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1. IEC 60601 1 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 2 6 3 14 10 RM RESULTS TABLE Verification N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 14 11 RM RESULTS TABLE PEMS validation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 14 13 RM RESULTS TABLE Connection of PEMS by NETWORK DATA COUPLING N A to other equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 15 1 RM RESULTS TABLE Construction of ME equipment Arrangements of N A controls and indicators of ME equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Test Report No 1403042002 Page 188 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 15 3 TABLE Mechanical Strength tests Pass Clause Name of Test Test conditions Observed results Remarks 15 3 2 Push Test Force 250 N 10 N for 5s There was no cracking of the enclosure and were no live parts Part under test that became accessible Unit Top Unit S
2. IEC 60601 1 Requirement Test Result Remark 15 4 3 5 RM RESULTS TABLE Excessive current and voltage protection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 15 4 4 RM RESULTS TABLE Indicators N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 5 RM RESULTS TABLE Pre set controls N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 15 4 6 TABLE actuating parts of controls of ME EQUIPMENT torque amp axial pull tests N A Rotating control Gripping Torque from Axial force Unacceptable Remarks under test diameter d of Table 30 Nm applied RISK occurred control knob N Yes No mm Supplementary information Gripping diameter d is the maximum width of a control knob regardless of its shape e g control knob with pointer 15 4 7 3b RM RESULTS TABLE Entry of liquids N A Test Report No 1403042002 Page 194 of 197 Issued 25 July 2014 60601 1TRF_A fos NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2
3. IEC 60601 1 Requirement Test Result Remark 9 2 4 RM RESULTS TABLE Emergency stopping devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 5 6 2 6 3 6 4 6 5 6 6 9 2 5 RM RESULTS TABLE Release of patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 3 RM RESULTS TABLE Hazards associated with surfaces corners and edges Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 02 H with the enclosure shape have been 01 C 03 identified 44 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Evaluation of risk before measures F 02 H 01 C 03 Test Report No 1403042002 Page 156 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 3 RM RESULTS TABLE Hazards associated with surfaces corners and edges Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 ONYX BE381D
4. Te SFC Ground Open 264 60 78 63 S1 1 S5 0S7 0 After Humidity Condition eap ane TC NC 264 60 7 26 S1 1 S5 1 57 1 TC NC 264 60 7 33 1 1 S55 0 S7 1 TC SFC Neutral Open 264 60 10 45 S1 0 S5 1 S7 1 TC SFC Neutral Open 264 60 10 65 S1 0 S5 0 S7 1 TC SFC Ground Open 264 60 82 12 S1 1 S5 1 S7 0 TC SFC Ground Open 264 60 82 08 1 1 55 0 S7 0 MD2 between plastic Before Humidity Condition enclosure with foil and metal enclosure TC NC 264 60 0 96 S1 1 S5 1 87 1 TC NC 264 60 0 98 S1 1 S5 0 87 1 TC SFC Neutral Open 264 60 1 09 S1 0 S5 1 S7 1 TC SFC Neutral Open 264 60 111 S1 0 S5 0 S7 1 TC SFC Ground Open 264 60 9 07 1 1 55 1 S7 0 TC SFC Ground Open 264 60 8 97 1 1 55 0 S7 0 MD2 between plastic After Humidity Condition enclosure with foil and metal enclosure TC NC 264 60 1 03 1 1 S5 1 S7 1 TC NC 264 60 1 06 1 1 55 0 S7 1 TC SFC Neutral Open 264 60 1 76 S1 0 S5 1 S7 1 TC SFC Neutral Open 264 60 1 66 S1 0 S5 0 S7 4 TC SFC Ground Open 264 60 10 23 S1 1 S5 1 S770 TC SFC Ground Open 264 60 10 13 S1 1 S5 0 S7 0 Measured with a non frequency _ _ Maximum allowed values weighted device 10 mA NC 10 mA SFC Before Humidity Condition aee any TC NC 264 60 111 1 1 S5 1 S7 1 TC NC 264 60 111 S1 1 S5 0 S7 1 TC SFC Neutral Open 264 60 16 6 1
5. Test Report No 1403042002 Page 4 of 197 Issued 25 July 2014 60601 1TRF_A LN vV VICTRONIC TECHNOLOGY CORPORATION Copy of marking plate The artwork below may be only a draft The use of certification marks on a product must be authorized by the respective NCBs that own these marks ONYX Healthcare Inc QR eens ONYX BE381DT A1 1010 c UL us sone on Cli C Fe re 18 5 Bedside Touch Monitor HDMI Input ee ee Resistive Touch Reading Light Webcam Smart Card Reader a4 For use only Power Supply HiTRON HEMGS50 S120420 7 A Input 100 240 VAC 60 50Hz Output 12 VDC 4 2 A Display Input Rating 12 V DC 4 2 A A O sace ran 2F No 135 Lane235 Pao Chiao Rd Hsin Tien City Taipei Taiwan ROC S N XXXXXXXX Test Report No 1403042002 Page 5 of 197 Issued 25 July 2014 60601 1TRF_A v VICTRONIC TECHNOLOGY CORPORATION GENERAL INFORMATION Test item particulars see also Clause 6 Classification of installation and USE ccccceeeeeeees fransportable portable stationary ilo Lfi f hand held Device type component sub assembly equipment Equipment AE P E E E E E edereavtexterseccexess Intended use Including type of patient application As part of Monitor for use in the Medical Ce ct 10 1 Beene ee eee ee gt System Mode OF OPSFAtlON s sorsi nnrir aaa Continuous men centinueus SUPPly COMNECHION aisciisssscscsccsnieicseteccessscieastanenct
6. 008 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 ecceeeeees 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 ccccsssseeccssseeeeeessseeeneseeeeees Test Report No 1403042002 Page 75 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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
7. 0 Degree of protection against ingress of water N A specified as in IEC 60529 Separating transformer assembly marked N A according to 7 2 and 7 3 MULTIPLE SOCKET OUTLET permanently N A 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 A SYSTEM will not interrupt the protective earthing of any other part without simultaneous disconnection of electrical supply to that part Additional PROTECTIVE EARTH CONDUCTORS can be N A detachable only by use of a TOOL Conductors connecting different items within an ME SYSTEM protected against mechanical damage ELECTROMAGNETIC COMPATIBILITY OF ME EQUIPMENT AND ME N A SYSTEMS Risks associated with items addressed in Risk Not evaluated by Victronic MANAGEMENT PROCESS as confirmed by review Technology Corporation electromagnetic phenomena at locations where ME EQUIPMENT Or ME SYSTEM is to be used as stated in ACCOMPANYING DOCUMENTS introduction of electromagnetic phenomena into environment by ME EQUIPMENT or ME SYSTEM that might degrade performance of other devices electrical equipment and systems Test Report No 1403042002 Page 103 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark ANNEX G PROTEC
8. a Transformers forming MEANS OF PROTECTION as required by 8 5 comply with IEC 61558 1 19 CIAUSC 5 M cccam for ME system is not considered in current status Only HAZARDS arising from combining various equipment to form a ME SYSTEM considered ME SYSTEM provides the level of safety within the 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 in NORMAL CONDITION except as specified tests performed under operating conditions specified by MANUFACTURER of ME SYSTEM Safety tests previously conducted on individual equipment of ME SYSTEM according to relevant standards not repeated RISK MANAGEMENT methods optionally used by MANUFACTURER of an ME SYSTEM reconfigurable by RESPONSIBLE ORGANIZATION Or OPERATOR to determine configurations with highest Risks and measures to ensure any configuration of ME SYSTEM will not present unacceptable RISKS Non ME EQUIPMENT used in ME SYSTEM complied with applicable IEC or Iso safety standards Equipment relying only on BASIC INSULATION for protection against electric shock not used in ME SYSTEM ACCOMPANYING DOCUMENTS of an ME SYSTEM Test Report No 1403042002 Page 98 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 6060
9. assembly of ME SYSTEMS and modifications during actual service life shall be evaluated based on the requirements of this standard 16 3 Instructions for use of ME EQUIPMENT intended to Product is a Monitor receive its power from other equipment in an application and assessment ME SYSTEM describe the other equipment to for ME system is not ensure compliance with these requirements considered in current status Parts of non ME EQUIPMENT in PATIENT Product is a Monitor ENVIRONMENT Subject to contact by OPERATOR application and assessment during maintenance calibration after removal for ME system is not of covers connectors etc without use of a considered in current TOOL operated at a voltage lt voltage in 8 4 2 c status supplied from a source separated from SUPPLY MAINS by two MEANS OF OPERATOR PROTECTION Safety measures incorporating a SEPARATION Product is a Monitor DEVICE applied when FUNCTIONAL CONNECTION application and assessment between ME EQUIPMENT and other items of an ME for ME system is not SYSTEM or other systems can cause allowable considered in current values of LEAKAGE CURRENT to exceed status Test Report No 1403042002 Page 100 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark SEPARATION DEVICE has dielectric strength CREEPAGE and CLEARANCES required for one MEANS OF OPERATOR PROTECTION appropriate f
10. 6 5 ONYX BE381DT_RMF_ Version 1 000 Project Team Team Member Task Status Misc Lead the risk benefit analysis when applicable ONYX BE381DT_RMF_ Version 1 00 Section Evaluation of Residual Risk Remaining Residual Risk Assessment Summary ONYX BE381DT_RMF __ Version 1 00 Section Evaluation After Measures Risk Benefit Analysis When applicable Project Team will lead the risk benefit analysis Pass 6 6 ONYX BE381DT_RMF __ Version 1 00 Section Evaluation After Measures ONYX BE381DT_RMF_ Version 1 00 Section Evaluation of Residual Risk The risk control measures have been reviewed to identify if other hazards are introduced Pass 6 7 ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk The manufacturer assures that the risk s from all identified hazards have been evaluated Pass Test Report No 1403042002 60601 1TRF_A Page 116 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 2 RM RESULTS TABLE Risk Management Process for ME Equipment or ME Pass Systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 7 ONYX BE381DT_RMF_ After all risk control measures have been Pass Version 1 00 Section implemented and verified the manufacturer Evaluation of Residual deci
11. After tests of this Clause settings of THERMAL No THERMAL CUT OUTS and CUT OUTS and OVER CURRENT RELEASES did not OVER CURRENT RELEASES change sufficiently to affect their safety function limits for LEAKAGE CURRENT in SINGLE FAULT See appended Table 8 7 3 CONDITION based on 8 7 3 did not exceed voltage limits for ACCESSIBLE PARTS including See appended Table 8 7 3 APPLIED PARTS in 8 4 2 did not exceed 0 ME EQUIPMENT complied with the requirements of 9 1 to 9 8 for specific MECHANICAL HAZARDS SINGLE FAULT CONDITIONS 2 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 applied in least favourable combination ME EQUIPMENT complied with 13 2 2 13 2 12 See appended Table 13 2 ME EQUIPMENT remained safe after tests of 13 2 13 2 to 13 2 13 4 inclusive and cooling down to room temperature 13 2 13 2 2 ME EQUIPMENT examined for compliance or appropriate tests such as dielectric strength of motor insulation according to 8 8 3 conducted Test Report No 1403042002 Page 82 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 at a temperature 25 C higher than
12. IEC 60601 1 15 3 3 RM RESULTS TABLE Impact test Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 02 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 15 3 4 2 RM RESULTS TABLE Portable ME equipment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RM mention the Intended use intended Pass Version 1 00 Section purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with failure of the protective enclosure have 02 C 02 been identified 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 02 C 02 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 02 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 15 3 5 RM RESULTS TABLE
13. Page 10 of 197 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 GENERAL REQUIREMENTS Pass 4 1 Requirements of this standard applied in NORMAL USE and reasonably foreseeable misuse A RISK MANAGEMENT PROCESS complying with See appended RM Results ISO 14971 was performed Table 4 2 4 3 ESSENTIAL PERFORMANCE functions identified The product is used for N A according to MANUFACTURER S policy for RISK information displaying which acceptability in RISK MANAGEMENT FILE willinot result unacceptable risk when function absence or degradation ESSENTIAL PERFORMANCE functions maintained N A following particular tests as applicable 4 4 EXPECTED SERVICE LIFE Stated in RISK The Monitor expected live Pass MANAGEMENT FILE ia esceedeetecececeeeeeeeeneeereeereeeneeeeenens was 43 800 hours Completed by inspection 4 5 Alternative means of addressing particular No alternative means applied N A RISKS considered acceptable based on in the evaluation of RM MANUFACTURER S justification that RESIDUAL RISKS report resulting from application of alternative means equal to or less than RESIDUAL RISKS resulting from requirements of this standard 1 4 6 RISK MANAGEMENT PROCESS identifies parts that The Monitor was no N A can come into contact with PATIENT but not identifies parts that can defined as APPLIED PARTS Subjected to the come into con
14. Satisfactory evidence of compliance provided See appended RM Results by manufacturer for resistance to heat gt Table 8 8 4 1 Tests conducted in absence of satisfactory evidence for resistance to heat b Parts of insulating material supporting Evaluated in part of power uninsulated parts of MAINS PART subjected to supply ball pressure testin a except at 125 C 2 C or ambient indicated in technical description 2 C plus temperature rise determined during test of 11 1 of relevant part if higher C Test not performed on parts of ceramic No such construction material insulating parts of commutators brush caps and similar and on coil formers not used as REINFORCED INSULATION 8 8 4 2 Resistance to environmental stress a ENCLOSURE and other external parts of See appended Table 8 8 4 1 insulating material except insulation of flexible cords and parts of ceramic material subjected to ball pressure test using apparatus of Fig 21 8 3 Test Report No 1403042002 Page 44 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Insulating characteristics and mechanical No such construction strength of all MEANS OF PROTECTION not likely to be impaired by environmental stresses including deposition of dirt resulting from wear of parts within EQUIPMENT potentially reducing CREEPAGE and CLEARANCES
15. z Supply voltage ME EQUIPMENT with heating elements 110 of the maximum RATED voltage Motor operated ME EQUIPMENT least favourable voltage between 90 of the minimum RATED and 110 of the maximum RATED voltage ME EQUIPMENT operated under normal load and normal DUTY CYCLE Combined heating and motor operated and other ME EQUIPMENT tested both at 110 of the maximum RATED voltage and at 90 of the minimum RATED voltage 5 APPLIED PARTS intended to supply heat to a PATIENT See RISK MANAGEMENT FILE containing temperatures and clinical effects Also see instructions for use 11 1 1 RM RESULTS TABLE Maximum temperature during normal use Pass Table 23 or 24 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF__ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with the heat generated by the device have 02 C 01 been identified 44 ONYX BE381DT RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 02 C 01 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the ri
16. ISO 14971 Document No amp paragraph Test Report No 1403042002 Page 151 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 10 5 RM RESULTS TABLE Mechanical protection of wiring Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with the forces to which the device would be 01 C 21 C 22 subject to unwanted movement of wiring has been identified 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 C 21 C 22 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 21 C 22 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF__ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 008 RC 026 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had been
17. Meanings of symbols used for marking Explanation provided for described in instructions for use 0 0 Leach related marking see Safety Symbol Description and Front Button Functions Symbols used for controls and performance No such function conform to the IEC or ISO publication where symbols are defined as applicable Colours of the insulation of conductors PROTECTIVE EARTH CONDUCTOR identified by Evaluated in part of power green and yellow insulation supply Insulation on conductors inside ME EQUIPMENT forming PROTECTIVE EARTH CONNECTIONS identified by green and yellow at least at terminations 7 7 3 Green and yellow insulation identify only PROTECTIVE EARTH CONDUCTORS Evaluated in part of power supply POTENTIAL EQUALIZATION CONDUCTORS No such construction Test Report No 1403042002 Page 24 of 197 Issued 25 July 2014 60601 1TRF_A following conductors fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark N A Neutral conductors of POWER SUPPLY CORDS are No power supply cord light blue specified in IEC 60227 1 or IEC 60245 1 7 7 5 Colours of conductors in POWER SUPPLY CORDS No power supply cord N A in accordance with IEC 60227 1 or IEC 60245 1 provides Indicator lights and controls Pass 7 8 1 Red indicator lights mean Warning i e No red colour indicator light N A immediate response by OPERATOR required Yellow in
18. Requirement Test Result Remark 8 5 5 2 TABLE DEFIBRILLATION PROOF APPLIED PARTS or PATIENT CONNECTIONS of N A DEFIBRILLATION PROOF APPLIED PARTS Energy reduction test measurement of Energy delivered to a 100 Q load F Measured Energy Measured Energy Energy E1 Test Voltage applied to E1 mJ E2 mJ as of E2 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 Supplementary information For compliance E1 must at least 90 of E2 E1 Measured energy delivered to 100 with ME Equipment connected E2 Measured energy delivered to 100 without ME equipment connected 8 6 3 RM RESULTS TABLE Protective earthing of moving parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 TABLE Impedance and current carrying capability of PROTECTIVE EARTH N A CONNECTIONS Type of ME EQUIPMENT amp impedance Test current Voltage drop Maximum M
19. Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 019 6 3 ONYX BE381DT RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had been verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 019 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 11 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 8 10 2 RM RESULTS TABLE Fixing of wiring Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Pass Test Report No 1403042002 60601 1TRF_A Page 150 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 8 10 2 RM RESULTS TABLE Fixing of wiring Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 ONYX BE381DT_RMF__ The estimates of the risk s
20. 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark b Proximity and response of OPERATOR to N A actuate emergency stopping device could be relied upon to prevent HARM c Emergency stopping device actuator was N A readily accessible to OPERATOR d Emergency stopping device s are not part N A 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 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 k Emergency stopping device is suitable for its application Means provided to permit quick and safe No such construction release of PATIENT in event of breakdown of ME EQUIPMENT or failure of power supply activation of a protective measure or emergency stopping and Uncontrolled or unintended movement of ME EQUIPMENT that could result in an unacceptable RISK prevented Situations where PATIEN
21. Document No amp paragraph 6 4 6 5 11 6 8 RM RESULTS TABLE Compatibility with substances used N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 1 RM RESULTS TABLE Accuracy of controls and equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 3 RM RESULTS TABLE Alarm systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 Test Report No 1403042002 Page 181 of 197 Issued 25 July 2014 60601 1TRF_A EN vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 12 3 RM RESULTS TABLE Alarm systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 5 12 4 1 RM RESULTS TABLE Intentional exceeding of safety limits N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 4 2 RM RESULTS TABLE Indication of parameters relevant to safety N A Clause of Document Ref in RMF Result Rem
22. Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 10 7 RM RESULTS TABLE RIsk associated with ultraviolet radiation other than N A emitted by lasers and LEDS Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 11 1 1 TABLE Excessive temperatures in ME EQUIPMENT Pass Model NO iis dion wiatkinebdncdkinns ONYX BE381DT XX XXXX Test ambient C ccecccesseesseeeeseeeeeeees See below Test Report No 1403042002 Page 169 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Test Report No 1403042002 60601 1TRF_A Page 170 of 197 Test supply voltage frequency V Hz A 90 60 N B B E B 264 60 Max allowable Max Thermo temperature from measured Model No couple Thermocouple location Table 22 23 or 24 faniberatune Remarks No or RM file for AP pa C C J See See below See below A B below 1 T1 coil power supply 120 65 3 63 5 2 T1 core power supply 120 62 9 61 0 gq e ee tent 60 54 9 51 1 40 s lt t lt 1min T1 power supply m 1min 4 Switch body 48 44 8 42 7 lt t lt 10min z Amin 2 Panel body 48 45 2 42 8 lt t lt 40min 6
23. IEC 60601 1 Requirement Test Result Remark Before Humidity Condition sleet lhe wis W oe P NC 264 60 8 08 S1 1 S5 N S7 1 13 1 P NC 264 60 8 02 S1 1 S5 R S7 1 813 1 P SFC Neutral Open 264 60 7 85 S1 0 S5 N S7 1 13 1 P SFC Neutral Open 264 60 7 88 S1 0 S5 R S7 1 S13 1 P SFC_ Ground Open 264 60 7 18 S1 1 S5 N S7 0 13 1 P SFC Ground Open 264 60 7 89 S1 1 S5 R S7 0 13 1 P SFC Ground Open 264 60 19 10 S1 1 S5 N S7 1 S13 0 P SFC Ground Open 264 60 19 14 S1 1 S5 R S7 1 S13 0 After Humidity Condition Ea a aeie o P NC 264 60 8 64 S1 1 S5 N S7 1 813 1 P NC 264 60 8 62 S1 1 S5 R S7 13 1 P SFC Neutral Open 264 60 8 16 S1 0 S5 N S7 1 S13 1 P SFC Neutral Open 264 60 8 2 S1 0 S5 R S7 1 S13 1 P SFC Ground Open 264 60 8 64 S1 1 S5 N S7 0 13 1 P SFC Ground Open 264 60 8 58 S1 1 S5 R S7 0 S13 1 P SFC Ground Open 264 60 19 94 S1 1 S5 N S7 1 S13 0 P SFC Ground Open 264 60 19 92 S1 1 S5 R S7 1 513 0 Before Humidity Condition ole aa Barn ta Touch P NC 264 60 92 5 S1 1 S5 N S7 1 813 1 P NC 264 60 92 8 S1 1 S5 R S7 1 813 1 P SFC Neutral Open 264 60 7 60 S1 0 S5 N S7 1 13 1 P SFC
24. L25 coil 105 65 8 62 6 7 C57 body 105 58 0 55 0 8 L56 coil 105 59 7 56 7 9 C115 body 105 56 8 54 2 10 PWB under U8 105 64 4 61 5 11 C77 body 105 58 7 55 9 12 PWB under U5 105 HoH 952 13 C26 body 53 7 50 8 14 C1 body Display board 100 56 2 53 4 15 L1 coil Display board 105 58 0 55 2 16 C3 body Display board 105 57 5 54 8 47 Plastic enclosure inside near 65 496 47 0 main board Plastic enclosure outside near 1min T of main board a nee See lt t lt 10min Metal part outside near USB 1min 19 port 48 47 0 45 5 lt t lt 10min 20 Test corner near rear 90 40 7 40 1 enclosure 21 Ambient _ 40 0 40 0 i 27 7 27 5 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Supplementary information Unit test position Let the I O section be always in the bottom side Table 23 Enclosure outside near T1 power supply 10 s st lt 1min Table 24 Switch body 1min lt t lt 10min Panel body 1min st lt 10min Plastic enclosure outside near of main board 1min st lt 10min Metal part outside near USB port 1min lt t lt 10min Maximum allowable temperature on surfaces of test corner is 90 C Max temperature determined in accordance with 11 1 3e 3 When thermocouples used to determine temperature of windings limits of Table 22 reduced by 10 C
25. Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 10 2 RM RESULTS TABLE Alpha beta gamma neutron amp other particle radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 10 3 RM RESULTS TABLE Microwave radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 10 5 RM RESULTS TABLE Other visible electromagnetic radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Test Report No 1403042002 Page 168 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 10 5 RM RESULTS TABLE Other visible electromagnetic radiation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 6 2 6 3 6 4 6 5 10 6 RM RESULTS TABLE Risk associated with infrared radiation other than N A emitted by lasers and LEDS Clause of Document Ref in RMF Result Remarks Verdict ISO 14971
26. Type CF AP 10 uA NC 50 uA SFC d c or a c current Fig 18 Patient leakage current with external voltage on metal Accessible Part that is not Protectively Earthed Maximum allowed values Type B or BF AP 500 uA Type CF N A Fig 19 Patient Auxiliary Current Maximum allowed values Type B or BF AP 10 uA NC 50 uA SFC d c current 100 uA NC 500 uA SFC a c Type CF AP 10 uA NC 50 uA SFC d c or a c current Fig 15 and 20 Total Patient Leakage Current with all AP of same type connected together Maximum allowed values Type B or BF AP 50 uA NC 100uA SFC d c current 500 uA NC 1000 uA SFC a c Type CF AP 50 uA NC 100 uA SFC d c or a c current Fig 17 and 20 Total Patient Leakage Current with all AP of same type connected together with external voltage on SIP SOP Maximum allowed values Type B or BF AP 50 uA NC 100uA SFC d c current 500 uA NC 1000 uA SFC a c Type CF AP 50 uA NC 100 uA SFC d c or a c current Test Report No 1403042002 60601 1TRF_A Page 141 of 197 Issued 25 July 2014 fo A 17 VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Fig 16 and 20 Total Patient Leakage Current with all AP of same type connected together with external voltage on F type AP Maximum allowed values Type B NA Type BF 5000uA Type CF
27. Worst case voltage between pins of plug and Evaluated in part of power between either supply pin and ENCLOSURE did supply not exceed 60 V one s after disconnecting the plug of ME EQUIPMENT or its parts V 0 A triggering circuit used to ensure disconnection occurred at peak of supply voltage waveform When voltage exceeded _ 60 V calculated or Evaluated in part of power measured stored charge didn t exceed 45 uC supply Residual voltage of conductive parts of Evaluated in part of power capacitive circuits having become accessible supply after ME EQUIPMENT was de energized after removal of ACCESS COVERS didn t exceed 60V or calculated stored charge didn t exceed 45uC A device manually discharging capacitors used when automatic discharging was not possible and ACCESS COVERS could be removed only with aid of a TOOL e Devices used to de energize parts when an Need tool to open access ACCESS COVER opened without a TOOL gives cover access to parts at voltages above levels permitted by this Clause comply with 8 11 1 for mains isolating switches and remain effective in SINGLE FAULT CONDITION Test Report No 1403042002 Page 33 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark Capacitor s and connected circuitry marked with symbol 24 of Table D 1 IEC 60417 5036 DB 2002 10 and manual discharging device
28. a Internal cables and wiring adequately See appended RM Results protected against contact with a moving part or Table 8 10 5 from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS SITUATION csscceseeeesecessaeeesseeenseeeesees i 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 No such construction 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 No such construction by breaking or cutting or secured at both ends is used on internal wiring of when b Sheath of a flexible cord not used as a No such construction MEANS OF PROTECTION inside ME EQUIPMENT when it is subject to mechanical or thermal stresses beyond its RATED characteristics c Insulated conductors subject to No such situation 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 s an a ME EQUIPMENT provided with means of electrically isolating its circuits from SUPPLY MAINS simultaneously on all poles ssse to a poly phase
29. amp paragraph 4 3 4 4 5 6 2 6 3 6 4 Test Report No 1403042002 Page 161 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 7 6 RM RESULTS TABLE Pressure control device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 5 9 7 7 RM RESULTS TABLE Pressure relief device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 8 1 RM RESULTS TABLE Hazards associated with support systems General Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 02 H with the support systems have been 01 C 02 considered 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 02 H 01 C 02 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section
30. extrapolated from Fig G 3 No extrapolation made for inductances larger N A than 900 mH Umax was the highest supply voltage N A occurring in circuit under investigation with sparking contact open taking into consideration MAINS VOLTAGE variations in 4 10 Test Report No 1403042002 Page 107 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark lmax 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 N A component under investigation producing sparks An equivalent circuit calculated to determine equivalent max capacitance inductance and equivalent Umax and Inax either as d c or a c peak values in case of a complicated circuit Temperature measurements made according to 11 ALE and Umax limax R Lmax and Cmax determined with application of Figs G 1 G 3 Alternatively compliance was verified by examination of e data 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 AESTHETIC MIXTURES WITH AIR that might have penetrated into ENCLOSURE of ME EQUIPMENT or part removed by ventilation before EQUIPMENT energized and penetra
31. 0 S5 1 S7 1 TC SFC Neutral Open 264 60 17 79 S1 0 S5 0 S7 1 TC SFC Ground Open 264 60 152 S1 1 S5 1 S7 0 Test Report No 1403042002 60601 1TRF_A Page 137 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Te SFC Ground Open 264 60 150 S1 1 S5 0S7 0 After Humidity Condition Aap ane TC NC 264 60 114 1 1 S5 1 S7 1 TC NC 264 60 114 1 1 S5 0 S7 1 TC SFC Neutral Open 264 60 17 7 S1 0 S5 1 S57 1 TC SFC Neutral Open 264 60 18 4 S1 0 S5 0 S7 1 TC SFC Ground Open 264 60 156 1 1 55 1 S7 0 TC SFC Ground Open 264 60 154 1 1 55 0 S7 0 MD2 between plastic Before Humidity Condition enclosure with foil and metal enclosure TC NC 264 60 25 07 S1 1 S5 1 87 1 TC NC 264 60 25 15 1 1 55 0 S7 1 TC SFC Neutral Open 264 60 24 18 S1 0 S5 1 S7 1 TC SFC Neutral Open 264 60 24 10 S1 0 S5 0 S7 1 TC SFC Ground Open 264 60 19 05 S1 1 S5 1 S7 0 TC SFC Ground Open 264 60 18 88 S1 1 S5 0 S7 0 MD2 between plastic After Humidity Condition m enclosure with foil and metal enclosure TC NC 264 60 26 12 1 1 S5 1 S7 1 TC NC 264 60 26 21 S1 1 S5 0 S7 1 TC SFC Neutral Open 264 60 25 22 S1 0 S5 1 S57 1 TC SFC Neutral O
32. 10 from mean value A VA W Marking includes long time and most relevant No such marking momentary volt ampere ratings when provided each plainly identified and indicated in ACCOMPANYING DOCUMENTS VA Marked input of ME EQUIPMENT provided with Monitor 12 V dc 4 2 A means for connection of supply conductors of Power Adapter 100 240 V other electrical equipment includes RATED and ac 60 50 Hz 1 2 0 63 A marked output of suchmeans A VA W Output connectors See 16 9 2 1 b for MULTIPLE SOCKET OUTLETS No MULTIPLE SOCKET OUTLETS N A integral with ME EQUIPMENT ME EQUIPMENT or its parts marked with the IP The equipment classified environmental Code per IEC 60529 according to IPX0 need not be marked classification in 6 3 Table D 3 Code 2 Degrees of protection against electric shock as classified in 6 2 for all APPLIED PARTS marked with relevant symbols as follows not applied to parts identified according to 4 6 TYPE B APPLIED PARTS with symbol 19 of Table D 1 IEC 60417 5840 DB 2002 10 not applied in such a way as to give the impression of being inscribed within a square in order to distinguish it from symbol IEC 60417 5333 TYPE BF APPLIED PARTS with symbol 20 of Table D 1 IEC 60417 5333 DB 2002 10 TYPE CF APPLIED PARTS with symbol 21 of Table D 1 IEC 60417 5335 DB 2002 10 DEFIBRILLATION PROOF APPLIED PARTS marked with symbols 25 27 of Table D 1 IEC 60417 5841 IEC 60417 5334 or IEC 60
33. 100 N for other components for 1 min when an axial pull was required in NORMAL USE with no unacceptable RISK issii Stops of adequate mechanical strength provided on rotating movable parts of controls of ME EQUIPMENT where necessary to prevent an unexpected change from max to min or vice versa of the controlled parameter when this could cause a HAZARDOUS SITUATION ccsseeees Torque values in Table 30 applied 10 times in each direction to rotating controls for 2 sec Application of an axial force of 60 N for electrical components and 100 N for other components to rotating or movable parts of controls for 1 min when an axial pull was required iM NORMAL USE cceseeseeeeeeceeeeeeeeseeenes N A N A N A N A IA 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 Not Cord connected hand N A complied with 15 3 4 1 held and foot operated control devices b Foot operated control device supported an actuating force of 1350 N for 1 min applied over an area of 30 mm diameter in its position of NORMAL USE with no damage to device pausing an unacceptable RISK s s ecceeeeeeeeeeeeeeeeeees Control device of HAND HELD and foot operated control devices turned in all possible abnormal positions and placed on a flat surface No unacceptable RISK caused by changing control setting when accidentally placed in an abnorma
34. 100 uA Fig 18 and 20 Total Patient Leakage Current with all AP of same type connected together with external voltage on metal Accessible Part not Protectively Earthed Maximum allowed values Type B amp BF 1000 uA Type CF N A Supplementary information Note 1 For EARTH LEAKAGE CURRENT See 8 7 3 d and 8 7 4 5 Note 2 For TOUCH CURRENT see 8 7 3 C and 8 7 4 6 Note 3 For PATIENT LEAKAGE CURRENT SEE 8 7 3 6 and 8 7 4 7 Note 4 Total PATIENT LEAKAGE CURRENT values are only relative to equipment with multiple APPLIED PARTS of the same type See 8 7 4 7 h The individual APPLIED PARTS complied with the PATIENT LEAKAGE CURRENT values Note 5 In addition to conditions indicated in the Table tests conducted at operating temperature and after humidity preconditioning of 5 7 EQUIPMENT energized in stand by condition and fully operating max rated supply frequency at 110 of the max RATED MAINS VOLTAGE and after relevant tests of Clause 11 6 i e overflow spillage leakage ingress of water and particulate matter cleaning amp disinfection amp sterilization ER Earth leakage current TC Touch current P Patient leakage current PA Patient auxiliary current TP Total Patient current PM Patient leakage current with mains on the applied parts MD Measuring device A After humidity conditioning B Before humidity conditioning 1 Switch closed or set to normal polari
35. 197 Issued 25 July 2014 60601 1TRF_A A 17 VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Only polyvinyl chloride insulated POWER SUPPLY Power supply cord used and CORD with appropriate temperature rating used metal parts of the outside for ME EQUIPMENT having external metal parts equipment lt 75 C with a temperature gt 75 C touchable by the Cord iN NORMAL USE i c secieteeeecseeteteteeeestctneeeets NOMINAL cross sectional area of conductors of POWER SUPPLY CORDS of ME EQUIPMENT is not lass than in Table 17 mm MUD PEE APPLIANCE COUPLERS complying with IEC 60320 1 are considered to comply with 8 11 3 5 and 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 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 components other than parts of cord anchorage e Co
36. 300 V were values MOPP are considered for r m s or d c RATED MAINS VOLTAGE in Table 13 plus additional CLEARANCE in Table 14 for PEAK WORKING VOLTAGE For ME EQUIPMENT intended for overvoltage category Ill Tables 13 to 15 inclusive not used for clearance instead values in the next MAINS TRANSIENT VOLTAGE column upwards used When PATIENT protection Table 12 is required for use of ME EQUIPMENT on overvoltage category lll SUPPLY MAINS guidance provided on values required in the rationale for Cl 8 9 used A SECONDARY CIRCUIT derived from a SUPPLY MAINS normally considered to be overvoltage category according to IEC 60664 1 when the MAINS PART is overvoltage category Il Table 15 Requirements for primary circuits in Tables 13 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 N A transient overvoltages applied to Test Report No 1403042002 Page 47 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark d c SECONDARY CIRCUITS reliably connected to Evaluated in part of power earth and have capacitive filtering limiting ee ripple
37. 5 6 2 6 3 6 4 6 5 9 2 2 5 c RM RESULTS TABLE Continuous activation N A Clause of ISO 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 4 2 Test Report No 1403042002 60601 1TRF_A Page 154 of 197 Issued 25 July 2014 N A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 2 2 5 c RM RESULTS TABLE Continuous activation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 2 2 6 RM RESULTS TABLE Speed of movement s N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 2 3 2 RM RESULTS TABLE Over travel N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 2 4 RM RESULTS TABLE Emergency stopping devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 Test Report No 1403042002 Page 155 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION
38. 6 2 See also RM Table for 4 6 8 4 2 TABLE TABLE Working Voltage Power Measurement N A Test supply voltage frequency V HZ sssssssssssesssesssessesssesseessesssesseesseesseeseesass Location Measured values From To Vime Vpk or Peak to Power Energy Remarks Vdc peak ripple WIVA J Test Report No 1403042002 60601 1TRF_A Page 130 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 4 2 TABLE TABLE Working Voltage Power Measurement N A Supplementary Information 1 The input supply voltage to the ME EQUIPMENT shall be the RATED voltage or the voltage within the RATED voltage range which results in the highest measured value See clause 8 5 4 2 If the d c peak to peak ripple gt 10 waveform considered as a c See clause 8 4 2 2 The adapter HITRON ELECTRONICS CORP model HEMG50 S120420 7 was certified by IEC 60601 1 2005 and EN 60601 1 2006 8 4 2 c RM RESULTS TABLE Accessible parts including applied parts Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analys
39. 8 11 1 clearly identified in technical description provided as source of electricity Table 8 1 b 1 8 1 b 2 and 8 1 b 3 NORMAL CONDITION considered as simultaneous occurrence of situations identified in 8 1a SINGLE FAULT CONDITION considered to include See appended RM Results the occurrences as specified in Clause 8 1b Table 8 1 b 1 8 1 b 2 and Test Report No 1403042002 Page 30 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark When ME EQUIPMENT specified for connection to Separated power supply a separate power source other than SUPPLY was considered as part of MAINS Separate power source considered as ME Equipment part of ME EQUIPMENT or combination considered as an ME SYSTEM Tests performed with ME EQUIPMENT connected to separate power supply when one specified When a generic separate power supply Specification of specified specified specification in ACCOMPANYING power supply examined DOCUMENTS examined No HAZARDOUS SITUATION other than absence of Design of plug will prevent ESSENTIAL PERFORMANCE developed when a wrong polarity connection connection with wrong polarity made for ME EQUIPMENT from an external d c source ME EQUIPMENT connected with correct polarity See appended RM Results did not present an unacceptable RISK Table 8 2 2 Protective devices that can be reset by anyone No re settable protecti
40. Attachment Main board Technical Documentation for details VESA Mount 8 screws provided M4 x 0 7 x 20mm Printed Various Various Minimum V 14 UL 796 UL Wiring Board 105 C LCD Panel AU Optronics M185XTN01 18 5 inch TFT Corp LCD with LED backlight Internal Various Various Minimum V 2 UL 94 UL Plastic Part Secondary Various Various 60 C minimum UL 758 UL Internal 30 V minimum Wiring low FEP PTFE Voltage PVC TFE neoprene polyimide or Test Report No 1403042002 60601 1TRF_A Page 148 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark marked VW 1 Power Listed supply cord Hospital Optional Grade maximum 4 5 m 14 76 ft long rated 105 C Type SJT flexible cord No 18 AWG min 3C One end terminates with NEMA 5 15P or NEMA 6 15P grounding type the other end with an appliance coupler Speaker 2 Various Various Two provided set 4ohm 2 5W optional Supplementary information 1 An asterisk indicates a mark which assures the agreed level of surveillance See Licenses and Certificates of Conformity for verification 8 10 1 RM RESULTS TABLE Fixing of components Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Int
41. Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards associated Risk Analysis F 01 H with accidental detachment of conductors 01 and connectors have been considered 8 2 2 RM RESULTS TABLE Connection to an external d c power sources Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards associated Risk Analysis F 08 H with connection to an external d c power 01 sources have been considered 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 08 H 01 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 08 H 01 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 8 3 d RM RESULTS TABLE Requirements of Type BF or CF Applied Parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph
42. HITRON ELECTRONICS CORP model HEMG50 S120420 7 was certified by IEC 60601 1 2005 and EN 60601 1 2006 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 60V Maximum allowable stored charge when residual voltage exceeded 60 V 45 uC Description of the capacitive circuit Measured residual Calculated stored i e accessible capacitor or circuit voltage V charge uC parts Supplementary information 8 5 2 2 RM RESULTS TABLE Type B applied parts Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT RMF _ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards associated Risk Analysis F 11 H with Type B applied part not protectively 01 earthed are separated by one means of patient protection from metal accessible parts not protectively earthed have been considered 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 11 H 01 Test
43. July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 7 2 17 RM RESULTS TABLE Protective packaging Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 4 ONYX BE381DT_RMF_ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 20 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 7 3 3 RM RESULTS TABLE Batteries N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 7 3 7 RM RESULTS TABLE Supply terminals N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 7 4 2 RM RESULTS TABLE Control devices N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 7 5 RM RESULTS TABLE Safety signs N A Test Report No 1403042002 Page 126 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 6
44. N indicate an output exists where an accidental or prolonged operation of output circuit could constitute a HAZARDOUS SITUATION Charging mode visibly indicated in ME EQUIPMENT incorporating a means for charging an INTERNAL ELECTRICAL POWER SOURCE RISKS associated with pre set controls No pre set controls function addressed in RISK MANAGEMENT PROCESS when applicable as verified by review of RISK MANAGEMENT FILE sccscccessesceensserseensseeeeensseeeeenss Actuating parts of controls of ME EQUIPMENT N A 15 4 6 1 a Actuating parts cannot be pulled off or No Actuating parts N loosened up during NORMAL USE IA b Indication of scales e g on off N A positions etc always corresponds to position of controls with adjustment that can result in a HAZARDOUS SITUATION for PATIENT Or OPERATOR while ME EQUIPMENT is in use c Incorrect connection of indicating device to relevant component prevented by adequate construction when it could be separated without use of a TOOL Test Report No 1403042002 Page 95 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark When torque values per Table 30 applied between control knob and shaft of rotating controls for not less than 2 s 10 times in each direction knobs did not rotate ceeee Tests conducted by applying an axial force of 60 N for electrical components and
45. N A Test Report No 1403042002 Page 186 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 14 1 RM RESULTS TABLE Programmable electrical medical systems General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 14 6 1 RM RESULTS TABLE Identification of known and foreseeable hazards N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 14 6 2 RM RESULTS TABLE Risk control N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 1 14 7 RM RESULTS TABLE Requirement specification N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 14 8 RM RESULTS TABLE Architecture N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 14 9 RM RESULTS TABLE Design and Implementation N A Test Report No 1403042002 Page 187 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION
46. Neutral Open 264 60 7 63 S1 0 S5 R S7 1 S13 1 P SFC Ground Open 264 60 91 6 S1 1 S5 N S7 0 13 1 P SFC Ground Open 264 60 91 3 S1 1 S5 R S7 0 13 1 P SFC Ground Open 264 60 69 3 S1 1 S5 N S7 1 S13 0 P SFC Ground Open 264 60 69 1 S1 1 S5 R S7 1 S13 0 After Humidity Condition are Benya Tougn PANC 264 60 94 8 S1 1 S5 N S7 1 S13 1 P NC 264 60 94 8 S1 1 S5 R S7 1 813 1 P SFC Neutral Open 264 60 8 12 S1 0 S5 N S7 1 S13 1 Test Report No 1403042002 60601 1TRF_A Page 140 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark P SFC Neutral Open 264 60 8 17 S1 0 S5 R S7 1 913 1 P SFC Ground Open 264 60 94 6 S1 1 S5 N S7 0 S13 1 P SFC Ground Open 264 60 94 4 S1 1 S5 R S7 0 S13 1 P SFC Ground Open 264 60 1 5 S1 1 S5 N S7 1 S13 0 P SFC Ground Open 264 60 AAA S1 1 S5 R S7 1 S13 0 Fig 16 Patient leakage current with mains on the F type applied parts PM Maximum allowed values Type B N A Type BF AP 5000 uA Type CF AP 50 uA Fig 17 Patient leakage current with external voltage on Signal Input Output part SIP SOP Maximum allowed values Type B or BF AP 10 uA NC 50 uA SFC d c current 100 uA NC 500 uA SFC aic
47. Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis Test Report No 1403042002 60601 1TRF_A Page 119 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 9 RM RESULTS TABLE Use of components with high integrity characteristics N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 TABLE Power Input Pass Voltage Frequency Current Power factor v Hz A cos Maimunvomaliad o o ow ma MeximunnomaliadT o oar ma Penman romaa wo 80 oa ma Maximunnomaliadrran 100 o oa ma Mexmuinnomaloadrossa 20 o om ma Maxim romai oea rossa 20 o poar ma MaximunnomaliadT o on me MeximunnomaliadT o ome aa Penman romaa ave ve aaa Supplementary Information Adapter HITRON ELECTRONICS CORP type HEMG50 S120420 7 MAXIMUM NORMAL LOAD was defined as follows LCD with max brightness and contrast with two USB2 0 two USB2 0 port total load 5W Operating Conditions Ratings 5 1 RM RESULTS TABLE Type Tests Pass Clause of Document Ref in RM
48. Risk Graph After Measures ONYX BE381DT_RMF _ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 8 9 2 TABLE Short circuiting of each single one of the CREEPAGE DISTANCES and AIR N A CLEARANCES for insulation in the MAINS PART between parts of opposite Test Report No 1403042002 Page 144 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark polarity in lieu of complying with the required measurements in 8 9 4 Test in lieu of HAZARDOUS SITUATION Specific areas of circuits short REEERGE Ouse eal ite hazard Remarks cireultediand test conditions DISTANCE or AIR shock hazard explosion CLEARANCE discharge of parts etc Yes No Supplementary information Note 1 AC AIR CLEARANCE CD CREEPAGE DISTANCE Test Report No 1403042002 Page 145 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 9 3 2 Table Thermal cycling tests on one sample of insulating compound forming N A solid insulation between conductive parts Dielectric strength test Test Each test duration and Dielectric test voltage after humidity Sequence temperature V Test voltage in 8 8 3 preconditioning p
49. Rough handling test N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 Test Report No 1403042002 Page 191 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 15 4 1 RM RESULTS TABLE Construction of connectors N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 15 4 2 1a RM RESULTS TABLE THERMAL CUT OUTS and OVER CURRENT RELEASES N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 15 4 2 1b RM RESULTS TABLE THERMAL CUT OUTS with a safety function N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 2 1c RM RESULTS TABLE Independent non SELF RESETTING THERMAL CUT OUT N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 2 1d RM RESULTS TABLE Loss of function of ME EQUIPMENT N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Test Report No 1403042002 Page 192 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV
50. Section Release Protocols of Measures RC 028 RC 029 measures had been verified and the results of the verification were recorded in the risk management file 7 2 13 RM RESULTS TABLE Physiological effects safety signs and warning N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 7 2 17 RM RESULTS TABLE Protective packaging Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose CCWersion Data O ONAA f 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with packing conditions 01 C 20 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded Pass Version 1 00 Section in the risk management file Risk Evaluation Before Measures F 01 H 01 C DV l 20 gt ese E 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 20 ONYX BE381DT RMF _ Version 1 00 Section Risk Graph Before Measures 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Test Report No 1403042002 60601 1TRF_A Page 125 of 197 Issued 25
51. TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 4 2 2 TABLE Instability overbalance excluding transport position N A ME EQUIPMENT Test Condition excluding transport Remarks preparation position Test either 5 incline and verify Warning marking or 10 incline Supplementary information 9 4 2 3 TABLE Instability overbalance from horizontal and vertical forces N A Remarks Test Condition force used direction of force weight of equipment location of force ME EQUIPMENT preparation Supplementary information N A 9 4 2 4 2 TABLE Castors and wheels Force for propulsion Test Condition force location and height Remarks ME EQUIPMENT preparation Supplementary information N A 9 4 2 4 3 TABLE Castors and wheels Movement over a threshold ME EQUIPMENT Test Condition speed of movement Remarks preparation Supplementary information 9 4 2 4 3 RM RESULTS TABLE Movement over a threshold N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 Page 158 of 197 Issued 25 July 2014 Test Report No 1403042002 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 4 2 4 3 RM RESULT
52. USE and comprised of at least two layers of material each passed N A the appropriate dielectric strength test or three layers of material for which all N A combinations of two layers together passed the appropriate dielectric strength test Dielectric strength test for one or two layers N A 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 Evaluated in part of power INSULATION required between windings of supply wound components separated by interleaved insulation complying with a or b or both except when c Wire with solid insulation other than solvent No such construction N A based enamel complying with a complying with Annex L e Finished wire with spirally wrapped or multi Evaluated in part of power layer extruded insulation complying with Annex L BASIC INSULATION minimum two wrapped layers or one extruded layer SUPPLEMENTARY INSULATION minimum two layers wrapped or extruded REINFORCED INSULATION minimum three layers wrapped or extruded In d and e for spirally wrapped insulation Evaluated in part of power with CREEPAGE DISTANCES between layers less supply than in Table 12 or 16 Pollution Degree 1 depending on type of insulation path between layers sealed as a cemented joint in 8 9 3 3 and test vo
53. VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 15 4 2 1h RM RESULTS TABLE ME EQUIPMENT with tubular heating elements N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 3 1 RM RESULTS TABLE Housing N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 3 2 RM RESULTS TABLE Connection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 3 3 RM RESULTS TABLE Protection against overcharging N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 3 4 RM RESULTS TABLE Lithium batteries N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 15 4 3 5 RM RESULTS TABLE Excessive current and voltage protection N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 Test Report No 1403042002 60601 1TRF_A Page 193 of 197 Issued 25 July 2014 fos NY VICTRONIC TECHNOLOGY CORPORATION
54. a time 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 Allowable Values Test Report No 1403042002 Page 41 of 197 Issued 25 July 2014 60601 1TRF_A 6 8 6 9 PY 7 1 7 2 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark a Allowable values in 8 7 3 b c and d See appended Table 8 7 measured based on and are relative to currents in Fig 12 a or by a device measuring frequency contents of currents as in Fig 12 b b Allowable values of PATIENT LEAKAGE and See appended Table 8 7 AUXILIARY CURRENTS are according to Tables 3 amp 4 and values of a c are relative to currents having a frequency not less than 0 1Hz f c TOUCH CURRENT did not exceed 100 pA in See appended Table 8 7 NORMAL CONDITION and 500 pA in SINGLE FAULT CONDITION linc ltsfc er er T 5 d EARTH LEAKAGE CURRENT did not exceed 5 mA See appended Table 8 7 in NORMAL CONDITION and 10 mA in SINGLE FAULT CONDITION lenc lesrc Scans eawaesuaneentwacwonsedaneaieauasmanamn a Higher values of EARTH LEAKAGE CURRENT Not permanently installed permitted for PERMANENTLY INSTALLED ME ME equipment EQUIPMENT connected to a su
55. below 8 9 Ceramic and similar materials not tightly No such construction sintered and beads alone not used as SUPPLEMENTARY Or REINFORCED INSULATION Insulating material with embedded heating No such construction conductors considered as one MEANS OF PROTECTION but not two MEANS OF PROTECTION Parts of natural latex rubber aged by No natural latex rubber suspending samples freely in an oxygen provided cylinder containing commercial oxygen to a pressure of 2 1 MPa 70 kPa with an effective capacity of at least 10 times volume of samples There were no cracks visible to naked eyes after samples kept in cylinder at 70 C 2 C for 96h and afterwards left at room temperature for at least 16h CREEPAGE DISTANCES and AIR CLEARANCES are gt _ Tables 12 distance for to values in Tables 11 to 16 inclusive except MOPP are considered as specified in Clauses 8 9 1 2 to 8 9 1 15 Tables 11 to 16 inclusive not applied to No such construction CREEPAGE and CLEARANCES forming MEANS OF OPERATOR PROTECTION per IEC 60950 1 for INSULATION CO ORDINATION and used under conditions compliance was tested Specified min CLEARANCE applied as min No such material CREEPAGE for CREEPAGE DISTANCES across glass mica ceramic and other inorganic insulating materials with similar tracking characteristics When min CREEPAGE derived from Tables 11 to 16 inclusive was less than min applicable CLEARANCE value of min CLEARANCE applied as min
56. benefit N A analysis Version 1 00 Section Release Protocols of Measures RC 010 recorded in the risk management file 9 8 2 RM RESULTS TABLE Tensile safety factor Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 02 H with the support systems have been 01 C 02 considered 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 02 H 01 C 02 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 02 H 01 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF__ The risk control measures selected were Pass Test Report No 1403042002 60601 1TRF_A Page 163 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 8 2 RM RESULTS TABLE Tensile safety factor Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Versi
57. by a convenient means causing Test Report No 1403042002 Page 71 of 197 Issued 25 July 2014 60601 1TRF_A A 17 VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Support system parts impaired by wear however they have TENSILE SAFETY FACTORS gt to values in Table 21 rows 3 and 4 PROTECTION AGAINST UNWANTED AND EXCESSIVE RADIATION HAZARDS X Radiation X radiation dose rate was lt 36 pA kg 5 uSv h No X Radiation 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 unfavourable RATED MAINS VOLTAGE and controls adjusted to emit maximum radiation Internal pre set controls not intended for adjustment during EXPECTED SERVICE LIFE of ME EQUIPMENT not taken into consideration Risk from unintended X radiation from ME EQUIPMENT producing X radiation for diagnostic and therapeutic purposes addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE see IEC 60601 1 3 amp 1 3 Risk associated with alpha beta gamma No alpha beta gamma neutron and other particle radiation when neutron and other particle applicable addressed i
58. for fixed EQUIPMENT or STATIONARY EQUIPMENT per IEC 60695 11 10 determined by ENCLOSURE examination or flammability classification based on 11 3a Ze ME EQUIPMENT and ME SYSTEMS intended for use with flammable anaesthetics ME EQUIPMENT ME SYSTEMS and parts described Not suitable to use with in ACCOMPANYING DOCUMENTS for use with flammable anaesthetics CATEGORY AP or anaesthetics with oxidants CATEGORY APG comply with Annex G MANUFACTURER S RISK MANAGEMENT PROCESS Not intended to use in addresses possibility of fire and associated conjunction with flammable mitigations as confirmed by examination of agents RISK MANAGEMENT FILE 0 ceseeeceeeeseeeeeeseeeneneeeesees 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 Liquid reservoir liable to overflow in NORMAL USE completely filled and 15 of its capacity poured in for over 14 min and except when restricted TRANSPORTABLE ME EQUIPMENT tilted through an angle of 15 in least favourable direction s and when necessary refilled starting from position Of NORMAL USE 008 ME EQUIPMENT met dielectric strength and L
59. for reliability of joint A winding of solvent based enameled wire replaced for the test by a metal foil or by a few turns of bare wire placed close to cemented joint and three samples tested as follows One sample subjected to thermal cycling PROCEDURE of 8 9 3 4 and immediately after the last period at highest temperature during thermal cycling it was subjected to dielectric strength test of 8 8 3 except at 1 6 times the test voltage LAANA A nannini 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 timMes cseeeeessseeeeeeeseeeees Components of ME EQUIPMENT likely to result in See appended RM Results an unacceptable Risk by their movements Table 8 10 1 mounted securely as indicated in RISK MANAGEMENT FILE 0csecccceeseeceeeeseeceeesssneeensssneeenes Test Report No 1403042002 Page 49 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Conductors and connectors of ME EQUIPMENT See appended RM Results adequately secured_or insulated to prevent Table 8 10 2 accidental detachment in a HAZARDOUS SITUATION ciiai sscnidians eta sehen peas eectees eee Conductors and connectors of ME EQUIPME
60. impulsive or impact acoustic energy dB RISK MANAGEMENT FILE examined for RISKS No Acoustic energy produce associated with infrasound or ultrasound by the device when present addressed in RISK MANAGEMENT PROCESS Hand transmitted vibration N A Means provided except for INTENDED USE No vibration produce by the N A vibrations to protect PATIENT and OPERATOR device when hand transmitted frequency weighted r m s acceleration generated in NORMAL USE exceeds specified values measured at points of hand contact with PATIENT or OPERATOR 2 5 m s for a cumulative time of 8 h during a N A 24 h period m s Accelerations for different times inversely N A proportional to square root of time m s iiri Pressure vessels and parts subject to pneumatic and hydraulic pressure N A N A Pneumatic and hydraulic parts of ME No Pressure vessels and EQUIPMENT Or ACCESSORIES met following parts subject to pneumatic requirements based on examination of RISK and hydraulic pressure MANAGEMENT FILE No unacceptable RISK resulted from loss of pressure or loss of vacuum No unacceptable RISK resulted from a fluid jet caused by leakage or a component failure Elements of ME EQUIPMENT or an ACCESSORY especially pipes and hoses leading to an unacceptable RISK protected against harmful external effects Test Report No 1403042002 Page 65 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY
61. interlock provided Sapa N A Marking on the inside of ME EQUIPMENT or ME EQUIPMENT parts NIA Maximum power loading of heating elements or No heating elements or N A lamp holders designed for use with heating lamp holders provided lamps marked near or in the heater W A marking referring to ACCOMPANYING DOCUMENTS provided for heating elements or lamp holders designed for heating lamps that can be changed only by SERVICE PERSONNEL using a TOOL Symbol 24 of Table D 4 symbol IEC 60417 5036 DB 2002 10 or safety sign 3 of Table D 2 used to mark presence of HIGH VOLTAGE parts Type of battery and mode of insertion when applicable is marked ccccceeseseeeeeeeeeeeeees An identifying marking provided referring to instructions in ACCOMPANYING DOCUMENTS for batteries intended to be changed only by SERVICE PERSONNEL using a TOOL Test Report No 1403042002 Page 21 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark A warning provided indicating replacement of lithium batteries or fuel cells when incorrect replacement by inadequately trained personnel would result in an unacceptable RISK e g excessive temperatures fire or explosion An identifying marking also provided referring See E RM Results to instructions in ACCOMPANYING DOCUMENTS E 7 3 3 Fuses replaceable THERMAL CUT OUTS and OVER Evaluated i
62. 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 to iF 7 l h Min number of cycles of operation 100 000 except for one time use devices bursting disks HAZARDS associated with support systems Pass ME EQUIPMENT parts designed to support loads See appended RM Results or provide actuating forces when a Table 9 8 1 mechanical fault could constitute an unacceptable RISK Construction of support suspension or Equipment weight 4 07kg actuation system complied with Table 21 and Safety Factor 6 TOTAL LOAD Total load 24 42kg Means of attachment of ACCESSORIES prevent No accessories 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 Test Report No 1403042002 Page 67 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Risk Analysis included effects of failures See appended RM Results such as excessive deflection plastic Table 9 8 1 deformation ductile brittle fracture fatigue fracture instability buckling stress assisted corrosion cracking wear material cr
63. large as possible for particular case When above marking not possible relevant information included in instructions for use Marking complied with tests and criteria of 7 1 2 and 7 1 3 Test Report No 1403042002 Page 104 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark CATEGORY AP ME EQUIPMENT prominently marked with a green coloured circle gt 2 cm in diameter with characters AP according to symbol 22 in Table Discs sesssccascssscesscessesasssassenecssnenstacesseneceazensiis i Marking is as large as possible for the particular case When above marking not possible the relevant information included in instructions for use Marking complied with tests and criteria of 7 1 2 and 7 1 3 The marking according to G 3 2 and G 3 3 placed on major part of ME EQUIPMENT for CATEGORY AP or APG parts and not repeated on detachable parts that can only be used with the marked EQUIPMENT 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 Common requirements for CATEGORY AP and CATEGORY APG ME EQUIPMENT FLAMMABLE ANESTHETIC MIXTURES b Connections except those in circuits described in G 5 3 and G 6 3 protected against ac
64. not overbalance when placed in different positions of NORMAL USE except transport positions on a 5 inclined plane from horizontal hard and flat surface A warning provided stating Transport only See appended Table 9 4 2 2 under conditions described in instructions for use or marked on ME EQUIPMENT with an indication of RESIDUAL RISK if ME EQUIPMENT or its parts overbalances when overbalance occurred during 10 inclined plane test N A a ME EQUIPMENT with a mass of 25 kg or more other than FIXED ME EQUIPMENT for use on floor did not overbalance due to pushing or resting Surfaces of ME EQUIPMENT where a RISK of overbalancing exists from pushing leaning resting etc permanently marked with a CLEARLY LEGIBLE warning of the RISK e g safety sign 5 of Table D 2 safety sign ISO 7010 P017 ME EQUIPMENT did not overbalance when placed on a horizontal plane and a force of 25 of its weight but not more than 220 N applied in different directions except a direction with an upward component Test Report No 1403042002 Page 61 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark b ME EQUIPMENT other than FIXED ME EQUIPMENT for use onthe 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 safet
65. of this risk evaluation were Pass Version 1 00 Section recorded in the riskmanagement file Release Protocols of Measures RC 011 7 9 2 4 RM RESULTS TABLE Electrical power source N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Test Report No 1403042002 60601 1TRF_A Page 127 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 7 9 2 4 RM RESULTS TABLE Electrical power source N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 3 7 9 3 2 RM RESULTS TABLE Replacement of fuses power supply cords other N A parts Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 8 1 b 1 RM RESULTS TABLE Fundamental rule of protection against electric shock Pass interruption of any one power carrying conductor Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards associated Risk Analysis F 01 H with interruption of any one supply 01 conductor have been considered 4 4 ONYX BE381DT RMF__ The estimates of the risk s were recorded in Pass Vers
66. 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 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 of aesthetic tubing mattresses and pads castor tires and other antistatic material complied with ISO 2882 based on measurements according to ISO 1853 ISO 2878 and ISO 23529 ccccceseeseeeeee Corona cannot be produced by components or parts of ME EQUIPMENT operating at more than 2000 V a c or 2400 V d c and not included in ENCLOSURES complying with G 5 4 or G 5 5 ME EQUIPMENT its parts or components do not Equipment not suitable for ignite FLAMMABLE AESTHETIC MIXTURES WITH AIR use in the presence of under NORMAL USE and CONDITIONS based on FLAMMABLE ANESTHETIC compliance with G 5 2 to G 5 5 inclusive MIXTURES Test Report No 1403042002 Page 106 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Alternatively ME EQUIPMENT its parts and N A 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 IE
67. 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 00 18 5 Bedside Infotainment Touch Monitor Trade Mark sssssssssesesesseseees onyx or ONYX Healthcare Inc Manufacturer s cciccesescatesessstecesseectecs Onyx Healthcare Inc 2F No 135 Ln 235 Baoqiao Rd Xindian Dist New Taipei City 231 Taiwan Model Type reference ONYX BE381DT xx xxxx Where x is 0 9 gt A Z gt or blank Test Report No 1403042002 Page 1 of 197 Issued 25 July 2014 60601 1TRF_A a NW VICTRONIC TECHNOLOGY CORPORATION Ratings cece Switching Power Adapter HITRON ELECTRONICS CORP HEMG50 S120420 7 Input 100 240Vac 60 50Hz 1 2 0 63A Monitor Input rating 12Vdc 4 2A Test Report No 1403042002 Page 2 of 197 Issued 25 July 2014 60601 1TRF_A vV VICTRONIC TECHNOLOGY CORPORATION Testing procedure and testing location Testing location address 2 6 Victronic Technology Corporation 4th FI 130 Ln 235 Baoqiao Rd X
68. per 13 2 10 13 2 13 4 ME EQUIPMENT RATED for NON CONTINUOUS OPERATION ME EQUIPMENT other than gt HAND HELD operated CONTINUOUS OPERATION N A 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 ssnin Requirements of this clause not applied to Since failure of PESS does PESS when it provided no BASIC SAFETY or not lead to unacceptable risk ESSENTIAL PERFORMANCE or for this device requirement of this clause will not be when application of ISO 14971 showed that failure of PEss does not lead to unacceptable RISK ccttssicctctae edie ee Every PROCESS has been followed throughout the PEMS DEVELOPMENT LIFE CYCLE and a RECORD of PROCESS has been made available as confirmed by RISK MANAGEMENT FILE REVIEW and assessment of PROCESSES cited in this Clause Test Report No 1403042002 Page 85 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark MANUFACTURER considered the need for N A additional RISK CONTROL measures when unable to follow all PROCESSES identified in Clause 14 for each constituent component of PEMS as confirmed by RISK MANAGEMENT FILE review an
69. results table for for the relevant test per instructions for use detail c When test results influenced by inlet No such construction pressure and flow or chemical composition of provided inside the a cooling liquid tests performed within the equipment limits in technical description Supply voltage during tests was the least Rated voltage 100 240 V ac favourable of the voltages specified in 4 10 or Tested at 90 100 240 264 V voltages marked on ME EQUIPMENT V ac Monitor unit 12 V dc ME EQUIPMENT marked with a RATED frequency Rated frequency 60 50 Hz range tested at the least favourable trequeney within the range HZ ccscssssseeeseeeseeeseeeeeenees ME EQUIPMENT with more than one RATED Tested at 90 100 240 264V ac voltage or both a c d c tested in conditions Single phase supply AC see 5 4 related to the least favourable voltagp current nature of supply and type of current Monitor unit 12 V dc ME EQUIPMENT tested with alternative No such construction ACCESSORIES and components specified in ACCOMPANYING DOCUMENTS to result in the ase favourable conditions ssssnesssnnennsnnnnnnnnrnnnnnnnnn 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 ME EQUIPMENT or parts thereof affected by See appended RM Results climatic conditions were set up comp
70. specification where appropriate and descriptive data on design environment included in RISK MANAGEMENT FILE A VERIFICATION plan containing the specified N A information used to verify and document functions implementing BASIC SAFETY ESSENTIAL PERFORMANCE or RISK CONTROL measures milestone s when VERIFICATION is to be performed for each function Test Report No 1403042002 Page 88 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark selection and documentation of VERIFICATION N A strategies activities techniques and appropriate level of independence of the personnel performing the VERIFICATION 14 11 A PEMS VALIDATION plan containing validation of N A BASIC SAFETY amp ESSENTIAL PERFORMANCE and requiring checks for unintended functioning of PEMS to perform and document PEMS VALIDATION The person with overall responsibility for PEMS N A VALIDATION is independent of design team and no member of a design team is responsible for PEMS VALIDATION of their own design All professional relationships of members of N A PEMS VALIDATION team with members of design team documented in RISK MANAGEMENT FILE providing methods amp results of PEMS VALIDATION Continued validity of previous design N A documentation assessed under a documented modification change PROCEDURE Technical description includes the following N A information whe
71. than 1 mm wide limited to widths c Relative positioning of CLEARANCE providing Evaluated in part of power a MEANS OF PROTECTION is such that the relevant supply parts are rigid and located by molding or there is no reduction of a distance below specified value by deformation or movement of parts Test Report No 1403042002 Page 48 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Normal or likely limited movements of relevant parts taken into consideration when calculating minimum AIR CLEARANCE Only solid insulation requirements applied No insulating compound where distances between conductive parts provided filled with insulating compound were such that CLEARANCES and CREEPAGE DISTANCES don t 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 cceceeeeseseeeeeeeeees Cracks or voids in insulating compound affecting homogeneity of material didn t occur Where insulating compound forms a cemented joint with other insulating parts three samples tested
72. to move while TRAPPING ZONE is accessible and stops movement when the GUARD is opened absence or failure of one of their components prevents starting and stops moving parts Movable GUARDS complied with all applicable tests as confirmed by review of RISK MANAGEMENT FILE protective measures prevented TRAPPING ZONE from reach or when it was reached system movement stopped once ME EQUIPMENT started to move and inthe latter case no HAZARD or damage resulted when protective measure was in a SINGLE FAULT CONDITION and an unacceptable RISK could arise one or more emergency stopping device s provided RISK MANAGEMENT FILE reviewed and all conditions confirmed Continuous activation N A TRAPPING ZONE not considered to present a No Trapping zone MECHANICAL HAZARD where impractical to make TRAPPING ZONE inaccessible when Protective measures provided in control system prevented moving parts from starting to move while in reach of persons Test Report No 1403042002 Page 58 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 allowed adequate control of positi
73. under SINGLE FAULT CONDITIONS self extinguished rapidly and no hazardous amount of toxic gases reached PATIENT as determined by analysis of gases 0sseee RISK of ignition under least favourable conditions did not occur and oxygen concentration did not exceed 25 in immediate surroundings due to location of external exhaust outlets of an OXYGEN RICH ENVIRONMENT when electrical components mounted outside of ME EQUIPMENT or ME SYSTEM 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 use in the presence of OXYGEN RICH ENVIRONMENT Failure of a barrier constructed in accordance with 11 2 2 1 b 3 csccsssseeesseeeen Failure of a component creating a source or ignition as defined in 11 2 2 1 a cecssseeeenees Test Report No 1403042002 Page 76 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Failure of solid insulation or creepage and clearances providing equivalent of at least one MEANS OF PA
74. with a min mass of 15 kg unless stated by MANUFACTURER Test Report No 1403042002 Page 68 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 Max allowable PATIENT mass gt 135 kg stated in ACCOMPANYING DOCUMENTS Examination of markings ACCOMPANYING DOCUMENTS and RISK MANAGEMENT FILE confirmed compliance Part of SAFE WORKING LOAD representing mass No patient or operator of PATIENTS Or OPERATORS is distributed on support systems 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 Compliance confirmed by examination 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 1m for 1 m
75. with the maximum allowed continuous output in amperes or volt amperes or marked to indicate the equipment or N A equipment parts it may safely be attached to MULTIPLE SOCKET OUTLET is a separate item or N A an integral part of ME EQUIPMENT or non ME EQUIPMENT c MULTIPLE SOCKET OUTLET complied with IEC N A 60884 1 and the following requirements It is CLASS I and PROTECTIVE EARTH CONDUCTOR N A is connected to earthing contacts in socket PROTECTIVE EARTH TERMINALS and PROTECTIVE N A EARTH CONNECTIONS comply with 8 6 except total impedance for ME SYSTEM was up to 400 mQ or higher when conditions of 8 6 4 b met mQ N A MAINS TERMINAL DEVICES and wiring complied with 8 11 4 when applicable RATINGS of components are not in conflict with Conditions Of USE ccccceeeseeseeeeeeeeeees Test Report No 1403042002 Page 102 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Electrical terminals and connectors of MULTIPLE SOCKET OUTLETS prevent incorrect connection of accessible connectors removable without a TOOL d Additional requirements applied when MULTIPLE SOCKET OUTLET combined with a separating transformer Separating transformer complied with IEC 61558 2 1 except requirements of maximum RATED output power of 1 kVA and degree of protection IPX4 were not applied
76. 0 ER SFC Neutral Open 264 60 289 1 0 S5 1 ER SFC Neutral Open 264 60 290 S1 0 S5 0 After Humidity Condition ER NC 264 60 176 1 1 S55 1 ER NC 264 60 174 1 1 S55 0 ER SFC Neutral Open 264 60 293 1 0 S5 1 ER SFC Neutral Open 264 60 293 S1 0 S5 0 Measured with a non frequency _ _ _ Maximum allowed values weighted device 10 mA NC 10 mA SFC Before Humidity Condition ER NC 264 60 207 1 1 S5 1 ER NC 264 60 204 1 1 55 0 ER SFC Neutral Open 264 60 317 S1 0 S5 1 ER SFC Neutral Open 264 60 315 S1 0 S5 0 After Humidity Condition ER NC 264 60 212 1 1 S5 1 ER NC 264 60 208 1 1 S55 0 ER SFC Neutral Open 264 60 322 1 0 S5 1 ER SFC Neutral Open 264 60 321 S1 0 S5 0 Fig 14 Touch Current TC En _ Maximum allowed values 100 uA NC 500 uA SFC MD1 between earth and output connector Before Humidity Condition TC NC 264 60 6 28 1 1 S5 1 S7 1 TC NC 264 60 6 44 S1 1 S5 0 S7 1 TC SFC Neutral Open 264 60 9 95 S1 0 S5 1 S7 1 TC SFC Neutral Open 264 60 9 88 S1 0 S5 0 S7 1 TC SFC Ground Open 264 60 79 35 S1 1 S5 1 S7 0 Test Report No 1403042002 Page 136 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark
77. 0601 1 Requirement Test Result Remark Clause of Document Ref in RMF Result Remarks Verdict ISO Document No amp paragraph 14971 4 2 4 3 4 4 5 6 3 7 9 1 RM RESULTS TABLE General accompanying documents See Table C 4 Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards associated Risk Analysis F 07 H with the content and format of the 01 H 02 H 03 accompanying documents have been evaluated 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 07 H 01 H 02 H 03 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 07 H 01 H 02 H 03 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 011 6 3 ONYX BE381DT_RMF_ The results
78. 1 1 Requirement Test Result Remark Documents containing all data necessary for Product is a Monitor ME SYSTEM to be used as intended by application and assessment MANUFACTURER including a contact address for ME system is not accompany ME SYSTEM or modified ME SYSTEM considered in current status ACCOMPANYING DOCUMENTS regarded as a part of N A ME SYSTEM ACCOMPANYING DOCUMENTS are optionally N A provided in electronic format e g electronic file format or CD ROM and ME SYSTEM is capable of displaying or printing these documents a ACCOMPANYING DOCUMENTS provided for each N A item of ME EQUIPMENT supplied by MANUFACTURER b ACCOMPANYING DOCUMENTS provided for each N A item of non ME EQUIPMENT supplied by MANUFACTURER specifications instructions for use as intended by MANUFACTURER and a list of all items forming the ME SYSTEM instructions for installation assembly and N A modification of ME SYSTEM to ensure continued compliance with this standard instructions for cleaning and when N A applicable disinfecting and sterilizing each item of equipment or equipment part forming part of the ME SYSTEM additional safety measures to be applied N A during installation of ME SYSTEM identification of parts of ME SYSTEM suitable N A for use within the PATIENT ENVIRONMENT additional measures to be applied during N A preventive maintenance a warning forbidding placement of MULTIPLE N A SOCKET OUTLE
79. 1 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Tension applied to wire during winding on mandrel calculated from the wire diameter equivalent to 118 MPa 11 8 MPa 000 Sample subjected to heat shock test 9 of IEC Evaluated in part of power 60851 6 1996 followed by dielectric strength supply test of clause 8 8 3 except test voltage applied between the wire and mandrel Test voltage was at least the voltage in Tables N A 6 and 7 but not less than the following 1500 V for BASIC and SUPPLEMENTARY N A INSULATION V Jannina 3000 V for REINFORCED INSULATION V n s oven temperature base on Table L2 6 7 Mandrel diameter and tension applied as in clause L 3 2 MPa N mm 2 wiveouscatmenbtnaanaveiceceuns Dielectric strength test conducted at room temperature after removal from the oven L34 Retention of electric strength after bending Five samples prepared as in L 3 2 subjected to Evaluated in part of power dielectric strength and bending tests supply Test voltage was at least the voltage in Tables N A 6 and 7 but not less than the following 1500 V for BASIC and SUPPLEMENTARY N A INSULATION V scicesesecssetsccct ccascieessisneseceenszeeescenvesti ___ 3000V for REWFORCED NSULATION V I a Test voltage applied between the shot and N A conductor Mandrel diameter and tension applied as in N A L 3 2 MPa NIMM LA Avissi
80. 13 instructions for use HIGH VOLTAGE TERMINAL DEVICES on the outside of No such construction ME EQUIPMENT accessible without the use of a TOOL marked with symbol 24 of Table D 1 symbol IEC 60417 5036 DB 2002 10 Requirements for cooling provisions marked N A e g supply of water or air X ME EQUIPMENT with limited mechanical stability No special limitation in mechanical stability Test Report No 1403042002 Page 20 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Packaging marked with special handling Packaging with special instructions for transport and or storage transportation and storage condition see carton label for detail Permissible environmental conditions for See Technical transport and storage marked on outside of Documentation carton PACK AG INA onsin Jabel for detail RATED maximum supply pressure from an No such construction external source marked on ME EQUIPMENT adjacent to each input connectot 00 00 Symbol 7 of Table D 1 IEC 60417 5017 No functional earth terminal DB 2002 10 marked on FUNCTIONAL EARTH TERMINAL Protective means required to be removed to No such protective means is use a particular function of ME EQUIPMENT with required alternate applications marked to indicate the necessity for replacement when the function is no longer needed 7 No marking applied when an
81. 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 4 2 4 3 4 4 5 6 2 Test Report No 1403042002 60601 1TRF_A Page 122 of 197 Issued 25 July 2014 fos NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 5 9 2 3 RM RESULTS TABLE Actuating mechanisms N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 6 4 6 5 7 1 2 TABLE Legibility of Marking Pass Markings tested Ambient illuminance Remarks Ix Outside Markings Clause 7 2 s 000 1500 Ix and 100 Ix Clearly readable Inside Markings Clause 7 3 0es Controls amp Instruments Clause 7 4 Safety Signs Clause 7 5 eteceeseerrenes i Symbols Clause 7 6 2 0 D n Annn Supplementary information Observer with a visual acuity of 0 on the log Minimum Angle of Resolution log MAR scale or 6 6 20 20 reads marking at ambient illuminance least favourable level in the range of 100 Ix to 1 500 Ix The ME EQUIPMENT or its part was positioned so that the viewpoint was the intended position of the OPERATOR at any point within the base of a cone subtended by an to the axis normal to the centre of the plane of the marking and at a distance of 1 m TABLE Durability of marking test Pass Characteristics of the Marki
82. 25 C 42 C 2hat0 C 42 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C A 1hat 25 C 2 C 2hat0 C 2 C 1 or more hat 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 Test Report No 1403042002 Page 147 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 10 TABLE List of critical components Pass Component Manufacturer Type No model Technical data Standard No Mark s amp Part No Trademark No Edition Certificates of conformity Label Car Tong Co CT M002 60 C UL969 UL Power Hitron HEMG50 I P 100 240 ANSI AAMI UL CSA TUV Adapter Electronics 120420 7 Vac 60 50 Hz ES60601 1 Corp 1 2 0 63 A O P 2005 12 Vdc 4 2A CSA C22 2 No 60601 1 2008 IEC 60601 1 2005 Plastic Sabic Innovative C2800 GG Min V 0 65 C UL 94 UL Enclosure Plastics USLL 1 5mm Cc thickness minimum see Attachment Technical Documentation for details Inner metal Overall see cover LCD Attachment Display Technical Documentation for details Internal Rear Overall see Bracket
83. 4 inclusive occurred when SINGLE FAULT CONDITIONS applied one at a time as in 4 7 and 13 2 Emissions deformation of ENCLOSURE or exceeding maximum temperature Emission of flames molten metal poisonous or ignitable substance in hazardous quantities did not occur Deformation of ENCLOSURE impairing compliance with 15 3 1 did not occur WE Temperatures of APPLIED PARTS did not a exceed allowable values in Table 24 when Measured as in 111 3 sisirin Temperatures of ME EQUIPMENT parts that are See appended table 13 2 for not APPLIED PARTS likely to be touched did not detail exceed values in Table 23 when measured and adjusted asin 111 34 cen ed es Test Report No 1403042002 Page 81 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark 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 N A exceeded 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 N A one minute after 15 W drawn from supply circuit or Parts and components completely contained within a fire ENCLOSURE complying with 11 3 as verified by review of design documentation
84. 4 3 4 4 TABLE transformer short circuit test short circuit applied at end of windings N A or at the first point that could be short circuited under SINGLE FAULT CONDITION Primary voltage most adverse value from 90 to 110 of RATED voltage V sane RATED input frequency HZ csecannsscninsises t naton SANN Snan Class of Type of Protective Time to THERMAL Maximum Maximum Windi insulation protective device device STABILITY when allowed winding Ambient ee ne A B E F fuse circuit operated protective device temp from temp sea este or H breaker Ratings Yes No did not Table 31 measured C operate Min C C Supplementary information 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 EVALUATED AT CERTIFIED POWER SUPPLY TABLE transformer overload test conducted only when protective device N A under short circuit test operated Primary voltage most adverse value between 90 to 110 of RATED voltage V RATED input frequency Hz Test current just below minimum current that would activate protective device amp achieve THERMAL STABILITY under method a A Test current based on Table 32 when protective device that operated under method a is external to transformer and it was shunted A Class of Type o
85. 4 3 and cannot be loosened without TOOL Screws for internal PROTECTIVE EARTH No Screw provided CONNECTIONS completely covered or protected against accidental loosening from outside Earth pin of APPLIANCE INLET forming supply Evaluated in part of power connection to ME EQUIPMENT regarded as supply PROTECTIVE EARTH TERMINAL PROTECTIVE EARTH TERMINAL not used for Evaluated in part of power mechanical connection between different parts supply of ME EQUIPMENT or securing components not related to protective or functional earthing Parts complying with IEC 60950 1 for protective earthing and serving as MEANS OF OPERATOR PROTECTION but not PATIENT PROTECTION exempted from requirements of Test Report No 1403042002 Page 39 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark PROTECTIVE EARTH CONNECTION not used for a Evaluated in part of power moving part except when MANUFACTURER supply demonstrated in RISK MANAGEMENT FILE connection will remain reliable during EXPECTED SERVICE LIFE sisewetesscstacaieeseccsssccivesieewnissscustecssaanniss a PROTECTIVE EARTH CONNECTIONS carried fault Evaluated in part of power currents reliably and without excessive voltage supply drop b Allowable TOUCH CURRENT and PATIENT Evaluated in part of power LEAKAGE CURRENT in SINGLE FAULT CONDITION were supply not exceeded when impedance of PROTE
86. 417 5336 all DB 2002 10 Test Report No 1403042002 Page 19 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Proper symbol marked adjacent to or on connector for APPLIED PART except marked on APPLIED PART when there is no connector or connector used for more than one APPLIED PART and different APPLIED PARTS with different classifications Safety sign 2 of Table D 2 ISO 7010 W001 placed near relevant outlet when protection against effect of discharge of a cardiac defibrillator is partly in the PATIENT cable An explanation indicating protection of ME EQUIPMENT against effects of discharge of a cardiac defibrillator depends on use of proper cables included in instructions for use ME EQUIPMENT not marked to the contrary The equipment work assumed to be suitable for CONTINUOUS continuously without OPERATION specified marking DUTY CYCLE for ME EQUIPMENT intended for non CONTINUOUS OPERATION E e marked an provide maximum on and off time A safety sign CLEARLY LEGIBLE and visible after No physiological effects INSTALLATION in NORMAL USE applied to a prominent location of EQUIPMENT that produce physiological effects capable of causing HARM to PATIENT Or OPERATOR not obvious to OPERATOR Nature of HAZARD and precautions for avoiding See appended RM Results or minimizing the associated RISK described in Table 7 2
87. 5 R S7 0 813 1 P SFC Ground Open 264 60 5 77 1 1 S5 N S7 0 S13 0 P SFC Ground Open 264 60 5 72 S1 1 S5 R S7 0 S13 0 Before Humidity Condition Hewa EatisoTouch P NC 264 60 1 56 S1 1 S5 N S7 1 13 1 P NC 264 60 1 57 S1 1 S5 R S7 1 S13 1 P SFC Neutral Open 264 60 2 42 S1 0 S5 N S7 1 S13 1 P SFC _ Neutral Open 264 60 2 46 S1 0 S5 R S7 1 S13 1 P SFC Ground Open 264 60 1 87 S1 1 S5 N S7 0 13 1 P SFC Ground Open 264 60 1 90 S1 1 S5 R S7 0 S13 1 P SFC Ground Open 264 60 5 81 S1 1 S5 N S7 0 S13 0 P SFC Ground Open 264 60 5 84 S1 1 S5 R S7 0 S13 0 After Humidity Condition oe Eorerteteuch P NC 264 60 1 78 1 1 S5 N S7 1 S 13 1 P NC 264 60 1 76 S1 1 S5 R S7 1 S13 1 P SFC Neutral Open 264 60 2 68 S1 0 S5 N S7 1 S13 1 P SFC Neutral Open 264 60 2 78 S1 0 S5 R S7 1 813 1 P SFC Ground Open 264 60 2 12 S1 1 S5 N S7 0 813 1 P SFC Ground Open 264 60 2 14 S1 1 S5 R S7 0 13 1 P SFC7 Ground Open 264 60 6 33 S1 1 S5 N S7 0 S13 0 P SFC Ground Open 264 60 6 38 S1 1 S5 R S7 0 S13 0 Measured with a non frequency _ E _ Maximum allowed values weighted device 10 mA NC 10 mA SFC Test Report No 1403042002 60601 1TRF_A Page 139 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION
88. 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 024 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had been verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 024 management file 6 4 ONYX BE381DT_RMF_ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 09 ONYX BE381DT RMF _ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 5 9 2 TABLE Determination of ACCESSIBLE parts Pass Location Determination method NOTE1 Comments Output connector rigid test finger The plastic metal enclosure serves as mechanical electrical fire enclosure Enclosure rigid test finger The plastic metal enclosure serves as mechanical electrical fire enclosure Supplementary information NOTE 1 The determination methods are visual rigid test finger jointed test finger test hook 5 9 2 3 RM RESULTS TABLE Actuati ng mechanisms N A Clause of ISO
89. 60601 1 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 Oxygen concentration sse Current AY asec ccseeccsz cass test casecese dee eed Voltage V sisccccccccindnniedunian Capacitance LF cscssseseeseeeee Inductance or resistance h or Q No of trials 300 Min csesseeeeee Sparks resulted in ignition Yes No Supplementary information Test procedure of 11 2 2 1 a 5 amp Figs 35 37 used for tests For circuits not in Figs 35 37 test voltage or current set at 3 times the worst case values with other parameters set at worst case values to determine if ignition can occur 11 3 RM RESULTS TABLE Constructional requirements for fire enclosures of ME Pass equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF__ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with potential ignition sources and spread of 02 C 02 fire has been identified 4 4 ONYX BE381DT_RMF_ The estimates
90. 7 which intended to supply the equipment have been evaluated and certified by UL Demko according to IEC 60601 1 ed 3 IEC 60601 1 ed 3 am1 Report no 1311060003 and Certificate no DK 37161 UL The maximum specified operational ambient temperature is 40 C Two MOPP means of patient protection are provide between primary circuit and secondary SIP SOP one MOPP means of patient protection are provided between secondary circuit and isolated protection at SIP SOP circuit Touch Panel and Plastic Enclosure treat as Type B applied part Model Differences ONYX BE381DT xx xxxx where x is 0 9 A Z or blank is identical with each other except for model designation Test Report No 1403042002 Page 7 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark INSULATION DIAGRAM LCD Monitor 12Vdc SELV Adapter SIP SOP SELV Plastic enclosure and Touch Panel treas as Applied Part Plastic enclosure Test Report No 1403042002 Page 8 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark TABLE To insulation diagram Pollution degree ssecssessesseesseenseeneees Overvoltage CateQOry eeceeeeseseneeees ll Altitude cna 0 3000 m Additional details on parts considered None X Areas
91. 81DT_RMF_ The manufacturer follow the process Pass Version 1 00 Section specified in 6 2 to 6 7 of ISO 14971 to control Decision about the risk s so that the residual risk s measures associated with each hazard is judged acceptable 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures Test Report No 1403042002 60601 1TRF_A Page 115 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 2 RM RESULTS TABLE Risk Management Process for ME Equipment or ME Systems Pass Clause of ISO 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 6 3 ONYX BE381DT_RMF_ Version 1 00 Section Release Protocols of Measures The effectiveness of the risk control measures had been verified and the results of the verification were recorded in the risk management file Pass 6 4 ONYX BE381DT_RMF_ Version 1 00 Section Evaluation After Measures ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk All residual risk that remains after the risk control measure s are applied and evaluated using the criteria that defined in the risk management plan Pass
92. A fuse or OVER CURRENT RELEASE provided in Evaluated in part of power each supply lead for cLASs and CLASS II ME supply EQUIPMENT with a functional earth connection per clause 8 6 9 and in at least one supply lead for other single phase CLASS II ME EQUIPMENT neutral conductor not fused for PERMANENTLY Not permanently installed N A INSTALLED ME EQUIPMENT ME equipment N A fuses or OVER CURRENT RELEASES omitted due No such situation 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 Fuses complying with IEC 60127 have high No such situation breaking capacity 1 500 A and prospective short circuit current gt 35 A or 10 times current rating of the fuse whichever is greater Justification for omission of fuses or OVER Evaluated in part of power N A CURRENT RELEASES is in RISK MANAGEMENT FILE supply a Cross sectional area of internal wiring in a Evaluated in part of power MAINS PART between MAINS TERMINAL DEVICE and___ supply protective devices is not less than minimum required for POWER SUPPLY CORD as in clause 8 11 3 3 MM CH NNN A jrgieiscnatesisasiasdundaceiaicanesds b Cross sectional area of other wiring in MAINS Eva
93. Alternatively per the Table i e __dc a d c test voltage equal to the peak value of the a c test voltage used 2 A Immediately after humidity treatment of 5 7 ME EQUIPMENT de energized B after required sterilization PROCEDURE ME EQUIPMENT de energized C after reaching steady state operating temperature as during heating test of 11 1 1 and D after relevant tests of 11 6 i e overflow spillage leakage ingress of water cleaning disinfection and sterilization 8 8 4 1 TABLE Resistance to heat Ball pressure test of thermoplastic parts Pass Frew Plastic Enclosure Sabic Innovative Plastics US L L C type C2800 GG Supplementary information Part material Test C temperature C diameter mm 8 8 4 1 RM RESULTS TABLE Mechanical strength and resistance to heat Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data Test Report No 1403042002 Page 143 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 8 4 1 RM RESULTS TABLE Mechanical strength and resistance to heat Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Docume
94. C 60079 6 and with this standard excluding G 5 2 to G 5 5 ME EQUIPMENT its parts and components in N A contact with gas mixtures in NORMAL USE and CONDITIONS not producing sparks and not resulting in surface temperatures above 150 C in case of restricted or 200 C in case of unrestricted vertical air circulation measured at 25 C comply with G5 iscisscsticsestecteceesscecceseateces ME EQUIPMENT its parts and components N A 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 Umax lt Uzr with Ip as in Fig G 1 N A Measured Umax lt Ue with Cmax as in Fig G 2 N A Measured lmax lzr with Uzr as in Fig G 1 i N A Measured Imax S lz with Lmax and a Umax S 24 a N A as in Fig G3 sonsiimsnnmaa cance Combinations of currents and corresponding N A voltages within the limitations IZR UZR lt 50 W extrapolated from Fig G 1 No extrapolation made for voltages above 42 V Po Combinations of capacitances and N A corresponding voltages within limitations of C 2U lt 1 2 mJ extrapolated from Fig G 2 No extrapolation made for voltages above 242V PN S Umax additionally determined using actual N A resistance R when the equivalent resistance R was less than 8000 Q Combinations of currents and corresponding N A inductances within limitations L 2I lt 0 3 mJ
95. CORPORATION IEC 60601 1 Requirement Test Result Remark Reservoirs and similar vessels leading to an unacceptable RISK are automatically depressurized when ME EQUIPMENT is isolated from its power supply Means provided for isolation or local depressurizing reservoirs and similar vessels and pressure indication when above not All elements remaining under pressure after isolation of ME EQUIPMENT or an ACCESSORY from its power supply resulting in an unacceptable RISK provided with clearly identified exhaust devices and a warning to depressurize these elements before setting or maintenance activity be subjected to in NORMAL and SINGLE FAULT parts subject to pneumatic CONDITIONS considered to be highest of and hydraulic pressure b Pressure setting of a pressure relief device provided as part of assembly c Max pressure that can develop by a source of pressure that is part of assembly unless pressure limited by a pressure relief device Max pressure in NORMAL and SINGLE FAULT No Pressure vessels and CONDITIONS did not exceed MAXIMUM PERMISSIBLE parts subject to pneumatic WORKING PRESSURE for EQUIPMENT part except and hydraulic pressure as allowed in 9 7 7 confirmed by examination of ME EQUIPMENT and RISK MANAGEMENT FILE and by functional tests z A pressure vessel withstood a HYDRAULIC TEST No Pressure vessels and PRESSURE when pressure was gt 50 kPa and parts subject to pneumatic product of pressure and v
96. CREEPAGE DISTANCE ME EQUIPMENT RATED to operate at an altitude specified by MANUFACTURER IM ssssesseteeeeeeees Test Report No 1403042002 Page 45 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Operating altitude corresponding to actual air pressure for ME EQUIPMENT intended for pressurized environments e g aircraft used to determine multiplication factor from Table 8 and AIR CLEARANCE was multiplied by this factor 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 Tables 11 to 16 inclusive CREEPAGE and CLEARANCES calculated as follows CREEPAGE DISTANCES determined by linear See Insulation Diagram and interpolation between the nearest two values To insulation diagram Table and the calculated spacing rounded off to the next higher 0 1 mm increment mm 0 CLEARANCES for PEAK WORKING VOLTAGES above Evaluated in part of power 2800 V peak or d c determined by linear supply interpolation between the nearest two values and the calculated spacing rounded off to the next higher 0 1 mm increment mm 0 for AIR CLEARANCES corresponding to PEAK WORKING VOLTAGE up to 2800 V peak or d c the higher of the two values applied Material groups classified in accordan
97. CTIVE EARTH CONNECTIONS exceeded values in 8 6 4 a and Table 8 6 4 due to limited current capability of relevant circuits cceseeeee Surface coatings Poorly conducting surface coatings on No such construction conductive elements removed at the point of contact Coating not removed when requirements for N A impedance and current carrying capacity met PROTECTIVE EARTH CONNECTION where Evaluated in part of power N A connection between SUPPLY MAINS and ME supply EQUIPMENT or between separate parts of ME EQUIPMENT made via a plug and socket was made before and interrupted after supply connections applied also where interchangeable parts are N A PROTECTIVELY EARTHED Terminal for connection of a POTENTIAL EQUALIZATION CONDUCTOR Terminal is accessible to OPERATOR with ME N A EQUIPMENT in any position of NORMAL USE RISK of accidental disconnection minimized in NORMAL USE Terminal allows conductor to be detached N A without a TOOL N A Terminal not used for a PROTECTIVE EARTH CONNECTION Terminal marked with symbol 8 of Table D 1 i e symbol IEC 60417 5021 N A Test Report No 1403042002 Page 40 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark Instructions for use contain information on N A function and use of POTENTIAL EQUALIZATION CONDUCTOR together with a reference to require
98. EAKAGE CURRENT tests and uninsulated electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were 11 6 3 Spillage on ME EQUIPMENT and ME SYSTEM Test Report No 1403042002 Page 78 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION A SS IEC 60601 1 Requirement Test Result Remark RISK MANAGEMENT PROCESS poured steadily on a point on top Of ME EQUIPMENT ccccceseeseeeee ME EQUIPMENT met dielectric strength and LEAKAGE CURRENT tests and uninsulated electrical parts or electrical insulation of parts that could result in a HAZARDOUS SITUATION were Leakage Ingress of water or particulate matter into ME EQUIPMENT and ME SYSTEMS N A ME EQUIPMENT with IP Code placed in least IPX0O N A favourable position of NORMAL USE and subjected to tests of IEC 60529 IP Code IA ME EQUIPMENT met dielectric strength and N LEAKAGE CURRENT tests and there were no bridging of insulation or electrical components that could result in a HAZARDOUS SITUATION in NORMAL CONDITION or in a SINGLE FAULT CONDITION ME EQUIPMENT ME SYSTEM and their parts and See appended Table 11 6 1 ACCESSORIES cleaned or disinfected once using methods specified in instructions for use including any cooling or drying period ME EQUIPMENT met dielectric strength and See appended RM Results LEAKAGE CURRENT tests with no deterioration Table 11 6 6 res
99. ED Test Report No 1403042002 Page 36 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark except when metal ACCESSIBLE PART S N A physically close to APPLIED PART and can be regarded as a part of APPLIED PART and RISK that metal ACCESSIBLE PART will make N A contact with a source of voltage or LEAKAGE CURRENT above permitted limits is acceptably low MTA LEAKAGE CURRENT tests conducted per 8 7 4 See appended table 8 7 Pass Dielectric strength test conducted per 8 8 3 gt See appended table 8 8 3 Relevant CREEPAGE and CLEARANCES measured per 8 9 and Tables 11 to 16 as applicable The RISK MANAGEMENT FILE reviewed See appended RM Results Table 8 5 2 2 A connector on a PATIENT lead located at the end of the lead remote from N 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 N A IA cannot be connected to earth or hazardous voltage while the PATIENT CONNECTIONS are in contact With PATIENT cccccsccsssesescssseeueneeessnsneees 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 CLEARANCE between connector pins and a flat surface is at least 0 5 mm conductive part plu
100. ENT protected against excessive equipment bending at inlet opening of equipment or of MAINS CONNECTOR by means of an insulating cord guard or by means of an appropriately shaped opening 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 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 Curvature of the cord radius immediately after mass attached was not less than 1 5 x D PERMANENTLY INSTALLED and ME EQUIPMENT with non DETACHABLE POWER SUPPLY CORD replaceable by SERVICE PERSONNEL provided with MAINS 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 Test Report No 1403042002 Page 54 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION A SS IEC 60601 1 Requirement Test Result Remark 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 Screws and nuts clamping external conductors do not serve to secure any other component except they also clamp internal conductors whe
101. F Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF__ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis with the risk analysis of unit type Test Report No 1403042002 Page 120 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 5 1 RM RESULTS TABLE Type Tests Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures 5 4a RM RESULTS TABLE Other Conditions Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards situation have Risk Analysis been identified 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Versi
102. GY CORPORATION IEC 60601 1 Requirement Test Result Remark Clause Results observed HAZARDOUS Ne Description of SINGLE FAULT CONDITION SON p Yes No 13 2 2 Electrical SINGLE FAULT CONDITIONS per Clause 8 1 13 2 3 Overheating of transformers per Clause 15 5 13 2 4 Failure of THERMOSTATS according to 13 2 13 amp 15 4 2 overloading THERMOSTATS short circuited or interrupted the less favourable of the two 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 favourable of the two 13 2 6 Leakage of liquid RISK MANAGEMENT FILE examined to determine the appropriate test conditions sealed rechargeable batteries exempted 13 2 7 Impairment of cooling that could result in a HAZARD using test method of 11 1 Ventilation opening blocked IP 0 214A to 0 214A No Test duration 3h Normal operation No hazards No component damaged Measure max tempat L25 coil 52 6 C Plastic enclosure outside near main board 34 7 C Ambient 28 0 C 13 2 8 Locking of moving parts Only one part locked at a time Also see 13 2 10 below Test Report No 1403042002 Page 185 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 R
103. ILE part with SAFE WORKING LOAD and in most adverse condition in NORMAL USE passed Rougy Handling tests ccccccecesseneeeseeneeeesseneeesseesneeens a Ascending step shock test conducted on the sample by pushing it 3 times in its normal direction of travel at 0 4 m s 0 1 m s against an ascending hardwood step obstruction without the sample going over the obstruction 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 the step until full descent 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 No damage resulting in an unacceptable RISK sustained as determined by examination of sample and RISK MANAGEMENT FILE Test Report No 1403042002 Page 91 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Examination of ENCLOSURE made from molded or formed thermoplastic material indicated that material distortion due to release of internal stresses by molding or forming operations will not result in an unacceptable RISK Mold st
104. IPMENT or under simulated conditions on the bench See Clause 15 5 2 for test parameters amp other details 16 1 RM RESULTS TABLE General requirements for ME Systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 TABLE LEAKAGE CURRENTS in ME SYSTEM _ TOUCH CURRENT MEASUREMENTS Specific area where TOUCH Allowable Measured Allowable TOUCH CURRENT Measured TOUCH CURRENT measured i e from TOUCH CURRENT TOUCH CURRENT in event of interruption of CURRENT in event of or between parts of ME SYSTEM in NORMAL in NORMAL PROTECTIVE EARTH interruption of within PATIENT ENVIRONMENT CONDITION uA CONDITION pA CONDUCTOR uA PROTECTIVE EARTH CONDUCTOR uA Supplementary information Test Report No 1403042002 Page 196 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 16 9 1 RM RESULTS TABLE Connection terminals and connectors N A Clause of Document Ref in RMF Result Remarks ISO 14971 Document No amp paragraph Verdict 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 ME systems 17 RM RESULTS TABLE Electromagnetic compatibility of ME equipment and N A 4 2 Clause of Document Ref in RMF Result Remarks ISO 14971 Document No amp paragr
105. LTAGE for d c voltages with superimposed ripple was average value when peak to peak ripple less than 10 of average value or peak voltage when peak to peak nipple exceeding 10 of average value V 00 WORKING VOLTAGE for each MEANS OF See Insulation Diagram and PROTECTION forming DOUBLE INSULATION was To insulation diagram Table voltage DOUBLE INSULATION as a whole Evaluated in part of power Subjected to V crunn supply Intentional or accidental earthing of PATIENT No patient connections regarded as a NORMAL CONDITION for WORKING VOLTAGE involving a PATIENT CONNECTION not connected to earth CONNECTIONS of an F TYPE APPLIED PART and ENCLOSURE was highest voltage appearing across insulation in NORMAL USE including earthing of any part of APPLIED PART V 0 WORKING VOLTAGE for DEFIBRILLATION PROOF No Defibrillation proof APPLIED PARTS determined disregarding applied parts possible presence of defibrillation voltages WORKING VOLTAGE was equal to resonance No motor provided 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 DEFIBRILLATION PROOF APPLIED PARTS Classification DEFIBRILLATION PROOF APPLIED PART applied to one APPLIED PART in its entirety but not separate functions of same APPLIED PART M WORKING VOLTAGE between PATIENT Test
106. MF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis with the support systems have been considered 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 02 H 01 C 02 5 ONYX BE381DT_RMF__ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 02 H 01 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 010 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section Release Protocols of Measures RC 010 measures had be verified and the results of the verification were recorded in the risk management file Test Report No 1403042002 60601 1TRF_A Page 166 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 8 5 RM RESULTS TABLE Systems without mechanical protective devices Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 4 ONYX BE381DT_RMF__ All resi
107. NT Considered when breaking free at their joint are not capable of touching circuit points resulting in a HAZARDOUS SITUATION as indicated in RISK MANAGEMENT FILE Breaking free of one means of mechanical Considered restraint considered a SINGLE FAULT CONDITION Stranded conductors are not solder coated No such construction N A when secured by clamping means to prevent HAZARDOUS SITUATIONS due to poor contact Flexible cords detachable without a TOOL used No such construction N A to interconnect different parts of ME EQUIPMENT provided with means for connection to comply with requirements for metal ACCESSIBLE PARTS of 8 4 when a connection is loosened or broken as shown by measurement or using test finger 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 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 Test Report No 1403042002 Page 50 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark
108. No 1403042002 Page 183 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 12 4 5 4 RM RESULTS TABLE Other ME equipment producing diagnostic or N A therapeutic radiation Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 12 4 6 RM RESULTS TABLE Diagnostic or therapeutic acoustic pressure N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 13 1 2 TABLE measurement of power or energy dissipation in parts amp components to N A waive 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 Power dissipated less than W cesssseeees 15 Energy dissipated less than J ssescssessesseesees 1900 Part or component Measured Calculated energy SINGLE FAULT CONDITIONS Remarks tested power dissipated J waived Yes No dissipated W Supplementary information 13 2 TABLE SINGLE FAULT CONDITIONS in accordance with 13 2 2 to 13 2 13 inclusive Pass Test Report No 1403042002 Page 184 of 197 Issued 25 July 2014 60601 1TRF_A fo vV VICTRONIC TECHNOLO
109. Page 27 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark A list of all system messages error messages and fault messages provided with an explanation of messages including important causes and possible action s to be taken to resolve the problem indicated by the message 7 9 2 11 Information provided for the OPERATOR to safely See User Manual Chapter 2 terminate operation of ME EQUIPMENT Information provided on cleaning disinfection See User Manual Appendix and sterilization methods and applicable parameters that can be tolerated by ME EQUIPMENT parts or ACCESSORIES specified Components ACCESSORIES or ME EQUIPMENT marked for single use except when required by MANUFACTURER to be cleaned disinfected or sterilized prior to use Instructions provided on preventive No calibration maintenance inspection calibration maintenance and its are required for this Monitor frequency because normal lifetime is expected to be 43 800 hours Information provided for safe performance 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 Instructions provided to ensure adequate See User Manual Safety amp maintenance of ME EQUIPMENT containing Warranty rechargeable ba
110. Plastic enclosure and as applied parts cccssseceseesseeeesssees Touch Panel See Clause 4 6 for details Number and type of Means of Protection MOOP MOPP known 1 1 BOP IIIb 250 3 0 1 6 Certified Power Supply 2 2 MOPP IIIb 364 11 2 7 0 Certified Power Supply 3 2 MOPP IIIb 250 8 0 5 0 Certified Power Supply 4 1 MOPP IIIb 250 4 0 25 Certified Power Supply 5 2 MOPP IIIb 250 8 0 5 0 Certified Power Supply 6 2 MOPP Ilb 250 8 0 5 0 The The Adapter equipme equipme Primary to nt is nt is equipment supplied supplied SIP SOP via via external external certified certified power power supply supply 7 1 MOPP Ilb 250 4 0 25 The The Monitor equipme equipme SIP SOP to nt is nt is plastic supplied supplied enclosure with via via foil external external certified certified power power supply supply 7 1 MOPP IIIb 250 4 0 2 5 The The Monitor equipme equipme SIP SOP to nt is nt is Touch Panel supplied supplied with foil via via Test Report No 1403042002 Page 9 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 external external certified certified power power supply supply 1 MOPP IIIb 250 4 0 25 The The Adapter Earth equipme equipme to plastic nt is nt
111. Report No 1403042002 Page 132 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 8 5 2 2 RM RESULTS TABLE Type B applied parts Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 11 H 01 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 8 5 2 3 RM RESULTS TABLE PATIENT Leads N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 TABLE defibrillation proof applied parts measurement of hazardous electrical energies Test Measurement Applied part with Test voltage Measured Condition made on test voltage polarity voltage between Figs 9 amp 10 accessible part Y1 and Y2 mV Supplementary information 8 5 5 1b TABLE defibrillation proof applied parts verification of recovery time NA Applied part with test Test voltage Recovery time from Measured voltage polarity documents s recovery time s Supplementary information Test Report No 1403042002 Page 133 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1
112. Report No 1403042002 Page 38 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Possibility of an OPERATOR 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 a No hazardous electrical energies appear during a discharge of cardiac defibrillator 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 Means provided to limit energy delivered toa See appended Table 8 5 5 2 100 load to at least 90 of energy delivered to this load with ME EQUIPMENT disconnected Protective and functional earthing and potential equalization of ME EQUIPMENT N A Requirements of 8 6 2 to 8 6 8 applied PN 8 6 2 to 8 6 8 PROTECTIVE EARTH TERMINAL is Suitable for No such construction 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 sscceseeeeeee Clamping means of PROTECTIVE EARTH TERMINAL No such construction of ME EQUIPMENT for FIXED supply conductors or POWER SUPPLY CORDS comply with 8 11
113. Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 11 6 6 RM RESULTS TABLE Cleaning and disinfection of ME equipment and ME Pass systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with use of the device in environment and 01 C 23 the required cleaning and disinfection of the device and its accessories have been identified 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Test Report No 1403042002 60601 1TRF_A Page 179 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 6 6 RM RESULTS TABLE Cleaning and disinfection of ME equipment and ME Pass systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 23 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Be
114. S TABLE Movement over a threshold N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 5 6 2 6 3 6 4 6 5 9 4 3 1 TABLE Instability from unwanted lateral movement including sliding in N A transport position ME EQUIPMENT Test Condition transport position Remarks Preparation working load locking device s caster position Supplementary information TABLE Instability from unwanted lateral movement including sliding excluding transport position ME EQUIPMENT Test Condition working load locking Remarks Preparation device s caster position force force location force direction Supplementary information 9 4 4 TABLE Grips and other handling devices N A Clause and Name of Test Test Condition Remarks Supplementary information 9 5 1 RM RESULTS TABLE Protective means N A Test Report No 1403042002 Page 159 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 6 1 RM RESULTS TABLE Acoustic energy General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp par
115. SUPPLY MAINS equipped with a ME 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 See appended Table 8 10 EQUIPMENT and external means described in technical description ccccceesesseeseeeeeeees i c A SUPPLY MAINS switch used to comply with Not Permanently installed 8 11 1 a complies with CREEPAGE and ME equipment CLEARANCES in IEC 61058 1 for a MAINS TRANSIENT VOLTAGE Of 4 KV ccscssesseeseeeseeeeeeeeeneees Test Report No 1403042002 Page 51 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark d A SUPPLY MAINS switch not incorporated ina Not Permanently installed POWER SUPPLY CORD or external flexible lead ME equipment e Direction of movement of actuator of a No supply mains switch SUPPLY MAINS switch used to comply with 8 11 1 a complies with IEC 60447 f A suitable plug device such as an APPLIANCE COUPLER or a flexible cord with a MAINS PLUG used in non PERMANENTLY INSTALLED ME EQUIPMENT to isolate it from SUPPLY MAINS considered to comply with 8 11 1 a assess i g A fuse or a semiconductor device not used Provided IEC 60601 1 2005 as an isolating means and ANSI AAMI ES60601 Certified Power Supply h ME EQUIPMENT not provided with a device S
116. T when provided and it is a separate item on the floor a warning indicating an additional MULTIPLE N A SOCKET OUTLET or extension cord not to be connected to ME SYSTEM a warning to connect only items that have N A been specified as part of ME SYSTEM or specified as being compatible with ME SYSTEM Test Report No 1403042002 Page 99 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark maximum permissible load for any MULTIPLE SOCKET OUTLET S used with ME SYSTEM 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 s 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 storage 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
117. T is subjected to unacceptable RISKS due to proximity of moving parts removal of normal exit routes or other HAZARDS prevented 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 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 Test Report No 1403042002 Page 60 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Rough surfaces sharp corners and edges of See appended RM Results ME EQUIPMENT that could result in an Table 9 3 unacceptable RISK avoided or covered Instability HAZARDS ME EQUIPMENT other than FIXED and hand held for placement on a surface did not overbalance tip over or move unexpectedly to the degree that it could present an unacceptable RISK to PATIENT Or OPERATOR as tested in 9 4 2 to 9 4 4 Instability overbalance ME EQUIPMENT or its parts did not overbalance No such construction 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 N A ME EQUIPMENT or its parts prepared based on N A a to g inclusive did
118. TECTIVE DEVICE intended to function once Further use of ME EQUIPMENT not possible No mechanical protective until replacement of MECHANICAL PROTECTIVE device provided ACCOMPANYING DOCUMENTS instruct once MECHANICAL PROTECTIVE DEVICE is activated SERVICE PERSONNEL Shall be called and MECHANICAL PROTECTIVE DEVICE must be replaced before ME EQUIPMENT can be used ME EQUIPMENT permanently marked with safety sign 2 of Table D 2 i e safety sign 7010 W001 Marking is adjacent to MECHANICAL PROTECTIVE DEVICE or its location relative to MECHANICAL PROTECTIVE DEVICE is obvious to service personnel Compliance confirmed by examination of ME EQUIPMENT ACCOMPANYING DOCUMENTS RISK MANAGEMENT FILE specifications and processing of materials and following test 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 system was capable of supporting a PATIENT Or OPERATOR No evidence of damage to MECHANICAL PROTECTIVE DEVICE affecting its ability to perform its intended function Systems without MECHANICAL PROTECTIVE DEVICES Support system parts have TENSILE SAFETY See appended RM Results FACTORS gt to values in Table 21 rows 1 and 2 Table 9 8 5 and are not impaired by wear A chain cable band spring belt jack screw nut pneumatic or hydraulic hose structural part or the like employed to support a load defeated
119. TIENT PROTECTION but less than two MEANS OF PATIENT PROTECTION that could create a source of ignition defined in 11 2 2 1 a i Failure of a pneumatic component resulting in saei of esd lla aS constructional requirements specifically analysed in RISK MANAGEMENT FILE sseeecsseeeees a Flammability classification of insulated wire within fire ENCLOSURE is FV 1 or better based on IEC 60695 series as determined by examination of data on materials Flammability classification of connectors printed circuit boards and insulating material on which components are mounted is FV 2 or better based on IEC 60695 11 10 as decided Ry examination of materials data c If no FV Certification FV tests based on IEC 60695 11 10 conducted on 3 samples of complete parts or sections of it including area with min thickness ventilation openings 2 No openings on the sides within the area No openings on the sides N A included within the inclined line C in Fig 39 Test Report No 1403042002 Page 77 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 3 ENCLOSURE baffles and flame barriers have See appended Table 8 10 adequate rigidity and made of appropriate metal or of non metallic materials except constructions based on Table 25 and a mesh FV 2 or better for TRANSPORTABLE ME EQUIPMENT FV 1 or better
120. TION AGAINST HAZARDS OF IGNITION OF FLAMMABLE N A ANESTHETIC MIXTURES a Locations and basic requirements Na Parts of CATEGORY APG ME EQUIPMENT in which a_ Equipment not suitable for FLAMMABLE ANESTHETIC MIXTURE WITH AIR occurs __ use in the presence of are CATEGORY AP or APG ME EQUIPMENT and FLAMMABLE ANESTHETIC complied with G 3 G 4 and G 5 MIXTURES FLAMMABLE AESTHETIC MIXTURE WITH AIR occurring due to a leakage or discharge of a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN Or NITROUS OXIDE from an ENCLOSURE considered 5 to 25 cm from point of occurrence A FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE contained in a completely partly enclosed ME EQUIPMENT part and in PATIENT S respiratory tract5 cm from an ENCLOSURE part where leakage or discharge occurs ME EQUIPMENT or parts thereof specified for use with FLAMMABLE AESTHETIC MIXTURE WITH AIR in a location as in G 2 2 are CATEGORY AP or APG ME EQUIPMENT and complied with G 4 and G 5 ME EQUIPMENT or parts thereof for use with FLAMMABLE AESTHETIC 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 N A CATEGORY APG ME EQUIPMENT prominently Equipment not suitable for N A marked with a green coloured band gt 2 cm use in the presence of Length of green coloured band is gt 4 cm and size of marking is as
121. T_RMF__ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 02 H 01 C 03 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 018 6 3 ONYX BE381DT RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 018 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 02 H 01 C the risk management plan 03 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 9 4 2 1 TABLE Instability overbalance in transport position N A ME EQUIPMENT preparation Test Condition transport position Remarks Supplementary information Test Report No 1403042002 60601 1TRF_A Page 157 of 197 Issued 25 July 2014 fo NY VICTRONIC
122. Y CORPORATION IEC 60601 1 Requirement Test Result Remark 12 4 5 f Diagnostic or therapeutic radiation IA Adequate provisions to protect OPERATORS No function for accuracy of N A PATIENTS other persons and sensitive devices controls and instruments and in vicinity of unwanted or excessive radiation protection against hazardous emitted by ME EQUIPMENT designed to produce outputs radiation for diagnostic therapeutic purposes Radiation safety ensured by compliance with N A requirements of appropriate standards IA RISKS associated with diagnostic X rays N addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE 00 RISKS associated with radiotherapy addressed in RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE sccssseeeees 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 MANAGEMENT FILE When applicable RISKS associated with No function for accuracy of diagnostic or therapeutic acoustic pressure controls and instruments and addressed in RISK MANAGEMENT PROCESS as protection against hazardous confirmed in RISK MANAGEMENT FILE 0 outputs HAZARDOUS SITUATIONS AND FAULT CONDITIONS Specific HAZARDOUS SITUATIONS 13 1 1 None of HAZARDOUS SITUATIONS in 13 1 2 13 1
123. _RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis with the use of the components under both normal and single fault conditions have been evaluated 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 C 07 C 08 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 07 C 08 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 001 RC 002 RC 031 RC 033 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had been verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 001 RC management file 002 RC 031 RC 033 6 4 ONYX BE381DT RMF _ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 07 C 08 ONYX BE381DT_RMF_ Version 1 00 Section
124. agraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 6 2 2 RM RESULTS TABLE Infrasound and ultrasound energy N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 7 2 RM RESULTS TABLE Pneumatic and hydraulic parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 Test Report No 1403042002 Page 160 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 7 2 RM RESULTS TABLE Pneumatic and hydraulic parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 2 6 3 6 4 6 5 9 7 4 RM RESULTS TABLE Pressure rating of ME equipment parts N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 7 5 TABLE Pressure vessels N A Hydraulic Pneumatic or Suitable Media and Test Pressure Permanent Vessel fluid Deformation substance Supplementary Information 9 7 6 RM RESULTS TABLE Pressure control device N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No
125. ain the overlap L 3 Type Test N A The wire subjected to tests of L 3 1 to L 3 4 at a Evaluated in part of power N A temperature anda relative humidity specified supply a Temperature CO ANV Ages cessiccscsacteccenetiveeessneee Le Humidiiy Fo asnnennenni Dielectric strength N A Dielectric strength test of Clause 8 8 3 for the Evaluated in part of power N A appropriate type and number of moP s supply 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 amp 7 but not less than below with no breakdown 3000 V for BASIC and SUPPLEMENTARY N A INSULATION V jcna 6000 V for REINFORCED INSULATION V Sf Flexibility and adherence N A Sample subjected to flexibility and adherence Evaluated in part of power N A test 8 of IEC 60851 3 1996 clause 5 1 1 using supply 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 Test voltage was at least the voltage in Tables 6 and 7but not less than the following 1500 V for BASIC and SUPPLEMENTARY NG INSULATION VW cccsszccciiagscceecuscccctcesiscssuadgs nc cansacnacetds 3000 V for REINFORCED INSULATION V 000 Test Report No 1403042002 Page 112 of 197 Issued 25 July 2014 6060
126. aph Verdict 4 3 4 4 5 6 2 6 3 6 4 6 5 SP TABLE Additional or special tests conducted N A Clause and Name of Test Test type and condition Observed results Supplementary information Test Report No 1403042002 60601 1TRF_A Page 197 of 197 Issued 25 July 2014
127. arks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 4 3 RM RESULTS TABLE Accidental selection of excessive output values N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Test Report No 1403042002 Page 182 of 197 Issued 25 July 2014 60601 1TRF_A EN vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 12 4 4 RM RESULTS TABLE Incorrect output N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 4 5 2 RM RESULTS TABLE Diagnostic X ray equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 4 5 3 RM RESULTS TABLE Radiotherapy equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 12 4 5 4 RM RESULTS TABLE Other ME equipment producing diagnostic or N A therapeutic radiation Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 Test Report
128. art of a PEMS identified with No such part a unique identifier such as revision level or date of release issue and identification are available to designated persons seee Symbol 11 on Table D 1 ISO 7000 1641 DB Provided on installation 2004 01 used optionally advice to OPERATOR Instruction see Installation to consult ACCOMPANYING DOCUMENTS Instruction for detail Test Report No 1403042002 Page 17 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 No accessories MANUFACTURER or supplier and with a MODEL or TYPE REFERENCE x Markings applied to individual packaging when not practical to apply to ACCESSORIES MODEL or TYPE REFERENCE of equipment to be No such construction connected to ME EQUIPMENT to provide power is marked adjacent to the relevant connection point when this connection could result in an unacceptable RISK See appended RM Results Table 7 2 5 Except for PERMANENTLY INSTALLED ME EQUIPMENT marking appearing on the outside of part containing SUPPLY MAINS connection and adjacent to connection point For PERMANENTLY INSTALLED ME EQUIPMENT Not permanently installed NoMINAL supply voltage or range marked inside ME equi
129. ass Systems Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 3 3a ONYX BE381DT_RMF_ The Risk Management Procedure define the Pass Version 1 00 Section policy for determining acceptable risk Additional documents taking into account relevant International Standards and national or regional regulations 3 5e ONYX BE381DT_RMF_ The Risk Management Plan defined the Pass Version 1 00 Section criteria for risk acceptability Definition of Risk Graph ONYX BE381DT_RMF_ Version 1 00 Section Release Criteria 4 1 ONYX BE381DT_RMF_ Risk Analysis procedure Pass Version 1 00 Section Release Criteria 4 2 ONYX BE381DT_RMF_ Intended use and identification of Pass Version 1 00 Section characteristics are well defined Version Data 4 3 ONYX BE381DT_RMF_ All hazards associated with the device have Pass Version 1 00 Section been identified The associated risk for some Risk Analysis of them would need to be re assessed based on the end system assembly and its intended use 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 1 ONYX BE3
130. athing when itwas surrounded by a FLAMMABLE AESTHETIC MIXTURE WITH AIR of a high concentration for atleast30 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 96h c Gas tightness of ENCLOSURE containing inlets for flexible cords maintained when the cords were stressed by bending or pulling Cords are fitted with adequate anchorages to limit stresses After the test in G 5 4 b an internal overpressure of 400 Pa was created and 30 pulls of the value in Table G 1 applied to each flexible cord in axial direction of cord inlet and in the least favourable direction for 1 s Overpressure not reduced below 200 Pa 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 N A ENCLOSURE was lt 150 C in 25 C C 8 N A Steady state operating temperature of ENCLOSURE also measured C ceseseeeceseseeeeens P CATEGORY APG ME EQUIPMENT parts and components thereof N A ME EQUIPMENT its parts and components did Equipment not suitable for N A not ignite FLAMMABLE AESTHETIC MIXTURE WITH use in the presence of OXYGEN OR NITROUS OXIDE under NORMAL USE and FLAMMABLE ANESTHETIC SINGLE FAULT CONDITION MIXTURES Test Report No 1403042002 Page 109 of 197 Is
131. ation Pass Test Report No 1403042002 Page 25 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark intended use of ME EQUIPMENT See User Manual Chapter 1 1 1 Introduction frequently used functions and No specified function be defined as frequently use known contraindication s to use of ME N A EQUIPMENT Classifications as in Clause 6 all markings per Clause 7 2 and explanation of safety signs and symbols marked on ME EQUIPMENT Instructions for use are in a language acceptable to the intended operator Written in English which is international common used language 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 See User Manual Safety amp Warranty 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 No multiple socket outlet No system be
132. aximum measured between parts A measured calculated allowable Duration s between impedance impedance parts V mQ mQ Test Report No 1403042002 Page 134 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 The adapter HITRON ELECTRONICS CORP model HEMG50 S120420 7 was certified by IEC 60601 1 2005 and EN 60601 1 2006 Test Report No 1403042002 Page 135 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 7 TABLE leakage current Pass Supply Supply Measured Type of leakage current and test ae f frequency max value Remarks condition including single faults Voltage I V Hz uA Fig 13 Earth Leakage ER _ Maximum allowed values 5 mA NC 10 mA SFC Before Humidity Condition ER NC 264 60 172 1 1 S5 1 ER NC 264 60 171 1 1 S55
133. bessveeanearncced internally powered permanently installed appliance coupler non detachable cord Accessories and detachable parts included 00 Power adapter for HITRON ELECTRONICS CORP HEMG50 120420 7 Other Options include serme ceneestbeeeee cece eeeeeseeeeeeeeeeeeeeneees NIA Testing Date of receipt of test iterm S cceececesseceeeseeeeeeeeeeeeeeeeeee 21 March 2014 Dates tests performed n nsnsnsnsnnnnnrnrnrnrnrnrnrnrnrnnnrnnnrnnnnnen 24 March 2014 to 12 June 2014 Possible test case verdicts test case does not apply to the test object N A test object does meet the requirement Pass P test object was not evaluated for the requirement N E test object does not meet the requirement Fail F Abbreviations used in the report normal condition N C single fault condition SFC means of Operator protection means of Patient protection MOPP General remarks see Attachment refers to additional information appended to the report see appended table refers to a table appended to the report The 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 attachment
134. ble protective measures 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 No Trapping zone MECHANICAL HAZARD when gaps of TRAPPING ZONE complied with dimensions per Table 20 A TRAPPING ZONE considered not to present a No Trapping zone MECHANICAL HAZARD when distances separating OPERATOR PATIENT and others from TRAPPING ZONES exceeded values in ISO 13852 Test Report No 1403042002 Page 57 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark Distances measured from expected positions of 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 No Trapping zone 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 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 was open they are associated with an interlock preventing relevant moving parts from starting
135. ce only RISK MANAGEMENT PROCESS as confirmed by display the status of device examination of RISK MANAGEMENT FILE n se and will not impact the basic safety Parts of ME EQUIPMENT subject to mechanical No unacceptable risk after wear electrical environmental degradation or examining ageing resulting in unacceptable RISK when See appended Table 15 3 for unchecked for a long period are accessible for related test results inspection replacement and maintenance 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 Mold stress relief push impact drop and See below rough handling tests did not result in unacceptable RISK and ME EQUIPMENT displayed adequate mechanical strength No damage resulting in an unacceptable Risk The test for enclosure sustained as determined by examination of material was conducted in RISK MANAGEMENT FILE this report and complied with standard Impact test conducted by subjecting a See appended Table 15 3 and complete ENCLOSURE or its largest non RM Results Table 15 3 3 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 seecseseerees i Test not applied to flat panel displays platen See appended RM Results glass of ME EQUIPMENT or cathod
136. ce shld Table 9 Material Group cccessseeseseereeeeeeees t Material group evaluated using 50 drops of solution A based on test data for material according to IEC 60112 ccccssesesesseeeeeeseees Client didn t mention the material group and treated as most worse condition IIIb Pollution degree 2 Micro environment with non conductive pollution except occasional 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 Test Report No 1403042002 Page 46 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Pollution degree 4 not used for insulation providing a MEANS OF PROTECTION Where insulation between MAINS PART and earth might be compromised measures such as maintenance ensure that micro environment is mitigated to a lower pollution degree Overvoltage category classification value of Evaluated in part of power MAINS TRANSIENT VOLTAGE determined from overvoltage category per IEC60664 1 and NOMINAL a c MAINS VOLTAGE using Table 10 AIR CLEARANCE for MAINS PARTS operating on Tables 12 distance for RATED MAINS VOLTAGES up to
137. cidental 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 complied with G 5 3 and G 6 3 a Opening of an ENCLOSURE providing protection against penetration of gases or vapours into ME EQUIPMENT or its parts possible only with a TOOL b ENCLOSURE complies with requirements to minimize arcing and sparking due to penetration of foreign Objects Test Report No 1403042002 Page 105 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 AESTHETIC MIXTURE WITH OXYGEN or NITROUS OXIDE ignitable gases alone or oxygen did not result in loss of integrity of the part an unacceptable temperature or other HAZARD a Electrostatic charges prevented
138. d assessment of PROCESSES cited in this Clause Assessment of PROCESSES cited in this Clause made by internal audits Documents produced from application of Clause 14 are maintained and form a part of RISK MANAGEMENT FILE in addition to RECORDS and documents required by ISO 14971 RISK MANAGEMENT plan required by 3 5 of ISO N A 14971 includes reference to PEMS VALIDATION A PEMS DEVELOPMENT LIFE CYCLE including a set N A of defined milestones has been documented At each milestone activities to be completed N A and VERIFICATION methods to be applied to activities have been defined Each activity including its inputs and outputs N A defined and each milestone identifies RISK MANAGEMENT activities that must be completed before that milestone PEMS DEVELOPMENT LIFE CYCLE tailored for a N A specific development by making plans detailing activities milestones and schedules PEMS DEVELOPMENT LIFE CYCLE includes N A documentation requirements A documented system for problem resolution N A within and between _all_phases and activities of PEMS DEVELOPMENT LIFE CYCLE has been developed and maintained where appropriate Problem resolution system meets the N A prescribed criteria depending on type of product it is documented as a part of PEMS N A DEVELOPMENT LIFE CYCLE it allows reporting of potential or existing N A problems affecting BASIC SAFETY or ESSENTIAL PERFORMANCE it includes an assessment of each problem for associate
139. d RISKS Test Report No 1403042002 Page 86 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark it identifies criteria that must be met for the N A issue to be closed it identifies the action to be taken to resolve N A each problem mae __ Rickmanacenenrrnocess SSSSCSCSC dC NAC 14 6 1 MANUFACTURER considered HAZARDS associated N A with software and hardware aspects of PEMS including NETWORK DATA COUPLING components of third party origin legacy subsystems when compiling list of known or foreseeable HAZARDS In addition to the material in ISO 14971 Annex N A D list of possible sources for HAZARDS associated with PEMS includes specified causes failure of NETWORK DATA COUPLING to provide N A characteristics necessary for PEMS to achieve its BASIC SAFETY or ESSENTIAL PERFORMANCE undesired feedback physical and data such N A as unsolicited out of range inconsistent input or input from electromagnetic interference unavailable data lack of integrity of data incorrect timing of data unintended interactions within amp among PESS unknown aspects or quality of third party software unknown aspects or quality of third party PESS Oooo oo y T Oo y T a T Woo Tm S T a A T lack of data security particularly N A vulnerability to tampering unintended interaction with other programs a
140. de the overall residual risk posed by the Risk monitor is acceptable using the criteria defined in the risk management plan 4 3 TABLE ESSENTIAL PERFORMANCE N A MANUFACTURER S document number reference or reference from this standard Remarks or collateral or particular standard s List of ESSENTIAL PERFORMANCE functions Supplementary Information ESSENTIAL PERFORMANCE is performance the absence or degradation of which would result in an unacceptable risk 4 3 RM RESULTS TABLE Essential Performance N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 4 5 RM RESULTS TABLE Equivalent Safety for ME Equipment of ME System N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 Test Report No 1403042002 Page 117 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 4 6 RM RESULTS TABLE ME Equipment or system parts contacting the patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 4 7 RM RESULTS TABLE Single Fault Condition for ME Equipment Pass Clause of Document Re
141. ded use intended Pass Version 1 00 Section purpose poo VersionData _ _ _ _ J S na S e 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with failure of the protective enclosure have 02 C 02 been identified 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 02 C Oo Oe Ne 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 02 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 15 3 3 RM RESULTS TABLE Impact test Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RM mention the Intended use intended Pass Version 1 00 Section purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with failure of the protective enclosure have 02 C 02 been identified 44 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION
142. dicator lights mean Caution i e No yellow colour indicator N A prompt response by OPERATOR required light Other colours if used Meaning other than red White for reading light yellow or green colour meaning Red used only for emergency control No such function N A 7 9 1 ME EQUIPMENT accompanied by documents User Manual provided 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 ONYX Healthcare Inc or address the RESPONSIBLE ORGANIZATION can be referred 10 cise eke A MANAGEMENT PROCESS includes instructions as to what is required in hard copy or as markings on ME EQUIPMENT for emergency operation ACCOMPANYING DOCUMENTS Specify special skills See User Manual Chapter 1 training and knowledge required of OPERATOR or 1 3 Specification RESPONSIBLE ORGANIZATION and environmental restrictions on locations of use MODEL Or TYPE REFERENCE cccccccsssssssseeeeeeeenneees Model name ONYX BE381DT xx xxxx Where x is 0 9 A Z gt or blank When ACCOMPANYING DOCUMENTS provided See appended RM Results electronically e g on CD ROM RISK Table 7 9 1 ACCOMPANYING DOCUMENTS written at a level N A consistent with education training and other needs of individuals for whom they are intended Instructions for use include the required inform
143. dual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 02 H 01 C the risk management plan 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF _ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 10 1 1 TABLE Measurement of X radiation N A Maximum allowable radiation pA kg uSv h mR h 36 5 wSv h 0 5 mR h Surface area under test Measured Radiation Remarks Surface no Description pA kg uSv h mR h 1 2 3 4l 5 6 7I 8 9 10 b a i a S a a a a Supplementary information 1 Measurements made at a distance of 5 cm from any surface to which OPERATOR other than SERVICE PERSONNEL can gain access without a TOOL is deliberately provided with means of access or is instructed to enter regardless of whether or nota TOOL is needed to gain access 10 1 2 RM RESULTS TABLE ME equipment intended to produce diagnostic or N A therapeutic X radiation Test Report No 1403042002 Page 167 of 197 Issued 25 July 2014 60601 1TRF_A EN vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Clause of Document Ref in RMF Result
144. e a c for ME EQUIPMENT and ME SYSTEMS 100 240 V ac current 1 2 with a RATED input lt 4 KVA V cesssseeeeeeteeeeetees 0 63A for Monitor unit 12 V dc 4 2 A 500 V for all other ME EQUIPMENT and ME N A SYSTEMS 4 11 Power input Pass Test Report No 1403042002 60601 1TRF_A Page 12 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Steady state measured input of ME EQUIPMENT or See appended Table 4 11 Pass ME SYSTEM at RATED voltage and at operating settings indicated in instructions for use did not exceed marked rating by more than 10 Measurements on ME EQUIPMENT or a ME See appended Table 4 11 Pass SYSTEM marked with one or more RATED voltage ranges made at both upper and lower limits of the rango oes secicccccccdcecesctescccdsiensccasiensccdeiensectsenstenened Measurements made at a voltage equal to the No such marking N A mean value of the range when each marking of RATED input was related to the mean value of relevant voltage range Power input expressed in volt amperes See appended Table 4 11 Pass measured with a volt ampere meter or calculated as the product of steady state current measured as described above and Supply voltage VAAN A erpeecssecsseecsecsseessecseeeseeennes TYPE TESTS determined in consideration of Clause 4 in particular 4 2 Test not performed when analys
145. e ray tubes Table 15 3 3 Test Report No 1403042002 Page 90 of 197 Issued 25 July 2014 60601 1TRF_A Push test conducted by subjecting external See appended Table 15 3 and parts of ENCLOSURE to a steady force of 250 N RM Results Table 15 3 2 10 N for 5 s applied to a circular 30mm plane surface except bottom of ENCLOSURE of an ME EQUIPMENT gt 18 kg using a suitable test tool fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark No damage resulting inan unacceptable Risk See appended RM Results sustained as shown in RISK MANAGEMENT FILE Table 15 3 3 Drop test Sample of HAND HELD ME EQUIPMENT and HAND See appended Table 15 3 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 lying Hay on a concrete or rigid DASC cccssseeeeeeeeeeees part with SAFE WORKING LOAD lifted to a height as in Table 29 above a 50 5 mm thick hardwood board lying flat on a concrete floor or rigid base dropped 3 times from each orientation in NORMAL USE cm See appended Table 15 3 and RM Results Table 15 3 4 2 No damage resulting in an unacceptable Risk See appended RM Results sustained as determined by examination of Table 15 3 4 2 sample and RISK MANAGEMENT FILE Each sample of MOBILE ME EQUIPMENT and MOB
146. eenens d Voltage and energy limits specified in c above also applied to the following internal parts other than contacts of plugs Product was designed with connectors and socket outlets touchable by construction that internal test pin in Fig 8 inserted through an opening in live part can t be touch by an ENCLOSURE and test pin rod and hook parts inside an ACCESS COVER that can be 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 Test Report No 1403042002 Page 32 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark internal parts touchable by a metal test rod with a diameter of 4mm and a length of 100 mm inserted through any opening on top of ENCLOSURE or through any opening provided for adjustment of pre set controls using a TOOL Test pin or the test rod inserted through relevant openings with minimal force of no more than 1N Test rod inserted in every possible position through openings provided for adjustment of pre set controls that can be adjusted in NORMAL USE with a force of 10 N Test repeated with a TOOL specified in N A instructions for use Test rod freely and vertically suspended through openings on top of ENCLOSURE A TOOL is required when it is possible to prevent the devices from operating
147. eep and deterioration and residual stresses from manufacturing PROCESSES Instructions on attachment of structures to a floor wall ceiling included in ACCOMPANYING DOCUMENTS making adequate allowances for quality of materials used to make the connection and list the required materials 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 in Table 21 except when an alternative method used to demonstrate structural integrity throughout EXPECTED SERVICE LIFE or for a foot rest examination of ME EQUIPMENT RISK MANAGEMENT Table 9 8 2 FILE specifications and material processing 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 N A N A accidental loosening of 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 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
148. electric strength test of Clause 8 8 at test voltage of Table 6 CREEPAGE and CLEARANCES forming a MEANS OF Evaluated in part of power PATIENT PROTECTION complied with Table 12 supply PROTECTIVE EARTH CONNECTIONS forming a MEANS Evaluated in part of power OF PATIENT PROTECTION complied with Cl 8 6 supply Test Report No 1403042002 Page 34 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark A Y1 capacitor complying with IEC 60384 14 Evaluated in part of power and having passed dielectric strength test for supply 2 MOPP provided two MEANS OF PATIENT PROTECTION considered between primary to equivalent to one MEANS OF PATIENT PROTECTION Secondary circuit Two capacitors used in series each RATED for Evaluated in part of power total WORKING VOLTAGE across the pair and have supply 2 MOPP provided the same NOMINAL capacitance between primary to secondary circuit NZ Voltage Total Working V and C Nominal uF OEETTETETET 5 MEANS OF OPERATOR PROTECTION MOOP Evaluated in part of power supply 2 MOPP provided between primary to secondary circuit Solid insulation forming a MEANS OF OPERATOR PROTECTION complied with dielectric strength test of 8 8 at test voltage N A of Table 6 or requirements of IEC 60950 1 for INSULATION N A CO ORDINATION CREEPAGE and CLEARANCES forming a MEANS OF N A OPERATOR PROTECTION with r
149. en defined Statement on ME EQUIPMENT for connection to a separate power supply indicating power supply is specified as a part of ME EQUIPMENT or combination is specified as a ME SYSTEM Specified power supply was indicated on the label Warning statement for mains operated ME EQUIPMENT with additional power source not automatically maintained in a fully usable The power supply is full usable condition no warning statement is condition indicating the necessity for periodic checking or replacement of power source required 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 cccceseesseeneeeeeeeeeeeeees Test Report No 1403042002 Page 26 of 197 60601 1TRF_A No primary battery used Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Specifications of replaceable INTERNAL ELECTRICAL POWER SOURCE when provided Warning indicating ME EQUIPMENT must be See appended RM Results connected to an appropriate power source Table 7 9 2 4 when loss of power source would result in an unacceptable RISK cssc EQUIPMENT its functions significant physical and performance characteristics together with the expected positions of OPERATOR PATIENT or other persons near ME EQUIPMENT in NORMAL USE Information provided on ma
150. ended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT RMF _ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with the forces to which the device would be 01 C 11 subject to unwanted movement of components used has been identified 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 C 11 Test Report No 1403042002 Page 149 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 3 ONYX BE381DT_RMF_ Version 1 00 Section Risk Analysis F 01 H 01 C 18 The manufacturer had compiled a list of known or foreseeable hazards associated with the forces to which the device would be subject to unwanted movement of wiring has been identified 8 10 1 RM RESULTS TABLE Fixing of components Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 11 ONYX BE381DT_RMF_ Version 1 00
151. ent file Risk Evaluation Before Measures F 01 H 01 C 07 C 11 ONYX BE381DT_RMF _ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 002 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had been verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 002 management file 6 4 ONYX BE381DT_RMF_ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 07 C 11 ONYX BE381DT RMF _ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF _ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 8 1 b 3 RM RESULTS TABLE Fundamental rule of protection against electric shock Pass accidental detachment of conductors and connectors Test Report No 1403042002 60601 1TRF_A Page 129 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Clause of
152. equirement Test Result Remark Clause Results observed HAZARDOUS No SITUATION Description of SINGLE FAULT CONDITION poet Oe Yes No 13 2 9 Interruption and short circuiting of motor capacitors Motor capacitors short amp open circuited Also see 13 10 V measured V measured 13 2 10 Additional test criteria for motor operated ME EQUIPMENT in 13 2 8 amp 13 2 9 For every test in SINGLE FAULT CONDITION of 13 2 8 and 13 2 9 motor operated EQUIPMENT stared from 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 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 Temperatures did not exceed limits of Table 26 13 2 11 Failures of components in ME EQUIPMENT used in conjunction with OXYGEN RICH ENVIRONMENTS 13 2 12 Failure of parts that might result in a MECHANICAL HAZARD See 9 amp 15 3 Supplementary information 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 13 2 6 RM RESULTS TABLE Leakage of liquid
153. equirements of IEC 60950 1 for INSULATION CO ORDINATION PROTECTIVE EARTH CONNECTIONS forming a MEANS OF OPERATOR PROTECTION complied with CI 8 6 or requirements and tests of IEC 60950 1 for protective earthing ccecccesseneeeesseeeeseeteenees A Y2 capacitor complying with IEC 60384 14 and passing dielectric strength test for one MEANS OF OPERATOR PROTECTION considered equivalent to one MEANS OF OPERATOR PROTEC TON irnia iaa A Y1 capacitor complying with IEC 60384 14 and having passed dielectric strength test for two MEANS OF OPERATOR PROTECTION considered equivalent to two MEANS OF OPERATOR PROTECTION aca Two capacitors used in series each RATED for total WORKING VOLTAGE across the pair and have the same NOMINAL capacitance Voltage Total Working V and C Nominal uF eee reer i Test Report No 1403042002 Page 35 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Points at which impedances of components N A CREEPAGE CLEARANCES PROTECTIVE EARTH CONNECTIONS or insulation prevent ACCESSIBLE PARTS from exceeding limits in 8 4 examined whether a failure at any of these points is to be regarded as a NORMAL Or SINGLE FAULT CONDITION A MEANS OF PROTECTION protecting APPLIED PARTS or parts identified by 4 6 as parts subject to the same requirements considered MEANS OF PATIENT PROTECTION scssssceesseeeseeee
154. er cl 5 7 No times 1 6 except for 48 h only Breakdown Yes No 68hatT1 2 C _ C 1hat 25 C 42 C f 2hat0 C 2 C 1 or more h at 25 C 2 C 68h atT1 2 C __ C 1hat 25 C 2 C g 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C _ C 1hat 25 C 42 C i 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C _ C 1hat 25 C 42 C g 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 Test Report No 1403042002 Page 146 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 9 3 4 Table Thermal cycling tests on one sample of cemented joint see 8 9 3 3 N A Dielectric strength test Test Each test duration and Dielectric test voltage after humidity Sequence temperature V Test voltage in 8 8 3 preconditioning per cl 5 7 No times 1 6 except for 48 h only Breakdown Yes No 68hatT1 2 C __ C 1hat 25 C 42 C i 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C __ C 1hat25 C 2 C a 2hat0 C 2 C 1 or more h at 25 C 2 C 68hatT1 2 C _ C 1hat
155. es that can also result in HAZARD evaluated as part of RISK MANAGEMENT PROCESS Measurements not made when engineering See appended RM Results judgment and rationale by MANUFACTURER Table 11 1 3 indicated temperature limits could not exceed as documented in RISK MANAGEMENT FILE i Test corner not used where engineering The test corner is used and judgment and rationale by MANUFACTURER its surfaces shall not exceed indicated test corner will not impact 90 C measurements as documented in RISK MANAGEMENT FILE Probability of occurrence and duration of Touch Panel and Plastic contact for parts likely to be touched and for enclosure or parts likely to APPLIED PARTS documented in RISK MANAGEMENT be touched GUARDS preventing contact with hot or cold No such construction accessible surfaces removable only with a TOOL 11 2 1 ENCLOSURE has strength and rigidity necessary to prevent a fire caused by reasonably foreseeable misuse and met mechanical strength tests for ENCLOSURES in 15 3 11 2 2 Me equipment and me systems used in conjunction with OXYGEN RICH ENVIRONMENTS 11 2 2 1 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 the following GONGITIONS nen Test Report No 1403042002 Page 74 o
156. eses A MEANS OF PROTECTION protecting other parts N A considered MEANS OF OPERATOR PROTECTION Separation of PATIENT CONNECTIONS N A PATIENT CONNECTIONS of F TYPE APPLIED PART No PATIENT CONNECTIONS N A separated from all other parts by equivalent to provided one MEANS OF PATIENT PROTECTION for a WORKING VOLTAGE equal to maximum MAINS VOLTAGE and complied with limit for PATIENT LEAKAGE CURRENT at 110 of max MAINS VOLTAGE Separation requirement not applied between No F TYPE applied part 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 are to be considered as all within One APPLIED PART or as multiple APPLIED PARTS Classification as TYPE BF CF or DEFIBRILLATION PROOF applied to one entire APPLIED PART LEAKAGE CURRENT tests conducted per 8 7 4 Dielectric strength test conducted per 8 8 3 CREEPAGE and CLEARANCES measured per 8 9 and Tables 11 to 16 as applicable A protective device connected between PATIENT 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 PROTECTIVELY EARTHED are separated by one MEANS OF PATIENT PROTECTION from metal ACCESSIBLE PARTS not PROTECTIVELY EARTH
157. essed taking into consideration NORMAL USE of ME EQUIPMENT 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 Test Report No 1403042002 Page 63 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 Grips and other handling devices a ME EQUIPMENT other than PORTABLE No such construction 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 b PORTABLE ME EQUIPMENT with a mass gt 20 kg No such construction p
158. evented where a application and assessment HAZARDOUS SITUATION could otherwise exist Ifor ME system is not Interruption and restoration of relevant power Product is a Monitor connections of ME SYSTEM one ata time and all application and assessment connections simultaneously did not result ina _ for ME system is not 7 ME SYSTEM complied with applicable Product is a Monitor requirements of Clause 9 when a MECHANICAL application and assessment 8 considered in current status Connectors complied with Clause 15 4 1 L ed N A Test Report No 1403042002 Page 101 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Plugs for connection of PATIENT leads could N A not be connected to other outlets of the same ME SYSTEM likely to be located in PATIENT ENVIRONMENT except when examination of connectors and interchanging them proved no HAZARDOUS SITUATION could result a MULTIPLE SOCKET OUTLET only allows N A connection using a TOOL or MULTIPLE SOCKET OUTLET is of a type that N A cannot accept MAINS PLUGS of any of the kinds specified in IEC TR 60083 or MULTIPLE SOCKET OUTLET is supplied via a N A separating transformer b MULTIPLE SOCKET OUTLET marked with safety N A sign 2 of Table D 2 i e safety sign ISO 7010 W001 visible in NORMAL USE and marked either individually or in combinations N A
159. f in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF__ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis with the unit in both normal and fault conditions 44 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 H 02 F 02 H 01 H 02 F 03 H 01 F 04 H 01 F 05 H 01 F 06 H 01 F 07 H 01 H 02 H 03 F 08 H 01 F 09 H 01 F 10 H 01 F 11 H 01 H 02 4 8 RM RESULTS TABLE Components of ME Equipment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data Test Report No 1403042002 Page 118 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 8 RM RESULTS TABLE Components of ME Equipment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT
160. f 197 Issued 25 July 2014 60601 1TRF_A A 17 VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 causing sparking or increasing material temperature to its ignition temperature 3 when parts affecting safety cracked or changed outer shape exposing temperatures higher than 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 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 worstcase 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 ecseseeeen 5 A safe upper limit determined by dividing upper limit of voltage or current respectively with safety margin factor of three s00 b RESIDUAL RISK of fire in an OXYGEN RICH ENVIRONMENT as determined by application of RISK MANAGEMENT PROCESS is based on rarang configurations or in combination
161. f protective device Maximum allowed Maximum Winding tested insulation used fuse circuit temp from winding temp A B E F H breaker Ratings Table 31 C measured C Ambient Test Report No 1403042002 Page 195 of 197 Issued 25 July 2014 60601 1TRF_A fo 7 VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Supplementary information 1Loads 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 TABLE Transformer dielectric strength after humidity preconditioning of 5 7 Transformer Test voltage applied between Test Test Breakdown Deterioration Model Type Part voltage frequency Yes No Yes No No V Hz Primary amp secondary windings Primary winding amp frame Secondary winding amp frame Supplementary information Tests conducted under the conditions of 11 1 in ME EQU
162. f solid SUPPLEMENTARY or REINFORCED INSULATION Test Report No 1403042002 Page 62 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark CREEPAGE DISTANCES and AIR CLEARANCES measured compared favourably with min distances in clause 8 9 Small chips not adversely affecting protection against electric shock or moisture disregarded 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 iniits 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 movement creepage and pivoting of castors no further movement of MOBILE ME EQUIPMENT gt 50 mm in relation to inclined plane occurred mm Risk due to any initial movement assessed taking into consideration NORMAL USE of ME EQUIPMENT Instability excluding transport a Further movement of ME EQUIPMENT after No Such construction 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 Risk due to initial movements ass
163. fore Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 022 6 3 ONYX BE381DT RMF__ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 022 management file 6 4 ONYX BE381DT_RMF_ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 23 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 11 6 7 RM RESULTS TABLE Sterilization of ME equipment and ME systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 Test Report No 1403042002 60601 1TRF_A Page 180 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 6 7 RM RESULTS TABLE Sterilization of ME equipment and ME systems N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971
164. ggable into a mains socket protected from making contact with parts at MAINS VOLTAGE by insulation with a CREEPAGE DISTANCE Of at least 1 0 mm a 1500 V dielectric strength and complying with 8 8 4 1 required test finger did not make electrical contact 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 OF a flat SUIPACE ee eceeeceeseeete cece teeeeeeeeeeeeeeeeenees MAXIMUM MAINS VOLTAGE MAXIMUM MAINS VOLTAGE determined to be the 240 Vac highest RATED supply voltage for single phase or d c SUPPLY MAINS powered ME EQUIPMENT as well as INTERNALLY POWERED ME EQUIPMENT with a means of connection to a SUPPLY MAINS V Test Report No 1403042002 Page 37 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark When less than 100 V MAXIMUM MAINS VOLTAGE was 250 V MAXIMUM MAINS VOLTAGE was the highest RATED Not poly phase ME phase to neutral supply voltage for poly m EQUIPMENT ME EQUIPMENT V Jaic ierra asenaan enaa aeiae for other INTERNALLY POWERED ME EQUIPMENT maximum mains voltage was 250 V Input supply voltage to ME EQUIPMENT was 240 V ac RATED voltage or voltage within RATED range resulting in highest measured value V WORKING VO
165. hat became accessible checked using standard test finger and by inspection Conductive parts of actuating mechanisms of electrical controls accessible after removal of handles knobs levers and the like regarded as ACCESSIBLE PARTS esscssessessesseeseeseeseesseeseeseeseesaneas Test Report No 1403042002 Page 15 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Conductive parts of actuating mechanisms not considered ACCESSIBLE PARTS when removal of handles knobs etc required use of a TOOL and inspection of RISK MANAGEMENT FILE indicated the relevant part is unlikely to detach unintentionally during EXPECTED SERVICE LIFE of ME EQUIPMENT LT CLASSIFICATION OF ME EQUIPMENT AND ME SYSTEMS Pass CLASS II ME EQUIPMENT externally powered Po INTERNALLY POWERED ME EQUIPMENT EQUIPMENT with means of connection to a Device is a Monitor which SUPPLY MAINS complied with CLASS or CLASS II ME connected to a switching EQUIPMENT requirements when so connected power adapter and when not connected to SUPPLY MAINS with INTERNALLY POWERED ME EQUIPMENT requirements Tweens S Teesra S we cramueoranr Si Dsremsvoweroorammmoremrs ENCLOSURES classified according to degree of protection against ingress of water and particulate matter IPN N2 as per IEC 60529 eee appended RM Rasuli Table 11 6 5 ME EQUIPMENT or its parts in
166. hrough Risk benefit N A analysis 11 1 2 1 RM RESULTS TABLE Applied parts intended to supply heat to patient N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 11 1 2 2 RM RESULTS TABLE Applied parts not intended to supply heat to patient Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Test Report No 1403042002 60601 1TRF_A Page 172 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 1 2 2 RM RESULTS TABLE Applied parts not intended to supply heat to patient Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with the heat generated by the device have 02 C 01 been identified 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 02 C 01 5 ONYX BE381DT RMF_ The results of this risk evaluation were Pass Vers
167. ic forces due to loading from persons N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 8 3 3 TABLE Support Suspension System Dynamic forces due to loading from N A persons ME EQUIPMENT Safe Working part or area Load Supplementary Information 9 8 4 1 RM RESULTS TABLE Systems with mechanical protective devices General N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 8 4 3 RM RESULTS TABLE Mechanical protective device for single activation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 Test Report No 1403042002 Page 165 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 8 4 3 RM RESULTS TABLE Mechanical protective device for single activation N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 4 5 6 2 6 3 6 4 6 5 9 8 5 RM RESULTS TABLE Systems without mechanical protective devices Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT R
168. icable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE 0 00 11 PROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER HAZARDS Excessive temperatures in ME EQUIPMENT Temperatures on ME EQUIPMENT parts did not See appended Table 11 1 1 exceed values in Tables 22 and 23 operating in and appended RM Results worst case NORMAL USE at maximum rated Table 11 1 1 ambient operating temperature T THERMAL CUT OUTS did not operate in NORMAL No THERMAL CUT OUTS N A CONDITION Temperature of APPLIED PARTS Temperatures hot or cold surfaces and when Touch Panel and Plastic appropriate clinical effects of APPLIED PARTS enclosure was defined for supplying heat to a PATIENT determined and the product documented in RISK MANAGEMENT FILE and instructions TOF USC siriana Surfaces of test corner did not exceed 90 C Pass Test Report No 1403042002 Page 73 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark APPLIED PARTS not supplying heat to a PATIENT See appended RM Results met Table 24 with max surface temperatures gt Table 11 1 2 2 41 C disclosed in instructions for use and clinical effects regarding maturity of PATIENTS body surface surface pressure medications taken as shown in RISK MANAGEMENT FILE 4 Surfaces of APPLIED PARTS cooled below ambient temperatur
169. ide Unit Bottom 15 3 3 Impact Test Steel ball 50 mm in dia 500g 25 There was no cracking of the g falling from a 1 3 m enclosure and were no live parts Part undertest that became accessible Unit Top Unit Side Unit Bottom 15 3 4 1 Drop Test hand Free fall height m held 15 3 4 2 Drop Test portable Drop height cm 5 cm There was no damage tothe interior or exterior of the tested sample which caused exposure to live parts or increased risk of electric shock 15 3 5 Rough handling test Travel speed m s 15 3 6 Mould Stress Relief 7h in oven at temperature C There was no warping cracking 70 C breaking and exposure of live parts Supplementary information As applicable Push Impact Drop Mould Stress Relief and Rough Handling Tests delete not applicable rows Test Report No 1403042002 Page 189 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 02 Version 1 00 Section Risk Evaluation Before Measures F 01 H 02 C Test Report No 1403042002 60601 1TRF_A the risk management file Page 190 of 197 15 3 2 RM RESULTS TABLE Push test Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RM mention the Inten
170. in Kg Damage or deflection resulting in an unacceptable RISK did not occur on foot rest and its secured joints 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 Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing and by a test 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 l Test Report No 1403042002 Page 69 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark PATIENT support suspension system set in N A most unfavourable NORMAL USE position and a mass of 60 of part of SAFE WORKING LOAD simulating PATIENT Or OPERATOR or a min 80 kg placed on support or suspension system with centre of load 60 mm from outer edge of support or suspension system for at least one minute Kg Deflection of support suspension system N A resulting in an unacceptable RISK not occur N A Dynamic forces that can be exerted on No patient or operator equipment parts supporting or suspendinga support systems PATIENT Or OPERATOR N NORMAL USE did not result in an unacceptable RISK as confirmed by following test PATIENT support suspension system set i
171. in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 2 2 2 TABLE Measurement of gap a according to Table 20 ISO 13852 1996 Part of body Allowable adult Measured adult Allowable children Measured children Test Report No 1403042002 Page 153 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark gap mm gap mm gap mm gap mm 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 25or lt 8 gt 25o0r lt 4 Supplementary information In general gaps for adults used except when the device is specifically designed for use with children values for children applied 9 2 2 4 3 RM RESULTS TABLE Movable guards N A Clause of ISO 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 2 2 4 4 RM RESULTS TABLE Protective measures N A Clause of ISO 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 4 2 4 3 4 4
172. indian Dist New Taipei 231 Taiwan Tested by name signature Ella Chang EN a Lhe F Approved by signature Pavin Tsai Z gt PA gt Test Report No 1403042002 Page 3 of 197 Issued 25 July 2014 60601 1TRF_A pia vV VICTRONIC TECHNOLOGY CORPORATION List of Attachments including a total number of pages in each attachment Photo Documentation 9 pages Technical Documentation 4 pages Manual 38 pages Summary of testing Tests performed name of test and test clause Testing location Power Input Test 4 11 Victronic Technology Humidity Preconditioning Treatment 5 7 Corporation 4th FI 130 on Ln 235 Baoqiao Rd Legibility of Markings 7 1 2 Xindian Dist New Taipei Durability of Marking Test 7 1 3 231 Taiwan Dielectric Voltage Withstand 8 8 3 Ball Pressure 8 8 4 1 Temperature Test 11 Overflow Spillage Leakage Cleaning Sterilization and Disinfection Harmful Ingress of Liquids 11 6 Interruption of Power Supply 11 8 Abnormal Operation and Single Fault Conditions 13 Enclosure Mechanical Strength 15 3 Drop Impact Test 15 3 4 Mold Stress Relief Test 15 3 6 Leakage Current Test 8 7 Suspension Systems Without Mechanical Protective Devices 9 8 5 Summary of compliance with National Differences List of countries addressed CA CA Canada XX The product fulfils the requirements of EN 60601 1 2006 CAN CSAC22 2 No 60601 1 08
173. ing means operated when heater switched on with container empty and prevented 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 review of design and RISK MANAGEMENT FILE Temperature settings clearly indicated when means provided to vary setting of THERMOSTATS 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 review of design and RISK MANAGEMENT FILE sssseeee h 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 Means provided to prevent incorrect See appended RM Results connection of polarity when a HAZARDOUS Table 15 4 3 2 SITUATION may develop by incorrect connection or replacement of a battery ccccssseeeeeeeeeees Overcharging of battery prevented by virtue of See appended RM Results design when it could result in an unacceptable Table 15 4 3 3 RISK as verified by review of design Lithium batteries that could become a HAZARD See appended RM Results complied with appropriate tests of IEC 60086 4 Table 15 4 3 4 Tests of IEC 60086 4 waived on the lithium batte
174. ion 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 8 1 b 2 RM RESULTS TABLE Fundamental rule of protection against electric shock Pass unintended movement of a component Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data Test Report No 1403042002 Page 128 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 8 1 b 2 RM RESULTS TABLE Fundamental rule of protection against electric shock Pass unintended movement of a component Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards associated Risk Analysis F 01 H with unintended movement of components 01 C 07 C 11 have been considered 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 C 07 C 11 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk managem
175. ion 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 02 C 01 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 032 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 032 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 02 C the risk management plan 01 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis Test Report No 1403042002 60601 1TRF_A Page 173 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 1 3 TABLE Temperature of windings by change of resistance method N A Temperature T of wi
176. is F 04 H with the accessible parts have been 01 identified 4 4 ONYX BE381DT_RMF_ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 04 H 01 8 4 3 TABLE ME EQUIPMENT for connection to a power source by a plug N A measurement of voltage or calculation of stored charge 1 s after disconnection of plug from mains supply Maximum allowable voltage V cessesesneesneeeeeeeeeeeeseeeeeneseneneeeseneneeeneeeneeeneeeeneeeneeenseensneas 60 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 measured voltage exceeded 60 v uc 145 Calculated stored charge uc Voltage Measured Between 1 2 3 4 5 6 7 8 9 10 Plug pins 1 and 2 Test Report No 1403042002 Page 131 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Plug pin 1 and plug earth pin Plug pin 2 and plug earth pin Plug pin 1 and enclosure Plug pin 2 and enclosure Supplementary information The adapter
177. is enclosure with supplied supplied foil via via external external certified certified power power supply supply 1 MOPP IIIb 250 4 0 25 The The Adapter Earth equipme equipme to Touch nt is nt is Panel with foil supplied supplied via via external external certified certified power power supply supply INSULATION DIAGRAM CONVENTIONS and GUIDANCE A measured value must be provided in the value columns for the device under evaluation The symbol gt greater than sign must not be used Switch mode power supplies must be re evaluated in the device under evaluation therefore N A must not be used with a generic statement that the component is certified Insulation diagram is a graphical representation of equipment insulation barriers protective impedance and protective earthing If feasible use the following conventions to generate the diagram All isolation barriers are identified by letters between 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 operatoronly are extended outside of the enclosure but are not terminated withyan arrow Test Report No 1403042002 Issued 25 July 2014 60601 1TRF_A
178. is indicated No such condition condition being tested was adequately evaluated by other tests or methods Fr Appended RM Results Table 5 1 Results of Risk ANALYSIS used to determine See appended RM Results combination s of simultaneous faults to be Table 5 1 tested TYPE TESTS conducted on one representative sample under investigation multiple samples used simultaneously when validity of results was not significantly affected a Tests conducted within the environmental conditions specified in technical description Temperature C Relative Humidity 0 5 i Atmospheric Pressure kPa 700 1060 hPa b ME EQUIPMENT shielded from other No such situation N A influences that might affect the validity of tests N A c Test conditions modified and results No such situation adjusted accordingly when ambient temperature could not be maintained Test Report No 1403042002 Page 13 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark a ME EQUIPMENT tested under least favourable See appended RM Results working conditions specified in instructions for Table 5 4 a use and identified during Risk ANALYSIS except as noted b ME EQUIPMENT with adjustable or controlled This equipment was tested operating values by anyone other than SERVICE with the maximum normal PERSONNEL adjusted to values least favourable load see test
179. l position a Foot operated control device is at least IPX1 amp complies with tests of IEC 60529 IP Code b ENCLOSURE of foot operated control devices containing electrical circuits is at least IPX6 and complies with IEC 60529 if in NORMAL USE liquids are likely to be found IP Code Probability of occurrence estimated as part of RISK MANAGEMENT PROCESS Test Report No 1403042002 Page 96 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Aluminum wires less than 16 mm in cross No aluminum wires sectional area are not used a Oil container in PORTABLE ME EQUIPMENT No oil container allows for expansion of oil and is adequately sealed to prevent loss of oil in any position b Oil containers in MOBILE ME EQUIPMENT sealed N A to prevent loss of oil during transport A pressure release device operating during N A NORMAL USE is optionally provided c Partially sealed oil filled ME EQUIPMENT and its N A 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 OF ME EQUIPMENT and transformers providing separation in accordance with 8 5 Overheating Transformers of ME EQUIPMENT are protected Evaluated in part of power against overheating in the event
180. letely or Table 5 7 partially with covers detached and subjected to a humidity preconditioning prior to tests of Clauses 8 7 4 and 8 8 3 ccssecceseteeseeeseeeeseeeeeee Test Report No 1403042002 Page 14 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Manually detachable parts removed and No such construction treated concurrently with major parts and manually removable ACCESS COVERS were opened and detached When RISK MANAGEMENT PROCESS indicated ME EQUIPMENT can be exposed to high humidity for extended periods i e out door use test time extended proportionally h scesseeeeeerees 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 See clause 4 6 reference to ACCOMPANYING DOCUMENTS 0008 A Monitor was defined for the equipment Accessibility when necessary determined using standard test finger of Fig 6 applied in a bent or straight position Openings preventing entry of test finger of Fig 6 mechanically tested with a straight un jointed test finger of the same dimensions with a force When the straight un jointed test finger entered test with the standard test finger Fig 6 was repeated ifnecessary by pushing the finger through the opening All additional parts t
181. llowing 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 cccccsssssseeseneeseeneeeees i SELF RESETTING THERMAL CUT OUTS and OVER CURRENT RELEASES including circuits performing equivalent functions other than PTC s Certified according to appropriate 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 When certification based on IEC standards or data from MANUFACTURER demonstrating reliability of component to perform its safety related function is not available manual reset THERMAL CUT OUTS and OVER CURRENT RELEASES operated 10 times Test Report No 1403042002 Page 93 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Thermal protective devices tested separately from ME EQUIPMENT when engineering judgment indicated test results would not be impacted g Protective device provided on ME EQUIPMENT incorporating a fluid filled container with heat
182. lt in a HAZARDOUS SITUATION except interruption of its intended function protection against hazardous outputs RISK of poor USABILITY including identification marking and documents addressed in a USABILITY ENGINEERING PROCESS as confirmed by review of provided records 2 cccceseesseeeee The need for alarm systems as a means of RISK CONTROL and RISKS associated with operation or failure of alarm system addressed in RISK MANAGEMENT PROCESS esceseeeceseeeseeeeeeseeeeseeeeees from intentional exceeding of safety limits controls and instruments and addressed in RISK MANAGEMENT PROCESS as protection against hazardous confirmed in RISK MANAGEMENT FILE eeccessseeees When applicable need for indication of parameters associated with hazardous output addressed in RISK MANAGEMENT PROCESS as confirmed in RISK MANAGEMENT FILE 02 00200 RISKS associated with accidental selection of excessive output values for ME EQUIPMENT with a multi purpose unit designed to provide low and high intensity outputs for different treatments addressed in RISK MANAGEMENT PROCESS confirmed in RISK MANAGEMENT FILE When applicable RISKS associated with incorrect output addressed in RISK MANAGEMENT PROCESS as confirmed by review of RISK MANAGEMENT FILE ceseeccecessecceseseecerseseeenenseeeens i Test Report No 1403042002 Page 80 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOG
183. ltages of TYPE TESTS in L 3 equal 1 6 times of normal values d Wire with multi layer extruded or spirally Evaluated in part of power wrapped insulation complying with b and supply Test Report No 1403042002 Page 43 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Protection against mechanical stress provided Evaluated in part of power where two insulated wires or one bare and one supply 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 Evaluated in part of power N A dielectric strength tests Of 8 8 3 s esseeeee supply Tests of Annex L not repeated since material Evaluated in part of power N A data sheets confirm compliance 1 supply Dielectric Strength Solid insulating materials with a safety See appended Table 8 8 3 function withstood dielectric strength test WONAGES nnen a Insulation other than wire insulation 8 8 4 1 Resistance to heat retained by all insulation and insulating partition walls during EXPECTED SERVICE LIFE of ME EQUIPMENT ME EQUIPMENT and RISK MANAGEMENT FILE See appended RM Results examined in conjunction with resistance to Table 8 8 4 1 moisture dielectric strength and mechanical StrENnQth tosis siicieisessiecesicecessiareieecseeceeeareeeeacaes
184. luated in part of power PART and sizes of tracks on printed wiring circuits sufficient to prevent fire in case of fault Co 6 ee reiini reani reiia When necessary ME EQUIPMENT connected toa Evaluated in part of power SUPPLY MAINS with max available short circuit supply fault and subsequent simulation of a fault in a single insulation in MAINS PART did not result in any of the HAZARDOUS SITUATIONS in 13 1 2 Test Report No 1403042002 Page 56 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark PROTECTION AGAINST MECHANICAL HAZARDS OF ME EQUIPMENT AND ME SYSTEMS ME EQUIPMENT complies with Clause 4 for design and manufacture and mechanical strength 15 3 HAZARDS associated with moving parts When ME EQUIPMENT with moving parts No moving part PROPERLY INSTALLED used per ACCOMPANYING DOCUMENTS or under foreseeable misuse RISKS associated with moving parts reduced to an acceptable level Risk from contact with moving parts reduced to an acceptable level using protective measures access function shape of parts energy speed of motion and benefits to PATIENT considered RESIDUAL RISK associated with moving parts considered acceptable when exposure was needed for ME EQUIPMENT to perform its function Warnings marked on ME EQUIPMENT or included in instructions for use when HAZARDS persisted after implementing all reasona
185. made in accordance with 11 1 or Umax Imax R Lmax and Cmax determined togeiner with application of Figs G 4 G 6 c ME EQUIPMENT its parts and components heating a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE provided with a non SELF RESETTING THERMAL CUT OUT and coe With 15 4 207 ni Current carrying part of heating element is not in direct contact with FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE Test apparatus for flammable mixtures EN Test apparatus used was in accordance with Equipment not suitable for this Clause and Fig G 7 use in the presence of FLAMMABLE ANESTHETIC MIXTURES ANNEX L INSULATED WINDING WIRES FOR USE WITHOUT INTERLEAVED N A INSULATION Alternatively compliance verified by comparison with design data Test Report No 1403042002 Page 111 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark BASIC SUPPLEMENTARY DOUBLE and REINFORCED Evaluated in part of power INSULATION in wound components without supply interleaved insulation complied with this Annex covering round winding wires between 0 05 mm and 5 00 mm diameters 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 Layers of spirally wrapped wire insulation are sufficiently secured to maint
186. ment file Test Report No 1403042002 60601 1TRF_A Page 174 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 1 3 RM RESULTS TABLE Measurements Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 02 C the risk management plan 01 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 11 2 2 1 RM RESULTS TABLE Risk of fire in an oxygen rich environment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 11 2 2 1 TABLE Alternative method to 11 2 2 1 a 5 to determine existence of an N A ignition source Areas where sparking might cause ignition Remarks 1 2 3 5 6 Test Report No 1403042002 Page 175 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC
187. ments in Clause 7 1 2 cccccseeeeesseeeeet b Markings required by 7 2 7 6 remained See appended Table 7 1 3 CLEARLY LEGIBLE after marking durability test Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts At least markings in 7 2 2 7 2 5 7 2 6 not for See Copy of marking plate PERMANENTLY INSTALLED ME EQUIPMENT 7 2 10 for detail and 7 2 13 were applied when size of EQUIPMENT its part an ACCESSORY or ENCLOSURE did not permit application of all required markings s sssrssnnsrnnnnnnnnnnnnnnnnn annnm Remaining markings fully recorded in ACCOMPANYING DOCUMENTS 2ccceseeeceseeesseeeeeeeeeses Markings applied to individual packaging when No such markings impractical to apply to ME EQUIPMENT A material component ACCESSORY or ME No single use construction N A 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 MANUFACTURER S name or trademark marked on onyx ME EQUIPMENT and detachable components or ONYX Healthcare Inc provided on the label Misidentification does not present an See appended RM Results unacceptable risk Table 7 2 2 MODEL OR TYPE REFERENCE also marked except Models name ONYX when misidentification would not present an BE381DT xx xxxx Where x Unacceptable RISK ssicececccericscseccacsccterecssnecceseedeceess Jis 0 9 A Z gt or blank Software forming p
188. ments of this standard POWER SUPPLY CORD does not incorporate a N A POTENTIAL EQUALIZATION CONDUCTOR FUNCTIONAL EARTH TERMINAL not used to provide No FUNCTIONAL EARTH N A a PROTECTIVE EARTH CONNECTION Class II ME EQUIPMENT N A Third conductor of POWER SUPPLY CORD Class equipment N A connected to protective earth contact of MAINS PLUG provided with CLASS II ME EQUIPMENT with isolated internal screens used as functional earth connection to the screen s FUNCTIONAL EARTH TERMINAL coloured green and yellow Two MEANS OF PROTECTION provided by insulation of internal screens and all internal wiring connected to them with a related explanation in technical description LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS a Electrical isolation providing protection See appended Table 8 7 against electric shock limits currents to values WOW B72 ces cies r EE E T b Specified values of EARTH LEAKAGE TOUCH See appended Table 8 7 PATIENT LEAKAGE and PATIENT AUXILIARY CURRENTS applied in combination of conditions in appended Table 8 7 scsssesseeeeeeeeeeeeeeesees Allowable values specified in 8 7 3 applied under SINGLE FAULT CONDITIONS of 8 1 b except where insulation used_in conjunction with a PROTECTIVE EARTH CONNECTION insulation short circuited only under conditions in 8 6 4 b the only SINGLE FAULT CONDITION for EARTH LEAKAGE CURRENT was interruption of one supply conductor at
189. mpedance of SUPPLY MAINS permissible range of values of inlet pressure and flow and chemical composition of cooling liquid used for cooling a description of means of isolating ME Medical grade power supply EQUIPMENT from SUPPLY MAINS when such provided as means of means not in ME EQUIPMENT insulation warning No modification of this equipment i warning Do not modify this equipment See User Manual en amp without authorization of the manufacturer Warranty warning If this equipment is modified appropriate inspection and testing must be conducted to ensure continued safe use of equipment Technical description separable from instructions for use contains required information as follows information as in clause 7 2 all applicable classifications in Clause 6 warning and safety notices and explanation of safety signs marked on ME EQUIPMENT a description of means for checking oil level in partially sealed oil filled ME EQUIPMENT or its parts when applicable a warning statement addressing HAZARDS that See below can result from unauthorized modification of ME EQUIPMENT according to following examples a brief description of ME EQUIPMENT how it functions and its significant physical and performance characteristics Test Report No 1403042002 Page 29 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requiremen
190. n most unfavourable NORMAL USE position and a mass equal to SAFE WORKING LOAD simulating PATIENT Or OPERATOR dropped from 150 mm above seat area on an area of support suspension a PATIENT Or OPERATOR Can sit Systems with MECHANICAL PROTECTIVE DEVICES N A a A MECHANICAL PROTECTIVE DEVICE provided No mechanical protective when a support system or its parts impaired device provided by wear have a TENSILE SAFETY FACTOR gt to values in Table 21 rows 5 and 6 but less than Designed based on TOTAL LOAD and includes 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 unacceptable Risk Takes into account Clauses 9 2 5 and 9 8 4 3 Compliance confirmed by examination of ME EQUIPMENT RISK MANAGEMENT FILE specifications of materials and their processing Test Report No 1403042002 Page 70 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark Activation of MECHANICAL PROTECTIVE DEVICE is No mechanical protective made obvious to OPERATOR when ME EQUIPMENT device provided 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 PRO
191. n PEMS is to be connected to other equipment outside control of PEMS MANUFACTURER by NETWORKI DATA COUPLING T a characteristics of NETWORK DATA COUPLING necessary for PEMS to achieve its INTENDED USE failure of NETWORK DATA COUPLING to provide the specified characteristics c instructions to RESPONSIBLE ORGANIZATION containing required information and warnings E connection of PEMS to a NETWORK DATA N A COUPLING that includes other equipment could result in previously unidentified Risks and RESPONSIBLE ORGANIZATION Shall identify analyze and control such RISKS o i subsequent changes to NETWORK DATA COUPLING introducing new RISKS and requiring new analysis and changes to NETWORK DATA COUPLING include NETWORK DATA COUPLING configuration change connection of additional items to NETWORKI DATA COUPLING p b list of HAZARDOUS SITUATIONS resulting from a Test Report No 1403042002 Page 89 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark disconnecting items from NETWORK DATA N A COUPLING update of equipment connected to N A NETWORK DATA COUPLING upgrade of equipment connected to N A NETWORK DATA COUPLING CONSTRUCTION OF ME EQUIPMENT EZE R sKs associated with arrangement of controls Arrangement of controls and and indicators of ME EQUIPMENT addressed in indicators of this devi
192. n RISK MANAGEMENT radiation PROCESS as shown in RISK MANAGEMENT FILE Risk associated with microwave radiation No microwave radiation when applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE ssesccsseeeeceseseceeneseseneeseseseaneeeeees Test Report No 1403042002 Page 72 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Relevant requirements of IEC 60825 1 1993 No lasers and laser light applied to lasers light emitting diodes LEDs barriers or similar products and laser light barriers or similar products This product contains only LEDs Class 1 operating in the range of 400 700 nm wavelength No IEC60825 1 evaluation was deemed necessary Additional review may be required at the discretion of the accepting NCB RISK associated with visible electromagnetic See appended RM Results radiation other than emitted by lasers and LEDS Table 10 5 when applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE 0sssecessesceceseeeceeeseeceeeeseeneeenseaes Risk associated with infrared radiation other No such hazard than emitted by lasers and LEDS as applicable addressed in RISK MANAGEMENT PROCESS as indicated in RISK MANAGEMENT FILE 0 00 l 10 7 Risk associated with ultraviolet radiation other No UV N A than emitted by lasers and LEDS as appl
193. n part of power CURRENT RELEASES accessible by use of a TOOL supply marked by type and full rating at the component or by reference to ACCOMPANYING DOCUMENTS Voltage V and Current A rating 0 Te sw sw lz Operating speed s and Breaking capacity _ _ PROTECTIVE EARTH TERMINAL marked with symbol Evaluated in part of power 6 of Table D 1 IEC 60417 5019 DB 2002 10 supply except for the PROTECTIVE EARTH TERMINAL in an APPLIANCE INLET according to IEC 60320 1 Symbol 7 of Table D 1 IEC 60417 5017 DB No FUNCTIONAL EARTH N A 2002 10 marked on FUNCTIONAL EARTH TERMINALS TERMINALS Terminals for supply conductors marked Evaluated in part of power adjacent to terminals except when no HAZARD supply would result when interchanging connections Terminal markings included in ACCOMPANYING DOCUMENTS when ME EQUIPMENT too small to accommodate markings Terminals exclusively for neutral supply Not PERMANENTLY INSTALLED conductor in PERMANENTLY INSTALLED ME ME EQUIPMENT EQUIPMENT marked with Code 1 of Table D 3 Code in IEC 60445 Marking for connection to a 3 phase supply if Single phase N A necessary complies with IEC 60445 Markings on or adjacent to electrical connection No such construction points not applied to parts requiring removal to make connection and remained visible after connection made Markings on or adjacent to PROTECTIVE EARTH TERMINALS not applied to parts requiring removal
194. n unlikely to be displaced when fitting the supply conductors 8 11 4 2 Arrangement of MAINS TERMINAL DEVICES N A N A b PROTECTIVE EARTH CONDUCTOR connections complied with 8 6 c Marking of MAINS TERMINAL DEVICES complied with 7 3 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 is stripped 8 mm and a single free wire is bent in each possible direction 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 re wirable POWER SUPPLY CORD to allow for 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 8 11 5 Mains fuses and OVER CURRENT RELEASES N A Test Report No 1403042002 Page 55 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark
195. nd viruses S 2o o r 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 VAG a E E E A documented requirement specification for PEMS and each of its subsystems e g for a PEss which includes ESSENTIAL PERFORMANCE and RISK CONTROL measures implemented by that system or subsystem 1 seeeeeeeseeseeeeeneeeenens i Test Report No 1403042002 Page 87 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark An architecture satisfying the requirement is N A specified for PEMS and_each of subsystems The architecture specification makes use of N A considers the specified items to reduce RISK to an acceptable level where appropriate a COMPONENTS WITH HIGH INTEGRITY N A CHARACTERISTICS f defensive design potentially limiting N A hazardous effects by restricting available output power or by introducing means to limit travel of actuators g allocation of RISK CONTROL measures to subsystems and components of PEMS h failure modes of components and their effects j systematic failures k test interval duration and diagnostic coverage m protection from reasonably foreseeable misuse n NETWORK DATA COUPLING Specification when applicable Design is broken up into subsystems each with a design and test
196. nding t4 C R Q t2 C R2 Q T C Allowed Insulatio Tmax C n class Supplementary information 11 1 3 RM RESULTS TABLE Measurements Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 ONYX BE381DT_RMF_ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF_ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with the heat generated by the device have 02 C 01 been identified 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 02 C 01 5 ONYX BE381DT_RMF__ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 02 C 01 ONYX BE381DT_RMF _ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 032 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 032 manage
197. nductors 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 MEANS OF PROTECTION Test Report No 1403042002 Page 53 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Conductors of POWER SUPPLY CORD supplied by N A 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 subjected to a torque in Table 18 for 1 N A min immediately after pull tests Cord anchorage did not allow cord sheath to N A be longitudinally displaced by more than 2 mm or conductor ends to move over a distance of more than 1 mm from their connected position CREEPAGE and CLEARANCES not reduced below limits in 8 9 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 Not stationary ME ME EQUIPM
198. ng Label tested Remarks Material of Marking Label c cssecseesseeseeeseees Car Tong Co type CT M002 Ink other printing material or process Ink Material composition of Warning Label gt oe Ink other printing material or process gt Otek annaa N oe COE ee z Supplementary information Marking rubbed by hand first for 15 s with a cloth rag soaked with distilled water then for 15 s with a cloth rag soaked with methylated spirit and then for 15 s with a cloth rag soaked with isopropyl alcohol 7 2 2 RM RESULTS TABLE Identification Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Test Report No 1403042002 Page 123 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 7 2 2 RM RESULTS TABLE Identification Pass Clause of ISO 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 4 2 ONYX BE381DT_RMF_ Version 1 00 Section Version Data The RMF mention the Intended use intended purpose Pass 4 3 ONYX BE381DT_RMF_ Version 1 00 Section Risk Analysis F 07 H 01 H 02 H 03 The manufacturer had compiled a list of known or foreseeable hazards abo
199. nsideration 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 circuit Umax additionally determined with actual resistance R when equivalent resistance R in Fig G 5 was less than 8000 Q Peak value taken into consideration when a c N A supplied Test Report No 1403042002 Page 110 of 197 Issued 25 July 2014 60601 1TRF_A Measured Imax lt Iz With Lmax and a Umax lt 24 a as in Fig G O sssini fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 An equivalent circuit calculated to determine N A max capacitance inductance and Umax and Imax either as d c or a c peak values in case of a complicated circuit sissit When energy produced in an inductance or N A capacitance in a circuit is limited by voltage or current limiting devices two independent components applied to obtain the required limitation even when a first fault Short or open circuit in one of these components Above requirement not applied to transformers complying with this standard 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 APG ME EQUIPMENT parts and components or Temperature measurements
200. nt No amp paragraph 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known and foreseeable hazards under both Risk Analysis F 01 H normal and single fault conditions 01 C 17 associated with the insulating materials have been evaluated 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file RMF Risk Evaluation Before Measures F 01 H 01 C 17 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 17 ONYX BE381DT_RMF _ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 004 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had been verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 004 management file 6 4 ONYX BE381DT_RMF_ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 17 ONYX BE381DT RMF _ Version 1 00 Section
201. of short supply circuit or overload of output windings and comply with this Clause and tests of 15 5 1 2 3 During tests windings did not 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 Transformer output winding short circuited Evaluated in part of power and test continued until protective device supply operated or THERMAL STABILITY achieved i 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 Evaluated in part of power with more than one protective device to evaluate worst case NORMAL USE loading and protectiOM siccsssccstedcscsdssssscasesssevessscasseescerveianaancese Transformer windings provided with adequate Evaluated in part of power insulation to prevent internal short circuits that supply could cause overheating which could result in a HAZARDOUS SITUATION Test Report No 1403042002 Page 97 of 197 Issued 25 July 2014 60601 1TRF_A fos A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Dielectric strength tests were conducted in accordance with requirements of this clause with no breakdown of insulation system and no detectable deterioration of transformer
202. of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 02 C 02 Test Report No 1403042002 Page 176 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 3 RM RESULTS TABLE Constructional requirements for fire enclosures of ME Pass equipment Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 02 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 006 6 3 ONYX BE381DT_RMF__ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 006 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in mea
203. olume was more and hydraulic pressure than 200 kPal Pressure control device regulating pressure in No Pressure vessels and ME EQUIPMENT with pressure relief device parts subject to pneumatic completed 100 000 cycles of operation under and hydraulic pressure RATED load and prevented pressure from exceeding 90 of setting of pressure relief device in different conditions of NORMAL USE Test Report No 1403042002 Page 66 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark Pressure relief device s used where MAXIMUM No Pressure vessels and PERMISSIBLE WORKING PRESSURE could otherwise parts subject to pneumatic be exceeded met the following as confirmed and hydraulic pressure by MANUFACTURER S data ME EQUIPMENT RISK MANAGEMENT FILE and functional tests a Connected as close as possible to pressure vessel or parts of system it is to protect b Installed to be readily accessible for inspection maintenance and repair c Could be adjusted or rendered inoperative without a TOOL d With discharge opening located and directed as to not to release material towards any person e With discharge opening located and Y directed as to 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
204. on 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 010 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s aresapplied and New evaluation after evaluated using the criteria that defined in measures F 02 H 01 C the risk management plan 02 ONYX BE381DT_RMF _ Version 1 00 Section Risk Graph After Measures ONYX BE381DT RMF _ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 9 8 3 1 RM RESULTS TABLE Strength of patient or operator support or suspension N A systems General Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 6 3 6 4 6 5 9 8 3 2 TABLE PATIENT support suspension system Static forces N A ME EQUIPMENT part L Ar or area Position Load Ara blll Test Report No 1403042002 Page 164 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 8 3 2 TABLE PATIENT support suspension system Static forces N A Supplementary Information 9 8 3 2a b RM RESULTS TABLE Stat
205. on 1 00 Section the risk management file Risk Evaluation Before Measures 5 7 RM RESULTS TABLE Humidity preconditioning treatment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph Version 1 00 Section Risk Evaluation Before Measures F 01 H 01 C 09 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures recorded in the risk management file 4 2 ONYX BE381DT_RMF__ The RMF mention the Intended Pass Version 1 00 Section use intended purpose Version Data 4 3 ONYX BE381DT_RMF__ The manufacturer had compiled a list of Pass Version 1 00 Section known or foreseeable hazards associated Risk Analysis F 01 H with the humidity preconditioning treatment 01 C 09 4 4 ONYX BE381DT_RMF__ The estimates of the risk s were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 C 09 5 ONYX BE381DT_RMF_ The results of this risk evaluation were Pass Test Report No 1403042002 60601 1TRF_A Page 121 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 5 7 RM RESULTS TABLE Humidity preconditioning treatment Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph
206. oning 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 No Trapping zone EQUIPMENT or PATIENT when contact with ME EQUIPMENT could result ina 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 Min ee i RISK Controls Dior iaanos vos win moving pars ANa o recessed or protected by other means and could not be accidentally actuated to result in unacceptable RISK except when ergonomic considerations for a PATIENT with special needs require otherwise Risk due to over travel past range limits of ME EQUIPMENT parts reduced to an acceptable level and stops or other means with mechanical strength to withstand intended loading in NORMAL USE and foreseeable misuse provided limiting measure in NORMAL and SINGLE FAULT CONDITION Emergency stopping devices S stopping devices Where necessary to have one or more No Emergency stopping emergency stopping device s emergency devices stopping device complied with all the following except for actuating switch papable of interrupting all power Test Report No 1403042002 Page 59 of 197 Issued
207. or 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 16 60 LEAKAGE CURRENTS N A TOUCH CURRENT in NORMAL CONDITION from or Product is a Monitor between parts of ME SYSTEM within the PATIENT application and assessment ENVIRONMENT did not exceed 100 WA for ME system is not considered in current status 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 cccccccesssssceeceeeeesnesssaneeseeeensensssanes 16 6 2 Current in PROTECTIVE EARTH CONDUCTOR of MULTIPLE SOCKET OUTLET did not exceed 5 mA 16 6 3 PATIENT LEAKAGE 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 scccscsseeee Measurements made using a device as in clause 8 7 4 4 16 HAZARD existed 2 ccseeececeseeeseenseeeeeenseeeeeenseeneeenss for ME system is not considered in current status 16 HAZARDOUS SITUATION other than interruption of considered in current its intended function status ME SYSTEM connections and wiring N A 16 9 1 Incorrect connection of accessible connectors Product is a Monitor N A removable without a TOOL pr
208. pea NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Medical electrical equipment Part 1 General requirements for basic safety and essential performance Report Reference No ccse 1403042002 Date Of ISSUEC ccccseseeeeeeeeeeeeeees z 29July 2074 s saasstcasnsusnetassaseeactaassnendedadneteatasneiaeias Total number of pages 497 q qj q gics culscatenuetieaneentaatanmadtsinnenmapemanenesise CB Testing Laboratory 005 Victronic Technology Corporation ROQGESS eais u a aterm 4th FI 130 Ln 235 Baoqiao Rd Xindian Dist New Taipei 231 Taiwan Applicant s name 00cccee Onyx Healthcare Inc Addres Sacia 2F No 135 Ln 235 Baoqiao Rd Xindian Dist New Taipei City 231 Taiwan Test specification Standatd scnannnnr eee ely IEC 60601 1 2005 CORR 1 2006 CORR 2 2007 EN 60601 1 2006 Test procedure c cseseeeeeeees CB Scheme Non standard test None Test Report Form No assesses 60601 1TRF_A Test Report Form Originator Victronic Technology Corporation Master TRF eceeceeeeeeseeseeeeee 2011 11 29 Copyright 2010 IEC System for Conformity Testing and Certification of Electrical Equipment IECEE Geneva Switzerland All rights reserved This publication may be reproduced in whole or in part for non commercial purposes as long as the IECEE is acknowledged as copyright
209. pen 264 60 25 16 S1 0 S5 0 S7 4 TC SFC Ground Open 264 60 20 04 S1 1 S5 1 S770 TC SFC Ground Open 264 60 19 82 S1 1 S5 0 S7 0 Maximum allowed values Fig 15 Patient Leakage Current P Type B AP 100 uA NC 500 uA SFC a c Before Humidity Condition elehan N era P NC 264 60 1 63 S1 1 S5 N S7 1 S13 1 P NC 264 60 1 67 S1 1 S5 R S7 1 S13 1 P SFC Neutral Open 264 60 2 57 S1 0 S5 N S7 1 S13 1 P SFC Neutral Open 264 60 2 58 S1 0 S5 R S7 1 S13 1 P SFC Ground Open 264 60 1 96 S1 1 S5 N S7 0 13 1 Test Report No 1403042002 60601 1TRF_A Page 138 of 197 Issued 25 July 2014 fo gt vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark P SFC Ground Open 264 60 2 04 1 1 S5 R S7 0 S13 1 P SFC Ground Open 264 60 5 26 S1 1 S5 N S7 0 S13 0 P SFC Ground Open 264 60 5 15 S1 1 S5 R S7 0 S13 0 After Humidity Condition oo oo P NC 264 60 1 88 S1 1 S5 N S7 1 S13 1 P NC 264 60 1 86 S1 1 S5 R S7 1 S13 1 P SFC Neutral Open 264 60 2 84 S1 0 S5 N S7 1 S13 1 P SFC Neutral Open 264 60 2 89 S1 0 S5 R S7 1 S13 1 P SFC Ground Open 264 60 2 32 S1 1 S5 N S7 0 S13 1 P SFC Ground Open 264 60 231 S1 1 S
210. pment or outside of ME EQUIPMENT preferably adjacent to supply connection terminals RATED supply voltage s or RATED voltage For Adapter 100 240 V ac range s with a hyphen between minimum rae and maximum voltages V V V per poniior 12V de voltages or multiple RATED supply voltage ranges Nature of supply e g No of phases except Single phase single phase and type of current Symbols 1 5 Table D 1 symbols of IEC 60417 Symbol IEC 60417 5032 and 5032 5032 1 5032 2 5031 and 5033 all DB IEC 60417 5031 were used 2002 10 used optionally for same parameters for external adapter RATED supply frequency or RATED frequency 60 50 Hz range in hertz Symbol 9 of Table D 1 symbol IEC 60417 Class equipment 5172 DB 2003 02 used for CLASS II ME EQUIPMENT RATED input in amps or volt amps or in watts Rated input in amps marked when power factor exceeds 0 9 A VA W i Test Report No 1403042002 Page 18 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark RATED input for one or more RATED voltage For Adapter AC 1 2 0 63A ranges provided for upper and lower limits of For Monitor DC 4 2 A the range or ranges when the range s is are greater than 10 of the mean value of specified range A VA W Input at mean value of range marked when No such marking range limits do not differ by more than
211. pply circuit 8 8 2 supplying only this ME EQUIPMENT according to local regulations or IEC 60364 7 710 LEAKAGE and PATIENT AUXILIARY CURRENTS See appended Table 8 7 measurements cceceseeeseceseeessesseeeeeesseeseeneeeeaes 8 8 1 Insulation relied on aS MEANS OF PROTECTION including REINFORCED INSULATION and insulation between parts of opposite polarity of MAINS PART On SUPPLY MAINS side of mains fuse or OVER CURRENT RELEASE Insulation exempted from test complies with IEC 60601 1 2005 and ANSI clause 4 8 AAMI ES60601 of Certified Power Supply Insulation forming MEANS OF OPERATOR No MOOP PROTECTION and complying with IEC 60950 1 for INSULATION CO ORDINATION not tested as in 8 8 Distance through solid insulation or use of thin sheet material Solid insulation forming SUPPLEMENTARY or REINFORCED INSULATION for a PEAK WORKING VOLTAGE greater than 71 V provided with a 0 4 mm min distance through insulation or e LEAKAGE CURRENTS regardless of waveform See appended Table 8 7 and frequency did not exceed 10 mA r m s in NORMAL or in SINGLE FAULT CONDITION measured with a non frequency weighted device Test Report No 1403042002 Page 42 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark b does not form part of an ENCLOSURE and not N A subject to handling or abrasion during NORMAL
212. rchangeable as verified by review Of RISK MANAGEMENT FILE scssecceeeeeeesees Temperature and overload control devices N A a THERMAL CUT OUTS and OVER CURRENT No such component is RELEASES with automatic resetting not used in incorporated ME EQUIPMENT when their use could result in a HAZARDOUS SITUATION by resetting action as verified by review of RISK MANAGEMENT FILE Test Report No 1403042002 Page 92 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 ssssscesseccesseeessecesssnensseeenseeeeesees 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 eccsseeesseeeeeeeeeeseeeeees d Based on design and RISK MANAGEMENT FILE review loss of function of ME EQUIPMENT due to operation of THERMAL CUT OUT or OVER CURRENT RELEASE doesn t result in a HAZARDOUS SITUATION e Capacitors or other spark suppression devices not connected between contacts of THERMAL CUT OUTS f Use of THERMAL CUT OUTS or OVER CURRENT RELEASES do not affect safety of ME EQUIPMENT as verified by fo
213. recorded in the risk management file Risk Evaluation Before Measures F 02 H 01 C 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section Release Protocols of Measures RC 010 recorded in the risk management file Test Report No 1403042002 60601 1TRF_A Page 162 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 9 8 1 RM RESULTS TABLE Hazards associated with support systems General Pass Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 010 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s areapplied and New evaluation after evaluated using the criteria that defined in measures F 02 H 01 C the risk management plan 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT RMF _ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk
214. ress relief test conducted by placing See appended Table 15 3 for one sample of complete ME EQUIPMENT detail ENCLOSURE or a portion of larger ENCLOSURE for 7 hours in a circulating air oven at 10 C over the max temperature measured on ENCLOSURE in 11 1 3 but no less than 70 C aesan INTENDED USE EXPECTED SERVICE LIFE and See RMF ONYX conditions for transport and storage were BE381DT_RMF_ Version taken into consideration for selection and 1 00 Section Version data 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 No any outlet is provided on removable without a TOOL prevented where an the power adapter except for unacceptable Risk exists in particular dc output connector itself 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 oe no unacceptable Risk could result 0 b Medical gas connections on ME EQUIPMENT No Medical gas connections for different gases to be operated in NORMAL USE are not inte
215. rovided with one or more carrying handles suitably placed to enable carrying by two or more persons as confirmed by actual carrying c Carrying handles and grips and their means No such construction of attachment withstood loading test Expelled parts HAZARD Suitability of means of protecting against No expelled part unacceptable RISK of expelled parts determined by assessment and examination o 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 No Acoustic energy produce vibration from ME EQUIPMENT doesn t result in by the device unacceptable RISK as confirmed in RISK MANAGEMENT FILE including audibility of auditory alarm signals PATIENT sensitivity ang tests of 9 6 2 and 9 6 3 2 0 2 cesceeseeeeeeeeeeeeeeeseeeeeel 9 6 2 Acoustic energy Test Report No 1403042002 Page 64 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark PATIENT OPERATOR and other persons are not No Acoustic energy produce exposed to acoustic energy from ME EQUIPMENT by the device in NORMAL USE except for auditory alarm 80 dBA for a cumulative exposure of 24 h over a 24 h period dBA 83 dBA when halving the cumulative exposure time dBA 140 dB un weighted sound pressure level for
216. rupted Heating period stopped when a heating element or an intentionally weak part of a non SELF RESETTING THERMAL CUT OUT ruptured or current interrupted before THERMAL STABILITY without possibility of automatic restoration Test Report No 1403042002 Page 83 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION 3 IEC 60601 1 Requirement Test Result Remark Test duration was equal to RATED operating time for non CONTINUOUS OPERATION c Heating parts of ME EQUIPMENT tested with ME N A EQUIPMENT operated in NORMAL CONDITION at 110 Of RATED Supply voltage and as in 11 1 and 1 Controls limiting temperature in NORMAL N A CONDITION disabled except THERMAL CUT OUTS N A 2 When more than one control provided they were disabled in turn BE 3 ME EQUIPMENT operated at RATED DUTY CYCLE N A 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 gt gt gt To determine compliance with 13 2 9 and 13 2 10 motors in circuits running at 42 4 V peak a c 60 V d c or less are covered with a single layer of cheesecloth which did not ignite during the test Z gt a 2 Tests on ME EQUIPMENT containing heating parts conducted at prescribed voltage with motor amp hea
217. ry based on examination of design A properly RATED protective device provided within INTERNAL ELECTRICAL POWER SOURCE to protect against fire caused by excessive currents when in case of a short circuit layout of internal wiring cross sectional area rating of connected components can result in a fire Protective device has adequate breaking capacity to interrupt the maximum fault current Test Report No 1403042002 Page 94 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Justification for OVER CURRENT RELEASES or FUSE exclusion is included in RISK MANAGEMENT FILE Indicator lights provided to indicate ME EQUIPMENT is ready for NORMAL USE except when apparent to OPERATOR from normal operating position and marking of 7 4 1 are insufficient for this pUrposSe 20 ccceeseeseeeeee An additional indicator light provided on ME No stand by or warm up EQUIPMENT with a stand by state or a warm up state state exceeding 15 s except when apparent to OPERATOR from normal operating position Indicator lights provided on ME EQUIPMENT incorporating non luminous heaters to indicate heaters are operational when a HAZARDOUS SITUATION could exist except when apparent to OPERATOR from normal operating position Requirement not applied to heated stylus pens N A for recording purposes IA Indicator lights provided on ME EQUIPMENT to
218. s indicated by other unambiguous Ls oe e status indicated by other unambiguous m 7 4 2 Different positions of control devices switches The symbol Dis provided indicated by figures letters or other visual Controls provided with an associated No setting control will indicating device when change of setting of a__ result risk to patient when control could result in an unacceptable RISK to normal use PATIENT in NORMAL USE or an indication of direction in which magnitude of the function changes Numeric indications of parameters on ME No such function EQUIPMENT expressed in SI units according to Iso 31 except the base quantities listed in Table 1 expressed in the indicated units Test Report No 1403042002 Page 23 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark ISO 1000 applied for application of si units N A their multiples and certain other units All Markings in Sub clause 7 4 complied with N A tests and criteria of 7 1 2 and 7 1 3 N A Markings used to convey a warning No such situation prohibition or mandatory action mitigating a RISK not obvious to OPERATOR are safety signs from ISO 7010 Affirmative statement together with safety sign placed in instructions for use if insufficient space on ME EQUIPMENT Safety signs including any supplementary text or symbols described in instructions for use
219. s to this report Throughout this report a _ comma x point is used as the decimal separator Manufacturer s Declaration per sub clause 6 2 5 of IECEE 02 Test Report No 1403042002 Page 6 of 197 Issued 25 July 2014 60601 1TRF_A ea NY VICTRONIC TECHNOLOGY CORPORATION The application for obtaining a CB Test Certificate _ Yes includes more than one factory location and a IX Not applicable declaration from the Manufacturer stating that the sample s submitted for evaluation is are representative of the products from each factory has been provided cceccsseneeeseeeeseeeeseeeeseeeesenenes When differences exist they shall be identified in the General product information section Name and address of factory i S sscceeeeeee AAEON Technology Inc 5F No 135 Ln 235 Baoqiao Rd Xindian Dist New Taipei City 231 Taiwan Onyx Healthcare Inc 2F No 135 Ln 235 Baoqiao Rd Xindian Dist New Taipei City 231 Taiwan General product information A bedside monitor solution for ultimate patient services that boosts patient satisfaction and well beings 18 5 wide color TFT LCD touch monitor lightweight and displays with 2048 x 2048 resolution Moreover they feature flexible I O ports such as two External USB2 0 on bottom I O two rear USB2 0 for connecting Host computer one HDMI VGA port and two speakers The power adapter source HITRON ELECTRONICS CORP and model HEMG50 S120420
220. sk management file Risk Evaluation Before Measures F 01 H 02 C 01 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures Test Report No 1403042002 Page 171 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 1 1 RM RESULTS TABLE Maximum temperature during normal use Pass Table 23 or 24 Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 032 6 3 ONYX BE381DT_RMF_ The effectiveness of the risk control Pass Version 1 00 Section measures had be verified and the results of Release Protocols of the verification were recorded in the risk Measures RC 032 management file 6 4 ONYX BE381DT_RMF_ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 02 C the risk management plan 01 ONYX BE381DT RMF _ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk t
221. specified in technical description Separation of parts MEANS OF PROTECTION MOP Two MEANS of PROTECTION provided for ME EQUIPMENT to prevent APPLIED and other ACCESSIBLE PARTS from exceeding limits in 8 4 Each MEANS OF PROTECTION categorized as a Evaluated in part of power MEANS OF PATIENT PROTECTION or a MEANS OF supply 2 MOPP provided OPERATOR PROTECTION taking into account between primary to Clause 4 6 and flow chart in Fig A 12 secondary circuit Varnishing enameling oxidation and similar No such construction 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 MOPP considered and MEANS OF PROTECTION complying with IEC 60950 provided 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 8 5 1 2 MEANS OF PATIENT PROTECTION MOPP MOPP considered and provided Solid insulation forming a MEANS OF PATIENT PROTECTION complied with di
222. ssed for conditions of use in ME EQUIPMENT and they complied with one of the following a Applicable safety requirements of a relevant See appended table 8 10 Pass IEC or ISO standard b Requirements of this standard applied in the Power adapter complied with Pass absence of a relevant IEC or Iso standard the requirements of IEC 60601 1 2005 EN 60601 1 2006 and ANSI AAMI ES60601 1 4 9 A COMPONENT WITH HIGH INTEGRITY No high integrity component N A CHARACTERISTICS provided because a fault ina used particular component can generate an unacceptable RISK cseccsseeesseeeeseeeeseeeeseeeeeeeel COMPONENTS WITH HIGH INTEGRITY N A CHARACTERISTICS selected and evaluated consistent with their conditions of use and reasonable foreseeable misuse during EXPECTED SERVICE LIFE Of ME EQUIPMENT by reviewing RISK MANAGEMENT FILE 2 0000 4 10 Power supply Pass 4 10 1 ME EQUIPMENT is Suitable for connection to a The product is specified to Pass SUPPLY MAINS specified to be connected to a be connected to a separate separate power supply can be powered by an power supply INTERNAL ELECTRICAL POWER SOURCE or a combination of the three ccssssseesseeeeeeel 4 10 2 Maximum rated voltage for ME EQUIPMENT Not Hand Held device N A intended to be connected to SUPPLY MAINS is 250 V for HAND HELD ME EQUIPMENT V ssesseeseees 250 V d c or single phase a c or 500 V For adapter single phase Pass polyphas
223. stisctsincinisoinnrscisinvts f Tests during manufacture EE Production line dielectric strength tests Not required since all conducted by the manufacture according to related insulation will be L 4 2 ANC L 4 3 ee eceeeeeeeeteeeeeeeeees Confirmed during power supply manufacturing 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 Test Report No 1403042002 Page 113 of 197 Issued 25 July 2014 60601 1TRF_A fo A NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 3000 V r m s or 4200 V peak for REINFORCED INSULATION V Sampling tests conducted using twisted pair Not required since all samples IEC 60851 5 1996 clause 4 4 1 related insulation will be confirmed during power supply manufacturing Minimum breakdown test voltage at least twice N A the voltage in Tables 6 and 7 but not less than 3000 V r m s or 4200 V peak for BASic and N A SUPPLEMENTARY INSULATION 6000 V r m s or 8400 V peak for REINFORCED N A INSULATION Test Report No 1403042002 Page 114 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 2 RM RESULTS TABLE Risk Management Process for ME Equipment or ME P
224. sued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 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 minina 12 2 0 4 ether by volume oxygen mixture Parts and components of CATEGORY APG ME EQUIPMENT operating in a FLAMMABLE AESTHETIC MIXTURE WITH OXYGEN OR NITROUS OXIDE supplied from a source isolated from earth by insulation equal to one MEANS OF PATIENT PROTECTION and from electrical parts by insulation twice the MEANS OF PATIENT PROTECTION cccesseceeeeesseeeeees Test of G 6 1 waived when the following requirements were met in NORMAL USE and under NORMAL and SINGLE FAULT CONDITIONS a no sparks produced and temperatures did not exceed 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 requirements taking Cmax and Lmax into consideration Measured Umax lt Uzr with lzr as in Fig G 4 Measured U max lt Uzc with Cmax as in Fig G 5 Measured lmax lzr With Uzr as in Fig G 4 gt 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 co
225. sures F 01 H 02 C the risk management plan 02 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 11 5 RM RESULTS TABLE ME equipment and ME systems intended for use in N A conjunction with flammable agents Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 6 2 Test Report No 1403042002 60601 1TRF_A Page 177 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 11 5 RM RESULTS TABLE ME equipment and ME systems intended for use in N A conjunction with flammable agents Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 6 3 6 4 6 5 11 6 1 TABLE overflow spillage leakage ingress of water cleaning disinfection Pass sterilization compatibility with substances Clause Test Name Test Condition Part under test Remarks Cleaning 11 6 6 Cleaning used cloth Unit No dielectric breakdown and leakage current test compliances Cleaning 11 6 6 Cleaning used Water or rubbing Unit No dielectric breakdown alcohol and leakage current test compliances Cleaning 11 6 6 Cleaning
226. t Test Result Remark MANUFACTURER S optional requirements for minimum qualifications of SERVICE PERSONNEL documented in technical description The technical description contains the following required information type and full rating of fuses used in SUPPLY Not permanently installed MAINS external to PERMANENTLY INSTALLED ME ME equipment EQUIPMENT when type and rating of fuses are not apparent from information on RATED current and mode of operation of ME EQUIPMENT a statement for ME EQUIPMENT with a non Detachable power supply DETACHABLE POWER SUPPLY CORD if POWER SUPPLY cord used CORD is replaceable by SERVICE PERSONNEL and if so instructions for correct connection and anchoring to ensure compliance with 8 11 3 instructions for correct replacement of No such instruction is interchangeable or detachable parts specified required by MANUFACTURER as replaceable by SERVICE PERSONNEL and warnings identifying nature of HAZARD when replacement of a component could result in an unacceptable Risk and when replaceable by SERVICE PERSONNEL all information necessary to safely replace the component Technical description indicates MANUFACTURER See User Manual Safety amp will provide circuit diagrams component part Warranty lists descriptions calibration instructions to assist to SERVICE PERSONNEL in parts repair Means used to comply with requirements of Isolation power supply
227. tact with requirements for APPLIED PARTS except for PATIENT Clause 7 2 70 wivsccscsascessscsssecserssrsccetasersssenmsneacdant 4 7 ME EQUIPMENT remained SINGLE FAULT SAFE or The requirements of Clause Pass the RISK remained acceptable as determined by 8 1 item a b and Clause 13 Clause AD nnna yoy ecev cece eeerecn ea venr eee are checked by inspection and or by test and compliance with IEC 60601 1 requirements See appended RM Results Table 4 7 Failure of any one component at a time that See appended RM Results Pass could result in a HAZARDOUS SITUATION including Table 4 7 those in 13 1 simulated physically or theoretically cia cecciseladedhednciheinadnnadecd Risk associated with failure of component Pass during EXPECTED SERVICE LIFE of ME EQUIPMENT taken into account to evaluate if a component should be subjected to failure simulation Test Report No 1403042002 Page 11 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark 4 8 All components and wiring whose failure could All components are used Pass result in a HAZARDOUS SITUATION used according within their specified ratings to their applicable ratings except as ees or by RISK MANAGEMENT PROCESS secsseeeseeeeeee 209 Appamiod AM Resula Table 4 8 Reliability of components used as MEANS OF Pass PROTECTION asse
228. temperature of insulation measured during tests of 13 2 13 2 to 13 2 13 4 inclusive 43 2 13 2 ME EQUIPMENT with heating elements a 1 thermostatically controlled ME EQUIPMENT No heating elements with heating elements for building in or for unattended operation or with a capacitor not protected by a fuse connected in parallel with THERMOSTAT contacts met tests of 13 2 13 2 b amp 13 2 13 2 c 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 N A met test of 13 2 13 2 b When more than one test was applicable to same ME EQUIPMENT tests performed consecutively Test repeated on a second sample when interruption was due to rupture of a heating element or an intentionally weak part Both samples met 13 1 2 and open circuiting of a heating element or_an intentionally weak part in second sample not considered a failure by itself b ME EQUIPMENT with heating elements tested per 11 1without adequate heat discharge and supply voltage set at 90 or 110 of RATED supply voltage least favourable of the two V Operating period stopped when a non SELF RESETTING THERMAL CUT OUT operated or current interrupted without possibility of automatic restoration before THERMAL STABILITY ME EQUIPMENT switched off as soon as THERMAL STABILITY established and allowed to cool to room temperature when current not inter
229. tended to be No such function for the sterilized classified according to method s or product sterilization in instructions for use 0000 The application of this clause shall be evaluated in end application ME EQUIPMENT and ME SYSTEMS intended for use Equipment not suitable for in an OXYGEN RICH ENVIRONMENT Classified for use in the presence of such use and complied with 11 2 2 OXYGEN RICH ENVIRONMENT CONTINUOUS or Non CONTINUOUS OPERATION CONTINUOUS ME EQUIPMENT IDENTIFICATION MARKING AND DOCUMENTS RISK of poor USABILITY associated with the The equipment which used N A design of ME EQUIPMENT S identification and for information display and marking addressed in a USABILITY ENGINEERING its intended performance PROCESS ie cessce cece ae a aa aaan will not be affect by usability Test Report No 1403042002 Page 16 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Legibility of Markings Test for Markings See appended Table 7 1 2 specified in ClauSe 7 2 7 6 csssssccssssseessseees Required markings can be removed only with a TOOL or by appreciable force are durable and remain CLEARLY LEGIBLE during EXPECTED SERVICE LIFE of ME EQUIPMENT in NORMAL USE a After tests adhesive labels didn t loosen up See appended Table 7 1 3 or curl up at edges and markings complied with require
230. terials and ingredients PATIENT or OPERATOR is exposed to when such exposure can constitute an unacceptable RISK Restrictions specified on other equipment or NETWORK DATA COUPLINGS other than those forming part of an ME SYSTEM to which a SIGNAL INPUT OUTPUT PART may be connected Information provided indicating where the installation instructions may be found or information on qualified personnel who can perform the installation Instructions provided indicating not to position The disconnection device of ME EQUIPMENT to make it difficult to operate the the Monitor is power supply disconnection device when an APPLIANCE cord which will not be COUPLER or separable plug is used as isolation _ difficult to disconnect means to meet 8 11 1 a Necessary information provided for OPERATOR See User Manual Chapter 2 to bring ME EQUIPMENT into operation including initial control settings and connection to or positioning of PATIENT prior to use of ME EQUIPMENT its parts or ACCESSORIES Information provided to operate ME EQUIPMENT See User Manual Chapter 1 including explanation of controls displays and signals sequence of operation connection of detachable parts or ACCESSORIES replacement of material consumed during operation Meanings of figures symbols warning See User Manual Safety statements abbreviations and indicator lights Symbol Description described in instructions for use Test Report No 1403042002
231. ting parts operated simultaneously to produce the least favourable condition a 3 Tests performed consecutively when more tests were applicable to the same ME EQUIPMENT gt b Motor met running overload protection test of this clause when 1 it is intended to be remotely or automatically controlled by a single control device with no redundant protection or 2 it is likely to be subjected to CONTINUOUS OPERATION while unattended Motor winding temperature determined during each steady period and maximum value did not exceed Table 27 Insulation Class Maximum temperature Measured C ccccesseeeeseereeeseees f Motor removed from ME EQUIPMENT and tested separately when load could not be changed in appropriate steps gt Test Report No 1403042002 Page 84 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Running overload testfor 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 maintained a substantially constant drive current Test not conducted based on other justifications justification cceeeee i 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
232. tion 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 seh RN inside ENCLOSURE was 75 Pa IN NORMAL CONDITION Pa ssccesseeeeeseenes 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 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 Test Report No 1403042002 Page 108 of 197 Issued 25 July 2014 60601 1TRF_A VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark c Ignition sources de energized automatically by means used where G 4 does not apply or complied with G 5 when during operation overpressure dropped below 50 Pa Pa d External surface of ENCLOSURE in which internal overpressure was maintained did not exceed 150 C in 25 C ambient under NORMAL USE and CONDITION C cccessseeeeeessceeeeeseseeeens ME EQUIPMENT its parts and components enclosed in an ENCLOSURE with restricted breathing complied with the following a A FLAMMABLE AESTHETIC MIXTURE WITH AIR did not form inside ENCLOSURE with restricted bre
233. to 10 of d c voltage and For PEAK WORKING VOLTAGES above 1400 V peak Evaluated in part of power or d c Table 15 not applied since all the following conditions were met insulation complied with dielectric strength test of 8 8 3 using an a c test voltage with an r m s value equal to 1 06 times PEAK WORKING VOLTAGE or 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 8 9 1 14 Minimum CREEPAGE DISTANCES for two MEANS OF OPERATOR PROTECTION obtained by doubling values in Table 16 for one MEANS OF OPERATOR PROTECTION 8 9 1 15 CREEPAGE DISTANCES and AIR CLEARANCES for No defibrillation proof DEFIBRILLATION PROOF APPLIED PARTS are 4 mm or applied parts more to meet 8 5 5 1 a Short circuiting of each single one of Evaluated in part of power CREEPAGE DISTANCES and CLEARANCES in turn did supply not result in a HAZARDOUS SITUATION for insulation in MAINS PART between parts of opposite polarity therefore min CREEPAGE and CLEARANCES not applied cccccsseseeeceeeeeeeeees b Contribution to CREEPAGE DISTANCES of grooves or air gaps less
234. to make the connection and remained visible after connection made Test Report No 1403042002 Page 22 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark For supply connections use wiring materials Evaluated in part of power suitable for at least X C where X gt than max supply temperature measured in terminal box or wiring compartment under NORMAL USE or equivalent marked at the point of supply connections Statement not applied to parts requiring N A removal to make the connection and CLEARLY LEGIBLE after connections made Marking of controls and instruments Pass The on amp off positions of switch to control No ON OFF switch provided N A power to ME EQUIPMENT or its parts including mains switch marked with symbols 12 and 13 of Table D 1 IEC 60417 5007 DB 2002 10 and IEC 60417 5008 DB 2002 10 or indicated by an adjacent indicator light or 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 status indicated by adjacent indicator light 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 status indicated by adjacent indicator light statu
235. tteries to be maintained by anyone other than SERVICE PERSONNEL Other equipment providing power to ME SYSTEM sufficiently described e g part number RATED VOLTAGE max or min power protection class intermittent or continuous service RISKS associated with disposal of waste See User Manual Appendix products residues etc and of ME EQUIPMENT A and ACCESSORIES at the end of their EXPECTED SERVICE LIFE are identified and instructions provided on minimizing these RISKS ussat Instructions for use include information specified in 7 9 3 or identify where it can be found e g in a service manual Test Report No 1403042002 Page 28 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Technical description Pass All essential data provided for safe operation See below transport storage and measures or conditions necessary for installing ME EQUIPMENT and preparing it for use including the following information as in clause 7 2 permissible environmental conditions of use EE User Manual Chapter 1 including conditions for transport and storage 1 3 Specification all characteristics of ME EQUIPMENT including See User Manual Chapter 1 range s accuracy and precision of displayed 1 3 Specification values or where they can be found special installation requirements such as max permissible apparent i
236. ty 0 Switch open or set to reversed polarity NC Normal condition SFC Single fault condition 8 8 3 TABLE Dielectric strength test of solid insulating materials with safety Pass function MEANS OF OPERATOR PROTECTION MOOP MEANS OF PATIENT PROTECTION MOPP Reference Voltage i i Insulation under test Insulation Type A C test E area from insulation 1 or 2 PEAK WORKING PEAK WORKING voltages in V aes diagram MOOP MOPP VOLTAGE U VOLTAGE U nme after 1minute Vey V dc Yes No Adapter primary to Adapter earth 4 1MOPP 354 1500Vac No a ull aly ae 2MOPP 600 i 4698Vac No monitor SIP SOP 6 Test Report No 1403042002 60601 1TRF_A Page 142 of 197 Issued 25 July 2014 fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Adapter primary to monitor plastic 2MOPP 600 4698Vac No enclosure with foil 5 Adapter primary to Touch Panel with foil 2MOPP 600 4698Vac No 5 Adapter Earth to plastic enclosure with 1MOPP 600 1849Vac No foil 8 Adapter Earth to Touch Panel with foil 1MOPP 600 1849Vac No 8 Monitor SIP SOP to plastic enclosure with 1MOPP 354 1500Vac No foil 7 Monitor SIP SOP to Touch Panel with foil 1MOPP 354 1500Vac No 7 Supplementary information Test reference voltage 600 V determined by power adapter type HITRON ELECTRONICS CORP HEMG50 S120420 7 1
237. uch device is not provided causing disconnection of ME EQUIPMENT from SUPPLY MAINS by producing a short circuit resulting in operation of an overcurrent protection device i Parts within ENCLOSURE of ME EQUIPMENT with a Evaluated in part of power circuit gt 42 4 V peak a c or 60 V d c that supply cannot be disconnected from its supply by an external switch or a plug device accessible at all times is protected against touch even after opening ENCLOSURE by an additional covering A clear warning notice is marked on outside of Not exceed allowable ME EQUIPMENT to indicate it exceeds allowable voltage no warning is touch voltage symbol 10 of Table D 1 is required 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 Standard test finger of Fig 6 applied 8 11 2 MULTIPLE SOCKET OUTLETS integral with ME EQUIPMENT complied with 16 2 d second dash lt lt e 16 9 2 8 11 3 PoweRsupPLycorpS o SUPPLY CORDS 8 11 3 1 MAINS PLUG not fitted with more than one POWER Evaluated in part of power SUPPLY CORD supply 8 11 3 2 POWER SUPPLY CORDS are no less robust than ordinary tough rubber sheathed flexible cord IEC 60245 1 2003 Annex A designation 53 or ordinary polyvinyl chloride sheathed flexible cord IEC 60227 1 1993 Annex A design 53 Test Report No 1403042002 Page 52 of
238. ulting in an unacceptable RISK present See appended Tables 8 7 and 8 8 3 Effects of multiple cleanings disinfections Expected service life will not during EXPECTED SERVICE LIFE of EQUIPMENT be impacted since cleaning evaluated by MANUFACTURER and assurance that test shows solution will no unacceptable Risk will occur verified by RISK cause no harm degradation MANAGEMENT FILE r ViGW 00seesseeeeeceeeeeeeeseenes to device insulation ME EQUIPMENT ME SYSTEMS and their parts or Not intended to be sterilized ACCESSORIES intended to be sterilized assessed and documented according to ISO 11134 ISO 11135 or ISO 11137 as appropriate 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 s s00e i Test Report No 1403042002 Page 79 of 197 Issued 25 July 2014 60601 1TRF_A fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark RISKS associated with compatibility of substances used with ME EQUIPMENT addressed in RISK MANAGEMENT PROCESS as confirmed by examination of RISK MANAGEMENT FILE 0006 ME EQUIPMENT ME SYSTEM and ACCESSORIES coming into direct or indirect contact with biological tissues cells or body fluids assessed and documented per ISO 10993 Interruption and restoration of power supply did not resu
239. used Vacuum cleaner Unit No dielectric breakdown and leakage current test compliances Cleaning 11 6 6 Cleaning used Cotton swabs Unit No dielectric breakdown and leakage current test compliances Cleaning 11 6 6 Cleaning used Foam swabs Unit No dielectric breakdown and leakage current test compliances Supplementary information 11 6 2 RM RESULTS TABLE Overflow in ME equipment N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 4 3 4 4 5 11 6 3 RM RESULTS TABLE Spillage on ME equipment and ME system N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 2 Test Report No 1403042002 60601 1TRF_A Page 178 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Version 1 00 Section Risk Evaluation Before Measures F 01 H 01 C 23 the risk management file 11 6 3 RM RESULTS TABLE Spillage on ME equipment and ME system N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 11 6 5 RM RESULTS TABLE Ingress of water or particulate matter into ME N A EQUIPMENT and ME SYSTEMS Clause of Document Ref in RMF
240. ut identification of equipment Pass 4 4 ONYX BE381DT_RMF _ Version 1 00 Section Risk Evaluation Before Measures F 07 H 01 H 02 H 03 The estimates of the risk s were recorded in the risk management file Pass ONYX BE381DT RMF _ Version 1 00 Section Risk Evaluation Before Measures F 07 H 01 H 02 H 03 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures The results of this risk evaluation were recorded in the risk management file Pass 6 4 ONYX BE381DT_RMF_ Version 1 00 Section New evaluation after measures F 07 H 01 H 02 H 03 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF _ Version 1 00 Section Overview of the Results of the Risk All residual risk that remains after the risk control measure s are applied and evaluated using the criteria that defined in the risk management plan Pass 7 2 5 RM RESULTS TABLE ME EQUIPMENT powered from other equipment N A Clause of ISO 14971 Document Ref in RMF Document No amp paragraph Result Remarks Verdict 4 2 4 3 4 4 5 6 4 Test Report No 1403042002 60601 1TRF_A Page 124 of 197 Issued 25 July 2014 fo A vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark Version 1 00
241. ve without a TOOL restore correct operation on device reset Classification of APPLIED PARTS Pass a APPLIED PART specified in ACCOMPANYING DOCUMENTS as Suitable for DIRECT CARDIAC APPLICATION is TYPE CF b An APPLIED PART provided with a PATIENT 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__ Touch Panel and Plastic TYPE B BF Or CF Enclosure treat as Type B applied part d Requirements of a TYPE B APPLIED PART N A applied 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 appended RM Results N A applied as in RISK MANAGEMENT PROCESS Table 8 3 d Limitation of voltage current or energy Pass PATIENT CONNECTIONS intended to deliver Current Limits in 8 4 2 not applied to currents intended See appended Table 8 7 N A to flow through body of PATIENT to produce a physiological effect during NORMAL USE ACCESSIBLE PARTS including APPLIED PARTS Pass Test Report No 1403042002 Page 31 of 197 Issued 25 July 2014 60601 1TRF_A fo NY VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark a Currents from to or between PATIENT No PATIENT CONNECTIONS CONNECTIONS did not exceed limits for PATIENT LEAKAGE CURRENT and PATIENT AUXILIARY CURRENT per Tables 3 and 4
242. verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 008 RC management file 026 6 4 ONYX BE381DT RMF _ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 C the risk management plan 21 C 22 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis Test Report No 1403042002 60601 1TRF_A Page 152 of 197 Issued 25 July 2014 EN vV VICTRONIC TECHNOLOGY CORPORATION IEC 60601 1 Requirement Test Result Remark TABLE Cord anchorages Cord under test Mass of Pull N Torque Nm Remarks equipment kg Supplementary information 8 11 3 6 TABLE Cord guard N A Cord under test Test mass Measured curvature Remarks Supplementary information 8 11 5 RM RESULTS TABLE Mains fuses and over current releases N A Clause of Document Ref in RMF Result Remarks Verdict ISO 14971 Document No amp paragraph 4 3 4 4 5 6 2 6 3 6 4 6 5 9 2 1 RM RESULTS TABLE HAZARDS associated with moving parts General N A Clause of Document Ref
243. were recorded in Pass Version 1 00 Section the risk management file Risk Evaluation Before Measures F 01 H 01 C 18 5 ONYX BE381DT_RMF__ The results of this risk evaluation were Pass Version 1 00 Section recorded in the risk management file Risk Evaluation Before Measures F 01 H 01 C 18 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph Before Measures 6 2 ONYX BE381DT_RMF_ The risk control measures selected were Pass Version 1 00 Section recorded in the risk management file Release Protocols of Measures RC 026 6 3 ONYX BE381DT_RMF__ The effectiveness of the risk control Pass Version 1 00 Section measures had been verified and the results Release Protocols of of the verification were recorded in the risk Measures RC 026 management file 6 4 ONYX BE381DT_RMF__ All residual risk that remains after the risk Pass Version 1 00 Section control measure s are applied and New evaluation after evaluated using the criteria that defined in measures F 01 H 01 the risk management plan C 18 ONYX BE381DT_RMF_ Version 1 00 Section Risk Graph After Measures ONYX BE381DT_RMF_ Version 1 00 Section Overview of the Results of the Risk 6 5 N A No reduction of risk through Risk benefit N A analysis 8 10 5 RM RESULTS TABLE Mechanical protection of wiring Pass Clause of Document Ref in RMF Result Remarks Verdict
244. when measured according 10 Clause 8T A vsctinacadcisscstsriinaateandeniad nessa b LEAKAGE CURRENTS from to or between See appended Table 8 7 ACCESSIBLE PARTS did not exceed limits for TOUCH CURRENT in Cl 8 7 3 c when measured per Clause 8 7 4 MA scceeccssseeenseseeeeeneeeeenens c c Limits specified in b not applied to parts See appended Table 8 7 and when probability of a connection to a PATIENT RM Results Table 8 4 2 c directly or through body of OPERATOR is negligible in NORMAL USE and the OPERATOR is appropriately instructed accessible contacts of connectors contacts of fuseholders accessible during replacement of fuse contacts of lampholders accessible after removal of lamp Voltage to earth or to other ACCESSIBLE PARTS Evaluated in part of power did not exceed 42 4 V peak a c or 60 V d c for supply above parts in NORMAL or single fault condition V a c OF dC ccssccstictsescsccsssscseenessnitectesisiectsennticts Limit of 60 V d c applied with no more than 10 peak to peak ripple and when ripple larger than specified value 42 4 V peak limit applied V dC AGcGivcrsseheessstecessecnseseneeeensneeens 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 LEAKAGE CURRENT limits referred to in 8 4 2 b applied when voltages higher than limits in 8 4 2 c were present IMA csceceseseerenseee
245. y signs ISO 7010 P018 or ISO 7010 P019 as appropriate ME EQUIPMENT did not overbalance when placed on a horizontal plane and a constant force of 800 N applied at the point of maximum moment to working surfaces offering an foothold or sitting surface of a min 20 x 20 cm area and at a height 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 indicated more than one person needed N MOBILE ME EQUIPMENT exceeding 45 kg configured with a SAFE WORKING LOAD moved 10 times in forward direction over a solid vertical plane obstruction with wheels impacting the obstruction at a speed of 0 4 m s 0 1 m s for manual or with max speed for motor driven MOBILE ME EQUIPMENT ME EQUIPMENT went up the obstruction without overbalancing or any other unacceptable RISK as determined by examination of RISK MANAGEMENT FILE ME EQUIPMENT and its parts 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 o

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