Bone Instrument Attachment Tips

Electric Handpieces and Attachments

Processing Instructions

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
• Clean and sterilize the equipment, as indicated, before first and every use
• Prior to cleaning and sterilization, remove all detachable components and single-use cutting accessories from
the handpieces. Detachable components include cords, handswitches, attachments, and batteries
• Use the cleaning methods as indicated in these instructions. Using other cleaning methods may prevent proper sterilization
• All disposable accessories are intended for single use only. DO NOT reuse, reprocess, or repackage
CAUTIONS
• DO NOT immerse any equipment into liquid for longer than is necessary to thoroughly wet all surfaces
(approximately 10 to 30 seconds). DO NOT 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.

NOTE Equipment may be placed under running water and/or dipped into liquid to ensure thorough wetting and
contact with liquid while articulating moving parts
• DO NOT use solvents, lubricants, or other chemicals, unless otherwise specified
• Always use a soft, non-metallic brush in the lumen or nose of an Elite or Saber SD Series attachment.
ALWAYS use light pressure and DO NOT push the brush any farther after you feel resistance
• DO NOT bend connectors pins during cleaning
• DO NOT use pipe cleaners or cotton swabs to clean lumens
• Use of compressed air is only recommended for drying of equipment
Limitations of Processing
Repeated processing has a minimal effect on the equipment. See the Inspection and Testing and/or Periodic
Maintenance sections in the Instructions for Use and/or Care Instructions manual supplied with the equipment
for additional guidance on evaluating the device functionality.

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
Remove gross soil from the equipment using disposable 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
Cleaning Agents
WARNINGS
• Read, understand, and follow the indications, instructions, and WARNING information supplied with the cleaning
agent for correct handling and use of the product. Pay particular attention to the concentration used and the total
dispersion of the detergent. Prepare the cleaning solution according to the manufacturer’s recommendations.
• To clean the equipment, use specifically formulated cleaning agents (detergents) only.
• ALWAYS provide personal protective equipment (PPE) for processing personnel according to the instructions and
safety data sheets supplied with the cleaning agent
CAUTIONS
• ALWAYS use a cleaning agent that is suitable for use on aluminum surfaces if aluminum surfaces are present.
• A mild alkaline agent (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 cleaning agent
NOTES
• The table entitled Validated Cleaning Agents lists the agents used by Stryker Instruments during the validation of
the manual and automated (washer-disinfector) cleaning processes described in these instructions
• Stryker Instruments does not recommend these cleaning agents in preference to other agents. Other agents may
perform equally well or better. However, alternative cleaning agents must be verified by referencing the information
provided by the cleaning agent supplier and/or physical testing

WARNING Use filtered water for diluting cleaning agents 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
Two methods of cleaning are described: a manual cleaning method and an automated cleaning method
Whichever method is used, use PPE at all times
NOTE Removal of all gross soil is required for both cleaning methods

Manual Cleaning

Recommended Equipment
• Non-abrasive, soft, flexible brushes
• Syringe
• PPE as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield)
• Disposable absorbent wipes or soft, lint-free cloth
• Medical-grade compressed air (< 20 psi)
Instructions
1. Remove all gross soil from the equipment using disposable absorbent wipes or soft, lint-free cloth moistened
with the prepared cleaning solution
2. Make sure all surfaces of the equipment are thoroughly wetted using warm water with a temperature of 80 °F
(27 °C) to 110 °F (44 °C). The water should not exceed 140 °F (60 °C) and should be warm to the touch
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 cleaning solution
4. Use a soft brush of appropriate diameter for lumens. Ensure that the brush passes the whole length of the lumen
5. Actuate all moving parts of the equipment to access all 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
6. Hold the equipment on an incline, distal end pointing down, and rinse in warm running water until all traces of
cleaning 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 cleaning solution
7. Visually inspect the equipment for any remaining soil or cleaning solution. If soil or cleaning solution remains,
repeat the cleaning and rinsing procedure using fresh cleaning solution
8. Allow the equipment to drain on disposable absorbent wipes
9. Dry the equipment with a soft, lint-free cloth or medical-grade compressed air (< 20 psi)
10. After cleaning, inspect and test the equipment immediately. See 5.0 Inspection and Testing

Automated Cleaning

Recommended Equipment
• PPE as recommended by the cleaning agent supplier (minimum overalls, gloves, face/eye shield)
• Disposable absorbent wipes
• Washer-disinfector
• Cleaning/rinsing agents as required by the washer-disinfector
• Medical-grade compressed air (< 20 psi)
Instructions
1. Remove all gross soil from the equipment using disposable absorbent wipes moistened with prepared cleaning solution
2. Make sure all surfaces of the equipment are thoroughly wetted using warm water with a temperature of 80 °F
(27 °C) to 110 °F (44 °C). The water should not exceed 140 °F (60 °C) and should be warm to the touch
3. Visually inspect the equipment for any remaining soil and repeat the steps above if necessary
4. Allow the equipment to drain on absorbent wipes or load the equipment into 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 and disinfection during the automated washer-disinfector cycle
• NEVER use sterilization trays or sterilization tray inserts to hold equipment in the washer-disinfector
These trays are for use with the sterilization process only. Use of these inserts in a washer-disinfector may
damage the equipment
5. Load the equipment into the washer-disinfector in a wire basket always avoiding contact between multiple components.
Orient the equipment vertically to assist in drainage. Articulating components should be in the open position
6. Operate the washer-disinfector. The cycle should include the following steps:
VALIDATED AUTOMATED WASHER-DISINFECT OR CYCLE PARAMETERS

 

Phase Time Water Temp. Detergent Type
Pre-Rinse 2–4 minutes 58 °F– 62 °F (14 °C–17 °C) EnzyCare* or Enzol*
Wash 2–4 minutes 140 °F–248 °F2 (60 °C –120 °C)2 EnzyCare* or Enzol*
Rinse 2–4 minutes 140 °F–248 °F2 (60 °C –120 °C)2 N/A
Dry Time 15 minutes Maximum 279 °F (137 °C) N/A
  • EnzyCare is a trademark an or registered trademark of Steris corporation. Enzol is a trademark and /or registered trademark of Advanced Products, Division of Ethicon Inc. a Johnson & Johnson company.
    1 Cleaning agent may be omitted at the pre-rinse stage if the washer-disinfector equipment does not have this capability
    2 Temperatures above this constitute steam sterilization. These products are not validated for use in washer-sterilizers
    7. On completion, unload the washer-disinfector
    8. Visually inspect the equipment for remaining soil. If soil remains, repeat the cleaning process
    9. Dry the equipment with medical-grade compressed air (< 20 psi) or by heating in an oven below 230 °F (110 °C)
    10. After cleaning, inspect and test the equipment immediately. See 5.0 Inspection and Testin
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