Stryker LEIBINGER Cleaning and Sterilization Guide Implants , Instruments , Accessories

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

Page 4

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

Page 8

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