D-0128226-A – 2020/12
Air Fx Caloric Irrigator – Instructions for Use - US
Page
12
4
Maintenance
4.1 General cleaning procedure
4.1.1 General Precautions
•
Before cleaning always switch off and disconnect from the power supply
•
Do not autoclave, sterilize, or immerse the instrument or accessory in any fluid
•
Do not use hard or pointed objects to clean any part of the instrument or accessory
•
Do not let parts that have been in contact with fluids dry before cleaning
•
Disinfectant. The use of organic solvents and aromatic oils must be avoided.
•
Ensure that isopropyl alcohol does not have contact with, any screens on the instruments
•
Ensure that isopropyl alcohol does not have contact with, any silicone tubes or rubber parts
•
To prevent a degradation of the material by the Isopropanol it is recommended to irrigate the
water system with distilled water after disinfecting with 70-85% v/v Isopropyl alcohol.
•
It is recommended that the operator use gloves during the operation of the Air Fx Caloric Irrigator
and the accessories. The gloves are to be changed after each patient, to minimize the contact
points and cross contamination.
•
Single use components should be replaced after every patient use to avoid potential cross
contamination from patient to patient.
4.1.2 Recommended cleaning agent and frequency
The Air Fx caloric irrigator and the temperature-controlled air is intended for contact with intact skin only.
According to the Spaulding classification used by WHO
, it is therefore regarded a non-critical low risk
product in regard to contamination control. The WHO’s recommended level of decontamination for non-
critical devices is cleaning. Disinfection and sterilization are not recommended. However, in case of an
epidemic outbreak, disinfection of the system can be performed.
1.
WHO "Decontamination and Reprocessing of Medical Devices for Health-care Facilities"
Cleaning Agent
The Air Fx Caloric Irrigator is recommended to undergo the regular cleaning procedure with appropriate
cleaning agent. The cleaning agent must be able to remove any foreign material (e. g. , soil,
organic, in-
organic, and microbial contaminants) from the system.
It is recommended to use nonabrasive cleaning
solution like pH neutral detergent as cleaning agent.
Disinfectant
Though the Air Fx Caloric Irrigator is categorized as non-critical device, it is also recommended to
disinfect the system on a regular interval with an appropriate disinfectant to reduce biofilm development.
It is recommended to use
70-85% v/v Isopropyl alcohol
as disinfectant agent for the Air Fx Caloric
Irrigator which is also approved by WHO
Error! Bookmark not defined.
1
as standard disinfectant agent. Isopropyl
alcohol 70-85% v/v will also have a mild effect on the materials.
Frequency
The minimum requirement for cleaning and disinfection frequencies are discussed below in detail.
However, the user can decide to improve their cleaning standards with additional cleaning/disinfection
especially during any epidemic outbreaks as per local clinic standards & requirements and WHO
recommendations.
4.2 After each patient
After each examination of a patient, it should be ensured that there is no contamination on the parts in
connection with the patient. Wipe the outside of the otoscope head and replace the single use speculum
after each patient.
