Stryker
System 7 Battery Powered Heavy Duty Systems Care Instructions Rev C Aug 2012
Care Instructions
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Heavy Duty System 7 Battery Powered Heavy Duty Systems
Care Instructions
ENGLISH (EN) 2012-08
7200-001-700 Rev-C
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EN
7200-001-700 Rev-C
Contents Introduction... 3 User/Patient Safety... 3 Accessories... 4 Processing Instructions... 5 1.0
Point of Use... 5
2.0
Transport to Decontamination Processing Area... 5
3.0
Preparation for Cleaning... 6
4.0
5.0
6.0
3.1
Detergents... 6
3.2
Water Quality... 8
Handpiece and Attachment Cleaning... 8 4.1
Manual Cleaning... 10
4.2
Automated Cleaning... 15
Battery Pack Cleaning... 18 5.1
Manual Cleaning... 20
5.2
Automated Cleaning... 22
Inspection and Testing... 26 6.1
Limitations of Processing... 26
6.2
Visual Inspection... 27
6.3
Functional Inspection... 27
7.0
Preparation for Sterilization... 28
8.0
Packaging... 28
9.0
Handpiece and Attachment Sterilization... 28
10.0 Battery Pack Sterilization... 32 11.0 Storage and Handling... 36 11.1 Sterile Equipment... 36 11.2 Non-sterile Equipment... 36 Disposal/Recycle... 37
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Introduction This Care Instructions manual is the most comprehensive source of information for the maintenance and sterile processing of your product. This manual may be used by in-service trainers, biomedical equipment technicians, and central supply/sterile processing technicians. Keep and consult this reference manual during the life of the product. The following conventions are used in this manual: •
A WARNING highlights a safety-related issue. ALWAYS comply with this information to prevent patient and/or healthcare staff injury.
•
A CAUTION highlights a product reliability issue. ALWAYS comply with this information to prevent product damage.
•
A NOTE supplements and/or clarifies procedural information.
If additional information or in-service training is required, contact your Stryker sales representative or call Stryker customer service. Outside the US, contact your nearest Stryker subsidiary. Trademarks not the property of Stryker Corporation are the property of their respective owners.
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 crossinfection. 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.
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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. Outside the US, contact your nearest Stryker subsidiary. The following Stryker-approved accessories are sold separately:
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DESCRIPTION
REF
ProClean Instrument Detergent
3000-002-000
System 7 Insert Trays
7102-45X-XXX series
Sterilization Cases
7102-45X-XXX series
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Processing Instructions Processing equipment, operators, detergents, and procedures all contribute to the efficacy of medical device processing. The healthcare 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 minimize 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 repeated cleaning procedures.
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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. 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 detergent (neutral up to pH 10.3) is preferred. If a washer-disinfector is used, see the instructions for use supplied with the washer-disinfector machine to select the recommended detergent.
•
ALWAYS use a detergent that is suitable for use on aluminum and stainless steel surfaces if aluminum and stainless steel surfaces are present.
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3.1 Detergents (continued) NOTES: •
The Validated Detergents table lists the detergents used by Stryker during the validation of the manual and automated (washer-disinfector) cleaning processes described in these instructions.
•
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
Product
Suitability
Process
Stryker
ProClean Instrument Detergent
All materials
Manual Cleaning
Steris
Prolystica 2x Concentrate Enzymatic and Prolystica 2x Concentrate Neutral
Aluminum, stainless steel, soft metals, and plastics
Automated Cleaning
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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 Handpiece and Attachment 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 attachments and battery packs.
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Use the cleaning methods as indicated in these instructions. Using other cleaning methods may prevent proper sterilization of the equipment.
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Use PPE at all times during cleaning.
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4.0 Handpiece and Attachment Cleaning (continued) CAUTIONS: •
These cleaning instructions are not appropriate for Stryker battery packs. See the 5.0 Battery Pack Cleaning section for information on how to properly clean battery packs.
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DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified.
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DO NOT use ultrasonic cleaning equipment.
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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.
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DO NOT use pipe cleaners or cotton swabs to clean lumens.
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ALWAYS make sure the detergent solution is completely rinsed off before drying the equipment.
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Use of compressed air is only recommended for drying of equipment.
NOTES: •
Equipment may be placed under running water 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.
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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 Handpieces and Attachments 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 detergent solution. See the Special Cleaning Considerations: Handpieces and Attachments table.
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4.1.2 To Clean Handpieces and Attachments (continued) 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. See the Special Cleaning Considerations: Handpieces and Attachments table. NOTE: When removing debris from a wire collet, gently insert a 2.5 mm brush approximately 6 mm deep inside of the nose. Use light pressure to remove debris. Insert a 6 mm brush approximately 76 mm into the back of the collet to clean the rest of the lumen. 6 mm
2.5 mm
76 mm
6 mm
5. Actuate all moving parts of the equipment to clean hidden surfaces. See the Special Cleaning Considerations: Handpieces and Attachments table. NOTE: When removing debris from a reciprocating saw or sternum saw, rotate the blade collar to access all surfaces.
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4.1.2 To Clean Handpieces and Attachments (continued) SPECIAL CLEANING CONSIDERATIONS: HANDPIECES AND ATTACHMENTS Component
Moving Parts
Critical Areas
Brush Sizes
Single and Dual Trigger Rotary Handpieces
Yes
Function switch, shift collar, attachment collar, trigger(s), lumen
6 mm
Reciprocating Saw
Yes
Function switch, blade collar, trigger
0.75 mm, 2 mm, 3 mm
Sternum Saw
Yes
Function switch, guard collar, blade collar, trigger
0.75 mm, 2 mm, 3 mm
Sagittal Saw
Yes
Function switch, blade mount, blade mount lever, trigger
0.75 mm, 2 mm
Stryker Precision® Oscillating Tip Saw
Yes
Function switch, tabs, drive pins, post, cartridge mount lever, trigger
2 mm
Sternum Blade Guard
No
Foot
2 mm, 2.25 mm, 2.5 mm
Lumen
19 mm
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4.1.2 To Clean Handpieces and Attachments (continued) SPECIAL CLEANING CONSIDERATIONS: HANDPIECES AND ATTACHMENTS (CONTINUED) Component
Moving Parts
Critical Areas
Brush Sizes
Wire Collets
Yes
Nose, pre-adjust knob, lever axle, lumen
0.75 mm, 2.5 mm, 6 mm
Pin Collets/ Large Collets
Yes
Nose, pre-adjust knob, lever axle, lumen
0.75 mm, 6 mm
Chuck with Key
Yes
Jaws, lumen
5 mm, 7 mm
Keyless Chuck
Yes
Jaws, lumen
5 mm, 7 mm
AO Small Drill
Yes
Retaining collar, lumen
3.3 mm, 5 mm
Hudson
Yes
Retaining collar, lumen
5 mm, 7 mm, 8 mm
Hudson/ Modified Trinkle
Yes
Retaining collar, lumen
5 mm, 7 mm
Modified Trinkle
Yes
Retaining collar, lumen
5 mm, 7 mm, 8 mm
Trinkle
Yes
Retaining collar, lumen
5 mm, 7 mm
Triathlon
Yes
Retaining collar, lumen
2 mm, 3 mm, 5 mm
AO Large Reamer
Yes
Retaining collar, lumen
5 mm, 7 mm, 10 mm, 13 mm
DHS/DCS Quick Lock
Yes
Retaining collar, lumen
5 mm, 7 mm, 8 mm
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4.1.2 To Clean Handpieces and Attachments (continued) 6. Hold the equipment on an incline, distal end of handpieces 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 of the equipment to remove any remaining detergent solution. NOTE: A final rinse of the equipment using deionized 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 the 6.0 Inspection and Testing section. 14
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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] 4.2.2 To Clean Handpieces and Attachments 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. 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. See the Special Cleaning Considerations: Handpieces and Attachments table. 4. Actuate all moving parts of the equipment to clean hidden surfaces. See the Special Cleaning Considerations: Handpieces and Attachments table. 5. Hold the equipment on an incline, distal end of handpieces 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 of the equipment to remove any remaining detergent solution.
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4.2.2 To Clean Handpieces and Attachments (continued) 6. Visually inspect the equipment for any remaining gross soil and repeat the cleaning steps if necessary. 7. Allow the equipment to drain on absorbent wipes or load the equipment into the washer-disinfector immediately. WARNING: ALWAYS load the equipment carefully to prevent movement that may inhibit proper cleaning during the automated washer-disinfector cycle. 8. Load the equipment into the washer-disinfector in an appropriate insert tray or a wire basket. Always avoid contact between multiple components. Orient the equipment vertically to assist in drainage. Place any moving parts, such as chuck jaws, in the open position. NOTE: The equipment illustrated is representational only and may not reflect the actual equipment configuration.
CAUTION: DO NOT use any type of lubricant in the automated washerdisinfector. Use of additional lubrication is not required and may leave residue on the equipment after cleaning. 9. Operate the washer-disinfector. The Validated Automated WasherDisinfector Cycle Parameters: Handpieces and Attachments table lists the phases that should be included in the cycle.
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4.2.2 To Clean Handpieces and Attachments (continued) VALIDATED AUTOMATED WASHER-DISINFECTOR CYCLE PARAMETERS: HANDPIECES AND ATTACHMENTS Phase
Time
Water Temperature
Cleaning Agent
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]
–
Dry Time
15 minutes
Maximum 137 °C [279 °F]
–
*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 medical-grade compressed air or by heating the equipment in an oven below 110 °C [230 °F]. 13. After cleaning, inspect and test the equipment immediately. See the 6.0 Inspection and Testing section.
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5.0 Battery Pack 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. Using other cleaning methods may prevent proper sterilization of the equipment.
•
Use PPE at all times during cleaning.
CAUTIONS: •
These cleaning instructions are not appropriate for Stryker handpieces and attachments. See the 4.0 Handpiece and Attachment Cleaning section for information on how to properly clean handpieces and attachments.
•
DO NOT use detergent solution with pH levels higher than 10.3. 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 washer-disinfector require a drying phase, the other devices should be processed separately from the battery packs.
•
To prevent damage when using a washer-disinfector, select the lowest possible spray pressure setting. This is typically a gentle or low impingement setting.
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5.0 Battery Pack Cleaning (continued) CAUTIONS: •
DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified.
•
DO NOT use ultrasonic cleaning equipment.
•
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.
•
ALWAYS make sure the detergent solution is completely rinsed off before drying the equipment.
•
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 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 equipment. Manual cleaning per these instructions is preferred.
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5.1 Manual Cleaning 5.1.1 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] 5.1.2 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. See the Special Cleaning Considerations: Battery Packs table. 4. Actuate all moving parts of the equipment to clean hidden surfaces. See the Special Cleaning Considerations: Battery Packs table. NOTE: When removing debris from a battery pack, fully depress the battery latch to access all surfaces.
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