FujiCEM GC004647 2 Automix Dispenser Instruction Manual
- June 6, 2024
- FujiCEM
Table of Contents
2 Dispenser
Prior to use, carefully read the instructions for use.
For use only by a dental professional in the recommended indications.
INTENDED USE
To dispense material from GC FujiCEM and GC FujiCEM 2 Paste Pak cartridges. (Not intended for use with other GC Paste Pak products.)
IDENTIFICATION OF PARTS
(Paste Pak Cartridge) 1. Cover 2. Inner plunger 3. Cartridge tips (GC FujiCEM 2 Dispenser) 4. Body 5. Plunger (Fig. 1)
DIRECTIONS FOR USE
-
Cartridge loading (Fig. 2) Retract the plunger completely into the body of the dispenser. Ensure the mark (▲) on the cartridge lines up with the mark (▲) on the dispenser as illustrated. Turn the cartridge fully to the right position. Ensure that the cartridge is properly attached to the ispenser. After cartridge loading, slide the plunger forward until it stops. Remove the cover. Note: To remove the cartridge, retract the plunger
fully and turn the cartridge back to the marked positions. -
Dispensing
Before dispensing the first material from a new cartridge or when dispensing after a long interval, bleed the pastes in order to prevent the incorporation of air bubbles into the material.
Hand mixing
Push the center of the plunger to dispense the paste onto a mixing pad (Fig. 3).
While pushing the plunger, level and cut off the extruded material from the
cartridge tips by moving the cartridge and Dispenser to an upright position on
the mixing pad. When the plunger is released after dispensing, residual pastes
at the tips are retracted into the cartridge. Replace the cartridge cover.
Note: The minimum dispensing amount is indicated in Fig. 4 (real size).
The amount less than indicated may yield an inappropriate paste/paste ratio.
Automixing
Before attaching the mixing tip, check the two openings of the cartridge tip and confirm the pastes are at the same level to ensure even flow from the cartridge. Attach the GC FujiCEM Mixing tip correctly on the cartridge by aligning the guide pin on the GC FujiCEM Mixing Tip with the hole on the cartridge, simultaneously pushing the tip until it clicks on the cartridge (Fig. 5).
Slowly push the center of the plunger to dispense the material into the appliance. To remove the GC FujiCEM Mixing Tip, push the GC FujiCEM Mixing Tip forward while depressing the release tab with one hand, and move the front part of the GC FujiCEM Mixing Tip from side to side with the other hand (Fig. 6)
Clean the cartridge tip and replace the cartridge cover.
Note:
a. Make sure GC FujiCEM Mixing Tip is securely attached to the cartridge. If
not, remove the mixing tip and reattach.
b. If the material has been refrigerated, leave the cartridge in room
temperature for 10 minutes.
c. Do not leave the used GC FujiCEM Mixing Tip on the cartridge for a long
period of time.
d. Before dispensing the material into the appliances, bleed a small amount of
the mixed paste on a pad.
e. The amount of remaining paste in the cartridge can be confirmed by the
position of the inner plunger seen through the cylinders. When only a small
amount of paste remains in the cartridge, the paste may not be dispensed from
the GC FujiCEM Mixing Tip.
f. To avoid damage, do not drop the dispenser with the cartridge and mixing
tip.
Cleaning / Sterilization of GC FujiCEM 2 Dispenser
- Clean the dispenser with water and soap or detergent. The dispenser may be disinfected using alcohol moistened gauze or steam autoclaved using either of the following conditions.
a. 115-118°C (239-244°F) for 30 minutes
b. 121-124°C (250-255°F) for 15 minutes
c. 126-132°C (259-270°F) for 10 minutes Use purified water for autoclave. Do not use dry heat sterilization.
Note:
a. Some cleaning agents like glutaraldehyde
or phenol based cleaner may cause
discoloration of GC FujiCEM 2 Dispenser.
b. Refer to the manufacturer’s instructions
for use of the cleaning agent or
instrument.
c. Autoclave temperature should not exceed
132°C (270°F).
d. After autoclave, let the dispenser cool
before use.
STORAGE
Store away from direct sunlight.
PACKAGE
1 piece
Some products referenced in the present IFU may be classified as hazardous
according to GHS. Always familiarize yourself with the safety data sheets
available at: http://www.gceurope.com or for The Americas
http://www.gcamerica.com They can also be obtained from your supplier.
Undesired effects- Reporting: If you become aware of any kind of undesired
effect, reaction or similar events experienced by use of this product,
including those not listed in this instruction for use, please report them
directly through the relevant vigilance system, by selecting the proper
authority of your country
accessible through the following link: https://ec.europa.eu/growth/sectors
/medical-devices/contacts_en as well as to our internal vigilance system:
vigilance@gc.dental In this way you will
contribute to improving the safety of this product.
Last revised: 01/2021
References
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