Integra LifeSciences Bipolar Cable, Disposable - Manual

CAUTION
Please read all of the following information and instructions prior to use. Federal (USA) law restricts this device to sale by or on the order of a physician.
HOW SUPPLIED
This product is disposable, supplied sterile and intended for single use only. Prior to the expiration date, contents are sterile if the package has not
been opened or damaged. Do not re-sterilize.
INDICATIONS FOR USE
Disposable bipolar instrument cords are designed to connect an electrosurgical device, such as Bipolar Forceps, to a compatible electrosurgical
generator. In particular, the Padgett disposable sterile bipolar instrument cables are intended for use with bipolar forceps during general surgical
procedures. We recommend that you review the Instructions for Use on PADGETT BIPOLAR FORCEPS (Ref. No. PAD-IFU-BIPLR). These instructions
are readily available and downloadable from our website at www.miltex.com.
CONTRAINDICATIONS
Any use of this instrument cable for tasks other than for which is it indicated, can lead to premature wear, result in a damage or can cause hazards to
patients and users.
CAUTION & WARNING – CONNECT BIPOLAR ACCESSORIES TO THE BIPOLAR RECEPTACLE ONLY AND MONOPOLAR ACCESSORIES TO THE
MONOPOLAR RECEPTACLE ONLY. DO NOT ATTEMPT TO CONNECT OR INTERCHANGE BIPOLAR AND MONOPOLAR ACCESSORIES AND
RECEPTACLE CONNECTIONS. IMPROPER CONNECTION OF ACCESSORIES MAY RESULT IN INADVERTENT ACCESSORY ACTIVATION OR
OTHER POTENTIALLY HAZARDOUS CONDITIONS.
ADVERSE REACTIONS or SIDE-EFFECTS
None known.
SETUP and USE
Attach the sterile Bipolar cord to the sterile Bipolar instrument, ensuring that the contact pins are fully seated in the cable receptacles. Connect the
cord to the generator only while it is in the “OFF” or “STANDBY” mode. Failure to do so may result in injury or electrical shock to the patient or
operating room personnel.
At the lowest power setting, test the instrument connections by pressing the generator’s activating switch. If the generator fails to activate, check the
line connection with the cable. Always review and follow generator manufacturer operating and use instructions.
RETURNED GOODS POLICY
Products must be returned with proof of purchase and in unopened packages with manufacturer’s seals intact to be accepted for replacement or
credit unless returned due to a complaint or product defect. Determination of a product defect will be by Miltex. Products will not be accepted for
replacement if they have been in the possession of the customer for more than 120 days.
PRODUCT INFORMATION DISCLOSURE
Miltex, Integra and manufacturer exclude all warranties, whether expressed or implied, including but not limited to, any implied warranties or
merchantability or fi tness for a particular purpose. Neither Miltex, Integra nor manufacturer shall be liable for any incidental or consequential loss,
damage, or expense, directly or indirectly arising from use of this product. Neither Miltex, Integra nor Manufacturer assume nor authorize any person
to assume for them any other or additional liability of responsibility in connection with these products.
INSTRUCTIONS FOR USE - PADGETT DISPOSABLE (STERILE) BIPOLAR INSTRUMENT CABLE
SYMBOLS USED ON LABELING
See Instructions for Use
Consult Instructions for Use
Use by: Year-Month
Single Patient Use
Batch Code / Lot Number
Catalog Number
CAUTION: USA Federal Law restricts
this device to sale by or on the order of
a physician only.
STERILE – STERILIZED BY IRRADIATION
Sterility guaranteed unless package opened or
damaged. Do not re-sterilize.
LOT
Manufactured for:
Miltex, Inc.
589 Davies Drive
York, PA 17402
toll free phone: 866-854-8300
phone: 717-840-9335
fax: 717-840-9347
www.miltex.com
Padgett is a registered trademark of Integra LifeSciences Corporation.
The Integra wave logo is a trademark of Integra LifeSciences Corporation.
©2006 Integra LifeSciences Corporation. All Rights Reserved.
IFU-PM9450D 0907/0/A/1