Onpharma Onset Mixing Pen User manual

Reference Guide
System

Prime the Onset Mixing Pen
1: Reset Piston Rod
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-
nger and turn the dosing mechanism counter clockwise until the piston rod is fully retracted, as in Figure 2.
Onset Mixing Pen
The Onset Mixing Pen is a high-precision dispensing device for
mixing two solutions together. The pen is used to dispense a
solution from a standard 3 mL cartridge to a second uid container,
allowing the solutions to be mixed via a sterile uid path. For
example, the pen may be used to dispense sodium bicarbonate
8.4% USP buer solution to a standard 1.7 mL cartridge of lidocaine
with epinephrine to mix the solutions.
7
1
2
3
45 6
Dosing Mechanism
Cartridge Chamber
Figure 2
Piston Rod Fully Retracted
Figure 1
Piston Rod Not Retracted
Onset Mixing Pen Parts
1- Chamber Barrel 2- Cartridge Window 3- Piston Rod 4- Reset
Mechanism 5- Volume Window 6- Volume Dial 7- Dispensing
Button
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, 3 mL cartridge refers to the sodium bicarbon-
ate pH buer solution sold by Onpharma, while 1.7 mL cartridge re-
fers to Lidocaine, Mepivicaine, Prilocaine, or Articaine solutions sold
by third parties.
2: Insert a 3 mL Cartridge
Insert a 3 mL cartridge (such as sodium bicarbonate
8.4% pH buer solution) into the small end of the pen’s
cartridge chamber with the septum entering rst, then
reattach the dosing mechanism.
3mL Cartridge
Buffering Chart
Dial 9
2% lidocaine 1:100,00 Ephinephrine
2% lidocaine 1:50,000 Ephinephrine
4% Articaine 1:100,000 Ephinephrine
4% Articaine 1:200,000 Ephinephrin
3% Mepivacaine
4% Prilocaine
4% Prilocaine 1:200,000 Ephinephrine
3: Prime the Onset Mixing Pen
After loading a new 3 mL cartridge, you must rst
prime the pen to ensure the piston rod makes con-
tact with the 3 mL cartridge.
Dial Volume to any Number
The 3ml cartridge contains spacer in addition to the
stopper. Prime against the spacer by dialing the pen
to a low setting (such as 9) and gently push the center
of the dispensing button straight down until you feel
the piston rod make contact with the 3 mL cartridge.
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 day procedures, even in
those patients with infections.
- After giving the injection buered with
Onset, stay with your patient instead of
leaving the operatory.
- Using Onset you can begin your proce-
dure much sooner versus using un-bu-
ered local anesthetic.

4: Attach an Onset Cartridge Connector
Remove an Onset Cartridge Connector from its sterile pouch and, using aseptic technique, carefully remove the
safety cap.
Align Arrow with Position #1
Align the arrow on the cartridge connector with
Position #1 on the pen.
Push the cartridge connector in approximately
one-quarter inch until you hear a “click.”
Load a 1.7 mL Cartridge
5: Load a 1.7 mL Cartridge
Load a 1.7 mL cartridge (for example, a 1.7 mL cartridge
of lidocaine with epinephrine) into the Onset Cartridge
Connector with the septum entering rst, pushing
straight and rmly into place.
Check that the 1.7 mL cartridge is fully seated by mak-
ing sure the metal cap is hidden from view in the pen.
Load the 1.7mL Cartridge
6: Lock the 1.7 mL Cartridge
Lock the 1.7 mL cartridge in place by rotating it clockwise to Position #2, approximately one-quarter turn. Push
straightforward into Position #3.
Turn to Position #2 Push Forward into Position #3
Push in until it “clicks”
When the piston rod is in the proper position after
priming successfully, the dial will not go all the way
to the 0 setting. Turn the volume dial back to 0 before
mixing your rst cartridge, as shown in.
Return to 0
7: Dial Volume to Be Dispensed
Dial the desired volume of solution to be mixed. For
example, you may dial the pen to “9” (.09 mL) to mix
sodium bicarbonate 8.4% pH buer solution with a
standard cartridge of lidocaine with epinephrine. This
represents a 19:1 ratio of lidocaine with epinephrine
to sodium bicarbonate.
Dial Volume
Push Dispensing Button
Prime the Onset Mixing Pen
It is important to depress the button straight down
in a vertical position to decrease the possibility of the
pen jamming. You may need to repeat this step if the
volume dial reaches 0and you have not yet felt the
piston rod make contact with the cartridge.
For best results, use the 3 mL cartridge of Sodium Bicarbonate within a 5-day
period once released from the pressurized tray.

Mix Solution
8: Dispense Solution to Mix
Depress the center of the dispensing button all the way. Do
not force the button. Press gently along the pen axis until the
volume window returns to 0.
It is important to push the dispensing button straight in, with-
out 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, relaxing the pressure of your thumb on the dis-
pensing button and then resuming that pressure will return
the pen to proper functions. You may also try tapping with
your thumb or nger 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 a pen with a jammed dosing mecha-
nism, sometimes the mechanism is stuck and dialing to 60 may
clear the jam. If not, please contact customer care.
Push Dispensing Button
9: Unlock the 1.7 mL Cartridge
To unlock the mixed 1.7 mL cartridge, pull the Onset®Cartridge Connector straight out, approximately one-quar-
ter inch to Position #2
Turn the connector counterclockwise back to Position #1.
Remove Mixed Cartridge
10: Removal of Mixed 1.7 mL Cartridge
Remove the mixed 1.7 mL cartridge by pulling it
straight out. Use immediately.
Note: Always inspect any solution prior to use. Do
not use if solution is cloudy. Use combined solutions
immediately. Do Not Store.
Pull out to Position #2 Turn to Position #1
Remove 1.7mL Cartridge
Push in Locking Lever
Reloading the Onset Mixing Pen
Once the 3 mL cartridge (such as sodium bicarbonate 8.4% pH buer solution) is empty, remove it from the pen
by unscrewing the dosing mechanism. You will also need to remove the Cartridge Connector in conjunction.
Check to make sure the Onset Cartridge Connector arrow is in Position #1, then push in the two locking levers
with your thumb and forenger and carefully pull the connector out. Dispose in a sharps container.
Follow steps 1-4 to reload the pen.
To ensure best results, a new sodium bicarbonate cartridge must be used within a 5-day period.
Once the solutions are mixed, start your injection within one minute for best results.
For best results, use the 3 mL cartridge of Sodium
Bicarbonate within a 5-day period once released
from the pressurized tray.
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

Please see accompanying package insert and usage instructions.
These materials are copyrighted by Onpharma Co., 2019. MK047, Rev. C
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