Special version - ONYX Healthcarefr.onyx-healthcare.com/product/88/certification/RMF_ONYX... ·...

12-14-2011

Project number: 1112024003

Project name: 18.5" Bedside Terminal, models xxxx-ONYX-BE18xDT-xxxxxxx

ONYX-BE18xDTShort name:

Version number:

Workable version for evaluation purposeVersion description:

Project manager:

Subst. project manager: James Chen

Steven Chen

Functional designLife cycle phase:

Project data

1.00

Project manager:

Subst. project manager:

Steven Chen

James Chen

Description of project

The models xxxx-ONYX-BE18xDT-xxxxxxx are 18.5" Bedside Terminal for medical equipment used.

Risk responsible: Steve Chen

Name of superior project:

Name of subordinate project:

Structure plan of complete project:

Marking:

Title:

Number:

Location:

Path:

References:

Product type: ISO 14971:2007

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12-14-2011




Version number:


Project manager:


Steven Chen


Version data

1.00

Version number:

Workable version for evaluation purpose

Version description:

1.00 Derived from version:

NoSpecial version:

Freezing of analysis and evaluation part: inactive

Intended use/purpose:

1. 18.5" RISC Mini Bedside Terminal benefits medical staff by providing secure access to electronic patient data with an optimized hospital workflow. As an aid to

professional diagnosis, the terminal can remotely retrieve electronic patient records, access databases from the bedside and comply with Hospital Information Systems

(HIS) requirements. Hospital administrators will see their medical facilities gain operational efficiencies, increase patient and visitor satisfaction, and improve their quality

of care, while boosting profitability. RISC Mini Bedside Terminal the xxxx-ONYX-BE18xDT-xxxxxxx (x = 0-9, A-Z, "-" or blank) is a 18.5" multi-function terminal with

touchscreen, WiFi, RFID, and smart card reader. The xxxx-ONYX-BE18xDT-xxxxxxx (x = 0-9, A-Z, "-" or blank) is certified to ANSI/AAMI ES 60601-1 and EN60601-1:

2006 medical standards. The WiFi, and Ethernet (RJ-45) connectivity provides video phone service to help patients communicate with their families by internet .

Identification recognition for both patients and hospital staff is made possible with RFID and a smart card reader. Two USB ports, an earphone jack and a microphone

provide added flexibility. Additionally, an LED light indicator button help alert hospital staff to important incidents. Equipped with a slim, clean, hospital-fit design. There is a VESA compliant for mounting the support arm.

2. The rated input: 24V dc, 2.91 A (There is a VESA compliant for appropriate wall mount apparatus); 100-240 V ac, 50/60 Hz, 1.8-0.8 A (for power supply, model GMPU70A-6 by Eljintek Inc.)

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 Terminal intended to be used at any altitudes between 0 to 3,000 m.

5. The Bedside Terminal expected services life was 43,800 hours

6. This Bedside Terminal was judged on the basis of the required creepage and clearances in the Third Edition of the Standard for Medical Electrical Equipment, IEC

60601-1 3rd Ed., Sub. clause 8.9 which covers the end-use product for which the component was designed.

7. This Bedside Terminal was tested on a 20 A branch circuit. If used on a branch circuit greater than this, additional evaluation was necessary.

8. This Bedside Terminal has not been evaluated for patient connected applications .

9. This Bedside Terminal has been evaluated as a Class I, continuous operation, ordinary equipment and has not been evaluated for use in the presence of a flammable

anesthetic mixture with air, oxygen, or nitrous oxide. An additional evaluation shall be made if the power supply is intended for use in other than Class I equipment.

10. This Bedside Terminal shall be installed assembled maintained or repair .

11. This Bedside Terminal incorporates the UL R/C and IEC 6060-1-1 certified power adapter, model GMPU70A-6 by ELJINTEK INC. This power is used in

the conditions of overvoltage category II, Pollution Degree II.

12. This Bedside Terminal does not deliverer the energy to or extract the energy from the patient .

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Project number: 1112024003 Version: 1.00 Short name: ONYX-BE18xDT 12-14-2011

Onyx Healthcare Inc.

13. This Bedside Terminal does not deliver the substances to or extract the substances from the patient .

14. No any biological materials processed by the Ward Terminal for subsequent re -use.

15. This Bedside Terminal does not supply sterile or intended to be sterilized by the user , or other applicable microbiological controls.

16. This Bedside Terminal is not intended to be routinely cleaned and disinfected by the user .

17. This Bedside Terminal is not intended to modify the patient environment .

18. This Bedside Terminal does not take any measurements.

19. This Bedside Terminal is not intended for use in conjunction with medicines or other medical technologies .

20. This Bedside Terminal has no unwanted outputs of energy.

21. This Bedside Terminal is susceptible to environmental influences (ambient, emc).

22. This Bedside Terminal influences the environment (emi).

23. This Bedside Terminal does not provided the essential consumables or accessories .

24. This Bedside Terminal is no need to maintenance and/or calibration.

25. This Bedside Terminal contain ssoftware, but the failure of the software does not lead to an unacceptable RISK.

26. This Bedside Terminal has a restricted shelf-life.

27. This Bedside Terminal has no any delayed and/or long-term use effects.

28. This Bedside Terminal does not subject mechanical forces.

29. This Bedside Terminal is not intended for single use.

30. No need to safe decommissioning or disposal of the Bedside Terminal .

31. Installation or use of the Bedside Terminal is required special training .

32. This Bedside Terminal has no output wire to connection end-product.

33. This Bedside Terminal is not used by person with special needs.

34. This Bedside Terminal did not use an alarm system.

35. This Bedside Terminal 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 time

Touch Panel Surface < 1min

Plastic Enclosure < 1min

Metal Enclosure < 1sec

Adapter Plastic Enclosure 10 sec - 1 min

Reasonably foreseeable misuse:

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

Life cycle phase: Functional design

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Reused components of other projects:

Description: Project: Abbreviation: Proj.-No: Vers.-No:

Additional information:

Marking: Name: References:

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Additional documents:

Description: Title: No.: Location: Path: References:

IEC Standard Medical electrical

equipment -- Part

1: General

requirements for

basic safety and

essential

performance

IEC

60601-1:

2005

IEC Standard Medical electrical

equipment -- Part

1-2: General

requirements for

basic safety and

essential

performance -

Collateral

standard:

Electromagnetic

compatibility -

Requirements

and tests

IEC

60601-1-2:

2007

(Modified)

IEC Standard Analysis

techniques for

system reliability

- Procedure for

failure mode and

effects analysis

(FMEA)

IEC60812:

2006

IEC Standard Information

technology

equipment -

Safety - Part 1:

General

requirements

IEC

60950-1

ed. 2:

2005

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Additional documents:

Description: Title: No.: Location: Path: References:

ISO Standard Medical devices

- Application of

risk management

to medical

devices

ISO

14971:

2007

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Version number:


Project manager:


Steven Chen


Project team

1.00

Project number: 1112024003 Version: 1.00 Short name: ONYX-BE18xD

T

12-14-2011


Project manager:


Steven Chen

James Chen

Risk responsible: Steve Chen

Team members:

Steven Chen

Implement measures:

Validate measures:

Release measures:

Rights:

Data at time of risk control:

Position:

Yes

Yes

Yes

Task / status in the project:

Qualification:

Comments:

Location:

E-Mail:

Fax:

Phone:

Division:

Close version:

Create project:

JamesUser name:

Current data:

Yes

Yes

Others:

Date, Signature Signature

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Project number: 1112024003 Version: 1.00 Short name: ONYX-BE18xDT

12-14-2011


James Chen

Implement measures:

Validate measures:

Release measures:

Rights:


QCPosition:

Yes

Yes

Yes


Qualification:

O025

Comments:

Location:

E-Mail:

Fax:

Phone:

Division:

Close version:

Create project:

James_Chen_OnyxUser name:

Current data:

Yes

Yes

- Provide guidance for applying the risk management

process

- Approve Risk Management File and risk review records

Others:


Steve Chen

Implement measures:

Validate measures:

Release measures:

Rights:


PMPosition:

Yes

Yes

Yes


Qualification:

O013

Comments:

Location:

E-Mail:

Fax:

Phone:

Division:

Close version:

Create project:

Steve_Chen_OnyxUser name:

Current data:

Yes

Yes

- Provide guidance regarding hazardous situation

identification

- Provide the severity and likelihood of harm values and

rationales for the hazardous situation

Others:

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- Approve all changes to Risk Management File


Mike Ho

Implement measures:

Validate measures:

Release measures:

Rights:


SalesPosition:

Yes

Yes

Yes

Task / status in the project: Product Surveillance

Director

Qualification:

O032

Comments:

Location:

E-Mail:

Fax:

Phone:

Division:

Close version:

Create project:

Mike_Ho_OnyxUser name:

Current data:

Yes

Yes

Ensure post-production risk assessments follow this

procedure.

Ensure all post-production monitoring activities are

executed according to this procedure.

Others:


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Owen Hsieh

Implement measures:

Validate measures:

Release measures:

Rights:


HW EngineerPosition:

Yes

Yes

Yes

Task / status in the project: Lead System Design

Engineer

Qualification:

O042

Comments:

Location:

E-Mail:

Fax:

Phone:

Division:

Close version:

Create project:

Owen_Hsieh_OnyxUser name:

Current data:

Yes

Yes

- Lead the Risk Management Project Team and facilitate

meetings

- Identify the Risk Management Project Team and

determine the assignments of each functional role

- Assign administrative duties

- Manage product architecture, design, quality, and risk

- Ensure deliverables are complete and executing the

Go/No Go decision

Others:


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12-14-2011


Peter Pan

Implement measures:

Validate measures:

Release measures:

Rights:


MEPosition:

Yes

Yes

Yes

Task / status in the project: Engineering

Representative

Qualification:

O038

Comments:

Location:

E-Mail:

Fax:

Phone:

Division:

Close version:

Create project:

Peter_Pan_OnyxUser name:

Current data:

Yes

Yes

- Manage the product’s Risk Management File (RMF)

- Provide the technical input including probability of

occurrence of the hazardous situation (P1) value and

rationale regarding the risk assessment

- Update the product’s Risk Management File in

post-production

Others:


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Version number:


Project manager:


Steven Chen


Definition of risk-graph

1.00

Defined graph

P5

P4

P3

P2

P1

S1 S2 S3 S4 S5

Intolerable region

ALARP region

Broadly acceptable region

Severity:

Description:Abbreviat Criteria: Example:

S1 Negligible Inconvenience or temporary

discomfort.

S2 Minor Results in temporary injury or

impairment not requiring

professional medical intervention.

S3 Serious Results in injury requiring

professional medical intervention

S4 Critical Results in permanent impairment or

life-threatening injury

S5 Catastrophic Results in patient death.

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Probability:

Description:Abbreviat Criteria: Example:

P1 Improbable < 1/1,000,000 Event is not reproducible or cannot be

replicated under the specified

operating conditions of the device.

P2 Remote <1/100,000 and >= 1/1,000,000 Event occurs infrequently during the life

of the product under the specified


P3 Occasional <1/10,000 and >= 1/100,000 Event occurs occasionally during the

life of the product under the specified


P4 Probable < 1/1000 and >= 1/10,000 Event occurs proable during the life of

the product under the specified


P5 Frequent >= 1/1,000 Event can be replicated repeatedly

and/or is likely to occur regularly or

many times during the life of the

product under the specified operating

conditions of the device.

Defined filters:

Filter name:

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Version number:


Project manager:


Steven Chen


Criteria for release of risk analysis

1.00

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

Required documentation:

References:

QD2-010 - Risk Management Procedure

When is a risk acceptable:

The criteria for risk acceptability were based upon applicable national or regional regulations and relevant

International Standards, and takes into account available information such as the generally accepted state of the

art and known stakeholder concerns.

Risk = Severity x Probability

Results:

1... 6 (exclude 5): Acceptable;

5, 8.... 25: Not acceptable

References:

- Definition Risk Graph with the mentioned parameters

- QD2-010 - Risk Management Procedure

Criteria of the QM system:

QD2-001 Verification Planning

QP2-002 Design Validation

QD2-010 Risk Management Procedure

QQ2-002 Retention Time of Quality Records

References:

QQ1-001 Quality Manual

Reference to the review plan:

Annual Review as Review Plan QQ2-010

QQ2-006 Preparation and Management of the Technial Documentation

QQ2-001 501 Management

References:

QQ1-001 Quality Manual

Procedure to prove the effectiveness of risk control:

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.

References:


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Limits of acceptance for the procedure:

Method is only acceptable when either all non-acceptable risks have been eliminated or satisfactory reasons have

been given for the release in the enabling sheet.

References:


Procedure for verification:

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

References:


Limits of acceptance for verification:

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

References:


Procedure for validation:

Checking the results of the user studies (focus groups) QP2-002 Design Validation and taking them into

consideration, then: regular market investigations and updates of the risk analysis

References:


Limits of acceptance for validation:

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

References:


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Project number: 1112024003 Shorty: ONYX-BE18xDT Version number: 1.00 12-14-2011

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12-14-2011




Version number:


Project manager:


Steven Chen


Risk analysis

1.00



F-01Function: Connect to Mains

F-01

Hazard: Cause: Effect on: Measure: Type of measure:

The limits specified in IEC

60601-1, Clause 8.4 is not be

exceeded for ACCESSIBLE

PARTS

M-01Short circuit of any or all

insulation that does not comply

with the requirements of IEC

60601-1, 3rd Ed., Clause. 8.8

Electromagnetic energyH-01 C-01




PARTS

M-01Short circuit of any or all

CREEPAGE DISTANCES or AIR

CLEARANCES that do not

comply with the requirements of

IEC 60601-1, 3rd Ed., Clause 8.9

C-02




PARTS

M-01Open circuit of any or all earth

connections that do not comply


60601-1, Clause 8.6, including

any functional earth connection.

C-03

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

M-01Short circuit of any one insulation

that complies with the

requirements for one MEANS OF

PROTECTION as specified in

IEC 60601-1, Clause 8.8

C-04

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F-01


The HAZARDOUS


Clause 13.1.2 to 13.1.4



M-01Short circuit of any one

CREEPAGE DISTANCE or AIR

CLEARANCE that complies with

the requirements for one MEANS

OF PROTECTION as specified in

IEC 60601-1, Clause 8.9


The HAZARDOUS


Clause 13.1.2 to 13.1.4



M-01Open circuit of any one

PROTECTIVE EARTH

CONDUCTOR or internal

PROTECTIVE EARTH

CONNECTION that complies with

the requirements of IEC

60601-1, Clause 8.6

C-06

All components, including

wiring shall be used in

accordance with their specified

ratings.

M-01All components, including wiring,

the failure of which could result in

a HAZARDOUS SITUATION.

C-07

All components, including

wiring, the failure of which

could result in a HAZARDOUS

SITUATION are fixed in place

by UL R/C non-chemical

bounding compound.

M-02

They shall comply with the

applicable safety requirements

of a relevant IEC, UL or ISO

standard;

M-01The reliability of components that

are used as MEANS OF

PROTECTION are not assessed

for the conditions of use in the

PC.

C-08

Where there is no relevant IEC

or ISO standard, the

requirements of IEC 60601-1,

3rd Ed. were applied.

M-02

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F-01


The humidity preconditioning

treatment is performed in a

humidity cabinet containing air

with a relative humidity of 93 %

± 3 % @ 25°C 48 hr

M-01Storage (humidity preconditioning

treatment)


The strength of packing carton

/ fixed frame. The

transportation stimulation for

the verification. All connections

were mechanically secure.

M-01TransportC-10

Said components were

secured in place on pcb by UL

Recognized non-chemical

bounding compound.

M-01Components of PC, unwanted

movement of which could result

in an unacceptableb RISK, is not

mounted securely to prevent such

movement.

C-11

Meet IEC 60601-1, Clause 8.7

LEAKAGE CURRENTS and

PATIENT AUXILIARY

CURRENTS requirements

M-01Too high leakage current, causing

a death or serious injury to a

patient.

C-12



PATIENT AUXILIARY


M-01The LEAKAGE CURRENTS

from, to or between

ACCESSIBLE PARTS other than

PATIENT CONNECTIONS

C-13

Supplied by SELV power

adapter and DC/AC inverter

meet LCC requirements.

M-01ACCESSIBLE PARTS exceed

42.4 V peak a.c. or 60 V d.c. in

NORMAL CONDITION or in

SINGLE FAULT CONDITION.

C-14

The suitable enclosure shall be

provided.

M-01Internal parts, other than contacts

of plugs, connectors and

socket-outlets, that can be

touched by the test pin shown in

IEC 60601-1, Figure 8.

C-15

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F-01


The HAZARDOUS


Clause 13.1.2 to 13.1.4



M-01Accidental detachment of

conductors and connectors where

breaking free could lead to a

HAZARDOUS SITUATION.


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); and

mechanical strength (see IEC

60601-1, Clause 15.3).

M-01The resistance to heat is not

retained by all types of insulation,

including insulating partition walls,

during the EXPECTED SERVICE

LIFE of the PC.

C-17

Ball pressure test - according

to IEC 60601-1, Clause

8.8.4.1, b) requirements

M-02

Internal cables and wiring is

fixed in place by cable tie to

protect against contact with a

moving part or from friction at

sharp corners and edges

where damage to insulation

M-01Internal cables and wiring is not

adequately protected against

contact with a moving part or

from friction at sharp corners and

edges where damage to

insulation.

C-18

Meet IEC 60601-1-2

requirements

M-01Electromagnetic compatibility of

PC.

C-19

The permissible environmental

conditions for transport and

storage were marked on the

outside of the packaging.

M-01PackingC-20

All wirings are tied together by

cable tie to prevent accidental

detachment.

M-01Wirings and connectors of Panel

PC Monitor supply is not secured

or insulated that accidental

detachment can result in a


C-21

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F-01


The internal wirings were

secured in place on PCB by UL

R/C non-chemical bounding

component.

M-01Internal cables and wiring were

not adequately protected against

contact from friction at sharp

corners and edges where

damage to insulation could result

in a HAZARDOUS SITUATION.


The equipment complied with


60601-1, Clause 11.6.

M-01CleaningC-23

When PC is operated in

worst-case NORMAL USE

including the maximum

ambient operating

temperature, the parts shall not

reach temperatures exceeding

the values given in IEC

60601-1, Table 22 and Table

23.

M-01Excessive temperatures in PC

and/or power supply.

Thermal EnergyH-02 C-01

Compliance with the

mechanical strength tests for

ENCLOSURES (see IEC

60601-1, Clause 15.3)

M-01ENCLOSURES have no the

strength and rigidity necessary to

avoid a fire.

C-02

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F-02Function: Enclosure

F-02


Meet IEC 60601-1, Clause

9.4.2 requiremets.

M-01FallingMechanical energyH-01 C-01

Meet IEC 60601-1 Clause

9.8.2 and Table 21

requirements.

M-01Suspended massesC-02

Rounding of sharp edges and

corners.

M-01Sharp edges and cornersC-03




ambient operating





23.

M-01Excessive temperatures in

enclosure


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F-03Function: Rear Bracket

F-03



9.8.2 and Table 21

requirements.

M-01CrackMechanical energyH-01 C-01


9.8.2 and Table 21

requirements.

M-01Suspended massesC-02


9.8.2 and Table 21

requirements.

M-01InstabilityC-03

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F-04Function: Signal input

F-04


Supplied by SELV power

adapter and DC/AC inverter

meet LCC requirements.

M-01ACCESSIBLE PARTS exceed





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F-05Function: Signal output

F-05


Meet IEC 60950-1, Annex

NAD Acoustic tests

requirements

M-01earphoneAcoustic energy (sound)H-01 C-01

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F-06Function: User control and indicator

F-06


Indicated by an adjacent

indicator light

M-01Switches used to control power to

PC or its parts, including

switches, did not have their "on"

and "off" positions.

OperationalH-01 C-01

Marked with symbols IEC

60417

M-02

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F-07Function: Information

F-07


PC marked the name or

trademark of Onyx with model

no.

M-01PC did not marke with the name

or trademark of Onyx and with a

MODEL OR TYPE REFERENCE

LabelingH-01 C-01

Meet IEC 60601-1, Clause 7

requirements.

M-01Incomplete instructions for useC-02


requirements.

M-01Inadequate description of

performance characteristics

C-03


requirements.

M-01Inadequate specification of

intended use.

C-04


requirements.

M-01Inadequate disclosure of

limitations

C-05


requirements.


accessories to be used with the

medical device.

Operating instructionsH-02 C-01


requirements.


pre-use checks.

C-02


requirements.

M-01Over-complicated operating

instructions.

C-03


requirements.

M-01Installation instructionSpecification of service and

maintenance

H-03 C-01

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

F-08


Provided a connector that has

special housing to prevent a

connection with the wrong

polarity is made.

M-01When a connection with the

wrong polarity is made.


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F-09Function: Display

F-09


The intensity of visible light

from monitor can be controlled

by the user. The highest

intensity achievable cannot

produce detrimental biological

effects.

M-01Visible LightRadiation energyH-01 C-01

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

F-10


Battery circuits is designed so

that discharging at a rate

exceeding the battery

manufacturer’s

recommendations, and

unintentional charging, are

prevented.

M-01Lithium battery explosionMechanical energyH-01 C-01

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F-11Function: Touch Panel & Plastic Enclosure (TYPE B APPLIED PART)

F-11




PATIENT AUXILIARY


M-01Too high leakage current, causing


patient.



worst-case ABNORMAL USE


ambient operating





24.

M-01Excessive temperatures in touch

panel


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Version number:


Project manager:


Steven Chen


Evaluation of risk (before measures)

1.00


F-01

Hazard: Cause: Severity: Probability: Region of risk: Comment:

C-01 Short circuit of any or all



60601-1, 3rd Ed., Clause. 8.8

Serious Occasional Intolerable regionElectromagnetic energyH-01






Serious Occasional Intolerable region

C-03 Open circuit of any or all earth





Critical Remote Intolerable region

C-04 Short circuit of any one insulation




IEC 60601-1, Clause 8.8

Critical Occasional Intolerable region

C-05 Short circuit of any one





IEC 60601-1, Clause 8.9


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F-01


C-06 Open circuit of any one

PROTECTIVE EARTH


PROTECTIVE EARTH



60601-1, Clause 8.6

Critical Remote Intolerable regionElectromagnetic energyH-01

C-07 All components, including wiring,




C-08 The reliability of components that




PC.

Serious Remote Broadly

acceptable

region

C-09 Storage (humidity preconditioning

treatment)

Minor Occasional Broadly

acceptable

region

C-10 Transport Minor Occasional Broadly

acceptable

region

C-11 Components of PC, unwanted




movement.


acceptable

region

C-12 Too high leakage current, causing


patient.


C-13 The LEAKAGE CURRENTS

from, to or between


PATIENT CONNECTIONS


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F-01


C-14 ACCESSIBLE PARTS exceed





C-15 Internal parts, other than contacts






C-16 Accidental detachment of





acceptable

region

C-17 The resistance to heat is not




LIFE of the PC.


C-18 Internal cables and wiring is not





insulation.

Minor Remote Broadly

acceptable

region

C-19 Electromagnetic compatibility of

PC.


C-20 Packing Serious Occasional Intolerable region

C-21 Wirings and connectors of Panel






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F-01


C-22 Internal cables and wiring were







acceptable

region

Electromagnetic energyH-01

C-23 Cleaning Minor Occasional Broadly

acceptable

region

C-01 Excessive temperatures in PC


Serious Occasional Intolerable regionThermal EnergyH-02

C-02 ENCLOSURES have no the


avoid a fire.

Critical Remote Intolerable region


F-02


C-01 Falling Serious Occasional Intolerable regionMechanical energyH-01

C-02 Suspended masses Critical Remote Intolerable region

C-03 Sharp edges and corners Minor Occasional Broadly

acceptable

region

C-01 Excessive temperatures in

enclosure


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F-03


C-01 Crack Serious Occasional Intolerable regionMechanical energyH-01

C-02 Suspended masses Critical Occasional Intolerable region

C-03 Instability Serious Occasional Intolerable region


F-04






Serious Occasional Intolerable regionElectromagnetic energyH-01


F-05


C-01 earphone Serious Occasional Intolerable regionAcoustic energy (sound)H-01


F-06


C-01 Switches used to control power to




Serious Occasional Intolerable regionOperationalH-01

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F-07


C-01 PC did not marke with the name




acceptable

region

LabelingH-01

C-02 Incomplete instructions for use Serious Occasional Intolerable region

C-03 Inadequate description of



C-04 Inadequate specification of

intended use.


C-05 Inadequate disclosure of

limitations




medical device.

Serious Occasional Intolerable regionOperating instructionsH-02


pre-use checks.


acceptable

region

C-03 Over-complicated operating

instructions.


acceptable

region

C-01 Installation instruction Serious Occasional Intolerable regionSpecification of service and

maintenance

H-03


F-08


C-01 When a connection with the



acceptable

region

Thermal EnergyH-01

of 148




F-09


C-01 Visible Light Minor Occasional Broadly

acceptable

region

Radiation energyH-01


F-10


C-01 Lithium battery explosion Critical Remote Intolerable regionMechanical energyH-01


F-11




patient.


C-01 Excessive temperatures in touch

panel


of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Risk-graph (before measures)

1.00

Both states

P5

P4

9 23 5

P3

2 3 7

P2

P1

S1 S2 S3 S4 S5

Operation state

P5

P4

9 23 5

P3

2 3 7

P2

P1

S1 S2 S3 S4 S5

of 148


12-14-2011


Fault state

P5

P4

P3

P2

P1

S1 S2 S3 S4 S5

Intolerable region ALARP region Broadly acceptable reg

of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Decision about measures

1.00

Measure:

All components, including wiring shall be used in accordance with their specified

ratings.

Implement: Yes RC-001Measure number:

Cause: Hazard: Function: Evaluation:

All components, including wiring,



Electromagnetic energy Connect to Mains Efficient

Measure:

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







Measure:

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



Wirings and connectors of Panel






of 148



Measure:

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



The resistance to heat is not




LIFE of the PC.


Measure:

Battery circuits is designed so that discharging at a rate exceeding the battery

manufacturer’s recommendations, and unintentional charging, are prevented.



Lithium battery explosion Mechanical energy BIOS (Basic Input/Output System -

real time clock)

Efficient

Measure:

Compliance with the mechanical strength tests for ENCLOSURES (see IEC

60601-1, Clause 15.3)



ENCLOSURES have no the


avoid a fire.

Thermal Energy Connect to Mains Efficient

of 148



Measure:

Indicated by an adjacent indicator light



Switches used to control power to

PC or its parts, including switches,

did not have their "on" and "off"

positions.

Operational User control and indicator Efficient

Measure:

Internal cables and wiring is fixed in place by cable tie to protect against contact with a moving part or from friction at sharp corners and edges where damage to

insulation



Internal cables and wiring is not


contact with a moving part or from

friction at sharp corners and edges

where damage to insulation.


Measure:

Marked with symbols IEC 60417



Switches used to control power to

PC or its parts, including switches,

did not have their "on" and "off"

positions.

Operational User control and indicator Efficient

of 148



Measure:

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



Crack Mechanical energy Rear Bracket Efficient

Suspended masses Mechanical energy Enclosure Efficient

Suspended masses Mechanical energy Rear Bracket Efficient

Instability Mechanical energy Rear Bracket Efficient

Measure:

Meet IEC 60601-1, Clause 7 requirements.



Incomplete instructions for use Labeling Information Efficient

Inadequate description of


Labeling Information Efficient

Inadequate specification of

intended use.


Inadequate disclosure of

limitations




medical device.

Operating instructions Information Efficient


pre-use checks.


Over-complicated operating

instructions.


Installation instruction Specification of service and

maintenance

Information Efficient

of 148



Measure:

Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements



Too high leakage current, causing


patient.


Too high leakage current, causing


patient.

Electromagnetic energy Touch Panel & Plastic Enclosure

(TYPE B APPLIED PART)

Efficient

The LEAKAGE CURRENTS from,

to or between ACCESSIBLE

PARTS other than PATIENT

CONNECTIONS


Measure:

Meet IEC 60601-1, Clause 9.4.2 requiremets.



Falling Mechanical energy Enclosure Efficient

Measure:

Meet IEC 60601-1-2 requirements



Electromagnetic compatibility of

PC.


Measure:

Meet IEC 60950-1, Annex NAD Acoustic tests requirements



earphone Acoustic energy (sound) Signal output Efficient

of 148



Measure:

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



PC did not marke with the name or

trademark of Onyx and with a



Measure:

Provided a connector that has special housing to prevent a connection with the wrong polarity is made.



When a connection with the wrong

polarity is made.

Thermal Energy Connection to an external d.c.

power source

Efficient

Measure:

Rounding of sharp edges and corners.



Sharp edges and corners Mechanical energy Enclosure Efficient

Measure:

Said components were secured in place on pcb by UL Recognized non -chemical

bounding compound.



Components of PC, unwanted

movement of which could result in

an unacceptableb RISK, is not


movement.


of 148



Measure:

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); and

mechanical strength (see IEC 60601-1, Clause 15.3).



The resistance to heat is not




LIFE of the PC.


Measure:

Supplied by SELV power adapter and DC/AC inverter meet LCC requirements.



ACCESSIBLE PARTS exceed




Electromagnetic energy Signal input Efficient

ACCESSIBLE PARTS exceed





Measure:

The equipment complied with the requirements of IEC 60601-1, Clause 11.6.



Cleaning Electromagnetic energy Connect to Mains Efficient

of 148



Measure:

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



Short circuit of any one insulation



PROTECTION as specified in IEC

60601-1, Clause 8.8


Short circuit of any one





IEC 60601-1, Clause 8.9


Open circuit of any one

PROTECTIVE EARTH


PROTECTIVE EARTH



60601-1, Clause 8.6


Accidental detachment of





Measure:

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



Storage (humidity preconditioning

treatment)


of 148



Measure:

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



Visible Light Radiation energy Display Efficient

Measure:

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



Internal cables and wiring were not



corners and edges where damage

to insulation could result in a



Measure:

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



Short circuit of any or all insulation

that does not comply with the

requirements of IEC 60601-1, 3rd

Ed., Clause. 8.8


Short circuit of any or all






Open circuit of any or all earth



60601-1, Clause 8.6, including any

functional earth connection.


of 148



Measure:

The permissible environmental conditions for transport and storage were marked on the outside of the packaging.



Packing Electromagnetic energy Connect to Mains Efficient

Measure:

The strength of packing carton / fixed frame. The transportation stimulation for

the verification. All connections were mechanically secure.



Transport Electromagnetic energy Connect to Mains Efficient

Measure:

The suitable enclosure shall be provided.



Internal parts, other than contacts


socket-outlets, that can be touched

by the test pin shown in IEC

60601-1, Figure 8.


Measure:

They shall comply with the applicable safety requirements of a relevant IEC, UL or ISO standard;



The reliability of components that



for the conditions of use in the PC.


of 148



Measure:

When PC is operated in worst-case NORMAL USE and ABNORMAL USE including the maximum

ambient operating temperature, the parts shall not reach temperatures exceeding

the values given in IEC 60601-1, Table 22, Table 23 and Table 24.



Excessive temperatures in touch

panel

Thermal Energy Touch Panel & Plastic Enclosure


Efficient

Excessive temperatures in

enclosure

Thermal Energy Enclosure Efficient

Excessive temperatures in PC


Thermal Energy Connect to Mains Efficient

Measure:

Where there is no relevant IEC or ISO standard, the requirements of IEC 60601-1,




The reliability of components that



for the conditions of use in the PC.


of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Risk control

1.00

Measure State Responsible Planning Actual values Effort Vali-

dation

Re-

leaseRealization Supervising Start End Start End Planned Actual

No.

All components, including wiring

shall be used in accordance with

their specified

ratings.

Ho Hsieh 10-01-2011 12-30-2011 10-12-2011 11-23-2011Finished Yes YesRC-001



a HAZARDOUS SITUATION are

fixed in place by UL R/C

non-chemical bounding

compound.

Hsieh Pan 10-01-2011 12-30-2011 10-12-2011 11-28-2011Finished Yes YesRC-002

All wirings are tied together by


detachment.

Pan Ho 10-08-2011 12-30-2011 10-12-2011 12-06-2011Finished Yes YesRC-003

Ball pressure test - according to

IEC 60601-1, Clause 8.8.4.1, b)

requirements


Battery circuits is designed so that

discharging at a rate exceeding

the battery

manufacturer’s recommendations,

and unintentional charging, are

prevented.


Compliance with the mechanical

strength tests for ENCLOSURES

(see IEC

60601-1, Clause 15.3)


Indicated by an adjacent indicator

light


of 148




dation

Re-


No.

Internal cables and wiring is fixed

in place by cable tie to protect

against contact with a moving part

or from friction at sharp corners

and edges where damage to

insulation


Marked with symbols IEC 60417 Pan Chen 10-01-2011 12-31-2011 10-12-2011 11-29-2011Finished Yes YesRC-009

Meet IEC 60601-1 Clause 9.8.2

and Table 21 requirements.



requirements.




PATIENT AUXILIARY CURRENTS

requirements


Meet IEC 60601-1, Clause 9.4.2

requiremets.


Meet IEC 60601-1-2 requirements Hsieh Pan 10-01-2011 12-31-2011 10-12-2011 11-23-2011Finished Yes YesRC-014

Meet IEC 60950-1, Annex NAD

Acoustic tests requirements


PC marked the name or trademark

of Onyx with model no.


Provided a connector that has

special housing to prevent a

connection with the wrong polarity

is made.


Rounding of sharp edges and

corners.


Said components were secured in

place on pcb by UL Recognized

non-chemical

bounding compound.


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); and

mechanical strength (see IEC

60601-1, Clause 15.3).


of 148




dation

Re-


No.

Supplied by SELV power adapter

and DC/AC inverter meet LCC

requirements.


The equipment complied with the

requirements of IEC 60601-1,

Clause 11.6.


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


The humidity preconditioning

treatment is performed in a

humidity cabinet containing air

with a relative humidity of 93 % ± 3

% @ 25°C 48 hr


The intensity of visible light from

monitor can be controlled by the

user. The highest intensity

achievable cannot produce

detrimental biological effects.


The internal wirings were secured

in place on PCB by UL R/C

non-chemical bounding

component.





PARTS


The permissible environmental

conditions for transport and

storage were marked on the

outside of the packaging.


The strength of packing carton /

fixed frame. The transportation

stimulation for

the verification. All connections



The suitable enclosure shall be

provided.


of 148




dation

Re-


No.

They shall comply with the

applicable safety requirements of

a relevant IEC, UL or ISO

standard;





ambient operating temperature,

the parts shall not reach

temperatures exceeding

the values given in IEC 60601-1,

Table 22 and Table 23.


Where there is no relevant IEC or

ISO standard, the requirements of

IEC 60601-1,



of 148

12-14-2011


Project manager:

Life cycle phase:

Version description:

Project name:

Version number:

Short name:Project number:

Release protocols of measures

1112024003

1.00

18.5" Bedside Terminal, models xxxx-ONYX-BE18xDT-xxxxxxxWorkable version for evaluation purpose

Functional design

Steven Chen

James Chen

ONYX-BE18xDT

Measure number: RC-001

Measure text:

All components, including wiring shall be used in accordance with their specified

ratings.

State of measure:

Responsible

Implementation: Supervising: Owen HsiehMike Ho

Finished

Plan:

Start: End:10-1-2011 12-30-2011

Actual values:

Start: End:10-12-2011 11-23-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:

Validated on:Steven Chen

Yes

12-09-2011

Release:

Release through: James ChenIs released:

Release on:

Yes

12-9-2011

All components, including wiring shall be used in accordance with their specified ratings.

Decided tasks:

Where safety is involved, components shall comply either with the requirements of IEC 60601-1 or with the

safety aspects of the relevant IEC component standards.

Comment:

Assigned functions, hazards, causes:

Connect to Mains Electromagnetic energy All components, including wiring, the

failure of which could result in a


Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan

Procedure for evidence of efficiency for measures: References:

of 148


12-14-2011Project number: Version: Short name:1112024003 1.00 ONYX-BE18xDT


Evaluation and testing of components shall be conducted as follows:

- a component that has been demonstrated to comply with a standard

harmonized with the relevant IEC component standard shall be checked

for correct application and use in accordance with its rating. It shall be

subjected to the applicable tests of IEC 60601-1 as part of the equipment

with the exception of those tests which are part of the relevant IEC

component standard;

- a component that has not been demonstrated to comply with a relevant

standard as above shall be checked for correct application and use in

accordance with its specified rating. It shall be subjected to the applicable

tests of IEC 60601-1, as part of the equipment, and to the applicable

tests of the component standard, under the conditions occurring in the

equipment;

- where no relevant IEC component standard exists, or where

components are used in circuits not in accordance with their specified

ratings, the components shall be tested under the conditions occurring in

the equipment. The number of samples required for test is, in general,

the same as required by an equivalent standard.

QD2-001, QD2-004 and QD2-005

Limits of acceptance for procedure of evidence: References:

see above QD2-001, QD2-004 and QD2-005

Procedure for verification: References:


References:Limits of acceptance for verification:


References:Procedure for validation:


References:Limits of acceptance for validation:


of 148




Measure text:

All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in place

by UL R/C non-chemical bounding compound.

State of measure:

Responsible

Implementation: Supervising: Peter PanOwen Hsieh

Finished

Plan:

Start: End:10-1-2011 12-30-2011

Actual values:

Start: End:10-12-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:

Release on:James ChenYes

12-9-2011

All components, including wiring, the failure of which could result in a HAZARDOUS SITUATION are fixed in

place by UL R/C non-chemical bounding compound.

Decided tasks:

Conductors shall be provided with a means (for example, barriers or fixing), or be so terminated, that they and

their terminators (for example, ring terminals and flat quick-connect terminals) cannot, in normal use, become

so displaced that CLEARANCES or CREEPAGE DISTANCES are reduced to less than the values specified in

IEC 60601-1.

Comment:


Connect to Mains Electromagnetic energy All components, including wiring, the

failure of which could result in a


Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Having used the unjointed probe, which was in the shape of the standard

test finger and which incorporated a force gauge, a steady force of 10 N

for internal parts was applied for a period of 5 seconds.

QD2-001 and QM2-011


During the application of the test force, clearances behind earthed or

unearthed conductive accessable parts were not reduced to a level that

would result in an energy hazard.

QD2-001 and QM2-011


See above QD2-001 and QM2-011

of 148










of 148




Measure text:

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

State of measure:

Responsible

Implementation: Supervising: Mike HoPeter Pan

Finished

Plan:

Start: End:10-8-2011 12-30-2011

Actual values:

Start: End:10-12-2011 12-06-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:

Release on:Steven ChenYes

12-9-2011

Tied together by cable tie.

Decided tasks:

Conductors shall be provided with a means (for example, barriers or fixing), or be so terminated, that they and

their terminators (for example, ring terminals and flat quick-connect terminals) cannot, in normal use, become

so displaced that CLEARANCES or CREEPAGE DISTANCES are reduced to less than the values specified in

IEC 60601-1.

Comment:


Connect to Mains Electromagnetic energy Wirings and connectors of Panel PC

Monitor supply is not secured or

insulated that accidental detachment

can result in a HAZARDOUS

SITUATION.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan





QD2-001 and QM2-011





QD2-001 and QM2-011



of 148










of 148




Measure text:

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

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-30-2011

Actual values:

Start: End:10-12-2011 12-07-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

Compliance is checked by subjecting the part to the ball-pressure test according to IEC 60695-10-2 and IEC

60601-1, Clause 8.8.4.1, b)

Decided tasks:

Thermoplastic parts on which parts at HAZARDOUS VOLTAGE are directly mounted shall be resistant to

abnormal heat.

Comment:


Connect to Mains Electromagnetic energy The resistance to heat is not retained

by all types of insulation, including

insulating partition walls, during the

EXPECTED SERVICE LIFE of the

PC.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


A sample of each external part of insulating material indicated in the table

was tested using the test apparatus shown in Fig. 21 of IEC 60601-1, 3rd

Edition. (In this apparatus, a steel ball of 5 mm diameter exerts a force of

20 N when pressed against a surface). The apparatus and a fire (or

sand) brick were placed in an air-circulating oven. Once the apparatus

and brick attained the oven temperature, the sample was placed in the

oven on top of the brick. The steel ball was then positioned such that the

apparatus was balanced on the surface of the sample. After 1 h, it was

removed and the diameter of the impression made by the ball was

measured.

The specified oven temperature was the higher of the following:

a. the sum of the specified ambient and the temperature rise of relevant

part during the Temperature Test; AND

b. 75°C ± 2°C (test per Clause 8.8.4.1a), OR 125°C ± 2°C (test per

Clause 8.8.4.1b)

IEC 60601-1, 3rd Edition, Clause 8.8.4.1

of 148





The results were less 2 mm.

Cracks were not visible to the naked eye.



see above IEC 60601-1, 3rd Edition, Clause 8.8.4.1







of 148




Measure text:

Battery circuits is designed so that discharging at a rate exceeding the battery

manufacturer’s recommendations, and unintentional charging, are prevented.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-30-2011

Actual values:

Start: End:10-12-2011 11-29-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:

Validated on:Steven ChenYes

12-09-2011

Release:

Release through: James ChenIs released:

Release on:

Yes

12-9-2011

Battery circuits is designed so that discharging at a rate exceeding the battery manufacturer’s

recommendations, and unintentional charging, are prevented.

Decided tasks:

Equipment containing batteries shall be designed to reduce the risk of fire, explosion and chemical leaks under

normal conditions and after a single fault in the equipment, including a fault in circuitry within the equipment

battery pack.

Comment:


BIOS (Basic Input/Output System -

real time clock)

Mechanical energy Lithium battery explosion

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


The non-rechargeable battery cell was subjected to the test detailed

below.

The unit was connected to rated input voltage and operated at maximum

normal load. The following conditions were imposed one at a time.

1) Unintentional charging of a non-rechargeable battery cell. The battery

was charged while briefly subjected to the simulation of any single

component failure that was likely to occur in the charging circuit

and that would result in unintentional charging of the battery. To minimize

testing time, the failure was chosen that causes the highest charging

current. The battery was then charged for a single period of 7 h with that

simulated failure in place.

2) Excessive discharging rate for any battery (pack or cell). The battery

was subjected to rapid discharge by open-circuiting or short-circuiting any

current-limiting or voltage-limiting components in the load circuit of the

battery under test.

3) Reversing - The connections of the battery were reversed and the

equipment was energized. The battery was examined for emission of

flames, toxic gases, molten metal, risk of explosion.

IEC 60601-1, Clause 8.8.3 and 15.4.3

of 148





These tests shall not result in any of the following:

- chemical leaks caused by cracking, rupturing or bursting of the battery

jacket, if such leakage could adversely affect required insulation ; or

- spillage of liquid from any pressure relief device in the battery, unless

such spillage is contained by the equipment without risk of damage to the

insulation or harm to the USER; or

- explosion of the battery, if such explosion could result in injury to a

USER; or

- emission of flame or expulsion of molten metal to the outside of the

equipment ENCLOSURE.

After completion of the tests, the equipment is subjected to the electric

strength tests of IEC 60601-1, Clause 8.8.3

IEC 60601-1, Clause 8.8.3 and 15.4.3


see above IEC 60601-1, Clause 8.8.3 and 15.4.3







of 148




Measure text:

Compliance with the mechanical strength tests for ENCLOSURES (see IEC

60601-1, Clause 15.3)

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-5-2011 11-24-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The suitable plastic enclosure is provided.

Decided tasks:

The monitor or its parts shall have adequate mechanical strength and shall not result in an unacceptable RISK

due to moulding stress or when subjected to mechanical stress caused by pushing, impact, dropping, and

rough handling.

Comment:


Connect to Mains Thermal Energy ENCLOSURES have no the strength

and rigidity necessary to avoid a fire.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Compliance is checked by application of the tests in Table 28. The tests

are not applied to handles, levers, knobs, the face of cathode ray tubes

(see 9.5.2), or to transparent or translucent covers of indicating or

measuring devices unless with the handle, lever, knob, or cover removed

there is an unacceptable RISK of electric shock.

IEC 60601-1, Clause 15.3


There was no cracking of the enclosure.

There were no live parts that became accessible.

IEC 60601-1, Clause 15.3


of 148




Force (15.3.2) - A sample of the unit was subjected to inward directed

force of 250 N plus or minus 10 N for a period of 5 seconds applied to

different parts of the enclosure via a test tool providing contact over a

circular plane surface 30 mm in diameter as indicated in Table 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 a solid steel 50mm (approx) ball of

mass 500 g plus or minus 25 g, fall freely from 1.3 meter height. The unit

was rigidly supported and the impact was applied to the locations

indicated in Table 15.3.

IEC 60601-1, Clause 15.3


see above IEC 60601-1, Clause 15.3





of 148




Measure text:

Indicated by an adjacent indicator light

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-5-2011 11-22-2011

Effort:

Planned: Actual:

Validation:

Validated through: Steven ChenIs validated:

Validated on:

Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The colours of indicator lights and their meanings shall comply with Table 2 of IEC 60601-1.

Decided tasks:

It is important for an OPERATOR and SERVICE PERSONNEL to be able to determine the functional status of

ME EQUIPMENT. In NORMAL USE, the OPERATOR needs to be able to distinguish between ME

EQUIPMENT in stand-by and ME EQUIPMENT in a fully functional state.

Comment:


User control and indicator Operational Switches used to control power to PC

or its parts, including switches, did

not have their "on" and "off" positions.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


QD2-001 and QM2-011 IEC 60601-1, Clause 7.8.1 and 15.4.4







of 148








of 148




Measure text:

Internal cables and wiring is fixed in place by cable tie to protect against contact with a moving part or from friction

at sharp corners and edges where damage to insulation

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011


Decided tasks:

Wireways shall be smooth and free from sharp edges. Wires shall be protected so that they do not come into

contact with burrs, cooling fins, moving parts, etc., which could cause damage to the insulation of conductors.

Holes in metal, through which insulated wires pass, shall have smooth well-rounded surfaces or shall be

provided with bushings.

Comment:


Connect to Mains Electromagnetic energy Internal cables and wiring is not

adequately protected against contact

with a moving part or from friction at

sharp corners and edges where

damage to insulation.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


QD2-001, QD2-010, QM2-011 and QD2-009 QQ1-001


QD2-001, QD2-010, QM2-011 and QD2-009 QQ1-001


QD2-001, QD2-010, QM2-011 and QD2-009 QQ1-001

of 148





QD2-001, QD2-010, QM2-011 and QD2-009 QQ1-001


QD2-001, QD2-010, QM2-011 and QD2-009 QQ1-001


QD2-001, QD2-010, QM2-011 and QD2-009 QQ1-001

of 148




Measure text:

Marked with symbols IEC 60417

State of measure:

Responsible

Implementation: Supervising: James ChenPeter Pan

Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-29-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

- marked with symbols IEC 60417,

- ndicated by an adjacent indicator light

Decided tasks:

Switches used to control power to ME EQUIPMENT or its parts, including mains switches, shall have their "on"

and "off" positions

Comment:


User control and indicator Operational Switches used to control power to PC

or its parts, including switches, did

not have their "on" and "off" positions.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Compliance with the requirements is checked by inspection and by

application of the tests and criteria in 7.1.2 and 7.1.3 of IEC 60601-1.

IEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1

and 15.4.4


The colours of indicator lights and their meanings shall comply with Table

2 of IEC 60601-1.

IEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1

and 15.4.4


see above IEC 60601-1, Clause 7.4.1, 7.4.2, 7.8.1

and 15.4.4

of 148






and 15.4.4



and 15.4.4



and 15.4.4

of 148




Measure text:

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

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:11-9-2011 11-16-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The construction of the support, suspension or actuation system shall be designed based upon Table 21 of IEC

60601-1 and the TOTAL LOAD.

Decided tasks:

Where ME EQUIPMENT parts are designed to support loads, then a mechanical fault could not constitute an

unacceptable RISK.

Comment:


Enclosure Mechanical energy Suspended masses

Rear Bracket Mechanical energy Crack

Rear Bracket Mechanical energy Suspended masses

Rear Bracket Mechanical energy Instability

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


The suspension system parts indicated in the table below (chain, cable,

band, spring, belt, jack screw nut, pneumatic, hydraulic hoses, or the like)

employed to support a load, were defeated by convenient means (cut or

removed suddenly), thereby causing the maximum normal load to fall

from the most adverse position permitted by the construction of the

equipment and to activate a safety device. The travel after such defeat

was measured as well as other observed results that could affect the risk

of possible injury.

IEC 60601-1, Clause 9.8.2


There was no evidence of damage to a safety catch or other restraining

means that would affect its ability to perform its intended function .

IEC 60601-1, Clause 9.8.2

of 148





see above IEC 60601-1, Clause 9.8.2







of 148




Measure text:

Meet IEC 60601-1, Clause 7 requirements.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-6-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

For Ward Terminal to be well designed, its markings and ACCOMPANYING DOCUMENTS should be clear,

consistent, and help to reduce potential use erro.

Decided tasks:

Additional markings are permitted, provided that they do not give rise to misunderstanding. Where symbols are

used, they shall conform to ISO 7000 or IEC 60417 where appropriate symbols exist. Sufficient information

shall be provided to the USER concerning any condition necessary to ensure that , when used as prescribed by

the manufacturer, the equipment is unlikely to present a hazard within the meaning of IEC 60601-1.

Comment:


Information Labeling Incomplete instructions for use

Information Labeling Inadequate description of


Information Labeling Inadequate specification of intended

use.

Information Labeling Inadequate disclosure of limitations

Information Operating instructions Inadequate specification of


medical device.

Information Operating instructions Inadequate specification of pre-use

checks.

Information Operating instructions Over-complicated operating

instructions.

Information Specification of service and

maintenance

Installation instruction

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Each specified marking was rubbed by hand, without undue pressure,

first for 15 s with a cloth rag soaked with distilled water, then for 15 s with

a cloth rag soaked in methylated spirit at ambient temperature, and then

for 15 s with a cloth rag soaked with isopropyl alcohol.

IEC 60601-1, 3rd Edition, Clause 7.1.3b

of 148





The markings worked and did not curl at the edges. The markings were

clearly readable.

IEC 60601-1, 3rd Edition, Clause 7.1.3b


see above IEC 60601-1, 3rd Edition, Clause 7.1.3b







of 148




Measure text:

Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-23-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

Meet IEC 60601-1, Clause 8.7 LEAKAGE CURRENTS and PATIENT AUXILIARY CURRENTS requirements.

Decided tasks:

The electrical isolation providing protection against electric shock shall be of such quality that currents flowing

through it are limited to the values specified in IEC 60601-1, Clause 8.7.3.

Comment:


Connect to Mains Electromagnetic energy Too high leakage current, causing a

death or serious injury to a patient.

Connect to Mains Electromagnetic energy The LEAKAGE CURRENTS from, to

or between ACCESSIBLE PARTS

other than PATIENT CONNECTIONS

Touch Panel & Plastic Enclosure


Electromagnetic energy Too high leakage current, causing a

death or serious injury to a patient.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Testing was conducted after thermal stabilization and was repeated

Humidity Preconditioning. Following the humidity conditioning (see

Humidity Conditioning Test for further details), the equipment was located

in an environment with a temperature approximately equal to t where t is

the temperature of the humidity cabinet and a relative humidity between

45% and 65% and was conducted 1 hour after the end of the humidity

preconditioning treatment. In Normal Condition and in the specified

Single Fault Conditions (IEC

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 any position. With the equipment

connected to a supply source with the highest rated supply frequency and

110% of the highest rated Mains Voltage as indicated in the RESULTS

table.

IEC 60601-1, 3rd Edition, Clause 8.7

of 148





IEC 60601-1, 3rd Ed. Table 3 and Table 4 IEC 60601-1, 3rd Edition, Clause 8.7


see above IEC 60601-1, 3rd Edition, Clause 8.7







of 148




Measure text:

Meet IEC 60601-1, Clause 9.4.2 requiremets.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-29-2011

Effort:

Planned: Actual:

Validation:

Validated through: Steven ChenIs validated:

Validated on: Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The equipment did not overbalance.

Decided tasks:

PC or its parts shall not overbalance when placed in any transport position of NORMAL USE on a plane inclined

at an angle of 10° from the horizontal plane.

Comment:


Enclosure Mechanical energy Falling

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


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.

IEC 60601-1, 3rd Edition, Clause 9.4.2


The equipment did not overbalance. IEC 60601-1, 3rd Edition, Clause 9.4.2


see above IEC 60601-1, 3rd Edition, Clause 9.4.2



of 148








of 148




Measure text:


State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-23-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011


Decided tasks:

Electromagnetic emission requirements are necessary for the protection of:

- safety services (e.g. police, fire and ambulance communications);

- other ME EQUIPMENT and ME SYSTEMS;

- non-ME EQUIPMENT (e.g. computers);

- telecommunications (e.g. radio/TV, telephone, radio-navigation).

Comment:


Connect to Mains Electromagnetic energy Electromagnetic compatibility of PC.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


IEC 60601-1-2 EMC Test Report (Report No.

T111031202-E)



T111031202-E)



T111031202-E)

of 148






T111031202-E)



T111031202-E)



T111031202-E)

of 148




Measure text:

Meet IEC 60950-1, Annex NAD Acoustic tests requirements

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-6-2011 11-23-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The equipment having acoustic outputs at communication receivers and similar devices used for voice

elecommunication, regardless of transmission medium (e.g., TELECOMMUNICATION NETWORK, CABLE

DISTRIBUTION NETWORK, wireless network), shall demonstrate that the equipment complies with the

appropriate acoustics requirements related to

short duration impulses and long duration disturbances as described in NAD.3 and NAD.4. of IEC 60950-1.

Decided tasks:

These requirements apply to equipment that is intended to be connected directly or indirectly to a

ELECOMMUNICATION NETWORK or CABLE DISTRIBUTION SYSTEM or other transmission medium, and

that contains an earpiece or receiver that is held against or in the ear. The effect on human hearing of impulsive

noise or of disturbances that are less than 0,5 s in duration shall be evaluated under NAD.3. The effect of

longer disturbances, such as those that might be produced during tone-type dialing, shall be evaluated under

NAD.4.

Comment:


Signal output Acoustic energy (sound) earphone

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


of 148




The headset of the equipment was placed according to the general setup

page and operating for the exchange of calls (such as talking state with

the handset raised). A short duration peak applied to the tip and ring by

applying digital codes to the receive input of the device. This may be

performed by using an

analog test set to drive a reference codec, or by use of a digital code

generator. The analog level shall be set to switch between the maximum

positive and the maximum negative values for the reference codec. The

switching rate shall be through the range of 100 Hz to 3400 Hz for narrow

band and 100 Hz to 6800 Hz for wideband. The duration of the ON codes

shall be a number of complete cycles approximating but exceeding 500

ms. The ON codes must be followed by a quiet interval of at least 500 ms

before repeating the codes. For equipment not intended to be directly

connected to the Telecommunication Network, such as equipment used

with specialized PBX or Key systems and the like, the short duration peak

was applied

between the tip and ring terminals of the system.

The equipment was checked for self generated acoustic impulses such

as those produced by operation of the hook switch or by dialing.

IEC 60950-1, Annex NAD


The peak acoustic pressure did not exceed 136 dB ERP IEC 60950-1, Annex NAD


see above IEC 60950-1, Annex NAD







of 148




Measure text:

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

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

Marked the name or trademark and with model no.

Decided tasks:

Identification

Comment:


Information Labeling PC did not marke with the name or

trademark of Onyx and with a


Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Meet IEC 60601-1 3rd Ed. Clause 7.2.2 requirements IEC 60601-1 3rd Ed. Clause 7.2.2


see above IEC 60601-1 3rd Ed. Clause 7.2.2





of 148








of 148




Measure text:


State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-7-2011 11-24-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011


Decided tasks:

No HAZARDOUS SITUATION, other than absence of ESSENTIAL PERFORMANCE, shall develop when a

connection with the wrong polarity is made.

Comment:


Connection to an external d.c.

power source

Thermal Energy When a connection with the wrong

polarity is made.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


QD2-001, QD2-009 and QD2-010 QQ1-001


QD2-001, QD2-009 and QD2-010 QQ1-001


QD2-001, QD2-009 and QD2-010 QQ1-001


QD2-001, QD2-009 and QD2-010 QQ1-001

of 148





QD2-001, QD2-009 and QD2-010 QQ1-001


QD2-001, QD2-009 and QD2-010 QQ1-001

of 148




Measure text:

Rounding of sharp edges and corners.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-6-2011 11-18-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

Rounding of sharp edge and corner.

Decided tasks:

Rough surfaces, sharp corners and edges of Bedside Terminal that could result in an unacceptable RISK.

Comment:


Enclosure Mechanical energy Sharp edges and corners

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Accessible edges or corners of the unit, except those required for proper

functioning of the equipment, were subjected to this test. Surfaces

described below were judged using the Sharp Edge Tester . The curved

face of the tester head was covered with three layers of tape: bottom

layer 1.6 mm black vinyl foam tape; middle layer 0.8 mm white vinyl foam

tape; outer layer 0.08 mm (3 mil) Teflon tape skived. The tape-covered

head of the tester was positioned on the edge to check for sharpness.

The arm of the tester was calibrated so that a 6.7 N force was present at

the center of the head when the arm was between stops. This force was

applied on the sharp edge. The tester was immediately moved 50.5 mm

along the edge and then back to its starting position without removing the

tester so that total distance traveled was 101 mm. The time of travel was

no longer than 5 seconds nor less than 2 seconds.

IEC 60601-1, Clause 9.3


The edges and corners were considered to be rounded and smooth. IEC 60601-1, Clause 9.3

of 148












of 148




Measure text:

Said components were secured in place on pcb by UL Recognized non -chemical

bounding compound.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-5-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

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

Decided tasks:

Components of power supply, unwanted movement of which could result in an unacceptable RISK, shall be

mounted securely to prevent such movement.

Comment:


Connect to Mains Electromagnetic energy Components of PC, unwanted

movement of which could result in an

unacceptableb RISK, is not mounted

securely to prevent such movement.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan





QD2-001, QD2-010, QM2-011 and

QD2-009





QD2-001, QD2-010, QM2-011 and

QD2-009


see above QD2-001, QD2-010, QM2-011 and

QD2-009

of 148






QD2-009



QD2-009



QD2-009

of 148




Measure text:

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); and

mechanical strength (see IEC 60601-1, Clause 15.3).

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-15-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

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); and mechanical strength (see IEC 60601-1, clause 15.3).

Decided tasks:

The resistance to heat shall retained by all types of insulation, including insulating partition walls, during the

EXPECTED SERVICE LIFE of the PC.

Comment:


Connect to Mains Electromagnetic energy The resistance to heat is not retained

by all types of insulation, including

insulating partition walls, during the

EXPECTED SERVICE LIFE of the

PC.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


A sample of each external part of insulating material indicated in the table

was tested using the test apparatus shown in Fig. 21 of IEC 60601-1, 3rd

Edition. (In this apparatus, a steel ball of 5 mm diameter exerts a force of

20 N when pressed against a surface). The apparatus and a fire (or

sand) brick were placed in an air-circulating oven. Once the apparatus

and brick attained the oven temperature, the sample was placed in the

oven on top of the brick. The steel ball was then positioned such that the

apparatus was balanced on the surface of the sample. After 1 h, it was

removed and the diameter of the impression made by the ball was

measured. The specified oven temperature was the higher of the

following:

a. the sum of the specified ambient and the temperature rise of relevant

part during the Temperature Test; AND

b. 75°C ± 2°C (test per Clause 8.8.4.1a), OR 125°C ± 2°C (test per

Clause 8.8.4.1b)


of 148





The results were less 2 mm.

Cracks were not visible to the naked eye.










of 148




Measure text:

Supplied by SELV power adapter and DC/AC inverter meet LCC requirements.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-13-2011 11-24-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

Supplied by SELV power adapter and DC/AC inverter meet LCC requirements

Decided tasks:

ACCESSIBLE PARTS (output connector) shall not exceed 42.4 V peak a.c. or 60 V d.c. in NORMAL

CONDITION or in SINGLE FAULT CONDITION.

Comment:


Connect to Mains Electromagnetic energy ACCESSIBLE PARTS exceed 42.4 V

peak a.c. or 60 V d.c. in NORMAL

CONDITION or in SINGLE FAULT

CONDITION.

Signal input Electromagnetic energy ACCESSIBLE PARTS exceed 42.4 V

peak a.c. or 60 V d.c. in NORMAL

CONDITION or in SINGLE FAULT

CONDITION.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


A short of the operational or basic insulation indicated in the table was

made. The voltage present at the accessible parts/circuitry was

measured, recorded and compared to 42.4 V pk ac and 60 V dc.

QD2-001, QD2-010, QM2-011 and

QD2-009


The voltage did not exceed 42.4 V peak ac or 60 V dc. QD2-001, QD2-010, QM2-011 and

QD2-009


of 148





QD2-009



QD2-009



QD2-009



QD2-009

of 148




Measure text:

The equipment complied with the requirements of IEC 60601-1, Clause 11.6.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-17-2011 11-25-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The equipment complied ]with the requirements of IEC 60601-1, Clause 11.6.

Decided tasks:

The monitor and their parts, including ACCESSORIES, shall be capable of withstanding, without damage or

deterioration of safety provisions, the cleaning or disinfection PROCESSES specified in the instructions for use.

Comment:


Connect to Mains Electromagnetic energy Cleaning

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


The equipment was cleaned/disinfected as specified in the instructions

for use. After an adequate cooling and drying period, the unit was

subjected to Leakage Current and Dielectric Voltage Withstand Tests as

noted below. The effect of multiple cleanings/disinfections over the

expected service life of the equipment was considered.



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.

IEC 60601-1, 3rd Edition, Clause 11.6)


see above IEC 60601-1, 3rd Edition, Clause 11.6)

of 148










of 148




Measure text:

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

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-12-2011 11-30-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

Meet Clause 13 of IEC 60601-1, 3rd Ed. requirements.

Decided tasks:

HAZARDOUS SITUATIONS and fault conditions.

Comment:


Connect to Mains Electromagnetic energy Short circuit of any one insulation that

complies with the requirements for

one MEANS OF PROTECTION as

specified in IEC 60601-1, Clause 8.8

Connect to Mains Electromagnetic energy Short circuit of any one CREEPAGE

DISTANCE or AIR CLEARANCE that

complies with the requirements for

one MEANS OF PROTECTION as

specified in

IEC 60601-1, Clause 8.9

Connect to Mains Electromagnetic energy Open circuit of any one

PROTECTIVE EARTH


PROTECTIVE EARTH

CONNECTION that complies with the

requirements of IEC

60601-1, Clause 8.6

Connect to Mains Electromagnetic energy Accidental detachment of conductors

and connectors where breaking free

could lead to a HAZARDOUS

SITUATION.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


of 148




The device was operated until ultimate results were obtained. All final

results were recorded. If required, final temperatures were measured and

recorded. The normal conditions were also applied in the least

favorable combination.

- The unit was positioned in the same way as for the Temperature Test

- Failure of Components - The components were short circuited or

opened, one at a time.

- The load current was then increased by 5 % with the supply voltage

maintained at its original value. When steady thermal conditions were

again established, the load was again increased. These steps were

continued until the overload protector operated or until thermal stability

was reached.

- For each fault condition, the Dielectric Voltage Withstand Test was

repeated immediately following the conclusion of the test.

IEC 60601-1, 3rd Edition, Clause 13


1. Self-resetting thermal cutouts did not operate.

2. The setting of any thermostat, thermal cutout or overload release did

not change due to heating, vibration or other causes.

3. The measured temperatures did not exceed those allowable.

4. In each case the hazardous situations described in Clauses 13.1.2 to

13.1.4 of IEC 60601-1, 3rd ED. did not occur.

5. See Table 11 of IEC 60601-1, 3rd ED. for Temperatures obtained

during the indicated Abnormal Operation tests.



see above IEC 60601-1, 3rd Edition, Clause 13







of 148




Measure text:

The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity of

93 % ± 3 % @ 25°C 48 hr

State of measure:

Responsible


Finished

Plan:

Start: End:12-1-2011 12-31-2011

Actual values:

Start: End:10-4-2011 11-23-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-09-2011

Release:

Release through:

Is released:


12-9-2011

The humidity preconditioning treatment is performed in a humidity cabinet containing air with a relative humidity

of 93 % ± 3 % @ 25°C 48 hr

Decided tasks:

Storage (humidity preconditioning treatment)

Comment:


Connect to Mains Electromagnetic energy Storage (humidity preconditioning

treatment)

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


PC or its parts shall be set up complete. Covers used during transport

and storage are detached. This treatment is applied only to those power

supply parts which are influenced by the climatic conditions

that are simulated by the test. Parts that can be detached without the use

of a TOOL are detached but are treated simultaneously with the major

part. ACCESS COVERS that can be opened or detached without the use

of a TOOL are opened and detached.

A humidity chamber having relative humidity of 90 to 96 % was set to any

convenient Temperature T between 20 and 32°C. The unit, before being

placed in the chamber was brought to a temperature between T and T +

4°C and kept at this temperature a minimum of 4 h. Then the sample was

placed in the humidity chamber and kept there for the time specified in

Table 5.7 of IEC 60601-1, 3rd Ed. (minimum 48 h). During this time the

temperature of the air in the chamber was maintained at T ± 2°C.

Immediately after the treatment and while still in the chamber, the sample

was subjected to Dielectric Voltage Withstand Test. Then the unit was

removed from the chamber, placed in normal environment (temperature

approximately T, humidity 45-65%). Immediately following the humidity

preconditioning treatment, the power supply was subjected to a repeat of

the dielectric withstand and leakage current tests.


of 148





There was no dielectric breakdown IEC 60601-1, 3rd Edition, Clause 5.7









of 148




Measure text:

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

produce detrimental biological effects.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-6-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

Computer monitors emit electromagnetic radiation in a broad range of frequencies. Although the

electromagnetic radiation field intensities are measurable, they are not substantially above background office

levels. The effect on health from the use of monitors has been studied for many years , and the research

continues. The present consensus of experts is that there are no data to suggest a health risk from exposure to

the electromagnetic fields associated with the use of monitors.

Decided tasks:

PC users have expressed concerns about the possible health effects from the electromagnetic radiation that

monitors produce. The concerns generally center around adverse pregnancy outcome (spontaneous abortion or

birth defects). It has been postulated that these effects are due to electromagnetic radiation exposure from

monitors. The biological effects of exposure to VLF and ELF fields similar to those produced by monitors have

been studied for many years, and the research continues today. Cancer and reproductive outcomes are the

topics studied most intensively. Current available scientific information does not identify a health risk from

exposure to the electromagnetic fields associated with the use of computer monitors.

Comment:


Display Radiation energy Visible Light

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


https://ehs.mit.edu/site/content/radiation-computer-monitors https://ehs.mit.edu/site/content/radiation-c

omputer-monitors


see above see above

of 148





see above see above


see above see above


see above see above


see above see above

of 148




Measure text:


State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-7-2011 11-24-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

Internal cables and wiring shall adequately protected against contact from friction at sharp corners and edges

where damage to insulation could result in a HAZARDOUS SITUATION.

Decided tasks:


Comment:


Connect to Mains Electromagnetic energy Internal cables and wiring were not

adequately protected against contact


edges where damage to insulation

could result in a HAZARDOUS

SITUATION.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan





QD2-001, QD2-010, QM2-011 and

QD2-009





QD2-001, QD2-010, QM2-011 and

QD2-009



QD2-009

of 148






QD2-009



QD2-009



QD2-009

of 148




Measure text:

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

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-7-2011 11-29-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

The insulation that is relied upon as a MEANS OF PROTECTION, including REINFORCED INSULATION shall

be subject to testing.

Decided tasks:

Insulation

Comment:


Connect to Mains Electromagnetic energy Short circuit of any or all insulation

that does not comply with the


Ed., Clause. 8.8

Connect to Mains Electromagnetic energy Short circuit of any or all CREEPAGE

DISTANCES or AIR CLEARANCES

that do not comply with the


Ed., Clause 8.9

Connect to Mains Electromagnetic energy Open circuit of any or all earth

connections that do not comply with

the requirements of IEC 60601-1,

Clause 8.6, including any functional

earth connection.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


A short of the operational or basic insulation indicated in the table was

made. The voltage present at the accessible parts/circuitry was

measured, recorded and compared to 42.4 V pk ac and 60 V dc.

QD2-001, QD2-010, QM2-011, QD2-009,,


and 8.11.1


of 148




The voltage did not exceed 42.4 V peak ac or 60 V dc. QD2-001, QD2-010, QM2-011, QD2-009,,


and 8.11.1


see above QD2-001, QD2-010, QM2-011, QD2-009,,


and 8.11.1




and 8.11.1




and 8.11.1




and 8.11.1

of 148




Measure text:

The permissible environmental conditions for transport and storage were marked on the outside of the packaging.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-3-2011 11-30-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

The permissible environmental conditions for transport and storage were marked on the outside of the

packaging.

Decided tasks:

Packing

Comment:


Connect to Mains Electromagnetic energy Packing

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001

of 148





QD2-001 and QM2-007 QQ1-001

of 148




Measure text:

The strength of packing carton / fixed frame. The transportation stimulation for

the verification. All connections were mechanically secure.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-5-2011 11-24-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

The strength of packing carton / fixed frame. The transportation stimulation for the verification. All connections


Decided tasks:

Transport

Comment:


Connect to Mains Electromagnetic energy Transport

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001

of 148





QD2-001 and QM2-007 QQ1-001


QD2-001 and QM2-007 QQ1-001

of 148




Measure text:

The suitable enclosure shall be provided.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-6-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

Compliance is checked by the mechanical strength tests for ENCLOSURES (see 15.3).

Decided tasks:

ENCLOSURES shall have the strength and rigidity necessary to avoid a fire that could occur as a result of a

total or partial collapse caused by reasonably foreseeable misuse.

Comment:


Connect to Mains Electromagnetic energy Internal parts, other than contacts of

plugs, connectors and socket-outlets,

that can be touched by the test pin

shown in IEC 60601-1, Figure 8.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


- Force (15.3.2) - A sample of the unit was subjected to inward directed

force of 250 N plus or minus 10 N for a period of 5 seconds applied to

different parts of the enclosure via a test tool providing contact over a

circular plane surface 30 mm in diameter as indicated in Table 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 a solid steel 50 mm (approx) ball of

mass 500 g plus or minus 25 g, fall freely from 1,3 meter height. The unit

was rigidly supported and the impact was applied to the locations

indicated in Table 15.3.



There was no cracking of the enclosure.

There were no live parts that became accessible.


of 148












of 148




Measure text:


State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-3-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011


Decided tasks:

The reliability of components that are used as MEANS OF PROTECTION shall be assessed for the conditions

of use in the monitor and power supply.

Comment:


Connect to Mains Electromagnetic energy The reliability of components that are

used as MEANS OF PROTECTION

are not assessed for the conditions of

use in the PC.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


Evaluation and testing of components shall be conducted as follows:

- a component that has been demonstrated to comply with a standard

harmonized with the relevant IEC component standard shall be checked

for correct application and use in accordance with its rating. It shall be

subjected to the applicable tests of IEC 60601-1 as part of the equipment

with the exception of those tests which are part of the relevant IEC

component standard;

- a component that has not been demonstrated to comply with a relevant

standard as above shall be checked for correct application and use in

accordance with its specified rating. It shall be subjected to the applicable

tests of IEC 60601-1, as part of the equipment, and to the applicable

tests of the component standard, under the conditions occurring in the

equipment;

- where no relevant IEC component standard exists, or where

components are used in circuits not in accordance with their specified

ratings, the components shall be tested under the conditions occurring in

the equipment. The number of samples required for test is, in general,

the same as required by an quivalent standard.

QD2-001, QD2-010, QM2-011, QD2-009

and IEC 60601-1, Clause 4.8

of 148





see above QD2-001, QD2-010, QM2-011, QD2-009














of 148




Measure text:

When PC is operated in worst-case NORMAL USE including the maximum

ambient operating temperature, the parts shall not reach temperatures exceeding

the values given in IEC 60601-1, Table 22 and Table 23.

State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-13-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

When PC and power supply is operated in worst-case NORMAL USE including the maximum ambient

operating temperature, the parts shall not reach temperatures exceeding the values given in IEC 60601-1,

Table 22 and Table 23.

Decided tasks:

Excessive temperatures in PC and/or power supply.

Comment:


Connect to Mains Thermal Energy Excessive temperatures in PC and/or

power supply.

Enclosure Thermal Energy Excessive temperatures in enclosure

Touch Panel & Plastic Enclosure


Thermal Energy Excessive temperatures in touch

panel

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


The sample was placed in a test corner. The test corner consisted of two

walls at right angles, and a floor, all of dull black painted plywood of 20

mm thickness. The linear dimensions of the test corner were at least 115

percent of the linear dimensions of the unit. The unit was positioned as

near to the walls as possible and to the floor. The power supply is

operated until THERMAL STABILITY is reached.




of 148












of 148




Measure text:

Where there is no relevant IEC or ISO standard, the requirements of IEC 60601-1,


State of measure:

Responsible


Finished

Plan:

Start: End:10-1-2011 12-31-2011

Actual values:

Start: End:10-5-2011 11-28-2011

Effort:

Planned: Actual:

Validation:

Validated through:

Is validated:


Yes

12-11-2011

Release:

Release through:

Is released:


12-11-2011

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

Decided tasks:

The reliability of components that are used as MEANS OF PROTECTION are not assessed for the conditions

of use in the PC.

Comment:


Connect to Mains Electromagnetic energy The reliability of components that are

used as MEANS OF PROTECTION

are not assessed for the conditions of

use in the PC.

Realization team:

James Chen

Steve Chen

Mike Ho

Owen Hsieh

Peter Pan


QD2-001, QD2-010, QM2-011 and QD2-009 IEC 60601-1, Clause 4.8







of 148








of 148

12-14-2011




Version number:


Project manager:


Steven Chen


New evaluation after measures

1.00


F-01





60601-1, 3rd Ed., Clause. 8.8


acceptable

region








acceptable

region

C-03 Open circuit of any or all earth





Critical Improbable Broadly

acceptable

region

C-04 Short circuit of any one insulation




IEC 60601-1, Clause 8.8


acceptable

region

C-05 Short circuit of any one





IEC 60601-1, Clause 8.9


acceptable

region

C-06 Open circuit of any one

PROTECTIVE EARTH



acceptable

region

of 148



F-01


PROTECTIVE EARTH



60601-1, Clause 8.6

C-07 All components, including wiring,




acceptable

region

C-08 The reliability of components that




PC.

Serious Improbable Broadly

acceptable

region

C-09 Storage (humidity preconditioning

treatment)


acceptable

region

C-10 Transport Minor Remote Broadly

acceptable

region

C-11 Components of PC, unwanted




movement.


acceptable

region



patient.


acceptable

region

C-13 The LEAKAGE CURRENTS

from, to or between


PATIENT CONNECTIONS


acceptable

region






acceptable

region

C-15 Internal parts, other than contacts




acceptable

region

of 148



F-01




C-16 Accidental detachment of





acceptable

region

C-17 The resistance to heat is not




LIFE of the PC.


acceptable

region

C-18 Internal cables and wiring is not





insulation.


acceptable

region

C-19 Electromagnetic compatibility of

PC.


acceptable

region

C-20 Packing Serious Remote Broadly

acceptable

region

C-21 Wirings and connectors of Panel






acceptable

region

C-22 Internal cables and wiring were







acceptable

region

C-23 Cleaning Minor Remote Broadly

acceptable

region

of 148



F-01


C-01 Excessive temperatures in PC



acceptable

region

Thermal EnergyH-02

C-02 ENCLOSURES have no the


avoid a fire.


acceptable

region


F-02


C-01 Falling Serious Remote Broadly

acceptable

region

Mechanical energyH-01

C-02 Suspended masses Critical Improbable Broadly

acceptable

region

C-03 Sharp edges and corners Minor Remote Broadly

acceptable

region

C-01 Excessive temperatures in

enclosure


acceptable

region

Thermal EnergyH-02

of 148




F-03


C-01 Crack Serious Remote Broadly

acceptable

region


C-02 Suspended masses Critical Improbable Broadly

acceptable

region

C-03 Instability Serious Remote Broadly

acceptable

region


F-04







acceptable

region



F-05


C-01 earphone Serious Remote Broadly

acceptable

region

Acoustic energy (sound)H-01


F-06


C-01 Switches used to control power to





acceptable

region

OperationalH-01

of 148




F-07


C-01 PC did not marke with the name




acceptable

region

LabelingH-01

C-02 Incomplete instructions for use Serious Remote Broadly

acceptable

region

C-03 Inadequate description of



acceptable

region


intended use.


acceptable

region

C-05 Inadequate disclosure of

limitations


acceptable

region



medical device.


acceptable

region

Operating instructionsH-02


pre-use checks.


acceptable

region

C-03 Over-complicated operating

instructions.


acceptable

region

C-01 Installation instruction Serious Remote Broadly

acceptable

region

Specification of service and

maintenance

H-03


F-08


C-01 When a connection with the



acceptable

region

Thermal EnergyH-01

of 148




F-09


C-01 Visible Light Minor Remote Broadly

acceptable

region

Radiation energyH-01


F-10


C-01 Lithium battery explosion Critical Improbable Broadly

acceptable

region



F-11




patient.

<not yet

evaluated>Electromagnetic energyH-01

C-01 Excessive temperatures in touch

panel

<not yet

evaluated>Thermal EnergyH-02

of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Risk-graph (after measures)

1.00

Both states

P5

P4

P3

11 22

P2

3 11

P1

S1 S2 S3 S4 S5

Operation state

P5

P4

P3

11 22

P2

3 11

P1

S1 S2 S3 S4 S5

of 148


12-14-2011


Fault state

P5

P4

P3

P2

P1

S1 S2 S3 S4 S5


of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Graph before and after

1.00

before measures after measures

Both states

P5

P4

9 23 5P3

2 3 7P2

P1

S1 S2 S3 S4 S5

Both states

P5

P4

P3

11 22P2

3 11P1

S1 S2 S3 S4 S5

Operation state

P5

P4

9 23 5P3

2 3 7P2

P1

S1 S2 S3 S4 S5

Operation state

P5

P4

P3

11 22P2

3 11P1

S1 S2 S3 S4 S5

of 148


12-14-2011


before measures after measures

Fault state

P5

P4

P3

P2

P1

S1 S2 S3 S4 S5

Fault state

P5

P4

P3

P2

P1

S1 S2 S3 S4 S5


of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Release protocol of this version

1.00

Version is not yet closed.

of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Post-production information

1.00

Corrective measure Date Result of post-production information Evidence

of 148

12-14-2011




Version number:


Project manager:


Steven Chen


Summary of risk control

1.00


F-01

Hazard Cause Has effect on Risk before

measures

Measure imple-

ment

released Risk after

measures

M-01 The limits specified in IEC

60601-1, Clause 8.4 is not be exceeded

for ACCESSIBLE PARTS

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable


insulation that does not

comply with the

requirements of IEC

60601-1, 3rd Ed.,

Clause. 8.8

C-01Electromagnetic

energy

H-01

H-01H-01H-01C-01C-01C-01M-01 The limits specified in IEC



Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable


CREEPAGE

DISTANCES or AIR

CLEARANCES that do

not comply with the

requirements of IEC

60601-1, 3rd Ed.,

Clause 8.9

C-02

C-02C-02C-02M-01 The limits specified in IEC



Yes YesS4 / P2

Intolerable

S4 / P1

Broadly

acceptable

Open circuit of any or

all earth connections

that do not comply with


60601-1, Clause 8.6,

including any functional

earth connection.

C-03

C-03C-03C-03

of 148

Project number: 1112024003 Version: Short name: ONYX-BE18xDT 12-14-2011


1.00

F-01


measures

Measure imple-

ment

released Risk after

measures

M-01 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

Yes YesS4 / P3

Intolerable

S4 / P1

Broadly

acceptable


insulation that complies

with the requirements

for one MEANS OF

PROTECTION as

specified in IEC

60601-1, Clause 8.8

C-04Electromagnetic

energy

H-01

H-01H-01H-01C-04C-04C-04M-01 The HAZARDOUS SITUATIONS

in IEC 60601-1, Clause 13.1.2 to 13.1.4


power adapter

Yes YesS4 / P3

Intolerable

S4 / P1

Broadly

acceptable


CREEPAGE

DISTANCE or AIR

CLEARANCE that

complies with the

requirements for one

MEANS OF

PROTECTION as

specified in

IEC 60601-1, Clause

8.9

C-05

C-05C-05C-05M-01 The HAZARDOUS SITUATIONS

in IEC 60601-1, Clause 13.1.2 to 13.1.4


power adapter

Yes YesS4 / P2

Intolerable

S4 / P1

Broadly

acceptable

Open circuit of any one

PROTECTIVE EARTH

CONDUCTOR or

internal

PROTECTIVE EARTH

CONNECTION that

complies with the

requirements of IEC

60601-1, Clause 8.6

C-06

C-06C-06C-06M-01 All components, including wiring

shall be used in accordance with their

specified

ratings.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

All components,

including wiring, the

failure of which could

result in a

HAZARDOUS

SITUATION.

C-07

C-07C-07C-07 of 148



1.00

F-01


measures

Measure imple-

ment

released Risk after

measures

M-02 All components, including wiring,

the failure of which could result in a

HAZARDOUS SITUATION are fixed in

place by UL R/C non-chemical bounding

compound.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

All components,

including wiring, the

failure of which could

result in a

HAZARDOUS

SITUATION.

C-07Electromagnetic

energy

H-01

H-01H-01H-01C-07C-07C-07M-01 They shall comply with the

applicable safety requirements of a

relevant IEC, UL or ISO standard;

Yes YesS3 / P2

Broadly

acceptable

S3 / P1

Broadly

acceptable

The reliability of

components that are

used as MEANS OF

PROTECTION are not

assessed for the

conditions of use in the

PC.

C-08

C-08C-08C-08M-02 Where there is no relevant IEC or

ISO standard, the requirements of IEC

60601-1,


Yes YesS3 / P2

Broadly

acceptable

S3 / P1

Broadly

acceptable

M-01 The humidity preconditioning

treatment is performed in a humidity

cabinet containing air with a relative

humidity of 93 % ± 3 % @ 25°C 48 hr

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

Storage (humidity

preconditioning

treatment)

C-09

C-09C-09C-09 M-01 The strength of packing carton /

fixed frame. The transportation

stimulation for

the verification. All connections were

mechanically secure.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

TransportC-10

C-10C-10C-10 M-01 Said components were secured in

place on pcb by UL Recognized

non-chemical

bounding compound.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

Components of PC,

unwanted movement of

which could result in an

unacceptableb RISK, is

not mounted securely to

prevent such

movement.

C-11

C-11C-11C-11 of 148



1.00

F-01


measures

Measure imple-

ment

released Risk after

measures

M-01 Meet IEC 60601-1, Clause 8.7

LEAKAGE CURRENTS and PATIENT

AUXILIARY CURRENTS requirements

Yes YesS4 / P3

Intolerable

S4 / P1

Broadly

acceptable

Too high leakage

current, causing a

death or serious injury

to a patient.

C-12Electromagnetic

energy

H-01

H-01H-01H-01C-12C-12C-12 M-01 Meet IEC 60601-1, Clause 8.7



Yes YesS4 / P3

Intolerable

S4 / P1

Broadly

acceptable

The LEAKAGE

CURRENTS from, to or

between ACCESSIBLE

PARTS other than

PATIENT

CONNECTIONS

C-13

C-13C-13C-13M-01 Supplied by SELV power adapter


requirements.

Yes YesS4 / P2

Intolerable

S4 / P1

Broadly

acceptable

ACCESSIBLE PARTS

exceed 42.4 V peak

a.c. or 60 V d.c. in

NORMAL CONDITION

or in SINGLE FAULT

CONDITION.

C-14

C-14C-14C-14M-01 The suitable enclosure shall be

provided.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Internal parts, other

than contacts of plugs,

connectors and

socket-outlets, that can

be touched by the test

pin shown in IEC

60601-1, Figure 8.

C-15

C-15C-15C-15M-01 The HAZARDOUS SITUATIONS

in IEC 60601-1, Clause 13.1.2 to 13.1.4


power adapter

Yes YesS3 / P2

Broadly

acceptable

S3 / P1

Broadly

acceptable

Accidental detachment

of conductors and

connectors where

breaking free could lead

to a HAZARDOUS

SITUATION.

C-16

C-16C-16C-16

of 148



1.00

F-01


measures

Measure imple-

ment

released Risk after

measures

M-01 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); and

mechanical strength (see IEC 60601-1,

Clause 15.3).

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

The resistance to heat

is not retained by all

types of insulation,

including insulating

partition walls, during

the EXPECTED

SERVICE LIFE of the

PC.

C-17Electromagnetic

energy

H-01

H-01H-01H-01C-17C-17C-17M-02 Ball pressure test - according to

IEC 60601-1, Clause 8.8.4.1, b)

requirements

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

M-01 Internal cables and wiring is fixed

in place by cable tie to protect against

contact with a moving part or from

friction at sharp corners and edges

where damage to insulation

Yes YesS2 / P2

Broadly

acceptable

S2 / P2

Broadly

acceptable

Internal cables and

wiring is not adequately

protected against

contact with a moving

part or from friction at

sharp corners and

edges where damage

to insulation.

C-18

C-18C-18C-18M-01 Meet IEC 60601-1-2 requirements Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Electromagnetic

compatibility of PC.

C-19

C-19C-19C-19 M-01 The permissible environmental

conditions for transport and storage

were marked on the outside of the

packaging.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

PackingC-20

C-20C-20C-20 M-01 All wirings are tied together by


detachment.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Wirings and connectors

of Panel PC Monitor

supply is not secured or

insulated that accidental

detachment can result

in a HAZARDOUS

SITUATION.

C-21

C-21C-21C-21 of 148



1.00

F-01


measures

Measure imple-

ment

released Risk after

measures

M-01 The internal wirings were secured

in place on PCB by UL R/C

non-chemical bounding component.

Yes YesS2 / P2

Broadly

acceptable

S2 / P2

Broadly

acceptable

Internal cables and

wiring were not

adequately protected

against contact from

friction at sharp corners

and edges where

damage to insulation

could result in a

HAZARDOUS

SITUATION.

C-22Electromagnetic

energy

H-01

H-01H-01H-01C-22C-22C-22M-01 The equipment complied with the

requirements of IEC 60601-1, Clause

11.6.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

CleaningC-23

C-23C-23C-23 M-01 When PC is operated in

worst-case NORMAL USE including the

maximum

ambient operating temperature, the

parts shall not reach temperatures

exceeding

the values given in IEC 60601-1, Table

22 and Table 23.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Excessive temperatures

in PC and/or power

supply.

C-01Thermal EnergyH-02

H-02H-02H-02C-01C-01C-01M-01 Compliance with the mechanical

strength tests for ENCLOSURES (see

IEC

60601-1, Clause 15.3)

Yes YesS4 / P2

Intolerable

S4 / P1

Broadly

acceptable

ENCLOSURES have no

the strength and rigidity

necessary to avoid a

fire.

C-02

C-02C-02C-02

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1.00


F-02


measures

Measure imple-

ment

released Risk after

measures

M-01 Meet IEC 60601-1, Clause 9.4.2

requiremets.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

FallingC-01Mechanical

energy

H-01

H-01H-01H-01C-01C-01C-01 M-01 Meet IEC 60601-1 Clause 9.8.2


Yes YesS4 / P2

Intolerable

S4 / P1

Broadly

acceptable

Suspended massesC-02

C-02C-02C-02 M-01 Rounding of sharp edges and

corners.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

Sharp edges and

corners

C-03

C-03C-03C-03 M-01 When PC is operated in

worst-case NORMAL USE including the

maximum



exceeding


22 and Table 23.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable


in enclosure


H-02H-02H-02C-01C-01C-01F-03Function: Rear Bracket

F-03


measures

Measure imple-

ment

released Risk after

measures

M-01 Meet IEC 60601-1 Clause 9.8.2


Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

CrackC-01Mechanical

energy

H-01

H-01H-01H-01C-01C-01C-01 M-01 Meet IEC 60601-1 Clause 9.8.2


Yes YesS4 / P3

Intolerable

S4 / P1

Broadly

acceptable

Suspended massesC-02

C-02C-02C-02 M-01 Meet IEC 60601-1 Clause 9.8.2


Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

InstabilityC-03

C-03C-03C-03 of 148



1.00


F-04


measures

Measure imple-

ment

released Risk after

measures

M-01 Supplied by SELV power adapter


requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

ACCESSIBLE PARTS

exceed 42.4 V peak

a.c. or 60 V d.c. in

NORMAL CONDITION

or in SINGLE FAULT

CONDITION.

C-01Electromagnetic

energy

H-01

H-01H-01H-01C-01C-01C-01F-05Function: Signal output

F-05


measures

Measure imple-

ment

released Risk after

measures

M-01 Meet IEC 60950-1, Annex NAD

Acoustic tests requirements

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

earphoneC-01Acoustic energy

(sound)

H-01

H-01H-01H-01C-01C-01C-01F-06Function: User control and indicator

F-06


measures

Measure imple-

ment

released Risk after

measures

M-01 Indicated by an adjacent indicator

light

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Switches used to

control power to PC or

its parts, including

switches, did not have

their "on" and "off"

positions.

C-01OperationalH-01

H-01H-01H-01C-01C-01C-01M-02 Marked with symbols IEC 60417 Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

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1.00


F-07


measures

Measure imple-

ment

released Risk after

measures

M-01 PC marked the name or

trademark of Onyx with model no.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

PC did not marke with

the name or trademark

of Onyx and with a

MODEL OR TYPE

REFERENCE

C-01LabelingH-01

H-01H-01H-01C-01C-01C-01 M-01 Meet IEC 60601-1, Clause 7

requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Incomplete instructions

for use

C-02

C-02C-02C-02 M-01 Meet IEC 60601-1, Clause 7

requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Inadequate description

of performance

characteristics

C-03


requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Inadequate

specification of

intended use.

C-04


requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Inadequate disclosure

of limitations

C-05


requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Inadequate

specification of

accessories to be used

with the medical device.

C-01Operating

instructions

H-02

H-02H-02H-02C-01C-01C-01 M-01 Meet IEC 60601-1, Clause 7

requirements.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

Inadequate

specification of pre-use

checks.

C-02


requirements.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

Over-complicated

operating instructions.

C-03


requirements.

Yes YesS3 / P3

Intolerable

S3 / P2

Broadly

acceptable

Installation instructionC-01Specification of

service and

maintenance

H-03

H-03H-03H-03C-01C-01C-01 of 148



1.00


F-08


measures

Measure imple-

ment

released Risk after

measures

M-01 Provided a connector that has

special housing to prevent a connection

with the wrong polarity is made.

Yes YesS3 / P2

Broadly

acceptable

S3 / P1

Broadly

acceptable

When a connection with

the wrong polarity is

made.


H-01H-01H-01C-01C-01C-01F-09Function: Display

F-09


measures

Measure imple-

ment

released Risk after

measures

M-01 The intensity of visible light from

monitor can be controlled by the user.

The highest intensity achievable cannot

produce detrimental biological effects.

Yes YesS2 / P3

Broadly

acceptable

S2 / P2

Broadly

acceptable

Visible LightC-01Radiation energyH-01

H-01H-01H-01C-01C-01C-01F-10Function: BIOS (Basic Input/Output System - real time clock)

F-10


measures

Measure imple-

ment

released Risk after

measures

M-01 Battery circuits is designed so that

discharging at a rate exceeding the

battery

manufacturer’s recommendations, and

unintentional charging, are prevented.

Yes YesS4 / P2

Intolerable

S4 / P1

Broadly

acceptable

Lithium battery

explosion

C-01Mechanical

energy

H-01

H-01H-01H-01C-01C-01C-01

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1.00


F-11


measures

Measure imple-

ment

released Risk after

measures

M-01 Meet IEC 60601-1, Clause 8.7



Yes YesS4 / P2

Intolerable

not ev. / not ev.

<not ev.>

Too high leakage

current, causing a

death or serious injury

to a patient.

C-01Electromagnetic

energy

H-01

H-01H-01H-01C-01C-01C-01 M-01 When PC is operated in

worst-case ABNORMAL USE including the

maximum



exceeding


23 and Table 24.

Yes YesS3 / P3

Intolerable

not ev. / not ev.

<not ev.>


in touch panel


H-02H-02H-02C-01C-01C-01

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12-14-2011




Version number:


Project manager:


Residual risk evaluation

1.00

The risk management for the product "18.5" Bedside Terminal, models xxxx-ONYX-BE18xDT-xxxxxxx" has been performed

and documented according to the international standard DIN EN ISO 14971.

Residual risk evaluation

Description of project:

The models xxxx-ONYX-BE18xDT-xxxxxxx are 18.5" Bedside Terminal for medical equipment used.

Intended use/purpose

1. 18.5" RISC Mini Bedside Terminal benefits medical staff by providing secure access to electronic patient data with an

optimized hospital workflow. As an aid to professional diagnosis, the terminal can remotely retrieve electronic patient

records, access databases from the bedside and comply with Hospital Information Systems (HIS) requirements. Hospital

administrators will see their medical facilities gain operational efficiencies , increase patient and visitor satisfaction, and

improve their quality of care, while boosting profitability. RISC Mini Bedside Terminal the xxxx-ONYX-BE18xDT-xxxxxxx

(x = 0-9, A-Z, "-" or blank) is a 18.5" multi-function terminal with touchscreen, WiFi, RFID, and smart card reader. The

xxxx-ONYX-BE18xDT-xxxxxxx (x = 0-9, A-Z, "-" or blank) is certified to ANSI/AAMI ES 60601-1 and EN60601-1: 2006

medical standards. The WiFi, and Ethernet (RJ-45) connectivity provides video phone service to help patients

communicate with their families by internet. Identification recognition for both patients and hospital staff is made possible

with RFID and a smart card reader. Two USB ports, an earphone jack and a microphone provide added flexibility.

Additionally, an LED light indicator button help alert hospital staff to important incidents . Equipped with a slim, clean,

hospital-fit design. There is a VESA compliant for mounting the support arm.2. The rated input: 24V dc, 2.91 A (for Ward Terminal Unit); 100-240 V ac, 50/60 Hz, 1.8-0.8 A (for power supply, model

GMPU70A-6 by Eljintek Inc.)

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 Terminal intended to be used at any altitudes between 0 to 3,000 m.

5. The Bedside Terminal expected services life was 43,800 hours

6. This Bedside Terminal was judged on the basis of the required creepage and clearances in the Third Edition of the

Standard for Medical Electrical Equipment, IEC 60601-1 3rd Ed., Sub. clause 8.9 which covers the end-use product for

which the component was designed.

7. This Bedside Terminal was tested on a 20 A branch circuit. If used on a branch circuit greater than this, additional

evaluation was necessary.

8. This Bedside Terminal has not been evaluated for patient connected applications .

9. This Bedside Terminal has been evaluated as a Class I , continuous operation, ordinary equipment and has not been

evaluated for use in the presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide. An additional

evaluation shall be made if the power supply is intended for use in other than Class I equipment.

10. This Bedside Terminal shall be installed assembled maintained or repair .

11. This Bedside Terminal incorporates the UL R/C and IEC 6060-1-1 certified power adapter, model

GMPU70A-6 by ELJINTEK INC. This power is used in the conditions of overvoltage category II, Pollution Degree II.

12. This Bedside Terminal does not deliverer the energy to or extract the energy from the patient .

13. This Bedside Terminal does not deliver the substances to or extract the substances from the patient .

14. No any biological materials processed by the Ward Terminal for subsequent re -use.

15. This Bedside Terminal does not supply sterile or intended to be sterilized by the user , or other applicable

microbiological controls.

16. This Bedside Terminal is not intended to be routinely cleaned and disinfected by the user .

17. This Bedside Terminal is not intended to modify the patient environment .

18. This Bedside Terminal does not take any measurements.

19. This Bedside Terminal is not intended for use in conjunction with medicines or other medical technologies .

20. This Bedside Terminal has no unwanted outputs of energy.

21. This Bedside Terminal is susceptible to environmental influences (ambient, emc).

22. This Bedside Terminal influences the environment (emi).

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23. This Bedside Terminal does not provided the essential consumables or accessories .

24. This Bedside Terminal is no need to maintenance and/or calibration.

25. This Bedside Terminal contain ssoftware, but the failure of the software does not lead to an unacceptable RISK.

26. This Bedside Terminal has a restricted shelf-life.

27. This Bedside Terminal has no any delayed and/or long-term use effects.

28. This Bedside Terminal does not subject mechanical forces.

29. This Bedside Terminal is not intended for single use.

30. No need to safe decommissioning or disposal of the Bedside Terminal .

31. Installation or use of the Bedside Terminal is required special training .

32. This Bedside Terminal has no output wire to connection end-product.

33. This Bedside Terminal is not used by person with special needs.

34. This Bedside Terminal did not use an alarm system.

35. This Bedside Terminal 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 time

Touch Panel Surface < 1min

Plastic Enclosure < 1min

Metal Enclosure < 1sec

Adapter Plastic Enclosure 10 sec - 1 min

Identification of known or predictable hazards and evaluation of the risks:

1. All reasonable hazards and their cause were identified and the resulting risks have been evaluated. All of the data

have been documented in the enclosed tables before the required measures for the risk diminution have been defined

and a final evaluation has been carried out.

2. The aim of this analysis is to improve the security of the product. The assessment is based on the companies'

security policy which was implemented for the product in the definition of the risk graph. There areas were defined:

"broadly acceptable" and "intolerable".

3. The definite acceptance of the product can only be carried out when the evaluation are located mainly in the "broadly

acceptable" region.

4. The product is not marketable according to the safety philosophy of our company if it does contain evaluations in the

"intolerable" region after implementation of the measures.

Residual risk, evaluation:

1) In this risk analysis the "present state" of the device has been evaluated.

2) Having carried out the evaluation of the product, the risk of appearance of a not acceptable fault is quit low.

3) The product construction, its function as well as the application does - under normal conditions- not represent any risk

for the user.

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