THE OR COMPANY PS003 AntiFog Solution for Endoscopic Optics User Manual
- June 9, 2024
- THE OR COMPANY
Table of Contents
THE OR COMPANY PS003 AntiFog Solution for Endoscopic Optics
INDICATIONS FOR USE / CLINICAL BENEFITS
The AntiFogOR is a sterile, single-use, disposable medical device intended to prevent condensation on the distal lens of endoscopes and laparoscopes. The AntiFogOR consists of a 6ml vial of solution and a sponge with adhesive on the back.
CONTRAINDICATIONS
This device is not intended for use except as indicated
CAUTIONS / WARNINGS
- AntiFogOR was designed, tested and manufactured for single patient use only.
- Reuse or reprocessing of the device may lead to its failure and subsequent patient injury.
- Reprocessing/re-sterilization of this device may create the risk of contamination and patient infection.
- Upon completion of the procedure, AntiFogOR should be discarded in biohazardous waste as per standard procedure
INSTRUCTIONS FOR USE
- Open the sterile pouch, remove the AntiFogOR bottle and place it on the sterile field.
- Attach the sponge to the patient drape or instrument table.
- Open the AntiFogOR bottle and wet the sponge with the solution.
- Press the distal tip of the endoscope onto the sponge and carefully turn it to apply a membrance of the AntiFogOR solution.
- Remove the endoscope from the sponge
Any serious incident that has occurred in relation to this device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.
- Product conforms with requirements of European Medical Device Regulation 2017/745.
- Caution, consult accompanying documents.
- Do not re-sterilize
- Keep away from sunlight
- Keep dry.
- Sterilized using irradiation
- Single sterile barrier system with protective packaging outside.
- Use-by date.
- Caution: US Federal Law restricts this device to sale by or on the order of a physician.
- Single Sterile Barrier System
- Do not use if package is damaged.
- Consult Instructions for Use
- Not made with natural rubber latex.
- Do not reuse.
- Medical Device
- Store between 15°C to 25°C temperature.
Trademark protected
Distributed exclusively in USA by: Symmetry Surgical, 3034 Owen Drive,
Antioch, TN 37013, USA Email:
customerservice@symmetrysurgical.com,
Telephone : USA & CANADA +1
800-251-3000 (Monday-Friday, 7:00AM –
5:30PM CST)
The O R Company Pty Ltd, 4/47 Wangara Road, Cheltenham, VIC, 3192, AUSTRALIA.
www.theorcompany.com
OBELIS SA, Bd Général Wahis 53, 1030 Brussels, BELGIUM,
Tel : +(32) 2 7325954
References
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