Risk AnalysisFanless Slim Medical Panel PC,models xxxx-ONYX-2121DTy-xxxxxxx

Abbreviation: ONYX-2121DT

Project Number:

Project Description: The models xxxx-ONYX-2121DTy-xxxxxxxare Fanless Slim Medical Panel PC formedical equipment used.

1307033002

Version Number:

Version Description:

Life Cycle Phase:

1.00

Workable version for evaluation purpose

Functional design

2013-08-22

ONYX HEALTHCARE INC.

Creation Date:

Company:

Table of Content

2013-08-22 Page 2 of 141

The Following Documents have been Compiled as a Report: Page

Project Data 3

Version Data 4

Project Team 7

Definition of the Risk Graph 13

Release Criteria 15

Grey Box 17

Risk Analysis 18

Risk Evaluation Before Measures 26

Risk Graph Before Measures 33

Decision about Measures 34

Risk Control 48

Release Protocol of Measures 54

Evaluation After Measures 120

Risk Graph After Measures 128

Risk Graph Before and After Measures 129

Evaluation of Residual Risk 131

Post production 132

Overview of the Results of the Risk Management 133

Project Data

2013-08-22 Page 3 of 141

Project DataProject: 1307033002, ONYX-2121DT | Version: 1.00

Abbreviation: ONYX-2121DT

Project Number: 1307033002

Project Name: Fanless Slim Medical Panel PC, models xxxx-ONYX-2121DTy-xxxxxxx

Project Description: The models xxxx-ONYX-2121DTy-xxxxxxx are FanlessSlim Medical Panel PC for medical equipment used.

Product Type: EN ISO 14971:2012ProductProject Type:

Project Management

Project Leader:Substitute:Responsible for the Risk:

Mac Lin

James ChenMac Lin

Version Data

2013-08-22 Page 4 of 141

Version DataProject: 1307033002, ONYX-2121DT | Version: 1.00

Version No.:Derived from Version:

Version Description:

Special Version:

Freeze Analysis and Evaluation Part:

1.00 -

Workable version for evaluation purpose

Intended Use:

1. The xxxx-ONYX-2121DTy-xxxxxxx were Fanless Slim Medical Panel PC with Intel Atom D525 1.8GHz Dual Core processor-based computer that is designed to serve as a point of care station. It is aPC-based system with 22" true color TFT LCD display, Zero Noise solution; integrated multimediafunctions make them the perfect platforms to build comprehensive lifestyle computing applications.There is a VESA compliant for mounting the support arm.2. The rated input: 24 V dc, 2.91 A (for LCD Monitor); 100-240 V ac, 50/60 Hz, 1.8-0.8 A (for powersupply, model GMPU70A-6)3. The operation temperature/humidity: 10-40 °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 hours6. This Slim Medical Panel PC was judged on the basis of the required creepage and clearances in theThird Edition of the Standard for Medical Electrical Equipment, IEC 60601-1 3rd Ed., Sub. clause 8.9which 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 greaterthan 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, ordinaryequipment and has not been evaluated for use in the presence of a flammable anesthetic mixture withair, oxygen, or nitrous oxide. An additional evaluation shall be made if the power supply is intended foruse 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 60601-1 certified power adapter, modelGMPU70A-6 by Eljintek. This power is used in the conditions of overvoltage category II, Pollution

Version Data

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 5 of 141

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 thepatient .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 otherapplicable 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 medicaltechnologies .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 anunacceptable 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 enclosurecan be touched within 60 sec. Power adapter can be touched within 10 sec.

Possible Misuse: Diagnose use in computed tomography (CT), magnetic resonance imaging (MRI), endoscopy,ultrasound physiotherapy equipment and digital mammography system.

Life Cycle Phase: Functional design

Version Data

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 6 of 141

Additional Documents

Description Titel No. Location References Link

IEC Standard

Medical electrical equipment-- Part 1: Generalrequirements for basic safetyand essential performance

IEC 60601-1: 2005

IEC Standard

Medical electrical equipment-- Part 1-2: Generalrequirements forbasic safety and essentialperformance - Collateralstandard: Electromagneticcompatibility - Requirementsand tests

IEC 60601-1-2:2007(Modified)

IEC Standard

Analysis techniques forsystem reliability - Procedurefor failure mode and effectsanalysis (FMEA)

IEC 60812: 2006

ISO Standard

Medical devices -Application of riskmanagement to medicaldevices

ISO 14971: 2007

Project Team

2013-08-22 Page 7 of 141

Project TeamProject: 1307033002, ONYX-2121DT | Version: 1.00

Project Management

Project Leader: Mac Lin

Substitute Project Leader: James ChenRisk Responsible: Mac Lin

Team Members: see next page

Project TeamProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 8 of 141

Chen, James

User Data:

Username: James_Chen_Onyx

-Fax:QCPosition:

E-Mail: - -Location: -Phone: -Department:

Qualification: O025Risk ManagerTask/Status :

Miscellaneous: - Provide guidance for applying the risk management process- Approve Risk Management File and risk review records

Rights:

Date, Signature Team Member

Manage Version DataManage Project DataDefine GraphImplement AnalysisImplement EvaluationRelease MeasuresDecide about Implementation of MeasuresValidate MeasuresClose Versions

Manage Project TeamManage Measure DocumentationManage Version DocumentationImplement ReevaluationEvaluate Residual RiskPrint ReportsManage Post Production InformationManage Measure Details

Datee,, SiSSiSiSSSSSSSSSSSSSSSSSiSSSiiSSSSSSSiSSSSSSSSSSSSSS gngnggggggnggggggggngggggggggggggggggggggggggg ature Team Member

Project TeamProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 9 of 141

Lin, Eason

User Data:

Username: Eason_Lin_Onyx

-Fax:SalesPosition:

E-Mail: - -Location: -Phone: -Department:

Qualification: O056Product Surveillance Leader (PSL)Task/Status :- 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

Comment:

Rights:

Date, Signature Team Member

Manage Version DataManage Project DataDefine GraphImplement AnalysisImplement EvaluationRelease MeasuresDecide about Implementation of MeasuresValidate MeasuresClose Versions

Manage Project TeamManage Measure DocumentationManage Version DocumentationImplement ReevaluationEvaluate Residual RiskPrint ReportsManage Post Production InformationManage Measure Details

Project TeamProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 10 of 141

Lin , Mac

User Data:

Username: Mac_Lin_Onyx

-Fax:Project ManagerPosition:

E-Mail: - -Location: -Phone: -Department:

Qualification: TUV Rh training - General safety requirements for medical appliances acc. IEC/EN 60601-1UL training - Advanced Workshop on International Regulations of Medical DeviceUL training - Introduction of ISO14971 and IEC60601-1Project ManagerTask/Status :

Miscellaneous: - Provide guidance regarding hazardous situation identification- Provide the severity and likelihood of harm values and rationales for the hazardoussituation- Approve all changes to Risk Management File

Rights:

Date, Signature Team Member

Manage Version DataManage Project DataDefine GraphImplement AnalysisImplement EvaluationRelease MeasuresDecide about Implementation of MeasuresValidate MeasuresClose Versions

Manage Project TeamManage Measure DocumentationManage Version DocumentationImplement ReevaluationEvaluate Residual RiskPrint ReportsManage Post Production InformationManage Measure Details

Project TeamProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 11 of 141

Yuan, Andy

User Data:

Username: Andy_Yuan_Onyx

-Fax:EEPosition:

E-Mail: - -Location: -Phone: -Department:

Qualification: TUV Rh training - General safety requirements for medical appliances acc. IEC/EN 60601-1UL training - Advanced Workshop on International Regulations of Medical DeviceUL training - Introduction of ISO14971 and IEC60601-1MDIC training - Risk Management for Medical DevicesEngineering RepresentativeTask/Status :

Miscellaneous: - 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 aspart 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:

Date, Signature Team Member

Manage Version DataManage Project DataDefine GraphImplement AnalysisImplement EvaluationRelease MeasuresDecide about Implementation of MeasuresValidate MeasuresClose Versions

Manage Project TeamManage Measure DocumentationManage Version DocumentationImplement ReevaluationEvaluate Residual RiskPrint ReportsManage Post Production InformationManage Measure Details

Project TeamProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 12 of 141

Chen, Ernest

User Data:

Username: Ernest_Chen_Onyx

-Fax:MEPosition:

E-Mail: - -Location: -Phone: -Department:

Qualification: TUV Rh training - General safety requirements for medical appliances acc. IEC/EN 60601-1UL training - Advanced Workshop on International Regulations of Medical DeviceUL training - Introduction of ISO14971 and IEC60601-1MDIC training - Risk Management for Medical DevicesEngineering RepresentativeTask/Status :

Miscellaneous: - 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 aspart 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:

Date, Signature Team Member

Manage Version DataManage Project DataDefine GraphImplement AnalysisImplement EvaluationRelease MeasuresDecide about Implementation of MeasuresValidate MeasuresClose Versions

Manage Project TeamManage Measure DocumentationManage Version DocumentationImplement ReevaluationEvaluate Residual RiskPrint ReportsManage Post Production InformationManage Measure Details

Definition of the R

isk Graph

2013-08-22 Page 13 of 141

Definition of the Risk GraphProject: 1307033002, ONYX-2121DT | Version: 1.00

Defined Graph

Acceptable Area

ALARP Area

InacceptableArea

Severity

Abbreviation Description Criterion ExampleS1 Negligible Inconvenience or temporary discomfort Slight rube faction, pressure sores, hot

fingers, short-time failure of singlefunctions which can, however, becorrected by the user withoutexpenditure

S2 Minor Results in temporary injury orimpairment not requiring professionalmedical intervention

Slight cuts, minor scalds, unintentionalswitch-off, reversible malfunction innormal operation

S3 Serious Results in injury requiring professionalmedical intervention

Cuts, moderate scalds

S4 Critical Results in permanent impairment orlife-threatening injury

Scalds, cuts, electric shocks,longerterm and lasting failure offunctions

Definition of the R

isk Graph

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 14 of 141

Abbreviation Description Criterion ExampleS5 Catastrophic Results in patient death. Severe scalds, heavy electric shocks,

death, complete destruction of thedevice, severe damage to theenvironment (damage caused by fireor by water)

Probability

Abbreviation Description Criterion ExampleP1 Improbable < 1/1,000,000 Event is not reproducible or cannot be

replicated under the specifiedoperating conditions of the device.

P2 Remote <1/100,000 and >= 1/1,000,000 Event occurs infrequently during thelife of the product under the specifiedoperating conditions of the device.

P3 Occasional <1/10,000 and >= 1/100,000 Event occurs occasionally during thelife of the product under the specifiedoperating conditions of the device.

P4 Probable < 1/1000 and >= 1/10,000 Event occurs proable during the life ofthe product under the specifiedoperating conditions of the device.

P5 Frequent >= 1/1,000 Event can be replicated repeatedlyand/or is likely to occur regularly ormany times during the life of theproduct under the specified operatingconditions of the device.

Defined Risk Graph Areas

Area DescriptionAcceptable Area Acceptable

ALARP Area As low as reasonably possible

Inacceptable Area Not acceptable

Release C

riteria

2013-08-22 Page 15 of 141

Release CriteriaProject: 1307033002, ONYX-2121DT | Version: 1.00

Complete risk management documentation including the complete release report of single action.

Required Documentation

Description LinksQD2-010 Risk Management Procedure

The criteria for risk acceptability were based upon applicable national or regional regulations and relevantInternational Standards, and takes into account available information such as the generally accepted state of theart and known stakeholder concerns.

Risk = Severity x ProbabilityResults:1... 6 (exclude 5): Acceptable;5, 8.... 25: Not acceptable

When is a Risk Acceptable?

Description Links- Definition Risk Graph with the mentioned parameters- QD2-010 Risk Management Procedure

QD2-001 Verification PlanningQP2-002 Design ValidationQD2-010 Risk Management ProcedureQQ2-002 Retention Time of Quality Records

Criteria of the QM System

Description LinksQQ1-001 Quality Manual

Annual Review as Review Plan QQ2-010QQ2-006 Preparation and Management of the Technical DocumentationQQ2-001 501 Management

Review Plan

Description LinksQQ1-001 Quality Manual

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.

Procedure to Prove the Effectiveness of Risk Management

Description LinksQD2-010 Risk Management Procedure

Release C

riteriaProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 16 of 141

Method is only acceptable when either all non-acceptable risks have beeneliminated or satisfactory reasons have been given for the release in theenabling sheet.

Limits of acceptance for the procedure of evidence

Description LinksQD2-010 Risk Management Procedure

Checking the risk management on correctness and completeness before it is enabled by the technical manager.

Procedure for Verification

Description LinksQD2-010 Risk Management Procedure

Exceptions from the procedure only with the writtenapproval of the entire management.

Limit of Acceptance for Verification

Description LinksQD2-010 Risk Management Procedure

Checking the results of the user studies (focus groups) QP2-002 Design Validation and taking them intoconsideration, then: regular market investigations and updates of the risk analysis

Procedure for Validation

Description LinksQD2-010 Risk Management Procedure

Exceptions from the procedure only with the written approval of the entire management.

Limit of Acceptance for Validation

Description LinksQD2-010 Risk Management Procedure

Grey B

oxProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 17 of 141

Risk A

nalysis

2013-08-22 Page 18 of 141

Risk AnalysisProject: 1307033002, ONYX-2121DT | Version: 1.00

Function: F-01 Connect to Mains

MeasureEffect onCauseHazard

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 19 of 141

MeasureEffect onCauseHazardH-01 Electromagnetic energy C-01 Short circuit of any or all

insulation that does notcomply with therequirements of IEC60601-1, 3rd Ed., Clause.8.8

M-01 The limits specified in IEC 60601-1, Clause 8.4 is not be exceededfor ACCESSIBLE PARTS

C-02 Short circuit of any or allCREEPAGE DISTANCESor AIR CLEARANCESthat do not comply withthe requirements of IEC60601-1, 3rd Ed., Clause8.9

M-01 The limits specified in IEC 60601-1, Clause 8.4 is not be exceededfor ACCESSIBLE PARTS

C-03 Open circuit of any or allearth connections that donot comply with therequirements of IEC60601-1, Clause 8.6,including any functionalearth connection.

M-01 The limits specified in IEC 60601-1, Clause 8.4 is not be exceededfor ACCESSIBLE PARTS

C-04 Short circuit of any oneinsulation that complieswith the requirements forone MEANS OFPROTECTION asspecified in IEC 60601-1,Clause 8.8

M-01 The HAZARDOUS SITUATIONS in IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur in the PC and power adapter.

C-05 Short circuit of any oneCREEPAGE DISTANCEor AIR CLEARANCE thatcomplies with therequirements for oneMEANS OFPROTECTION asspecified in IEC 60601-1,Clause 8.9

M-01 The HAZARDOUS SITUATIONS in IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur in the PC and power adapter.

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 20 of 141

MeasureEffect onCauseHazardC-06 Open circuit of any one

PROTECTIVE EARTHCONDUCTOR or internalPROTECTIVE EARTHCONNECTION thatcomplies with therequirements of IEC60601-1, Clause 8.6

M-01 The HAZARDOUS SITUATIONS in IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur in the PC and power adapter.

C-07 All components, includingwiring, the failure ofwhich could result in aHAZARDOUSSITUATION.

M-01 All components, including wiring shall be used in accordance withtheir specified ratings.

M-02 All components, including wiring, the failure of which could result ina HAZARDOUS SITUATION are fixed in place by UL R/C non-chemical bonding compound.

C-08 The reliability ofcomponents that areused as MEANS OFPROTECTION are notassessed for theconditions of use in thePC.

M-01 They shall comply with the applicable safety requirements of arelevant IEC, UL or ISO standard;

M-02 Where there is no relevant IEC or ISO standard, the requirementsof IEC 60601-1, 3rd Ed. were applied.

C-09 Storage (humiditypreconditioningtreatment)

M-01 The humidity preconditioning treatment is performed in a humiditycabinet 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 transportationstimulation for the verification. All connections were mechanicallysecure.

C-11 Components of PC,unwanted movement ofwhich could result in anunacceptableb RISK, isnot mounted securely toprevent such movement.

M-01 Said components were secured in place on pcb by UL Recognizednon-chemical bonding compound.

C-12 Too high leakage current,causing a death orserious injury to a patient.

M-01 Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS andPATIENT AUXILIARY CURRENTS requirements

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 21 of 141

MeasureEffect onCauseHazardC-13 The LEAKAGE

CURRENTS from, to orbetween ACCESSIBLEPARTS other thanPATIENTCONNECTIONS

M-01 Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS andPATIENT AUXILIARY CURRENTS requirements

C-14 ACCESSIBLE PARTSexceed 42.4 V peak a.c.or 60 V d.c. in NORMALCONDITION or inSINGLE FAULTCONDITION.

M-01 Supplied by SELV power adapter and DC/AC inverter meet LCCrequirements.

C-15 Internal parts, other thancontacts of plugs,connectors and socket-outlets, that can betouched by the test pinshown in IEC 60601-1,Figure 8.

M-01 The suitable enclosure shall be provided.

C-16 Accidental detachment ofconductors andconnectors wherebreaking free could leadto a HAZARDOUSSITUATION

M-01 The HAZARDOUS SITUATIONS in IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur in the PC and power adapter.

C-17 The resistance to heat isnot retained by all typesof insulation, includinginsulating partition walls,during the EXPECTEDSERVICE LIFE of thePC.

M-01 Shall compliance with the following tests: resistance to moisture,etc. (see IEC 60601-1, Clause 11.6); dielectric strength (see IEC60601-1, Clause 8.8.3); and mechanical strength (see IEC60601-1, Clause 15.3).

M-02 Ball pressure test - according to IEC 60601-1, Clause 8.8.4.1, b)requirements

C-18 Internal cables and wiringis not adequatelyprotected against contactwith a moving part or

M-01 Internal cables and wiring is fixed in place by cable tie to protectagainst contact with a moving part or from friction at sharp cornersand edges where damage to insulation

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 22 of 141

MeasureEffect onCauseHazardfrom friction at sharpcorners and edges wheredamage to insulation.

C-19 Electromagneticcompatibility of PC.

M-01 Meet IEC 60601-1-2 requirements

C-20 Packing M-01 The permissible environmental conditions for transport and storagewere marked on the outside of the packaging.

C-21 Wirings and connectorsof Panel PC Monitorsupply is not secured orinsulated that accidentaldetachment can result ina HAZARDOUSSITUATION.

M-01 All wirings are tied together by cable tie to prevent accidentaldetachment

C-22 Internal cables and wiringwere not adequatelyprotected against contactfrom friction at sharpcorners and edges wheredamage to insulationcould result in aHAZARDOUSSITUATION.

M-01 The internal wirings were secured in place on PCB by UL R/C non-chemical bonding component.

C-23 Cleaning M-01 The equipment complied with the requirements of IEC 60601-1,Clause 11.6.

H-02 Thermal Energy C-01 Excessive temperaturesin PC and/or powersupply.

M-01 When PC is operated in worst-case NORMAL USE including themaximum ambient operating temperature, the parts shall notreach temperatures exceeding the values given in IEC 60601-1,Table 22 and Table 23.

C-02 ENCLOSURES have nothe strength and rigiditynecessary to avoid a fire.

M-01 Compliance with the mechanical strength tests for ENCLOSURES(see IEC 60601-1, Clause 15.3)

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 23 of 141

Function: F-02 Enclosure

MeasureEffect onCauseHazardH-01 Mechanical energy C-01 Falling M-01 Meet IEC 60601-1, Clause 9.4.2 requirements.

C-02 Suspended masses M-01 Meet IEC 60601-1 Clause 9.8.2 and Table 21 requirements.

C-03 Sharp edges and corners M-01 Rounding of sharp edges and corners.

H-02 Thermal Energy C-01 Excessive temperaturesin enclosure

M-01 When PC is operated in worst-case NORMAL USE including themaximum ambient operating temperature, the parts shall notreach temperatures exceeding the values given in IEC 60601-1,Table 22 and Table 23.

Function: F-03 Rear Bracket

MeasureEffect onCauseHazardH-01 Mechanical energy C-01 Crack M-01 Meet IEC 60601-1 Clause 9.8.2 and Table 21 requirements.

C-02 Suspended masses M-01 Meet IEC 60601-1 Clause 9.8.2 and Table 21 requirements.

C-03 Instability M-01 Meet IEC 60601-1, Clause 9.4.2 requirements.

Function: F-04 Signal input

MeasureEffect onCauseHazardH-01 Electromagnetic energy C-01 ACCESSIBLE PARTS

exceed 42.4 V peak a.c.or 60 V d.c. in NORMALCONDITION or inSINGLE FAULTCONDITION.

M-01 Supplied by SELV power adapter and DC/AC inverter meet LCCrequirements.

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 24 of 141

Function: F-05 Signal output

MeasureEffect onCauseHazardH-01 Acoustic energy (sound) C-01 earphone M-01 Meet IEC 60950-1, Annex NAD Acoustic tests requirements

Function: F-06 User control and indicator

MeasureEffect onCauseHazardH-01 Operational C-01 Switches used to control

power to PC or its parts,including switches, didnot have their "on" and"off" positions

M-01 Indicated by an adjacent indicator light

M-02 Marked with symbols IEC 60417

Function: F-07 Information

MeasureEffect onCauseHazardH-01 Labeling C-01 PC did not marke with

the name or trademark ofOnyx and with a MODELOR TYPE REFERENCE

M-01 PC marked the name or trademark of Onyx with model no.

C-02 Incomplete instructionsfor use

M-01 Meet IEC 60601-1, Clause 7 requirements.

C-03 Inadequate description ofperformancecharacteristics

M-01 Meet IEC 60601-1, Clause 7 requirements.

C-04 Inadequate specificationof intended use.

M-01 Meet IEC 60601-1, Clause 7 requirements.

C-05 Inadequate disclosure oflimitations

M-01 Meet IEC 60601-1, Clause 7 requirements.

Risk A

nalysis

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 25 of 141

MeasureEffect onCauseHazardH-02 Operating instructions C-01 Inadequate specification

of accessories to be usedwith the medical device.

M-01 Meet IEC 60601-1, Clause 7 requirements.

C-02 Inadequate specificationof pre-use checks.

M-01 Meet IEC 60601-1, Clause 7 requirements.

C-03 Over-complicatedoperating instructions

M-01 Meet IEC 60601-1, Clause 7 requirements.

H-03 Specification of serviceand maintenance

C-01 Installation instruction M-01 Meet IEC 60601-1, Clause 7 requirements.

Function: F-08 Connection to an external d.c. power source

MeasureEffect onCauseHazardH-01 Thermal Energy C-01 When a connection with

the wrong polarity ismade

M-01 Provided a connector that has special housing to prevent aconnection with the wrong polarity is made

Function: F-09 Display

MeasureEffect onCauseHazardH-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 detrimentalbiological effects.

Function: F-10 BIOS (Basic Input/Output System - real time clock)

MeasureEffect onCauseHazardH-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 unintentionalcharging, are prevented.

Risk Evaluation B

efore Measures

2013-08-22 Page 26 of 141

Risk Evaluation Before MeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

Function: F-01 Connect to Mains

CommentRegion of RiskProbabilitySeverityHazard Cause

Risk Evaluation B

efore Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 27 of 141

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Electromagnetic energy C-01 Short circuit of any or all insulation thatdoes not comply with the requirements ofIEC 60601-1, 3rd Ed., Clause. 8.8

Serious Occasional InacceptableArea

C-02 Short circuit of any or all CREEPAGEDISTANCES or AIR CLEARANCES that donot comply with the requirements of IEC60601-1, 3rd Ed., Clause 8.9

Serious Occasional InacceptableArea

C-03 Open circuit of any or all earth connectionsthat do not comply with the requirementsof IEC 60601-1, Clause 8.6, including anyfunctional earth connection.

Serious Occasional InacceptableArea

C-04 Short circuit of any one insulation thatcomplies with the requirements for oneMEANS OF PROTECTION as specified inIEC 60601-1, Clause 8.8

Critical Occasional InacceptableArea

C-05 Short circuit of any one CREEPAGEDISTANCE or AIR CLEARANCE thatcomplies with the requirements for oneMEANS OF PROTECTION as specified inIEC 60601-1, Clause 8.9

Critical Remote InacceptableArea

C-06 Open circuit of any one PROTECTIVEEARTH CONDUCTOR or internalPROTECTIVE EARTH CONNECTION thatcomplies with the requirements of IEC60601-1, Clause 8.6

Critical Occasional InacceptableArea

C-07 All components, including wiring, thefailure of which could result in aHAZARDOUS SITUATION.

Serious Remote AcceptableArea

C-08 The reliability of components that are usedas MEANS OF PROTECTION are notassessed for the conditions of use in thePC.

Critical Remote InacceptableArea

C-09 Storage (humidity preconditioningtreatment)

Serious Occasional InacceptableArea

Risk Evaluation B

efore Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 28 of 141

CommentRegion of RiskProbabilitySeverityHazard Cause

C-10 Transport Serious Remote AcceptableArea

C-11 Components of PC, unwanted movementof which could result in an unacceptablebRISK, is not mounted securely to preventsuch movement.

Serious Remote AcceptableArea

C-12 Too high leakage current, causing a deathor serious injury to a patient.

Critical Occasional InacceptableArea

C-13 The LEAKAGE CURRENTS from, to orbetween ACCESSIBLE PARTS other thanPATIENT CONNECTIONS

Critical Occasional InacceptableArea

C-14 ACCESSIBLE PARTS exceed 42.4 V peaka.c. or 60 V d.c. in NORMAL CONDITIONor in SINGLE FAULT CONDITION.

Critical Occasional InacceptableArea

C-15 Internal parts, other than contacts of plugs,connectors and socket-outlets, that can betouched by the test pin shown in IEC60601-1, Figure 8.

Serious Remote AcceptableArea

C-16 Accidental detachment of conductors andconnectors where breaking free could leadto a HAZARDOUS SITUATION

Serious Occasional InacceptableArea

C-17 The resistance to heat is not retained by alltypes of insulation, including insulatingpartition walls, during the EXPECTEDSERVICE LIFE of the PC.

Serious Occasional InacceptableArea

C-18 Internal cables and wiring is notadequately protected against contact witha moving part or from friction at sharpcorners and edges where damage toinsulation.

Serious Occasional InacceptableArea

C-19 Electromagnetic compatibility of PC. Critical Occasional InacceptableArea

C-20 Packing Serious Occasional Inacceptable

Risk Evaluation B

efore Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 29 of 141

CommentRegion of RiskProbabilitySeverityHazard Cause

AreaC-21 Wirings and connectors of Panel PC

Monitor supply is not secured or insulatedthat accidental detachment can result in aHAZARDOUS SITUATION.

Serious Remote AcceptableArea

C-22 Internal cables and wiring were notadequately protected against contact fromfriction at sharp corners and edges wheredamage to insulation could result in aHAZARDOUS SITUATION.

Serious Remote AcceptableArea

C-23 Cleaning Minor Remote AcceptableArea

H-02 Thermal Energy C-01 Excessive temperatures in PC and/orpower supply.

Serious Occasional InacceptableArea

C-02 ENCLOSURES have no the strength andrigidity necessary to avoid a fire.

Critical Remote InacceptableArea

Function: F-02 Enclosure

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Mechanical energy C-01 Falling Serious Occasional InacceptableArea

C-02 Suspended masses Serious Occasional InacceptableArea

C-03 Sharp edges and corners Minor Probable InacceptableArea

H-02 Thermal Energy C-01 Excessive temperatures in enclosure Serious Occasional InacceptableArea

Risk Evaluation B

efore Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 30 of 141

Function: F-03 Rear Bracket

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Mechanical energy C-01 Crack Serious Occasional InacceptableArea

C-02 Suspended masses Serious Remote AcceptableArea

C-03 Instability Serious Occasional InacceptableArea

Function: F-04 Signal input

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Electromagnetic energy C-01 ACCESSIBLE PARTS exceed 42.4 V peaka.c. or 60 V d.c. in NORMAL CONDITIONor in SINGLE FAULT CONDITION.

Critical Remote InacceptableArea

Function: F-05 Signal output

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Acoustic energy (sound) C-01 earphone Serious Occasional InacceptableArea

Function: F-06 User control and indicator

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Operational C-01 Switches used to control power to PC or itsparts, including switches, did not have their"on" and "off" positions

Serious Occasional InacceptableArea

Risk Evaluation B

efore Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 31 of 141

Function: F-07 Information

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Labeling C-01 PC did not marke with the name ortrademark of Onyx and with a MODEL ORTYPE REFERENCE

Minor Occasional AcceptableArea

C-02 Incomplete instructions for use Critical Occasional InacceptableArea

C-03 Inadequate description of performancecharacteristics

Serious Occasional InacceptableArea

C-04 Inadequate specification of intended use. Critical Occasional InacceptableArea

C-05 Inadequate disclosure of limitations Critical Occasional InacceptableArea

H-02 Operating instructions C-01 Inadequate specification of accessories tobe used with the medical device.

Serious Remote AcceptableArea

C-02 Inadequate specification of pre-usechecks.

Minor Occasional AcceptableArea

C-03 Over-complicated operating instructions Minor Occasional AcceptableArea

H-03 Specification of service andmaintenance

C-01 Installation instruction Serious Occasional InacceptableArea

Function: F-08 Connection to an external d.c. power source

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Thermal Energy C-01 When a connection with the wrong polarityis made

Serious Occasional InacceptableArea

Risk Evaluation B

efore Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 32 of 141

Function: F-09 Display

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Radiation energy C-01 Visible Light Minor Occasional AcceptableArea

Function: F-10 BIOS (Basic Input/Output System - real time clock)

CommentRegion of RiskProbabilitySeverityHazard Cause

H-01 Mechanical energy C-01 Lithium battery explosion Critical Occasional InacceptableArea

Risk G

raph Before M

easures

2013-08-22 Page 33 of 141

Acceptable Area ALARP Area Inacceptable Area

Risk Graph Before MeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

Both Conditions Operating Condition

Failure Mode

Decision about M

easures

2013-08-22 Page 34 of 141

Decision about MeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

Implement:

RC-001Measure:All components, including wiring shall be used in accordance with their specified ratings.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveAll components, including wiring,

the failure of which could result ina HAZARDOUS SITUATION.

Electromagnetic energyConnect to Mains

Implement:

RC-002Measure:All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in place by UL R/C non-chemical bonding compound.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveAll components, including wiring,

the failure of which could result ina HAZARDOUS SITUATION.

Electromagnetic energyConnect to Mains

Implement:

RC-003Measure:All wirings are tied together by cable tie to prevent accidental detachment

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 35 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveWirings and connectors of Panel

PC Monitor supply is not securedor insulated that accidentaldetachment can result in aHAZARDOUS SITUATION.

Electromagnetic energyConnect to Mains

Implement:

RC-004Measure:Ball pressure test - according to IEC 60601-1, Clause 8.8.4.1, b) requirements

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveThe resistance to heat is not

retained by all types of insulation,including insulating partition walls,during the EXPECTED SERVICELIFE of the PC.

Electromagnetic energyConnect to Mains

Implement:

RC-005Measure:Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer’s recommendations, and unintentional charging, are prevented.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveLithium battery explosionMechanical energyBIOS (Basic Input/Output System

- real time clock)

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 36 of 141

Implement:

RC-006Measure:Compliance with the mechanical strength tests for ENCLOSURES (see IEC 60601-1, Clause 15.3)

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveENCLOSURES have no the

strength and rigidity necessary toavoid a fire.

Thermal EnergyConnect to Mains

Implement:

RC-007Measure:Indicated by an adjacent indicator light

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveSwitches used to control power to

PC or its parts, including switches,did not have their "on" and "off"positions

OperationalUser control and indicator

Implement:

RC-008Measure: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 damageto insulation

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 37 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveInternal cables and wiring is not

adequately protected againstcontact with a moving part or fromfriction at sharp corners and edgeswhere damage to insulation.

Electromagnetic energyConnect to Mains

Implement:

RC-009Measure:Marked with symbols IEC 60417

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveSwitches used to control power to

PC or its parts, including switches,did not have their "on" and "off"positions

OperationalUser control and indicator

Implement:

RC-010Measure:Meet IEC 60601-1 Clause 9.8.2 and Table 21 requirements.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveSuspended massesMechanical energyEnclosure

EffectiveCrackMechanical energyRear Bracket

EffectiveSuspended massesMechanical energyRear Bracket

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 38 of 141

Implement:

RC-011Measure:Meet IEC 60601-1, Clause 7 requirements.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveIncomplete instructions for useLabelingInformation

EffectiveInadequate description ofperformance characteristics

LabelingInformation

EffectiveInadequate specification ofintended use.

LabelingInformation

EffectiveInadequate disclosure oflimitations

LabelingInformation

EffectiveInadequate specification ofaccessories to be used with themedical device.

Operating instructionsInformation

EffectiveInadequate specification of pre-use checks.

Operating instructionsInformation

EffectiveOver-complicated operatinginstructions

Operating instructionsInformation

EffectiveInstallation instructionSpecification of service andmaintenance

Information

Implement:

RC-012Measure:Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveToo high leakage current, causing

a death or serious injury to apatient.

Electromagnetic energyConnect to Mains

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 39 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveThe LEAKAGE CURRENTS from,

to or between ACCESSIBLEPARTS other than PATIENTCONNECTIONS

Electromagnetic energyConnect to Mains

Implement:

RC-013Measure:Meet IEC 60601-1, Clause 9.4.2 requirements.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveFallingMechanical energyEnclosure

EffectiveInstabilityMechanical energyRear Bracket

Implement:

RC-014Measure:Meet IEC 60601-1-2 requirements

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveElectromagnetic compatibility of

PC.Electromagnetic energyConnect to Mains

Implement:

RC-015Measure:Meet IEC 60950-1, Annex NAD Acoustic tests requirements

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 40 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveearphoneAcoustic energy (sound)Signal output

Implement:

RC-016Measure:PC marked the name or trademark of Onyx with model no.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectivePC did not marke with the name or

trademark of Onyx and with aMODEL OR TYPE REFERENCE

LabelingInformation

Implement:

RC-017Measure:Provided a connector that has special housing to prevent a connection with the wrong polarity is made

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveWhen a connection with the wrong

polarity is madeThermal EnergyConnection to an external d.c.

power source

Implement:

RC-018Measure:Rounding of sharp edges and corners.

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 41 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveSharp edges and cornersMechanical energyEnclosure

Implement:

RC-019Measure:Said components were secured in place on pcb by UL Recognized non-chemical bonding compound.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveComponents of PC, unwanted

movement of which could result inan unacceptableb RISK, is notmounted securely to prevent suchmovement.

Electromagnetic energyConnect to Mains

Implement:

RC-020Measure:Shall compliance with the following tests: resistance to moisture, etc. (see IEC 60601-1, Clause 11.6); dielectric strength (see IEC 60601-1, Clause 8.8.3); andmechanical strength (see IEC 60601-1, Clause 15.3).

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveThe resistance to heat is not

retained by all types of insulation,including insulating partition walls,during the EXPECTED SERVICELIFE of the PC.

Electromagnetic energyConnect to Mains

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 42 of 141

Implement:

RC-021Measure:Supplied by SELV power adapter and DC/AC inverter meet LCC requirements.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveACCESSIBLE PARTS exceed

42.4 V peak a.c. or 60 V d.c. inNORMAL CONDITION or inSINGLE FAULT CONDITION.

Electromagnetic energyConnect to Mains

EffectiveACCESSIBLE PARTS exceed42.4 V peak a.c. or 60 V d.c. inNORMAL CONDITION or inSINGLE FAULT CONDITION.

Electromagnetic energySignal input

Implement:

RC-022Measure:The equipment complied with the requirements of IEC 60601-1, Clause 11.6.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveCleaningElectromagnetic energyConnect to Mains

Implement:

RC-023Measure:The HAZARDOUS SITUATIONS in IEC 60601-1, Clause 13.1.2 to 13.1.4 (inclusive) do not occur in the PC and power adapter.

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 43 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveShort circuit of any one insulation

that complies with therequirements for one MEANS OFPROTECTION as specified in IEC60601-1, Clause 8.8

Electromagnetic energyConnect to Mains

EffectiveShort circuit of any oneCREEPAGE DISTANCE or AIRCLEARANCE that complies withthe requirements for one MEANSOF PROTECTION as specified inIEC 60601-1, Clause 8.9

Electromagnetic energyConnect to Mains

EffectiveOpen circuit of any onePROTECTIVE EARTHCONDUCTOR or internalPROTECTIVE EARTHCONNECTION that complies withthe requirements of IEC 60601-1,Clause 8.6

Electromagnetic energyConnect to Mains

EffectiveAccidental detachment ofconductors and connectors wherebreaking free could lead to aHAZARDOUS SITUATION

Electromagnetic energyConnect to Mains

Implement:

RC-024Measure:The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of 93 % ± 3 % @ 25 °C 48 hr

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveStorage (humidity preconditioning

treatment)Electromagnetic energyConnect to Mains

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 44 of 141

Implement:

RC-025Measure:The intensity of visible light from monitor can be controlled by the user. The highest intensity achievable cannot produce detrimental biological effects.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveVisible LightRadiation energyDisplay

Implement:

RC-026Measure:The internal wirings were secured in place on PCB by UL R/C non-chemical bonding component.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveInternal cables and wiring were

not adequately protected againstcontact from friction at sharpcorners and edges where damageto insulation could result in aHAZARDOUS SITUATION.

Electromagnetic energyConnect to Mains

Implement:

RC-027Measure:The limits specified in IEC 60601-1, Clause 8.4 is not be exceeded for ACCESSIBLE PARTS

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveShort circuit of any or all insulation

that does not comply with therequirements of IEC 60601-1, 3rdEd., Clause. 8.8

Electromagnetic energyConnect to Mains

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 45 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveShort circuit of any or all

CREEPAGE DISTANCES or AIRCLEARANCES that do not complywith the requirements of IEC60601-1, 3rd Ed., Clause 8.9

Electromagnetic energyConnect to Mains

EffectiveOpen circuit of any or all earthconnections that do not complywith the requirements of IEC60601-1, Clause 8.6, including anyfunctional earth connection.

Electromagnetic energyConnect to Mains

Implement:

RC-028Measure:The permissible environmental conditions for transport and storage were marked on the outside of the packaging.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectivePackingElectromagnetic energyConnect to Mains

Implement:

RC-029Measure:The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections were mechanically secure.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveTransportElectromagnetic energyConnect to Mains

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 46 of 141

Implement:

RC-030Measure:The suitable enclosure shall be provided.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveInternal parts, other than contacts

of plugs, connectors and socket-outlets, that can be touched by thetest pin shown in IEC 60601-1,Figure 8.

Electromagnetic energyConnect to Mains

Implement:

RC-031Measure:They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard;

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveThe reliability of components that

are used as MEANS OFPROTECTION are not assessedfor the conditions of use in the PC.

Electromagnetic energyConnect to Mains

Implement:

RC-032Measure:When PC is operated in worst-case NORMAL USE including the maximum ambient operating temperature, the parts shall not reach temperatures exceedingthe values given in IEC 60601-1, Table 22 and Table 23.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveExcessive temperatures in PC

and/or power supply.Thermal EnergyConnect to Mains

Decision about M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 47 of 141

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveExcessive temperatures in

enclosureThermal EnergyEnclosure

Implement:

RC-033Measure:Where there is no relevant IEC or ISO standard, the requirements of IEC 60601-1, 3rd Ed. were applied.

Function Hazard Cause Effectiveness Assessment of the MeasureEffectiveThe reliability of components that

are used as MEANS OFPROTECTION are not assessedfor the conditions of use in the PC.

Electromagnetic energyConnect to Mains

Risk C

ontrol

2013-08-22 Page 48 of 141

Risk ControlProject: 1307033002, ONYX-2121DT | Version: 1.00

MeasureNo. State ofWork

Responsible PlanningRe-lease

Actual Values EffortValida-tionImplementa-

tion Supervision Begin End Begin End Planned Is

RC-001 All components,including wiring shall beused in accordance withtheir specified ratings.

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 6/18/20135/2/2013Completed Yes Yes

RC-002 All components,including wiring, thefailure of which couldresult in a HAZARDOUSSITUATION are fixed inplace by UL R/C non-chemical bondingcompound.

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/17/20135/3/2013Completed Yes Yes

RC-003 All wirings are tiedtogether by cable tie toprevent accidentaldetachment

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 7/5/20135/12/2013Completed Yes Yes

RC-004 Ball pressure test -according to IEC60601-1, Clause 8.8.4.1,b) requirements

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/28/20135/6/2013Completed Yes Yes

RC-005 Battery circuits isdesigned so thatdischarging at a rateexceeding the batterymanufacturer’srecommendations, andunintentional charging,are prevented.

Yuan, Andy Lin, Eason 5/1/2013 8/31/2013 6/18/20135/8/2013Completed Yes Yes

Risk C

ontrol

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 49 of 141

MeasureNo. State ofWork

Responsible PlanningRe-lease

Actual Values EffortValida-tionImplementa-

tion Supervision Begin End Begin End Planned Is

RC-006 Compliance with themechanical strengthtests for ENCLOSURES(see IEC 60601-1,Clause 15.3)

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/25/20135/13/2013Completed Yes Yes

RC-007 Indicated by an adjacentindicator light

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/18/20135/14/2013Completed Yes Yes

RC-008 Internal cables andwiring is fixed in place bycable tie to protectagainst contact with amoving part or fromfriction at sharp cornersand edges wheredamage to insulation

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/20/20135/3/2013Completed Yes Yes

RC-009 Marked with symbols IEC60417

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/25/20135/2/2013Completed Yes Yes

RC-010 Meet IEC 60601-1Clause 9.8.2 and Table21 requirements.

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 7/5/20135/8/2013Completed Yes Yes

RC-011 Meet IEC 60601-1,Clause 7 requirements.

Lin, Eason Chen, Ernest 5/1/2013 8/31/2013 7/5/20135/6/2013Completed Yes Yes

RC-012 Meet IEC 60601-1,Clause 8.7 LEAKAGECURRENTS andPATIENT AUXILIARYCURRENTSrequirements

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/15/20135/6/2013Completed Yes Yes

RC-013 Meet IEC 60601-1,Clause 9.4.2requirements.

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/27/20135/9/2013Completed Yes Yes

Risk C

ontrol

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 50 of 141

MeasureNo. State ofWork

Responsible PlanningRe-lease

Actual Values EffortValida-tionImplementa-

tion Supervision Begin End Begin End Planned Is

RC-014 Meet IEC 60601-1-2requirements

Yuan, Andy Lin, Eason 5/1/2013 8/31/2013 6/19/20135/10/2013Completed Yes Yes

RC-015 Meet IEC 60950-1,Annex NAD Acoustictests requirements

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/8/20135/3/2013Completed Yes Yes

RC-016 PC marked the name ortrademark of Onyx withmodel no.

Lin, Eason Chen, Ernest 5/1/2013 8/31/2013 6/21/20135/8/2013Completed Yes Yes

RC-017 Provided a connectorthat has special housingto prevent a connectionwith the wrong polarity ismade

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/25/20135/7/2013Completed Yes Yes

RC-018 Rounding of sharp edgesand corners.

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/25/20135/13/2013Completed Yes Yes

RC-019 Said components weresecured in place on pcbby UL Recognized non-chemical bondingcompound.

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/28/20135/24/2013Completed Yes Yes

RC-020 Shall compliance with thefollowing tests:resistance to moisture,etc. (see IEC 60601-1,Clause 11.6); dielectricstrength (see IEC60601-1, Clause 8.8.3);and mechanical strength(see IEC 60601-1,Clause 15.3).

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/8/20135/17/2013Completed Yes Yes

Risk C

ontrol

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 51 of 141

MeasureNo. State ofWork

Responsible PlanningRe-lease

Actual Values EffortValida-tionImplementa-

tion Supervision Begin End Begin End Planned Is

RC-021 Supplied by SELV poweradapter and DC/ACinverter meet LCCrequirements.

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/22/20135/5/2013Completed Yes Yes

RC-022 The equipment compliedwith the requirements ofIEC 60601-1, Clause11.6.

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/11/20135/7/2013Completed Yes Yes

RC-023 The HAZARDOUSSITUATIONS in IEC60601-1, Clause 13.1.2to 13.1.4 (inclusive) donot occur in the PC andpower adapter.

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 6/28/20135/3/2013Completed Yes Yes

RC-024 The humiditypreconditioning treatmentis performed in ahumidity cabinetcontaining air with arelative humidity of 93 %± 3 % @ 25 °C 48 hr

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/26/20135/8/2013Completed Yes Yes

RC-025 The intensity of visiblelight from monitor can becontrolled by the user.The highest intensityachievable cannotproduce detrimentalbiological effects.

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 7/4/20135/7/2013Completed Yes Yes

RC-026 The internal wirings weresecured in place on PCBby UL R/C non-chemicalbonding component.

Chen, Ernest Yuan, Andy 5/1/2013 8/31/2013 6/25/20135/8/2013Completed Yes Yes

Risk C

ontrol

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 52 of 141

MeasureNo. State ofWork

Responsible PlanningRe-lease

Actual Values EffortValida-tionImplementa-

tion Supervision Begin End Begin End Planned Is

RC-027 The limits specified inIEC 60601-1, Clause 8.4is not be exceeded forACCESSIBLE PARTS

Yuan, Andy Lin, Eason 5/1/2013 8/31/2013 7/9/20135/8/2013Completed Yes Yes

RC-028 The permissibleenvironmental conditionsfor transport and storagewere marked on theoutside of the packaging.

Chen, Ernest Lin, Eason 5/1/2013 8/31/2013 7/18/20135/8/2013Completed Yes Yes

RC-029 The strength of packingcarton / fixed frame. Thetransportation stimulationfor the verification. Allconnections weremechanically secure.

Chen, Ernest Lin, Eason 5/1/2013 8/31/2013 7/15/20135/9/2013Completed Yes Yes

RC-030 The suitable enclosureshall be provided.

Chen, Ernest Lin, Eason 5/1/2013 8/31/2013 7/2/20135/2/2013Completed Yes Yes

RC-031 They shall comply withthe applicable safetyrequirements of arelevant IEC, UL or ISOstandard;

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/12/20135/8/2013Completed Yes Yes

RC-032 When PC is operated inworst-case NORMALUSE including themaximum ambientoperating temperature,the parts shall not reachtemperatures exceedingthe values given in IEC60601-1, Table 22 andTable 23.

Yuan, Andy Chen, Ernest 5/1/2013 8/31/2013 7/10/20135/7/2013Completed Yes Yes

Risk C

ontrol

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 53 of 141

MeasureNo. State ofWork

Responsible PlanningRe-lease

Actual Values EffortValida-tionImplementa-

tion Supervision Begin End Begin End Planned Is

RC-033 Where there is norelevant IEC or ISOstandard, therequirements of IEC60601-1, 3rd Ed. wereapplied.

Lin , Mac Yuan, Andy 5/1/2013 8/31/2013 6/27/20135/6/2013Completed Yes Yes

Release Protocol of M

easures

2013-08-22 Page 54 of 141

Release Protocol of MeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/2/2013 End: 6/18/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: All components, including wiring shall be used inaccordance with their specified ratings.

Comment: Where safety is involved, components shall complyeither with the requirements of IEC 60601-1 or with thesafety aspects of the relevant IEC component standards.

RC-001Measure Number:Measure Text:

Measure Status:

All components, including wiring shall be used in accordance with theirspecified ratings.Completed

Functions Hazards CausesAll components, including wiring, thefailure of which could result in aHAZARDOUS SITUATION.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 55 of 141

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 IECcomponent standard shall be checked for correct application and use in accordance with its rating. It shall besubjected to the applicable tests of IEC 60601-1 as part of the equipment with the exception of those tests whichare 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 forcorrect application and use in accordance with its specified rating. It shall be subjected to the applicable tests ofIEC 60601-1, as part of the equipment, and to the applicable tests of the component standard, under theconditions occurring in the equipment;- where no relevant IEC component standard exists, or where components are used in circuits not in accordancewith their specified ratings, the components shall be tested under the conditions occurring in the equipment. Thenumber of samples required for test is, in general, the same as required by an equivalent standard.Description LinkQD2-001, QD2-004, QD2-005

Limits of Acceptance for Procedure of Evidence:see aboveDescription LinkQD2-001, QD2-004, QD2-005

Procedure of Verification:see aboveDescription LinkQD2-001, QD2-004, QD2-005

Limits of Acceptance for Verification:see aboveDescription LinkQD2-001, QD2-004, QD2-005

Procedure of Validation:see aboveDescription LinkQD2-001, QD2-004, QD2-005

Limits of Acceptance for Validation:see aboveDescription LinkQD2-001, QD2-004, QD2-005

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 56 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/3/2013 End: 7/17/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: All components, including wiring, the failure of whichcould result in a HAZARDOUS SITUATION are fixed inplace by UL R/C non-chemical bonding compound.

Comment: Conductors shall be provided with a means (forexample, barriers or fixing), or be so terminated, thatthey and their terminators (for example, ring terminalsand flat quick-connect terminals) cannot, in normal use,become so displaced that CLEARANCES orCREEPAGE DISTANCES are reduced to less than thevalues specified in IEC 60601-1.

RC-002Measure Number:Measure Text:

Measure Status:

All components, including wiring, the failure of which could result in aHAZARDOUS SITUATION are fixed in place by UL R/C non-chemicalbonding compound.Completed

Functions Hazards CausesAll components, including wiring, thefailure of which could result in aHAZARDOUS SITUATION.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 57 of 141

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 aforce gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds.Description LinkQD2-001, QM2-011

Limits of Acceptance for Procedure of Evidence:During the application of the test force, clearances behind earthed or unearthed conductive accessable partswere not reduced to a level that would result in an energy hazard.Description LinkQD2-001, QM2-011

Procedure of Verification:See aboveDescription LinkQD2-001, QM2-011

Limits of Acceptance for Verification:See aboveDescription LinkQD2-001, QM2-011

Procedure of Validation:See aboveDescription LinkQD2-001, QM2-011

Limits of Acceptance for Validation:See aboveDescription LinkQD2-001, QM2-011

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 58 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/12/2013 End: 7/5/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Tied together by cable tie.

Comment: Conductors shall be provided with a means (forexample, barriers or fixing), or be so terminated, thatthey and their terminators (for example, ring terminalsand flat quick-connect terminals) cannot, in normal use,become so displaced that CLEARANCES orCREEPAGE DISTANCES are reduced to less than thevalues specified in IEC 60601-1.

RC-003Measure Number:Measure Text:

Measure Status:

All wirings are tied together by cable tie to prevent accidental detachment

Completed

Functions Hazards CausesWirings and connectors of Panel PCMonitor supply is not secured orinsulated that accidental detachmentcan result in a HAZARDOUSSITUATION.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

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 aforce gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds.Description LinkQD2-001, QM2-011

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 59 of 141

Limits of Acceptance for Procedure of Evidence:During the application of the test force, clearances behind earthed or unearthed conductive accessible partswere not reduced to a level that would result in an energy hazard.Description LinkQD2-001, QM2-011

Procedure of Verification:See aboveDescription LinkQD2-001, QM2-011

Limits of Acceptance for Verification:See aboveDescription LinkQD2-001, QM2-011

Procedure of Validation:See aboveDescription LinkQD2-001, QM2-011

Limits of Acceptance for Validation:See aboveDescription LinkQD2-001, QM2-011

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 60 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/6/2013 End: 6/28/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Compliance is checked by subjecting the part to the ball-pressure test according to IEC 60695-10-2 and IEC60601-1, Clause 8.8.4.1, b)

Comment: Thermoplastic parts on which parts at HAZARDOUSVOLTAGE are directly mounted shall be resistant toabnormal heat.

RC-004Measure Number:Measure Text:

Measure Status:

Ball pressure test - according to IEC 60601-1, Clause 8.8.4.1, b)requirementsCompleted

Functions Hazards CausesThe resistance to heat is not retainedby all types of insulation, includinginsulating partition walls, during theEXPECTED SERVICE LIFE of thePC.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 61 of 141

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 apparatusshown in Fig. 21 of IEC 60601-1, 3rd Edition. (In this apparatus, a steel ball of 5 mm diameter exerts a force of20 N when pressed against a surface). The apparatus and a fire (or sand) brick were placed in an air-circulatingoven. Once the apparatus and brick attained the oven temperature, the sample was placed in the oven on top ofthe 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; ANDb. 75 °C ± 2 °C (test per Clause 8.8.4.1a), OR 125 °C ± 2 °C (test per Clause 8.8.4.1b)Description LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Limits of Acceptance for Procedure of Evidence:The results were less 2 mm.Cracks were not visible to the naked eye.Description LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 62 of 141

Responsible:Implementation: Yuan, Andy Supervision: Lin, Eason

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 6/18/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Battery circuits is designed so that discharging at a rateexceeding the battery manufacturer’s recommendations,and unintentional charging, are prevented.

Comment: Equipment containing batteries shall be designed toreduce the risk of fire, explosion and chemical leaksunder normal conditions and after a single fault in theequipment, including a fault in circuitry within theequipment battery pack.

RC-005Measure Number:Measure Text:

Measure Status:

Battery circuits is designed so that discharging at a rate exceeding thebattery manufacturer’s recommendations, and unintentional charging, areprevented.Completed

Functions Hazards CausesLithium battery explosionMechanical energyBIOS (Basic Input/Output System -

real time clock)

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 63 of 141

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 conditionswere imposed one at a time.1) Unintentional charging of a non-rechargeable battery (pack or cell). The battery was charged while brieflysubjected to the simulation of any single component failure that was likely to occur in the charging circuit and thatwould result in unintentional charging of the battery. To minimize testing time, the failure was chosen that causesthe highest charging current. The battery was then charged for a single period of 7 h with that simulated failure inplace.2) Excessive discharging rate for any battery (pack or cell). The battery was subjected to rapid discharge byopen-circuiting or short-circuiting any current-limiting or voltage-limiting components in the load circuit of thebattery under test.3) Reversing - The connections of the battery were reversed and the equipment was energized. The battery wasexamined for emission of flames, toxic gases, molten metal, risk of explosion.Description LinkIEC 60601-1, Clause 8.8.3 and 15.4.3

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 adverselyaffect required insulation; or- spillage of liquid from any pressure relief device in the battery, unless such spillage is contained by theequipment 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 60601-1, Clause8.8.3Description LinkIEC 60601-1, Clause 8.8.3 and 15.4.3

Procedure of Verification:see aboveDescription LinkIEC 60601-1, Clause 8.8.3 and 15.4.3

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, Clause 8.8.3 and 15.4.3

Procedure of Validation:see aboveDescription LinkIEC 60601-1, Clause 8.8.3 and 15.4.3

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, Clause 8.8.3 and 15.4.3

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 64 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/13/2013 End: 6/25/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The suitable plastic enclosure is provided.

Comment: The PC or its parts shall have adequate mechanicalstrength and shall not result in an unacceptable RISKdue to moulding stress or when subjected to mechanicalstress caused by pushing, impact, dropping, and roughhandling.

RC-006Measure Number:Measure Text:

Measure Status:

Compliance with the mechanical strength tests for ENCLOSURES (seeIEC 60601-1, Clause 15.3)Completed

Functions Hazards CausesENCLOSURES have no the strengthand rigidity necessary to avoid a fire.

Thermal EnergyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures: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 ormeasuring devices unless with the handle, lever, knob, or cover removed there is an unacceptable RISK ofelectric shock.Description LinkIEC 60601-1, Clause 15.3

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 65 of 141

Limits of Acceptance for Procedure of Evidence:There was no cracking of the enclosure.There were no live parts that became accessible.Description LinkIEC 60601-1, 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 aperiod of 5 seconds applied to different parts of the enclosure via a test tool providing contact over a circularplane surface 30 mm in diameter as indicated in Table 15.3.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 asolid steel 50 mm (approx) ball of mass 500 g plus or minus 25 g, fall freely from 1.3 meter height. The unit wasrigidly supported and the impact was applied to the locations indicated in Table 15.3.Description LinkIEC 60601-1, Clause 15.3

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, Clause 15.3

Procedure of Validation:see aboveDescription LinkIEC 60601-1, Clause 15.3

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, Clause 15.3

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 66 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/14/2013 End: 6/18/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The colours of indicator lights and their meanings shallcomply with Table 2 of IEC 60601-1.

Comment: It is important for an OPERATOR and SERVICEPERSONNEL to be able to determine the functionalstatus of ME EQUIPMENT. In NORMAL USE, theOPERATOR needs to be able to distinguish between MEEQUIPMENT in stand-by and ME EQUIPMENT in a fullyfunctional state.

RC-007Measure Number:Measure Text:

Measure Status:

Indicated by an adjacent indicator light

Completed

Functions Hazards CausesSwitches used to control power toPC or its parts, including switches,did not have their "on" and "off"positions

OperationalUser control and indicator

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:QD2-001, QM2-011Description LinkIEC 60601-1, Clause 7.8.1 and 15.4.4

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 67 of 141

Limits of Acceptance for Procedure of Evidence:QD2-001, QM2-011Description LinkIEC 60601-1, Clause 7.8.1 and 15.4.4

Procedure of Verification:QD2-001, QM2-011Description LinkIEC 60601-1, Clause 7.8.1 and 15.4.4

Limits of Acceptance for Verification:QD2-001, QM2-011Description LinkIEC 60601-1, Clause 7.8.1 and 15.4.4

Procedure of Validation:QD2-001, QM2-011Description LinkIEC 60601-1, Clause 7.8.1 and 15.4.4

Limits of Acceptance for Validation:QD2-001, QM2-011Description LinkIEC 60601-1, Clause 7.8.1 and 15.4.4

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 68 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/3/2013 End: 6/20/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The internal wirings were secured in place on PCB byUL R/C non-chemical bounding component.

Comment: Wireways shall be smooth and free from sharp edges.Wires shall be protected so that they do not come intocontact with burrs, cooling fins, moving parts, etc., whichcould cause damage to the insulation of conductors.Holes in metal, through which insulated wires pass, shallhave smooth well-rounded surfaces or shall be providedwith bushings.

RC-008Measure Number:Measure Text:

Measure Status:

Internal cables and wiring is fixed in place by cable tie to protect againstcontact with a moving part or from friction at sharp corners and edgeswhere damage to insulationCompleted

Functions Hazards CausesInternal cables and wiring is notadequately protected against contactwith a moving part or from friction atsharp corners and edges wheredamage to insulation.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 69 of 141

Procedure for Evidence of Efficency of Measures:QD2-001, QD2-010, QM2-011, QD2-009Description LinkQQ1-001

Limits of Acceptance for Procedure of Evidence:QD2-001, QD2-010, QM2-011, QD2-009Description LinkQQ1-001

Procedure of Verification:QD2-001, QD2-010, QM2-011, QD2-009Description LinkQQ1-001

Limits of Acceptance for Verification:QD2-001, QD2-010, QM2-011, QD2-009Description LinkQQ1-001

Procedure of Validation:QD2-001, QD2-010, QM2-011, QD2-009Description LinkQQ1-001

Limits of Acceptance for Validation:QD2-001, QD2-010, QM2-011, QD2-009Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 70 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/2/2013 End: 6/25/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: - marked with symbols IEC 60417,- indicated by an adjacent indicator light

Comment: Switches used to control power to ME EQUIPMENT orits parts, including mains switches, shall have their "on"and "off" positions

RC-009Measure Number:Measure Text:

Measure Status:

Marked with symbols IEC 60417

Completed

Functions Hazards CausesSwitches used to control power toPC or its parts, including switches,did not have their "on" and "off"positions

OperationalUser control and indicator

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:Compliance with the requirements is checked by inspection and by application of the tests and criteria in 7.1.2and 7.1.3 of IEC 60601-1.Description LinkIEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1 and 15.4.4

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 71 of 141

Limits of Acceptance for Procedure of Evidence:The colours of indicator lights and their meanings shall comply with Table 2 of IEC 60601-1.Description LinkIEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1 and 15.4.4

Procedure of Verification:see aboveDescription LinkIEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1 and 15.4.4

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1 and 15.4.4

Procedure of Validation:see aboveDescription LinkIEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1 and 15.4.4

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1 and 15.4.4

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 72 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 7/5/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The construction of the support, suspension or actuationsystem shall be designed based upon Table 21 of IEC60601-1 and the TOTAL LOAD.

Comment: Where ME EQUIPMENT parts are designed to supportloads, then a mechanical fault could not constitute anunacceptable RISK.

RC-010Measure Number:Measure Text:

Measure Status:

Meet IEC 60601-1 Clause 9.8.2 and Table 21 requirements.

Completed

Functions Hazards CausesSuspended massesMechanical energyEnclosure

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures: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 orremoved suddenly), thereby causing the maximum normal load to fall from the most adverse position permittedby the construction of the equipment and to activate a safety device. The travel after such defeat was measuredas well as other observed results that could affect the risk of possible injury.Description LinkIEC 60601-1, Clause 9.8.2

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 73 of 141

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 toperform its intended function.Description LinkIEC 60601-1, Clause 9.8.2

Procedure of Verification:see aboveDescription LinkIEC 60601-1, Clause 9.8.2

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, Clause 9.8.2

Procedure of Validation:see aboveDescription LinkIEC 60601-1, Clause 9.8.2

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, Clause 9.8.2

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 74 of 141

Responsible:Implementation: Lin, Eason Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/6/2013 End: 7/5/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: For Ward Terminal to be well designed, its markings andACCOMPANYING DOCUMENTS should be clear,consistent, and help to reduce potential use error.

Comment: Additional markings are permitted, provided that they donot give rise to misunderstanding. Where symbols areused, they shall conform to ISO 7000 or IEC 60417where appropriate symbols exist. Sufficient informationshall be provided to the USER concerning any conditionnecessary to ensure that , when used as prescribed bythe manufacturer, the equipment is unlikely to present ahazard within the meaning of IEC 60601-1.

RC-011Measure Number:Measure Text:

Measure Status:

Meet IEC 60601-1, Clause 7 requirements.

Completed

Functions Hazards CausesIncomplete instructions for useLabelingInformation

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:Each specified marking was rubbed by hand, without undue pressure, first for 15 s with a cloth rag soaked withdistilled water, then for 15 s with a cloth rag soaked in methylated spirit at ambient temperature, and then for 15 swith a cloth rag soaked with isopropyl alcohol.Description LinkIEC 60601-1, 3rd Edition, Clause 7.1.3b

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 75 of 141

Limits of Acceptance for Procedure of Evidence:The markings worked and did not curl at the edges. The markings were clearly readable.Description LinkIEC 60601-1, 3rd Edition, Clause 7.1.3b

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 7.1.3b

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 7.1.3b

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 7.1.3b

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 7.1.3b

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 76 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/6/2013 End: 7/15/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTSand PATIENT AUXILIARY CURRENTS requirements

Comment: The electrical isolation providing protection againstelectric shock shall be of such quality that currentsflowing through it are limited to the values specified inIEC 60601-1, Clause 8.7.3.

RC-012Measure Number:Measure Text:

Measure Status:

Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS and PATIENTAUXILIARY CURRENTS requirementsCompleted

Functions Hazards CausesToo high leakage current, causing adeath or serious injury to a patient.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 77 of 141

Procedure for Evidence of Efficency of Measures:Testing was conducted after thermal stabilization and was repeated Humidity Preconditioning. Following thehumidity conditioning (see Humidity Conditioning Test for further details), the equipment was locatedin an environment with a temperature approximately equal to t where t is the temperature of the humidity cabinetand a relative humidity between 45% and 65% and was conducted 1 hour after the end of the humiditypreconditioning treatment.In Normal Condition and in the specified Single Fault Conditions (IEC 60601-1, 3rd Ed., 8.7.2)With the Equipment energized in stand-by and fully operating and with any switch in the Mains Part in anyposition. With the equipment connected to a supply source with the highest rated supply frequency and110% of the highest rated Mains Voltage as indicated in the RESULTS table.Description LinkIEC 60601-1, 3rd Edition, Clause 8.7

Limits of Acceptance for Procedure of Evidence:IEC 60601-1, 3rd Ed. Table 3 and Table 4Description LinkIEC 60601-1, 3rd Edition, Clause 8.7

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.7

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.7

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.7

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.7

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 78 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/9/2013 End: 6/27/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The equipment did not overbalance.

Comment: PC or its parts shall not overbalance when placed in anytransport position of NORMAL USE on a plane inclinedat an angle of 10° from the horizontal plane.

RC-013Measure Number:Measure Text:

Measure Status:

Meet IEC 60601-1, Clause 9.4.2 requirements.

Completed

Functions Hazards CausesFallingMechanical energyEnclosure

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:10° Incline (9.4.2.1) - 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 9.4.2.2.Description LinkIEC 60601-1, 3rd Edition, Clause 9.4.2

Limits of Acceptance for Procedure of Evidence:The equipment did not overbalance.Description LinkIEC 60601-1, 3rd Edition, Clause 9.4.2

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 79 of 141

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 9.4.2

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 9.4.2

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 9.4.2

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 9.4.2

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 80 of 141

Responsible:Implementation: Yuan, Andy Supervision: Lin, Eason

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/10/2013 End: 6/19/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Meet IEC 60601-1-2 requirements

Comment: Electromagnetic emission requirements are necessaryfor the protection of:- safety services (e.g. police, fire and ambulancecommunications);- other ME EQUIPMENT and ME SYSTEMS;- non-ME EQUIPMENT (e.g. computers);- telecommunications (e.g. radio/TV, telephone, radio-navigation).

RC-014Measure Number:Measure Text:

Measure Status:

Meet IEC 60601-1-2 requirements

Completed

Functions Hazards CausesElectromagnetic compatibility of PC.Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:IEC 60601-1-2Description LinkEMC test report

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 81 of 141

Limits of Acceptance for Procedure of Evidence:see aboveDescription LinkEMC test report

Procedure of Verification:see aboveDescription LinkEMC test report

Limits of Acceptance for Verification:see aboveDescription LinkEMC test report

Procedure of Validation:see aboveDescription LinkEMC test report

Limits of Acceptance for Validation:see aboveDescription LinkEMC test report

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 82 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/3/2013 End: 7/8/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The equipment having acoustic outputs atcommunication receivers and similar devices used forvoice Telecommunication, regardless of transmissionmedium (e.g., TELECOMMUNICATION NETWORK,CABLE DISTRIBUTION NETWORK, wireless network),shall demonstrate that the equipment complies with theappropriate acoustics requirements related to shortduration impulses and long duration disturbances asdescribed in NAD.3 and NAD.4. of IEC 60950-1.

Comment: These requirements apply to equipment that is intendedto be connected directly or indirectly to aTELECOMMUNICATION NETWORK or CABLEDISTRIBUTION SYSTEM or other transmissionmedium, and that contains an earpiece or receiver thatis held against or in the ear. The effect on humanhearing of impulsive noise or of disturbances that areless than 0,5 s in duration shall be evaluated underNAD.3. The effect of longer disturbances, such as thosethat might be produced during tone-type dialing, shall beevaluated under NAD.4.

RC-015Measure Number:Measure Text:

Measure Status:

Meet IEC 60950-1, Annex NAD Acoustic tests requirements

Completed

Functions Hazards CausesearphoneAcoustic energy (sound)Signal output

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 83 of 141

Procedure for Evidence of Efficency of Measures:The headset of the equipment was placed according to the general setup page and operating for the exchangeof calls (such as talking state with the handset raised). A short duration peak applied to the tip and ring byapplying digital codes to the receive input of the device. This may be performed by using an analog test set todrive a reference codec, or by use of a digital code generator. The analog level shall be set to switch betweenthe maximum positive and the maximum negative values for the reference codec. The switching rate shall bethrough the range of 100 Hz to 3400 Hz for narrow band and 100 Hz to 6800 Hz for wideband. The duration ofthe ON codes shall be a number of complete cycles approximating but exceeding 500 ms. The ON codes mustbe followed by a quiet interval of at least 500 ms before repeating the codes. For equipment not intended to bedirectly connected to the Telecommunication Network, such as equipment used with specialized PBX or Keysystems 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 thehook switch or by dialing.Description LinkIEC 60950-1, Annex NAD

Limits of Acceptance for Procedure of Evidence:The peak acoustic pressure did not exceed 136 dB ERPDescription LinkIEC 60950-1, Annex NAD

Procedure of Verification:see aboveDescription LinkIEC 60950-1, Annex NAD

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60950-1, Annex NAD

Procedure of Validation:see aboveDescription LinkIEC 60950-1, Annex NAD

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60950-1, Annex NAD

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 84 of 141

Responsible:Implementation: Lin, Eason Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 6/21/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Marked the name or trademark and with model no.

Comment: Identification

RC-016Measure Number:Measure Text:

Measure Status:

PC marked the name or trademark of Onyx with model no.

Completed

Functions Hazards CausesPC did not marke with the name ortrademark of Onyx and with aMODEL OR TYPE REFERENCE

LabelingInformation

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirementsDescription LinkIEC 60601-1 3rd Ed. Clause 7.2.2

Limits of Acceptance for Procedure of Evidence:Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirementsDescription LinkIEC 60601-1 3rd Ed. Clause 7.2.2

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 85 of 141

Procedure of Verification:Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirementsDescription LinkIEC 60601-1 3rd Ed. Clause 7.2.2

Limits of Acceptance for Verification:Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirementsDescription LinkIEC 60601-1 3rd Ed. Clause 7.2.2

Procedure of Validation:Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirementsDescription LinkIEC 60601-1 3rd Ed. Clause 7.2.2

Limits of Acceptance for Validation:Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirementsDescription LinkIEC 60601-1 3rd Ed. Clause 7.2.2

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 86 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/7/2013 End: 6/25/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Provided a connector that has special housing toprevent a connection with the wrong polarity is made.

Comment: No HAZARDOUS SITUATION, other than absence ofESSENTIAL PERFORMANCE, shall develop when aconnection with the wrong polarity is made.

RC-017Measure Number:Measure Text:

Measure Status:

Provided a connector that has special housing to prevent a connectionwith the wrong polarity is madeCompleted

Functions Hazards CausesWhen a connection with the wrongpolarity is made

Thermal EnergyConnection to an external d.c.power source

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:QD2-001, QD2-009 and QD2-010Description LinkQQ1-001

Limits of Acceptance for Procedure of Evidence:QD2-001, QD2-009 and QD2-010Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 87 of 141

Procedure of Verification:QD2-001, QD2-009 and QD2-010Description LinkQQ1-001

Limits of Acceptance for Verification:QD2-001, QD2-009 and QD2-010Description LinkQQ1-001

Procedure of Validation:QD2-001, QD2-009 and QD2-010Description LinkQQ1-001

Limits of Acceptance for Validation:QD2-001, QD2-009 and QD2-010Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 88 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/13/2013 End: 6/25/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Rounding of sharp edge and corner.

Comment: Rough surfaces, sharp corners and edges of WardTerminal that could result in an unacceptable RISK.

RC-018Measure Number:Measure Text:

Measure Status:

Rounding of sharp edges and corners.

Completed

Functions Hazards CausesSharp edges and cornersMechanical energyEnclosure

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:Accessible edges or corners of the unit, except those required for proper functioning of the equipment, weresubjected to this test. Surfaces described below were judged using the Sharp Edge Tester. The curved face ofthe tester head was covered with three layers of tape: bottom layer 1.6 mm black vinyl foam tape; middle layer0.8 mm white vinyl foam tape; outer layer 0.08 mm (3 mil) Teflon tape skived. The tape-covered head of thetester was positioned on the edge to check for sharpness. The arm of the tester was calibrated so that a 6.7 Nforce was present at the center of the head when the arm was between stops. This force was applied on thesharp edge. The tester was immediately moved 50.5 mm along the edge and then back to its starting positionwithout removing the tester so that total distance traveled was 101 mm. The time of travel was no longer than 5seconds nor less than 2 seconds.Description LinkIEC 60601-1, Clause 9.3

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 89 of 141

Limits of Acceptance for Procedure of Evidence:The edges and corners were considered to be rounded and smooth.Description LinkIEC 60601-1, Clause 9.3

Procedure of Verification:see aboveDescription LinkIEC 60601-1, Clause 9.3

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, Clause 9.3

Procedure of Validation:see aboveDescription LinkIEC 60601-1, Clause 9.3

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, Clause 9.3

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 90 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/24/2013 End: 6/28/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Said components were secured in place on pcb by ULRecognized non-chemical bonding compound.

Comment: Components of power supply, unwanted movement ofwhich could result in an unacceptable RISK, shall bemounted securely to prevent such movement.

RC-019Measure Number:Measure Text:

Measure Status:

Said components were secured in place on pcb by UL Recognized non-chemical bonding compound.Completed

Functions Hazards CausesComponents of PC, unwantedmovement of which could result in anunacceptableb RISK, is not mountedsecurely to prevent such movement.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

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 aforce gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds.Description LinkQD2-001, QD2-010, QM2-011, QD2-009

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 91 of 141

Limits of Acceptance for Procedure of Evidence:During the application of the test force, clearances behind earthed or unearthed conductive accessible partswere not reduced to a level that would result in an energy hazard.Description LinkQD2-001, QD2-010, QM2-011, QD2-009

Procedure of Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009

Limits of Acceptance for Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009

Procedure of Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009

Limits of Acceptance for Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 92 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/17/2013 End: 7/8/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Shall compliance with the following tests: resistance tomoisture, etc. (see IEC 60601-1, clause 11.6); dielectricstrength (see IEC 60601-1, clause 8.8.3); andmechanical strength (see IEC 60601-1, clause 15.3).

Comment: The resistance to heat shall retained by all types ofinsulation, including insulating partition walls, during theEXPECTED SERVICE LIFE of the PC.

RC-020Measure Number:Measure Text:

Measure Status:

Shall compliance with the following tests: resistance to moisture, etc. (seeIEC 60601-1, Clause 11.6); dielectric strength (see IEC 60601-1, Clause8.8.3); and mechanical strength (see IEC 60601-1, Clause 15.3).Completed

Functions Hazards CausesThe resistance to heat is not retainedby all types of insulation, includinginsulating partition walls, during theEXPECTED SERVICE LIFE of thePC.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 93 of 141

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 apparatusshown in Fig. 21 of IEC 60601-1, 3rd Edition. (In this apparatus, a steel ball of 5 mm diameter exerts a force of20 N when pressed against a surface). The apparatus and a fire (or sand) brick were placed in an air-circulatingoven. Once the apparatus and brick attained the oven temperature, the sample was placed in the oven on top ofthe 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 specifiedoven 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; ANDb. 75 °C ± 2 °C (test per Clause 8.8.4.1a), OR 125 °C ± 2 °C (test per Clause 8.8.4.1b)Description LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Limits of Acceptance for Procedure of Evidence:The results were less 2 mm.Cracks were not visible to the naked eye.Description LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 8.8.4.1

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 94 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/5/2013 End: 7/22/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Supplied by SELV power adapter and DC/AC invertermeet LCC requirements

Comment: ACCESSIBLE PARTS (output connector) shall notexceed 42.4 V peak a.c. or 60 V d.c. in NORMALCONDITION or in SINGLE FAULT CONDITION.

RC-021Measure Number:Measure Text:

Measure Status:

Supplied by SELV power adapter and DC/AC inverter meet LCCrequirements.Completed

Functions Hazards CausesACCESSIBLE PARTS exceed 42.4 Vpeak a.c. or 60 V d.c. in NORMALCONDITION or in SINGLE FAULTCONDITION.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:A short of the operational or basic insulation indicated in the table was made. The voltage present at theaccessible parts/circuitry was measured, recorded and compared to 42.4 V pk ac and 60 V dc.Description LinkQD2-001, QD2-010, QM2-011 and QD2-009

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 95 of 141

Limits of Acceptance for Procedure of Evidence:The voltage did not exceed 42.4 V peak ac or 60 V dc.Description LinkQD2-001, QD2-010, QM2-011 and QD2-009

Procedure of Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Limits of Acceptance for Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Procedure of Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Limits of Acceptance for Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 96 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/7/2013 End: 7/11/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The equipment complied ]with the requirements of IEC60601-1, Clause 11.6.

Comment: The monitor and their parts, including ACCESSORIES,shall be capable of withstanding, without damage ordeterioration of safety provisions, the cleaning ordisinfection PROCESSES specified in the instructionsfor use.

RC-022Measure Number:Measure Text:

Measure Status:

The equipment complied with the requirements of IEC 60601-1, Clause11.6.Completed

Functions Hazards CausesCleaningElectromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:The equipment was cleaned/disinfected as specified in the instructions for use. After an adequate cooling anddrying 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.Description LinkIEC 60601-1, 3rd Edition, Clause 11.6)

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 97 of 141

Limits of Acceptance for Procedure of Evidence:The equipment complied with the requirements of IEC 60601-1, Clause 11.6.The equipment did not show signs of wetting of uninsulated live parts.There were no dielectric breakdown and/or leakage current test non-compliances.Description LinkIEC 60601-1, 3rd Edition, Clause 11.6)

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11.6)

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11.6)

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11.6)

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11.6)

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 98 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/3/2013 End: 6/28/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Meet clause 13 of IEC 60601-1, 3rd Ed. requirements.

Comment: HAZARDOUS SITUATIONS and fault conditions.

RC-023Measure Number:Measure Text:

Measure Status:

The HAZARDOUS SITUATIONS in IEC 60601-1, Clause 13.1.2 to 13.1.4(inclusive) do not occur in the PC and power adapter.Completed

Functions Hazards CausesShort circuit of any one insulationthat complies with the requirementsfor one MEANS OF PROTECTIONas specified in IEC 60601-1, Clause8.8

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 99 of 141

Procedure for Evidence of Efficency of Measures:The device was operated until ultimate results were obtained. All final results were recorded. If required, finaltemperatures were measured and recorded. The normal conditions were also applied in the least favorablecombination. - 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. Whensteady thermal conditions were again established, the load was again increased. These steps were continueduntil the overload protector operated or until thermal stability was reached.- For each fault condition, the Dielectric Voltage Withstand Test was repeated immediately following theconclusion of the test.Description LinkIEC 60601-1, 3rd Edition, Clause 13

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 orother causes.3. The measured temperatures did not exceed those allowable.4. In each case the hazardous situations described in Clauses 13.1.2 to 13.1.4 of IEC 60601-1, 3rd ED. did notoccur.5. See Table 11 of IEC 60601-1, 3rd ED. for Temperatures obtained during the indicated Abnormal Operationtests.Description LinkIEC 60601-1, 3rd Edition, Clause 13

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 13

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 13

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 13

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 13

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 100 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 6/26/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The humidity preconditioning treatment is performed in ahumidity cabinet containing air with a relative humidity of93 % ± 3 % @ 25 °C, 48 hr

Comment: Storage (humidity preconditioning treatment)

RC-024Measure Number:Measure Text:

Measure Status:

The humidity preconditioning treatment is performed in a humidity cabinetcontaining air with a relative humidity of 93 % ± 3 % @ 25 °C 48 hrCompleted

Functions Hazards CausesStorage (humidity preconditioningtreatment)

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 101 of 141

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 treatmentis applied only to those power supply parts which are influenced by the climatic conditions that are simulated bythe test. Parts that can be detached without the use of a TOOL are detached but are treated simultaneously withthe major part. ACCESS COVERS that can be opened or detached without the use of a TOOL are opened anddetached.A humidity chamber having relative humidity of 90 to 96 % was set to any convenient Temperature T between 20and 32 °C. The unit, before being placed in the chamber was brought to a temperature between T and T + 4 °Cand kept at this temperature a minimum of 4 h. Then the sample was placed in the humidity chamber and keptthere for the time specified in Table 5.7 of IEC 60601-1, 3rd Ed. (minimum 48 h). During this time thetemperature 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 VoltageWithstand Test. Then the unit was removed from the chamber, placed in normal environment (temperatureapproximately T, humidity 45-65%). Immediately following the humidity preconditioning treatment, the powersupply was subjected to a repeat of the dielectric withstand and leakage current tests.Description LinkIEC 60601-1, 3rd Edition, Clause 5.7

Limits of Acceptance for Procedure of Evidence:There was no dielectric breakdownDescription LinkIEC 60601-1, 3rd Edition, Clause 5.7

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 5.7

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 5.7

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 5.7

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 5.7

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 102 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/7/2013 End: 7/4/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Computer monitors emit electromagnetic radiation in abroad range of frequencies. Although theelectromagnetic radiation field intensities aremeasurable, they are not substantially abovebackground office levels. The effect on health from theuse of monitors has been studied for many years , andthe research continues. The present consensus ofexperts is that there are no data to suggest a health riskfrom exposure to the electromagnetic fields associatedwith the use of monitors.

Comment: PC users have expressed concerns about the possiblehealth effects from the electromagnetic radiation thatmonitors produce. The concerns generally center aroundadverse pregnancy outcome (spontaneous abortion orbirth defects). It has been postulated that these effectsare due to electromagnetic radiation exposure frommonitors. The biological effects of exposure to VLF andELF fields similar to those produced by monitors havebeen studied for many years, and the researchcontinues today. Cancer and reproductive outcomes arethe topics studied most intensively. Current availablescientific information does not identify a health risk fromexposure to the electromagnetic fields associated withthe use of computer monitors.

RC-025Measure Number:Measure Text:

Measure Status:

The intensity of visible light from monitor can be controlled by the user.The highest intensity achievable cannot produce detrimental biologicaleffects.Completed

Functions Hazards CausesVisible LightRadiation energyDisplay

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 103 of 141

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:https://ehs.mit.edu/site/content/radiation-computer-monitorsDescription Linkhttps://ehs.mit.edu/site/content/radiation-computer-monitors

Limits of Acceptance for Procedure of Evidence:see above

Procedure of Verification:see above

Limits of Acceptance for Verification:see above

Procedure of Validation:see above

Limits of Acceptance for Validation:see above

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 104 of 141

Responsible:Implementation: Chen, Ernest Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 6/25/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The internal wirings were secured in place on PCB byUL R/C non-chemical bonding component.

Comment: Internal cables and wiring shall adequately protectedagainst contact from friction at sharp corners and edgeswhere damage to insulation could result in aHAZARDOUS SITUATION.

RC-026Measure Number:Measure Text:

Measure Status:

The internal wirings were secured in place on PCB by UL R/C non-chemical bonding component.Completed

Functions Hazards CausesInternal cables and wiring were notadequately protected against contactfrom friction at sharp corners andedges where damage to insulationcould result in a HAZARDOUSSITUATION.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

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 aforce gauge, a steady force of 10 N for internal parts was applied for a period of 5 seconds.Description LinkQD2-001, QD2-010, QM2-011 and QD2-009

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 105 of 141

Limits of Acceptance for Procedure of Evidence:During the application of the test force, clearances behind earthed or unearthed conductive accessable partswere not reduced to a level that would result in an energy hazard.Description LinkQD2-001, QD2-010, QM2-011 and QD2-009

Procedure of Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Limits of Acceptance for Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Procedure of Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Limits of Acceptance for Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011 and QD2-009

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 106 of 141

Responsible:Implementation: Yuan, Andy Supervision: Lin, Eason

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 7/9/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The insulation that is relied upon as a MEANS OFPROTECTION, including REINFORCED INSULATIONshall be subject to testing.

Comment: Insulation

RC-027Measure Number:Measure Text:

Measure Status:

The limits specified in IEC 60601-1, Clause 8.4 is not be exceeded forACCESSIBLE PARTSCompleted

Functions Hazards CausesShort circuit of any or all insulationthat does not comply with therequirements of IEC 60601-1, 3rdEd., Clause. 8.8

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:A short of the operational or basic insulation indicated in the table was made. The voltage present at theaccessible parts/circuitry was measured, recorded and compared to 42.4 V pk ac and 60 V dc.Description LinkQD2-001, QD2-010, QM2-011, QD2-009 IEC 60601-1,3rd Edition, Clause 8.4.2 and 8.11.1

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 107 of 141

Limits of Acceptance for Procedure of Evidence:The voltage did not exceed 42.4 V peak ac or 60 V dc.Description LinkQD2-001, QD2-010, QM2-011, QD2-009 IEC 60601-1,3rd Edition, Clause 8.4.2 and 8.11.1

Procedure of Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 IEC 60601-1,3rd Edition, Clause 8.4.2 and 8.11.1

Limits of Acceptance for Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 IEC 60601-1,3rd Edition, Clause 8.4.2 and 8.11.1

Procedure of Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 IEC 60601-1,3rd Edition, Clause 8.4.2 and 8.11.1

Limits of Acceptance for Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 IEC 60601-1,3rd Edition, Clause 8.4.2 and 8.11.1

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 108 of 141

Responsible:Implementation: Chen, Ernest Supervision: Lin, Eason

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 7/18/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The permissible environmental conditions for transportand storage were marked on the outside of thepackaging

Comment: Packing

RC-028Measure Number:Measure Text:

Measure Status:

The permissible environmental conditions for transport and storage weremarked on the outside of the packaging.Completed

Functions Hazards CausesPackingElectromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:QD2-001, QM2-007Description LinkQQ1-001

Limits of Acceptance for Procedure of Evidence:QD2-001, QM2-007Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 109 of 141

Procedure of Verification:QD2-001, QM2-007Description LinkQQ1-001

Limits of Acceptance for Verification:QD2-001, QM2-007Description LinkQQ1-001

Procedure of Validation:QD2-001, QM2-007Description LinkQQ1-001

Limits of Acceptance for Validation:QD2-001, QM2-007Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 110 of 141

Responsible:Implementation: Chen, Ernest Supervision: Lin, Eason

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/9/2013 End: 7/15/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: The strength of packing carton / fixed frame. Thetransportation stimulation for the verification. Allconnections were mechanically secure.

Comment: Transport

RC-029Measure Number:Measure Text:

Measure Status:

The strength of packing carton / fixed frame. The transportationstimulation for the verification. All connections were mechanically secure.Completed

Functions Hazards CausesTransportElectromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:QD2-001 and QM2-007Description LinkQQ1-001

Limits of Acceptance for Procedure of Evidence:QD2-001 and QM2-007Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 111 of 141

Procedure of Verification:QD2-001 and QM2-007Description LinkQQ1-001

Limits of Acceptance for Verification:QD2-001 and QM2-007Description LinkQQ1-001

Procedure of Validation:QD2-001 and QM2-007Description LinkQQ1-001

Limits of Acceptance for Validation:QD2-001 and QM2-007Description LinkQQ1-001

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 112 of 141

Responsible:Implementation: Chen, Ernest Supervision: Lin, Eason

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/2/2013 End: 7/2/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Compliance is checked by the mechanical strength testsfor ENCLOSURES (see 15.3).

Comment: ENCLOSURES shall have the strength and rigiditynecessary to avoid a fire that could occur as a result of atotal or partial collapse caused by reasonablyforeseeable misuse.

RC-030Measure Number:Measure Text:

Measure Status:

The suitable enclosure shall be provided.

Completed

Functions Hazards CausesInternal parts, other than contacts ofplugs, connectors and socket-outlets,that can be touched by the test pinshown in IEC 60601-1, Figure 8.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 113 of 141

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 aperiod of 5 seconds applied to different parts of the enclosure via a test tool providing contact over acircular plane surface 30 mm in diameter as indicated in Table 15.3. Note: not applied to the bottom of a producthaving 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 asolid steel 50 mm (approx) ball of mass 500 g plus or minus 25 g, fall freely from 1,3 meter height. The unit wasrigidly supported and the impact was applied to the locations indicated in Table 15.3.Description LinkIEC 60601-1, 3rd Edition, Clause 15.3

Limits of Acceptance for Procedure of Evidence:There was no cracking of the enclosure.There were no live parts that became accessibleDescription LinkIEC 60601-1, 3rd Edition, Clause 15.3

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 15.3

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 15.3

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 15.3

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 15.3

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 114 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/8/2013 End: 7/12/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: They shall comply with the applicable safetyrequirements of a relevant IEC, UL or ISO standard;

Comment: The reliability of components that are used as MEANSOF PROTECTION shall be assessed for the conditionsof use in the monitor and power supply.

RC-031Measure Number:Measure Text:

Measure Status:

They shall comply with the applicable safety requirements of a relevantIEC, UL or ISO standard;Completed

Functions Hazards CausesThe reliability of components that areused as MEANS OF PROTECTIONare not assessed for the conditionsof use in the PC.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 115 of 141

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 IECcomponent standard shall be checked for correct application and use in accordance with its rating. It shall besubjected to the applicable tests of IEC 60601-1 as part of the equipment with the exception of those tests whichare 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 forcorrect application and use in accordance with its specified rating. It shall be subjected to the applicable tests ofIEC 60601-1, as part of the equipment, and to the applicable tests of the component standard, under theconditions occurring in the equipment;- where no relevant IEC component standard exists, or where components are used in circuits not in accordancewith their specified ratings, the components shall be tested under the conditions occurring in the equipment. Thenumber of samples required for test is, in general, the same as required by an quivalent standard.Description LinkQD2-001, QD2-010, QM2-011, QD2-009 and IEC60601-1, Clause 4.8

Limits of Acceptance for Procedure of Evidence:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 and IEC60601-1, Clause 4.8

Procedure of Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 and IEC60601-1, Clause 4.8

Limits of Acceptance for Verification:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 and IEC60601-1, Clause 4.8

Procedure of Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 and IEC60601-1, Clause 4.8

Limits of Acceptance for Validation:see aboveDescription LinkQD2-001, QD2-010, QM2-011, QD2-009 and IEC60601-1, Clause 4.8

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 116 of 141

Responsible:Implementation: Yuan, Andy Supervision: Chen, Ernest

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/7/2013 End: 7/10/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: When PC and power supply is operated in worst-caseNORMAL USE including the maximum ambientoperating temperature, the parts shall not reachtemperatures exceeding the values given in IEC60601-1, Table 22 and Table 23.

Comment: Excessive temperatures in PC and/or power supply.

RC-032Measure Number:Measure Text:

Measure Status:

When PC is operated in worst-case NORMAL USE including themaximum ambient operating temperature, the parts shall not reachtemperatures exceeding the values given in IEC 60601-1, Table 22 andTable 23.Completed

Functions Hazards CausesExcessive temperatures in PC and/orpower supply.

Thermal EnergyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:The sample was placed in a test corner. The test corner consisted of two walls at right angles, and a floor, all ofdull black painted plywood of 20 mm thickness. The linear dimensions of the test corner were at least 115percent of the linear dimensions of the unit. The unit was positioned as near to the walls as possible and to thefloor. The power supply is operated until THERMAL STABILITY is reached.Description LinkIEC 60601-1, 3rd Edition, Clause 11

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 117 of 141

Limits of Acceptance for Procedure of Evidence:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11

Procedure of Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11

Limits of Acceptance for Verification:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11

Procedure of Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11

Limits of Acceptance for Validation:see aboveDescription LinkIEC 60601-1, 3rd Edition, Clause 11

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 118 of 141

Responsible:Implementation: Lin , Mac Supervision: Yuan, Andy

Planning:Begin: 5/1/2013 End: 8/31/2013

Actual Values:Begin: 5/6/2013 End: 6/27/2013

Effort:planned: Is:

Validation:Validated by: Validated on: 7/19/2013

Validated:Chen, James

Release:Released by: Release on: 7/19/2013

Released:Lin, Mac

Decided Individual Measures: Where there is no relevant IEC or ISO standard, therequirements of IEC 60601-1 3rd Ed. were applied.

Comment: The reliability of components that are used as MEANSOF PROTECTION are not assessed for the conditions ofuse in the PC.

RC-033Measure Number:Measure Text:

Measure Status:

Where there is no relevant IEC or ISO standard, the requirements of IEC60601-1, 3rd Ed. were applied.Completed

Functions Hazards CausesThe reliability of components that areused as MEANS OF PROTECTIONare not assessed for the conditionsof use in the PC.

Electromagnetic energyConnect to Mains

Implementation Team:

Chen, JamesLin , MacLin, EasonChen, ErnestYuan, Andy

Procedure for Evidence of Efficency of Measures:QD2-001, QD2-010, QM2-011 and QD2-009Description LinkIEC 60601-1, Clause 4.8

Release Protocol of M

easuresProject: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 119 of 141

Limits of Acceptance for Procedure of Evidence:QD2-001, QD2-010, QM2-011 and QD2-009Description LinkIEC 60601-1, Clause 4.8

Procedure of Verification:QD2-001, QD2-010, QM2-011 and QD2-009Description LinkIEC 60601-1, Clause 4.8

Limits of Acceptance for Verification:QD2-001, QD2-010, QM2-011 and QD2-009Description LinkIEC 60601-1, Clause 4.8

Procedure of Validation:QD2-001, QD2-010, QM2-011 and QD2-009Description LinkIEC 60601-1, Clause 4.8

Limits of Acceptance for Validation:QD2-001, QD2-010, QM2-011 and QD2-009Description LinkIEC 60601-1, Clause 4.8

Evaluation After M

easures

2013-08-22 Page 120 of 141

Evaluation After MeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

Function: F-01 Connect to Mains

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 121 of 141

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Electromagnetic energy C-01 Short circuit of any or allinsulation that does not complywith the requirements of IEC60601-1, 3rd Ed., Clause. 8.8

Serious Remote AcceptableArea

C-02 Short circuit of any or allCREEPAGE DISTANCES or AIRCLEARANCES that do notcomply with the requirements ofIEC 60601-1, 3rd Ed., Clause 8.9

Serious Remote AcceptableArea

C-03 Open circuit of any or all earthconnections that do not complywith the requirements of IEC60601-1, Clause 8.6, includingany functional earth connection.

Serious Remote AcceptableArea

C-04 Short circuit of any one insulationthat complies with therequirements for one MEANS OFPROTECTION as specified in IEC60601-1, Clause 8.8

Critical Improbable AcceptableArea

C-05 Short circuit of any oneCREEPAGE DISTANCE or AIRCLEARANCE that complies withthe requirements for one MEANSOF PROTECTION as specified inIEC 60601-1, Clause 8.9

Critical Improbable AcceptableArea

C-06 Open circuit of any onePROTECTIVE EARTHCONDUCTOR or internalPROTECTIVE EARTHCONNECTION that complies withthe requirements of IEC 60601-1,Clause 8.6

Critical Improbable AcceptableArea

C-07 All components, including wiring,the failure of which could result ina HAZARDOUS SITUATION.

Serious Improbable AcceptableArea

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 122 of 141

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

C-08 The reliability of components thatare used as MEANS OFPROTECTION are not assessedfor the conditions of use in thePC.

Critical Improbable AcceptableArea

C-09 Storage (humidity preconditioningtreatment)

Serious Improbable AcceptableArea

C-10 Transport Serious Remote AcceptableArea

C-11 Components of PC, unwantedmovement of which could result inan unacceptableb RISK, is notmounted securely to prevent suchmovement.

Serious Remote AcceptableArea

C-12 Too high leakage current, causinga death or serious injury to apatient.

Critical Improbable AcceptableArea

C-13 The LEAKAGE CURRENTS from,to or between ACCESSIBLEPARTS other than PATIENTCONNECTIONS

Critical Improbable AcceptableArea

C-14 ACCESSIBLE PARTS exceed42.4 V peak a.c. or 60 V d.c. inNORMAL CONDITION or inSINGLE FAULT CONDITION.

Critical Improbable AcceptableArea

C-15 Internal parts, other than contactsof plugs, connectors and socket-outlets, that can be touched bythe test pin shown in IEC60601-1, Figure 8.

Serious Improbable AcceptableArea

C-16 Accidental detachment ofconductors and connectors wherebreaking free could lead to aHAZARDOUS SITUATION

Serious Improbable AcceptableArea

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 123 of 141

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

C-17 The resistance to heat is notretained by all types of insulation,including insulating partition walls,during the EXPECTED SERVICELIFE of the PC.

Serious Remote AcceptableArea

C-18 Internal cables and wiring is notadequately protected againstcontact with a moving part or fromfriction at sharp corners andedges where damage toinsulation.

Serious Remote AcceptableArea

C-19 Electromagnetic compatibility ofPC.

Critical Improbable AcceptableArea

C-20 Packing Serious Improbable AcceptableArea

C-21 Wirings and connectors of PanelPC Monitor supply is not securedor insulated that accidentaldetachment can result in aHAZARDOUS SITUATION.

Serious Improbable AcceptableArea

C-22 Internal cables and wiring werenot adequately protected againstcontact from friction at sharpcorners and edges wheredamage to insulation could resultin a HAZARDOUS SITUATION.

Serious Remote AcceptableArea

C-23 Cleaning Minor Improbable AcceptableArea

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 124 of 141

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-02 Thermal Energy C-01 Excessive temperatures in PCand/or power supply.

Serious Remote AcceptableArea

C-02 ENCLOSURES have no thestrength and rigidity necessary toavoid a fire.

Critical Improbable AcceptableArea

Function: F-02 Enclosure

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Mechanical energy C-01 Falling Serious Remote AcceptableArea

C-02 Suspended masses Serious Remote AcceptableArea

C-03 Sharp edges and corners Minor Remote AcceptableArea

H-02 Thermal Energy C-01 Excessive temperatures inenclosure

Serious Remote AcceptableArea

Function: F-03 Rear Bracket

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Mechanical energy C-01 Crack Serious Remote AcceptableArea

C-02 Suspended masses Serious Remote AcceptableArea

C-03 Instability Serious Remote AcceptableArea

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 125 of 141

Function: F-04 Signal input

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Electromagnetic energy C-01 ACCESSIBLE PARTS exceed42.4 V peak a.c. or 60 V d.c. inNORMAL CONDITION or inSINGLE FAULT CONDITION.

Critical Improbable AcceptableArea

Function: F-05 Signal output

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Acoustic energy (sound) C-01 earphone Serious Remote AcceptableArea

Function: F-06 User control and indicator

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Operational C-01 Switches used to control power toPC or its parts, includingswitches, did not have their "on"and "off" positions

Serious Remote AcceptableArea

Function: F-07 Information

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 126 of 141

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Labeling C-01 PC did not marke with the nameor trademark of Onyx and with aMODEL OR TYPE REFERENCE

Minor Remote AcceptableArea

C-02 Incomplete instructions for use Critical Improbable AcceptableArea

C-03 Inadequate description ofperformance characteristics

Serious Remote AcceptableArea

C-04 Inadequate specification ofintended use.

Critical Improbable AcceptableArea

C-05 Inadequate disclosure oflimitations

Critical Improbable AcceptableArea

H-02 Operating instructions C-01 Inadequate specification ofaccessories to be used with themedical device.

Serious Improbable AcceptableArea

C-02 Inadequate specification of pre-use checks.

Minor Remote AcceptableArea

C-03 Over-complicated operatinginstructions

Minor Remote AcceptableArea

H-03 Specification of service andmaintenance

C-01 Installation instruction Serious Remote AcceptableArea

Function: F-08 Connection to an external d.c. power source

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Thermal Energy C-01 When a connection with thewrong polarity is made

Serious Improbable AcceptableArea

Function: F-09 Display

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

Evaluation After M

easures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 127 of 141

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Radiation energy C-01 Visible Light Minor Remote AcceptableArea

Function: F-10 BIOS (Basic Input/Output System - real time clock)

CommentRisk-Benefit-AnalysisRisk AreaProbabilitySeverityHazard Cause

H-01 Mechanical energy C-01 Lithium battery explosion Critical Improbable AcceptableArea

Risk G

raph After M

easures

2013-08-22 Page 128 of 141

Acceptable Area ALARP Area Inacceptable Area

Risk Graph After MeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

Both Conditions Operating Condition

Failure Mode

Risk G

raph Before and A

fter Measures

2013-08-22 Page 129 of 141

Acceptable Area ALARP Area Inacceptable Area

Risk Graph Before and AfterMeasuresProject: 1307033002, ONYX-2121DT | Version: 1.00

After MeasuresBefore Measures

Both Conditions

Operating Condition

Both Conditions

Operating Condition

Risk G

raph Before and A

fter Measures

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 130 of 141

Acceptable Area ALARP Area Inacceptable Area

Failure Mode Failure Mode

Evaluation of Residual R

isk

2013-08-22 Page 131 of 141

Evaluation of Residual RiskProject: 1307033002, ONYX-2121DT | Version: 1.00

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 thedata have been documented in the enclosed tables before the required measures for the risk diminution havebeen 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 weredefined: "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 evaluationsin the "intolerable" region after implementation of the measures.

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 representany risk for the user.

Remaining Residual Risk, Summarizing Evaluation

Post production

2013-08-22 Page 132 of 141

Post productionProject: 1307033002, ONYX-2121DT | Version: 1.00

Overview

of the Results of the R

iskM

anagement

2013-08-22 Page 133 of 141

Overview of the Results of the RiskManagementProject: 1307033002, ONYX-2121DT | Version: 1.00

Function: F-01 Connect to Mains

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Electromagneticenergy

C-01 Short circuit of any or allinsulation that does notcomply with therequirements of IEC60601-1, 3rd Ed., Clause.8.8

S3 / P3InacceptableArea

S3 / P2Acceptable Area

The limits specified in IEC60601-1, Clause 8.4 is not beexceeded for ACCESSIBLEPARTS

YesM-01 Yes

C-02 Short circuit of any or allCREEPAGE DISTANCESor AIR CLEARANCES thatdo not comply with therequirements of IEC60601-1, 3rd Ed., Clause8.9

S3 / P3InacceptableArea

S3 / P2Acceptable Area

The limits specified in IEC60601-1, Clause 8.4 is not beexceeded for ACCESSIBLEPARTS

YesM-01 Yes

C-03 Open circuit of any or allearth connections that donot comply with therequirements of IEC60601-1, Clause 8.6,including any functionalearth connection.

S3 / P3InacceptableArea

S3 / P2Acceptable Area

The limits specified in IEC60601-1, Clause 8.4 is not beexceeded for ACCESSIBLEPARTS

YesM-01 Yes

C-04 Short circuit of any oneinsulation that complieswith the requirements forone MEANS OFPROTECTION asspecified in IEC 60601-1,

S4 / P3InacceptableArea

S4 / P1Acceptable Area

The HAZARDOUS SITUATIONSin IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur inthe PC and power adapter.

YesM-01 Yes

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 134 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

Clause 8.8C-05 Short circuit of any one

CREEPAGE DISTANCE orAIR CLEARANCE thatcomplies with therequirements for oneMEANS OFPROTECTION asspecified in IEC 60601-1,Clause 8.9

S4 / P2InacceptableArea

S4 / P1Acceptable Area

The HAZARDOUS SITUATIONSin IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur inthe PC and power adapter.

YesM-01 Yes

C-06 Open circuit of any onePROTECTIVE EARTHCONDUCTOR or internalPROTECTIVE EARTHCONNECTION thatcomplies with therequirements of IEC60601-1, Clause 8.6

S4 / P3InacceptableArea

S4 / P1Acceptable Area

The HAZARDOUS SITUATIONSin IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur inthe PC and power adapter.

YesM-01 Yes

C-07 All components, includingwiring, the failure of whichcould result in aHAZARDOUSSITUATION.

S3 / P2Acceptable Area

S3 / P1Acceptable Area

All components, including wiringshall be used in accordance withtheir specified ratings.

YesM-01 Yes

All components, including wiring,the failure of which could result ina HAZARDOUS SITUATION arefixed in place by UL R/C non-chemical bonding compound.

YesM-02 Yes

C-08 The reliability ofcomponents that are usedas MEANS OFPROTECTION are notassessed for theconditions of use in thePC.

S4 / P2InacceptableArea

S4 / P1Acceptable Area

They shall comply with theapplicable safety requirements ofa relevant IEC, UL or ISOstandard;

YesM-01 Yes

Where there is no relevant IEC orISO standard, the requirementsof IEC 60601-1, 3rd Ed. wereapplied.

YesM-02 Yes

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 135 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

C-09 Storage (humiditypreconditioning treatment)

S3 / P3InacceptableArea

S3 / P1Acceptable Area

The humidity preconditioningtreatment is performed in ahumidity cabinet containing airwith a relative humidity of 93 % ±3 % @ 25 °C 48 hr

YesM-01 Yes

C-10 Transport S3 / P2Acceptable Area

S3 / P2Acceptable Area

The strength of packing carton /fixed frame. The transportationstimulation for the verification. Allconnections were mechanicallysecure.

YesM-01 Yes

C-11 Components of PC,unwanted movement ofwhich could result in anunacceptableb RISK, isnot mounted securely toprevent such movement.

S3 / P2Acceptable Area

S3 / P2Acceptable Area

Said components were securedin place on pcb by ULRecognized non-chemicalbonding compound.

YesM-01 Yes

C-12 Too high leakage current,causing a death orserious injury to a patient.

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Meet IEC 60601-1, Clause 8.7LEAKAGE CURRENTS andPATIENT AUXILIARYCURRENTS requirements

YesM-01 Yes

C-13 The LEAKAGECURRENTS from, to orbetween ACCESSIBLEPARTS other thanPATIENT CONNECTIONS

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Meet IEC 60601-1, Clause 8.7LEAKAGE CURRENTS andPATIENT AUXILIARYCURRENTS requirements

YesM-01 Yes

C-14 ACCESSIBLE PARTSexceed 42.4 V peak a.c. or60 V d.c. in NORMALCONDITION or in SINGLEFAULT CONDITION.

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Supplied by SELV power adapterand DC/AC inverter meet LCCrequirements.

YesM-01 Yes

C-15 Internal parts, other thancontacts of plugs,connectors and socket-outlets, that can betouched by the test pin

S3 / P2Acceptable Area

S3 / P1Acceptable Area

The suitable enclosure shall beprovided.

YesM-01 Yes

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 136 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

shown in IEC 60601-1,Figure 8.

C-16 Accidental detachment ofconductors andconnectors wherebreaking free could lead toa HAZARDOUSSITUATION

S3 / P3InacceptableArea

S3 / P1Acceptable Area

The HAZARDOUS SITUATIONSin IEC 60601-1, Clause 13.1.2 to13.1.4 (inclusive) do not occur inthe PC and power adapter.

YesM-01 Yes

C-17 The resistance to heat isnot retained by all types ofinsulation, includinginsulating partition walls,during the EXPECTEDSERVICE LIFE of the PC.

S3 / P3InacceptableArea

S3 / P2Acceptable Area

Shall compliance with thefollowing tests: resistance tomoisture, etc. (see IEC 60601-1,Clause 11.6); dielectric strength(see IEC 60601-1, Clause 8.8.3);and mechanical strength (seeIEC 60601-1, Clause 15.3).

YesM-01 Yes

Ball pressure test - according toIEC 60601-1, Clause 8.8.4.1, b)requirements

YesM-02 Yes

C-18 Internal cables and wiringis not adequatelyprotected against contactwith a moving part or fromfriction at sharp cornersand edges where damageto insulation.

S3 / P3InacceptableArea

S3 / P2Acceptable Area

Internal cables and wiring is fixedin place by cable tie to protectagainst contact with a movingpart or from friction at sharpcorners and edges wheredamage to insulation

YesM-01 Yes

C-19 Electromagneticcompatibility of PC.

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Meet IEC 60601-1-2requirements

YesM-01 Yes

C-20 Packing S3 / P3InacceptableArea

S3 / P1Acceptable Area

The permissible environmentalconditions for transport andstorage were marked on theoutside of the packaging.

YesM-01 Yes

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 137 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

C-21 Wirings and connectors ofPanel PC Monitor supplyis not secured or insulatedthat accidentaldetachment can result in aHAZARDOUSSITUATION.

S3 / P2Acceptable Area

S3 / P1Acceptable Area

All wirings are tied together bycable tie to prevent accidentaldetachment

YesM-01 Yes

C-22 Internal cables and wiringwere not adequatelyprotected against contactfrom friction at sharpcorners and edges wheredamage to insulation couldresult in a HAZARDOUSSITUATION.

S3 / P2Acceptable Area

S3 / P2Acceptable Area

The internal wirings were securedin place on PCB by UL R/C non-chemical bonding component.

YesM-01 Yes

C-23 Cleaning S2 / P2Acceptable Area

S2 / P1Acceptable Area

The equipment complied with therequirements of IEC 60601-1,Clause 11.6.

YesM-01 Yes

H-02 Thermal Energy C-01 Excessive temperatures inPC and/or power supply.

S3 / P3InacceptableArea

S3 / P2Acceptable Area

When PC is operated in worst-case NORMAL USE including themaximum ambient operatingtemperature, the parts shall notreach temperatures exceedingthe values given in IEC 60601-1,Table 22 and Table 23.

YesM-01 Yes

C-02 ENCLOSURES have nothe strength and rigiditynecessary to avoid a fire.

S4 / P2InacceptableArea

S4 / P1Acceptable Area

Compliance with the mechanicalstrength tests for ENCLOSURES(see IEC 60601-1, Clause 15.3)

YesM-01 Yes

Function: F-02 Enclosure

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Mechanical energy C-01 Falling S3 / P3Inacceptable

S3 / P2Acceptable Area

Meet IEC 60601-1, Clause 9.4.2requirements.

YesM-01 Yes

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 138 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

AreaC-02 Suspended masses S3 / P3

InacceptableArea

S3 / P2Acceptable Area

Meet IEC 60601-1 Clause 9.8.2and Table 21 requirements.

YesM-01 Yes

C-03 Sharp edges and corners S2 / P4InacceptableArea

S2 / P2Acceptable Area

Rounding of sharp edges andcorners.

YesM-01 Yes

H-02 Thermal Energy C-01 Excessive temperatures inenclosure

S3 / P3InacceptableArea

S3 / P2Acceptable Area

When PC is operated in worst-case NORMAL USE including themaximum ambient operatingtemperature, the parts shall notreach temperatures exceedingthe values given in IEC 60601-1,Table 22 and Table 23.

YesM-01 Yes

Function: F-03 Rear Bracket

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Mechanical energy C-01 Crack S3 / P3InacceptableArea

S3 / P2Acceptable Area

Meet IEC 60601-1 Clause 9.8.2and Table 21 requirements.

YesM-01 Yes

C-02 Suspended masses S3 / P2Acceptable Area

S3 / P2Acceptable Area

Meet IEC 60601-1 Clause 9.8.2and Table 21 requirements.

YesM-01 Yes

C-03 Instability S3 / P3InacceptableArea

S3 / P2Acceptable Area

Meet IEC 60601-1, Clause 9.4.2requirements.

YesM-01 Yes

Function: F-04 Signal input

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 139 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Electromagneticenergy

C-01 ACCESSIBLE PARTSexceed 42.4 V peak a.c. or60 V d.c. in NORMALCONDITION or in SINGLEFAULT CONDITION.

S4 / P2InacceptableArea

S4 / P1Acceptable Area

Supplied by SELV power adapterand DC/AC inverter meet LCCrequirements.

YesM-01 Yes

Function: F-05 Signal output

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Acoustic energy(sound)

C-01 earphone S3 / P3InacceptableArea

S3 / P2Acceptable Area

Meet IEC 60950-1, Annex NADAcoustic tests requirements

YesM-01 Yes

Function: F-06 User control and indicator

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Operational C-01 Switches used to controlpower to PC or its parts,including switches, did nothave their "on" and "off"positions

S3 / P3InacceptableArea

S3 / P2Acceptable Area

Indicated by an adjacent indicatorlight

YesM-01 Yes

Marked with symbols IEC 60417 YesM-02 Yes

Function: F-07 Information

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Labeling C-01 PC did not marke with thename or trademark ofOnyx and with a MODELOR TYPE REFERENCE

S2 / P3Acceptable Area

S2 / P2Acceptable Area

PC marked the name ortrademark of Onyx with model no.

YesM-01 Yes

C-02 Incomplete instructions foruse

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 140 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

C-03 Inadequate description ofperformancecharacteristics

S3 / P3InacceptableArea

S3 / P2Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

C-04 Inadequate specification ofintended use.

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

C-05 Inadequate disclosure oflimitations

S4 / P3InacceptableArea

S4 / P1Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

H-02 Operatinginstructions

C-01 Inadequate specification ofaccessories to be usedwith the medical device.

S3 / P2Acceptable Area

S3 / P1Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

C-02 Inadequate specification ofpre-use checks.

S2 / P3Acceptable Area

S2 / P2Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

C-03 Over-complicatedoperating instructions

S2 / P3Acceptable Area

S2 / P2Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

H-03 Specification ofservice andmaintenance

C-01 Installation instruction S3 / P3InacceptableArea

S3 / P2Acceptable Area

Meet IEC 60601-1, Clause 7requirements.

YesM-01 Yes

Function: F-08 Connection to an external d.c. power source

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Thermal Energy C-01 When a connection withthe wrong polarity is made

S3 / P3InacceptableArea

S3 / P1Acceptable Area

Provided a connector that hasspecial housing to prevent aconnection with the wrongpolarity is made

YesM-01 Yes

Function: F-09 Display

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

Overview

of the Results of the R

iskM

anagement

Project: 1307033002, ONYX-2121DT | Version: 1.00 ONYX HEALTHCARE INC.

2013-08-22 Page 141 of 141

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Radiation energy C-01 Visible Light S2 / P3Acceptable Area

S2 / P2Acceptable Area

The intensity of visible light frommonitor can be controlled by theuser. The highest intensityachievable cannot producedetrimental biological effects.

YesM-01 Yes

Function: F-10 BIOS (Basic Input/Output System - real time clock)

Risk AfterMeasures

Relea-se

Imple-mentMeasureRisk Before

MeasuresEffect onCauseHazard

H-01 Mechanical energy C-01 Lithium battery explosion S4 / P3InacceptableArea

S4 / P1Acceptable Area

Battery circuits is designed sothat discharging at a rateexceeding the batterymanufacturer’srecommendations, andunintentional charging, areprevented.

YesM-01 Yes