Risk Analysis Fanless Slim Medical Panel PC, models xxxx-onyx-2121dtyxxxxxxx

Transcription

1 Risk Analysis Fanless Slim Medical Panel PC, models xxxx-onyx-2121dtyxxxxxxx Company: Creation Date: Abbreviation: Project Number: Project : Version Number: Version : Life Cycle Phase: ONYX-2121DT The models xxxx-onyx-2121dty-xxxxxxx are Fanless Slim Medical Panel PC for medical equipment used Workable version for evaluation purpose Functional design

2 Table of Content The Following Documents have been Compiled as a Report: Page Project Data 3 Version Data 4 Project Team 7 Definition of the Risk Graph 13 Release Criteria 15 Grey Box 17 Risk Analysis 18 Risk Evaluation Before Measures 26 Risk Graph Before Measures 33 Decision about Measures 34 Risk Control 48 Release Protocol of Measures 54 Evaluation After Measures 120 Risk Graph After Measures 128 Risk Graph Before and After Measures 129 Evaluation of Residual Risk 131 Post production 132 Overview of the Results of the Risk Management Page 2 of 141

3 Project Data Project: , ONYX-2121DT Version: 1.00 Project Data Abbreviation: ONYX-2121DT Project Number: Project Name: Fanless Slim Medical Panel PC, models xxxx- ONYX-2121DTy-xxxxxxx Project : The models xxxx-onyx-2121dty-xxxxxxx are Fanless Slim Medical Panel PC for medical equipment used. Product Type: EN ISO 14971:2012 Project Type: Product Project Management Project Leader: Substitute: Responsible for the Risk: Mac Lin James Chen Mac Lin Page 3 of 141

4 Version Data Project: , ONYX-2121DT Version: 1.00 Version Data Version No.: Derived from Version: Special Version: Version : Workable version for evaluation purpose Freeze Analysis and Evaluation Part: Intended Use: 1. The xxxx-onyx-2121dty-xxxxxxx were Fanless Slim Medical Panel PC with Intel Atom D GHz Dual Core processor-based computer that is designed to serve as a point of care station. It is a PC-based system with 22" true color TFT LCD display, Zero Noise solution; integrated multimedia functions make them the perfect platforms to build comprehensive lifestyle computing applications. There is a VESA compliant for mounting the support arm. 2. The rated input: 24 V dc, 2.91 A (for LCD Monitor); V ac, 50/60 Hz, A (for power supply, model GMPU70A-6) 3. The operation temperature/humidity: C, 30%-75 % RH and suitable storage from -20 C to 60 C, 10% - 90% RH. 4. This Slim Medical Panel PC intended to be used at any altitudes between 0 to 3,000 m. 5. The Slim Medical Panel PC expected services life was 50,000 hours 6. This Slim Medical Panel PC was judged on the basis of the required creepage and clearances in the Third Edition of the Standard for Medical Electrical Equipment, IEC rd Ed., Sub. clause 8.9 which covers the end-use product for which the component was designed. 7. This Slim Medical Panel PC was tested on a 20 A branch circuit. If used on a branch circuit greater than this, additional evaluation was necessary. 8. This Slim Medical Panel PC has not been evaluated for patient connected applications. 9. This Slim Medical Panel PC has been evaluated as a Class I, continuous operation, ordinary equipment and has not been evaluated for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. An additional evaluation shall be made if the power supply is intended for use in other than Class I equipment. 10. This Slim Medical Panel PC shall be installed assembled maintained or repair. 11. This Slim Medical Panel PC incorporates the IEC certified power adapter, model GMPU70A-6 by Eljintek. This power is used in the conditions of overvoltage category II, Pollution Page 4 of 141

5 Possible Misuse: Life Cycle Phase: Degree II. 12. This Slim Medical Panel PC does not deliverer the energy to or extract the energy from the patient. 13. This Slim Medical Panel PC does not deliver the substances to or extract the substances from the patient. 14. No any biological materials processed by the Slim Medical Panel PC for subsequent re -use. 15. This Slim Medical Panel PC does not supply sterile or intended to be sterilized by the user, or other applicable microbiological controls. 16. This Slim Medical Panel PC is not intended to be routinely cleaned and disinfected by the user. 17. This Slim Medical Panel PC is not intended to modify the patient environment. 18. This Slim Medical Panel PC does not take any measurements. 19. This Slim Medical Panel PC is not intended for use in conjunction with medicines or other medical technologies. 20. This Slim Medical Panel PC has no unwanted outputs of energy. 21. This Slim Medical Panel PC is susceptible to environmental influences (ambient, emc). 22. This Slim Medical Panel PC influences the environment (emi). 23. This Slim Medical Panel PC does not provide the essential consumables or accessories. 24. This Slim Medical Panel PC is no need to maintenance and/or calibration. 25. This Slim Medical Panel PC contains software, but the failure of the software does not lead to an unacceptable RISK. 26. This Slim Medical Panel PC has a restricted shelf-life. 27. This Slim Medical Panel PC has no any delayed and/or long-term use effects. 28. This Slim Medical Panel PC does not subject mechanical forces. 29. This Slim Medical Panel PC is not intended for single use. 30. No need to safe decommissioning or disposal of the Slim Medical Panel PC. 31. Installation or use of the Slim Medical Panel PC is required special training. 32. This Slim Medical Panel PC has output wire to connection end-product. 33. This Slim Medical Panel PC is not used by person with special needs. 34. This Slim Medical Panel PC did not use an alarm system. 35. This Slim Medical Panel PC did not hold data critical to patient care. 36. The least favourable working conditions are: maximum normal load and placed in a test corner. 37. The metal enclosure of Slim Medical Panel PC can be touched within 1 sec and plastic enclosure can be touched within 60 sec. Power adapter can be touched within 10 sec. Diagnose use in computed tomography (CT), magnetic resonance imaging (MRI), endoscopy, ultrasound physiotherapy equipment and digital mammography system. Functional design Version Data Page 5 of 141

6 Additional Documents Titel No. Location References IEC Standard IEC Standard IEC Standard ISO Standard Medical electrical equipment -- Part 1: General requirements for basic safety and essential performance Medical electrical equipment -- Part 1-2: General requirements for basic safety and essential performance - Collateral standard: Electromagnetic compatibility - Requirements and tests Analysis techniques for system reliability - Procedure for failure mode and effects analysis (FMEA) Medical devices - Application of risk management to medical devices IEC : 2005 IEC : 2007 (Modified) IEC 60812: 2006 ISO 14971: 2007 Version Data Page 6 of 141

7 Project Team Project: , ONYX-2121DT Version: 1.00 Project Team Project Management Project Leader: Substitute Project Leader: Risk Responsible: Mac Lin James Chen Mac Lin Team Members: see next page Page 7 of 141

8 Chen, James User Data: Project Team Username: James_Chen_Onyx Location: Department: Position: - - QC - Phone: - Fax: - Qualification: Task/Status : Miscellaneous: O025 Risk Manager - Provide guidance for applying the risk management process - Approve Risk Management File and risk review records Rights: Manage Version Data Manage Project Data Define Graph Implement Analysis Implement Evaluation Release Measures Decide about Implementation of Measures Validate Measures Close Versions Manage Project Team Manage Measure Documentation Manage Version Documentation Implement Reevaluation Evaluate Residual Risk Print Reports Manage Post Production Information Manage Measure Details Date, Signature Team Member Page 8 of 141

9 Lin, Eason User Data: Project Team Username: Eason_Lin_Onyx Location: Department: Position: - - Sales - Phone: - Fax: - Qualification: Task/Status : Comment: O056 Product Surveillance Leader (PSL) - Perform as Risk Management Project Team leader for complaint risk assessments - Ensure complaint risk assessment follow this work instruction - Provide input to the determination of probability of occurrence of the hazardous situation(s) for complaint risk assessments Rights: Manage Version Data Manage Project Data Define Graph Implement Analysis Implement Evaluation Release Measures Decide about Implementation of Measures Validate Measures Close Versions Manage Project Team Manage Measure Documentation Manage Version Documentation Implement Reevaluation Evaluate Residual Risk Print Reports Manage Post Production Information Manage Measure Details Date, Signature Team Member Page 9 of 141

10 Lin, Mac User Data: Project Team Username: Mac_Lin_Onyx Location: Department: Position: - - Project Manager - Phone: - Fax: - Qualification: TUV Rh training - General safety requirements for medical appliances acc. IEC/EN UL training - Advanced Workshop on International Regulations of Medical Device UL training - Introduction of ISO14971 and IEC Task/Status : Miscellaneous: Rights: Project Manager - Provide guidance regarding hazardous situation identification - Provide the severity and likelihood of harm values and rationales for the hazardous situation - Approve all changes to Risk Management File Manage Version Data Manage Project Data Define Graph Implement Analysis Implement Evaluation Release Measures Decide about Implementation of Measures Validate Measures Close Versions Manage Project Team Manage Measure Documentation Manage Version Documentation Implement Reevaluation Evaluate Residual Risk Print Reports Manage Post Production Information Manage Measure Details Date, Signature Team Member Page 10 of 141

11 Yuan, Andy User Data: Project Team Username: Andy_Yuan_Onyx Location: Department: Position: - - EE - Phone: - Fax: - Qualification: TUV Rh training - General safety requirements for medical appliances acc. IEC/EN UL training - Advanced Workshop on International Regulations of Medical Device UL training - Introduction of ISO14971 and IEC Task/Status : Miscellaneous: Rights: MDIC training - Risk Management for Medical Devices Engineering Representative - Identify hazard(s) and hazardous situations - Identify the root cause of the hazard(s) and hazardous situation(s) - Identify mitigations - Determine the probability of occurrence of the hazardous situation(s) and/or root cause as part of the RMPT - Provide standards applicable to manage a hazard or a hazardous situation - Lead the risk/benefit analysis when applicable - Update risk management documentation based on post-production risk activities - Ensure risk assessments for non-conformances following this work instruction - Develop and update the Risk Management File (RMF) for legacy products without an RMF Manage Version Data Manage Project Data Define Graph Implement Analysis Implement Evaluation Release Measures Decide about Implementation of Measures Validate Measures Close Versions Manage Project Team Manage Measure Documentation Manage Version Documentation Implement Reevaluation Evaluate Residual Risk Print Reports Manage Post Production Information Manage Measure Details Date, Signature Team Member Page 11 of 141

12 Chen, Ernest User Data: Project Team Username: Ernest_Chen_Onyx Location: Department: Position: - - ME - Phone: - Fax: - Qualification: TUV Rh training - General safety requirements for medical appliances acc. IEC/EN UL training - Advanced Workshop on International Regulations of Medical Device UL training - Introduction of ISO14971 and IEC Task/Status : Miscellaneous: Rights: MDIC training - Risk Management for Medical Devices Engineering Representative - Identify hazard(s) and hazardous situations - Identify the root cause of the hazard(s) and hazardous situation(s) - Identify mitigations - Determine the probability of occurrence of the hazardous situation(s) and/or root cause as part of the RMPT - Provide standards applicable to manage a hazard or a hazardous situation - Lead the risk/benefit analysis when applicable - Update risk management documentation based on post-production risk activities - Ensure risk assessments for non-conformances following this work instruction - Develop and update the Risk Management File (RMF) for legacy products without an RMF Manage Version Data Manage Project Data Define Graph Implement Analysis Implement Evaluation Release Measures Decide about Implementation of Measures Validate Measures Close Versions Manage Project Team Manage Measure Documentation Manage Version Documentation Implement Reevaluation Evaluate Residual Risk Print Reports Manage Post Production Information Manage Measure Details Date, Signature Team Member Page 12 of 141

13 Definition of the Risk Graph Project: , ONYX-2121DT Version: 1.00 Defined Graph Definition of the Risk Graph Acceptable ALARP Inacceptable Severity Abbreviation Criterion Example S1 Negligible Inconvenience or temporary discomfort Slight rube faction, pressure sores, hot fingers, short-time failure of single functions which can, however, be corrected by the user without expenditure S2 Minor Results in temporary injury or impairment not requiring professional medical intervention S3 Serious Results in injury requiring professional medical intervention S4 Critical Results in permanent impairment or life-threatening injury Slight cuts, minor scalds, unintentional switch-off, reversible malfunction in normal operation Cuts, moderate scalds Scalds, cuts, electric shocks, longerterm and lasting failure of functions Page 13 of 141

14 Abbreviation Criterion Example S5 Catastrophic Results in patient death. Severe scalds, heavy electric shocks, death, complete destruction of the device, severe damage to the environment (damage caused by fire or by water) Probability Abbreviation Criterion Example P1 Improbable < 1/1,000,000 Event is not reproducible or cannot be replicated under the specified operating conditions of the device. P2 Remote <1/100,000 and >= 1/1,000,000 Event occurs infrequently during the life of the product under the specified operating conditions of the device. P3 Occasional <1/10,000 and >= 1/100,000 Event occurs occasionally during the life of the product under the specified operating conditions of the device. P4 Probable < 1/1000 and >= 1/10,000 Event occurs proable during the life of the product under the specified operating conditions of the device. P5 Frequent >= 1/1,000 Event can be replicated repeatedly and/or is likely to occur regularly or many times during the life of the product under the specified operating conditions of the device. Definition of the Risk Graph Defined Risk Graph s Acceptable ALARP Inacceptable Acceptable As low as reasonably possible Not acceptable Page 14 of 141

15 Release Criteria Project: , ONYX-2121DT Version: 1.00 Release Criteria Required Documentation Complete risk management documentation including the complete release report of single action. QD2-010 Risk Management Procedure s When is a Risk Acceptable? The criteria for risk acceptability were based upon applicable national or regional regulations and relevant International Standards, and takes into account available information such as the generally accepted state of the art and known stakeholder concerns. Risk = Severity x Probability Results: (exclude 5): Acceptable; 5, : Not acceptable - Definition Risk Graph with the mentioned parameters - QD2-010 Risk Management Procedure s Criteria of the QM System QD2-001 Verification Planning QP2-002 Design Validation QD2-010 Risk Management Procedure QQ2-002 Retention Time of Quality Records QQ1-001 Quality Manual s Review Plan Annual Review as Review Plan QQ2-010 QQ2-006 Preparation and Management of the Technical Documentation QQ Management QQ1-001 Quality Manual s Procedure to Prove the Effectiveness of Risk Management Recognition of all functions, hazards and their causes, assessment of the individual risks, introduction, implementation and enabling of all individual measures decided to be necessary for the implementation, reassessment of the risks and acceptance of the residual risks. QD2-010 Risk Management Procedure s Page 15 of 141

16 Limits of acceptance for the procedure of evidence Method is only acceptable when either all non-acceptable risks have been eliminated or satisfactory reasons have been given for the release in the enabling sheet. Release Criteria QD2-010 Risk Management Procedure s Procedure for Verification Checking the risk management on correctness and completeness before it is enabled by the technical manager. QD2-010 Risk Management Procedure s Limit of Acceptance for Verification Exceptions from the procedure only with the written approval of the entire management. QD2-010 Risk Management Procedure s Procedure for Validation Checking the results of the user studies (focus groups) QP2-002 Design Validation and taking them into consideration, then: regular market investigations and updates of the risk analysis QD2-010 Risk Management Procedure s Limit of Acceptance for Validation Exceptions from the procedure only with the written approval of the entire management. QD2-010 Risk Management Procedure s Page 16 of 141

17 Grey Box Page 17 of 141

18 Risk Analysis Project: , ONYX-2121DT Version: 1.00 Risk Analysis Function: F-01 Connect to Mains Hazard Cause Effect on Measure Page 18 of 141

19 Hazard Cause H-01 Electromagnetic energy C-01 Short circuit of any or all insulation that does not comply with the requirements of IEC , 3rd Ed., Clause. 8.8 C-02 Short circuit of any or all CREEPAGE DISTANCES or AIR CLEARANCES that do not comply with the requirements of IEC , 3rd Ed., Clause 8.9 C-03 Open circuit of any or all earth connections that do not comply with the requirements of IEC , Clause 8.6, including any functional earth connection. C-04 Short circuit of any one insulation that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause 8.8 C-05 Short circuit of any one CREEPAGE DISTANCE or AIR CLEARANCE that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause 8.9 Effect on Measure M-01 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS Risk Analysis M-01 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS M-01 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter. M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter Page 19 of 141

20 Hazard Cause C-06 Open circuit of any one PROTECTIVE EARTH CONDUCTOR or internal PROTECTIVE EARTH CONNECTION that complies with the requirements of IEC , Clause 8.6 C-07 All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. C-08 The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. C-09 Storage (humidity preconditioning treatment) Effect on Measure M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter. M-01 All components, including wiring shall be used in accordance with their specified ratings. M-02 All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in place by UL R/C nonchemical bonding compound. M-01 They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard; M-02 Where there is no relevant IEC or ISO standard, the requirements of IEC , 3rd Ed. were applied. M-01 The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 25 C 48 hr C-10 Transport M-01 The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure. C-11 Components of PC, unwanted movement of which could result in an unacceptableb RISK, is not mounted securely to prevent such movement. C-12 Too high leakage current, causing a death or serious injury to a patient. M-01 Said components were secured in place on pcb by UL Recognized non-chemical bonding compound. M-01 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Risk Analysis Page 20 of 141

21 Hazard Cause C-13 The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT CONNECTIONS C-14 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. C-15 Internal parts, other than contacts of plugs, connectors and socketoutlets, that can be touched by the test pin shown in IEC , Figure 8. C-16 Accidental detachment of conductors and connectors where breaking free could lead to a HAZARDOUS SITUATION C-17 The resistance to heat is not retained by all types of insulation, including insulating partition walls, during the EXPECTED SERVICE LIFE of the PC. C-18 Internal cables and wiring is not adequately protected against contact with a moving part or Effect on Measure M-01 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Risk Analysis M-01 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements. M-01 The suitable enclosure shall be provided. M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter. M-01 Shall compliance with the following tests: resistance to moisture, etc. (see IEC , Clause 11.6); dielectric strength (see IEC , Clause 8.8.3); and mechanical strength (see IEC , Clause 15.3). M-02 Ball pressure test - according to IEC , Clause , b) requirements M-01 Internal cables and wiring is fixed in place by cable tie to protect against contact with a moving part or from friction at sharp corners and edges where damage to insulation Page 21 of 141

22 Hazard Cause from friction at sharp corners and edges where damage to insulation. C-19 Electromagnetic compatibility of PC. Effect on Measure M-01 Meet IEC requirements C-20 Packing M-01 The permissible environmental conditions for transport and storage were marked on the outside of the packaging. C-21 Wirings and connectors of Panel PC Monitor supply is not secured or insulated that accidental detachment can result in a HAZARDOUS SITUATION. C-22 Internal cables and wiring were not adequately protected against contact from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS SITUATION. H-02 Thermal Energy C-01 Excessive temperatures in PC and/or power supply. M-01 All wirings are tied together by cable tie to prevent accidental detachment M-01 The internal wirings were secured in place on PCB by UL R/C nonchemical bonding component. C-23 Cleaning M-01 The equipment complied with the requirements of IEC , Clause C-02 ENCLOSURES have no the strength and rigidity necessary to avoid a fire. M-01 When PC is operated in worst-case NORMAL USE including the maximum ambient operating temperature, the parts shall not reach temperatures exceeding the values given in IEC , Table 22 and Table 23. M-01 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) Risk Analysis Page 22 of 141

23 Function: F-02 Enclosure Hazard Cause Effect on Measure H-01 Mechanical energy C-01 Falling M-01 Meet IEC , Clause requirements. Risk Analysis C-02 Suspended masses M-01 Meet IEC Clause and Table 21 requirements. C-03 Sharp edges and corners M-01 Rounding of sharp edges and corners. H-02 Thermal Energy C-01 Excessive temperatures in enclosure M-01 When PC is operated in worst-case NORMAL USE including the maximum ambient operating temperature, the parts shall not reach temperatures exceeding the values given in IEC , Table 22 and Table 23. Function: F-03 Rear Bracket Hazard Cause Effect on Measure H-01 Mechanical energy C-01 Crack M-01 Meet IEC Clause and Table 21 requirements. C-02 Suspended masses M-01 Meet IEC Clause and Table 21 requirements. C-03 Instability M-01 Meet IEC , Clause requirements. Function: F-04 Signal input Hazard Cause H-01 Electromagnetic energy C-01 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Effect on Measure M-01 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements Page 23 of 141

24 Function: F-05 Signal output Hazard Cause Effect on Measure H-01 Acoustic energy (sound) C-01 earphone M-01 Meet IEC , Annex NAD Acoustic tests requirements Risk Analysis Function: F-06 User control and indicator Hazard Cause H-01 Operational C-01 Switches used to control power to PC or its parts, including switches, did not have their "on" and "off" positions Effect on Measure M-01 Indicated by an adjacent indicator light M-02 Marked with symbols IEC Function: F-07 Information Hazard Cause H-01 Labeling C-01 PC did not marke with the name or trademark of Onyx and with a MODEL OR TYPE REFERENCE C-02 Incomplete instructions for use C-03 Inadequate description of performance characteristics C-04 Inadequate specification of intended use. C-05 Inadequate disclosure of limitations Effect on Measure M-01 PC marked the name or trademark of Onyx with model no. M-01 Meet IEC , Clause 7 requirements. M-01 Meet IEC , Clause 7 requirements. M-01 Meet IEC , Clause 7 requirements. M-01 Meet IEC , Clause 7 requirements Page 24 of 141

25 Hazard Cause H-02 Operating instructions C-01 Inadequate specification of accessories to be used with the medical device. Effect on Measure M-01 Meet IEC , Clause 7 requirements. Risk Analysis C-02 Inadequate specification of pre-use checks. M-01 Meet IEC , Clause 7 requirements. C-03 Over-complicated operating instructions M-01 Meet IEC , Clause 7 requirements. H-03 Specification of service and maintenance C-01 Installation instruction M-01 Meet IEC , Clause 7 requirements. Function: F-08 Connection to an external d.c. power source Hazard Cause H-01 Thermal Energy C-01 When a connection with the wrong polarity is made Effect on Measure M-01 Provided a connector that has special housing to prevent a connection with the wrong polarity is made Function: F-09 Display Hazard Cause Effect on Measure H-01 Radiation energy C-01 Visible Light M-01 The intensity of visible light from monitor can be controlled by the user. The highest intensity achievable cannot produce detrimental biological effects. Function: F-10 BIOS (Basic Input/Output System - real time clock) Hazard Cause Effect on Measure H-01 Mechanical energy C-01 Lithium battery explosion M-01 Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer s recommendations, and unintentional charging, are prevented Page 25 of 141

26 Risk Evaluation Before Measures Project: , ONYX-2121DT Version: 1.00 Function: F-01 Connect to Mains Hazard Cause Severity Probability Region of Risk Comment Risk Evaluation Before Measures Page 26 of 141

27 Hazard Cause H-01 Electromagnetic energy C-01 Short circuit of any or all insulation that does not comply with the requirements of IEC , 3rd Ed., Clause. 8.8 C-02 Short circuit of any or all CREEPAGE DISTANCES or AIR CLEARANCES that do not comply with the requirements of IEC , 3rd Ed., Clause 8.9 C-03 Open circuit of any or all earth connections that do not comply with the requirements of IEC , Clause 8.6, including any functional earth connection. C-04 Short circuit of any one insulation that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause 8.8 C-05 Short circuit of any one CREEPAGE DISTANCE or AIR CLEARANCE that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause 8.9 C-06 Open circuit of any one PROTECTIVE EARTH CONDUCTOR or internal PROTECTIVE EARTH CONNECTION that complies with the requirements of IEC , Clause 8.6 C-07 All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. C-08 The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. C-09 Storage (humidity preconditioning treatment) Severity Probability Region of Risk Serious Occasional Inacceptable Serious Occasional Inacceptable Serious Occasional Inacceptable Critical Occasional Inacceptable Critical Remote Inacceptable Critical Occasional Inacceptable Serious Remote Acceptable Critical Remote Inacceptable Serious Occasional Inacceptable Comment Risk Evaluation Before Measures Page 27 of 141

28 Hazard Cause Severity Probability Region of Risk C-10 Transport Serious Remote Acceptable C-11 Components of PC, unwanted movement of which could result in an unacceptableb RISK, is not mounted securely to prevent such movement. C-12 Too high leakage current, causing a death or serious injury to a patient. C-13 The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT CONNECTIONS C-14 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. C-15 Internal parts, other than contacts of plugs, connectors and socket-outlets, that can be touched by the test pin shown in IEC , Figure 8. Serious Remote Acceptable Critical Occasional Inacceptable Critical Occasional Inacceptable Critical Occasional Inacceptable Serious Remote Acceptable Comment Risk Evaluation Before Measures C-16 Accidental detachment of conductors and connectors where breaking free could lead to a HAZARDOUS SITUATION Serious Occasional Inacceptable C-17 The resistance to heat is not retained by all types of insulation, including insulating partition walls, during the EXPECTED SERVICE LIFE of the PC. Serious Occasional Inacceptable C-18 Internal cables and wiring is not adequately protected against contact with a moving part or from friction at sharp corners and edges where damage to insulation. Serious Occasional Inacceptable C-19 Electromagnetic compatibility of PC. Critical Occasional Inacceptable C-20 Packing Serious Occasional Inacceptable Page 28 of 141

29 Hazard Cause C-21 Wirings and connectors of Panel PC Monitor supply is not secured or insulated that accidental detachment can result in a HAZARDOUS SITUATION. C-22 Internal cables and wiring were not adequately protected against contact from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS SITUATION. Severity Probability Region of Risk Serious Remote Acceptable Serious Remote Acceptable C-23 Cleaning Minor Remote Acceptable H-02 Thermal Energy C-01 Excessive temperatures in PC and/or power supply. C-02 ENCLOSURES have no the strength and rigidity necessary to avoid a fire. Serious Occasional Inacceptable Critical Remote Inacceptable Comment Risk Evaluation Before Measures Function: F-02 Enclosure Hazard Cause Severity Probability Region of Risk H-01 Mechanical energy C-01 Falling Serious Occasional Inacceptable C-02 Suspended masses Serious Occasional Inacceptable C-03 Sharp edges and corners Minor Probable Inacceptable H-02 Thermal Energy C-01 Excessive temperatures in enclosure Serious Occasional Inacceptable Comment Page 29 of 141

30 Function: F-03 Rear Bracket Hazard Cause Severity Probability Region of Risk H-01 Mechanical energy C-01 Crack Serious Occasional Inacceptable C-02 Suspended masses Serious Remote Acceptable C-03 Instability Serious Occasional Inacceptable Comment Risk Evaluation Before Measures Function: F-04 Signal input Hazard Cause H-01 Electromagnetic energy C-01 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Severity Probability Region of Risk Critical Remote Inacceptable Comment Function: F-05 Signal output Hazard Cause Severity Probability Region of Risk H-01 Acoustic energy (sound) C-01 earphone Serious Occasional Inacceptable Comment Function: F-06 User control and indicator Hazard Cause H-01 Operational C-01 Switches used to control power to PC or its parts, including switches, did not have their "on" and "off" positions Severity Probability Region of Risk Serious Occasional Inacceptable Comment Page 30 of 141

31 Function: F-07 Information Hazard Cause H-01 Labeling C-01 PC did not marke with the name or trademark of Onyx and with a MODEL OR TYPE REFERENCE Severity Probability Region of Risk Minor Occasional Acceptable C-02 Incomplete instructions for use Critical Occasional Inacceptable C-03 Inadequate description of performance characteristics Serious Occasional Inacceptable C-04 Inadequate specification of intended use. Critical Occasional Inacceptable C-05 Inadequate disclosure of limitations Critical Occasional Inacceptable H-02 Operating instructions C-01 Inadequate specification of accessories to be used with the medical device. C-02 Inadequate specification of pre-use checks. H-03 Specification of service and maintenance Serious Remote Acceptable Minor Occasional Acceptable C-03 Over-complicated operating instructions Minor Occasional Acceptable C-01 Installation instruction Serious Occasional Inacceptable Comment Risk Evaluation Before Measures Function: F-08 Connection to an external d.c. power source Hazard Cause H-01 Thermal Energy C-01 When a connection with the wrong polarity is made Severity Probability Region of Risk Serious Occasional Inacceptable Comment Page 31 of 141

32 Function: F-09 Display Hazard Cause Severity Probability Region of Risk H-01 Radiation energy C-01 Visible Light Minor Occasional Acceptable Function: F-10 BIOS (Basic Input/Output System - real time clock) Hazard Cause Severity Probability Region of Risk H-01 Mechanical energy C-01 Lithium battery explosion Critical Occasional Inacceptable Comment Comment Risk Evaluation Before Measures Page 32 of 141

33 Risk Graph Before Measures Project: , ONYX-2121DT Version: 1.00 Both Conditions Operating Condition Risk Graph Before Measures Failure Mode Acceptable ALARP Inacceptable Page 33 of 141

34 Decision about Measures Project: , ONYX-2121DT Version: 1.00 Measure: RC-001 All components, including wiring shall be used in accordance with their specified ratings. Implement: Decision about Measures Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. Effective Measure: RC-002 All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in place by UL R/C non-chemical bonding compound. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. Effective Measure: RC-003 All wirings are tied together by cable tie to prevent accidental detachment Implement: Page 34 of 141

35 Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Wirings and connectors of Panel PC Monitor supply is not secured or insulated that accidental detachment can result in a HAZARDOUS SITUATION. Effective Measure: RC-004 Ball pressure test - according to IEC , Clause , b) requirements Decision about Measures Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy The resistance to heat is not retained by all types of insulation, including insulating partition walls, during the EXPECTED SERVICE LIFE of the PC. Effective Measure: RC-005 Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer s recommendations, and unintentional charging, are prevented. Implement: Function Hazard Cause Effectiveness Assessment of the Measure BIOS (Basic Input/Output System Mechanical energy Lithium battery explosion Effective - real time clock) Page 35 of 141

36 Measure: RC-006 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Thermal Energy ENCLOSURES have no the strength and rigidity necessary to avoid a fire. Effective Decision about Measures Measure: RC-007 Indicated by an adjacent indicator light Implement: Function Hazard Cause Effectiveness Assessment of the Measure User control and indicator Operational Switches used to control power to PC or its parts, including switches, did not have their "on" and "off" positions Effective Measure: RC-008 Internal cables and wiring is fixed in place by cable tie to protect against contact with a moving part or from friction at sharp corners and edges where damage to insulation Implement: Page 36 of 141

37 Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Internal cables and wiring is not adequately protected against contact with a moving part or from friction at sharp corners and edges where damage to insulation. Effective Measure: Marked with symbols IEC RC-009 Decision about Measures Implement: Function Hazard Cause Effectiveness Assessment of the Measure User control and indicator Operational Switches used to control power to PC or its parts, including switches, did not have their "on" and "off" positions Effective Measure: RC-010 Meet IEC Clause and Table 21 requirements. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Enclosure Mechanical energy Suspended masses Effective Rear Bracket Mechanical energy Crack Effective Rear Bracket Mechanical energy Suspended masses Effective Page 37 of 141

38 Measure: RC-011 Meet IEC , Clause 7 requirements. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Information Labeling Incomplete instructions for use Effective Information Labeling Inadequate description of performance characteristics Effective Information Labeling Inadequate specification of intended use. Effective Information Labeling Inadequate disclosure of limitations Effective Information Operating instructions Inadequate specification of accessories to be used with the medical device. Effective Information Operating instructions Inadequate specification of preuse checks. Effective Information Operating instructions Over-complicated operating instructions Effective Information Specification of service and maintenance Installation instruction Effective Decision about Measures Measure: RC-012 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Too high leakage current, causing a death or serious injury to a patient. Effective Page 38 of 141

39 Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT CONNECTIONS Effective Measure: RC-013 Meet IEC , Clause requirements. Decision about Measures Implement: Function Hazard Cause Effectiveness Assessment of the Measure Enclosure Mechanical energy Falling Effective Rear Bracket Mechanical energy Instability Effective Measure: Meet IEC requirements RC-014 Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Electromagnetic compatibility of Effective PC. Measure: RC-015 Meet IEC , Annex NAD Acoustic tests requirements Implement: Page 39 of 141

40 Function Hazard Cause Effectiveness Assessment of the Measure Signal output Acoustic energy (sound) earphone Effective Measure: RC-016 PC marked the name or trademark of Onyx with model no. Implement: Decision about Measures Function Hazard Cause Effectiveness Assessment of the Measure Information Labeling PC did not marke with the name or trademark of Onyx and with a MODEL OR TYPE REFERENCE Effective Measure: RC-017 Provided a connector that has special housing to prevent a connection with the wrong polarity is made Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connection to an external d.c. Thermal Energy When a connection with the wrong Effective power source polarity is made Measure: RC-018 Rounding of sharp edges and corners. Implement: Page 40 of 141

41 Function Hazard Cause Effectiveness Assessment of the Measure Enclosure Mechanical energy Sharp edges and corners Effective Measure: RC-019 Said components were secured in place on pcb by UL Recognized non-chemical bonding compound. Implement: Decision about Measures Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Components of PC, unwanted movement of which could result in an unacceptableb RISK, is not mounted securely to prevent such movement. Effective Measure: RC-020 Shall compliance with the following tests: resistance to moisture, etc. (see IEC , Clause 11.6); dielectric strength (see IEC , Clause 8.8.3); and mechanical strength (see IEC , Clause 15.3). Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy The resistance to heat is not retained by all types of insulation, including insulating partition walls, during the EXPECTED SERVICE LIFE of the PC. Effective Page 41 of 141

42 Measure: RC-021 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Effective Signal input Electromagnetic energy ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Effective Decision about Measures Measure: RC-022 The equipment complied with the requirements of IEC , Clause Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Cleaning Effective Measure: RC-023 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter. Implement: Page 42 of 141

43 Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Short circuit of any one insulation that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause 8.8 Effective Connect to Mains Electromagnetic energy Short circuit of any one CREEPAGE DISTANCE or AIR CLEARANCE that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause 8.9 Effective Connect to Mains Electromagnetic energy Open circuit of any one PROTECTIVE EARTH CONDUCTOR or internal PROTECTIVE EARTH CONNECTION that complies with the requirements of IEC , Clause 8.6 Effective Connect to Mains Electromagnetic energy Accidental detachment of conductors and connectors where breaking free could lead to a HAZARDOUS SITUATION Effective Decision about Measures Measure: RC-024 The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 25 C 48 hr Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Storage (humidity preconditioning Effective treatment) Page 43 of 141

44 Measure: RC-025 The intensity of visible light from monitor can be controlled by the user. The highest intensity achievable cannot produce detrimental biological effects. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Display Radiation energy Visible Light Effective Decision about Measures Measure: RC-026 The internal wirings were secured in place on PCB by UL R/C non-chemical bonding component. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Internal cables and wiring were not adequately protected against contact from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS SITUATION. Effective Measure: RC-027 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Short circuit of any or all insulation that does not comply with the requirements of IEC , 3rd Ed., Clause. 8.8 Effective Page 44 of 141

45 Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Short circuit of any or all CREEPAGE DISTANCES or AIR CLEARANCES that do not comply with the requirements of IEC , 3rd Ed., Clause 8.9 Effective Connect to Mains Electromagnetic energy Open circuit of any or all earth connections that do not comply with the requirements of IEC , Clause 8.6, including any functional earth connection. Effective Decision about Measures Measure: RC-028 The permissible environmental conditions for transport and storage were marked on the outside of the packaging. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Packing Effective Measure: RC-029 The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Transport Effective Page 45 of 141

46 Measure: RC-030 The suitable enclosure shall be provided. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy Internal parts, other than contacts of plugs, connectors and socketoutlets, that can be touched by the test pin shown in IEC , Figure 8. Effective Decision about Measures Measure: RC-031 They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard; Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. Effective Measure: RC-032 When PC is operated in worst-case NORMAL USE including the maximum ambient operating temperature, the parts shall not reach temperatures exceeding the values given in IEC , Table 22 and Table 23. Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Thermal Energy Excessive temperatures in PC Effective and/or power supply Page 46 of 141

47 Function Hazard Cause Effectiveness Assessment of the Measure Enclosure Thermal Energy Excessive temperatures in Effective enclosure Measure: RC-033 Where there is no relevant IEC or ISO standard, the requirements of IEC , 3rd Ed. were applied. Decision about Measures Implement: Function Hazard Cause Effectiveness Assessment of the Measure Connect to Mains Electromagnetic energy The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. Effective Page 47 of 141

48 Risk Control Project: , ONYX-2121DT Version: 1.00 Risk Control No. Measure RC-001 All components, including wiring shall be used in accordance with their specified ratings. RC-002 All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in place by UL R/C nonchemical bonding compound. RC-003 All wirings are tied together by cable tie to prevent accidental detachment RC-004 Ball pressure test - according to IEC , Clause , b) requirements RC-005 Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer s recommendations, and unintentional charging, are prevented. State of Work Validation Responsible Implementation Planning Actual Values Effort Supervision Begin End Begin End Planned Is Release Completed Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 5/2/2013 6/18/2013 Yes Yes Completed Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 5/3/2013 7/17/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/12/2013 7/5/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/6/2013 6/28/2013 Yes Yes Completed Yuan, Andy Lin, Eason 5/1/2013 8/31/2013 5/8/2013 6/18/2013 Yes Yes Page 48 of 141

49 No. Measure RC-006 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) RC-007 Indicated by an adjacent indicator light RC-008 Internal cables and wiring is fixed in place by cable tie to protect against contact with a moving part or from friction at sharp corners and edges where damage to insulation RC-009 Marked with symbols IEC RC-010 Meet IEC Clause and Table 21 requirements. RC-011 Meet IEC , Clause 7 requirements. RC-012 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements RC-013 Meet IEC , Clause requirements. State of Work Validation Responsible Implementation Planning Actual Values Effort Supervision Begin End Begin End Planned Is Release Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/13/2013 6/25/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/14/2013 6/18/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/3/2013 6/20/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/2/2013 6/25/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/8/2013 7/5/2013 Yes Yes Completed Lin, Eason Chen, Ernest 5/1/2013 8/31/2013 5/6/2013 7/5/2013 Yes Yes Completed Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 5/6/2013 7/15/2013 Yes Yes Completed Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 5/9/2013 6/27/2013 Yes Yes Risk Control Page 49 of 141