The O R Company Ps-500-m Liquid Scope Warmer User Manual

THE O R COMPANY PS-500-M Liquid Scope Warmer

INDICATIONS FOR USE / CLINICAL BENEFITS

The Liquid Scope WarmOR is indicated to warm endoscopes and laparoscopes before and during surgery to prevent condensation on the scope lens.

CONTRAINDICATIONS

This device is not intended for use except as indicated.

CAUTIONS / WARNINGS

• Device is designed for short term use. DO NOT use for more than 24 hours.
• Take care when placing the endoscope into the Liquid Scope WarmOR.
• DO NOT use if punctured. Exposure to the sodium acetate solution may cause irritation to the eyes and skin. Immediately rinse with water.
• DO NOT insert endoscope / laparoscope after the device has been activated and changed its consistency (turned rigid).
• Peak temperature (approximate): 50 +/- 5°C.
• For single patient use only. The design of this device may not perform as intended by the manufacturer if it is reused. The manufacturer cannot guarantee the performance, safety and reliability of a reprocessed device.

INSTRUCTIONS FOR USE

1. Remove the Liquid Scope WarmOR from its sterile packaging. Inspect the device for damage or contamination, and discard if any is noted. Otherwise, place on sterile field.
2. Place the distal tip of the endoscope / laparoscope in the middle of the Liquid Scope WarmOR and align it to the centre fold of the Liquid Scope WarmOR (Step #1). Close the buttons of the device (Step #2).
3. Locate and flex the metal disk inside the fluid pack 2 or 3 times to start the warning (Step #3).
4. Allow 3 to 5 minutes to warm (Step #4). The Liquid Scope WarmOR will reach its peak temperature in 5 minutes. Note: For best result, activate the Liquid Scope WarmOR about 5 to 7 minutes before surgery. Wrap the device and the endoscope / laparoscope in a double layer sterile towel to prolong the heating period for approximately 45 minutes up to one hour.
5. Carefully remove the endoscope / laparoscope from the Liquid Scope WarmOR ready for use (Step #5).
6. Upon completion of the procedure, the Liquid Scope WarmOR should be discarded in biohazardous waste as per standard procedure.

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.

SAFETY SYMBOLS

• 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
• Lower limit of safe temperature exposure.
• 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.
• Use-by date.

CUSTOMER SERVICE

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, 7:00AM – 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

• Minimally Invasive Surgery - Non-Invasive Surgical Instruments - Symmetry Surgical®