Maintenance; General Cleaning Procedure; General Precautions; Recommended Cleaning Agent And Frequency - Interacoustics Aqua Stim Instructions For Use Manual

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 AquaStim™ Caloric
•
Irrigator and the accessories. The gloves are to be changed after each patient, to minimize the
contact points and cross contamination.
distilled or demineralised water
• Use
recommended to use
This will prevent bacterial and algae growth and deposit of minerals on critical internal
components. When the Aqua Stim is not in use, the hose should be coiled using the hose
management tape.
• 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 AquaStim™ caloric irrigator and the temperature-controlled water is intended for contact with intact
skin only. According to the Spaulding classification used by WHO
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 both the surface of the device and the entire water system can be
performed.
1. WHO "Decontamination and Reprocessing of Medical Devices for Health-care Facilities"
Cleaning Agent
The AquaStim™ 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.
cleaning solution like pH neutral detergent as cleaning agent.
Disinfectant
Though the AquaStim™ 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 AquaStim™ Caloric
Irrigator which is also approved by WHO
will also have a mild effect on the materials. The user can also alternatively use chlorine solution
according to their local standards as disinfectant agent.
Frequency
The minimum requirement for cleaning and disinfection frequencies are discussed below in detail.
However, if 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.
D-0128227-A – 2020/12
Aqua Stim Water Irrigator – Instructions for Use - US
if the local tap water available is of poor quality. It is also
distilled or demineralised water
as standard disinfectant agent. Isopropyl alcohol 70-85% v/v
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if the system usage frequency is low.
, it is therefore regarded a non-critical
1
It is recommended to use nonabrasive
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