Gima OTOCLEAR EAR IRRIGATION TIPS User guide

OtoClear® Tip

INSTRUCTIONS FOR USE

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1030 Brussels, BELGIUM
Tel: +(32) 2.732.59.54
Fax: +(32) 2.732.60.03
E-Mail: [e-mail]

Bionix LLC
1670 Indian Wood Circle
Maumee, Ohio 43537, United States
Phone: [phone]
Fax: [phone]
www.Bionix.com

Importer, Importeur, Importör,
Importador, Importateur,
Εισαγωγέας, Importeur,
Maahantuoja, Importatore:

MedEnvoy

Prinses Margrietplantsoen 33 - Suite 123
2595 AM The Hague
The Netherlands

This manual applies to the numbers indicated below:

#7200 #7202 #7270 #7275
#7280 #7245 #7290 #7295
#7240 #7235

©2021 Bionix LLC | 1670 Indian Wood Circle
Maumee, Ohio 43537 | United States
Phone: [phone] | Fax: [phone]
Email: [e-mail]
www.bionix.com | RM95-0029 | Rev. E

ENGLISH

OTOCLEAR® TIP - USER INSTRUCTIONS

Intended use: The intended use of the OtoClear is to flush cerumen
and/or foreign bodies from a patient’s ear canal without causing
in jur y.

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.

1. Grasp the OtoClear tip and twist onto the luer lock fitting of the

adapter wand until it stops.

2. 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.

3. Prime the unit by discharging into a sink.

4. Insert OtoClear tip fully into the ear canal. The flared design of

the OtoClear tip protects against over-insertion. Tip: Fully insert­ing OtoClear Tip will help eliminate backsplash.

5. Place a basin beneath the outer ear to capture draining effluent.

Note: The OtoClear 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.

6. 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.

7. 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
establ ished.

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

Manufacturer

Date of manufacture

Use-By Date

Lot Code Caution

Reorder Number Warning

Serial number

Sterilized using

irradiation

Do Not Resterilize

Non-sterile Temperature limitation

Do Not Use i f Package is

Damaged

Do Not Reu se

Single-Use Device

Single patient-

multiple use

Consult Instructions

For Use (IFU)

Authorized representative

in the European Com-

munity

European Conformity

Prescription Only or

”For Use by o r on the order

of a licensed medical

professional”