THE O R COMPANY InsufflatOR Needle Veress Instructions

THE O R COMPANY InsufflatOR Needle Veress

DESCRIPTION

• IN-12-4: 12cm InsufflatOR Needle
• IN-15-4: 15cm Bariatric InsufflatOR Needle

INDICATIONS FOR USE
The InsufflatOR Needle is intended for percutaneous insertion into the peritoneal cavity for the purpose of insufflation with carbon dioxide, to establish pneumoperitoneum prior to the placement of trocars during laparoscopic procedures.

CONTRAINDICATIONS
This device is not intended for use except as indicated, and when laparoscopic and other minimally invasive surgical techniques are contraindicated.

CAUTIONS / WARNINGS

• Procedures for minimally invasive surgery should be performed only by qualified and trained physicians familiar with minimally invasive surgical techniques.
• Verify compatibility of all instruments and accessories prior to initiation of the procedure.
• DO NOT attempt to use the InsufflatOR Needle if the stylet is not functioning properly.
• Protect the InsufflatOR Needle with protective sleeve when not in use.
• Being a needle it can cause injuries.
• 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.
• After use, this product may be a potential biohazard. Handle in a manner which will prevent accidental puncture. Dispose of in accordance with applicable laws and regulations. Carefully place the used needle in a sharps biohazard container after the procedure is completed.

INSTRUCTIONS FOR USE

Prepare the patient in accordance with proper laparoscopic technique prior to insertion of the needle.

1. Using sterile technique, remove the InsufflatOR Needle from the packaging. Inspect the needle to ensure that the stylet moves freely in and out with minimal pressure applied to the stylet. Do not attempt to use the needle if the stylet does not return over the sharp end when tension on the stylet is halted.

2. The InsufflatOR Needle is inserted into the abdomen per standard
   insertion technique.

3. During insertion, inspect the instrument handle to ensure that the ‘red safety indicator’ is in the clear portion of the handle. This action indicates the retraction of the blunt stylet and exposure of the sharp needle tip to allow penetration. Do not attempt to use the InsufflatOR Needle if the blunt stylet does not retract into the needle sleeve. Once the blunt stylet is free
   of tension from the tissue, the ‘red safety indicator’ resets itself back into the shaded distal portion of the handle.

4. Check to ensure that the InsufflatOR Needle is safely in the abdominal cavity. If the saline drop test indicates correct placement, connect the needle via the Luer Lock to the insufflation line, turn the Stopcock to initiate/stop the gas flow and distend the abdomen. Follow the instructions provided by the insufflation pump manufacturer.

5. Once insufflation is complete and the desired abdominal pressure is complished, remove the InsufflatOR Needle from the abdomen and proceed with the procedure.

6. Discard the needle after single use in the approved medical waste container in accordance with institutional policy

Figure 1

• Importer
• Manufacturer
• Caution, consult accompanying documents.
• Consult Instructions for Use.
• Keep away from sunlight.
• Keep dry.
• Not made with natural rubber latex.
• Method of sterilization using ethylene oxide
• Single sterile barrier system
• Use by date
• Do not reuse
• Distributor
• Authorized representative in the European Community/ European Union
• Caution: US Federal Law restricts this device to sale by or on the order of a physician.
• Do not use if package is damaged
• Store between 15°C to 25°C temperature.
• Do not re-sterilize.
• Product conforms with essential requirements in European Medical
• Devices Directive 93/42/EEC. Notified body: DNV Product Assurance AS, with CE2460
• Single sterile barrier system with protective packaging outside
• Medical Device

Australian Sponsor: The O R Company Pty Ltd, 4/47 Wangara Road, Cheltenham,
VIC, 3192, AUSTRALIA
Imoprted and 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)
Advanced Medical Design Co. Ltd, 4F~5F, No. 29, Wuquan 5th Road, Wugu District,
24888 New Taipei City, TAIWAN www.amdintl.com.tw
OBELIS S.A, Bd. Général Wahis, 53, 1030 Brussels, Belgium
Telephone: +3227325954,
Fax: +3227326003,
E-mail: mail@obelis.net

References

• Advanced Medical Design

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