Gima LIGHTED ARTICULATING CURETTES User guide

The Lighted Articulating

Ear Curette

INSTRUCTIONS FOR USE

Obelis s.a
Boulevard Général Wahis 53
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:

#2511 – Lighted Articulating VersaScoop

©2021 Bionix LLC | 1670 Indian Wood Circle
Maumee, Ohio 43537 | United States
Phone: [phone] | Fax: [phone]
Email: [e-mail]
www.bionix.com | Patent # 8,728,107
RM95-0011 | Rev. C

®

ENGLISH

Intended use: The intended use of the Lighted Articulating Ear Curette
is to remove cerumen and/or foreign bodies from and illuminate a
patient’s ear canal without causing injury.

Indications for use: The Lighted Articulating Ear Curette is indicated
for use in cases of impacted cerumen and/or foreign bodies occluding
the ear canal.

Assembly/Disassembly:

1. To assemble the Lighted Articulatin g Ear Curette, insert the end
of the curette into the light source by aligning t he pegs with the
grooves inside the light source. Push down and tw ist FIRMLY
clockwise until rotation stops. This will lock the curette into place
and activate the light.

2. To attach the magnific ation lens, snap the lens onto the neck of the
blue light source so that the top of the lens a ngles toward the curette
tip.

3. To disassemble, push the c urette into the light source and rotate
counter clockwise to remove. The light will go off when the curette
is removed. Discard the used curette and keep the light source and
magnification lens for the next procedure.

Instructions for Cerumen Removal - Using the Lighted Articulating
Ear Curette™ with Magnification

The Lighted Articulating Ear C urette offers a new approach to cerumen
and foreign body removal , with an articulating, lighted tip that can be
made to flex and firmly, yet gently, remove obstructing wax or objects.

To use the Lighted Articulating Ear Curette:

1. Position the patient comfortably on the exami nation table. Smaller
children may be rest rained on their parent’s lap or shoulder during
the procedure. Visit ww w.Bionix.com and view the Bionix Cerumen
Removal Tips and Techniques videos for more detail.

2. Using an otoscope, examine the ear canal notin g the presence and
location of any obstructing cerumen or foreign body.

3. Straighten the ear canal by gently pull ing the ear up and away from
the patient. Position the tip of the Lighted Ar ticulating Ear Curette
adjacent to the obstruction or behind it if there is room between the
obstruction and the ear canal wall.

4. Grasp the handle of the Li ghted Articulating Curet te in your palm
placing your index fin ger in the trigger and gently pull back. This
will cause the tip of the curette to bend.

5. Hold the tip in t he flexed position and gently roll the obs truction
from the ear canal.

6. Use an otoscop e to re-examine the ear canal, noting the presence and
location of any remaining obstr uction.

7. Repeat the above procedure as needed to until the tympanic
membrane can be adequately visualized, or the foreign body has
been removed.

8. Remove the otoscope a nd discard t he curette tip.

CAUTI ON : Discontinue curettage immediately if bleeding,
irritation, or other trauma to the ear canal or tympanic membrane
occurs.

CAUTI ON : This product is a spring-loaded device; improper
assembly may cause ejection of the ear curette.

CAUTI ON : DO NOT hold device by light source as accidental
ejection of curette may occur if not assembled properly. Special Note:
The Lighted Articulating Ear Curette is intended for single-patient use.
Discontinue use of the curette if the hinge no longer functions. Re-use
of the curette can cause the hinge to stop functioning. Use of alcohol
wipes or cold sterilization can also negatively affect the functioning of
the curette. The light source and magnification lens are designed for
multi-procedure use.

WARNING: Cross-contamination risk. Do not reuse disposable
curette 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: There are no absolute contraindications for

cerumen removal.

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”