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.

ENGLISH

INSTRUCTIONS FOR USE – REUSABLE SURGICAL INSTRUMENTS

EXAMINATION

The user must examine instruments both visually and functionally before using them in surgery.
Examine the instrument to make sure that the following features are visually and functionally acceptable and that none of the components are
missing:
working surfaces
pivots
racks
spring when accessible or viewable
torsional components
cleanliness of holes or lumens
presence of cracks
bent components or entire instrument
deformed
distorted

Do not use instruments that appear too worn to use, damaged, missing components or otherwise non-functional.

Visual Inspection

Check to ensure:
All markings are clearly visible.
Instrument does not have any cracks.
There are no stains, discoloration or rust.
Check to ensure that handle to shaft connection is secure.
There are no cuts, nicks, tears, gouges or other damage to the silicone
Insulation is not damaged
The (working end) functional features are not damaged. Sharp edges should be sharp.
Threads appear to be free of damage. Check fit with mating part.
Ensure no parts are missing, loose or damaged. These parts include but are not limited to spring, screws and pins.
No damage that would inhibit or affect mating function. Check fit with mating part.
Check to ensure lumens are intact and free of obstructions.

Functional Inspection

Check to ensure:

 Moving parts move freely (smoothly without being sloppy).
 Springs function as intended to return the lever, handle or component it is connected to back to its original position.
 Retention tabs are intact and fully functional.
 Instrument mates and functions with compatible mating parts.
 Ball detents are intact and function to hold parts together.
 Sharp edges appear intact and sharp.
 Tips close together properly.
 Ratchet teeth are not damaged or missing. If the teeth are not visible, perform a check by connecting a mating instrument and cycle

instrument through at least one full rotation in each direction.

 Driver tips are not excessively worn. Check mating with appropriate part.
 Do not bend or cut rods in situ or in vivo as fragments could break off into the patient or rod bender could slip or accidentally spring open

and strike implants causing harm to patient.

 Bending, un-bending or re-bending could induce fatigue and possible failure in the rod implant. Hand bendable rod templates can be

used to determine ideal rod implant shape and positioning (placement) prior to bending and placing the rod implant.

There is no exact limit to the life of the instrument, the instrument may be used until it fails visual or functional inspection.

REPROCESSING – GENERAL INSTRUCTIONS (CONSIDERATIONS)
Cleaning is defined as the removal of organic material or soil, microorganisms and lubricants.
Proper cleaning will accomplish the following:
Reduce to a minimum or eliminate the transfer of soil from one patient to another.
Helps ensure that the following steps of reprocessing are successful.
Reduces the level of soil enough to help make sterilization successful and therefore helps the entire reprocessing process be successful.
Sterilization should promptly follow the cleaning steps in order to accomplish successful reprocessing.

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

ENGLISH

INSTRUCTIONS FOR USE – REUSABLE SURGICAL INSTRUMENTS

NOTE: instruments requiring disassembly should be taken apart prior to cleaning.

Blood borne Pathogens

Universal precautions for handling this device after use should be observed by all hospital personnel according to OSHA Standard 29 CFR

1910.1030, Occupational Exposure to Blood borne Pathogens.
Instruments used on patients with suspected or confirmed infectious disease especially Creutzfeldt-Jakob Disease (CJD) or Transmissible
Spongiform Encephalopathy (TSE) infected tissue must be thoroughly sterilized according to local laws and procedures.
These instructions do not include recommendations for the inactivation of TSE agents also known as prions. The user may refer to the World
Health Organization (WHO) Infection Control Guidelines for TSE for instructions on the inactivation of prions.

Automated Cleaning

For thorough cleaning it is recommended that automated cleaning be preceded by manual cleaning steps, automated cleaning alone may not be
enough.

Manual Cleaning

It is recommended that enzymatic cleaners be used to remove organic soil. Disinfection solutions may not have the cleaning properties of an
enzymatic cleaner. These cleaning instructions were validated using an enzymatic cleaner.

Cleaning Agents and Cleaning Tools

The following cleaning agents, solutions, or tools should NOT be used:

• Saline solution

• Alkaline cleaning agents

• Solutions containing chlorine (e.g., bleach) or aldehydes (e.g., gluteraldehyde)

• Formalin, mercury, chlorides, bromides, iodides, or ringers solution

• Metal brushes or scouring pads

The following cleaning agents and tools are recommended for use:

• Soft bristled brushes and pipe cleaners of appropriate sizes

• Neutral pH enzymatic cleaners

• Cloths and towels used for cleaning must be clean and lint free.

• Use only low foaming cleaning agents, so that instruments are visible in the cleaning solution.

Discard worn brushes as these will not clean effectively.
Use appropriate size brush for lumen being cleaned because if it is too small it will not clean thoroughly and if it too big it will not fit into the lumen.
Brushes, towels and other cleaning tools should themselves be cleaned and disinfected or sterilized so that they do not add bio burden to the
instruments.
If using highly alkaline cleaners the instrument must be properly neutralized and then thoroughly flushed and rinsed with de-ionized water. Use of
alkaline chemicals could cause rusting and pitting.
Highly Aggressive agents like Sodium hydroxide (NaOH) or Sodium hypochlorite (NaOCl) commonly known as bleach may discolor or corrode
instruments.
Use of cleaners with rust inhibitors could help prevent or reduce the formation of rust, follow manufacturer’s directions for temperature, dilution
and application.
Sort instruments by similar metal for subsequent processing so that galvanic corrosion due to contact between dissimilar metals will not occur. It is
not recommended to clean plated instruments in an ultrasonic cleaner since the ultrasonic vibration and the presence of other sharp instruments
may crack or otherwise damage the plating.
Rinse cleaning agents thoroughly off the instruments to prevent accumulation of residue.

Note: features that are difficult to clean include but are not limited to blind holes, lumens, rough surfaces, teeth, springs, ball detents, and mated
surfaces with narrow gaps.

Cleaning and Rinsing Water

Use softened tap water when available. The use of de-ionized water for the final rinse step will prevent mineral deposits or water stains being left
behind on instruments.

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

ENGLISH

INSTRUCTIONS FOR USE – REUSABLE SURGICAL INSTRUMENTS

LUBRICANTS

Do not use mineral oil or silicone based lubricants as they cannot be easily removed by cleaning. These types of lubricants may coat surface
microorganisms and reduce the effectiveness of steam sterilization. They may even provide nutrients for microbial growth. Oil based lubricants
may be used to lubricate the internal mechanisms of powered instruments if specified in the manufacturer's written instructions.
It is recommended that a water soluble lubricant compatible with the sterilization method be used for lubrication. Follow manufacturer's written
instructions for dilution, temperature and whether to rinse or soak the instrument.

RESPONSIBILITIES OF THE USER

Health care personnel should wear personal protective equipment like face mask, goggles and gloves when handling, cleaning or transporting
contaminated instruments.
The healthcare facility is responsible for making sure that trained personnel, equipment and the environment necessary to maintain safe handling
and reprocessing of surgical instruments can be achieved. Refer personnel considerations in ANSI/ AAMI ST79 Comprehensive Guide to Steam
Sterilization and Sterility Assurance in Health Care Facilities is recommended.

MANUAL CLEANING INSTRUCTIONS

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.

At Place of Use

Remove all visible soil using a lint free towel. Remove all blood and stains with a non-shedding towel.
Place instruments in a tray of water covered with damp towels. Clean instruments within 30 minutes of use.

At Dedicated Cleaning Area

NOTE: instruments requiring disassembly should be taken apart prior to cleaning. Take the covered instruments to the cleaning area.
Rinse instruments under cool water (<104°F/ 40°C) to remove gross soiling (large particles of blood and contamination) within 30 minutes after use.
Do not use a fixating detergent or hot water (>104°F/ 40°C) as this can cause fixation of residual matter.
Soak/submerge the instrument in an enzymatic cleaner for at least 45-60 minutes after a steady stream of bubbles (indicating evacuating air) is no
longer observed.
Actuate all moving parts during soak while flushing all inside channels with a syringe.
Use a soft bristle brush to remove debris, pay special attention to threads, crevices and hard to reach areas. Brush all inside channels with a
suitable diameter brush.
Instruments with lumens should be soaked vertically or thoroughly flushed to prevent trapped air bubbles and ensure complete contact with
cleaning solutions.
Rinse and flush instruments under running tap water for 3 minutes.
Use a syringe to flush all hard to reach areas.
Scrub entire instrument including all lumens and cavities.
Use appropriate size brush for lumen being cleaned because if it is too small it will not clean thoroughly and if it too big it will not fit into the lumen.
Scrub until all visible soil (blood and contamination) is removed.
Prepare enzymatic solution with tap water.
Follow manufacturer's written instructions for dilution, temperature and whether to rinse or soak the instrument.
Soak/submerge the instrument in an enzymatic cleaner for at least 45-60 minutes after a steady stream of bubbles (indicating evacuating air) is no
longer observed. Actuate all moving parts during soak while flushing all inside channels with a syringe. Use a soft bristle brush to remove debris,
pay special attention to threads, crevices and hard to reach areas. Brush all inside channels with a suitable diameter brush.
Prepare a second enzymatic solution.
Follow manufacturer's written instructions for dilution, temperature and whether to rinse or soak the instrument.
Soak/submerge the instrument in an enzymatic cleaner for at least 45-60 minutes after a steady stream of bubbles (indicating evacuating air) is no
longer observed.
Actuate all moving parts during soak while flushing all inside channels with a syringe.
Use a soft bristle brush to remove debris, pay special attention to threads, crevices and hard to reach areas. Brush all inside channels with a
suitable diameter brush.
Remove instrument from enzymatic solution and ensure all cavities are flushed in the water stream.
Brush all inside channels with a suitable diameter brush. Rinse with running deionized or tap water for 3 minutes.

Prepare a second enzymati solution.
Follow manufacturer’s written instructions for dilution, temperature and whether to rinse or soak the instrument.
Ultrasonic Cleaner: Submerge instrument in the enzymatic solution and, use a neutral pH detergent and sonic ate for 45 - 60 minutes.
Remove the instrument from the Ultrasonic cleaner. Ensure all cavities are flushed. Rinse for 3 minutes.

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

ENGLISH

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

DRYING TIME

Steam

Gravity-Displacement

250°F (121°C)

30 minutes

30 minutes

Steam

Gravity-Displacement

270°F (132°C)

15 minutes

30 minutes

Steam

Gravity-Displacement

275°F (135°C)

10 minutes

30 minutes

Steam

Dynamic-Air-Removal

270°F (132°C)

4 minutes

30 minutes

Steam

Dynamic-Air-Removal

275°F (135°C)

3 minutes

16 minutes

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

DRYING TIME

Steam

Gravity-Displacement

273°F (134°C)

20 minutes

30 minutes

Steam

Dynamic-Air-Removal

273°F (134°C)

4 minutes

30 minutes

Steam

Dynamic-Air-Removal

273°F (134°C)

20 minutes

30 minutes

EXPLANATION OF SYMBOLS

Batch code

Catalog number

Authorized European representative

Product is sold non-sterile

℞ CAUTION: Federal law (USA) restricts these devices to sale by or

on the order of a physician.

This instrument complies with the European Medical Device

Directive MDD 93/42/EEC

Manufacturer

Consult Instructions for Use

INSTRUCTIONS FOR USE – REUSABLE SURGICAL INSTRUMENTS

Rinse with running deionized or tap water for 3 minutes.

Drying: Instrument may be dried with a lint free towel. Clean filtered compressed air may be used to dry inside channels and highly inaccessible
areas.
Maintenance of sterility is based on wrap used, wrapping method and storage conditions.
Wrapping method is based on healthcare personnel wrapping technique. Refer to ANSI/AAMI ST79.
Wraps used during the steam sterilization process are to be FDA cleared wraps.
The following sterilization instructions have been validated to a Sterility Assurance Level (SAL) of 10-6.
Only legally marketed devices, accessories and chemicals should be used for the reprocessing procedure.
Local laws and ordinances must be followed by the user when they are more stringent than those described in these instructions.

Table 1: Steam Sterilization Cycle Parameters for Medical Facilities in the United States and its Territories

The sterilization cycles listed in Table 2 are not considered by the FDA to be standard sterilization cycles.

Table 2: Steam Sterilization Cycle Parameters for Medical Facilities outside the United States and its Territories

NOTE: Chamber size and chamber load differences may exist between industrial and health care facility sterilizer models. The sterilization
parameters listed in Tables 1 and 2 can be achieved in both health care facility and larger, industrial sterilizer models. Because of the many
variables involved in sterilization, each medical facility should calibrate and verify the sterilization process (e.g. temperatures, times) used for their
equipment.

CE mark is only valid if it is also printed on the product and product label.

MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany [phone]

Gauthier Biomedical, Inc., 2221 Washington Street, Grafton, WI 53024 USA
http://www.gauthierbiomedical.com
[phone]

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