Medtronic A15000400 Instructions for Use
IMPORTANT MEDICAL INFORMATION
Orthopaedic instruments
EN - VALID ONLY FOR THE USA
Manufactured by:
MEDICREA® INTERNATIONALS.A. (Customer service department)
5389 Route de Strasbourg – Vancia – 69140 Rillieux la Pape – France
Phone: +33 (0)4 72 01 87 87. Fax: +33 (0)4 72 01 87 88
E-mail : customerservice@medicrea.com
CAUTION: USA Federal law restrict s this device to sale by or on the order
of physician.
SUBJECT
The reusable orthopaedic instruments supplied by MEDICREA® INTERNATIONALS.A.
are designed to insert various implantable medical devices during surgical
operations. Instructions provided in this document are intended to assist health
care personnel in safe handling practices and eective reprocessing of MEDICREA®
INTERNATIONAL S.A. instruments. These instructions are recommended for
cleaning, disinfection, maintenance, sterilization, and storage of instruments,
to prevent damage or misuse. This information is not applicable to single-use
instruments that are sold sterile and cannot be resterilized.
WARNINGS AND PRECAUTIONS
The labels, the instructions for use and the surgical technique concerning each
implant must be consulted by the surgeon and the operating personnel to nd
out about the indications and contraindications, the patient risk, the operating
instructions, the warnings and specic precautions.
The specic set of instruments designed for each range of
MEDICREA® INTERNATIONAL S.A. implants must be used for implant
insertion. Instruments supplied by other manufacturers cannot be used with
MEDICREA®INTERNATIONALS.A. implants, unless this is specically recommended in
the surgical technique of the implant or in another MEDICREA® INTERNATIONALS.A.
document.
WARNING
Instruments must only be used by a surgeon who is familiar with them, their intended
use, the associated implants and with the required surgical technique.
The orthopaedic instruments have been designed for repeated use, and they are
subjected to wear (chipped, scratched, blunt, etc...). When an instrument with a
cutting edge (rasps, drills) becomes particularly blunt after excessive use, it should
not be used and should be returned to MEDICREA® INTERNATIONALS.A. or the
distributor. The instruments should not, under any circumstances, be sharpened by
the surgeon or the operating personnel.
NOTE
It is important to limit excessive heating caused by the friction between instruments
and implants or between instruments and bone surfaces. Excessive heating may lead
to necrosis and premature failure of the implants and/or instruments.
HANDLING PROCEDURES
Sterilized instruments should be handled in accordance with appropriate aseptic
procedures. Instruments should be kept away from accidental contact with the
implants, which could damage the implant surface. The care unit should carry out
a visual inspection of each instrument before use. Any instrument showing signs of
damage should not be used.
Further information about the instruments can be available upon request from
MEDICREA® INTERNATIONALS.A. or the distributor.
DECONTAMINATION, CLEANING AND STERILIZATION
All non-sterile instruments must be thoroughly cleaned and sterilized prior to use.
WARNINGS
1. Do not use saline or sodium hypochlorite solution (bleach) because they
encourage corrosion.
2. Do not use solutions containing aldehyde.
3. Comply with the instructions and warnings provided by the suppliers of the
cleansing and disinfection products.
4. Special precautions linked to unconventional transmissible agents: for some risk
classications, the World Health Organization (WHO) or the relevant authorities
recommend special procedures to inactivate unconventional transmissible
agents MEDICREA® INTERNATIONAL S.A. recommends that these procedures
should be followed. For further information, please consult the local regulations
and those from the WHO.
5. The reprocessing procedure for medical devices described below must be carried
out in accordance with the sta protection rules adopted by the health-care
facility, in order to minimize the sta exposure to pathogenic agents.
6. All instruments that have been removed from their packaging, including those
supplied and/or loaned, and those which have lain in the operating theater,
should be thoroughly decontaminated and cleaned before being returned to
MEDICREA® INTERNATIONALS.A..
LIMITS OF REPROCESSING
Repeated reprocessing, according to the instructions in this leaet, has minimal
eect on MEDICREA® INTERNATIONALS.A. instruments. End of life for metal surgical
instruments is normally determined by wear and damage due to the intended
surgical use and not to reprocessing.
Medical devices must be checked after each reprocessing cycle (see paragraph
“CONTROL TESTS AND PERFORMANCE TRIALS”) in order to make sure that they have
not reached the end of their useful life. Surgical instruments which no longer perform
properly because of long use must be returned to the distributor or MEDICREA®
INTERNATIONALS.A..
Any instrument displaying defects that could aect its performance or safety must
not be used. MEDICREA® INTERNATIONAL S.A. declines any responsibility if the
instruments used are damaged, incomplete, display signs of excessive wear, or have
been repaired or sharpened without the company’s control.
MEDICREA® INTERNATIONALS.A.
PROCEDURES TO BE PERFORMED AT THE POINT OF USE
Excess body uids and tissue should be removed from instruments with a cloth or
a disposable paper. Instruments should be placed in a basin of distilled water or in
a tray covered with damp towels, possibly containing an enzymatic solution that
facilitates cleaning.
It is recommended that the instruments should be reprocessed as soon as possible
after use. Do not allow soiling to dry.
PREPARATION FOR CLEANING
Cleaning is an essential step to ensure that sterilization is eective.
Failure to carry out the steps described below can jeopardize the successful
sterilization of MEDICREA® INTERNATIONALS.A. medical devices.
The manual cleaning procedure is recommended for complex devices (hinges, mobile
parts, grooved surfaces).
Fragile instruments should be cleaned separately.
Multi-component instruments should be disassembled before cleaning following
the instructions detailed in the document “MAINTENANCE MANUAL DISMANTLING
PROCESS” in order to avoid any risk of damage that could impair their performance.
Re-assembly should be carried out after cleaning step.
MANUAL CLEANING/DISINFECTION PROCEDURE
The cleaning/disinfection procedure must be applied for the instruments and also for
the trays.
The cleaning/disinfection step cannot replace sterilization: all reusable MEDICREA®
INTERNATIONALS.A. instruments should be sterilized before surgery according to the
method described in paragraph “STERILIZATION”.
Cleaning products should have the following characteristics: a low lather potential in
order to facilitate rinsing, a neutral pH in order to minimize risks of corrosion, and
be suitable for cold washing, in order to avoid proteins coagulation in the soiling.
It is recommended to follow manufacturer’s instructions for preparation and use of
the solutions. The washing tanks should be relled for each use unless otherwise
specied by the manufacturer or if eectiveness of the tank is available.
To thoroughly clean the instruments, the instructions below must be followed:
1. Immerse the instruments in an enzymatic detergent for 20 minutes.
2. While keeping the instruments completely immersed to avoid any risk of
splashing, remove the soiling and debris by brushing with a soft, non-abrasive
brush, paying particular attention to the places that are dicult to reach
(mechanisms, grooved surfaces, threading...). Use brushes with appropriate
diameter and length (check that the brush gets right to the end of the central
cavity for instance). For cannulated instruments: use a brush suitable for the
central cavity to remove the debris by rotating while moving up and down. For
articulated instruments: activate the mechanisms or bend exible stems in order
to release any debris.
3. Rinse with distilled water and at room temperature for at least 4 minutes, paying
particular attention to the hard-to-reach areas and mobilizing the articulations.
4. Immerse the instruments in an ultrasound bath set to 40–45 kHz for 15 minutes.
Place the instruments in the baskets ensuring as much as possible that the
dicult-to-reach areas are exposed to the ultrasound.
5. Rinse with distilled water and at room temperature for at least 4 minutes, paying
particular attention to the hard-to-reach areas and mobilizing the articulations.
6. Carry out a visual inspection to check that the soiling and debris have been
removed. If this is not the case, repeat steps 4 and 5 using a fresh bath. If there is
no visual contamination go to step 7.
7. Dry the instruments using a disposable absorbent paper that does not shed bers.
AUTOMATED CLEANING/DISINFECTION PROCEDURE
The cleaning/disinfection procedure must be applied for the instruments and also for
the trays.
The cleaning/disinfection step cannot replace sterilization: all reusable MEDICREA®
INTERNATIONALS.A. instruments should be sterilized before surgery according to the
method described in paragraph “STERILIZATION”.
Automated washer/disinfector systems are not recommended as the sole cleaning
method to thoroughly clean the surgical instruments. If automated cleaning is
performed, a manual pre-cleaning should be carried out (see paragraph “MANUAL
CLEANING/DISINFECTION PROCEDURE” – Step 1 to 3). Automated cleaning must be
carried out using a certied washer/disinfector. The washing cycle must be a standard
instrument cleaning cycle, including the following steps: pre-disinfection, washing,
rinsing, heat disinfection (at 93°C / 200°F for at least 1 minute or any other parameter
validated to obtain a level of disinfection of A0=600) and drying. The detergent must
be used in accordance with the detergent manufacturer’s instructions and should be
prepared at the use-dilution recommended. It must not be recycled.
Instruments should be placed on an appropriate loading tray, to facilitate access to
any indented zones, with concave surfaces facing downwards in order to avoid the
accumulation of water and optimize drying.
CONTROL TESTS AND PERFORMANCE TRIALS
Visual inspection and performance trials should be thoroughly performed after each
cleaning procedure.
- Carefully inspect each device to ensure that all visible contamination has
been removed, particularly in conned areas (recess, thread, mechanisms). If
contamination is noted, repeat the cleaning/disinfection procedure.
- Articulated and multi-components instruments (hinges, joints, ratchets, screws, nuts):
check the action of moving parts to ensure smooth operation throughout the intended
range of motion. Check that the locking mechanisms work properly (ratchets).
- Instruments with cutting edge must be free from any nicks and display a continuous edge.
- Check instruments with long slender features (particularly rotating instruments)
for distortion.
- Where instruments form part of a larger assembly, check that the devices assemble
readily with mating components.
Some visible defects are associated with normal wear, and are not indicative of any
impairment of functional performance.
If damage or wear is noted that may compromise the function of the instrument or
may have an impact on the safety of the patient or user, instruments should not be
used and should be returned to MEDICREA® INTERNATIONALS.A. or the distributor.
MAINTENANCE/LUBRICATION
When friction is detected during visual inspection, instruments with moving parts
should be systematically lubricated.
In order to reduce friction and wear, hinges, ratchet systems, screws, nuts, and
joints should be lubricated with a water soluble product (e.g. Instrument lotion
or equivalent lubricant) intended for surgical instruments. Mineral oil or silicone
lubricants should not be used because they coat microorganisms, they prevent direct
contact of the surface with steam and they are dicult to remove.
STERILIZATION
The instruments and the trays must have undergone the cleaning steps described
above before being sterilized.
WARNING: Do not stack trays during sterilization.
It is the end user’s responsibility to use only sterilizers and accessories (such
as sterilization wraps, sterilization pouches, chemical indicators, biological
indicators, and sterilization cassettes) that have been cleared by the Food and Drug
Administration (FDA) for the selected sterilization cycle specications (time and
temperature).
If a sterilization box with a paper lter is used, check that the lters are intact before
each sterilization. MEDICREA® INTERNATIONALS.A. has validated the parameters
described in the table below in a porous load autoclave to obtain a sterility assurance
level (SAL) of 10-6:
Standard
Method
cycle
U.S.A. Steam Pre-vacuum
In order to ensure that the recommended temperature is reached at all points in the
load, throughout the full exposure time, the autoclave used by the health-care unit
must be qualied, calibrated and properly maintained. The sterilization must be
carried out according to the procedures validated by the health-care unit, particularly
regarding the loading plan.
Other methods of sterilization may be used, but they must have been validated by
the health care-unit. Any modication of the sterilization procedures indicated in this
document is the responsibility of the user facility.
The instructions provided above have been validated by
MEDICREA®INTERNATIONALS.A. to prepare a medical device for re-use. It remains
the duty of the competent department to make sure that the sterilization process
used and involving the equipment, materials and sta of the sterilization facilities,
does produce the desired result. This generally requires the validation and routine
control testing of the procedures. Any deviation from the instructions provided by the
competent service should be assessed correctly in order to determine its ecacy and
any harmful consequences.
PACKAGING AND TRANSPORT
Instruments must be packed in their respective trays.
If loaner kits or consignment sets are used, instruments should be carefully checked
before their use to ensure that there is nothing missing and no sign of damage. Any
instrument showing signs of damage or scratches on its surface should not be used
and should be returned to MEDICREA® INTERNATIONALS.A. or the distributor.
Special attention must be paid to instruments with cutting/slicing parts. They should
be placed in a resistant container to avoid any risk of cutting or puncturing the
container.
STORAGE CONDITIONS
No special storage conditions are required.
ADDITIONAL INFORMATION
For any further information about the orthopaedic instruments supplied by
MEDICREA® INTERNATIONALS.A. or to request a surgical technique, please contact
MEDICREA® INTERNATIONALS.A. customer service department or the distributor.
CLAIMS CONCERNING THE PRODUCT
Any customer or user of this system who wishes to put in a claim or is not fully
satised with the product quality, identication, durability, reliability, safety,
ecacy and/ or performance, should contact the distributor or MEDICREA®
INTERNATIONAL S.A.. Furthermore, malfunction or suspected malfunction of a
product should be reported to the distributor or to MEDICREA® INTERNATIONALS.A..
Any serious undesirable eect or death, that might have been provoked by incorrect
functioning of a MEDICREA® INTERNATIONALS.A. product, should be immediately
reported to the distributor or to MEDICREA® INTERNATIONALS.A. by telephone, fax or
in writing. For any claim, please mention name, catalog number, and manufacturing
lot number of the product, as well as your full name and address and the nature of
your claim. Also, please specify whether a written report is requested from the
distributor or MEDICREA® INTERNATIONAL S.A.. For any product returned to the
distributor or to MEDICREA® INTERNATIONALS.A., a certicate guaranteeing that it
has been cleaned, disinfected and sterilized must be provided.
WARNING
The manufacturer’s liability is limited solely to the applications and uses specied in
this document.
Cycle
Temperature
132°C – 270 °F
Duration
of
treatment
4 minutes
Drying
Time
20-30
minutes
ORTHOPAEDIC INSTRUMENTS
EN INSTRUCTIONS FOR USE
VALID ONLY FOR THE USA
REFERENCE : C00D01006 - Version 04
Last revised update : 04/2021
Symbols
Caution
Consult instructions for use
Non sterile
Catalogue number
Batch code
Quantity
QTY
Manufacturer
Date of manufacture
Caution : Federal law restricts this device to sale by or
Rx Only
on the order of a physician
Loading...