4
EN Instruction for use
DEVICES DESCRIPTION
DENTAPEN is a non-sterile, cordless, and motorized device, powered by
a lithium battery, intended to assist medical practitioners to inject dental
anesthesia.
DENTAPEN is to be used with:
• A cartridge holder, compatible with most 1.7/1.8ml/2.2ml anesthesia
cartridges on the market and with standard dental needles (Ref. DP03,
DP05 or DP07),
• Finger grip to connect DENTAPEN with the cartridge holder, and to
activate DENTAPEN (Ref. DP02 or DP04),
• Single-use sleeves to protect DENTAPEN during the operation (Ref.
PS02)
• O-ring to allow active aspiration (Ref. OR01),
• A battery Lithium 6V/170 mAh (certified IEC60086-4) (Ref. BP04).
The use of any other accessory may deteriorate the functioning of DENTAPEN.
GENERAL RECOMMANDATIONS
DENTAPEN is intended for professional use only. Its use and the results
thereof are the exclusive responsibility of the practitioner.
The practitioner shall proceed only after having fully familiarized with both
the product and its instructions for use.
The practitioner is sole responsible for evaluating the indications and
contraindications relative to the injection technique and the anesthesia to
administer.
• Always check whether DENTAPEN is functioning properly before use.
• Check the proper aspect of the aspiration O-ring.
PRECAUTIONS FOR USE
Do not sterilize DENTAPEN or the battery.
Any alteration of DENTAPEN may cause its dysfunctions.
Dispose of the cartridge holder, finger grips or battery according to your
local environmental regulations.
Conform to EMC information (see last page).
Keep the DENTAPEN out of reach of children.
Keep DENTAPEN away from water and chemical products.
DENTAPEN should not be used in an inflammable environment
Battery may present a fire or chemical burn hazard if mistreated. Do not
recharge battery, open, dispose of in fire, put in backwards, mix with used
or other battery types, short circuit, disassemble, heat above 100°C (212°F),
or incinerate.
Do not use if the package is open or damaged.
Do not touch the keyboard while inserting the battery.
ADVERSE REACTIONS AND CONTRAINDICATIONS
It is the practitioner’s full responsibility to read and follow those Instructions
for use in order to avoid any adverse reactions or complaints.
Possible sides effects and contraindications can result from the use of products
in conjunction with the DENTAPEN (e.g anesthesia cartridge, needle, etc.).
HANDLING CONDITIONS
OPERATING 0-2000 m TRANSPORT & STORAGE
Temperature
20°C
25°C
77°F
- 20°C
40°C
104°F
Humidity 60% RH AT 86°F / 30°C non-condensing
It is recommended to store and transport DENTAPEN in its original packaging.
CLEANING
Between patients, appropriate care should be taken to ensure the cleanness
of DENTAPEN.
After each use clean DENTAPEN as soon as practical after use:
• Press the reverse button to bring the lead screw (free of any liquid)
back to its original position.
• Wipe carefully DENTAPEN with a damp cloth to remove visible organic
residue (e.g., residue of blood) and inorganic salts.
The finger grips and cartridge holders can be disassembled one from each
other and autoclaved at max. 135°C/275°F for 3 minutes. They can get
a worn appearance after a number of autoclave cycles, so it is up to the
Dentist to replace those regularly.
Warning:
Do not immerse, soak or spray DENTAPEN, its screw and its accessories
in or with liquids.
Do not use an automatic washer to clean the DENTAPEN.
Inspect DENTAPEN surfaces for breaks in integrity that would impair cleaning.
Do not use DENTAPEN if it cannot be properly cleaned.
ASSEMBLY AND USE
1. Insert the battery.
2. Put the cartridge into the cartridge holder.
3. Engage the cartridge holder into the finger grips.
4. Slip DENTAPEN into a single-use sleeve, connect the finger grips to
the main body and rotate until you hear a“Click”.
5. Attach the needle onto the cartridge holder without removing the cap.
6.
Press the ON/OFF button (automatic priming). The green LED indicates
that the device is turned ON and ready to use. If the On/Off light is
orange or red, change the battery.
7.
Remove the needle cap and rotate the cartridge holder to orientate the
needle as wished. Removing the needle cap as the power is off may
spill anesthetic solution.
8. Select the delivery speed, ramp mode or intraligamentary mode.
ON/OFF button, light indicator
DENTAPEN inactivated:
• Green led: battery charged
• Orange led: weak battery
• Red led: battery to be replaced
DENTAPEN activated:
Intraligamentary mode:
• Blinking blue led: low pressure
• Slow blinking purple led: expected
pressure
• Fast blinking purple led: high pressure
Other than intraligamentary modes:
• Slow blinking blue led: expected injection
pressure
9. Press the top part of the finger grips to perform the injection. Pressing
it another time stops the injection. The injection will automatically stop
when the anesthesia cartridge is empty.
10. DENTAPEN turns off automatically, when not in use, after 4 minutes.
Note:
In case of excessive pressure, DENTAPEN stops and displays an orange
steady led. Reposition the needle and initiate again the injection.
To perform aspiration, the dentist should press the activation button twice in
a short lapse of time. DENTAPEN will then generate a self-aspiration feature
by pulling backwards its plunger and holding it still for a few seconds. This
allows the Dentist to notice if blood gets into the cartridge. If so, the Dentists
should remove the needle from this site and replace the cartridge by a new
one to perform another injection.
If the O-ring is cracked or deteriorated, replace it prior to use: extend the
plunger while no accessory is assembled, remove the old O-ring and slide
a new one into the O-ring groove at the end of the plunger.
WARRANTY
The warranty period of DENTAPEN is 24 months.
The warranty period for accessories is 3 months.
Battery excluded.
LEGEND
Activation
On/Off
Speed set-up
Ramp
& Intraligamentary
activation
Reverse
No protection
against
ingress of solid
and liquid
Type
BF applied part
Do not
throw
away
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