Symmetry Surgical H-250 HolstOR Surgical Instrument Holder Instructions
- June 9, 2024
- Symmetry Surgical
Table of Contents
Symmetry Surgical H-250 HolstOR Surgical Instrument Holder
INDICATIONS FOR USE / CLINICAL BENEFITS
HolstOR is a surgical instrument holder, designed specifically to improve safety by reducing unnecessary instrument exchanges between surgeon and scrub personnel in the operation room.
CONTRAINDICATIONS
This device is not intended for use except as indicated.
CAUTIONS / WARNINGS
- Choose the HolstOR size in relation to the surgical instruments used. Do not overload the instrument holder.
- Each HolstOR requires its own towel clamp, even when connected to another HolstOR.
- The device is intended for single 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
- Remove the HolstOR from the sterile packaging and place it on the sterile instrument table.
- Drape patient as required.
- Secure the HolstOR to the sterile patient drape using a towel, Kelly or artery clamp and supplied 4mm key ring. See diagram B.
- Ensure the HolstOR is adequately secured to the sterile patient drapes prior to inserting any instrumentation.
- The HolstOR will comfortably accommodate up to three (3) separate surgical instruments.
- Additional HolstOR instrument holders can be connected utilising the accessory clips located on the side of the HolstOR.
- After the procedure, discard the device in the approved medical waste container in accordance with institutional policy.
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.
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 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.
Trademark protected.
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
- Parked at Loopia
- Minimally Invasive Surgery - Non-Invasive Surgical Instruments - Symmetry Surgical®