Symmetry Surgical SW-5-12-R Lap Scope WarmOR Instructions
- June 9, 2024
- Symmetry Surgical
Table of Contents
Symmetry Surgical SW-5-12-R Lap Scope WarmOR
INDICATIONS FOR USE / CLINICAL BENEFITS
The Lap Scope WarmOR is indicated to be used before and during endoscopic and laparoscopic surgery to prevent condensation and fogging of the scope.
CONTRAINDICATIONS
This device is not intended for use except as indicated.
CAUTIONS / WARNINGS
- The device is sterile if the package is dry, unopened, and undamaged. Do not use if the pouch is damaged or the packaged seal is broken.
- Verify compatibility. Inspect the endoscope/laparoscope and trocar for sharp edges that could interfere with the components of the Scope WarmOR.
- The device is designed for short-term use. Do not use it for more than 24 hours.
- The peak temperature of the Lap Scope WarmOR (approximate): 50 +/- 5°C
- Lap Scope WarmOR is designed to be used with a 5V AC adaptor approved for medical use (SW-PA-5V) or a 10000mAh power bank. NOTE: The AC adaptor and power bank are reusable and non-sterile.
- Improper use of the Lap Scope WarmOR may lead to patient injuries and/or damage of the endoscope/laparoscope and trocar.
- Do not place Lap Scope WarmOR on the patient.
- The Lap Scope WarmOR was designed, tested, and manufactured for single-patient use only. Reuse or reprocessing of this device may lead to its failure and subsequent patient injury.
- Do not re-sterilize the device. Re-sterilization may compromise the integrity of the device and create the risk of contamination and unintended patient infection.
- Upon completion of the procedure, the Lap Scope WarmOR should be discarded in bio hazardous waste as per the standard procedure.
INSTRUCTIONS FOR USE
the sterile pouch, remove the Scope WarmOR and place it onto the sterile field. Using the Lap Scope WarmOR:
- If using an AC adaptor, connect a reusable, non-sterile AC adaptor (SW-PA-5V) to a power socket.
- Pass the Lap Scope WarmOR cord to the scout nurse/theatre technician to connect Lap Scope WarmOR to either a 5V AC adaptor (Figure 1) or charged power bank.
- Insert the distal tip of the endoscope/laparoscope into the Lap Scope WarmOR and allow it to warm for 5- 10 minutes (for optimal performance).
- Carefully remove the endoscope/laparoscope from the Lap Scope WarmOR ready for use.
Note: If 7.4V Rechargeable Battery (NLM3000) is used, it must be charged
with a 9V AC Adaptor before connecting to Lap Scope WarmOR. 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.
The product conforms with the requirements of European Medical Device
Regulation 2017/745.
Caution, consult accompanying documents.
Do not re-sterilize.
Keep away from sunlight.
Keep dry.
Method of sterilization using ethylene oxide.
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 it if the package is damaged.
Consult Instructions for Use.
Not made with natural rubber latex.
Do not reuse.
Medical Device.
Trademark protected.
Distributed exclusively in USA by Symmetry Surgical, 3034 Owen Drive,
Antioch,
TN 37013, USA
Email:
[email protected],
Telephone: USA & CANADA +1 800-251-3000
(Monday-Friday, 7:00 AM – 5:30 PM CST)
The O R Company Pty Ltd,
4/47 Wangara Road,
Cheltenham, VIC, 3192,
AUSTRALIA.
www.theorcompany.com
OBELIS SA,
1030 Brussels,
BELGIUM,
Tel: +(32) 2 7325954