Revision Rev A

Page 1

Batteries

Cleaning & Sterilisation

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.

Small S7 Battery

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 2 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 cleaning agents (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.

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 To Clean Battery Packs

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 cleaning such as inner and outer crevices of the

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

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

5. Rinse the equipment in warm running water until all traces of detergent solution are removed. Pay particular

attention to rough surfaces and the battery contacts. Actuate all moving parts to remove any remaining

detergent solution.

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

6. Visually inspect the equipment for any remaining soil or detergent solution. If soil or cleaning solution remains,

repeat the cleaning and rinsing procedure using fresh detergent solution.

7. Allow the equipment to drain on absorbent wipes.

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

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

10. Charge the battery pack as required. See the instructions for use supplied with the battery pack.

5.0 Inspection and Testing

WARNINGS

• Only individuals trained and experienced in the maintenance of reusable medical devices should inspect and test

this equipment.

• Perform recommended inspection and testing as indicated in these instructions.

• DO NOT use any equipment if damage is apparent.

• DO NOT use any system component if the inspection criteria are not met

• DO NOT service this equipment. If the equipment fails to meet the inspection and testing criteria, contact your

Stryker sales representative or call Stryker Customer Service. Outside the US, contact your nearest Stryker subsidiary.

NOTES

• The useful life of this equipment is dependent upon many factors including, but not limited to, the method and

duration of each use, and the handling of the equipment between uses.

• Routine and careful inspection and functional testing of the equipment is the best method for determining the

serviceable life span of the equipment.

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

4.0 Cleaning

WARNINGS

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

• Prior to cleaning, remove the battery pack from the handpiece.

• 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.

• Use PPE at all times during cleaning.

CAUTIONS

• These cleaning instructions are not appropriate for Stryker handpieces and attachments.

• DO NOT use detergent solution with pH levels higher than 10.5. See the detergent MSDS to verify the pH range.

Failure to comply may cause the housing material to crack.

• DO NOT leave battery packs in the washer-disinfector for the drying phase. If other devices in the washerdisinfector require a drying phase, the other devices should be processed separately from the battery packs.

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

• DO NOT use ultrasonic cleaning equipment.

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

• DO NOT immerse or soak any equipment into 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.

• Drying battery contacts with compressed air is recommended. Residual moisture from cleaning may lead to

oxidation of the contacts.

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.

• Automated cleaning may reduce the useful life of the product. Manual cleaning per these instructions

is preferred.

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 cleaning, such as inner and outer crevices of the device.

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

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

5. Visually inspect the equipment for any remaining soil and repeat the cleaning steps above if necessary.

6. Rinse the equipment in warm running water until all traces of detergent solution are removed. Pay particular

attention to rough surfaces and the battery contacts. Actuate all moving parts of the equipment to remove any

remaining detergent solution.

7. 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.

• DO NOT use insert trays to hold battery packs in the washer-disinfector.

CAUTION DO NOT allow the battery contacts to touch the wire basket or any

metal objects inside of the basket. Failure to comply may short circuit the battery pack.

8. Load the equipment into the washer-disinfector in a wire basket. Avoid contact between multiple components.

Orient battery packs so that the battery latch is on the side and the latch is pointing down.

CAUTIONS

• 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.

• DO NOT use the drying phase with the automated washer-disinfector. Use of the drying phase may shorten the

life of the battery pack.

9. 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

Pre-Rinse

Time

2 to 4 minutes

Water Temp.

<21°C (<70°F)

Enzyme Wash

2 to 4 minutes

43 to 66°C (110 to 150°F)

Wash

Rinse

2 to 4 minutes

2 to 4 minutes

60 to 82°C (140 to 180°F)

43 to 82°C (110 to 180°F)

6.0 Preparation for Sterilisation

WARNING ALWAYS use a chemical indicator within every sterilisation load to make sure the proper

sterilisation conditions of time, temperature, and saturated steam are achieved.

Where appropriate, load equipment into an appropriate sterilisation tray.

7.0 Packaging

Enclose the equipment using a sterilisation wrap that is suitable for the equipment, such as a grade 500 or higher,

before sterile processing.

Follow the Association for the Advancement of Medical Instrumentation (AAMI) and the Association of

periOperative Registered Nurses (AORN) recommended guidelines for appropriate wrapping configurations.

NOTE The packaging material will maintain the sterility of the equipment after exposure.

8.0 Sterilisation

WARNINGS

• Sterilise the equipment as indicated before first and every use.

• Prior to sterilisation, remove the battery pack from the handpiece.

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

instructions manual supplied with the equipment. Using other sterilisation methods may prevent proper

sterilisation of the equipment and/or damage the equipment.

• Follow the recommended dry times to prevent moisture from accumulating inside the equipment. Moisture may

cause the equipment to corrode and prevent proper sterilisation.

• After sterilisation, allow the equipment to cool to room temperature prior to use. Failure to comply may result in

burned patient tissue or health-care staff, and/or damage to the equipment.

CAUTIONS

• These sterilisation instructions are not appropriate for Stryker handpieces and attachments.

• Always make sure the equipment is completely dry before sterilisation.

• Poor water quality can adversely affect the life of medical devices. Always follow the water quality requirements

per AAMI TIR 34.

• DO NOT sterilise a battery pack that is not intended to be sterilised, such as an aseptic battery pack, where only

the outer housing is intended to be sterilised.

• DO NOT leave battery packs in a hot steriliser for more than the prescribed time as this will shorten battery pack life.

If possible, open steriliser door and remove the battery packs when the cycle completes to prevent extended exposure

to elevated temperatures.

• If the steriliser requires a dry time setting, ALWAYS use the minimum time allowed by the steriliser. Failure to

comply will shorten battery pack life.

• DO NOT sterilise a battery pack if damage is apparent (cracks or other damage).

• After sterilisation, ALWAYS allow battery packs to cool for at least one hour before recharging.

Failure to comply may result in damage and a shortened battery pack life.

• Dry battery packs before placing them in the charger to avoid damage to the battery packs and charger.

NOTES

• Steam sterilisation (moist heat) is recommended. Stryker has validated several autoclave cycles for the

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.

Cleaning Agent

Prepared detergent*

Prepared enzymatic

detergent

Prepared detergent

N/A

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

10. On completion, unload the washer-disinfector.

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

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

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

14. Charge the battery pack as required. See the instructions for use supplied with the battery pack.

sterilisation of this equipment. However, autoclave design and performance can affect the efficacy of the process.

Health-care facilities should verify the process they use, employing the actual equipment and operators that

routinely process the equipment.

• The final responsibility for verification of sterilisation techniques lies directly with the hospital. To ensure the

efficacy of hospital processing, all cycles and methods should be verified for different sterilisation chambers,

wrapping methods and/or various loading configurations.

• After sterilisation, allow the equipment to cool to a comfortable operating temperature.

To obtain optimum performance, perform one of the following sterilisation cycles validated by Stryker:

1

VALIDATED STEAM STERILIZATION CYCLE PARAMETERS

5.2 Visual Inspection

Perform recommended inspection and testing as indicated in the Inspection and Testing and/or Periodic

Maintenance sections of the instructions for use and/or care instructions supplied with the product.

CD2 Battery

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.

Repeated processing has a minimal effect on this equipment. See the 5.2 Visual Inspection and 5.3 Functional

Inspection sections for additional guidance on evaluating device functionality.

5.3 Functional Inspection

S4/5 Battery

Supplier

Wrapping

Method

Cycle

Wrapped

Dynamic Air Removal

(Pre-vacuum)

Unwrapped

Sterilization

Temp.

Minimum

Exposure

132°C (270°F)

4 minutes

134°C (273°F)

3 minutes

Dynamic Air Removal

(Pre-vacuum)

132°C (270°F)

4 minutes

Unwrapped

Gravity

132°C (270°F)

3 minutes

Riley FlashPak

Dynamic Air Removal

(Pre-vacuum)

132°C (270°F)

5 minutes

5.1 Limitations of Processing

Visually inspect all equipment before sterilisation.

Pay particular attention to the following:

• Locations where soil may become trapped, such as mating surfaces, hinges, and shafts

• Recessed features, such as holes and lumens

• Features where soil may be pressed into contact with the equipment

Large S6 Battery

Validated Detergents

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

• Detergent 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)

Small S6 Battery

• 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.

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.

Large S7 Battery

2

Maximum

Exposure

Minimum

Dry Time

5 minutes

No dry time

5 minutes

No dry time

Gravity

1

2

Validation is based on the Association for the Advancement of Medical Instrumentation (AAMI) protocol

Sterilisation parameters for Australia/New Zealand per AS/NZS 4187-2003

Sterilisation parameters for Netherlands per Field Standard for Loaner Instruments, Revision 03.02, April 2008

Sterilisation parameters for Europe and the United Kingdom per EN ISO 17664

Sterilisation parameters for Canada per CSA ISO 17664

STERRAD Gas Plasma

Follow the sterilisation instructions provided by Sterrad. Contact your Sterrad representative for more information.

NOTE Stryker equipment that is compatible with Sterrad systems is listed on the Sterrad Sterility Guide

(SSG) web site.

• 100NX System Standard and Express Cycles

• NX System Standard Cycle

• 200 System Short Cycle

• 100S System Short Cycle

• 50 System

Steris Amsco V-PRO

Follow the sterilisation instructions provided by Steris. Contact your Steris representative for more information.

• Steris Amsco V-PRO 1 Cycle

• Steris Amsco V-PRO 1 Plus Lumen Cycle

• Steris Amsco V-PRO 1 Plus Non-lumen Cycle

• Steris Amsco V-PRO maX Lumen Cycle

• Steris Amsco V-PRO maX Non-lumen Cycle

• Steris Amsco V-PRO maX Flexible Cycle

9.0 Storage and Handling

9.1 Sterile Equipment

WARNINGS

• ALWAYS transport wrapped equipment with care to prevent damaging the sterile barrier.

• ALWAYS store wrapped, processed equipment in a controlled environment and avoid extremes in temperature

and moisture.

• Excessive handling of wrapped equipment will increase the likelihood of damaging the sterile barrier and may

lead to contamination.

NOTE See the instructions for use supplied with the sterilisation wrap for maximum shelf-life information.

9.2 Non-Sterile Equipment

CAUTION ALWAYS store the equipment within the specified environmental condition values throughout its useful

life. See the Specifications section of the instructions for use supplied with the equipment.

To ensure longevity, performance, and safety, use of the original packaging materials is recommended when

storing or transporting this equipment.

Disposal/Recycle

WARNINGS

• ALWAYS follow the current local recommendations and/or regulations governing environmental protection and

the risks associated with recycling or disposing of the equipment at the end of its usual life.

• ALWAYS follow the current local regulations governing the safe handling and disposal of sharps.

• ALWAYS follow the current local regulations governing biohazard waste to safely handle and dispose of surgical waste.

To comply with Batteries Directive 2006/66/EC, battery packs have been designed to be recycled by the end user

as a complete unit. Disassembly is not required. Infected battery packs must be decontaminated before they are

sent for recycling.

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

Literature Number:a9100-002-137SSP Rev A

Allied/P.S

Copyright © 2013 Stryker

Stryker Australia

8 Herbert Street, St Leonards NSW 2065

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

Stryker New Zealand

515 Mt Wellington Highway, Mt Wellington Auckland

T: 64 9 573 1890 F: 64 9 573 1891

www.stryker.com

www.strykermeded.com