Revision Rev B

Page 1

Handpieces

& Attachments

Cleaning

System 7

System 6

System 5

User/Patient Safety

WARNINGS

• Only individuals trained and experienced in the processing of reusable medical devices should process this equipment.

• Before processing any equipment, read and understand the instructions. Pay particular attention to WARNING

information. Become familiar with the equipment prior to processing.

• DO NOT reuse, reprocess, or re-package single use cutting accessories. All cutting accessories are intended

for a single use only. Reuse may create a serious risk of contamination and lead to infection or cross-infection.

Reprocessing may compromise the structural integrity of the cutting accessory and result in fragmentation

during use. Critical product information may be lost if the cutting accessory is re-packaged.

Accessories

WARNING Use only Stryker-approved system components and accessories, unless otherwise specified.

DO NOT modify any system component or accessory.

NOTE For a complete list of accessories, contact your Stryker sales representative.

Processing Instructions

Processing equipment, operators, detergents, and procedures all contribute to the efficacy of medical device

processing. The health-care facility should make sure that the combination used results in a medical device that is

safe for use. Alternative methods of processing may be equally suitable.

1.0 Point of Use

CAUTION DO NOT use saline to wet or soak the equipment before transport to the decontamination processing area

NOTE If transport to the decontamination processing area is delayed, cover the equipment with a damp cloth or

spray the equipment with a pre-cleaning foam. The pre-cleaning foam will minimise the drying of soil and facilitate

later decontamination processing.

1. Separate reusable equipment from disposable waste.

2. Discard waste into an appropriate container; use a puncture-resistant container for sharps.

3. Remove gross soil from the equipment using absorbent wipes.

2.0 Transport to Decontamination Processing Area

WARNING During transport, pay particular attention to sharp, cutting edges to avoid injury.

CAUTION Avoid mechanical damage during transport. DO NOT mix heavy devices with delicate devices.

NOTE Clean the equipment as soon as practical, typically within two hours, to preclude extended or repeat

cleaning procedures.

3.0 Preparation for Cleaning

3.1 Detergents

WARNINGS

• Read, understand, and follow the indications, instructions, and WARNING information supplied with the detergent

for correct handling and use of the product. Pay particular attention to the concentration used and the total

dispersion of the detergent. Prepare the detergent solution according to the manufacturer’s recommendations.

• ALWAYS provide personal protective equipment (PPE) for processing personnel according to the instructions and

material safety data sheets (MSDS) supplied with the detergent.

• To clean the equipment, use specifically formulated detergents only.

CAUTIONS

• To clean the equipment, a mild alkaline agent (neutral up to pH 10.5) is preferred. If a washer-disinfector is used,

see the instructions supplied with the washer-disinfector machine to select the recommended detergent.

• ALWAYS use a detergent that is suitable for use on aluminum surfaces if aluminum surfaces are present.

NOTES

• The table entitled Validated Detergents lists the detergents used by Stryker during the validation of

the manual and automated (washer-disinfector) cleaning processes described in these instructions.

CD4

C

A

B

CAUTIONS

• DO NOT allow attachments to remain continuously under running water throughout the cleaning.

• DO NOT orient any attachment vertically under running water.

6. Rinse the equipment:

6.1 For attachments only, hold the attachment on an incline,

distal end pointing up, and rinse the lumen under warm

running water. For dead-ended lumens, once the water comes

back out of the attachment, immediately point the distal end

of the attachment down to allow the water to drain out.

Repeat this step one or two more times until the water

draining from the attachment is clear.

6.2 For all other equipment, hold the equipment on an incline, distal

end pointing down, and rinse the equipment in warm running

water until all traces of detergent solution are removed.

Pay particular attention to rough surfaces, lumens, hinges, blind

holes, and joints between mating parts. Actuate all moving

parts to remove any remaining detergent solution.

NOTE A final rinse of the equipment using deionised or filtered water is recommended.

7. Visually inspect the equipment for any remaining soil or detergent solution. If soil or detergent solution

remains, repeat the cleaning and rinsing procedure using fresh detergent solution.

8. Allow the equipment to drain on absorbent wipes.

9. Dry the equipment with a soft, lint-free cloth or medical-grade compressed air.

10. After cleaning, inspect and test the equipment immediately. See 5.0 Inspection and Testing.

SABO 2

SABO

RemB

CORE

TPS

• Stryker does not recommend these detergents in preference to other products. Other products may

perform equally well or better. However, alternative detergents must be verified by referencing the information

provided by the product supplier and/or physical testing.

Validated Detergents

Supplier

Designation

Suitability

Process

Stryker

ProClean Instrument Detergent

All materials

Manual Cleaning

Steris

Prolystica 2x Concentrate Enzymatic and

Prolystica 2x Concentrate Neutral

Stainless steel, aluminum,

soft metals, and plastics

Automated Cleaning

3.2 Water Quality

WARNING Use filtered water for diluting detergents and for rinsing the equipment. Mineral residues from hard

water can stain the equipment and/or prevent effective cleaning and decontamination.

CAUTION Poor water quality can adversely affect the life of medical devices. ALWAYS follow the water quality

requirements per AAMI TIR 34.

4.0 Cleaning

WARNINGS

• Clean the equipment, as indicated, before first and every use.

• Prior to cleaning, remove all detachable components and single use cutting accessories from the handpieces.

Detachable components include cords, handswitches, bur guards, shields, irrigation clips, attachments, and

battery packs.

• Use the cleaning methods as indicated in these instructions or the instructions for use and/or care instructions manual

supplied with the equipment. Using other cleaning methods may prevent proper sterilisation of the equipment.

• Brushes should not be visibly larger or smaller than the diameter of the lumen to be cleaned. Incorrectly sized brushes will

not clean all surfaces.

• Use PPE at all times during cleaning.

CAUTIONS

• These cleaning instructions are not appropriate for Stryker battery packs.

• DO NOT immerse or soak any equipment in liquid. DO NOT allow moisture or liquid to soak into electrical plugs,

receptacles or openings. Moisture or liquid may enter the equipment, cause corrosion, and damage the electrical

and/or mechanical components.

• DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified.

• DO NOT use ultrasonic cleaning equipment.

• Before cleaning and/or sterilising a handswitch, ALWAYS set the safety switch between the RUN and SAFE positions.

• ALWAYS use a non-abrasive, soft, flexible, nylon-bristle brush in the lumen or nose of an Elite or Saber SD Series

attachment or an Impaction Drill Bur Guard. ALWAYS use light pressure and DO NOT force the brush any farther

after you feel resistance.

• When cleaning a Bur Guard, DO NOT force a brush or cleaning tool through the bur insert hole.

• DO NOT bend connector pins during cleaning.

• DO NOT use pipe cleaners or cotton swabs to clean lumens.

• ALWAYS make sure the detergent solution is completely rinsed off before drying equipment.

• Use of compressed air is only recommended for drying of equipment.

NOTES

• Equipment may be placed under running water and/or dipped into liquid to ensure thorough wetting and

contact with liquid while actuating moving parts.

• Two methods of cleaning are described: a manual cleaning method and an automated cleaning method.

Removal of all gross soil is required for both cleaning methods.

4.1 Manual Cleaning

4.1.1 Recommended Equipment

• Non-abrasive, soft, flexible nylon-bristle brushes

• Syringe

• PPE as recommended by the detergent supplier (minimum: overalls, gloves, face/eye shield)

• Absorbent wipes

• Soft, lint-free cloth

• Warm water with an optimum temperature range of 27 to 44°C (80 to 110°F). The water should not exceed 60°C

(140°F) and should be warm to the touch.

• Medical-grade compressed air <140 kPa (< 20 psi)

4.1.2 Instructions

1. Remove all gross soil from the equipment using absorbent wipes or a soft, lint-free cloth moistened

with the prepared detergent solution.

2. Make sure all surfaces of the equipment are thoroughly wetted using warm water.

3. Using suitable brushes, clean the equipment thoroughly. Pay particular attention to rough surfaces, crevices, and

difficult to reach areas where soil may be shielded from brushing such as details around a trigger or connector.

Flush difficult to reach areas with a syringe filled with the detergent solution.

4. Use soft brushes of appropriate diameters to clean lumens. If a lumen passes all the way through a device, make

sure that the brush cleans the whole length of the lumen. For dead-ended lumens, use light pressure and do not

force the brush any farther after you feel resistance.

5. Actuate all moving parts of the equipment to clean hidden surfaces.

NOTES

A. When removing debris from a handswitch, completely extend the finger rest to access all surfaces.

B. When removing debris from a sagittal saw handpiece or sagittal saw attachment, pull out the blade mount, and

depress the button to open the blade mount, to access all surfaces.

C. When removing debris from an oscillating saw handpiece, actuate the blade mount collar to access all surfaces.

CD3

4.2 Automated Cleaning

4.2.1 Recommended Equipment

• Non-abrasive, soft, flexible, nylon-bristle brushes

• PPE as recommended by the detergent supplier (minimum: overalls, gloves, face/eye shield)

• Absorbent wipes

• Soft, lint-free cloth

• Washer-disinfector

• Detergents and rinsing agents as required by the washer-disinfector

• Warm water with an optimum temperature range of 27 to 44°C (80 to 110°F). The water should not exceed 60°C

(140°F) and should be warm to the touch.

• Medical-grade compressed air <140 kPa (<20 psi)

Instructions

1. Remove all gross soil from the equipment using absorbent wipes or a soft, lint-free cloth moistened with

prepared detergent solution.

2. Make sure all surfaces of the equipment are thoroughly wetted using warm water.

3. Using suitable brushes, clean the equipment thoroughly. Pay particular attention to rough surfaces, crevices, and

difficult-to-reach areas where soil may be shielded from brushing, such as details around a trigger or connector.

Flush difficult-to-reach areas with a syringe filled with the detergent solution.

4. Use soft brushes of appropriate diameters to clean lumens. If a lumen passes all the way through a device, make

sure the brush cleans the whole length of the lumen. For dead-ended lumens, use light pressure and do not force

the brush any farther after you feel resistance.

5. Actuate all moving parts of the equipment to clean hidden surfaces.

6. Rinse the equipment:

6.1 For attachment only, hold the attachment on an incline, distal end pointing up, and rinse the lumen under

warm running water. For dead-ended lumens, once the water comes back out of the attachment, immediately

point the distal end of the attachment down to allow the water to drain out. Repeat this step one or two more

times until the water draining from the attachment is clear.

6.2 For all other equipment, hold the equipment on an incline, distal end pointing down, and rinse the equipment

in warm running water until all traces of detergent solution are removed. Pay particular attention to rough

surfaces, lumens, hinges, blind holes, and joints between mating parts. Actuate all moving parts to remove any

remaining detergent solution.

NOTE A final rinse of the equipment using deionised or filtered water is recommended.

7. Visually inspect the equipment for any remaining soil and

repeat the cleaning steps if necessary.

8. Allow the equipment to drain on absorbent wipes or load the

equipment into the washer-disinfector immediately.

NOTE The equipment illustrated is representational only and may

not reflect the actual equipment configuration.

WARNINGS

• ALWAYS load the equipment carefully to prevent movement that may inhibit proper cleaning during the

automated washer-disinfector cycle.

• DO NOT use sterilisation trays to hold equipment in the washer-disinfector. Sterilisation trays are for use with the

sterilisation process only and must be washed separately.

NOTE A System 6 or System 7 insert tray, when removed from the sterilisation tray, may be used to hold System 6 or

System 7 equipment in place during automated cleaning in a washer-disinfector. See the instructions for use supplied

with the sterilisation tray.

9. Load the equipment into the washer-disinfector in a wire basket. Always avoid contact between multiple components.

If possible, orient the equipment vertically to assist in drainage. Place any moving parts, such as chuck jaws, in

the open position. Placing the equipment in a horizontal position is also acceptable.

CAUTION DO NOT use any type of lubricant in the automated washer-disinfector. Use of additional lubrication is not

required and may leave residue on the equipment after cleaning.

10. Operate the washer-disinfector. The table entitled Validated Automated Washer-Disinfector Cycle Parameters

lists the phases that should be included in the cycle.

VALIDATED AUTOMATED WASHER-DISINFECTOR CYCLE PARAMETERS

Phase

Time

Water Temp.

Detergent Type

Pre-Rinse

2 to 4 minutes

<21°C (<70°F)

Prepared detergent*

Enzyme Wash

2 to 4 minutes

43 to 66°C (110° to 150°F)

Prepared enzymatic

detergent

Wash

2 to 4 minutes

60 to 82°C (140° to 180°F)

Prepared detergent

Rinse

2 to 4 minutes

43 to 82°C (110 to 180°F)

N/A

Dry Time

15 minutes

N/A

N/A

*Detergent may be omitted at the pre-rinse stage if the washer-disinfector does not have this capability.

Trademarks not the property of Stryker Corporation are the property of their respective owners.

The information presented in this brochure is intended to demonstrate the breadth of Stryker product offerings.

Always refer to the package insert, product label and/or user instructions before using any Stryker product.

Products may not be available in all markets. Product availability is subject to the regulatory or medical practices

that govern individual markets. Please contact your Stryker representative if you have questions about the

availability of Stryker products in your area.

Products referenced with TM designation are trademarks of Stryker. Products referenced with ® designation are

registered trademarks of Stryker.

11. On completion, unload the washer-disinfector.

12. Visually inspect the equipment for remaining soil. If soil remains, repeat the cleaning process.

13. Dry the equipment with medical-grade compressed air or by heating the equipment in an oven below 110 °C (230 °F).

14. After cleaning, inspect and test the equipment immediately. See 5.0 Inspection and Testing.

Literature Number: 9100-002-135SSP Rev B

Allied/P.S

Copyright © 2013 Stryker

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T: 61 2 9467 1000 F: 61 2 9467 1010

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