Getting Started; Before You Begin - Bionix OtoClear Instrucciones De Uso

Thank you for purchasing OtoClear
OtoClear ® , powered by Aquabot
patient safety, patient discomfort, and compacted cerumen removal. The key
to this system is the OtoClear ear irrigation tips that are attached to the end
of the wand. OtoClear ear irrigation tips direct water to the ear canal wall at
30 degree angles avoiding directly impacting the tympanic membrane.
This manual is designed to explain the proper assembly instructions for the
entirety of the kit, including bottle assembly, cleaning, and tip placement.
Note: Any other use for the product outside of the intended use stated here-
in, Bionix shall not be held liable.

Getting Started:

Unpacking and Verifying Contents:
Before continuing, inspect the package for any damage during shipping.
If you find any damage notify your local distributor.
Next, check to ensure that your OtoClear
plete.
Contents include:
• Aquabot Bottle
®
• Adapter wand
• Either 20 OtoClear Tips or 5 OtoClear Tips
• Ear basin
If any item is missing please contact your distributor.
Intended use: The intended use of OtoClear powered by Aquabot is to flush
cerumen and/or foreign bodies from a patient's ear canal without causing
injury.
Indications for use: The OtoClear powered by Aquabot is indicated for use on
patients 6 months or older with impacted cerumen and/or foreign bodies
occluding the ear canal where no infection and/or eardrum perforation is
known or suspected.
CAUTION: DO NOT perform irrigation if the tympanic membrane is per-
forated or if tympanostomy tubes are present. Discontinue irrigation immedi-
ately if bleeding, irritation or other trauma to the ear canal or tympanic mem-
brane occurs.
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® , powered by Aquabot
® provides a simple, yet effective, solution to
® , powered by Aquabot ® is com-
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WARNINGS:
• Use only warm water (98°F - 104°F / 37°C - 40°C) to reduce the risk of
dizziness or vertigo
• If pain or discharge occurs see your physician
• Cross-contamination risk. Do not reuse the disposable OtoClear Tips as this
may spread contamination from one patient to another patient.
Medical Device Reporting: Notice to Users and/or Patients in EU: Any serious
incident that has occurred in relation to the device should be reported to the
manufacturer and the competent authority of the Member State in which the
user and/or patient is established.
Clinical Benefits: Indicated in Intended Use.
Contraindications:
• The person has previously had complications following ear irrigation
procedures
• There is a history of a middle ear infection in the last six weeks
• There is discharge from the ear canal or ear pain or tenderness
• The person has or suspects an ear drum perforation
• The person has had ANY form of ear surgery
• The person has cleft palate, repaired or not
• The person has tympanostomy tubes
• There is a foreign body present in the ear canal
• There is a history of inner ear problems (especially vertigo)
Residual Risk: Risk associated with the use of this product has been re-
duced as far as possible, but the product cannot completely eliminate poten-
tial patient or user harm arising from the following:
• Harm from mechanical hazards
• Harm from misuse, or use error
• Harm from unanticipated origins

Before you begin:

Exam the ear canal and tympanic membrane with an otoscope noting the
type and location of any cerumen. Hard or impacted wax may require a
cerumenolytic agent.
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