Lap Scope WarmOR Instructions for Use

Indications for Use / Clinical Benefits

The Lap Scope WarmOR is indicated for use before and during endoscopic and laparoscopic surgery to prevent condensation and fogging of the scope, and to keep the scope's lens and trocar valves free from debris.

Contraindications

This device is not intended for use except as indicated.

Cautions / Warnings

Device is sterile if the package is dry, unopened, and undamaged. Do not use if the pouch is damaged or the packaging seal is broken.
Verify compatibility. Inspect the endoscope/laparoscope and trocar for sharp edges that could interfere with the components of the Scope WarmOR.
Device is designed for short-term use. Do not use for more than 24 hours.
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 is reusable and non-sterile.
Improper use of the Lap Scope WarmOR may lead to patient injuries and/or damage of the endoscope/laparoscoope 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 biohazardous waste as per standard procedure.

Instructions for Use

Open sterile pouch, remove the Scope WarmOR, and place onto sterile field.
Using the Lap Scope WarmOR: Connect the reusable, non-sterile 5V AC adaptor (SW-PA-5V) into the power socket.
Pass Lap Scope WarmOR cord to the scout nurse/theatre technician to connect Lap Scope WarmOR to either the 5V AC adaptor (Figure 1) or charged power bank (Figure 2).
Insert distal tip of endoscope/laparoscope into the Lap Scope WarmOR and allow to warm for 5-10 minutes (for optimal performance).
Carefully remove endoscope/laparoscope from the Lap Scope WarmOR ready for use.

Note: If a 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.

Manufacturer and Distributor Information

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

Product Markings and Symbols

PM_SW_101_V8
Consult Instructions for Use ?
Single Sterile Barrier System ?️
Caution: US Federal Law restricts this device to sale by or on the order of a physician. ?‍⚕️
Not made with natural rubber latex. ??
Do not use if package is damaged. ❌?
2797
Method of sterilization using ethylene oxide. ?
Trademark protected. ™
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. ?➡️?
Do not reuse. ?♻️
Medical Device. Single sterile barrier system with protective packaging outside. ⚕️
Use-by date. ?