Directions For Use
Symbols used on packaging
Symbol
P
h
g
Meaning
Authorized
Representative in the
European Community
Catalogue Number
Batch Code
Not made with natural
rubber latex
Symbol
M
d
Y
i
Meaning
Allegro™ I/A Handpiece™
Manufacturer
Non Sterile
Caution
Consult instructions for
use
Patents Pending
67-0070-01 Rev A
Graphic Illustration may differ in design
MST Allegro™ Instructions
CAUTION: This instrument is packaged in a non-sterile condition. To ensure patient safety, handpiece
the instrument carefully and protect it from damage. Do not use this instrument if it appears damaged
in any manner. Do not attempt to alter or repair the instrument. Prior to initial and each subsequent
use, wash, flush, rinse, dry, & sterilize the instrument.
INTENDED USE
The MST Allegro™ handpiece provides the user with a means to aspirate material, and supply irrigation fluid
during cataract surgery.
DIRECTIONS FOR USE
The MST Allegro™ handpiece must be sterilized in a steam autoclave prior to each use. The handpiece and tip
should not be assembled during autoclaving.
Connection to the Phaco System
1. Follow the manufacturer’s instructions for priming the system.
2. Connect the female Luer to the aspiration port and the male Luer to the irrigation port of the I/A handpiece.
3. Insert the Allegro™ Single Use Silicone I/A tip onto the handpiece making sure that it is correctly engaged, as
shown in the figures below.
CAUTION: Only touch the white base. Twist the tip onto the handpiece using the white base finger tight.
The recommended cleaning process for the Allegro™ system is as follows:
1. DURING THE PROCEDURE
Immediately after use, soak the Allegro handpiece in distilled water.
2. POST PROCEDURE CLEANING
This procedure describes the cleaning of the Allegro™ handpiece without the Allegro™ Single Use Silicone
I/A tip attached to the handpiece.
Part I:
a. Fill a 10cc syringe with distilled water.
b. Connect syringe to the handpiece irrigation port and expel the water.
c. Disconnect the syringe and repeat steps a and b two more times.
d. Repeat this same process for the handpiece aspiration port.
Part II:
a. Sonicate the handpiece in fresh DI water for 3 minutes.
Part III:
a. Flush both lumens of the handpiece with 10cc of air 3 times each.
b. Dry the handpiece with clean lint-free cloth
NOTE: To avoid damage due to incidental contact, the Allegro™ handpiece should be kept apart from
other instruments during cleaning and sterilization.
NOTE: When the Allegro™ handpiece will not be immediately sterilized, it is important to make sure that
the instrument is clean and dry. Using a syringe free of water, force 10cc of air through the irrigation line to
ensure the line is clear. Repeat this step twice to clear and dry the irrigation path. This same procedure
should be followed for the aspiration path.
STERILIZATION
CAUTION: Do not sterilize prior to performing cleaning procedure described above.
1. Sterilize to your facility’s standard practice or to industry standards.
2. The following techniques, times and temperatures are recommended by MicroSurgical Technology:
Gravity Displacement
Pouched
Unwrapped
132°C (270°F)
132°C (270°F )
15 min 15 min
15 min
dry time
CAUTION: Never touch the silicone as that will twist /damage the tip and will result in leakage or lack of
aspiration.
PreVacuum Cycle
Pouched
Unwrapped
132°C (270°F)
132°C (270°F) 4
4 min 20 min dry
min
time
MAINTENANCE
The MST Allegro™ handpiece requires regular cleaning after each use. The MST Allegro™ handpiece must be
sterilized before each use.
The Allegro™ handpiece should be inspected for signs of damage or buildup of cortical material in the fluid
pathways at least once per day of use.
Patents Pending
4. Initiate irrigation fluid flow (following the manufacturer’s instructions) and verify fluid flow out of the
irrigation ports.
CLEANING
The MST Allegro™ handpiece must be sterilized in a steam autoclave prior to each use. The handpiece and tip
should not be assembled during autoclaving.
CAUTION: Improper or inadequate cleaning may result in particulate matter adhering to the instrument
and exfoliation into the surgical field. In addition, the function and life expectancy may become
compromised.
M
MicroSurgical Technology Inc.
8415 154th Ave NE
Redmond, WA USA 98052
Phone 425.861.4002
email: [email protected]
GmbH
P MDSS
Schiffgraben 41
30175 Hannover, Germany
C0473
67-0070-01 Rev A