Gima NASAL SPECULUM User guide

Disposable Nasal Speculum

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:

#9878 - 20 per Box #9877 - 48 per Box

©2021 Bionix LLC | 1670 Indian Wood Circle
Maumee, Ohio 43537 | United States
Phone: [phone] | Fax: [phone]
Email: [e-mail]
www.bionix.com | RM95-0028 | Rev. D

ENGLISH

DISPOSABLE NASAL SPECULUM ­USER INSTRUCTIONS

Intended Use: The intended use of the
Disposable Nasal Speculum is to allow direct
examination of the anterior part of the nose.

Indications for Use: The Disposable Nasal
Speculum is indicated for use in diagnosis,
extraction of foreign bodies, and nasal pack­ing by healthcare professionals on all patient
populations.

Instructions:

To use, hold the Disposable Nasal Speculum
comfortably in one hand. Position the patient
in a manner that ensures proper access and
adequate lighting. Gently insert the
Disposable Nasal Speculum tip into the
patient’s nares, with the blades in the “closed”
position. Slowly squeeze the handle to spread
the Disposable Nasal Speculum blades and
open the nares. Stop when adequate exposure
has been obtained.

CAUTION: Discontinue use of the
Disposable Nasal Speculum if the patient
experiences pain or trauma to the nose or the
nasal mucosa.

WARNING: Cross-contamination risk. Do
not reuse the Disposable Nasal Speculum 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 related to the use of the
Disposable Nasal Speculum.

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

Do Not Use i f Package is

Damaged

Do Not Reu se

Single-Use Device

Single patient-

multiple use

Consult Instructions

For Use (IFU)

Lot Code Caution

Reorder Number Warning

Serial number

Sterilized using

irradiation

Do Not Resterilize

Non-sterile Temperature limitation

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”