Xuyi Careyou Medical

Document No.： KEY-QS-TF-2-12 Version：5 Page：1/28

Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

Risk Management Report For

Nebulizer with Mask
(Aerosal Mask with Connecting Tube)

Compile: Juan Liu Review: Xianou Gong Approved: Sumei Duan

Date: 2021-01-10 Date: 2021-01-10 Date: 2021-01-10

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Document No.： KEY-QS-TF-2-12 Version：5 Page：2/28
Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

Content
1. Introduction ...................................................................................................................................................... 3
2. Purpose .............................................................................................................................................................5
3. Product Description ..........................................................................................................................................5
3.1 General Information ...............................................................................................................................5
3.2 Product Pictures ..................................................................................................................................... 5
3.3 Raw materials .........................................................................................................................................5
3.4 Product specifications ............................................................................................................................ 5
3.5 Packaging and Shelf-life ........................................................................................................................5
3.6 Intended Use .......................................................................................................................................... 6
3.7Combination with other devices ............................................................................................................. 6
3.8 Warnings and Precautions ......................................................................................................................6
3.9 Instructions for Use ................................................................................................................................6
4. Qualification of personnel ................................................................................................................................6
5. Risk Management Plan .................................................................................................................................... 6
5.1Scope ....................................................................................................................................................... 6
5.2Assignment of responsibilities and authorities .......................................................................................6
5.3 Reference ............................................................................................................................................... 7
5.4 Requirements for review of risk management activities ....................................................................... 7
5.5 Criteria of Risk Evaluation .................................................................................................................... 7
5.6 Verification activities ............................................................................................................................. 9
5.7 Methods of obtaining relevant post-production information ................................................................ 9
6. Risk Analysis ....................................................................................................................................................9
6.1 Risk Analysis Process ............................................................................................................................ 9
6.2 Intended Use and identification of Characteristics Related to the Safety of the Medical Device ......10
6.3 Identification of Hazards ..................................................................................................................... 10
6.4 Estimation of the Risks for Each Hazardous Situation ....................................................................... 11
7. Risk Evaluation .............................................................................................................................................. 11
8. Risk Control ................................................................................................................................................... 11
8.1 Risk Reduction ..................................................................................................................................... 11
8.2 Risk Control Opting Analysis .............................................................................................................. 11
8.3 Implementation of Risk Control Measures ..........................................................................................11
8.4 Residual Risk Evaluation ..................................................................................................................... 11
8.5 Risk/Benefit Analysis ...........................................................................................................................11
8.6 Risk Arising from Control Measures ................................................................................................... 11
8.7 Completeness of Risk Control ............................................................................................................. 11
9. Evaluation of Overall Residual Risk Acceptability ....................................................................................... 11
10. Production/Post-Production Information .....................................................................................................12
11. Annual Risk Management ............................................................................................................................12
12. Results and Conclusion ................................................................................................................................13
Appendix A: Identification of hazards and characteristics of safety .................................................................14
Appendix B: The details of implementation of risk control measure(s) ........................................................... 21
Appendix C: Evaluation of Overall Residual Risk Acceptability ..................................................................... 27
Appendix D: Production and post-production information ...............................................................................28

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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

1. Introduction
The top management provided adequate resources and assigned qualified personnel for risk management
process.

Top management defined and documented the policy for determining criteria for risk acceptability, this
policy ensures that criteria are based upon applicable national or regional regulations and relevant
International Standards, and take into account available information such as the generally accepted state of
the art and known stakeholder concerns.

Also, top management reviewed the suitability of the risk management process at planned intervals to ensure
continuing effectiveness of the risk management process and document and decisions and actions taken, this
review is part of the quality management system review. The following figure is provided to give and
overview of the risk management process for Nebulizer with Mask(Aerosal Mask with Connecting Tube)
manufacturedby Xuyi Careyou Medical Product Co., Ltd.

As indicated in Figure 1, the process needs to be iterative, covering each risk in turn, and returning to earlier
steps if risk control measures introduce new hazards or if new information becomes available.

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CE Technical Documentation Risk Management Report Effective Date：2021-01-10

Figure 1 — Overview of risk management activities as applied to medical devices

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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

2. Purpose
The purpose of this risk management is to assist Xuyi Careyou Medical Product Co., Ltd. following
ISO14971:2019 in establishing, documenting and maintaining a risk management process for Nebulizer
with Mask to identify hazards and hazardous conditions, estimate and evaluate the associated risks,
control those risks,
and continually monitor the effectiveness of the controls put in place throughout the product life cycle.
3. Product Description
3.1 General Information
Product name: Nebulizer with Mask(Aerosal Mask with Connecting Tube)
The main raw material is PVC. It is made of veil, transporting oxygen catheter, nose clamp, fasting strap and
tie-in. They have big, middle, small and infant specifications according to dimension. In the course of
production every working procedure must be under strict control to ensure that the product conforms to the
requirements of the standards. The transmitted parts are smooth, the joint parts are fast, the surface of mask is
smooth, the hand of tube body is soft, and it has elasticity, no vitro cytotoxicity, no subcutaneous stimulation
and skin allergy. In the process of using it, the sponges will not bring out poisonous matters. In order to
ensure that the product is for single use, it should be destroyed immediately after using.
3.2Product Pictures

Fig 2-1: Basic structure diagram of Nebulizer with Mask

3.3 Raw materials

3.4 Product specifications

Reference CE-07 Product Specification.
3.5 Packaging and Shelf-life
Nebulizer with Mask(Aerosal Mask with
Connecting Tube) are packaged as follows:
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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

• Paper plastic bag/PE bag, One device per bag;

• 5 year.
3.6 Intended Use
This product is intended for connecting with active respiration equipment, and intended for rhinitis
, pharyngitis, laryngitis, tracheitis, bronchitis and other respiratory diseases treated by inhalation.
3.7Combination with other devices
Oxygen supply equipment.
3.8 Warnings and Precautions
 For single use. Discard after use.

 Do not if package is open or damaged.

 Do not store at extreme temperature and humidity.

 Store in cool and dry place.

 Ensure that all connections are secure and air circulates freely through the tubing.
3.9 Instructions for Use

4. Qualification of personnel
Persons performing risk management tasks have the knowledge and experience appropriate to the tasks
assigned to them. These include, where appropriate, knowledge and experience of the particular medical
device (or similar medical devices) and its use, the technologies involved or risk management techniques.
Appropriate qualification records are showing in 5.2.
5. Risk Management Plan
5.1Scope
This risk management report specifies a process for Xuyi Careyou Medical Product Co., Ltd. to identify the
hazards associated with Nebulizer with Mask, to estimate and evaluate the associated risks,
to control these risks,and to monitor the effectiveness of the controls.
The requirements of the risk management report are applicable to all stages of the life-cycle of a medical
device.
5.2Assignment of responsibilities and authorities
The responsibilities and authorities of the risk team are assigned as followings:
Name Title Responsibility Authority
Manager Manager
Sumei Duan Approves risk management plan and report
Representative Representative

Team leader, responsible for the implementation

Technology
Sumei Duan Supervisor of risk management. Evaluates the probability of
Department
hardware failure in the view of technology.

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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

Production Evaluates the probability of hardware failure in

Xianou Gong Supervisor
Department the view of production.

Section Evaluates the possible manufacturing defect in

Dan Qian Sales Department
Manager the view of application and customer feedback.

Section Evaluates the severity of hazards in the view of

Sumei Duan Quality Department
Manager biological, physical and practical point.

Vice-principal of
Medical Evaluates the potential use hazard in the view of
XuDong Chen Guangzhou
consultant clinical application.
Baiyunshan Hospital

5.3 Reference
Refer to ISO 14971:2019 Medical devices. Application of risk management to medical devices.
Risk management control procedures
5.4 Requirements for review of risk management activities
The risk management plan details how and when these management reviews will occur for a specific medical
device. The requirements for the review of risk management activities is part of the quality system review
requirement.
Stage of life-cycle Risk management process Date
Design and development planning Preliminary Hazard Analysis 2017.8
Design and development inputs Identification of hazards 2017.9-11
Estimation of the risks for each
Design and development outputs 2017.11
hazardous situation
Design and development verification Risk evaluation 2017.11-2018.3
Design and development trial-produce Risk mitigation and control 2018.3-2019.6
Design and development validation Overall residual risk evaluation 2020.6-2020.11
Product realization
Production/Post-production information 2020.11
Post-production
Control of design and development changes Risk evaluation ---
Post-production Review of Post-production information ---
5.5 Criteria of Risk Evaluation
The criteria for risk acceptability are essential for the ultimate effectiveness of the risk management process.
For each risk we choose appropriate risk acceptability criteria, which are determined according to our policy
for determining criteria for risk acceptability and thus are based upon applicable national or regional
regulations and relevant International Standards, and take into account available information such as the
generally accepted state of the art and known stakeholder concerns.
5.5.1Severity Levels
Severity level of each harm must be estimated (in the form of severity level) by the risk management group.
No. Severity Description Definition
Inconvenience or temporary
1 Negligible No complaint or complaints without request.
discomfort
Results in temporary injury or Feedback of causation analysis and corrective
2 Minor
impairment not requiring (prevention) measures is required after complaints

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professional medical
intervention
Results in injury or impairment
3 Serious requiring professional medical Cause general compensation
intervention
Results in permanent
4 Critical impairment or life-threatening Cause serious compensation
injury
Cause major compensation results in company
5 Catastrophic Results in patient death
insolvency.
5.5.2 Probability of Occurrence
Probability of occurrence of each potential cause must be estimated. In addition, the relative information
resources are:
 Use of relevant historical data
 Prediction of probabilities using analytical or simulation techniques
 Use of experimental data
 Reliability estimates
 Production data
 Post-production information
 Use of expert judgment
Such level estimations carried out by risk management group can be divided into the following 6 categories.
No Category Description

1 Almost impossible Less than millionth.

2 extremely less Between hundred thousandth and millionth

3 Seldom The typical condition is: package of 1 in 1000 cannot be tear open
4 Often The typical condition is: 1 was found in 100 products
5 Frequent The typical condition is: occur every 10 products

6 Always The typical condition is: occurred in each use

5.5.3 Criteria for Risk Acceptability

Severity level (S)
Probability of occurrence
1 Negligible 2 3 4 5 Catastrophic
(P)
Minor Serious Critical
6 Always AC NAC NAC NAC NAC
5 Frequent AC NAC NAC NAC NAC
4 Often AC AC NAC NAC NAC
3 Seldom AC AC AC NAC NAC
2 Extremely less AC AC AC AC NAC
1Almost impossible AC AC AC AC AC
NAC=not acceptable
AC=acceptable
All risks estimated for each harm must be recorded in column “R” of the Appendix B form with range level
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(AC/NAC) per criteria defined in the table above, and described separately whether control measures are
available.
5.6 Verification activities
Per ISO 14971:2019 the risk management plan should specify two distinct verification activities. The first
verification is required to make sure that the risk control measure has been implemented in the final design.
The second verification is required to ensure that the measure as implemented actually reduces the risk. The
effectiveness of the risk control measures is verified by a clinical study and the collection of clinical data. The
verification activities reference to the plan are showing in the following:
Verification activity Location in the technical files or Report No.

Package verification Validation of packaging

Sterilization verification Validation of sterilization

Performance test Total performance test report

Biological test Biocompatibility assessment report

Shelf life verification Total performance test report

Collection clinical data Clinical Evaluation Report

Clinical study Clinical Evaluation Report

Labels Label and language

Instructions for Use IFU

Supplier audits Supplier management procedure

5.7 Methods of obtaining relevant post-production information

The methods of obtaining post-production information are part of the established quality management system
procedures at Xuyi Careyou Medical Product Co., Ltd., which includes:
<Advise notice and adverse event report procedure>
<Customer feedback management procedure>
Xuyi Careyou Medical Product Co., Ltd. has established generic procedures to collect information from
various sources while a reference to the quality management system procedures can suffice in most cases,
any product-specific requirements can be directly added to the risk management plan. The risk management
plan includes documentation of decisions, based on a risk analysis, about what sort of post-market
surveillance is appropriate for the device, for example, whether reactive surveillance is adequate or whether
proactive studies are needed. Details of clinical studies envisaged should be specified.
6. Risk Analysis
6.1 Risk Analysis Process
Risk analysis is performed for Nebulizer with Mask as described in 6.2 to 6.4.
It includes intended use and identification of characteristics related to the safety of the medical device
, identification of hazards and estimation of the risks for each hazardous situation.
The implementation of the planned risk analysis activities
and the results of the risk analysis are recorded in the risk management file.
Similar medical device information is used in the process and between Nebulizer with Mask
and similar medical device whether these introduce new hazards or significant differences in outputs,
characteristics, performance,or results.
Some risk analysis technique is used in this process, such as: Failure Mode and Effects Analysis (FMEA).
In addition to the records required in 6.2 to 6.4, the documentation of the conduct and results of the risk
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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

analysis include the following.

a) Identification of the persons and organization who carried out the risk analysis
Name Title Responsibility Authority
Manager Manager
Sumei Duan Approves risk management plan and report
Representative Representative

Team leader, responsible for the implementation

Technology
Sumei Duan Supervisor of risk management. Evaluates the probability of
Department
hardware failure in the view of technology.

Production Evaluates the probability of hardware failure in

Xianou Gong Supervisor
Department the view of production.

Section Evaluates the possible manufacturing defect in

Dan Qian Sales Department
Manager the view of application and customer feedback.

Section Evaluates the severity of hazards in the view of

Sumei Duan Quality Department
Manager biological, physical and practical point.

Vice-principal of
Medical Evaluates the potential use hazard in the view of
XuDong Chen Guangzhou
consultant clinical application.
Baiyunshan Hospital

b) Scope and date of the risk analysis

The risk management report includes all stages of the life-cycle of a medical device including verification
and evaluation process.
Stage of life-cycle Risk management process Date
Design and development planning Preliminary Hazard Analysis 2017.8
Design and development inputs Identification of hazards 2017.9-11
Estimation of the risks for each
Design and development outputs 2017.11
hazardous situation
Design and development verification Risk evaluation 2017.11-2018.3
Design and development trial-produce Risk mitigation and control 2018.3-2019.6
Design and development validation Overall residual risk evaluation 2020.6-2020.11
Product realization
Production/Post-production information 2020.11
Post-production
Control of design and development changes Risk evaluation ---
Post-production Review of Post-production information ---
6.2 Intended Use and identification of Characteristics Related to the Safety of the Medical Device
We document the intended use and reasonably foreseeable misuse for Nebulizer with Mask,
Those qualitative and quantitative characteristics that could affect the safety of Nebulizer with
Maskare identified and documented in Appendix A:
Identification of hazards and characteristics of safety Nebulizer with Mask
6.3 Identification of Hazards
According to the experience with the same and similar types of device, publications and other available
sources, the documentation on known and foreseeable hazards associated with Nebulizer with
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and fault conditions are compiled in the Appendix B: The details of implementation of risk control
measure(s).
6.4 Estimation of the Risks for Each Hazardous Situation
Reasonably foreseeable sequences or combinations of events that can result in a hazardous situation have
been considered and the resulting hazardous situations have been recorded in the risk management file in
Appendix B: The details of implementation of risk control measure(s).
7. Risk Evaluation
For each identified hazardous situation, we used the criteria defined in the risk management plan to evaluate
each harm. Results of the risk evaluation are recorded in the risk management file in Appendix B: The details
of implementation of risk control measure(s).
8. Risk Control
8.1 Risk Reduction
When risk reduction is required, risk control option analysis, implementation of risk control measures,
residual risk evaluation, risk/benefit analysis, risk arising from risk control measures, and completeness of
risk control activities are performed.
8.2 Risk Control Opting Analysis
Appropriate risk control measures are identified for reducing the risks to an acceptable level. The following
risk control options are used in the priority order listed:
a) Protective measures in the medical device itself or in the manufacturing process;
b) Information for safety.
The risk control measures selected are recorded in the risk management file in Appendix B: The details of
implementation of risk control measure(s).
8.3 Implementation of Risk Control Measures
The risk control measures selected are implemented and the implementation of each risk
control measure is verified. The verification is recorded in the risk management file. The effectiveness of the
risk control measures is verified and the results are recorded in the risk management file in Appendix B: The
details of implementation of risk control measure(s).
8.4 Residual Risk Evaluation
After the risk control measures are applied, any residual risk will be evaluated using the criteria defined in the
risk management plan. The results of the evaluation are recorded in the risk management file in Appendix B:
The details of implementation of risk control measure(s).
The residual risks are judged acceptable using these criteria and included in the accompanying documents in
order to disclose those residual risks.
8.5 Risk/Benefit Analysis
The residual risk is judged acceptable using the criteria established in the risk management plan and risks are
outweighed by the benefits. Necessary information is decided for safety to disclose the residual risk. The
results of the evaluation are recorded in the risk management file.
8.6 Risk Arising from Control Measures
There is no new risk arising from risk control measures. The results are recorded in the risk management file
in Appendix B: The details of implementation of risk control measure(s).
8.7 Completeness of Risk Control
The risks from all identified hazardous situations have been considered. The results of this activity are
recorded in the risk management file in Appendix B: The details of implementation of risk control
measure(s).
9. Evaluation of Overall Residual Risk Acceptability
After all risk control measures have been implemented and verified, the overall residual risk posed by the
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medical device is acceptable using the criteria defined in the risk management plan.
Overall residual risk evaluation is the point where residual risk is viewed from broad perspective. Overall
residual risk evaluation is performed by persons with the knowledge, experience, and authority to perform
such tasks described in the risk management plan.
It involves application specialists with knowledge of and experience with the medical device. Review of
warnings and operating instructions were selected to disclose overall residual risk. For details please refer to
Appendix C: Evaluation of Overall Residual Risk Acceptability.
10. Production/Post-Production Information
A system is establishing, document and maintain to collect and review information about the medical device
or similar devices in the production and the post-production phases. For details please refer to <Advise notice
and adverse event report procedure> and <Customer feedback management procedure> at Xuyi Careyou
Medical Product Co., Ltd. When establishing a system to collect and review information about the medical
device, the following things are considered:
a) The mechanisms by which information generated by the operator, the user, or those accountable for the
installation, use and maintenance of the medical device is collected and processed, and
b) New or revised standards; and
c) Design change; and
d) Change of material supplier or manufacture process.
The system can also collect and review publicly available information about similar medical devices on the
market. The information will be evaluated for possible relevance to safety,
especially the following:
----if previously unrecognized hazards or hazardous situations are present or;
----if the estimated risks arising from a hazardous situation are no longer acceptable.
If any of the above conditions occur:
1) The impact on previously implemented risk management activities shall be evaluated and shall be fed back
as an input to the risk management process and;
2) A review of the risk management file for the medical device shall be conducted; if there is a potential that
the residual risks or its acceptability has changed, the impact on previously
implemented risk control measures shall be evaluated. The results of this evaluation will be recorded in the
risk management file.
3) Production and post-production information shall be collected, monitored and analyzed as per company’s
quality system procedures/work instructions and recorded in the appendix D: Production and post-production
information
11. Annual Risk Management
Risk management will be review annually, the following information will be considered especially:
No. Information Department
1 New or revised standards Regulatory
2 Adverse event Sales & Regulatory & Quality
3 Notice/Recall Sales & Regulatory & Quality
4 Feedback or Customer complain Sales & Regulatory & Quality
5 Internal audit Quality
Monitoring and measurement of
6 Quality
processes
Monitoring and measurement of
7 Quality
product

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Change of design or manufacture

8 Technology & Regulatory & Quality
process

12. Results and Conclusion

The implementing of the risk management process is completely according to ISO 14971:2019. The main
raw material is PVC. It is made of mask, transporting oxygen catheter, nose clamp, fasting strap,
nebulizer cup and tie-in nebulizer with mask.They have big, middle, small and infant specifications accordi
ng to dimension. In the course of production every working procedure must be under strict control to ensure
that the product conforms to the requirements of the standards. The transmitted parts are smooth, the joint pa
rts are fast, the surface of mask is smooth, the hand of tube body is soft, and it has elasticity, no vitro cytot
oxicity, no subcutaneous stimulation and skin allergy. In the process of using it, the sponges will not brin
g out poisonous matters. In order to ensure that the product is for single use, it should be destroyed immedia
tely after using.

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Appendix A: Identification of hazards and characteristics of safety

Hazard
Question No Question Characteristics Determination Possible Risks
Identification
H4.1
This product is intended for H4.2
What is the Hazards related
connecting with active respiration H4.3
intended use and to the use of the
equipment, and introducing oxygen H4.4
A.2.1 how is the device and
to human body. H4.5
medical device to contributory
This product is used by the Medical H4.6
used? factors
staff following IFU. H4.7
H4.8

Is the medical
A.2.2 device intended No. / /
to be implanted?

Is the medical
device intended Biological
H2.2
A.2.3 to be in contact Yes, contact user skin. hazards and
H2.3
with the patient chemical hazards
or other persons?
What materials
or components
are utilized in the
Biological
medical device H2.2
A.2.4 The material is PVC. hazards and
or are used with, H2.3
chemical hazards
or are in contact
with, the medical
device?
Is energy
delivered to or
A.2.5 No. / /
extracted from
the patient?

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Are substances
delivered to or
A.2.6 No. / /
extracted from
the patient?
Are biological
materials
processed by the
medical device
A.2.7 No. / /
for subsequent
re-use,
transfusion or
transplantation?
Yes. This product is provided in
Is the medical non-sterilized or sterile. The device
device supplied
sterile or is packaged in a single-use package.
intended to be The product is expected to be valid Biological
A.2.8 sterilized by the hazards and H2.3
user, or are other for 5 years. All of the above chemical hazards
microbiological information needs to be reflected in
controls
applicable? the product manual and

identification label.
Is the medical
device intended
to be routinely
A.2.9 No. / /
cleaned and
disinfected by
the user?
Is the medical
device intended
A.2.10 to modify the No. / /
patient
environment?
Are
A.2.11 measurements No. / /
taken?
Is the medical
A.2.12 device No. / /
interpretative?
Is the medical Hazards related H4.1
device intended to the use of the H4.2
A.2.13 Yes, Oxygen supply equipment.
for use in device and H4.3
conjunction with contributory H4.4

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other medical factors H4.5

devices H4.6
medicines or H4.7
other medical H4.8
technologies?
Are there
unwanted
A.2.14 No. / /
outputs of energy
or substances?
Biological
hazards and H2.3
chemical hazards
Yes. This product is provided in Environmental
H3.1
non-sterilized or sterile. And the hazards and
Is the medical H5.3
raw materials of the product are contributory
device H5.4
surgical materials, the packaging factors
A.2.15 susceptible to
materials have been verified by
environmental
simulated transport, the temperature Hazards arising
influences?
and humidity are required during from functional
H5.1
storage. failure,
H5.2
maintenance and
ageing

H4.1
H4.2
Hazards related
Yes, the product may influence the H4.3
Does the medical to the use of the
environment, it should be disposed H4.4
A.2.16 device influence device and
as medical waste in accordance H4.5
the environment? contributory
with local regulation. H4.6
factors
H4.7
H4.8
Are there
essential
consumables or
A.2.17 No. / /
accessories with
the medical
device?
Is maintenance
A.2.18 or calibration No. / /
necessary?
Does the medical
A.2.19 device contain No. / /
software?

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Hazards related
to the use of the
device and H4.7
Does the medical contributory
device have a Yes, the aging test report support 5 factors
A.2.20
restricted years shelf-life. Hazards arising
shelf-life? from functional
H5.1
failure,
H5.2
maintenance and
ageing
Are there any
delayed or
A.2.21 No.
long-term use
effects?
To what
mechanical
A.2.22 forces will the No.
medical device
be subjected?

Biological
H2.3
hazards
What determines
Yes, Product materials, packaging Hazards arising
the lifetime of H5.1
A.2.23 materials determine the life of the from functional
the medical H5.2
product. failure,
device? H5.3
maintenance and
H5.4
ageing
Hazards related
Is the medical to the use of the
A.2.24 device intended Yes, it is for single use. device and H4.8
for single use? contributory
factors
Is safe Yes, destroyed as medical waste Hazards related
decommissioning after use. The device does not to the use of the
A.2.25 or disposal of the produce toxic substances and the device and H4.8
medical device material does not need to be contributory
necessary? recycled. factors
Does installation
Hazards related
or use of the
to the use of the
medical device Yes, the product must be used by
A.2.26 device and H4.6
require special trained medical professionals.
contributory
training or
factors
special skills?
How will Yes, refer to user manual or device Hazards related H4.1
A.2.27
information for label. Use the device by the to the use of the H4.2

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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

safe use be skilled/trained personnel. device and H4.3

provided? contributory H4.4
factors H4.5
H4.6
H4.7
H4.8
Will new
manufacturing
A.2.28 processes need to No. / /
be established or
introduced?
Is successful
application of the
medical device
critically
A.2.29 No. / /
dependent on
human factors
such as the user
interface?
Can the user
interface design
A.2.29.1 features No. / /
contribute to use
error?
Is the medical
device used in an
environment
A.2.29.2 No. / /
where
distractions can
cause use error?

Does the medical

device have
A.2.29.3 No. / /
connecting parts
or accessories?

Does the medical

A.2.29.4 device have a No / /
control interface?
Does the medical
A.2.29.5 device display No / /
information?
Is the medical
A.2.29.6 device controlled No / /
by a menu?
A.2.29.7 Is the successful Yes, the product used by Hazards related H4.1
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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

use of the professionals. to the use of the H4.2

medical device device and H4.3
dependent on a contributory H4.4
user’s factors H4.5
knowledge, skills H4.6
and abilities? H4.7
H4.8
H4.1
H4.2
Hazards related
Will the medical H4.3
to the use of the
device be used Yes, the product used by H4.4
A.2.29.8 device and
by persons with professionals. H4.5
contributory
special needs? H4.6
factors
H4.7
H4.8
Can the user
interface be used
A.2.29.9 No. / /
to initiate user
actions?
Does the medical
A.2.30 device use an No. / /
alarm system?
H4.1
H4.2
In what way(s) Hazards related
H4.3
might the The medical device might be to the use of the
H4.4
A.2.31 medical device deliberately misused by not strictly device and
H4.5
be deliberately following the instruction for use. contributory
H4.6
misused? factors
H4.7
H4.8
Does the medical
device hold data
A.2.32 No. / /
critical to patient
care?
Is the medical
device intended
A.2.33 No. / /
to be mobile or
portable?
Does the use of Hazards arising
the medical Yes, the essential performance from functional
H5.1
A.2.34 device depend on determines the safety and failure,
H5.2
essential effectiveness of the product. maintenance and
performance? ageing
Does the medical
A.2.35 No. / /
device have a
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Product Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2021-01-10

degree of
autonomy?

Does the medical

device produce
an output that is
A.2.36 No. / /
used as an input
in determining
clinical action?

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 Xuyi Careyou Medical Product
Document No.：CE-AC-12 Edition：A0 Page：21/32
Co., Ltd.
CE Technical Documentation Risk Management Report Effective Date：2020-06-10

Appendix B: The details of implementation of risk control measure(s)

Risk Evaluation
Risk NAC/
Foreseeable Hazardous Risk Reduction After Adopting
No. Hazard Harm Evaluation AC
sequence of events situation Measure Evidence the Measure
S P RL S P RL
1. Energy Hazards
H1.1 Mechanical force / / / / / / / / / / / /
2. Biological and chemical hazards
H2.1 Bio-contamination / / / / / / / / / / / /
1. Make the key raw
material and
The contact purchased parts
between the standards, raw
product and Cause
human body specific materials and
the material itself will produce changes in purchased parts should
toxicity, organ Biocompatibility
H2.2 Bio-incompatibility is biological 3 2 6 meet the medical 3 1 3 AC
irritation, function evaluation report
incompatibility. teratogenicity and even requirements.
and local death of 2.Final product pass
inflammation the body. Biocompatibility
to cells and the
evaluation
whole body;
3. Strictly implement
the procurement
control procedures
The product is Bacteria 1. Product packing
The production mixed with into the
foreign body is shall be strictly carried
process does not Product package
H2.3 Bio- contamination microorganism, bacteremi 3 2 6 out in accordance with 3 1 3
follow the which causes a, body validation report
the package operating
operation process. uncontrollable infection
infection to septicemia procedures.
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CE Technical Documentation Risk Management Report Effective Date：2021-01-10

patients when , infection 2. Make validation on

used in shock. product package.
operation.
H2.4 Chemical Toxicity / / / / / / / / / / / /
H2.5 Acid-base hazard / / / / / / / / / / / /
H2.6 Heavy metal / / / / / / / / / / / /
3. Environmental hazards and contributory factors
It will affect
the service life
of the product
package, and it Bacteria
Store the product will not reach into the
Storage or operation the validity body is
in high period It is declared the
outside prescribed bacteremi
storage condition in Instruction for
H3.1 temperature, high specified in the a, body 2 2 4 2 1 2
environmental the Instruction for Use
humidity, and other product infection
Use.
conditions manual, and it septicemia
harsh conditions. may be used , infection
out of date. It shock.
causes
microbial
infection.
4. Hazards related to the use of the device and contributory factors
Failure to
achieve
the
Inadequate intended It is declared the usage
Inadequate labeling User follow the
H4.1 labeling will cause use or 2 2 4 in the “Instruction for Instruction for Use 2 1 2
and IFU wrong label.
incorrect using. unexpecte Use”
d harm.,
Even
death.
Inadequate Inadequate User follow the Failure to Usage and attention of
H4.2 2 2 4 Instruction for Use. 2 1 2
Operating Operating wrong achieve using are elaborated

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Instructions Instructions will Operating the 1n the “Instruction for

Instructions. intended Use”
cause incorrect
use or
using. unexpecte
d harm,
Even
death.
Failure to
achieve
the
Product inspection intended The specification of
Inadequate User use the
H4.3 does not meet the use or 2 2 4 product listed in the Instruction for Use. 2 1 2
Specification Wrong Size.
standard. unexpecte “Instruction for Use”
d harm.,
Even
death.
Failure to
Inadequate achieve
specification of the Check the product
Inadequate intended before use and
Pre-use checks will User the wrong Instruction for
H4.4 Specification of use or 2 2 4 attentions are 2 1 2
cause the product specification. Use.
Pre-use checks unexpecte elaborated in the
cannot match the d harm., “Instruction for Use”
user. Even
death.
Inadequat
e
specificati
Overcomplicated
on of
Overcomplicated operating User follow the Instructions for use in
Pre-use Instruction for
Operating Instructions, wrong “Instruction for Use
H4.5 checks 2 2 4 2 1 2
Operating “are simple and easy Use.
instructions Product is used will cause
Instructions. to understand
incorrectly the
product
cannot
match the

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user.
Inadequat
e
specificati
Use by on of
Use by
unskilled/untrained Pre-use The warning for the
unskilled/untrained Wrong use of checks device must be used
H4.6 personnel will 2 2 4 Instruction for Use. 2 1 2
personnel/ device will cause by the medical
cause the device the professionals
Incorrect operation
doesn’t working. product
cannot
match the
user.
Inadequat
e
specificati
on of
Insufficient warning Used wrongly and
Pre-use
of side effects and used the product warnings are
User follow the checks
H4.7 2 2 4 elaborated in the Instruction for Use. 2 1 2
cannot use beyond beyond the date of wrong IFU will cause
“Instruction for Use”
the
the date of expiry expiry.
product
cannot
match the
user.
Inadequat
e
Failing to destroy specificati
Inadequate warning on of The warning of only
the product after Pre-use single use are
of hazards likely User follow the Instruction for Use.
H4.8 use and be re-used, checks 2 2 4 elaborated in the 2 1 2
with re-use of single wrong IFU Label
harm the user and will cause “Instruction for Use”
use devices. the and label.
the patient. product
cannot
match the

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user.
5. Hazards arising from functional failure, maintenance and ageing
It cannot 1.Process inspection
The production achieve 2.Final inspection;
the 3.Make the key raw 1.Process inspection
process is not up to The joint of the
expected material and report.
standard and there product causes
purpose of purchased parts 2.Final product
H5.1 Connection leakage the connection 2 2 4 2 1 2
is liquid leakage treatment standards, raw inspection report.
leakage at this
and delay materials and 3.Incoming
between part.
the purchased parts should inspection report.
components. patient's meet the medical
treatment. requirements.
It cannot 1.Process inspection
The production achieve 2.Final inspection;
the 3.Make the key raw 1.Process inspection
process is not up to
expected material and report.
standard and there Poor sealing
purpose of purchased parts 2.Final product
H5.2 Air tightness and leakage of 2 2 4 2 1 2
is Air leakage treatment standards, raw inspection report.
injection.
and delay materials and 3.Incoming
between
the purchased parts should inspection report.
components. patient's meet the medical
treatment. requirements.
Bacteria
into the
Inadequate It may cause the blood is Select suitable packing
packaging medical device bacteremi materials and packing
The product is a, blood forms, Make the Product package
H5.3 (contamination damage and 3 2 6 3 1 3
contaminated. line package validation to validation report
and/or deterioration terminal user infection make sure the packing
of the device) sterilization failure. septicemia is effective.
, infection
shock.
The product package It may cause Contact 1.make the shelf life Package and Shelf
The product is with verification and
H5.4 failure product terminal 2 2 4 life verification 2 1 2
contaminated. human package validation
and product aging user sterilization wounds, 2. clarify the product protocol and report

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CE Technical Documentation Risk Management Report Effective Date：2021-01-10

failure. causing shelf life and storage IFU and label

wound condition in IFU and
infection label
and other
unexpecte
d injuries.

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Appendix C: Evaluation of Overall Residual Risk Acceptability

C1. General
After all risk control measures have been implemented and verified,
the overall residual risk posed by are acceptable using the criteria defined in the risk management plan.
Overall residual risk evaluation isviewed from a broad perspective and performed by persons with the knowl
edge, experience, and authority to perform such tasks.
It is involving application specialists with knowledge of and experience with Nebulizer with Mask(Aerosal
Mask with Connecting Tube)
Review for conflicting requirements, review of warnings, review of the operating instructions is choosing for
evaluating overall residual risk.

The necessary information is included in the Labels and Instructions for Use to disclose the overall residual risk.

C2. Information for safety

The information for safety and effectively is developed to provide to patients, users and others who will contact
with the product. It is provided in labels and instructions for use which including an explanation of risk, the
consequences of exposure and what should be done or avoided to prevent harm. In developing the information,
the following have been considering:

---the level of priority appropriate to classify an action (warning, caution, etc.);

---the level or detail of information needed;
---the location for the information for safety (e.g. a warming label);
---the wording or pictures to be used to ensure clarity and understandability;
---the immediate recipients (e.g. users, service personnel, patients);
---the appropriate media for providing the information, (e.g. labels and instructions for use);
---regulatory requirement.

C3. Disclosure of residual risks

When developing the disclosure of overall residual risks, the indication, instructions for use, contraindication,
warning, storage and presentations are identified to be communicated and the medical staffer is directed in order
to inform, motivate and enable the user to use the device safely and effectively.

According to examine the residual risks what should be disclosed is determined. The followings are considered:

---the level or detail needed;

---the wording to be used to ensure clarity and understandability;
---the immediate recipients (e.g. users, service personnel, installers, patients);
---the means/media to be used (e.g. labels and instructions for use on paper in package).

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CE Technical Documentation Risk Management Report Effective Date：2021-01-10

Appendix D: Production and post-production information

Post-market surveillance records for Nebulizer with Mask
Marketing period: 2020-2021
Sales figures: pcs
Reportable Events & FSCAs: Details are listed in below tables:
Year Sales (China)/pc Sales (Oversea)/pc Complaints Incidents CAPA instigated

2020~2021 0 0 0 0 0

Conclusion: We collect and analysis the PMS data in the recently years, 0 customer complaint happened

and then 0 CAPA, no adverse events which can prove product is safe and has good performance.