74 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict Flammability classification of connectors printed See appended Table 8 10 and circuit boards and insulating material on which related Certification for components are mounted is FV 2 or better material data based on IEC 60695 11 10 as determined by examination of data on materials In absence of Certification FV tests based on EC 60695 11 10 conducted on 3 samples of complete parts or sections of a part including area with minimum thickness and ventilation openings b Fire ENCLOSURE met following 1 No openings at bottom or as specified in Fig 39 constructed with baffles as in Fig 38 or made of perforated metal as in Table 25 or a metal screen w
139. harge of parts etc Remarks Yes No Supplementary information No MAINS PART Note 1 AC AIR CLEARANCE CD CREEPAGE DISTANCE Page 124 of 163 Report No TRS11120147 8 9 3 2 Table Thermal cycling tests on one sample of insulating compound forming N solid insulation between conductive parts Dielectric strength test oa Each test duration and temperature Heuk test voltage E mE No U elie ae I kee to 5 7 except for 48 h only HES 18 Breakdown Yes No 68hatT1 2 C __ C 1 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hat Ti 2 C C 2 That25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C 3 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C 4 1hat25 C 2 C 2hat0 C 2 C 1 or more h at 25 C 2 C Supplementary information 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 Page 125 of 163 Report No TRS11120147 8 9 3 4 Table Thermal cycling tests on one sample of cemented joint see 8 9 3 3 N Dielectric strength test a ee Each test duration and temperature Heuk test voltage PO aE EN ER a a No MS ES eae E to 5
140. he application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Bee eae Type B applied parts Has the manufacturer identified in their risk management file unearthed Type B applied parts that are not separated from unearthed conductive accessible parts however determined that the level of risk that the unearthed accessible part will make contact with a source of voltage or leakage current above permitted limits is acceptably low If so accepted If not then one means of protection is required PATIENT Leads Has the manufacturer identified in their risk management process connectors for electrical connections on a patient lead at the end of the lead remote from the patient and that contains a conductive part that is not separated from all patient connections by one MOPP for a working voltage equal to the maximum mains voltage that will not present an unacceptable risk from contact with objects other than a mains socket or a flat surface e g corners or edges If so during product safety verification the test using a straight unjointed test finger with a force of 10 N is not required however the remaining inspections of this clause are required Protective earthing of Does the manufacturer s risk management file indicate the need to bond moving parts to the protective moving parts earth connection If so has the manufacturer demonstrated the reliability of the connection during the expected ser
141. ic strength and bending tests by removing each sample from the mandrel and placing it in a container surrounded by min 5 mm of metal shot Page 107 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict The ends of conductor in the sample were sufficiently long to avoid flash over and the shot was no more than 2 mm in diameter and consisted of stainless nickel or nickel plated iron The shot was gently poured into container until sample covered by at least 5 mm of shot and the shot cleaned periodically with a suitable solvent e g 1 1 1 trichloroethane 1500 V for BASIC and SUPPLEMENTARY N INSULATION Usa tes cae i esa sesaantasa ae aaa rs E V Test voltage applied between the shot and N conductor Mandrel diameter and tension applied as in L 3 2 N 118 MPa 11 8 MPa 118 N mm 11 8 NMA e ates en n a n I na i Tests during manufacture Production line dielectric strength tests conducted N by the manufacture according to L 4 2 and L 4 3 Test voltage for routine testing 100 testing is at 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 SUPPLEMENTARY INSULATION V 0 scceeeesteeeeeeees d 3000 V r m s or 4200 V peak for REINFORCED INSULATION V cccccsscccssseecsteeecseecceeecseeeeaeeesseeenes Sampling tests conducted using twisted pair samples according to IEC 60851 5 1996 clause
142. icular tests as applicable 4 4 EXPECTED SERVICE LIFE stated in RISK See Risk Management Report P MANAGEMENT FILE 45 Alternative means of addressing particular RISKS See Risk Management Report P considered acceptable based on MANUFACTURER S justification that RESIDUAL RISKS resulting from application of alternative means are lt to RESIDUAL RISKS resulting from requirements of this standard 4 6 RISK MANAGEMENT PROCESS identifies parts that See Risk Management Report P can come into contact with PATIENT but not defined as APPLIED PARTS subjected to the requirements for APPLIED PARTS except for 7 2 10 4 7 ME EQUIPMENT remained SINGLE FAULT SAFE or the considered P RISK remained acceptable as determined by 4 2 Page 7 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a ME EQUIPMENT with a single means of reducing See Risk Management Report P a RISK having negligible probability of failure considered SINGLE FAULT SAFE or Risoses appended lables 10 b a SINGLE FAULT CONDITION occurred except as See Risk Management Report P follows initial fault detected during EXPECTED SERVICE P LIFE of ME EQUIPMENT and before a second means for reducing a RISK failed e g suspended masses with MECHANICAL PROTECTIVE DEVICES or probability that the second means of reducing P the RISK would fail during EXPECTED SERVICE LIFE of ME EQUIPMENT was n
143. id RISK MANAGEMENT FILE examined to determine the appropriate test conditions sealed rechargeable batteries exempted No liquid used during normal use of the equipment N 13 2 7 Impairment of cooling that could result in a HAZARD using test method of 11 1 No cooling mean N 13 2 8 Locking of moving parts Only one part locked at a time Also see 13 2 10 below No moving parts provided N 13 2 9 Interruption and short circuiting of motor capacitors Motor capacitors short amp open circuited Also see 13 10 No Motor capacitors N 13 2 10 Additional test criteria for motor operated ME EQUIPMENT in 13 2 8 amp 13 2 9 Page 135 of 163 Report No TRS11120147 Clause Results observed HAZARDOUS No caer SITUATION Description of SINGLE FAULT CONDITION Yes No For every test in SINGLE FAULT CONDITION of 13 2 8 See remark in Clause N and 13 2 9 motor operated EQUIPMENT stared from 13 2 10 COLD CONDITION at RATED voltage or at the upper limit of RATED voltage range for specified time Temperatures of windings determined at the end of N specified test periods or at the instant of operation of fuses THERMAL CUT OUTS motor protective devices Temperatures measured as specified in 11 1 3 d _ N Temperatures did not exceed limits of Table 26 N 13 2 11 Failures of components
144. ide of metal ENCLOSURE using a standard test finger as in Fig 6 complied with requirements for CREEPAGE and CLEARANCES When relevant CREEPAGE and CLEARANCES measured after use of test hook in 5 9 2 2 Conductors and connectors of ME EQUIPMENT adequately secured or insulated to prevent accidental detachment in a HAZARDOUS SITUATION their support point are not capable of touching circuit points resulting in a HAZARDOUS SITUATION as indicated in RISK MANAGEMENT FILE Stranded conductors are not solder coated when secured by clamping means to prevent poor contact which could create HAZARDOUS SITUATIONS 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 indicated by measurement or using test finger Page 50 of 163 EN60601 1 Report No TRS11120147 Clause Requirement Test Result Remark Verdict 8 10 4 8 10 4 1 Cord connected HAND HELD parts and cord connected foot operated control devices Control devices of ME EQUIPMENT and their associated 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 two MEANS OF PROTECTION d c limit of 60 V applied to d c with no more than 10 peak to peak ripple 42 4 V peak limit applied when ripple
145. ied in the risk management file the need to protect against contact with of wiring moving parts friction at sharp corners and edges or damage during assembly or the opening or closing of access covers of internal cables wiring cord forms or components where the damage or insulation damage could result in a hazardous situation If so inspect these parts carefully considering their location and potential damage during assembly disassembly contact with moving parts and friction at sharp corners and edges Mains fuses and over Has the manufacturer provided justification for omission of fuses or over current releases in the risk current releases management file If so inspect the circuit according to the requirements of this clause ensuring double insulation and acceptable fault condition tests results 9 Protection against mechanical hazards of MEE and MES HAZARDs associated Are protective measures used to reduce the risk from contact with moving parts with moving parts G neral Considering use as indicated in the Accompanying Documents or reasonably foreseeable misuse and bearing in mind the ease of access the ME Equipment function the shape of the parts the energy and speed of the motion and the benefits to the patient is this risk reduced to an acceptable level Is exposure to moving parts needed for MEE to perform its intended function Have all reasonable protective measures including warning markings on the M
146. igurations constitute the highest risks and which measures are needed to ensure that the reconfiguration does not constitute an unacceptable risk 17 Electromagnetic compatibility of MEE and MES Electromagnetic Does the risk management process address the risks associated with the electromagnetic phenomena existing compatibility of ME at the locations where the ME equipment or ME System is intended to be used as indicated in the equipment and ME accompanying documents systems Does the risk management process address the risks associated with the introduction by the ME equipment or ME system of electromagnetic phenomena into the environment that might degrade the performance of other devices electrical equipment and systems Page 158 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria a Note This document includes clauses from IEC 60601 1 which have guidance for inspection requirements of the manufacturer s risk management file risk control measures and risk management process The document does not address other clauses from IEC 60601 1 which include key terms for example RISK with or without qualifying words such as unacceptable acceptable and significant HAZARD HAZARDOUS SITUATION These clauses do not necessarily require the manufacturer to include them in their ri
147. ilar N unacceptable RISK are automatically vessels depressurized when ME EQUIPMENT is isolated from its power supply Means provided for isolation or local N depressurizing reservoirs and similar vessels and pressure indication when above not possible Page 64 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict provided with clearly identified exhaust devices __ from its power supply and a warning to depressurize these elements before setting or maintenance activity Maximum pressure a part of ME EQUIPMENT can be N subjected to in NORMAL and SINGLE FAULT CONDITIONS considered to be highest of following a RATED maximum supply pressure from an No external source N external source b Pressure setting of a pressure relief device No such part N provided as part of assembly 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 All elements remaining under pressure after No elements remaining under N isolation of ME EQUIPMENT or an ACCESSORY from _ pressure after isolation of ME its power supply resulting in an unacceptable RISK EQUIPMENT or an ACCESSORY A pressure vessel withstood a HYDRAULIC TEST PRESSURE when pressure was gt 50 kPa and product of pressure and volume was gt 200 kPa l
148. in equipment and ME normal or foreseeable misuse and the type of sterilization systems Page 152 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria ke Compatibility with Has the manufacturer identified all substances to which the ME Equipment may come into contact with substances used with in normal or foreseeable misuse the ME equipment 12 Accuracy of controls and instruments and protection against hazardous outputs Accuracy of controls Has the manufacturer identified all controls and instruments contained on the ME Equipment and instruments Has the manufacturer conducted a hazard analysis to identify the risks associated with the accuracy of the above identified controls and instruments Alarm systems Has the manufacturer considered in their option analysis the inclusion of alarms as a means to mitigate 3 9 the risk of accuracy of controls and instruments for controlling hazards against hazardous outputs If yes has the use of alarms been implemented as a means of mitigating the risk of accuracy of controls and instruments for controlling hazards against hazardous outputs If yes has the manufacturer in their risk analysis explored and addressed the hazards of operation or failure of the alarm systems Does the residual risk of such hazards meet IEC 60601 1 8 12 4 1
149. in the sense of this clause h ME EQUIPMENT not provided with a device Only Internally powered causing disconnection of ME EQUIPMENT from equipment no mains parts SUPPLY MAINS by producing a short circuit resulting in operation of an overcurrent protection device i Parts within ENCLOSURE of ME EQUIPMENT with a_ No parts within enclosure of circuit gt 42 4 V peak a c or 60 V d c that cannot me equipment with a circuit gt be disconnected from its supply by an external 42 4 Vpeak a c or 60 V d c switch or a plug device accessible at all times is protected against touch even after opening ENCLOSURE by an additional covering EQUIPMENT to indicate it exceeds allowable touch voltage symbol 10 of Table D 1 is insufficient 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 MULTIPLE SOCKET OUTLETS integral with ME No Multiple socket outlets EQUIPMENT complied with 16 2 d second dash 8 11 3 POWER SUPPLY CORDS 8 11 3 1 MAINS PLUG not fitted with more than one POWER Only Internally powered SUPPLY CORD equipment no mains parts and Power supply cords N A clear warning notice is marked on outside of ME Page 52 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 8 11 3 2 POWER SUPPLY CORDS are no less robust than ordinary tough rubber sheathed fl
150. ins part RATED MAINS VOLTAGES up to 300 V were values for r m s or d c RATED MAINS VOLTAGE in Table 13 plus additional CLEARANCE in Table 14 for PEAK WORKING VOLTAGE 8 9 1 11 Overvoltage category II applied according to IEC Only internally power supply 60664 1 equipment 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 was required for use of ME EQUIPMENT on overvoltage category II SUPPLY MAINS guidance provided on values required in the rationale for 8 9 used A SECONDARY CIRCUIT derived from a SUPPLY Internally powered me MAINS normally considered to be overvoltage equipment category according to IEC 60664 1 when the MAINS PART is overvoltage category II Table 15 Table 15 applied to earthed SECONDARY CIRCUIT or INTERNALLY POWERED ME EQUIPMENT and 14 used for an unearthed SECONDARY CIRCUIT derived from a SUPPLY MAINS 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 Table 15 column for circuits not subject to transient overvoltages applied to d c SECONDARY CIRCUITS reliably connected to earth and have capacitive filtering limiting peak to peak ripple to 10 of d c vol
151. intended to protect b Installed to be readily accessible for inspection N maintenance and repair c Could be adjusted or rendered inoperative N without a TOOL d With discharge opening located and directed as i not to release material towards any person e With discharge opening located and directed as gt not to deposit material on parts that could result in an unacceptable RISK 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 in control of supply pressure g No shut off valve provided between a pressure relief device and parts it is intended to protect h Min number of cycles of operation 100 000 except for one time use devices bursting disks ME EQUIPMENT parts designed to support loads or provide actuating forces when a mechanical fault could constitute an unacceptable RISK Construction of support suspension or actuation system complied with Table 21 and TOTAL LOAD Means of attachment of ACCESSORIES prevent possibility of incorrect attachment that could result in an unacceptable RISK 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 RISK ANALYSIS included effects of failures such as excessive deflection plas
152. ith a mesh lt 2 x 2 mm centre to centre and wire diameter of at least 0 45 mm 2 No openings on the sides within the area that is included within the inclined line C in Fig 39 3 ENCLOSURE baffles and flame barriers have See appended Table 8 10 and adequate rigidity and made of metal except related Certification for magnesium or of non metallic materials except material data constructions based on Table 25 and a mesh FV 2 or better for TRANSPORTABLE ME EQUIPMENT and FV 1 or better for fixed ME EQUIPMENT or STATIONARY ME EQUIPMENT per IEC 60695 11 10 as determined by examination of ENCLOSURE or flammability classification based on 11 3 a anesthetics CATEGORY AP or anesthetics with oxidants CATEGORY APG comply with Annex G MANUFACTURER S RISK MANAGEMENT PROCESS Not intended for use in addresses possibility of fire and associated conjunction with flammable mitigations as confirmed by examination of RISK agents MANAGEMENT FILE Overflow spillage leakage ingress of water or particulate matter cleaning disinfection sterilization and compatibility with substances used with the ME EQUIPMENT Sufficient degree of protection provided against overflow spillage leakage ingress of water or particulate matter cleaning disinfection and sterilization and compatibility with substances used with ME EQUIPMENT Page 75 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdi
153. ithium batteries that could become a HAZARD No Lithium batteries used N complied with appropriate tests of IEC 60086 4 Tests of IEC 60086 4 waived on the lithium N battery based on examination of design 15 4 3 5 A properly RATED protective device provided within Not such risk that can result in N INTERNAL ELECTRICAL POWER SOURCE to protect against fire caused by excessive currents when in case of a short circuit cross sectional area and layout of internal wiring or rating of connected components can result in a fire Protective device has adequate breaking capacity m to interrupt the maximum fault current Justification for OVER CURRENT RELEASES or FUSE exclusion is included in RISK MANAGEMENT FILE 15 4 4 Indicator lights provided to indicate ME EQUIPMENT The apparent to operator from is ready for NORMAL USE except when apparent to normal operating position and OPERATOR from normal operating position and marking of 7 4 1 are marking of 7 4 1 are insufficient for this purpose insufficient for this purpose An additional indicator light provided on ME No stand by state or warm up EQUIPMENT with a stand by state or a warm up requirements state exceeding 15 s except when apparent to OPERATOR from normal operating position Indicator lights provided on ME EQUIPMENT No non luminous heaters incorporating non luminous heaters to indicate used heaters are operational when a HAZARDOUS SITUATION could exist except when apparent to OPERATO
154. lause 7 2 permissible environmental conditions of use See Specifications in the including conditions for transport and storage User manual all characteristics of ME EQUIPMENT including See Specifications in the range s accuracy and precision of displayed User manual values or where they can be found special installation requirements such as max __ Not special installation N permissible apparent impedance of SUPPLY MAINS permissible range of values of inlet pressure No cooling liquid used and flow and chemical composition of cooling liquid used for cooling a description of means of isolating ME It has such means in ME EQUIPMENT from SUPPLY MAINS when such means EQUIPMENT not in ME EQUIPMENT a description of means for checking oil level in No oil filled ME EQUIPMENT or partially sealed oil filled ME EQUIPMENT or its parts its parts when applicable Page 25 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a warning statement addressing HAZARDS that See Operating Instructions in can result from unauthorized modification of ME the User manual EQUIPMENT according to following examples WARNING No modification of this equipment is allowed WARNING Do not modify this equipment without authorization of the manufacturer WARNING If this equipment is modified appropriate inspection and testing must be
155. llowing conditions 1 when temperature of material raised to its ignition temperature 2 when temperatures affected solder or solder joints causing loosening short circuiting or other failures resulting in sparking or increasing material temperature to its ignition temperature 3 when parts affecting safety cracked or changed their outer shape exposing temperatures gt 300 C or sparks due to overheating 4 when temperatures of parts or components exceeded 300 C atmosphere was 100 oxygen contact material solder and fuel cotton Page 72 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict 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 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 Alternative test in this clause did not identify existence of ignition sources at highest voltage or current respectively A safe upper limit determined by dividing upper limit of voltage or current respectively with safety margin factor Of three ee eeeeeeeeeeneeeeeeeeees b RESIDUAL RISK of fire in an OXYGEN RICH ENVIRONMENT as determined by application of RISK MANAGEMENT PROCESS is based on following configurations each by itself or in combinatio
156. lti purpose unit designed to provide low and high intensity outputs for different treatments addressed in RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE 12 4 4 When applicable RISKS associated with incorrect output addressed in RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE 12 4 5 Diagnostic or therapeutic radiation 12 4 2 When applicable need for indication of Not applicable parameters associated with hazardous output addressed in RISK MANAGEMENT PROCESS as Page 77 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 12 4 5 1 Adequate provisions made to protect PATIENTS No Diagnostic or therapeutic OPERATORS other persons and sensitive devices radiation in vicinity of unwanted or excessive radiation emitted by ME EQUIPMENT designed to produce radiation for diagnostic or therapeutic purposes Radiation safety ensured by compliance with requirements of appropriate standards RISKS associated with diagnostic X rays i addressed in RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE RISKS associated with radiotherapy addressed in i RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE 12 4 5 4 RISKS associated with ME EQUIPMENT producing diagnostic or therapeutic radiation other than diagnostic X rays and radiotherapy addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANA
157. lts would not be impacted g Protective device provided on ME EQUIPMENT incorporating a fluid filled container with heating means operated when heater switched on with container empty preventing occurrence of an unacceptable RISK due to overheating 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 examination of design and RISK MANAGEMENT FILE 15 4 2 2 Temperature settings clearly indicated when means provided to vary setting of THERMOSTATS 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 accumulation and ignition as verified by examination of design and RISK MANAGEMENT FILE Page 89 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 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 15 4 3 3 Overcharging of battery prevented by virtue of No chargeable battery used design when it could result in an unacceptable RISK as verified by review of design 15 4 3 4 L
158. mbination considered as an ME SYSTEM Tests performed with ME EQUIPMENT connected to separate power supply when one specified When a generic separate power supply specified specification in ACCOMPANYING DOCUMENTS examined No HAZARDOUS SITUATION other than absence of N ESSENTIAL PERFORMANCE developed when a connection with wrong polarity made for ME EQUIPMENT supplied from an external d c source ME EQUIPMENT connected with correct polarity did not present an unacceptable RISK Protective devices that can be reset by anyone without a TOOL restore correct operation on reset Classification of APPLIED PARTS DOCUMENTS as suitable for DIRECT CARDIAC APPLICATION iS TYPE CF b An APPLIED PART provided with a PATIENT The applied part is type BF 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 or b is a TYPE B BF Or CF d Requirements of a TYPE B APPLIED PART applied The applied part is type BF to a part in 4 6 to be subjected to requirements for an APPLIED PART except marking Requirements for a TYPE BF or CF APPLIED PART See Risk Management applied as in RISK MANAGEMENT PROCESS Report 8 1 8 2 8 2 2 8 3 8 4 Limitation of voltage current or energy i a APPLIED PART specified in ACCOMPANYING No type CF applied parts Page 27 of 163 Report No TRS11120147 EN60601 1 Requirement Test
159. ment PORTABLE part with SAFE WORKING LOAD lifted to a height as in Table 29 above a 50 mm 5 mm thick hardwood board at least the size of sample lying flat on a concrete floor or rigid base dropped 3 times from each orientation in NORMAL USE No damage resulting in an unacceptable RISK sustained as determined by examination of sample and RISK MANAGEMENT FILE Each sample of MOBILE ME EQUIPMENT and MOBILE Not mobile me equipment and part with SAFE WORKING LOAD and in most adverse no mobile part condition in NORMAL USE passed specified tests 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 attached to a floor without the sample going over obstruction 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 on a rigid base with direction of movement perpendicular to face of descending step until full descent was achieved 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 affixed to a vertical rigid support with movement perpendicular to face of obstacle No damage resulting in an u
160. mplies with requirements to minimize arcing and sparking due to penetration Of foreign objects 0 eee eee eeeeeeeeeeteeeeeettaeeeeeenaes no openings on top covers of ENCLOSURE except for openings for controls covered by control knobs openings in side covers prevented penetration of a solid cylindrical test rod of 4 mm in diameter applied in all possible directions 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 c Short circuiting conductor s to a conductive part without presence of explosive gasses where insulation may contact a part containing a FLAMMABLE ANESTHETIC 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 a Electrostatic charges prevented on CATEGORY AP and APG ME EQUIPMENT by a combination of appropriate measures Use of antistatic materials with a limited electrical resistance as specified in G 4 3 b Page 101 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict 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 b Electrical resistance limits o
161. n 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 identified in 11 2 3 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 0 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 Effect of possible leaks and failures under SINGLE FAULT CONDITION that could cause ignition evaluated using a RISK ASSESSMENT to determine maintenance intervals by examination of documentation and RISK MANAGEMENT FILE 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 having reached PATIENT Page 73 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result
162. n appropriately shaped opening Cord guard complied with test of IEC 60335 1 2001 Clause 25 14 or 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 D gram D in mm attached to the free end of cord g Cord guard of temperature sensitive material tested at 23 C 2 C and flat cords bent in the plane of least resistance Radius of curvature of the cord immediately after mass was attached was not less than 1 5 x D MAINS TERMINAL DEVICES N PERMANENTLY INSTALLED and ME EQUIPMENT with Only Internally powered Non DETACHABLE POWER SUPPLY CORD replaceable equipment no Mains terminal by SERVICE PERSONNEL provided with MAINS devices TERMINAL DEVICES ensuring reliable connection 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 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 Zz Screws and nuts clamping external conductors do 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 4 2 Arrangement of MAINS TERMINAL DEVICES Page 54 of 163 Report No TRS11120147 EN60601
163. n of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Annee Type Tests The tests to be performed are determined taking into consideration the requirements of clause 4 in particular 4 2 For the selection of the tests to be performed is a risk management process according to IS014971 applied If so this requirement is fulfilled The results of the risk analysis are used to determine which combination s of simultaneous faults are to be tested For the determination of which combination s of simultaneous faults have to be tested is a risk assessment applied Other conditions Unless otherwise specified in this standard ME equipment is to be tested under the least favorable working conditions as specified in the Instructions for Use that are identified during the risk analysis For testing of the ME equipment have the least favorable working conditions been identified via the risk analysis Humidity Where the risk management process suggests that the ME equipment can be exposed to high humidity preconditioning for extended periods the period is extended appropriately treatment Has it been determined via the application of the risk management process whether the ME equipment can be exposed to high humidity for extended periods If so is the period for testing been extended appropriately following the conclusions of the risk management process Actuating mechanisms nspection of the risk management file demo
164. n the function is no longer needed No marking applied when an interlock provided es er O Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts Maximum power loading of heating elements or lamp holders designed for use with heating lamps marked near heater or in heater itself W No used with heating elements or heating lamps An identifying marking referring to instruction in ACCOMPANYING DOCUMENTS provided for heating elements or lamp holders designed for use with heating lamps that can be changed only by SERVICE PERSONNEL using a TOOL Symbol 24 of Table D 1 symbol IEC 60417 5036 DB 2002 10 or safety sign 3 of Table D 2 used to mark presence of HIGH VOLTAGE parts No high voltage parts Type of battery and mode of insertion when applicable is marked cceeeceeeeeeeteeeeteees An identifying marking provided referring to instructions in ACCOMPANYING DOCUMENTS for batteries intended to be changed only by SERVICE PERSONNEL using a TOOL 4 x AA batteries used in equipment The battery can be changed by the user Page 18 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict 7 4 A warning provided indicating replacement of No such risk 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 An i
165. nacceptable RISK sustained as determined by examination of sample and RISK MANAGEMENT FILE When appropriate review of available data and The material of had been examination of ENCLOSURE constructed from approved molded or formed thermoplastic material indicated shrinkage or distortion of material due to release of internal stresses caused by molding or forming operations will not result in an unacceptable RISK See appended table 8 10 Page 87 of 163 EN60601 1 Requirement Test Report No TRS11120147 Result Remark Verdict Mould stress relief test conducted in the absence of data by placing one sample of complete ME EQUIPMENT ENCLOSURE and framework or for large EQUIPMENT a portion of ENCLOSURE ina circulating air oven at 10 C over than max temperature measured on ENCLOSURE in 11 1 3 but no less than 70 C for 7h 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 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 Incorrect connection of accessible connectors removable without a TOOL prevented where an unaccep
166. nation of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing and tests 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 m for 1 min Kg Damage or deflection resulting in an unacceptable RISK did not occur on foot rest and its secured joints Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing and by a test PATIENT support suspension system set in most unfavorable NORMAL USE position and a mass of 60 of part of SAFE WORKING LOAD simulating PATIENT Of OPERATOR or a min 80 kg placed on support or suspension system with center of load 60 mm from outer edge of support or suspension system for at least one minute Kg Deflection of support suspension system resulting N in an unacceptable RISK did not occur Dynamic forces that can be exerted on equipment parts supporting or suspending a PATIENT or OPERATOR in NORMAL USE did not result in an unacceptable RISK as confirmed by following test PATIENT Support suspension system set in most unfavorable NORMAL USE position and a mass as in Fig 33 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
167. nd no detectable deterioration of transformer a For RATED voltage lt 500 V or RATED frequency lt 60 Hz test voltage 5 times RATED voltage or 5 times upper limit of RATED voltage range of that winding and a frequency 5 times RATED frequency RATED frequency is the normal operating frequency of transformer input voltage b For rated voltage gt 500 V or RATED frequency gt 60 Hz twice RATED voltage or twice the upper limit of RATED voltage range of that winding and a frequency gt twice RATED frequency Test voltage at winding with highest RATED voltage did not exceed test voltage in Table 6 for one MEANS OF PROTECTION when RATED voltage of such a winding was considered as WORKING VOLTAGE When above occurred test voltage on primary winding reduced accordingly and test frequency adapted to produce in the core approximately magnetic induction present in NORMAL USE 3 phase transformers tested using a 3 phase testing device or by 3 consecutive tests using a single phase testing device Value of test voltage with respect to core and to any screen between primary and secondary windings was based on specification of relevant transformer Connection point for neutral of SUPPLY MAINS on primary winding connected to core and screen when provided except when core and screen are for connection to an unearthed part of circuit Connections to core omitted where core of transformer was isolated from all external conducti
168. necessary i Measuring device connected to each PATIENT CONNECTION in turn since PATIENT CONNECTIONS of APPLIED PART are loaded under NORMAL USE ME EQUIPMENT with an APPLIED PART except for Only one applied part with one with only a single PATIENT CONNECTION tested only a single patient based on Fig 19 with a measuring supply circuit connection PATIENT AUXILIARY CURRENT measured between a single PATIENT CONNECTION and all other PATIENT CONNECTIONS connected directly together or loaded as in NORMAL USE PATIENT LEAKAGE and AUXILIARY CURRENTS for ME _ Only one applied part with EQUIPMENT with multiple PATIENT CONNECTIONS did only a single patient not exceed limits for NORMAL CONDITION while one connection or more PATIENT CONNECTIONS are disconnected from the PATIENT and disconnected from the PATIENT and earthed fr st Actual measurements limited to representative number of combinations 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 aS one MEANS OF PROTECTION Insulation forming MEANS OF OPERATOR PROTECTION and complying with IEC 60950 1 for INSULATION CO ORDINATION not tested as in 8 8 Solid insulation forming SUPPLEMENTARY or No such peak working voltage REINFORCED INSULATION for a PEAK WORKING greater than 71 V and no such VOLTAGE greater than 71 V provi
169. nent A statement in technical description indicates See Maintenance information upon request MANUFACTURER will provide circuit in the User manual diagrams component part lists descriptions calibration instructions or other information to assist SERVICE PERSONNEL to repair parts 7 9 3 4 Means used to comply with requirements of Not intended connected to 8 11 1 clearly identified in technical description supply mains 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 Page 26 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 8 PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT Limits specified in Clause 8 4 not exceeded for See Clause 8 4 ACCESSIBLE PARTS and APPLIED PARTS in NORMAL or SINGLE FAULT CONDITIONS NORMAL CONDITION considered as simultaneous occurrence of situations identified in Clause 8 1a SINGLE FAULT CONDITION considered to include the occurrences as specified in Clause 8 1b Lo ACCESSIBLE PARTS determined according to 5 9 ie SS l E LEAKAGE CURRENTS measured according to 8 7 See clause 8 7 Requirements related to power sources 8 2 1 When ME EQUIPMENT specified for connection toa Supplied by internal batteries separate power source other than SUPPLY MAINS separate power source considered as part of ME EQUIPMENT or co
170. ng all reasonable protective measures N No such trapping zone a i a Gaps in Clause 9 2 2 2 or Page 56 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Safe distances in Clause 9 2 2 3 or GUARDS and protective measures in 9 2 2 4 or Continuous activation in Clause 9 2 2 5 Control of relevant motion complied with 9 2 2 6 when implementation of above protective measures were inconsistent with INTENDED USE of ME EQUIPMENT Or ME SYSTEM A TRAPPING ZONE considered not to present a MECHANICAL HAZARD when gaps of TRAPPING ZONE complied with dimensions specified in Table 20 N A TRAPPING ZONE considered not to present a N MECHANICAL HAZARD when distances separating OPERATOR PATIENT and others from TRAPPING ZONES exceeded values in ISO 13852 Distances measured from expected positions of N OPERATOR PATIENT and others near EQUIPMENT in NORMAL USE or under foreseeable misuse 9 2 2 4 GUARDS and protective measures A TRAPPING ZONE considered not to present 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 FIXED GUARDS securely held in place by systems that cannot be dismantled without a TOOL Movable GUARDS that can be opened without a TOOL remained attached when GUARD wa
171. ng test were damages sustained that resulted in an unacceptable risk identified 15 4 1 Construction of Has the manufacturer identified electrical hydraulic and pneumatic or gas connection terminals and 3 to9 connectors connectors removable without the use of a tool where incorrect connection to other outlets intended for other functions would not result in unacceptable risks If so ensure that incorrect connection does not result in an unacceptable risk Gas connectors must comply with item b of this clause 15 4 2 1 Temperature and Has the manufacturer identified in the risk management file any automatic resetting thermal cut outs 3 to 4 a overload control or over current releases where their use would not result in an unacceptable risk devices If so ensure that the resetting of these devices does not result in unacceptable risks Application Application Has the manufacturer identified in the risk management file the use of thermal cut outs with a safety 3 to5 function If so ensure that such components are not of the types that have to be reset by a soldering operation that can affect the operating value Page 156 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Considerations for application of RM criteria Evidence ISO 14971 2000 15 4 2 1 Application Has the manufacturer identified the use of a thermostat in the
172. nly items that have been specified as part of ME SYSTEM or specified as being compatible with ME SYSTEM maximum permissible load for any MULTIPLE SOCKET OUTLET S used with ME SYSTEM Page 95 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 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 an explanation indicating RISKS of connecting any equipment supplied as a part of ME SYSTEM to MULTIPLE SOCKET OUTLET permissible environmental conditions of use for ME SYSTEM including conditions for transport and instructions to OPERATOR not to simultaneously touch parts referred to in 16 4 and PATIENT d the following instructions provided for use by RESPONSIBLE ORGANIZATION adjustment cleaning sterilization and disinfection PROCEDURES 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 sufficiently describe the other equipment to ens
173. nstrates that the relevant part is unlikely to become detached 4 unintentionally during the expected service life of the ME equipment Has the result of the risk analysis demonstrated that the relevant part is unlikely to become detached unintentionally during the expected service life time of the ME equipment and that an acceptable residual risk results MEE Identification markings and documents Usability of the Compliance is checked by inspection of the usability engineering process identification marking as the manufacturer addressed in a usability engineering process the risk of poor usability and documents Page 144 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Bae eae General Compliance is checked by inspection of the risk management file accompanying Has the manufacturer applied the risk management process to determine which information also needs documents format to be provided as hard copy or as marking on the ME equipment see also Table C 4 8 Protection against electrical hazards from MEE Fundamental rule of Has the manufacturer identified in their risk analysis if the interruption of any one power carrying 4 3 protection against conductor between MEE parts in separate enclosures might cause permitted limits voltage current electric shock ene
174. nternally powered me RATED voltage or voltage within RATED voltage equipment range resulting in highest measured value V WORKING VOLTAGE for d c voltages with superimposed ripple was average value when peak to peak ripple did not exceed 10 of average value or peak voltage when peak to peak ripple exceeded 10 of average value V WORKING VOLTAGE for each MEANS OF Subjected to 1000Vd c PROTECTION forming DOUBLE INSULATION was voltage DOUBLE INSULATION as a whole subjected Intentional or accidental earthing of PATIENT regarded as a NORMAL CONDITION for WORKING VOLTAGE involving a PATIENT CONNECTION not connected to earth 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 ahy part Of APPLIED PART V eeens WORKING VOLTAGE for DEFIBRILLATION PROOF No defibrillation proof applied APPLIED PARTS determined disregarding possible parts presence of defibrillation voltages WORKING VOLTAGE was equal to resonance No such motor used 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 conductors V eeen Classification DEFIBRILLATION PROOF APPLIED PART applied to one APPLIED PART in its entirety but not separate functions of same APPLIED PART Possibility of an OPERA
175. ntifies criteria that must be met for the issue to be closed it identifies the action to be taken to resolve each problem RISK MANAGEMENT PROCESS MANUFACTURER considered HAZARDS associated with software and hardware aspects of PEMS including NETWORK DATA COUPLING components of third party origin and legacy subsystems when compiling list of known or foreseeable HAZARDS In addition to the material in ISO 14971 Annex D See Section safety list of possible sources for HAZARDS associated characteristics identification with PEMS includes specified causes and Risk analysis and control in Risk management report failure of NETWORK DATA COUPLING to provide Not including network data N characteristics necessary for PEMS to achieve its coupling BASIC SAFETY or ESSENTIAL PERFORMANCE undesired feedback physical and data No signal input or output possibilities include unsolicited input out of range or inconsistent input and input originating from electromagnetic interference unavailable data See the software validation Report lack of integrity of data See the software validation Report incorrect data See the software validation Report incorrect timing of data See the software validation Report unintended interactions within and among PESs See the software validation Report unknown aspects or quality of third party N software lack of data security particularly vuln
176. nts using the term PATIENT considered as applicable to individual s for whom 4 2 ME EQUIPMENT Or ME SYSTEM is designed for Ee P A RISK MANAGEMENT PROCESS complying with ISO See Attachments related to this 14971 was performed c cceeeceeeeteteteeteteeees ISO 14971applied with the specified P considerations Term medical device assumed same as ME P EQUIPMENT or ME SYSTEM Term fault conditions not limited to SINGLE P FAULT CONDITIONS Policy to determine acceptable RISK and See Risk Management control P acceptability of RESIDUAL RISK s established by procedure for Medical Device MANUFACTURER which is a procedure document of the manufacture Verifiable requirements of this and associated See Risk Management Report P standards complied with for particular RISKS including RESIDUAL RISKS presumed to be acceptable unless there was OBJECTIVE EVIDENCE to the contrary Requirements for inspection of RISK MANAGEMENT See Risk Management Report P FILE considered satisfied based on MANUFACTURERS established RISK MANAGEMENT PROCESS acceptable levels of RISK and acceptable RESIDUAL RISK s according to the policy for determining acceptable RISK 4 3 ESSENTIAL PERFORMANCE functions identified See Risk Management Report P according to MANUFACTURERS policy for RISK acceptability in RISK MANAGEMENT FILE ESSENTIAL PERFORMANCE functions maintained P following part
177. o TRS11120147 EN60601 1 Requirement Test Result Remark Verdict b PORTABLE ME EQUIPMENT with a mass gt 20 kg N provided with one or more carrying handles suitably placed to enable carring by two or more persons as confirmed by actual carrying c Carrying handles and grips and their means of N attachment withstood application of a force four times weight of ME EQUIPMENT in different directions of NORMAL USE and transport N j Force distributed between multiple handles when N supplied of PORTABLE ME EQUIPMENT by measuring percentage of ME EQUIPMENT weight sustained by each handle with ME EQUIPMENT in normal carrying position N Each handle of ME EQUIPMENT with multiple handles able of be carried by only one handle was capable of sustaining total force N i Force applied uniformly over a 7 cm length of handle at centre starting at zero and gradually increased to test value in 5 to 10 s and maintained for 1 min Handles did not break loose did not exhibit permanent distortion cracking or other evidence of breakdown Expelled parts HAZARD Suitability of means of protecting against No such part unacceptable RISK of expelled parts determined by assessment and examination of RISK MANAGEMENT FILE Cathode ray tube s complied with IEC 60065 2001 Clause 18 or IEC 61965 Acoustic energy including infra and ultrasound and vibration Human exposure to acoustic energy and vibration N
178. o acoustic energy and from ME EQUIPMENT doesn t result in unacceptable vibration from ME EQUIPMENT 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 Acoustic energy 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 24 h period ABA ceeecceeeeeceeeeeeeteeeeeeneeeeeeaas 140 dB un weighted sound pressure level for impulsive or impact acoustic energy noise 7 Maximum A weighted sound pressure level was measured at min distances of PATIENT OPERATOR or other persons from source of noise in NORMAL USE or calculated per ISO 3746 ISO 9614 1 or IEC61672 1 under following conditions Page 63 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a ME EQUIPMENT operated under worst case N NORMAL CONDITION b All protective means provided or called for in N ACCOMPANYING DOCUMENTS were in place during sound measurement c Sound level meters used in measurement N conform to IEC 61672 1 and IEC 61672 2 d Test room was semi reverberant with hard N reflecting floor distance between any wall or other object and surface of ME EQUIPMENT was 3 m RISK MANAGEMENT FILE examined for RISKS N associated with infrasound or ultrasound when present addressed
179. oduct emits intentional X ray radiation for diagnostic purposes equipment Has the manufacturer identified and explored risks associated with emission of X Ray radiation for diagnostic purposes 12 4 5 3 Radiotherapy Has the manufacturer identified if the product is intended for radiotherapy purposes l equipment Has the manufacturer identified and explored risks associated with emission radiation for therapeutic purposes 12 4 5 4 Other ME equipment Has the manufacturer identified if the product is intended for radiotherapy purposes producing diagnostic or Has the manufacturer identified and explored risks associated with emission radiation for therapeutic therapeutic radiation purposes Diagnostic or Has the manufacturer identified if the equipment emits an acoustic pressure output therapeutic acoustic Has the manufacturer identified and explored risks associated with emission of such acoustic pressure pressure 13 Hazardous situations and fault conditions 13 2 6 Leakage of liquid Has the manufacturer determined the appropriate test conditions for the evaluation of liquid leakage 14 Programmable electrical medical systems PEMS Programmable Does the application of ISO 14971 demonstrate that the failure of the PEss does not lead to an unacceptable electrical medical RISK systems General Programmable Have all PEMS records and documents been maintained and included in the risk management file electrical medical systems
180. og oz oe 06002 m oz oe or os og oz og 06 DOE o oz os or os og os oe o8 00r Photo 4 complete internal component V PCB 90 100 10 20 30 40 50 60 70 80 FTTH 60 70 0 10 20 30 40 50 60 70 80 90 100 10 20 30 40 5 OZ Of Ov OS 09 OL 08 06 QOL OL OZ OF OF OS 09 OL 08 06004 oz os o6 OOL oL oz os ov os og oz og os 00Z oL oz OF OF OS HTL EEE Page 161 of 161 Report No TRS11120147 Photo 5 e 3 N 8 g complete p R A o internal 8 8 g component R lt g V PCB g g amp S 2 o R g 8 8 g 7 lt 4 Eo o y 4 ii z u OL OZ Of OF OS 09 OL 08 06 QOL OL OZ Of OF OS 09 OL 08 06007 0L g 02 06 Ov OS 09 oz o8 06 OOL oL oz oe OF OS 09 OL 08 06 00Z oL oz os OF os 09 s n Photo 6 complete internal component V pump Report No TRS11120147 Page 162 of 162 Photo 7 complete internal component V pump Photo 8 complete internal component V Electron magnetic value Page 163 of 163 Report No TRS11120147 Photo 9 complete internal component V Electron magnetic value END OF TEST REPORT
181. onent E Page 60 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict 9 4 3 b ME EQUIPMENT other than FIXED ME 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 appropriate ME EQUIPMENT did not overbalance when placed on a horizontal plane and a constant downward 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 lt 1 m from the floor Means used for transportation of MOBILE ME EQUIPMENT e g castors or wheels did not result in an unacceptable RISK when MOBILE ME EQUIPMENT moved or parked in NORMAL USE Force required to move MOBILE ME EQUIPMENT along a hard and flat horizontal surface did not 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 for use indicated more than one person needed N n se MOBILE ME EQUIPMENT exceeding 45 kg configured with a SAFE WORKING LOAD moved as in NORMAL USE 10 times in forward direction over up and down a solid vertical plane obstruction installed on the floor with wheels impacting the obstruction at a speed of 0 4 m s 0 1 m s for manual or with max speed f
182. or motor driven MOBILE ME EQUIPMENT ME EQUIPMENT went up the obstruction without overbalancing or any other unacceptable RISK as determined by examination of ME EQUIPMENT its parts and RISK MANAGEMENT FILE There was no reduction of CREEPAGE and CLEARANCES below 8 9 no access to parts exceeding limits in 8 4 and no access to moving parts capable of causing HARM and Dielectric strength test of 8 8 3 conducted to evaluate integrity of solid SUPPLEMENTARY or REINFORCED INSULATION CREEPAGE DISTANCES and AIR CLEARANCES measured compared favorably with min distances in clause 8 9 Small chips not adversely affecting protection against electric shock or moisture disregarded Instability from unwanted lateral movement including sliding Page 61 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict a Brakes of power driven MOBILE ME EQUIPMENT normally activated and could only be released by continuous actuation of a control b MOBILE ME EQUIPMENT provided with locking means to prevent unwanted movements of ME EQUIPMENT or its parts in transport position c 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 Following initial elastic mov
183. otective device activate before travel movement produces an unacceptable devices General risk 9 8 4 3 Mechanical protective Does the MEE use mechanical protective devices intended for single activation 3to9 device intended for Where risks caused by mechanical hazards which have been reduced by the use of mechanical single activation i protective devices intended for single activation Page 149 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria Beery eae Systems without Has the manufacturer determined that the use of mechanical protective devices in the MEE is not mechanical protective required devices Has the manufacturer justified the reasons not to use mechanical protective devices 10 Protection against unwanted and excessive radiation hazards ME equipment When applicable has the manufacturer identified hazards and hazardous situations associated with intended to produce production of X radiation in the risk management file diagnostic or therapeutic X radiation Alpha beta gamma _ When applicable has the manufacturer identified hazards and hazardous situations associated with neutron and other production of alpha beta gamma neutron or other particle radiation in the risk management file particle radiation Microwave radiation When applicable has
184. plied part more than one APPLIED PART and different APPLIED PARTS with different classifications Safety sign 2 of Table D 2 safety sign ISO 7010 No Defibrillation proof patient W001 placed near relevant outlet when protection cable against effect of discharge of a cardiac defibrillator is partly in the PATIENT cable An explanation indicating protection of ME No Defibrillation proof patient EQUIPMENT against effects of discharge of a cardiac cable defibrillator depends on use of appropriate cables included in instructions for use ME EQUIPMENT not marked to the contrary assumed continuous operation to be suitable for CONTINUOUS OPERATION DUTY CYCLE for ME EQUIPMENT intended for non CONTINUOUS OPERATION appropriately marked to provide maximum on and off time Type and full rating of a fuse voltage current No fuse used in equipment operating speed and breaking capacity marked adjacent to ACCESSIBLE fuse holder A safety sign CLEARLY LEGIBLE and visible after No impossible to product such INSTALLATION in NORMAL USE applied to a prominent physiological effects location of EQUIPMENT that produce physiological effects capable of causing HARM to PATIENT or OPERATOR not obvious to OPERATOR Nature of HAZARD and precautions for avoiding or minimizing the associated RISK described in instructions for use Page 17 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdi
185. pment or NETWORK DATA COUPLINGS other than those forming part of an ME SYSTEM to which a SIGNAL INPUT OUTPUT PART may be connected APPLIED PARTS specified BF applied part is indicated in instructions 7 9 2 6 Information provided indicating where the See Battery Installation in installation instructions may be found e g the user manual technical description or information on qualified personnel who can perform the installation 7 9 2 7 Instructions provided indicating not to position ME Only powered by internal EQUIPMENT to make it difficult to operate the batteries disconnection device when an APPLIANCE COUPLER or separable plug is used as isolation means to meet 8 11 1 a 7 9 2 8 Necessary information provided for OPERATOR to See Setting the monitor in bring ME EQUIPMENT into operation including initial the User manual control settings and connection to or positioning of PATIENT together with information on treatment and handling required prior to use of ME EQUIPMENT its parts or ACCESSORIES 7 9 2 9 All necessary information provided to operate ME See Monitor display and EQUIPMENT according to its specification including Symbols information in the explanation of controls displays and signals User manual sequence of operation connection disconnection of detachable parts or ACCESSORIES replacement of material consumed during operation Meanings of figures symbols warning statement
186. r Ratings Table 31 C measured C Supplementary information No Transformer 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 Page 138 of 163 Report No TRS11120147 15 5 2 TABLE Transformer dielectric strength after humidity preconditioning of 5 7 Transformer Test voltage applied Test voltage Test frequency Breakdown Deterioration Model Type Part No between V Hz Yes No Yes No Primary amp secondary windings Primary winding amp frame Secondary winding amp frame Supplementary information No Transformer 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 16 6 1 TABLE LEAKAGE CURRENTS in ME SYSTEM _ TOUCH CURRENT MEASUREMENTS
187. r disconnection of plug from mains supply Maximum allowable voltage V 02 1 60 Remarks Voltage measured V Voltage Measured Between 1 2 3 4 5 6 7 8 9 10 Plug pins 1 and 2 Plug pin 1 and plug earth pin Plug pin 2 and plug earth pin Plug pin 1 and enclosure Plug pin 2 and enclosure Maximum allowable stored charge when 45 Remarks measured voltage exceeded 60 V uC Calculated stored charge uC Voltage Measured 1 2 3 4 5 6 7 8 9 10 Between Plug pins 1 amp 2 Plug pin 1 amp plug earth pin Plug pin 2 and plug earth pin Plug pin 1 and enclosure Plug pin 2 and enclosure Supplementary information Only Internally powered Equipment Page 110 of 163 Report No TRS11120147 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 f Maximum allowable stored charge when residual voltage exceeded 60 V uC Description of the capacitive circuit Measured residual Calculated stored i e accessible capacitor or circuit voltage V charge uC parts Remarks Supplementary information Internally powered Equipment 8 5 5 1a TABLE defibrill
188. r imprinted with characters AP according to symbol 22 in Table D 1 i e ella IEC 60417 5331 DB 2002 10 Marking is as large as possible for the particular case When above marking not possible the relevant information included in instructions for use i i i iteri N Page 100 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict 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 ACCOMPANYING DOCUMENTS contain an indication enabling the RESPONSIBLE ORGANIZATION to distinguish between CATEGORY AP and APG parts Marking clearly indicates which parts are CATEGORY AP or APG when only certain ME EQUIPMENT parts are CATEGORY AP or APG a CREEPAGE and CLEARANCES between points of POWER SUPPLY CORD connection are according to Table 12 for one MEANS OF PATIENT PROTECTION 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 c CATEGORY AP and APG not provided with a DETACHABLE POWER SUPPLY CORD except when circuit eee with G 5 3 and G 6 3 a Opening of an ENCLOSURE providing protection against penetration of gases or vapors into ME EQUIPMENT or its parts possible only with a TOOL b ENCLOSURE co
189. rature tests has been established and Non CONTINUOUS OPERATION After operating in Continuous operation standby quiescent mode until THERMAL STABILITY reached ME EQUIPMENT operated in NORMAL USE over consecutive cycles until THERMAL STABILITY was achieved again or for 7 h the shorter of the two and RATED on off periods used d Temperatures measured based on this clause See appended Tables 11 1 1 using thermocouples and or for copper windings and 11 1 2 2 by the change of resistance method e THERMAL CUT OUTS were not de activated and No Thermal cut outs test criteria was based on this clause GUARDS preventing contact with hot or cold No hot or cold accessible accessible surfaces removable only witha TOOL __ surfaces Fire prevention 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 RISK of fire in an OXYGEN RICH ENVIRONMENT Not used in conjunction with reduced by means limiting spread of fire under oxygen rich environments NORMAL or SINGLE FAULT CONDITIONS when source of ignition is in contact with ignitable material 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 a No sources of ignition discovered in an OXYGEN RICH ENVIRONMENT in NORMAL and SINGLE FAULT CONDITIONS under any of fo
190. ravel of actuators g allocation of RISK CONTROL measures to subsystems and components of PEMS a n NETWORK DATA COUPLING specification when Not including NETWORK DATA applicable COUPLING Design is broken up into subsystems each with a See Software design design and test specification where appropriate requirements specification in and descriptive data on design environment Software Validation Report included in RISK MANAGEMENT FILE Fi 8 failure modes of components and their effects Po 9 PERFORMANCE or RISK CONTROL measures Software Validation Report And see Risk management Plan in Risk Management Report milestone s when VERIFICATION is to be performed for each function 14 10 A VERIFICATION plan containing the specified See Traceability Analysis information used to verify and document functions Debugging Flow Chart and implementing BASIC SAFETY ESSENTIAL Software development SOP in eo Ea Ee ea za reat Ea aS Ea Pe Page 84 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict selection and documentation of VERIFICATION strategies activities techniques and appropriate level of independence of the personnel performing the VERIFICATION A PEMS VALIDATION plan containing validation of See Risk management Plan in BASIC SAFETY and ESSENTIAL PERFORMANCE and __ Risk Management Report and requiring checks for unintended functioning of Se
191. records for risk management See section 6 in Chapter 2 of personnel training tools training etc the Risk management Report 3 5 Risk Management a Procedure for plan See Risk management Plan development procedure b A verification plan See Chapter 2 of the Risk R c Description of device anegeMmenk Henan ae See section 7 in the Chapter 2 d Allocation of responsibilities of the Risk management e Summary of review activities nepon See section 6 in Chapter 2 of f Evidence of risk acceptability the Risk management Report criteria 3 6 Risk Management Evidence of file structure for all risk See Risk management Report File management activities 4 1 Risk Analysis Procedure for risk analysis See Risk management Procedure procedure 4 2 Intended Record of safety issue analysis See the table of Chapter 3 of use intended the Risk management Report purpose etc 4 3 Hazard Record of hazard analysis See the table of Chapter 3 of Identification the Risk management Report 4 4 Risk estimation a Definition of methods used for See the table of Chapter 4 of estimating risks the Risk management Report b Description of method s used See the table of Chapter 4 of c Record of risk estimation ine Bistmanagemenl MAPON activities See Chapter 4 of the Risk management Report 5 0 Risk evaluation a Record of risk evaluation See table in Chapter 4 of the activities Risk management Report Page 140 of 163
192. removal of No such parts parts including lamps fuses and fuse holders without a TOOL or based on instructions for use N Openings preventing entry of test finger of Fig 6 N mechanically tested with a straight un jointed test finger of the same dimensions with a force of 30 N N N 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 5 9 2 2 Test hook of Fig 7 inserted in all openings of ME No such openings in the me EQUIPMENT and pulled with a force of 20 N for 10 s equipment All additional parts that became accessible N checked using standard test finger and by inspection Conductive parts of actuating mechanisms of No such accessible parts of electrical controls accessible after removal of the tested equipment handles knobs levers and the like regarded as ACCESSIBLE PARTS 5 9 2 3 Conductive parts of actuating mechanisms not No conductive parts of considered ACCESSIBLE PARTS when removal of actuating mechanisms handles knobs etc required use of a TOOL and inspection of RISK MANAGEMENT FILE indicated the relevant part is unlikely to detach unintentionally during EXPECTED SERVICE LIFE of ME EQUIPMENT CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS ME EQUIPMENT parts thereof and APPLIED PARTS classified against electric shock as follows CLASS ME EQUIPMENT externally powered CLASS II ME EQ
193. rgency No such requirement stopping device s emergency stopping device complied with all the following except for actuating switch capable of interrupting all power a Emergency stopping device reduced RISK to an acceptable level b Proximity and response of OPERATOR to actuate emergency stopping device could be relied upon to prevent HARM c Emergency stopping device actuator was readily accessible to OPERATOR d Emergency stopping device s are not part of normal operation of ME EQUIPMENT e Emergency switching operation or stopping means neither introduced further HAZARD nor interfered with operation necessary to remove original HAZARD f Emergency stopping device was able to break full load of relevant circuit including possible stalled motor currents and the like 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 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 k Emergency stopping device is suitable for its application RISK MANAGEMENT FILE reviewed
194. rgy to be exceeded 4 4 If so then during product safety verification this must be one of the SFC s tested Has the manufacturer identified in their risk management process that a component s movement must be considered as a SFC because its lack of securement 8 10 1 over the expected service life of the MEE may cause permitted limits voltage current energy to be exceeded If so then during product safety verification this must be one of the SFC s tested Classification of Has the manufacturer identified in their risk management process the need for parts not being applied 4 3 applied parts parts to be subject to the requirements for an applied part of Type BF or Type CF re 5 If so then during product safety verification these parts are to be tested accordingly Accessible parts Has the manufacturer identified parts not being applied parts where a current exceeding the allowable 4 including applied parts touch current could flow either directly or through the body of an operator however the risk analysis determined that the probability in normal use is negligible If so then during product safety verification these identified parts do not require touch current testing Inspect the instructions for use includes instructions for the operator not to touch the relevant part and the patient simultaneously Page 145 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for t
195. rupture of a heating element or an intentionally weak part Both samples met 13 1 2 and open circuiting of a N heating element or an intentionally weak part in second sample not considered a failure by itself b ME EQUIPMENT with heating elements tested per N 11 1without adequate heat discharge and supply voltage set at 90 or 110 of RATED supply voltage least favorable of the two V 008 f Operating period stopped when a non SELF N RESETTING THERMAL CUT OUT operated or current interrupted without possibility of automatic restoration before THERMAL STABILITY ME EQUIPMENT switched off as soon as THERMAL N STABILITY established and allowed to cool to room temperature when current not interrupted Test duration was equal to RATED operating time N for non CONTINUOUS OPERATION c Heating parts of ME EQUIPMENT tested with ME N EQUIPMENT operated in NORMAL CONDITION at 110 of RATED supply voltage and as in 11 1 and 1 Controls limiting temperature in NORMAL N CONDITION disabled except THERMAL CUT OUTS 2 When more than one control provided they N were disabled in turn i l 3 ME EQUIPMENT operated at RATED DUTY CYCLE until THERMAL STABILITY achieved regardless of RATED operating time 13 2 13 3 ME EQUIPMENT with motors 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 To determine compliance with 13 2 9 and
196. s Has the RM process determined suitable limits for temperature based on the risk acceptability criteria and risk benefit analysis in association with patient state of health and whether adult paediatric or neonate Table 24 Has the manufacturer identified applied parts of the ME Equipment that can contact more than 10 of the surface area operator or patient s body or 10 of the surface area of the patient s or operator s head during normal or foreseeable misuse Has the manufacturer identified the duration of continuous or aggregate contact of these applied parts Has the manufacturer identified and addressed such risks Has the RM process determined suitable limits for temperature based on the risk acceptability criteria If the temperature limits exceed the values in table 24 has a favourable risk benefit analysis in association with patient state of health and whether adult paediatric or neonate been documented Applied parts intended s any part of the ME Equipment intended to supply heat or otherwise intended to cool a patient to supply heat to a Has the manufacturer identified and addressed the clinical risks associated with hazards patient Has the manufacturer disclosed such risks Applied parts not Does the ME equipment have any applied parts that are not intended to heat or cool the patient that intended to supply heat Could in normal or foreseeable misuse exceed 41 C or cool below ambient temperature to a patient Mea
197. s abbreviations and indicator lights described in instructions for use 7 9 2 10 A list of all system messages error messages See Troubleshooting in the and fault messages provided except when User manual messages are self explanatory an explanation of messages including important causes and possible action s that can be taken to resolve the problem indicated by the message 7 9 2 11 Necessary information provided for the OPERATOR See Taking the measurement to safely terminate operation of ME EQUIPMENT in the User manual 7 9 2 12 Detailed information provided on cleaning See Maintenance and disinfection and sterilization methods and storage in the User manual applicable parameters i e temperature pressure humidity time limits and number of cycles that can be tolerated by ME EQUIPMENT parts or ACCESSORIES specified Not applied to materials components No materials components ACCESSORIES Or ME EQUIPMENT marked for single ACCESSORIES or ME EQUIPMENT use except when required by MANUFACTURER to marked for single use be cleaned disinfected or sterilized prior to use 7 9 2 13 Detailed instructions provided on preventive See Maintenance and inspection maintenance calibration and storage in the User manual frequency of such maintenance Page 24 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Information provided for safe performance
198. s when ME EQUIPMENT or its parts were so positioned that viewpoint was the intended position of the OPERATOR or at any point within the base of a cone subtended by an angle of 30 to the axis normal to center of plane of marking and at 1 m Ambient luminance was the least favorable level in the range of 100 to 1500 Ix and observer had a visual acuity of 0 on the log Minimum Angle of Resolution log MAR scale or 6 6 20 20 corrected when necessary IX eeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeeaes markings were clearly legible for warning statements instructive statements safety signs and drawings on outside of ME EQUIPMENT from position of person performing related function markings were clearly legible for FIXED ME EQUIPMENT when the ME EQUIPMENT mounted in its position of NORMAL USE markings were clearly legible for TRANSPORTABLE and STATIONARY ME EQUIPMENT not FIXED in NORMAL USE or after dislodging ME EQUIPMENT from a wall against which it was positioned or after turning ME EQUIPMENT from its position of NORMAL USE and for dismountable rack units after removal from rack markings inside ME EQUIPMENT or parts were clearly legible when viewed from the intended position of person performing related function Page 14 of 163 Report No TRS11120147 EN60601 1 Requirement Test Result Remark Verdict Required markings can be removed only with a TOOL or by appreciable force are durable and remain
199. s de energized automatically by means located in a place where G 4 does not apply or complied with G 5 when during operation overpressure dropped below 50 Pa Pa d External surface of ENCLOSURE in which internal overpressure was maintained did not exceed 150 C in 25 C ambient under NORMAL USE and ME EQUIPMENT its parts and components enclosed in an ENCLOSURE with restricted breathing complied with the following a A FLAMMABLE ANESTHETIC MIXTURE WITH AIR did not form inside ENCLOSURE with restricted breathing when it was surrounded by a FLAMMABLE ANESTHETIC MIXTURE WITH AIR of a high concentration for at least 30 min without any pressure difference inside ENCLOSURE 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 c Gas tightness of ENCLOSURE containing inlets for flexible cords maintained when the cords were stressed by bending or pulling After the test in G 5 4 b an internal overpressure N 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 favorable perpendicular direction for 1 s Overpressure not reduced below 200 Pa ae a O N Tests waived when examination of ENCLOSURE indicated it is completely sealed or gas tight without a doubt 100 degree of certainty Operating temperature of external surface of ENCLOSURE
200. s open they are associated with an interlock preventing relevant moving parts from starting to move while TRAPPING ZONE is accessible and stops movement when the GUARD is opened Movable GUARDS complied with all applicable tests as confirmed by review of RISK MANAGEMENT FILE Protective measures provided in control system prevented moving parts from starting to move while in reach of persons N N N N N N N protective measures prevented TRAPPING ZONE N 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 when protective measure was in a SINGLE FAULT N CONDITION and an unacceptable RISK could arise one or more emergency stopping device s absence or failure of one of their components prevents starting and stops moving parts Page 57 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict RISK MANAGEMENT FILE reviewed and all conditions N confirmed Continuous activation TRAPPING ZONE not considered to present a N MECHANICAL HAZARD where impractical to make TRAPPING ZONE inaccessible when ae 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 Manually operated movements complied with this clause since mass and velocity allo
201. secured joints SAFE WORKING LOAD of ME EQUIPMENT or its parts supporting or suspending PATIENTS or OPERATORS is sum of mass of PATIENTS or mass of OPERATORS plus mass of ACCESSORIES supported or suspended by ME EQUIPMENT or its parts 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 Maximum mass of PATIENT included in SAFE WORKING LOAD of ME EQUIPMENT or its parts supporting or suspending PATIENTS adapted when MANUFACTURER Specified applications Max allowable PATIENT mass lt 135 kg marked on ME EQUIPMENT and stated in ACCOMPANYING DOCUMENTS Examination of markings ACCOMPANYING DOCUMENTS and RISK MANAGEMENT FILE confirmed compliance Page 67 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 Part of SAFE WORKING LOAD representing mass of ACCESSORIES deployed as in NORMAL USE and when not defined at worst case position permitted by configuration or ACCESSORIES attachment on support suspension parts a Entire mass of PATIENT or OPERATOR distributed over an area of 0 1 m on a foot rest temporarily supporting a standing PATIENT or OPERATOR Compliance confirmed by exami
202. sk management process Additional information The Task Force MEE Terms of Reference will basically be but not limited to Establish a consensus with methods acceptable to determine compliance with all the relevant clauses related to ISO 14971 of IEC 60601 1 Ed 3 Develop a Guideline document amp Work Instruction on how to implement the relevant clauses related to ISO 14971 of IEC 60601 1 Ed 3 Develop a Checklist aiming at to assist ME Industry Official Authorities and Stakeholders around the world Testing Laboratories and Certification Bodies to properly deal with Risk Management Develop an addendum to the Test Report Form IEC 60601 1 to cover the overall requirements pertaining to ISO 14971 To set up the content of possible trainings to cover Risk Management issues To be the Advisory Group on common understanding of ISO 14971 related to IEC 60601 1 Page 159 of 159 ANNEX photos Report No TRS11120147 Photo 1 V complete internal component PCB Photo 2 V complete internal component PCB Page 160 of 160 Report No TRS11120147 Photo 3 P g 9 complete ER e e ae V Arm cuff Sg 2 e R g component ie Q s 3 3 PCB e 2 s 2 g Boog R g g 2 8 2 s g 2 g amp s gs g 2 UT ENTE o 0z 0e Or 0S 09 OL 08 0 QOL OL OZ Oc OP 0S 09 OL en OL OZ 0C OP 0S O 05 o9 oz os 06 OOL or oz og or os
203. surements Has the manufacturer identified hazardous situations that relate to maximum heating effect of nearby surfaces If no hazardous situations are apparent has the manufacturer made appropriate declarations in the RMF Has the manufacturer identified all conditions of intended use and foreseeable misuse to determine occurrence and duration of contact with parts and applied parts that could be touched Page 151 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition con ee Considerations for application of RM criteria Evidence ISO 14971 2000 11 1 3e Measurements Has the manufacturer identified hazardous situations that relate to maximum heating effect of nearby surfaces If no hazardous situations are apparent has the manufacturer made appropriate declarations in the RMF Has the manufacturer identified all conditions of intended use and foreseeable misuse to determine occurrence and duration of contact with parts and applied parts that could be touched Risk of fire in an Has the manufacturer identified that there is a risk of fire from an oxygen rich environment oxygen rich Where scenario number 3 is applicable has the manufacturer conducted a risk assessment to determine environment hazards associated with leaks or component failures causing a source of ignition been conducted Constructional Have the specific requirements of this clause
204. t of PROCESSES cited in this Clause Documents produced from application of Clause See Risk management files 14 have been maintained and form a part of RISK and the software documents MANAGEMENT FILE in addition to RECORDS and provided by the manufacture documents required by ISO 14971 plan amp Software Validation Report provided by the manufacture At each milestone activities to be completed and VERIFICATION methods to be applied to activities have been defined Each activity including its inputs and outputs defined and each milestone identifies RISK MANAGEMENT activities that must be completed before that milestone PEMS DEVELOPMENT LIFE CYCLE tailored for a specific development by making plans detailing activities milestones and schedules A documented system for problem resolution See the Chapter II Device within and between all phases and activities of Hazard Analysis in the PEMS DEVELOPMENT LIFE CYCLE has been software validation Report developed and maintained where appropriate Problem resolution system meets the prescribed criteria depending on type of product it is documented as a part of PEMS DEVELOPMENT LIFE CYCLE Page 82 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict it allows reporting of potential or existing problems affecting BASIC SAFETY or ESSENTIAL PERFORMANCE it includes an assessment of each problem for associated RISKS it ide
205. t voltage of Table 6 CREEPAGE and CLEARANCES forming a MEANS OF PATIENT PROTECTION complied with Table 12 PROTECTIVE EARTH CONNECTIONS forming a MEANS OF PATIENT PROTECTION complied with 8 6 having passed dielectric strength test for two MEANS OF PATIENT PROTECTION considered equivalent to one MEANS OF PATIENT PROTECTION WORKING VOLTAGE across the pair and have the same NOMINAL Capacitance Vw Cn seese 8 5 1 3 Solid insulation forming a MEANS OF OPERATOR PROTECTION complied with dielectric strength test of 8 8 at test voltage of Table 6 or requirements of IEC 60950 1 for INSULATION CO ORDINATION CREEPAGE and CLEARANCES forming a MEANS OF OPERATOR PROTECTION complied with ae limits of Tables 13 to 16 inclusive or requirements of IEC 60950 1 for INSULATION CO ORDINATION PROTECTIVE EARTH CONNECTIONS forming a MEAN OF OPERATOR PROTECTION complied with Cl 8 6 or requirements and tests of IEC 60950 1 for protective earthing Page 30 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict A Y2 capacitor complying with IEC 60384 14 and No Y2 capacitor used 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 No Y1 capacitor used having passed dielectric strength test for two MEANS OF OPERATOR PROTECTION considered equivalent to
206. table RISK exists in particular 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 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 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 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 examination of design and RISK MANAGEMENT FILE 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 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 See Environmental requirement in User manual and see the approved material information in the appended table 8 10 Only one plugs for connection of patient leads NIBP cuff connection No Medical gas used No Thermal cut outs and ov
207. taeGutts nnana Test ambient C ccceeeeeeeeeeees f RATED supply voltage V 0ean j Model No Thermo Max allowable Max couple temperature from measured No RISK MANAGEMENT temperature FILE C C Thermocouple location Remarks Supplementary information No hot or cold surfaces 1 See RISK MANAGEMENT FILE containing temperatures and clinical effects Also see instructions for use Max temperature determined in accordance with 11 1 3 e Page 131 of 163 Report No TRS11120147 11 1 2 2 TABLE Excessive temperatures in ME EQUIPMENT measurement of P maximum temperature during NORMAL USE for APPLIED PARTS not intended to supply heat to a PATIENT Model No c cceseeeeeeeeeeeeeeeeeeeteeeeens ORA211 Test ambient C cccccsseeseereeeees 26 5 RATED supply voltage V f 4 AA batteries 6Vd c Model No Thermo Max allowable Max Ambient couple Thermocouple temperature from measured temperatur Remarks No EA Table 24 C temperatur e Adjust e C to 40 C C ORA211 107 Cuff 43 27 1 40 6 Supplementary information 1 Max temperature determined in accordance with 11 1 3 e 11 1 3d TABLE Temperature of windings by change of resistance method N Temperature T of winding t C R1 Q t C
208. tage Test voltage for WORKING VOLTAGE applicable to insulation was gt than in Table 6 b No breakdown occurred during tests Breakdown indicated by a rapid uncontrolled increase in current when insulation unable to restrict flow of current Corona discharge or a single momentary flashover not regarded as insulation breakdown c A large part or entire ME EQUIPMENT tested when individual solid insulation could not be tested different types and levels of insulation not overstressed and following was considered Metal foil used on non conductive surfaces of ENCLOSURE or part of it positioned to prevent flashover at edges of insulation linings When applicable metal foil moved to test all parts of surface Circuits on either side of insulation under test connected or short circuited to prevent stress on components within circuits Insulation other than wire insulation Resistance to heat retained by all insulation and insulating partition walls during EXPECTED SERVICE LIFE of ME EQUIPMENT ME EQUIPMENT and RISK MANAGEMENT FILE examined in conjunction with resistance to moisture dielectric strength and mechanical strength tests Satisfactory evidence of compliance provided by See appended table 8 10 manufacturer for resistance to heat Tests conducted in absence of satisfactory evidence for resistance to heat a ENCLOSURE and other external parts of insulating material except insulation of flexible cords and parts
209. tage and 8 9 1 13 Table 15 for PEAK WORKING VOLTAGES above 1400 No peak working voltages V peak or d c not applied because all the above 1400 Vpeak or d c following conditions were met E Requirements for primary circuits in Tables 13 8 9 1 12 Page 47 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 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 CLEARANCE path was partly or entirely through air or along the surface of an insulating material of material group 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 Minimum CREEPAGE DISTANCES for two MEANS OF OPERATOR PROTECTION obtained by doubling values in Table 16 for one MEANS OF OPERATOR PROTECTION CREEPAGE DISTANCES and AIR CLEARANCES for No defibrillation proof applied DEFIBRILLATION PROOF APPLIED PARTS are 4 mm or parts more to meet 8 5 5 1 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 CLEARANC
210. tary symbol or an affirmative statement describing the anticipated principal RISK S g Causes burns Risk of explosion etc c Safety sign 4 of Table D 2 general prohibition No use such Safety sign sign ISO 7010 2003 P001 placed together with a supplementary symbol or a statement describing what is prohibited Do not open etc d Safety sign 9 of Table D 2 general mandatory No use such Safety sign action sign ISO 7010 2003 M001 placed together with a supplementary symbol or a text statement consisting of a command describing the required action e g Wear protective gloves etc Affirmative statement together with safety sign See User manual placed in instructions for use due to insufficient space on ME EQUIPMENT Specified colors in ISO 3864 1 used for safety No used such signs SIQMSecisrs a a a E aA Safety notices include appropriate precautions or See User manual instructions on how to reduce RISK S Safety signs including any supplementary See User manual symbols or text described in instructions for use Meanings of symbols used for marking described See User manual in instructions for use Symbols required by this standard conform to IEC or ISO publication referenced 7 6 7 6 1 Lo 7 6 3 Symbols used for controls and performance conform to the IEC or ISO publication where symbols are defined as applicable 7 7 Colors of the insulation of conductors 7 7 1 PROT
211. there a risk management plan including resources and commitment for the device considered clause 3 of IS014971 e Is the overall residual risk for the device considered acceptable 4 3 Essential performance Compliance is checked by inspection of the risk management file 4 Have apart from the essential performance identified in the particular standards hazardous situations be identified whereby the residual risk is unacceptable due to the absence of performance of the device 5 If so has this performance been identified as essential performance for the device during the risk 6 4 assessment process If so have risk control measures or particular tests been identified to check whether this performance is maintained If so has this been checked by inspection or by functional test 4 Expected service life Compliance is checked by inspection of the risk management file Inspection Has the expected service life of the device been identified 45 Equivalent safety for Compliance is checked by inspection of the risk management file 4 ME Equipment of ME Are there particular risks for which alternative means of controlling these risks are applied such that the 5 System resulting risk level is acceptable for these risks If so have these risks been identified as such during the risk assessment process If so is the resulting risk level equal or less than the residual risk that results from applying the requirements of this standard Page
212. tic deformation ductile brittle fracture fatigue fracture instability buckling stress assisted corrosion cracking wear material creep and deterioration and residual stresses from manufacturing PROCESSES Page 66 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Instructions on attachment of structures to a floor wall ceiling etc included in ACCOMPANYING DOCUMENTS making adequate allowances for quality of materials used to make the connection and list the required materials Additional instructions provided on checking adequacy of surface of structure parts will be attached to Support systems maintain structural integrity during EXPECTED SERVICE LIFE and TENSILE SAFETY FACTORS are not less than Table 21 except when an alternative method used to demonstrate structural integrity throughout EXPECTED SERVICE LIFE or when support is a foot rest Compliance with 9 8 1 and 9 8 2 confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications and processing of materials 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 ME EQUIPMENT parts supporting or immobilizing PATIENTS minimize RISK of physical injuries and accidental loosening of
213. tify analyze and control such RISKS subsequent changes to NETWORK DATA COUPLING introducing new RISKS and requiring new analysis and changes to NETWORK DATA COUPLING include changes in NETWORK DATA COUPLING configuration connection of additional items to NETWORK DATA COUPLING to other equipment outside control of PEMS MANUFACTURER by NETWORK DATA COUPLING Page 85 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict disconnecting items from NETWORK DATA N COUPLING update of equipment connected to N NETWORK DATA COUPLING upgrade of equipment connected to N NETWORK DATA COUPLING CONSTRUCTION OF ME EQUIPMENT P RISKS associated with arrangement of controls See Risk management report and indicators of ME EQUIPMENT addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE 15 2 Parts of ME EQUIPMENT subject to mechanical No such part N wear electrical and environmental degradation or ageing resulting in unacceptable RISK when unchecked for a long period are accessible for inspection replacement and maintenance E 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 15 3 1 Mold stress relief push impact drop and rough handling tests did not result in unacceptable RISK and
214. tion 1 The model ORA211 and ORA210 Blood Pressure Monitor are arm type Blood Pressure Monitor which measuring the Blood pressure through arm cuff 2 All devices are powered by internal batteries 3 Unless otherwise specified all the tests are conducted on model ORA211 to represent other models 4 max operating temperature 40 degree C 5 All the models have the same construction circuit diagram and PCB layout except model ORA211 equipment have voice function Details see the following table Model ORA211 Product Picture blood pressure range pulse rate blood pressure precision pulse precision PCB layouts PCB material Construction Operation Software Enclosure material Schematic Components Voice function Has such function No such function Power supply 4xAA batteries Arm cuff dimension Size 49x14 5cm Apply to 22 32cm arm circumference Note The test subject was ORA211 Page 5 of 163 Report No TRS11120147 INSULATION DIAGRAM C 1MOPP for External Mains on A P ENCLOSURE NIBP Cuff AP Internal circuit 2MOOP 2MOPP B 2MOPP Area Operational basic voltage creepage clearance creepage clearance Remarks supplementary mm mm mm mm double reinforced A double reinforced 6 0Vdc 3 4 1 6 gt 4 0 gt 4 0 Live part battery 2MOOP to plastic enclosure 2MOPP
215. tion 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 No such Protection used N 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 dielectric strength tests of 8 8 3 Tests of Annex L not repeated since material data N sheets confirm compliance Solid insulating materials with a safety function See appended Table 8 8 3A amp withstood dielectric strength test voltages applied 8 8 3B in accordance with methods of this Clause a Waveform and frequency of test voltage resulted in dielectric stress on insulation at least equal to that in NORMAL USE Test voltage with a different waveform and N frequency than the voltage in NORMAL USE applied when manufacturer demonstrated dielectric stress on insulation tested was not diminished waveform frequency HZ esseeeeeeeeeeeeeees In d and e for spirally wrapped insulation with CREEPAGE DISTANCES between layers less than in Page 43 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Test performed with a 50 or 60 Hz sinusoidal voltage in NORMAL USE and relevant insulation subjected to a non sinusoidal a c vol
216. tive to emission of flames molten metal or ignitable substances Power dissipated less than W cceeeeeeeeeees 15 Energy dissipated less than J 900 Part or component Measured power Calculated energy SINGLE FAULT CONDITIONS Remarks tested dissipated W dissipated J waived Yes No Supplementary information See the remark in clause 13 1 2 Page 134 of 163 Report No TRS11120147 13 2 TABLE SINGLE FAULT CONDITIONS in accordance with 13 2 2 to 13 2 13 inclusive P Clause Results observed HAZARDOUS Ne Description of SINGLE FAULT CONDITION Se p Yes No 13 2 2 Electrical SINGLE FAULT CONDITIONS according to 8 1 According to the circuit structure of the Blood N Pressure Monitor It is impossible to have those electrical single fault conditions according to 8 1 13 2 3 Overheating of transformers according to 15 5 No transformers N 13 2 4 Failure of THERMOSTATS according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or interrupted the less favorable of the two NO THERMOSTATS N 13 2 5 Failure of temperature limiting devices according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or interrupted the less favorable of the two NO THERMOSTATS _ N 13 2 6 Leakage of liqu
217. uency of lt 1 KHZ HZ i a frequency deviation of lt 1 Hz from NOMINAL frequency up to 100 Hz and lt 1 from NOMINAL frequency from 100 Hz to 1 kHz Hz or deviation from NOMINAL frequency protective measures per IEC 60364 4 41 ad c voltage as measured by a moving coil Supplied by internal batteries meter or equivalent method having a peak to peak ripple lt 10 of average value V dc Peak voltage applied when peak to peak ripple exceeded 10 of average value Additional safety measures applied to ME EQUIPMENT Or ME SYSTEM intended to be operated from a SUPPLY MAINS with characteristics different from SUPPLY MAINS described in this clause i 4 11 Power input supplied by internal batteries 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 f 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 range 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 Steady state current measured with a true r m s reading instrument Power input expressed in volt amperes measured with a volt ampere meter or c
218. ult in a HAZARDOUS SITUATION in NORMAL CONDITION or in a SINGLE FAULT CONDITION ME EQUIPMENT ME SYSTEM and their parts and ACCESSORIES Cleaned or disinfected once in accordance with methods specified in instructions for use including any cooling or drying period ME EQUIPMENT met dielectric strength and See appended Tables 8 7B LEAKAGE CURRENT tests and there was no 8 7 3B 8 7 4 7 8 8 3A and deterioration resulting in an unacceptable RISK 8 8 3B Effects of multiple cleanings disinfections during See Risk Management EXPECTED SERVICE LIFE of EQUIPMENT their parts Report and ACCESSORIES evaluated by MANUFACTURER and assurance that no unacceptable RISK will occur verified by RISK MANAGEMENT FILE review 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 Page 76 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict 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 11 11 12 12 12 11 6 8 RISKS associated with compatibility of substances See Risk Management used with ME EQUIPMENT addressed in RISK Report MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE ME EQUIPMENT ME SYSTEM and ACCESSORIES Evaluated by the manu
219. ure compliance with these requirements Parts of non ME EQUIPMENT in PATIENT ENVIRONMENT subject to contact by OPERATOR during maintenance calibration etc after 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 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 WORKING VOLTAGE was highest voltage across SEPARATION DEVICE during a fault condition but not less than MAXIMUM MAINS VOLTAGE V n se Page 96 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict TOUCH CURRENT in NORMAL CONDITION from or between parts of ME SYSTEM within the PATIENT ENVIRONMENT did not exceed 100 pA 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 16 6 2 Current in PROTECTIVE EARTH CONDUCTOR of MULTIPLE SOCKET OUTLET did not exceed 5 mA 16 6 3 PATIENT LEAKAG
220. ve connections Core and screen connected to a source with an appropriate voltage and frequency with respect to neutral connection point In the absence of a neutral connection point each side of primary winding in turn connected to core and screen when provided except when core and screen specified for connection to an unearthed part of circuit Core and screen connected to a source with an appropriate voltage and frequency with respect to each side of primary winding in turn Page 93 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict All windings not intended for connection to N SUPPLY MAINS left open and common earth connection point of windings or a point nearly at earth potential connected to core except when core is for connection to an unearthed circuit part Core connected to a source with an appropriate N voltage and frequency with respect to windings Initially no more than half prescribed voltage N applied and raised over 10 s to full value maintained for 1 min and then reduced gradually and switched off Tests not conducted at resonant frequencies aa es Slight corona discharges neglected provided they N ceased when test voltage temporarily dropped to a lower value higher than WORKING VOLTAGE and discharges did not provoke a drop in test voltage 15 5 3 Transformers forming MEANS OF PROTECTION as N required by 8 5 comply with IEC 61558 1 1997 Cl
221. vice life Mechanical strength Has the manufacturer identified in the risk management file the need for insulations of all types and resistance to heat Considering its resistance to heat in the application and the expected service life Has the manufacturer identified any specific test protocols that must be performed during product safety verification If so conduct the tests required in this clause and any additional tests or inspections identified in the risk management file Fixing of components Has the manufacturer identified components the movement of which could result in an unacceptable risk in their risk management file If so verify that such identified components are securely mounted and will remain so for the expected service life Page 146 of 163 Report No TRS11120147 IEC 60601 1 2005 3 edition risk management requirements guidance for the application of ISO 14971 2000 1st edition Subject Considerations for application of RM criteria abst ee iyi iri Has the manufacturer identified in their risk management file the need to restrain by double securement 4 Fixing of wiring aes 4 6 any conductors and connectors where if they were to break free and touch circuit points this could result in a hazardous situation If so inspect the construction and restraint of these conductors and connectors to ensure that they are held in place by use of double securement Mechanical protection Has the manufacturer identif
222. was lt 150 C in 25 C C 05 Steady state ike temperature of ENCLOSURE also measured Requirements and tests for CATEGORY APG ME EQUIPMENT parts and components Ba thereof Page 104 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict ME EQUIPMENT its parts and components did not ignite FLAMMABLE ANESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE under NORMAL USE and SINGLE FAULT CONDITION 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 ina 12 2 0 4 ether by volume oxygen mixture Parts and components of CATEGORY APG ME EQUIPMENT operating in a FLAMMABLE ANESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE supplied from a source isolated from earth by insulation equal to at least one MEANS OF PATIENT PROTECTION and from electrical parts by insulation twice the MEANS OF PATIENT PROTECTION 5 Test of G 6 1 waived when the following requirements were met in NORMAL USE and under NORMAL and SINGLE FAULT CONDITIONS 0005 no sparks produced and temperatures did not acd 90 C or 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 the requirements taking Cmax and Lmax into consideration
223. wed adequate control of positioning without causing an unacceptable RISK 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 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 positioning without resulting in an unacceptable RISK Over travel stopping distance of such movement occurring after operation of a control to stop movement did not result in an unacceptable RISK RISK MANAGEMENT FILE reviewed and all conditions confirmed Controls positioned recessed or protected by It has a motor to inflate air for other means and could not be accidentally cuff No such risk actuated to result in unacceptable RISK except when ergonomic considerations for a PATIENT with special needs require otherwise RISK due to over travel past range limits of ME No such movement risk as the EQUIPMENT parts reduced to an acceptable level motor was only used to inflate and stops or other means with mechanical air for cuff strength to withstand intended loading in NORMAL USE and foreseeable misuse provided limiting measure in NORMAL and SINGLE FAULT CONDITION Page 58 of 163 Report No TRS11120147 EN60601 1 Clause Requirement Test Result Remark Verdict Where necessary to have one or more eme
224. zhong BZVO6A 6 0Vdc max gnetic value Electronic Factory 0 36W max operating temperature 40 degree C Arm cuff Wenzhou Bokang 0661 49cm x14 5cm Instruments Co Ltd Supplementary information 1 An asterisk indicates a mark which assures the agreed level of surveillance See Licenses and Certificates of Conformity for verification Page 127 of 163 Report No TRS11120147 9 2 2 2 TABLE Measurement of gap a according to Table 20 ISO 13852 1996 N Part of body Allowable adult Measured adult Allowable children gap mm gap mm gap mm N Measured Remarks mm children gap Body gt 500 gt 500 Head gt 300 or lt 120 gt 300 or lt 60 Leg gt 180 gt 180 Foot gt 120 or lt 35 gt 120 or lt 25 Toes gt 50 gt 50 Arm gt 120 gt 120 Hand wrist fist gt 100 gt 100 Finger gt 25 or lt 8 gt 25or lt 4 Supplementary information No such gaps values for children applied In general gaps for adults used except when the device is specifically designed for use with children 10 1 1 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 1 2 Measured radiation pA kg uSv h mR h Remarks 3 Al 5 6 7 8 ll m tm tm tm t mt m itm

Test report link - 163 pages Medical Electrical

Contents

Download Pdf Manuals

Related Search

Related Contents