Onpharma Onset Mixing Pen User manual

Reference Guide
System

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Dosing Mechanism
Cartridge Chamber
2% lidocaine 1:100,000 Epinephrine
2% lidocaine 1:150,000 Epinephrine
4% Articaine 1:100,000 Epinephrine
4% Articaine 1:200,000 Epinephrine
4% Prilocaine 1:200,000 Epinephrine
3% Mepivacaine
4% Prilocaine
System
Designed for safety and precision, the Onset Mixing Pen conveniently
provides a method for healthcare professionals to precisely and safely
mix two parenteral solutions prior to injection.
This Reference Guide provides a brief overview of setting up the pen
and mixing two solutions together using an Onset Cartridge Connec-
tor (sold separately by Onpharma). For more information, please refer
to the Instructions for Use provided with the Onset Mixing Pen.
In this Reference Guide, "3mL Buffering Cartridge"refers to the 3mL
cartridge of Onset Sodium Bicarbonate Inj., 8.4%, USP Neutralizing
Additive Solution sold by Onpharma, while "1.7mL Anesthetic
Cartridge"refers to 1.7mL cartridges of Lidocaine, Mepivicaine,
Prilocaine, or Articaine solutions sold by third parties.
Buffering Char t
Use Onset with all your local anesthetic
injections to give you more control of
your daily schedule.
• Onset can help maximize the
predict-ability on same-dayprocedures,
even in those patients with infections.
• After giving the injection buffered
with Onset, staywith your patient
instead of leaving the operatory.
• Using Onset you can begin your
proce-dure much sooner versus using
un-buffered local anesthetic.
Dial 9 on the Mixing Pen
Dialing 9 will set the proper mixing ratio of 1:19
when combining fluid from a 3mL vial of
Onset Sodium Bicarbonate Neutralizing Additive
Solution with the anesthetic solution in a 1.7mL
cartridge containing any of the following:
Onset Mixing Pen
The Onset Mixing Pen is ahigh-precision
dispensing device for mixing two solutions
together. The pen is used to dispense asolution
from astandard 3mL cartridge to astandard
1.7ml cartridge, allowing the solutions to be mixed
via a sterile fluid path. For example, the pen may be
used to dispense solution from a 3mL Buffering
Cartridge to a 1.7mL Anesthetic Cartridge to mix the
solutions. Parts references for this Guide:
1 -Chamber Barrel 2-Cartridge Window 3-Piston
Rod 4-Reset Mechanism 5-Volume Window 6-
Volume Dial 7- Dispensing Button

Step 1. Prime the Onset Mixing Pen
First, Reset Piston Rod
Before loading the Mixing Pen, unscrew the Dosing Mechanism from the Cartridge Chamber and check to
make sure the Piston Rod is fully retracted.
If the Piston Rod is not fully retracted, as in Figure 1,grip the red Reset Mechanism with your thumb
and fore-finger and turn the Dosing Mechanism counter clockwise until the Piston Rod is fully retracted,
as in Figure 2.
Figure 2
Piston Rod Fully Retracted
Figure 1
Piston Rod Not Retracted
Second, Insert a 3mL Cartridge
Insert a new 3mL cartridge (such as 3mL
Buffering Cartridge) into the small end of the
pen’s Cartridge Chamber with the septum entering
first, then reattach the Dosing Mechanism.
3mL Cartridge
Third, Prime the Onset Mixing Pen
After inserting anew 3mL cartridge, you must first
prime the pen to ensure the Piston Rod makes
contact with the 3mL cartridge (not shown). Note: 3mL
Buffering Cartridges contain a spacer in addition to the
stopper. The Piston Rod will contact the pacer.
Dial Volume to 9
To prime the pen, turn the Volume Dial to 9 and
gently push the center of the Dispensing Button
straight down until you feel the Piston Rod make
contact with the spacer in the 3mL Buffering
Cartridge.
Step-By-Step Guide

First, remove an Onset Cartridge Connector from its sterile pouch and, using aseptic technique, carefully
remove the safety cap.
Align Arrow with Position #1
Second, align the clear plastic arrow on the
Cartridge Connector with Position #1, which appears
as a "1" in a black arrow on the pen.
Third, push the Cartridge Connector in towards
Position #1 approximately one-quarter inch until
you hear a “click.”
Push in until it “clicks”
Gently Push Dispensing Button
Be aware that when priming by pushing the
Dispensing Button, it is important to depress the
button straight along the axis of the pen to decrease
the possibility of jamming the pen.
If the Volume Dial reaches 0 and you have not yet felt
the piston rod make contact with the cartridge, repeat
this third step.
Once you feel the Piston Rod make contact with the
cartridge, you have primed the Mixing Pen successfully. Forbestresults,usethe3mLcartridgeof
SodiumBicarbonatewithin7-daysafter
youhaveloaded it intothe Mixing Pen.
Step 2. Attach an Onset Cartridge Connector to the Mixing Pen

Step 3. Load a 1.7mL Cartridge
First, insert a 1.7mL cartridge (for example, a 1.7mL
cartridge of lidocaine with epinephrine)into the
Cartridge Connector by pushing the septum end of
the 1.7mL cartridge straight into the open end of the
Cartridge Connector, pushing the 1.7mL cartridge
straight in and firmly into place.
Check that the 1.7mL cartridge is fully inserted by
making sure the metal cap is fully seated into the
Cartridge Connector and hidden from view by the end
of the pen.
Load the 1.7mL Cartridge
Second, Lock the 1.7mL cartridge in place in the Cartridge Connector by rotating the Cartridge Connector
clockwise to Position #2, approximately one-quarter turn. Then push the Cartridge Connector straight forward
into the Mixing Pen to Position #3.
Turn to Position #2 to Lock
Push Forward into Position #3
Step 4. Set the Mixing Volume
Dial the the pen to “9”(.09 mL) to mix the Sodium
Bicarbonate 8.4% Inj. pH Neutralizing Additive
Solution with a standard 1.7mL cartridge of local
ansethetic. "9" is the mixing volume setting for all
anesthetics listed in the Buffering Chart, above.
This represents a 19:1 ratio of local anesthetic
solution to sodium bicarbonate buffering solution.Dial Volume to "9"

Push Dispensing Button
After mixing the two solutions together by depressing the Dispensing Button, it is time to remove the 1.7mL cartridge.
Pull out to Position #2 Turn to Position #1
Step 5. Mix Solution
Dispense Solution to Mix. Depress the center of the
dispensing button all the way until it stops. Do not force
the button, but rather press gently down along the pen
axis until the volume window reads "0".
It is important to push the dispensing button straight
in, without pressing against the rotating dial or
pressing at an angle. If the button will not depress
smoothly or seems stuck, check to make sure the
rotating dial is not caught on your thumb or glove while
pushing in.
In most cases, if the dispensing button hangs up,
relaxing the pressure of your thumb on the
dispensing button and then resuming that pressure will
returnthe button to proper function. You may also
try tapping with your thumb or finger on the top of the
button to move it along.
Note: NEVER force the button as this may damage
the pen mechanism. In case of apen with ajammed
dosing mechanism, sometimes the mechanism is
stuck and dialing to 60 and then depressing the
button may clear the jam. If not, please contact
customer care.
Forbest results, usethe3mL cartridgeof
SodiumBicarbonatewithin7-days after you
haveloadeditintothe mixing pen.
First, pull the Onset Cartridge Connector straight out
from Position #3, approximately one-quarter inch to
Position #2, where it will stop.
Second, turn the Cartridge Connector counterclockwise
back to Position #1, which unlocks the 1.7mL cartridge
from the Cartridge Connector.
Step 6. Remove the Mixed Cartridge.

Push Dispensing Button Third, release the mixed 1.7mL cartridge by
pulling it straight out. Use immediately, do
not store for later use.
Note: Always inspect any solution prior to use.
Do not use if solution is cloudy.
Once the solutions are mixed, start
your injection within one minute for
best results.
Remove 1.7mL Cartridge
Push in Locking Levers to
Release the Cartridge Connector
To ensure best results, a newly-loaded 3mL Buffering Cartridge must be used within
a 7-day period.
Reloading the Onset Mixing Pen
Note: You will need to remove and discard the Cartridge Connector each time you replace the 3mL cartridge in
the Pen.
Clean with Disenfectant Wipe
Cleaning the Onset Mixing Pen
Clean the inside of the cartridge chamber with
warm water and soap using the cleansing brush.
Use a disinfectant wipe for the dosing mechanism.
Do not autoclave the dosing mechanism.
Remove the 3 mL Cartridge
First, remove the empty 3mL cartridge from the pen by
unscrewing the dosing mechanism and separating the
dosing mechanism from the cartridge chamber.
Second, with the Cartridge Connector arrow at Position
#1,push in the two locking levers with your thumb and
forefinger and pull the connector out. Dispose in a
sharps container. Follow steps 1-2to reload the pen.

Have a
Question?
Call the Onset Team
We are here to help you make your local anesthetic better.
Customer Care
877.336.6738
[email protected]
Hours
Monday - Thursday | 7AM - 5PM PST
Friday | 7AM - 2PM PST
Please see accompanying package insert and usage instructions.
These materials are copyrighted by Onpharma Co., 2021. MK047, Rev. E SKU 503