Medtronic G109800 Instructions for Use

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

IFU-002 Rev. 3 Date: 2016-04 Reorder Part no. GP011912

©2013 - 2016 Gauthier Biomedical, Inc. All rights reserved. 1

Instructions for Use

Reusable Ratcheting Torque Handles

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

IFU-002 Rev. 3 Date: 2016-04 Reorder Part no. GP011912

©2013 - 2016 Gauthier Biomedical, Inc. All rights reserved. 2

IMPORTANT INFORMATION FOR REUSABLE RATCHETING TORQUE HANDLES FROM GAUTHIER
BIOMEDICAL

SCOPE

This instruction for use will apply to reusable manual surgical instruments that are Torque
handles, Ratcheting handles and Ratcheting Torque handles.

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.

Attachment Mechanism

Actuate attachment mechanism (or release collar if present) at front of handle, then insert shaft
type instrument into connector while rotating slightly until it clicks into place. Check that shaft
type instrument assembles readily with the mating connector on the torque handle.
Pull on shaft type instrument to ensure that it is securely connected.
Push on release collar to release shaft type instrument from the torque handle.

Mating Geometry

Instruments intended to mate with other instruments or the implant during use should be verified
prior to use. Any mating geometry present on the instrument should be verified to fit with the
appropriate mating parts before use.

Torque Mechanism
The torque handle is intended to limit torque transmission to a preset torque value or to indicate
torque.
Torque handles may be bi-directional or uni-directional depending on the
mechanism. Verify direction of torque mechanism before use.

Verify torque value before use. Ensure that a backup torque handle is available should the main
torque handle be out of calibration.
Calibration: Device must be sent to manufacturer for evaluation or calibration every 6 months,
unless otherwise specified on the device labeling. Device must be sent to manufacturer for
evaluation or calibration when torque handle is determined to be out of calibration.

Ratcheting Mechanism
Handles with a ratcheting mechanism may have a DIRECTION CONTROL CAP with which to select
the ratcheting direction or locked position. It is important for the user to familiarize themselves
with the device functions before use in the surgery.
If a direction control cap is present, while holding the handle, rotate the direction control cap
through the various detent positions, there could be two or three detents.
Each detent position will be one of the following:

(1) Drive clockwise and ratchet counterclockwise
(2) Locked in both directions or

(3) Drive counter clockwise and ratchet clockwise
If no direction control cap is present, the instrument will drive in one direction and ratchet in the
other direction.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

IFU-002 Rev. 3 Date: 2016-04 Reorder Part no. GP011912

©2013 - 2016 Gauthier Biomedical, Inc. All rights reserved. 3

It is important to verify the ratcheting handle drive direction before use.

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.
For Torque Handle with an Impact Cap: If an Impact cap is present on the handle, the impact
cap will be engraved with the words “IMPACT CAP”. If the words “IMPACT CAP” are not
engraved on a cap then it is not an impact cap. Handles often have caps that are not impact
caps.
If an impact cap is present on the instrument, then the instrument may be impacted with light to
medium impacts and only on the impact cap. Impact may only be applied with a surgical mallet
or similar instrument.
A medium impact is defined as an impact applied with a mallet not exceeding 1.65lb (748 gms)
from a distance of no more than (14) inches (356 mms) with a medium speed. Medium speed is
defined as approx. ½ - 1 sec from start to end of impact stroke.
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 for prying, bending or elevating/spreading. Do not apply heavy impact.
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.