RONVIG DENTAL Calaject User manual

1
/
Computer Assisted Local Analgesia
Instructions for Use
USA
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 1 16-01-2019 17:41:06

2
DESCRIPTION OF CONTROL UNIT
FRONT PANEL WITH FINGER TOUCH DISPLAY
1. On/Off switch
2. Bar-scale for display of current injection pressure/resistance
3. Program selection I, II, III
4. Piston rod retraction. Returns the piston rod to start position
5. Charging and battery level indicator
REAR PANEL
6. charge socket
Battery charger plug is the disconnecting device
7. Socket for handpiece
8. pedal connection to foot switch
9. volume control for sound signal
10. sound aperture
CONGRATULATIONS ON YOUR NEW CALAJECT™!
Please read these instructions thoroughly before you start using your CALAJECT™.
INTENDED USE
CALAJECT™ is intended for performing dental local analgesia.
CALAJECT™ MAY ONLY BE USED BY TRAINED PERSONNEL authorized to
perform dental injections. For this reason, this manual does not include specific in-
structions in injection techniques. The manufacturer cannot be held liable for injuries
in patients due to unauthorized or incorrect use.
Federal (USA) law restricts this device to sale by or on the order of a dentist or physician.
R
1
4
2
3
5
89 7
6
10
R
1 Stand for handpiece
1 Charger (Friwo FW7401M/12)
1 User instructions
CONTENTS
1 Control unit
1 Handpiece with cord
1 Footswitch
3 Cartridge barrels, material PSU polymer
2118
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 2 16-01-2019 17:41:06

3
TEST AND TRAINING
New users must read these instructions carefully and familiarize themselves with the functions
and different programs before using CALAJECT™.
CLEANING
•The CALAJECT™ unit, handpiece + cord, Handpiece Holder should be disinfected with an
EPA-registered disinfectant unless the item is visibly contaminated with blood; in that case
a tuberculocidal agent (or a disinfectant with specific label claims for HBV and HIV) or a
1:100 dilution of a hypochlorite solution (500–600 ppm free chlorine) should be used.
•The footswitch + cord can be wiped over with a clean cloth moistened with a mild detergent
or disinfection solution.
Do not immerse into liquid. Do not autoclave. The CALAJECT™ unit and the
handpiece contain sensitive electronic components that do not withstand
sterilization or immersion in liquid.
•Clean the cartridge barrel in water and a mild detergent.
STERILIZATION
The cartridge barrels are delivered non-sterile and should be sterilized before first use.
Place the cartridge barrel in a sterilization pouch and seal it. Sterilize it in a steam
sterilization autoclave at 121°C / 250°F for 15 minutes, or at 134°C / 275°F for 3 minutes.
The cartridge barrel may get a frosted appearance after a number of sterilizations, so it is
recom- mended to replace the cartridge regularly in order to keep a clear view to the cartridge.
The cartridge barrel should also be replaced if it is damaged or if the thread appears to be worn.
Replacement barrels (3 pcs. per pack) can be ordered through your CALAJECT™ dealer.
PLACING
CALAJECT™ should be placed on a stable base during use. Ensure good access to all sockets
and plugs during use and charging.
CHARGING
CALAJECT™ may only be charged with the charger supplied with the system. Use
of other chargers may damage the equipment and compromise the electrical safety.
For battery lifetime reasons it is recommended to remove the mains cable during use and oper-
ate on battery only. Avoid draining the battery completely - that might shorten longevity as well.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 3 16-01-2019 17:41:06

4
GETTING STARTED
Do not place CALAJECT™ in an environment of flammable gases.
CALAJECT™ should not be placed close to devices that are sensitive to
- or generate - electromagnetic interference.
•Connect the handpiece cord plug to the CALAJECT™ rear panel
– the red dot on CALAJECT™ and the handpiece plug must be aligned.
Unplug by pulling the grooved sliding ring backwards (do not turn).
Do not touch patient and connectors of control unit / battery charger at the same time.
•Turn on CALAJECT™ by touching the on/off key at the front panel. By this, the piston will
automatically return to starting position.
PREVENTIVE INSPECTION OF EQUIPMENT
The user should check if the cords are intact and also inspect the parts for possible damages
and wear. Possible traces of leaked analgesic at the piston rod opening in the CALAJECT™
handpiece can be removed by using a cotton stick moistened with a surface disinfectant - blow
it dry with clean air.
OPTION
CALAJECT™ is operated by a separate foot control included in the package. But the system
can also be connected to the multi-function foot switch of your dental unit by a dental service
engineer. When connecting to the dental unit choose a potential free contact (relaycontact). The
assistant call function can often be used for this purpose. Connect to Calaject with a screened
cable less than 3m long and with a 3.5mm minijack plug.
SERVICE WARRANTY & REPAIR
CALAJECT™ is covered by a 2-year guarantee on materials and construction. Normal wear and
tear and damages due to inadequate use or maintenance are not covered by the warranty. In
the event of malfunction, please return the device to your CALAJECT™ dealer for repair. Repairs
must be performed by authorized technical personnel only. CALAJECT™ may not be serviced or
maintained during use.
MAINTENANCE BY USER
Replace the piston O-ring annually or if worn or damaged.
Extend the piston out. Use your fingers or a rubber tipped instrument to remove the old O-ring
- do not use a metal tool.
Roll a new O-ring into the piston groove. Coat the O-ring and piston surface with a thin layer of
food-grade PTFE grease by using a cotton swab or microbrush. Move the piston back and forth.
Wipe off excess grease with a clean cloth. IMPORTANT: Do not use other types of lubricants,
especially any containing solvents or silicone.
Repeat the described lubricating procedure if anesthesia fluid has leaked into the handpiece.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 4 16-01-2019 17:41:07

5
•Check the battery status on the display. At one remaining dot at the battery display, max
one injection can be completed. Charging time approx. 3 hours.
Operating time approx. 5 hours, when fully charged.
•Attach a needle on the cartridge barrel and insert an anaesthetic cartridge.
To avoid leakage at the membrane of the cartridge it is advised to screw on the needle
first and then insert the cartridge. The cartridge barrel fits standard 1.7/1.8 ml dental
cartridges and standard dental needles.
Make sure that the needle is completely mounted and that the needle fits the applied
cartridge barrel (standard metric thread (M6) or imperial inch thread (7/32”)).
•Mount the loaded cartridge barrel onto the handpiece. Before the barrel is screwed
onto the handpiece, the piston rod should be retracted to starting position. It will automati-
cally return to starting position, when CALAJECT™ is turned on. The piston rod can
also be returned to starting position by pressing ”R” on the display.
•Prime the needle, by applying a quick tap on the foot switch. The plunger will then move
forward for 2 sec. after which it will stop automatically. Now the piston is fully engaged
in the cartridge and CALAJECT™ is ready for injection. This priming mode is indicated by a
rotating light signal at the front panel.
Do not inject in prime-needle mode.
•Select program. When the foot switch is activated again, the chosen injection program
will be active.
• CALAJECT™ will stop automatically, when the cartridge is empty - a long beep will be heard.
Return the piston rod by pressing “R” at the display. Make sure to let the piston retract
completely, before you unscrew the barrel from the handpiece.
CALAJECT™ will stop automatically when it reaches the pre-programmed maximum pressure.
In such case, a long sound signal will be heard and the pressure bar-scale on the display will
turn off. Wait a moment or move the needle to a new position before you continue the injection.
Change the needle if you suspect a clogging of the cannula. Otherwise this may result in a high
back pressure and automatic stop. CALAJECT™ will also turn off automatically, if it has been
turned on for a continuous period of 6 hours (=battery protection). Can be restarted in the normal
way after such incident.
ASPIRATION
CALAJECT™ aspirates automatically whenever the foot switch is deactivated during injection
in Program I, II and III.
SAFE NEEDLE HANDLING
The cavity in the CALAJECT™ handpiece holder is designed for parking the needle sheath
during injection. It facilitates one-handed recapping after and between injections and allows
you to place the handpiece safely in the holder with reduced risk of injuring yourself on a used,
contaminated needle.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 5 16-01-2019 17:41:07

6
• Activate the foot switch and hold it down. CALAJECT™ starts
in slow injection mode, 0.006 ml/sec. Option: The speed can be
increased to 0.009 ml/sec by a quick release/re-activation of the
foot switch. The speed can be changed back again by a renewed
release/re-activation.
• The PDL-technique requires a relatively high injection pressure
initially. This is why Program 1 allows a substantially higher
injection pressure / resistance than program 2 and 3
before the automatic stop is activated.
•Automatic suck-back / aspiration when foot switch is deactivated.
Minimizes after-dripping from the needle.
PROGRAM 1 Recommended for intraligamental – and also palatal – analgesia
For intraligamental (PDL) analgesia it is recommended to dose 0.2 – 0.9 ml per root depending
on the size of the root and the expected duration of the procedure. For further guidance on the
PDL technique, we refer to the published literature on the subject.
If the pressure has become so high that CALAJECT™ stops, the needle opening may have be-
come blocked and it is recommended to rotate the needle slightly in order to obtain a good flow.
TIP
TIP
R
R
R
VISUAL SIGNALS
When CALAJECT™ has been prepared and is switched on, Program II will illuminate as default.
The piston will retract automatically, which is indicated by three illuminated LEDs rotating around
the “R” key.
During activation, the LED of the selected program will blink with the two-tone signal and thereby
reflect the injection speed.
The back pressure on the piston can be read on the bar-scale at top of the display. At increased
counter pressure, the bar will iluminate gradually from left to the right with green LEDs. Finally
the bar will turn orange and red, after which CALAJECT™ will stop automatically.
The battery indicator is green only. 4 LED dots indicate full charge.
AUDIBLE SIGNALS
Two-tone signal
By injection in program I, II, and III, the frequency of the sound indicates the current injection speed.
Long, continuous beep: • cartridge is empty
• automatic stop
The beep intensity may be adjusted by the volume button (9) by using a flathead screwdriver or
a mini-spatula.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 6 16-01-2019 17:41:07

7
TECHNICAL SPECIFICATIONS
CALAJECT Type CJ2 Control unit Handpiece Stand
Length 95 mm
Foot switch cable: 2.2 m 200 mm (incl. barrel) Handpiece cord: 1.7 m
Width 120 mm Ø 12 mm Ø 60 mm
Height 115 mm 34 mm
Weight 750 g 50 g 410 g
Nominal voltage 7.2 V, 1.2Ah
Battery (Lithium-ion) 5 hours on each charge
Charging time Approx. 3 hours
Dental Cartridge 1.7/1.8 ml standard cartridges
Dental Needles Standard M6 and 7/32”
Charging: 12V-DC/1ADC
PROGRAM 3 Recommended for regional nerve block analgesia
•Activate the footswitch and hold it down throughout the injection.
CALAJECT™ begins slowly, 0.006 ml/sec. By releasing/re-activating
the foot control in one swift movement, the injection speed will
increase gradually over the next 5 seconds to high speed
(approx. 0.04 ml/sec). Hereafter, high speed at every stop/start.
•Aspirates automatically whenever the foot switch is released.
The small suck-back will also prevent after-dripping from the
needle.
R
R
R
PROGRAM 2 Recommended for infiltration analgesia
•Activate the foot switch and hold it down throughout the injection.
The sequence begins with 10 seconds slow speed (0.006 ml/sec)
followed by a gradual increase over 5 seconds to medium
injection speed 0.03 ml/sec.
• When the injection has been stopped and is reactivated again, the
same sequence will repeat: First 10 seconds slowly with gradual
increase to medium speed. No option of speed change in Program 2.
•Aspirates automatically whenever the foot switch is released.
The small suck-back will also prevent after-dripping from the
needle.
R
R
R
CHARGER: 100-240v - 50-60hZ/280 - 140mA
ENVIRONMENT: Temperature: Operation at 10 to 35°C / 50 to 95°F.
Storage and transportation at -20 to 50°C / -4 to 122°F.
Altitude: Operation in 0-3000 m.
Storage and transportation: no restrictions.
Humidity: Operation, storage and transportation: 10-95%.
Classification: Council directive 93/42/EEC, Class IIa. Internally powered equipment, Class IIa battery charger, type b
applied part, ipx 7 foot control, suitable for continuous operation.
Standards: EN60601-1
Disposal: Separate collection of electronic waste.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 7 16-01-2019 17:41:07

8
TROUBLESHOOTING
Problem Cause Solution Future remedy
Unstable function Damaged handpiece
cord If any visible damages on plug or cord -> send
it in for repair.
Read instructions for cor-
rect connection / removal
of plug. Avoid squeez-
ing damages and sharp
bending of the cord.
Damaged foot switch
cable If any visible damages on plug or cable -> send
it in for repair.
Avoid passing over the
cable with your chair.
Avoid squeezing dam-
ages and sharp bending
of the cable.
Loose connection in
wires, plugs, terminals or
foot switch.
Visual inspection not
possible. Check the
function by using
another CALAJECT
foot switch. Send in for
repair.
Read instructions for
correct connection /
removal of plug. Avoid
squeezing damages
and sharp bending of
cables.
Premature illumination
of pressure indicator. Blocked needle Change the needle
Automatic stop
happens often. Piston moves slowly – too much friction between the
moving parts inside the
handpiece.
Send in for repair.
Piston does not retract Piston O-ring has become
dry. Lubricate the O-ring with PTFE grease ac-
cording to “Maintenance
by User”.
Lubricate regulary as
advised in “Maintenance
by User”.
Leakage The needle was screwed
onto the barrel after inser-
tion of the cartridge. That
can cause an uneven per-
foration of the membrane,
which leaves a hole in the
membrane that is too big.
Mount the needle first
to the empty cartridge
barrel. Hereafter insert
the cartridge and push it
forward. This ensures a
straight and clean cut of
the cartridge membrane.
The rear part of the needle
cannula is relatively long.
(rear cannula length varies
among needle brands)
In such case, the op-
posite sequence is
recommended: Insert
cartridge first after which
you mount the needle.
The membrane of the
applied cartridge is
relatively small – a risk that
the needle will penetrate at
the edge of the membrane
and loosen the membrane
at the metal cap.
Change cartridge brand.
The diameter of the
membrane must be
bigger.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 8 16-01-2019 17:41:07

9
TROUBLESHOOTING
Problem Cause Solution Future remedy
The cartridge broke
during injection. 1. Piston O-ring has been damaged.
2. This specific car-
tridge was weak and
did not withstand the
higher injection pres-
sure required for intra-
liga-mental injections.
A rare, but well-known
risk at intraligamental
injections.
1. Change the O-ring
and apply a thin
layer of PTFE grease as
described under “Main-
tenance by User”.
2. Disconnect the
cartridge barrel and
remove the fragments
of glass very care-
fully. Check if liquid has
leaked at the piston rod
opening.
Clean it by using a
cotton stick moistened
with a surface disinfect-
ant. Blow it dry with
clean air.
If leakage is extensive,
send the handpiece in
for cleaning and repair.
Battery level does not
improve at charging Charger is defective. Try another
CALAJECT™charger
(other chargers may
not be used)
The built-in Li-Ion bat-
tery is defective or worn
out.
Send in CALAJECT™
for battery change. Extend battery lifetime by charging regularly. Avoid
draining the battery com-
pletely several times.
CONTRA-INDICATIONS AND PHYSIOLOGICAL HAZARDS
Contra-indications:
No specific for CALAJECT™beyond the contra-indications described in the product page and
package insert of the applied analgesic solution purchased separately.
Possible physiological hazards:
In the event of the most serious technical failure that can be foreseen, the dental cartridge will
be emptied in 30 seconds at maximum speed. Injection of 1.8 ml local analgesic at this speed
may cause the following physiological complications:
Nerve block analgesia and infiltrations: No known. Discomfort and after pain may occur.
Intraligamentary and palatal injections: No known, but injection at this high speed level may
be associated with discomfort and pain, and the patient will react.
Intravascular injection:
By accidental intravascular injection of 1.8 ml local analgesic containing adrenaline as a vaso-
constricting agent, the patient may feel heart palpitations and discomfort. Patients with heart and
cardiovascular diseases may risk more serious complications - therefore, please study the package
insert of the applied local analgesic solution.
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 9 16-01-2019 17:41:07

10
Table 2 Electromagnetic immunity
The “CALAJECT™” is intended for use in the electromagnetic environment specified below. The customer or the user
of the “CALAJECT™” should assure that it is used in such an environment.
Immunity test IEC 60601-1
Test level Compliance level Electromagnetic envi- ronment guidance
Electrostatic discharge
(ESD)
IEC 60601-1-2
IEC61000-4-2
±6KV contact
±8KV air
±15KV air
±6KV contact
±8KV air
±15KV air
Floors should be wood,
concrete or ceramic tile.
If floors are covered with
synthetic material, the rela-
tive humidity should be at
least 40%.
Electrical fast transient/
burst
IEC 60601-1-2
IEC61000-4-4
±2KV for power supply
lines
±1KV for input/output lines
±2KV for power supply
lines
±1KV for input/output lines
Mains power supply quality
should be that of typical
residential area.
Surge
IEC 60601-1-2
IEC61000-4-5
±1KV differential mode ±1KV differential mode
Voltage dips, short
interruptions and voltage
variations on power supply
input lines.
IEC 60601-1-2
IEC61000-4-11
<5% UT for 0.5 cycle
40%UT for 5 cycles
70%UT for 25 cycles
<5%UT for 250 cycles
<5% UT for 0.5 cycle
40%UT for 5 cycles
70%UT for 25 cycles
<5%UT for 250 cycles
Mains power supply quality
should be that of typical
residential area.
Power frequency (50-60Hz)
magnetic field.
IEC 60601-1-2
IEC61000-4-8
30A/m 30A/m Power frequency magnetic
fields should be that of
typical residential area.
EMC Technical Information
Table 1 Electromagnetic emissions
The “CALAJECT™” is intended for use in the electromagnetic environment specified below. The customer or the user
of the “CALAJECT™” should assure that it is used in such an environment.
Emissions test Compliance Electromagnetic environment guidance
RF emissions
CISPR11
IEC 60601-1-2
EN55011
Group 1 The device uses RF energy only for its internal function.
Therefore, its RF emissions are very low and are not likely to
cause any interference in nearby electronic equipment.
RF emissions
CISPR11
IEC 60601-1-2
EN55011
Class B
The device is suitable for use in all establishments, including
domestic establishments and those directly connected to the
public low-voltage power supply network that supplies build-
ings used for domestic purposes.
Harmonic emissions
IEC 60601-1-2
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 60601-1-2
IEC 61000-3-3
Complies
RD_brugervejledning_IFU-CALAJECT-USA-2019.01-VER 7_090119.indd 10 16-01-2019 17:41:07