D-0116684-B – 2020/03
OtoRead™ - Instructions for Use - US Page 52
Recommended cleaning and disinfection solutions:
Warm water with mild, nonabrasive cleaning solution (soap)
70% isopropyl alcohol
Procedure:
Clean the instrument by wiping the outer case with a lint-free cloth lightly dampened in cleaning solution
Clean probe and cable with a lint-free cloth lightly dampened in cleaning solution
Make sure not to get moisture in the speaker portion of the probe and similar parts.
Ear tips:
Use new ear tips for each patient. Ear tips are for single patient use only.
Probe tube:
The probe tube, which does not make direct contact with the patient, should be replaced if there is any sign
of contamination or if the test will not progress past the Probe Check phase. Disinfection of the probe tube
between patients is not required. The probe tube requires replacement only when it becomes clogged.
The cleaning instruction outlined in this Instruction for Use may not conform to the infection control
guidelines of the user’s facility. The disinfection materials and procedures applied in the user’s facility may be
more appropriate for their circumstances than the methods outlined above (see cautions below). The
frequency of cleaning and disinfecting is dependent on the facility’s risk assessment, usage, and test
environment.
Do not immerse the instrument or probe in fluids or attempt to sterilize
the instrument or any of its accessories.
Do not allow any fluid to enter the device
Do not use autoclave sterilization
Take care not to put excessive pressure on the clear display window
or allow any utensil to puncture the display window or control panel
4.3 Concerning repair
Interacoustics is only considered to be responsible for the validity of the CE marking, effects on safety,
reliability and performance of the equipment if:
assembly operations, extensions, readjustments, modifications or repairs are carried out by authorised
persons
a 1 year service interval is maintained
the electrical installation of the relevant room complies with the appropriate requirements, and
the equipment is used by authorised personnel in accordance with the documentation supplied by
Interacoustics.
It is important that the customer (distributor) fills out the RETURN REPORT every time a problem arises.
This should also be done every time an instrument is returned to Interacoustics. (This of course also applies
in the unthinkable worst case of death or serious deterioration to patient or user).
4.4 Warranty
Interacoustics warrants that:
The OtoRead
TM
is free from defects in material and workmanship under normal use and service for a period
of 12 months from the date of delivery by Interacoustics to the first purchaser
Accessories are free from defects in material and workmanship under normal use and service for a period of
ninety (90) days from the date of delivery by Interacoustics to the first purchaser
If any product requires service during the applicable warranty period, the purchaser should communicate
directly with the local Interacoustics service centre to determine the appropriate repair facility. Repair or
replacement will be carried out at Interacoustics’ expense, subject to the terms of this warranty. The product
requiring service should be returned promptly, properly packed, and postage prepaid. Loss or damage in
return shipment to Interacoustics shall be at purchaser's risk.
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