Ceek Women s Health Nella KIND Single Use Vaginal Speculum Instruction Manual

July 17, 2024
Ceek Women s Health

Ceek Women s Health Nella KIND Single Use Vaginal Speculum

Single-Use Vaginal Speculum with Integrated LED Light Source

  • REF NSRL096
  • REF NSRL024

DESCRIPTION

The Nella KIND is a single-use vaginal speculum with integrated sidewall retractors.

INTENDED USE

The Nella KIND Single-Use is intended to dilate the vagina and expose the interior of the vagina and exterior of the cervix during gynecologic examinations and procedures.

WARNINGS AND CAUTIONS

  • WARNING: The Speculum is provided clean but not sterile.
  • WARNING: Inspect the speculum before every use. Do not use if damaged.
  • WARNING: Treat used vaginal specula as biohazardous infectious material. Dispose of used vaginal specula in suitable disposable units or under local regulations.
    • This document indicates conditions or practices that could lead to illness, injury, or death (“WARNING”).
    • This document indicates conditions or practices that may result in minor or moderate injury to the user or patient or damage to the equipment or other property (“CAUTION”).
    • Consult Instructions for Use.
    • Federal law restricts this device to sale by or on the order of a medical professional.
    • Do not use if packaging is damaged.
    • Not made with natural rubber latex.
    • Fragile
    • Store at room temperature.
    • Store out of direct sunlight.
    • Product Identifier
    • Lot Identifier
    • Date of Manufacture
    • Medical Device
    • Do not re-use, Single-use device
    • Use by Date
    • This way up

DIRECTIONS FOR USE

Always inspect Nella Single-Use for integrity before use. Do not use it if any flaws or signs of damage are found. Nella Single-Use is shipped in the locked position.

  1. Slide the switch (A) up so it is in the unlocked position.
  2. Activate the integrated LED Light Source by pulling the activation ring (B) located along the upper bill just before use and dispose of the ring.
  3. Insert into the vaginal canal and open by depressing the thumb tab (C). When opened su˘ciently, slide switch (A) down to lock bills in position.
  4. If necessary, increase the open angle by further pushing down the thumb tab (C).
  5. To unlock, slide switch (A) up to unlock bills.

WARRANTY

Please visit ceekwomenshealth.com/warranty for warranty information. Ceek Women’s Health should be notified immediately of any defective units.

MANUFACTURER
Ceek Women’s Health 2175 NW Raleigh Street, Suite 110 Portland, OR 97210 ceekwomenshealth.com 1-855-559-CEEK Report any potential serious incidents to Ceek Women‘s Health and the compentent authority of the clinic‘s member state.Made in Malaysia Patents: ceekwomenshealth.com/patents © 2018–2023 Ceek Women’s Health NSUIFUR1-2023

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