stryker_leibinger_cleaning__and_sterilization_guide.pdf
Page 1
IMPORTANT INFORMATION: File in your records
Cleaning and Sterilization Guide
Implants, Instruments, Accessories
Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
D-79111 Freiburg
Germany
Phone: ++49 ( 761) 4512 - 0
Fax:
++49 (761) 4512 - 120
Stryker Leibinger Inc.
4100 E. Milham Avenue
Kalamazoo, MI 4900-1-6197
USA
Phone: (800) 962-6558
Fax:
(269) 324-5346
90-00010
12/02 Rev.0
1
Page 2
1. Important Information
Contents
1.
2.
3.
3.1.
3.2.
3.2.1.
3.2.2.
3.2.3.
Important Information
Introduction
Cleaning
Medical Device Cleaning Groups
Cleaning General Notes
Safety Notes
General Caution Notes
Caution Notes for Instruments
with Electronics
3.3.
Cleaning Methods
3.4.
Cleaning Equipment
3.5.
Manual Cleaning Instructions
3.5.1. Manual
3.5.1.1. Manual Cleaning Instructions for
Instruments with Electronics
3.6.
Machine Cleaning Instructions
(Recommended)
4.
Inspection Recommendations
5.
Sterilization Instructions
6.
Appendix 1: Cleaning, Rinsing
and Washing Agents; and
Washing Machine
WARNING - CAUTION – NOTE
2
2
3
3
3
3
3
3
4
4
4
4
5
5
6
6
7
List of Tables
Table 1: Medical Device Cleaning Groups
Table 2: Cleaning Tools
Table 3: Successfully Tested Cleaning
Agents for Manual Cleaning
Table 4: Successfully Tested Washing
Agents for Machine Cleaning
Table 5: Successfully Tested Rinsing
Agents for Machine Cleaning
Table 6: Successfully Tested
Washing Machine
3
4
7
7
7
7
List of Flow Diagrams
Flow diagram 1: Introduction
Flow diagram 2: Manual Cleaning
Flow diagram 3: Automated Cleaning
Please read this manual and follow its instructions carefully. The
words WARNING, CAUTION and NOTE carry special meanings
and should be carefully reviewed.
WARNING:
The personal safety of the patient and user may be involved.
Disregarding this information could result in injury to the patient
and/or user.
CAUTION:
In general, these instructions point out special service procedures or
precautions that must be followed to avoid damaging the instrument.
In addition, cleaning instruction steps related to a particular group are
specified in a caution note.
NOTE:
This provides special information to make maintenance easier or
important instructions clearer.
An exclamation point within a triangle displayed on the product is
intended to alert the user to the presence of important operating
and maintenance instructions in this manual.
2. Introduction
This booklet provides detailed cleaning instructions and general
sterilization recommendations of the Stryker Leibinger Implants,
Instruments and Accessories. For Navigation Systems and
components refer to Cleaning and Sterilization Guide Ref. No. 6000005-750. General information about the maintenance and care are
also included.
This Cleaning and Sterilization Guide is intended to be used with the
Instructions For Use supplied with the devices. These Instructions
provide specific information for maintenance and care as well as
disassembling instructions if necessary. In addition, refer to the
Instructions For Use for technical specifications or special cleaning/
sterilization recommendations related to the product/system.
Keep all instructions where they are easily accessible for the persons
handling the product.
If you have any question or need help during a procedure, contact
your Stryker Leibinger Sales Representative
or Customer Service at +1-800-962-6558. Outside the U.S.A.,
contact the nearest Stryker subsidiary or
Customer Support at +49-761-4512-0.
Medical Device Cleaning Group Definition
See chapter 3.1 in this manual for general information
See Instructions For Use for instrument classification
2
4
5
Cleaning Safety / Caution Notes
See chapter 3.2 in this manual for general information
See Instructions For Use for special notes and recommendations
related to the device
List of Acronyms
AAMI:
CSR:
HF:
TC:
Association for the Advancement of Medical
Instrumentation
Central Sterilization Room
High Frequency
Temperature Controlled
Disassembling Instructions
Contained in the Instructions For Use if needed
Cleaning Instructions
See Instructions For Use for material specification and recommendation
of the cleaning method to be used (manual/automated)
See cleaning equipment (3.4) and detailed instructions (3.5) in this
manual
List of Terms and Definitions
Flow Diagram 1: Introduction
Device: Implant, Instrument, container or accessories
Treat: Clean and sterilize
2
Inspection Recommendations
See chapter 4 in this manual
Maintenance Recommendations
Contained in the Instructions For Use if needed
Sterilization Instructions
Unless otherwise specified in the Instructions For Use, follow the
instructions in this manual (5)
Page 3
3. Cleaning
3.1. Medical Device Cleaning Groups
For proper handling during cleaning, reusable Stryker Leibinger
devices are classified into six groups. Some instruments may belong
to more than one group. In this case, the cleaning method should be
the most aggressive or combine the instructions outlined for each
corresponding group. If an instrument is not included in the list below
and you are in doubt about the cleaning group it belongs to, refer
to the Instructions For Use supplied with the instrument. Contact
Stryker Leibinger Customer Service for clarification purposes. See
contact information below.*
Group
I
Description
Representative Product Samples
II
(Bone) Cutting
devices that cut, pierce or
scrape
Instruments/Accessories:
countersinks, drill bits, taps, osteotomes,
bone elevators, curettes, spoons,
dissectors, knives, scissors, raspatories,
rasps, needles, awls, ear loops,
perforators, chisels, scalpels, gouges,
pluggers, saw blades, burrs, cutters,
separators, cutting cylinders osseous
microtome, trephines, trocars, plate
deburrers,etc.
Implants:
one-piece screws, one-piece fixation
pins, etc.
III
Cannulated
cannulated devices (with
cannula or features whose
diameter is less,
than or equal to 1/6 of the
device‘s length)
Instruments/Accessories:
drill/pin guides and sleeves, trocars,
speculae, ear syringes, cannular gauges,
cannulae, fixation sleeve, insertion tool,
suction tubes, guiding tubes, catheters,
tubes, suction dissectors, etc.
Implants:
cannulated screws, cannulated fixation
pins, etc.
Articulated and MultiComponent
articulated devices and
those consisting of at least
two pieces (with moving or
detachable parts)
Instruments/Accessories:
articulated bone forceps, articulated tissue
forceps, roller benders, clamps, multicomponent retractors, biopsy probes,
screwdriver handle, haematom evacuators,
needleholder, suture forceps, drill
handle, multi-component hooks, probes,
multi-component tongue depressors,
multi-component mirrors, coagulation
instruments, measuring instruments, depth
measuring gauges, fascia applicators,
razor blade holders, rongeurs, ear snare,
bone punches, spreaders, osseous
microtome, multi-component or articulated
wiring instruments, hand traction system,
lag screw target bow, etc.
Implants:
bone distractors, multi-component screws,
multi-component plates, etc.
Instruments/Accessories:
electrodes (TC string electrodes, TC
straight, electrodes, TC needle electrodes,
TC electrodes), and connecting cables, IM
reamers, fiber optic cables, etc.
Implants:
distraction rods, etc.
implant modules, sterilization trays, screw
holders, sterilization containers, instrument
trays, etc.
IV
Basic
one-piece devices(with
no moving or detachable
part),
devices that do not cut,
scrape or pierce bone,
non-cannulated, nonarticulated devices
V
Flexible
devices with flexible shaft,
cables
VI
Storage/Sterilization
Boxes, Trays
instrument containers
Instruments/Accessories:
one-piece screwdrivers, spatulae, femoral
clamps, screwdriver blades, one-piece
cheek retractors, fixation plates, nonarticulated forceps, one-piece hooks,
probes, one-piece tongue depressors,
mirrors, suture pushers, tissue picks,
rulers, ligature guides, retractor blades,
mallets, guide wires, forks, cotton
applicators, ear loops, one-piece mouth
gags, one-piece mouth openers, mouth
props, scalpel handles, strippers, onepiece wiring instruments, arch bars, etc.
Implants:
one-piece plates, etc.
Table 1: Medical Device Cleaning Groups
*For further information, contact your Stryker Leibinger Sales
Representative or Customer Service at +1-800-962-6558. Outside
the U.S.A., contact the nearest Stryker subsidiary or Customer
Support at +49-761-4512-0.
3.2. Cleaning General Notes*
3.2.1. Safety Notes
Read carefully the following notes prior to cleaning.
WARNINGS
Clean devices before first and every use and before returning them
to service.
After cleaning, sterilize as directed prior to use.
•
Only trained personnel should treat devices as instructed in
this manual.
•
Handle sharp-edged and pointed instruments with care
•
Do not place contaminated devices in containers.
•
Use protective garments as recommended in the
instructions supplied with the cleaning agent.
•
Whenever possible, disassemble the device and/or loosen all
connections prior to treatment. Open hinged/jointed devices as
recommended. Refer to the Instructions For Use supplied with
the device.
•
Ensure the devices are completely immersed in the cleaning
solution.
•
To avoid higher risk of corrosion and contamination, treat
devices immediately after use.
•
To avoid contamination and to prevent debris from drying out,
transport devices to the cleaning area, covered with a damp
cloth or closed in a heat-sealed bag.
•
For proper cleaning, use preferably a protease-based cleaning
agent. Refer to Appendix 1.
•
Depending on the conditions of use, replace the cleaning
solution daily or more frequently. Dirt accumulation and
increased concentration due to evaporation may compromise
cleaning effectiveness and risk of corrosion.
•
For proper loading of the washing machine, follow the
instructions contained in this manual and the manufacturer’s
recommendations. Avoid overloading to ensure that all
surfaces are reached by the cleaning solution.
•
Strictly follow the dosage, temperature, exposure time,
material compatibility specifications and, after use, disposal
restrictions of the cleaning agent as recommended by the
manufacturer.
•
If medical compressed air is used, a sterile filter must be
available.
3.2.2. General Caution Notes
CAUTION
•
•
•
•
To avoid product damage (pitting, rust, degradation), DO NOT
use highly aggressive agents (NaOH, NaOCL), salt solutions
and other unsuitable cleaning agents.
To avoid surface discoloration or stains, dissolve powders
completely if used as cleaning agents.
Use suitable cleaning tools as instructed in this anual. Never
use metal brushes or metal sponges for debris removal.
Rinse thoroughly and carefully. If agents lacking a foam
inhibitor are used, take care to remove foam during rinsing.
Sterile demineralized water facilitates water spots removal
from the surface.
3.2.3. Caution Notes for Instruments
with Electronics
CAUTION
•
•
•
•
•
DO NOT immerse instruments/cables. If water runs into the
battery holder or enters the housing, the electronics can fail
and the communication with the system will cease.
To avoid malfunction of the instrument, DO NOT scratch or
damage the Light Emitting Diodes (LEDs) or the transceiver
cover. Check them for proper functioning after cleaning. See
Instructions For Use supplied with the device.
DO NOT use solvents, lubricants, or other chemicals unless
otherwise specified.
DO NOT use aggressive or scouring agents, or other
chemicals.
Use a neutral enzymatic cleaner.
*For further information, contact your Stryker Leibinger Sales
Representative or Customer Service at +1-800-962-6558. Outside
the U.S.A., contact the nearest Stryker subsidiary or Customer
Support at +49-761-4512-0
3
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3.3. Cleaning Methods
3.5. Manual Cleaning Instructions for Groups I-VI
Both manual and machine cleaning methods can be used. Whenever
possible, the washing machine should be used to avoid prolonged
contact with contaminated devices and the cleaning agents.
Prepare Cleaning Water Solution
At 40°C (104°F), homogenise the solution
3.4. Cleaning Equipment
Prepare for Soaking
Disassemble removable parts, loosen connections
Manual Cleaning (and Pre-cleaning Stage Prior to Machine
Cleaning)
Protective Garments:
• Single use shirt
• Single use gloves
• Safety glasses
• Anti-splash mask (see recommendations supplied with cleaner)
Soak in Bath
Completely for 15 min
Clean with Proper Tool
See table 2
Material Equipment:
• Sterile purified water
• Running water
• Appropriate cleaning agent (Appendix 1)
• Soaking pans (preferably stainless steel):
Vol. 500 ml at 25 l capacity
• Ultrasound bath with adjustable temperature and stainless steel
basket (Frequency: 25-50 kHz, min. Power: 238 W), large
enough for complete immersion of all devices intended to be
cleaned
• Sterile syringe (approx. Vol. 50 ml)
• Single use drying paper
• Medical compressed air
• Thermometer
• Suitable cleaning tool as follows:
Group
I
Cleaning Tool
Supple (soft) polishing brush
II
Hard (nylon) bristle brush
III
Flexible bottle brush
IV
Syringe for solution injection into
hard-to- reach parts
V
Brush with fine stiff bristles
VI.
Supple polishing brush
Rinse in Running Water
For II, IV, V apply rinsing solution to hard-to-reach parts with syringe
Drain
For Instruments
without Electronics
Soak in Ultrasound Bath
Completely for 15 min.
at 40°C (104°F)
Note
Drain
Dry
For III, IV, V with medical
compressed air
Choose appropriate size. Scrub
flexible parts.
Choose appropriate size. Pay
attention to
and bottle brush holes and slots.
Flow Diagram 2: Manual Cleaning
Table 2: Cleaning Tools
Sterile purified water
Running water
Cleaning/washing agent (Appendix 1)
Rinsing product (Appendix 1)
Washing machine compliant with EN ISO 15883 (Appendix 1)
Dry
With medical compressed air if
necessary
Rinse in Sterile Running
Water
Completely at 20°-30°C
(68 - 86°F)
Diameter and length depending
on device
Choose appropriate diameter.
Carefully clean cutting
areas.
Choose appropriate diameter.
Scrub the inside of
the cannulae repeatedly.
Use only sterile tools and syringe.
Take care to clean articulated
parts.
Machine Cleaning
Material Equipment:
For Containers
Inspect
Macroscopically for visible soil
Repeat procedure if required
Sterilize
3.5.1. Manual
CAUTION
For Group VI, follow only steps 1 through 6 and step 12.
For instruments with electronics refer to section
3.5.1.1 Manual Cleaning Instructions for Instruments
Electronics.
1.
1.1.
1.2
2.
2.1.
2.2
2.3
3.
with
Prepare Cleaning Water Solution
Dilute the cleaning agent at minimum 40°C (104°F). Read
the instructions supplied with the agent carefully.
Stir the mixture to homogenise the solution.
Prepare Device for Soaking
Handle the devices with care. Do not let them collide
during transport to the soaking area.
Whenever possible, disassemble the device (for the
removable parts) and/or loosen connections.See
Instructions For Use supplied with the device.
Remove heavy or large debris using single use absorbent
paper wipes soaked in appropriate cleaning solution.
Soak Device
CAUTION
Soak immediately after use. To avoid risk of corrosion, DO NOT
exceed 15 minute soaking time.
3.1
4
Whenever possible, operate articulated parts and bend
Page 5
3.2
flexible elements. Using a syringe, aspirate and squirt the
solution several times into hard-to-reach
areas (cannulae, grooves, holes, joints, flexible parts).
Immerse the device in the solution completely for 15
minutes. If articulated or flexible devices are soaked, operate
articulated parts and bend flexible elements.
4. Clean Device
4.1.
Remove any debris using the suitable cleaning tool (see
table 2). Pay attention to reach all areas.
them as required.
10.2.
If debris is still visible on the surface, repeat steps 7
through 10.
11.
11.1.
Drain Instrument
Allow to drain on single use blotting paper.
12.
12.1.
Dry Instrument/Container
Dry the instruments and containers with single use blotting
paper and/or medical compressed air.
Note
The cleaning bath has 24-hour effectiveness. For very dirty devices,
replace it several times.
CAUTION
5.
5.1.
Rinse Device
Rinse thoroughly the device in running water until it is no
longer slippery to the touch.
For Group II, IV, V, use a syringe to apply rinsing solution under
pressure to hard-to-reach areas (for example cannulae, bending /
moving parts) while operating/bending them.
5.2.
Inspect the device for remaining debris, in particular
hard-to-reach areas. Repeat steps 3 and 4 for residual
debris removal if necessary.
6.
6.1.
6.2.
Drain Device
Allow to drain on single use blotting paper.
For instruments, proceed to ultrasound cleaning bath.
During transport, handle instruments with care. Cover them
with a pan or close them in a heat-sealed bag to prevent
contamination.
7.
Prepare Ultrasound Bath for Instruments
Note
The bath has 24-hour effectiveness. Prior to reusing the bath,
inspect it for debris and impurity. When the bath is replaced, it must
be ultrasonically degassed for 5 minutes.
7.1.
7.2.
8.
8.1.
9.
Dilute the cleaning agent in the ultrasound bath as
required at minimum 40°C (104°F).
Stir the mixture to homogenise the solution.
Prepare Instrument for Ultrasound Bath
Handle instruments with care. Do not let them collide.
Avoid mixing instruments of different materials and
conditions (operational instruments with damaged
ones).
Immerse Instrument in Ultrasound Bath for Cleaning
WARNING
Ensure the ultrasound bath temperature is at 40°C (104°F). Failure
to comply compromises cleaning effectiveness.
CAUTION
For Groups III, IV, V, always use medical compressed air to ensure
proper treatment of hard-to-reach parts (for example interiors of
cannulae).
12.2.
After inspection (follow inspection recommendations),
repeat the pre-cleaning stage and the washing cycle if
needed.
3.5.1. 1. Manual Cleaning Instructions For
Instruments with Electronics
1.
2.
Remove and discard the battery. Check with your local
environmental protection agency for special disposal
restrictions for lithium batteries.
Using a mild detergent that contains NO abrasive
materials, remove debris, paying special attention to
the LEDs and transceiver unit.
Note
For instruments with cannular features (suction tubes, etc), apply
the cleaning solution under pressure to the cannula using a syringe.
3.
4.
5.
6.
Using a damp cloth, wipe away detergent. For pointed
and flexible/long-shaft instruments (for example
pointers, feelers, seekers, electrodes), rinse in addition
the long tip and shaft thoroughly with running water.
Brush validation disks using a soft bristle brush needed.
Be very careful not to damage the electrical contacts
when cleaning with a cloth or a towel.
Using a lint-free towel, dry the instrument.
3.6. Machine Cleaning Instructions (Recommended)
For devices without electronics
grouped into III,IV,V
For devices without electronics
grouped into I,II
Prepare Cleaning Water
Solution
At 40°C (104°F) homogenise
the solution
Prepare for Soaking
Disassemble removable parts,
loosen connections
CAUTION
For Groups III, IV, V, operate articulated parts and bend flexible
elements. Using a syringe, aspirate and squirt the solution several
times into hard-to-reach areas (cannulae, grooves, holes, joints,
flexible parts).
9.1.
9.2.
10.
10.1.
Ensure that the instruments in the bath are completely
submerged for 15 minutes and do not overlap.
After 15-minute immersion, brush the instrument
vigourously to remove debris from the surface completely.
Use proper cleaning tool. See table 2.
Soak in Bath
Completely for 15 minutes
Clean with Proper Tool
See table 2
Rinse with running water
Until no longer slippery to the
touch
Rinse after Ultrasound Bath
Rinse thoroughly with sterile purified running water at
20° - 30°C (68-86°F).
CAUTION
Load Instrument / Container
Do not overload
Load Washing and Rinsing
Agent
Flow Diagram 3: Automated Cleaning
Start Washing Cycle
For Groups III, IV, V, use a syringe to apply rinsing solution under
pressure to hard-to-reach parts when bending or operating
5
Page 6
4. Inspection Recommendations
CAUTION
•
To avoid product damage, DO NOT use machine cleaning
method for instruments with Electronics.
WARNING:
Perform pre-cleaning stage (step 1) for Groups III, IV, V.
1.
1.1.
1.2.
1.3.
1.4.
Pre-cleaning Stage
Whenever possible, disassemble devices (for the
removable parts), open joints and/or loosen
connections.
Dilute the cleaning agent in the ultrasound
bath as required at 40 °C (104°F). Read the instructions
supplied with the agent carefully.
Stir the mixture to homogenise the solution.
Place instruments in the ultrasound bath with diluted
solution.
Take care to immerse the device completely for 15
minutes.
CAUTION
Soak immediately after use. To avoid risk of corrosion, DO NOT
exceed 15 minute soaking time.
1.5.
Use suitable cleaning tool (see table 2). Whenever possible,
use a syringe to apply the cleaning solution under pressure to
hard-to-reach parts (cannulae, joints, slots) while operating
articulated parts and bending flexible elements.
Note
The cleaning bath has 24-hour effectiveness. For very dirty
instruments, replace it several times.
1.6.
Rinse thoroughly with running water.
2.
2.1.
Load Devices for Cleaning
Place devices so that they do not collide during
operation.
Place heavy items at the bottom and hollow objects in the
washing machine baskets.
Ensure that no part is obstructed by large objects
(plates, cups).
Place articulated instruments in fully open position and
cannulated instruments in horizontal position.
Place disassembled instruments in the washing
machine baskets.
2.2.
2.3.
2.4.
2.5.
WARNING
CAUTION
Inspect Device Prior to Sterilization.
Before preparing for sterilization all medical devices should be
inspected. Generally un-magnified visual inspection under good
light conditions is sufficient. All parts of the devices should be
checked for visible soil and/or corrosion. Particular attention should
be paid to:
•
•
•
•
•
Functional checks should be performed where possible:
•
mating devices should be checked for proper assembly (see
appropriate assembly/disassembly instructions on page 3)
•
medical devices with moving parts should be operated to check
correct operation (medical grade, silicone-free and non-mineral
oil based lubricant suitable for steam sterilisation can be applied
as required)
•
rotating devices (e.g. drill bits, reamers) should be checked for
straightness (this can be simply achieved by rolling the device
on a flat surface), sharpness and damages
•
„flexible” devices (e.g. distraction rods) should be checked for
damage to the spiral element.
CAUTION
Remove and repair damaged instruments/containers.
CAUTION
Stryker Leibinger does not define the maximum number of uses
appropriate for re-usable medical devices. The useful life of these
devices is dependent on many factors including the method and
duration of each use, and the handling between uses. Careful
inspection and functional testing of the device before use is the best
method of determining the end of serviceable life for the medical
device.
5. Sterilization Instructions
Avoid overloading. Failure to comply compromises cleaning
effectiveness.
3.
3.1.
4.
4.1.
4.1.1.
4.1.2.
4.1.3.
4.1.4.
4.2.
4.3.
4.4.
4.5.
6
Load Washing and Rinsing Agents
Put the required quantity of washing and rinsing
agents into the washing machine as instructed by the
manufacturer.
Washing Machine and Drying Cycle
Operate the washing machine cycle including
(4.1.3. not required for aluminum):
Washing phase with increasing temperature up to 93°C98°C (200-208°F).
Thermal cleaning phase at 93°C-98°C (200-208°F) for 10
minutes (without addition of any particular agent).
Neutralisation phase after adding a neutralisation agent if
necessary (some agents do not require a neutraliser).
Successive rinsing phases with demineralised water.
At the end of the cleaning cycle, remove the basket
from the washing machine.
If the washing process does not include a drying cycle,
allow the devices to dry after the cleaning cycle in an
oven at a temperature below 110°C (230°F).
For cannulated, flexible and articulated
instruments, dry in addition with medical compressed
air if necessary (depending on the washing machine).
After inspection (follow inspection recommendations), repeat
the pre-cleaning stage and the washing cycle if needed.
soil „traps” such as mating surfaces, hinges, shafts of flexible
devices, e.g. distraction rods
recessed features (holes, cannulations)
features where soil may be pressed into contact with the
device, e.g. drillflutes adjacent to the cutting tip, sides of teeth
on broaches and rasps
cutting edges should be checked for sharpness and damage
for devices that may be impacted check that the device is not
damaged to the extent that it malfunctions or that burrs have
been produced that could damage tissues or surgical gloves.
CAUTION
Ensure the sterilization procedure for individual devices and systems
complies with accepted standard requirements.
1.
1.1.
1.2.
2.
•
•
Preparation
Whenever possible, disassemble instruments
(with removable parts), open joints/hinges/locks and/or
loosen connections.
If heavy loads can not be avoided, place the
instruments in different trays/cases to facilitate
penetration of the agent transferring heat (steam). In
addition, special care should be taken on completion to
inspect the instruments for dryness prior to storage.
Operation
Pre-vacuum cycles are recommended. Pre-vacuum cycles
can also be referred to as „forced air removal“.
Cycle C is not recommended for instrument cases with
multiple cases within them.
CAUTION
Sterilization exposure time at 134°-137°C can be extended to
18 minutes. As prolonged exposure time may affect product life,
carefully inspect the device for visible damage and malfunction after
treatment.
Page 7
Perform sterilization according to the following parameters
unless otherwise specified in the Instructions for Use of the
individual product or system.
Pre-vacuum Autoclave Cycles - Cycle A
• Pre-vacuumed sterilizer
• 132°C-137°C (270°F-279°F) - 45 psi (3 bar)
• Double wrapped (AAMI CSR technique)
• 15-minute minimum exposure time
• 5-minute minimum drying time
Cycle B
• Pre-vacuumed sterilizer
• 132°C-137°C (270°F-279°F) - 45 psi (3 bar)
• Double wrapped (AAMI CSR technique)
• 15-minute minimum pre-heating time
• 10-minute minimum exposure time
• 5-minute minimum drying time
Gravity Displacement Cycles - Cycle C
• Gravity displacement sterilizer
• 121°C-123°C (250° F-252°F) - 35 psi (2.4 bar)
• Double wrapped (AAMI CSR technique)
• 15-minute minimum pre-heating time
• 40-minute minimum exposure time
Cycle D
• Gravity Displacement sterilizer
• 132°C-137°C (270°F-279°F) - 45 psi (3 bar)
• Double wrapped (AAMI CSR technique)
• 15-minute minimum pre-heating time
• 20-minute minimum exposure time
6. Appendix 1: Cleaning, Rinsing and Washing
Agents; and Washing Machine
For soaking and manual cleaning, enzymatic agents with both
bacteriocidal and fungicidal properties are recommended.
For machine cleaning, use only agents recommended by the
machine‘s manufacturer.
For aluminum surfaces, a neutral-pH agent should be used. To
prevent corrosion, avoid contact with strong alkaline solutions (pH
over 10.5) or agents containing iodine or chlorine.
The agents and washing machines listed below have been used
during validation of the processing instructions contained in this
manual. We do not recommend them in preference to others which
may be equally suitable.
CAUTION
To avoid product damage, ensure aluminum surfaces are treated
using suitable agents (see tables 3, 4, 5).
See material specifications contained in the Instructions
For Use supplied with the device
.
CAUTION
Ensure the washing machine is compliant with EN ISO 15883 (see
table 6).
7
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Stryker Leibinger GmbH & Co. KG
Bötzinger Straße 41
D-79111 Freiburg
Germany
Phone: ++49 ( 761) 4512 - 0
Fax:
++49 (761) 4512 - 120
8
Stryker Leibinger Inc.
4100 E. Milham Avenue
Kalamazoo, MI 4900-1-6197
USA
Phone: (800) 962-6558
Fax:
(269) 324-5346