Medtronic 25000095 Instructions for Use

Medtronic Reusable Instruments for

M708348B450E Rev. E

use with the IPC™ POWEREASE™
System

2021-07-14

IMPORTANT INFORMATION FOR MEDTRONIC REUSABLE INSTRUMENTS FOR USE
WITH THE IPC™ POWEREASE™ SYSTEM

DESCRIPTION

Medtronic Reusable Instruments compatible with Medtronic’s IPC™ POWEREASE™ System are spine preparation
instruments, manufactured from materials commonly used in orthopedic procedures which meet available national or
international standards specifications. Instruments may be connected to the POWEREASE™ Driver or used manually. These
instruments are also compatible with various Medtronic spinal implant systems.

INDICATIONS FOR USE

The IPC™ System is indicated for the incision/cutting, removal, drilling and sawing of soft and hard tissue and bone, and
biomaterials in Neurosurgical (Cranial, Craniofacial), Orthopedic, Arthroscopic, Spinal, Sternotomy, and General surgical
procedures.

The IPC™ POWEREASE™ System is indicated for drilling, tapping and driving screws and working end attachments during
spinal surgery, including open and minimally invasive procedures. It is also used in placement or cutting of screws, posts and
rods.

Do not implant instruments.
If there is any doubt or uncertainty concerning the proper use of these instruments, contact Medtronic.
Medtronic does not and cannot warrant the use of this instrument, nor any instrument component parts upon which repairs were

made or attempted, except as performed by Medtronic or an authorized Medtronic repair representative. Implied warranties of
merchantability and fitness for a particular purpose or use are specifically excluded.

WARNINGS

▪ Breakage, slippage, misuse, or mishandling of instruments, such as on sharp edges, may cause injury to patients or

operative personnel.

▪ Improper maintenance, handling, or poor cleaning procedures can render instruments unsuitable for its intended purpose or

even dangerous to patients or surgical staff.

▪ It is important the surgeon exercise extreme caution when working in close proximity to vital organs, nerves, or vessels and

forces applied while correcting the position of instrumentation are not excessive, such that it might cause injury to patients.

PRECAUTIONS

▪ Excessive force applied by instruments to implants can dislodge devices.
▪ Never expose instruments to temperatures >135°C that may considerably modify physical characteristics.
▪ Extreme care should be taken to ensure instruments remain in good working order. During the procedure, successful use of

instruments is extremely important. Instruments should not be bent or damaged. Misuse of instruments resulting in
corrosion, “freezing-up”, scratching, loosening, bending, or fracture of any or all sections of instruments may inhibit or
prevent proper function.

▪ Instruments should be carefully placed in trays, cleaned after each use, and stored in a dry environment.
▪ Do not use instruments for actions for which they are not intended.
▪ Regularly review the operational state of instruments and, if necessary, make use of repair and replacement services.
▪ To avoid injury, instruments should be carefully examined for functionality or damage before use. Damaged instruments

should not be used. Additional back-up instruments should be available.

▪ Preoperative and operating procedures, including knowledge of surgical techniques, are important considerations in

successful use. Further, proper selection and compliance of patients greatly affect results.

▪ Proper patient selection and operative care are critical to success of surgery and avoidance of injury during surgery. Read

and follow all product information supplied by the manufacturer of implants or instruments.

▪ Special precautions are needed during pediatric use. Care should be taken when using instruments in pediatric patients

since these patients can be more susceptible to stresses involved in their use.

▪ Some surgeries require use of instruments which incorporate a measuring function. Ensure these are not worn and surface

engravings are clearly visible.

POSSIBLE ADVERSE EFFECTS

▪ Nerve damage, paralysis, pain, or damage to soft tissue, visceral organs, or joints.
▪ Infection if instruments are not properly cleaned and sterilized.
▪ Pain, discomfort, or abnormal sensations resulting from the presence of instruments.
▪ Nerve damage due to surgical trauma.
▪ Dural leak in cases of excessive load application.
▪ Impingement of close vessels, nerves, and organs by slippage or misplacement of instruments.
▪ Damage due to spontaneous release of clamping devices or spring mechanisms of certain instruments.
▪ Cutting of skin or gloves of operating staff.
▪ Bony fracture in cases of deformed spine or weak bone.
▪ Tissue damage to patients, physical injury to operating staff, and/or increased operating time that may result from

disassembly of multi-component instruments occurring during surgery.

▪ Methods of use of instruments are determined by the user's experience and training in surgical procedures. A successful

result is not always achieved in every surgical case. This fact is especially true in spinal surgery where other patient
conditions may compromise results.

Physician note: although the physician is the learned intermediary between the company and the patient, the important medical
information in this document should be conveyed to the patient.

For US audiences only
Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.
These instruments should be used only by physicians familiar with the device, their intended use, any additional

instrumentation, and any available surgical techniques.

PACKAGING

Packages for instrument components should be intact upon receipt. All sets should be checked for completeness and all
instrument components should be checked for signs of damage before use. Damaged packages or products should not be used
and should be returned to Medtronic.

Instruments used in surgery must be cleaned and sterilized by the hospital before use.
Remove packaging material prior to cleaning and sterilization. Only sterile instruments should be used in surgery. Always

immediately clean and resterilize instruments used in surgery. Instruments should be thoroughly cleaned before resterilization.
This process must be performed before handling, or before returning product to Medtronic.

EXAMINATION

Instruments must always be examined by the user before surgery.
Examination should be thorough and must include a visual and functional inspection of working surfaces, spring or torsional

operation, cleanliness of location holes or cannulations, and the presence of cracks, bending, deformation, or distortion, and
that all components are complete.

Never use instruments with obvious signs of excessive wear, damage, or that are incomplete or otherwise nonfunctional.

Visual Inspection

Make certain of the following:

▪ Laser etchings, engravings, and other markings are legible.
▪ No cracks are present in instrument handles or any part of the instrument.
▪ Discoloration, corrosion, stains, or rust do not exist. If present, attempt to remove in accordance with the cleaning

instructions provided in the Processing section of this document.

▪ The handle-to-shaft connection is secure.
▪ No cuts or gouges in silicone are present.
▪ There is no damage (cuts, tears, etc.) to insulation.
▪ There is no damage to working ends of instruments. Instruments should be free of cracks, sharp edged gouges, and other

damage. When applicable, working ends should be sharp.

▪ There is no damage to threads.
▪ All parts are present and free of damage and deterioration.
▪ Mating ends are free of damage (nicks, gouges, bends, etc.) that would interfere with the mating function.
▪ Cannulated instruments with a guide wire or other insertion tool are visually checked.

Functional Inspection

Make certain of the following:

▪ Parts intended to move will do so freely without sticking, binding, or grinding.
▪ Retention mechanisms hold appropriate mating parts and are not damaged.
▪ Instruments function as intended with the appropriate mating parts.
▪ Ball detents hold mating parts and are free from damage.
▪ Sharp edges are sharp to the touch and are not dull, have no nicks, or any other damage.
▪ Driver tips are not worn beyond functional use. If necessary, mate the instrument with the appropriate part.

DIRECTIONS FOR USE

Instruments are precision devices which may incorporate a measuring function and have uses described on the label. Unless
labeled for single use, instruments may be re-used.

Use with the IPC™ POWEREASE™ System

See the IPC™ POWEREASE™ System package insert (M726750B246) for instructions on setting up and operating the system.

1. Attach the reusable instrument to the POWEREASE™ Driver (Figure 1).
a. On the POWEREASE™ Driver, pull back and hold the quick disconnect to unlock the collet.

Note: the quick disconnect must be held in the unlocked position ① when inserting or removing tools.

b. Insert the proximal end of the instrument into the collet.
c. Align the flat sides of the instrument shaft with the marks on the collet ⑧ and insert into the collet until fully seated

(Figure 2).

d. Release the quick disconnect to place the assembly in the locked position ②. Verify the instrument is secured in the

POWEREASE™ Driver by ensuring it cannot be pulled out of the device.

When using the POWEREASE™ Driver with reusable instruments, avoid bending the instrument by applying direct force
only along the instrument assembly axis (Figure 3).

Instructions for Manual Use

1. Secure the manual handle to the connection end of the instrument. Use only the Medtronic quick connect ratcheting handle

(G900000) or Medtronic quick connect T- handle (G900100).

2. Retract the collar on the handle and snap the proximal end of the instrument shaft into the handle.

3. Verify the handle is secured to the instrument by ensuring it cannot be pulled out of the device.

PROCESSING - GENERAL CONSIDERATIONS

Definitions

Cleaning is the removal of organic soil. Effective cleaning:

▪ Minimizes organic soil transfer from one patient to another.
▪ Prevents accumulation of residual soil throughout the product’s use life.
▪ Allows for successful follow up sterilization. Adequate processing is contingent upon the thoroughness of cleaning.

Cleaning is the initial step and sterilization occurs later in processing and is intended to kill microorganisms to reduce likelihood
of transmission and possibilities of infection. To ensure acceptable processing, there should be no delay between steps in this
document.

Bloodborne Pathogens

Universal precautions for handling instruments after use should be observed by all hospital personnel according to OSHA
Standard 29 CFR 1910.1030 regarding occupational exposure to bloodborne pathogens.

Thorough Cleaning of Instruments

It is critical all reusable instruments are thoroughly cleaned by the hospital prior to use and after each use following specific
cleaning steps listed in this document. Ineffective or incomplete cleaning can hinder subsequent sterilization.

Automated Cleaning

A fully automated washer/disinfector cycle is not recommended as the sole cleaning method. Manual cleaning is required.

Manual Cleaning

Disinfection agents such as sanitizing and chemical solutions act to reduce microbes on surfaces but may not act as cleaners.
Other types of soaps or detergents may not clean to an appropriate level of cleanliness. Enzymatic cleaning agents are
recommended. This type of cleaner was shown to effectively remove organic soils, such as blood, from instruments. Cleaning
instructions were validated by Medtronic 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 Ringer's solution.
▪ Metal brushes or scouring pads.

The use of neutral pH enzymatic cleaners and soft bristled brushes and soft pipe cleaners are recommended.

Cleaning and Rinsing Water

If available, softened tap water should be used. De-ionized water should be used for the final rinse step to prevent mineral
deposits on instrument surfaces.

Use of Mineral Oil or Silicone-Based Lubricants

These types of lubricants should never be used as they may not be removed by these cleaning instructions. Lubricants may
coat microorganisms, prevent direct contact of steam with instrument surfaces, and hinder sterilization.

MANUAL CLEANING INSTRUCTIONS

Proper Handling After Use

Do not allow instruments to dry after use and before cleaning. Cleaning and subsequent sterilization may be hindered when
blood or bloody solutions are allowed to dry on instruments.

Cleaning Instructions - Point of Use

1. Remove visible soil from instruments using non-shedding wipes.

2. Place instruments in a tray of water or cover with damp towels. Instruments should be cleaned within 30 minutes of use to

minimize potential for drying.

Cleaning Instructions - Dedicated Cleaning Area

1. Immediately transport the tray containing covered instruments to a work area dedicated to further processing.

2. Rinse instruments under running tap water for 3 minutes.

3. Scrub instruments with an appropriately-sized soft bristle brush to aid in the removal of visible soil.

4. Repeat steps 2 and 3 until visible soil is removed.

5. Using tap water, prepare enzymatic cleaning solution according to the manufacturer’s instructions, dilution

recommendations, and temperatures.

6. Place instruments in enzymatic cleaner, completely submerged, and soak for 45-60 minutes.

7. Remove instruments from enzymatic cleaner and rinse under running tap water for 3 minutes. Ensure lumens and cavities

are flushed in the water stream.

8. Using tap water, prepare a second enzymatic cleaning solution according to the manufacturer’s instructions, dilution

recommendations, and temperatures in an appropriately-sized sonicator.

9. Place instruments in enzymatic cleaner, completely submerged, and sonicate for 45-60 minutes.

10. Remove instruments from the sonicator and rinse using running tap water for 3 minutes. Ensure lumens and cavities are

flushed in the water stream.

11. Repeat step 10 using de-ionized water for an additional 3 minutes.

12. Dry instruments using clean, absorbent, non-shedding wipes.

13. Carefully inspect instruments, including lumens and cavities, to ensure contamination is removed. If soil is still present,

repeat the cleaning process or contact Medtronic immediately to arrange for disposal or replacement. Do not proceed with
processing of a soiled instrument.

Sanitization

Medtronic reusable instruments are considered critical devices and must be cleaned and sterilized before initial use, or in
adherence to these processing instructions before re-use. Sanitization with disinfectant solutions or chemicals is unnecessary
and not recommended.

Sterilization Instructions

Only sterile products should be placed in the operative field. Unless marked sterile and clearly labeled as such in an unopened
sterile package provided by Medtronic, instruments used in surgery must be cleaned and sterilized by the hospital before use.

It is the user’s responsibility to use only sterilizers and accessories (such as sterilization wraps, pouches, chemical indicators,
biological indicators, and sterilization trays) cleared by the Food and Drug Administration (FDA) for selected sterilization cycle
parameters (time and temperature).

The following sterilization instructions were validated to a sterility assurance level of 10

1. Wrap instruments.

2. Inspect packaging to ensure no rips, punctures, or seal failures are present in or on packaging prior to loading into the

sterilizer.

3. Load instruments into the sterilizer by following the sterilizer manufacturer’s recommended loading procedures and load

configurations.

4. Follow the sterilizer manufacturer’s recommended procedures to program the sterilizer with sterilization cycle parameters in

Table 1 and Table 2.

Table 1: Sterilization cycle parameters for the US and its territories

Method Cycle Temperature Exposure time

Steam Dynamic-air-removal 270°F (132°C) 4 Minutes 30 Minutes
Steam Dynamic-air-removal 275°F (135°C) 3 Minutes 30 Minutes

-6

.

Minimum dry time

1

For medical facilities located outside the US and its territories, some non-US health care authorities recommend sterilization
according to these parameters to minimize the risk of transmission of Creutzfeldt-Jakob disease, especially of surgical
instruments that could come into contact with the central nervous system.

Table 2: Sterilization cycle parameters for medical facilities outside the US and its territories

Method Cycle Temperature Exposure time

Minimum dry time

1

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

1

Minimum dry times were validated using sterilizers having vacuum drying capabilities. Drying cycles using ambient atmospheric

pressure may require longer dry times. Refer to the sterilizer manufacturer’s recommendations.

Note: chamber size and chamber load differences may exist between industrial and health care facility sterilizer models.
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.

Sterilization cycles listed in Table 2 are not considered by the Food and Drug Administration (FDA) to be standard sterilization
cycles. It is the user’s responsibility to use only sterilizers and accessories (e.g. sterilization wraps, sterilization pouches,
chemical indicators, biological indicators, and sterilization cassettes) cleared by the FDA for selected sterilization cycle
specifications (time and temperature).

FURTHER INFORMATION

Recommended directions for use of this system (surgical operative techniques) are available at no charge upon request. If
further information is required, contact Medtronic.

PRODUCT COMPLAINTS

To report product problems, contact Medtronic.
©2021 Medtronic Sofamor Danek USA, Inc. All rights reserved.

Figure 1: POWEREASE™ Driver

Table 3

①

Quick disconnect unlocked

②

Quick disconnect locked

③

Mechanized working collar locking pins (2)

④

Variable speed trigger

⑤

Finger sensor trigger

⑥

NIM-ECLIPSE cable connector

⑦

Mode select switch

⑧

Flat side indicators

Figure 2: Instrument Seating in POWEREASE™ Driver

Figure 3: POWEREASE™ Driver Assembly

Medtronic Sofamor Danek USA, Inc.

1800 Pyramid Place
Memphis, TN 38132
Telephone: [phone] (USA)

901 396 3133 (Outside USA)

Fax: [phone]

EXPLANATION OF SYMBOLS

Authorized representative in the European Community

CAUTION: Federal law (USA) restricts these devices to
sale by or on the order of a physician.

Batch code

Manufacturer

Catalogue number

For US audiences only

This device complies with applicable European Union
regulations and directives.

This device complies with applicable European Union
regulations and directives.

Medtronic B.V.

Earl Bakkenstraat 10
6422 PJ Heerlen
The Netherlands
Tel: + 31 45 566 80 00

Consult instructions for use at this website.