Medtronic G109800 Instructions for Use

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INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

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

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

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.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

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 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 a 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 successful. A positive patient 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 tubings 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.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

Remove instrument from packaging then clean and sterilize instrument prior to use in surgery. 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.

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 springs, 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 (where present): 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. Visible ratchet teeth are not damaged or missing. Verify ratcheting mechanism is fully functional by ratcheting the instrument at least one full rotation. When a direction control cap is present, verify driving and ratcheting directions in all positions. Mating component may be required to verify ratcheting and driving functions.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

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, unbending 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. 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 as 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., glutaraldehyde)

• 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 is too big it will not fit into the lumen.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

Brushes, towels and other cleaning tools should themselves be cleaned and disinfected or sterilized so that they do not add bioburden 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 such as 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 electrolytic (galvanic corrosion) due to contact between dissimilar metals will not occur. Plated instruments should not be cleaned in an ultrasonic cleaner since the ultrasonic vibration and the presence of other sharp instruments may crack or rupture 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.

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, unless otherwise specified on the labeling. 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 a face mask, goggles and gloves when handling, cleaning or transporting contaminated instruments. The healthcare facility is responsible for making sure that personnel, equipment and the environment necessary to maintain safe handling and reprocessing of surgical instruments can be achieved. Reference to 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.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

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. Prepare an enzymatic solution with tap water. Follow manufacturer’s written instructions for dilution and temperature. 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, paying 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 to 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 an 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, paying 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 an enzymatic solution with tap water. 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 sonicate for 45 - 60 minutes. Remove the instrument from the ultrasonic cleaner. Ensure all cavities are flushed. Rinse for 3 minutes.

Rinse with running deionized or tap water for 3 minutes. Inspect instrument to make sure all blood and contamination have been removed. Do not proceed with reprocessing a soiled instrument. Cleaning (Automated): Instrument must be cleaned manually prior to using the automated cleaner. Load instrument so that the instrument can drain. 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. Follow wrap manufacturers written instructions for use and sterility maintenance. 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)

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

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

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

DRYING TIME

Steam

Gravity-Displacement

270°F (132°C)

15 minutes

30 minutes

Steam

Dynamic-Air-Removal

270°F (132°C)

4 minutes

30 minutes

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

METHOD

CYCLE

TEMPERATURE

EXPOSURE TIME

DRYING TIME

Steam

Gravity-Displacement

273°F (134°C)

20 minutes

30 minutes Dynamic-Air-Removal

273°F (134°C)

4 minutes

30 minutes

Steam

Dynamic-Air-Removal

273°F (134°C)

20 minutes

30 minutes

Instrument must be properly dried for effective sterilization. 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.

INSTRUCTIONS FOR USE – REUSABLE RATCHETING TORQUE HANDLES

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

EXPLANATION OF SYMBOLS

Batch code

Catalog number

Authorized European representative

Product is sold non-sterile

℞ Only 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

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

MDSS GmbH, Schiffgraben 41, 30175 Hannover, Germany

Gauthier Biomedical, Inc., 2221 Washington Street, Grafton, WI 53024 USA

http://www.gauthierbiomedical.com

+1-262-546-0010

Medtronic G109800 Instructions for Use

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