Medtronic GC101210 Instructions for Use

ENGLISH

INSTRUCTIONS FOR USE – REUSABLE SURGICAL INSTRUMENTS

IMPORTANT INFORMATION FOR REUSABLE SURGICAL INSTRUMENTS FROM GAUTHIER BIOMEDICAL.

SCOPE

This instruction for use will apply to reusable manual surgical instruments.

INTENDED USE

This instrument is intended for use in surgical procedures on bone and tissue by a physician trained in its intended use, some instruments may be
used in conjunction with other instruments.
This instrument may be connected to shaft type instruments, such as awls, taps, screw drivers and similar instruments used to prepare for
installation, driving or adjusting fasteners or constructs into bone with the appropriate instrument connector.
Device is sold non-sterile. Sterilize before use per manufacturer’s reprocessing instructions below.
This instrument may be used in orthopedic surgical procedures which are also known as bone surgical procedures in Japan.

DO NOT IMPLANT THE INSTRUMENTS.
Any attempt to change or modify this instrument will void the warranty.

WARNINGS

If the instrument slips, is dropped, mishandled or used improperly the patient and health care personnel may be injured by sharp edges.
Failure to follow proper maintenance, handling, cleaning, sterilization and storage procedures could make the instrument unfit for use and even be
dangerous to the patient or health care personnel.
Impacts applied to the instrument not intended for impact or excessively high impact forces could cause the instrument to become damaged.
A light impact is defined as an impact applied with a mallet not exceeding 1.65lb (748 gms)from a distance of no more than 4 inches (102 mms)
with a medium speed. Medium speed is defined as approx. ½ - 1 sec from start to end of impact stroke.
Sharp edges could cut or injure health care personnel and patient. Chips, fragments or components could dislodge or break off the instrument and
become implanted in the patient. The instrument is not intended to be implanted.
Rod bending or rod cutting instruments have the specific risks of producing broken bits of
material. These instruments could apply very high forces and sometimes bits of material can
be produced when rods or other materials are bent or cut. This is why it is hazardous to use
them in situ. Any material left in the body of the patient could cause an allergic reaction or an
infection.
The physician and rest of healthcare personnel should wear PPE (personal protection
equipment) like mask, eye protection (goggles), gloves.
The physician should take extreme care when operating near vital organs, nerves or blood
vessels as slippage, excessive force or a combination of the two could cause harm.

PRECAUTIONS

Take care while applying high forces as this could dislodge or damage (implants/constructs)(devices, particularly hooks).
Do not expose the instrument to temperatures exceeding 135°C as this could damage the instrument.
Take care to make sure that instruments are well maintained and remain fully functional.
Handle instruments with care. Store the instrument in a clean, dry space that avoids direct sunlight and extreme temperatures.
Do not redesign or modify the instruments in any way as this could damage the instrument, make it dangerous to operate and it may not function
as intended.
Do not use the instrument for any use other than that which it is intended for.
Periodically review instrument function and make use of repair and replacement services.
Do not use damaged instruments or instruments that are not fully functional. Additional backup instruments should be available.
The physician must be knowledgeable of pre- and post-operative procedures in order to properly use the instrument.
Proper patient selection and their adherence to recommended procedures will influence outcomes.
Care should be taken while operating on pediatric patients since they are more vulnerable to stresses from the manipulation of bone and tissue.
If the instrument has a measuring function, ensure that all necessary markings are clearly visible.

PRECAUTIONS

Take care while applying high forces as this could dislodge or damage implants, especially hooks.
Do not expose the instrument to temperatures exceeding 275°F (135°C) as this could damage the instrument.
Take care to make sure that instruments are well maintained and remain fully functional.
Handle instruments with care. Store the instrument in a clean, dry space that avoids direct sunlight and extreme temperatures.

IFUN-003 Rev. 0 Date: 2013-06 ENGLISH ONLY © 2013 Gauthier Biomedical, Inc. All ights reserved.

ENGLISH

INSTRUCTIONS FOR USE – REUSABLE SURGICAL INSTRUMENTS

Do not redesign or modify the instruments in any way, this could damage the instrument, make it dangerous to operate and it may not function as
intended.
Do not use the instrument for any use other than that which it is intended for.
Periodically review instrument function.
Do not use damaged instruments or instruments that are not fully functional. Additional back-up instruments should be available.
The physician must be knowledgeable of pre and post-operative procedures in order to properly use the instrument.
Proper patient selection and their adherence to recommended procedures will influence outcomes.
Care should be taken while operating on pediatric patients since they are more vulnerable to stresses from the manipulation of bone and tissue.
If the instrument has a measuring function, ensure that all necessary markings are clearly visible.

POSSIBLE ADVERSE EFFECTS

Damage to nerves, soft tissue, organs or joints which could result in paralysis and pain.
The health care personnel or patient could become infected from improperly cleaned or sterilized instruments. The patient could also become
infected due to surgical complications.
The patient could experience pain, discomfort or abnormal sensations when the instrument is present.
Nerves are fragile and could be damaged during surgery.
A tear in the membrane that surrounds the brain and spinal cord known as Dura can leak as an unintentional consequence of surgery.
Blood vessels, nerves and organs could be struck and damaged by an accidentally dropped or misplaced instrument.
Injury may be caused by sudden unintentional release of clamped or spring loaded instrument components.
Skin or gloves of health care personnel could be cut by sharp edges.
Bone fracture especially in the case of weak or deformed spine could occur.
Injury to patient or healthcare personnel may result from the instrument components breaking apart, becoming disassembled.
The health care personnel especially the physicians’ training and expertise in the surgical procedure determine the usage of the instrument. The
patient outcomes are not always positive and some surgeries are not successfull. A positive outcome (successful surgery) is dependent on a variety
of patient factors.
Severe inflammatory reactions from endotoxin contamination of surgical instruments may result.
Used ultrasonic cleaner liquid may be contaminated by bacteria or the cleaning fluid could result in endotoxin contamination.

Alkaline cleaners are corrosive
Alcohols are not recommended for sterilizing medical materials because they do not have the ability to effectively kill spores and they cannot
penetrate protein-rich materials.
Alcohols tend to swell and harden rubber and some plastic tubing after prolonged and repeated use. Alcohols also tend to bleach rubber and
plastic tiles.

Hinged instruments must be fully opened when loaded in an automated washer to allow adequate contact with the detergent solution.
Do not stack instruments in the automated washer as this will reduce surface area exposed to contact with the detergent solutions, flushing and
rinsing liquids.
Instruments should be disassembled when possible to improve cleaning.

PHYSICIAN NOTE: Since the physician is the person between the company and the patient, the important medical information in this document
should be communicated to the patient.

CAUTION: FEDERAL (U.S.) LAW RESTRICTS THESE DEVICES TO SALE BY OR ON THE ORDER OF A PHYSICIAN ONLY.
This instrument should only be used by physicians that know and understand its intended use, the mating instruments and the surgical procedures
that this instrument is to be used for.

PACKAGING
Check to make sure the packaging is not open nor damaged when received. Check product to make sure there is no damage and product is in
working order prior to use.
Damaged packages should be returned to local distributor.
Remove instrument from packaging then clean and sterilize instrument prior to use in surgery. Instruments must be cleaned and sterilized
immediately after surgery, failure to do so could result in organic soil drying on the instrument thereby making them more difficult to clean and
sterilize.
Instruments must be cleaned and sterilized prior to returning product to distributor. Health care personnel or the responsible person should
include a note to notify the recipient that the instrument has been cleaned and sterilized and therefore is not a biohazard.
Instrument cases must be wrapped with a sterilization wrap to create a sterile barrier and maintain sterility of instruments within the case.

IFUN-003 Rev. 0 Date: 2013-06 ENGLISH ONLY © 2013 Gauthier Biomedical, Inc. All ights reserved.