• The total weight of a wrapped instrument tray or case should not exceed 11.4kg/25lbs. When
placed in a sterilization container with gasketed lid the total sterilization package should not
• Any device capable of disassembly must be disassembled prior to placement in the case.
• All devices must be arranged to ensure steam penetration to all instrument surfaces.
Instruments should not be stacked or placed in close contact.
• The user must ensure that the instrument case is not tipped or the contents shifted once the
devices are arranged in the case. Silicon mats may be used to keep devices in place.
• Only devices manufactured and/or distributed by Zimmer should be included in Zimmer
instrument trays. Zimmer validated reprocessing instructions are not applicable to Zimmer trays
that include devices that are not manufactured and/or distributed by Zimmer.
• Disinfection is only acceptable as a precursor to full sterilization for reusable surgical
instruments. See Table 6 for recommended minimum sterilization parameters that have been
validated by Zimmer to provide a 10-6 sterility assurance level (SAL).
• The hospital is responsible for in-house procedures for the reassembly, inspection, and
packaging of the instruments after they are thoroughly cleaned in a manner that will ensure
steam sterilant penetration and adequate drying. Provisions for protection of any sharp or
potentially dangerous areas of the instruments should also be recommended by the hospital.
• Moist heat/steam sterilization is the preferred and recommended method for Zimmer
orthopaedic instrument sets.
• Sterilizer manufacturer recommendations should always be followed. When sterilizing multiple
instrument sets in one sterilization cycle, ensure that the manufacturer’s maximum load is not
• Instrument sets should be properly prepared and packaged in trays and/or cases that will allow
steam to penetrate and make direct contract with all surfaces.
• Ethylene oxide or gas plasma sterilization methods should not be used unless package inserts
for the applicable product specifically provide instructions for sterilization using these methods.
• Gravity displacement sterilization cycles are not recommended because cycle times are too long
to be practical.
• Sterile, packaged instruments should be stored in a designated, limited access area that is well
ventilated and provides protection from dust, moisture, insects, vermin, and temperature/
Hospital Responsibilities for Zimmer Loaner Instruments
• Orthopaedic surgical instruments generally have a long service life; however, mishandling or
inadequate protection can quickly diminish their life expectancy. Instruments which no longer
perform properly because of long use, mishandling, or improper care should be returned to
Zimmer to be discarded. Notify your Zimmer representative of any instrument problems.
• Loaner sets should undergo all steps of decontamination, cleaning, disinfection, inspection,
and terminal sterilization before being returned to Zimmer. Documentation of decontamination
should be provided with instruments being returned to Zimmer.
Instrument Care, Cleaning
Table 6. Recommended Steam Sterilization Parameters
In accordance with ISO 17664
• Additional information is available in Zimmer document 97-5000-170-00 R3 which should
be used in conjunction with this Quick Reference Guide.
• This guide pertains to all Zimmer reusable instruments and should be studied carefully.
This manual supercedes Zimmer and Centerpulse instrument manuals published prior to
• This guide includes processing instructions for all Zimmer reusable devices including legacy
Centerpulse instruments marked with processing category codes [a, a+, b, b+, c]. All Zimmer
devices may be safely and efficiently reprocessed using the manual or combination manual/
automated cleaning instructions outlined in this manual.
• The user/processor should comply with local laws and ordinances in countries where
reprocessing requirements are more stringent than those detailed in this manual.
• New and used instruments must be thoroughly processed according to these instructions
prior to use.
Not recommended due to excessively long sterilization cycles which are
Minimum validated steam sterilization time
required to achieve a 10-6 sterility assurance
Minimum validated steam sterilization
temperature required to achieve a 10-6 sterility
assurance level (SAL).
Local or national specifications should
be followed where steam sterilization
requirements are stricter or more conservative
than those listed in this table.
Disinfection/steam sterilization parameters
recommended by the World Health
Organization (WHO) for reprocessing
instruments where there is concern regarding
AAMI/AORN steam sterilization cycles with
longer times than those listed are also
Drying times vary according to load size and
should be increased for larger loads.
For Universal Instrument Cases without
defined load configurations.
Gravity cycle parameters are available on
request from Customer Service.
Warnings & Precautions
Note: The Sterilizer Manufacturer’s instructions for operation and load configuration should be followed explicitly.
• The instructions provided in this Quick Reference Guide have been validated by Zimmer as
being capable of preparing orthopaedic devices for use. It is the responsibility of the Hospital
to ensure that reprocessing is performed using the appropriate equipment and materials,
and that personnel in the reprocessing facility have been adequately trained in order to
achieve the desired result. Equipment and processes should be validated and routinely
monitored. Any deviation by the processor from these instructions should be properly
evaluated for effectiveness to avoid potential adverse consequences.
Customer Service Information
1800 West Center Street
Warsaw, Indiana 46580, USA
Inside USA: 1-800-348-2759
Outside USA: Local International Access Code
CH-8404 Winterthur, Switzerland
+41 (0)52 262 60 70
This Zimmer reprocessing manual and the associated Quick Reference Guide can be found at
www.zimmer.com under the “Medical Professional” heading.
Page 1 of 2
Contact your Zimmer representative or visit us at www.zimmer.com
97-5000-701-00 5ML Printed in USA ©2006 Zimmer, Inc.
• Trays and cases with lids may be wrapped in standard medical grade, steam sterilization
wrap using the AAMI double wrap method or equivalent.
• Trays and cases with lids may also be placed in an approved sterilization container with
gasketed lid for sterilization. Follow the sterilization container manufacturer’s instructions for
inserting and replacing sterilization filters in sterilization containers.
Note: Areas designated for specific devices shall contain only devices specifically intended for
Note: These validated reprocessing instructions are not applicable to Zimmer trays that include
devices that are not manufactured and/or distributed by Zimmer. Instrument trays and cases
without defined, preconfigured layouts or containing undefined universal spaces or
compartments should only be used under the following conditions:
• Universal Precautions should be observed by all hospital personnel that work with
contaminated or potentially contaminated medical devices. Caution should be exercised when
handling devices with sharp points or cutting edges.
• Personal Protective Equipment (PPE) should be worn when handling or working with
contaminated or potentially contaminated materials, devices and equipment. PPE includes
gown, mask, goggles or face shield, gloves and shoe covers.
• Do not place heavy instruments on top of delicate devices.
• Metal brushes or scouring pads must not be used during manual cleaning procedures. These
materials will damage the surface and finish of instruments. Soft-bristled, nylon brushes and
pipe cleaners should be used.
• Do not allow contaminated devices to dry prior to reprocessing. All subsequent cleaning and
sterilization steps are facilitated by not allowing blood, body fluid, bone and tissue debris,
saline, or disinfectants to dry on used devices.
• Saline and cleaning/disinfection agents containing aldehyde, mercury, active chlorine,
chloride, bromine, bromide, iodine or iodide are corrosive and should not be used.
Instruments must not be placed or soaked in Ringers Solution.
• Mineral oil or silicone lubricants should not be used because they: 1) coat microorganisms;
2) prevent direct contact of the surface with steam; and 3) are difficult to remove.
Limitations & Restrictions
• Automated cleaning using a washer/disinfector alone may not be effective for orthopaedic
instruments. A thorough, manual or combination manual/automated cleaning process is
• Neutral pH enzymatic and cleaning agents are recommended and preferred for cleaning Zimmer
reusable devices. Alkaline agents with pH < 12 may be used to clean stainless steel and some
polymer instruments in countries where required by law or local ordinance; or where prion
diseases such as Transmissible Spongiform Encephalopathy (TSE) and Creutzfeldt-Jakob
Disease (CJD) are a concern. It is critical that alkaline cleaning agents be completely and
thoroughly neutralized and rinsed from devices.
Note: Drill bits, reamers, rasps and other cutting devices should be carefully inspected after
processing with alkaline detergents to ensure that cutting edges are fit for use.
• Instruments must be removed from metal or polymer trays for manual and/or automated
cleaning procedures. Instrument trays, cases and lids must be cleaned separately. Non-sterile,
single-use plate and screw implants are an exception to this rule. Plates and screws may
remain in the tray or caddy for reprocessing.
• Repeated processing, according to the instructions in this manual has minimal affect on
Zimmer reusable manual instruments unless otherwise noted. End of life for stainless
steel or other metal surgical instruments is normally determined by wear and damage due
to the intended surgical use and not to reprocessing.
• Use of hard water should be avoided. Softened tap water may be used for initial rinsing.
Purified water should be used for final rinsing to eliminate mineral deposits on
instruments. One or more of the following processes may be used to purify water:
ultra-filter (UF), reverse-osmosis (RO), deionized (DI), or equivalent.
• Ethylene oxide (EO), gas plasma and dry heat sterilization methods are not recommended
for sterilization of Zimmer reusable instruments. Steam (moist heat) is the recommended
sterilization method for Zimmer instruments.
Point of Use
• Remove excess body fluids and tissue from instruments with a disposable, non-shedding
wipe. Place devices in a tray of distilled water or cover with damp towels.
• Instruments should be cleaned within 30 minutes of use to minimize the potential for
drying prior to cleaning.
• Used instruments must be transported to the central supply in closed or covered
containers to prevent unnecessary contamination risk.
Preparation Before Cleaning
• Symbols or specific instructions etched on instruments or instrument trays and cases
should be strictly followed.
• Where applicable, multi-component instruments should be disassembled for appropriate
cleaning. Disassembly, where necessary is generally self-evident. Care should be
exercised to avoid losing small screws and components.
Manual Cleaning/Disinfection Procedure
Inspection, Testing, Maintenance & Lubrication
Note: If stainless steel instruments are stained or corroded, an acidic, anti-corrosion agent
in an ultrasonic cleaner may be sufficient to remove surface deposits. Care must be taken to
thoroughly rinse acid from devices. Acidic, anti-corrosion agents should only be used on an
as needed basis.
Completely submerge instruments in enzyme solution and allow to soak for 20
minutes. Scrub using a soft-bristled, nylon brush until all visible soil has been
Remove the device from the enzyme solution and rinse in tap water for a minimum of 3 minutes. Throughly and aggressively flush lumens, holes and other
difficult to reach areas.
• Carefully inspect each device to ensure that all visible contamination has been removed. If
contamination is noted, repeat the cleaning/disinfection process.
• Check the action of moving parts (e.g. hinges, box-locks, connectors, sliding parts, etc.) to
ensure smooth operation throughout the intended range of motion.
• Check instruments with long slender features (particularly rotating instruments) for
• Where instruments form part of a larger assembly, check that devices assemble readily
with mating components.
• Hinged, rotating, or articulating instruments should be lubricated with a water soluble
product (e.g. Instrument Milk or equivalent lubricant) intended for surgical instruments
that must be sterilized. Some water-based instrument lubricants contain bacteriostatic
agents which are beneficial. Manufacturer’s expiration dates should be adhered to for
both stock and use-dilution concentrations.
Place prepared cleaning agents in a somication unit. Completely submerge
device in cleaning solution and sonicate for 10 minutes at 45-50 kHz.
Processing Category Codes
Rinse instrument in purified water for at least 3 minutes or until there is no sign
of blood or soil on the device or in the rinse stream. Thoroughly and aggressively
flush lumens, holes and other difficult to reach areas.
Repeat the sonication and rinse steps above.
Processing codes listed in Table 5. are etched on some instruments and provide information
useful in the selection of cleaning agents with appropriate pH. Zimmer recommends that all
devices (regardless of etching) are processed in accordance with the manual or combination
manual/automated cleaning instructions contained in this reprocessing guide.
Remove excess moisture from the instrument with a clean, absorbent and
Table 2. Manual Cleaning Steps
Manual Cleaning/Disinfection Procedure
Table 1. Cleaning/Disinfection Options
Manual (Table 2)
Enzymatic soak and scrub followed by sonication.
Enzymatic soak and scrub followed by an
automated washer/disinfector cycle.
Automated cycle – Not recommended
without manual pre-cleaning.
Steel/metal Instruments without cannulated bores/ lumens or non-metal/
polymer handles, or other components. These devices are tolerant of
alkaline cleaning agents when followed by acidic neutralization and
thorough rinsing. These devices may be cleaned with rust-removal agents.
Steel/metal instruments with cannulated bores/lumens but without
non-metal/polymer handles or other components. These devices are
tolerant of alkaline cleaning agents when followed by acidic neutralization
and thorough rinsing. These devices can be cleaned with rust-removal
agents. Cannulations and hollow spaces must be cleaned manually.
Table 3. Combination Manual/Automated Cleaning Steps
Completely submerge the instruments in enzyme solution and allow to soak for
10 minutes. Use a soft nylon-bristled brush to gently scrub the device until all
visible soil has been removed. Particular attention must be given to crevices,
lumens, mated surfaces, connectors and other hard-to-clean areas. Lumens
should be cleaned with a long, narrow, soft nylon-bristled brush.
Remove devices from the enzyme solution and rinse in purified water for a minimum of 1 minute. Thoroughly and aggressively flush lumens, holes and other
difficult to reach areas.
Place instruments in a suitable washer/disinfector basket and
process through a standard washer/disinfector instrument cycle.
Preparation Before Cleaning
• All cleaning agents should be prepared at the use-dilution and temperature recommended
by the manufacturer. Softened tap water may be used to prepare cleaning agents. Use of
recommended temperatures is important for optimal performance of cleaning agents.
Note: Fresh cleaning solutions should be prepared when existing solutions become
grossly contaminated (bloody and/or turbid).
Table 5. Processing Category Codes
Note: Use of a sonicator at 45-50kHz will aid in thorough cleaning of devices.
Note: Use of a syringe or water jet will improve flushing of difficult to reach areas and closely
Automatic Washer/Disinfector Cycle
Table 4. Automated Washer/Disinfector Cycle Steps
Instruments made of polymers or metal instruments paired with polymer
components. These devices are tolerant of alkaline cleaning agents when
followed by acidic neutralization and thorough rinsing.
Instruments with cannulated bores, made of polymers or metal instruments
paired with polymer components. These devices are tolerant of alkaline
cleaning agents when followed by acidic neutralization and thorough
rinsing. Cannulations and hollow spaces must be cleaned manually.
Instruments made of titanium or aluminum alloys and/or having assembly/
disassembly or other reprocessing aids. These devices should be cleaned
using the manual or combination manual/automated cleaning procedures
provided in this manual. These devices should not be exposed to alkaline
Pre Wash; Cold Softened Tap Water; 2 minutes
Enzyme Spray, Hot Softened Tap Water; 20 seconds
Enzyme Soak; 1 minute
Packaging Individual Instruments
Rinse (X2); Cold Softened Tap Water; 15 seconds
Detergent Wash; Hot Softened Tap Water; (64-66°C/146-150°F); 2 minutes
• Commercially available, medical grade steam sterilization pouches or wrap may be used
to package individual instruments. The package should be prepared using the AAMI
double wrap or equivalent method.
Rinse (X2); Hot Softened Tap Water; 15 seconds
Thermal Rinse; Hot Softened Tap Water; (80-93°C/176-200°F); 2 minutes
Purified Water Rinse; (64-66°C/146-150°F), 10 seconds
Hot Air Dry; (116°C/240°F); 7 to 30 minutes
Page 2 of 2
Packaging instrument sets in rigid trays and cases with lids and defined, preconfigured
Safety Precaution: The total weight of a wrapped instrument tray or case should not exceed
11.4kg/25lbs for the safety of the personnel handling instrument sets. When placed in a
sterilization container with gasketed lid, the total package should not exceed 16kg/35lbs.