Risk Analysis 18.5 Bedside Touch Monitor, model...

Risk Analysis18.5" Bedside Touch Monitor, modelONYX-BE381DT

Abbreviation: ONYX-BE381DT

Project Number:

Project Description: The model ONYX-BE381DT are 18.5"Bedside Touch Monitor is considered as apart of Medical Device Data System(MDDS)

1403042003

Version Number:

Version Description:

Life Cycle Phase:

1.00

Workable version for evaluation purpose

Functional design

2014-06-17

ONYX HEALTHCARE INC.

Creation Date:

Company:

Table of Content

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The Following Documents have been Compiled as a Report: Page

Definitions and Abbreviations 3

Project Data 5

Version Data 6

Project Team 11

Definition of the Risk Graph 17

Release Criteria 19

Grey Box 21

Risk Analysis 22

Risk Evaluation Before Measures 32

Risk Graph Before Measures 40

Decision about Measures 41

Risk Control 55

Release Protocol of Measures 61

Evaluation After Measures 127

Risk Graph After Measures 135

Risk Graph Before and After Measures 136

Evaluation of Residual Risk 138

Post production 139

Overview of the Results of the Risk Management 140

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Definitions and AbbreviationsProject: 1403042003, ONYX-BE381DT | Version: 1.00

Definitions

Word ExplanationAbnormal Use Intended act or intended omission of an act by the user or operator of equipment as a

result of conduct that is beyond any reasonable means of risk mitigation by themanufacturer.

Adverse Event Any device-related event that has or may have caused or contributed to a death, orserious injury/deterioration (of patient, user or other person), or has allegedly involved adevice malfunction that would be likely to cause or contribute to a death or serious injury(deterioration) if the malfunction were to recur. Such events require notification to theappropriate regulatory agency per defined regulations.

Approval Agreement that an item or set of actions is complete, has been reviewed, and that theapprover concurs or agrees with the outcome and endorses any follow-up actionsthrough a valid signature. To give formal or official sanction to an item.

Design History File This contains or references the documents that constitute the compilation of recordsdescribing the design history of a finished device. The Design History File is notnecessarily in a single location. The Design History File covers the technicalrequirements for Quality System Regulations and the Medical Device Directive.

Direct Harm Caused by the energy or substance delivered, or not delivered, by/through the product.(i.e. Ventilator)

Harm Physical injury or damage to the health of people or damage to property or theenvironment.NOTE: Include unreasonable psychological stress or unwanted pregnancy as part of“damage to the health of people.”

Hazard Potential source of harm.

Hazardous Situation The possibility of any degree of injury, actual or potential, associated with an event.

Indirect Harm An injury caused when a product leads an individual to either perform an action or fail toperform an action based on its performance.

Intended Use Use of a product, process, or service in accordance with the specifications, instructions,and information provided by the manufacturer.

Labeling Written, printed, electronic, or graphical information included on the device, packagedwith the device, accompanied with the device or marketing material, including web-basedpromotional material. Labeling includes instructions for use, product labels, data sheets,marketing materials/information and promotional materials, installation and servicemanuals.

Medical Device Any instrument, apparatus, appliance, material or other article, whether used alone or incombination, including the software necessary for its proper application intended by themanufacturer to be used for human beings for the purpose of:- Diagnosis, prevention, monitoring, treatment or alleviation of disease,- Diagnosis, monitoring, treatment, alleviation of or compensation for an injury orhandicap,- Investigation, replacement or modification of the anatomy or of a physiological process,- Control of conception, and which does not achieve its principal intended action in or onthe human body by pharmacological, immunological or metabolic means, but which maybe assisted in its function by such means NOTE: The term “medical device” is defined bynational law; therefore, consult the laws of the host country.

Medical Intervention Intervention by a medical professional to help, treat or cure a condition, this includesmedical or surgical.

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Word ExplanationNormal Use Operation, including routine inspection and adjustments by any operator, and stand-by,

according to the instructions for use.NOTE: Normal use should not be confused with intended use. While both include theconcept of use as intended by the manufacturer, intended use focuses on the medicalpurpose while normal use incorporates not only the medical purpose, but maintenance,service, transport, others as well.

Operator Any person handling the (electromedical) equipment.

Patient Living being (person or animal) undergoing a medical, surgical, or dental procedure.NOTE: Include disabled persons.

Post Market Data Information regarding complaints, internal defect discoveries, reports on same or similarproducts.

Probability of Harm The combination of two factors, probability of occurrence (P1) and Likelihood of Harm(P2). Also known as Total Probability.(P = P1 * P2)

Product Change Any modification to the existing product or documentation changes (e.g. labeling,including warnings or instructions for use that may be hazard mitigations). This type ofchange also includes any observations made during the product development processand prior to product release.

Quality The totality of features and characteristics that bears on the ability of a device (orproduct) to satisfy fitness-for-use, including safety and performance (based on FDA CFR820). The degree to which a set of inherent characteristics fulfills requirements.(ISO/ANSI/ASQ Q9000-2000)

Reasonably Foreseeable Misuse Use by the operator in a way not intended by the manufacturer but which can result fromreadily predictable human behavior.

Residual Risk Risks remaining after risk mitigations have been taken.

Risk Combination of the probability of occurrence of harm and the severity of that harm.

Risk Analysis Systematic use of available information to identify hazards and to estimate the risk.

Risk Assessment Overall process comprising a risk analysis and a risk evaluation. Occurs in ProductDevelopment as initial and final risk assessments and in Commercial Release aspostproduction risk assessments.

Risk Estimation Process used to assign values to the probability of occurrence of harm and the severity ofthat harm.

Risk Evaluation Process of comparing the estimated risk against the given risk criteria to determine theacceptability of the risk.

Risk Management Systematic application of management policies, procedures and practices to the tasks ofanalyzing, evaluating and controlling and monitoring risk.

Risk Management File The set of records and documents produced by risk management. It is a subset of theproduct’s Design History File.

Risk Mitigation Process in which decisions are made and measures implemented by which risks arereduced to, or maintained within, specified levels.

Safety Freedom from unacceptable risk.

Severity Measure of the possible consequences of a hazard. Also known as the Potential Severityof Harm.

Single Point Failure A failure that is a direct cause of a hazardous situation.

User Authority responsible for the use and maintenance of equipment.

Medical Device Data System(MDDS)

1. A medical device data system (MDDS) is a device that is intended to provide one ormore of the following uses, without controlling or altering the functions or parameters ofany connected medical devices:- The electronic transfer of medical device data;- The electronic storage of medical device data;- The electronic conversion of medical device data from one format to another format inaccordance with a preset specification; or- The electronic display of medical device data.2. An MDDS may include software, electronic or electrical hardware such as a physicalcommunications medium (including wireless hardware), modems, interfaces, and acommunications protocol. This identification does not include devices intended to be usedin connection with active patient monitoring.

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Project DataProject: 1403042003, ONYX-BE381DT | Version: 1.00

Abbreviation: ONYX-BE381DT

Project Number: 1403042003

Project Name: 18.5" Bedside Touch Monitor, model ONYX-BE381DT

Project Description:The model ONYX-BE381DT are 18.5" Bedside TouchMonitor is considered as a part of Medical Device DataSystem (MDDS)

Product Type: Example DIN EN ISO 14971:2003

ProductProject Type:

Project Management

Project Leader:

Substitute:

Responsible for the Risk:

Peter ChenJames Chen

Peter Chen

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Version DataProject: 1403042003, ONYX-BE381DT | Version: 1.00

Version No.:

Derived from Version:

Version Description:

Special Version:

Freeze Analysis and Evaluation Part:

1.00

1.00

Workable version for evaluation purpose

Intended Use:

1. 18.5" Bedside Touch Monitor benefits medical staff by providing secure access to electronic patientdata with an optimized hospital workflow. As an aid to professional diagnosis, the terminal can remotelyretrieve electronic patient records, access databases from the bedside and comply with HospitalInformation Systems (HIS) requirements. Hospital administrators will see their medical facilities gainoperational efficiencies, increase patient and visitor satisfaction, and improve their quality of care, whileboosting profitability. Bedside Touch Monitor, model ONYX-BE381DT is a 18.5" multi-function terminalwith touch screen, WiFi, RFID, and smart card reader. The ONYX-BE381DT is certified to ANSI/AAMIES 60601-1 and EN60601-1: 2006 medical standards. The WiFi, and Ethernet (RJ-45) connectivityprovides video phone service to help patients communicate with their families by internet. Identificationrecognition for both patients and hospital staff is made possible with RFID and a smart card reader. TwoUSB ports, an earphone jack and a microphone provide added flexibility. Additionally, an LED lightindicator button help alert hospital staff to important incidents. Equipped with a slim, clean, hospital-fitdesign, the product is sealed with an IP65 - certified front panel with IPX1 drip-proof approval. There is aVESA compliant for mounting the support arm.2. The rated input: 12 V dc, 4.2 A (for Monitor); 100-240 V ac, 50/60 Hz, 1.2-0.63 A (for power supply,model HEMG50-S120420-7 by Hitron)3. The operation temperature/humidity: 0-40 °C, 30%-75% RH and suitable storage from -20 °C to 60°C, 10% - 90% RH.4. This Bedside Touch Monitor intended to be used at any altitudes between 0 to 3,000 m.5. The Bedside Touch Monitor expected services life was 43,800 hours6. This Bedside Touch Monitor 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.

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7. This Bedside Touch Monitor was tested on a 20 A branch circuit. If used on a branch circuit greaterthan this, additional evaluation was necessary.8. This Bedside Touch Monitor has not been evaluated for patient connected applications.9. This Bedside Touch Monitor 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 Bedside Touch Monitor shall be installed assembled maintained or repair.11. This Bedside Touch Monitor incorporates the UL R/C and IEC 6060-1-1 certified power adapter,model HEMG50-S120420-7 by Hitron. This power is used in the conditions of overvoltage category II,Pollution Degree II.12. This Bedside Touch Monitor does not deliverer the energy to or extract the energy from the patient.13. This Bedside Touch Monitor does not deliver the substances to or extract the substances from thepatient.14. No any biological materials processed by the Ward Terminal for subsequent re -use.15. This Bedside Touch Monitor does not supply sterile or intended to be sterilized by the user, or otherapplicable microbiological controls.16. This Bedside Touch Monitor is not intended to be routinely cleaned and disinfected by the user.17. This Bedside Touch Monitor is not intended to modify the patient environment.18. This Bedside Touch Monitor does not take any measurements.19. This Bedside Touch Monitor is not intended for use in conjunction with medicines or other medicaltechnologies.20. This Bedside Touch Monitor has no unwanted outputs of energy.21. This Bedside Touch Monitor is susceptible to environmental influences (ambient, emc).22. This Bedside Touch Monitor influences the environment (emi).23. This Bedside Touch Monitor does not provided the essential consumables or accessories.24. This Bedside Touch Monitor is no need to maintenance and/or calibration.25. This Bedside Touch Monitor contain software, but the failure of the software does not lead to anunacceptable RISK.26. This Bedside Touch Monitor has a restricted shelf-life.27. This Bedside Touch Monitor has no any delayed and/or long-term use effects.28. This Bedside Touch Monitor does not subject mechanical forces.29. This Bedside Touch Monitor is not intended for single use.30. No need to safe decommissioning or disposal of the Bedside Touch Monitor.31. Installation or use of the Bedside Touch Monitor is required special training.32. This Bedside Touch Monitor has no output wire to connection end-product.33. This Bedside Touch Monitor is not used by person with special needs.34. This Bedside Touch Monitor did not use an alarm system.

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35. This Bedside Touch Monitor 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. Allowable maximum time for the part can be touched.Location Touch timeEnclosure outside near T1 (power supply) < 1 sec.Switch body < 10 min.Panel body < 10 min.Plastic enclosure outside near of main board < 10 min.Metal part outside near USB port < 10 min.

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

Life Cycle Phase: Functional design

Additional Documents

Description Title No. Location References Link

EN StandardInformation supplied by themanufacturer of medicaldevices

EN 1041:2008

EN Standard

Medical devices. Symbols tobe used with medical devicelabels, labelling andinformation to be supplied -General requirements

EN ISO 15223-1:2012

ANSI Standard

Medical electrical equipment- Part 1: Generalrequirements for basic safetyand essential performance(IEC 60601-1:2005, MOD)(Consolidated Text) (includesANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012,C1:2009/(R)2012 andA2:2010/(R)2012)

ANSI/AAMIES60601-1:2005(R2012) WITHAMENDMENTS

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ANSI Standard

Medical electrical equipment- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibility- Requirements and tests

ANSI/AAMI/IEC60601-1-2: 2007(R2012)

CAN/CSA Standard

Medical Electrical Equipment- Part 1: GeneralRequirements for BasicSafety and EssentialPerformance

CAN/CSA-C22.2NO. 60601- 1-08(R2008)

CAN/CSA Standard

Medical Electrical Equipment- Part 1: GeneralRequirements for BasicSafety and EssentialPerformance (Adopted IEC60601-1:2005, third edition,2005-12, includingcorrigendum 1:2006, andwith Canadian deviations)

CAN/CSA-C22.2NO. 60601- 1-08(R2013)

EN Standard

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

EN 60601-1:2006

EN Standard

Medical electrical equipment-- Part 1-2: Generalrequirements for basic safetyand essential performance -Collateral standard:Electromagnetic compatibility- Requirements and tests

EN 60601-1-2:2007

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IEC Standard

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

IEC 60601-1:2005+A1:2012

EN Standard

Medical devices - Applicationof risk management tomedical devices (ISO14971:2007, Correctedversion 2007-10-01)

EN ISO 14971:2012

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 for basic safetyand essential performance -Collateral standard:Electromagneticcompatibility - Requirementsand tests

IEC 60601-1-2:2007

IEC Standard

Analysis techniques forsystem reliability - Procedurefor failure mode andeffects analysis (FMEA)

IEC60812: 2006

ISO StandardMedical devices - Applicationof risk management tomedical devices

ISO 14971: 2007

IEC StandardInformation technologyequipment - Safety - Part 1:General requirements

IEC 60950-1 ed. 2:2005

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Project TeamProject: 1403042003, ONYX-BE381DT | Version: 1.00

Project Management

Project Leader: Peter ChenSubstitute Project Leader: James Chen

Risk Responsible: Peter Chen

Team Members: see next page

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