bionix 7200 OtoClear Tip Ear Irrigation Instruction Manual

: June 9, 2024
: BIONIX

Table of Contents

INSTRUCTIONS FOR USE
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References
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bionix 7200 OtoClear Tip Ear Irrigation

INSTRUCTIONS FOR USE

Intended use: The intended use of the O to Clear is to flush cerumen and/or foreign bodies from a patient’s ear canal without causing injury

Indications for use: The OtoClear 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.

How to Use
The BIONIX® OtoClear Tip was designed to make ear irrigation safer, quicker and more effective using The Ear Lavage System or the Spray Wash Bottle. OtoClear Tips are also compatible with a Tabletop Waterpik or Luer lock Syringe. These instructions are written in order to help you,and therefore, your patients, get the greatest benefit possible from the irrigation procedure.

Before You Begin:

Examine 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.

CAUTION: DO NOT perform irrigation if the tympanic membrane is perforated or if tympanostomy tubes are present.
Discontinue irrigation immediately if bleeding, irritation or other trauma to the ear canal or tympanic membrane occurs.

If you are using the Spray Wash Bottle, first connect the inner tube to the bottle.

Grasp the OtoClear tip and twist onto the luer lock fitting of the adapter wand until it stops.
Fill the water reservoir of the delivery device with warm water (approximate body temperature). DO NOT use cold or hot water as it may cause dizziness in some patients.
Prime the unit by discharging into a sink.
Insert O to Clear tip fully into the ear canal. The flared design of the O to Clear tip protects against over-insertion. Tip: Fully inserting O to Clear Tip will help eliminate backsplash.
Place a basin beneath the outer ear to capture draining effluent.
Note: The O to Clear tip directs the water towards the walls of the ear canal creating a turbulent lavage that effectively dislodges the cerumen. The exit portals control backsplash and deliver the effluent into the basin.
Reexamine the ear canal. Repeat the irrigation procedure as needed. Sometimes a large plug of wax will not exit through the portal. In these cases, we recommend the use of a Safe Ear Curette™ to extract any remaining cerumen.
Remove any remaining water in the ear canal with an absorbent sponge. When procedure is complete, remove and dispose of the single-use OtoClear tip.

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 reduced as far as possible, but the product cannot completely eliminate potential patient or user harm arising from the following:

Harm from mechanical hazards
Harm from misuse, or use error
Harm from unanticipated origins

| Medical Device| | Do Not Use if Package is Damaged
---|---|---|---
| Manufacturer| | Do Not Reuse Single-Use Device
| Date of manufacture| | Single patient- multiple use
| Use-By Date| | Consult Instructions For Use (IFU)
| Lot Code| | Caution
| Reorder Number| | Warning
| Serial number| | Authorized representative in the European Com- munity
| Sterilized using irradiation|