Expiratory valve components reprocessing

guidance

Tables of Contents
1 General rules for cleaning and disinfection ................................................ 1
2 Expiratory Valve ......................................................................................... 2
3 Reprocessing the expiratory valve in accordance with EN ISO 17664 ...... 5
3.1 Reprocessing overview .................................................................... 5
3.2 Preparation and reprocessing after use ........................................... 6
4 Cleaning and Disinfection Agents .............................................................. 6
5 Cleaning and Disinfection of Components ................................................. 7
5.1 Expiratory Valve ............................................................................... 7
5.1.1 Disassembly ........................................................................... 7
5.1.2 Manual Cleaning ..................................................................... 8
5.1.3 Mechanical Cleaning and Disinfection .................................... 9
5.1.4 Packaging ............................................................................. 11
5.1.5 Visual test ............................................................................. 11
5.1.6 Sterilization ........................................................................... 11
5.1.7 Assembly .............................................................................. 12
6 Testing before use ................................................................................... 12
7 Expiratory valve life span ......................................................................... 12
8 Packaged expiratory valve: life span and storage conditions .................. 12

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Reprocessing guide per EN ISO 17664
Beijing Aeonmed Co., Ltd. holds the copyrights to this non-public published
guidance, and reserves the rights to keep it as a secure document. Only
Aeonmed may provide permission for the use of or copies of this document to
others.
Proprietary materials protected by the copyright law are included in this
guidance. No section of it may be duplicated, copied, or translated into other
languages without prior written approval from Aeonmed who reserves the
copyright.
Everything written within this guidance is considered to be correct, but it is not
a substitute for the exercise of professional judgment. Aeonmed is not legally
responsible for any mistakes printed within and/or any damages caused by
incorrect connection and operation of equipment. Aeonmed does not supply
privileges endowed by the patent law to any other parties. Aeonmed is not
legally responsible for the results caused by patent law breaking or any rights
of the third party violating.
The company will not undertake the responsibility for the safety, reliability and
performance if equipment is used improperly. The company will not offer
complimentary service for misused equipment.
Aeonmed has the right to revise any content in this guidance without notice;
and has no obligation to update either hardware or software of the equipment
described herein to the user or owner.

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1 General rules for cleaning and disinfection

WARNING: This notice warns the user of the possibility of injury, death or

other serious undesirable reactions associated with the use or misuse of the
device.

WARNING: To prevent electrical shock hazard and possible personal injury,

always disconnect electrical power sources before servicing the ventilator.
Follow accepted safety practices for electrical equipment when testing or
making equipment, adjustment, or repairs.

WARNING: Our company recognizes that cleaning and disinfection

practices vary widely among medical institutions. It is not possible to specify
or require specific practices that will meet all needs, or to be responsible for
the effectiveness of cleaning, disinfection, and other practices carried out in
the patient care setting.

WARNING: Do not use talc, zinc stearate, calcuim carbonate, corn starch
or similar material to prevent sticking, as these materials may enter the
patient’s lungs or airway, causing irritation or injury.

WARNING: Never use a ventilator or any components or accessories that

appear to be damaged. If any signs of damage are evident, contact your
equipment supplier.

WARNING: Please wear safety gloves and glasses for cleaning and

disinfection.

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 WARNING: Do not inhale any gas or fumes that are generated in cleaning

and disinfection process.

WARNING: Before the first use clean and disinfect the ventilator.

Disposable components must be disposed in accordance with local regulations.

Don’t use hard brushes or other sharp tools in cleaning to avoid damage to
parts.

WARNING: Before cleaning the ventilator, first disconnect the ventilator

and the patient circuit.

NOTE: Cleaning and disinfection guidance must be in accordance with EN

ISO 17664.

CAUTION: This notice warns the user of the possibility of a problem with

the device in connection with its use or misuse, such as device malfunction,
device failure, damage to the device, or damage to third parties.

2 Expiratory Valve

Expiratory valve is suitable for VG70 and VG60. Expiratory valve materials
mainly include aluminum alloy、polysulfone、silicone rubber. All materials used
are heat resistant up to 137°C (278.6°F).

Expiratory valve components are shown in Figure 1.

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 Figure 1 Expiratory valve components

NO. Part Number Part Name Replacement Period

Rubber o-sealing ring Need to be changed in every 20
1 304000105
for 29x1.8 times of sterilization
Need to be changed in every 20
2 130009661 Water tray
times of sterilization
3 130004350 End cover
Need to be changed in every 20
4 130012614 Gasket
times of sterilization
5 130000229 Scale board
Need to be changed in every 20
6 130000231 Diaphragm
times of sterilization
7 130009651 Water trap cup 6 months or as needed
8 130009945 Expiratory connector

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NO. Part Number Part Name Replacement Period
Rubber o-sealing ring
9 304000099 One year or as needed
for 16x1.8
10 130007655 One-way valve core
11 130001347 One-way diaphragm One year or as needed
Rubber o-sealing ring
12 304000102 One year or as needed
for 22x1.8

Diaphragm and gasket replacement method: refer to section 5.1.1 and

5.1.7.
Water tray replacement method:
Rotate the water trap cup (Part 7), then pull it out, then you can see water tray
(Part 2), remove it, reassemble the water tray in the reverse order, as shown in
Figure 1.
Rubber o-sealing ring for 29x1.8 replacement method:
After remove the water tray (Part 2), and then you can see there is a rubber
o-sealing ring for 29x1.8 (Part 1), remove it, reassemble the rubber o-sealing
ring for 29x1.8 in the reverse order, as shown in Figure 1.

WARNING:
 Clean and disinfect the expiratory valve directly after use.
 Follow hospital infection control procedures, as well as local laws and
regulations. This applies in particular to the various regulations regarding
an effective deactivation of prions.
 Our company cannot be held responsible for the correct functioning of
expiratory valve components that are not reprocessed and used according
to these instructions.
 Disposal: A used expiratory valve must be handled as a contaminated item.
Follow all local, state, and federal regulations with respect to
environmental protection when disposing of used expiratory valve.

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 CAUTION:
 The expiratory valve has a limited life span. The expiratory valve may be
damaged due to the use of hard brushes, scouring agents, or by the
exertion of too much force.
 After disinfection the components of the ventilator, they should be dried
before being stored for use.
 The use of rinse aids will reduce the life span of the expiratory valve, as it
can lead to early failure and cracks in the plastic expiratory valve housing.
 For Europe: disinfectant approved for cleaning and disinfection of medical
devices.
 (USA only): Only use EPA registered cleaning and disinfection solutions.

3 Reprocessing the expiratory valve in

accordance with EN ISO 17664

Make sure that the reprocessing does not damage the expiratory valve
components, especially Diaphragm and One-way diaphragm.

3.1 Reprocessing overview

The expiratory valve components must be cleaned and disinfected after each
use. After each reprocessing cycle, the expiratory valve housing must be
inspected for damage. If any changes are visible, the valve must be discarded.
Perform a tightness test after each reprocessing cycle. If the test fails, it may
be repeated once. The expiratory valve must be replaced if the tightness test
fails the second time.
It is recommended to use drinking quality water for rinsing. Rinse aid can
cause premature damage and shorten the life of the product. Unsuitable rinse
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aid should therefore not be used. Our company does not guarantee the
lifespan of the expiratory valve components if unsuitable cleaning agents are
used.

3.2 Preparation and reprocessing after use

Reprocess the expiratory valve components immediately after use. The

reprocessing cycle comprises cleaning and disinfection. Remove macroscopic
impurities of the expiratory valve by rinsing or wiping. You can add an
aldehyde-free disinfection agent to the rinse water. You must not use any hard
tools or hard brushes to remove resilient impurities.

4 Cleaning and Disinfection Agents

Agent Classification

Detergent
• Mild dishwashing detergent
Detergent
• Soapy water with detergent PH
between 7.0 and 10.5

• Sodium hypochloride-(bleach) in Disinfectant

water (10% solution) Disinfectant
• Hydrogen peroxide (3% solution)

• Alkaline solution dominated by

Approved disinfectant
glutaraldehyde

CAUTION: It is recommended to use only the appropriate detergents and

disinfectants, as shown here. Hospitals can select detergents and disinfectants
corresponding to these specifications and according to their own needs.

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5 Cleaning and Disinfection of Components

5.1 Expiratory Valve

5.1.1 Disassembly

Figure 2 Figure 3

Figure 4

To remove the components from expiratory valve:

a. Press the button(Part 1);

b. Pull out the expiratory valve component (Part 2 in Figure 2, Figure 3);
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c. Use a suitable tool (such as end cover tooling, part number 130015084) to
remove the end cover(Part 3) and the gasket (Part 4);

d. Remove the scale board(Part 5)and the diaphragm(Part 6);

e. Rotate the water trap cup (Part 7), then pull it out;

f. Rotate the expiratory connector (Part 8) clockwise, then pull it out.

5.1.2 Manual Cleaning

When selecting the cleaning agent, consider whether the agents in question
are suitable for the expiratory valve components. In addition, instructions for
cleaning with the selected agents must be available.

5.1.2.1 Manual Cleaning

1. Disassemble the expiratory valve.

2. The expiratory valve components include end cover、gasket、scale board 、

diaphragm、water trap、expiratory connector and so on.

3. Recommend detergent neodisher MediClean forte. Submerge the

expiratory valve components in the 1% neodisher MediClean forte solution;
at 60℃, duration 10 minutes. Make sure that all parts of the expiratory
valve components are fully submerged in the solution.

4. Repeat the cleaning process if the last cleaning solution was not clear or
there are still visible impurities on the expiratory valve components.

5. Rinse after cleaning. Rinse with purify water at room temperature for 1
minute.

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5.1.3 Mechanical Cleaning and Disinfection

Automatic disinfection process meets standardization requirements, the effect

of automatic disinfection is better than manual disinfection, so manual
disinfection is not used.
The expiratory valve components must be reprocessed in such a manner that
hygienic and safe reuse can be assured. Cleaning / disinfection should only be
carried out in a cleaning and disinfection device that complies with EN ISO
15883 and has been proven to be effective. Place the expiratory valve
components in such a manner that it is easy to clean and the effectiveness of
cleaning and disinfection is not impaired.

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 Figure 5 Arranging components in the device

To ensure safe cleaning, the expiratory valve housing must be connected to

the corresponding receptors. The expiratory valve must not disconnect from
the receptor during reprocessing. Expiratory valves that disconnect during
reprocessing must be processed again. After the cleaning process is
completed, check that the expiratory valve is completely dry and undamaged.
Damaged expiratory valve components must be discarded. The program
parameters in Table 1 must be met for successful mechanical cleaning.
Table 1 Mechanical cleaning program parameters

Program parameters Specification

Pre-rinse one cycle using cold water for 1 min
Cleaning one cycle at 60℃ (140°F) for 10 min
Rinsing one cycle using cold water for 1 min
Thermic disinfection one cycle at 90℃ (194°F) for 5 min
Drying ＞100℃ (212°F) for 10 min

Table 2 Supported cleaning agents

Manufacturer Product Concentration

Dr. Weigert Neodisher Mediclean forte max. 1.00%

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5.1.4 Packaging

Make sure that the expiratory valve components are not moist during
packaging.
The packaging must conform to ISO 11607 and EN 868.
(USA only): For packaging, only use an FDA approved sterilization pouch.
Recommended material for self-sealing sterilization pouch: France PPF (60g)
medical self-adhesive paper + PET/CPP complex film.

5.1.5 Visual test

After each cleaning and disinfection cycle, the expiratory valve must be
macroscopically clean, that is, free of visible residual matter and other
impurities. If it is not, the entire cleaning and disinfection process must be
repeated. Visually check for external damage, such as cracks, broken or
deformed parts, or discoloration.

5.1.6 Sterilization

For each sterilization cycle, recommending ten (10) test articles as a maximum
load specified by the manufacturer.
Sterilize the expiratory valve components after cleaning and disinfection and
prior to reuse according to the following: Steam sterilization, fractional vacuum
process validated according to EN ISO 17665, sterilization at 134 ° C, with an
exposure time of at least 3 minutes.
Place the expiratory valve components horizontally into the sterilizer; do not
stack them. Note that our company is not responsible for the efficacy of any
sterilization method, including but not limited to hot-air, ethylene oxide,
formaldehyde, radiation, and low-temperature plasma sterilization.
After sterilization, dry the expiratory valve components for at least 16 minutes.

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5.1.7 Assembly

Reassemble the components in the reverse order.

After connection, please perform a pre-use test and verify all tests passed.
Pre-use test mainly includes pressure sensor test, flow sensor test, inspiratory
valve test, expiratory valve test, leakage test and patient circuit test.

6 Testing before use

WARNING: Defective expiratory valve must not be used.

Carry out a visual check and a tightness test as described in your ventilator’s
User Manual. Replace defective expiratory valve components.

7 Expiratory valve life span

As long as the expiratory valve passes the tightness test during the
preoperational check, the expiratory valve can be used. Tests and calibrations
must be carried out as specified in the ventilator’s User Manual. It is the user’s
responsibility to validate the processes used if the reprocessing procedures
used differ from those in this guide.

8 Packaged expiratory valve: life span and

storage conditions

The lifespan of a packaged expiratory valve depends on how long the

packaging of the expiratory valve can be kept sterile. Follow the packaging
manufacturer’s specifications.
The guidelines for storage of expiratory valve are the same as for the ventilator
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itself and this is specified in the User Manual.

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This manual No.: 130020209

Beijing Aeonmed Co., Ltd.

Tel: +86-10-83681616
Fax: +86-10-83681616-8130
E-Mail: service@aeonmed.com
Website: http://www.aeonmed.com

Edition: V00.05
March 2021
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