12.

0 Cleaning and Disinfection

Methods for Cleaning and Disinfection .......................................................................................................... 12-3

Disassemble the Ventilator’s Cleanable and Disinfectable Parts........................................................... 12-5

Operator’s Manual of Ventilator 12 - 1

 Cleaning and Disinfection

WARNING: Obey applicable safety precautions.

WARNING: Read the material safety data sheet for each cleaning agent.

WARNING: Read the operation and service instructions for all disinfection
equipment.

WARNING: Wear gloves and safety glasses. A damaged O2 sensor can leak and
cause burns (contains potassium hydroxide).

WARNING: Reuse of undisinfected reusable accessories or components may cause

cross-contamination.

WARNING: To prevent leaks, avoid damaging any component in case of

disassembling and reassembling the breathing system. Ensure the
correct installation of the system. Make sure of the applicability and
correctness of the cleaning and disinfection methods.

WARNING: Disassemble and reassemble the breathing system as described in this

manual. If you need further disassembly and reassembly, contact us.
Improper disassembling and reassembling may cause breathing
system to leak and compromise normal system use.

WARNING: Seeping liquid into the control assembly can damage the equipment or
cause personal injury. When cleaning the housing, ensure that no liquid
flows into the control assemblies and always disconnect the equipment from
the AC mains. Reconnect the AC mains after the cleaned parts are fully dry.

WARNING: To avoid sticky residuals, do not use talc, zinc stearate, calcium
carbonate, corn starch, or equivalent materials. These materials can go
into the patient’s lungs and airways and cause irritation or injury.

CAUTION: To prevent patient exposure to disinfection agents and to prevent

premature deterioration of parts, use the cleaning and disinfection
methods and agents recommended in this section.

CAUTION: To reduce the risk of electrical shock, disconnect electrical power from
the ventilator before cleaning and disinfection.

NOTE: Clean and disinfect the equipment as required before it is put into use
for the first time. Refer to this chapter for the cleaning and disinfection
methods.

NOTE: To help prevent damage, refer to the manufacturer’s data if you have
questions about a cleaning agent.

NOTE: Do not use organic, halogenated, or petroleum based solvents, anesthetic

agents, glass cleaners, acetone, or other harsh cleaning agents.

NOTE: Do not use abrasive cleaning agents (such as steel wool, silver polish, or
cleaner).

NOTE: Keep all liquids away from electronic parts.

NOTE: Do not permit liquid to go into the equipment housings.

NOTE: Cleaning solutions must have a pH of 7.0 to 10.5.

NOTE: After cleaning and disinfection is completed, run System Check before using
the equipment. Use the equipment only when System Check is passed.

NOTE: After cleaning and disinfection is completed, check whether there is

any damage to or cracks on the components (e.g., expiratory valve
membrane). If so, replace the component in a timely manner.

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Cleaning and Disinfection Methods for Cleaning and Disinfection

12.1 Methods for Cleaning and Disinfection

CAUTION: The process for autoclave sterilization of the ventilator inspiration
safety valve assembly and the ventilator expiration valve assembly
have been tested and found to be in compliance with ISO 17664:2017.
Compliance to ISO 17664:2017 only applies when bacterial filters are
used to filter the air. Filters must be properly installed on the
inspiratory and expiratory ports.

Some of the ventilator’s parts can be cleaned and disinfected. Different parts of the ventilator should
be disinfected using different methods. You need to select the appropriate method to clean and
disinfect the parts based on the actual situations to avoid cross-contamination between the
ventilator user and the patient.

This table is our recommended cleaning and disinfection methods for the ventilator parts, including
use for the first time and use after many times.

Cleaning Disinfection
Recommended
Parts Frequency Interval
① ② A B C D

Ventilator Housing

External ventilator surface

(including housing, plug-in
module housing, backup air
supply module housing,
Each patient ① A or D
power cord and gas supply
hose).
Trolley and support arm Each patient ① A or D
Touch screen Each patient ① A or D
Every four weeks/as
Fan dust filter
necessary* ② B

Main Unit Air Outlet Dust Every four weeks/as

Filter necessary* ② B

Every four weeks/as

Air intake dust filter
necessary* ② B

Ventilator Inspiration Safety Valve Assembly

Inspiration safety valve

assembly
as necessary* ② B or C

Ventilator Expiration Valve Assembly (Reusable)

Expiration valve membrane

(silicone)
Each patient/weekly ② B or C

Expiration valve assembly

(except membrane)
Each patient/weekly ② B or C

Ventilator Patient Tubing (Reusable)

Patient tubing (including

water trap, Y piece and Each patient/weekly ② B or C
adapter)
Table 12-1

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Methods for Cleaning and Disinfection Cleaning and Disinfection

Neonatal Flow Sensor (Reusable, Thermal Type)

Neonatal flow sensor as necessary* ② B or C

Proximal flow sensor cable as necessary* ① A or D

Other

Refer to the cleaning and disinfection methods

CO2 Module Each patient/weekly
provided by the mainstream CO2 vendor.
Refer to the cleaning and disinfection methods
SpO2 Sensor Each patient/weekly
provided by the attached package insert.
Refer to the cleaning and disinfection methods
SpO2 Sensor Cable Each patient/weekly
provided by the attached package insert.
Refer to the cleaning and disinfection methods
Nebulizer Each patient/weekly
provided by the nebulizer vendor.
Refer to the cleaning and disinfection methods
Humidifier Each patient/weekly
provided by the humidifier vendor.
Cleaning Methods:
① Wipe: wipe with a damp cloth immersed in alkalescent detergent (soapy water, etc.) or alcohol
solution, and then wipe off the remaining detergent with a dry lint-free cloth.
② Immersion: flush with water first and then immerse it in alkalescent detergent (soapy water, etc., water
temperature of 40ºC recommended) for approximately three minutes. Finally, clean with water and dry
completely.
Methods for Disinfection:
A: Wipe: wipe with a damp cloth immersed in medium- or high-efficiency detergent and then wipe off the
remaining detergent with a dry lint free cloth.
B: Immersion: immerse it in medium- or high-efficiency detergent for more than 30 minutes
(recommended time). Then clean with water and dry completely.
C: Steam autoclave at 134ºC for 10 to 20 minutes (recommended time).
D: Ultraviolet radiation for 30 to 60 minutes (recommended time).
Table 12-1
As necessary*: shorten the cleaning and disinfection intervals if the equipment is used in dusty
environment to ensure that the equipment surface is not covered by dust. Clean and disinfect the
inspiration safety valve assembly only when the patient’s exhaled gas may contaminate the
inspiratory limb. For disassembling and installation methods, refer to 12.2.2.

The table below lists the cleaning and disinfecting agents and autoclaving process that may be used
on the ventilator.

Name Type

Ethanol (75%) Moderately efficient disinfectant

Isopropanol (70%) Moderately efficient disinfectant
Glutaraldehyde (2%) Highly efficient disinfectant
Ortho-Phthalaldehyde disinfectant (such as Cidex®OPA) Highly efficient disinfectant
Soap water (pH value of 7.0~10.5) Rinsing agent
Clean water Rinsing agent
Steam autoclave* Highly efficient disinfection
Table 12-2
Steam autoclave*: The recommended temperature of this disinfection method is 134ºC (273ºF).

12 - 4 Operator’s Manual of Ventilator

Cleaning and Disinfection Disassemble the Ventilator’s Cleanable and Disinfectable Parts

12.2 Disassemble the Ventilator’s Cleanable and

Disinfectable Parts
12.2.1 Expiration Valve Assembly and Membrane

D
E

Figure 12-1
A. Expiration valve assembly
B. Expiration valve handwheel
C. Expiration valve membrane
D. Locked state of the expiration valve
E. Unlocked state of the expiration valve

• To disassemble:

1. Rotate the expiration valve handwheel until the indicating arrow on the handwheel is

aligned with the position. Then pull the expiration valve assembly out horizontally.

2. Remove the expiration valve membrane.

• To install:
1. Install the expiration valve membrane onto the expiration valve assembly.

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Disassemble the Ventilator’s Cleanable and Disinfectable Parts Cleaning and Disinfection

2. Ensure that the indicating arrow on the handwheel is aligned with the position. Push
the expiratory valve assembly into the corresponding connector on the ventilator horizontally
until it is fully inserted. Then rotate the expiratory valve handwheel clockwise (and press the

handwheel in the direction the expiratory valve is installed) until the indicating arrow on the

handwheel is aligned with the position.

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Cleaning and Disinfection Disassemble the Ventilator’s Cleanable and Disinfectable Parts

12.2.2 Inspiration Safety Valve Assembly

12.2.2.1 Inspiration Safety Valve Assembly

A
B

D
E

Figure 12-2
A. Sealing ring
B. Safety valve assembly
C. Safety valve handwheel
D. Locked state of the inspiration safety valve
E. Unlocked state of the inspiration safety valve

Operator’s Manual of Ventilator 12 - 7

Disassemble the Ventilator’s Cleanable and Disinfectable Parts Cleaning and Disinfection

• To disassemble:
Ensure the ventilator in standby or off status. Rotate the inspiratory safety valve knob

anticlockwise until the indicating arrow on the safety valve knob is aligned with

the position. Then pull out the inspiratory safety valve assembly horizontally. Check if the
sealing ring at the end of the inspiration safety valve is disconnected. If it is disconnected, re-
install the sealing ring onto the inspiration safety valve.

• To install:
Push the inspiratory safety valve assembly into the corresponding connector on the ventilator

horizontally until it is fully inserted. Ensure that the indicating arrow on the knob is aligned

with the position. Then rotate the inspiratory safety valve knob clockwise (and press the

knob in the direction the inspiratory safety valve is installed) until the indicating arrow on the

knob is aligned with the position.

12.2.2.2 Inspiration Safety Valve Membrane

B
C

F
E

Figure 12-3
A. Safety valve body
B. Membrane fixing knob
C. Safety valve membrane
D. Membrane support
E. Groove of safety valve body
F. Guides on membrane fixing knob

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Cleaning and Disinfection Disassemble the Ventilator’s Cleanable and Disinfectable Parts

• To disassemble:
1. Face the membrane fixing knob and rotate the membrane fixing knob counter-clockwise to the
end position. When the knob guides reach the grooves of safety valve body, pull out the
membrane fixing knob.
2. Remove the safety valve membrane.

• To install:
1. Assemble the safety valve membrane to the membrane fixing knob. The 3 holes on the
membrane match the 3 posts on the membrane fixing knob, as shown below. Ensure the metal
side of the membrane support can be seen through the hole on the membrane fixing knob.

Figure 12-4
2. Align the guides on membrane fixing knob with the grooves of safety valve body. Insert the
membrane fixing knob, press it tightly and rotate it clockwise to the right end position.

Operator’s Manual of Ventilator 12 - 9