Risk Management File Slim Medical Panel PC, models xxxxx-onyx-adty-xxxxxxx

Transcription

1 Risk Management File Slim Medical Panel PC, models xxxxx-onyx-adty-xxxxxxx Company: Creation Date: 10/17/12 Abbreviation: Project Number: Project : Version Number: Version : Life Cycle Phase: ONYX-15/17/1921DT The models xxxxx-onyx-adty-xxxxxxx (where a can be 1521, 1721 or 1921, y can be T or blank, x can be 0-9, A-Z, - or blank) are Slim Medical Panel PC for medical equipment used ) Adding one alternate enclosure shape. 2) Adding one alternate LCD panel. 3) Adding new model designation xxxxx- ONYX-1521DTy-xxxxxxx 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 28 Risk Graph Before Measures 35 Decision about Measures 36 Risk Control 49 Release Protocol of Measures 55 Evaluation After Measures 121 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 /17/12 Page 2 of 142

3 Project Data Project: , ONYX-15/17/1921DT Version: 1.02 Abbreviation: ONYX-15/17/1921DT Project Number: Project Name: Project : Slim Medical Panel PC, models xxxxx-onyx-adty-xx The models xxxxx-onyx-adty-xxxxxxx (where a can be 1521, 1721 or 1921, y can be T or blank, x can be 0-9, A-Z, - or blank) are Slim Medical Panel PC for medical equipment used. Name of Superior Project: Name of Inferior Project: Product Type: ISO 14971:2007 Project Type: Product Project Management Project Leader: Substitute: Responsible for the Risk: Lin Mac James Chen Mac Lin Project Structure : Title: Number: Location: Path: s: 10/17/12 Page 3 of 142

4 Version Data Project: , ONYX-15/17/1921DT Version: 1.02 Version No.: Derived from Version: Special Version: Version : 1) Adding one alternate enclosure shape. 2) Adding one alternate LCD panel. 3) Adding new model designation xxxxx-onyx-1521dty-xxxxxxx Freeze Analysis and Evaluation Part: Intended Use: 1. The ONYX-1521/1721/1921 is a 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 17"/19" 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: V dc, A (for LCD Monitor); V ac, Hz, A (for power supply, model GMPU70A-3 and 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 10/17/12 Page 4 of 142

5 -3 and GMPU70A-6 by Eljintek. This power is used in the conditions of overvoltage category II, Pollution 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. 38. Two COM port and Two LAN Port were considered as PATIENT CONNECTION(s) and provided 2 MOPP (for working voltage) or 1 MOPP (for Maximum Mains voltage) between these ports and SIGNAL INPUT/OUTPUT PART Version Data Possible Misuse: Diagnose use in computed tomography (CT), magnetic resonance imaging (MRI), endoscopy, ultrasound physiotherapy equipment and digital mammography system. 10/17/12 Page 5 of 142

6 Life Cycle Phase: Additional Documents Functional design Version Data Titel No. Location Path 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: /17/12 Page 6 of 142

7 Project Team Project: , ONYX-15/17/1921DT Version: 1.02 Project Management Project Leader: Substitute Project Leader: Risk Responsible: Mac Lin James Chen Mac Lin Team Members: Date, Signature Team Member 10/17/12 Page 7 of 142

8 Chen, James User Data: Project Team Username: James_Chen_Onyx Location: Department: Position: - - QC Phone: Fax: Qualification: Task/Status : Miscellaneous: Comment: 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 10/17/12 Page 8 of 142

9 Lin, Eason User Data: Project Team Username: Eason_Lin_Onyx Location: Department: Position: - - Sales Phone: Fax: Qualification: Task/Status : Miscellaneous: 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 10/17/12 Page 9 of 142

10 Lin, Mac User Data: Project Team Username: Mac_Lin_Onyx Location: Department: Position: - - Project Manager Phone: Fax: Qualification: Task/Status : Miscellaneous: Comment: 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 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 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 10/17/12 Page 10 of 142

11 Pan, Peter User Data: Project Team Username: Peter_Pan_Onyx Location: Department: Position: - - ME Phone: Fax: Qualification: Task/Status : Miscellaneous: Comment: O038 Engineering Representative - Manage the product s Risk Management File (RMF) - Provide the technical input including probability of occurrence of the hazardous situation (P1) value and rationale regarding the risk assessment - Update the product s Risk Management File in post-production 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 10/17/12 Page 11 of 142

12 Wu, Allen User Data: Project Team Username: Allen_Wu_Onyx Location: Department: Position: - RD Project Engineer Phone: Fax: Qualification: Task/Status : Miscellaneous: Comment: 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 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 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 10/17/12 Page 12 of 142

13 Definition of the Risk Graph Project: , ONYX-15/17/1921DT Version: 1.02 Defined Graph Inacceptable ALARP Acceptable 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 10/17/12 Page 13 of 142

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 10/17/12 Page 14 of 142

15 Release Criteria Project: , ONYX-15/17/1921DT Version: 1.02 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 Technial 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 10/17/12 Page 15 of 142

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 10/17/12 Page 16 of 142

17 Grey Box 10/17/12 Page 17 of 142

18 Risk Analysis Project: , ONYX-15/17/1921DT Version: 1.02 Function: F-01 Connect to Mains Hazard Cause Effect on Measure 10/17/12 Page 18 of 142

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 Effect on Measure M-01 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS Risk Analysis 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 M-01 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS 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. M-01 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS 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 M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter 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 M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter 10/17/12 Page 19 of 142

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 bounding 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 bounding compound. M-01 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Risk Analysis 10/17/12 Page 20 of 142

21 Hazard Cause C-13 The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT CONNECTIONS Effect on Measure M-01 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Risk Analysis C-14 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. M-01 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements. 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. M-01 The suitable enclosure shall be provided C-16 Accidental detachment of conductors and connectors where breaking free could lead to a HAZARDOUS SITUATION M-01 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter 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. 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 C-18 Internal cables and wiring is not adequately protected against contact with a moving part or 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 10/17/12 Page 21 of 142

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. 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 bounding component. C-23 Cleaning M-01 The equipment complied with the requirements of IEC , Clause C-24 Electromagnetic compatibility of PC (adding one alternate main board) M-1 Meet IEC requirements Risk Analysis 10/17/12 Page 22 of 142

23 Hazard Cause H-02 Thermal Energy C-01 Excessive temperatures in PC and/or power supply. Effect on Measure 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. Risk Analysis C-02 ENCLOSURES have no the strength and rigidity necessary to avoid a fire. M-01 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) C-03 Excessive temperatures in PC and/or power supply (adding one alternate main board) M-1 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. C-04 Adding one alternate LCD panel and enclosure shape. 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-02 Enclosure Hazard Cause Effect on Measure H-01 Mechanical energy C-01 Falling M-01 Meet IEC , Clause requiremets. 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. C-04 Adding new enclosure shape H-02 Thermal Energy C-01 Excessive temperatures in enclosure M-01 Rounding of sharp edges and corners. 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 /17/12 Page 23 of 142

24 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. Risk Analysis C-02 Suspended masses M-01 Meet IEC Clause and Table 21 requirements. C-03 Instability M-01 Meet IEC , Clause requiremets. 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. 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 10/17/12 Page 24 of 142

25 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 Risk Analysis 10/17/12 Page 25 of 142

26 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 Effect on Measure M-01 PC marked the name or trademark of Onyx with model no. M-01 Meet IEC , Clause 7 requirements. Risk Analysis C-03 Inadequate description of performance characteristics C-04 Inadequate specification of intended use. C-05 Inadequate disclosure of limitations 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. C-03 Over-complicated operating instructions 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. M-01 Meet IEC , Clause 7 requirements. 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 10/17/12 Page 26 of 142

27 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. Risk Analysis 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. 10/17/12 Page 27 of 142

28 Risk Evaluation Before Measures Project: , ONYX-15/17/1921DT Version: 1.02 Function: F-01 Connect to Mains Hazard Cause Severity Probability of Risk Comment 10/17/12 Page 28 of 142

29 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 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 10/17/12 Page 29 of 142

30 Hazard Cause Severity Probability 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 Serious Remote Acceptable Critical Occasional Inacceptable Critical Occasional Inacceptable Comment Risk Evaluation Before Measures C-14 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Critical Occasional Inacceptable 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 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 10/17/12 Page 30 of 142

31 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 of Risk Serious Remote Acceptable Serious Remote Acceptable C-23 Cleaning Minor Remote Acceptable C-24 Electromagnetic compatibility of PC (adding one alternate main board) 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. C-03 Excessive temperatures in PC and/or power supply (adding one alternate main board) C-04 Adding one alternate LCD panel and enclosure shape. Critical Occasional Inacceptable Serious Occasional Inacceptable Critical Remote Inacceptable Serious Occasional Inacceptable Serious Occasional Inacceptable Comment Risk Evaluation Before Measures Function: F-02 Enclosure Hazard Cause Severity Probability of Risk Comment 10/17/12 Page 31 of 142

32 Hazard Cause Severity Probability 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 C-04 Adding new enclosure shape Minor Probable Inacceptable H-02 Thermal Energy C-01 Excessive temperatures in enclosure Serious Occasional Inacceptable Comment Risk Evaluation Before Measures Function: F-03 Rear Bracket Hazard Cause Severity Probability 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 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 of Risk Critical Remote Inacceptable Comment 10/17/12 Page 32 of 142

33 Function: F-05 Signal output Hazard Cause Severity Probability of Risk H-01 Acoustic energy (sound) C-01 earphone Serious Occasional Inacceptable 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 of Risk Serious Occasional Inacceptable Comment Comment Risk Evaluation Before Measures 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 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 Comment 10/17/12 Page 33 of 142

34 Hazard Cause H-02 Operating instructions C-01 Inadequate specification of accessories to be used with the medical device. H-03 Specification of service and maintenance C-02 Inadequate specification of pre-use checks. Severity Probability of Risk 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 of Risk Serious Occasional Inacceptable Comment Function: F-09 Display Hazard Cause Severity Probability of Risk H-01 Radiation energy C-01 Visible Light Minor Occasional Acceptable Comment Function: F-10 BIOS (Basic Input/Output System - real time clock) Hazard Cause Severity Probability of Risk H-01 Mechanical energy C-01 Lithium battery explosion Critical Occasional Inacceptable Comment 10/17/12 Page 34 of 142

35 Risk Graph Before Measures Project: , ONYX-15/17/1921DT Version: 1.02 Both Conditions Operating Condition Failure Mode Inacceptable ALARP Acceptable 10/17/12 Page 35 of 142

36 Decision about Measures Project: , ONYX-15/17/1921DT Version: 1.02 Measure: RC-026 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Connect to Mains Connect to Mains Electromagnetic energy Electromagnetic energy Electromagnetic energy Short circuit of any or all insulation that does not comply with the requirements of IEC , 3rd Ed., Clause. 8.8 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 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 Effective Effective Measure: RC-022 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter Implement: Function Hazard Cause Evaluation of Effectiveness 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 10/17/12 Page 36 of 142

37 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Connect to Mains Connect to Mains Electromagnetic energy Electromagnetic energy 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 Open circuit of any one PROTECTIVE EARTH CONDUCTOR or internal PROTECTIVE EARTH CONNECTION that complies with the requirements of IEC ,Clause 8.6 Accidental detachment of conductors and connectors where breaking free could lead to a HAZARDOUS SITUATION Effective Effective Effective Decision about Measures Measure: RC-001 All components, including wiring shall be used in accordance with their specified ratings. Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. Effective Measure: Implement: 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 bounding compound. 10/17/12 Page 37 of 142

38 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Measure: Electromagnetic energy RC-030 They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard; All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. Effective Decision about Measures Implement: Function Hazard Cause Evaluation of Effectiveness 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 Where there is no relevant IEC or ISO standard, the requirements of IEC , 3rd Ed. were applied. Implement: Function Hazard Cause Evaluation of Effectiveness 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-023 The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 25 C 48 hr Implement: 10/17/12 Page 38 of 142

39 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy Storage (humidity preconditioning treatment) Effective Measure: RC-028 The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure. Implement: Decision about Measures Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy Transport Effective Measure: RC-018 Said components were secured in place on pcb by UL Recognized non-chemical bounding compound. Implement: Function Hazard Cause Evaluation of Effectiveness 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-011 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy Too high leakage current, causing a death or serious injury to a patient. Effective 10/17/12 Page 39 of 142

40 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Measure: Electromagnetic energy RC-020 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements. The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT CONNECTIONS Effective Decision about Measures Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Signal input Electromagnetic energy Electromagnetic energy ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Effective Effective Measure: RC-029 The suitable enclosure shall be provided Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy Internal parts, other than contacts of plugs, connectors and socket-outlets, that can be touched by the test pin shown in IEC , Figure 8. Effective 10/17/12 Page 40 of 142

41 Measure: Implement: RC-019 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). Function Hazard Cause Evaluation of Effectiveness 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 Decision about Measures Measure: RC-004 Ball pressure test - according to IEC , Clause , b) requirements Implement: Function Hazard Cause Evaluation of Effectiveness 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: Implement: RC-007 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 10/17/12 Page 41 of 142

42 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Measure: Meet IEC requirements Electromagnetic energy RC-013 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 Decision about Measures Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Connect to Mains Electromagnetic energy Electromagnetic energy Electromagnetic compatibility of PC. Electromagnetic compatibility of PC (adding one alternate main board) Effective Effective Measure: RC-027 The permissible environmental conditions for transport and storage were marked on the outside of the packaging. Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy Packing Effective Measure: RC-003 All wirings are tied together by cable tie to prevent accidental detachment Implement: 10/17/12 Page 42 of 142

43 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Measure: Electromagnetic energy RC-025 The internal wirings were secured in place on PCB by UL R/C non-chemical bounding component. Wirings and connectors of Panel PC Monitor supply is not secured or insulated that accidental detachment can result in a HAZARDOUS SITUATION. Effective Decision about Measures Implement: Function Hazard Cause Evaluation of Effectiveness 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-021 The equipment complied with the requirements of IEC , Clause Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Electromagnetic energy Cleaning Effective Measure: Implement: RC-031 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 /17/12 Page 43 of 142

44 Function Hazard Cause Evaluation of Effectiveness Connect to Mains Connect to Mains Enclosure Connect to Mains Thermal Energy Thermal Energy Thermal Energy Thermal Energy Excessive temperatures in PC and/or power supply. Excessive temperatures in PC and/or power supply (adding one alternate main board) Excessive temperatures in enclosure Adding one alternate LCD panel and enclosure shape. Effective Effective Effective Effective Decision about Measures Measure: RC-005 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) Implement: Function Hazard Cause Evaluation of Effectiveness Connect to Mains Thermal Energy ENCLOSURES have no the strength and rigidity necessary to avoid a fire. Effective Measure: RC-012 Meet IEC , Clause requiremets. Implement: Function Hazard Cause Evaluation of Effectiveness Enclosure Mechanical energy Falling Effective Rear Bracket Mechanical energy Instability Effective 10/17/12 Page 44 of 142

45 Measure: RC-009 Meet IEC Clause and Table 21 requirements. Implement: Function Hazard Cause Evaluation of Effectiveness Enclosure Mechanical energy Suspended masses Effective Rear Bracket Mechanical energy Crack Effective Rear Bracket Mechanical energy Suspended masses Effective Decision about Measures Measure: RC-017 Rounding of sharp edges and corners. Implement: Function Hazard Cause Evaluation of Effectiveness Enclosure Mechanical energy Sharp edges and corners Effective Enclosure Mechanical energy Adding new enclosure shape Effective Measure: RC-014 Meet IEC , Annex NAD Acoustic tests requirements Implement: Function Hazard Cause Evaluation of Effectiveness Signal output Acoustic energy (sound) earphone Effective 10/17/12 Page 45 of 142

46 Measure: Implement: RC-006 Indicated by an adjacent indicator light Function Hazard Cause Evaluation of Effectiveness 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 Decision about Measures Measure: Marked with symbols IEC RC-008 Implement: Function Hazard Cause Evaluation of Effectiveness 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-015 PC marked the name or trademark of Onyx with model no. Implement: Function Hazard Cause Evaluation of Effectiveness Information Labeling PC did not marke with the name or trademark of Onyx and with a MODEL OR TYPE REFERENCE Effective 10/17/12 Page 46 of 142

47 Measure: Implement: RC-010 Meet IEC , Clause 7 requirements. Function Hazard Cause Evaluation of Effectiveness Information Information Information Information Information Information Information Information Labeling Labeling Labeling Labeling Operating instructions Operating instructions Operating instructions Specification of service and maintenance Incomplete instructions for use Inadequate description of performance characteristics Inadequate specification of intended use. Inadequate disclosure of limitations Inadequate specification of accessories to be used with the medical device. Inadequate specification of pre-use checks. Over-complicated operating instructions Installation instruction Effective Effective Effective Effective Effective Effective Effective Effective Decision about Measures Measure: RC-016 Provided a connector that has special housing to prevent a connection with the wrong polarity is made Implement: Function Hazard Cause Evaluation of Effectiveness Connection to an external d.c. power source Thermal Energy When a connection with the wrong polarity is made Effective 10/17/12 Page 47 of 142

48 Measure: RC-024 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 Evaluation of Effectiveness Display Radiation energy Visible Light Effective Decision about Measures Measure: RC-033 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 Evaluation of Effectiveness BIOS (Basic Input/Output System - real time clock) Mechanical energy Lithium battery explosion Effective 10/17/12 Page 48 of 142

49 Risk Control Project: , ONYX-15/17/1921DT Version: 1.02 Validation No. Measure Status Responsible Planning Actual Values Effort Implementation Supervision Begin End Begin End Planned Is 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 bounding 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 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) RC-006 Indicated by an adjacent indicator light Release Finished Lin, Eason Lin, Eason 10/1/ /31/ /5/ /30/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /3/ /28/2011 Yes Yes Finished Pan, Peter Lin, Eason 10/1/ /31/ /12/ /24/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /7/ /22/2011 Yes Yes Finished Pan, Peter Lin, Eason 10/1/ /30/ /12/ /24/2011 Yes Yes Finished Pan, Peter Lin, Eason 10/1/ /31/ /11/ /1/2011 Yes Yes 10/17/12 Page 49 of 142

50 Validation No. Measure Status Responsible Planning Actual Values Effort Implementation Supervision Begin End Begin End Planned Is RC-007 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-008 Marked with symbols IEC RC-009 Meet IEC Clause and Table 21 requirements. RC-010 Meet IEC , Clause 7 requirements. RC-011 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements RC-012 Meet IEC , Clause requiremets. RC-013 Meet IEC requirements RC-014 Meet IEC , Annex NAD Acoustic tests requirements RC-015 PC marked the name or trademark of Onyx with model no. Release Finished Wu, Allen Lin, Eason 10/1/ /31/ /11/ /2/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /4/ /25/2011 Yes Yes Finished Pan, Peter Wu, Allen 10/1/ /31/ /12/ /18/2011 Yes Yes Finished Wu, Allen Lin, Eason 10/1/ /31/ /5/ /1/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /10/ /18/2011 Yes Yes Finished Pan, Peter Lin, Eason 10/1/ /31/ /5/ /29/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /11/ /23/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /3/ /30/2011 Yes Yes Finished Pan, Peter Wu, Allen 10/1/ /31/ /3/ /30/2011 Yes Yes Risk Control 10/17/12 Page 50 of 142

51 Validation No. Measure Status Responsible Planning Actual Values Effort Implementation Supervision Begin End Begin End Planned Is RC-016 Provided a connector that has special housing to prevent a connection with the wrong polarity is made RC-017 Rounding of sharp edges and corners. RC-018 Said components were secured in place on pcb by UL Recognized nonchemical bounding compound. RC-019 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). RC-020 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements. RC-021 The equipment complied with the requirements of IEC , Clause Release Finished Wu, Allen Lin, Eason 10/1/ /31/ /5/ /24/2011 Yes Yes Finished Wu, Allen Pan, Peter 10/1/ /31/ /12/ /28/2011 Yes Yes Finished Pan, Peter Wu, Allen 10/1/ /31/ /12/ /30/2011 Yes Yes Finished Wu, Allen Lin, Eason 10/1/ /31/ /12/ /24/2011 Yes Yes Finished Lin, Mac Pan, Peter 10/1/ /31/ /5/ /2/2011 Yes Yes Finished Pan, Peter Lin, Eason 10/1/ /31/ /7/ /29/2011 Yes Yes Risk Control 10/17/12 Page 51 of 142

52 Validation No. Measure Status Responsible Planning Actual Values Effort Implementation Supervision Begin End Begin End Planned Is RC-022 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter RC-023 The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 25 C 48 hr RC-024 The intensity of visible light from monitor can be controlled by the user. The highest intensity achievable cannot produce detrimental biological effects. RC-025 The internal wirings were secured in place on PCB by UL R/C non-chemical bounding component. RC-026 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS RC-027 The permissible environmental conditions for transport and storage were marked on the outside of the packaging. Release Finished Wu, Allen Lin, Eason 10/1/ /31/ /7/ /30/2011 Yes Yes Finished Lin, Mac Pan, Peter 10/1/ /31/ /13/ /22/2011 Yes Yes Finished Pan, Peter Wu, Allen 10/1/ /31/ /13/ /1/2011 Yes Yes Finished Wu, Allen Lin, Eason 10/1/ /31/ /14/ /28/2011 Yes Yes Finished Lin, Mac Pan, Peter 10/1/ /31/ /13/ /2/2011 Yes Yes Finished Pan, Peter Wu, Allen 10/1/ /31/ /6/ /5/2011 Yes Yes Risk Control 10/17/12 Page 52 of 142

53 Validation No. Measure Status Responsible Planning Actual Values Effort Implementation Supervision Begin End Begin End Planned Is RC-028 The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure. RC-029 The suitable enclosure shall be provided RC-030 They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard; RC-031 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. RC-032 Where there is no relevant IEC or ISO standard, the requirements of IEC , 3rd Ed. were applied. Release Finished Wu, Allen Lin, Eason 10/1/ /31/ /13/ /16/2011 Yes Yes Finished Lin, Mac Pan, Peter 10/1/ /31/ /12/ /24/2011 Yes Yes Finished Pan, Peter Lin, Eason 10/1/ /31/ /13/ /10/2011 Yes Yes Finished Wu, Allen Lin, Eason 10/1/ /31/ /14/ /30/2011 Yes Yes Finished Lin, Mac Pan, Peter 10/1/ /31/ /4/ /30/2011 Yes Yes Risk Control 10/17/12 Page 53 of 142

54 Validation No. Measure Status Responsible Planning Actual Values Effort Implementation Supervision Begin End Begin End Planned Is RC-033 Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer s recommendations, and unintentional charging, are prevented. Release Finished Wu, Allen Pan, Peter 10/1/ /31/ /6/ /17/2011 Yes Yes Risk Control 10/17/12 Page 54 of 142

55 Release Protocol of Measures Project: , ONYX-15/17/1921DT Version: 1.02 Measure Number: Measure Text: Measure Status: RC-001 All components, including wiring shall be used in accordance with their specified ratings. Finished Responsible: Implementation: Lin, Eason Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/5/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: All components, including wiring shall be used in accordance with their specified ratings. Where safety is involved, components shall comply either with the requirements of IEC or with the safety aspects of the relevant IEC component standards. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. 10/17/12 Page 55 of 142

56 Procedure for Evidence of Efficency of Measures: Evaluation and testing of components shall be conducted as follows: - a component that has been demonstrated to comply with a standard harmonized with the relevant IEC component standard shall be checked for correct application and use in accordance with its rating. It shall be subjected to the applicable tests of IEC as part of the equipment with the exception of those tests which are part of the relevant IEC component standard; - a component that has not been demonstrated to comply with a relevant standard as above shall be checked for correct application and use in accordance with its specified rating. It shall be subjected to the applicable tests of IEC , as part of the equipment, and to the applicable tests of the component standard, under the conditions occurring in the equipment; - where no relevant IEC component standard exists, or where components are used in circuits not in accordance with their specified ratings, the components shall be tested under the conditions occurring in the equipment. The number of samples required for test is, in general, the same as required by an equivalent standard. QD2-001, QD2-004, QD2-005 Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: QD2-001, QD2-004, QD2-005 Procedure of Verification: QD2-001, QD2-004, QD2-005 Limits of Acceptance for Verification: QD2-001, QD2-004, QD2-005 Procedure of Validation: QD2-001, QD2-004, QD2-005 Limits of Acceptance for Validation: QD2-001, QD2-004, QD /17/12 Page 56 of 142

57 Measure Number: Measure Text: Measure Status: 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 bounding compound. Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Release Protocol of Measures Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/3/2011 End: 11/28/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in place by UL R/C non-chemical bounding compound. Conductors shall be provided with a means (for example, barriers or fixing), or be so terminated, that they and their terminators (for example, ring terminals and flat quick-connect terminals) cannot, in normal use, become so displaced that CLEARANCES or CREEPAGE DISTANCES are reduced to less than the values specified in IEC Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. 10/17/12 Page 57 of 142

58 Procedure for Evidence of Efficency of Measures: Having used the unjointed probe, which was in the shape of the standard test finger and which incorporated a force gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds. QD2-001, QM2-011 Limits of Acceptance for Procedure of Evidence: During the application of the test force, clearances behind earthed or unearthed conductive accessable parts were not reduced to a level that would result in an energy hazard. QD2-001, QM2-011 Release Protocol of Measures Procedure of Verification: See above QD2-001, QM2-011 Limits of Acceptance for Verification: See above QD2-001, QM2-011 Procedure of Validation: See above QD2-001, QM2-011 Limits of Acceptance for Validation: See above QD2-001, QM /17/12 Page 58 of 142

59 Measure Number: Measure Text: Measure Status: RC-003 All wirings are tied together by cable tie to prevent accidental detachment Finished Responsible: Implementation: Pan, Peter Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/12/2011 End: 11/24/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Tied together by cable tie. Conductors shall be provided with a means (for example, barriers or fixing), or be so terminated, that they and their terminators (for example, ring terminals and flat quick-connect terminals) cannot, in normal use, become so displaced that CLEARANCES or CREEPAGE DISTANCES are reduced to less than the values specified in IEC Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: Electromagnetic energy Wirings and connectors of Panel PC Monitor supply is not secured or insulated that accidental detachment can result in a HAZARDOUS SITUATION. Having used the unjointed probe, which was in the shape of the standard test finger and which incorporated a force gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds. QD2-001, QM /17/12 Page 59 of 142

60 Limits of Acceptance for Procedure of Evidence: During the application of the test force, clearances behind earthed or unearthed conductive accessable parts were not reduced to a level that would result in an energy hazard. QD2-001, QM2-011 Procedure of Verification: See above QD2-001, QM2-011 Release Protocol of Measures Limits of Acceptance for Verification: See above QD2-001, QM2-011 Procedure of Validation: See above QD2-001, QM2-011 Limits of Acceptance for Validation: See above QD2-001, QM /17/12 Page 60 of 142

61 Measure Number: Measure Text: Measure Status: RC-004 Ball pressure test - according to IEC , Clause , b) requirements Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/7/2011 End: 11/22/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Compliance is checked by subjecting the part to the ballpressure test according to IEC and IEC , Clause , b) Thermoplastic parts on which parts at HAZARDOUS VOLTAGE are directly mounted shall be resistant to abnormal heat. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen 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. 10/17/12 Page 61 of 142

62 Procedure for Evidence of Efficency of Measures: A sample of each external part of insulating material indicated in the table was tested using the test apparatus shown in Fig. 21 of IEC , 3rd Edition. (In this apparatus, a steel ball of 5 mm diameter exerts a force of 20 N when pressed against a surface). The apparatus and a fire (or sand) brick were placed in an air-circulating oven. Once the apparatus and brick attained the oven temperature, the sample was placed in the oven on top of the brick. The steel ball was then positioned such that the apparatus was balanced on the surface of the sample. After 1 h, it was removed and the diameter of the impression made by the ball was measured. The specified oven temperature was the higher of the following: a. the sum of the specified ambient and the temperature rise of relevant part during the Temperature Test; AND b. 75 C ± 2 C (test per Clause a), OR 125 C ± 2 C (test per Clause b) IEC , 3rd Edition, Clause Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: The results were less 2 mm. Cracks were not visible to the naked eye. IEC , 3rd Edition, Clause Procedure of Verification: IEC , 3rd Edition, Clause Limits of Acceptance for Verification: IEC , 3rd Edition, Clause Procedure of Validation: IEC , 3rd Edition, Clause Limits of Acceptance for Validation: IEC , 3rd Edition, Clause /17/12 Page 62 of 142

63 Measure Number: Measure Text: Measure Status: RC-005 Compliance with the mechanical strength tests for ENCLOSURES (see IEC , Clause 15.3) Finished Responsible: Implementation: Pan, Peter Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/30/2011 Release Protocol of Measures Actual Values: Begin: 10/12/2011 End: 11/24/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The suitable plastic enclosure is provided. The monitor or its parts shall have adequate mechanical strength and shall not result in an unacceptable RISK due to moulding stress or when subjected to mechanical stress caused by pushing, impact, dropping, and rough handling. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Thermal Energy Procedure for Evidence of Efficency of Measures: ENCLOSURES have no the strength and rigidity necessary to avoid a fire. Compliance is checked by application of the tests in Table 28. The tests are not applied to handles, levers, knobs, the face of cathode ray tubes (see 9.5.2), or to transparent or translucent covers of indicating or measuring devices unless with the handle, lever, knob, or cover removed there is an unacceptable RISK of electric shock. IEC , Clause /17/12 Page 63 of 142

64 Limits of Acceptance for Procedure of Evidence: There was no cracking of the enclosure. There were no live parts that became accessible. IEC , Clause 15.3 Procedure of Verification: Force (15.3.2) - A sample of the unit was subjected to inward directed force of 250 N plus or minus 10 N for a period of 5 seconds applied to different parts of the enclosure via a test tool providing contact over a circular plane surface 30 mm in diameter as indicated in Table Note: not applied to the bottom of a product having a mass of greater than 18 kg. Impact (15.3.3) - The impact resistance of an enclosure was tested by application of an impact conveyed via a solid steel 50mm (approx) ball of mass 500 g plus or minus 25 g, fall freely from 1.3 meter height. The unit was rigidly supported and the impact was applied to the locations indicated in Table IEC , Clause 15.3 Release Protocol of Measures Limits of Acceptance for Verification: IEC , Clause 15.3 Procedure of Validation: IEC , Clause 15.3 Limits of Acceptance for Validation: IEC , Clause /17/12 Page 64 of 142

65 Measure Number: Measure Text: Measure Status: RC-006 Indicated by an adjacent indicator light Finished Responsible: Implementation: Pan, Peter Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/11/2011 End: 12/1/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The colours of indicator lights and their meanings shall comply with Table 2 of IEC It is important for an OPERATOR and SERVICE PERSONNEL to be able to determine the functional status of ME EQUIPMENT. In NORMAL USE, the OPERATOR needs to be able to distinguish between ME EQUIPMENT in stand-by and ME EQUIPMENT in a fully functional state. Functions Hazards Causes User control and indicator Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Operational Switches used to control power to PC or its parts, including switches, did not have their "on" and "off" positions Procedure for Evidence of Efficency of Measures: QD2-001, QM2-011 IEC , Clause and /17/12 Page 65 of 142

66 Limits of Acceptance for Procedure of Evidence: QD2-001, QM2-011 IEC , Clause and Procedure of Verification: QD2-001, QM2-011 IEC , Clause and Release Protocol of Measures Limits of Acceptance for Verification: QD2-001, QM2-011 IEC , Clause and Procedure of Validation: QD2-001, QM2-011 IEC , Clause and Limits of Acceptance for Validation: QD2-001, QM2-011 IEC , Clause and /17/12 Page 66 of 142

67 Measure Number: Measure Text: Measure Status: RC-007 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 Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Release Protocol of Measures Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/11/2011 End: 12/2/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The internal wirings were secured in place on PCB by UL R/C non-chemical bounding component. Wireways shall be smooth and free from sharp edges. Wires shall be protected so that they do not come into contact with burrs, cooling fins, moving parts, etc., which could cause damage to the insulation of conductors. Holes in metal, through which insulated wires pass, shall have smooth well-rounded surfaces or shall be provided with bushings. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen 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. 10/17/12 Page 67 of 142

68 Procedure for Evidence of Efficency of Measures: QD2-001, QD2-010, QM2-011, QD2-009 QQ1-001 Limits of Acceptance for Procedure of Evidence: QD2-001, QD2-010, QM2-011, QD2-009 QQ1-001 Release Protocol of Measures Procedure of Verification: QD2-001, QD2-010, QM2-011, QD2-009 QQ1-001 Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011, QD2-009 QQ1-001 Procedure of Validation: QD2-001, QD2-010, QM2-011, QD2-009 QQ1-001 Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011, QD2-009 QQ /17/12 Page 68 of 142

69 Measure Number: Measure Text: Measure Status: RC-008 Marked with symbols IEC Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/4/2011 End: 11/25/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: - marked with symbols IEC 60417, - Indicated by an adjacent indicator light Comment: Switches used to control power to ME EQUIPMENT or its parts, including mains switches, shall have their "on" and "off" positions Functions Hazards Causes User control and indicator Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Operational Procedure for Evidence of Efficency of Measures: Switches used to control power to PC or its parts, including switches, did not have their "on" and "off" positions Compliance with the requirements is checked by inspection and by application of the tests and criteria in and of IEC IEC , Clause 7.4.1, 7.4.2, and /17/12 Page 69 of 142

70 Limits of Acceptance for Procedure of Evidence: The colours of indicator lights and their meanings shall comply with Table 2 of IEC IEC , Clause 7.4.1, 7.4.2, and Procedure of Verification: IEC , Clause 7.4.1, 7.4.2, and Release Protocol of Measures Limits of Acceptance for Verification: IEC , Clause 7.4.1, 7.4.2, and Procedure of Validation: IEC , Clause 7.4.1, 7.4.2, and Limits of Acceptance for Validation: IEC , Clause 7.4.1, 7.4.2, and /17/12 Page 70 of 142

71 Measure Number: Measure Text: Measure Status: RC-009 Meet IEC Clause and Table 21 requirements. Finished Responsible: Implementation: Pan, Peter Supervision: Wu, Allen Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/12/2011 End: 11/18/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The construction of the support, suspension or actuation system shall be designed based upon Table 21 of IEC and the TOTAL LOAD. Where ME EQUIPMENT parts are designed to support loads, then a mechanical fault could not constitute an unacceptable RISK. Functions Hazards Causes Enclosure Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Mechanical energy Procedure for Evidence of Efficency of Measures: Suspended masses The suspension system parts indicated in the table below (chain, cable, band, spring, belt, jack screw nut, pneumatic, hydraulic hoses, or the like) employed to support a load, were defeated by convenient means (cut or removed suddenly), thereby causing the maximum normal load to fall from the most adverse position permitted by the construction of the equipment and to activate a safety device. The travel after such defeat was measured as well as other observed results that could affect the risk of possible injury. IEC , Clause /17/12 Page 71 of 142

72 Limits of Acceptance for Procedure of Evidence: There was no evidence of damage to a safety catch or other restraining means that would affect its ability to perform its intended function. IEC , Clause Procedure of Verification: IEC , Clause Release Protocol of Measures Limits of Acceptance for Verification: IEC , Clause Procedure of Validation: IEC , Clause Limits of Acceptance for Validation: IEC , Clause /17/12 Page 72 of 142

73 Measure Number: Measure Text: Measure Status: RC-010 Meet IEC , Clause 7 requirements. Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/5/2011 End: 12/1/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: For Ward Terminal to be well designed, its markings and ACCOMPANYING DOCUMENTS should be clear, consistent, and help to reduce potential use erro Additional markings are permitted, provided that they do not give rise to misunderstanding. Where symbols are used, they shall conform to ISO 7000 or IEC where appropriate symbols exist. Sufficient information shall be provided to the USER concerning any condition necessary to ensure that, when used as prescribed by the manufacturer, the equipment is unlikely to present a hazard within the meaning of IEC Functions Hazards Causes Information Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Labeling Procedure for Evidence of Efficency of Measures: Incomplete instructions for use Each specified marking was rubbed by hand, without undue pressure, first for 15 s with a cloth rag soaked with distilled water, then for 15 s with a cloth rag soaked in methylated spirit at ambient temperature, and then for 15 s with a cloth rag soaked with isopropyl alcohol. IEC , 3rd Edition, Clause 7.1.3b 10/17/12 Page 73 of 142

74 Limits of Acceptance for Procedure of Evidence: The markings worked and did not curl at the edges. The markings were clearly readable. IEC , 3rd Edition, Clause 7.1.3b Procedure of Verification: IEC , 3rd Edition, Clause 7.1.3b Release Protocol of Measures Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 7.1.3b Procedure of Validation: IEC , 3rd Edition, Clause 7.1.3b Limits of Acceptance for Validation: IEC , 3rd Edition, Clause 7.1.3b 10/17/12 Page 74 of 142

75 Measure Number: Measure Text: Measure Status: RC-011 Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/10/2011 End: 11/18/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Meet IEC , Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements The electrical isolation providing protection against electric shock shall be of such quality that currents flowing through it are limited to the values specified in IEC , Clause Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Too high leakage current, causing a death or serious injury to a patient. 10/17/12 Page 75 of 142

76 Procedure for Evidence of Efficency of Measures: Testing was conducted after thermal stabilization and was repeated Humidity Preconditioning. Following the humidity conditioning (see Humidity Conditioning Test for further details), the equipment was located in an environment with a temperature approximately equal to t where t is the temperature of the humidity cabinet and a relative humidity between 45% and 65% and was conducted 1 hour after the end of the humidity preconditioning treatment. In Normal Condition and in the specified Single Fault Conditions (IEC , 3rd Ed., 8.7.2) With the Equipment energized in stand-by and fully operating and with any switch in the Mains Part in any position. With the equipment connected to a supply source with the highest rated supply frequency and 110% of the highest rated Mains Voltage as indicated in the RESULTS table. IEC , 3rd Edition, Clause 8.7 Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: IEC , 3rd Ed. Table 3 and Table 4 IEC , 3rd Edition, Clause 8.7 Procedure of Verification: IEC , 3rd Edition, Clause 8.7 Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 8.7 Procedure of Validation: IEC , 3rd Edition, Clause 8.7 Limits of Acceptance for Validation: IEC , 3rd Edition, Clause /17/12 Page 76 of 142

77 Measure Number: Measure Text: Measure Status: RC-012 Meet IEC , Clause requiremets. Finished Responsible: Implementation: Pan, Peter Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/5/2011 End: 11/29/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The equipment did not overbalance. PC or its parts shall not overbalance when placed in any transport position of NORMAL USE on a plane inclined at an angle of 10 from the horizontal plane. Functions Hazards Causes Enclosure Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Mechanical energy Procedure for Evidence of Efficency of Measures: Falling 10 Incline ( ) - The equipment was placed in any normal use transport position on a plane inclined 10 from the horizontal. Prior to testing the equipment was prepared as noted in accordance with Clause IEC , 3rd Edition, Clause Limits of Acceptance for Procedure of Evidence: The equipment did not overbalance. IEC , 3rd Edition, Clause /17/12 Page 77 of 142

78 Procedure of Verification: IEC , 3rd Edition, Clause Limits of Acceptance for Verification: IEC , 3rd Edition, Clause Release Protocol of Measures Procedure of Validation: IEC , 3rd Edition, Clause Limits of Acceptance for Validation: IEC , 3rd Edition, Clause /17/12 Page 78 of 142

79 Measure Number: Measure Text: Measure Status: RC-013 Meet IEC requirements Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/11/2011 End: 11/23/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Meet IEC requirements Electromagnetic emission requirements are necessary for the protection of: - safety services (e.g. police, fire and ambulance communications); - other ME EQUIPMENT and ME SYSTEMS; - non-me EQUIPMENT (e.g. computers); - telecommunications (e.g. radio/tv, telephone, radionavigation). Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Electromagnetic compatibility of PC. Procedure for Evidence of Efficency of Measures: IEC EMC test report 10/17/12 Page 79 of 142

80 Limits of Acceptance for Procedure of Evidence: EMC test report Procedure of Verification: EMC test report Release Protocol of Measures Limits of Acceptance for Verification: EMC test report Procedure of Validation: EMC test report Limits of Acceptance for Validation: EMC test report 10/17/12 Page 80 of 142

81 Measure Number: Measure Text: Measure Status: RC-014 Meet IEC , Annex NAD Acoustic tests requirements Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/3/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The equipment having acoustic outputs at communication receivers and similar devices used for voice elecommunication, regardless of transmission medium (e.g., TELECOMMUNICATION NETWORK, CABLE DISTRIBUTION NETWORK, wireless network), shall demonstrate that the equipment complies with the appropriate acoustics requirements related to short duration impulses and long duration disturbances as described in NAD.3 and NAD.4. of IEC These requirements apply to equipment that is intended to be connected directly or indirectly to a ELECOMMUNICATION NETWORK or CABLE DISTRIBUTION SYSTEM or other transmission medium, and that contains an earpiece or receiver that is held against or in the ear. The effect on human hearing of impulsive noise or of disturbances that are less than 0,5 s in duration shall be evaluated under NAD.3. The effect of longer disturbances, such as those that might be produced during tone-type dialing, shall be evaluated under NAD.4. Functions Hazards Causes Signal output Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Acoustic energy (sound) earphone 10/17/12 Page 81 of 142

82 Procedure for Evidence of Efficency of Measures: The headset of the equipment was placed according to the general setup page and operating for the exchange of calls (such as talking state with the handset raised). A short duration peak applied to the tip and ring by applying digital codes to the receive input of the device. This may be performed by using an analog test set to drive a reference codec, or by use of a digital code generator. The analog level shall be set to switch between the maximum positive and the maximum negative values for the reference codec. The switching rate shall be through the range of 100 Hz to 3400 Hz for narrow band and 100 Hz to 6800 Hz for wideband. The duration of the ON codes shall be a number of complete cycles approximating but exceeding 500 ms. The ON codes must be followed by a quiet interval of at least 500 ms before repeating the codes. For equipment not intended to be directly connected to the Telecommunication Network, such as equipment used with specialized PBX or Key systems and the like, the short duration peak was applied between the tip and ring terminals of the system. The equipment was checked for self generated acoustic impulses such as those produced by operation of the hook switch or by dialing. IEC , Annex NAD Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: The peak acoustic pressure did not exceed 136 db ERP IEC , Annex NAD Procedure of Verification: IEC , Annex NAD Limits of Acceptance for Verification: IEC , Annex NAD Procedure of Validation: IEC , Annex NAD Limits of Acceptance for Validation: IEC , Annex NAD 10/17/12 Page 82 of 142

83 Measure Number: Measure Text: Measure Status: RC-015 PC marked the name or trademark of Onyx with model no. Finished Responsible: Implementation: Pan, Peter Supervision: Wu, Allen Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/3/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Marked the name or trademark and with model no. Identification Functions Hazards Causes Information Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Labeling PC did not marke with the name or trademark of Onyx and with a MODEL OR TYPE REFERENCE Procedure for Evidence of Efficency of Measures: Meet IEC rd Ed. Clause requirements IEC rd Ed. Clause Limits of Acceptance for Procedure of Evidence: Meet IEC rd Ed. Clause requirements IEC rd Ed. Clause /17/12 Page 83 of 142

84 Procedure of Verification: Meet IEC rd Ed. Clause requirements IEC rd Ed. Clause Limits of Acceptance for Verification: Meet IEC rd Ed. Clause requirements IEC rd Ed. Clause Release Protocol of Measures Procedure of Validation: Meet IEC rd Ed. Clause requirements IEC rd Ed. Clause Limits of Acceptance for Validation: Meet IEC rd Ed. Clause requirements IEC rd Ed. Clause /17/12 Page 84 of 142

85 Measure Number: Measure Text: Measure Status: RC-016 Provided a connector that has special housing to prevent a connection with the wrong polarity is made Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/5/2011 End: 11/24/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Provided a connector that has special housing to prevent a connection with the wrong polarity is made. No HAZARDOUS SITUATION, other than absence of ESSENTIAL PERFORMANCE, shall develop when a connection with the wrong polarity is made. Functions Hazards Causes Connection to an external d.c. power source Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Thermal Energy When a connection with the wrong polarity is made Procedure for Evidence of Efficency of Measures: QD2-001, QD2-009 and QD2-010 QQ1-001 Limits of Acceptance for Procedure of Evidence: QD2-001, QD2-009 and QD2-010 QQ /17/12 Page 85 of 142

86 Procedure of Verification: QD2-001, QD2-009 and QD2-010 QQ1-001 Limits of Acceptance for Verification: QD2-001, QD2-009 and QD2-010 QQ1-001 Release Protocol of Measures Procedure of Validation: QD2-001, QD2-009 and QD2-010 QQ1-001 Limits of Acceptance for Validation: QD2-001, QD2-009 and QD2-010 QQ /17/12 Page 86 of 142

87 Measure Number: Measure Text: Measure Status: RC-017 Rounding of sharp edges and corners. Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/12/2011 End: 11/28/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 10/17/2012 Release: Released: Released by: Lin, Mac Release on: 10/17/2012 Decided Individual Measures: Comment: Rounding of sharp edge and corner. Rough surfaces, sharp corners and edges of Ward Terminal that could result in an unacceptable RISK. Functions Hazards Causes Enclosure Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Mechanical energy Procedure for Evidence of Efficency of Measures: Sharp edges and corners Accessible edges or corners of the unit, except those required for proper functioning of the equipment, were subjected to this test. Surfaces described below were judged using the Sharp Edge Tester. The curved face of the tester head was covered with three layers of tape: bottom layer 1.6 mm black vinyl foam tape; middle layer 0.8 mm white vinyl foam tape; outer layer 0.08 mm (3 mil) Teflon tape skived. The tape-covered head of the tester was positioned on the edge to check for sharpness. The arm of the tester was calibrated so that a 6.7 N force was present at the center of the head when the arm was between stops. This force was applied on the sharp edge. The tester was immediately moved 50.5 mm along the edge and then back to its starting position without removing the tester so that total distance traveled was 101 mm. The time of travel was no longer than 5 seconds nor less than 2 seconds. IEC , Clause /17/12 Page 87 of 142

88 Limits of Acceptance for Procedure of Evidence: The edges and corners were considered to be rounded and smooth. IEC , Clause 9.3 Procedure of Verification: IEC , Clause 9.3 Release Protocol of Measures Limits of Acceptance for Verification: IEC , Clause 9.3 Procedure of Validation: IEC , Clause 9.3 Limits of Acceptance for Validation: IEC , Clause /17/12 Page 88 of 142

89 Measure Number: Measure Text: Measure Status: RC-018 Said components were secured in place on pcb by UL Recognized nonchemical bounding compound. Finished Responsible: Implementation: Pan, Peter Supervision: Wu, Allen Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/12/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Said components were secured in place on pcb by UL Recognized non-chemical bounding compound. Components of power supply, unwanted movement of which could result in an unacceptable RISK, shall be mounted securely to prevent such movement. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: Electromagnetic energy Components of PC, unwanted movement of which could result in an unacceptableb RISK, is not mounted securely to prevent such movement. Having used the unjointed probe, which was in the shape of the standard test finger and which incorporated a force gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds. QD2-001, QD2-010, QM2-011, QD /17/12 Page 89 of 142

90 Limits of Acceptance for Procedure of Evidence: During the application of the test force, clearances behind earthed or unearthed conductive accessible parts were not reduced to a level that would result in an energy hazard. QD2-001, QD2-010, QM2-011, QD2-009 Procedure of Verification: QD2-001, QD2-010, QM2-011, QD2-009 Release Protocol of Measures Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011, QD2-009 Procedure of Validation: QD2-001, QD2-010, QM2-011, QD2-009 Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011, QD /17/12 Page 90 of 142

91 Measure Number: Measure Text: Measure Status: RC-019 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). Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Release Protocol of Measures Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/12/2011 End: 11/24/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: 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). The resistance to heat shall retained by all types of insulation, including insulating partition walls, during the EXPECTED SERVICE LIFE of the PC. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen 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. 10/17/12 Page 91 of 142

92 Procedure for Evidence of Efficency of Measures: A sample of each external part of insulating material indicated in the table was tested using the test apparatus shown in Fig. 21 of IEC , 3rd Edition. (In this apparatus, a steel ball of 5 mm diameter exerts a force of 20 N when pressed against a surface). The apparatus and a fire (or sand) brick were placed in an air-circulating oven. Once the apparatus and brick attained the oven temperature, the sample was placed in the oven on top of the brick. The steel ball was then positioned such that the apparatus was balanced on the surface of the sample. After 1 h, it was removed and the diameter of the impression made by the ball was measured. The specified oven temperature was the higher of the following: a. the sum of the specified ambient and the temperature rise of relevant part during the Temperature Test; AND b. 75 C ± 2 C (test per Clause a), OR 125 C ± 2 C (test per Clause b) IEC , 3rd Edition, Clause Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: The results were less 2 mm. Cracks were not visible to the naked eye. IEC , 3rd Edition, Clause Procedure of Verification: IEC , 3rd Edition, Clause Limits of Acceptance for Verification: IEC , 3rd Edition, Clause Procedure of Validation: IEC , 3rd Edition, Clause Limits of Acceptance for Validation: IEC , 3rd Edition, Clause /17/12 Page 92 of 142

93 Measure Number: Measure Text: Measure Status: RC-020 Supplied by SELV power adapter and DC/AC inverter meet LCC requirements. Finished Responsible: Implementation: Lin, Mac Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/5/2011 End: 12/2/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Supplied by SELV power adapter and DC/AC inverter meet LCC requirements ACCESSIBLE PARTS (output connector) shall not exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: Electromagnetic energy ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. A short of the operational or basic insulation indicated in the table was made. The voltage present at the accessible parts/circuitry was measured, recorded and compared to 42.4 V pk ac and 60 V dc. QD2-001, QD2-010, QM2-011 and QD /17/12 Page 93 of 142

94 Limits of Acceptance for Procedure of Evidence: The voltage did not exceed 42.4 V peak ac or 60 V dc. QD2-001, QD2-010, QM2-011 and QD2-009 Procedure of Verification: QD2-001, QD2-010, QM2-011 and QD2-009 Release Protocol of Measures Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011 and QD2-009 Procedure of Validation: QD2-001, QD2-010, QM2-011 and QD2-009 Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011 and QD /17/12 Page 94 of 142

95 Measure Number: Measure Text: Measure Status: RC-021 The equipment complied with the requirements of IEC , Clause Finished Responsible: Implementation: Pan, Peter Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/7/2011 End: 11/29/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The equipment complied ]with the requirements of IEC , Clause The monitor and their parts, including ACCESSORIES, shall be capable of withstanding, without damage or deterioration of safety provisions, the cleaning or disinfection PROCESSES specified in the instructions for use. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: Electromagnetic energy Cleaning The equipment was cleaned/disinfected as specified in the instructions for use. After an adequate cooling and drying period, the unit was subjected to Leakage Current and Dielectric Voltage Withstand Tests as noted below. The effect of multiple cleanings/disinfections over the expected service life of the equipment was considered. IEC , 3rd Edition, Clause 11.6) 10/17/12 Page 95 of 142

96 Limits of Acceptance for Procedure of Evidence: The equipment complied with the requirements of IEC , Clause The equipment did not show signs of wetting of uninsulated live parts. There were no dielectric breakdown and/or leakage current test non-compliances. IEC , 3rd Edition, Clause 11.6) Procedure of Verification: IEC , 3rd Edition, Clause 11.6) Release Protocol of Measures Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 11.6) Procedure of Validation: IEC , 3rd Edition, Clause 11.6) Limits of Acceptance for Validation: IEC , 3rd Edition, Clause 11.6) 10/17/12 Page 96 of 142

97 Measure Number: Measure Text: Measure Status: RC-022 The HAZARDOUS SITUATIONS in IEC , Clause to (inclusive) do not occur in the PC and power adapter Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/7/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Meet clause 13 of IEC , 3rd Ed. requirements. HAZARDOUS SITUATIONS and fault conditions. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Short circuit of any one insulation that complies with the requirements for one MEANS OF PROTECTION as specified in IEC , Clause /17/12 Page 97 of 142

98 Procedure for Evidence of Efficency of Measures: The device was operated until ultimate results were obtained. All final results were recorded. If required, final temperatures were measured and recorded. The normal conditions were also applied in the least favorable combination. - The unit was positioned in the same way as for the Temperature Test - Failure of Components - The components were short circuited or opened, one at a time. - The load current was then increased by 5 % with the supply voltage maintained at its original value. When steady thermal conditions were again established, the load was again increased. These steps were continued until the overload protector operated or until thermal stability was reached. - For each fault condition, the Dielectric Voltage Withstand Test was repeated immediately following the conclusion of the test. IEC , 3rd Edition, Clause 13 Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: 1. Self-resetting thermal cutouts did not operate. 2. The setting of any thermostat, thermal cutout or overload release did not change due to heating, vibration or other causes. 3. The measured temperatures did not exceed those allowable. 4. In each case the hazardous situations described in Clauses to of IEC , 3rd ED. did not occur. 5. See Table 11 of IEC , 3rd ED. for Temperatures obtained during the indicated Abnormal Operation tests. IEC , 3rd Edition, Clause 13 Procedure of Verification: IEC , 3rd Edition, Clause 13 Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 13 Procedure of Validation: IEC , 3rd Edition, Clause 13 Limits of Acceptance for Validation: IEC , 3rd Edition, Clause 13 10/17/12 Page 98 of 142

99 Measure Number: Measure Text: Measure Status: RC-023 The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 25 C 48 hr Finished Responsible: Implementation: Lin, Mac Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/13/2011 End: 11/22/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 25 C 48 hr Storage (humidity preconditioning treatment) Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Storage (humidity preconditioning treatment) 10/17/12 Page 99 of 142

100 Procedure for Evidence of Efficency of Measures: PC or its parts shall be set up complete. Covers used during transport and storage are detached. This treatment is applied only to those power supply parts which are influenced by the climatic conditions that are simulated by the test. Parts that can be detached without the use of a TOOL are detached but are treated simultaneously with the major part. ACCESS COVERS that can be opened or detached without the use of a TOOL are opened and detached. A humidity chamber having relative humidity of 90 to 96 % was set to any convenient Temperature T between 20 and 32 C. The unit, before being placed in the chamber was brought to a temperature between T and T + 4 C and kept at this temperature a minimum of 4 h. Then the sample was placed in the humidity chamber and kept there for the time specified in Table 5.7 of IEC , 3rd Ed. (minimum 48 h). During this time the temperature of the air in the chamber was maintained at T ± 2 C. Immediately after the treatment and while still in the chamber, the sample was subjected to Dielectric Voltage Withstand Test. Then the unit was removed from the chamber, placed in normal environment (temperature approximately T, humidity 45-65%). Immediately following the humidity preconditioning treatment, the power supply was subjected to a repeat of the dielectric withstand and leakage current tests. IEC , 3rd Edition, Clause 5.7 Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: There was no dielectric breakdown IEC , 3rd Edition, Clause 5.7 Procedure of Verification: IEC , 3rd Edition, Clause 5.7 Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 5.7 Procedure of Validation: IEC , 3rd Edition, Clause 5.7 Limits of Acceptance for Validation: IEC , 3rd Edition, Clause /17/12 Page 100 of 142

101 Measure Number: Measure Text: Measure Status: RC-024 The intensity of visible light from monitor can be controlled by the user. The highest intensity achievable cannot produce detrimental biological effects. Finished Responsible: Implementation: Pan, Peter Supervision: Wu, Allen Release Protocol of Measures Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/13/2011 End: 12/1/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Computer monitors emit electromagnetic radiation in a broad range of frequencies. Although the electromagnetic radiation field intensities are measurable, they are not substantially above background office levels. The effect on health from the use of monitors has been studied for many years, and the research continues. The present consensus of experts is that there are no data to suggest a health risk from exposure to the electromagnetic fields associated with the use of monitors. PC users have expressed concerns about the possible health effects from the electromagnetic radiation that monitors produce. The concerns generally center around adverse pregnancy outcome (spontaneous abortion or birth defects). It has been postulated that these effects are due to electromagnetic radiation exposure from monitors. The biological effects of exposure to VLF and ELF fields similar to those produced by monitors have been studied for many years, and the research continues today. Cancer and reproductive outcomes are the topics studied most intensively. Current available scientific information does not identify a health risk from exposure to the electromagnetic fields associated with the use of computer monitors. Functions Hazards Causes Display Radiation energy Visible Light 10/17/12 Page 101 of 142

102 Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: Procedure of Verification: Limits of Acceptance for Verification: Procedure of Validation: Limits of Acceptance for Validation: 10/17/12 Page 102 of 142

103 Measure Number: Measure Text: Measure Status: RC-025 The internal wirings were secured in place on PCB by UL R/C nonchemical bounding component. Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/14/2011 End: 11/28/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The internal wirings were secured in place on PCB by UL R/C non-chemical bounding component. Internal cables and wiring shall adequately protected against contact from friction at sharp corners and edges where damage to insulation could result in a HAZARDOUS SITUATION. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: 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. Having used the unjointed probe, which was in the shape of the standard test finger and which incorporated a force gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds. QD2-001, QD2-010, QM2-011 and QD /17/12 Page 103 of 142

104 Limits of Acceptance for Procedure of Evidence: During the application of the test force, clearances behind earthed or unearthed conductive accessable parts were not reduced to a level that would result in an energy hazard. QD2-001, QD2-010, QM2-011 and QD2-009 Procedure of Verification: QD2-001, QD2-010, QM2-011 and QD2-009 Release Protocol of Measures Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011 and QD2-009 Procedure of Validation: QD2-001, QD2-010, QM2-011 and QD2-009 Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011 and QD /17/12 Page 104 of 142

105 Measure Number: Measure Text: Measure Status: RC-026 The limits specified in IEC , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS Finished Responsible: Implementation: Lin, Mac Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/13/2011 End: 12/2/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The insulation that is relied upon as a MEANS OF PROTECTION, including REINFORCED INSULATION shall be subject to testing Insulation Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Procedure for Evidence of Efficency of Measures: Electromagnetic energy Short circuit of any or all insulation that does not comply with the requirements of IEC , 3rd Ed., Clause. 8.8 A short of the operational or basic insulation indicated in the table was made. The voltage present at the accessible parts/circuitry was measured, recorded and compared to 42.4 V pk ac and 60 V dc. QD2-001, QD2-010, QM2-011, QD2-009 IEC , 3rd Edition, Clause and /17/12 Page 105 of 142

106 Limits of Acceptance for Procedure of Evidence: The voltage did not exceed 42.4 V peak ac or 60 V dc. QD2-001, QD2-010, QM2-011, QD2-009 IEC , 3rd Edition, Clause and Procedure of Verification: QD2-001, QD2-010, QM2-011, QD2-009 IEC , 3rd Edition, Clause and Release Protocol of Measures Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011, QD2-009 IEC , 3rd Edition, Clause and Procedure of Validation: QD2-001, QD2-010, QM2-011, QD2-009 IEC , 3rd Edition, Clause and Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011, QD2-009 IEC , 3rd Edition, Clause and /17/12 Page 106 of 142

107 Measure Number: Measure Text: Measure Status: RC-027 The permissible environmental conditions for transport and storage were marked on the outside of the packaging. Finished Responsible: Implementation: Pan, Peter Supervision: Wu, Allen Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/6/2011 End: 12/5/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The permissible environmental conditions for transport and storage were marked on the outside of the packaging Packing Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Packing Procedure for Evidence of Efficency of Measures: QD2-001, QM2-007 QQ1-001 Limits of Acceptance for Procedure of Evidence: QD2-001, QM2-007 QQ /17/12 Page 107 of 142

108 Procedure of Verification: QD2-001, QM2-007 QQ1-001 Limits of Acceptance for Verification: QD2-001, QM2-007 QQ1-001 Release Protocol of Measures Procedure of Validation: QD2-001, QM2-007 QQ1-001 Limits of Acceptance for Validation: QD2-001, QM2-007 QQ /17/12 Page 108 of 142

109 Measure Number: Measure Text: Measure Status: RC-028 The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure. Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/13/2011 End: 11/16/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure. Transport Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Transport Procedure for Evidence of Efficency of Measures: QD2-001 and QM2-007 QQ1-001 Limits of Acceptance for Procedure of Evidence: QD2-001 and QM2-007 QQ /17/12 Page 109 of 142

110 Procedure of Verification: QD2-001 and QM2-007 QQ1-001 Limits of Acceptance for Verification: QD2-001 and QM2-007 QQ1-001 Release Protocol of Measures Procedure of Validation: QD2-001 and QM2-007 QQ1-001 Limits of Acceptance for Validation: QD2-001 and QM2-007 QQ /17/12 Page 110 of 142

111 Measure Number: Measure Text: Measure Status: RC-029 The suitable enclosure shall be provided Finished Responsible: Implementation: Lin, Mac Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/12/2011 End: 11/24/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Compliance is checked by the mechanical strength tests for ENCLOSURES (see 15.3). ENCLOSURES shall have the strength and rigidity necessary to avoid a fire that could occur as a result of a total or partial collapse caused by reasonably foreseeable misuse. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy Internal parts, other than contacts of plugs, connectors and socket-outlets, that can be touched by the test pin shown in IEC , Figure 8. 10/17/12 Page 111 of 142

112 Procedure for Evidence of Efficency of Measures: - Force (15.3.2) - A sample of the unit was subjected to inward directed force of 250 N plus or minus 10 N for a period of 5 seconds applied to different parts of the enclosure via a test tool providing contact over a circular plane surface 30 mm in diameter as indicated in Table Note: not applied to the bottom of a product having a mass of greater than 18 kg. - Impact (15.3.3) - The impact resistance of an enclosure was tested by application of an impact conveyed via a solid steel 50 mm (approx) ball of mass 500 g plus or minus 25 g, fall freely from 1,3 meter height. The unit was rigidly supported and the impact was applied to the locations indicated in Table IEC , 3rd Edition, Clause 15.3 Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: There was no cracking of the enclosure. There were no live parts that became accessible IEC , 3rd Edition, Clause 15.3 Procedure of Verification: IEC , 3rd Edition, Clause 15.3 Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 15.3 Procedure of Validation: IEC , 3rd Edition, Clause 15.3 Limits of Acceptance for Validation: IEC , 3rd Edition, Clause /17/12 Page 112 of 142

113 Measure Number: Measure Text: Measure Status: RC-030 They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard; Finished Responsible: Implementation: Pan, Peter Supervision: Lin, Eason Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/13/2011 End: 11/10/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard; The reliability of components that are used as MEANS OF PROTECTION shall be assessed for the conditions of use in the monitor and power supply. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. 10/17/12 Page 113 of 142

114 Procedure for Evidence of Efficency of Measures: Evaluation and testing of components shall be conducted as follows: - a component that has been demonstrated to comply with a standard harmonized with the relevant IEC component standard shall be checked for correct application and use in accordance with its rating. It shall be subjected to the applicable tests of IEC as part of the equipment with the exception of those tests which are part of the relevant IEC component standard; - a component that has not been demonstrated to comply with a relevant standard as above shall be checked for correct application and use in accordance with its specified rating. It shall be subjected to the applicable tests of IEC , as part of the equipment, and to the applicable tests of the component standard, under the conditions occurring in the equipment; - where no relevant IEC component standard exists, or where components are used in circuits not in accordance with their specified ratings, the components shall be tested under the conditions occurring in the equipment. The number of samples required for test is, in general, the same as required by an equivalent standard. QD2-001, QD2-010, QM2-011, QD2-009 and IEC , Clause 4.8 Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: QD2-001, QD2-010, QM2-011, QD2-009 and IEC , Clause 4.8 Procedure of Verification: QD2-001, QD2-010, QM2-011, QD2-009 and IEC , Clause 4.8 Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011, QD2-009 and IEC , Clause 4.8 Procedure of Validation: QD2-001, QD2-010, QM2-011, QD2-009 and IEC , Clause 4.8 Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011, QD2-009 and IEC , Clause /17/12 Page 114 of 142

115 Measure Number: Measure Text: Measure Status: RC-031 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. Finished Responsible: Implementation: Wu, Allen Supervision: Lin, Eason Release Protocol of Measures Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/14/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 10/17/2012 Release: Released: Released by: Lin, Mac Release on: 10/17/2012 Decided Individual Measures: Comment: When PC and power supply 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. Excessive temperatures in PC and/or power supply. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Thermal Energy Procedure for Evidence of Efficency of Measures: Excessive temperatures in PC and/or power supply. The sample was placed in a test corner. The test corner consisted of two walls at right angles, and a floor, all of dull black painted plywood of 20 mm thickness. The linear dimensions of the test corner were at least 115 percent of the linear dimensions of the unit. The unit was positioned as near to the walls as possible and to the floor. The power supply is operated until THERMAL STABILITY is reached. IEC , 3rd Edition, Clause 11 10/17/12 Page 115 of 142

116 Limits of Acceptance for Procedure of Evidence: IEC , 3rd Edition, Clause 11 Procedure of Verification: IEC , 3rd Edition, Clause 11 Release Protocol of Measures Limits of Acceptance for Verification: IEC , 3rd Edition, Clause 11 Procedure of Validation: IEC , 3rd Edition, Clause 11 Limits of Acceptance for Validation: IEC , 3rd Edition, Clause 11 10/17/12 Page 116 of 142

117 Measure Number: Measure Text: Measure Status: RC-032 Where there is no relevant IEC or ISO standard, the requirements of IEC , 3rd Ed. were applied. Finished Responsible: Implementation: Lin, Mac Supervision: Pan, Peter Planning: Begin: 10/1/2011 End: 12/31/2011 Release Protocol of Measures Actual Values: Begin: 10/4/2011 End: 11/30/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/6/2011 Release: Released: Released by: Lin, Mac Release on: 12/6/2011 Decided Individual Measures: Comment: Where there is no relevant IEC or ISO standard, the requirements of IEC rd Ed. were applied. The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. Functions Hazards Causes Connect to Mains Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Electromagnetic energy The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. Procedure for Evidence of Efficency of Measures: QD2-001, QD2-010, QM2-011 and QD2-009 IEC , Clause /17/12 Page 117 of 142

118 Limits of Acceptance for Procedure of Evidence: QD2-001, QD2-010, QM2-011 and QD2-009 IEC , Clause 4.8 Procedure of Verification: QD2-001, QD2-010, QM2-011 and QD2-009 IEC , Clause 4.8 Release Protocol of Measures Limits of Acceptance for Verification: QD2-001, QD2-010, QM2-011 and QD2-009 IEC , Clause 4.8 Procedure of Validation: QD2-001, QD2-010, QM2-011 and QD2-009 IEC , Clause 4.8 Limits of Acceptance for Validation: QD2-001, QD2-010, QM2-011 and QD2-009 IEC , Clause /17/12 Page 118 of 142

119 Measure Number: Measure Text: Measure Status: RC-033 Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer s recommendations, and unintentional charging, are prevented. Finished Responsible: Implementation: Wu, Allen Supervision: Pan, Peter Release Protocol of Measures Planning: Begin: 10/1/2011 End: 12/31/2011 Actual Values: Begin: 10/6/2011 End: 11/17/2011 Effort: planned: Is: Validation: Validated: Validated by: Chen, James Validated on: 12/7/2011 Release: Released: Released by: Lin, Mac Release on: 12/7/2011 Decided Individual Measures: Comment: Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer s recommendations, and unintentional charging, are prevented. Equipment containing batteries shall be designed to reduce the risk of fire, explosion and chemical leaks under normal conditions and after a single fault in the equipment, including a fault in circuitry within the equipment battery pack. Functions Hazards Causes BIOS (Basic Input/Output System - real time clock) Implementation Team: Chen, James Lin, Eason Lin, Mac Pan, Peter Wu, Allen Mechanical energy Lithium battery explosion 10/17/12 Page 119 of 142

120 Procedure for Evidence of Efficency of Measures: The non-rechargeable battery cell was subjected to the test detailed below. The unit was connected to rated input voltage and operated at maximum normal load. The following conditions were imposed one at a time. 1) Unintentional charging of a non-rechargeable battery (pack or cell). The battery was charged while briefly subjected to the simulation of any single component failure that was likely to occur in the charging circuit and that would result in unintentional charging of the battery. To minimize testing time, the failure was chosen that causes the highest charging current. The battery was then charged for a single period of 7 h with that simulated failure in place. 2) Excessive discharging rate for any battery (pack or cell). The battery was subjected to rapid discharge by open-circuiting or short-circuiting any current-limiting or voltage-limiting components in the load circuit of the battery under test. 3) Reversing - The connections of the battery were reversed and the equipment was energized. The battery was examined for emission of flames, toxic gases, molten metal, risk of explosion. IEC , Clause and Release Protocol of Measures Limits of Acceptance for Procedure of Evidence: These tests shall not result in any of the following: - chemical leaks caused by cracking, rupturing or bursting of the battery jacket, if such leakage could adversely affect required insulation; or - spillage of liquid from any pressure relief device in the battery, unless such spillage is contained by the equipment without risk of damage to the insulation or harm to the USER; or - explosion of the battery, if such explosion could result in injury to a USER; or - emission of flame or expulsion of molten metal to the outside of the equipment ENCLOSURE. After completion of the tests, the equipment is subjected to the electric strength tests of IEC , Clause IEC , Clause and Procedure of Verification: IEC , Clause and Limits of Acceptance for Verification: IEC , Clause and Procedure of Validation: IEC , Clause and Limits of Acceptance for Validation: IEC , Clause and /17/12 Page 120 of 142

121 Evaluation After Measures Project: , ONYX-15/17/1921DT Version: 1.02 Function: F-01 Connect to Mains Hazard Cause Severity Probability Risk Area Comment 10/17/12 Page 121 of 142

122 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 Severity Probability Risk Area Serious Remote Acceptable Serious Remote Acceptable Comment Evaluation After Measures 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. Serious Remote Acceptable 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 Critical Improbable Acceptable 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 Critical Improbable Acceptable 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 Critical Improbable Acceptable C-07 All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION. Serious Improbable Acceptable C-08 The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions of use in the PC. Critical Improbable Acceptable C-09 Storage (humidity preconditioning treatment) Serious Improbable Acceptable 10/17/12 Page 122 of 142

123 Hazard Cause Severity Probability Risk Area 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. Serious Remote Acceptable Critical Improbable Acceptable Comment Evaluation After Measures C-13 The LEAKAGE CURRENTS from, to or between ACCESSIBLE PARTS other than PATIENT CONNECTIONS Critical Improbable Acceptable C-14 ACCESSIBLE PARTS exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL CONDITION or in SINGLE FAULT CONDITION. Critical Improbable Acceptable 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 Improbable Acceptable C-16 Accidental detachment of conductors and connectors where breaking free could lead to a HAZARDOUS SITUATION Serious Improbable Acceptable 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 Remote Acceptable 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 Remote Acceptable C-19 Electromagnetic compatibility of PC. Critical Improbable Acceptable C-20 Packing Serious Improbable Acceptable 10/17/12 Page 123 of 142

124 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 Risk Area Serious Improbable Acceptable Serious Remote Acceptable C-23 Cleaning Minor Improbable Acceptable C-24 Electromagnetic compatibility of PC (adding one alternate main board) 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. C-03 Excessive temperatures in PC and/or power supply (adding one alternate main board) C-04 Adding one alternate LCD panel and enclosure shape. Critical Improbable Acceptable Serious Remote Acceptable Critical Improbable Acceptable Serious Remote Acceptable Serious Remote Acceptable Comment Evaluation After Measures Function: F-02 Enclosure Hazard Cause Severity Probability Risk Area Comment 10/17/12 Page 124 of 142

125 Hazard Cause Severity Probability Risk Area H-01 Mechanical energy C-01 Falling Serious Remote Acceptable C-02 Suspended masses Serious Remote Acceptable C-03 Sharp edges and corners Minor Remote Acceptable C-04 Adding new enclosure shape Minor Remote Acceptable H-02 Thermal Energy C-01 Excessive temperatures in enclosure Serious Remote Acceptable Comment Evaluation After Measures Function: F-03 Rear Bracket Hazard Cause Severity Probability Risk Area H-01 Mechanical energy C-01 Crack Serious Remote Acceptable C-02 Suspended masses Serious Remote Acceptable C-03 Instability Serious Remote Acceptable Comment 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 Risk Area Critical Improbable Acceptable Comment 10/17/12 Page 125 of 142

126 Function: F-05 Signal output Hazard Cause Severity Probability Risk Area H-01 Acoustic energy (sound) C-01 earphone Serious Remote Acceptable Function: F-06 User control and indicator Comment Evaluation After Measures 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 Risk Area Serious Remote Acceptable Comment 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 Risk Area Minor Remote Acceptable C-02 Incomplete instructions for use Critical Improbable Acceptable C-03 Inadequate description of performance characteristics Serious Remote Acceptable C-04 Inadequate specification of intended use. Critical Improbable Acceptable C-05 Inadequate disclosure of limitations Critical Improbable Acceptable Comment 10/17/12 Page 126 of 142

127 Hazard Cause H-02 Operating instructions C-01 Inadequate specification of accessories to be used with the medical device. H-03 Specification of service and maintenance C-02 Inadequate specification of pre-use checks. Severity Probability Risk Area Serious Improbable Acceptable Minor Remote Acceptable C-03 Over-complicated operating instructions Minor Remote Acceptable C-01 Installation instruction Serious Remote Acceptable Comment Evaluation After 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 Risk Area Serious Improbable Acceptable Comment Function: F-09 Display Hazard Cause Severity Probability Risk Area H-01 Radiation energy C-01 Visible Light Minor Remote Acceptable Comment Function: F-10 BIOS (Basic Input/Output System - real time clock) Hazard Cause Severity Probability Risk Area H-01 Mechanical energy C-01 Lithium battery explosion Critical Improbable Acceptable Comment 10/17/12 Page 127 of 142

128 Risk Graph After Measures Project: , ONYX-15/17/1921DT Version: 1.02 Both Conditions Operating Condition Failure Mode Inacceptable ALARP Acceptable 10/17/12 Page 128 of 142

129 Risk Graph Before and After Measures Project: , ONYX-15/17/1921DT Version: 1.02 Before Measures Both Conditions After Measures Both Conditions Operating Condition Operating Condition Inacceptable ALARP Acceptable 10/17/12 Page 129 of 142

130 Failure Mode Failure Mode Risk Graph Before and After Measures Inacceptable ALARP Acceptable 10/17/12 Page 130 of 142

131 Evaluation of Residual Risk Project: , ONYX-15/17/1921DT Version: 1.02 Identification of Known or Predictable Hazards and Evaluation of the Risks: 1. All reasonable hazards and their cause were identified and the resulting risks have been evaluated. All of the data have been documented in the enclosed tables before the required measures for the risk diminution have been defined and a final evaluation has been carried out. 2. The aim of this analysis is to improve the security of the product. The assessment is based on the companies' security policy which was implemented for the product in the definition of the risk graph. There areas were defined: "broadly acceptable" and "intolerable". 3. The definite acceptance of the product can only be carried out when the evaluation are located mainly in the "broadly acceptable" region. 4. The product is not marketable according to the safety philosophy of our company if it does contain evaluations in the "intolerable" region after implementation of the measures. Remaining Residual Risk, Summarizing Evaluation In this risk analysis the "present state" of the device has been evaluated. Having carried out the evaluation of the product, the risk of appearance of a not acceptable fault is quite low. The product construction, its function as well as the application does - under normal conditions- not represent any risk for the user. 10/17/12 Page 131 of 142

132 Post production Project: , ONYX-15/17/1921DT Version: /17/12 Page 132 of 142

133 Overview of the Results of the Risk Management Project: , ONYX-15/17/1921DT Version: 1.02 Function: F-01 Connect to Mains Hazard H-01 Electromagnetic energy Cause 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 , Effect on Risk Before Measures S3 / P3 Inaccep table Measure Implemense Measures Relea- Risk After M-01 The limits specified in IEC Yes Yes S3 / P , Clause 8.4 is not be Accepta exceeded for ACCESSIBLE ble PARTS S3 / P3 M-01 The limits specified in IEC Yes Yes Inaccep table , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS S3 / P3 M-01 The limits specified in IEC Yes Yes Inaccep table , Clause 8.4 is not be exceeded for ACCESSIBLE PARTS S4 / P3 M-01 The HAZARDOUS SITUATIONS Yes Yes Inaccep table in IEC , Clause to (inclusive) do not occur in the PC and power adapter S3 / P2 Accepta ble S3 / P2 Accepta ble S4 / P1 Accepta ble 10/17/12 Page 133 of 142