Name: 21g Irrigating Handpiece
Reprocessing Instructions for
following are instrument care instructions for all reusable medical devices
supplied by Bausch + Lomb, unless different instructions are supplied
with the device.
following instructions have been validated by Bausch + Lomb as being
CAPABLE of preparing a medical device for reuse. It remains the responsibility
of the processor to ensure that the processing is actually performed using
equipment, materials and personnel in the facility to achieve the desired
results. This requires validation and routine monitoring of the process.
Likewise any deviation by the processor from the instructions provided should
be properly evaluated for effectiveness and potential adverse consequences. All
cleaning and sterilization processes require validation at the point of use.
Their effectiveness will depend on many factors and it is only possible to
provide general guidance on proper device cleaning and sterilization.
unless stated otherwise are supplied from Bausch + Lomb in a
non-sterile state and are not to be used without being cleaned, disinfected and
instructions are intended for use only by persons with the required knowledge
and Disinfecting Processing Equipment should be qualified and validated to
ensure suitability for its intended purpose.
- Do not
soak instruments in solutions containing chlorine or chlorides as these may
cause corrosion and damage the instrument.
- Do not process microsurgical
instruments in an automated washer unless it has a delicate cycle.
- Do not process powered instruments in
an ultrasonic cleaner.
- Do not process single use
- Flash sterilization processing should
be reserved for emergency reprocessing only and should not be employed for
routine sterilization processing of the instrument. Flash sterilized items
should be used immediately, and not stored for later use. See ANSI/AAMI
ST79:2010 and A1:2010 and your institution’s policies for restrictions
regarding the use of flash sterilization.
narrow cannulations and blind holes require particular attention during
- Do not
use this procedure for diamond knives.
according to the instructions provided below should not adversely affect the functionality
of instruments. The useful life of the instrument is determined by wear and
damage during use.
Point of Use
Containment and Transport
- Following use, the instrument
should be cleaned of excess soil using a disposable cloth/paper wipe as soon as
- The instrument should be kept moist
to prevent soil from drying on the instrument.
Do not soak instruments in solutions containing chlorine or chlorides
as these may cause corrosion and damage the instrument.
Single use instruments should not be reprocessed.
Preparation for Decontamination and Cleaning
- The instruments should be reprocessed as soon as
instruments should be placed in a suitable container to protect personnel from
contamination during transport to the decontamination area.
precautions should be followed including the use of suitable personal
protective equipment (gloves, face shield, apron, etc.) according to your
Automated Cleaning and Thermal
WARNING: Do not
process microsurgical instruments in an automated washer unless it has a
1. Follow the instructions of the washer
2. Use only neutral pH cleaning solutions.
3. If gross soiling is evident on the instrument
manual pre-cleaning with a neutral pH cleaning solution may be necessary.
4. Ensure that any hinged instruments are open
and that instruments with lumens can drain effectively. Where the washer has
provisions for lumen adaptors these should be employed for lumened
5. Place the instruments in suitable carriers
such that they are not subject to excessive movement or contact with other
6. Process the instrument according to the conditions
indicated below. The cleaning times and conditions may be adjusted based on the
amount of soiling present on the instrument. The following conditions were
validated using a neutral pH detergent (Getinge Neutrawash) and a severe
organic soil challenge (Biomedical Instrumentation and Technology
| Phase || Time ||
|| 3 minutes
|| 30ºC (86ºF)
|| 10 minutes
|| 40ºC (104ºF)
|| 10 minutes
|| 3 minutes
Heated Final Rinse
|| 50 minutes at 80ºC
(176ºF) or 10 minutes at 90ºC (194ºF)²
|| By observation - Do not exceed
detergent: Adjust concentration according to the detergent
manufacturer’s directions regarding water quality and the extent of
conditions for thermal disinfection.
3As cleaning frequently
involves mixed instrument loads, the efficacy of drying will vary based on the
equipment and the nature and volume of the load being processed. Therefore, the
drying parameters must be determined by observation.
7. Following processing carefully inspect the
instrument for cleanliness, any evidence of damage, and proper operation. If
visible soil remains on the instrument following processing it should be
reprocessed or manually cleaned.
1. Disassemble the instrument as applicable and
inspect the instrument for damage or corrosion.
2. Pre-rinse the instrument by holding it under
cold running water for at least 30 seconds, rotating the instrument to expose
all surfaces and cavities to flowing water. Additional rinsing may be necessary
depending on the size and extent of soiling of the instrument.
3. Place the instrument into a suitable clean
basin filled with fresh neutral pH cleaning solution prepared according to the
directions of the solution manufacturer. Use only cleaning solutions that are
labeled for use with medical devices or surgical instruments. Ensure that the
instrument is fully immersed in the cleaning solution. The following conditions
were validated using a neutral pH detergent (Steris ProKlenz NpH) and a severe
organic soil challenge (Biomedical Instrumentation and Technology
4. Using a soft cleaning brush gently scrub all
surfaces of the instrument while keeping the instrument submerged in the
cleaning solution for at least 5 minutes. Clean the instrument until all
visible soil has been removed.
5. Rinse the instrument by holding it under cold
running water for at least 30 seconds, rotating the instrument to expose all
surfaces and cavities to flowing water. Additional rinsing may be necessary
depending on the size of the instrument and the amount of soil.
6. Place the instrument in an ultrasonic bath
filled with fresh neutral pH cleaning solution and sonicate for 5 minutes. Use
only cleaning solutions that are labeled for use with medical devices or
surgical instruments. Ensure that the instrument is fully immersed in the
cleaning solution. Do not overload the ultrasonic bath or allow instruments to
contact one another during cleaning. Do not process dissimilar metals in the
same ultrasonic cleaning cycle.
Do not process powered instruments in an ultrasonic cleaner.
The cleaning solution should be changed before it becomes visibly soiled. The
ultrasonic bath should be drained and cleaned each day it is in use or more
frequently if visible soiling is evident. Follow the instructions of the
manufacturer for the cleaning and draining of the ultrasonic bath.
Repeat steps 4-6 as necessary if visible soil remains on the instrument.
Rinse the instrument by holding it
under warm (27˚C – 44˚C; 80˚F – 111˚F) running water for at
least 30 seconds, rotating the instrument to expose all surfaces and cavities
to flowing water. Additional rinsing may be necessary depending on the size of
10. If the instrument has lumens the lumens
should be flushed using a syringe filled with 50cc of warm distilled or
deionized water using a stopcock as follows:
a. Place syringe tip into a
beaker of warm (30˚C – 40˚C/86˚F – 104˚F) distilled or
deionized water and fill to the 50cc mark.
b. Connect the end of the syringe to the center
c. Rotate the stopcock lever to the male luer
fitting (irrigation) or to the female luer fitting (aspiration) to allow fluid
flow to the appropriate luer fitting.
d. Connect the stopcock to the appropriate luer
connector on the instrument.
e. Push on the syringe plunger to force fluid
through the lumen into another beaker for proper disposal. Do not draw flushing
fluid back through the lumen. Disconnect the syringe. Disconnect the
syringe/stopcock from the instrument.
f. Repeat steps A-E at least three times, for each
g. Fill the syringe with 50cc of air, reattach
the stopcock, and push on the plunger to force air through each lumen.
Disconnect the syringe/stopcock from the instrument.
NOTE: The CX7120
Universal Maintenance Kit contains a syringe and stopcock suitable for cleaning
11. Immerse the instrument in clean basin
containing fresh deionized or distilled water and soak the instrument for at
least three minutes.
12. Immerse the instrument in second clean basin containing fresh deionized or distilled water and soak for at least three minutes.
13. Perform a final rinse of the instrument with
sterile distilled or deionized water for at least 30 seconds, rotating the
instrument to expose all surfaces and cavities to flowing water.
Due to the potential for residual chemicals to
remain on the instrument and cause an adverse reaction Bausch + Lomb
Incorporated does not recommend the use of liquid chemical disinfectants or
sterilants with instruments. See Automated Cleaning and Thermal Disinfection
above for procedures for thermal disinfection of instruments in an automated
Carefully dry the instrument with a lint free
surgical wipe or blow the instrument dry with micro filtered forced air.
Maintenance, Inspection and Testing
Following cleaning inspect the instrument to
ensure that all visible soil has been removed and that the instrument operates
Package the instrument in a suitable
sterilization pouch or instrument tray.
Unless otherwise indicated in the Directions for
Use provided with the specific instrument, instruments and instrument trays may
be sterilized by the following moist heat (steam) sterilization methods:
- Prevacuum High
Temperature Autoclave: 274˚F (134˚C) for 3 minutes; wrapped.
As per ANSI/AAMI ST79:2010 and A1:2010 270˚F (132˚C) for 4 minutes and 275˚F
(135˚C) for 3 minutes are acceptable minimum cycle times for
dynamic-air-removal steam sterilization cycles.
- Standard Gravity
Autoclave: 250˚F/15.2 psi (121˚C/104.8kPa [1.048 bar]) for 30 minutes;
Speed (Flash) Autoclave: 270˚F/27.1 psi (132˚C/186.8kPa [1.868 bar]) for 10 minutes;
unwrapped, but covered.
- High Vacuum (Pre-vacuum)
Autoclave: 274˚F/30.0 psi (134˚C/206.8kPa [2.086 bar]) for 3
processed in a wrapped instrument tray should be placed within the tray in a
manner that allows steam to contact all surfaces of the instrument. Do not pile
instruments on top of each other as this may block steam penetration and
condensate drainage. Do not overload the tray. Heavily loaded instrument trays
should be processed by high temperature pre-vacuum steam sterilization.
sterilization processing should be reserved for emergency reprocessing only and
should not be employed for routine sterilization processing of the instrument.
Flash sterilized items should be used immediately, and not stored for later
use. See ANSI/AAMI ST79:2010 and A1:2010 and your institution’s
policies for restrictions regarding the use of flash sterilization.
WARNING: Single use
instruments should not be reprocessed.
The instrument and/or instrument tray should be
processed through a complete sterilization drying cycle as residual moisture
from autoclaves can promote staining, discoloration, and rust.
Following sterilization processing packaged
instruments may be stored in a clean area free of temperature and humidity
extremes in accordance with your institution’s policies.
-- ASCRS/ASORN Special Report Recommendations
for the cleaning and sterilization of intraocular cataract surgical equipment.
J. Cataract Refract Surg. 2007; 33(6):1095-1100.
additional information regarding the reprocessing of instruments and
information regarding the reprocessing of diamond knives and other specialty
instruments see http://www.storzeye.com/instrument-care
- For information on
cleaning powered instruments consult the instrument’s Owners
additional information regarding the reprocessing of ophthalmic instruments
-- ANSI/AAMI ST79:2010 and A1:2010 Comprehensive
guide to steam sterilization and sterility assurance.
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